A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

NCT03161093 — Phase 3, Completed, 3307 participants, Regeneron Pharmaceuticals

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

Registry	NCT03161093, acronym FACT OA1
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	3307 (Actual)
Sponsor	Regeneron Pharmaceuticals (Industry); collaborators: Teva Pharmaceutical Industries, Ltd.
Conditions	Osteoarthritis, Knee, Osteoarthritis, Hip
Interventions	Fasinumab, Naproxen, Fasinumab-matching placebo, Naproxen-matching placebo (Drug)
Dates	start 2017-08-17, primary completion 2019-09-09, completion 2021-08-27, first posted 2017-05-19, last updated 2022-11-14
Locations	139 sites in United States, Denmark, Germany, Hungary, Lithuania, Poland, Romania, Russia and 4 more countries

-Summary

The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.

The secondary objectives of the study are:

1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip
5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip
6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip

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+Arms and interventions

Arm	Type	Interventions	Description
Fasinumab dosing regimen 1	Experimental	Drug: Fasinumab; Drug: Naproxen-matching placebo	Fasinumab Subcutaneous (SC) dosing regimen 1 and naproxen-matching placebo oral
Fasinumab dosing regimen 2	Experimental	Drug: Fasinumab; Drug: Naproxen-matching placebo	Fasinumab SC dosing regimen 2 and naproxen-matching placebo oral
Fasinumab-matching placebo and naproxen	Experimental	Drug: Naproxen; Drug: Fasinumab-matching placebo
Fasinumab-matching placebo and naproxen-matching placebo	Experimental	Drug: Fasinumab-matching placebo; Drug: Naproxen-matching placebo

Fasinumab (Drug), also known as REGN475: Solution for injection in pre-filled syringe
Naproxen (Drug): Pharmaceutical form: Capsule
Fasinumab-matching placebo (Drug): Solution for injection in pre-filled syringe
Naproxen-matching placebo (Drug): Capsule

+Outcome measures

Primary outcomes

Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

Secondary outcomes

Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo [Baseline to Week 16]: The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen [Baseline to Week 16]: The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo [Baseline to Week 44]: The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores [Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo [Baseline to Week 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen [Baseline to Week 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo [Baseline to average score across weeks 4, 8, 12 and 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo [Baseline to average score across weeks 36, 40 and 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo [Baseline to Week 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen [Baseline to Week 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo [Baseline to average score across weeks 4, 8, 12 and 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo [Baseline to average score across weeks 36, 40 and 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo [Baseline to Week 16]: The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen [Baseline to Week 16]: The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo [Baseline to Week 44]: The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo [Baseline to Week 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo [Baseline to average score across weeks 4, 8, 12 and 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo [Baseline to average score across weeks 36, 40 and 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo [Baseline to Week 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo [Baseline to average score across weeks 4, 8, 12 and 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores [Baseline to Week 16]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo [Baseline to average score across weeks 36, 40 and 44]: The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1 [Baseline to Week 52]
Number of Participants With AA (as Confirmed by Adjudication) - Year 2 [First dose of study drug in Year 2 through week 104E]
Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2 [Day 1 through week 104E (Extension)]
Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1 [Baseline to Week 52]
Number of Participants With DA (as Confirmed by Adjudication) - Year 2 [First dose of study drug in Year 2 through week 104E]
Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2 [Day 1 through week 104E]
Number of Treatment Emergent Adverse Events (TEAEs) - Year 1 [Baseline to Week 52]
Number of TEAEs - Year 2 [First dose of study drug in Year 2 through week 104E]
Number of TEAEs - Year 1 and Year 2 [Day 1 through week 104E]
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 [Baseline to Week 52]
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2 [First dose of study drug in Year 2 through week 104E]
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2 [Day 1 through week 104E]
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 [Baseline to Week 52]
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2 [First dose of study drug in Year 2 through week 104E]
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2 [Day 1 through week 104E]
Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1 [Baseline to Week 52]
Number of Participants With Any Type of All-Cause JR in Year 2 [First dose of study drug in Year 2 through week 104E]
Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2 [Day 1 through week 104E]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria include, but are not limited to, the following:

Year 1:

1. Male and female patients, at least 18 years of age, at screening
2. A clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit
3. Moderate to severe pain in the index joint defined at both the screening and randomization visits
4. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol) to be taken as needed with a maximum daily dose of 2500 mg (countries where 500 mg strength tablets/capsules are available) or 2600 mg (countries where 325 mg strength tablets/capsules are available)
5. A history of at least 12 weeks of analgesics use for pain due to OA of the knee or hip, as defined by:

1. Inadequate pain relief from acetaminophen/paracetamol AND
2. Intolerance to or inadequate pain relief from opioid or tramadol therapy, unwillingness to take opioid or tramadol therapy for a medically acceptable reason, or lack of access to an opioid or to tramadol
6. Currently using a stable dose of NSAID.
7. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment
8. Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period
9. Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere prior to and during the study period to be shared with the investigator
10. Willing to maintain current activity and exercise levels throughout the study
11. Willing and able to comply with clinic visits and study-related procedures and willing to provide follow-up information related to any JR surgery that occurs within the period of time covered by their intended participation in the study
12. Able to understand and complete study-related questionnaires

Year 2:

Note: Any Year 1 patient attending their week 52 visit on or after 26 March 2020 will no longer have the option to enroll into Year 2.

1. Completed the treatment period of Year 1
2. Did not permanently discontinue study drug during Year 1
3. Received no less than 10 of the 13 planned doses of SC study drug during the treatment period of Year 1
4. Provide informed consent for Year 2
5. Willing to continue to maintain current activity and exercise levels throughout Year 2

Exclusion Criteria include, but are not limited to, the following:

1. Non-compliance with the Numeric Rating Scale (NRS) recording during the pre-randomization period
2. History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
3. History or presence on imaging of arthropathy, neuropathic joint arthropathy, hip or knee dislocation, extensive subchondral cysts, significant bone collapse or bone loss, or pathologic fractures
4. Trauma to the index joint within 3 months prior to the screening visit
5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
6. Patient is not a candidate for MRI
7. Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
9. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
10. History of naproxen intolerance, or existence of a medical condition that is high risk for naproxen-associated complications
11. Resting heart rate of <50 beats per minute (bpm) or >100 bpm at the screening or randomization visits
12. History or presence of 2nd or 3rd degree heart block, 1st degree heart block with abnormal Complex of Q, R, and S waves on an electrocardiogram (QRS) complex, or bifascicular block by ECG assessment at the screening visit
13. History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits
14. History of poorly controlled hypertension
15. Use of systemic corticosteroid within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
16. Exposure to an anti-Nerve growth factor (NGF) antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies

+Posted results

Participant flow

Milestone	Placebo	Naproxen	Fasinumab 1 mg SC Q8W	Fasinumab 1 mg SC Q4W	Fasinumab 3mg Q4W	Fasinumab 6mg Q8W
Started	354	1063	551	1054	145	140
As treated	352	1056	554	1052	145	139
Completed	299	919	465	867	102	99
Not completed	55	144	86	187	43	41

Outcome results

Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo (Primary), Least squares mean, Score on a scale: Placebo -1.82 +/- 0.162; Fasinumab 1 mg SC Q4W -2.49 +/- 0.098 (p 0.0002)
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo (Primary), Least squares mean, Score on a scale: Placebo -1.71 +/- 0.161; Fasinumab 1 mg SC Q4W -2.42 +/- 0.096 (p <0.0001)
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo (Primary), Least squares mean, Score on a scale: Placebo -2.09 +/- 0.231; Fasinumab 1 mg SC Q8W -2.19 +/- 0.144 (p 0.7036)
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo (Primary), Least squares mean, Score on a scale: Placebo -1.91 +/- 0.223; Fasinumab 1 mg SC Q8W -2.09 +/- 0.137 (p 0.4605)
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo (Secondary), Least squares mean, Score on a scale: Placebo -0.64 +/- 0.064; Fasinumab 1 mg SC Q4W -0.92 +/- 0.040
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen (Secondary), Least squares mean, Score on a scale: Naproxen -0.78 +/- 0.040; Fasinumab 1 mg SC Q4W -0.92 +/- 0,040
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo (Secondary), Least squares mean, Score on a scale: Placebo -0.60 +/- 0.074; Fasinumab 1 mg SC Q4W -0.79 +/- 0.043
Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores (Secondary), Number, Percentage of participants: Placebo 43.9; Fasinumab 1 mg SC Q4W 56.2
Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores (Secondary), Number, Percentage of participants: Naproxen 50.5; Fasinumab 1 mg SC Q4W 56.2
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen (Secondary), Mean, Score on a scale: Naproxen -2.42 +/- 2.095; Fasinumab 1 mg SC Q4W -2.88 +/- 2.099
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo (Secondary), Least squares mean, Score on a scale: Placebo -1.69 +/- 0.188; Fasinumab 1 mg SC Q4W -2.20 +/- 0.114
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen (Secondary), Least squares mean, Score on a scale: Naproxen -2.15 +/- 0.115; Fasinumab 1 mg SC Q4W -2.20 +/- 0.114
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo (Secondary), Least squares mean, Score on a scale: Placebo -1.37 +/- 0.137; Fasinumab 1 mg SC Q4W -2.25 +/- 0.088
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo (Secondary), Least squares mean, Score on a scale: Placebo -1.50 +/- 0.172; Fasinumab 1 mg SC Q4W -1.99 +/- 0.113
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen (Secondary), Least squares mean, Score on a scale: Naproxen -1.98 +/- 0.101; Fasinumab 1 mg SC Q4W -2.42 +/- 0.096
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo (Secondary), Least squares mean, Score on a scale: Placebo -1.60 +/- 0.186; Fasinumab 1 mg SC Q4W -2.07 +/- 0.109
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen (Secondary), Least squares mean, Score on a scale: Naproxen -2.00 +/- 0.113; Fasinumab 1 mg SC Q4W -2.07 +/- 0.109
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo (Secondary), Least squares mean, Score on a scale: Placebo -1.46 +/- 0.140; Fasinumab 1 mg SC Q4W -2.30 +/- 0.090
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo (Secondary), Least squares mean, Score on a scale: Placebo -1.57 +/- 0.184; Fasinumab 1 mg SC Q4W -2.06 +/- 0.118
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo (Secondary), Least squares mean, Score on a scale: Placebo -0.79 +/- 0.094; Fasinumab 1 mg SC Q8W -0.77 +/- 0.057
29 more outcome measures not shown.

Adverse events

Time frame: From first dose up to week 124

Arm	Deaths	Serious adverse events	Other adverse events
Placebo	5/352 (1.4%)	49/352 (13.9%)	215/352 (61.1%)
Naproxen	13/1056 (1.2%)	103/1056 (9.8%)	687/1056 (65.1%)
Fasinumab 1mg Q8W	12/554 (2.2%)	81/554 (14.6%)	382/554 (69.0%)
Fasinumab 1mg Q4W	13/1052 (1.2%)	175/1052 (16.6%)	727/1052 (69.1%)
Fasinumab 3mg Q4W	0/145 (0.0%)	7/145 (4.8%)	41/145 (28.3%)
Fasinumab 6mg Q8W	0/139 (0.0%)	6/139 (4.3%)	58/139 (41.7%)

Serious adverse events by term

Term	Organ system	Placebo	Naproxen	Fasinumab 1mg Q8W	Fasinumab 1mg Q4W	Fasinumab 3mg Q4W	Fasinumab 6mg Q8W
Arthralgia	Musculoskeletal and connective tissue disorders	4/352	11/1056	10/554	8/1052	1/145	2/139
Rapidly progressive osteoarthritis	Musculoskeletal and connective tissue disorders	1/352	4/1056	13/554	44/1052	1/145	1/139
Osteoarthritis	Musculoskeletal and connective tissue disorders	3/352	3/1056	3/554	6/1052	1/145	0/139
Back pain	Musculoskeletal and connective tissue disorders	0/352	1/1056	2/554	1/1052	0/145	0/139
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	0/352	1/1056	0/554	0/1052	0/145	0/139
Haemarthrosis	Musculoskeletal and connective tissue disorders	0/352	1/1056	0/554	0/1052	0/145	0/139
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	0/352	1/1056	0/554	0/1052	0/145	0/139
Osteonecrosis	Musculoskeletal and connective tissue disorders	0/352	1/1056	0/554	1/1052	0/145	0/139
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	0/352	1/1056	1/554	0/1052	0/145	1/139
Spinal stenosis	Musculoskeletal and connective tissue disorders	0/352	1/1056	0/554	0/1052	0/145	0/139
Arthritis	Musculoskeletal and connective tissue disorders	0/352	0/1056	1/554	0/1052	1/145	0/139
Bursitis	Musculoskeletal and connective tissue disorders	0/352	0/1056	0/554	1/1052	0/145	0/139
Exostosis	Musculoskeletal and connective tissue disorders	1/352	0/1056	0/554	0/1052	0/145	0/139
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	0/352	0/1056	0/554	1/1052	0/145	0/139
Joint effusion	Musculoskeletal and connective tissue disorders	0/352	0/1056	0/554	1/1052	0/145	0/139
Limb mass	Musculoskeletal and connective tissue disorders	0/352	0/1056	0/554	1/1052	0/145	0/139
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	0/352	0/1056	1/554	2/1052	0/145	1/139
Spinal synovial cyst	Musculoskeletal and connective tissue disorders	0/352	0/1056	1/554	0/1052	0/145	0/139
Subchondral insufficiency fracture	Musculoskeletal and connective tissue disorders	0/352	0/1056	1/554	1/1052	1/145	0/139
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	0/352	0/1056	0/554	1/1052	0/145	0/139
COVID-19 pneumonia	Infections and infestations	2/352	3/1056	1/554	0/1052	0/145	0/139
COVID-19	Infections and infestations	0/352	2/1056	2/554	3/1052	0/145	0/139
Cellulitis	Infections and infestations	1/352	2/1056	0/554	1/1052	0/145	0/139
Gastroenteritis	Infections and infestations	0/352	2/1056	2/554	1/1052	1/145	0/139
Sepsis	Infections and infestations	0/352	2/1056	0/554	0/1052	0/145	0/139
Arthritis infective	Infections and infestations	0/352	1/1056	0/554	0/1052	0/145	0/139
Diverticulitis	Infections and infestations	0/352	1/1056	0/554	0/1052	0/145	0/139
Empyema	Infections and infestations	0/352	1/1056	0/554	0/1052	0/145	0/139
Gastric ulcer helicobacter	Infections and infestations	0/352	1/1056	0/554	0/1052	0/145	0/139
Infectious pleural effusion	Infections and infestations	0/352	1/1056	0/554	0/1052	0/145	0/139
Peritonsillar abscess	Infections and infestations	0/352	1/1056	0/554	0/1052	0/145	0/139
Pneumonia	Infections and infestations	1/352	1/1056	1/554	3/1052	0/145	0/139
Pneumonia klebsiella	Infections and infestations	0/352	1/1056	0/554	0/1052	0/145	0/139
Post procedural infection	Infections and infestations	0/352	1/1056	0/554	0/1052	0/145	0/139
Urinary tract infection	Infections and infestations	1/352	1/1056	0/554	2/1052	0/145	0/139
Appendicitis	Infections and infestations	0/352	0/1056	1/554	1/1052	0/145	0/139
Erysipelas	Infections and infestations	0/352	0/1056	1/554	0/1052	0/145	0/139
Escherichia urinary tract infection	Infections and infestations	0/352	0/1056	0/554	1/1052	0/145	0/139
Infected bite	Infections and infestations	0/352	0/1056	0/554	1/1052	0/145	0/139
Lower respiratory tract infection	Infections and infestations	0/352	0/1056	0/554	2/1052	0/145	0/139
Lung abscess	Infections and infestations	0/352	0/1056	0/554	1/1052	0/145	0/139
Meningitis	Infections and infestations	0/352	0/1056	0/554	1/1052	0/145	0/139
Meningitis pneumococcal	Infections and infestations	0/352	0/1056	1/554	0/1052	0/145	0/139
Pneumonia bacterial	Infections and infestations	0/352	0/1056	0/554	1/1052	0/145	0/139
Post procedural cellulitis	Infections and infestations	0/352	0/1056	0/554	0/1052	1/145	0/139
Pyelonephritis	Infections and infestations	0/352	0/1056	0/554	1/1052	0/145	0/139
Tuberculosis	Infections and infestations	0/352	0/1056	1/554	0/1052	0/145	0/139
Wound infection staphylococcal	Infections and infestations	0/352	0/1056	0/554	1/1052	0/145	0/139
Knee arthroplasty	Surgical and medical procedures	7/352	7/1056	4/554	17/1052	0/145	0/139
Hip arthroplasty	Surgical and medical procedures	0/352	5/1056	5/554	3/1052	0/145	0/139
Joint arthroplasty	Surgical and medical procedures	2/352	3/1056	4/554	8/1052	0/145	1/139
Joint resurfacing surgery	Surgical and medical procedures	0/352	0/1056	1/554	0/1052	0/145	0/139
Knee operation	Surgical and medical procedures	0/352	0/1056	0/554	1/1052	0/145	0/139
Acute coronary syndrome	Cardiac disorders	0/352	2/1056	0/554	0/1052	0/145	0/139
Coronary artery disease	Cardiac disorders	1/352	2/1056	0/554	1/1052	0/145	0/139
Myocardial infarction	Cardiac disorders	1/352	2/1056	2/554	1/1052	0/145	0/139
Atrial fibrillation	Cardiac disorders	1/352	1/1056	0/554	0/1052	0/145	0/139
Cardiovascular disorder	Cardiac disorders	0/352	1/1056	0/554	0/1052	0/145	0/139
Myocardial ischaemia	Cardiac disorders	0/352	1/1056	0/554	1/1052	0/145	0/139
Acute myocardial infarction	Cardiac disorders	1/352	0/1056	0/554	0/1052	0/145	0/139

146 more terms not shown.

Other adverse events by term

Term	Organ system	Placebo	Naproxen	Fasinumab 1mg Q8W	Fasinumab 1mg Q4W	Fasinumab 3mg Q4W	Fasinumab 6mg Q8W
Arthralgia	Musculoskeletal and connective tissue disorders	76/352	232/1056	152/554	284/1052	13/145	30/139
Back pain	Musculoskeletal and connective tissue disorders	39/352	117/1056	83/554	124/1052	4/145	4/139
Pain in extremity	Musculoskeletal and connective tissue disorders	20/352	62/1056	34/554	65/1052	2/145	3/139
Osteoarthritis	Musculoskeletal and connective tissue disorders	18/352	34/1056	22/554	47/1052	1/145	2/139
Rapidly progressive osteoarthritis	Musculoskeletal and connective tissue disorders	5/352	27/1056	38/554	109/1052	3/145	8/139
Nasopharyngitis	Infections and infestations	28/352	92/1056	54/554	95/1052	5/145	2/139
Upper respiratory tract infection	Infections and infestations	25/352	90/1056	41/554	92/1052	5/145	6/139
Urinary tract infection	Infections and infestations	24/352	86/1056	41/554	79/1052	4/145	5/139
Influenza	Infections and infestations	24/352	55/1056	31/554	70/1052	1/145	2/139
Bronchitis	Infections and infestations	19/352	50/1056	30/554	41/1052	1/145	1/139
Headache	Nervous system disorders	67/352	216/1056	127/554	236/1052	13/145	8/139
Carpal tunnel syndrome	Nervous system disorders	15/352	20/1056	26/554	58/1052	4/145	5/139
Constipation	Gastrointestinal disorders	8/352	65/1056	12/554	22/1052	2/145	2/139
Gastritis	Gastrointestinal disorders	12/352	54/1056	27/554	33/1052	0/145	1/139
Hypertension	Vascular disorders	31/352	77/1056	36/554	55/1052	2/145	1/139

+Locations (139)

Facility	City	Country
Arizona Arthritis & Rheumatology Research, PLLC	Mesa, Arizona	United States
Arizona Research Center	Phoenix, Arizona	United States
Tucson Orthopaedic Research Center	Tucson, Arizona	United States
Baptist Health Center for Clinical Research	Little Rock, Arkansas	United States
Medvin Clinical Research	Covina, California	United States
TriWest Research Associates, LLC	El Cajon, California	United States
BioSolutions Clinical Research	La Mesa, California	United States
Pacific Arthritis Care Center	Los Angeles, California	United States
Artemis Institute for Clinical Research	San Diego, California	United States
Artemis Clinical Research	San Marcos, California	United States
Lynn Institute of Denver	Aurora, Colorado	United States
Lynn Institute of the Rockies	Colorado Springs, Colorado	United States
Panorama Orthopedics & Spine Center	Golden, Colorado	United States
Arthritis and Rheumatic Disease Specialties	Aventura, Florida	United States
Jacksonville Center for Clinical Research	Jacksonville, Florida	United States
Clinical Neuroscience Solutions, Inc.	Jacksonville, Florida	United States
Sensible Healthcare	Ocoee, Florida	United States
Clinical Neuroscience Solutions, Inc.	Orlando, Florida	United States
Jewett Orthopaedic Clinic	Orlando, Florida	United States
Lovelace Scientific Resources	Venice, Florida	United States
Meridian Clinical Research	Savannah, Georgia	United States
Advanced Clinical Research	Meridian, Idaho	United States
Medex Healthcare Research, Inc.	Chicago, Illinois	United States
Northwestern University	Chicago, Illinois	United States
Healthcare Research Network II, LLC	Flossmoor, Illinois	United States
Integrated Clinical Trial Services, Inc.	West Des Moines, Iowa	United States
Klein & Associates, MD PA	Cumberland, Maryland	United States
Klein & Associates, MD, PA	Hagerstown, Maryland	United States
The Center for Rheumatology and Bone Research	Wheaton, Maryland	United States
Clinical Pharmacology Study Group	Worcester, Massachusetts	United States
The Center for Pharmaceutical Research	Kansas City, Missouri	United States
Medex Healthcare Research, Inc.	St Louis, Missouri	United States
Sundance Clinical Research, LLC	St Louis, Missouri	United States
Physician Research Collaboration, LLC	Lincoln, Nebraska	United States
Lovelace Scientific Resources, Inc.	Albuquerque, New Mexico	United States
United Medical Associates	Binghamton, New York	United States
Regional Clinical Research, Inc.	Endwell, New York	United States
Medex Healthcare Research	New York, New York	United States
Buffalo Rheumatology and Medicine, PLLC	Orchard Park, New York	United States
Orchard Park Family Practice	Orchard Park, New York	United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary	Cary, North Carolina	United States
DJL Clinical Research, PLLC	Charlotte, North Carolina	United States
Hickory Family Practice Associates	Hickory, North Carolina	United States
Peters Medical Research LLC	High Point, North Carolina	United States
PMG Research of Salisbury, LLC	Salisbury, North Carolina	United States
PMG Research of Winston-Salem, LLC	Winston-Salem, North Carolina	United States
Sterling Research Group, Ltd.	Cincinnati, Ohio	United States
Hillcrest Clinical Research	Oklahoma City, Oklahoma	United States
Altoona Center for Clinical Research	Duncansville, Pennsylvania	United States
Low Country Rheumatology, PA	Charleston, South Carolina	United States
PMG Research of Charleston, LLC	Mt. Pleasant, South Carolina	United States
Clinical Research Solutions	Franklin, Tennessee	United States
PMG Research of Knoxville	Knoxville, Tennessee	United States
Clinical Neuroscience Solutions, Inc.	Memphis, Tennessee	United States
Pioneer Research Solutions, Inc.	Cypress, Texas	United States
Southwest Rheumatology Research, LLC	Mesquite, Texas	United States
Center for Arthritis and Rheumatic Diseases	Chesapeake, Virginia	United States
Rheumatology & Pulmonary Clinic	Beckley, West Virginia	United States
CCBR Vejle	Vejle	Denmark
Synexus Clinical Research GmbH	Leipzig, Saxony	Germany
Synexus Clinical Research GmbH	Berlin	Germany
Synexus Clinical Research GmbH	Bochum	Germany
Synexus Clinical Research GmbH	Frankfurt	Germany
Qualiclinic Kft.	Budapest	Hungary
Synexus Magyarorszag Kft	Budapest	Hungary
Synexus Magyarorszag Kft.	Debrecen	Hungary
Synexus Magyarorszag Kft.	Gyula	Hungary
BKS Research Kft.	Hatvan	Hungary
Hevizgyogyfurdo es Szent Andraes ReumaKorhaz	Hévíz	Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Josa Andras Oktatokorhaza Klinikai Kutatasi Osztaly	Nyíregyháza	Hungary
Synexus Magyarorszag Egeszsegugyi Kft.	Zalaegerszeg	Hungary
Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas	Lithuania
Saules Seimos Medicinos Centras, Jsc	Kaunas	Lithuania
Republican Panevezys Hospital	Panevezys	Lithuania
Center Outpation Clinic, Public Institution	Vilnius	Lithuania
Synexus Polska Sp. z o.o Oddzial w Poznaniu	Poznan, Greater Poland Voivodeship	Poland
Krakowskie Centrum Medyczne Sp. z o.o.	Krakow, Lesser Poland Voivodeship	Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw, Lower Silesian Voivodeship	Poland
MCBK Sc lwona Czajkowska Monika Barney	Grodzisk Mazowiecki, Masovian Voivodeship	Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warsaw, Masovian Voivodeship	Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o.	Warsaw, Masovian Voivodeship	Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gdynia, Pomeranian Voivodeship	Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia, Pomeranian Voivodeship	Poland
ClinicMed Daniluk, Nowak Sp.j.	Bialystok	Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach	Katowice	Poland
Malopolskie Centrum Kliniczne	Krakow	Poland
CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa	Skierniewice	Poland
Etg Zgierz	Zgierz	Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02 - SOMED - Lodzkie Centrum Osteoporozy	Lodz, Łódź Voivodeship	Poland
Clinica Medicala Synexus Ltd.	Bucharest	Romania
SC Policlinica CCBR SRL	Bucharest	Romania
"SBEIHPE ""Kazan State Medical University"" of MHSD of Russia"	Kazan', Tatarstan Republic	Russia
"CDCR ""Healthy Joints"" L.L.C."	Novosibirsk	Russia
City Out-Patient Clinic #109	Saint Petersburg	Russia
Samara Regional Clinical Hospital n.a.V.D.Seredavin	Samara	Russia
"State Autonomous Healthcare Institution of Yaroslavl Oblast ""Clinical Hospital #3"""	Yaroslavl	Russia
Tread Research-Tygerberg Hospital	Parow, Cape Town	South Africa
Welkom Clinical trial Centre	Welkom, Free State	South Africa
Wits Clinical Research	Johannesburg, Gauteng	South Africa
University of Pretoria	Pretoria, Gauteng	South Africa

39 more sites not listed.

+Publications

Results publication: DiMartino SJ, Cicirello H, Magyar A, Eng S, Ho T, Manvelian G, Patel Y, Pervin K, Trinh N, Fetell M, Braunstein N, Geba GP, Dakin P. A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip. RMD Open. 2026 Jan 16;12(1):e006436. doi: 10.1136/rmdopen-2025-006436. PMID 41545313
Results publication: DiMartino SJ, Gao H, Neogi T, Fuerst T, Zaim S, Eng S, Ho T, Manvelian G, Braunstein N, Geba GP, Dakin P. Prevalence of preexisting articular bone pathology in patients with osteoarthritis screened for fasinumab clinical trials identified by X-ray or magnetic resonance imaging. Osteoarthritis Cartilage. 2024 Dec;32(12):1601-1609. doi: 10.1016/j.joca.2024.07.001. Epub 2024 Jul 14. PMID 39004211

+Study documents

Study Protocol (PDF, 2020-08-26)
Statistical Analysis Plan (PDF, 2020-07-01)

+Investigators

Clinical Trial Management, Study director, Regeneron Pharmaceuticals

+Funding

NIH grants: 2016

My Notes

Public

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