A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
| Registry | NCT01970488 |
|---|
| Status | Completed |
|---|
| Phase | Phase 3 |
|---|
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
|---|
| Enrollment | 350 (Actual) |
|---|
| Sponsor | Amgen (Industry) |
|---|
| Conditions | Psoriasis |
|---|
| Interventions | Adalimumab, ABP 501 (Biological) |
|---|
| Dates | start 2013-10-18, primary completion 2014-08-14, completion 2015-03-18, first posted 2013-10-28, last updated 2019-04-03 |
|---|
| Locations | 3 sites in Australia, Canada, Hungary |
|---|
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Psoriasis All trials of Adalimumab All trials of ABP 501
-Summary
The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| ABP 501 | Experimental | Biological: ABP 501 | Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48. |
| Adalimumab | Active comparator | Biological: Adalimumab | Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48. |
- Adalimumab (Biological), also known as HUMIRA®: Administered by subcutaneous injection
- ABP 501 (Biological), also known as Adalimumab-atto, AMJEVITA™: Administered by subcutaneous injection
+Outcome measures
Primary outcomes
- Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 [Baseline and Week 16]: The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Secondary outcomes
- Percentage of Participants With a PASI 75 Response at Week 16 [Baseline and Week 16]: A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
- Percentage of Participants With a PASI 75 Response at Week 32 [Baseline and week 32]: A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
- Percentage of Participants With a PASI 75 Response at Week 50 [Baseline and week 50]: A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
- Percent Improvement From Baseline in PASI at Week 32 [Baseline and week 32]: The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
- Percent Improvement From Baseline in PASI at Week 50 [Baseline and week 50]: The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
- Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16 [Week 16]: The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
- Percentage of Participants With a sPGA Response at Week 32 [Week 32]: The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
- Percentage of Participants With a sPGA Response at Week 50 [Week 50]: The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
- Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16 [Baseline and Week 16]: A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from baseline (negative value) indicates improvement.
- Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32 [Baseline and week 32]: A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement.
- Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50 [Baseline and week 50]: A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement.
- Number of Participants With Adverse Events [From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.]: The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.
A serious AE is defined as an AE that meets at least 1 of the following serious criteria:
* fatal
* life threatening
* requires inpatient hospitalization or prolongation of existing hospitalization
* results in persistent or significant disability/incapacity
* congenital anomaly/birth defect
* other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups.
- Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab [For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.]: Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).
Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.
+Eligibility
Sex: All, ages: 18 Years to 75 Years
Inclusion criteria:
1. Men or women ≥ 18 and ≤ 75 years of age at time of screening
2. Stable moderate to severe plaque psoriasis for at least 6 months before baseline
3. Moderate to severe psoriasis defined at screening and baseline by:
Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
4. No known history of active tuberculosis
5. Subject is a candidate for systemic therapy or phototherapy procedures
6. Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
Exclusion Criteria:
1. Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
2. Ongoing use of prohibited treatments
3. Prior use of 2 or more biologics for treatment of psoriasis
4. Previous receipt of adalimumab or a biosimilar of adalimumab
Other Inclusion/Exclusion criteria may apply
+Posted results
Participant flow
| Milestone | Part 1: ABP 501 | Part 1: Adalimumab | Part 2: ABP 501/ABP 501 | Part 2: Adalimumab/Adalimumab | Part 2: Adalimumab/ABP 501 |
|---|
| Started | 175 | 175 | 0 | 0 | 0 |
| Received treatment | 174 | 173 | 0 | 0 | 0 |
| Completed | 164 | 162 | 0 | 0 | 0 |
| Not completed | 11 | 13 | 0 | 0 | 0 |
Outcome results
- Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Primary), Mean, percent change: Part 1: ABP 501 80.91 +/- 24.237; Part 1: Adalimumab 83.06 +/- 25.195
- Percentage of Participants With a PASI 75 Response at Week 16 (Secondary), Number, percentage of participants: Part 1: ABP 501 74.4; Part 1: Adalimumab 82.7
- Percentage of Participants With a PASI 75 Response at Week 32 (Secondary), Number, percentage of participants: Part 2: ABP 501/ABP 501 82.5; Part 2: Adalimumab/Adalimumab 84.7; Part 2: Adalimumab/ABP 501 84.5
- Percentage of Participants With a PASI 75 Response at Week 50 (Secondary), Number, percentage of participants: Part 2: ABP 501/ABP 501 85.1; Part 2: Adalimumab/Adalimumab 87.1; Part 2: Adalimumab/ABP 501 81.2
- Percent Improvement From Baseline in PASI at Week 32 (Secondary), Mean, percent change: Part 2: ABP 501/ABP 501 87.62 +/- 18.387; Part 2: Adalimumab/Adalimumab 88.16 +/- 18.181; Part 2: Adalimumab/ABP 501 86.98 +/- 16.637
- Percent Improvement From Baseline in PASI at Week 50 (Secondary), Mean, percent change: Part 2: ABP 501/ABP 501 87.16 +/- 19.559; Part 2: Adalimumab/Adalimumab 88.11 +/- 20.957; Part 2: Adalimumab/ABP 501 85.82 +/- 21.864
- Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16 (Secondary), Number, percentage of participants: Part 1: ABP 501 58.7; Part 1: Adalimumab 65.3
- Percentage of Participants With a sPGA Response at Week 32 (Secondary), Number, percentage of participants: Part 2: ABP 501/ABP 501 66.4 +/- 18.387; Part 2: Adalimumab/Adalimumab 72.2 +/- 18.181; Part 2: Adalimumab/ABP 501 70.4 +/- 16.637
- Percentage of Participants With a sPGA Response at Week 50 (Secondary), Number, percentage of participants: Part 2: ABP 501/ABP 501 68.7; Part 2: Adalimumab/Adalimumab 74.3; Part 2: Adalimumab/ABP 501 69.6
- Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16 (Secondary), Mean, percentage of BSA: Part 1: ABP 501 -18.0 +/- 13.57; Part 1: Adalimumab -22.1 +/- 17.11
- Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32 (Secondary), Mean, percentage of BSA: Part 2: ABP 501/ABP 501 -20.6 +/- 13.87; Part 2: Adalimumab/Adalimumab -25.3 +/- 15.94; Part 2: Adalimumab/ABP 501 -23.8 +/- 16.17
- Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50 (Secondary), Mean, percentage of BSA: Part 2: ABP 501/ABP 501 -20.7 +/- 13.58; Part 2: Adalimumab/Adalimumab -25.5 +/- 16.14; Part 2: Adalimumab/ABP 501 -25.1 +/- 17.43
- Number of Participants With Adverse Events (Secondary), Number, participants: Part 1: ABP 501 117; Part 1: Adalimumab 110; Part 2: ABP 501/ABP 501 108; Part 2: Adalimumab/Adalimumab 52; Part 2: Adalimumab/ABP 501 54
- Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab (Secondary), Number, percentage of participants: Part 1: ABP 501 55.2; Part 1: Adalimumab 63.6; Part 2: ABP 501/ABP 501 68.4; Part 2: Adalimumab/Adalimumab 74.7; Part 2: Adalimumab/ABP 501 72.7
- Percentage of Participants With a PASI 90 Response at Week 16 (Post hoc), Number, percentage of participants: Part 1: ABP 501 47.1; Part 1: Adalimumab 47.4
- Percentage of Participants With a PASI 90 Response at Week 32 (Post hoc), Number, percentage of participants: Part 2: ABP 501/ABP 501 62.2 +/- 18.387; Part 2: Adalimumab/Adalimumab 65.3 +/- 18.181; Part 2: Adalimumab/ABP 501 57.7 +/- 16.637
- Percentage of Participants With a PASI 90 Response at Week 50 (Post hoc), Number, percentage of participants: Part 2: ABP 501/ABP 501 59.0; Part 2: Adalimumab/Adalimumab 64.3; Part 2: Adalimumab/ABP 501 66.7
- Percentage of Participants With a PASI 100 Response at Week 16 (Post hoc), Number, percentage of participants: Part 1: ABP 501 16.9; Part 1: Adalimumab 19.7
- Percentage of Participants With a PASI 100 Response at Week 32 (Post hoc), Number, percentage of participants: Part 2: ABP 501/ABP 501 32.9 +/- 18.387; Part 2: Adalimumab/Adalimumab 33.3 +/- 18.181; Part 2: Adalimumab/ABP 501 25.4 +/- 16.637
- Percentage of Participants With a PASI 100 Response at Week 50 (Post hoc), Number, percentage of participants: Part 2: ABP 501/ABP 501 32.8; Part 2: Adalimumab/Adalimumab 35.7; Part 2: Adalimumab/ABP 501 34.8
Adverse events
Time frame: From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Part 1: ABP 501 | 0 | 6/174 (3.4%) | 50/174 (28.7%) |
| Part 1: Adalimumab | 0 | 5/173 (2.9%) | 60/173 (34.7%) |
| Part 2: ABP 501/ABP 501 | 0 | 4/152 (2.6%) | 48/152 (31.6%) |
| Part 2: Adalimumab/Adalimumab | 0 | 4/79 (5.1%) | 31/79 (39.2%) |
| Part 2: Adalimumab/ABP 501 | 0 | 4/77 (5.2%) | 34/77 (44.2%) |
Serious adverse events by term
| Term | Organ system | Part 1: ABP 501 | Part 1: Adalimumab | Part 2: ABP 501/ABP 501 | Part 2: Adalimumab/Adalimumab | Part 2: Adalimumab/ABP 501 |
|---|
| Acute myocardial infarction | Cardiac disorders | 1/174 | 0/173 | 0/152 | 0/79 | 0/77 |
| Arrhythmia | Cardiac disorders | 1/174 | 0/173 | 0/152 | 0/79 | 0/77 |
| Coronary artery disease | Cardiac disorders | 0/174 | 0/173 | 1/152 | 0/79 | 0/77 |
| Drug-induced liver injury | Hepatobiliary disorders | 0/174 | 0/173 | 1/152 | 0/79 | 0/77 |
| Hypersensitivity | Immune system disorders | 1/174 | 0/173 | 0/152 | 0/79 | 0/77 |
| Appendicitis | Infections and infestations | 1/174 | 0/173 | 0/152 | 0/79 | 0/77 |
| Bronchitis | Infections and infestations | 0/174 | 1/173 | 0/152 | 0/79 | 0/77 |
| Diverticulitis | Infections and infestations | 0/174 | 0/173 | 1/152 | 0/79 | 0/77 |
| Ophthalmic herpes zoster | Infections and infestations | 0/174 | 0/173 | 0/152 | 0/79 | 1/77 |
| Postoperative abscess | Infections and infestations | 1/174 | 0/173 | 0/152 | 0/79 | 0/77 |
| Urinary tract infection | Infections and infestations | 0/174 | 0/173 | 0/152 | 0/79 | 1/77 |
| Dyslipidaemia | Metabolism and nutrition disorders | 0/174 | 0/173 | 1/152 | 0/79 | 0/77 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 0/174 | 0/173 | 0/152 | 1/79 | 0/77 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 0/174 | 1/173 | 0/152 | 0/79 | 0/77 |
| Patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | 0/174 | 1/173 | 0/152 | 0/79 | 0/77 |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | 0/174 | 0/173 | 1/152 | 0/79 | 0/77 |
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/174 | 0/173 | 0/152 | 0/79 | 0/77 |
| Cerebral ischaemia | Nervous system disorders | 0/174 | 0/173 | 1/152 | 0/79 | 0/77 |
| Headache | Nervous system disorders | 0/174 | 0/173 | 0/152 | 1/79 | 0/77 |
| Migraine | Nervous system disorders | 0/174 | 0/173 | 0/152 | 1/79 | 0/77 |
| Syncope | Nervous system disorders | 0/174 | 1/173 | 0/152 | 0/79 | 0/77 |
| Transient ischaemic attack | Nervous system disorders | 0/174 | 0/173 | 0/152 | 0/79 | 1/77 |
| Depression | Psychiatric disorders | 0/174 | 0/173 | 0/152 | 1/79 | 0/77 |
| Metrorrhagia | Reproductive system and breast disorders | 0/174 | 1/173 | 0/152 | 0/79 | 0/77 |
| Ovarian cyst | Reproductive system and breast disorders | 0/174 | 0/173 | 0/152 | 0/79 | 1/77 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 1/174 | 0/173 | 0/152 | 0/79 | 0/77 |
Other adverse events by term
| Term | Organ system | Part 1: ABP 501 | Part 1: Adalimumab | Part 2: ABP 501/ABP 501 | Part 2: Adalimumab/Adalimumab | Part 2: Adalimumab/ABP 501 |
|---|
| Diarrhoea | Gastrointestinal disorders | 2/174 | 3/173 | 3/152 | 4/79 | 8/77 |
| Nasopharyngitis | Infections and infestations | 25/174 | 27/173 | 25/152 | 14/79 | 18/77 |
| Upper respiratory tract infection | Infections and infestations | 9/174 | 9/173 | 9/152 | 6/79 | 7/77 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 5/174 | 7/173 | 4/152 | 5/79 | 2/77 |
| Back pain | Musculoskeletal and connective tissue disorders | 7/174 | 1/173 | 5/152 | 5/79 | 1/77 |
| Headache | Nervous system disorders | 12/174 | 18/173 | 5/152 | 8/79 | 2/77 |
| Psoriasis | Skin and subcutaneous tissue disorders | 2/174 | 2/173 | 10/152 | 5/79 | 4/77 |
+Locations (3)
| Facility | City | Country | Status |
|---|
| Research Site | Saint Leonards, New South Wales | Australia | |
| Research Site | St. John's, Newfoundland and Labrador | Canada | |
| Research Site | Nyíregyháza, Szabolcs-Szatmár-Bereg | Hungary | |
+Publications
- Results publication: Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2017 Dec;177(6):1562-1574. doi: 10.1111/bjd.15857. Epub 2017 Dec 1. PMID 28755394
+Investigators
- MD, Study director, Amgen