19 completed, 1 recruiting. 8 Phase 4, 6 Phase 2, 4 Phase 3, 1 Phase 1.
By phase and status
Follow Pegloticase: new trials by email Literature Review of Pegloticase trials Research Report on Pegloticase
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
Pegloticase, Methotrexate - Uncontrolled Gout | Phase 3 | Recruiting | Amgen | 270 | 2026-02-09 | 2026-10-19 |
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout
Pegloticase, Methotrexate - Gout | Phase 4 | Completed | Amgen | 306 | 2024-03-18 | 2026-09-17 |
Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome
Pegloticase, Rasburicase - Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm | Phase 4 | Completed | M.D. Anderson Cancer Center | 10 | 2022-04-05 | 2026-05-06 |
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
Pegloticase, Methotrexate (MTX) - Uncontrolled Gout | Phase 4 | Completed | Amgen | 11 | 2021-03-08 | 2024-06-27 |
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
Pegloticase, Methotrexate (MTX) - Uncontrolled Gout, Chronic Gout | Phase 4 | Completed | Amgen | 54 | 2021-01-26 | 2026-05-19 |
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
Pegloticase with MTX - Chronic Uncontrolled Gout, Gout | Phase 4 | Completed | Amgen | 191 | 2020-10-02 | 2025-10-20 |
Uric Acid Lowering Trial in Youth Onset T2D
Pegloticase 8 MG/ML [Krystexxa] - Diabetic Kidney Disease, Hyperuricemia | Phase 2 | Completed | University of Colorado, Denver | 11 | 2020-01-01 | 2026-07-28 |
Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant
Pegloticase - Uncontrolled Gout, Kidney Transplant | Phase 4 | Completed | Amgen | 20 | 2019-09-09 | 2024-06-26 |
Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout
Pegloticase, methotrexate, placebo - Gout | Phase 4 | Completed | Amgen | 152 | 2019-06-13 | 2024-06-26 |
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
SEL-212, KRYSTEXXA® - Chronic Gout | Phase 2 | Completed | Selecta Biosciences, Inc. | 170 | 2019-05-07 | 2023-10-17 |
Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout
Pegloticase, Methotrexate (MTX), Standard Gout Flare Prophylaxis - Gout | Phase 4 | Completed | Amgen | 14 | 2018-09-26 | 2024-06-26 |
REduCing Immunogenicity to PegloticasE (RECIPE) Study
Pegloticase 8 MG/ML [Krystexxa], MMF, Placebo - Gout Chronic | Phase 2 | Completed | University of Alabama at Birmingham | 35 | 2018-06-14 | 2022-03-16 |
Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
Pegloticase, Azathioprine - Gout | Phase 2 | Completed | Ampel BioSolutions, LLC | 132 | 2015-12-01 | 2021-10-11 |
Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
Pegloticase - Chronic Kidney Disease Stage 5 | Phase 1 | Completed | Savient Pharmaceuticals | 12 | 2012-12-01 | 2013-10-25 |
Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout
Pegloticase - Refractory Chronic Gout | | Completed | Horizon Pharma Rheumatology LLC | 188 | 2011-11-15 | 2019-01-11 |
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
pegloticase 8 mg i.v. - Chronic Gout Refractory to Conventional Therapy | Phase 3 | Completed | Savient Pharmaceuticals | 7 | 2008-05-01 | 2011-06-28 |
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
pegloticase - Gout | Phase 3 | Completed | Savient Pharmaceuticals | 151 | 2006-12-01 | 2011-12-02 |
Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
placebo, pegloticase - Gout | Phase 3 | Completed | Savient Pharmaceuticals | 225 | 2006-05-01 | 2011-02-28 |
Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
Pegloticase - Gout | Phase 2 | Completed | John Sundy | 30 | 2004-12-01 | 2014-10-03 |
A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
Puricase - Gout | Phase 2 | Completed | Savient Pharmaceuticals | 40 | 2004-03-01 | 2013-06-03 |
Conditions studied
Gout (12) · Arthritis, Gouty (1) · Diabetes Complications (1) · Diabetes Mellitus (1) · Diabetes Mellitus, Type 2 (1) · Diabetic Nephropathies (1) · Hematologic Neoplasms (1) · Hyperuricemia (1) · Renal Insufficiency, Chronic (1) · Tumor Lysis Syndrome (1)
Sponsors
Amgen (8) · Savient Pharmaceuticals (5) · Ampel BioSolutions, LLC (1) · Horizon Pharma Rheumatology LLC (1) · John Sundy (1) · M.D. Anderson Cancer Center (1) · Selecta Biosciences, Inc. (1) · University of Alabama at Birmingham (1) · University of Colorado, Denver (1)
Countries
United States (20) · Canada (1) · Mexico (1) · Puerto Rico (1)
Top investigators
Harry Alcorn, Pharm D (1) · Jeffery Nieves, PharmD (1) · John S. Sundy, MD, PhD (1) · Kenneth G Saag, MD (1) · Sreedhar Mandayam, MD (1) · Supra Verma, MD (1)
Results publications
PMID 24286509, PMID 24588936, PMID 31203212, PMID 18759308, PMID 20660758, PMID 21846852, PMID 24447425, PMID 24602182, PMID 31079535, PMID 32934137, PMID 33750034, PMID 35293984, PMID 36008814, PMID 36099211, PMID 36575505, PMID 37138473, PMID 37449908, PMID 38447697, PMID 39678124, PMID 40371056, PMID 42775939