22 completed, 1 recruiting, 1 terminated, 1 unknown. 14 Phase 2, 7 Phase 3, 3 Phase 1, 1 Early Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 12, Recruiting 1, Withdrawn 1 |
| Phase 3 | 7 | Completed 6, Terminated 1 |
| Phase 1 | 3 | Completed 3 |
| Early Phase 1 | 1 | Unknown 1 |
| Not applicable | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow rilonacept: new trials by email Literature Review of rilonacept trials Research Report on rilonacept
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 |
|---|---|---|---|---|---|---|
| Rilonacept in Subjects With Cardiac Sarcoidosis Rilonacept - Cardiac Sarcoidosis | Phase 2 | Recruiting | Mayo Clinic | 60 | 2025-03-05 | 2026-08-20 |
| Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis Rilonacept, Placebo - Recurrent Pericarditis | Phase 3 | Completed | Kiniksa Pharmaceuticals (UK), Ltd. | 86 | 2019-01-07 | 2023-09-06 |
| A Pilot Study of KPL-914 in Recurrent Pericarditis KPL-914 - Recurrent Pericarditis | Phase 2 | Completed | Kiniksa Pharmaceuticals (UK), Ltd. | 26 | 2018-01-24 | 2021-05-27 |
| Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss Rilonacept - Autoimmune Neurosensory Hearing Loss (ANSHL) | Early Phase 1 | Unknown | Stanley Cohen | 10 | 2017-02-01 | 2017-09-13 |
| Cold Contact Urticaria Treatment With Rilonacept Rilonacept, Placebo - Cold Contact Urticaria | Phase 2 | Completed | Charite University, Berlin, Germany | 20 | 2015-01-01 | 2018-07-17 |
| A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis Mycophenolate mofetil, Prednisolone, Rilonacept - Alcoholic Hepatitis | Phase 2 | Completed | Southern California Institute for Research and Education | 4 | 2014-12-01 | 2025-06-12 |
| Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis Rilonacept, Corticosteroid - Subacromial Bursitis | Not applicable | Completed | Keesler Air Force Base Medical Center | 33 | 2013-03-01 | 2014-08-04 |
| Rilonacept for Deficiency of the Interleukin-1 Receptor Antagonist (DIRA) Rilonacept - DIRA | Phase 2 | Completed | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | 6 | 2013-02-12 | 2017-10-16 |
| Inflammation in Chronic Kidney Disease and Cardiovascular Disease - The Role of Genetics and Interleukin-1 Receptor Antagonist (IL-1ra) Rilonacept, Placebo - Chronic Kidney Disease, Cardiovascular Disease | Phase 2 | Completed | VA Office of Research and Development | 15 | 2013-01-01 | 2019-10-01 |
| Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD) Rilonacept, Placebo - Renal Insufficiency, Chronic | Phase 4 | Completed | University of Colorado, Denver | 42 | 2012-08-01 | 2016-09-12 |
| IL1-TRAP, Rilonacept, in Systemic Sclerosis Rilonacept, Placebo - Scleroderma, Systemic Sclerosis | Phase 1 / Phase 2 | Completed | Boston University | 24 | 2011-12-01 | 2018-05-01 |
| Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares Rilonacept, Placebo, Allopurinol - Gout | Phase 3 | Terminated | Regeneron Pharmaceuticals | 220 | 2011-11-01 | 2017-07-18 |
| Rilonacept in Diabetes Mellitus Type 1: Safety Study Rilonacept - Type 1 Diabetes Mellitus | Phase 1 | Completed | University of Texas Southwestern Medical Center | 13 | 2011-02-01 | 2014-02-24 |
| PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2) Placebo, Rilonacept - Gout | Phase 3 | Completed | Regeneron Pharmaceuticals | 248 | 2009-07-01 | 2017-04-28 |
| Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE) Rilonacept, Placebo - Gout | Phase 3 | Completed | Regeneron Pharmaceuticals | 1315 | 2009-03-01 | 2017-04-28 |
| Study Utilizing Rilonacept in Gout Exacerbations Rilonacept, Indomethacin, Placebo (for Indomethacin) - Acute Gout Flare | Phase 3 | Completed | Regeneron Pharmaceuticals | 225 | 2009-03-01 | 2017-04-28 |
| PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 Placebo, Rilonacept 80 mg, Rilonacept 160 mg - Intercritical Gout | Phase 3 | Completed | Regeneron Pharmaceuticals | 241 | 2009-02-01 | 2017-04-28 |
| Safety and Tolerability of Rilonacept in Muckle-Wells Syndrome (MWS) or Schnitzler Syndrome (SchS) rilonacept - Muckle-Wells Syndrome, Schnitzler Syndrome | Phase 2 | Completed | Charite University, Berlin, Germany | 10 | 2009-01-01 | 2012-05-31 |
| Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults Rilonacept - Juvenile Idiopathic Arthritis | Phase 2 | Completed | Montefiore Medical Center | 71 | 2008-11-01 | 2015-12-11 |
| Rilonacept for Treatment of Familial Mediterranean Fever (FMF) Rilonacept, Placebo - Familial Mediterranean Fever | Phase 2 | Completed | The Cleveland Clinic | 14 | 2008-08-01 | 2013-02-11 |
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Gout (6) · Genetic Diseases, Inborn (5) · Inflammation (5) · Arthritis (4) · Joint Diseases (4) · Metabolic Diseases (4) · Metabolism, Inborn Errors (4) · Musculoskeletal Diseases (4) · Purine-Pyrimidine Metabolism, Inborn Errors (4) · Rheumatic Diseases (4) · Cryopyrin-Associated Periodic Syndromes (3) · Renal Insufficiency, Chronic (3) · Arthritis, Juvenile (2) · Familial Mediterranean Fever (2) · Pericarditis (2)
Regeneron Pharmaceuticals (9) · Charite University, Berlin, Germany (2) · Kiniksa Pharmaceuticals (UK), Ltd. (2) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (2) · Boston University (1) · Keesler Air Force Base Medical Center (1) · Mayo Clinic (1) · Montefiore Medical Center (1) · National Heart, Lung, and Blood Institute (NHLBI) (1) · Southern California Institute for Research and Education (1) · Stanley Cohen (1) · The Cleveland Clinic (1) · University of Colorado, Denver (1) · University of Texas Southwestern Medical Center (1) · VA Office of Research and Development (1)
United States (23) · Germany (4) · India (2) · Indonesia (2) · South Africa (2) · Taiwan (2) · Australia (1) · Canada (1) · Israel (1) · Italy (1)
Robert Evans, PharmD (3) · Adriana M Hung, MD MPH (1) · Andrew Rosenbaum (1) · Gary Swergold, MD, PhD (1) · Gina A Montealegre, M.D. (1) · Karoline Krause, MD (1) · Kristen L Jablonski Nowak, Ph.D. (1) · Marcus Maurer, MD (1) · Matthew B Carroll, MD (1) · Norman T. Ilowite, MD (1) · Perrin C White, MD (1) · Philip J Hashkes, MD, MSc (1) · Richard O Cannon, MD (1)
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