32 completed. 21 Phase 1, 6 Phase 2, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 21 | Completed 21 |
| Phase 2 | 6 | Completed 6 |
| Phase 3 | 4 | Completed 4 |
Follow peficitinib: new trials by email Literature Review of peficitinib trials Research Report on peficitinib
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 Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects peficitinib - Healthy Volunteers | Phase 1 | Completed | Astellas Pharma China, Inc. | 36 | 2019-12-05 | 2024-10-21 |
| Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis Peficitinib - Rheumatoid Arthritis (RA) | Completed | Astellas Pharma Inc | 3000 | 2019-09-02 | 2026-06-10 | |
| A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX) Peficitinib, Plaebo, Disease-modifying antirheumatic drugs (DMARDs) - Rheumatoid Arthritis (RA) | Phase 3 | Completed | Astellas Pharma China, Inc. | 385 | 2018-09-27 | 2024-10-21 |
| A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin peficitinib, Metformin - Healthy Subjects | Phase 1 | Completed | Astellas Pharma Inc | 24 | 2016-05-15 | 2024-10-16 |
| Pharmacokinetics Study in Patients With Impaired Hepatic Function ASP015K - Patients With Impaired Hepatic Function | Phase 1 | Completed | Astellas Pharma Inc | 24 | 2015-12-28 | 2024-10-16 |
| Pharmacokinetics Study in Patients With Impaired Renal Function and Subjects With Normal Renal Function ASP015K - Patients With Impaired Renal Function | Phase 1 | Completed | Astellas Pharma Inc | 31 | 2015-11-24 | 2024-10-16 |
| Bioequivalence Evaluation of a New and Current Tablet of ASP015K peficitinib - Healthy Volunteers | Phase 1 | Completed | Astellas Pharma Inc | 40 | 2015-06-21 | 2024-10-16 |
| A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs Peficitinib, Placebo, Etanercept - Rheumatoid Arthritis | Phase 3 | Completed | Astellas Pharma Inc | 509 | 2014-08-08 | 2024-10-28 |
| A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment Peficitinib, Placebo, Methotrexate - Rheumatoid Arthritis | Phase 3 | Completed | Astellas Pharma Inc | 519 | 2014-07-25 | 2024-10-28 |
| A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K in Healthy Subjects ASP015K, Placebo - Healthy Volunteers, Pharmacokinetics of ASP015K | Phase 1 | Completed | Astellas Pharma Global Development, Inc. | 16 | 2014-03-01 | 2014-06-04 |
| A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis Placebo, JNJ-54781532 25 mg once daily, JNJ-54781532 75 mg once daily - Colitis, Ulcerative | Phase 2 | Completed | Janssen Research & Development, LLC | 219 | 2013-11-15 | 2019-01-04 |
| A Study to Evaluate the Effect of Verapamil on the Pharmacokinetics of ASP015K in Healthy Adult Subjects ASP015K, verapamil - Healthy Subjects, Pharmacokinetics of ASP015K | Phase 1 | Completed | Astellas Pharma Global Development, Inc. | 24 | 2013-10-01 | 2014-04-11 |
| Drug-Drug Interaction Study Evaluating Effects of ASP015K on Rosuvastatin ASP015K, Rosuvastatin - Healthy Subjects, Pharmacokinetics of ASP015K | Phase 1 | Completed | Astellas Pharma Global Development, Inc. | 24 | 2013-05-01 | 2013-10-10 |
| A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects ASP015K - Bioavailability of ASP015K, Healthy Subjects | Phase 1 | Completed | Astellas Pharma Global Development, Inc. | 36 | 2013-05-01 | 2013-09-16 |
| A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study peficitinib - Arthritis, Rheumatoid | Phase 2 | Completed | Astellas Pharma Global Development, Inc. | 611 | 2012-09-26 | 2024-10-21 |
| A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate peficitinib, Placebo, methotrexate - Arthritis, Rheumatoid | Phase 2 | Completed | Astellas Pharma Inc | 379 | 2012-07-06 | 2025-05-29 |
| A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis peficitinib, Placebo - Arthritis, Rheumatoid | Phase 2 | Completed | Astellas Pharma Global Development, Inc. | 289 | 2012-06-19 | 2025-05-21 |
| A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K Peficitinib - Arthritis, Rheumatoid | Phase 3 | Completed | Astellas Pharma Inc | 843 | 2012-06-13 | 2024-10-28 |
| A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects peficitinib, Placebo - Arthritis, Rheumatoid | Phase 2 | Completed | Astellas Pharma Inc | 281 | 2012-03-01 | 2024-10-21 |
| A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New Formulation ASP015K - Pharmacokinetics of ASP015K, Bioavailability of ASP015K | Phase 1 | Completed | Astellas Pharma Inc | 24 | 2011-09-01 | 2011-12-05 |
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Arthritis, Rheumatoid (12) · Psoriasis (3) · Colitis, Ulcerative (1) · Lymphoma, Follicular (1) · Motor Activity (1) · Renal Insufficiency (1)
Astellas Pharma Inc (23) · Astellas Pharma Global Development, Inc. (6) · Astellas Pharma China, Inc. (2) · Janssen Research & Development, LLC (1)
United States (19) · Japan (10) · Bulgaria (4) · Hungary (4) · Poland (4) · Belgium (3) · Czechia (3) · Mexico (3) · South Korea (3) · Taiwan (3) · China (2) · Colombia (2) · Australia (1) · Canada (1) · France (1)
PMID 33068028, PMID 33929089, PMID 34429152, PMID 25704750, PMID 26672064, PMID 27748083, PMID 27878567, PMID 28118538, PMID 29917064, PMID 30721964, PMID 31350269, PMID 31350270, PMID 31410787, PMID 31729626, PMID 32164762, PMID 32274653, PMID 32591978, PMID 32618438, PMID 33656739, PMID 35267027, PMID 35586186, PMID 38357391