peficitinib

DRUG15 trials

Sponsors

Astellas Pharma Inc, Astellas Pharma Global Development, Inc., Astellas Pharma China, Inc.

Conditions

Arthritis, RheumatoidHealthy SubjectsHealthy VolunteerHealthy VolunteersPharmacokinetics of ASP015KPsoriasisRheumatoid ArthritisRheumatoid Arthritis (RA)

Phase 1

Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers

CompletedNCT01225224

Astellas Pharma IncHealthy Volunteer, Pharmacokinetics of ASP015K

Start: 2009-11-18End: 2010-03-10Updated: 2024-10-16

A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis

CompletedNCT01754805

Astellas Pharma IncRheumatoid Arthritis

Start: 2010-01-22End: 2010-03-25Updated: 2024-10-21

Bioequivalence Evaluation of a New and Current Tablet of ASP015K

CompletedNCT02531191

Astellas Pharma IncHealthy Volunteers

Start: 2015-06-21End: 2015-07-15Updated: 2024-10-16

A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin

CompletedNCT02760342

Astellas Pharma IncHealthy Subjects

Start: 2016-05-15End: 2016-06-26Updated: 2024-10-16

A Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects

CompletedNCT04143477

Astellas Pharma China, Inc.Healthy Volunteers

Start: 2019-12-05End: 2020-12-21Updated: 2024-10-21

Phase 2

A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis

CompletedNCT01096862

Astellas Pharma IncPsoriasis

Start: 2010-03-23End: 2011-07-27Updated: 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

CompletedNCT01554696

Astellas Pharma IncArthritis, Rheumatoid

Start: 2012-07-06End: 2014-02-11Updated: 2025-05-29

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis

CompletedNCT01565655

Astellas Pharma Global Development, Inc.Arthritis, Rheumatoid

Start: 2012-06-19End: 2013-12-02Updated: 2025-05-21

A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects

CompletedNCT01649999

Astellas Pharma IncArthritis, Rheumatoid

Start: 2012-03-01End: 2013-07-20Updated: 2024-10-21

A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

CompletedNCT01711814

Astellas Pharma Global Development, Inc.Arthritis, Rheumatoid

Start: 2012-09-26End: 2016-03-25Updated: 2024-10-21

Phase 3

A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

CompletedNCT01638013

Astellas Pharma IncArthritis, Rheumatoid

Start: 2012-06-13End: 2019-09-30Updated: 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

CompletedNCT02305849

Astellas Pharma IncRheumatoid Arthritis

Start: 2014-07-25End: 2017-11-28Updated: 2024-10-28

A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs

CompletedNCT02308163

Astellas Pharma IncRheumatoid Arthritis

Start: 2014-08-08End: 2017-11-22Updated: 2024-10-28

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)

CompletedNCT03660059

Astellas Pharma China, Inc.Rheumatoid Arthritis (RA)

Start: 2018-09-27End: 2021-11-02Updated: 2024-10-21

Unknown Phase

Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

CompletedNCT03971253

Astellas Pharma IncRheumatoid Arthritis (RA)

Start: 2019-09-02End: 2026-05-29Updated: 2026-06-10

Related Papers

Monitoramento do Horizonte Tecnológico (MHT) de Inibidores de Janus Quinase (JAKi) para o Tratamento de Artrite Reumatoide

Epidemiologia e Serviços de Saúde2025-01-01

Safety and efficacy of peficitinib in Asian patients with rheumatoid arthritis who had an inadequate response or intolerance to methotrexate: results of a multicenter, randomized, double-blind, placebo-controlled phase 3 study.

2023-10-185 citations

Pharmacokinetics and Safety of Single and Multiple Doses of Peficitinib (ASP015K) in Healthy Chinese Subjects

Drug Design Development and Therapy2022-05-013 citations

<i>Post hoc</i> analysis of clinical characteristics of patients with radiographic progression in a Japanese phase 3 trial of peficitinib and methotrexate treatment (RAJ4)

Modern Rheumatology2022-03-106 citations

Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis.

2021-08-248 citations

Exposure–response modeling of peficitinib efficacy in patients with rheumatoid arthritis

Pharmacology Research & Perspectives2021-04-301 citations

Safety and Effectiveness of Peficitinib (ASP015K) in Patients with Rheumatoid Arthritis: Final Results (32 Months of Mean Peficitinib Treatment) From a Long-Term, Open-Label Extension Study in Japan, Korea, and Taiwan

Rheumatology and Therapy2021-03-0121 citations

Investigation of Potential Drug-Drug Interactions between Peficitinib (ASP015K) and Methotrexate in Patients with Rheumatoid Arthritis.

2020-09-012 citations

Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects.

2020-05-014 citations

Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan

Arthritis Research & Therapy2020-03-1229 citations

Two-Year Safety and Effectiveness of Peficitinib in Moderate-To-Severe Rheumatoid Arthritis: A Phase IIb, Open-Label Extension Study.

2019-08-1313 citations

Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III randomised, double-blind, placebo-controlled trial (RAJ4) in Japan.

2019-07-2694 citations

Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3).

2019-07-2684 citations

Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study.

2015-12-15117 citations

A phase 2a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate-to-severe psoriasis.

2015-06-1979 citations