Peficitinib

Generic Name: Peficitinib

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₂N_₄O_₂

CAS Number: 944118-01-8

Unique Ingredient Identifier: HPH1166CKX

Background: Peficitinib has been used in trials studying the treatment and basic science of Psoriasis, Pharmacodynamics, Drug Interactions, Colitis, Ulcerative, and RHEUMATOID ARTHRITIS, among others.

Indication: 用于治疗对常规疗法反应不足的类风湿性关节炎（包括预防结构性关节损伤）患者。

Associated Conditions: -

Associated Therapies: -

Clinical Trials

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

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: peficitinib

First Posted Date: 2019-10-29

Last Posted Date: 2024-10-21

Lead Sponsor: Astellas Pharma China, Inc.

Target Recruit Count: 36

Registration Number: NCT04143477

Locations: 🇨🇳
Site CN86001, Beijing, China

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

Recruiting

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: Peficitinib

First Posted Date: 2019-06-03

Last Posted Date: 2024-12-17

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 3000

Registration Number: NCT03971253

Locations: 🇯🇵
Site JP00005, Akita, Japan
🇯🇵
Site JP00038, Ehime, Japan
🇯🇵
Site JP00002, Aomori, Japan

and more 44 locations

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)

Phase 3

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: Peficitinib
Drug: Disease-modifying antirheumatic drugs (DMARDs)
Drug: Plaebo

First Posted Date: 2018-09-06

Last Posted Date: 2024-10-21

Lead Sponsor: Astellas Pharma China, Inc.

Target Recruit Count: 385

Registration Number: NCT03660059

Locations: 🇨🇳
Site CN00061, Changchun, China
🇨🇳
Site CN00072, Guangzhou, China
🇰🇷
Site KR00035, Seoul, Korea, Republic of

and more 40 locations

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

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: peficitinib
Drug: Metformin

First Posted Date: 2016-05-03

Last Posted Date: 2024-10-16

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 24

Registration Number: NCT02760342

Locations: 🇯🇵
Site JP00001, Kagoshima, Japan

Bioequivalence Evaluation of a New and Current Tablet of ASP015K

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: peficitinib

First Posted Date: 2015-08-24

Last Posted Date: 2024-10-16

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 40

Registration Number: NCT02531191

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

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Peficitinib
Biological: Etanercept

First Posted Date: 2014-12-04

Last Posted Date: 2024-10-28

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 509

Registration Number: NCT02308163

Locations: 🇯🇵
JP00099, Chiyoda, Tokyo, Japan
🇯🇵
JP00018, Fukuoka, Japan
🇯🇵
JP00078, Kawachinagano, Osaka, Japan

and more 150 locations

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

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Peficitinib
Drug: Methotrexate

First Posted Date: 2014-12-03

Last Posted Date: 2024-10-28

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 519

Registration Number: NCT02305849

Locations: 🇯🇵
JP00109, Nagoya, Aichi, Japan
🇯🇵
JP00068, Yatomi, Aichi, Japan
🇯🇵
JP00106, Kurume, Fukuoka, Japan

and more 143 locations

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

Phase 1

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: peficitinib
Drug: methotrexate

First Posted Date: 2012-12-21

Last Posted Date: 2024-10-21

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 15

Registration Number: NCT01754805

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

Phase 2

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: peficitinib

First Posted Date: 2012-10-22

Last Posted Date: 2024-10-21

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 611

Registration Number: NCT01711814

Locations: 🇧🇪
Site BE3314, Brussels, Belgium
🇨🇴
Site CO3297, Bogota, Colombia
🇵🇱
Site PL3603, Krakow, Poland

and more 48 locations

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

Phase 2

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Placebo
Drug: peficitinib

First Posted Date: 2012-07-25

Last Posted Date: 2024-10-21

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 281

Registration Number: NCT01649999

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