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

NCT ID: NCT01649999

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-01
• Study Completion Date: 2013-07-20

Brief Summary

This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects given ASP015K for 12 weeks.

Detailed Description

This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, dose-finding, monotherapy, multi-center study with once daily oral ASP015K or matching placebo in subjects with moderate to severe RA, with or without prior antirheumatic medication, and regardless of responsiveness to the medication.

The study is comprised of up to a 4-week Screening period, a 12-week Treatment period and a 4-week Follow-up period.

Subjects in each treatment group will take ASP015K or matching placebo orally, once daily, after breakfast for 12 weeks after the screening period.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ASP015K lowest dose

Oral

Group Type: EXPERIMENTAL

peficitinib

Intervention Type: DRUG

oral

ASP015K low dose

Oral

Group Type: EXPERIMENTAL

peficitinib

Intervention Type: DRUG

oral

ASP015K medium dose

Oral

Group Type: EXPERIMENTAL

peficitinib

Intervention Type: DRUG

oral

ASP015K high dose

Oral

Group Type: EXPERIMENTAL

peficitinib

Intervention Type: DRUG

oral

Placebo

Oral

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

Interventions

peficitinib

oral

Intervention Type: DRUG

Placebo

oral

Intervention Type: DRUG

Other Intervention Names

ASP015K

Eligibility Criteria

Inclusion Criteria

• Subject has received a full explanation of the study drug and this study in advance, and written informed consent to participate in the study has been obtained from the subject himself/herself
• Outpatient has RA that was diagnosed according to the 1987 revised criteria of the ACR at least 6 months prior to screening
• At screening subject has active RA as evidenced by all of the following:

• ≥ 6 tender/painful joints;
• ≥ 6 swollen joints;
• CRP of ≥ 0.5 mg/dL or ESR of ≥ 28 mm/h.C-Reactive Protein (CRP) of ≥ 0.8 mg/dL or Erythrocyte Sedimentation Rate (ESR) of ≥ 28 mm/hr
• Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA, Class I, II or, III at screening

Exclusion Criteria

• Positive tuberculin (TB) test within 90 days of Screening
• Abnormal chest x-ray indicative of an acute or chronic infectious process or malignancy
• Receipt of live or live attenuated virus vaccination within 30 days prior to the first dose of study drug
• Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
• Any other autoimmune rheumatic disease, other than Sjogren's syndrome
• Previous history of clinically significant infections or illness (requiring hospitalization or requiring parenteral therapy) within 90 days of the Screening visit, or a history of any illness that would preclude participation in the study
• History of any malignancy, except for successfully treated basal or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
• Does not meet specified washout criteria for the following RA medications: etanercept, certolizumab, adalimumab, golimumab, infliximab and tocilizumab, rituximab, abatacept, anakinra, methotrexate, sulfasalazine, hydroxychloroquine, gold, penicillamine or leflunomide
• Previous intolerance to Janus kinase (JAK) inhibitors
• Receipt of intra-articular or parenteral corticosteroid within 28 days prior to the first dose of study drug
• Receipt of plasma exchange therapy within 60 days prior to the start of study drug
• Receipt of any investigational agent within 30 days or 5 half-lives, whichever is longer, prior to first dose of study drug
• Receipt of medications that are CYP3A substrates with narrow therapeutic range within 14 days prior to first dose of study drug
• History of heart failure, defined as New York Heart Association (NYHA) grade 3 or greater

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Chugoku, , Japan

Chūbu, , Japan

Hokkaido, , Japan

Kansai, , Japan

Kantou, , Japan

Kyushu, , Japan

Tōhoku, , Japan

Countries

Japan

References

Toyoshima J, Kaibara A, Shibata M, Kaneko Y, Izutsu H, Nishimura T. Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacol Res Perspect. 2021 May;9(3):e00744. doi: 10.1002/prp2.744.

Reference Type: DERIVED

PMID: 33929089 (View on PubMed)

Takeuchi T, Tanaka Y, Iwasaki M, Ishikura H, Saeki S, Kaneko Y. 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. Ann Rheum Dis. 2016 Jun;75(6):1057-64. doi: 10.1136/annrheumdis-2015-208279. Epub 2015 Dec 15.

Reference Type: DERIVED

PMID: 26672064 (View on PubMed)

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=334

Link to results on Astellas Clinical Study Results website

Other Identifiers

015K-CL-RAJ1

Identifier Type: -

Identifier Source: org_study_id