A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ASP015K lowest dose Oral |
Drug: peficitinib
oral
Other Names:
|
| Experimental: ASP015K low dose Oral |
Drug: peficitinib
oral
Other Names:
|
| Experimental: ASP015K medium dose Oral |
Drug: peficitinib
oral
Other Names:
|
| Experimental: ASP015K high dose Oral |
Drug: peficitinib
oral
Other Names:
|
| Placebo Comparator: Placebo Oral |
Drug: Placebo
oral
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response [Week 12]
Secondary Outcome Measures
- Percentage of Subjects achieving ACR 50 response [Week 12]
- Percentage of Subjects achieving ACR 70 response [Week 12]
- Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) [Baseline and Week 12]
- Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and clinical labo-tests [During 12-week treatment period and 4-week follow-up period]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chubu | Japan | |||
| 2 | Chugoku | Japan | |||
| 3 | Hokkaido | Japan | |||
| 4 | Kansai | Japan | |||
| 5 | Kantou | Japan | |||
| 6 | Kyushu | Japan | |||
| 7 | Touhoku | Japan |
Sponsors and Collaborators
- Astellas Pharma Inc
Investigators
- Study Director: Medical Director, Astellas Pharma Inc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 015K-CL-RAJ1