NCT01565655CompletedPhase 2
A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Patients
Astellas Pharma Global Development, Inc.38 sites in 6 countries289 target enrollmentStarted: June 19, 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 289
- Locations
- 38
- Primary Endpoint
- Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects
Detailed Description
Subjects will take ASP015K or matching placebo orally with food for 12 weeks after randomization. Potential subjects who have previously used disease-modifying antirheumatic drugs (DMARDs) and/or biologic agents may be eligible to participate after completing a washout period. Subjects who complete the 12-week dosing period in this study may be eligible to participate in a long-term, open-label Extension Study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 6 tender/painful joints; ≥ 6 swollen joints
- •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 Global Functional Status in RA Class I, II or III at Screening and Baseline
- •Use of non-steroidal anti-inflammatory drugs [NSAIDs], cyclooxygenase-2 (COX-2) inhibitors, or oral corticosteroids for the treatment of RA must be stable for at least 28 days prior to start of the study
- •Male and female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation
- •Female subject must not be breastfeeding at Screening or during the study period, and for 60 days after the final study drug administration
- •Subject agrees not to participate in another interventional study while on treatment
Exclusion Criteria
- •Positive Mycobacterium tuberculosis (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
- •Known history of positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody or history of a positive test for human immunodeficiency virus (HIV) infection
- •History of 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 Baseline 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: gold, azathioprine, minocycline, penicillamine, etanercept, certolizumab, adalimumab, golimumab, infliximab, cyclophosphamide, and 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 or is currently taking > 30 mg oral morphine (or narcotic equivalent) per day
- •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
- •History of long QT syndrome or prolonged QT interval
- •Any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or infectious disease, or any ongoing illness which would make the subject unsuitable for the study
- •Subject has any condition possibly affecting oral absorption (e.g., gastrectomy, other malabsorption syndromes, or clinically significant diabetic gastroenteropathy)
Arms & Interventions
ASP015K lowest dose
Experimental
ASP015K lowest dose once daily
Intervention: peficitinib (Drug)
ASP015K low dose
Experimental
ASP015K low dose once daily
Intervention: peficitinib (Drug)
ASP015K medium dose
Experimental
ASP015K medium dose once daily
Intervention: peficitinib (Drug)
ASP015K high dose
Experimental
ASP015K high dose once daily
Intervention: peficitinib (Drug)
Placebo
Placebo Comparator
Matching placebo once daily
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response
Time Frame: Week 12
Trough plasma concentration of ASP015K and metabolite(s)
Time Frame: up to Week 12 (6 time points)
Secondary Outcomes
- Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP)(Baseline and Week 12)
- Percentage of subjects achieving ACR 50 response(Week 12)
- Percentage of subjects achieving ACR 70 response(Week 12)
Investigators
Study Sites (38)
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