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

Phase 2

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Placebo; Drug: peficitinib

• Registration Number: NCT01565655
• Lead Sponsor: Astellas Pharma Global Development, Inc.

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 Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Study Start: 2012-06-19
• Primary Completion: 2013-12-02
• Study Completion: 2013-12-02
• Disposition First Submitted: 2014-12-01
• Disposition First Submitted QC: 2014-12-01
• Disposition First Posted: 2014-12-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo once daily
ASP015K high dose	peficitinib	ASP015K high dose once daily
ASP015K lowest dose	peficitinib	ASP015K lowest dose once daily
ASP015K low dose	peficitinib	ASP015K low dose once daily
ASP015K medium dose	peficitinib	ASP015K medium dose once daily

Primary Outcome Measures

Name	Time	Method
Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response	Week 12
Trough plasma concentration of ASP015K and metabolite(s)	up to Week 12 (6 time points)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (38)

Cliditer S.A. de C.V.; 🇲🇽 México, Distrito Federal, Mexico

Zespol Poradni Specjalistycznych, REUMED sp. Zo.o; 🇵🇱 Lublin, Poland

MHAT Burgas; 🇧🇬 Burgas, Bulgaria

PV-MEDICAL s.r.o.; 🇨🇿 Zlin, Czechia

Revmatologicky ustav; 🇨🇿 Praha 2, Czechia

Austin Rheumatology Research PA; 🇺🇸 Austin, Texas, United States

Mountain State Clinical Research; 🇺🇸 Clarksburg, West Virginia, United States

MHAT Plovdiv AD; 🇧🇬 Plovdiv, Bulgaria

MHAT "Sv. Ivan Rilski"; 🇧🇬 Sofia, Bulgaria

Kenezy Hospital Institute of Clinical Pharmacology; 🇭🇺 Debrecen, Hungary

Revmatologicka ambulance; 🇨🇿 Praha-Nusle, Czechia

Budai Irgalmasrendi Korhaz; 🇭🇺 Budapest,, Hungary

Szpital Uniwersytecki nr. 2 im. Dr. Jana Biziela; 🇵🇱 Bydgoszcz, Poland

Orszgos Reumatolgiai s Fizioterpis Intzet; 🇭🇺 Budapest, Hungary

MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o.; 🇨🇿 Uherske Hradiste, Czechia

Revita Clinic Rheumatology; 🇭🇺 Budapest, Hungary

Rethy Pal Korhaz es Rendelointezet; 🇭🇺 Bekescsaba, Hungary

Pacific Arthritis Center Medical Group; 🇺🇸 Santa Maria, California, United States

Achieve Clinical Research, LLC; 🇺🇸 Birmingham, Alabama, United States

Desert Medical Advances; 🇺🇸 Palm Desert, California, United States

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Arthritis Associates of Colorado Springs; 🇺🇸 Colorado Springs, Colorado, United States

Arthritis Associates; 🇺🇸 Orlando, Florida, United States

Deerbrook Medical Asssociates; 🇺🇸 Vernon Hills, Illinois, United States

Center for Arthritis and Osteoporosis; 🇺🇸 Elizabethtown, Kentucky, United States

Illinois Bone & Joint Institute; LLC; 🇺🇸 Morton Grove, Illinois, United States

Health Research of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

The Center for Rheumatology and Bone Research; 🇺🇸 Wheaton, Maryland, United States

PMG Research; 🇺🇸 Hickory, North Carolina, United States

Clincal Research Center of Reading; 🇺🇸 Wyomissing, Pennsylvania, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Dr Javier Orozco Alcala Private Doctor´s office; 🇲🇽 Guadalajara, Mexico

Centro de Investigacion Clinica de Morelia, S.C.; 🇲🇽 Morelia, Mexico

NZOZ Centrum Medyczne ProMiMed; 🇵🇱 Krakow, Poland

ARS Rheumatica; 🇵🇱 Warszawa, Poland

University of California San Diego; 🇺🇸 La Jolla, California, United States

Rheumatology Consultants, PLLC; 🇺🇸 Knoxville, Tennessee, United States