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

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

The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Placebo; Drug: peficitinib

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 Type: Interventional
• Enrollment (Actual): 289
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Burgas, Bulgaria, 8000
    • MHAT Burgas
  • Plovdiv, Bulgaria, 4003
    • MHAT Plovdiv AD
  • Sofia, Bulgaria, 1612
    • MHAT "Sv. Ivan Rilski"
• Czechia
  • Praha 2, Czechia, 128 50
    • Revmatologicky ustav
  • Praha-Nusle, Czechia, 140 00
    • Revmatologicka ambulance
  • Uherske Hradiste, Czechia, 68601
    • MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o.
  • Zlin, Czechia, 760 01
    • PV-MEDICAL s.r.o.
• Hungary
  • Bekescsaba, Hungary, 5600
    • Rethy Pal Korhaz es Rendelointezet
  • Budapest, Hungary, 1027
    • Revita Clinic Rheumatology
  • Budapest, Hungary, 1027
    • Orszgos Reumatolgiai s Fizioterpis Intzet
  • Budapest,, Hungary, 1027
    • Budai Irgalmasrendi Korhaz
  • Debrecen, Hungary, H-4043
    • Kenezy Hospital Institute of Clinical Pharmacology
• Mexico
  • Guadalajara, Mexico, 44650
    • Dr Javier Orozco Alcala Private Doctor´s office
  • Morelia, Mexico, 58070
    • Centro de Investigacion Clinica de Morelia, S.C.
  • Distrito Federal
    • México, Distrito Federal, Mexico, 6700
      • Cliditer S.A. de C.V.
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr. 2 im. Dr. Jana Biziela
  • Krakow, Poland, 31-637
    • NZOZ Centrum Medyczne ProMiMed
  • Lublin, Poland, 20-582
    • Zespol Poradni Specjalistycznych, REUMED sp. Zo.o
  • Warszawa, Poland, 02-653
    • ARS Rheumatica
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
  • California
    • La Jolla, California, United States, 92093-0943
      • University of California San Diego
    • Palm Desert, California, United States, 92260
      • Desert Medical Advances
    • Palo Alto, California, United States, 94304
      • Stanford University School of Medicine
    • Santa Maria, California, United States, 93454
      • Pacific Arthritis Center Medical Group
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Arthritis Associates of Colorado Springs
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Orlando, Florida, United States, 32804
      • Arthritis Associates
  • Illinois
    • Morton Grove, Illinois, United States, 60053
      • Illinois Bone & Joint Institute; LLC
    • Vernon Hills, Illinois, United States, 60061
      • Deerbrook Medical Asssociates
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Center for Arthritis and Osteoporosis
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • North Carolina
    • Hickory, North Carolina, United States, 28602
      • PMG Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Health Research of Oklahoma
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Clincal Research Center of Reading
  • Tennessee
    • Knoxville, Tennessee, United States, 37909-1907
      • Rheumatology Consultants, PLLC
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Rheumatology Research PA
  • West Virginia
    • Clarksburg, West Virginia, United States, 26301
      • Mountain State Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP015K lowest dose; ASP015K lowest dose once daily	Drug: peficitinib; oral; Other Names: ASP015K
Experimental: ASP015K low dose; ASP015K low dose once daily	Drug: peficitinib; oral; Other Names: ASP015K
Experimental: ASP015K medium dose; ASP015K medium dose once daily	Drug: peficitinib; oral; Other Names: ASP015K
Experimental: ASP015K high dose; ASP015K high dose once daily	Drug: peficitinib; oral; Other Names: ASP015K
Placebo Comparator: Placebo; Matching placebo once daily	Drug: Placebo; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Global Development, Inc.
• Investigators: Study Director: Senior Medical Director, Astellas Pharma Global Development

Publications and helpful links

General Publications

• Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.
• Genovese MC, Greenwald M, Codding C, Zubrzycka-Sienkiewicz A, Kivitz AJ, Wang A, Shay K, Wang X, Garg JP, Cardiel MH. Peficitinib, a JAK Inhibitor, in Combination With Limited Conventional Synthetic Disease-Modifying Antirheumatic Drugs in the Treatment of Moderate-to-Severe Rheumatoid Arthritis. Arthritis Rheumatol. 2017 May;69(5):932-942. doi: 10.1002/art.40054.

Helpful Links

• Link to results on the Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2012
• Primary Completion (Actual): December 2, 2013
• Study Completion (Actual): December 2, 2013

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimated): March 29, 2012

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; ASP015K
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Peficitinib
• Other Study ID Numbers: 015K-CL-RA22; 2011-006020-20 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
• IPD Sharing Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• IPD Sharing Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR