A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin. The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time. Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD). Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \>=19 years of age.
• The participant has completed the 52-week treatment period in one of the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002) independent of treatment assignment, and without meeting the criteria for permanent discontinuation of trial intervention defined in the parent studies.
• The participant must be deemed by the investigator to benefit from continued or newly initiated (that is, for participants randomized to active comparator in parent study TAK-279-PsA-3001) zasocitinib therapy.
Locations
United States
California
First OC Dermatology Research Inc.
RECRUITING
Fountain Valley
Purushotham & Akther Kotha MD
RECRUITING
La Mesa
Triwest Research Associates LLC
RECRUITING
La Mesa
The Cohen Medical Centers
RECRUITING
Thousand Oaks
Colorado
Denver Arthritis Clinic - Lowry
RECRUITING
Denver
Florida
Direct Helpers Research Center
RECRUITING
Hialeah
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
RECRUITING
Hialeah
IRIS Research and Development
RECRUITING
Plantation
Maryland
Klein and Associates, M.D., P.A.
RECRUITING
Hagerstown
Ohio
Paramount Medical Research & Consulting, LLC
RECRUITING
Middleburg Heights
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Texas
Accurate Clinical Research
RECRUITING
Baytown
Novel Research LLC
RECRUITING
Bellaire
Northwest Houston Arthritis Center
RECRUITING
Houston
Novel Research | Abigail Neiman - Houston, TX
RECRUITING
Houston
West Texas Clinical Research
RECRUITING
Lubbock
Advanced Rheumatology of Houston
RECRUITING
The Woodlands
Other Locations
Australia
R.K. Will Pty Ltd
RECRUITING
Victoria Park
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Guangzhou First People's Hospital
RECRUITING
Guangzhou
Linyi People's Hospital
RECRUITING
Linyi Shi
First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital
RECRUITING
Zhuzhou
Estonia
North Estonia Medical Centre Foundation
RECRUITING
Tallinn
MediTrials OÜ
RECRUITING
Tartu
Germany
Hamburger Rheuma Forschungszentrum (HRF II) II
RECRUITING
Hamburg
Israel
Galilee Medical Center
RECRUITING
Nahariya
Japan
St. Luke's International Hospital
RECRUITING
Chuo-ku
National Hospital Organization Tokyo Medical Center
RECRUITING
Meguro-ku
Kyorin University Hospital
RECRUITING
Mitaka-shi
Nagoya City University Hospital
RECRUITING
Nagoya
Nippon Life Hospital
RECRUITING
Osaka
Mie University Hospital
RECRUITING
Tsu, Mie
Poland
INTER CLINIC Piotr Adrian Klimiuk
RECRUITING
Bialystok
Pratia MCM Krakow
RECRUITING
Krakow
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj
RECRUITING
Poznan
MICS Centrum Medyczne Torun
RECRUITING
Torun
Centrum Medyczne Reuma Park
RECRUITING
Warsaw
ETG Warszawa Sp. z o.o.
RECRUITING
Warsaw
MTZ Clinical Research Powered by PRATIA - PPDS
RECRUITING
Warsaw
Puerto Rico
Centro Reumatologico de Caguas
RECRUITING
Caguas
GCM Medical Group, PSC
RECRUITING
San Juan
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date:2026-03-11
Estimated Completion Date:2029-12-18
Participants
Target number of participants:1182
Treatments
Experimental: Zasocitinib Dose A or Dose B
Participants assigned to zasocitinib in the either parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) will continue to receive zasocitinib Dose A or Dose B at the same dose, oral tablets, QD for up to Week 104.
Experimental: Re-randomized Participants - Zasocitinib Dose A or Dose B
Participants assigned to active comparator in the parent study (TAK-279-PsA-3001 \[NCT06671483\]) will be re-randomized to blinded treatment with zasocitinib Dose A or Dose B, oral tablets, QD for up to Week 104.