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Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis

NCT07286058 · Takeda
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Official title
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
About this study
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 criteria
Inclusion Criteria: 1. 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. 2. 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. 3. 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. Exclusion Criteria: 1. Any participant who is deemed by the investigator to be not benefiting from the trial intervention based upon lack of improvement or worsening of their symptoms in the respective parent study. 2. Any participant who met the criteria for permanent discontinuation of trial intervention defined in the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002). 3. The participant has developed any disease(s) that might confound the evaluations of benefit of zasocitinib therapy since enrollment in the respective parent study, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia. 4. The participant has developed evidence of a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).
Study design
Enrollment target: 1182 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-03-11
Estimated completion: 2029-12-18
Last updated: 2026-09-09
Interventions
Drug: Zasocitinib
Primary outcomes
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From start of study drug administration up to follow-up (up to Week 108))
  • Number of Participants With Adverse Events of Special Interest (AESI) (From start of study drug administration up to follow-up (up to Week 108))
  • Number of Participants With Clinically Significant Changes in Vital Sign Values (From start of study drug administration up to follow-up (up to Week 108))
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (78)
Jeffrey Loomer, MD Arizona Arthritis & Rheumatology ResearchRecruiting
Tucson, Arizona, United States
First OC Dermatology Research Inc.Recruiting
Fountain Valley, California, United States
Purushotham & Akther Kotha MDRecruiting
La Mesa, California, United States
Triwest Research Associates LLCRecruiting
La Mesa, California, United States
The Cohen Medical CentersRecruiting
Thousand Oaks, California, United States
Denver Arthritis Clinic - LowryRecruiting
Denver, Colorado, United States
Direct Helpers Research CenterRecruiting
Hialeah, Florida, United States
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical ResearchRecruiting
Hialeah, Florida, United States
IRIS Research and DevelopmentRecruiting
Plantation, Florida, United States
Klein and Associates, M.D., P.A.Recruiting
Hagerstown, Maryland, United States
Paramount Medical Research & Consulting, LLCRecruiting
Middleburg Heights, Ohio, United States
West Tennessee Research InstituteRecruiting
Jackson, Tennessee, United States
Accurate Clinical ResearchRecruiting
Baytown, Texas, United States
Novel Research LLCRecruiting
Bellaire, Texas, United States
Novel Research | Abigail Neiman - Houston, TXRecruiting
Houston, Texas, United States
Northwest Houston Arthritis CenterRecruiting
Houston, Texas, United States
West Texas Clinical ResearchRecruiting
Lubbock, Texas, United States
Southwest Rheumatology Research, LLCRecruiting
Mesquite, Texas, United States
Advanced Rheumatology of HoustonRecruiting
The Woodlands, Texas, United States
R.K. Will Pty LtdRecruiting
Victoria Park, Western Australia, Australia
The First Affiliated Hospital Of Bengbu Medical CollegeRecruiting
Bengbu, Anhui, China
Peking University Third HospitalRecruiting
Beijing, Beijing Municipality, China
Peking Union Medical College HospitalRecruiting
Beijing, Beijing Municipality, China
Guangzhou First People's HospitalRecruiting
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)Recruiting
Wuhan, Hubei, China
Central South University - Xiangya School of Medicine - Zhuzhou Central HospitalRecruiting
Zhuzhou, Hunan, China
The First Affiliated Hospital of Baotou Medical CollegeRecruiting
Baotou Shi, Inner Mongolia, China
Jiangxi Pingxiang People's HospitalRecruiting
Pingxiang, Jiangxi, China
Linyi People's HospitalRecruiting
Linyi Shi, Shandong, China
First Hospital of Shanxi Medical UniversityRecruiting
Taiyuan, Shanxi, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's HospitalRecruiting
Chengdu, China
Clinical Hospital Center Rijeka - PPDSRecruiting
Rijeka, Croatia
CCR Ostrava s.r.o.Recruiting
Ostrava, Czechia
Pratia Czech s.r.o.Recruiting
Pardubice, Czechia
PraglandiaRecruiting
Prague, Czechia
MEDICAL Plus s.r.o.Recruiting
Uherské Hradiště, Czechia
Pv Medical ServicesRecruiting
Zlín, Czechia
Innomedica OURecruiting
Tallinn, Estonia
North Estonia Medical Centre FoundationRecruiting
Tallinn, Estonia
Clinical Research Centre LtdRecruiting
Tartu, Estonia
MediTrials OÜRecruiting
Tartu, Estonia
Hamburger Rheuma Forschungszentrum (HRF II) IIRecruiting
Hamburg, Germany
Vital Medical CenterRecruiting
Veszprém, Hungary
Galilee Medical CenterRecruiting
Nahariya, Israel
Kojunkai Social Medical Corporation Daido ClinicRecruiting
Minami-ku, Nagoya-shi, Aichi-ken, Japan
Nagoya City University HospitalRecruiting
Nagoya, Aichi-ken, Japan
Fukuoka University HospitalRecruiting
Fukuoka, Hukuoka, Japan
Mie University HospitalRecruiting
Tsu, Mie, Mie-ken, Japan
Sasebo Chuo HospitalRecruiting
Sasebo-shi, Nagasaki, Japan
Nippon Life HospitalRecruiting
Osaka, Osaka, Japan
St. Luke's International HospitalRecruiting
Chuo-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical CenterRecruiting
Meguro-Ku, Tokyo, Japan
Kyorin University HospitalRecruiting
Mitaka-shi, Tokyo-To, Japan
Orto klīnikaRecruiting
Riga, Latvia
CGM Research TrustRecruiting
Christchurch Central, New Zealand
Porter Rheumatology LtdRecruiting
Nelson, New Zealand
INTER CLINIC Piotr Adrian KlimiukRecruiting
Bialystok, Poland
Zdrowie Osteo Medic sc L i A Racewicz, A i J SupronikRecruiting
Bialystok, Poland
Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i FizjoterapeutyRecruiting
Bialystok, Poland
NZOZ BIF-MED S.C. Arkadiusz Wawiernia, Mariola Roykiewicz, Rafal RoykiewiczRecruiting
Bytom, Poland
Pratia MCM KrakowRecruiting
Krakow, Poland
Twoja Przychodnia - Nowosolskie Centrum Medyczne sp. z o.oRecruiting
Nowa Sól, Poland
Twoja Przychodnia Opolskie Centrum MedyczneRecruiting
Opole, Poland
Pratia PoznańRecruiting
Poznan, Poland
Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o.Recruiting
Poznan, Poland
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel HrycajRecruiting
Poznan, Poland
RCMed Oddzial SochaczewRecruiting
Sochaczew, Poland
MICS Centrum Medyczne TorunRecruiting
Torun, Poland
Rheuma Medicus Sp. z o.o.Recruiting
Warsaw, Poland
MTZ Clinical Research Powered by PRATIA - PPDSRecruiting
Warsaw, Poland
Centrum Medyczne Reuma ParkRecruiting
Warsaw, Poland
ETG Warszawa Sp. z o.o.Recruiting
Warsaw, Poland
FutureMeds WroclawRecruiting
Wroclaw, Poland
Centro Reumatologico de CaguasRecruiting
Caguas, Puerto Rico
GCM Medical Group, PSCRecruiting
San Juan, Puerto Rico
Hospital Universitario Marques de ValdecillaRecruiting
Santander, Cantabria, Spain
Clinical Trial Center of Chung Shan Medical University HospitalRecruiting
Taichung, Taiwan
Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis · TrialPath