Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
Recruiting · NCT07286058 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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).
- 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.
- 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).
Where it is running
60 locations listed across 8 US states.
- Jeffrey Loomer, MD Arizona Arthritis & Rheumatology Research - Tucson, Arizona, United States
- First OC Dermatology Research Inc. - Fountain Valley, California, United States
- Purushotham & Akther Kotha MD - La Mesa, California, United States
- Triwest Research Associates LLC - La Mesa, California, United States
- The Cohen Medical Centers - Thousand Oaks, California, United States
- Denver Arthritis Clinic - Lowry - Denver, Colorado, United States
- Direct Helpers Research Center - Hialeah, Florida, United States
- Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research - Hialeah, Florida, United States
- IRIS Research and Development - Plantation, Florida, United States
- Klein and Associates, M.D., P.A. - Hagerstown, Maryland, United States
- Paramount Medical Research & Consulting, LLC - Middleburg Heights, Ohio, United States
- West Tennessee Research Institute - Jackson, Tennessee, United States
- Accurate Clinical Research - Baytown, Texas, United States
- Novel Research LLC - Bellaire, Texas, United States
- Novel Research | Abigail Neiman - Houston, TX - Houston, Texas, United States
- Northwest Houston Arthritis Center - Houston, Texas, United States
- West Texas Clinical Research - Lubbock, Texas, United States
- Southwest Rheumatology Research, LLC - Mesquite, Texas, United States
- Advanced Rheumatology of Houston - The Woodlands, Texas, United States
- INTER CLINIC Piotr Adrian Klimiuk - Bialystok, Poland
- Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik - Bialystok, Poland
- Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty - Bialystok, Poland
- NZOZ BIF-MED S.C. Arkadiusz Wawiernia, Mariola Roykiewicz, Rafal Roykiewicz - Bytom, Poland
- Centro Reumatologico de Caguas - Caguas, Puerto Rico
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital - Chengdu, China
- CGM Research Trust - Christchurch Central, New Zealand
- Hamburger Rheuma Forschungszentrum (HRF II) II - Hamburg, Germany
- Pratia MCM Krakow - Krakow, Poland
- Galilee Medical Center - Nahariya, Israel
- Porter Rheumatology Ltd - Nelson, New Zealand
- Twoja Przychodnia - Nowosolskie Centrum Medyczne sp. z o.o - Nowa Sól, Poland
- Twoja Przychodnia Opolskie Centrum Medyczne - Opole, Poland
- CCR Ostrava s.r.o. - Ostrava, Czechia
- Pratia Czech s.r.o. - Pardubice, Czechia
- Pratia Poznań - Poznan, Poland
- Twoja Przychodnia - Poznanskie Centrum Medyczne Sp. z o.o. - Poznan, Poland
- Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj - Poznan, Poland
- Praglandia - Prague, Czechia
- Orto klīnika - Riga, Latvia
- Clinical Hospital Center Rijeka - PPDS - Rijeka, Croatia
- GCM Medical Group, PSC - San Juan, Puerto Rico
- RCMed Oddzial Sochaczew - Sochaczew, Poland
- Clinical Trial Center of Chung Shan Medical University Hospital - Taichung, Taiwan
- Innomedica OU - Tallinn, Estonia
- North Estonia Medical Centre Foundation - Tallinn, Estonia
- Clinical Research Centre Ltd - Tartu, Estonia
- MediTrials OÜ - Tartu, Estonia
- MICS Centrum Medyczne Torun - Torun, Poland
- MEDICAL Plus s.r.o. - Uherské Hradiště, Czechia
- Vital Medical Center - Veszprém, Hungary
- Rheuma Medicus Sp. z o.o. - Warsaw, Poland
- MTZ Clinical Research Powered by PRATIA - PPDS - Warsaw, Poland
- Centrum Medyczne Reuma Park - Warsaw, Poland
- ETG Warszawa Sp. z o.o. - Warsaw, Poland
- FutureMeds Wroclaw - Wroclaw, Poland
- Pv Medical Services - Zlín, Czechia
- Kojunkai Social Medical Corporation Daido Clinic - Minami-ku, Nagoya-shi, Aichi-ken, Japan
- Nagoya City University Hospital - Nagoya, Aichi-ken, Japan
- The First Affiliated Hospital Of Bengbu Medical College - Bengbu, Anhui, China
- Peking University Third Hospital - Beijing, Beijing Municipality, China
Showing 60 of 78 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →