Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
Purpose
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.
Condition
- Psoriatic Arthritis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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. 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
- 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
First OC Dermatology Research Inc.
Fountain Valley, California 92708
Fountain Valley, California 92708
The Cohen Medical Centers
Thousand Oaks, California 91360-3967
Thousand Oaks, California 91360-3967
Denver Arthritis Clinic - Lowry
Denver, Colorado 80230
Denver, Colorado 80230
Direct Helpers Research Center
Hialeah, Florida 33012
Hialeah, Florida 33012
IRIS Research and Development
Plantation, Florida 33324
Plantation, Florida 33324
Klein and Associates, M.D., P.A.
Hagerstown, Maryland 21740-6138
Hagerstown, Maryland 21740-6138
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio 44130
Middleburg Heights, Ohio 44130
West Tennessee Research Institute
Jackson, Tennessee 38305
Jackson, Tennessee 38305
Accurate Clinical Research
Baytown, Texas 77521
Baytown, Texas 77521
Novel Research LLC
Bellaire, Texas 77401
Bellaire, Texas 77401
Northwest Houston Arthritis Center
Houston, Texas 77090
Houston, Texas 77090
West Texas Clinical Research
Lubbock, Texas 79424
Lubbock, Texas 79424
Centro Reumatologico de Caguas
Caguas, Puerto Rico 00725
Caguas, Puerto Rico 00725
More Details
- Status
- Recruiting
- Sponsor
- Takeda