A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Purpose
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.
Condition
- Psoriatic Arthritis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Age: 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. Disease Characteristics: 2. The participant has a diagnosis of PsA. 3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening. 4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria). 5. The participant has active arthritis as shown by a minimum of >=3 tender joints in TJC68 and >=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits. 6. The participant has at least 1 active lesion of plaque PsO >=2 cm in diameter, or any nail or nail bed changes characteristic of PsO. Medications for PsA: 7. The participant has had at least one of the following: 1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union [EU]/ European Economic Area [EEA]), OR 2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).
Exclusion Criteria
PsA and PsO: 1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia. 2. The participant has 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 |
Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52. |
|
|
Experimental Zasocitinib Dose B |
Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52. |
|
|
Active Comparator Active Comparator Dose C |
Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52. |
|
|
Experimental Placebo + Zasoctinib |
Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52. |
|
Recruiting Locations
Chandler, Arizona 85225
Phoenix, Arizona 85032
Phoenix, Arizona 85032
Phoenix, Arizona 85306
Fountain Valley, California 92708
La Mesa, California 91942
La Mesa, California 91942
Thousand Oaks, California 91360-3967
Tujunga, California 91042
Whittier, California 90602-1005
Denver, Colorado 80230
Aventura, Florida 33180
Boca Raton, Florida 33486-1390
Clearwater, Florida 33765
Cooper City, Florida 33024
Coral Gables, Florida 33134-3901
Davie, Florida 33024
Hialeah, Florida 33016
Miami, Florida 33143
Ormond Beach, Florida 32174
Plantation, Florida 33324
Sarasota, Florida 34239
Tamarac, Florida 33321
Tampa, Florida 33606
Marietta, Georgia 30060
Schaumburg, Illinois 60195
Lake Charles, Louisiana 70605
Hagerstown, Maryland 21740
Grand Blanc, Michigan 48439-2451
Howell, Michigan 48843
Lansing, Michigan 48911-4285
Saint Clair Shores, Michigan 48081
St Louis, Missouri 63119
Albuquerque, New Mexico 87102-1710
Santa Fe, New Mexico 87505-1102
Brooklyn, New York 11201
Hickory, North Carolina 28602
Cleveland, Ohio 44106
Middleburg Heights, Ohio 44130
Wyomissing, Pennsylvania 19610-3206
Jackson, Tennessee 38305
Baytown, Texas 77521
Houston, Texas 77024
Houston, Texas 77024
Houston, Texas 77089
Houston, Texas 77090
Lubbock, Texas 79424
Mesquite, Texas 75150
Plano, Texas 75075
Spokane, Washington 99204
Caguas, Puerto Rico 00725
San Juan, Puerto Rico 00917
More Details
- Status
- Recruiting
- Sponsor
- Takeda