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 5289282, Arizona 5551752 85225
Phoenix 5308655, Arizona 5551752 85032
Phoenix 5308655, Arizona 5551752 85032
Phoenix 5308655, Arizona 5551752 85306
Fountain Valley 5350207, California 5332921 92708
La Mesa 5363990, California 5332921 91942
La Mesa 5363990, California 5332921 91942
Thousand Oaks 5402405, California 5332921 91360-3967
Tujunga 5403767, California 5332921 91042
Whittier 5409059, California 5332921 90602-1005
Denver 5419384, Colorado 5417618 80230
Aventura 4146429, Florida 4155751 33180
Boca Raton 4148411, Florida 4155751 33486-1390
Clearwater 4151316, Florida 4155751 33765
Cooper City 4151824, Florida 4155751 33024
Coral Gables 4151871, Florida 4155751 33134-3901
Davie 4152820, Florida 4155751 33024
Hialeah 4158476, Florida 4155751 33016
Miami 4164138, Florida 4155751 33143
Orlando 4167147, Florida 4155751 32819
Ormond Beach 4167178, Florida 4155751 32174
Plantation 4168782, Florida 4155751 33324
Sarasota 4172131, Florida 4155751 34239
Tamarac 4174738, Florida 4155751 33321
Tampa 4174757, Florida 4155751 33606
Marietta 4207783, Georgia 4197000 30060
Orland Park 4904937, Illinois 4896861 60467
Schaumburg 4910713, Illinois 4896861 60195
Lake Charles 4330236, Louisiana 4331987 70605
Hagerstown 4357141, Maryland 4361885 21740
Grand Blanc 4994320, Michigan 5001836 48439-2451
Howell 4996655, Michigan 5001836 48843
Lansing 4998830, Michigan 5001836 48911-4285
Saint Clair Shores 5010978, Michigan 5001836 48081
St Louis 4407066, Missouri 4398678 63119
Albuquerque 5454711, New Mexico 5481136 87102-1710
Santa Fe 5490263, New Mexico 5481136 87505-1102
Hickory 4470778, North Carolina 4482348 28602
Cleveland 5150529, Ohio 5165418 44106
Middleburg Heights 5162851, Ohio 5165418 44130
Wyomissing 5220248, Pennsylvania 6254927 19610-3206
Jackson 4632595, Tennessee 4662168 38305
Baytown 4672731, Texas 4736286 77521
Houston 4699066, Texas 4736286 77024
Houston 4699066, Texas 4736286 77024
Houston 4699066, Texas 4736286 77089
Houston 4699066, Texas 4736286 77090
Lubbock 5525577, Texas 4736286 79424
Mesquite 4710826, Texas 4736286 75150
Plano 4719457, Texas 4736286 75075
Spokane 5811696, Washington 5815135 99204
Caguas 4563008, Puerto Rico 00725
San Juan 4568127, Puerto Rico 00917
More Details
- Status
- Recruiting
- Sponsor
- Takeda