A Study of Zasocitinib for Psoriatic Arthritis
This study is looking at how well zasocitinib works for adults with psoriatic arthritis (PsA), a long-lasting condition that affects your joints and skin. You might be able to join if you have PsA, are at least 18 years old, and haven't taken certain biologic medicines before. Participants will receive either zasocitinib, an active comparator (another drug), or a placebo (an inactive pill that looks like the study drug). The main goal is to see if zasocitinib helps improve your PsA symptoms by Week 16, measured by a standard assessment called ACR20. The study plans to enroll about 1088 people and will last up to 60 weeks.
- Study design
- This interventional study plans to enroll about 1088 adult participants with psoriatic arthritis. Participants will be randomly assigned to receive zasocitinib, an active comparator, or a placebo.
- What's involved
- Participants will be in the study for up to 60 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at Week 16.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
At a glance
Conditions
Where it's being run
188 sites across 87 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to PlaceboAt Week 16
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as: greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and \>=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of psoriatic arthritis (PsA) pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.