Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Incyte Corporation
- Study ID
- NCT05936567
- Phase
- PHASE2
- Status
- Completed
Conditions
- Angioedema
- Chronic Idiopathic Urticaria
- Chronic Spontaneous Urticaria
- Hives
- Pruritis
- Urticaria
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Povorcitinib — DRUGoral; tablet
- Placebo — DRUGoral; tablet
Study Details
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
Key Dates
- Start date
- Jul 31, 2023
- Status verified
- Mar 2026
- Primary completion
- Feb 28, 2025
- Completion
- Oct 9, 2025
Study Design
- Enrollment
- 136 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Povorcitinib Dose AParticipants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.
- Experimental: Povorcitinib Dose BParticipants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.
- Experimental: Povorcitinib Dose CParticipants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
- Experimental: Placebo followed by Povorcitinib Dose A, B, or CParticipants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period.
Primary Outcome Measure
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 [ Time Frame: Baseline; Week 12 ]
Locations (22)
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