Povorcitinib for Chronic Spontaneous Urticaria

Recruiting in Palo Alto (17 mi)

+50 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called povorcitinib for adults with a chronic skin condition called CSU. These patients haven't found relief with standard treatments. The medication works by reducing the body's overactive immune response.

Eligibility Criteria

Adults with Chronic Spontaneous Urticaria (CSU) not responding well to standard antihistamines can join. They must have had CSU for at least 3 months, be on a stable dose of second-generation H1 antihistamine, and stick to their current treatment plan during the trial. People with other chronic itching diseases or who've used certain biologics recently can't participate.

Inclusion Criteria

My chronic hives don't improve with standard allergy pills.

I have been taking a consistent dose of a second-generation antihistamine and will continue to do so.

I have been diagnosed with chronic spontaneous urticaria for at least 3 months.

Exclusion Criteria

My chronic hives have a known cause other than chronic spontaneous urticaria.

I am not pregnant, considering pregnancy, or breastfeeding.

I have had an organ transplant and am on ongoing immunosuppressants.

I have a long-lasting or frequently returning infection.

I have a history of serious blood, heart, or circulation problems.

Participant Groups

The trial is testing Povorcitinib's effectiveness and safety in adults whose CSU isn't controlled by usual treatments. Participants will either receive Povorcitinib or a placebo without knowing which one they're getting to compare results fairly.

4Treatment groups

Experimental Treatment

Group I: Povorcitinib Dose CExperimental Treatment1 Intervention

Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.

Group II: Povorcitinib Dose BExperimental Treatment1 Intervention

Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.

Group III: Povorcitinib Dose AExperimental Treatment1 Intervention

Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.

Group IV: Placebo followed by Povorcitinib Dose A, B, or CExperimental Treatment2 Interventions

Participants 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.