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Treatment of Moderate-to-severe Papulopustular Rosacea With Deucravacitinib
This will be a double-blind, randomized placebo-controlled study in which participants will be randomized 2:1 to receive 6 mg deucravacitinib or placebo once daily for 8 weeks, followed by an open label extension during which all participants will receive 6 mg deucravacitinib once daily for an additional 8 weeks. The open-label extension has been incorporated in order to ensure all participants receive benefit from the study, as well as to benefit from the intra-patient comparison of placebo to drug, and to provide longer-term clinical data. The study will include 33 adult participants with moderate-to-severe Papulopustular Rosacea (PPR). participants will have baseline Investigator Global Assessment (IGA) score of at least 3 and at least 12 inflammatory lesions. Beginning at Baseline/Week 0 enrolled participants will receive 6mg deucravacitinib or placebo once daily for 8 weeks. At week 8, those participants originally randomized to placebo will initiate dosing with 6mg deucravacitinib once daily for 8 weeks until Week 16. Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16. All participants will return for visits at Weeks 4, 8, 12 and 16 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip collection, blood and urine sample collections, and monitoring for adverse events.
Details
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2024-11 |
| Completion | 2026-01 |
Conditions
- Papulopustular Rosacea
Interventions
- Deucravacitinib
- Placebo
Primary outcomes
- Percent change in inflammatory lesion (papule/pustule) count — Baseline and Week 8
This outcome looks at the percent change in inflammatory lesion presence (papule/pustule) from Baseline and Week 8 in deucravacitinib-treated vs. placebo patients. Lesions will be physically counted.
Countries
United States