WithdrawnPhase 2

Deucravacitinib Rosacea

Stopped: This study is being closed due to sponsor withdrawal of funding and support.

United States0Started 2024-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female participants ≥ 18 years of age at the time of signing the informed consent document. * Participant is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures. * Participant is able to adhere to the study visit schedule and other protocol requirements. * Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12 * Participant agrees to discontinue all treatments for PPR from screening through study completion aside from the study drug * Participant is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a participant does not have uncontrolled significant co-morbid conditions). * Participant agrees not to receive a live vaccine during the study and for at least 4 weeks after the last study drug dose. * Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on the study drug and for at least 90 days after the last dose of the study drug, male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: * Option 1: Any one of the following highly effective contracept…

What they're measuring

Percent change in inflammatory lesion (papule/pustule) count

Timeframe: Baseline and Week 8

Trial details

NCT IDNCT06532136

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01