A Phase 2 interventional study of Deucravacitinib and Placebo in Papulopustular Rosacea, sponsored by Icahn School of Medicine at Mount Sinai. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Treatment
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.
After providing consent, all subjects will be assessed for study eligibility, which includes a review of the subjects past and current medical conditions, familial medical history and detailed review of past and current medications. Subjects will also undergo a review of past topical treatments/therapies for PPR, and clinical assessments (inflammatory lesion count, IGA, CEA, PSA). Subjects will have urine (for urinalysis) and blood (for Complete Blood Count with differential, Comprehensive Metabolic Panel, lipid panel, creatinine kinase, C-Reactive Protein, HIV, HCV and HBV) collected for safety analysis. In addition, subjects will be screened for tuberculosis via PPD or quantiferon gold testing, and pregnancy (if applicable) via serum pregnancy test.
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:
The female participant's chosen form of contraception must be effective by the time the female participant is enrolled into the study.
Exclusion Criteria:
The presence of any of the following will exclude a participant from enrollment:
ANY of the following abnormalities in the clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary
Participants receiving 6mg deucravacitinib once daily for 8 weeks. Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16.
Drug: Deucravacitinib
Participants receiving 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.
Drug: Deucravacitinib · Drug: Placebo
Deucravacitinib 6 mg orally once daily.
Matching placebo orally once daily.
Percent change in inflammatory lesion (papule/pustule) count
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.
Time frame: Baseline and Week 8
Investigator Global Assessment (IGA) Success
IGA Success is defined by a clear (0) or almost clear (1) and a reduction from baseline of ≥ 2 points score of 0 or 1 at weeks 4, 8, 12, and 16 in deucravacitinib-treated patients. IGA is a 5-point scale defined by the following parameters: 0 (clear), 1 (almost clear), 2 (mild disease), 3 (moderate disease), 4 (severe disease), with higher rating indicating more severe outcomes.
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
The Clinical Erythema Assessment
The Clinical Erythema Assessment assesses the redness of skin. This outcome is measuring change in erythema. It is defined by the following parameters: 0 - Clear (clear skin with no signs of erythema), 1 - Almost Clear (almost clear, slight redness), 2 - Mild (mild erythema; definite redness), 3 - Moderate (moderate erythema; marked redness), 4 - Severe (severe erythema; fiery redness). Higher rating indicates more severe outcomes.
Time frame: Week 4, Week 4, Week 8, Week 12, Week 16
The Clinical Patient Severity Assessment
The Clinical Patient Severity Assessment assesses the patient's perspective of the redness of their skin. This outcome is measuring change in patient's perspective of erythema. It is defined by the following parameters: 0 - Clear (clear of unwanted redness), 1 - Almost Clear (nearly clear of wanted redness), 2 - Mild (somewhat more redness than I prefer), 3 - Moderate (more redness than I prefer), 4 - Severe (completely unacceptable redness).
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Change from baseline in The Dermatology Life Quality Index (DLQI
The Dermatology Life Quality Index (DLQI) measures how much the patient's rosacea has affected their life over the previous week. It is a 10 question instrument. This outcome is measuring change in quality of life impaired by rosacea. The answer to each question is scored according to the following: Question unanswered - scored 0, Not relevant - scored 0, Not at all - scored 0, A little - scored 1, A lot - scored 2, Very much - scored 3. The DLQI is calculated by summing the score of each question. The maximum score is 30 and the minimum score is 0. A higher score represents a quality of life that is more impaired. Overall DLQI scores are defined as 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11 - 20 = very large effect on patient's life, 21 -30 = extremely large effect on patient's life.
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Change from baseline in Ocular Surface Disease Index (OSDI)
The Ocular Surface Disease Index (OSDI) is used for measuring dry eye disease in patients. This outcome is measuring change in dry eye disease and effect on vision-related function. OSDI is a 12 question instrument. The answer to each question is scored according to the following: All of the time - scored 4, Most of the time - scored 3, Half of the time - scored 2, Some of the time - scored 1, None of the time - scored 0. OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Change in Inflammatory (papule/pustule) lesion count
Change from Baseline and from Week 8 in inflammatory (papule/pustule) lesion count at Week 16. A lesser lesion count at Week 16 indicates disease improvement.
Time frame: Baseline, Week 8, Week 16
Change from baseline in IGA score at 4, 8, 12, and 16 weeks
Change from Baseline in IGA score at Week 4, 8, 12, and 16. IGA is a 5-point scale defined by the following parameters: 0 (clear), 1 (almost clear), 2 (mild disease), 3 (moderate disease), 4 (severe disease). A decrease in IGA indicated improvement in disease, while an increase in IGA indicates worsening disease.
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Percent change from baseline in IGA score at 4, 8, 12, and 16 weeks
Percent change from Baseline in IGA score at Week 4, 8, 12, and 16. IGA is a 5-point scale defined by the following parameters: 0 (clear), 1 (almost clear), 2 (mild disease), 3 (moderate disease), 4 (severe disease). A decrease in IGA indicated improvement in disease, while an increase in IGA indicates worsening disease.
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Frequency Adverse Events (AEs)
Safety and tolerability will be evaluated from the frequency of AEs.
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Duration of AEs
Safety and tolerability will be evaluated from the duration of AEs. This outcome will assess the safety of treatment.
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Severity of AEs
Safety and tolerability will be evaluated from the severity of AEs. Severity of AEs is measured through a grading system Common Terminology Criteria for Adverse Events (CTCAE), which assigns severity grades ranging from 1 to 5. The scale is as follows: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Potentially life-threatening Grade 5: Results in Death Mild is defined as not significantly interfering with the patient's usual function. Moderate is defined as interfering to some extent with the patient's usual function. Severe is defined as preventing the patient from performing their usual functions.
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Plan to share: No — Results will be provided as aggregated data.
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Icahn School of Medicine at Mount Sinai