Deucravacitinib Rosacea
NCT Number: NCT06532136
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Papulopustular Rosacea
Interventions: DRUG: Deucravacitinib|DRUG: Placebo
Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-01
Locations: Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States

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.

Primary Outcome Measures: 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., Baseline and Week 8
Secondary Outcome Measures: 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., 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., 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)., 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., 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., 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., 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., 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., 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., 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., 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., Baseline, Week 4, Week 4, Week 8, Week 12, Week 16