Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement

Incyte Corporation77 enrolled

Overview

This is a randomized, double blind, vehicle controlled Phase 2 study with a 4-week open label extension in adolescent and adult participants with atopic dermatitis and head and/or neck involvement. It is intended to compare the efficacy and safety of ruxolitinib cream 1.5% BID versus vehicle cream, then further evaluate ruxolitinib cream as maintenance during the open label extension period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Ruxolitinib creamDRUG

Ruxolitinib cream 1.5% applied twice a day (BID)"

VehicleDRUG

Vehicle cream applied twice a day (BID) to affected areas

Eligibility

Sex: ALLMin age: 12 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with diagnosis of AD for at least 6 months. * Participants with an overall and a face and/or neck IGA score of 2 or 3 at screening and baseline. * Participants with AD affecting the following at screening and baseline: 1. ≥ 0.5% of the total BSA on the face and/or neck 2. Up to a total of 20% BSA (face and/or neck plus other body areas) * Willingness to avoid pregnancy or fathering children based on the criteria outlined in the protocol. * Further inclusion criteria apply. Exclusion Criteria: * Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline. * Participants with concurrent conditions and history of other diseases such as immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with the evaluation of AD or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids. * Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * Previous treatment with systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib). * Participants who are pregnant (or who are considering pregnancy) or lactating. * Laboratory values outside of the protocol -defined criteria * Further exclusion criteria apply.

Locations (1)

Science37

Culver City, California, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Achieve a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) of the Head and Neck Region at Week 4

The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck.

Time frame: Baseline; Week 4

Secondary Outcomes

Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8

Time frame: Baseline; Weeks 2 and 8

Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8

Data from ClinicalTrials.gov

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The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.

Time frame: Baseline; Weeks 2, 4, and 8

Double-Blind Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

A TEAE was defined as any adverse event (AE) either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug.

Time frame: up to approximately 4 weeks plus 30 days

Open-Label Period: Number of Participants With Any TEAE

Time frame: from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days)

Double-Blind Period: Number of Participants With Any Grade 3 or Higher TEAE

A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. The severity of AEs was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grades 1 to 5). Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE.

Time frame: up to approximately 4 weeks plus 30 days

Open-Label Period: Number of Participants With Any Grade 3 or Higher TEAE

Time frame: from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days)