Clinical trial NCT05127421: Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
Official title: A Phase 2, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
adolescent
adults
in-home
telemedicine
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 77
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is 2:1 assignment to rux and vehicle creams.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline; Week 4
Secondary outcomes:
measure: Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8
timeFrame: Baseline; Weeks 2 and 8
measure: Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8
timeFrame: Baseline; Weeks 2, 4, and 8
measure: Double-Blind Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to approximately 4 weeks plus 30 days
measure: Open-Label Period: Number of Participants With Any TEAE
timeFrame: 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)
measure: Double-Blind Period: Number of Participants With Any Grade 3 or Higher TEAE
timeFrame: up to approximately 4 weeks plus 30 days
measure: Open-Label Period: Number of Participants With Any Grade 3 or Higher TEAE
timeFrame: 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)
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Science37
state: California
Study officials:
affiliation: Incyte Corporation
name: Haq Nawaz, MD
role: STUDY_DIRECTOR
References: