Phase 2
N=77
Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT05127421 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: 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 — 17.4; 37.0 percentage of participants — p=0.091
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib cream (Drug); Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
17.4; 37.0 | 0.091 |
| SECONDARY Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8 |
16.7; 14.6; 35.3; 53.3 | — |
| SECONDARY Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8 |
5.6; 10.4; 33.3; 29.2; 35.3; 33.3 | — |
| SECONDARY Double-Blind Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
5; 6 | — |
| SECONDARY Open-Label Period: Number of Participants With Any TEAE |
4; 9 | — |
| SECONDARY Double-Blind Period: Number of Participants With Any Grade 3 or Higher TEAE |
0; 1 | — |
| SECONDARY Open-Label Period: Number of Participants With Any Grade 3 or Higher TEAE |
1; 1 | — |
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:
- ≥ 0.5% of the total BSA on the face and/or neck
- 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.
Data sourced from ClinicalTrials.gov (NCT05127421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.