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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT05127421

Run by

Incyte Corporation

People needed

77

Starts

2021-11-10

Expected to finish

2023-09-29

Last updated by the study team

2024-08-15

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Science37 — Culver City, California, United States

Full record on ClinicalTrials.gov

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