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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2023-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is 2:1 assignment to rux and vehicle creams.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

4 week double-blind treatment

Study Groups

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Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BID

Participants will be treated with ruxolitinib cream 1.5% or vehicle cream twice a day (BID) in a double-blind fashion.

Group Type EXPERIMENTAL

Ruxolitinib cream

Intervention Type DRUG

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

Vehicle

Intervention Type DRUG

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

Open Label Extension: Ruxolitiib cream 1.5%

Patients will be treated with Ruxoltinib cream 1.5% twice per day (BID) during the open label extension period. Participants who complete the double-blind period will continue into this open-label extension period for an additional 4 weeks of treatment.

Group Type EXPERIMENTAL

Ruxolitinib cream

Intervention Type DRUG

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

Interventions

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Ruxolitinib cream

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

Intervention Type DRUG

Vehicle

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

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No