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

Incyte

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Vehicle; Drug: Ruxolitinib cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT05127421

INCB 18424-215

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Ruxolitinib cream

Drug: Vehicle

Open Label Extension: Ruxolitiib cream 1.5%

Experimental group

Description:

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.

Treatment:

Drug: Ruxolitinib cream