A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib Cream — DRUG
  Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
• Vehicle Cream — DRUG
  Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Study Details

This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.

Key Dates

Start date

Apr 26, 2024

Status verified

May 2026

Primary completion

May 21, 2025

Completion

Oct 17, 2025

Study Design

Enrollment

241 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: VC Period: Ruxolitinib 1.5% Cream BID
  Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
• Placebo Comparator: VC Period: Vehicle Cream BID
  Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
• Experimental: VC Extension Period/Escape Arm: Ruxolitinib 1.5% Cream BID
  Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 24 during the Vehicle Control Extension (VCE) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
• Placebo Comparator: VC Extension Period/Escape Arm: Vehicle Cream BID
  Participants who applied vehicle cream during the VC Period, continued applying vehicle cream as a thin film twice daily (BID) from Weeks 8 to 24 during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants will be eligible to enter the ruxolitinib 1.5% cream open-label escape arm as defined in the protocol.
• Experimental: VC Extension Period: Ruxolitinib 1.5% cream open-label escape arm
  Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Primary Outcome Measure

Percentage of Participants Achieving a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) at Week 8 [ Time Frame: Baseline; Week 8 ]

Locations (18)

Find similar trials in Little Rock, AR

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