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

NCT05127421 | Completed Phase 2 Results FDA Drug

• 1 other identifier: INCB 18424-215
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; adolescent; adults; in-home; telemedicine

Outcome Measures

Primary Outcomes (1)

• 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

  The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck.

  Baseline; Week 4

Secondary Outcomes (6)

• Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8

  Baseline; Weeks 2 and 8

• Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8

  Baseline; Weeks 2, 4, and 8

• Double-Blind Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  up to approximately 4 weeks plus 30 days

• Open-Label Period: Number of Participants With Any TEAE

  from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days)

• Double-Blind Period: Number of Participants With Any Grade 3 or Higher TEAE

  up to approximately 4 weeks plus 30 days

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Ruxolitinib cream; Drug: Vehicle

Open Label Extension: Ruxolitiib cream 1.5%

EXPERIMENTAL

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.

Drug: Ruxolitinib cream

Interventions

Ruxolitinib cream DRUG

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

Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BID; Open Label Extension: Ruxolitiib cream 1.5%

Vehicle DRUG

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

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

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Science37

Culver City, California, 90230, United States

Location

Related Publications (1)

• Chiesa Fuxench ZC, Lai Z, Kuo Y, Nawaz H, Cotliar J. Ruxolitinib cream monotherapy for facial and/or neck atopic dermatitis: results from a decentralized, randomized phase 2 clinical trial. J Dermatolog Treat. 2025 Dec;36(1):2480744. doi: 10.1080/09546634.2025.2480744. Epub 2025 Mar 25.

  PMID: 40132224 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Haq Nawaz, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 4 week double-blind treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 19, 2021
• Study Start: November 10, 2021
• Primary Completion: August 3, 2023
• Study Completion: September 29, 2023
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

US (1)