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

Sponsor
Incyte Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05127421
Collaborator
(none)
75
1
2
12.6
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is 2:1 assignment to rux and vehicle creams.This is 2:1 assignment to rux and vehicle creams.
Masking:
Double (Participant, Investigator)
Masking Description:
4 week double-blind treatment
Primary Purpose:
Treatment
Official Title:
A Phase 2, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
Actual Study Start Date :
Nov 10, 2021
Anticipated Primary Completion Date :
Sep 26, 2022
Anticipated Study Completion Date :
Nov 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

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

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Double-Blind Period: Proportion of participants who achieve an EASI75 of the head and neck region [Week 4]

    Defined as >=75% improvement in Eczema Area and Severity Index (EASI) score of the head and neck region. EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

Secondary Outcome Measures

  1. Proportion of participants who achieve an EASI75 of the head and neck region [Weeks 2 and 8]

    Defined as >=75% improvement in Eczema Area and Severity Index (EASI) score of the head and neck region. EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

  2. Proportion of participants who achieve overall EASI75 [Weeks 2, 4 and 8]

    Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score. EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI 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. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

  3. Number of treatment-related adverse events [Approximately 12 weeks]

    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Science37 Culver City California United States 90230

Sponsors and Collaborators

  • Incyte Corporation

Investigators

  • Study Director: Haq Nawaz, MD, Incyte Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT05127421
Other Study ID Numbers:
  • INCB 18424-215
First Posted:
Nov 19, 2021
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Incyte Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022