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

Atopic Dermatitis Clinical Trial

Official title:

A Phase 2, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127421
• Other study ID #: INCB 18424-215
• Status: Completed
• Phase: Phase 2
• Start date: November 10, 2021
• Est. completion date: September 29, 2023

Study information

• Verified date: October 2023
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 29, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Ruxolitinib cream
Ruxolitinib cream 1.5% applied twice a day (BID)"
• Vehicle
Vehicle cream applied twice a day (BID) to affected areas

Locations

Country	Name	City	State
United States	Science37	Culver City	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Double-Blind Period: Proportion of participants who achieve an EASI75 of the head and neck region	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.	Week 4
Secondary	Proportion of participants who achieve an EASI75 of the head and neck region	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.	Weeks 2 and 8
Secondary	Proportion of participants who achieve overall EASI75	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.	Weeks 2, 4 and 8
Secondary	Number of treatment-related adverse events	Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.	Approximately 12 weeks