Back to resultsRuxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ruxolitinib cream
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatiits, adolescent, adults, in-home, telemedicine
Eligibility Criteria
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:
- ≥ 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.
- 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.
Sites / Locations
- Science37
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BID
Open Label Extension: Ruxolitiib cream 1.5%
Arm Description
Participants will be treated with ruxolitinib cream 1.5% or vehicle cream twice a day (BID) in a double-blind fashion.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05127421
Brief Title
Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
Official Title
A Phase 2, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
August 3, 2023 (Actual)
Study Completion Date
September 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatiits, adolescent, adults, in-home, telemedicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is 2:1 assignment to rux and vehicle creams.
Masking
ParticipantInvestigator
Masking Description
4 week double-blind treatment
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BID
Arm Type
Experimental
Arm Description
Participants will be treated with ruxolitinib cream 1.5% or vehicle cream twice a day (BID) in a double-blind fashion.
Arm Title
Open Label Extension: Ruxolitiib cream 1.5%
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib cream
Intervention Description
Ruxolitinib cream 1.5% applied twice a day (BID)"
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle cream applied twice a day (BID) to affected areas
Primary Outcome Measure Information:
Title
Double-Blind Period: Proportion of participants who achieve an EASI75 of the head and neck region
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve an EASI75 of the head and neck region
Description
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.
Time Frame
Weeks 2 and 8
Title
Proportion of participants who achieve overall EASI75
Description
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.
Time Frame
Weeks 2, 4 and 8
Title
Number of treatment-related adverse events
Description
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
Approximately 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
≥ 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haq Nawaz, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Science37
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing 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.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
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