Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).

Official Title
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A Phase 2, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema

Conditions
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Hand Eczema

Intervention / Treatment
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* Drug: Ruxolitinib cream
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months. Screening and baseline IGA-CHE 3 or 4. Baseline CHE-related Itch NRS ≥ 4. Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated. Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol. Exclusion Criteria: Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study. Any serious illness or medical, physical, or psychiatric condition(s). Laboratory values outside of the protocol-defined criteria. Use of protocol-defined treatments within the indicated washout period before baseline. Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline. Pregnant or lactating participants, or those considering pregnancy during the period of their study participation. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will receive ruxolitinib cream (1.5%) or vehicle cream for 16 weeks, after which they will be offered the opportunity to receive ruxilitinib cream (1.5%) in the open-label treatment extension period for another 16 weeks.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ruxolitinib<br>Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period. | Drug: Ruxolitinib cream<br>* Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.<br>* Other names: INCB18424 cream;|
| Placebo Comparator: Vehicle<br>Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period. | Drug: Vehicle<br>* Vehicle cream is a topical formulation applied as a thin film to affected areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving IGA-CHE-TS | The Investigator's Global Assessment-Chronic Hand Eczema (IGA-CHE) is an instrument used to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch Numerical Rating Scale (NRS) score | The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). | Week 16 | 
| Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score | The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). | Week 4 | 
| Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score | The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). | Week 1 (Day 7) | 
| Proportion of participants achieving an IGA-CHE-TS from baseline | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline. | Up to Week 32 | 
| Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score | The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). | Day 3 | 
| Change from baseline in CHE-related Itch NRS score | The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). | Up to Week 32 | 
| Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score | The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). | Up to Week 32 | 
| Change from baseline in CHE-related Skin Pain NRS score | The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). | Up to Week 32 | 
| Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score | The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). | Week 16 | 
| Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score | The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). | Up to Week 32 | 
| Percentage change from baseline in Hand Eczema Severity Index (HECSI) | The Hand Eczema Severity Index (HECSI) is an instrument used to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. | Week 16 | 
| Proportion of participants with each score on the PGIC | The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse. | Up to Week 32 | 
| Change from baseline in DLQI score | The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire to measure how much the skin problem has affected the participant over the previous 7 days and participant will rate each question as 1-very much, 2- a lot, 3-a little, or 4-not at all. | Up to week 32 | 
| Change from baseline in EQ-5D-5L score | The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1 = no problems, Level 2 = slight problems, Level 3 = moderate problems, Level 4 = severe problems, and Level 5 = extreme problems. | Up to Week 32 | 
| Change from baseline in QOLHEQ score | The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is a disease-specific instrument to assess disease-specific health-related quality of life in participants with CHE over the past 7 days. It consists of 30 items covering impairments in 4 domains: 1) symptoms, 2) emotions, 3) limitations in functioning, and 4) treatment and prevention. Each item is scored in a 5-point scale: 0) never, 1) rarely, 2) sometimes, 3) often, and 4) all the time. | Up to week 32, followed by 30 days follow-up | 
| Change from baseline in WPAI-ChHD | The Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-ChHD) questionnaire is a 6-item questionnaire used to assess the impact of chronic hand dermatitis on job performance and productivity over the past 7 days. | Up to week 32, followed by 30 days follow-up | 
| Number of Participants with Treatment Emergent Adverse Events (TEAE) | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to week 32, followed by 30 days follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eczema, chronic hand eczema (CHE), dermatitis, skin disease, JAK inhibitor