Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

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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Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1 (TRuE-CHE1): A Phase 3, 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 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. Recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin. Willingness to avoid pregnancy or fathering children based on the criteria below. 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. Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline. Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection. 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. 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. Further exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials 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 NRS score | The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis. | Week 16 | 
| Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score | The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). | Week 16 | 
| Change from baseline in the modified Total Lesion Symptom Score (mTLSS) | The mTLSS is a validated tool for assessing hand eczema. The scale quantifies the 7 features (erythema, scaling, hyperkeratosis/lichenification, vesiculation, oedema, fissures, and pruritus/pain) of HE (0 = none, 1 = mild, 2 = moderate, and 3 = severe). | Up to Week 32 | 
| 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 in clinical trials 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 | 
| Change from baseline in CHE-related Itch Numerical Rating Scale (NRS) score (weekly average) | The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject 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 Pain NRS score (weekly average) | The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject 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 | 
| Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score | The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis. | Up to Week 32 | 
| Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score. | The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) on a daily basis. | Up to Week 32 | 
| Percentage change in Hand Eczema Severity Index (HECSI) | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials 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 HECSI-75 | HECSI is an instrument used in clinical trials 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. | Weeks 2, 8, 16 and 32 | 
| Proportion of participants with HECSI-90 | HECSI is an instrument used in clinical trials 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. | Weeks 2, 8, 16, and 32 | 
| Mean Patient Global Impression of Change (PGIC) score | The Patient Global Impression of Change (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 | 
| 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 | 
| Proportion of Participants with a score of either 1 or 2 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 | 

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