Topical Ruxolitinib Evaluation in Chronic Hand Eczema (Tru-CHE)
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ruxolitinib 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
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Names:
|
| Placebo Comparator: Vehicle Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period. |
Drug: Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants achieving IGA-CHE-TS [Week 16]
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.
Secondary Outcome Measures
- Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score [Week 16]
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).
- Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score [Week 4]
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).
- Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score [Week 1 (Day 7)]
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).
- Proportion of participants achieving an IGA-CHE-TS from baseline [Up to Week 32]
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.
- Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score [Day 3]
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).
- Change from baseline in CHE-related Itch Numerical Rating Scale (NRS) score [Up to Week 32]
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).
- Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score [Week 16]
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).
- Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score [Up to Week 32]
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).
- Percentage change from baseline in Hand Eczema Severity Index (HECSI) [Week 16]
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.
- Proportion of participants with each score on the PGIC [Up to Week 32]
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.
- Change from baseline in DLQI score [Up to week 32]
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.
- Change from baseline in EQ-5D-5L score [Up to Week 32]
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.
- Change from baseline in QOLHEQ score [Up to week 32, followed by 30 days follow-up]
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.
- Change from baseline in WPAI-ChHD [Up to week 32, followed by 30 days follow-up]
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.
- Number of Participants with Treatment Emergent Adverse Events (TEAE) [Up to week 32, followed by 30 days follow-up]
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
Inclusion Criteria:
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Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months.
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Screening and baseline IGA-CHE 3 or 4.
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Baseline CHE-related Itch NRS ≥ 4.
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Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
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Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.
Exclusion Criteria:
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Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
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Any serious illness or medical, physical, or psychiatric condition(s).
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Laboratory values outside of the protocol-defined criteria.
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Use of protocol-defined treatments within the indicated washout period before baseline.
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Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
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Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Incyte Corporation
Investigators
- Study Director: Incyte Medical Monitor, Incyte Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INCB 18424-226
- 2022-502827-23-00