Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Hand Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05906628
• Other study ID #: INCB 18424-226
• Secondary ID: 2022-502827-23-0
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 31, 2023
• Est. completion date: January 17, 2025

Study information

• Verified date: April 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 186
• Est. completion date: January 17, 2025
• Est. primary completion date: August 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eczema
• Hand Eczema

Intervention

Drug:
• Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
• Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.

Locations

Country	Name	City	State
Canada	Simcomed Health Ltd	Barrie	Ontario
Canada	Dermatology Research Institute Inc.	Calgary	Alberta
Canada	Care Clinic	Red Deer	Alberta
Germany	Fachklinik Bad Bentheim Dermatologie	Bad Bentheim
Germany	Derma-Study-Center Fn Gmbh	Friedrichshafen
Germany	Dermatologische Gemeinschaftspraxis Mahlow	Mahlow
Germany	Beldio Research Gmbh	Memmingen
Poland	Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.	Elblag
Poland	Centrum Badan Klinicznych Pi-House Sp. Z O.O.	Gdansk
Poland	Laser Clinic S.C.	Szczecin
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	Klinika Ambroziak	Warszawa
Poland	Dermmedica Sp. Z O.O.	Wroclaw
United States	Delricht Research	Baton Rouge	Louisiana
United States	Bexley Dermatology	Bexley	Ohio
United States	Onsite Clinical Solutions, Llc Charlotte Central Office	Charlotte	North Carolina
United States	Henry Ford Medical Center	Detroit	Michigan
United States	First Oc Dermatology	Fountain Valley	California
United States	Marvel Clinical Research Llc	Huntington Beach	California
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Jubilee Clinical Research Inc	Las Vegas	Nevada
United States	Dermatology Research Associates	Los Angeles	California
United States	Skin Research of South Florida, Llc	Miami	Florida
United States	Well Pharma Medical Research Corporation	Miami	Florida
United States	International Clinical Research Tennessee Llc	Murfreesboro	Tennessee
United States	Delricht Research	New Orleans	Louisiana
United States	Juva Skin and Laser Center	New York	New York
United States	Midwest Allergy Sinus Asthma, Sc	Normal	Illinois
United States	Central Sooner Research	Oklahoma City	Oklahoma
United States	Austin Institute For Clinical Research Aicr Pflugerville	Pflugerville	Texas
United States	Southwest Skin Specialists Phoenix Biltmore	Phoenix	Arizona
United States	The Indiana Clinical Trials Center Ictc	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Forcare Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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