Topical Ruxolitinib Evaluation in Chronic Hand Eczema

NCT ID: NCT05906628

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-12-13

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).

Conditions

Hand Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ruxolitinib cream

Intervention Type: DRUG

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Vehicle

Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle cream is a topical formulation applied as a thin film to affected areas.

Interventions

Ruxolitinib cream

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Intervention Type: DRUG

Vehicle

Vehicle cream is a topical formulation applied as a thin film to affected areas.

Intervention Type: DRUG

Other Intervention Names

INCB18424 cream

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Incyte Medical Monitor

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Southwest Skin Specialists Phoenix Biltmore

Phoenix, Arizona, United States

First Oc Dermatology

Fountain Valley, California, United States

Marvel Clinical Research Llc

Huntington Beach, California, 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

Forcare Clinical Research

Tampa, Florida, United States

Midwest Allergy Sinus Asthma, Sc

Normal, Illinois, United States

The Indiana Clinical Trials Center Ictc

Plainfield, Indiana, United States

Delricht Research

Baton Rouge, Louisiana, United States

Delricht Research

New Orleans, Louisiana, United States

Henry Ford Medical Center

Detroit, Michigan, United States

Jubilee Clinical Research Inc

Las Vegas, Nevada, United States

Forest Hills Dermatology Group

Kew Gardens, New York, United States

Juva Skin and Laser Center

New York, New York, United States

Onsite Clinical Solutions, Llc Charlotte Central Office

Charlotte, North Carolina, United States

Bexley Dermatology

Bexley, Ohio, United States

Central Sooner Research

Oklahoma City, Oklahoma, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Oregon Medical Research Center

Portland, Oregon, United States

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, United States

Austin Institute For Clinical Research Aicr Pflugerville

Pflugerville, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Dermatology Research Institute Inc.

Calgary, Alberta, Canada

Care Clinic

Red Deer, Alberta, Canada

Simcomed Health Ltd

Barrie, Ontario, Canada

Fachklinik Bad Bentheim Dermatologie

Bad Bentheim, , Germany

Derma-Study-Center Fn Gmbh

Friedrichshafen, , Germany

Dermatologische Gemeinschaftspraxis Mahlow

Mahlow, , Germany

Beldio Research Gmbh

Memmingen, , Germany

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

Warsaw, , Poland

Dermmedica Sp. Z O.O.

Wroclaw, , Poland

Countries

United States; Canada; Germany; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-502827-23-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

INCB 18424-226

Identifier Type: -

Identifier Source: org_study_id