Topical Ruxolitinib Evaluation in Chronic Hand Eczema

NCT05906628 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: INCB 18424-2262022-502827-23-00
• Study Type: interventional
• Target: 186
• Locations: 4 countries
• Sites: 36

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

Keywords

eczema; chronic hand eczema (CHE); dermatitis; skin disease; JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at 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 CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). IGA-CHE TS is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from Baseline.

  Baseline; Week 16

Secondary Outcomes (21)

• Percentage of Participants Achieving ITCH4 Response at Weeks 4 and 16

  Baseline; Weeks 4 and 16

• Percentage of Participants Achieving ITCH4 Response at Day 3 and Week 1 (Day 7)

  Baseline; Day 3; Week 1 (Day 7)

• Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit

  Baseline; Weeks 2, 4, 8, 12, 16, 24, and 32

• Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit

  Baseline; Weeks 1-32

• Time to ≥4-point Improvement From Baseline in CHE-related Itch NRS Score

  Baseline; up to Week 32

Study Arms (2)

Ruxolitinib

EXPERIMENTAL

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

Vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Interventions

Ruxolitinib cream DRUG

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

Also known as: INCB18424 cream

Ruxolitinib

Vehicle DRUG

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

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (36)

Southwest Skin Specialists Phoenix Biltmore

Phoenix, Arizona, 85018, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Marvel Clinical Research Llc

Huntington Beach, California, 92647, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Skin Research of South Florida, Llc

Miami, Florida, 33173, United States

Location

Well Pharma Medical Research Corporation

Miami, Florida, 33173, United States

Location

Forcare Clinical Research

Tampa, Florida, 33613, United States

Location

Midwest Allergy Sinus Asthma, Sc

Normal, Illinois, 61761, United States

Location

The Indiana Clinical Trials Center Ictc

Plainfield, Indiana, 46168, United States

Location

Delricht Research

Baton Rouge, Louisiana, 70809, United States

Location

Delricht Research

New Orleans, Louisiana, 70115, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48084, United States

Location

Jubilee Clinical Research Inc

Las Vegas, Nevada, 89106, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11415, United States

Location

Juva Skin and Laser Center

New York, New York, 10022, United States

Location

Onsite Clinical Solutions, Llc Charlotte Central Office

Charlotte, North Carolina, 28277, United States

Location

Bexley Dermatology

Bexley, Ohio, 43209, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73118, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Austin Institute For Clinical Research Aicr Pflugerville

Pflugerville, Texas, 78660, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Dermatology Research Institute Inc.

Calgary, Alberta, T2J 7E1, Canada

Location

Care Clinic

Red Deer, Alberta, T4P-1K4, Canada

Location

Simcomed Health Ltd

Barrie, Ontario, L4M 1G7, Canada

Location

Fachklinik Bad Bentheim Dermatologie

Bad Bentheim, 48455, Germany

Location

Derma-Study-Center Fn Gmbh

Friedrichshafen, 88045, Germany

Location

Dermatologische Gemeinschaftspraxis Mahlow

Mahlow, 15831, Germany

Location

Beldio Research Gmbh

Memmingen, 87700, Germany

Location

Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.

Elblag, 82-300, Poland

Location

Centrum Badan Klinicznych Pi-House Sp. Z O.O.

Gdansk, 80-546, Poland

Location

Laser Clinic S.C.

Szczecin, 70-332, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

Klinika Ambroziak

Warsaw, 02-953, Poland

Location

Dermmedica Sp. Z O.O.

Wroclaw, 51-318, Poland

Location

MeSH Terms

Conditions

Eczema; Dermatitis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: July 31, 2023
• Primary Completion: July 15, 2024
• Study Completion: December 13, 2024
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

CA (3); DE (4); PL (6); US (23)