Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2

NCT ID: NCT05233410

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-09-22

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

Chronic Hand Eczema (CHE)

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haq Nawaz, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

University of Alabama Hospital

Birmingham, Alabama, United States

Marvel Clinical Research LLC

Huntington Beach, California, United States

Advanced RX Clin Research

Westminster, California, United States

Advanced Rx Clinical Research

Westminster, California, United States

Forcare Clinical Research

Tampa, Florida, United States

Midwest Allergy Sinus Asthma, Sc

Springfield, Illinois, United States

The Indiana Clinical Trials Center Ictc

Plainfield, Indiana, United States

Delricht Research

Baton Rouge, Louisiana, United States

Jubilee

Las Vegas, Nevada, United States

Onsite Clinical Solutions, Llc Charlotte Central Office

Charlotte, North Carolina, United States

Progressive Clinical Research

San Antonio, Texas, United States

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Medical Center Unimed Eood

Sevlievo, , Bulgaria

Dcc 'Alexandrovska', Eood

Sofia, , Bulgaria

Medical Center Hera Eood

Sofia, , Bulgaria

Dcc Xxviii

Sofia, , Bulgaria

Mc 'Synexus - Sofia', Eood

Sofia, , Bulgaria

Dcc 'Alexandrovska', Eood

Sofia, , Bulgaria

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, Canada

Simcomed Health Ltd

Barrie, Ontario, Canada

Xlr8 Medical Research

Windsor, Ontario, Canada

Fakultni Nemocnice U Sv. Anny V Brne

Brno, , Czechia

Clintrial SRO

Prague, , Czechia

Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.

Ústí nad Labem, , Czechia

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, , Germany

Universitaetsklinikum Frankfurt

Frankfurt, , Germany

Derma-Study-Center Friedrichshafen Gmbh

Friedrichshafen, , Germany

Dermatologikum Hamburg Gemeinschaftspraxis Gbr

Hamburg, , Germany

Universitaetsklinikum Schleswig Holstein - Campus Luebeck

Lübeck, , Germany

Gemeinschaftspraxis

Mahlow, , Germany

Beldio Research Gmbh

Memmingen, , Germany

Dermatologische Klinik Der Technischen Universitat Munchen

München, , Germany

Klifos - Klinische Forschung Osnabrück

Osnabrück, , Germany

Etg Warszawa

Warsaw, , Poland

Hospital General Universitario de Alicante

Alicante, , Spain

Clinica Dermomedic

Madrid, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Hospital Universitario Quironsalud Madrid

Madrid, , Spain

Hospital de Manises

Valencia, , Spain

Countries

United States; Bulgaria; Canada; Czechia; Germany; Poland; Spain

Other Identifiers

INCB 18424-314

Identifier Type: -

Identifier Source: org_study_id