Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Last updated: January 21, 2025
Sponsor: Incyte Corporation
Overall Status: Completed

Phase

2

Condition

Allergies & Asthma

Eczema (Atopic Dermatitis - Pediatric)

Hand Dermatitis

Treatment

Vehicle

Ruxolitinib cream

Clinical Study ID

NCT05906628
INCB 18424-226
2022-502827-23-00
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of chromic handeczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares withinthe 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 wasnot advisable or contraindicated.

  • Willingness to avoid pregnancy or fathering children based on the criteria definedin the protocol.

Exclusion

Exclusion Criteria:

  • Known triggers for CHE (allergic or irritant, such as those identified by previouspatch 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 beforebaseline.

  • Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4weeks before baseline.

  • Pregnant or lactating participants, or those considering pregnancy during the periodof their study participation.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Total Participants: 186
Treatment Group(s): 2
Primary Treatment: Vehicle
Phase: 2
Study Start date:
July 31, 2023
Estimated Completion Date:
December 13, 2024

Connect with a study center

  • Dermatology Research Institute Inc.

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Care Clinic

    Red Deer, Alberta T4P-1K4
    Canada

    Site Not Available

  • Simcomed Health Ltd

    Barrie, Ontario L4M 1G7
    Canada

    Site Not Available

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • Derma-Study-Center Fn Gmbh

    Friedrichshafen, 88045
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Mahlow

    Mahlow, 15831
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. Scholz, Dr. Sebastian

    Mahlow, 15831
    Germany

    Active - Recruiting

  • Beldio Research Gmbh

    Memmingen, 87700
    Germany

    Site Not Available

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

    Elblag, 82-300
    Poland

    Site Not Available

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

    Gdansk, 80-546
    Poland

    Site Not Available

  • Laser Clinic S.C.

    Szczecin, 70-332
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • Klinika Ambroziak

    Warszawa, 02-953
    Poland

    Site Not Available

  • Klinika Ambroziak Estederm

    Warszawa, 02-953
    Poland

    Site Not Available

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-318
    Poland

    Site Not Available

  • Southwest Skin Specialists Phoenix Biltmore

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • First Oc Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Marvel Clinical Research Llc

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Wallace Medical Group

    Los Angeles, California 90056
    United States

    Site Not Available

  • Skin Research of South Florida, Llc

    Miami, Florida 33173
    United States

    Site Not Available

  • Well Pharma Medical Research Corporation

    Miami, Florida 33173
    United States

    Site Not Available

  • Forcare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Midwest Allergy Sinus Asthma, Sc

    Normal, Illinois 61761
    United States

    Site Not Available

  • The Indiana Clinical Trials Center Ictc

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Delricht Research

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Delricht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Henry Ford Medical Center

    Detroit, Michigan 48084
    United States

    Site Not Available

  • Jubilee Clinical Research Inc

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Forest Hills Dermatology Group

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Juva Skin and Laser Center

    New York, New York 10022
    United States

    Site Not Available

  • Onsite Clinical Solutions, Llc Charlotte Central Office

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Bexley Dermatology

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Central Sooner Research

    Oklahoma City, Oklahoma 73118
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223
    United States

    Site Not Available

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Austin Institute For Clinical Research Aicr Pflugerville

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

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