Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2

Last updated: November 7, 2022
Sponsor: Incyte Corporation
Overall Status: Trial Not Available

Phase

3

Condition

Allergy

Atopic Dermatitis

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT05233410
INCB 18424-314
  • Ages 18-99
  • 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 chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3months 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 totreatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), ororal alitretinoin; or intolerance or contraindication to TCS or TCI or oralalitretinoin.
  • Willingness to avoid pregnancy or fathering children based on the criteria below.

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.
  • Participants who have an unstable course of AD (spontaneously improving or rapidlydeteriorating) as determined by the investigator in the 4 weeks prior to baseline.
  • Participants with concurrent conditions and history of other diseases such as otheractive skin disease or infection on the hands; immunocompromised; chronic or acuteinfection requiring systemic treatments; active acute skin infection; otherconcomitant skin conditions that may interfere with study assessments or compromiseparticipant safety; other types of eczema; chronic asthma requiring high dose ofinhaled corticosteroids; current or history of hepatitis B or C virus infection.
  • Any serious illness or medical, physical, or psychiatric condition(s) that, in theinvestigator's opinion, would interfere with full participation in the study,including administration of study drug and attending required study visits; pose asignificant 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 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.
  • Further exclusion criteria apply.

Study Design

Study Start date:
January 31, 2023
Estimated Completion Date:
September 22, 2024

Connect with a study center

  • Medical Center Unimed Eood

    Sevlievo, 05402
    Bulgaria

    Site Not Available

  • Dcc 'Alexandrovska', Eood

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Dcc Xxviii

    Sofia, 01592
    Bulgaria

    Site Not Available

  • Mc 'Synexus - Sofia', Eood

    Sofia, 01784
    Bulgaria

    Site Not Available

  • Medical Center Hera Eood

    Sofia, 01510
    Bulgaria

    Site Not Available

  • MEDICAL CENTRE SYNEXUS SOFIA EOOD €� BRANCH STARA ZAGORA

    Stara Zagora, 06000
    Bulgaria

    Site Not Available

  • Dr. Chih-Ho Hong Medical Inc.

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Simcomed Health Ltd

    Barrie, Ontario L4M 1G7
    Canada

    Site Not Available

  • Xlr8 Medical Research

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Fakultni Nemocnice U Sv. Anny V Brne

    Brno, 656 91
    Czechia

    Site Not Available

  • Clintrial SRO

    Praha 10, 100 00
    Czechia

    Site Not Available

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

    Usti Nad Labem, 401 13
    Czechia

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • Derma-Study-Center Friedrichshafen Gmbh

    Friedrichshafen, 88045
    Germany

    Site Not Available

  • Dermatologikum Hamburg Gemeinschaftspraxis Gbr

    Hamburg, 20354
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig Holstein - Campus Luebeck

    Luebeck, 23538
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Mahlow, 15381
    Germany

    Site Not Available

  • Beldio Research Gmbh

    Memmingen, 87700
    Germany

    Site Not Available

  • Dermatologische Klinik Der Technischen Universitat Munchen

    Muenchen, 80802
    Germany

    Site Not Available

  • Dermatologische Klinik Der Technischen Universitat Munchen

    Muenshen, 80802
    Germany

    Site Not Available

  • Klifos - Klinische Forschung Osnabrück

    Osnabruck, 49074
    Germany

    Site Not Available

  • Synexus Affiliate - Bialystok - Clinicmed Daniluk Nowak Spolka Jawna

    Bialystok, 15-879
    Poland

    Site Not Available

  • Wojewodzki Szpital Zespolony W Elblagu

    Elblag, 82-300
    Poland

    Site Not Available

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

    Gdansk, 80-546
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

    Kielce, 25-316
    Poland

    Site Not Available

  • Etg Lublin

    Lublin, 20-412
    Poland

    Site Not Available

  • Laser Clinic S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki

    Szczecin, 70-332
    Poland

    Site Not Available

  • Etg Warszawa

    Warsaw, 02-777
    Poland

    Site Not Available

  • Royalderm

    Warszawa, 02-962
    Poland

    Site Not Available

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-318
    Poland

    Site Not Available

  • Clinica Dermomedic

    Alcorcon, 28922
    Spain

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Clinica Dermomedic

    Madrid, 28001
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223
    Spain

    Site Not Available

  • Hospital de Manises

    Valencia, 46940
    Spain

    Site Not Available

  • University of Alabama Hospital

    Birmingham, Alabama 35249
    United States

    Site Not Available

  • Marvel Clinical Research LLC

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Advanced RX Clin Research

    Westminster, California 92683
    United States

    Site Not Available

  • Advanced Rx Clinical Research

    Westminster, California 92683
    United States

    Site Not Available

  • Forcare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Midwest Allergy Sinus Asthma, Sc

    Springfield, Illinois 62704
    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

  • Jubilee

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Onsite Clinical Solutions, Llc Charlotte Central Office

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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