Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

Last updated: November 14, 2022
Sponsor: Incyte Corporation
Overall Status: Trial Not Available

Phase

3

Condition

Hand Dermatitis

Eczema (Atopic Dermatitis - Pediatric)

Dermatitis, Atopic

Treatment

N/A

Clinical Study ID

NCT05219864
INCB 18424-313
  • 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

  • Dermatology Research Institute Inc.

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Care Clinic

    Red Deer, Alberta T4P-1K4
    Canada

    Site Not Available

  • Cca Medical Research

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Fakultni Nemocnice U Sv. Anny V Brne

    Brno, 656 91
    Czechia

    Site Not Available

  • Ccr Ostrava S.R.O.

    Ostrava, 702 00
    Czechia

    Site Not Available

  • Ccr Czech A.S.

    Pardubice, 53000
    Czechia

    Site Not Available

  • Clintrial S.R.O.

    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

  • Klinikum Der Johann Wolfgang Goethe-Universitaet

    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

    Kiel, 24105
    Germany

    Site Not Available

  • Praxis Dr. Beate Schwarz

    Langenau, 89129
    Germany

    Site Not Available

  • Beldio Research Gmbh

    Memmingen, 87700
    Germany

    Site Not Available

  • Klifos - Klinische Forschung Osnabruck

    Osnabruck, 49074
    Germany

    Site Not Available

  • Klifos - Klinische Forschung Osnabruck

    Osnabrã¼ck, 49074
    Germany

    Site Not Available

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

    Elblag, 82-300
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Krakow

    Krakow, 30-002
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • Etg Warszawa

    Warszawa, 02-793
    Poland

    Site Not Available

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-318
    Poland

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital de Manises

    Manises, 46940
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon, 28223
    Spain

    Site Not Available

  • Southwest Skin Specialists Phoenix Biltmore

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Raoof Md Encino

    Encino, California 91436
    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

  • Well Pharma Medical Research Corporation

    Miami, Florida 33173
    United States

    Site Not Available

  • Psoriasis Treatment Center of South Florida

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • Lenus Research Medical Group, Llc

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Delricht Research

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Midwest Allergy Sinus Asthma, Sc

    Springfield, Illinois 62604
    United States

    Site Not Available

  • Dermatologist Specialist

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Grafton Dermatology and Cosmetic Surgery

    Houma, Louisiana 70364
    United States

    Site Not Available

  • Delricht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Jubilee Clinical Research Inc

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Juva Skin and Laser Center

    New York, New York 10022
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center

    Memphis, Tennessee 38119
    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

    Houston, Texas 77056
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Center For Clinical Studies Webster

    Webster, Texas 77598
    United States

    Site Not Available

  • University of Utah

    Murray, Utah 84107
    United States

    Site Not Available

  • West End Dermatology Associates

    Richmond, Virginia 23233
    United States

    Site Not Available

  • Dermatology Specialists of Spokane

    Spokane, Washington 99202
    United States

    Site Not Available

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