Psoriasis Clinical Trial

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

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).

View Eligibility Criteria

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.
Further exclusion criteria apply.

Study is for people with:

Psoriasis

Phase:

Phase 3

Study ID:

NCT05219864

Recruitment Status:

Withdrawn

Sponsor:

Incyte Corporation

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There are 49 Locations for this study

See Locations Near You

Southwest Skin Specialists Phoenix Biltmore
Phoenix Arizona, 85018, United States
Raoof Md Encino
Encino California, 91436, United States
First Oc Dermatology
Fountain Valley California, 92708, United States
Marvel Clinical Research Llc
Huntington Beach California, 92647, United States
Well Pharma Medical Research Corporation
Miami Florida, 33173, United States
Psoriasis Treatment Center of South Florida
Pembroke Pines Florida, 33028, United States
Lenus Research Medical Group, Llc
Sweetwater Florida, 33172, United States
Delricht Research
Marietta Georgia, 30060, United States
Arlington Dermatology
Rolling Meadows Illinois, 60008, United States
Midwest Allergy Sinus Asthma, Sc
Springfield Illinois, 62604, United States
Dermatologist Specialist
Louisville Kentucky, 40241, United States
Grafton Dermatology and Cosmetic Surgery
Houma Louisiana, 70364, United States
Delricht Research
New Orleans Louisiana, 70115, United States
Washington University
Saint Louis Missouri, 63110, United States
Jubilee Clinical Research Inc
Las Vegas Nevada, 89106, United States
Juva Skin and Laser Center
New York New York, 10022, United States
Oregon Medical Research Center
Portland Oregon, 97223, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center
Memphis Tennessee, 38119, United States
International Clinical Research Tennessee Llc
Murfreesboro Tennessee, 37130, United States
Austin Institute For Clinical Research Aicr Pflugerville
Houston Texas, 77056, United States
Progressive Clinical Research
San Antonio Texas, 78213, United States
Center For Clinical Studies Webster
Webster Texas, 77598, United States
University of Utah
Murray Utah, 84107, United States
West End Dermatology Associates
Richmond Virginia, 23233, United States
Dermatology Specialists of Spokane
Spokane Washington, 99202, United States
Dermatology Research Institute Inc.
Calgary Alberta, T2J 7, Canada
Care Clinic
Red Deer Alberta, T4P-1, Canada
Cca Medical Research
Ajax Ontario, L1S 7, Canada
Lynderm Research Inc
Markham Ontario, L3P 1, Canada
Fakultni Nemocnice U Sv. Anny V Brne
Brno , 656 9, Czechia
Ccr Ostrava S.R.O.
Ostrava , 702 0, Czechia
Ccr Czech A.S.
Pardubice , 53000, Czechia
Clintrial S.R.O.
Praha 10 , 100 0, Czechia
Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.
Usti Nad Labem , 401 1, Czechia
Klinikum Der Johann Wolfgang Goethe-Universitaet
Frankfurt , 60590, Germany
Derma-Study-Center Friedrichshafen Gmbh
Friedrichshafen , 88045, Germany
Dermatologikum Hamburg Gemeinschaftspraxis Gbr
Hamburg , 20354, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel , 24105, Germany
Praxis Dr. Beate Schwarz
Langenau , 89129, Germany
Beldio Research Gmbh
Memmingen , 87700, Germany
Klifos - Klinische Forschung Osnabruck
Osnabruck , 49074, Germany
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
Elblag , 82-30, Poland
Etg Warszawa
Warszawa , 02-79, Poland
Hospital General Universitario de Alicante
Alicante , 03010, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona , 08041, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain
Hospital de Manises
Manises , 46940, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon , 28223, Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Study ID:

NCT05219864

Recruitment Status:

Withdrawn

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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