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).
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.
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There are 49 Locations for this study
Phoenix Arizona, 85018, United States
Encino California, 91436, United States
Fountain Valley California, 92708, United States
Huntington Beach California, 92647, United States
Miami Florida, 33173, United States
Pembroke Pines Florida, 33028, United States
Sweetwater Florida, 33172, United States
Marietta Georgia, 30060, United States
Rolling Meadows Illinois, 60008, United States
Springfield Illinois, 62604, United States
Louisville Kentucky, 40241, United States
Houma Louisiana, 70364, United States
New Orleans Louisiana, 70115, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89106, United States
New York New York, 10022, United States
Portland Oregon, 97223, United States
Portland Oregon, 97239, United States
Memphis Tennessee, 38119, United States
Murfreesboro Tennessee, 37130, United States
Houston Texas, 77056, United States
San Antonio Texas, 78213, United States
Webster Texas, 77598, United States
Murray Utah, 84107, United States
Richmond Virginia, 23233, United States
Spokane Washington, 99202, United States
Calgary Alberta, T2J 7, Canada
Red Deer Alberta, T4P-1, Canada
Ajax Ontario, L1S 7, Canada
Markham Ontario, L3P 1, Canada
Brno , 656 9, Czechia
Ostrava , 702 0, Czechia
Pardubice , 53000, Czechia
Praha 10 , 100 0, Czechia
Usti Nad Labem , 401 1, Czechia
Frankfurt , 60590, Germany
Friedrichshafen , 88045, Germany
Hamburg , 20354, Germany
Kiel , 24105, Germany
Langenau , 89129, Germany
Memmingen , 87700, Germany
Osnabruck , 49074, Germany
Elblag , 82-30, Poland
Warszawa , 02-79, Poland
Alicante , 03010, Spain
Barcelona , 08041, Spain
Madrid , 28007, Spain
Manises , 46940, Spain
Pozuelo de Alarcon , 28223, Spain
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