Topical Ruxolitinib Evaluation in Chronic Hand Eczema (NCT05906628) | Clinical Trial Compass
CompletedPhase 2
Topical Ruxolitinib Evaluation in Chronic Hand Eczema
United States186 participantsStarted 2023-07-31
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of CHE for at least 6 months prior to screening. 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.
* Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
* Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.
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.
* 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 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.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
What they're measuring
1
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Week 16