A Phase 2, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema

INCB 18424-226

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).

2023-07-31

2024-08-26

2025-01-17

Active (not recruiting)

Early phase I

186

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will receive ruxolitinib cream (1.5%) or vehicle cream for 16 weeks, after which they will be offered the opportunity to receive ruxilitinib cream (1.5%) in the open-label treatment extension period for another 16 weeks.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 186, 'type': 'ACTUAL'}}

2024-04-10