Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Incyte

Status and phase: Active, not recruiting; Phase 2

Conditions: Hand Eczema

Treatments: Drug: Ruxolitinib cream; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT05906628

2022-502827-23-00 (Registry Identifier)

INCB 18424-226

Details and patient eligibility

About

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).

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 2 patient groups, including a placebo group

Ruxolitinib

Experimental group

Description:

Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.

Treatment:

Drug: Ruxolitinib cream

Vehicle

Placebo Comparator group

Description:

Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.

Treatment:

Drug: Vehicle