The trial is taking place at:
J

Jubilee Clinical Research Inc | Las Vegas, NV

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Topical Ruxolitinib Evaluation in Chronic Hand Eczema

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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

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

Trial contacts and locations

36

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Central trial contact

Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)

Data sourced from clinicaltrials.gov

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