Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

Phase 3WithdrawnNCT05219864

Incyte Corporation

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Hand Eczema

Interventions

Ruxolitinib creamDRUG

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

VehicleDRUG

Vehicle cream is a topical formulation applied as a thin film to affected areas.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (49)

Outcomes

Primary Outcomes

Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)

The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

Time frame: Week 16

Secondary Outcomes

Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score

The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.

Time frame: Week 16

Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score

The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).

Time frame: Week 16

Change from baseline in the modified Total Lesion Symptom Score (mTLSS)

The mTLSS is a validated tool for assessing hand eczema. The scale quantifies the 7 features (erythema, scaling, hyperkeratosis/lichenification, vesiculation, oedema, fissures, and pruritus/pain) of HE (0 = none, 1 = mild, 2 = moderate, and 3 = severe).

Time frame: Up to Week 32

Proportion of participants achieving an IGA-CHE-TS from baseline

Data from ClinicalTrials.gov

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