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Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1 (TRuE-CHE1)

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Incyte

Status and phase

Withdrawn
Phase 3

Conditions

Hand Eczema

Treatments

Drug: Vehicle
Drug: Ruxolitinib cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT05219864
INCB 18424-313

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).

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 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

49

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Data sourced from clinicaltrials.gov

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