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Janus Kinase (JAK) Inhibitor

Ruxolitinib cream for Hand Eczema (TRuE-CHE1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 8, 16 and 32
Awards & highlights

TRuE-CHE1 Trial Summary

This trial will test whether ruxolitinib cream can improve symptoms of moderate to severe chronic hand eczema.

Eligible Conditions
  • Hand Eczema

TRuE-CHE1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

TRuE-CHE1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 8, 16 and 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 8, 16 and 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)
Secondary outcome measures
Change from baseline in CHE-related Itch Numerical Rating Scale (NRS) score (weekly average)
Change from baseline in CHE-related Pain NRS score (weekly average)
Change from baseline in the modified Total Lesion Symptom Score (mTLSS)
+11 more

TRuE-CHE1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RuxolitinibExperimental Treatment1 Intervention
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.
Group II: VehiclePlacebo Group1 Intervention
Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib cream
2022
Completed Phase 3
~1850

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
362 Previous Clinical Trials
55,088 Total Patients Enrolled
1 Trials studying Hand Eczema
180 Patients Enrolled for Hand Eczema
Haq Nawaz, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
257 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can middle-aged adults participate in this research?

"Eligibility for this particular trial is restricted to individuals aged 18 to 99. Out of the total of 206 clinical trials, 87 are for those under 18 years old and 119 are for seniors over the age of 65."

Answered by AI

Are there multiple locations participating in this research project in the city?

"Patients can be enrolled at any of the 32 locations for this trial, which include Progressive Clinical Research in San Antonio, Texas, Center For Clinical Studies Webster in Webster, California, and First Oc Dermatology in Fountain Valley, Louisiana."

Answered by AI

Has the cream version of Ruxolitinib been cleared by the FDA?

"Ruxolitinib cream is currently being trialled in Phase 3 clinical trials, which means that while there is some data supporting its efficacy, there is also multiple rounds of data supporting its safety. As such, our team at Power have given it a safety rating of 3."

Answered by AI

Are there any specific medical requirements to participate in this research?

"This clinical trial is seeking 180 participants that suffer from eczema. The individuals must be between 18-99 years old and meet the following criteria: a diagnosis of chronic hand eczema, recent history of inadequate response to treatment with topical corticosteroids or topical calcineurin inhibitors, or oral alitretinoin, and a willingness to avoid pregnancy or fathering children."

Answered by AI
~0 spots leftby Apr 2024