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Janus Kinase (JAK) Inhibitor

Ruxolitinib cream for Hand Eczema (TRuE-CHE2 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 8, 16, 32
Awards & highlights

TRuE-CHE2 Trial Summary

This trial will test whether the drug Ruxolitinib can help people with moderate to severe chronic hand eczema.

Eligible Conditions
  • Hand Eczema

TRuE-CHE2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 8, 16, 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 8, 16, 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
Percentage 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 NRS score (weekly average)
Pain
Change from baseline in Dermatology Life Quality Index (DLQI) score
+17 more

TRuE-CHE2 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
365 Previous Clinical Trials
55,189 Total Patients Enrolled
2 Trials studying Hand Eczema
186 Patients Enrolled for Hand Eczema
Haq Nawaz, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
257 Total Patients Enrolled
1 Trials studying Hand Eczema

Frequently Asked Questions

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

In how many areas is this test being conducted?

"Currently, patients are being enrolled for this clinical trial at Onsite Clinical Solutions, Llc Charlotte Central Office in Charlotte, North carolina, Delright Research in Tampa, Florida, and Forcare Clinical Research in Plainfield, Indiana. There are also 16 other potential sites for enrollment."

Answered by AI

Are there any positions available for participants in this trial?

"Yes, this is an ongoing study that is currently looking for participants. The clinical trial was originally posted on 1/31/2023 and was last edited on 10/17/2022. The trial is looking for 180 patients at 16 sites."

Answered by AI

What is the Ruxolitinib cream FDA status?

"Ruxolitinib cream's safety is rated a 3. This is because there is some clinical data supporting its efficacy and multiple rounds of data supporting its safety."

Answered by AI

Does this research include elderly participants over the age of 85?

"This clinical trial includes patients aged 18 to 99. There are 84 other trials for patients under 18 and 118 for those 65 and older."

Answered by AI

How many people are going to be included in this experiment?

"Indeed, the listing on clinicaltrials.gov contains information indicating that the trial is presently looking for subjects. The trial was first posted on 1/31/2023 and has since been edited on 10/17/2022. The trial is set to enroll 180 individuals from 16 different sites."

Answered by AI

Who does this trial cater to?

"This clinical trial is admitting 180 participants, within the ages of 18 and 99 who have eczema. It is important that patients also meet the following criteria: Screening and baseline IGA-CHE 3 or 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.,"

Answered by AI
~0 spots leftby Apr 2025