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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Lichen Planus

Phase 2
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
Clinical diagnosis of LP with predominant cutaneous involvement.
Clinical diagnosis of LP with predominant cutaneous involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 weeks
Awards & highlights

Study Summary

This trial will study a cream to treat a skin condition called Lichen Planus, to see if it is effective and safe.

Who is the study for?
This trial is for individuals with a skin condition called Cutaneous Lichen Planus, who experience itching and have moderate to severe symptoms. Participants must not be pregnant or planning pregnancy and should not have other skin infections or inflammatory conditions that could affect the study results.Check my eligibility
What is being tested?
The study tests Ruxolitinib cream's effectiveness and safety against a placebo (Vehicle cream) in treating Cutaneous Lichen Planus. It starts with a 16-week double-blind phase where neither participants nor researchers know who gets which cream, followed by an open-label phase of another 16 weeks.See study design
What are the potential side effects?
Possible side effects of Ruxolitinib cream may include irritation at the application site, increased risk of infection due to immune system effects, headaches, and potential allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition mainly affects my skin.
Select...
My condition mainly affects my skin.
Select...
My condition mainly affects my skin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 weeks 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 with Investigator's Global Assessment Treatment Success (IGA-TS)
Secondary outcome measures
Change from baseline in the Skin Pain Numeric Rating Scale (NRS) score
Number of Treatment Emergent Adverse Events (TEAEs)
Proportion of Participants achieving IGA-TS
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ruxolitinib creamExperimental Treatment2 Interventions
Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.
Group II: Vehicle CreamPlacebo Group1 Intervention
Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vehicle cream
2011
Completed Phase 3
~5360
Ruxolitinib cream
2022
Completed Phase 3
~1790

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
361 Previous Clinical Trials
54,986 Total Patients Enrolled
Haq Nawaz, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
193 Total Patients Enrolled

Media Library

Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05593432 — Phase 2
Cutaneous Lichen Planus Research Study Groups: Ruxolitinib cream, Vehicle Cream
Cutaneous Lichen Planus Clinical Trial 2023: Ruxolitinib Cream Highlights & Side Effects. Trial Name: NCT05593432 — Phase 2
Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05593432 — Phase 2
Cutaneous Lichen Planus Patient Testimony for trial: Trial Name: NCT05593432 — Phase 2

Frequently Asked Questions

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

When can patients expect Ruxolitinib cream to be available?

"Ruxolitinib cream is a medication that is currently being trialed in Phase 2 clinical trials. This suggests that while there is evidence of safety, there is no data yet to support its efficacy."

Answered by AI

Are there several sites running this study in other developed countries?

"There are 6 available for this trial including Arlington Center For Dermatology in Arlington, Oregon Medical Research Center in Portland, and Clinohio Research Services in Columbus. The other locations where the study is being conducted have not been specified."

Answered by AI

Are researchers currently looking for participants for this trial?

"Unfortunately, this particular trial is no longer enrolling patients. This is according to the clinicaltrials.gov website, which also reports that the last edit to this study was on 11/7/2022. Although this specific study has ended recruitment, there are 13 other trials that are still looking for candidates."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
What site did they apply to?
Central Sooner Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have been to a Dermatologist and tried what she has given and it is still there and doesn't seem to want to go away.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How many times would I need to come to Norman?
PatientReceived 2+ prior treatments
~27 spots leftby Mar 2025