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Janus Kinase (JAK) Inhibitor
Ruxolitinib Cream for Lichen Sclerosus
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 12 to week 24 plus 30 days
Summary
This trial is testing a cream called Ruxolitinib on people with Lichen Sclerosus, a chronic skin condition. The cream works by blocking enzymes that cause inflammation and immune responses. The study will last for several months. Ruxolitinib cream has been tested in various conditions such as atopic dermatitis and vitiligo, showing anti-inflammatory and repigmentation effects.
Who is the study for?
This trial is for individuals with Lichen Sclerosus, specifically those who have a confirmed diagnosis in the anogenital area and are experiencing itching. Participants must not be pregnant or planning pregnancy and should not have other infections or conditions that could explain their symptoms.
What is being tested?
The study is testing Ruxolitinib cream's effectiveness and safety against a placebo (vehicle cream) over a 12-week period, followed by another 12 weeks where everyone receives Ruxolitinib to further assess its effects.
What are the potential side effects?
While specific side effects of Ruxolitinib cream are not listed here, similar medications can cause skin irritation, headaches, dizziness, and increased risk of infection. The trial will monitor participants closely for any adverse reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 12 to week 24 plus 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 12 to week 24 plus 30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With ITCH4 at Week 12
Secondary study objectives
Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12
Change From Baseline in the Skin Pain NRS Score at Week 12
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ruxolitinib creamExperimental Treatment2 Interventions
Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
Group II: Vehicle CreamPlacebo Group1 Intervention
Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib cream
2022
Completed Phase 3
~1850
Vehicle cream
2011
Completed Phase 3
~5360
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Lichen Sclerosus include potent topical corticosteroids like clobetasol propionate and JAK inhibitors like Ruxolitinib cream. Clobetasol propionate works by reducing inflammation and suppressing the immune response, which helps alleviate symptoms and promote healing of the affected skin.
Ruxolitinib cream, a JAK inhibitor, blocks the JAK-STAT signaling pathway, which is involved in the inflammatory process. By inhibiting this pathway, Ruxolitinib reduces inflammation and immune activity in the skin.
These treatments are crucial for Lichen Sclerosus patients as they help manage symptoms, prevent disease progression, and improve the quality of life.
Drugs targeting the JAK/STAT pathway for the treatment of immune-mediated inflammatory skin diseases: protocol for a scoping review.Lichen sclerosus. Therapy with clobetasol propionate.
Drugs targeting the JAK/STAT pathway for the treatment of immune-mediated inflammatory skin diseases: protocol for a scoping review.Lichen sclerosus. Therapy with clobetasol propionate.
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
392 Previous Clinical Trials
63,880 Total Patients Enrolled
Haq Nawaz, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have a specific condition affecting the anal or genital area.You are suspected of having other conditions that cause vaginal symptoms such as yeast infection, chlamydia, trichomoniasis, gonorrhea, bacterial vaginosis, or herpes.You have genital or vulvar sores that are not related to lichen sclerosus.You have a long-term or recent infection that needs to be treated with strong medications within 2 weeks before the study starts.Your initial IGA score is 2 or higher for LS.You have a score of 4 or higher for itching in the anogenital area before starting the study.Your lab test results do not meet the requirements set by the study.Diagnosed with LS in the anogenital area through a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib cream
- Group 2: Vehicle Cream
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.