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Janus Kinase (JAK) Inhibitor
Ruxolitinib Cream for Hidradenitis Suppurativa
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
Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study.
Baseline Skin Pain or Itch NRS score ≥ 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 40 weeks
Awards & highlights
Study Summary
This trial tests a new cream to treat Hidradenitis Suppurativa. It's a 32-week, double-blind trial with a placebo and an open label extension period.
Who is the study for?
This trial is for individuals with Hidradenitis Suppurativa (HS), a skin condition, who have had it for at least 3 months. Participants should have a certain number of painful or itchy skin bumps in specific areas without tunnels. They must not use antibiotics or certain antiseptic washes during the study and agree to avoid pregnancy.Check my eligibility
What is being tested?
The study tests Ruxolitinib cream's effectiveness and safety against HS compared to a placebo cream over 16 weeks, followed by all participants receiving Ruxolitinib for another 16 weeks. It's randomized and double-blind initially, meaning neither researchers nor participants know who gets which treatment.See study design
What are the potential side effects?
While the side effects are not specified here, generally topical treatments like creams can cause local reactions such as redness, itching, burning sensation at the application site; systemic side effects are less common but may include headaches or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to use any antibiotics for HS during the study.
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I experience skin pain or itching.
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I have 3 to 10 painful skin bumps without any tunnels.
Select...
I agree not to use any antibiotics for HS during the study.
Select...
I experience skin pain or itching.
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I agree not to use certain skin cleansers on my HS lesions during the study.
Select...
I have been diagnosed with HS for at least 3 months.
Select...
I have mild to moderate HS with 3 to 10 active nodules and no tunnels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 40 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in abscess and inflammatory nodules (AN) count at Week 16.
Secondary outcome measures
Change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) score
Change from baseline in the Itch NRS score
Change from baseline in the Skin Pain Numeric Rating Scale (NRS)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Vehicle CreamExperimental Treatment1 Intervention
Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
Group II: Ruxolitinib CreamExperimental Treatment1 Intervention
Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an 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
~1850
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
368 Previous Clinical Trials
55,392 Total Patients Enrolled
7 Trials studying Hidradenitis Suppurativa
2,438 Patients Enrolled for Hidradenitis Suppurativa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have 3 to 10 affected areas on my body.You need to have at least three distinct areas of your body affected by the condition.I agree not to use any antibiotics for HS during the study.I experience skin pain or itching.I have 3 to 10 painful skin bumps without any tunnels.I have been diagnosed with HS for at least 3 months.I have not had a skin infection like herpes or chicken pox in the last 2 weeks.I agree not to use any antibiotics for HS during the study.I experience skin pain or itching.If you have at least 3 acne lesions, they should be in at least 1 different area of your body. If you have more than 3 but no more than 10 lesions, they should be in at least 2 different areas.I agree not to use certain skin cleansers on my HS lesions during the study.I have draining tunnels in my skin.I do not have skin conditions that could affect HS assessment.I have a condition that weakens my immune system.I haven't taken antibiotics or antivirals for infections in the last 2 weeks.I have been diagnosed with HS for at least 3 months.Your lab test results are not within the required range for the study.You have another skin condition that could affect the study or your safety, like a serious rash or scarring.I have mild to moderate HS with 3 to 10 active nodules and no tunnels.I am not taking any medications that are not allowed in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib Cream
- Group 2: Vehicle Cream
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Hidradenitis Suppurativa Patient Testimony for trial: Trial Name: NCT05635838 — Phase 2
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