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Study of ruxolitinib cream applied to the skin for people with hidradenitis suppurativa

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Hidradenitis Suppurativa, a chronic skin condition that causes painful bumps to form under the skin, typically in areas where skin rubs together. The research evaluates a medication called ruxolitinib cream, which is applied to the skin twice daily. The cream contains 1.5% of the active ingredient and will be compared to a vehicle cream (a cream without the active medication).

The purpose of this research is to determine how well ruxolitinib cream works in treating mild to moderate Hidradenitis Suppurativa. The study will include people who have had this condition for at least 6 months and have bumps in at least two different body areas. During the study, participants will either use the ruxolitinib cream or the vehicle cream on affected areas of their skin.

The main study period lasts 16 weeks, after which some participants may continue treatment in an extended phase. Throughout the study, participants will need to avoid using certain skin treatments, including antibiotics and antiseptic washes, on the affected areas. Regular check-ups will be conducted to monitor the condition's response to treatment and ensure participant safety.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening and qualification
During the screening visit, you must be at least 12 years old and have been diagnosed with Hidradenitis Suppurativa (HS) for at least 6 months
Your condition must be mild to moderate, with at least 4 affected areas in at least 2 different body regions (such as underarms, groin folds, or under-breast areas)
You must not have any draining tunnels
Step 2
Treatment period begins
You will receive either ruxolitinib 1.5% cream or a cream without active ingredients (vehicle cream)
The cream needs to be applied to affected areas twice daily
This double-blind period lasts for 16 weeks, meaning neither you nor the study staff will know which cream you are using
Step 3
Treatment restrictions
During the study, you cannot use any antibiotics for HS treatment
You must avoid using antiseptic products on affected areas, including special washes containing chlorhexidine, iodine, bleach, or benzoyl peroxide
Regular soap and water are permitted for cleaning
Step 4
Evaluation period
At week 16, your condition will be evaluated to measure the treatment's effectiveness
The main goal is to achieve at least 75% reduction in the number of affected areas
Your skin pain levels will be assessed if you had significant pain at the start of the study
Step 5
Extended treatment period
After the initial 16 weeks, the study continues with an open-label extension period
The same treatment restrictions regarding antibiotics and antiseptics continue through week 20 of this extension period

Who can join the trial?

8 criteria

Must be able to understand and agree to sign a written Informed Consent Form (ICF) for the study
Must be 12 years of age or older at the time of screening
Must have been diagnosed with Hidradenitis Suppurativa (HS) for at least 6 months before screening, confirmed by a skin specialist
Can be either new to treatment or have had previous unsuccessful treatments (excluding basic washes and antiseptics)
Must have mild to moderate HS with at least 4 inflamed bumps in at least 2 different body areas (such as underarms, groin folds, or under breast areas), without tunneling wounds
Must agree not to use any antibiotic treatments (applied to skin or taken by mouth) for HS during specific periods of the study
Must agree not to use antiseptic products (such as chlorhexidine, iodine, bleach, or benzoyl peroxide) on affected areas during specific study periods. Regular soap and water are allowed
Must be willing to avoid pregnancy or fathering children during the study period (additional details will be provided)

Who cannot join the trial?

14 criteria

Age below 18 years or above 65 years
Pregnant or breastfeeding women
Presence of any active skin infection other than Hidradenitis Suppurativa
Current use of systemic immunosuppressive medications (medications that weaken the immune system)
History of allergic reactions to similar medications
Significant chronic medical conditions that are not well controlled
Active or chronic infections such as tuberculosis, hepatitis B, or HIV
Major surgery in the past 8 weeks
Current participation in other clinical trials
Use of other investigational drugs within 30 days before starting this study
Severe kidney or liver disease
History of skin cancer or other malignancies in the past 5 years
Mental conditions that could interfere with study compliance
Substance abuse or alcohol dependency within the past 6 months

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

Ruxolitinib cream is a topical medication applied directly to the skin. It belongs to a class of drugs called JAK inhibitors, which work by reducing inflammation in the body. In this trial, it is being studied as a treatment for hidradenitis suppurativa, a chronic inflammatory skin condition that causes painful bumps under the skin. The cream is designed to reduce inflammation and symptoms associated with this condition when applied twice daily to affected areas.

Ruxolitinib

What is already known about the treatment

Ruxolitinib Cream - A topical medication administered as a 1.5% cream applied twice daily to affected areas of the skin for treating Hidradenitis Suppurativa (HS), a chronic inflammatory skin condition. This JAK inhibitor works at the molecular level by blocking specific enzymes called Janus kinases, which are involved in the inflammatory process, thereby reducing inflammation and associated symptoms. Currently undergoing Phase 3 clinical trials to evaluate its efficacy and safety in HS treatment, this medication represents a novel approach in topical therapy for inflammatory skin conditions and belongs to the pharmacological class of targeted immunomodulators.

Investigated diseases

Hidradenitis Suppurativa - A chronic skin condition that causes small, painful lumps to form under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. The condition begins with blockage of hair follicles, leading to inflammation and the development of painful bumps that can grow larger and deeper. These bumps can break open, releasing fluid and potentially connecting with other affected areas to form tunnel-like tracts under the skin. The condition tends to be recurring, with periods of flare-ups and relative calm. Hidradenitis Suppurativa most commonly affects areas with many sweat glands and can cause scarring over time.