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Study of ruxolitinib cream for treating hidradenitis suppurativa in adult patients

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical trial studies the effectiveness of ruxolitinib cream in people with Hidradenitis Suppurativa, a chronic skin condition that causes painful bumps under the skin, typically in areas where skin rubs together. The study tests a cream containing ruxolitinib (also known as INCB018424 or Opzelura) compared to a cream without active ingredients (vehicle cream).

The purpose of this research is to determine how well ruxolitinib cream works when applied to the skin twice daily in treating Hidradenitis Suppurativa. The cream is being tested in people who have mild to moderate forms of the condition affecting at least two different body areas, such as the underarms or groin regions.

The study is organized in a way where some participants will receive the ruxolitinib cream while others will receive the vehicle cream. During the study, participants will not be allowed to use certain other treatments for their condition, such as antibiotics or antiseptic washes. The main treatment period lasts for 16 weeks, after which the effectiveness of the treatment will be evaluated based on the reduction in the number of affected areas.

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 assessment
The trial involves participants with Hidradenitis Suppurativa (HS), a skin condition that must have been diagnosed at least 6 months before screening
Your skin condition will be evaluated to confirm mild to moderate HS (Hurley Stage I or II) with at least 4 affected areas, without draining tunnels
The affected areas must be present in at least 2 different body locations (such as underarms, groin folds, or under breast areas)
Step 2
Treatment period start
You will be randomly assigned to receive either ruxolitinib 1.5% cream or a placebo cream (cream without active medication)
The cream needs to be applied to affected areas twice daily
This phase of the study will last for 16 weeks
Step 3
Treatment restrictions
During the treatment period, you cannot use:
- Any antibiotics (topical or oral) for HS treatment
- Topical antiseptics, including products containing chlorhexidine, iodine, bleach, or benzoyl peroxide
Regular soap and water are permitted for cleansing
Step 4
Evaluation at week 16
Your condition will be assessed 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 evaluated 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 extended treatment period
The same restrictions regarding antibiotics and antiseptics continue through weeks 16 to 20
Regular assessments will continue to monitor your progress

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 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
Must have mild to moderate HS with at least 4 inflammatory bumps, without tunnels under the skin, affecting at least 2 separate body areas (such as underarms, groin folds, or under breast areas)
Must agree not to use any antibiotics (applied to skin or taken by mouth) for treating HS during specific study periods
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
Can be either new to HS treatment or have previously tried other treatments that didn't work well or caused problems

Who cannot join the trial?

15 criteria

Age below 18 or above 75 years
Pregnancy or breastfeeding
Active skin infections in the treatment areas
Use of systemic antibiotics within 4 weeks before study start
History of serious allergic reactions to topical medications
Current participation in other clinical trials
Significant medical conditions that could interfere with study evaluation, including immunodeficiency disorders (conditions that weaken the immune system)
Previous treatment with biologics (specialized medications that target specific parts of the immune system) within 12 weeks before study start
History of skin cancer or pre-cancerous lesions in treatment areas
Severe liver or kidney disease
Uncontrolled diabetes
Active substance abuse
Mental conditions that could affect ability to follow study procedures
Use of medications that could interact with the study treatment
Previous unsuccessful treatment with similar medications

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Verified sites

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

Verified
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Turin, Italy
Verified
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Verified
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, Italy

Trial locations

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Investigated drugs

Ruxolitinib cream
is a topical medication that is 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 be applied twice daily to affected areas of the skin.
Vehicle cream
(placebo) is a cream that looks and feels identical to the active medication but does not contain any active drug. It is used as a comparison to help determine if the active medication is effective.

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 for treating Hidradenitis Suppurativa (HS), a chronic inflammatory skin condition. This JAK1/JAK2 inhibitor works at the molecular level by blocking specific cellular signaling pathways that are responsible for inflammation in the skin. Currently undergoing Phase 3 clinical trials, ruxolitinib cream represents a novel approach to treating HS by targeting the condition directly through the skin, potentially offering a more targeted treatment option compared to systemic medications. The medication belongs to the class of topical JAK inhibitors and has shown promise in managing inflammatory skin conditions through its ability to modulate the immune response locally.

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 the blockage of hair follicles, leading to inflammation and the development of painful bumps that can break open and drain. Over time, these areas can develop scarring and tunnel formation beneath the skin. The condition tends to be recurring, with periods of flare-ups and remission. It commonly affects areas with sweat glands and can cause significant discomfort during daily activities.