Study of ruxolitinib cream for treating hidradenitis suppurativa in adult patients

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What is this study about?

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.

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)

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
St. Josef-Hospital Bochum Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Havelklinik GmbH & Co. KG Berlin Germany
Klinikum Darmstadt GmbH Darmstadt Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Universitaetsklinikum Erlangen AöR Erlangen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda USL Toscana Centro Prato Italy
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Universita’ Degli Studi Di Ferrara Ferrara Italy
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
Uzxxhyqkhs Miqjcrl Cajybe Hbywiwcqkspizxzgc Hamburg Germany
Ijbsmt Izaxpori Frilojjxvlyuc Oclbbmxlmvx Rome Italy
Mbzykecgh Iefidbhxxc Cmbidxld Sfexlgio Svh z ocyd Warsaw Poland
Pkvlykatuea Ecuevbmmfbwi Wroclaw Poland
Abxpbml Oynhesbpfza Unekjafkyfocc Czseeraidyut Dcojr Syxcal E Dnqye Sztsqpq Dc Tjmzsp Turin Italy
Hgxlmbvy Uanvarzoihsaj Hxzjedaf Travc y Ppsgod Ihuygoem Clgobo dwrhqfbstjzvfiaeo (gpne Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
12.09.2025
France France
Recruiting
12.09.2025
Germany Germany
Recruiting
12.09.2025
Italy Italy
Recruiting
12.09.2025
Poland Poland
Recruiting
12.09.2025
Spain Spain
Recruiting
12.09.2025

Trial locations

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.

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.

Trial ID:
2024-517632-22-00
Protocol code:
INCB018424-324
NCT ID:
NCT06959225
Trial Phase:
Therapeutic confirmatory (Phase III)

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