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Efficacy and Safety Evaluation of Tulisokibart in Moderate to Severe Hidradenitis Suppurativa: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Trial

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What is this study about?

This clinical trial is focused on studying hidradenitis suppurativa, a chronic skin condition that causes small, painful lumps to form under the skin. The study will evaluate a treatment called tulisokibart (also known by its code name MK-7240), which is administered as a solution for injection using a pre-filled injector. The trial will compare the effects of tulisokibart with a placebo to determine its effectiveness and safety in treating moderate to severe cases of hidradenitis suppurativa.

The purpose of the study is to assess how well tulisokibart works in reducing the symptoms of hidradenitis suppurativa. Participants in the study will receive either tulisokibart or a placebo and will be monitored over a period of time to see if there is an improvement in their condition. The study will last for several weeks, and participants will have regular check-ups to track their progress and any changes in their symptoms.

Throughout the study, researchers will look at various outcomes, such as the percentage of participants who experience a significant reduction in their symptoms and any changes in their quality of life. The study will also monitor any side effects or adverse events that participants may experience. This research aims to provide valuable information about the potential benefits and risks of using tulisokibart for treating hidradenitis suppurativa.

Who Can Join the Study?

  • You must have signs and symptoms of hidradenitis suppurativa, which is a skin condition that causes painful lumps and sores, for at least 6 months before the study begins.
  • You must have been officially diagnosed with hidradenitis suppurativa by a doctor.
  • Your condition must be moderate or severe, meaning you have at least 5 abscesses (painful, swollen lumps filled with pus) or inflammatory nodules (painful bumps under the skin) in at least two different parts of your body.
  • At least one area of your skin must be at Hurley Stage II or III, which are terms used to describe more advanced stages of the disease involving deeper lumps or connected tunnels under the skin.
  • You must have a history of not getting enough relief from systemic antibiotics, which are medicines taken by mouth or through a vein to fight infection, or you must have had a bad reaction to these medicines.
  • You must have 20 or fewer draining tunnels, which are narrow paths or tracks that form under the skin, at the time you start the study.
  • You can be either male or female.
  • You must be between the ages of 6 and 17 years old.

Who Cannot Join the Study?

  • You have other active skin conditions that the doctor believes might make it difficult to measure how well the study treatment works for your specific condition.
  • You have a history of significant drug or alcohol abuse within the last 6 months.
  • You have previously used the medication tulisokibart.
  • You have had laser therapy or surgery on your skin sores in the last 6 weeks, or you plan to have these procedures during the study.
  • You have a known allergy or sensitivity to tulisokibart or any of the excipients, which are the inactive ingredients used to make the medicine.
  • You have an immune-mediated inflammatory condition (a disease where your body’s defense system attacks your own tissues) that is not well controlled and might require biologic therapy (medicines made from living organisms used to treat complex diseases).
  • You have had an organ transplant and need to take systemic immunosuppression (medication that lowers your body’s ability to fight infections) on an ongoing basis.
  • You have a history of cancer within the last 5 years, unless it was a specific type of skin cancer or a very early stage of cervical cancer that was completely removed by surgery.
  • You have had medical tests, such as imaging (like X-rays or scans) of the chest or breast, that suggest you might have malignancy (cancer), and doctors cannot rule it out through further testing.
  • You have a known infection with hepatitis B, hepatitis C, or HIV (a virus that affects the immune system).
  • You have any active infection currently occurring in your body.
  • You have tuberculosis, which is a serious bacterial infection.
  • You have had major surgery in the last 3 months or have a major surgery planned during the study period.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Hospital Edouard Herriot Lyon France
Amphia Hospital Breda The Netherlands
Hospital Universitario Virgen De Las Nieves Granada Spain
Universita’ Politecnica Delle Marche Ancona Italy
Hopital Beaujon Clichy France
Direction Centrale Du Service De Sante Des Armees Toulon France
Ezunkog Ujrpgqturtso Mwjyezn Cjsxclx Rffcyqzbd (jeqhdwq Mtm Rotterdam The Netherlands
Gloojc Uvrtuvkmmh Fmhzksxyu Frankfurt Germany
Hkrkapqz Vtea dvenbtda Barcelona Spain

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
17.06.2025
Germany Germany
Not recruiting
17.06.2025
Italy Italy
Not recruiting
17.06.2025
Spain Spain
Not recruiting
17.06.2025
The Netherlands The Netherlands
Not recruiting
17.06.2025

Trial locations

Investigated drugs:

Tulisokibart is an injectable medicine given under the skin. It is being studied to see how well it works and how safe it is for people living with moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps and inflammation.

Investigated diseases:

Hidradenitis Suppurativa – This is a chronic skin condition that primarily affects areas where skin rubs together, such as the armpits and groin. It begins with the formation of painful lumps under the skin. Over time, these lumps may develop into larger abscesses or sores. The condition often leads to the creation of tunnels or tracts beneath the skin’s surface. These tunnels can connect different lumps and may drain fluid or pus. The process can recur repeatedly over long periods.

Trial ID:
2024-520039-33-00
Protocol code:
MK-7240-012
Trial Phase:
Therapeutic use (Phase IV)

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