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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 trial about?

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

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation
Participation in the study begins with the administration of either tulisokibart or a placebo, which is an inactive substance used for comparison.
The medication tulisokibart is provided as a solution for injection in a pre-filled injector and is administered through a subcutaneous injection, which means it is injected into the fatty tissue just under the skin.
Step 2
Treatment and evaluation
The treatment process continues for at least 16 weeks.
At the 16-week mark, the effectiveness of the medication is evaluated by measuring the hidradenitis suppurativa clinical response, which refers to the visible improvement in skin symptoms associated with the condition hidradenitis suppurativa.

Who can join the trial?

8 criteria

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 trial?

13 criteria

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.

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Verified sites

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

Amphia Hospital
Verified
Breda, The Netherlands
Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

Trial locations

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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.

Tulisokibart

What is already known about the treatment

Placebo for MK-7240
This is an inactive substance that contains no medicine and is used as a comparison in clinical trials. It is administered in the same way as the test medication to ensure the study results are accurate. This substance has no therapeutic effect and is not used to treat any medical conditions.
tulisokibart
This medication is an experimental treatment given as an injection under the skin to help manage moderate to severe hidradenitis suppurativa, a painful skin condition. Currently being studied in clinical trials, it belongs to a class of drugs known as biological therapies. It works at a molecular level by targeting and blocking specific proteins in the body that cause excessive inflammation and skin lesions.

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.