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Study on Izokibep for Patients with Moderate to Severe Hidradenitis Suppurativa

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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 a skin condition called Hidradenitis Suppurativa, which is characterized by painful lumps under the skin, often in areas like the armpits and groin. The study is testing a treatment called Izokibep, which is given as an injection under the skin. The purpose of the study is to evaluate how effective and safe Izokibep is for people with moderate to severe forms of this condition.

Participants in the study will be randomly assigned to receive either Izokibep or a placebo, which looks like the treatment but does not contain the active medicine. The study will last for several weeks, during which participants will receive regular injections and attend follow-up visits to monitor their progress and any changes in their condition. The main goal is to see if the treatment helps reduce the symptoms of Hidradenitis Suppurativa by a significant amount by the end of the study period.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The study aims to provide valuable information on whether Izokibep can be a beneficial treatment option for those suffering from this challenging skin condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and randomization
Upon joining the study, the participant is enrolled and randomly assigned to receive either izokibep or a placebo. This process ensures that the study results are unbiased and reliable.
Step 2
Treatment administration
The participant receives the assigned treatment, which is administered as a solution for injection under the skin (subcutaneous injection).
The treatment involves the use of izokibep, a medication being tested for its effectiveness in treating moderate to severe hidradenitis suppurativa, or a placebo, which is an inactive substance used for comparison.
Step 3
Treatment duration
The treatment is administered over a period leading up to Week 12. During this time, the participant continues to receive the injections as per the study schedule.
Step 4
Evaluation of treatment efficacy
The primary goal is to assess the effectiveness of izokibep by measuring the percentage of participants achieving a significant reduction in symptoms, known as HiSCR75, at Week 12.
Secondary evaluations include achieving HiSCR90 and HiSCR100, monitoring for any flares, and assessing changes in skin pain and quality of life.
Step 5
Safety monitoring
Throughout the study, the participant's health is closely monitored. This includes tracking any adverse events, changes in laboratory values, and vital signs to ensure the safety of the treatment.
Step 6
Study completion
The study is expected to conclude by December 17, 2025. At this point, all data collected will be analyzed to determine the overall efficacy and safety of izokibep in treating hidradenitis suppurativa.

Who can join the trial?

5 criteria

The person must be at least 18 years old or the legal age of consent in their area when they sign the consent form.
The person must have Hidradenitis Suppurativa lesions in at least two different body areas, such as both armpits or one armpit and the groin area. One of these areas must be classified as Hurley Stage II or Hurley Stage III, which are ways to describe the severity of the condition.
The person must have a total count of at least 5 AN (abscesses and nodules) at the time of screening and on the first day before joining the study.
The person must have tried oral antibiotics for at least 3 months to treat their condition and found them not effective, or they had a return of symptoms after stopping the antibiotics, or they could not tolerate them, or they have a medical reason not to use them, as determined by the study doctor after talking with the person and reviewing their medical history.
The person must have a negative TB (tuberculosis) test at the time of screening.

Who cannot join the trial?

10 criteria

Patients who have a different skin condition other than Hidradenitis Suppurativa cannot participate. Hidradenitis Suppurativa is a long-term skin condition that causes small, painful lumps under the skin.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who are taking certain medications that might interfere with the study cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have a known allergy to the study medication cannot participate.
Patients who have a serious infection or illness cannot participate.

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Verified sites

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

Centre Hospitalier Universitaire De Dijon
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Dijon, France
Centre Hospitalier Universitaire De Montpellier
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Montpellier, France
Centre Hospitalier Universitaire De Nantes
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Nantes, France

Trial locations

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Investigated drugs

Izokibep is a medication being studied for its effectiveness in treating moderate to severe hidradenitis suppurativa, a chronic skin condition characterized by painful lumps under the skin. The trial aims to determine how well izokibep works in reducing the symptoms of this condition by comparing it to a placebo.

Izokibep

What is already known about the treatment

Izokibep – Izokibep is administered through injection and is currently being studied in clinical trials for its effectiveness in treating moderate to severe Hidradenitis Suppurativa, a chronic skin condition. It is in the Phase 3 stage of clinical trials, which means it is being tested for safety and efficacy in a larger group of patients. The main therapeutic indication for Izokibep is to reduce the symptoms of Hidradenitis Suppurativa. At the molecular level, Izokibep works by targeting specific proteins in the immune system to reduce inflammation. It is classified pharmacologically as a biologic agent, specifically an interleukin inhibitor.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the formation of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of tunnels under the skin and scarring. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not well understood, but it is believed to involve hair follicles becoming blocked and inflamed. It is not contagious and varies in severity from person to person.