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Study of Eltrekibart for Adults 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 a chronic inflammatory disease that causes painful lumps under the skin, often in areas like the armpits, groin, and under the breasts. The study is specifically looking at adults with moderate to severe forms of this condition. The treatment being tested is a medication called Eltrekibart, which is a type of protein known as a monoclonal antibody. This protein is designed to target and block certain substances in the body that are involved in inflammation, potentially reducing the symptoms of Hidradenitis Suppurativa.

The purpose of the study is to determine if Eltrekibart is more effective than a placebo in improving the condition of participants with moderate to severe Hidradenitis Suppurativa. Participants in the study will receive either Eltrekibart or a placebo through a method called subcutaneous injection, which means the medication is injected under the skin. The study will last for a period of up to 50 weeks, during which participants will be monitored to see if there is an improvement in their symptoms.

Throughout the study, researchers will assess the participants' response to the treatment by looking for a specific improvement known as the Hidradenitis Suppurativa Clinical Response 50 (HiSCR50). This measure indicates a significant reduction in the number of painful lumps and other symptoms. The study aims to provide valuable information on whether Eltrekibart can be a beneficial treatment option for people suffering from this challenging skin condition.

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
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of hidradenitis suppurativa (HS) for at least 12 months, presence of HS lesions in at least two distinct anatomical regions, and an abscess plus inflammatory nodule count of at least five.
Participants must agree to use topical antiseptics daily and have had an inadequate response or intolerance to a 28-day course of oral antibiotics.
Step 2
Randomization and treatment allocation
Participants are randomly assigned to receive either the investigational drug eltrekibart or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.
Eltrekibart is administered as a subcutaneous injection, which means it is injected under the skin.
Step 3
Treatment phase
During the treatment phase, participants receive the assigned treatment. The frequency and dosage of eltrekibart are determined by the study protocol, which is not specified in the provided data.
Participants are monitored regularly to assess the response to treatment and any potential side effects.
Step 4
Evaluation of primary endpoint
The primary endpoint is evaluated at week 16. This involves assessing the percentage of participants achieving a 50% reduction in HS symptoms, known as Hidradenitis Suppurativa Clinical Response 50 (HiSCR50).
This evaluation helps determine the effectiveness of eltrekibart compared to the placebo.
Step 5
Follow-up and study completion
After the treatment phase, participants may undergo follow-up assessments to monitor long-term effects and gather additional data.
The study is estimated to conclude by July 8, 2026, with recruitment starting on July 12, 2024.

Who can join the trial?

8 criteria

Must be an adult, meaning you are 18 years or older.
Must have been diagnosed with **Hidradenitis Suppurativa (HS)**, a skin condition, for at least 12 months.
Must have HS lesions, which are affected areas on the skin, in at least 2 different body areas.
At least one of these lesions must be classified as **Hurley Stage II or III**, which are more advanced stages of the condition.
Must have a count of at least 5 for **abscesses** (swollen areas filled with pus) plus **inflammatory nodules** (small lumps under the skin).
Must agree to use **topical antiseptics** (medicines applied to the skin to prevent infection) every day.
Must have had an inadequate response or intolerance to a 28-day course of oral antibiotics, meaning the antibiotics did not work well or caused side effects.
Both males and females can participate.

Who cannot join the trial?

4 criteria

Individuals who do not have moderate to severe Hidradenitis Suppurativa cannot participate. Hidradenitis Suppurativa is a skin condition that causes small, painful lumps under the skin.
Participants must be adults, meaning they should be within the age range specified for adults in the study.
Both males and females are eligible, but if someone does not identify as either, they may not be able to participate.
People who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

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Verified sites

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Goethe University Frankfurt
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Frankfurt, Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn
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Bonn, Germany
Universitaetsklinikum Erlangen AöR
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Erlangen, Germany

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Investigated drugs

Eltrekibart is a medication being tested to see if it can help people with moderate to severe Hidradenitis Suppurativa, a skin condition that causes painful lumps under the skin. The study aims to find out if this medication can improve the symptoms of the condition better than a placebo.

Humanised Igg4 Kappa Monoclonal Antibody Against Cxcl1, Cxcl2, Cxcl3, Cxcl5, Cxcl6, Cxcl7 And Cxcl8

What is already known about the treatment

Eltrekibart – Eltrekibart is administered orally in the form of tablets. It is currently being studied in clinical trials, specifically in a Phase 2b study, to assess its effectiveness in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. The main therapeutic indication for eltrekibart is to improve the symptoms of this condition by achieving a significant clinical response. At the molecular level, eltrekibart works by modulating specific pathways involved in inflammation, thereby reducing the inflammatory response associated with the disease. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the development 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 abscesses 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 more common in women and may be associated with other conditions like obesity and metabolic syndrome. The severity of symptoms can vary, with some individuals experiencing mild discomfort and others facing significant pain and skin damage.