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Study on Amlitelimab 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 and groin. The trial is testing a new treatment called amlitelimab, which is given as a solution for injection under the skin. Amlitelimab is a type of protein designed to help reduce inflammation and improve symptoms in people with moderate to severe forms of this condition.

The purpose of the study is to evaluate how effective and safe amlitelimab is for treating hidradenitis suppurativa. Participants in the study will receive either amlitelimab or a placebo, which looks like the treatment but does not contain the active substance. The study will follow participants over a period of time to observe any changes in their condition and to monitor for any side effects. The main goal is to see if participants experience a reduction in the severity of their symptoms.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. This includes monitoring the number and size of skin lumps, as well as any changes in pain levels and overall quality of life. The study aims to provide valuable information on whether amlitelimab can be a beneficial treatment option for those suffering from hidradenitis suppurativa.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be between 18 and 70 years old and have a history of hidradenitis suppurativa (HS) for at least one year. HS lesions must be present in at least two distinct areas, with one area being classified as Hurley Stage II or III. An inadequate response to a 12-week trial of an oral antibiotic for HS is also required.

  2. Step 2

    Treatment administration

    Participants receive a subcutaneous injection of either amlitelimab or a placebo. The placebo is a solution without the active substance but contains the same excipients as the test product. The injections are administered using a pre-filled syringe.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants are monitored for clinical response and safety. The primary measure of success is the percentage of participants achieving a 50% reduction in HS symptoms by Week 16, known as HiSCR50.

    Secondary assessments include the time to achieve HiSCR50, changes in lesion count, and improvements in quality of life and pain scores. Safety is evaluated through the incidence of adverse events and laboratory test results.

  4. Step 4

    Study duration

    The study is expected to conclude by November 20, 2024. Participants are involved in the study from the start of recruitment, estimated to begin on February 1, 2024, until the end of the study period.

Who can join the trial?

4 criteria

  • Participant must be between 18 years (or the age of adulthood in their country if it's older than 18) and 70 years old at the time of signing the consent form.
  • Participants should have had signs and symptoms of **Hidradenitis** for at least 1 year before starting the study. **Hidradenitis** is a skin condition that causes small, painful lumps under the skin.
  • Participants must have **Hidradenitis** lesions in at least 2 different body areas, such as both armpits or an 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.
  • Participant must have tried taking an oral antibiotic for at least 12 weeks to treat **Hidradenitis** but did not have a good enough response.

Who cannot join the trial?

10 criteria

  • Participants who have a known allergy or sensitivity to the study medication or its ingredients.
  • Individuals with a history of severe allergic reactions, which are intense and potentially life-threatening responses by the body to certain substances.
  • Patients who are currently participating in another clinical trial or have participated in one within the last 30 days.
  • Individuals with a significant medical condition that could interfere with the study, such as uncontrolled diabetes or heart disease.
  • Women who are pregnant or breastfeeding, as the study medication may affect the baby.
  • Participants who have a history of drug or alcohol abuse, which means using these substances in a harmful way.
  • Individuals with a compromised immune system, meaning their body's defense system is weakened and may not respond well to the study medication.
  • Patients who have had a major surgery within the last 3 months.
  • Individuals with a current or recent infection that requires treatment with antibiotics.
  • Participants who have received a live vaccine within the last 4 weeks. A live vaccine contains a small amount of the actual virus or bacteria to help the body build protection.
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Investigated drugs

Amlitelimab is a medication being studied for its potential to help people with moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps under the skin. The trial aims to see how effective and safe this medication is for treating the symptoms of this condition.

What is already known about the treatment

Amlitelimab – Amlitelimab is administered as an injection, typically under the skin. It is currently being studied in clinical trials for its potential use in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. The medication works by targeting specific immune pathways to reduce inflammation and the formation of painful nodules. It is classified as a monoclonal antibody, which is a type of biologic drug designed to interact with specific proteins in the immune system.

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 condition often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not fully understood, but it is believed to involve hair follicles becoming blocked and inflamed. Factors such as genetics, hormones, and lifestyle may contribute to its development. The progression of the disease can vary, with some individuals experiencing mild symptoms and others having more severe and widespread involvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505803-22-00Protocol codeACT17967Estimated enrolment84 patientsSponsorSanofi-Aventis Recherche & Developpement

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