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Study on the Effectiveness and Safety of Sonelokimab 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 will evaluate a treatment called sonelokimab, which is given as a subcutaneous injection, meaning it is injected under the skin. Sonelokimab is a type of medication known as a nanobody, which works by inhibiting proteins called IL-17A and IL-17F that are involved in inflammation. The study will compare the effects of sonelokimab with a placebo, which is a sterile solution that looks like the medication but does not contain any active ingredients.

The purpose of the study is to assess how effective and safe sonelokimab is for adults with moderate to severe hidradenitis suppurativa. Participants in the study will receive either sonelokimab or a placebo over a period of 16 weeks. During this time, researchers will monitor the participants to see if there is a 75% improvement in their condition, which is measured by a specific score called the Hidradenitis Suppurativa Clinical Response (HiSCR) score. The study will also track any side effects or adverse events that occur during the treatment period.

Throughout the study, participants will undergo regular check-ups, including physical examinations and laboratory tests, to ensure their safety and to gather data on the treatment's effects. The trial aims to provide valuable information on whether sonelokimab can be a beneficial treatment option for those suffering from hidradenitis suppurativa, potentially improving their quality of life by reducing the severity of their symptoms.

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, the participant will be randomly assigned to receive either the medication sonelokimab or a placebo. The placebo is a sterile solution that looks like the medication but does not contain the active ingredient.

    The medication or placebo will be administered through a subcutaneous injection, which means it is injected under the skin.

  2. Step 2

    Treatment phase

    The treatment phase lasts for 16 weeks. During this time, the participant will receive regular injections of either sonelokimab or placebo.

    The main goal of this phase is to evaluate the effectiveness of sonelokimab in improving the condition known as hidradenitis suppurativa (HS).

  3. Step 3

    Monitoring and assessments

    Throughout the study, the participant will undergo various assessments to monitor their health and the effects of the treatment.

    These assessments include physical examinations, vital signs checks, and laboratory tests such as blood and urine analysis.

    The participant's response to the treatment will be measured using the Hidradenitis Suppurativa Clinical Response (HiSCR) score, with a focus on achieving a 75% improvement by the end of the 16 weeks.

  4. Step 4

    Completion of the study

    At the end of the 16-week treatment period, the participant will have a final assessment to evaluate the overall effectiveness and safety of the treatment.

    The study aims to determine if sonelokimab is more effective than the placebo in treating moderate to severe hidradenitis suppurativa.

Who can join the trial?

8 criteria

  • Participants must be at least 18 years old.
  • Participants need to fill out an electronic diary for at least 4 out of 7 days in at least one of the two weeks before starting the study.
  • Participants should have tried antibiotics for their **hidradenitis suppurativa (HS)** but did not get enough help from them, or they couldn't take them due to side effects or other reasons. This should be decided by the study doctor. Usually, antibiotics should have been tried for at least 8 to 12 weeks.
  • If participants are taking antibiotics, they must be on a stable dose, meaning the dose hasn't changed in the 28 days before starting the study treatment.
  • Female participants can join if they are not pregnant or breastfeeding. If they can have children, they must agree to use very effective birth control during the study and for at least 8 weeks after the last treatment. They must have a negative pregnancy test before starting the study.
  • Male participants must agree to use a condom when having sex with a female partner who can have children during the study and for at least 8 weeks after the last treatment, unless they are surgically sterile.
  • Participants must be able to understand and sign a consent form, which means they agree to follow the study rules and requirements.
  • Participants must have been diagnosed with **hidradenitis suppurativa (HS)** by the study doctor and have had symptoms for at least 6 months before signing the consent form.

Who cannot join the trial?

5 criteria

  • Participants who have a different condition than hidradenitis suppurativa (HS) cannot join the study. HS is a skin condition that causes small, painful lumps under the skin.
  • Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
  • Participants who are not classified within the specific clinical trial groups required for the study cannot participate.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals considered part of a vulnerable population are not included in this study. A vulnerable population might include people who are unable to give informed consent or who are at a higher risk of harm.
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Investigated drugs

Sonelokimab is a medication being studied for its effectiveness in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. It is administered through an injection under the skin. The trial aims to see how well this medication works in reducing the symptoms of the condition over a period of 16 weeks.

What is already known about the treatment

Sonelokimab – This medication is administered through subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating moderate to severe hidradenitis suppurativa (HS). Sonelokimab is not yet widely available in medical practice, as it is still under investigation to confirm its safety and efficacy. The main therapeutic indication for sonelokimab is to reduce the symptoms of HS, a chronic skin condition. It works by targeting specific proteins in the immune system to reduce inflammation. Sonelokimab is classified as a monoclonal antibody, which is a type of biologic drug designed to interfere with specific pathways in the immune response.

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 tunnels under the skin. Over time, the condition can cause scarring and the formation of sinus tracts, which are channels that connect the lumps under the skin. The disease often progresses with periods of flare-ups and remission, where symptoms may temporarily improve. The exact cause of Hidradenitis Suppurativa is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511360-87-00Protocol codeM1095-HS-301Estimated enrolment400 patientsSponsorMoonLake Immunotherapeutics AG

sourced from the EU Clinical Trials Register and site verification

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