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Study on the Effects 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 study 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 that works by inhibiting proteins called IL-17A and IL-17F, which are involved in inflammation. The trial 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, as 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 study aims to provide valuable information on whether sonelokimab can be a beneficial treatment option for those suffering from hidradenitis suppurativa.

The research process

The trial runs in 6 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, participants are required to provide informed consent, confirming their understanding and agreement to comply with the study requirements and restrictions.

  2. Step 2

    Initial assessment

    Participants undergo an initial assessment to confirm eligibility, which includes a review of medical history and a physical examination.

    Female participants of childbearing potential must have a negative pregnancy test before starting the study treatment.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either the active medication, sonelokimab, or a placebo. The placebo is a sterile solution administered in the same manner as the active medication.

  4. Step 4

    Treatment phase

    Participants receive subcutaneous injections of either sonelokimab or placebo. The treatment is administered over a period of 16 weeks.

    The primary goal is to evaluate the improvement in the condition known as hidradenitis suppurativa, measured by a 75% improvement in the HiSCR score at Week 16.

  5. Step 5

    Monitoring and assessments

    Throughout the study, participants are monitored for any side effects or adverse events. Regular assessments include physical examinations, vital signs, and laboratory tests.

    Participants are also evaluated using various scales and questionnaires to assess the impact of the treatment on their quality of life and symptoms.

  6. Step 6

    Completion of treatment

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

Who can join the trial?

8 criteria

  • Participants must be at least 18 years old.
  • Participants need to complete at least 4 out of 7 days of electronic diary entries in at least 1 of the 2 weeks before joining the study.
  • Participants must have been diagnosed with hidradenitis suppurativa (HS) and have had signs and symptoms of HS for at least 6 months before joining the study.
  • Participants should have had an inadequate response to appropriate systemic antibiotics for treating HS, or they should have shown intolerance or had a reason not to use these antibiotics, as determined by the study doctor. Typically, this means they should have tried antibiotics for at least 8 to 12 weeks without success.
  • Participants in the antibiotic group must be on a stable dose, meaning their dose has not changed in the 28 days before starting the study treatment.
  • Female participants must not be pregnant or breastfeeding. They should either be unable to have children or agree to use highly effective birth control methods during the study and for at least 8 weeks after the last dose of study treatment. They must have a negative pregnancy test before starting the study.
  • Male participants must agree to use a condom when sexually active with a female partner who can have children during the study and for at least 8 weeks after the last dose of study treatment, unless they are surgically sterile.
  • Participants must be able to give signed informed consent, which means they understand and agree to follow the study's requirements and restrictions.

Who cannot join the trial?

3 criteria

  • Participants who do not have moderate to severe Hidradenitis Suppurativa (HS) cannot join the study. HS is a skin condition that causes small, painful lumps under the skin.
  • Participants who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Participants who belong to a vulnerable population, which means they might need special protection or care, are not eligible for the study.
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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 sonelokimab works in reducing the symptoms of this 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 a phase 3 clinical trial for its effectiveness in treating moderate to severe hidradenitis suppurativa (HS). Sonelokimab is not yet widely used in medical practice, as it is still under investigation. It is designed to help reduce inflammation and symptoms associated with HS by targeting specific proteins in the immune system. Sonelokimab belongs to the class of drugs known as monoclonal antibodies, which work by blocking certain pathways that lead to inflammation.

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. Over time, the condition can cause scarring and the development of more persistent lesions. The disease 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 a combination of genetic, hormonal, and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511363-28-00Protocol codeM1095-HS-302Estimated enrolment400 patientsSponsorMoonLake Immunotherapeutics AG

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