Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Long-term safety and effectiveness study of sonelokimab injections for patients with moderate to severe hidradenitis suppurativa

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with moderate to severe hidradenitis suppurativa, a chronic skin condition that causes painful bumps and abscesses in areas where skin rubs together. The study will test a medication called sonelokimab (also known as M1095), which is given as an injection under the skin (subcutaneous injection). This medication works by blocking specific proteins in the body called IL-17A and IL-17F that are involved in inflammation.

The purpose of this study is to evaluate how safe and well-tolerated sonelokimab is when used for an extended period in people with hidradenitis suppurativa. This is an extension study, which means that participants who completed previous studies with this medication may continue their treatment to gather long-term information about the medication's effects.

During the study, participants will receive regular doses of sonelokimab through subcutaneous injections. The treatment period will last approximately 100 weeks, during which participants will have regular check-ups to monitor their health and any side effects that may occur. The maximum daily dose that participants may receive is 120 mg/ml, with a total maximum dose of 3120 mg/ml over the course of the study.

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

    Initial qualification

    Your eligibility for the study will be verified if you have completed previous treatment in the parental study within the last 8 weeks

    A medical assessment will determine if you can reliably follow the study protocol and schedule

    You will need to provide signed informed consent to participate in the study

  2. Step 2

    Medical requirements verification

    If you are a woman who can become pregnant, you must have a negative pregnancy test within one week before starting the treatment

    You must agree to use effective birth control methods during the study and for 8 weeks after the last dose

    Male participants must agree to use condoms when sexually active with partners who can become pregnant, during the study and for 8 weeks after the last dose

  3. Step 3

    Treatment administration

    You will receive sonelokimab through subcutaneous injection (injection under the skin)

    The treatment will continue to monitor the long-term safety and effectiveness of sonelokimab for hidradenitis suppurativa (a chronic skin condition)

  4. Step 4

    Monitoring and follow-up

    Regular check-ups will include monitoring of vital signs and heart activity (ECG)

    Blood tests will be performed to check your general health status

    Any side effects or health changes will be recorded and monitored

    The study will continue until approximately June 2028

Who can join the trial?

11 criteria

  • Must have completed previous treatment in the parent study within the last 8 weeks
  • Must have completed the end of treatment visit at either Week 52 or Week 24 in the previous study
  • For women who can become pregnant:
    • Must not be pregnant or breastfeeding
    • Must use highly effective contraception during the study and for 8 weeks after
    • Must have a negative pregnancy test before starting treatment
    • Must not donate eggs during the study and for 8 weeks after
    • For men:
      • Must use condoms when sexually active with partners who can become pregnant
      • Must continue using condoms for 8 weeks after the last treatment
      • Must not donate sperm during the study and for 8 weeks after
      • Must be able to follow study instructions and attend scheduled visits as determined by the study doctor
      • Must be able to understand and sign an informed consent form (for minors, parent/guardian consent is required)

Who cannot join the trial?

14 criteria

  • Current or past active tuberculosis (an infectious disease affecting the lungs)
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Serious or active infections requiring treatment
  • Pregnancy or breastfeeding
  • Known allergies to the study medication or its components
  • Immunocompromised condition (weakened immune system)
  • Participation in another clinical trial within the past 30 days
  • Major surgery planned during the study period
  • Serious heart, liver, or kidney disease
  • Use of prohibited medications within specified timeframes
  • History of substance abuse within the past year
  • Chronic viral infections such as HIV, Hepatitis B, or Hepatitis C
  • Mental health conditions that could interfere with study participation
  • Unable to comply with study procedures or visits
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Sonelokimab is a medication given by injection under the skin (subcutaneously) that is being studied for treating moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition. It works by targeting specific proteins in the body that are involved in inflammation. This medication is designed to help reduce the symptoms and severity of hidradenitis suppurativa over a long period of time.

What is already known about the treatment

Sonelokimab - A novel biologic medication administered through subcutaneous injection that is currently being investigated in Phase 3 clinical trials for treating moderate to severe hidradenitis suppurativa (HS), a chronic inflammatory skin condition. This monoclonal antibody works by targeting specific inflammatory proteins in the immune system, helping to reduce inflammation and symptoms associated with HS. As an investigational drug, sonelokimab belongs to the class of biological disease-modifying agents, and researchers are studying its long-term safety, tolerability, and effectiveness in clinical settings for patients who have not responded adequately to conventional treatments.

Investigated diseases

Hidradenitis suppurativa - A chronic skin condition that causes small, painful lumps to form under the skin, typically in areas where skin rubs together, such as the armpits, groin, buttocks, and under the breasts. The condition begins with tender areas of skin that develop into swollen bumps, which may break open and leak fluid. Over time, these areas can develop tunnels under the skin and form deep scars. The condition tends to start after puberty and can persist for many years, with periods of flare-ups and remission. It develops when hair follicles become blocked and inflamed, leading to the formation of painful nodules and abscesses.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520564-17-00Protocol codeM1095-HS-303Estimated enrolment809 patientsSponsorMoonLake Immunotherapeutics AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.