Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

A Study of Brivekimig Compared to Placebo in Patients with Moderate to Severe Hidradenitis Suppurativa

Verified siteInvestigational
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 is being conducted for people with hidradenitis suppurativa, a long-term skin condition that causes painful lumps, abscesses (collections of pus under the skin), and tunnels that drain fluid under the skin, usually in areas where skin rubs together such as the armpits, groin, and under the breasts. The condition being studied ranges from moderate to severe forms. The treatment being tested in this study is called brivekimig, which is also known by its code name SAR442970. Some people in the study will receive brivekimig while others will receive placebo. The purpose of this study is to evaluate how well different doses of brivekimig work in treating people with moderate to severe hidradenitis suppurativa.

The study will test different amounts of brivekimig to find out which dose works best for treating the symptoms of hidradenitis suppurativa. Participants will receive the study treatment for a period of time, followed by a maintenance period where treatment continues. During the study, doctors will measure how much the skin condition improves by counting the number of abscesses and inflammatory nodules (swollen, painful bumps), as well as the number of draining tunnels (channels under the skin that leak fluid). They will also assess how the condition affects pain levels and quality of life. The study is designed so that neither the participants nor the doctors know who is receiving brivekimig and who is receiving placebo until the study is completed.

People taking part in this study must have been diagnosed with moderate to severe hidradenitis suppurativa for at least six months and must have lesions in at least two different body areas. They should have tried treatment with oral antibiotics that either did not work well enough, caused problems, or cannot be used for medical reasons. Participants may have never used biologic medications before, or they may have previous experience with them. Throughout the study, doctors will monitor participants for any side effects and will measure the levels of brivekimig in the blood to understand how the medication works in the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    During this phase, you will receive either brivekimig or placebo (an inactive substance that looks like the actual treatment but contains no medication). This is a double-blind study, which means neither you nor your doctor will know which treatment you are receiving.

    The study will test different dosing regimens (amounts and schedules) of brivekimig to determine which works best for treating hidradenitis suppurativa.

    This initial treatment period will last until Week 16.

  2. Step 2

    Assessment at Week 8

    At Week 8, your skin pain will be assessed using the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale. This is a questionnaire where you will rate your pain level on a numbered scale.

    This assessment helps determine if the treatment is reducing your pain symptoms.

  3. Step 3

    Assessment at Week 16

    At Week 16, several assessments will be performed to evaluate how well the treatment is working.

    Your doctor will count the number of draining tunnels (channels under the skin that drain fluid) and compare this to the count at the beginning of the study.

    Your disease severity will be measured using the International Hidradenitis Suppurativa Severity Score System, which is a standardized way to assess how severe your condition is.

    You will complete questionnaires about your quality of life, including the Hidradenitis Suppurativa Quality of Life questionnaire and the Dermatology Life Quality Index. These help measure how the condition affects your daily activities and well-being.

    Your doctor will assess your clinical response by measuring the reduction in abscesses (pus-filled lumps) and inflammatory nodules (swollen, painful lumps) compared to the start of the study.

  4. Step 4

    Maintenance period

    After the initial treatment period, you will enter a maintenance period where treatment continues.

    The specific duration and dosing schedule for this phase will be determined based on the treatment group you are assigned to.

    During this period, you will continue to receive the same treatment (either brivekimig or placebo) that you received during the initial phase.

  5. Step 5

    Ongoing monitoring throughout the study

    Throughout the entire study, your doctor will monitor you for any adverse events (unwanted or harmful reactions to the treatment).

    Blood samples will be taken regularly to measure the amount of brivekimig in your bloodstream and to check for any laboratory abnormalities.

    Your blood will also be tested to see if your body develops an immune response to brivekimig (antibodies against the medication).

    The study is expected to continue until May 2028.

Who can join the trial?

8 criteria

  • You must have been diagnosed with moderate to severe hidradenitis suppurativa, which is a skin condition that causes painful lumps under the skin, for at least 6 months before starting the study
  • You must have hidradenitis suppurativa lesions, meaning affected areas of skin, in at least 2 different body areas, such as left and right armpit, or left armpit and left groin area, and one of these areas must be classified as Hurley Stage II or Hurley Stage III, which means moderate to severe disease
  • You must have previously tried treatment with an oral antibiotic, which is a medication taken by mouth to fight infection, and it either did not work well enough for you, your condition came back after stopping the antibiotic, you could not tolerate the antibiotic due to side effects, or you have a medical reason why you cannot take antibiotics for your condition
  • You may be someone who has never received biologic treatment before, which are medications made from living cells, or you may have used biologic treatments in the past
  • You must have at least 5 abscesses and inflammatory nodules in total at the start of the study, which are painful, swollen lumps filled with pus or fluid under the skin
  • You must have 20 or fewer draining tunnels at the start of the study, which are channels under the skin that leak fluid or pus
  • You can be male or female
  • You must be an adult to participate in this study

Who cannot join the trial?

4 criteria

  • The specific reasons why patients cannot participate in this study have not been provided in the available information
  • Generally, clinical trials have rules about who can join to ensure patient safety and study accuracy
  • These rules typically consider factors such as other health conditions, medications being taken, previous treatments, and test results
  • For this particular study, you would need to discuss with the study team to learn the complete list of reasons that would prevent participation
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.

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

Brivekimig is an investigational medication being studied for the treatment of hidradenitis suppurativa, a chronic skin condition that causes painful lumps under the skin. This medication is being tested to see if it can help reduce the symptoms of moderate to severe forms of this condition. In this study, participants will receive brivekimig at different dose levels to determine which dosing approach works best.

A placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of brivekimig against no treatment, helping researchers understand if the medication is truly effective.

What is already known about the treatment

Brivekimig – Brivekimig is an investigational medication currently being studied in clinical trials and is not yet approved for general medical use. It is being tested as a treatment for moderate to severe hidradenitis suppurativa, a chronic skin condition that causes painful lumps under the skin, typically in areas where skin rubs together. The medication is administered through injection and works by targeting specific proteins in the immune system that contribute to inflammation and skin damage. Brivekimig belongs to a class of drugs called biologic therapies, which are designed to modify the body's immune response to reduce symptoms and improve the condition of affected skin areas.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis suppurativa is a chronic skin condition that affects areas of the body where skin rubs together, such as the armpits, groin, buttocks, and under the breasts. The disease begins with painful lumps under the skin that can become inflamed and may break open, releasing fluid or pus. Over time, these lumps can recur in the same areas and may lead to the formation of tunnels under the skin that connect the inflamed areas. The condition typically starts after puberty and can persist for many years with periods of flare-ups and remission. As the disease progresses, it may cause scarring and thick, rope-like scars in the affected areas. The repeated inflammation and healing process can significantly impact the skin's appearance and cause ongoing discomfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522333-61-00Protocol codeDRI19220Estimated enrolment278 patientsSponsorSanofi-Aventis Recherche & Developpement

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.