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Study on the Effectiveness and Safety of SAR444656 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 characterized by painful lumps under the skin, often in areas like the armpits or groin. The study is testing a new treatment called SAR444656, which is taken as a film-coated tablet. The purpose of the study is to evaluate how effective and safe SAR444656 is for adults with moderate to severe forms of this condition.

Participants in the study will be randomly assigned to receive either the SAR444656 tablet or a placebo, which looks like the treatment but does not contain the active substance. The study will last for 16 weeks, during which the participants will take the tablets orally. The main goal is to see if there is a reduction in the number of abscesses and inflammatory nodules, which are the painful lumps associated with hidradenitis suppurativa.

Throughout the study, researchers will monitor the participants' health and any changes in their condition. They will also track any side effects or adverse events that may occur. The study aims to provide valuable information on whether SAR444656 can be a beneficial treatment option for those suffering from this challenging skin condition.

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

    Joining the study

    Upon joining the study, the participant will be assessed to ensure they meet the necessary criteria. This includes having a history of hidradenitis suppurativa (HS) for at least one year, lesions in at least two distinct areas, and a specific count of abscesses and nodules.

    The participant must have previously tried an oral antibiotic for at least three months without adequate results.

  2. Step 2

    Baseline visit

    During the baseline visit, the participant's current condition will be documented. This includes counting the number of abscesses and nodules, as well as any draining tunnels.

    A blood test will be conducted to measure C-reactive protein (CRP) levels, which should be greater than 3 mg/L.

  3. Step 3

    Treatment phase

    The participant will receive either the investigational drug SAR444656 or a matched placebo. The medication is administered orally in the form of a film-coated tablet.

    The treatment will continue for a period of 16 weeks, during which the participant will take the medication as directed by the study protocol.

  4. Step 4

    Ongoing assessments

    Throughout the study, the participant will be required to maintain a diary to record daily symptoms and any changes in their condition.

    Regular assessments will be conducted to monitor the participant's response to the treatment, including changes in abscess and nodule counts, pain levels, and any adverse events.

  5. Step 5

    End of treatment evaluation

    At the end of the 16-week treatment period, a final evaluation will be conducted to assess the overall effectiveness of the treatment.

    The primary focus will be on the percentage change in the total count of abscesses and nodules from the baseline.

Who can join the trial?

8 criteria

  • Participant must have had signs and symptoms of hidradenitis suppurativa (HS) for at least 1 year before starting the study. HS is a skin condition that causes small, painful lumps under the skin.
  • Participant must have HS lesions in at least 2 different body areas, with at least one area being classified as Hurley Stage II or Hurley Stage III. Hurley Stages are used to describe the severity of HS, with Stage II and III being more advanced.
  • Participant must have tried taking an oral antibiotic for HS for at least 3 months, but it did not work well enough, as determined by the study doctor.
  • Participant must have a total count of abscesses and inflammatory nodules (AN) of 5 or more at the start of the study. Abscesses are swollen areas filled with pus, and nodules are solid lumps under the skin.
  • Participant must have a count of draining tunnels of 20 or fewer at the start of the study. Draining tunnels are channels under the skin that can leak fluid.
  • Participant must have a CRP level greater than 3 mg/L at the screening. CRP, or C-reactive protein, is a substance in the blood that increases when there is inflammation in the body.
  • Participant must be willing and able to keep a diary for the entire study period as required by the study rules.
  • Participants who can have children must use birth control methods that follow local rules for clinical studies. This applies to men with partners who can have children and to women.

Who cannot join the trial?

9 criteria

  • Participants who have a different skin condition other than hidradenitis suppurativa, which is a chronic skin condition that causes small, painful lumps under the skin.
  • Participants who are not within the specified age range for the study.
  • Participants who are not able to follow the study procedures or attend the required visits.
  • Participants who have a medical condition that might interfere with the study or pose a risk to their health.
  • Participants who are currently taking medications that could affect the study results.
  • Participants who have participated in another clinical trial recently.
  • Participants who are pregnant or breastfeeding.
  • Participants who have a history of drug or alcohol abuse.
  • Participants who have a known allergy to the study medication or its ingredients.
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Investigated drugs

SAR444656 is an investigational medication being studied for its potential to treat moderate to severe hidradenitis suppurativa, a chronic skin condition characterized by painful lumps under the skin. The trial aims to assess how effective this medication is in reducing the number of abscesses and inflammatory nodules in patients over a 16-week period.

What is already known about the treatment

SAR444656 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. It is in Phase 2 of clinical trials, which means it is being tested for both safety and efficacy. The main therapeutic indication for SAR444656 is to reduce the number of abscesses and inflammatory nodules in patients with this condition. At the molecular level, SAR444656 works by targeting specific pathways involved in inflammation, helping to decrease the symptoms associated with hidradenitis suppurativa. It is classified pharmacologically as an anti-inflammatory agent.

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 abscesses and tunnels under the skin. Over time, the condition can cause scarring and the development of sinus tracts, which are channels that connect the lumps under the skin. The disease often progresses with periods of flare-ups and remission, and the severity can vary greatly among individuals. It is not considered a rare disease and can significantly impact the quality of life due to pain and discomfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504328-25-00Protocol codeACT17841Estimated enrolment370 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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