SAR445399 for Hidradenitis Suppurativa

(CLAROS Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Oral antibiotics

Disqualifiers: Active skin disease, Immunosuppression, Transplant history, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 16 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of two different doses of SAR445399, an experimental treatment, for adults with moderate to severe hidradenitis suppurativa (HS). HS is a skin condition that causes painful lumps and abscesses. The study compares these doses to a placebo, which contains no active medication, to determine the most effective option. It suits individuals who have experienced HS symptoms for at least six months, have lesions in at least two different areas, and have not responded well to antibiotics. Participants will engage in the study for up to 30 weeks, with a 16-week treatment phase. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that SAR445399 is likely to be safe for humans?

Research has shown that SAR445399 is being tested for safety and effectiveness in treating moderate to severe hidradenitis suppurativa, a long-lasting skin condition. In earlier studies with patients, the treatment was generally well-tolerated, with most side effects being mild to moderate, such as headaches and mild skin reactions. Serious side effects were rare.

The current study focuses on finding the right dose, indicating that earlier studies have already demonstrated the treatment's safety for further testing. This is a positive sign that SAR445399 could be a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hidradenitis suppurativa?

Most treatments for Hidradenitis Suppurativa, like antibiotics and TNF inhibitors, aim to reduce inflammation and suppress the immune response. However, SAR445399 is unique because it targets specific pathways involved in the disease's progression, potentially offering a more precise approach to treatment. Researchers are excited about SAR445399 because it may provide relief for patients who don't respond well to existing therapies, and its targeted mechanism could mean fewer side effects. This new approach could represent a significant advancement in managing this challenging condition.

What evidence suggests that SAR445399 might be an effective treatment for hidradenitis suppurativa?

Research suggests that SAR445399 could help treat moderate to severe hidradenitis suppurativa, a chronic skin condition. Early studies show that it reduces inflammation through specific pathways in the body. This method may lessen the painful skin sores often seen with the disease. Previous patients in those studies showed improvement in skin inflammation, indicating potential effectiveness. The current trial aims to confirm these early results by testing different doses of SAR445399 in separate treatment arms to find the best treatment option. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults with moderate to severe hidradenitis suppurativa (HS), having lesions in at least two areas, one being Hurley Stage II or III. They must have ≥5 abscesses and nodules, a 6-month history of HS symptoms, an inadequate response to oral antibiotics for HS, or intolerance/contraindication to them. Participants can be biologic-naïve or experienced.

Inclusion Criteria

I have had symptoms of hidradenitis suppurativa for at least 6 months.

I have 5 or more abscesses and nodules combined.

I have tried antibiotics for HS without success, had HS return after stopping antibiotics, or can't take antibiotics due to side effects or other reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAR445399 or placebo for 16 weeks to assess efficacy and safety

16 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10-12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAR445399

Trial Overview

The trial is testing the effectiveness and safety of two doses of SAR445399 compared to a placebo in adults with moderate to severe HS. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment versus placebo during the 16-week treatment period over up to 30 weeks.

How Is the Trial Designed?

Group I: SAR445399 dose regimen B Experimental Treatment 1 Intervention

Participants will receive SAR445399 dose regimen B.

Group II: SAR445399 dose regimen A Experimental Treatment 1 Intervention

Participants will receive SAR445399 dose regimen A.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive SAR445399-matching placebo.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07225569

A Study to Investigate Efficacy and Safety With SAR445399 ...

The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07225569?rank=6

A Study to Investigate Efficacy and Safety With SAR445399 ...

The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe ...

3.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/SNYNF/pressreleases/36627548/sanofis-sar445399-study-a-potential-breakthrough-in-hidradenitis-suppurativa-treatment/

Sanofi's SAR445399 Study: A Potential Breakthrough in ...

The study aims to evaluate the effectiveness and safety of SAR445399 in treating moderate to severe hidradenitis suppurativa, a chronic skin ...

4.

firstwordpharma.com

firstwordpharma.com/story/5994389

EADV: Sanofi builds on legacy in immunology with new ...

Proof-of-mechanism study evaluating SAR445399, a novel IL1R3 mAb in reducing skin inflammation via the IL1 and IL36 pathways. Brivekimig, ...

5.

sanofi.com

sanofi.com/en/media-room/press-releases/2025/2025-09-03-05-00-00-3143274

Media Update: EADV

New phase 2a results for brivekimig evaluating efficacy and safety in moderate-to-severe hidradenitis suppurativa. Paris, September 3, 2025 ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-investigate-efficacy-and-safety-with-sar445399-in-adult-participants-with-moderate-to-sev

A Study to Investigate Efficacy and Safety With SAR445399 in ...

The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with ...