Brivekimig for Hidradenitis Suppurativa

(BRIGHTEN Trial)

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must not be taking: Anti-TNF therapy

Disqualifiers: Active skin disease, Serious infection, Immunosuppression, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

188 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new drug, brivekimig, for individuals with moderate to severe hidradenitis suppurativa (HS), a painful skin condition characterized by recurring lumps and sores. The study will compare different doses of brivekimig to determine the most effective one, with some participants receiving a placebo (a dummy treatment). It targets individuals who have had HS for at least six months, with sores in at least two body areas, and who haven't responded to antibiotic treatments. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer based on your specific situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that brivekimig is safe. Most importantly, participants reported no serious side effects. Common side effects included mild issues like nasopharyngitis, a medical term for a cold. This suggests that brivekimig is generally well-tolerated. The study found no major safety concerns, making it a potentially 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?

Unlike standard treatments for Hidradenitis Suppurativa, which often include antibiotics and anti-inflammatory drugs like biologics targeting TNF-alpha, Brivekimig targets a different pathway, potentially offering a new mechanism of action. Researchers are excited about Brivekimig because it is designed to specifically modulate the immune system in a way that might reduce inflammation differently and more effectively. This novel approach could lead to improved outcomes for patients who do not respond well to current therapies.

What evidence suggests that this trial's treatments could be effective for hidradenitis suppurativa?

Research has shown that brivekimig may help treat hidradenitis suppurativa (HS). In earlier studies, 67% of patients taking brivekimig experienced a significant reduction in symptoms, known as HiSCR50, compared to only 37% of those who took a placebo. This indicates at least a 50% decrease in the number of painful lumps and bumps without worsening of their condition. Additionally, patients on brivekimig had a 56% reduction in draining tunnels, while those on placebo saw an increase of 10.9%. These results suggest that brivekimig could be an effective new treatment option for people with moderate to severe HS. Participants in this trial will receive one of several dose regimens of brivekimig or a placebo to further evaluate its effectiveness. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for people who've had moderate to severe hidradenitis suppurativa (HS) for at least 6 months. They should have HS in at least two areas, with one area being significantly affected. Participants must have tried antibiotics without success or cannot take them due to intolerance or contraindications.

Inclusion Criteria

I have 5 or more abscesses and nodules.

I have HS lesions in at least 2 different body areas, with one area being moderate or severe.

I have tried antibiotics for my HS without success, had a recurrence, can't tolerate them, or can't take them due to other health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive randomized treatment with Brivekimig or placebo for up to 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Long-term extension (optional)

Participants may opt into continuation of treatment in a long-term extension study

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Brivekimig

Trial Overview The study tests the safety and effectiveness of Brivekimig, a new treatment for HS, compared to a placebo over approximately 48 weeks. It's double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo during the study.

How Is the Trial Designed?

Group I: Brivekimig dose regimen C Experimental Treatment 1 Intervention

Participants will receive Brivekimig dose regimen C.

Group II: Brivekimig dose regimen B Experimental Treatment 1 Intervention

Participants will receive Brivekimig dose regimen B.

Group III: Brivekimig dose regimen A Experimental Treatment 1 Intervention

Participants will receive Brivekimig dose regimen A.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive Brivekimig 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. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-09-17-05-00-00-3151353

Press Release: EADV: Sanofi's brivekimig achieved ... EADV: Sanofi's brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study. In phase 2a study, brivekimig led to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07170917

NCT07170917 | Brivekimig for the Treatment of Moderate ... Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from Baseline in the total AN count, with no increase from Baseline in ...

3. dermatologytimes.com dermatologytimes.com/view/sanofi-announces-positive-phase-2a-results-for-brivekimig-in-hs

Sanofi Announces Positive Phase 2a Results for ... Brivekimig showed significant efficacy in HS, with 67% achieving HiSCR50 versus 37% with placebo, indicating potential as a novel treatment ...

4. hcplive.com hcplive.com/view/hs-obtain-brivekimig-achieves-positive-results-hidradenitis-suppurativa

HS-OBTAIN: Brivekimig Achieves Positive Results in ... The HS-OBTAIN phase 2a study demonstrated significant efficacy of brivekimig, with 67% achieving HiSCR50 compared to 37% on placebo.

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/eadv-25-sanofis-brivekimig-in-phase-iia-hs-trial/

EADV 25: Sanofi's brivekimig success in Phase IIa HS trial In the brivekimig cohort, draining tunnel count reduced by 56%, while in the placebo cohort it increased by 10.9%.

6. biopharmaboardroom.com biopharmaboardroom.com/news/56/3786/sanofis-brivekimig-demonstrates-positive-phase-2a-results-in-moderate-to-severe-hidradenitis-suppurativa.html

Sanofi's Brivekimig Demonstrates Positive Phase 2a ... HiSCR90 was achieved by 31% of patients treated with brivekimig versus 9% with placebo (estimated difference of 20%; 90% CI: 5%–34%; p=0.0576).