SAR442970 for Hidradenitis Suppurativa

(HS OBTAIN Trial)

No longer recruiting at 73 trial locations

Overseen By Trial transparency email recommended (Toll free for US & Canada

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

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: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment, SAR442970, for individuals with moderate to severe hidradenitis suppurativa (HS), a painful skin condition that causes lumps and abscesses. Participants will receive either the experimental drug SAR442970 or a placebo to determine which is more effective. Candidates for this trial include those who have experienced HS symptoms for at least a year, have lesions in two areas, and have not responded well to antibiotics. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in HS treatment.

Do I need to stop my current medications for the trial?

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.

Is there any evidence suggesting that SAR442970 is likely to be safe for humans?

Research has shown that SAR442970 is generally well-tolerated. Previous studies found no serious unexpected medical problems with its use. Some participants experienced side effects, but these were not severe. This suggests that SAR442970 might be safe for people with moderate to severe hidradenitis suppurativa, although more research is needed to confirm this. ^{1 2 3 4 5}

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

Unlike the standard treatments for hidradenitis suppurativa, which often include antibiotics or biologics targeting TNF-alpha, SAR442970 stands out due to its unique mechanism of action. This experimental drug is designed to target different inflammatory pathways, potentially offering relief to patients who don’t respond well to current therapies. Researchers are excited because SAR442970 might provide a novel approach to reduce flare-ups and improve skin condition more effectively than existing options. Additionally, the treatment is administered every two weeks, which could offer a convenient dosing schedule for patients.

What evidence suggests that SAR442970 might be an effective treatment for hidradenitis suppurativa?

Researchers are investigating SAR442970 as a potential treatment for hidradenitis suppurativa (HS), a skin condition that causes painful bumps. In this trial, participants will receive either SAR442970 or a placebo. Limited human data exists on SAR442970's effectiveness for HS, but it is under study due to its novel approach. This treatment targets specific parts of the immune system believed to cause inflammation in HS. Early studies aim to determine if SAR442970 can reduce the severity and frequency of HS flare-ups. While specific results for SAR442970 in HS are still being collected, the treatment is based on promising methods that address the root causes of HS. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

Adults with moderate to severe hidradenitis suppurativa (HS) who have lesions in at least two areas and an inadequate response to antibiotics can join. They must not have had certain treatments, have a CRP >3 mg/L, and be judged as needing systemic treatment. Exclusions include adverse reactions to anti-TNF therapy, allergies that affect study participation, breastfeeding or planning pregnancy during the study, substance abuse history, serious infections or immunosuppression.

Inclusion Criteria

I have tried oral antibiotics for HS without success, had HS return after stopping them, can't tolerate them, or can't take them for medical reasons.

I have not used biologic or small molecule immunosuppressives, or I have used TNF blockers.

My doctor thinks I should get treatment that affects my whole body.

Exclusion Criteria

I am breastfeeding or might become pregnant during the study.

History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator

Laboratory exclusion criteria apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period A

Participants receive SAR442970 or placebo every two weeks from Day 1 to Week 16

16 weeks

8 visits (in-person)

Treatment Period B

Participants receive SAR442970 every two weeks up to Week 28

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SAR442970

Trial Overview The trial is testing SAR442970 against a placebo in adults with HS. It aims to see if SAR442970 is effective and safe for treating this skin condition. Participants will randomly receive either the actual drug or a placebo without knowing which one they are getting.

How Is the Trial Designed?

Group I: SAR442970 Experimental Treatment 1 Intervention

Participants will receive SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo Q2W in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28).

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/NCT05849922

NCT05849922 | A Study to Test the Efficacy and Safety of ... A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (HS OBTAIN). ClinicalTrials.gov ID NCT05849922. Sponsor Sanofi.

2. trialx.com trialx.com/clinical-trials/listings/226478/a-study-to-test-the-efficacy-and-safety-of-sar442970-in-adults-with-hidradenitis-suppurativa/

A Study to Test the Efficacy and Safety of SAR442970 ... This is a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study is to evaluate the efficacy and ...

3. clinicaltrials.eu clinicaltrials.eu/inn/sar442970/

Sar442970 – Application in Therapy and Current ... Hidradenitis Suppurativa Trial: This is a Phase 2 study comparing SAR442970 to a placebo in adults with moderate to severe HS. The study aims to evaluate both ...

4. academic.oup.com academic.oup.com/bjd/article/190/2/149/7275339

Hidradenitis suppurativa: new insights into disease ... A study to test the efficacy and safety of SAR442970 in adults with hidradenitis suppurativa (HS OBTAIN). Available at. : https://classic.clinicaltrials.gov ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40601333/

A Living Systematic Review and Network Meta-Analysis This network meta-analysis provides evidence for the comparative efficacy and safety of currently approved and pipeline medications for moderate to severe HS

6. firstwordpharma.com firstwordpharma.com/story/6093093

EADV25: Sanofi details mid-stage data that supported ... In terms of safety, Sanofi said that brivekimig was well tolerated with no serious adverse events (AEs) reported. The most frequent AEs ...