SAR442970 for Hidradenitis Suppurativa

(HS OBTAIN Trial)

Recruiting at 66 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

86 Participants Needed

Trial Summary

What is the purpose of this trial?

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 safety of SAR442970 compared to placebo.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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