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SAR442970 for Hidradenitis Suppurativa (HS OBTAIN Trial)

Verified Trial

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to Baseline

Participants must have HS lesions present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III

Must not have

Any other active skin disease or condition that may interfere with assessment of HS

History of recurrent or recent serious infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 36

Summary

This trial is testing a new drug to treat adults with moderate-severe hidradenitis suppurativa (HS). Its safety & effectiveness will be studied.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of SAR442970 aren't listed here, common side effects for drugs treating HS may include pain at injection site, infection risk increase, headache, nausea and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had symptoms of hidradenitis suppurativa for at least 1 year.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any skin conditions that could affect HS assessment.

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I have had serious infections recently or that keep coming back.

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I have a history of or currently have a weakened immune system.

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I have had a solid organ transplant.

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I have had my spleen removed.

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I have had serious heart failure in the past.

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I have a history of diseases that affect the protective covering of nerves.

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I have an inflammatory condition that is not HS.

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I have not had thoughts or attempts of suicide in the past 6 months.

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I had a bad reaction to anti-TNF therapy that means I can't take it again.

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I am breastfeeding or might become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)

Secondary study objectives

Change in absolute score from Baseline in IHS4 at week 16

Incidence of anti-SAR442970 antibody positive response throughout the study

Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SAR442970Experimental Treatment1 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: PlaceboPlacebo Group1 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).

0 / 13Eligibility criteria met