A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (CLAROS)

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: SAR445399; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07225569

DRI20674

2025-522695-83-00 (Registry Identifier)

U1111-1322-6148 (Other Identifier)

Details and patient eligibility

About

This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa.

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 hidradenitis suppurativa.

The study duration (per participant) will be up to 30 weeks with a total of 12 visits. The treatment duration will be 16 weeks.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

• Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
• Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III.
• Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
• Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
• Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
• History of recurrent or recent serious infection
• Known history of or suspected current immunosuppression
• History of solid organ transplant or stem cell transplant.
• History of splenectomy
• History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured.
• Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 3 patient groups, including a placebo group

SAR445399 dose regimen A

Experimental group

Description:

Participants will receive SAR445399 dose regimen A.

Treatment:

Drug: SAR445399

SAR445399 dose regimen B

Experimental group

Description:

Participants will receive SAR445399 dose regimen B.

Treatment:

Drug: SAR445399

Placebo

Placebo Comparator group

Description:

Participants will receive SAR445399-matching placebo.

Treatment:

Drug: Placebo