A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT07225569
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
144 participants
INTERVENTIONAL
2025-12-26
2027-12-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR445399 dose regimen A
Participants will receive SAR445399 dose regimen A.
SAR445399
Pharmaceutical form: Solution for injection/infusion -Route of administration: Injection/infusion
SAR445399 dose regimen B
Participants will receive SAR445399 dose regimen B.
SAR445399
Pharmaceutical form: Solution for injection/infusion -Route of administration: Injection/infusion
Placebo
Participants will receive SAR445399-matching placebo.
Placebo
Pharmaceutical form: Solution for injection -Route of administration: Injection/infusion
Interventions
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SAR445399
Pharmaceutical form: Solution for injection/infusion -Route of administration: Injection/infusion
Placebo
Pharmaceutical form: Solution for injection -Route of administration: Injection/infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Investigational Site Number : 3480001
Debrecen, Gangwon-do, Hungary
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Other Identifiers
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2025-522695-83-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1322-6148
Identifier Type: OTHER
Identifier Source: secondary_id
DRI20674
Identifier Type: -
Identifier Source: org_study_id