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A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Study of an Investigational Treatment for Hidradenitis Suppurativa

Recruiting
18-70 years
All
Phase 2

This study investigates the effects of an investigational treatment on individuals with Hidradenitis Suppurativa (HS), a chronic skin condition characterized by painful lumps under the skin. These lumps can become infected and lead to scarring. The study aims to evaluate the safety and effectiveness of this treatment in participants who have not responded adequately to previous oral antibiotic treatments.

Participants in this study will undergo specific procedures, including maintaining a diary to record symptoms and treatment effects. The study will involve assessments of HS lesions in different body areas, including the counting of abscesses and draining tunnels. Participants must be willing to follow the study protocol, which includes specific contraceptive guidelines for men and women.

  • Who can participate: Participants must be adults with a history of Hidradenitis Suppurativa for at least one year, with lesions in at least two areas of the body. They should have previously tried oral antibiotics without sufficient improvement and meet specific criteria for abscess and draining tunnel counts.
  • Study details: Participants will be required to complete a diary throughout the study to track their symptoms and treatment effects. They must follow contraceptive guidelines as per local regulations. The study will assess HS lesions and requires participants to have a certain number of abscesses and draining tunnels at baseline.
Study details
    Hidradenitis Suppurativa

NCT06028230

Sanofi

9 May 2025

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