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Hidradenitis SuppurativaDrugPhase 2

What this study is

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 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.

What's being tested

  • SAR445399

    Intervention · DRUG

  • Placebo

    Intervention · DRUG

Both interventions

Pharmaceutical form: Solution for injection -Route of administration: Injection

Study details

Official title
A Randomized, Double-blind, Placebo-controlled, Phase 2, Dose-finding Study to Investigate the Efficacy and Safety of SAR445399 in Participants With Moderate to Severe Hidradenitis Suppurativa
Sponsor
Sanofi
Conditions
Hidradenitis Suppurativa
Enrolling
144 people
Starts
2025-12-29
Est. completion
2027-11-19
Design
Quadruple-blind, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗