NCT07225569

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	SAR445399	Pharmaceutical form: Solution for injection/infusion -Route of administration: Injection/infusion
DRUG	Placebo	Pharmaceutical form: Solution for injection -Route of administration: Injection/infusion

Timeline

• Start date: 2025-12-29
• Primary completion: 2027-09-22
• Completion: 2027-12-01
• First posted: 2025-11-06
• Last updated: 2026-03-30

Locations

20 sites across 5 countries: United States, China, Hungary, Spain, Sweden

Regulatory

• FDA-regulated drug study