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

NCT07225569 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-05-04

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

SAR445399

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

DRUG

Placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-29
Primary Completion
2027-09-22
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Spain
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225569 on ClinicalTrials.gov