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NCT07225569 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Hidradenitis Suppurativa, sponsored by Sanofi.

Recruiting
Registry status
Phase 2
Development phase
144
Enrollment target
9
Study locations

NCT07225569 is a Phase 2 study of Hidradenitis Suppurativa that is actively recruiting participants, run by Sanofi. The registered enrollment target is 144 participants, below the 595-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (76% lower). The trial reports 9 study locations across 6 states.

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The verdict

NCT07225569, a Phase 2 study of Hidradenitis Suppurativa, is actively recruiting participants, sponsored by Sanofi.

RECRUITING
Registry status
Phase 2
Development phase
144 participants
Enrollment target
9
Study locations

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 30 weeks with a total of 12 visits. The treatment duration will be 16 weeks.

Conditions Studied

Hidradenitis Suppurativa

Interventions

  • DRUG Placebo
  • DRUG SAR445399

Study Locations (9)

Other

  • Investigational Site Number : 1560001 - Beijing
  • Investigational Site Number : 2760005 - Merzig
  • Investigational Site Number : 3480001 - Debrecen

Florida

  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007 - Fort Myers
  • Florida International Research Center- Site Number : 8400002 - Miami

Arizona

  • Scottsdale Clinical Trials- Site Number : 8400006 - Scottsdale

California

  • Carbon Health - North Hollywood - NoHo West- Site Number : 8400017 - North Hollywood

Kansas

  • Essential Medical Research- Site Number : 8400015 - Overland Park

New York

  • Equity Medical- Site Number : 8400010 - New York

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2025-12-29
Est. Completion 2027-12-01
Phase Phase 2

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07225569

The ClinicalTrials.gov registry entry for NCT07225569 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 595-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (76% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07225569 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Other, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT07225569 about?

NCT07225569 is a clinical study titled "A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa". 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 safe...

What is the current status of trial NCT07225569?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2025-12-29. Estimated completion is 2027-12-01.

What conditions does trial NCT07225569 study?

This clinical trial studies the following conditions: Hidradenitis Suppurativa.

What interventions are being tested in trial NCT07225569?

The interventions under investigation include: Placebo (DRUG), SAR445399 (DRUG).

Who is sponsoring clinical trial NCT07225569?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07225569 being conducted?

This trial has 9 study locations across Arizona, California, Florida, Kansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.