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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: Recruiting Phase 2 study of Hidradenitis Suppurativa, sponsored by Sanofi.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2025-12-29 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 2 |
What NCT07225569 shows while recruiting
NCT07225569 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 595-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (76% lower).
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 lists 9 locations in 6 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07225569's enrollment target sits among peer trials
144 27th of 52 higher than 26 of 52 other Hidradenitis Suppurativa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hidradenitis Suppurativa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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