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A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT07225569 · View on ClinicalTrials.gov ↗
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
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07225569 reports 9 study locations spanning 6 distinct geographic areas — top geographies include Other, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07225569?
The interventions under investigation include: Placebo (DRUG), SAR445399 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07225569?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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