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NCT06958536 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
A Phase 2 study of Crohn's Disease, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
- 20
- Study locations
NCT06958536: Recruiting Phase 2 study of Crohn's Disease, sponsored by Sanofi.
NCT06958536 is a Phase 2 study of Crohn's Disease that is actively recruiting participants, run by Sanofi. The registered enrollment target is 99 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06958536, a Phase 2 study of Crohn's Disease, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.
Primary Outcome
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic varia
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SAR442970
Study Locations (20)
Florida
- Investigational Site Number: 8400017 - Kissimmee
- Investigational Site Number: 8400015 - Lighthouse PT
- Investigational Site Number 84000028 - Miami
- Investigational Site Number: 8400012 - Miami
- Investigational Site Number: 8400007 - Orlando
- Investigational Site Number: 8400011 - Palmetto Bay
California
- Investigational Site Number: 8400005 - Escondido
- Investigational Site Number: 8400001 - Lancaster
Arizona
- Investigational Site Number: 84000024 - Tucson
Georgia
- Investigational Site Number: 8400019 - Marietta
Iowa
- Investigational Site Number: 8400025 - Iowa City
Kansas
- Investigational Site Number: 8400006 - Kansas City
Massachusetts
- Investigational Site Number: 8400022 - Boston
Michigan
- Investigational Site Number: 8400008 - Wyoming
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2025-06-03 |
| Est. Completion | 2029-10-17 |
| Phase | Phase 2 |
What NCT06958536 shows while recruiting
NCT06958536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06958536 names 20 study sites across 14 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06958536 about?
NCT06958536 is a clinical study titled "A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease". This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up ...
What is the current status of trial NCT06958536?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2025-06-03. Estimated completion is 2029-10-17.
What conditions does trial NCT06958536 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT06958536?
The interventions under investigation include: Placebo (DRUG), SAR442970 (DRUG).
Who is sponsoring clinical trial NCT06958536?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06958536 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06958536's enrollment target sits among peer trials
99 71st of 105 higher than 35 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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.
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