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NCT06867094 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
A Phase 2 study of Colitis, Ulcerative, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 204
- Enrollment target
- 20
- Study locations
NCT06867094: Recruiting Phase 2 study of Colitis, Ulcerative, sponsored by Sanofi.
NCT06867094 is a Phase 2 study of Colitis, Ulcerative that is actively recruiting participants, run by Sanofi. The registered enrollment target is 204 participants, below the 398-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06867094, a Phase 2 study of Colitis, Ulcerative, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 204 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
Primary Outcome
Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore \>1 (stool frequency \[SF\] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding \[RB\] of 0 and modified Mayo Endoscopic Subscore \[mMES\] of 0 or 1 where 1 does not include friability). Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Conditions Studied
Interventions
- DRUG SAR441566
- DRUG SAR441566 matching Placebo
Study Locations (20)
Florida
- Novum Research- Site Number : 8400018 - Clermont
- Clinical Research of Osceola- Site Number : 8400012 - Kissimmee
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002 - Miami Lakes
- GCP Clinical Research- Site Number : 8400016 - Tampa
Texas
- Gastro Health & Nutrition- Site Number : 8400007 - Katy
- SI Research Associates- Site Number : 8400019 - Lubbock
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400015 - Southlake
Illinois
- GI Alliance - Glenview- Site Number : 8400005 - Glenview
- Illinois Gastroenterology Group- Site Number : 8400004 - Gurnee
New York
- Icahn School of Medicine at Mount Sinai- Site Number : 8400001 - New York
- Queens Village Primary Medical Center- Site Number : 8400011 - Queens Village
Washington
- University of Washington Medical Center- Site Number : 8400014 - Seattle
- Washington Gastroenterology - Tacoma- Site Number : 8400009 - Tacoma
Arizona
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003 - Sun City
Connecticut
- Bristol Hospital- Site Number : 8400017 - Bristol
Michigan
- University of Michigan Health System - Ann Arbor- Site Number : 8400010 - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2025-03-28 |
| Est. Completion | 2028-05-11 |
| Phase | Phase 2 |
What NCT06867094 shows while recruiting
NCT06867094 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 398-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 2 interventions - of which SAR441566 is the first listed.
NCT06867094 names 20 study sites across 12 states, led by Florida, Texas, Illinois.
Frequently Asked Questions
What is clinical trial NCT06867094 about?
NCT06867094 is a clinical study titled "A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis". This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical...
What is the current status of trial NCT06867094?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 204 participants. The study started on 2025-03-28. Estimated completion is 2028-05-11.
What conditions does trial NCT06867094 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT06867094?
The interventions under investigation include: SAR441566 (DRUG), SAR441566 matching Placebo (DRUG).
Who is sponsoring clinical trial NCT06867094?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06867094 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Illinois, Michigan. 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 NCT06867094's enrollment target sits among peer trials
204 17th of 28 higher than 12 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative 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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