SAR443122: oral capsule
Placebo: oral capsule
This is a randomized, double-blind, placebo controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants with moderate to severe UC. Dose selection for further clinical development will be based on the multiple efficacy, safety and PK parameters.
The study consists of 4 parallel arms (3 dose groups of SAR443122 vs placebo) to assess the efficacy and safety of SAR443122 in participants with moderate to severe UC. All participants will receive a total of 52 weeks (a 12-week induction treatment phase and a 40-week maintenance phase) of study treatment, except if treatment should be discontinued per investigator's assessment.
At the end of the first 12 weeks of induction treatment, all participants in clinical response or remission will be offered study treatment up to 40 weeks and will continue with the same blinded treatment that was assigned. Participants who do not achieve clinical response or remission at the end of the initial 12 weeks induction treatment will roll over in an open-label treatment arm and will be treated with SAR443122 at the highest tested dose.
In addition, participants from the maintenance treatment that lose clinical efficacy at any time up to V10/Week 40 (Week 28 of maintenance) will be offered to roll over in the open-label treatment arm with SAR443122 at the highest dose.
| Facility | City | Region | Status |
|---|---|---|---|
| Om Research - Lancaster - 15th Street West- Site Number : 8400014 | Lancaster | California | |
| Agile Clinical Research Trials- Site Number : 8400024 | Atlanta | Georgia | |
| Endeavor Health - Evanston Hospital- Site Number : 8400027 | Evanston | Illinois | |
| BVL Research- Site Number : 8400015 | Liberty | Missouri | |
| Vector Clinical Trials- Site Number : 8400004 | Las Vegas | Nevada | |
| Sanmora Bespoke Clinical Research Solutions- Site Number : 8400016 | East Orange | New Jersey | |
| NY Scientific- Site Number : 8400013 | Brooklyn | New York | |
| Pioneer Clinical Research - New York- Site Number : 8400017 | New York | New York | |
| Gastro One - Walnut Run Road- Site Number : 8400002 | Cordova | Tennessee | |
| Houston Methodist Hospital- Site Number : 8400023 | Houston | Texas | |
| 1960 Family Practice- Site Number : 8400019 | Houston | Texas | |
| GI Alliance - Mansfield- Site Number : 8400010 | Mansfield | Texas | |
| Integrity Research - Sugar Land- Site Number : 8400026 | Sugar Land | Texas | |
| Richmond VA Medical Center- Site Number : 8400022 | Richmond | Virginia | |
| Investigational Site Number : 0320006 | CABA | Buenos Aires | |
| Investigational Site Number : 0320003 | Rosario | Santa Fe Province | |
| Investigational Site Number : 0320001 | San Miguel de Tucumán | Tucumán Province | |
| Investigational Site Number : 0320002 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320004 | Córdoba | Argentina | |
| Investigational Site Number : 0320005 | Córdoba | Argentina | |
| Investigational Site Number : 0320007 | Salta | Argentina | |
| Investigational Site Number : 1520004 | Talcahuano | Biobio | |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | |
| Investigational Site Number : 1520005 | Santiago | Reg Metropolitana de Santiago | |
| Investigational Site Number : 1520006 | Santiago | Reg Metropolitana de Santiago | |
| Investigational Site Number : 1520007 | Viña del Mar | Valparaiso | |
| Investigational Site Number : 1560001 | Guangzhou | China | |
| Investigational Site Number : 1560004 | Hangzhou | China | |
| Investigational Site Number : 1560003 | Hefei | China | |
| Investigational Site Number : 1560006 | Nanchang | China | |
| Investigational Site Number : 1560007 | Nanjing | China | |
| Investigational Site Number : 1560005 | Shanghai | China | |
| Investigational Site Number : 1560002 | Shenyang | China | |
| Investigational Site Number : 2030007 | České Budějovice | Czechia | |
| Investigational Site Number : 2030001 | Hradec Králové | Czechia | |
| Investigational Site Number : 2030002 | Klatovy | Czechia | |
| Investigational Site Number : 2030003 | Prague | Czechia | |
| Investigational Site Number : 2500007 | Marseille | France | |
| Investigational Site Number : 2500008 | Nantes | France | |
| Investigational Site Number : 2500006 | Neuilly-sur-Seine | France |
+ 66 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05588843 on ClinicalTrials.gov ↗ ← All trials in the USA