Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis
Public ClinicalTrials.gov record NCT05588843. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo Controlled, Dose-finding Study to Assess the Efficacy and Safety of SAR443122 in Adult Patients With Moderate to Severe Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05588843
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 187 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 24, 2022
- Primary completion
- Feb 9, 2026
- Completion
- Dec 1, 2026
- Last update posted
- Apr 26, 2026
2022 – 2026
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Om Research - Lancaster - 15th Street West- Site Number : 8400014 | Lancaster | California | 93534 | — |
| Agile Clinical Research Trials- Site Number : 8400024 | Atlanta | Georgia | 30328 | — |
| Endeavor Health - Evanston Hospital- Site Number : 8400027 | Evanston | Illinois | 60201 | — |
| BVL Research- Site Number : 8400015 | Liberty | Missouri | 64068 | — |
| Vector Clinical Trials- Site Number : 8400004 | Las Vegas | Nevada | 89128 | — |
| Sanmora Bespoke Clinical Research Solutions- Site Number : 8400016 | East Orange | New Jersey | 07018 | — |
| NY Scientific- Site Number : 8400013 | Brooklyn | New York | 11235 | — |
| Pioneer Clinical Research - New York- Site Number : 8400017 | New York | New York | 10016 | — |
| Gastro One - Walnut Run Road- Site Number : 8400002 | Cordova | Tennessee | 38018 | — |
| Houston Methodist Hospital- Site Number : 8400023 | Houston | Texas | 77030 | — |
| 1960 Family Practice- Site Number : 8400019 | Houston | Texas | 77090 | — |
| GI Alliance - Mansfield- Site Number : 8400010 | Mansfield | Texas | 76063 | — |
| Integrity Research - Sugar Land- Site Number : 8400026 | Sugar Land | Texas | 77478 | — |
| Richmond VA Medical Center- Site Number : 8400022 | Richmond | Virginia | 23249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 92 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05588843, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2026 · Synced Sep 13, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05588843 live on ClinicalTrials.gov.