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Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis
NCT05588843 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SAR443122
Study Locations (20)
Texas
- Houston Methodist Hospital- Site Number : 8400023 — Houston
- 1960 Family Practice- Site Number : 8400019 — Houston
- GI Alliance - Mansfield- Site Number : 8400010 — Mansfield
- Integrity Research - Sugar Land- Site Number : 8400026 — Sugar Land
Other
- Investigational Site Number : 0320002 — Buenos Aires
- Investigational Site Number : 0320004 — Córdoba
- Investigational Site Number : 0320005 — Córdoba
New York
- NY Scientific- Site Number : 8400013 — Brooklyn
- Pioneer Clinical Research - New York- Site Number : 8400017 — New York
California
- Om Research - Lancaster - 15th Street West- Site Number : 8400014 — Lancaster
Georgia
- Agile Clinical Research Trials- Site Number : 8400024 — Atlanta
Illinois
- Endeavor Health - Evanston Hospital- Site Number : 8400027 — Evanston
Missouri
- BVL Research- Site Number : 8400015 — Liberty
Nevada
- Vector Clinical Trials- Site Number : 8400004 — Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2022-11-25 |
| Est. Completion | 2026-12-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05588843
The ClinicalTrials.gov registry entry for NCT05588843 describes a study currently listed as active not 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 187 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 Colitis Ulcerative 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: NCT05588843 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, Other, New York. 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 NCT05588843 about?
NCT05588843 is a clinical study titled "Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis". 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 ...
What is the current status of trial NCT05588843?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2022-11-25. Estimated completion is 2026-12-02.
What conditions does trial NCT05588843 study?
This clinical trial studies the following conditions: Colitis Ulcerative. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05588843?
The interventions under investigation include: Placebo (DRUG), SAR443122 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05588843?
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 NCT05588843 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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