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A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis

NCT06867094 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-04-28

No results posted yet for this 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 (for participants not enrolling in the LTS study).

* 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.

Conditions

  • Colitis Ulcerative

Interventions

DRUG

SAR441566

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

SAR441566 matching Placebo

Pharmaceutical form: Tablet Route of administration: Oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-28
Primary Completion
2027-07-29
Completion
2028-05-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Czechia
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • India
  • Italy
  • Japan
  • Poland
  • South Africa
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06867094 on ClinicalTrials.gov