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A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

NCT06637631 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-05-20

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 Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.

This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance.

Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.

Conditions

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
2024-12-10
Primary Completion
2027-07-21
Completion
2029-05-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Croatia
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Mauritius
  • Netherlands
  • Poland
  • Romania
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
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 NCT06637631 on ClinicalTrials.gov