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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSanofi

About this trial

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.

Eligibility criteria

Qualifiers

Male or female participants aged 18 to 75 years at the time of signing the ICF

Confirmed diagnosis of CD for at least 3 months prior to Baseline

Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader

stool frequency (SF), abdominal pain (AP) score

Disqualifiers

Participants with active UC, indeterminate colitis or short bowel syndrome

Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement

Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of > 3 bowel resections

Participants with stool sample positive for infectious pathogens

Trial design

Treatments tested in this trial

  • SAR441566
  • SAR441566 matching Placebo

Treatment groups

260 Participants
are divided into 4 treatment groups

Sponsors and collaborators