Health Trials

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

ConditionCrohn'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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SAR441566

    Drug

    Pharmaceutical form: Tablet Route of administration: Oral

  • SAR441566 matching Placebo

    Drug

    Pharmaceutical form: Tablet Route of administration: Oral

Treatment groups

260 Participants
are divided into 4 treatment groups
Group A: SAR441566 dose 1Experimental treatment 1 intervention
Group B: SAR441566 dose 2Experimental treatment 1 intervention
Group C: SAR441566 dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants achieving endoscopic response

Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

Time frame
Week 12

Secondary outcomes

1

Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)

CDAI clinical remission is defined as CDAI score \<150. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.

Time frame
Week 12
2

Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission

PRO 2 remission is defined as the unweighted CDAI component of daily abdominal pain (AP) score ≤1, and the unweighted CDAI component of daily average stool frequency (SF) score ≤3 (ie, AP ≤1 and SF ≤3 and no worsening from baseline).

Time frame
Week 12
3

Proportion of participants achieving both clinical remission and endoscopic response

Clinical remission and endoscopic response based on CDAI \<150 and ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD)

Time frame
Week 12
4

Proportion of participants achieving endoscopic remission based on centrally read SES-CD

Endoscopic remission is defined as a centrally read SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease from baseline ≥2 points with no SES-CD sub score \>1 point

Time frame
From Baseline to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov
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