Testing SAR441566 against a placebo for Crohn's disease
Official title: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.
Interventions
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
SAR441566 matching Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Canadian Sites (3)
Investigational Site Number : 1240001
Calgary, Alberta, Canada
Investigational Site Number : 1240003
Montreal, Quebec, Canada
Investigational Site Number : 1240005
Québec, Quebec, Canada
Eligibility Criteria
See who this study is looking for29 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female participants aged 18 to 75 years at the time of signing the ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Participants are eligible to be included in the study only if all of the following criteria apply:
- +Confirmed diagnosis of CD for at least 3 months prior to BaselineBaselineYour starting measurements, taken before treatment begins.Read more →
- +Confirmed diagnosis of moderate to severe CD as assessed by:
- +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
- +History of prior exposure to standard treatmentStandard of careThe treatment normally given for a condition outside a study.Read more → (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
- +On stable doses of standard treatments prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)
- +Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.
Exclusion
- −Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening VisitScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
- −Participants are excluded from the study if any of the following criteria apply:
- −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
- −Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
- −Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
- −Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
- −History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit
- −Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit
- −Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
- −Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
- −Participants who received fecal microbial transplantation within 30 days prior to screening
- −Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
- −Participants who received IV corticosteroids within 14 days prior to screening or during screening period
- −Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
- −Screening laboratory and other analyses show abnormal results
- −The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: SAR441566, SAR441566 matching PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 260 people.
The study is currently expected to finish around May 2029.
The main measurement is taken over: Week 12.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proportion of participants achieving endoscopic response — measured over Week 12.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06637631 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SAR441566Drug
Pharmaceutical form: Tablet Route of administration: Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About SAR441566 matching PlaceboDrug
Pharmaceutical form: Tablet Route of administration: Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 12.
The study as a whole is currently expected to finish around 2029-05-23.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 260 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Calgary, Alberta, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada; Ann Arbor, Michigan, United States; Queens Village, New York, United States; Tacoma, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (3)
University of Michigan Health System - Ann Arbor- Site Number : 8400017
Ann Arbor, Michigan, United States
Queens Village Primary Medical Center- Site Number : 8400005
Queens Village, New York, United States
Washington Gastroenterology - Tacoma- Site Number : 8400008
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.