Crohn's Disease
Phase 2 Study of SAR441566 for Adults With Moderate to Severe Crohn’s Disease
This randomized phase 2 study is investigating the efficacy and safety of three oral doses of SAR441566 compared with placebo in adults with moderate to severe Crohn’s disease.
Registry title: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
19 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- SAR441566 or SAR441566 matching Placebo
- Design
- Randomized · Quadruple
- Central study contact
- Trial Transparency email recommended (Toll free for US & Canada)800-633-1610 ext. option 6contact-us@sanofi.com
- Sponsor
- Sanofi
Research question
Do different doses of SAR441566 improve Crohn’s disease outcomes compared with placebo, and what safety findings occur during treatment?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 to 75 with a confirmed Crohn’s disease diagnosis for at least three months.
- The study is looking for people whose Crohn’s disease is moderate to severe based on symptoms, the Crohn’s Disease Activity Index, and centrally reviewed endoscopy findings.
- The study is looking for people previously treated with at least one standard or advanced therapy that did not work adequately, stopped working, or was not tolerated.
- The study is multinational, with recruiting locations listed in the United States and numerous other countries; the study team must confirm whether a specific site is currently open.
Participation overview
What participation may involve
Participation may last up to 59 weeks: screening, 52 weeks of main-study treatment, and follow-up for participants who do not enter the long-term safety study. Eligible participants may be offered an open-label period within the main-study timeline. What participation may involve: - Screening lasts four weeks, with up to seven additional calendar days if needed. - Participants receive an oral tablet containing one of three doses of SAR441566 or matching placebo. - The double-blind treatment period includes 12 weeks of induction followed by 40 weeks of maintenance. - An open-label period of up to 40 weeks is offered to eligible participants; the combined double-blind maintenance and open-label periods cannot exceed 40 weeks. - Participants who do not enroll in the long-term safety study have a two-week follow-up after treatment ends. The anticipated participation duration is up to 59 weeks, although the timing of the open-label period depends on when an eligible participant switches.
Study interventions
What participants may receive or do
- SAR441566: Participants assigned to one of three experimental groups receive SAR441566 as an oral tablet at dose 1, dose 2, or dose 3.
- SAR441566 matching Placebo: Participants assigned to the placebo group receive an oral tablet designed to match SAR441566 but identified by the registry as placebo.
Study design
How the comparison works
This phase 2 treatment study assigns participants in parallel to one of three SAR441566 dose groups or a matching-placebo group. The main study includes blinded induction and maintenance periods, with an open-label period offered to eligible participants. Assignment is randomized, meaning the study determines which treatment group a participant enters by chance. The registry does not report the allocation ratio. During the double-blind portion, participants, care providers, investigators, and outcome assessors are masked to treatment assignment. The study compares three experimental SAR441566 dose groups with a matching-placebo control group. One study group receives a matching placebo tablet. The registry does not state an individual participant’s probability of receiving placebo.
Reported activities
Procedures and tests
- An endoscopy reviewed by a central reader is used to confirm moderate to severe Crohn’s disease during eligibility assessment.
- Ileocolonoscopy findings are scored with the Simple Endoscopic Score for Crohn’s Disease, which evaluates ulcers, affected surfaces, and narrowing in five bowel segments.
- Crohn’s Disease Activity Index assessments include seven-day symptom information, complications, antidiarrheal use, abdominal mass, hematocrit, and body weight.
- Participants’ daily abdominal pain and stool frequency are assessed as patient-reported outcomes.
- The 32-question Inflammatory Bowel Disease Questionnaire assesses bowel and systemic symptoms and emotional and social functioning.
- Blood plasma is collected at selected visits to measure SAR441566 concentrations before and after dosing.
- Safety monitoring records treatment-emergent adverse events, including serious opportunistic infections, psoriasis-like skin lesions, and other immune-mediated events.
- Screening may involve confirming that a stool sample is negative for infectious pathogens.
- Screening may involve tuberculosis, hepatitis B, hepatitis C, and human immunodeficiency virus testing or history review.
- Screening includes laboratory and other analyses, although the registry does not list the acceptable result ranges.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 to 75 years old when they sign the informed consent form.
- A Crohn’s disease diagnosis must have been confirmed at least three months before baseline.
- Moderate to severe disease must be confirmed using the Crohn’s Disease Activity Index, centrally reviewed endoscopic scoring, stool frequency, and abdominal pain.
- Participants must have had an inadequate response, loss of response, or intolerance to at least one listed standard or advanced therapy.
- Any listed standard treatment being used must be at a stable dose before screening.
- Contraception must follow local clinical-study rules, and women participants must not be pregnant or breastfeeding.
Possible reasons someone may not be able to join
- Active ulcerative colitis, indeterminate colitis, or short bowel syndrome excludes participation.
- Crohn’s disease isolated to the stomach, duodenum, jejunum, or perianal region without colon or ileum involvement is excluded.
- Certain ongoing Crohn’s complications, bowel resection within three months before screening, or a history of more than three bowel resections are exclusionary.
- A stool sample positive for an infectious pathogen excludes participation.
- Active tuberculosis or incompletely treated active or latent tuberculosis excludes participation under local guidelines.
- The listed positive hepatitis B or hepatitis C screening results are exclusionary.
- Known human immunodeficiency virus infection or positive HIV-1 or HIV-2 screening serology excludes participation.
- Active malignancy or lymphoproliferative disease, or recurrence within five years before screening, is exclusionary.
- Certain recent infections requiring intravenous, oral, or intramuscular anti-infective treatment exclude participation within the stated time windows.
- Recent use of certain immune-modifying drugs, fecal microbial transplantation, intravenous corticosteroids, or therapeutic enemas or suppositories may exclude participation within the stated windows.
Important unknowns
What the record does not make clear
- The registry describes study periods but does not state the number, frequency, length, or format of study visits.
- Four treatment groups are listed, including one placebo group, but the randomization ratio and individual chance of placebo assignment are not reported.
- Stable doses of certain standard treatments are required before screening, but the registry does not clearly explain which treatments continue, taper, or may change after enrollment.
- The criteria give timing restrictions for several treatments but do not provide a complete medication-specific washout plan.
- The registry does not explain what treatment is available if Crohn’s symptoms worsen during the study.
- The registry identifies a centrally reviewed screening endoscopy and endoscopic outcomes at week 12, but it does not fully describe the number, preparation, sedation, or other endoscopy requirements.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants are compensated.
- The registry does not report reimbursement or support for transportation, lodging, meals, or a caregiver’s travel.
- An open-label period and a separate long-term safety study are mentioned, but access to SAR441566 after those periods is not described.
- The overall study and listed locations are marked recruiting, but the registry does not confirm whether a particular site currently has space for a specific participant.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, including remote visits, blood draws, stool collections, questionnaires, and ileocolonoscopies?
- What is the chance of assignment to each SAR441566 dose or placebo?
- Which current Crohn’s medicines must remain stable, be stopped, or be tapered, and for how long?
- What happens if symptoms worsen during the blinded or open-label treatment periods?
- How many ileocolonoscopies are required, and what preparation, sedation, recovery time, and risks should I expect?
- Which study costs are covered, and are compensation or travel support available?
- What determines eligibility for the open-label period and the long-term safety study?
- Is the nearest listed site actively screening, and who should I contact there?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what clinical concerns would you want addressed before I contact the study team?
- How could the study’s medication restrictions affect my current treatment plan or risk of a flare?
- What approved treatment alternatives remain reasonable for me, and how do their known benefits and risks compare with the uncertainties of this phase 2 study?
- Are the study’s infection screening, endoscopies, blood sampling, and adverse-event monitoring appropriate in my clinical situation?
- How should your office and the research team coordinate medication decisions, laboratory results, endoscopy findings, and care if my symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Sanofi
- Organization class
- Industry
- Organization study ID
- DRI18212
- Lead sponsor
- Sanofi
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
SAR441566 dose 1
Participants will receive SAR441566 dose 1.
Interventions: Drug: SAR441566
Experimental
SAR441566 dose 2
Participants will receive SAR441566 dose 2.
Interventions: Drug: SAR441566
Experimental
SAR441566 dose 3
Participants will receive SAR441566 dose 3.
Interventions: Drug: SAR441566
Placebo Comparator
Placebo
Participants will receive SAR441566 matching placebo.
Interventions: Drug: SAR441566 matching Placebo
Interventions
Drug
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
Drug
SAR441566 matching Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (8)
- Male or female participants aged 18 to 75 years at the time of signing the ICFRegistry-derived · unreviewed
- Confirmed diagnosis of CD for at least 3 months prior to BaselineRegistry-derived · unreviewed
- Confirmed diagnosis of moderate to severe CD as assessed by:Registry-derived · unreviewed
- 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 readerRegistry-derived · unreviewed
- stool frequency (SF), abdominal pain (AP) scoreRegistry-derived · unreviewed
- History of prior exposure to standard treatment (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 therapiesRegistry-derived · unreviewed
- On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
Exclusion criteria (19)
- Participants with active UC, indeterminate colitis or short bowel syndromeRegistry-derived · unreviewed
- Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvementRegistry-derived · unreviewed
- 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 resectionsRegistry-derived · unreviewed
- Participants with stool sample positive for infectious pathogensRegistry-derived · unreviewed
- Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelinesRegistry-derived · unreviewed
- 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 VisitRegistry-derived · unreviewed
- Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplexRegistry-derived · unreviewed
- Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screeningRegistry-derived · unreviewed
- Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screeningRegistry-derived · unreviewed
- History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visitRegistry-derived · unreviewed
- Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visitRegistry-derived · unreviewed
- Participants requiring or receiving any parental nutrition and/or exclusive enteral nutritionRegistry-derived · unreviewed
- Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screeningRegistry-derived · unreviewed
- Participants who received fecal microbial transplantation within 30 days prior to screeningRegistry-derived · unreviewed
- Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)Registry-derived · unreviewed
- Participants who received IV corticosteroids within 14 days prior to screening or during screening periodRegistry-derived · unreviewed
- Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screeningRegistry-derived · unreviewed
- Screening laboratory and other analyses show abnormal resultsRegistry-derived · unreviewed
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Proportion of participants achieving endoscopic response
Time frame: Week 12
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.
Secondary outcome
Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)
Time frame: Week 12
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.
Secondary outcome
Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission
Time frame: Week 12
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).
Secondary outcome
Proportion of participants achieving both clinical remission and endoscopic response
Time frame: Week 12
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)
Secondary outcome
Proportion of participants achieving endoscopic remission based on centrally read SES-CD
Time frame: From Baseline to Week 12
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
Secondary outcome
Proportion of participants achieving CDAI clinical response
Time frame: From Baseline to Week 12
CDAI clinical response is defined as a CDAI reduction from baseline ≥100 points.
Secondary outcome
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission
Time frame: Week 12
IBDQ remission is defined as IBDQ total score ≥170 points. The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life.
Secondary outcome
Proportion of participants achieving IBDQ response
Time frame: From baseline to Week 12
IBDQ response defined as an improvement of IBDQ scores by 27 points or more at Week 12 compared with baseline
Secondary outcome
Change from baseline in the IBDQ scores
Time frame: From Baseline to week 12
The total IBDQ score ranges from 32 to 224 which indicates better quality of life. A positive change from Baseline indicates improvement.
Secondary outcome
Plasma pre-dose concentrations of SAR441566 at selected visits
Time frame: Up to week 52
Secondary outcome
Plasma post-dose concentrations of SAR441566 at selected visits
Time frame: Up to week 52
Secondary outcome
Number of participants experiencing any TEAEs
Time frame: Up to week 52
Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period
Secondary outcome
Number of participants experiencing any TEAEs
Time frame: From week 12 to week 52
Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during open-label treatment period
Recruiting locations in the United States
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020
RecruitingSun City, Arizona, 85351, United States
Bristol Hospital- Site Number : 8400007
RecruitingBristol, Connecticut, 06010, United States
Novum Research- Site Number : 8400021
RecruitingClermont, Florida, 34711, United States
Homestead Associates in Research- Site Number : 8400012
RecruitingHomestead, Florida, 33033, United States
Clinical Research of Osceola- Site Number : 8400013
RecruitingKissimmee, Florida, 34741, United States
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010
RecruitingMiami Lakes, Florida, 33016, United States
GCP Clinical Research- Site Number : 8400004
RecruitingTampa, Florida, 33609, United States
GI Alliance - Glenview- Site Number : 8400015
RecruitingGlenview, Illinois, 60026, United States
Illinois Gastroenterology Group- Site Number : 8400011
RecruitingGurnee, Illinois, 60031, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400017
RecruitingAnn Arbor, Michigan, 48109, United States
Gi Alliance - Flowood- Site Number : 8400019
RecruitingFlowood, Mississippi, 39232, United States
Vector Clinical Trials- Site Number : 8400001
RecruitingLas Vegas, Nevada, 89128, United States
Queens Village Primary Medical Center- Site Number : 8400005
RecruitingQueens Village, New York, 11428, United States
Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014
RecruitingGreenville, North Carolina, 27834, United States
Frontier Clinical Research - Uniontown- Site Number : 8400009
RecruitingUniontown, Pennsylvania, 15401, United States
Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016
RecruitingCharleston, South Carolina, 29401, United States
Gastro Health & Nutrition- Site Number : 8400003
RecruitingKaty, Texas, 77494, United States
Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
RecruitingSouthlake, Texas, 76092, United States
Washington Gastroenterology - Tacoma- Site Number : 8400008
RecruitingTacoma, Washington, 98405, United States
This study also lists 120 locations outside the United States. They are not shown here.
Central study contacts
Trial Transparency email recommended (Toll free for US & Canada)
Contact
Registry dates
- First posted
- Oct 15, 2024
- Primary completion
- Jul 21, 2027
- Overall completion
- May 23, 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.