Colitis Ulcerative
Phase 2 Study of SAR441566 for Adults With Moderate-to-Severe Ulcerative Colitis
This Phase 2 study is investigating the efficacy and safety of different oral doses of SAR441566 compared with placebo in adults with moderate-to-severe ulcerative colitis.
Registry title: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
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 clinical remission at Week 12, and what safety findings occur, in adults with moderate-to-severe ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75 with ulcerative colitis.
- Ulcerative colitis must have been clinically active for at least three months before screening and confirmed by screening endoscopy.
- The study is looking for moderate-to-severe active disease meeting detailed modified Mayo Score, bleeding, stool-frequency, endoscopy, and disease-extent requirements.
- Participants must have had an inadequate response, loss of response, intolerance, or corticosteroid dependence involving specified standard or advanced ulcerative colitis treatments.
Participation overview
What participation may involve
Participation may include screening, random assignment to oral SAR441566 or matching placebo, a 12-week induction period, a 40-week maintenance period, and two weeks of follow-up. Eligible participants may also be offered an open-label period. What participation may involve: - Complete a screening period lasting up to 28 days, with up to seven additional calendar days if needed. - Take an oral tablet assigned as one of three SAR441566 dose regimens or matching placebo. - Participate in a 12-week induction period followed by a 40-week maintenance period and two weeks of follow-up after treatment. - Eligible participants not entering the long-term study may be offered an open-label treatment period lasting up to 40 weeks. The registry states that study duration is up to 59 weeks and double-blind treatment is up to 52 weeks; it separately describes an optional open-label period of up to 40 weeks, so the total duration for someone entering that period is unclear. The registry reports 12 visits during the main study treatment period and eight during the open-label treatment period; it does not state the number of screening or follow-up visits.
Study interventions
What participants may receive or do
- SAR441566: An investigational drug taken by mouth as a tablet. The study uses three dose regimens.
- SAR441566 matching Placebo: An oral tablet designed to match SAR441566 but assigned as the placebo comparator.
Study design
How the comparison works
This Phase 2, parallel-group study randomly assigns participants to one of three SAR441566 dose regimens or matching placebo. The main treatment period is double-blind, and an open-label period may be offered to eligible participants. Participants are randomly assigned among four parallel groups: three SAR441566 dose regimens and one placebo group. During the double-blind period, the participant, care provider, investigator, and outcomes assessor are masked to treatment assignment. Results from the three SAR441566 dose groups are compared with a matching-placebo group. One study group receives an oral tablet matching SAR441566 as placebo; the registry does not report the chance of assignment to that group.
Reported activities
Procedures and tests
- Screening endoscopy is used to confirm active ulcerative colitis, disease extent, and the required endoscopic score.
- Ulcerative colitis activity is assessed with modified and full Mayo Scores, including stool frequency, rectal bleeding, endoscopic findings, and physician global assessment where applicable.
- Endoscopic response, improvement, and remission are assessed at Week 12.
- Histologic and endoscopic mucosal improvement is assessed at Week 12 using endoscopic findings and the original Geboes Score.
- Blood samples are used to measure SAR441566 plasma concentrations before and after dosing at selected visits.
- Participants complete the 32-item Inflammatory Bowel Disease Questionnaire to assess symptoms, functioning, and well-being.
- Treatment-emergent adverse events are monitored during induction, maintenance, and the open-label treatment period.
- Screening may involve stool testing for parasites, bacterial pathogens, and Clostridium difficile B toxin.
- Screening may involve testing for tuberculosis, hepatitis B, hepatitis C, and human immunodeficiency virus.
- Screening laboratory and other analyses must not show disqualifying abnormal results, but the registry does not specify the tests or thresholds.
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 through 75 years old when signing informed consent.
- Active ulcerative colitis must have been clinically evident for at least three months before screening and confirmed by endoscopy during screening.
- At screening, disease must meet all listed moderate-to-severe activity thresholds: modified Mayo Score 5–9, rectal bleeding and stool-frequency subscores of at least 1, centrally confirmed endoscopic subscore of at least 2, total subscores of at least 5, and disease extending more than 15 cm from the anal verge.
- Someone without prior approved advanced therapy exposure must have had an inadequate response, loss of response, intolerance, or corticosteroid dependence involving at least one listed standard treatment.
- Alternatively, someone previously treated with approved advanced therapy must have had an inadequate response, loss of response, or intolerance to at least one approved biologic or specified small-molecule treatment for ulcerative colitis.
- Men and women must use contraception consistent with local clinical-study regulations.
Possible reasons someone may not be able to join
- Active Crohn's disease, indeterminate colitis, ischemic colitis, or microscopic colitis excludes participation.
- Ongoing fulminant colitis, toxic megacolon, or another manifestation that might require bowel surgery during the study excludes participation.
- Prior colectomy, ostomy, or ileoanal pouch, or an anticipated colectomy during the study, excludes participation.
- A stool sample positive for parasites, bacterial pathogens, or Clostridium difficile B toxin excludes participation.
- Active tuberculosis, incompletely treated active tuberculosis, or latent tuberculosis infection under local guidelines excludes participation.
- Specified positive hepatitis B or hepatitis C screening results exclude participation.
- Known human immunodeficiency virus infection or positive HIV-1 or HIV-2 screening serology excludes participation.
- Active malignancy or lymphoproliferative disease, or recurrence of either within five years before screening, excludes participation.
- For extensive colitis lasting at least eight years or left-sided disease lasting more than ten years, a dysplasia-surveillance colonoscopy within one year is required; dysplasia or cancer on biopsies excludes participation.
- Pregnancy, breastfeeding, or considering pregnancy during the study or within three months after the last study-drug dose excludes participation.
- Use of intravenous anti-infectives within 30 days before screening or oral or intramuscular anti-infectives within 14 days before screening excludes participation.
- Recent or previous use of certain treatments may exclude participation, including cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, fecal microbial transplantation, natalizumab, carotegrast methyl, or intravenous corticosteroids within their specified windows.
Important unknowns
What the record does not make clear
- The registry states that study duration is up to 59 weeks but separately describes an optional open-label period lasting up to 40 weeks; it does not clearly state the total duration for participants entering that period.
- The registry lists three SAR441566 groups and one placebo group but does not report group sizes or the probability of placebo assignment.
- The registry describes previous ulcerative colitis treatment requirements but does not clearly state which current treatments may continue during the study.
- The eligibility criteria give timing restrictions for several treatments, but a complete washout schedule for all ulcerative colitis therapies is not reported.
- The registry does not explain what treatment is available if ulcerative colitis worsens during the study.
- A screening endoscopy and Week 12 endoscopic outcomes are described, but the total number, timing, preparation, sedation, and biopsy requirements are not fully reported.
- 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 receive compensation.
- The registry does not report reimbursement or assistance for travel, lodging, parking, or meals.
- The registry does not state whether any visits or assessments can be completed remotely.
- An open-label period may be offered to certain eligible participants, but access to SAR441566 after study participation is otherwise not described.
- The overall study is recruiting and many listed locations are recruiting, but site statuses vary and may change.
Before contacting the site
Questions for the study team
- What is the chance of assignment to each SAR441566 dose regimen or placebo?
- Which ulcerative colitis medicines can continue, and which must be stopped or tapered before or during the study?
- How many endoscopies or colonoscopies, biopsies, blood draws, stool samples, and questionnaires are required, and at which visits?
- Who can enter the open-label period, when does it begin, and what is the total study duration for those participants?
- What happens if ulcerative colitis worsens, and what rescue treatments or withdrawal options are available?
- Which study-related costs are covered, is compensation offered, and is travel support available?
- Is the site nearest me currently recruiting, and can any visits be completed remotely?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what would a change in my current treatment mean for disease control?
- What approved treatment alternatives are reasonable for me to consider alongside learning more about this study?
- Do my infection history, cancer history, prior surgery, laboratory results, or current medicines raise concerns about the study procedures or investigational drug?
- How should my regular gastroenterology care and monitoring be coordinated with the research team if I pursue screening?
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 UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study). * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
Study design and administration
- Organization
- Sanofi
- Organization class
- Industry
- Organization study ID
- DRI17822
- 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 regimen 1
Participants will receive SAR441566 dose regimen 1
Interventions: Drug: SAR441566
Experimental
SAR441566 dose regimen 2
Participants will receive SAR441566 dose regimen 2
Interventions: Drug: SAR441566
Experimental
SAR441566 dose regimen 3
Participants will receive SAR441566 dose regimen 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 (7)
- Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consentRegistry-derived · unreviewed
- Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening periodRegistry-derived · unreviewed
- Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent \>15 cm from the anal vergeRegistry-derived · unreviewed
- Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"):Registry-derived · unreviewed
- History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) ORRegistry-derived · unreviewed
- History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UCRegistry-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.Registry-derived · unreviewed
Exclusion criteria (20)
- Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitisRegistry-derived · unreviewed
- Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the studyRegistry-derived · unreviewed
- Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the studyRegistry-derived · unreviewed
- Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stoolsRegistry-derived · unreviewed
- Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelinesRegistry-derived · unreviewed
- Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) 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 gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit.Registry-derived · unreviewed
- If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \>10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.Registry-derived · unreviewed
- Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drugRegistry-derived · unreviewed
- Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit 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
- Screening laboratory and other analyses show abnormal results.Registry-derived · unreviewed
- The above information is not intended to contain all considerations relevant to a participant'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 clinical remission at Week 12 by modified Mayo Score (mMS)
Time frame: Week 12
Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore \>1 (stool frequency \[SF\] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding \[RB\] of 0 and modified Mayo Endoscopic Subscore \[mMES\] of 0 or 1 where 1 does not include friability). Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Secondary outcome
Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)
Time frame: Week 12
Clinical response by modified Mayo score (mMS) is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1. Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Secondary outcome
Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)
Time frame: Week 12
Clinical response by full Mayo score (MS) is defined as a decrease from baseline in the MS of ≥3 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1. The MS (also referred to as the full Mayo Score) is a composite index designed to measure ulcerative colitis (UC) disease activity and consists of 4 subscores: RB and SF, which are patient-reported subscores, Physician's global assessment (PGA), and endoscopic findings. Individual items are rated 0 to 3, giving the composite score a maximum of 12, with higher scores indicating greater disease severity.
Secondary outcome
Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)
Time frame: Week 12
Clinical remission by full Mayo score (MS) is defined as a MS ≤2 with no score \>1.
Secondary outcome
Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12
Time frame: Week 12
Patient-reported outcome 2 (PRO2) remission is defined as PRO2 score ≤1 with rectal bleeding (RB) of 0, and endoscopic remission is defined as mMES of 0. PRO2 score is defined as the sum of Mayo SF and RB subscores.
Secondary outcome
Proportion of participants achieving endoscopic remission at Week 12
Time frame: Week 12
Endoscopic remission is defined as mMES of 0.
Secondary outcome
Change from baseline in PRO2 from randomization to Week 12
Time frame: From Baseline to Week 12
PRO2 score is defined as the sum of the Mayo SF and RB subscores.
Secondary outcome
Proportion of participants achieving endoscopic response at Week 12
Time frame: Week 12
Endoscopic response is defined as mMES decrease of at least 1 point.
Secondary outcome
Proportion of participants achieving endoscopic improvement at Week 12
Time frame: Week 12
Endoscopic improvement is defined as mMES of 0 or 1 where 1 does not include friability.
Secondary outcome
Proportion of participants achieving HEMI at Week 12
Time frame: Week 12
Histologic endoscopic mucosal improvement (HEMI) is defined by achievement of modified Mayo endoscopic improvement (mMES of 0 or 1 where 1 does not include friability) and histological improvement (original Geboes Score \[OGS\] ≤3.1).
Secondary outcome
Plasma predose concentrations of SAR441566 at selected visits
Time frame: Up to Week 52
Secondary outcome
Plasma postdose concentrations of SAR441566 at selected visits
Time frame: Up to Week 52
Secondary outcome
Number of participants with any treatment-emergent adverse events (TEAEs) during induction and maintenance treatment period
Time frame: Up to Week 52
Secondary outcome
Number of participants with any treatment-emergent adverse events (TEAEs) during open-label treatment period
Time frame: From Week 12 to Week 52
Secondary outcome
Proportion achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12
Time frame: Week 12
Inflammatory Bowel Disease Questionnaire (IBDQ) remission is considered as an IBDQ-32 total score ≥170 points. IBDQ is designed to capture the patient's experience of IBD on 4 domains of functioning and well-being: bowel and systemic symptoms and emotional and social function. The total IBDQ score ranges from 32 to 224 which indicates better quality of life.
Secondary outcome
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 12
Time frame: Week 12
Inflammatory Bowel Disease Questionnaire (IBDQ) response is defined as an increase from baseline in the total IBDQ score in the range of 16 to 32 points.
Recruiting locations in the United States
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003
RecruitingSun City, Arizona, 85351, United States
Bristol Hospital- Site Number : 8400017
RecruitingBristol, Connecticut, 06010, United States
Novum Research- Site Number : 8400018
RecruitingClermont, Florida, 34711, United States
Clinical Research of Osceola- Site Number : 8400012
RecruitingKissimmee, Florida, 34741, United States
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002
RecruitingMiami Lakes, Florida, 33016, United States
GCP Clinical Research- Site Number : 8400016
RecruitingTampa, Florida, 33609, United States
GI Alliance - Glenview- Site Number : 8400005
RecruitingGlenview, Illinois, 60026, United States
Illinois Gastroenterology Group- Site Number : 8400004
RecruitingGurnee, Illinois, 60031, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400010
RecruitingAnn Arbor, Michigan, 48109, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400001
RecruitingNew York, New York, 10029, United States
Queens Village Primary Medical Center- Site Number : 8400011
RecruitingQueens Village, New York, 11428, United States
NexGen Research- Site Number : 8400020
RecruitingLima, Ohio, 45805, United States
Frontier Clinical Research - Uniontown- Site Number : 8400006
RecruitingUniontown, Pennsylvania, 15401, United States
Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008
RecruitingCharleston, South Carolina, 29401, United States
Gastro Health & Nutrition- Site Number : 8400007
RecruitingKaty, Texas, 77494, United States
SI Research Associates- Site Number : 8400019
RecruitingLubbock, Texas, 79424, United States
Texas Digestive Disease Consultants - Southlake- Site Number : 8400015
RecruitingSouthlake, Texas, 76092, United States
University of Washington Medical Center- Site Number : 8400014
RecruitingSeattle, Washington, 98195, United States
Washington Gastroenterology - Tacoma- Site Number : 8400009
RecruitingTacoma, Washington, 98405, United States
This study also lists 96 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
- Mar 10, 2025
- Primary completion
- Jul 29, 2027
- Overall completion
- May 11, 2028
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.