Ulcerative Colitis
SAR442970 Dose Study for Adults With Moderate-to-Severe Ulcerative Colitis
This Phase 2b study is investigating how different doses of subcutaneous SAR442970 compare with placebo in adults with moderate-to-severe ulcerative colitis.
Registry title: A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
21 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- SAR442970 or 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
How do different doses of SAR442970 compare with placebo for treating moderate-to-severe ulcerative colitis, including clinical remission at Week 16 and safety?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75.
- The study is looking for people with clinical evidence of active ulcerative colitis for at least three months, confirmed by screening endoscopy.
- The study is looking for moderate-to-severe active disease meeting specified modified Mayo Score, bleeding, stool-frequency, endoscopy, and disease-extent thresholds.
- The study is looking for people with a specified history of inadequate response, loss of response, intolerance, or dependence involving ulcerative colitis treatments.
Participation overview
What participation may involve
Participants may receive a subcutaneous SAR442970 dose regimen or matching placebo. Eligible participants may continue into an open-label long-term extension. What participation may involve: - Receive SAR442970 or matching placebo by subcutaneous administration according to the assigned arm. - Undergo assessments of ulcerative colitis symptoms and disease activity using Mayo-based scores. - Undergo endoscopic and tissue-based assessments of inflammation at reported study timepoints. - Provide blood samples for SAR442970 concentration and anti-drug antibody assessments. - Complete a 32-item Inflammatory Bowel Disease Questionnaire about symptoms, well-being, and daily functioning. The total study duration is reported as up to 168 weeks, with treatment lasting up to 158 weeks, including an open-label extension of up to 104 weeks for eligible participants.
Study interventions
What participants may receive or do
- SAR442970: Participants assigned to either SAR442970 dose-regimen arm receive the study drug by subcutaneous administration.
- Placebo: The registry describes a SAR442970-matching placebo given by subcutaneous administration; it is listed in the placebo arm and Dose Regimen B arm.
Study design
How the comparison works
This Phase 2 study randomly assigns participants to three parallel arms comparing two SAR442970 dose regimens with placebo, followed by an open-label long-term extension for eligible participants. The structured design reports quadruple masking, while the brief summary calls the study double-blind. Participants are randomly assigned among three parallel study arms. The structured design says participants, care providers, investigators, and outcome assessors are masked; the brief summary instead describes the study as double-blind. SAR442970 dose regimens are compared with a matching-placebo control arm. The registry includes a subcutaneous SAR442970-matching placebo and lists it in both the placebo arm and Dose Regimen B arm.
Reported activities
Procedures and tests
- Subcutaneous administration of SAR442970 or matching placebo.
- A screening endoscopy confirms active ulcerative colitis, and endoscopic findings are assessed during the study.
- Colon tissue biopsies are evaluated for histological inflammation using the Original Geboes Score and Robarts Histopathology Index.
- Stool frequency and rectal bleeding are recorded as components of Mayo-based disease-activity scores.
- Participants complete the 32-item Inflammatory Bowel Disease Questionnaire.
- Blood samples are assessed for serum SAR442970 concentrations and anti-drug antibodies.
- Screening may involve confirming that stool tests are negative for specified pathogens and Clostridium difficile B toxin.
- Screening may involve laboratory tests and checks for human immunodeficiency virus, hepatitis B, and hepatitis C.
- Treatment-emergent adverse events are assessed during induction, maintenance, and the long-term extension.
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 ages 18 through 75 when they sign informed consent.
- Active ulcerative colitis must have been clinically evident for at least three months before screening and confirmed by screening endoscopy.
- At screening, disease must meet all specified moderate-to-severe thresholds for modified Mayo Score, rectal bleeding, stool frequency, centrally reviewed endoscopy, total subscores, and extent of at least 15 cm.
- One permitted treatment-history pathway requires inadequate response, loss of response, intolerance, or corticosteroid dependence involving specified standard treatments, together with no prior advanced-therapy exposure.
- The alternative treatment-history pathway requires inadequate response, loss of response, or intolerance to at least one approved advanced therapy.
- Men and women must follow locally required contraception rules for clinical-study participants.
Possible reasons someone may not be able to join
- People with active Crohn's disease, indeterminate colitis, or microscopic colitis are excluded.
- A stool sample positive for specified aerobic pathogens, ova, or Clostridium difficile B toxin is exclusionary.
- An ostomy, ileoanal pouch, previous colectomy, or anticipated colectomy during the study excludes participation.
- Ongoing fulminant ulcerative colitis, toxic megacolon, or colonic dysplasia other than adenoma is exclusionary.
- Intestinal failure or short bowel syndrome requiring total parenteral nutrition is exclusionary.
- Specified recent or recurrent serious infections are exclusionary, including infections within defined windows before screening or baseline, with an exception for treatment required as part of an anti-tuberculosis regimen.
- Known or suspected significant current immunosuppression is exclusionary.
- A history of malignancy or lymphoproliferative disease is generally exclusionary, except for the specifically listed adequately treated localized cervical or nonmetastatic skin cancers.
- Human immunodeficiency virus infection or positive screening serology is exclusionary.
- Specified positive or indeterminate hepatitis B findings, or a positive hepatitis C antibody result, are exclusionary.
Important unknowns
What the record does not make clear
- The registry does not provide the number, frequency, length, or format of study visits.
- The registry lists three arms but does not report allocation ratios, and Dose Regimen B lists both SAR442970 and placebo.
- The registry does not clearly state which current ulcerative colitis medicines may continue or must change during the study.
- Medication washout requirements and timing are not stated.
- The registry does not describe rescue treatment if ulcerative colitis worsens.
- Screening endoscopy and endoscopic outcomes are reported, but the complete schedule, preparation, sedation, and biopsy requirements are not described.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- Compensation or reimbursement is not described.
- The registry does not state whether any visits or assessments can occur remotely.
- The registry does not describe access to SAR442970 after study treatment ends.
- The overall study and many listed sites are recruiting, but this does not confirm that a particular site or cohort currently has an opening.
- The structured design reports quadruple masking, while the brief summary calls the study double-blind.
Before contacting the site
Questions for the study team
- What is the chance of assignment to placebo, and why does Dose Regimen B list both SAR442970 and placebo?
- What is the full visit schedule, including visit length and which visits must occur at the study site?
- How many endoscopies and biopsies are required, and what preparation and sedation are used?
- Which current ulcerative colitis medicines may continue, and are any washout periods required?
- What happens if ulcerative colitis worsens during the blinded or extension periods?
- Which costs are covered, and is reimbursement available for travel, parking, lodging, meals, or time?
- Is my preferred site and treatment-history cohort currently accepting participants?
- Who is blinded during each study period, and at what point does the open-label extension begin?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what would worsening disease mean for considering a study with a placebo-controlled period?
- Which of my current treatments could safely continue, taper, or require replacement if I explored this study?
- What approved treatment alternatives remain appropriate for me, given my previous responses and side effects?
- Do my infection history, other conditions, surgeries, or laboratory results raise concerns about the study criteria or investigational treatment?
- How should my gastroenterology team and the research team coordinate routine care, flare management, endoscopies, and safety monitoring?
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 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Ulcerative Colitis. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.
Study design and administration
- Organization
- Sanofi
- Organization class
- Industry
- Organization study ID
- ACT18134
- 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
SAR442970 Dose Regimen A
Participants will receive SAR442970 dose regimen A
Interventions: Drug: SAR442970
Experimental
SAR442970 Dose Regimen B
Participants will receive SAR442970 dose regimen B
Interventions: Drug: SAR442970, Drug: Placebo
Placebo Comparator
Placebo
Participants will receive SAR442970-matching placebo
Interventions: Drug: Placebo
Interventions
Drug
SAR442970
Route of administration: Subcutaneous
Drug
Placebo
Route of administration: Subcutaneous
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 had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening periodRegistry-derived · unreviewed
- Must have 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, mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a minimum disease extent of 15 cm from the anal vergeRegistry-derived · unreviewed
- Must have received prior treatment for UC (either "a" or "b" below or combination of both):Registry-derived · unreviewed
- History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or history of corticosteroid dependence (defined as an inability to successfully taper corticosteroids without recurrence of UC) AND history of no prior exposure to Advanced Therapies (ATs), such as a biologic agent used to treat UC or advanced small molecules used to treat UCRegistry-derived · unreviewed
- History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent used to treat UC or advanced small molecules used to treat 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 studiesRegistry-derived · unreviewed
Exclusion criteria (22)
- Participants are excluded from the study if any of the following criteria apply:Registry-derived · unreviewed
- Participants with active Crohn's Disease (CD), indeterminate colitis or microscopic colitisRegistry-derived · unreviewed
- Participants with fecal sample positive for culture/ova for aerobic pathogens or positive for Clostridium difficile B toxin in stoolsRegistry-derived · unreviewed
- Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in the studyRegistry-derived · unreviewed
- Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic dysplasia except for adenomaRegistry-derived · unreviewed
- Participants with intestinal failure or short bowel syndrome requiring Total Parenteral NutritionRegistry-derived · unreviewed
- History of recurrent or recent serious infection within 4 weeks of screening, or infection(s) requiring hospitalization or treatment with IV anti-infectives within 30 days prior to baseline, or infections(s) requiring oral anti-infectives within 14 days prior to baseline, except as required as part of an anti-Tuberculosis (TB) regimenRegistry-derived · unreviewed
- Known history of or suspected significant current immunosuppression.Registry-derived · unreviewed
- History or solid organ transplant or splenectomyRegistry-derived · unreviewed
- History of moderate to severe congestive heart failure (New York Health Association Class III or IV), or recent cerebrovascular accident.Registry-derived · unreviewed
- History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating diseaseRegistry-derived · unreviewed
- Participants with a history of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skinRegistry-derived · unreviewed
- Participants with a diagnosis of inflammatory conditions other than UC (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc.)Registry-derived · unreviewed
- History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at ScreeningRegistry-derived · unreviewed
- History of Interstitial Lung DiseaseRegistry-derived · unreviewed
- Participants with any of the following results at Screening:Registry-derived · unreviewed
- Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,Registry-derived · unreviewed
- Positive total Hepatitis B core antibody (anti-HBc) confirmed by positive Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) or,Registry-derived · unreviewed
- Positive Hepatitis C Virus (HCV) antibodyRegistry-derived · unreviewed
- Screening laboratory and other analyses showing abnormal resultsRegistry-derived · unreviewed
- History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocolRegistry-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 who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS)
Time frame: At Week 16
Clinical remission is based on modified Mayo subscores. The mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Secondary outcome
Proportion of participants who achieve endoscopic improvement at Week 16
Time frame: At Week 16
Endoscopic improvement is defined as a modified Mayo Endoscopic Subscore (mMES) of 0 or 1 (where 1 does not include friability). The mMES ranges from 0 to 3 with higher scores indicating greater disease severity.
Secondary outcome
Proportion of participants who achieve endoscopic improvement at Week 52
Time frame: At Week 52
Endoscopic improvement is defined as an mMES of 0 or 1 (where 1 does not include friability). The mMES ranges from 0 to 3 with higher scores indicating greater disease severity.
Secondary outcome
Proportion of participants who achieve endoscopic response at Week 16
Time frame: At Week 16
Endoscopic response is defined as an mMES decrease of at least 1.
Secondary outcome
Proportion of participants who achieve endoscopic response at Week 52
Time frame: At Week 52
Endoscopic response is defined as an mMES decrease of at least 1.
Secondary outcome
Proportion of participants who achieve endoscopic remission at Week 16
Time frame: At Week 16
Endoscopic remission is defined as an mMES of 0.
Secondary outcome
Proportion of participants who achieve endoscopic remission at Week 52
Time frame: At Week 52
Endoscopic remission is defined as an mMES of 0.
Secondary outcome
Proportion of participants who achieve clinical remission by total Mayo Score (MS) at Week 16
Time frame: At Week 16
Clinical remission is defined as total MS ≤2 with no subscore \>1. The total Mayo score (MS) 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 who achieve clinical remission by total Mayo Score (MS) at Week 52
Time frame: At Week 52
Clinical remission is defined as total MS ≤2 with no subscore \>1.
Secondary outcome
Proportion of participants who achieve clinical response by total MS at Week 16
Time frame: At Week 16
Clinical response by total MS is defined as a decrease from baseline in the total MS of ≥3 points and at least 30% reduction from baseline, and a decrease in the RB subscore of ≥1 or an absolute RB subscore of 0 or 1.
Secondary outcome
Proportion of participants who achieve clinical response by total MS at Week 52
Time frame: At Week 52
Clinical response by total MS is defined as a decrease from baseline in the total MS of ≥3 points and at least 30% reduction from baseline, and a decrease in the RB subscore of ≥1 or an absolute RB subscore of 0 or 1.
Secondary outcome
Proportion of participants who achieve clinical response by mMS at Week 16
Time frame: At Week 16
Clinical response by 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 RB subscore ≥1 or an absolute RB subscore ≤1.
Secondary outcome
Proportion of participants who achieve clinical response by mMS at Week 52
Time frame: At Week 52
Clinical response by 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 RB subscore ≥1 or an absolute RB subscore ≤1.
Secondary outcome
Proportion of participants who achieve clinical remission by mMS at Week 52
Time frame: At Week 52
Clinical remission is defined as an mMS score of 0 to 2, including SF subscore of 0 or 1, RB subscore of 0, and mMES of 0 or 1 (score of 1 does not include friability).
Secondary outcome
Change from baseline in PRO-2 (Patient Reported Outcome) total score (SF and RB)
Time frame: From Baseline to Week 16 and up to End of Study (approximately 164 weeks)
PRO-2 (Patient Reported Outcome) score is defined as the sum of Mayo SF and RB subscores.
Secondary outcome
Change from baseline in mMS (SF, RB, and mMES)
Time frame: From Baseline to Week 16 and up to End of Study (approximately 164 weeks)
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
Change from baseline in Partial Mayo Score (PMS) (SF, RB, and Physician's Global Assessment [PGA])
Time frame: From Baseline to Week 16 and up to End of Study (approximately 164 weeks)
The Partial Mayo Score (PMS) includes the SF, RB, and PGA components. It ranges from 0 to 9 with higher score indicating highest severity.
Secondary outcome
Proportion of participants who achieve histological improvement by Original Geboes Score (OGS) to assess inflammation in UC
Time frame: At Week 16
Histological improvement is defined as OGS ≤3.1. Original Geboes Score (OGS) is a 6-grade classification system that assesses inflammation severity. Each grade includes subgrades for more specific histological features. Assessment uses the worst area of the biopsy rather than the average. Higher grades indicate greater inflammatory activity in the colon.
Secondary outcome
Proportion of participants who achieve histological remission by Robarts Histopathology Index (RHI)
Time frame: At Week 16
Histological remission is defined as RHI ≤3. The Robarts Histopathology Index (RHI) assesses 4 characteristics of mucosal activity, inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration, all of which are rated on a scale of 0 to 3. Each characteristic is weighted to produce a total score ranging from 0 (no disease activity) to 33 (most severe disease activity).
Secondary outcome
Proportion of participants who achieve histological remission by OGS to assess inflammation in UC
Time frame: At Week 16
Histological remission is defined as OGS \<2B.1.
Secondary outcome
Proportion of participants who achieve Histologic Endoscopic Mucosal Improvement (HEMI)
Time frame: At Week 16
HEMI is defined by achievement of modified Mayo endoscopic improvement (mMES of 0 or 1 where 1 does not include friability) and histologic improvement (OGS ≤3.1).
Secondary outcome
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: From Baseline to Week 16
This captures the patient's experience of inflammatory bowel disease (IBD) on 4 domains of functioning and well-being: bowel and systemic symptoms and emotional and social function. The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item instrument assessing health-related quality of life in IBD patients across four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Each question evaluates experiences over the previous two weeks on a 7-point Likert scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224, with higher scores indicating better quality of life. Both domain-specific and overall scores can be calculated.
Secondary outcome
Serum SAR442970 concentrations
Time frame: Up to end of study (approximately 164 weeks)
Secondary outcome
Incidence of Anti-drug Antibodies (ADAs)
Time frame: Up to end of study (approximately 164 weeks)
Secondary outcome
Number (percentage) of participants with any Treatment Emergent Adverse Events (TEAEs) during the Induction and Maintenance treatment periods
Time frame: From start of induction period to Week 52
Secondary outcome
Number (percentage) of participants with any TEAEs during the Long-term Extension (LTE) period
Time frame: From Week 52 (start of LTE period) up to end of the study (approximately 164 weeks)
Recruiting locations in the United States
Investigational Site Number: 8400009
RecruitingEscondido, California, 92025, United States
Investigational Site Number: 8400006
RecruitingLancaster, California, 93534, United States
Investigational Site Number: 8400025
RecruitingThousand Oaks, California, 91360, United States
Investigational Site Number: 8400024
RecruitingJacksonville, Florida, 32258, United States
Investigational Site Number: 8400030
RecruitingKissimmee, Florida, 347441, United States
Investigational Site Number: 8400003
RecruitingLighthouse PT, Florida, 33064, United States
Investigational Site Number: 8400001
RecruitingMiami, Florida, 33134, United States
Investigational Site Number: 8400011
RecruitingMiami, Florida, 33136, United States
Investigational Site Number: 8400010
RecruitingPalmetto Bay, Florida, 33176, United States
Investigational Site Number: 8400019
RecruitingTampa, Florida, 33609, United States
Investigational Site Number: 8400018
RecruitingMarietta, Georgia, 30060, United States
Investigational Site Number: 8400005
RecruitingIowa City, Iowa, 52242, United States
Investigational Site Number: 8400017
RecruitingBoston, Massachusetts, 02115, United States
Investigational Site Number: 8400012
RecruitingWyoming, Michigan, 49519, United States
Investigational Site Number: 8400014
RecruitingSt Louis, Missouri, 63110, United States
Investigational Site Number: 8400021
RecruitingNew York, New York, 10029, United States
Investigational Site Number: 8400029
RecruitingQueens Village, New York, 11428, United States
Investigational Site Number: 8400002
RecruitingChapel Hill, North Carolina, 27514, United States
Investigational Site Number: 8400013
RecruitingHarrisburg, Pennsylvania, 17110, United States
Investigational Site Number: 8400023
RecruitingHouston, Texas, 77030, United States
Investigational Site Number: 8400007
RecruitingOgden, Utah, 84405, United States
This study also lists 46 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
- May 16, 2025
- Primary completion
- Dec 17, 2026
- Overall completion
- Oct 17, 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.