Crohn's Disease
SAR442970 Dose Study for Adults With Moderate-to-Severe Crohn’s Disease
This phase 2 study is evaluating the efficacy and safety of two subcutaneous SAR442970 dose regimens compared with placebo in adults with moderate-to-severe Crohn’s disease.
Registry title: A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
20 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 efficacy and safety in adults with moderate-to-severe Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75.
- The study is looking for people diagnosed with Crohn’s disease at least three months before screening.
- The study is looking for people with confirmed moderate-to-severe Crohn’s disease.
- The study is looking for people who previously had an inadequate response, loss of response, or intolerance to at least one standard or advanced therapy.
- The study lists recruiting locations in the United States and several other countries, but the study team must confirm current local availability.
Participation overview
What participation may involve
Participants receive subcutaneous SAR442970 or placebo and undergo assessments of Crohn’s disease activity, endoscopic findings, symptoms, quality of life, fatigue, drug levels, antibodies, and adverse events. What participation may involve: - Receive subcutaneous SAR442970 under dose regimen A or B, or receive subcutaneous placebo. - Undergo ileocolonoscopy-based assessments scored with the Simple Endoscopic Score for Crohn’s Disease and read centrally. - Complete symptom and disease-activity assessments, including the Crohn’s Disease Activity Index and a two-item patient-reported outcome based on stool frequency and abdominal pain. - Complete questionnaires about inflammatory bowel disease-related quality of life and fatigue. - Provide samples for measurement of SAR442970 serum concentrations and anti-drug antibodies, and undergo monitoring for treatment-emergent adverse events. The total study duration is up to 168 weeks, including up to 158 weeks of treatment and an open-label long-term extension of up to 104 weeks for eligible participants.
Study interventions
What participants may receive or do
- SAR442970: Participants assigned to an experimental group receive SAR442970 by subcutaneous administration using either dose regimen A or dose regimen B.
- Placebo: Participants assigned to the placebo comparator group receive placebo by subcutaneous administration.
Study design
How the comparison works
This is a phase 2, three-group, parallel study comparing two SAR442970 dose regimens with placebo in an estimated 99 participants. Participants are assigned at random to one of the three study groups; the registry does not report the assignment ratio. The registry describes quadruple masking: participants, care providers, investigators, and outcome assessors are masked. The placebo group serves as the control for comparison with the two SAR442970 dose groups. One group receives subcutaneous placebo, but the registry does not state the chance of assignment or whether it is matched to SAR442970 in appearance and schedule.
Reported activities
Procedures and tests
- Subcutaneous administration of SAR442970 or placebo.
- Ileocolonoscopy and central scoring with the Simple Endoscopic Score for Crohn’s Disease at baseline and Week 16, with additional endoscopic outcomes assessed at Week 52.
- Crohn’s Disease Activity Index assessments incorporating seven days of symptoms, complications, antidiarrheal use, abdominal mass, hematocrit, and body weight.
- Patient-reported stool-frequency and abdominal-pain assessment.
- The 32-item Inflammatory Bowel Disease Questionnaire covering bowel and systemic symptoms, emotional function, and social function.
- The 13-item Functional Assessment of Chronic Illness Therapy–Fatigue questionnaire.
- Blood sampling to measure SAR442970 serum concentrations.
- Testing for anti-drug antibodies over time.
- Monitoring for treatment-emergent adverse events during the study’s treatment periods.
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
- Crohn’s disease must have been diagnosed at least three months before screening.
- The diagnosis must be confirmed as moderate-to-severe Crohn’s disease.
- Participants must have prior exposure to a listed standard or advanced therapy and have had an inadequate response, loss of response, or intolerance to at least one therapy.
- Any listed standard treatment being used before screening must be at a stable dose.
- Men and women must follow local clinical-study contraception requirements.
- The registry limits enrollment to people ages 18 through 75.
Possible reasons someone may not be able to join
- Active ulcerative colitis, indeterminate colitis, unremoved adenomatous colon polyps, colonic mucosal dysplasia, or short bowel syndrome are exclusions.
- Crohn’s disease isolated to the stomach, duodenum, jejunum, or perianal region without colonic or ileal involvement is excluded.
- A Crohn’s disease manifestation that might require bowel surgery during the study is an exclusion.
- People with an ostomy or ileoanal pouch are excluded.
- Conditions that could interfere with drug absorption, including short bowel syndrome, are exclusions.
- Bowel resection within three months before screening or a history of more than three bowel resections is an exclusion.
- The investigator may exclude someone if another condition is judged to make study participation risky.
Important unknowns
What the record does not make clear
- The registry does not provide the number, frequency, length, or format of study visits.
- Three study groups are listed, but their assignment ratio and each participant’s probability of receiving placebo are not reported.
- The criteria require stable doses of listed standard treatments before screening, but the registry does not explain which treatments may continue or change after enrollment.
- The registry does not provide washout rules or timing for previous standard or advanced therapies.
- The registry does not describe rescue treatment if Crohn’s disease worsens.
- Endoscopic outcomes are reported at baseline, Week 16, and Week 52, but preparation, sedation, biopsy requirements, and whether further endoscopies occur are not described.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report compensation for time or expenses.
- The registry does not describe reimbursement or support for transportation, lodging, meals, or a companion.
- The registry does not state whether any visits or assessments can occur remotely or through a local clinician.
- The registry does not explain whether SAR442970 may remain available after study treatment ends.
- The overall study and listed sites are marked recruiting, but the registry does not confirm whether a particular site currently has space or whether all cohorts are open.
Before contacting the site
Questions for the study team
- What is the randomization ratio, and what is the chance of receiving placebo during the masked period?
- What is the complete visit schedule, including visit length and which visits require travel to the study site?
- How many ileocolonoscopies are required, and what preparation, sedation, and biopsies are involved?
- Which current Crohn’s disease treatments may continue, and are any washout periods or dose changes required?
- What happens if Crohn’s disease worsens, including available rescue treatment and rules for leaving the assigned treatment?
- What determines eligibility for the open-label long-term extension, and what treatment is given during that period?
- Which study-related costs are covered, and are compensation, travel reimbursement, or lodging support available?
- Is my nearest listed site currently enrolling, and can any assessments be completed remotely or with my local clinician?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what clinical changes would make a placebo-controlled study especially concerning in my case?
- Which of my current treatments should remain unchanged while I ask the study team about screening, and what risks could interruption or washout create?
- What approved treatment alternatives are reasonable for me at this point, given my previous responses and intolerances?
- Do my disease location, prior bowel surgeries, anatomy, or current complications raise concerns about screening or study participation?
- How should you and the research team coordinate monitoring, test results, medication decisions, and care if my disease worsens?
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 Crohn's disease. 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 Crohn's disease. 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
- DRI18450
- 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
Placebo Comparator
Placebo
Participants will receive 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 (5)
- Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screeningRegistry-derived · unreviewed
- Confirmed diagnosis of moderate-to-severe CDRegistry-derived · unreviewed
- History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs), steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (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, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.)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 studiesRegistry-derived · unreviewed
Exclusion criteria (9)
- Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndromeRegistry-derived · unreviewed
- Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvementRegistry-derived · unreviewed
- Participants with following ongoing known complications of CD:Registry-derived · unreviewed
- Any manifestation that might require bowel surgery while enrolled in the studyRegistry-derived · unreviewed
- Participant with ostomy or ileoanal pouchRegistry-derived · unreviewed
- Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndromeRegistry-derived · unreviewed
- Participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resectionsRegistry-derived · unreviewed
- History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the studyRegistry-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
Percentage of participants who achieve endoscopic response at Week 16
Time frame: From Baseline to Week 16
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. 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. 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
Percentage of participants who achieve clinical remission based on Crohn's Disease Activity Index (CDAI) at Week 16
Time frame: At Week 16
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
Percentage of participants who achieve PRO-2 (Patient Reported Outcome) clinical remission at Week 16
Time frame: At Week 16
PRO-2 clinical remission is defined as using the average daily Stool Frequency (SF) ≤3 and not worse than baseline and average daily AP ≤1 and not worse than baseline.
Secondary outcome
Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 16
Time frame: At Week 16
Endoscopic remission is defined as SES-CD ≤4 and at least 2 point reduction versus baseline and no subscore \>1 in any individual variable based on central reading.
Secondary outcome
Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 16
Time frame: At Week 16
CDAI clinical remission is defined as CDAI score \<150, endoscopic response is defined as a decrease in SES-CD \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading.
Secondary outcome
Percentage of participants who achieve CDAI clinical response at Week 16
Time frame: At Week 16
CDAI clinical response is defined as reduction of CDAI ≥100 points from baseline.
Secondary outcome
Change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score
Time frame: From Baseline to Week 16
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
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score
Time frame: From Baseline to Week 16
The FACIT-F questionnaire assesses fatigue associated with anemia through 13 fatigue-related questions. Each item is scored on a 5-point Likert scale (0="not at all" to 4="very much"), with total scores ranging from 0 to 52. High scores represent less fatigue. For Crohn's Disease patients, a 7-10 point improvement on the FACIT-F total score may represent meaningful improvements.
Secondary outcome
On-treatment serum concentrations of SAR442970 at predefined timepoints
Time frame: Up to End of Study (approximately 164 weeks)
Secondary outcome
Number and percentage of participants with any Treatment Emergent Adverse Events (TEAEs) during induction, maintenance and Long-term Extension (LTE) treatment period
Time frame: Up to End of Study (approximately 164 weeks)
Secondary outcome
Number and percentage of participants with any TEAEs during open-label treatment period
Time frame: Up to Week 52
Secondary outcome
Incidence of Anti-drug Antibodies (ADAs) over time
Time frame: Up to End of Study (approximately 164 weeks)
Secondary outcome
Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 52
Time frame: At Week 52
Endoscopic remission is defined as SES-CD ≤4 and at least 2 point reduction versus baseline and no subscore \>1 in any individual variable based on central reading.
Secondary outcome
Percentage of participants achieving CDAI clinical remission at Week 52
Time frame: At Week 52
CDAI clinical remission is defined as CDAI \<150.
Secondary outcome
Percentage of participants achieving CDAI clinical remission at both Week 16 and at Week 52
Time frame: At Week 52
CDAI clinical remission is defined as CDAI \<150.
Secondary outcome
Percentage of participants who achieve endoscopic response at Week 52
Time frame: At Week 52
Endoscopic response is defined as decrease in SES-CD \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading.
Secondary outcome
Percentage of participants who achieve endoscopic response at both Week 16 and Week 52
Time frame: At Week 52
Endoscopic response is defined as decrease in SES-CD \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading.
Secondary outcome
Percentage of participants who achieve CDAI clinical response at Week 52
Time frame: At Week 52
CDAI clinical response is defined as reduction of CDAI ≥100 points from baseline.
Secondary outcome
Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 52
Time frame: At Week 52
CDAI clinical remission is defined as CDAI score \<150, endoscopic response is defined as a decrease in SES-CD \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading.
Recruiting locations in the United States
Investigational Site Number: 8400024
RecruitingTucson, Arizona, 85724, United States
Investigational Site Number: 8400005
RecruitingEscondido, California, 92025, United States
Investigational Site Number: 8400001
RecruitingLancaster, California, 93534, United States
Investigational Site Number: 8400017
RecruitingKissimmee, Florida, 34741, United States
Investigational Site Number: 8400015
RecruitingLighthouse PT, Florida, 33064, United States
Investigational Site Number: 8400012
RecruitingMiami, Florida, 33136, United States
Investigational Site Number 8400028
RecruitingMiami, Florida, 33134, United States
Investigational Site Number: 8400007
RecruitingOrlando, Florida, 32804, United States
Investigational Site Number: 8400011
RecruitingPalmetto Bay, Florida, 33176, United States
Investigational Site Number: 8400019
RecruitingMarietta, Georgia, 30060, United States
Investigational Site Number: 8400025
RecruitingIowa City, Iowa, 52242, United States
Investigational Site Number: 8400006
RecruitingKansas City, Kansas, 66160, United States
Investigational Site Number: 8400022
RecruitingBoston, Massachusetts, 02115, United States
Investigational Site Number: 8400008
RecruitingWyoming, Michigan, 49519, United States
Investigational Site Number: 8400013
RecruitingSt Louis, Missouri, 63110, United States
Investigational Site Number: 8400003
RecruitingChapel Hill, North Carolina, 27599, United States
Investigational Site Number: 8400009
RecruitingHarrisburg, Pennsylvania, 17110, United States
Investigational Site Number: 8400002
RecruitingFredericksburg, Texas, 78229, United States
Investigational Site Number: 8400016
RecruitingOgden, Utah, 84405, United States
Investigational Site Number: 8400027
RecruitingRichmond, Virginia, 23249, 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 6, 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.