Clinical trial NCT06958536: A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR442970 in Adults With Moderate to Severe Crohn's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-05-06
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2, 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 and the treatment duration is up to 158 weeks


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening
* Confirmed diagnosis of moderate-to-severe CD
* 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 therapies
* 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.)
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria:

* Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome
* Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
* Participants with following ongoing known complications of CD:

  * Any manifestation that might require bowel surgery while enrolled in the study
  * Participant with ostomy or ileoanal pouch
  * Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome
  * Participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resections
* History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Primary outcomes:
measure: Percentage of participants who achieve endoscopic response at Week 16
timeFrame: From Baseline to Week 16
Secondary outcomes:
measure: Percentage of participants who achieve clinical remission based on Crohn's Disease Activity Index (CDAI) at Week 16
timeFrame: At Week 16
measure: Percentage of participants who achieve PRO-2 (Patient Reported Outcome) clinical remission at Week 16
timeFrame: At Week 16
measure: Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 16
timeFrame: At Week 16
measure: Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 16
timeFrame: At Week 16
measure: Percentage of participants who achieve CDAI clinical response at Week 16
timeFrame: At Week 16
measure: Change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score
timeFrame: From Baseline to Week 16
measure: Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score
timeFrame: From Baseline to Week 16
measure: On-treatment serum concentrations of SAR442970 at predefined timepoints
timeFrame: Up to End of Study (approximately 164 weeks)
measure: Number and percentage of participants with any Treatment Emergent Adverse Events (TEAEs) during induction, maintenance and Long-term Extension (LTE) treatment period
timeFrame: Up to End of Study (approximately 164 weeks)
measure: Number and percentage of participants with any TEAEs during open-label treatment period
timeFrame: Up to Week 52
measure: Incidence of Anti-drug Antibodies (ADAs) over time
timeFrame: Up to End of Study (approximately 164 weeks)
measure: Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 52
timeFrame: At Week 52
measure: Percentage of participants achieving CDAI clinical remission at Week 52
timeFrame: At Week 52
measure: Percentage of participants achieving CDAI clinical remission at both Week 16 and at Week 52
timeFrame: At Week 52
measure: Percentage of participants who achieve endoscopic response at Week 52
timeFrame: At Week 52
measure: Percentage of participants who achieve endoscopic response at both Week 16 and Week 52
timeFrame: At Week 52
measure: Percentage of participants who achieve CDAI clinical response at Week 52
timeFrame: At Week 52
measure: Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 52
timeFrame: At Week 52
Other outcomes:
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