RECRUITING

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Description

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

Conditions

Crohn's Disease
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Related Conditions:

Crohn's Disease

Study Overview

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Study Details

Study overview

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

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

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

Lancaster

Gastro Care Institute - Site Number: 8400001, Lancaster, California, United States, 93534

Lighthouse Point

Alliance Medical Research LLC - Site Number: 8400015, Lighthouse Point, Florida, United States, 33064

Palmetto Bay

Tropical Clinical Trials - Site Number: 8400011, Palmetto Bay, Florida, United States, 33176

Wyoming

Gastroenterology Associates of Western Michigan - Site Number: 8400008, Wyoming, Michigan, United States, 49519

Harrisburg

Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400009, Harrisburg, Pennsylvania, United States, 17110

Fredericksburg

Gastroenterology Research of America, LLC. - Site Number: 8400002, Fredericksburg, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2029-10-17