RECRUITINGPhase 2INTERVENTIONAL
A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
SAR442970
Route of Administration: Subcutaneous
DRUG
Placebo
Route of Administration: Subcutaneous
Locations (20)
Investigational Site Number: 8400024
Tucson, Arizona, United States
Investigational Site Number: 8400005
Escondido, California, United States
Investigational Site Number: 8400001
Lancaster, California, United States
Investigational Site Number: 8400017
Kissimmee, Florida, United States
Investigational Site Number: 8400015
Lighthouse PT, Florida, United States
Investigational Site Number 8400028
Miami, Florida, United States
Investigational Site Number: 8400012
Miami, Florida, United States
Investigational Site Number: 8400007
Orlando, Florida, United States
Investigational Site Number: 8400011
Palmetto Bay, Florida, United States
Investigational Site Number: 8400019
Marietta, Georgia, United States
Investigational Site Number: 8400025
Iowa City, Iowa, United States
Investigational Site Number: 8400006
Kansas City, Kansas, United States
Investigational Site Number: 8400022
Boston, Massachusetts, United States
Investigational Site Number: 8400008
Wyoming, Michigan, United States
Investigational Site Number: 8400013
St Louis, Missouri, United States
Investigational Site Number: 8400003
Chapel Hill, North Carolina, United States
Investigational Site Number: 8400009
Harrisburg, Pennsylvania, United States
Investigational Site Number: 8400002
Fredericksburg, Texas, United States
Investigational Site Number: 8400016
Ogden, Utah, United States
Investigational Site Number: 8400027
Richmond, Virginia, United States