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Tests treatment safety and results for Crohn's Disease
Official title A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
ClinicalTrials.gov ID: NCT06637631
What this study is testing
What is SAR441566?
SAR441566 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for crohn's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female participants aged 18 to 75 years at the time of signing the ICF
- Confirmed diagnosis of CD for at least 3 months prior to Baseline
- Confirmed diagnosis of moderate to severe CD as assessed by:
- Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Participants with active UC, indeterminate colitis or short bowel syndrome
- Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
- Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon...
- Participants with stool sample positive for infectious pathogens
- Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
See the full eligibility criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female participants aged 18 to 75 years at the time of signing the ICF
- Confirmed diagnosis of CD for at least 3 months prior to Baseline
- Confirmed diagnosis of moderate to severe CD as assessed by:
- Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader
- stool frequency (SF), abdominal pain (AP) score
- History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or...
- On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or...
- Participants are excluded from the study if any of the following criteria apply:
- Participants with active UC, indeterminate colitis or short bowel syndrome
- Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
- Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of \> 3...
- Participants with stool sample positive for infectious pathogens
- Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
- Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit
- Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
- Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
- Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
- History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit
- Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit
- Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
- Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
- Participants who received fecal microbial transplantation within 30 days prior to screening
- Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
- Participants who received IV corticosteroids within 14 days prior to screening or during screening period
- Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
- Screening laboratory and other analyses show abnormal results The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Sun City, Arizona, United States
- Bristol, Connecticut, United States
- Clermont, Florida, United States
- Homestead, Florida, United States
- Kissimmee, Florida, United States
- Miami Lakes, Florida, United States
- Tampa, Florida, United States
- Glenview, Illinois, United States
- Gurnee, Illinois, United States
- Ann Arbor, Michigan, United States
- Flowood, Mississippi, United States
- Las Vegas, Nevada, United States
- Queens Village, New York, United States
- Greenville, North Carolina, United States
- Uniontown, Pennsylvania, United States
- Charleston, South Carolina, United States
- Katy, Texas, United States
- Southlake, Texas, United States
- Tacoma, Washington, United States
- San Miguel de Tucumán, Tucumán Province, Argentina
+ 92 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sun City, Arizona, United States; Bristol, Connecticut, United States; Clermont, Florida, United States; Homestead, Florida, United States; Kissimmee, Florida, United States; Miami Lakes, Florida, United States and 106 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.