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Tests treatment safety and results for Ulcerative Colitis
Official title A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
ClinicalTrials.gov ID: NCT06975722
What this study is testing
What is SAR442970?
SAR442970 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for ulcerative colitis.
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 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis. 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 Ulcerative Colitis.
- 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 inclusive, at the time of signing the informed consent
- Participants who have had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
- Must have active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician Global Assessment...
- Must have received prior treatment for UC (either "a" or "b" below or combination of both):
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Participants with active Crohn's Disease (CD), indeterminate colitis or microscopic colitis
- Participants with fecal sample positive for culture/ova for aerobic pathogens or positive for Clostridium difficile B toxin in stools
- Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in the study
- Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic dysplasia except for adenoma
- Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition
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 inclusive, at the time of signing the informed consent
- Participants who have had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
- Must have active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician Global Assessment (PGA), with a minimum Rectal Bleeding (RB) subscore ≥1, a minimum Stool...
- Must have received prior treatment for UC (either "a" or "b" below or combination of both):
- History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or...
- History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent used to treat UC or advanced small molecules used to treat UC
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Participants are excluded from the study if any of the following criteria apply:
- Participants with active Crohn's Disease (CD), indeterminate colitis or microscopic colitis
- Participants with fecal sample positive for culture/ova for aerobic pathogens or positive for Clostridium difficile B toxin in stools
- Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in the study
- Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic dysplasia except for adenoma
- Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition
- History of recurrent or recent serious infection within 4 weeks of screening, or infection(s) requiring hospitalization or treatment with IV anti-infectives within 30 days prior to baseline, or infections(s) requiring...
- Known history of or suspected significant current immunosuppression.
- History or solid organ transplant or splenectomy
- History of moderate to severe congestive heart failure (New York Health Association Class III or IV), or recent cerebrovascular accident.
- History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
- Participants with a history of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell...
- Participants with a diagnosis of inflammatory conditions other than UC (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, primary biliary cirrhosis, multiple...
- History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at Screening
- History of Interstitial Lung Disease
- Participants with any of the following results at Screening:
- Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,
- Positive total Hepatitis B core antibody (anti-HBc) confirmed by positive Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) or,
- Positive Hepatitis C Virus (HCV) antibody
- Screening laboratory and other analyses showing abnormal results
- History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol The above information is not intended to contain all considerations relevant...
The study team makes the final eligibility decision.
Where it's taking place
- Escondido, California, United States
- Lancaster, California, United States
- Thousand Oaks, California, United States
- Jacksonville, Florida, United States
- Kissimmee, Florida, United States
- Lighthouse PT, Florida, United States
- Miami, Florida, United States
- Palmetto Bay, Florida, United States
- Tampa, Florida, United States
- Marietta, Georgia, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Wyoming, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Queens Village, New York, United States
- Chapel Hill, North Carolina, United States
- Harrisburg, Pennsylvania, United States
- Houston, Texas, United States
- Ogden, Utah, United States
+ 43 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 Escondido, California, United States; Lancaster, California, United States; Thousand Oaks, California, United States; Jacksonville, Florida, United States; Kissimmee, Florida, United States; Lighthouse PT, Florida, United States and 57 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.