Crohn's Disease study: Brivekimig
Official title A Study to Investigate Efficacy and Safety of Brivekimig in Participants With Crohn's Disease
ClinicalTrials.gov ID: NCT06958536
What this study is testing
What is SAR442970?
an investigational subcutaneous injectable medicine 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
- The study aims to find out whether SAR442970 is effective and safe at two dose levels compared with placebo.
- Who it's for
- Adults who have moderate to severe Crohn's disease.
- What's involved
- Participants are randomly assigned to one of three groups (two dose levels or placebo) in a double‑blind setup and receive the study medication with regular clinic visits and tests.
- Time commitment
- Up to 158 weeks of treatment (about 3 years) with a total study period of up to 168 weeks, plus an optional long‑term extension of up to 104 weeks for eligible participants.
- 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
- 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 and having inadequate response to, loss of response to or intolerance to standard therapy with any of...
- On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or 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...
You likely can't join if
- Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or...
- Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
- 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
See the full 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 and having inadequate response to, loss of response to or intolerance to standard therapy with any of the following compounds: (5-Amino Salicylates (5-ASAs)...
- On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Fairhope, Alabama, United States
- Tucson, Arizona, United States
- Escondido, California, United States
- Lancaster, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Kissimmee, Florida, United States
- Lighthouse PT, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Palmetto Bay, Florida, United States
- Marietta, Georgia, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Wyoming, Michigan, United States
- St Louis, Missouri, United States
- Harrisburg, Pennsylvania, United States
- Fredericksburg, Texas, United States
- Houston, Texas, United States
+ 47 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, but 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?
This study is enrolling now at Fairhope, Alabama, United States; Tucson, Arizona, United States; Escondido, California, United States; Lancaster, California, United States; San Diego, California, United States; Colorado Springs, Colorado, United States and 61 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.