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RecruitingPhase 2

A Study to Investigate Efficacy and Safety of Brivekimig in Participants With Crohn's Disease

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Brivekimig in Adults With Moderate to Severe Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 168 weeks, 158 weeks, 104 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well different doses of brivekimig (SAR442970) work and how safe they are compared with a placebo, a treatment with no active drug. It is for people with moderate to severe Crohn’s disease whose past treatment did not help enough, stopped helping, or caused side effects they could not tolerate. The study may last up to 168 weeks.

This is a phase 2, 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have had a Crohn’s disease diagnosis for at least 3 months before screening.
  • Your Crohn’s disease is confirmed to be moderate to severe.
  • At least one standard Crohn’s treatment did not help enough, stopped helping, or caused side effects you could not tolerate.
  • Your doses of standard treatments have been stable before screening.
  • Any birth control use must follow local rules for people in clinical studies.

Who can't join

  • You have active ulcerative colitis or colitis of an unclear type—other forms of bowel inflammation.
  • You have certain colon growths called adenomatous polyps that have not been removed, or abnormal cells in the colon lining.
  • Your Crohn’s affects only the stomach, upper or middle small bowel, or area around the anus, but not the colon or end of the small bowel.
  • You have a Crohn’s complication that may need bowel surgery during the study.
  • You have an ostomy, a surgical opening for waste, or an ileoanal pouch, an internal pouch made from bowel.
  • You have short bowel syndrome or another condition that may affect how your body absorbs medicine.
  • You had part of your bowel removed within 3 months before screening, or have had more than 3 bowel removal surgeries.
  • You have another condition that the study doctor thinks would make joining unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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), 6-Mercaptopurine (6-MP), Azathioprine (AZA), Methotrexate (MTX), oral or corticosteroids 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, 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 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.

Study sites (20)

AZ

CA

FL

GA

IA

KS

MA

MI

MO

NC

PA

TX

UT

VA