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RecruitingPhase 2

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

Sanofi · NCT06958536

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
99
US sites recruiting
19
Study start
June 3, 2025
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: brivekimig; Placebo

Conditions: Crohn's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
A Study to Investigate Efficacy and Safety of Brivekimig in… (NCT06958536) | Bored Studies