Recruiting
Phase 2

SAR442970

Sponsor:

Sanofi

Code:

NCT06958536

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

brivekimig

Placebo

Study Details

Brief summary:

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.

Conditions

Crohn's Disease

Study ID

NCT06958536

Start date

Jun 3, 2025

Status verified date

Oct, 2026

Completion date

Oct 17, 2029

Anticipated

Primary completion date

Dec 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

99 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brivekimig Dose Regimen A

Participants will receive brivekimig dose regimen A

experimental: Brivekimig Dose Regimen B

Participants will receive brivekimig dose regimen B

placebo comparator: Placebo

Participants will receive placebo

Interventions

brivekimig

Route of Administration: Subcutaneous

Placebo

Route of Administration: Subcutaneous

Primary outcome measure

  • Percentage of participants who achieve endoscopic response at Week 16 [ Time Frame: From Baseline to Week 16 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

Investigational Site Number: 8400024

Recruiting

Tucson, Arizona, United States, 85724

Investigational Site Number: 8400005

Recruiting

Escondido, California, United States, 92025

Investigational Site Number: 8400001

Recruiting

Lancaster, California, United States, 93534

Investigational Site Number: 8400017

Recruiting

Kissimmee, Florida, United States, 34741

Investigational Site Number: 8400015

Recruiting

Lighthouse PT, Florida, United States, 33064

Investigational Site Number 8400028

Recruiting

Miami, Florida, United States, 33134

Investigational Site Number: 8400012

Recruiting

Miami, Florida, United States, 33136

Investigational Site Number: 8400007

Recruiting

Orlando, Florida, United States, 32804

Investigational Site Number: 8400011

Recruiting

Palmetto Bay, Florida, United States, 33176

Investigational Site Number: 8400019

Recruiting

Marietta, Georgia, United States, 30060

Investigational Site Number: 8400025

Recruiting

Iowa City, Iowa, United States, 52242

Investigational Site Number: 8400006

Recruiting

Kansas City, Kansas, United States, 66160

Investigational Site Number: 8400022

Recruiting

Boston, Massachusetts, United States, 02115

Investigational Site Number: 8400008

Recruiting

Wyoming, Michigan, United States, 49519

Investigational Site Number: 8400013

Recruiting

St Louis, Missouri, United States, 63110

Investigational Site Number: 8400009

Recruiting

Harrisburg, Pennsylvania, United States, 17110

Investigational Site Number: 8400002

Recruiting

Fredericksburg, Texas, United States, 78229

Investigational Site Number: 8400016

Recruiting

Ogden, Utah, United States, 84405

Investigational Site Number: 8400027

Recruiting

Richmond, Virginia, United States, 23249

More Information

Sponsor

Sanofi

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.