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Taking people in CzechiaPhase 2

Brivekimig versus a dummy drug for people with Crohn's disease

Tests several doses of brivekimig in adults with Crohn's disease.

Key facts

Who runs it
Sanofi
Where
Brno-Zidenice, České Budějovice, Hradec Králové, Olomouc, and Slaný, CzechiaSee the 5 sitesAlso in 11 other countries, 78 sites
Trial code
Registry title
A Study to Investigate Efficacy and Safety of Brivekimig in Participants With Crohn's Disease
Status
Recruiting
Phase
Phase 2
People taking part
99 people, planned
Started
3 Jun 2025
Expected to end
17 Oct 2029
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • brivekimig
  • Placebo
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe Crohn's disease who have already tried standard treatment without enough benefit.

Age
18 Years to 75 Years
Sex
All sexes can join.
Disease stage
Crohn's disease diagnosed at least 3 months before screening, confirmed as moderate to severe.
Earlier treatment
Must have had an inadequate response, loss of response or intolerance to at least one standard therapy (5-ASAs, 6-MP, azathioprine, methotrexate, corticosteroids, or biologics or small molecules). Must be on stable doses of standard treatments before screening.

Main reasons for not taking part

  • Active ulcerative colitis, indeterminate colitis, or short bowel syndrome
  • Crohn's disease only in the stomach, duodenum, jejunum or perianal region
  • Ostomy or ileoanal pouch
  • Bowel surgery within the past 3 months, or more than 3 bowel resections
  • Any complication that might need bowel surgery during the study

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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
  • Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Czechia

Also in 11 other countries, 78 sites

  • Vojenska Nemocnice BrnoBrno-Zidenice, CzechiaTaking people
  • Nemocnice České Budějovice, a.s.České Budějovice, CzechiaTaking people
  • Hepato-Gastroenterologie HK, s.r.o.Hradec Králové, CzechiaTaking people
  • PreventaMed, s.r.o.Olomouc, CzechiaTaking people
  • Nemocnice SlanySlaný, CzechiaTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Brivekimig Dose Regimen ATreatment being tested

    Participants will receive brivekimig dose regimen A

    Treatment: brivekimig

  • Brivekimig Dose Regimen BTreatment being tested

    Participants will receive brivekimig dose regimen B

    Treatment: brivekimig

  • PlaceboPlacebo, for comparison

    Participants will receive placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Brivekimig versus a dummy drug for people with Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06958536, who can take part
Record updated
2 November 2026