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

In plain English

What this trial is testing

This study is testing brivekimig (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 75
• Any sex

Some of the main requirements, copied from the record:

• 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),…
• 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

There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 99 participants are expected to take part.
• The study has 3 groups.
• Start date: 2025-06-03.
• Main results expected around 2026-12-17 (estimate from the record).
• 66 study sites listed (64 marked recruiting) in Australia, Belgium, China, Czechia and France and 7 more countries.

Groups in this study

• Brivekimig Dose Regimen A (listed as: experimental group)
• Brivekimig Dose Regimen B (listed as: experimental group)
• Placebo (listed as: placebo group)

Main thing being measured

• Percentage of participants who achieve endoscopic response at Week 16 (From Baseline to Week 16)

In the researchers’ words

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…

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.