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A study to evaluate the effectiveness and safety of duvakitug in patients with moderate to severe Crohn's disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the efficacy and safety of duvakitug in individuals with Crohn’s disease. Crohn’s disease is a type of immune system disease that causes inflammation in the digestive tract. The investigation focuses on how well duvakitug works as a maintenance therapy, which is a treatment used to keep symptoms under control and prevent flares of the disease over a long period.

Participants in the study will receive either duvakitug or a placebo through a subcutaneous injection, which is a shot administered just under the skin. This is a randomized study, meaning participants are assigned to a group by chance, and it is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The study involves monitoring the condition over a period of time to observe how the body responds to the medication.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the <b>maintenance phase</b>

    Administration of either duvakitug or a placebo (an inactive substance that looks like the medication) is performed via subcutaneous injection, which means the medicine is injected into the layer of fat just under the skin.

    The maintenance phase is designed to evaluate how the medicine works to manage Crohn's disease, an immune system disorder that affects the digestive tract.

  2. Step 2

    Monitoring and <b>assessment</b>

    Health status is monitored through various measurements, including clinical remission, which refers to a state where symptoms of the disease are significantly reduced or absent.

    endoscopic response is assessed, which involves using a camera to look inside the digestive tract to check for healing or improvement of the lining.

    Different tools are used to evaluate symptoms, such as the CDAI and PRO-2, which are scores used to measure how the disease affects physical well-being.

    The status of the digestive tract is also measured using the SES-CD, which is a way to grade the severity of inflammation seen during an endoscopy.

    Blood tests may be used to measure the amount of duvakitug in the body and to check for the development of antibodies, which are substances the immune system creates in response to a medication.

  3. Step 3

    Completion of the <b>study period</b>

    The primary observations and evaluations for this phase are conducted up to week 40 of the study.

Who can join the trial?

4 criteria

  • You must be at least 18 years old and no more than 80 years old at the start of the study. In some locations, people aged 16 to 17 may participate if they have reached Tanner stage 5, which is a term used to describe reaching the final stage of physical development during puberty.
  • For the maintenance part of the study, you must have shown a clinical response, meaning your symptoms improved, and you must have finished an endoscopy, which is a medical procedure where a doctor uses a small camera on a flexible tube to look inside your body.
  • For the open-label extension (OLE) part of the study, you must have finished either the maintenance part of this study or a previous specific study.
  • You must have Crohn's Disease (CD), which is a type of long-term inflammation in the digestive tract, that is considered moderately to severely active.

Who cannot join the trial?

2 criteria

  • People who have a medical condition or difficulty following the study rules that the investigator (the doctor leading the study) decides makes them unsuitable to participate.
  • People who have a known hypersensitivity (an extreme allergic reaction) to the study medicine, duvakitug.
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Investigated drugs

Duvakitug is a medication given as an injection under the skin. It is being studied to see if it can help maintain health and manage symptoms in people living with moderately to severely active Crohn’s disease.

What is already known about the treatment

Duvakitug - This medication is administered as a solution through a shot injected under the skin. Currently being studied in late-stage clinical trials, it is being developed to help manage moderately to severely active Crohn’s disease, an immune system disorder. It works at a molecular level by targeting specific parts of the immune response to reduce unwanted inflammation in the digestive tract. It is classified as an investigational biological therapy designed to maintain remission in patients.

Investigated diseases

Crohn's disease - This is a type of inflammatory bowel disease that causes chronic inflammation in the digestive tract. The inflammation can affect any part of the gastrointestinal tract from the mouth to the anus. It often progresses through periods of active symptoms followed by periods of remission. During active stages, the inflammation can lead to the development of ulcers or sores in the lining of the digestive system. Over time, this persistent inflammation may affect the thickness and function of the intestinal walls.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521037-86-00Protocol codeEFC18327Estimated enrolment751 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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