Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

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

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 a medication called duvakitug in people living with Crohn’s Disease. Crohn’s Disease is a type of immune system disease that causes inflammation, or swelling, in the digestive tract. The investigation focuses on individuals experiencing moderate to severe symptoms of this condition.

Participants in the study will receive either duvakitug or a placebo through a subcutaneous injection, which is a method of delivering medication just under the skin. This is an induction study, meaning the goal is to determine how well the treatment can quickly reduce active symptoms and inflammation. The study uses a randomized and double-blind approach, which means participants are assigned to groups by chance, and neither the participants nor the researchers know which specific treatment is being administered during the course of the study.

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

    Study participation and medication administration

    The induction phase begins with the administration of either duvakitug or a placebo. a placebo is a substance that looks like the medication but contains no active medicine.

    The medication, duvakitug, is provided as a solution for injection and is administered via subcutaneous injection, which means it is injected into the fatty tissue just under the skin.

    The induction therapy is conducted to evaluate how the medication works for Crohn's disease, an inflammatory condition of the digestive tract.

  2. Step 2

    Assessment at week 4

    At week 4, a clinical response is evaluated using the Crohn's Disease Activity Index (CDAI). this is a tool used to measure how active the Crohn's disease is based on symptoms.

  3. Step 3

    Assessment at week 12

    At week 12, several evaluations are performed to measure the effectiveness of the treatment.

    The status of the disease is checked for clinical remission. clinical remission means that symptoms are significantly reduced or absent. this is measured using the Crohn's Disease Activity Index (CDAI) and a 2-item patient-reported outcome (PRO-2), which is a simple survey about how the patient feels.

    The condition of the digestive tract is checked through an endoscopic response. an endoscopy is a procedure where a doctor uses a small camera to look inside the body. this is measured using the Simple Endoscopic Score for Crohn's Disease (SES-CD).

    Other measures taken at week 12 include checking for ulcer-free endoscopy, assessing fatigue levels, measuring bowel urgency, and evaluating hospitalization rates related to Crohn's disease.

Who can join the trial?

3 criteria

  • You must be at least 18 years old but no older than 80 years old. In some locations, people aged 16 to 17 may join if they have reached Tanner Stage 5, which is a medical way to describe reaching full physical maturity during puberty.
  • You must have a confirmed diagnosis of Crohn’s Disease, which is a type of long-term inflammation in the digestive tract, that has been moderately to severely active for at least 3 months.
  • You must have previously tried conventional therapies (standard treatments) or advanced therapies (more complex medications) and found that they did not work well enough, stopped working over time, or caused side effects that you could not tolerate.

Who cannot join the trial?

6 criteria

  • People who have Ulcerative Colitis (a type of inflammation in the large intestine) or indeterminate colitis (a condition where doctors cannot tell exactly which type of intestinal inflammation is present).
  • People who are missing entire sections of their intestines, specifically the terminal ileum (the end of the small intestine), the right colon, the transverse colon, the sigmoid colon, the left colon, or the rectum.
  • People who have had or currently have high-grade gastrointestinal dysplasia (a condition where cells in the digestive tract look abnormal and may lead to cancer).
  • People who are taking standard treatments but have not been on a stable dose (a regular, unchanging amount of medicine) before starting the study.
  • People who are using prohibited medications or therapies (medicines or treatments that are not allowed during this study).
  • People who have previously used anti-TL1A investigational therapy (experimental medicines that target a specific protein called TL1A in the body).
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Duvakitug is an experimental medicine given as a shot under the skin. It is being tested to see if it can help reduce symptoms and treat inflammation in people with moderately to severely active Crohn’s disease.

What is already known about the treatment

Duvakitug - This medication is an experimental drug delivered via a shot under the skin and is currently being studied in late-stage clinical trials to treat moderately to severely active Crohn’s disease. It belongs to a class of drugs designed to calm an overactive immune system, which is often responsible for causing inflammation in the digestive tract. At a molecular level, it works by targeting and blocking specific proteins that trigger the body's inflammatory response, thereby helping to reduce swelling and tissue damage. Although it is not yet widely available for general use, researchers are investigating its ability to help patients achieve remission.

Investigated diseases

Crohn's disease - This is a type of chronic inflammation that affects the digestive tract. It can involve any part of the gastrointestinal tract from the mouth to the anus. The condition often progresses through periods of inflammation that can cause swelling and sores in the lining of the digestive system. Over time, this inflammation may lead to the formation of narrow areas or deep wounds in the intestinal walls. The severity and location of the inflammation can vary significantly between different individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521036-11-00Protocol codeEFC18326Estimated enrolment1 935 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).