Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

A study comparing vedolizumab, filgotinib, ustekinumab, and infliximab to maintain remission in patients with ulcerative colitis

Verified siteRegistered drugNo 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 focuses on Ulcerative Colitis, a disease that causes inflammation and sores in the lining of the large intestine. The purpose of the study is to compare different types of advanced medicines used to keep the disease in a state of remission, which means a period where symptoms are minimal or absent. The medications being studied include ustekinumab, infliximab, filgotinib, and vedolizumab.

The treatments involve different methods of delivery. Some medicines, such as infliximab, ustekinumab, and vedolizumab, are given through intravenous infusion, which is a process where medicine is delivered directly into a vein. Another medicine, filgotinib, is taken as an oral tablet. These medications belong to different classes, including anti-TNF agents, anti-IL12/23, JAK inhibitors, and anti-integrins, which are specific ways that drugs work to target the parts of the immune system causing inflammation.

During the study, participants will receive one of these treatments to see how well it helps maintain health and manage the disease over time. The process involves regular monitoring to check for the disappearance of symptoms like rectal bleeding and changes in bowel habits. The study will observe how these different medicines perform in helping patients achieve long-term stability without the need for steroids, which are a type of medicine often used to reduce swelling and inflammation.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment assignment</b>

    One of four different medication strategies is assigned to manage ulcerative colitis, which is an inflammation of the lining of the large intestine.

    The assigned treatment will be one of the following options:

  2. Step 2

    <b>medication administration</b>

    Option one: receiving ustekinumab (22.5 mg) through an intravenous infusion, which is a liquid medication delivered directly into a vein.

    Option two: receiving infliximab (17.40 mg) through an intravenous infusion.

    Option three: taking filgotinib (45 mg) as oral tablets that are swallowed.

    Option four: receiving vedolizumab (15.40 mg) through an intravenous infusion.

  3. Step 3

    <b>monthly monitoring</b>

    Between week 4 and week 52, remission is assessed every 4 weeks. remission is defined as a state where there is no rectal bleeding, bowel habits are normal, faecal calprotectin (a marker of inflammation in the stool) is below 150 µg/g, and no steroids are required.

    At each visit, levels of faecal calprotectin are measured to check for inflammation.

  4. Step 4

    <b>long-term evaluations</b>

    At specific time points including week 16, week 52, and week 104, assessments are performed to check for endoscopic improvement or remission (looking at the inside of the intestine), histological healing (checking tissue samples for healing), and clinical remission (checking overall symptom control).

    At weeks 8, 16, 24, 32, 42, 52, 76, and 104, various factors are evaluated, such as drug acceptability, adverse events (side effects), quality of life, and disability levels.

    The total duration of monitoring for certain outcomes can extend up to 24 months.

Who can join the trial?

8 criteria

  • Both men and women can participate, but women who may become pregnant must use effective contraception (birth control) and have a negative pregnancy test.
  • You must be between 18 and 65 years old.
  • You must have been diagnosed with ulcerative colitis (a type of long-term inflammation in the large intestine) for at least 3 months.
  • Your disease must be classified as moderate to severe based on the modified Mayo score (a tool doctors use to measure the severity of your symptoms and disease activity).
  • Your endoscopic Mayo score must be 2 or higher (an endoscopic score is a measurement taken by a doctor using a camera to look inside your intestine to see the level of inflammation).
  • You must have not responded well to, failed to improve with, lost the benefits of, or not been able to tolerate 5-ASA (a type of anti-inflammatory medicine), steroids (medicines that reduce swelling and inflammation), or immunosuppressants (medicines that lower the activity of your immune system).
  • You must be able to give consent (formally agree to participate in the study).
  • You must be covered by the French healthcare system.

Who cannot join the trial?

18 criteria

  • You have a reason why you cannot take infliximab, filgotinib, vedolizumab, or ustekinumab, which are specific types of advanced medications used for treatment.
  • You have previously used other biologics (medicines made from living organisms) or experimental drugs (medicines that are still being tested).
  • You do not have health insurance.
  • You are pregnant or currently breastfeeding (lactating).
  • You are already participating in another medical research study, unless it is an observational study (a study where doctors simply watch and record what happens without changing your treatment).
  • You have a current infection with Clostridioides difficile, which is a type of bacteria that causes severe diarrhea and gut inflammation.
  • You have an HIV infection, which is a virus that attacks the body's immune system.
  • You do not speak or understand the French language.
  • You are under guardianship, curatorship, or safeguard of justice, which means a legal representative makes decisions for you.
  • You are a minor (under the age of 18).
  • You have taken more than 20 mg per day of steroids (strong anti-inflammatory medicines) within the last two weeks.
  • You have low proctitis, which means your inflammation is only located in the rectum (the very end of the large intestine) and covers a distance of less than 5 cm.
  • You have a history of thromboembolism, which refers to blood clots that form in blood vessels.
  • You have a history of major cardiovascular problems, such as a heart attack or a stroke (when blood flow to the brain is blocked).
  • You are a long-term smoker with a history of more than 40 pack years (a measurement based on how many cigarettes you smoke per day multiplied by the number of years you have smoked).
  • You have Crohn's disease, which is a different type of chronic inflammatory bowel disease.
  • You have a stoma (an opening surgically created on the abdomen to allow waste to leave the body) or have had a colectomy (surgical removal of part or all of the colon).
  • You have previously used anti-TNF agents, anti-integrins, anti-interleukines 12 and 23, or JAK inhibitors.
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.

Not 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

  • Ustekinumab

    is a medication given through an intravenous infusion that works by targeting specific proteins in the immune system to help reduce inflammation in patients with ulcerative colitis.

  • Infliximab

    is a medication administered by intravenous infusion that helps control inflammation by targeting a specific protein in the body that contributes to the disease.

  • Filgotinib

    is a medication taken as a pill that helps manage inflammation by blocking certain pathways in the immune system.

  • Vedolizumab

    is a medication given through an intravenous infusion that works by targeting specific cells in the immune system to limit inflammation in the digestive tract.

What is already known about the treatment

  • Ustekinumab

    This medication is an injectable liquid that is delivered into a vein through an intravenous infusion. It is a well-established treatment used to manage inflammatory conditions like ulcerative colitis by targeting specific proteins in the immune system called interleukin-12 and interleukin-23. By blocking these proteins, the medicine helps reduce the harmful inflammation that damages the digestive tract. It belongs to a group of drugs known as biologics.

  • Infliximab

    This medicine is administered as a liquid through an intravenous infusion into a vein. It is widely used in modern medicine to treat various inflammatory diseases, including ulcerative colitis. It works by attaching to and neutralizing a protein called tumor necrosis factor, which is a major cause of inflammation in the body. This drug is classified as a biologic therapy.

  • Filgotinib

    This medication is taken orally in the form of a swallowed tablet. It is currently used as a treatment for inflammatory conditions such as ulcerative colitis. The drug works inside the body by blocking specific enzymes called Janus kinases, which helps to stop the signaling processes that lead to inflammation. It belongs to a class of medicines known as JAK inhibitors.

  • Vedolizumab

    This treatment is given as a liquid through an intravenous infusion into a vein. It is a recognized therapy used to treat inflammatory bowel diseases like ulcerative colitis. The medication works by specifically blocking a protein called an integrin, which prevents inflammatory cells from entering the gut tissue and causing damage. It is classified as a biologic medication.

Investigated diseases

ulcerative colitis - This is a condition involving long-term inflammation of the inner lining of the large intestine and rectum. The inflammation typically occurs in a continuous pattern rather than in patches. As the disease progresses, it can cause irritation and swelling of the intestinal tissues. This may lead to symptoms such as frequent bowel movements and blood in the stool. The extent of the inflammation can vary from affecting only the rectum to involving the entire colon.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514964-24-00Protocol codePHRC N 2020 BUISSONEstimated enrolment240 patientsSponsorUniversity Hospital Of Clermont-Ferrand

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.