Which biologic works best first for ulcerative colitis? major trial aims to find out

NCT ID NCT07576452

Disease control Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

This study compares four different sequences of biologic drugs (infliximab, filgotinib, ustekinumab, and vedolizumab) in 240 adults with moderate to severe ulcerative colitis. The goal is to see which order of treatments works best to achieve and maintain remission without steroids. Participants will be followed for two years with regular check-ups and endoscopies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: infliximab, filgotinib, ustekinumab, vedolizumab
What this could lead to: If successful, this study could identify the best order of biologic treatments for ulcerative colitis, improving remission rates and quality of life.
What could go wrong: This is a Phase 4 trial comparing existing drugs, so no new treatment is being discovered. Results may not apply to all patients, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patients (using effective contraception and a negative pregnancy test for women of childbearing age) diagnosed with UC for at least 3 months * Age ≥ 18 years and ≤ 65 years * Moderate to severe UC according to modified Mayo score (from 5 to 9) * With endoscopic Mayo score ≥ 2 * With an inadequate response, failure, loss of response, or intolerance to 5-ASA, steroids, or immunosuppressants. * Patient capable of giving consent * Patient covered by the French healthcare system * Women of childbearing age using active contraception (contraceptive implant, oral contraception, female condom or abstinence)) for at least the duration of the study Exclusion Criteria: * Usual contra-indication to infliximab, filgotinib, vedolizumab or ustekinumab * Steroids \> 20 mg/day within two weeks before inclusion * Low proctitis (disease limited to the rectum with an extent \< 5 cm) * Prior history of thromboembolism events * Prior history of major cardiovascular problems (such as heart attack or stroke) * Long-standing smokers (\> 40 pack years) * Crohn's disease * Stoma or colectomy * Prior exposure to anti-TNF agents, anti-integrins, anti-interleukines 12 and 23 or JAK inhibitor * Prior exposure to other biologics or experimental drug * No health insurance * Pregnant or lactating women : a pregnancy test will be performed for women of childbearing age * Patients already included in biomedical research other than an observational study (e.g: registry, cohort) * Concomitant Clostridioides difficile infection * HIV infection * Patient who does not master the French language * Patient under guardianship, curatorship or safeguard of justice * Minors

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Which biologic works best first for ulcerative colitis? major trial aims to find out

What the study statuses mean