UCNot yet recruiting
FirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled Trial
Phase 4 · Testing 1: infliximab 2: filgotinib 3: ustekinumab 4: vedolizumab, 1: ustekinumab 2: vedolizumab… · 11 sites · University Hospital, Clermont-Ferrand
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing 1: infliximab 2: filgotinib 3: ustekinumab 4: vedolizumab (a drug), 1: ustekinumab 2: vedolizumab 3: infliximab 4: filgotinib (a drug), 1: vedolizumab 2: infliximab 3: filgotinib 4: ustekinumab (a drug) and 1: filgotinib 2: ustekinumab 3: vedolizumab 4: infliximab) (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 18 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 240 participants are expected to take part.
- The study has 4 groups.
- Start date: 2026-12-01 (planned).
- Main results expected around 2030-06-01 (estimate from the record).
- 11 study sites listed in France.
Groups in this study
- Time to efficacy (1: infliximab 2: filgotinib 3: ustekinumab 4: vedolizumab) (listed as: experimental group)
- Safety profile (1: ustekinumab 2: vedolizumab 3: infliximab 4: filgotinib) (listed as: experimental group)
- French current use* (1: vedolizumab 2: infliximab 3: filgotinib 4: ustekinumab) (listed as: experimental group)
- Convenience (1: filgotinib 2: ustekinumab 3: vedolizumab 4: infliximab) (listed as: experimental group)
Main thing being measured
- Clinical remission (Remission will be assessed as a binary criterion (yes/no) each month (i.e. 4 weeks-period) between week 4 and week 52,…)
In the researchers’ words
Ulcerative colitis (UC) is a chronic bowel disease. It causes inflammation of the rectum and sometimes the colon. This disease can also affect other parts of the body.
Words you might see
- Randomized: participants are put into groups by chance, like a coin flip.
- Fecal calprotectin: a stool test that measures inflammation in the gut.
- Endoscopy: a camera exam inside the digestive tract.
- Mayo score: a score used to measure how active ulcerative colitis is.
- Remission: a period when the disease is quiet or under control.
- Anti-TNF: a group of biologic medicines (such as infliximab or adalimumab) used in IBD.
- JAK inhibitor: a group of oral medicines that calm parts of the immune system.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
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.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | University Hospital, Clermont-Ferrand |
| Collaborators | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Enrollment | 240 (estimated) |
| Start date | 2026-12-01 |
| Primary completion (est.) | 2030-06-01 |
| First posted | 2026-05-08 |
| Last updated | 2026-10-15 |
| Official title | FirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled Trial |
| ClinicalTrials.gov ID | NCT07576452 |
Interventions
- 1: infliximab 2: filgotinib 3: ustekinumab 4: vedolizumab (Drug)
Follow the processing sequence based on time to efficacy. - 1: ustekinumab 2: vedolizumab 3: infliximab 4: filgotinib (Drug)
Follow the processing sequence based on safety. - 1: vedolizumab 2: infliximab 3: filgotinib 4: ustekinumab (Drug)
Follow the processing sequence based on French current use. - 1: filgotinib 2: ustekinumab 3: vedolizumab 4: infliximab) (Drug)
Follow the processing sequence based on convenience.
Full eligibility criteria (from the record)
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
Locations (11)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens | Amiens | France | |
| CH de la côte Basque | Bayonne | France | |
| CHU de Clermont-Ferrand | Clermont-Ferrand | France | |
| CHD de Vendée | La Roche-sur-Yon | France | |
| CHU de Montpellier, Service de Neurologie | Montpellier | France | |
| CHU de Nancy | Nancy | France | |
| CHU de Nîmes | Nîmes | France | |
| GHRE | St-Malo | France | |
| CHI de Toulon | Toulon | France | |
| CHU de Toulouse | Toulouse | France | |
| CH de Valence | Valence | France |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.