FirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled Trial

What To Know

This ClinicalTrials.gov record describes a randomized, interventional phase 4 trial comparing four first-line sequencing strategies for adults (18–65) with moderate-to-severe ulcerative colitis who require biologic therapy.

The four arms start with infliximab, filgotinib, ustekinumab, or vedolizumab in different orders and allow one planned treatment optimization and treatment-switching based on endoscopic scores. Participants will be followed for two years with regular blood/stool testing and endoscopies at weeks 16, 52, and 104.

The study’s primary outcome is monthly assessment of clinical remission (composite: no rectal bleeding, normalized stool frequency, and fecal calprotectin ≤20 mg/day) between weeks 4 and 52. Planned enrollment is 240 and the trial is listed as not yet recruiting.

The record lists common inclusion/exclusion criteria (adult UC of ≥3 months, need for biologic therapy) and exclusions such as prior exposure to biologics or JAK inhibitors, prior colectomy/stoma, and pregnancy. The trial is sponsored by University Hospital Clermont-Ferrand and designated phase 4 in the registry.