drugset
drugset / Trial / NCT06453317

Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis

NCT06453317 ↗

Phase 2 Recruiting 172 enrolled Medical University of Lodz Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań · collabMedical Research Agency, Poland · collabNorbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz · collabPoznan University of Medical Sciences · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination. The main questions it aims to answer are: Does the combination therapy improve the symptoms and heal the intestine quicker and better than these drugs administered alone? Does the combination therapy improve the quality of life better than these drugs administered alone? What medical problems do participants have when taking the combination therapy? Participants: Patients diagnosed with UC will be qualified to biologic therapy (infliximab/ustekinumab/infliximab + ustekinumab). Visit the clinic in stated periods for assessment and to apply medication. Take drugs based on the schedule.

Timeline

Start
2025-02-17
Primary completion
2028-04-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 5 mg/kg Intravenous
Subject Ustekinumab Monoclonal antibody 90 mg Intravenous

Indications

ulcerative colitis