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

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.

NCT Number	NCT06453317
Lead Sponsor	Medical University of Lodz Collaborators: Poznan University of Medical Sciences, Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań, Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz, Medical Research Agency, Poland
Conditions	Ulcerative Colitis, Inflammatory Bowel Diseases
Enrollment	172 participants
Start Date	2025-02-17
Primary Completion	2028-04-30 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-05-15