NCT06453317

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

Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis (COMBO-UC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Infliximab	Infliximab 5 mg/kg i.v at Weeks 0, 2, 6 and then every 8 weeks for 52 weeks.
BIOLOGICAL	Ustekinumab	Ustekinumab: first dose i.v. at Week 0 (Patients with body weight ≤55 kg - 260 mg, patients with body weight \>55-≤85 kg 390 mg, patients with body weight \>85 kg - 520 mg) then 90 mg s.c. every 8/12 weeks for 52 weeks.

Timeline

• Start date: 2025-02-17
• Primary completion: 2028-04-30
• Completion: 2028-06-30
• First posted: 2024-06-11
• Last updated: 2025-05-15

Locations

1 site across 1 country: Poland