RecruitingPhase 2NCT06453317

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)


Sponsor

Medical University of Lodz

Enrollment

172 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study compares three treatment approaches for moderate-to-severe ulcerative colitis (UC) — a chronic inflammatory disease of the large intestine: infliximab alone, ustekinumab alone, and a combination of both. Researchers want to see which approach is safest and most effective. **You may be eligible if...** - You are aged 18–65 with a confirmed diagnosis of ulcerative colitis for at least 3 months - Your UC is moderately to severely active - You are willing to use effective contraception during the study if you are a woman of childbearing age **You may NOT be eligible if...** - You have had a bowel surgery that removed part or all of the colon - You have active tuberculosis, a severe infection, or certain cancers - You are pregnant or planning to become pregnant during the study - You have previously failed both infliximab and ustekinumab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALInfliximab

Infliximab 5 mg/kg i.v at Weeks 0, 2, 6 and then every 8 weeks for 52 weeks.

BIOLOGICALUstekinumab

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.


Locations(1)

Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej USK nr 1 im. N. Barlickiego w Łodzi

Lodz, Poland

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NCT06453317


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