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

NCT06453317 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-05-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Poznan University of Medical Sciences

    collaborator OTHER

  • Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań

    collaborator OTHER

  • Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz

    collaborator UNKNOWN

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Renata Talar-Wojnarowska, Prof. · Medical University of Lodz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453317 on ClinicalTrials.gov