COMBO-UC trial

Project title: Comparison of ustekinumab, infliximab and COMBinatiOn therapy in moderately-to-severely active Ulcerative Colitis – the head to head COMBO-UC trial

Project data

Project financing: 19 868 246,28 PLN (including financing for UMED: 15 848 428,28 PLN), financed by the Medical Research Agency (ABM) - ABM/2022/3

Project description:

The Project’s clinical trial focuses on patients with ulcerative colitis, for whom monotherapy with biologic drugs is the standard of care when conventional therapies are ineffective. However, since the percentage of clinical remissions achieved using this method is still not satisfactory, the trial proposes a combination therapy with two biologic drugs (Infliximab: IFX and Ustekinumab: UST).

The planned study is a three-arm, parallel, randomized head to head study with one experimental group (IFX + UST) and two comparison groups (IFX or UST).

It is planned to recruit patients in 8 specialized gastroenterology centres in Poland – with a total recruitment target of 164 patients.

Beneficiary:

Consortium composed of:

  • Medical University of Lodz (Leader)
  • Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz (Partner)
  • Poznan University Of Medical Sciences (Partner)
  • Hospital of Lord’s Transfiguration of Poznan University Of Medical Sciences (Partner)

Coordinating Principal Investigator

Prof. Renata Talar-Wojnarowska, MD, PhD

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