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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506452-25-00
Acronym
COMBO/2022/3
Enrollment
172
Registered
2024-04-12
Start date
2025-03-27
Completion date
Unknown
Last updated
2025-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Brief summary

Percentage of clinical and endoscopic remission after remission induction phase.

Detailed description

Percentage of clinical response after remission induction phase., Percentage of clinical response at 52 wks., Percentage of clinical remission at 52 wks., Percentage of endoscopic remission or endoscopic improvement after the remission induction phase and at 52 wks., Percentage of laboratory remissions after the remission induction phase and at 52 weeks., Percentage of deep remissions after the remission induction phase and at 52 wks., Comparison of patients' quality of life after the remission induction phase and at 52 wks., Comparison of the number and type of adverse events and serious adverse events after the remission induction phase and at 52 wks.

Interventions

DRUGUSTEKINUMAB
DRUGINFLIXIMAB

Sponsors

Medical University Of Lodz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Percentage of clinical and endoscopic remission after remission induction phase.

Secondary

MeasureTime frame
Percentage of clinical response after remission induction phase., Percentage of clinical response at 52 wks., Percentage of clinical remission at 52 wks., Percentage of endoscopic remission or endoscopic improvement after the remission induction phase and at 52 wks., Percentage of laboratory remissions after the remission induction phase and at 52 weeks., Percentage of deep remissions after the remission induction phase and at 52 wks., Comparison of patients' quality of life after the remission induction phase and at 52 wks., Comparison of the number and type of adverse events and serious adverse events after the remission induction phase and at 52 wks.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026