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

PHASE2RecruitingINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

February 17, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

June 30, 2028

Conditions
Ulcerative ColitisInflammatory Bowel Diseases
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.

Trial Locations (1)

90-153

RECRUITING

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

Sponsors
All Listed Sponsors
collaborator

Poznan University of Medical Sciences

OTHER

collaborator

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

OTHER

collaborator

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

UNKNOWN

collaborator

Medical Research Agency, Poland

OTHER_GOV

lead

Medical University of Lodz

OTHER

NCT06453317 - Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis | Biotech Hunter | Biotech Hunter