49
Participants
Start Date
December 2, 2021
Primary Completion Date
July 8, 2024
Study Completion Date
August 8, 2024
BI 706321
One dose of 8 mg as tablets orally once per day in the morning
Ustekinumab
A single intravenous infusion of 260 mg (body weight ≤55 kg), 390 mg (body weight 55-85 kg), or 520 mg (body weight \>85 kg) was administered on Day 0, followed by subcutaneous injection of 90 mg every 8 weeks.
Placebo
One dose of placebo matching BI 706321 as tablets orally once per day in the morning
Brussels - UNIV St-Pierre, Brussels
Clinexpert Kft., Budapest
UZ Leuven, Leuven
Bugat Pal Hospital, Gyongyos, Gyöngyös
Centre Hospitalier Universitaire de Liège, Liège
University of Debrecen Clinical Centre, Debrecen
UNIV Ambroise Paré, Mons
AZ Maria Middelares, Ghent
AZ Sint-Lucas - Campus Sint Lucas, Ghent
Aalborg Sygehus Syd, Aalborg
payee-Hospital Universitario Reina Sofia. Cordoba, Córdoba
IRCCS Policlinico San Donato, San Donato Milanese (MI)
IRCCS Fondazione Ospedale Maggiore, Milan
IRCCS San Raffaele, Milan
Fondazione IRCCS Policlinico S. Matteo, Pavia
Carolina Digestive Diseases, Greenville
Hospital La Princesa, Madrid
Advanced Research Institute, Inc., Orlando
Sweet Hope Research Specialty Inc, Hialeah
Nature Coast Clinical Research, Inverness
I.H.S Health, LLC, Kissimmee
Osp.Sacro Cuore-Don Calabria, Negrar (VR)
Hospital Virgen Macarena, Seville
Hospital Politècnic La Fe, Valencia
Indiana University, Indianapolis
Gastroenterology Associates of Western Michigan, Wyoming
Hepato-Gastroenterologie HK, s.r.o., Hradec Králové
Rush University Medical Center, Chicago
BVL Clinical Research, Liberty
GI Alliance, Southlake
Houston Methodist Hospital, Houston
Southern Star Research Institute, LLC, San Antonio
University of Utah Health Sciences Center, Salt Lake City
NZOZ Medical Center KERmed, Bydgoszcz
Policlinico Universitario Mater Domini, Universita di Catanzaro, Catanzaro
Universitätsklinikum Ulm, Ulm
California Medical Research Associates Inc., Northridge
University of Washington, Seattle
University Hospital Ostrava, Ostrava
Az. Ospedaliera Universitaria Polic.Tor Vergata, Roma
Radboud Universitair Medisch Centrum, Nijmegen
St Elisabeth Ziekenhuis, Tilburg
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla, Knurów
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska sp. j., Ksawerów
Healthcare Center Gastromed - SCANMED GROUP, Lublin
Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin
National Medical Institute MSWiA, Warsaw
CEIC Corporacio Sanitaria Parc Taulí, Sabadell
Royal Liverpool University Hospital, Liverpool
Lead Sponsor
Boehringer Ingelheim
INDUSTRY