27
Participants
Start Date
February 5, 2019
Primary Completion Date
December 1, 2021
Study Completion Date
July 4, 2022
Spesolimab
Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). At week 12 Placebo patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20).
Placebo
Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). Patients with combined perianal fistula remission remained on Placebo and were treated with placebo intravenously every 4 weeks (week 12, 16 and 20).
Semmelweis University, Budapest
AKH - Medical University of Vienna, Vienna
Herlev and Gentofte Hospital, Herlev
UZ Leuven, Leuven
Centre Hospitalier Universitaire de Liège, Liège
Hospital Universitari de Girona Doctor Josep Trueta, Girona
Inje University Haeundae Paik Hospital, Busan
Universitätsklinikum Ulm, Ulm
Universitätsklinikum Erlangen, Erlangen
Amsterdam UMC, Locatie AMC, Amsterdam
Lead Sponsor
Boehringer Ingelheim
INDUSTRY