A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

February 5, 2019

Primary Completion Date

December 1, 2021

Study Completion Date

July 4, 2022

Conditions
Crohn Disease
Interventions
DRUG

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).

DRUG

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).

Trial Locations (10)

1088

Semmelweis University, Budapest

1090

AKH - Medical University of Vienna, Vienna

2730

Herlev and Gentofte Hospital, Herlev

3000

UZ Leuven, Leuven

4000

Centre Hospitalier Universitaire de Liège, Liège

17007

Hospital Universitari de Girona Doctor Josep Trueta, Girona

48108

Inje University Haeundae Paik Hospital, Busan

89081

Universitätsklinikum Ulm, Ulm

91054

Universitätsklinikum Erlangen, Erlangen

1105 AZ

Amsterdam UMC, Locatie AMC, Amsterdam

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT03752970 - A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease | Biotech Hunter | Biotech Hunter