A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

September 16, 2015

Primary Completion Date

June 19, 2019

Study Completion Date

June 19, 2019

Conditions
Crohn Disease
Interventions
DRUG

Risankizumab 600 mg IV

Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained

DRUG

Risankizumab 180 mg SC

Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.

Trial Locations (28)

1070

ULB Erasme /ID# 154987, Brussels

1200

Cliniques Universitaires Saint Luc /ID# 154985, Woluwe-Saint-Lambert

2820

Imelda Ziekenhuis /ID# 154984, Bonheiden

3000

UZ Leuven /ID# 154986, Leuven

4000

CHU de Liege /ID# 154988, Liège

8500

AZ Groeninge /ID# 154989, Kortrijk

8800

AZ-Delta /ID# 154983, Roeselare

20815

MGG Group, Inc.Chevy Chase Clinical Research /ID# 155068, Chevy Chase

28006

Hospital Univ de la Princesa /ID# 155065, Madrid

30625

Med Hochschule Hanover /ID# 155041, Hanover

42415

Yeungnam University Med Ctr /ID# 155056, Daegu

48047

Clin Res Inst of Michigan, LLC /ID# 155066, Chesterfield

91054

Universitaetsklinikum Erlangen /ID# 155039, Erlangen

L8S 4K1

McMaster University Med Cent /ID# 155019, Hamilton

1105 AZ

Academisch Medisch Centrum /ID# 155058, Amsterdam

6229 HX

Maastricht Universitair Medisch Centrum /ID# 155059, Maastricht

03-580

NZOZ Vivamed /ID# 155061, Warsaw

53-114

Lexmedica /Id# 155062, Wroclaw

03181

Kangbuk Samsung Hospital /ID# 155054, Jongno-Gu

03722

Severance Hospital /ID# 155055, Seoul

05505

Asan Medical Center /ID# 155053, Seoul

08907

Hospital Duran i Reynals /ID# 155063, L'Hospitalet de Llobregat

08036

Hospital Clinic de Barcelona /ID# 155064, Barcelona

SE1 9RT

Guy's and St Thomas' NHS Found /ID# 155046, London

CB2 0SP

Addenbrookes Hospital /ID# 155047, Cambridge

LS9 7TF

St. James University Hospital /ID# 155050, Leeds

NE1 4LP

The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 155049, Newcastle upon Tyne

OX3 9DU

John Radcliffe Hospital /ID# 155048, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Boehringer Ingelheim

INDUSTRY

lead

AbbVie

INDUSTRY