CA40192:Etrolizumab in patients with moderate to severe UC or CD
Research type
Research Study
Full title
A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PAEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE
IRAS ID
240702
Contact name
Andrew Fagbemi
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-003649-10
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This study will evaluate pharmacokinetics, pharmacodynamics and safety of etrolizumab in paediatric patients of 4 to <18 years of age with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn’s disease (CD). This study will consist of multiple phases; a randomized treatment phase that will evaluate pharmacokinetics, pharmacodynamics, and safety, followed by an open-label extention (OLE) phase, and then a progressive multifocal leukoencephalopathy (PML) monitoring phase.
The investigational medicinal product (IMP) for this study is etrolizumab. The total length of the study, from screening of the first patient to the end of the study, is expected to be approximately 5 years. Approximately 16 paediatric patients from 4 to <18 years of age with moderate to severe UC or with moderate to severe CD will be enrolled to target at least 12 patients with evaluable PK profiles. At least 4 patients from 4 years to <12 years of age should be enrolled.
The study is sponsored by F. Hoffman La Roche.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0102
Date of REC Opinion
15 May 2018
REC opinion
Further Information Favourable Opinion