GLPG2222-CL-201 in subjects with CF with F508del CFTR mutation
Research type
Research Study
Full title
A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation
IRAS ID
216022
Contact name
Stuart Elborn
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2016-002837-31
Duration of Study in the UK
0 years, 7 months, 15 days
Research summary
This is a Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis (CF) with one F508del CFTR mutation and a second gating (class III) mutation.\n\nUp to 35 participants are planned to be included in the study for a minimum of 6 weeks and a maximum of 10 weeks. All participants will be at least 18 years of age and have cystic fibrosis with at least one copy of the F508del (Class II) mutation. This study will investigate whether treatment with the corrector GLPG2222 in patients heterozygous for F508del and a gating mutation who are already receiving ivacaftor treatment (standard of care), will result in an additional improvement in CFTR function, as measured by sweat chloride and lung function.\n\nThe following countries are taking part in this study:\nAustralia, Czech Republic, Germany, UK and Ireland.\nEnrolment timelines: Planned start date 15 February 2017 and Last Patient In \n30 September 2017.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0787
Date of REC Opinion
30 Nov 2016
REC opinion
Further Information Favourable Opinion