GLPG2222-CL-202 In subjects with CF, homozygous for F508del mutation
Research type
Research Study
Full title
A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation
IRAS ID
222836
Contact name
Charles Haworth
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2016-004477-40
Duration of Study in the UK
0 years, 4 months, 20 days
Research summary
This is a Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation.
GLPG2222 is an experimental drug and currently under investigation and not approved for use in any country.
This study will investigate whether GLPG2222, taken orally, is safe, well-tolerated and effective in improving signs and symptoms of cystic fibrosis. The study will evaluate how the body processes the study drug by measuring the amount of drug in the blood at specific study visits and subsequently provide insights into the activity of GLPG2222 as a single drug. This will aid in dose selection for use in combination with a CFTR potentiator and a second CFTR corrector molecule.
50 participants are planned to be included in the study for maximum 10 weeks. All participants will be at least 18 years of age and have cystic fibrosis with two copies of the F508del CFTR mutation.
The participants will be included in the study with the first 25 participants assigned to Cohort A and the next 25 participants to be assigned to Cohort B.
Participants will have the option to participate in a sub-study where nasal brushings will be collected.
Belgium, Netherlands, Serbia, Spain, UK and USA are taking part in this study.
Planned enrolment start date is from June 2017 to September 2017.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0090
Date of REC Opinion
26 May 2017
REC opinion
Further Information Favourable Opinion