NCT03119649

A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic Fibrosis Transmembrane conductance Regulator (CFTR) mutation.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	GLPG2222 50 mg	Oral tablet(s) containing GLPG2222
DRUG	GLPG2222 100 mg	Oral tablet(s) containing GLPG2222
DRUG	Placebo	Matching oral tablet(s) containing placebo
DRUG	GLPG2222 200 mg	Oral tablet(s) containing GLPG2222
DRUG	GLPG2222 400 mg	Oral tablet(s) containing GLPG2222

Timeline

• Start date: 2017-03-18
• Primary completion: 2017-10-19
• Completion: 2017-10-19
• First posted: 2017-04-18
• Last updated: 2018-11-16
• Results posted: 2018-11-16

Locations

23 sites across 6 countries: United States, Belgium, Netherlands, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study