NCT03474042

GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis

A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2737 in Orkambi-treated Subjects With Cystic Fibrosis Homozygous for the F508del Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate GLPG2737 administered orally b.i.d. for 28 days to adult male and female subjects with a confirmed diagnosis of cystic fibrosis homozygous for the F508del CFTR mutation and on stable treatment with Orkambi.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	GLPG2737	GLPG2737 oral capsules administered twice daily for 28 days on top of Orkambi.
DRUG	Placebo	Placebo oral capsules administered twice daily for 28 days on top of Orkambi.

Timeline

• Start date: 2017-11-29
• Primary completion: 2018-04-10
• Completion: 2018-04-10
• First posted: 2018-03-22
• Last updated: 2018-06-11

Locations

9 sites across 1 country: Germany