At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Confirmed CF diagnosis with homozygous F508del CFTR mutation
- ✓Weight ≥40 kg
- ✓Stable concomitant CF treatment for ≥4 weeks prior to baseline
- ✕Unstable pulmonary status or respiratory tract infection requiring therapy change within 4 weeks of baseline
- ✕Need for supplemental oxygen >2 LPM during sleep or daytime supplemental oxygen
- ✕History of hepatic cirrhosis with portal hypertension
- ✕Abnormal liver function: AST/ALT/ALP/GGT ≥3x ULN or total bilirubin >1.5x ULN
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GLPG2222 50 mg, GLPG2222 100 mg, and 3 other interventions for Cystic Fibrosis. Completed, enrolled 59 participants across 23 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Oral tablet(s) containing GLPG2222
Oral tablet(s) containing GLPG2222
Matching oral tablet(s) containing placebo
Oral tablet(s) containing GLPG2222
Oral tablet(s) containing GLPG2222