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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT03119649

Run by

Lakefront Biotherapeutics NV

People needed

59

Starts

2017-03-18

Expected to finish

2017-10-19

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subject ≥ 18 years of age, on the day of signing the Informed Consent Form (ICF).
• A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation
• Weight ≥ 40 kg.
• Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline
• Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted normal for age, gender and height at screening

You may not qualify if…

• History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
• Unstable pulmonary status or respiratory tract infection requiring a change in therapy within 4 weeks of baseline.
• Need for supplemental oxygen during the day, and >2 liters per minute (LPM) while sleeping.
• Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to the first study drug administration.
• History of hepatic cirrhosis with portal hypertension.
• Abnormal liver function test at screening; defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/ or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥ 3x the upper limit of normal (ULN); and/or total bilirubin (>1.5 times ULN)
• Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula at screening.

Where it is running

• Child Health Research Unit at UAB — Chatom, Alabama, United States
• University of Arkansas for medical Sciences — Little Rock, Arkansas, United States
• Central Florida Pulmonary Group — Orlando, Florida, United States
• Cystic Fibrosis Center of Chicago — Glenview, Illinois, United States
• Maine Medical Center — Portland, Maine, United States
• John Hopkins University School of Medicine — Baltimore, Maryland, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UZ Antwerpen — Antwerp, Belgium
• UZ Brussel — Brussels, Belgium
• UZ Gent — Ghent, Belgium
• UZ Leuven — Leuven, Belgium
• AMC Amsterdam — Amsterdam, Netherlands
• Erasmus medisch centrum — Rotterdam, Netherlands
• Haga Ziekenhuis — The Hague, Netherlands
• UMC Utrecht — Utrecht, Netherlands
• Mother and child health institute of Serbia — New Belgrade, Serbia
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Universitario La Paz — Madrid, Spain
• Hospital Universitarii Plitecnic La Fe — Valencia, Spain
• Papworth Hospital — Cambridge, United Kingdom
• St James University Hospital — Leeds, United Kingdom
• Liverpool Heart and Chest Hospital — Liverpool, United Kingdom
• Southampton general Hospital — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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