Status:
COMPLETED
GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis
Lead Sponsor:
Galapagos NV
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Male or female subject ≥18 years of age on the day of signing the ICF.
- A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation.
- Stable intake of physician prescribed Orkambi (lumacaftor 400 mg/ivacaftor 250 mg b.i.d.) for at least 12 weeks prior to the first study drug administration, and planned continuation of Orkambi for the duration of the study.
- FEV1 ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).
- Sweat chloride concentration ≥60 mmol/L at screening.
Exclusion
- History of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to any component of the study drug.
- 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 (including rhinosinusitis) requiring a change in therapy within 4 weeks prior to the first study drug administration.
- History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices, etc.).
- Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or alkaline phosphatase and/or gammaglutamyl transferase (GGT) ≥3 x the upper limit of normal (ULN), and/or total bilirubin ≥1.5 x the ULN at screening.
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03474042
Start Date
November 29 2017
End Date
April 10 2018
Last Update
June 11 2018
Active Locations (9)
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1
Study Site II
Berlin, Germany
2
Study Site V
Cologne, Germany
3
Study Site X
Dresden, Germany
4
Study Site III
Essen, Germany