A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis
NCT ID: NCT03119649
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2017-03-18
2017-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort A: GLPG2222 50 mg once daily (QD)
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets orally, QD for 29 days.
GLPG2222 50 mg
Oral tablet(s) containing GLPG2222
Placebo
Matching oral tablet(s) containing placebo
Cohort A: GLPG2222 100 mg QD
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets orally, QD for 29 days.
GLPG2222 100 mg
Oral tablet(s) containing GLPG2222
Placebo
Matching oral tablet(s) containing placebo
Cohort B: GLPG2222 200 mg QD
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet orally, QD for 29 days.
Placebo
Matching oral tablet(s) containing placebo
GLPG2222 200 mg
Oral tablet(s) containing GLPG2222
Cohort B: GLPG2222 400 mg QD
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
Placebo
Matching oral tablet(s) containing placebo
GLPG2222 400 mg
Oral tablet(s) containing GLPG2222
Cohort A Placebo
Participants received three matching placebo tablets, orally, QD for 29 days.
Placebo
Matching oral tablet(s) containing placebo
Cohort B Placebo
Participants received three matching placebo tablets, orally, QD for 29 days.
Placebo
Matching oral tablet(s) containing placebo
Interventions
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GLPG2222 50 mg
Oral tablet(s) containing GLPG2222
GLPG2222 100 mg
Oral tablet(s) containing GLPG2222
Placebo
Matching oral tablet(s) containing placebo
GLPG2222 200 mg
Oral tablet(s) containing GLPG2222
GLPG2222 400 mg
Oral tablet(s) containing GLPG2222
Eligibility Criteria
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Inclusion Criteria
2. A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation
3. Weight ≥ 40 kg.
4. Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline
5. Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted normal for age, gender and height at screening
Exclusion Criteria
2. Unstable pulmonary status or respiratory tract infection requiring a change in therapy within 4 weeks of baseline.
3. Need for supplemental oxygen during the day, and \>2 liters per minute (LPM) while sleeping.
4. Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to the first study drug administration.
5. History of hepatic cirrhosis with portal hypertension.
6. 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)
7. Estimated creatinine clearance \< 60 mL/min using the Cockcroft-Gault formula at screening.
18 Years
99 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Olivier Van Steen, MD, MBA
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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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
Countries
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References
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Bell SC, Barry PJ, De Boeck K, Drevinek P, Elborn JS, Plant BJ, Minic P, Van Braeckel E, Verhulst S, Muller K, Kanters D, Bellaire S, de Kock H, Geller DE, Conrath K, Van de Steen O, van der Ent K. CFTR activity is enhanced by the novel corrector GLPG2222, given with and without ivacaftor in two randomized trials. J Cyst Fibros. 2019 Sep;18(5):700-707. doi: 10.1016/j.jcf.2019.04.014. Epub 2019 May 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GLPG2222-CL-202
Identifier Type: -
Identifier Source: org_study_id
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