A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis
NCT ID: NCT03045523
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2017-01-31
2017-08-11
Brief Summary
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Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.
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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GLPG2222 Dose 1
GLPG2222 150 mg q.d.
GLPG2222 150 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
GLPG2222 Dose 2
GLPG2222 300 mg q.d.
GLPG2222 300 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
Placebo
Placebo
Placebo administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
Interventions
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GLPG2222 150 mg q.d.
GLPG2222 150 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
GLPG2222 300 mg q.d.
GLPG2222 300 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
Placebo
Placebo administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
Eligibility Criteria
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Inclusion Criteria
2. A confirmed clinical diagnosis of CF.
3. One F508del mutation on one allele in the CFTR gene, a gating (class III) mutation (one of the following: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R) on the 2nd allele in the CFTR gene (documented in the subject's medical record or CF registry).
4. Weight ≥ 40 kg.
5. Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline (including physician prescribed ivacaftor (Kalydeco®) 150 mg b.i.d.).
6. Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).
Exclusion Criteria
2. Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) 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. History of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices, etc).
5. Abnormal liver function test at screening; defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or alkaline phosphatase and/or total bilirubin (\>1.5 times ULN (CTCAE Grade 2) and/or gamma-glutamyl transferase (GGT) ≥ 3x the upper limit of normal (ULN), and/or total bilirubin (\>1.5 times ULN (CTCAE Grade 2).
6. Estimated creatinine clearance \< 60mL/min using the Cockroft-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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The Prince Charles Hospital
Chermside, , Australia
The Alfred
Melbourne, , Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Westmead Hospital
Westmead, , Australia
UZ Brussel
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Fakultni nemocnice v Motole
Prague, , Czechia
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
University Children´s Hospital
Tübingen, , Germany
Cork University Hospital
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
St Vincents University Hospital
Dublin, , Ireland
Birmingham Heartlands
Birmingham, , United Kingdom
Royal Devon and Exeter
Exeter, , United Kingdom
St James's University
Leeds, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
University Hospital of South Manchester
Manchester, , United Kingdom
Royal Victoria Infirmary
Newcastle, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4.
Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.
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.
Other Identifiers
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GLPG2222-CL-201
Identifier Type: -
Identifier Source: org_study_id