the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise
Restore CFTR Function
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use
A phase IIa, randomized, double- blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation GLPG2222-CL-202
This is a Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis (CF) with one F508del CFTR mutation and a second gating (class III) mutation.
Up to 35 participants are planned to be included in the study for a minimum of 6 weeks and a maximum of 10 weeks.
All participants will be at least 18 years of age and have cystic fibrosis with at least one copy of the F508del (Class II) mutation. This study will investigate whether treatment with the corrector GLPG2222 in patients heterozygous for F508del and a gating mutation who are already receiving ivacaftor treatment (standard of care), will result in an additional improvement in CFTR function, as measured by sweat chloride and lung function.
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the name of the treatment or therapy being researched
GLPG2222 or Placebo
the number of participants who need to be recruited for the trial in the UK
Last edited date
18 August 2017
CF sponsor type