Albatross
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001681
- Last updated
- 22/10/2018
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
Study detailsThis 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.
- Phase
- Phase 2
- Recruitment target
- 35
- CF sponsor
- Galapagos NV
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18 years and older
- Including people
One F508del mutation and a second gating (class III) mutation (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R).
FEV1 = 40% of predicted normal for age, gender and height
Weight >=40Kg- Excluding people
History of solid organ or hematopoietic cell transplantation
Get in touch