Albatross

Details

Therapeutic category
Restore CFTR Function
Trial status
Completed Participating Centres
Phase
Phase II

Full title

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.
Trial Reference Number
88101
Trial type
Medication
Intervention
CFTR Modulator
Recruitment target
35
Last edited date
22/10/2018
CF sponsor
Galapagos NV
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • 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
Top exclusion criteria
  • History of solid organ or hematopoietic cell transplantation

Your donation will make a difference:

Select amount