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ELX/TEZ/IVA in Cystic Fibrosis with Non-F508del Responsive Mutations
NCT05274269Phase 3
Key facts
- Status
- Completed
- Start
- May 2022
- Primary completion
- Jul 2023
- Countries
- 15
- Sponsor
- Vertex Pharmaceuticals
- Modality
- Small Molecules
- Conditions
- cystic fibrosis (CF)
01
Overview
Phase 3, randomised, double-blind trial in cystic fibrosis (CF) comparing ELX/TEZ/IVA with Placebo (2 arms). Primary endpoint: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second at 24 weeks. Started May 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
ELX/TEZ/IVA
Trikafta (ELX/TEZ/IVA) AM + Ivacaftor PM
Placebo
Matched Placebo AM + PM
03
Who it enrols
Patients 6 years and older with a qualifying non-F508del ELX/TEZ/IVA-responsive CFTR mutation, FEV1 between 40-100% of predicted, and no history of solid organ transplantation or significant cirrhosis.
04
Endpoints
Primary
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second
Secondary
Absolute Change in Sweat Chloride
Absolute Change in Cystic Fibrosis Questionnaire-Revised Respiratory Domain Score
Absolute Change in Body Mass Index
Absolute Change in Weight
Number of Pulmonary Exacerbations
Number of Participants With Adverse Events and Serious Adverse Events
05
Results
Primary endpoints met
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