Who is sponsoring NCT02070744?

NCT02070744 is sponsored by Vertex Pharmaceuticals Incorporated.

What condition does NCT02070744 study?

NCT02070744 studies Cystic Fibrosis.

What drugs are being tested in NCT02070744?

Interventions: VX-661, Ivacaftor, Placebo matched to VX-661, Placebo matched to Ivacaftor.

What is the status of NCT02070744?

NCT02070744 is currently COMPLETED.

Last reviewed 2025-09-22 · How we verify

A Phase 2, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 in Combination With Ivacaftor for 12 Weeks in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation With an Open-Label Extension

NCT02070744 Phase 2 COMPLETED Results posted

The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation

Details

Lead sponsor	Vertex Pharmaceuticals Incorporated
Phase	Phase 2
Status	COMPLETED
Enrolment	40
Start date	2014-03
Completion	2016-05-27

Conditions

Cystic Fibrosis

Interventions

VX-661
Ivacaftor
Placebo matched to VX-661
Placebo matched to Ivacaftor

Primary outcomes

PC Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — Baseline (PC Phase) up to 112 days
AE: Any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation considered treatment-emergent. Baseline was defined as Day 1 of PC Phase.
OLE Phase: Number of Participants With Treatment-Emergent AEs and SAEs — Baseline (OLE Phase) up to 364 days
AE: Any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation considered treatment-emergent. Baseline was defined as Day 1 of the OLE Phase.

Countries

United States