Brief Summary

This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Nov 2016

Shorter than P25 for phase_2

Geographic Reach

1 country

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

October 26, 2016

Completed

6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed

Same day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

January 28, 2021

Completed

Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

October 26, 2016

Results QC Date

January 7, 2021

Last Update Submit

January 7, 2021

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (3)

Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 15 for Part 1 and Part 2 Cohort 2A
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
From Baseline at Day 15
Absolute Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
From Baseline Through Day 29

Secondary Outcomes (7)

Absolute Change in Sweat Chloride Concentrations at Day 15 for Part 1 and Part 2 Cohort 2A
From Baseline at Day 15
Absolute Change in Sweat Chloride Concentrations Through Day 29 for Part 2 Cohort 2B
From Baseline Through Day 29
Relative Change in ppFEV1 at Day 15 for Part 1 and Part 2 Cohort 2A
From Baseline at Day 15
Relative Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B
From Baseline Through Day 29
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 15 for Part 1 and Part 2 Cohort 2A
From Baseline at Day 15
+2 more secondary outcomes

Study Arms (8)

Part 1: Placebo

PLACEBO COMPARATOR

Drug: Placebo