A Study Evaluating the Safety of VX-152 Combination Thera... | NCT02951195 | Trialant
NCT02951195
Sponsor
Vertex Pharmaceuticals Incorporated
Status
Completed
Last Update Posted
Jan 28, 2021Actual
Enrollment
80Actual
Phase
Phase 2
Conditions
Cystic Fibrosis
Interventions
VX-152
TEZ/IVA
IVA
Placebo
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02951195
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VX16-152-102
Secondary IDs
Not provided
Brief Title
A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
Official Title
A Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
Acronym
Not provided
Organization
Vertex Pharmaceuticals IncorporatedINDUSTRY
Status Module
Record Verification Date
Jan 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2016Actual
Primary Completion Date
Jan 2018Actual
Completion Date
Jan 2018Actual
First Submitted Date
Oct 26, 2016
First Submission Date that Met QC Criteria
Oct 28, 2016
First Posted Date
Nov 1, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 7, 2021
Results First Submitted that Met QC Criteria
Jan 7, 2021
Results First Posted Date
Jan 28, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 9, 2019
Certification/Extension First Submitted that Passed QC Review
Jan 9, 2019
Certification/Extension First Posted Date
Jan 14, 2019Actual
Last Update Submitted Date
Jan 7, 2021
Last Update Posted Date
Jan 28, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Vertex Pharmaceuticals IncorporatedINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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).
Detailed Description
Not provided
Conditions Module
Conditions
Cystic Fibrosis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
80Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Placebo
Placebo Comparator
Drug: Placebo
Part 1 Cohort 1A: TC
Experimental
Drug: VX-152
Drug: TEZ/IVA
Drug: IVA
Part 1 Cohort 1B: TC
Experimental
Drug: VX-152
Drug: TEZ/IVA
Drug: IVA
Part 1 Cohort 1C: TC
Experimental
Drug: VX-152
Drug: TEZ/IVA
Drug: IVA
Part 2 Cohort 2A: TEZ/IVA
Active Comparator
Drug: TEZ/IVA
Drug: IVA
Drug: Placebo
Part 2 Cohort 2A: TC
Experimental
Drug: VX-152
Drug: TEZ/IVA
Drug: IVA
Part 2 Cohort 2B: TEZ/IVA
Active Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
VX-152
Drug
Tablet for oral administration.
Part 1 Cohort 1A: TC
Part 1 Cohort 1B: TC
Part 1 Cohort 1C: TC
Part 2 Cohort 2A: TC
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
Absolute Change in Sweat Chloride Concentrations at Day 15 for Part 1 and Part 2 Cohort 2A
Sweat samples were collected using an approved collection device.
From Baseline at Day 15
Absolute Change in Sweat Chloride Concentrations Through Day 29 for Part 2 Cohort 2B
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Willing and able to comply with scheduled visits, treatment pan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
Body weight ≥35 kg.
Sweat chloride value ≥ 60 mmol/L from test results obtained during screening.
Subjects must have an eligible CFTR genotype:
Cohorts 1A, 1B, 1C: Heterozygous for F508del and a minimal function mutation known or predicted not to respond to TEZ and/or IVA.
Cohorts 2A, 2B: Homozygous for F508del.
Subjects must have an FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height at the Screening Visit.
Stable CF disease as judged by the investigator.
Willing to remain on a stable CF medication regimen through the planned end of treatment or if applicable the Safety Follow-up Visit.
Exclusion Criteria:
History of any comorbidity that in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject.
History of cirrhosis with portal hypertension.
Risk factors for Torsade de Pointes.
History of hemolysis.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening.
Clinically significant abnormal laboratory values at screening.
An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before the first dose of study drug.
Lung infection with organisms associated with a more rapid decline in pulmonary status.
An acute illness not related to CF within 14 days before the first dose of study drug.
A standard digital ECG demonstrating QTc >450 msec at screening.
History of solid organ or hematological transplantation.
History or evidence of cataract or lens opacity determined to be clinically significant by the ophthalmologist or optometrist, based on the ophthalmologic examination during the Screening Period.
History of alcohol or drug abuse in the past year, including but not limited to, cannabis, cocaine, and opiates, as deemed by the investigator.
Ongoing or prior participation in an investigational drug study with certain exceptions.
Use of commercially available CFTR modulator within 14 days before screening (applies only to Cohorts 1A, 1B, and 1C).
Pregnant or nursing females: Females of childbearing potential must have a negative pregnancy test at screening and Day 1.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Birmingham
Alabama
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 80 participants were enrolled in the study (34 participants in Part 1 and 46 participants in Part 2). Out of 46 participants enrolled in Part 2, 4 participants discontinued during the run-in period and were not randomized in the treatment period. Therefore, results are presented for 76 participants in this study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Placebo
Participants received placebo matched to VX-152/TEZ/IVA triple combination (TC) for 2 weeks.
FG001
Part 1 Cohort 1A: TC
Participants received VX-152 100 milligram (mg) every 12 hours (q12h)/TEZ 100 mg once daily (qd)/IVA 150 mg q12h TC for 2 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 14, 2017
Jan 7, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Drug: TEZ/IVA
Drug: IVA
Drug: Placebo
Part 2 Cohort 2B: TC
Experimental
Drug: VX-152
Drug: TEZ/IVA
Drug: IVA
Part 2 Cohort 2B: TC
TEZ/IVA
Drug
Fixed-dose combination tablet for oral administration.
Part 1 Cohort 1A: TC
Part 1 Cohort 1B: TC
Part 1 Cohort 1C: TC
Part 2 Cohort 2A: TC
Part 2 Cohort 2A: TEZ/IVA
Part 2 Cohort 2B: TC
Part 2 Cohort 2B: TEZ/IVA
VX-661/VX-770
Tezacaftor/Ivacaftor
IVA
Drug
Tablet for oral administration.
Part 1 Cohort 1A: TC
Part 1 Cohort 1B: TC
Part 1 Cohort 1C: TC
Part 2 Cohort 2A: TC
Part 2 Cohort 2A: TEZ/IVA
Part 2 Cohort 2B: TC
Part 2 Cohort 2B: TEZ/IVA
VX-770
Ivacaftor
Placebo
Drug
Placebo matched to VX-152.
Part 2 Cohort 2A: TEZ/IVA
Part 2 Cohort 2B: TEZ/IVA
Placebo
Drug
Placebo matched to VX-152/TEZ/IVA triple combination (TC).
Part 1: Placebo
Sweat samples were collected using an approved collection device.
From Baseline Through Day 29
Relative Change in 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
Relative 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
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 15 for Part 1 and Part 2 Cohort 2A
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
From Baseline at Day 15
Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 29 for Part 2 Cohort 2B
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
From Baseline at Day 29
Pre-dose Plasma Concentration (Ctrough) of VX-152, TEZ, M1-TEZ, IVA, and M1-IVA
Pre-dose at Day 8, Day 15 and Day 29
La Jolla
California
United States
Los Angeles
California
United States
Orlando
Florida
United States
Chicago
Illinois
United States
Peoria
Illinois
United States
St Louis
Missouri
United States
Chapel Hill
North Carolina
United States
Akron
Ohio
United States
Cleveland
Ohio
United States
Portland
Oregon
United States
Philadelphia
Pennsylvania
United States
Charleston
South Carolina
United States
Fort Worth
Texas
United States
Houston
Texas
United States
Madison
Wisconsin
United States
FG002
Part 1 Cohort 1B: TC
Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
FG003
Part 1 Cohort 1C: TC
Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
FG004
Part 2 Cohort 2A: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
FG005
Part 2 Cohort 2A: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
FG006
Part 2 Cohort 2B: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
FG007
Part 2 Cohort 2B: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
FG0008 subjects
FG0016 subjects
FG00210 subjects
FG00310 subjects
FG0044 subjects
FG00510 subjects
FG0067 subjects
FG00721 subjects
COMPLETED
FG0008 subjects
FG0016 subjects
FG00210 subjects
FG00310 subjects
FG0044 subjects
FG00510 subjects
FG0067 subjects
FG00721 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Placebo
Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.
BG001
Part 1 Cohort 1A: TC
Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
BG002
Part 1 Cohort 1B: TC
Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
BG003
Part 1 Cohort 1C: TC
Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
BG004
Part 2 Cohort 2A: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
BG005
Part 2 Cohort 2A: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
BG006
Part 2 Cohort 2B: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
BG007
Part 2 Cohort 2B: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0016
BG00210
BG00310
BG0044
BG00510
BG0067
BG00721
BG00876
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<18 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<40 percent
BG0001
BG0010
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Safety Set included all participants who received at least 1 dose of study drug in the treatment period.
Posted
Number
participants
Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)
ID
Title
Description
OG000
Part 1: Placebo
Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.
OG001
Part 1 Cohort 1A: TC
Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG002
Part 1 Cohort 1B: TC
Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG003
Part 1 Cohort 1C: TC
Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG004
Part 2 Cohort 2A: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG005
Part 2 Cohort 2A: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG006
Part 2 Cohort 2B: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG007
Part 2 Cohort 2B: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Units
Counts
Participants
OG0008
OG0016
OG00210
OG003
Title
Denominators
Categories
Participants with TEAEs
Title
Measurements
OG0008
OG0013
OG0027
OG003
Primary
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.
Full Analysis Set (FAS) included all randomized participants with the intended cystic fibrosis transmembrane conductance regulator protein (CFTR) allele mutation who received at least 1 dose of study drug in the treatment period. As pre-specified in analysis plan, only Part 1 and Part 2 Cohort 2A arms were assessed for this outcome measure.
Posted
Least Squares Mean
95% Confidence Interval
percentage points
From Baseline at Day 15
ID
Title
Description
OG000
Part 1: Placebo
Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.
OG001
Part 1 Cohort 1A: TC
Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG002
Part 1 Cohort 1B: TC
Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG003
Part 1 Cohort 1C: TC
Primary
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.
FAS. As pre-specified in analysis plan, only Part 2 Cohort 2B arms were assessed for this outcome measure.
Posted
Least Squares Mean
95% Confidence Interval
percentage points
From Baseline Through Day 29
ID
Title
Description
OG000
Part 2 Cohort 2B: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG001
Part 2 Cohort 2B: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Units
Counts
Participants
Secondary
Absolute Change in Sweat Chloride Concentrations at Day 15 for Part 1 and Part 2 Cohort 2A
Sweat samples were collected using an approved collection device.
FAS. As pre-specified in analysis plan, only Part 1 and Part 2 Cohort 2A arms were assessed for this outcome measure.
Posted
Least Squares Mean
95% Confidence Interval
millimole per liter (mmol/L)
From Baseline at Day 15
ID
Title
Description
OG000
Part 1: Placebo
Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.
OG001
Part 1 Cohort 1A: TC
Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG002
Part 1 Cohort 1B: TC
Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG003
Part 1 Cohort 1C: TC
Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
Secondary
Absolute Change in Sweat Chloride Concentrations Through Day 29 for Part 2 Cohort 2B
Sweat samples were collected using an approved collection device.
FAS. As pre-specified in analysis plan, only Part 2 Cohort 2B arms were assessed for this outcome measure.
Posted
Least Squares Mean
95% Confidence Interval
mmol/L
From Baseline Through Day 29
ID
Title
Description
OG000
Part 2 Cohort 2B: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG001
Part 2 Cohort 2B: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Units
Counts
Participants
Secondary
Relative Change in 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.
FAS. As pre-specified in analysis plan, only Part 1 and Part 2 Cohort 2A arms were assessed for this outcome measure.
Posted
Least Squares Mean
95% Confidence Interval
percent change
From Baseline at Day 15
ID
Title
Description
OG000
Part 1: Placebo
Participants received placebo matched to VX-152/TEZ/IVA for 2 weeks.
OG001
Part 1 Cohort 1A: TC
Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG002
Part 1 Cohort 1B: TC
Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG003
Part 1 Cohort 1C: TC
Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
Secondary
Relative 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.
FAS. As pre-specified in analysis plan, only Part 2 Cohort 2B arms were assessed for this outcome measure.
Posted
Least Squares Mean
95% Confidence Interval
percent change
From Baseline Through Day 29
ID
Title
Description
OG000
Part 2 Cohort 2B: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG001
Part 2 Cohort 2B: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Units
Counts
Participants
Secondary
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 15 for Part 1 and Part 2 Cohort 2A
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
FAS. As pre-specified in analysis plan, only Part 1 and Part 2 Cohort 2A arms were assessed for this outcome measure.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
From Baseline at Day 15
ID
Title
Description
OG000
Part 1: Placebo
Participants received placebo matched to VX-152/TEZ/IVA for 2 weeks.
OG001
Part 1 Cohort 1A: TC
Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG002
Part 1 Cohort 1B: TC
Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG003
Part 1 Cohort 1C: TC
Secondary
Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 29 for Part 2 Cohort 2B
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
FAS. As pre-specified in analysis plan, only Part 2 Cohort 2B arms were assessed for this outcome measure.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
From Baseline at Day 29
ID
Title
Description
OG000
Part 2 Cohort 2B: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG001
Part 2 Cohort 2B: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Units
Counts
Secondary
Pre-dose Plasma Concentration (Ctrough) of VX-152, TEZ, M1-TEZ, IVA, and M1-IVA
Pharmacokinetic Set (PK) included all participants who received at least 1 dose of study drug in treatment period. Here "Number Analyzed" signifies those participants who were evaluable at specified time points. Day 29 assessments were planned for Part 2: Cohort 2B groups only. VX-152 Ctrough category was not applicable to Part 2: TEZ/IVA groups.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Pre-dose at Day 8, Day 15 and Day 29
ID
Title
Description
OG000
Part 1 Cohort 1A: TC
Participants received VX-152 100 mg q12h/TEZ 100 qd/IVA 150 mg q12h TC for 2 weeks.
OG001
Part 1 Cohort 1B: TC
Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG002
Part 1 Cohort 1C: TC
Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG003
Part 2 Cohort 2A: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Time Frame
Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Placebo
Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.
0
8
2
8
8
8
EG001
Part 1 Cohort 1A: TC
Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
0
6
0
6
3
6
EG002
Part 1 Cohort 1B: TC
Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
0
10
0
10
7
10
EG003
Part 1 Cohort 1C: TC
Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
0
10
1
10
9
10
EG004
Part 2 Cohort 2A: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
0
4
0
4
3
4
EG005
Part 2 Cohort 2A: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
0
10
0
10
6
10
EG006
Part 2 Cohort 2B: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
0
7
0
7
5
7
EG007
Part 2 Cohort 2B: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
0
21
0
21
18
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Infective pulmonary exacerbation of cystic fibrosis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG0031 affected10 at risk
EG004
Viral infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG0031 affected10 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected7 at risk
EG0070 affected21 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Eye swelling
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected6 at risk
EG0022 affected10 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected10 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Post-tussive vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0022 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Thirst
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Vessel puncture site haemorrhage
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected10 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected10 at risk
EG003
Infective pulmonary exacerbation of cystic fibrosis
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007232
Infant, Newborn, Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000654124
tezacaftor, ivacaftor drug combination
C545203
ivacaftor
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0
BG0040
BG0050
BG0060
BG0070
BG0080
>=18 and <65 years
Title
Measurements
BG0008
BG0016
BG00210
BG00310
BG0044
BG00510
BG0067
BG00721
BG00876
>=65 years
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
4
BG0033
BG0042
BG0056
BG0064
BG00714
BG00839
Male
BG0004
BG0014
BG0026
BG0037
BG0042
BG0054
BG0063
BG0077
BG00837
0
BG0031
BG0040
BG0050
BG0060
BG0070
BG0083
Not Hispanic or Latino
BG0006
BG0016
BG00210
BG0039
BG0044
BG00510
BG0067
BG00721
BG00873
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
White
BG0007
BG0015
BG00210
BG00310
BG0044
BG00510
BG0067
BG00721
BG00874
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Unknown or Not Reported
BG0001
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0082
BG002
2
BG0031
BG0040
BG0050
BG0060
BG0070
BG0084
≥40 to <70 percent
BG0005
BG0016
BG0027
BG0034
BG0043
BG00510
BG0065
BG00718
BG00858
≥70 to ≤90 percent
BG0002
BG0010
BG0021
BG0035
BG0041
BG0050
BG0062
BG0073
BG00814
>90 percent
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
10
OG0044
OG00510
OG0067
OG00721
10
OG0043
OG0056
OG0065
OG00719
Participants with SAEs
Title
Measurements
OG0002
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG004
Part 2 Cohort 2A: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG005
Part 2 Cohort 2A: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Units
Counts
Participants
OG0008
OG0016
OG00210
OG00310
OG0044
OG00510
Title
Denominators
Categories
Title
Measurements
OG000-0.8(-4.8 to 3.3)
OG0015.7(1.0 to 10.3)
OG0029.7(6.1 to 13.3)
OG0038.0(4.0 to 12.0)
OG004-1.0(-9.9 to 7.8)
OG0057.3(1.9 to 12.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effects Model for Repeated Measure
0.0207
LS Mean Difference
6.4
2-Sided
95
0.3
12.6
Superiority
OG000
OG002
Mixed-effects Model for Repeated Measure
0.0002
LS Mean Difference
10.5
2-Sided
95
5.0
15.9
Superiority
OG000
OG003
Mixed-effects Model for Repeated Measure
0.0019
LS Mean Difference
8.8
2-Sided
95
3.0
14.5
Superiority
OG004
OG005
Mixed-effects Model for Repeated Measure
0.0540
LS Mean Difference
8.3
2-Sided
95
-2.1
18.7
Superiority
OG0007
OG00121
Title
Denominators
Categories
Title
Measurements
OG000-2.2(-6.6 to 2.1)
OG0016.5(4.0 to 9.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effects Model for Repeated Measure
0.0007
LS Mean Difference
8.7
2-Sided
95
3.7
13.8
Superiority
OG004
Part 2 Cohort 2A: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG005
Part 2 Cohort 2A: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Units
Counts
Participants
OG0008
OG0016
OG00210
OG00310
OG0044
OG00510
Title
Denominators
Categories
Title
Measurements
OG000-0.1(-8.4 to 8.3)
OG001-19.5(-29.1 to -10.0)
OG002-13.6(-21.4 to -5.8)
OG003-27.5(-35.0 to -20.1)
OG0043.5(-9.2 to 16.2)
OG005-21.3(-29.5 to -13.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effects Model for Repeated Measure
0.0018
Least Squares (LS) Mean Difference
-19.5
2-Sided
95
-32.2
-6.8
Superiority
OG000
OG002
Mixed-effects Model for Repeated Measure
0.0106
LS Mean Difference
-13.6
2-Sided
95
-25.0
-2.1
Superiority
OG000
OG003
Mixed-effects Model for Repeated Measure
<0.0001
LS Mean Difference
-27.5
2-Sided
95
-38.6
-16.3
Superiority
OG004
OG005
Mixed-effects Model for Repeated Measure
0.0017
LS Mean Difference
-24.8
2-Sided
95
-40.0
-9.7
Superiority
OG000
7
OG00121
Title
Denominators
Categories
Title
Measurements
OG0001.6(-6.8 to 10.0)
OG001-22.3(-27.3 to -17.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effects Model for Repeated Measure
<0.0001
LS Mean Difference
-23.9
2-Sided
95
-33.7
-14.1
Superiority
OG004
Part 2 Cohort 2A: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG005
Part 2 Cohort 2A: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Units
Counts
Participants
OG0008
OG0016
OG00210
OG00310
OG0044
OG00510
Title
Denominators
Categories
Title
Measurements
OG000-2.3(-9.8 to 5.3)
OG00110.3(1.6 to 19.0)
OG00219.0(12.3 to 25.8)
OG00314.8(7.3 to 22.4)
OG004-1.4(-17.1 to 14.4)
OG00513.2(3.7 to 22.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effects Model for Repeated Measure
0.0166
LS Mean Difference
12.5
2-Sided
95
1.1
24.0
Superiority
OG000
OG002
Mixed-effects Model for Repeated Measure
<0.0001
LS Mean Difference
21.3
2-Sided
95
11.2
31.4
Superiority
OG000
OG003
Mixed-effects Model for Repeated Measure
0.0013
LS Mean Difference
17.1
2-Sided
95
6.3
27.8
Superiority
OG004
OG005
Mixed-effects Model for Repeated Measure
0.0563
LS Mean Difference
14.5
2-Sided
95
-3.8
32.9
Superiority
OG0007
OG00121
Title
Denominators
Categories
Title
Measurements
OG000-2.0(-9.2 to 5.1)
OG00111.5(7.4 to 15.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effects Model for Repeated Measure
0.0012
LS Mean Difference
13.6
2-Sided
95
5.3
21.9
Superiority
Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.
OG004
Part 2 Cohort 2A: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG005
Part 2 Cohort 2A: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
Units
Counts
Participants
OG0008
OG0016
OG00210
OG00310
OG0044
OG00510
Title
Denominators
Categories
Title
Measurements
OG000-7.6(-18.6 to 3.4)
OG0016.6(-6.0 to 19.1)
OG00221.8(12.1 to 31.6)
OG00318.6(8.8 to 28.5)
OG0045.8(-8.0 to 19.6)
OG00510.6(1.9 to 19.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.0476
LS Mean Difference
14.1
2-Sided
95
-2.6
30.9
Superiority
OG000
OG002
ANCOVA
0.0001
LS Mean Difference
29.4
2-Sided
95
14.8
44.0
Superiority
OG000
OG003
ANCOVA
0.0006
LS Mean Difference
26.2
2-Sided
95
11.3
41.1
Superiority
OG004
OG005
Mixed-effects Model for Repeated Measure
0.2714
LS Mean Difference
4.8
2-Sided
95
-11.6
21.2
Superiority
Participants
OG0007
OG00121
Title
Denominators
Categories
Title
Measurements
OG0004.8(-3.7 to 13.3)
OG00116.1(11.2 to 21.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effects Model for Repeated Measure
0.0138
LS Mean Difference
11.3
2-Sided
95
1.3
21.2
Superiority
OG004
Part 2 Cohort 2A: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG005
Part 2 Cohort 2B: TEZ/IVA
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.
OG006
Part 2 Cohort 2B: TC
Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.