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A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis

NCT ID: NCT02951195

Last Updated: 2021-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part 1: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matched to VX-152/TEZ/IVA triple combination (TC).

Part 1 Cohort 1A: TC

Group Type EXPERIMENTAL

VX-152

Intervention Type DRUG

Tablet for oral administration.

TEZ/IVA

Intervention Type DRUG

Fixed-dose combination tablet for oral administration.

IVA

Intervention Type DRUG

Tablet for oral administration.

Part 1 Cohort 1B: TC

Group Type EXPERIMENTAL

VX-152

Intervention Type DRUG

Tablet for oral administration.

TEZ/IVA

Intervention Type DRUG

Fixed-dose combination tablet for oral administration.

IVA

Intervention Type DRUG

Tablet for oral administration.

Part 1 Cohort 1C: TC

Group Type EXPERIMENTAL

VX-152

Intervention Type DRUG

Tablet for oral administration.

TEZ/IVA

Intervention Type DRUG

Fixed-dose combination tablet for oral administration.

IVA

Intervention Type DRUG

Tablet for oral administration.

Part 2 Cohort 2A: TEZ/IVA

Group Type ACTIVE_COMPARATOR

TEZ/IVA

Intervention Type DRUG

Fixed-dose combination tablet for oral administration.

IVA

Intervention Type DRUG

Tablet for oral administration.

Placebo

Intervention Type DRUG

Placebo matched to VX-152.

Part 2 Cohort 2A: TC

Group Type EXPERIMENTAL

VX-152

Intervention Type DRUG

Tablet for oral administration.

TEZ/IVA

Intervention Type DRUG

Fixed-dose combination tablet for oral administration.

IVA

Intervention Type DRUG

Tablet for oral administration.

Part 2 Cohort 2B: TEZ/IVA

Group Type ACTIVE_COMPARATOR

TEZ/IVA

Intervention Type DRUG

Fixed-dose combination tablet for oral administration.

IVA

Intervention Type DRUG

Tablet for oral administration.

Placebo

Intervention Type DRUG

Placebo matched to VX-152.

Part 2 Cohort 2B: TC

Group Type EXPERIMENTAL

VX-152

Intervention Type DRUG

Tablet for oral administration.

TEZ/IVA

Intervention Type DRUG

Fixed-dose combination tablet for oral administration.

IVA

Intervention Type DRUG

Tablet for oral administration.

Interventions

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VX-152

Tablet for oral administration.

Intervention Type DRUG

TEZ/IVA

Fixed-dose combination tablet for oral administration.

Intervention Type DRUG

IVA

Tablet for oral administration.

Intervention Type DRUG

Placebo

Placebo matched to VX-152.

Intervention Type DRUG

Placebo

Placebo matched to VX-152/TEZ/IVA triple combination (TC).

Intervention Type DRUG

Other Intervention Names

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VX-661/VX-770 Tezacaftor/Ivacaftor VX-770 Ivacaftor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

Site Status

La Jolla, California, United States

Site Status

Los Angeles, California, United States

Site Status

Orlando, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Peoria, Illinois, United States

Site Status

St Louis, Missouri, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Akron, Ohio, United States

Site Status

Cleveland, Ohio, United States

Site Status

Portland, Oregon, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Charleston, South Carolina, United States

Site Status

Fort Worth, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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VX16-152-102

Identifier Type: -

Identifier Source: org_study_id

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