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Trial record 7 of 16 for:    VX-661

A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02392234
First Posted: March 18, 2015
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
  Purpose
The purpose of this study is to evaluate the efficacy of VX-661 in combination with ivacaftor and ivacaftor monotherapy in subjects with Cystic Fibrosis (CF).

Condition Intervention Phase
Cystic Fibrosis Drug: VX-661/ivacaftor Drug: ivacaftor Drug: VX-661/ ivacaftor placebo Drug: ivacaftor placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Absolute Change From Study Baseline to Average of Week 4 and Week 8 Measurements in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, Week 4 and Week 8 of each treatment period ]

Secondary Outcome Measures:
  • Absolute Change From Study Baseline to Average of Week 4 and Week 8 Measurements in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score [ Time Frame: Baseline, Week 4 and Week 8 of each treatment period ]
  • Safety and tolerability assessments based on adverse events (AEs), clinical laboratory values, standard digital electrocardiograms (ECGs), vital signs, pulse oximetry, and spirometry [ Time Frame: Baseline up to 28 days after last dose (up to 28 weeks) ]
  • Relative Change From Study Baseline to Average of Week 4 and Week 8 Measurements in Percent Predicted FEV1 [ Time Frame: Baseline, Week 4 and Week 8 of each treatment period ]
  • Absolute Change From Study Baseline to Average of Week 4 and Week 8 Measurements in Sweat Chloride [ Time Frame: Baseline, Week 4 and Week 8 of each treatment period ]
  • Pharmacokinetic parameters; Area under the plasma concentration versus time curve (AUC), Peak Plasma Concentration (Cmax) of VX-661, M1-661, ivacaftor, and M1-ivacaftor, as determined by population analysis. [ Time Frame: Day 1 through Week 24 ]

Enrollment: 246
Study Start Date: March 2015
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VX-661/ ivacaftor combination

Morning dose: 1 tablet fixed-dose combination of VX-661 100 mg/ivacaftor 150 mg and 1 tablet ivacaftor placebo.

Evening dose: 1 tablet ivacaftor 150 mg

Drug: VX-661/ivacaftor Drug: ivacaftor Drug: ivacaftor placebo
Experimental: ivacaftor monotherapy

Morning dose: 1 tablet placebo visually matched to the fixed-dose combination tablet and 1 tablet ivacaftor 150 mg

Evening dose: 1 tablet ivacaftor 150 mg

Drug: ivacaftor Drug: VX-661/ ivacaftor placebo
Placebo Comparator: placebo

Morning dose: 1 tablet placebo visually matched to the fixed-dose combination tablet and 1 tablet placebo visually matched to ivacaftor 150 mg

Evening dose: 1 tablet placebo visually matched to ivacaftor 150 mg

Drug: VX-661/ ivacaftor placebo Drug: ivacaftor placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heterozygous for F508del-CFTR and a second allele with a CFTR mutation predicted to have residual function
  • Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to (≥) 40 percent (%) and less than or equal to (≤) 90% of predicted normal for age, sex, and height during screening.
  • Sweat chloride value ≥60 millimole per liter (mmol/L) from test results obtained during screening OR as documented in the subject's medical record.
  • Sweat chloride value less than (<) 60 mmol/L must have documented evidence of chronic sinopulmonary disease
  • Stable CF disease as judged by the investigator

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.
  • An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
  • A 12-lead electrocardiogram (ECG) demonstrating corrected QT interval (QTc) greater than (>) 450 milliseconds (msec) at the Screening Visit
  • History of solid organ or hematological transplantation
  • History or evidence of cataract, lens opacity, Y-suture, or lamellar rings determined to be clinically significant by the ophthalmologist during the ophthalmologic examination during the Screening Period
  • Ongoing or prior participation in an investigational drug study (including studies investigating VX-661, lumacaftor [VX-809], and/or ivacaftor) within 30 days of screening
  • Use of restricted medications or foods within the specified window before the first dose of study drug
  • Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Day 1).
  • Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
  • Colonization with organisms associated with a more rapid decline in pulmonary status
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392234


  Show 78 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
  More Information

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT02392234     History of Changes
Other Study ID Numbers: VX14-661-108
2014-004788-18 ( EudraCT Number )
First Submitted: March 12, 2015
First Posted: March 18, 2015
Last Update Posted: April 13, 2017
Last Verified: June 2016

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases


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