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A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy

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ClinicalTrials.gov Identifier: NCT03447262
Recruitment Status : Active, not recruiting
First Posted : February 27, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Description
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Brief Summary:
This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: VX-659 Drug: TEZ Drug: IVA Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : April 24, 2021
Estimated Study Completion Date : April 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open-label triple combination

Subjects will receive 240 mg VX-659 / 100 mg TEZ / 150 mg IVA as FDC tablets in the morning and 150 mg IVA as mono tablet in the evening.

Parent studies are Phase 3 Vertex studies investigating VX-659 in combination with TEZ and IVA. This includes Studies VX17-659-102 and VX17-659-103.

 Drug: VX-659
Fixed-dose combination (FDC) tablets (VX-659/TEZ/IVA)

Drug: TEZ
FDC tablets (VX-659/TEZ/IVA)
Other Name: tezacaftor; VX-661

Drug: IVA
FDC tablets (VX-659/TEZ/IVA)
Other Name: ivacaftor; VX-770

Drug: IVA
IVA tablet
Other Name: ivacaftor


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of long-term treatment with VX-659 in TC with TEZ and IVA based on adverse events (AEs) [ Time Frame: from baseline through safety follow-up (up to 100 weeks) ]

Secondary Outcome Measures :
  1. Absolute change from baseline in ppFEV1 [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  2. Absolute change in sweat chloride (SwCl) [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  3. Number of pulmonary exacerbations (PEx) [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  4. Time to first PEx [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  5. Absolute change in body mass index (BMI) [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  6. Absolute change in BMI z-score [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  7. Absolute change in body weight [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  8. Absolute change from baseline in CFQ-R respiratory domain score [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]

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

Inclusion Criteria:

  • Completed study drug treatment in a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.

Exclusion Criteria:

  • History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
  • Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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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): NCT03447262


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Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT03447262     History of Changes
Other Study ID Numbers: VX17-659-105
2017-004134-29 ( EudraCT Number )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
 Genetic Diseases, Inborn
Infant, Newborn, Diseases
Ivacaftor
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action