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A Phase 3 Open-label Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older Homozygous or Heterozygous for the F508del-CFTR Mutation

Study on Safety and Tolerability of Investigational Medication for Genetic Disorder Affecting Lungs and Digestion

Recruiting
6 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study investigates the safety and tolerability of an investigational medication for cystic fibrosis. Cystic fibrosis is a genetic disorder that affects the lungs and digestive system. The study focuses on individuals aged 6 years and older who have a specific genetic mutation called F508del.

Participants will either receive the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will monitor participants for any side effects and how well they tolerate the treatment.

  • Who can participate: Participants must be 6 years or older with cystic fibrosis and have the F508del mutation in both gene copies or in combination with another responsive mutation.
  • Study details: Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
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Study details
    cystic fibrosis

TX9368

19 February 2024

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