A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis

A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).

Key Inclusion Criteria:

• Homozygous for F508del or heterozygous for F508del and an RF mutation (as defined in the protocol).
• Participants with ppFEV1 of ≥70 percentage points adjusted for age, sex, height.
• Participants with a screening LCI2.5 result ≥7.5.
• Participants who are able to swallow tablets.

Key Exclusion Criteria:

• Clinically significant cirrhosis with or without portal hypertension.
• Colonization with organisms associated with a more rapid decline in pulmonary status.
• Solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.