A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

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Vertex Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Cystic Fibrosis

Treatments

Drug: IVA
Drug: Placebo
Drug: TEZ/IVA
Drug: VX-445/TEZ/IVA

Study type

Interventional

Funder types

Industry

Identifiers

NCT03525548
VX17-445-103
2018-000184-89 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)

Enrollment

113 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Homozygous for the F508del mutation (F/F)
  • Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

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

Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

113 participants in 2 patient groups

TEZ/IVA
Active Comparator group
Description:
Following a run-in period of 4 weeks with Tezacaftor (TEZ)/Ivacaftor (IVA), participants received TEZ 100 milligram (mg)/IVA 150 mg as fixed-dose combination (FDC) tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the triple combination (TC) treatment period.
Treatment:
Drug: TEZ/IVA
Drug: Placebo
Drug: IVA
VX-445/TEZ/IVA TC
Experimental group
Description:
Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-445 200 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
Treatment:
Drug: VX-445/TEZ/IVA
Drug: Placebo
Drug: IVA

Trial documents
2

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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