A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).

Key facts

Study ID

NCT02951195

Run by

Vertex Pharmaceuticals Incorporated

People needed

80

Starts

2016-11-01

Expected to finish

2018-01-01

Last updated by the study team

2021-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to comply with scheduled visits, treatment pan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
• Body weight ≥35 kg.
• Sweat chloride value ≥ 60 mmol/L from test results obtained during screening.
• Subjects must have an eligible CFTR genotype:
• Cohorts 1A, 1B, 1C: Heterozygous for F508del and a minimal function mutation known or predicted not to respond to TEZ and/or IVA.
• Cohorts 2A, 2B: Homozygous for F508del.
• Subjects must have an FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height at the Screening Visit.
• Stable CF disease as judged by the investigator.
• Willing to remain on a stable CF medication regimen through the planned end of treatment or if applicable the Safety Follow-up Visit.

You may not qualify if…

• 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.
• History of cirrhosis with portal hypertension.
• Risk factors for Torsade de Pointes.
• History of hemolysis.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening.
• Clinically significant abnormal laboratory values at screening.
• An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before the first dose of study drug.
• Lung infection with organisms associated with a more rapid decline in pulmonary status.
• An acute illness not related to CF within 14 days before the first dose of study drug.
• A standard digital ECG demonstrating QTc >450 msec at screening.
• History of solid organ or hematological transplantation.
• History or evidence of cataract or lens opacity determined to be clinically significant by the ophthalmologist or optometrist, based on the ophthalmologic examination during the Screening Period.
• History of alcohol or drug abuse in the past year, including but not limited to, cannabis, cocaine, and opiates, as deemed by the investigator.
• Ongoing or prior participation in an investigational drug study with certain exceptions.
• Use of commercially available CFTR modulator within 14 days before screening (applies only to Cohorts 1A, 1B, and 1C).
• Pregnant or nursing females: Females of childbearing potential must have a negative pregnancy test at screening and Day 1.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orlando, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — St Louis, Missouri, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Fort Worth, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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