Phase 2
Completed N=41
A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Source: ClinicalTrials.gov NCT02730208 ↗Enrolled (actual)
41
Serious AEs
51.2%
Results posted
Aug 2019
Primary outcomePrimary: Absolute Change in Total Brody/CF-CT Score — 0.90; 2.38 scores on a scale
Summary
The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Total Brody/CF-CT Score |
0.90; 2.38 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
20; 21; 8; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Homozygous for the F508del CFTR mutation
- Confirmed diagnosis of CF
- Percent predicted forced expiratory volume (ppFEV1) ≥70% of predicted normal for age, sex, and height during screening.
- Stable CF disease as judged by the investigator
Exclusion Criteria
- 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.
- An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug)
- Pregnant or nursing females.
- Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements.
- Any contraindication to undergoing chest imaging, as per the site's institutional guidelines
Data sourced from ClinicalTrials.gov (NCT02730208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.