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NCT05076149 (VX-121/TEZ/D-IVA ELX/TEZ/IVA IVA in Cystic Fibrosis): BVCT ex-ante prediction vs. reported outcome

On 3 Dec 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 5 Feb 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (once-daily).

Clinical Trial

NCTID
NCT05076149
Acronym
SKYLINE 103
Drug Name
VX-121/TEZ/D-IVA ELX/TEZ/IVA IVA
Drug MoA
CFTR modulator
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Cystic Fibrosis
Human Patients
597
Sponsor
Vertex Pharmaceuticals
Phase
Phase 3

Prediction of , index 1277

Prospective Prediction
Prediction Index
1277
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit with once-daily dosing regimen)
Technical Prediction
SUCCESS (statistically significant clinical benefit non-inferior and non-superior to Trikafta)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
64 days in advance
Readout Data Interpretation
all primary and key secondary endpoints of non-inferiority are met
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (once-daily)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation
Phase
Phase 3
Status
Completed
Enrollment
597
Lead sponsor
Vertex Pharmaceuticals Incorporated
Conditions
Cystic Fibrosis
Interventions
DRUG: VX-121/TEZ/D-IVA; DRUG: ELX/TEZ/IVA; DRUG: IVA; DRUG: Placebo (matched to VX-121/TEZ/D-IVA); DRUG: Placebo (matched to ELX/TEZ/IVA); DRUG: Placebo (matched to IVA)
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-10-27
Primary completion
2023-05-18
Completion
2023-11-30
Results first posted
2024-06-13
Primary outcomes
  • Absolute Change in Percent Predicted Forced Expiratory Volume in 1second (ppFEV1) (From Baseline Through Week 24)

NCT05076149 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials