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NCT05422222 (VX-121/TEZ/D-IVA in Cystic Fibrosis): BVCT ex-ante prediction vs. reported outcome

On 12 Oct 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
NCT05422222
Acronym
RIDGELINE 105
Drug Name
VX-121/TEZ/D-IVA
Drug MoA
CFTR modulator
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Cystic Fibrosis
Human Patients
210
Sponsor
Vertex Pharmaceuticals
Phase
Phase 3

Prediction of , index 1278

Prospective Prediction
Prediction Index
1278
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
116 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 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of Age
Phase
Phase 3
Status
Active not recruiting
Enrollment
210
Lead sponsor
Vertex Pharmaceuticals Incorporated
Conditions
Cystic Fibrosis
Interventions
DRUG: VX-121/TEZ/D-IVA
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-06-21
Primary completion
2030-06-30
Completion
2030-06-30
Primary outcomes
  • Part A: Observed Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ, D-IVA, and Relevant Metabolites (From Day 1 up to Day 22)
  • Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 up to Day 50)
  • Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 28)

NCT05422222 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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