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NCT05712538 (ARCT-032 in Cystic Fibrosis): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 28 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05712538
Drug Name
ARCT-032
Drug MoA
LNP-delivered CTFR mRNA medicine
Drug Modality
mRNA medicine
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Cystic Fibrosis
Human Patients
38
Sponsor
Arcturus Therapeutics
Phase
Phase 1

Prediction of , index 1461

Prospective Prediction
Prediction Index
1461
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
104 days in advance
Readout Data Interpretation
4% FEV1 improvement at day 8 (no SoC for mutation-agnostic CF).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Study in Two Parts: (Phase 1) A Randomized, Double-blinded, Placebo--controlled, Single-ascending-dose Study in Healthy Adult Subjects and (Phase 1b) an Open-label, Nested, Divided-dose Study in Adults With Cystic Fibrosis to Assess the Safety, Tolerability, and Pharmacokinetics of ARCT-032
Phase
Phase 1
Status
Completed
Enrollment
39
Lead sponsor
Arcturus Therapeutics, Inc.
Conditions
Cystic Fibrosis
Interventions
DRUG: ARCT-032; OTHER: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-02-15
Primary completion
2024-07-29
Completion
2024-07-29
Primary outcomes
  • Incidence, severity and dose-relationship of AEs (4 weeks)

NCT05712538 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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