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NCT05526066 (ARCT810 in Ornithine Transcarbamylase Deficiency): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 30 Jun 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably sufficient (no FDA approved drug for OTCD).

Clinical Trial

NCTID
NCT05526066
Drug Name
ARCT810
Drug MoA
LNP-delivered OTC
Drug Modality
mRNA medicine
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Ornithine Transcarbamylase Deficiency (OTCD)
Human Patients
8
Sponsor
Arcturus Therapeutics
Phase
Phase 2

Prediction of , index 492

Prospective Prediction
Prediction Index
492
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
502 days in advance
Readout Data Interpretation
ARCT810 achieved -2.5 µmol/L/day glutamine levels and +14.7% RUF (p=0.026)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably sufficient (no FDA approved drug for OTCD)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Nested Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARCT-810 in Adolescent and Adult Participants With Ornithine Transcarbamylase Deficiency
Phase
Phase 2
Status
Terminated
Enrollment
8
Lead sponsor
Arcturus Therapeutics, Inc.
Conditions
Ornithine Transcarbamylase Deficiency; OTC Deficiency; OTCD
Interventions
BIOLOGICAL: ARCT-810; OTHER: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2022-10-17
Primary completion
2024-10-31
Completion
2024-10-31
Primary outcomes
  • Incidence, severity and dose-relationship of adverse events (AEs) (Week 23)

NCT05526066 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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