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NCT05083364 (ARO-C3 in IgA nephropathy): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 10 Mar 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically probably significant and commercially TBD (pending eGFR data).

Clinical Trial

NCTID
NCT05083364
Drug Name
ARO-C3
Drug MoA
siRNA-GalNAc conjugate that suppresses APOC3 mRNA
Drug Modality
small interfering RNA (siRNA) antisense oligonucleotide
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
IgA nephropathy
Human Patients
62
Sponsor
Arrowhead Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 794

Prospective Prediction
Prediction Index
794
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
390 days in advance
Readout Data Interpretation
ARO-C3 achieved 87% C3 reduction; 89% UPCR reduction at week 24 without SAEs
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably significant and commercially TBD (pending eGFR data)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and/or Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Complement-Mediated Renal Disease
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
62
Lead sponsor
Arrowhead Pharmaceuticals
Conditions
C3 Glomerulopathy; IgA Nephropathy
Interventions
DRUG: ARO-C3; DRUG: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2022-02-01
Primary completion
2025-09-10
Completion
2025-09-10
Primary outcomes
  • Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Day 169 (up to day 169 (End of Study [EOS]))

NCT05083364 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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