BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05732402 (Povetacicept in immunoglobulin A nephropathy; membranous nephropathy; lupus-related…): BVCT ex-ante prediction vs. reported outcome

On 2 Oct 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 12 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant in UPCR and commercially insufficient for eGFR.

Clinical Trial

NCTID
NCT05732402
Acronym
RUBY-3
Drug Name
Povetacicept (ALPN-303)
Drug MoA
dual APRIL/BAFF antagonist
Drug Modality
Fc fusion protein
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
immunoglobulin A (IgA) nephropathy; membranous nephropathy; lupus-related kidney disease (lupus nephritis); anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis
Human Patients
56
Sponsor
ALPN Alpine Immune Sciences / Vertex Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 1260

Prospective Prediction
Prediction Index
1260
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit due to low clinical efficacy on eGFR)
Technical Prediction
SUCCESS (statistically significant clinical benefit for proteinuria)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
254 days in advance
Readout Data Interpretation
-47% UPCR and -0.2mL eGFR at 24 weeks (vs -18% UPCR and +1.0mL eGFR at 24 weeks by Tarpeyo).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant in UPCR and commercially insufficient for eGFR
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
An Open-Label, Multiple-Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Different Dose Levels of Povetacicept in Subjects With Autoantibody-Associated Glomerular Diseases (RUBY-3)
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
72
Lead sponsor
Alpine Immune Sciences, Inc.
Conditions
Lupus Nephritis; Immunoglobulin A Nephropathy; Membranous Nephropathy; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Interventions
DRUG: Povetacicept
Design
Single group · None
Primary purpose
Treatment
Start
2023-03-15
Primary completion
2028-03-02
Completion
2028-03-02
Primary outcomes
  • Part A: Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Study Day 1 Through 24 Weeks After Last Dose Of Study Drug)
  • Part B: Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Study Day 1 Through 12 Weeks After Last Dose Of Study Drug)

NCT05732402 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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