BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04716231 (Atacicept in IgA Nephropathy): BVCT ex-ante prediction vs. reported outcome

On 23 Jan 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 2 Jun 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (yet weak UPCR slightly inferior to sparsentan) and commercially TBD (eGFR data pending).

Clinical Trial

NCTID
NCT04716231
Acronym
ORIGIN 3
Drug Name
Atacicept
Drug MoA
recombinant fusion protein anti-BAFF and anti-APRIL inhibitor
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
IgA Nephropathy
Human Patients
376
Sponsor
Vera Therapeutics
Phase
Phase 3

Prediction of , index 1884

Prospective Prediction
Prediction Index
1884
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in eGFR inferior to budesonide/sparsentan/iptacopan)
Technical Prediction
partial SUCCESS (statistically maybe significant yet moderate clinical benefit in UPCR compared with placebo inferior to budesonide/sparsentan/iptacopan)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
130 days in advance
Readout Data Interpretation
tacicept achieved 42% placebo-adjusted UPCR at week 36 (p<0.0001); slightly inferior to sparsentan’s 45% placebo-adjusted UPCR at week 36 (using 5% UPCR reduction in the placebo group (see add'l link below); eGFR data pending
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (yet weak UPCR slightly inferior to sparsentan) and commercially TBD (eGFR data pending)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IgAN)
Phase
Phase 3
Status
Active not recruiting
Enrollment
376
Lead sponsor
Vera Therapeutics, Inc.
Conditions
IgA Nephropathy; Berger Disease
Interventions
BIOLOGICAL: Atacicept; OTHER: Placebo to match Atacicept
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-06-29
Primary completion
2025-05-15
Completion
2028-07
Primary outcomes
  • Change from baseline in urine protein to creatinine ratio (UPCR) (36 Weeks)

NCT04716231 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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