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NCT05067127 (Pegcetacoplan in C3 glomerulopathy or immune-complex membranoproliferative glomerulonephritis): BVCT ex-ante prediction vs. reported outcome

On 14 May 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 8 Aug 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
NCT05067127
Acronym
VALIANT
Drug Name
Pegcetacoplan
Drug MoA
PEGylated C3b inhibitor
Drug Modality
PEGylated peptide
Drug Class
First-In-Class
Therapeutic Area
Urogenital Diseases
Indication
C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN)
Human Patients
90
Sponsor
Apellis Pharmaceuticals
Phase
Phase 3

Prediction of , index 882

Prospective Prediction
Prediction Index
882
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in eGFR)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
86 days in advance
Readout Data Interpretation
Pegcetacoplan achieved 68% placebo-adjusted reduction in proteinuria (p<0.0001) and statistically significant improvement in eGFR secondary endpoint.
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 Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
Phase
Phase 3
Status
Completed
Enrollment
124
Lead sponsor
Apellis Pharmaceuticals, Inc.
Conditions
C3G; IC-MPGN; C3 Glomerulopathy; C3 Glomerulonephritis; Complement 3 Glomerulopathy; Complement 3 Glomerulopathy (C3G); Complement 3 Glomerulonephritis; Dense Deposit Disease; DDD; Membranoproliferative Glomerulonephritis; Membranoproliferative Glomerulonephritis (MPGN); Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Interventions
DRUG: Pegcetacoplan; OTHER: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2021-11-12
Primary completion
2024-06-26
Completion
2025-01-14
Results first posted
2025-08-06
Primary outcomes
  • Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26 (Baseline (Day -70 to Day 1) to Week 26)

NCT05067127 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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