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NCT04221477 (Obinutuzumab in Lupus Nephritis): BVCT ex-ante prediction vs. reported outcome

On 15 May 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 26 Sep 2024 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe sufficient (FDA approved new medicine that hasn't demonstrated eGFR improvement in registrational trials).

Clinical Trial

NCTID
NCT04221477
Acronym
REGENCY
Drug Name
Obinutuzumab
Drug MoA
type II anti-CD20 mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Lupus Nephritis
Human Patients
252
Sponsor
Roche Group
Phase
Phase 3

Prediction of , index 1627

Prospective Prediction
Prediction Index
1627
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in eGFR)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in CRR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
134 days in advance
Readout Data Interpretation
obinutuzumab achieved superiority over SoC alone in complete renal response at week 76 and in two other two secondary endpoints; yet eGFR secondary endpoint not met.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modelling of MoA with respect to the eGFR endpoint that has been materially improved.
Clinical Benefit Conclusion
statistically significant and commercially maybe sufficient (FDA approved new medicine that hasn't demonstrated eGFR improvement in registrational trials)
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis
Phase
Phase 3
Status
Active not recruiting
Enrollment
271
Lead sponsor
Hoffmann-La Roche
Conditions
Lupus Nephritis
Interventions
DRUG: Obinutuzumab; DRUG: MMF; DRUG: Prednisone; DRUG: Placebo; DRUG: Methylprednisolone; DRUG: Acetaminophen; DRUG: Diphenhydramine
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2020-08-10
Primary completion
2024-08-15
Completion
2031-03-02
Results first posted
2025-11-06
Primary outcomes
  • Percentage of Participants With Complete Renal Response (CRR) (At Week 76)

NCT04221477 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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