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NCT05662241 (Obexelimab in IgG4 Related Disease): BVCT ex-ante prediction vs. reported outcome

On 31 Jul 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 5 Jan 2026 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically significant yet commercially insufficient.

Clinical Trial

NCTID
NCT05662241
Acronym
INDIGO
Drug Name
Obexelimab
Drug MoA
bifunctional anti-CD19 x FcγRIIb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
IgG4 Related Disease
Human Patients
194
Sponsor
Zenas BioPharma
Phase
Phase 3

Prediction of , index 1999

Prospective Prediction
Prediction Index
1999
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit to GC in disease flare-free proportion slightly-to-moderately superior to inebilizumab + GC)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit to GC in disease flare-free proportion compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
158 days in advance
Readout Data Interpretation
obexelimab +GC met primary endpoint with placebo-adjusted 56% reduction in IgG4-RD flare risk (HR=0.44, p=0.0005), which is inferior to inebilizumab +GC that achieved placebo-adjusted 87% reduction in IgG4-RD flare risk (HR=0.13, p=0.0005) (see add'l link below); well tolerated
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modelling of FCgammaRIIb activation in the exact clinical setting of IgG4-RD that has been permanently improved
Clinical Benefit Conclusion
statistically significant yet commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With IgG4-Related Disease (INDIGO)
Phase
Phase 3
Status
Active not recruiting
Enrollment
194
Lead sponsor
Zenas BioPharma (USA), LLC
Conditions
IgG4 Related Disease
Interventions
DRUG: Obexelimab; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-01-09
Primary completion
2025-11-13
Completion
2029-02-15
Primary outcomes
  • Primary outcome measure (Randomization to Week 52)

NCT05662241 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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