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NCT05786573 (Obexelimab in Warm Autoimmune Hemolytic Anemia): BVCT ex-ante prediction vs. reported outcome

On 4 Dec 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 31 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (inferior to rituximab).

Clinical Trial

NCTID
NCT05786573
Acronym
SApHiAre
Drug Name
Obexelimab
Drug MoA
bifunction monoclonal antibody targeting CD19 and activating FcgammaRIIb
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Hemic and Lymphatic Diseases
Indication
Warm Autoimmune Hemolytic Anemia
Human Patients
134
Sponsor
Zenas BioPharma
Phase
Phase 3

Prediction of , index 1852

Prospective Prediction
Prediction Index
1852
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in durable Hgb response inferior to rituximab)
Technical Prediction
partial SUCCESS (statistically significant yet weak clinical benefit in durable Hgb response against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
27 days in advance
Readout Data Interpretation
obexelimab achieved an increase of >1g/dL of haemoglobin in 62.5% patients at week 24; inferior to rituximab that achieved an increase of >1g/dL of haemoglobin in 100% patients at week 8 (see add'l link below); obexelimab discontinued further development
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (inferior to rituximab)
Prediction Classification
True Negative (TN)

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 With An Open Label Safety and Dose Confirmation Run-In Period, To Evaluate the Efficacy and Safety of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
Phase
Phase 3
Status
Active not recruiting
Enrollment
134
Lead sponsor
Zenas BioPharma (USA), LLC
Conditions
Warm Autoimmune Hemolytic Anemia
Interventions
DRUG: Obexelimab; DRUG: Obexelimab; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-09-25
Primary completion
2026-06-30
Completion
2026-08-31
Primary outcomes
  • Safety and Dose Confirmation Run-in Period (SRP) (24 weeks)
  • Randomized Control Period (RCP) (24 weeks)

NCT05786573 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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