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NCT06907290 (Brelovitug in Chronic Hepatitis Delta Virus Infection): BVCT ex-ante prediction vs. reported outcome

On 21 Feb 2026, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 27 Apr 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT06907290
Acronym
AZURE-1
Drug Name
Brelovitug (BJT-778)
Drug MoA
targeting hepatitis B surface antigen (HBsAg) Brelovitug
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Chronic Hepatitis Delta Virus (HDV) Infection
Human Patients
108
Sponsor
Mirum Pharmaceuticals
Phase
Phase 2 Phase 3

Prediction of , index 2128

Prospective Prediction
Prediction Index
2128
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient clinical benefit in on-treatment HDV TND and off-treatment HDV TND slightly-to-moderately superior to bulevirtide/peginterferon alfa-2a yet slightly-to-moderately inferior to elebsiran + tobevibart
Technical Prediction
SUCCESS (statistically significant clinical benefit in the composite endpoint compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
65 days in advance
Readout Data Interpretation
Brelovitug 300mg QW achieved 30% HDV RNA TND and 45% ALT Normalisation at week 24, which are inferior to 41% HDV RNA TND and 47% ALT normalisation at Week 24 achieved by tobevibart + elebsiran (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-1)
Phase
Phase 2, Phase 3
Status
Active not recruiting
Enrollment
150
Lead sponsor
Mirum Pharmaceuticals, Inc.
Conditions
Chronic Hepatitis D Infection
Interventions
DRUG: Brelovitug 300 mg; DRUG: Brelovitug 900 mg; DRUG: Delayed Treatment with Brelovitug 300mg
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2025-03-25
Primary completion
2029-05
Completion
2029-09
Primary outcomes
  • Percentage of participants with a composite endpoint (Week 24)

NCT06907290 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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