NCT07298330

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.

Detailed description

The study consists of 3 study arms. Approximately 80 participants will be randomized 2:1:1 to one of the following treatment arms: Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks. Arm 2: Participants will receive brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks. Arm 3: Participants will attend study clinic visits and delay treatment with brelovitug for 12 weeks. At Week 12, participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.

Conditions

• Chronic Hepatitis D Infection

Interventions

Type	Name	Description
DRUG	Brelovitug 300 mg	Route of administration- Subcutaneous Injection
DRUG	Brelovitug 900 mg	Route of administration- Subcutaneous Injection
DRUG	Delayed Treatment with Brelovitug 300mg	Route of administration- Subcutaneous Injection

Timeline

• Start date: 2026-01-14
• Primary completion: 2026-08-01
• Completion: 2029-01-01
• First posted: 2025-12-23
• Last updated: 2026-03-02

Locations

27 sites across 10 countries: United States, Belgium, Bulgaria, Georgia, Hungary, Israel, Pakistan, Taiwan, Ukraine, Uzbekistan

Regulatory

• FDA-regulated drug study