NCT07200908

A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (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 evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.

Detailed description

Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 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 bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.

Conditions

• Chronic Hepatitis D Infection

Interventions

Type	Name	Description
DRUG	Brelovitug 300 mg	Route of administration- Subcutaneous Injection
DRUG	Bulevirtide 2 mg and Brelovitug - 300 mg	Route of Administration- Subcutaneous Injection

Timeline

• Start date: 2025-08-27
• Primary completion: 2027-06-30
• Completion: 2029-09-30
• First posted: 2025-10-01
• Last updated: 2026-03-27

Locations

44 sites across 10 countries: Austria, Czechia, France, Germany, Italy, Romania, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study