NCT07454837

Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

Detailed description

This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).

Conditions

• Chronic Hepatitis D

Interventions

Type	Name	Description
DRUG	Brelovitug (BJT-778)	Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.
DRUG	Bulevirtide	Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.

Timeline

• Start date: 2026-02-26
• Primary completion: 2027-08-31
• Completion: 2029-03-30
• First posted: 2026-03-06
• Last updated: 2026-04-17

Locations

13 sites across 5 countries: Austria, France, Germany, Romania, United Kingdom

Regulatory

• FDA-regulated drug study