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

Conditions

• Chronic Hepatitis D Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Brelovitug 300 mg — DRUG
  Route of administration- Subcutaneous Injection
• Brelovitug 900 mg — DRUG
  Route of administration- Subcutaneous Injection
• Delayed Treatment with Brelovitug 300mg — DRUG
  Route of administration- Subcutaneous Injection

Study Details

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.

Key Dates

Start date

Jan 14, 2026

Status verified

Feb 2026

Primary completion

Aug 31, 2026

Completion

Jan 31, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Brelovitug 300 mg
  Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
• Experimental: Brelovitug 900 mg
  Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks
• Active Comparator: Delayed treatment with brelovitug 300 mg
  Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks

Primary Outcome Measure

Percentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm [ Time Frame: Week 24 ]

Central Contacts

• Clinical Trials Mirum
  +16506674085
  [email protected]
• Mirum Pharmaceuticals, Inc., Clinical Trials

Locations (8)

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