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

Mirum Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Chronic Hepatitis D Infection

Treatments: Drug: Brelovitug 900 mg; Drug: Brelovitug 300 mg; Drug: Delayed Treatment with Brelovitug 300mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07298330

2025-522105-38-00 (EU Trial (CTIS) Number)

BJT-778-304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing and able to provide written informed consent
2. Chronic HDV infection
3. HDV RNA >500 IU/mL at Screening
4. ALT >ULN at Screening
5. Willing to take or already taking HBV nucleos(t)ide therapy.

Exclusion criteria

1. Pregnant or nursing females
2. Unwilling to comply with contraception requirements during the study
3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
5. Solid organ or bone marrow transplantation
6. Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.

Note - Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Brelovitug 300 mg

Experimental group

Description:

Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks

Treatment:

Drug: Brelovitug 300 mg

Brelovitug 900 mg

Experimental group

Description:

Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks

Treatment:

Drug: Brelovitug 900 mg

Delayed treatment with brelovitug 300 mg

Active Comparator group

Description:

Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks

Treatment:

Drug: Delayed Treatment with Brelovitug 300mg