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

Bluejay Therapeutics, Inc.

Status and phase: Enrolling; Phase 3

Conditions: Chronic Hepatitis D Infection

Treatments: Drug: Brelovitug 300 mg; Drug: Bulevirtide 2 mg and Brelovitug - 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07200908

BJT-778-302

2024-517167-23-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 neucleos(t)ide therapy.

Key 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 nonalcoholic steatohepatitis (NASH), 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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172 participants in 2 patient groups

Brelovitug

Experimental group

Description:

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

Treatment:

Drug: Brelovitug 300 mg

Bulevirtide for 48 weeks followed by brelovitug for 48 weeks

Active Comparator group

Description:

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.

Treatment:

Drug: Bulevirtide 2 mg and Brelovitug - 300 mg