A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

Bluejay Therapeutics, Inc.

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Chronic Hepatitis D Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06907290

BJT-778-301

Details and patient eligibility

About

This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.

Full description

Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms:

• Arm 1: Participants randomized to Arm 1 will receive brelovitug 300 mg subcutaneously once weekly.
• Arm 2: Participants randomized to Arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks.
• Arm 3: Participants randomized to Arm 3 will attend study clinic visits and delay treatment with brelovitug. At Week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide written informed consent.
• Chronic HDV infection
• HDV RNA >500 IU/mL at Screening.
• Abnormal ALT (>upper limit of normal) at Screening.
• Willing to take or already taking HBV nucleos(t)ide therapy

Exclusion criteria

• Pregnant or nursing females.
• Unwilling to comply with contraception requirements during the study.
• Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
• Presence of other liver disease(s) (does not include HBV or HDV infection) such as non-alcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
• Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
• Solid organ or bone marrow transplantation Note: other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Brelovitug 300mg

Experimental group

Description:

Dose - brelovitug 300 mg Frequency- once weekly

Treatment:

Drug: Brelovitug 300 mg

Brelovitug 900mg

Experimental group

Description:

Dose - brelovitug 900 mg Frequency- once every 4 weeks

Treatment:

Drug: Brelovitug 900 mg

Delayed Treatment with brelovitug 300mg

Active Comparator group

Description:

Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly

Treatment:

Drug: Delayed Treatment with Brelovitug 300mg