Clinical trial NCT06907290: A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
Official title: A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Chronic Hepatitis D Infection
Keywords: Hepatitis Delta virus
HDV
Hepatitis D infection
Hepatitis D virus
Lead sponsor: Bluejay Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with a composite endpoint
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS
timeFrame: Weeks 24, 48, 96, and 120, if applicable
measure: Percentage of participants that achieve that achieve virologic response and ALT normalization
timeFrame: Weeks 24, 48, 96, and 120, if applicable
measure: Percentage of participants with a composite endpoint by treatment regimen
timeFrame: Weeks 24, 48, 96, and 120, if applicable
measure: Percentage of participants with HDV associated liver disease progression
timeFrame: Weeks 24, 48, 96, and 120, if applicable
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Garden Grove
state: California
city: Huntington Beach
country: United States
facility: Huntington Beach
state: California
city: Long Beach
country: United States
facility: Long Beach
state: California
city: Miami
country: United States
facility: Miami
state: Florida
city: San Antonio
country: United States
facility: San Antonio
state: Texas
city: Chisinau
country: Moldova, Republic of
facility: Chisinau
Study officials:
affiliation: Bluejay Therapeutics
name: Bluejay Therapeutics
role: STUDY_DIRECTOR
References: