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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Hepatitis D Infection
• Intervention / Treatment: Drug: Brelovitug 300 mg; Drug: Brelovitug 900 mg; Drug: Delayed Treatment with Brelovitug 300mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • Camperdown, Australia
    • 101 Camperdown
  • Liverpool, Australia
    • 104 Liverpool
  • Victoria
    • Melbourne, Victoria, Australia
      • 102 Melbourne
• Bulgaria
  • Plovdiv, Bulgaria
    • 705 Plovdiv
  • Sofia, Bulgaria
    • 702 Bulgaria
  • Sofia, Bulgaria
    • 706 Sofia
  • Stara Zagora, Bulgaria
    • 704 Stara Zagora
  • Silven
    • Sliven, Silven, Bulgaria, 8800
      • 703 Sliven
• Canada
  • Calgary
    • Calgary, Calgary, Canada
      • 233 Calgary
  • Edmonton
    • Edmonton, Edmonton, Canada, T6G 2G5
      • 234 Alberta
  • Ontario
    • Toronto, Ontario, Canada
      • 231 Toronto
  • Quebec
    • Montreal, Quebec, Canada
      • 235 Montreal
• Georgia
  • Tbilisi, Georgia, 0105
    • 181 Tbilisi
  • Tbilisi, Georgia, 0105
    • 183 Tbilisi
  • Tbilisi, Georgia
    • 182 Tbilisi
• Israel
  • Beersheba, Israel
    • 211 Israel
  • Haifa District
    • Haifa, Haifa District, Israel
      • 212 Haifa
• Moldova
  • Chisinau, Moldova
    • 901 Chisinau
• New Zealand
  • Auckland, New Zealand
    • 001 Auckland
• Pakistan
  • Karachi
    • Karachi, Karachi, Pakistan
      • 221 Karachi City
• Serbia
  • Belgrade
    • Belgrade, Belgrade, Serbia
      • 291 Belgrade
• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye)
      • 191 Istanbul
• Ukraine
  • Kyiv, Ukraine, 01001
    • 110 Kyiv
• United States
  • California
    • Garden Grove, California, United States, 92840
      • 247 Garden Grove
    • Huntington Beach, California, United States, 92647
      • 242 Huntington Beach
    • Long Beach, California, United States, 90805
      • 252 Long Beach
    • Los Angeles, California, United States, 90033
      • 244 Los Angeles
  • Florida
    • Miami, Florida, United States, 33166
      • 250 Miami
  • Illinois
    • Chicago, Illinois, United States, 60612
      • 251, Illinois
  • Iowa
    • Cities in Iowa, Iowa, United States, 52242
      • 248 Lowa
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • 254 Baltimore
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • 241, Massachusetts
  • New York
    • New York, New York, United States, 10007
      • 245 New York
    • New York, New York, United States, 10065
      • 256 New York
    • New York, New York, United States, 10075
      • 253 New York
    • New York, New York, United States, 10075
      • 255 New York
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • 257 Philadelphia
  • Texas
    • San Antonio, Texas, United States, 78215
      • 249 San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brelovitug 300mg; Dose - brelovitug 300 mg Frequency- once weekly	Drug: Brelovitug 300 mg; Route of administration- Subcutaneous Injection
Experimental: Brelovitug 900mg; Dose - brelovitug 900 mg Frequency- once every 4 weeks	Drug: Brelovitug 900 mg; Route of administration- Subcutaneous Injection
Active Comparator: Delayed Treatment with brelovitug 300mg; Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly	Drug: Delayed Treatment with Brelovitug 300mg; Route of administration- Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with a composite endpoint	Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS	Frequency and severity of TEAEs and serious AEs	Weeks 24, 48, 96, and 120, if applicable
Percentage of participants that achieve that achieve virologic response and ALT normalization	Change from baseline in HDV RNA and ALT normalization	Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with a composite endpoint by treatment regimen	Compare the composite endpoint response (change from baseline HDV RNA and ALT normalization) between weekly versus every 4-week regimen of brelovitug	Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with HDV associated liver disease progression	Determined by an independent data monitoring committee based on changes in liver stiffness, APRI, CPT/MELD score (cirrhotic), and TEAEs.	Weeks 24, 48, 96, and 120, if applicable

Collaborators and Investigators

• Sponsor: Mirum Pharmaceuticals, Inc.
• Investigators: Study Director: Bluejay Therapeutics, Bluejay Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: HDV; Hepatitis Delta virus; Hepatitis D infection; Hepatitis D virus
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepatitis; Hepatitis D; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Time-to-Treatment; Treatment Delay
• Other Study ID Numbers: BJT-778-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No