Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis D
• Intervention / Treatment: Drug: Brelovitug (BJT-778); Drug: Bulevirtide

Detailed Description

This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Mirum; Phone Number: +16506674085; Email: clinicaltrials@mirumpharma.com
• Study Contact Backup: Name: Medinfo Mirum; Email: medinfo@mirumpharma.com

Study Locations

• Austria
  • Graz, Austria, 8010
    • Recruiting
    • Medical University of Graz
• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • Fakultni Nemocnice Brno (University Hospital Brno)
  • Prague, Czechia, 12000
    • Recruiting
    • Klin Med Ltd. (KLIN MED s.r.o.)
  • Prague, Czechia, 14021
    • Recruiting
    • Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine)
• France
  • Bordeaux, France, 33076
    • Recruiting
    • CHU de Bordeaux
  • Clichy, France, 92110
    • Recruiting
    • Hospital Beaujon
  • Toulouse, France, 31400
    • Recruiting
    • CHU Toulouse Hospital Rangueil, Toulouse
• Germany
  • Düsseldorf, Germany, 40225
    • Recruiting
    • University Hospital of Düsseldorf
  • Frankfurt, Germany, 60323
    • Recruiting
    • Goethe University Frankfurt
  • Hanover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover
  • Rostock, Germany, 18057
    • Recruiting
    • Universitätsmedizin Rostock
• Romania
  • Bucharest, Romania, 030303
    • Recruiting
    • Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes
  • Bucharest, Romania, 21105
    • Recruiting
    • National Institute Of Infectious Diseases Prof. Dr. Matei Bals
  • Constanța, Romania, 900709
    • Recruiting
    • Spitalul Clinic de Boli Infectioase Constanta
  • Lasi
    • Iași, Lasi, Romania, 700023
      • Recruiting
      • Centrul Medical Unirea S.R.L
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic i Provincial de Barcelona
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall d'Hebron Hospital
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College Hospital NHS Foundation Trust
  • London, United Kingdom, SW109NH
    • Recruiting
    • Chelsea and Westminster Hospital
  • London, United Kingdom, E12AT
    • Recruiting
    • Barts Health NHS Trust
  • Manchester, United Kingdom, M13 9WL
    • Recruiting
    • Manchester University NHS Foundation Trust
  • Yorkshire
    • Cottingham, Yorkshire, United Kingdom, HU165JQ
      • Recruiting
      • Castle Hill Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. Male or female, ≥18 years of age at Screening.
3. Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.
4. Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.
5. HDV RNA ≥100 IU/mL at Screening.

Exclusion Criteria:

1. Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding).
2. Known history of immune-complex disease.
3. Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
4. Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis).
5. History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Switch to Brelovitug; Participants will switch to brelovitug 300 mg once weekly for 96 weeks.	Drug: Brelovitug (BJT-778); Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.; Other Names: BJT-778
Experimental: Delayed Switch from Bulevirtide to Brelovitug; Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks.	Drug: Bulevirtide; Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.; Other Names: Hepcludex; BJT-778

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])	The proportion of participants with undetectable HDV RNA (<LLOQ, TND) at Week 24	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs)	Incidence and severity of treatment-emergent adverse events (TEAEs) during brelovitug and bulevirtide treatment periods.	Up to Week 96
Proportion of participants who permanently discontinue treatment due to an adverse event	Proportion of participants who permanently discontinue study treatment because of an adverse event.	Up to Week 96
Change from baseline in serum total bile salts	Mean change from baseline in serum total bile salt levels.	Up to Week 96
Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)	Proportion of participants with virologic response at Weeks 24, 48, 72, and 96.	Up to Week 96
Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96.		Up to Week 96
Proportion of participants achieving undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96.		Up to Week 96
Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96.		Up to Week 96
Proportion of participants achieving normal ALT with virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)	Proportion of participants with normal ALT and virologic response at Weeks 24, 48, 72, and 96.	Up to Week 96
Proportion of participants achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96.		Up to Week 96
11. Proportion of participants achieving normal ALT with undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96		Up to Week 96
Change from baseline in HDV RNA	Change from baseline in HDV RNA levels over time during treatment.	Up to Week 96
Change from baseline in ALT levels	Change from baseline ALT levels over time during treatment.	Up to Week 96
Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up		Up to Week 48

Collaborators and Investigators

• Sponsor: Mirum Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis D; Hepatitis D, Chronic; bulevirtide
• Other Study ID Numbers: BJT-778-303

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