Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection

NCT06245291 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: AB-729-203
• Study Type: interventional
• Target: N/A
• Locations: 8 countries
• Sites: 22

Brief Summary

This is a phase 2a, open-label, multicenter study investigating the safety, tolerability, and antiviral activity of durvalumab administered at targeted times during a 48-week treatment period of imdusiran in virologically-suppressed CHB subjects

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects

  • Number of participants with treatment emergent adverse events (TEAEs), immune related adverse events (irAEs), with discontinuations due to adverse events (AEs) and irAEs, with abnormal laboratory tests results, abnormal Vital signs, abnormal physical exam findings and abnormal electrocardiogram (ECG) readings

  Up to 96 weeks

Secondary Outcomes (3)

• To determine the effect of imdusiran and durvalumab on HBsAg

  Up to 96 Weeks

• To characterize the target engagement (TE) (pharmacodynamics [PD]) of durvalumab in CHB subjects over time

  Up to 48 Weeks

• To determine the proportion of subjects who meet NA treatment discontinuation criteria at Week 48

  Up to Week 48

Study Arms (3)

Cohort A

EXPERIMENTAL

Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints

Drug: Imdusiran; Drug: Durvalumab

Cohort B

EXPERIMENTAL

Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints

Drug: Imdusiran; Drug: Durvalumab

Cohort C

EXPERIMENTAL

Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints

Drug: Imdusiran; Drug: Durvalumab

Interventions

Imdusiran DRUG

subcutaneous injection

Cohort A; Cohort B; Cohort C

Durvalumab DRUG

intravenous injection

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the ages of 18-65
• Willing and able to provide informed consent
• Willing to follow protocol-specified contraception requirement

You may not qualify if:

• Have extensive fibrosis or cirrhosis of the liver
• Have or had liver cancer (hepatocellular carcinoma)
• Family history or personal history/current thyroid disease on or off replacement therapy
• Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
• Females who are breastfeeding, pregnant or who wish to become pregnant during the study
• Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.

Sponsors & Collaborators

• Arbutus Biopharma Corporation: lead

Study Sites (22)

Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, 0160, Georgia

Location

LLC "Neolab"

Tbilisi, 0186, Georgia

Location

Prince Of Wales Hospital - The Chinese University Of Hong Kong

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska

Gdansk, Poland

Location

ID Clinic Arkadiusz Pisula

Mysłowice, Poland

Location

Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska

Wroclaw, Poland

Location

Arensia Exploratory Medicine Srl Romania in colaborare cu Institutul National de Boli Infectioase

Bucharest, Romania

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Chia-yi Christian Hospital

Chia-Yi City, Taiwan

Location

Kaohsiung Medical University Chung-ho Memorial Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

The Hiv Netherlands Australia Thailand Research Collaboration

Bangkok, Thailand

Location

Srinagarind Hospital

Khon Kaen, Thailand

Location

Naresuan University Hospital

Phitsanulok, Thailand

Location

Imperial College Hospital

London, United Kingdom

Location

Royal London Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 7, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-06

Locations

TH (5); RO (1); PL (3); GB (2); ES (2); GE (2); TW (5); HK (2)