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

Phase 2

Withdrawn

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Imdusiran; Drug: Durvalumab

• Registration Number: NCT06245291
• Lead Sponsor: Arbutus Biopharma Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-07
• Study Start: 2024-05-01
• Status Verified: 2024-06
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Key

Exclusion Criteria

• 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	Imdusiran	Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints
Cohort B	Imdusiran	Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints
Cohort C	Imdusiran	Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints
Cohort A	Durvalumab	Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints
Cohort B	Durvalumab	Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints
Cohort C	Durvalumab	Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects	Up to 96 weeks	• 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

Secondary Outcome Measures

Name	Time	Method
To characterize the target engagement (TE) (pharmacodynamics [PD]) of durvalumab in CHB subjects over time	Up to 48 Weeks	• Measurement of soluble immune marker levels in plasma at multiple timepoints
To determine the proportion of subjects who meet NA treatment discontinuation criteria at Week 48	Up to Week 48	• Proportion of subjects at Week 48 who are HBeAg negative and meet protocol defined ALT, HBV DNA and HBsAg values
To determine the effect of imdusiran and durvalumab on HBsAg	Up to 96 Weeks	• Change in HBsAg levels from baseline during treatment and follow-up

Trial Locations

Locations (21)

China Medical University Hospital; 🇨🇳 Taichung City, Taiwan

The Hiv Netherlands Australia Thailand Research Collaboration; 🇹🇭 Bangkok, Thailand

Chia-yi Christian Hospital; 🇨🇳 Chia-Yi City, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan

Kaohsiung Medical University Chung-ho Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Infectious Diseases, AIDS and Clinical Immunology Research Center; 🇬🇪 Tbilisi, Georgia

LLC "Neolab"; 🇬🇪 Tbilisi, Georgia

Punkt Zdrowia Hlebowicz Jakubowski Lekarze Spółka Partnerska; 🇵🇱 Wrocław, Poland

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Arensia Exploratory Medicine Srl Romania in colaborare cu Institutul National de Boli Infectioase; 🇷🇴 Bucharest, Romania

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Naresuan University Hospital; 🇹🇭 Phitsanulok, Thailand

Imperial College Hospital; 🇬🇧 London, United Kingdom

Royal London Hospital; 🇬🇧 London, United Kingdom

Prince Of Wales Hospital - The Chinese University Of Hong Kong; 🇭🇰 Hong Kong, Hong Kong

Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand

ID Clinic Arkadiusz Pisula; 🇵🇱 Mysłowice, Poland