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

Arbutus Biopharma Corporation

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hepatitis B, Chronic

Interventions

ImdusiranDRUG

subcutaneous injection

DurvalumabDRUG

intravenous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Key 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.

Locations (22)

Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, Georgia

Outcomes

Primary Outcomes

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

Time frame: Up to 96 weeks

Secondary Outcomes

To determine the effect of imdusiran and durvalumab on HBsAg

• Change in HBsAg levels from baseline during treatment and follow-up

Time frame: Up to 96 Weeks

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

• Measurement of soluble immune marker levels in plasma at multiple timepoints

Time frame: Up to 48 Weeks

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

• Proportion of subjects at Week 48 who are HBeAg negative and meet protocol defined ALT, HBV DNA and HBsAg values

Time frame: Up to Week 48

Data from ClinicalTrials.gov

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