Hepatitis B, Chronic
Conditions
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
Interventions
DRUGImdusiran
subcutaneous injection
DRUGDurvalumab
intravenous injection
Sponsors
Arbutus Biopharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Georgia, Hong Kong, Poland, Romania, Spain, Taiwan, Thailand, United Kingdom
Outcome results
None listed