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

Arbutus Biopharma

Status and phase: Withdrawn; Phase 2

Conditions: Hepatitis B, Chronic

Treatments: Drug: Imdusiran; Drug: Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06245291

AB-729-203

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Cohort A

Experimental group

Description:

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

Treatment:

Drug: Durvalumab

Drug: Imdusiran

Cohort B

Experimental group

Description:

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

Treatment:

Drug: Durvalumab

Drug: Imdusiran

Cohort C

Experimental group

Description:

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

Treatment:

Drug: Durvalumab

Drug: Imdusiran