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

Hepatitis B, Chronic Clinical Trial

Official title:

A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects With Chronic HBV Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245291
• Other study ID #: AB-729-203
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: July 2027

Study information

• Verified date: February 2024
• Source: Arbutus Biopharma Corporation
• Contact: Arbutus Biopharma
• Phone: 267-469-0914
• Email: clinicaltrials[@]arbutusbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Imdusiran
subcutaneous injection
• Durvalumab
intravenous injection

Locations

Country	Name	City	State
Georgia	Infectious Diseases, AIDS and Clinical Immunology Research Center	Tbilisi
Georgia	LLC "Neolab"	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Arbutus Biopharma Corporation

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the effect of imdusiran and durvalumab on HBsAg	• Change in HBsAg levels from baseline during treatment and follow-up	Up to 96 Weeks
Secondary	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	Up to 48 Weeks
Secondary	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	Up to Week 48