study to evaluate safety and efficacy of vesatolimod for the treatment of chronic hepatitis b virus in virally-suppressed participants

Conditions: Chronic Hepatitis B

Summary: the primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis b (chb) infection currently being treated with oral antivirals (oav). participants will be randomized in 3 sequential cohorts (cohorts a, b, and c). within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).


Eligibility criteria:
key inclusion criteria: * must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures * documented evidence of chb infection (eg, hepatitis b surface antigen \[hbsag\] positive for more than 6 months) with detectable hbsag levels at screening * have been on approved hbv oav treatment for ≥ 1 year prior to screening, with hbv dna below lower limit of quantitation (lloq), measured at least once, 6 or more months prior to screening, and hbv dna \< 20 iu/ml at screening * currently taking an approved hbv oav (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening * willing to provide blood sample for toll-like receptor 7 (tlr-7) and interleukin 28 b (il28b) single-nucleotide polymorphism (snp) assessment * must be willing and able to comply with all study requirements key exclusion criteria: * extensive bridging fibrosis or cirrhosis * laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function * coinfection with hepatitis c virus (hcv), hiv, or hepatitis d virus (hdv) * evidence of hepatocellular carcinoma * malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). participants under evaluation for possible malignancy are not eligible. * significant cardiovascular, pulmonary, or neurological disease * any of the following conditions that may worsen in response to interferon (ifn): * autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis) * poorly controlled diabetes mellitus * significant psychiatric disorders * thyroid disorder (unless controlled under treatment) * significant pulmonary diseases (eg, chronic obstructive pulmonary disease) * retinal disease * immunodeficiency disorders * received solid organ or bone marrow transplant * received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal ab, interferon) within 3 months of screening * use of another investigational agents within 3 months of screening * current alcohol or substance abuse judged by the investigator to potentially interfere with compliance * females who are pregnant or may wish to become pregnant during the study note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hepatitis b hbv gs-9620 tlr-7 agonist