A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)

NCT06963710 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ALG-000184-202
• Study Type: interventional
• Target: 200
• Locations: 14 countries
• Sites: 58

Brief Summary

This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.

Conditions

Chronic Hepatitis B Infection

Keywords

Capsid Assembly Modulators; CAMs; CHB; HBV; Chronic Hepatitis B; Hepatitis B Infection; Hepatitis B

Outcome Measures

Primary Outcomes (2)

• HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected)

  HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target detected or target not detected) at Week 48

  48 weeks

• HBeAg negative: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target not detected)

  HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target not detected) at Week 48

  48 weeks

Secondary Outcomes (16)

• Safety and Tolerability

  96 Weeks

• HBV DNA levels

  48 weeks

• HBV DNA < lower limit of quantification [LLOQ] (target detected or target not detected) [HBeAg positive]

  48 weeks

• HBV DNA < Lower Limit of Quantification [LLOQ] (target not detected) [HBeAg negative]

  48 weeks

• Change in HBV DNA levels from baseline

  48 weeks

Other Outcomes (2)

• Change in levels of various HBV antigens at various time points from Baseline

  96 Weeks

• Histologic, virologic, immunologic and/or PK-related endpoints

  96 Weeks

Study Arms (2)

ALG-000184

EXPERIMENTAL

Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.

Drug: ALG-000184

TDF

ACTIVE COMPARATOR

Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.

Drug: TDF

Interventions

ALG-000184 DRUG

300 mg tablet

ALG-000184

TDF DRUG

300 mg tablet

TDF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements).
• HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
• HBsAg ≥LLOQ.
• HBV DNA ≥20,000 IU/mL.
• A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
• Must have the following chronic hepatitis B virus infection treatment status at screening:
• Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \[i.e., Treatment Naïve (TN) subjects\], OR
• Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects).

You may not qualify if:

• Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
• Positive for anti-HBs antibodies.
• History or current evidence of cirrhosis.
• Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
• History of, or current evidence of, hepatic decompensation.
• Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
• Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug
• Aspartate aminotransferase (AST) \>8×ULN,
• Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
• International Normalization Ratio (INR) \>1.2×ULN

Sponsors & Collaborators

• Aligos Therapeutics: lead

Study Sites (58)

Aligos Investigational Site

Chandler, Arizona, 85224, United States

RECRUITING

Aligos Investigational Site

Coronado, California, 92118, United States

RECRUITING

Aligos Investigational Site

Garden Grove, California, 92840, United States

RECRUITING

Aligos Investigational Site

Los Angeles, California, 90033, United States

RECRUITING

Aligos Investigational Site

Palo Alto, California, 94304, United States

RECRUITING

Aligos Investigational Site

Pasadena, California, 91105, United States

RECRUITING

Aligos Investigational Site

Rialto, California, 92377, United States

RECRUITING

Aligos Investigational Site

San Francisco, California, 94117, United States

RECRUITING

Aligos Investigational Site

San Jose, California, 95116, United States

RECRUITING

Aligos Investigational Site

Miami, Florida, 33136, United States

RECRUITING

Aligos Investigational Site

Miami, Florida, 33173, United States

RECRUITING

Aligos Investigational Site

Marrero, Louisiana, 70072, United States

RECRUITING

Aligos Investigational Site

Baltimore, Maryland, 21287, United States

RECRUITING

Aligos Investigational Site

Chevy Chase, Maryland, 20815, United States

RECRUITING

Aligos Investigational Site

Boston, Massachusetts, 02114, United States

RECRUITING

Aligos Investigational Site

Manhasset, New York, 10075, United States

RECRUITING

Aligos Investigational Site

New York, New York, 10016, United States

RECRUITING

Aligos Investigational Site

Durham, North Carolina, 27710, United States

RECRUITING

Aligos Investigational Site

Sliven, Bulgaria

RECRUITING

Aligos Investigational Sites

Sofia, Bulgaria

RECRUITING

Aligos Investigational Site

Stara Zagora, Bulgaria

RECRUITING

Aligos Investigational Site

Edmonton, Canada

RECRUITING

Aligos Investigational Site

Ottawa, Canada

RECRUITING

Aligos Investigational Site

Toronto, Canada

RECRUITING

Aligos Investigational Sites

Vancouver, Canada

RECRUITING

Aligos Investigational Sites

Beijing, China

RECRUITING

Aligos Investigational Site

Changchun, China

RECRUITING

Aligos Investigational Site

Chengdu, China

RECRUITING

Aligos Investigational Site

Chongqing, China

RECRUITING

Aligos Investigational Sites

Guangzhou, China

RECRUITING

Aligos Investigational Site

Nanjing, China

RECRUITING

Aligos Investigational Sites

Shanghai, China

RECRUITING

Aligos Investigational Site

Clichy, France

RECRUITING

Aligos Investigational Site

Limoges, France

RECRUITING

Aligos Investigational Site

Nice, France

RECRUITING

Aligos Investigational Site

Rennes, France

RECRUITING

Aligos Investigational Site

Rouen, France

RECRUITING

Aligos Investigational Site

Toulouse, France

RECRUITING

Aligos Investigational Sites

Hong Kong, Hong Kong

RECRUITING

Aligos Investigational Site

Milan, Italy

RECRUITING

Aligos Investigational Site

Chisinau, Moldova

RECRUITING

Aligos Investigational Site

Auckland, New Zealand

RECRUITING

Aligos Investigational Sites

Bucharest, Romania

RECRUITING

Aligos Investigational Site

Ansan, South Korea

RECRUITING

Aligos Investigational Site

Busan, South Korea

RECRUITING

Aligos Investigational Sites

Seoul, South Korea

RECRUITING

Aligos Investigational Site

Ulsan, South Korea

RECRUITING

Aligos Investigational Site

Yangsan, South Korea

RECRUITING

Aligos Investigational Site

Barcelona, Spain

RECRUITING

Aligos Investigational Site

Pontevedra, Spain

NOT YET RECRUITING

Aligos Investigational Site

Chiayi City, Taiwan

RECRUITING

Aligos Investigational Site

Kaohsiung City, Taiwan

RECRUITING

Aligos Investigational Site

Taichung, Taiwan

RECRUITING

Aligos Investigational Site

Tainan, Taiwan

RECRUITING

Aligos Investigational Site

Taipei, Taiwan

RECRUITING

Aligos Investigational Site

Glasgow, United Kingdom

RECRUITING

Aligos Investigational Site

Leicester, United Kingdom

RECRUITING

Aligos Investigational Sites

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aligos Therapeutics

CONTACT

(800) 466-6059; info@aligos.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 9, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2025-04

Locations

NZ (1); CN (7); BU (3); HK (1); RO (1); ES (2); CA (4); MO (1); FR (6); IT (1); KR (5); GB (3); TW (5); US (18)