Phase 2 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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aligos Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

3 Dec 2025 → ongoing

Decision date (initial)

2025-09-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Pharmacodynamic, Therapy, Safety

To assess and compare monotherapy with ALG-000184 versus TDF in HBeAg-positive (Part 1) and HBeAg-negative (Part 2) subjects as measured by plasma HBV DNA levels.

Secondary objectives 5

1. To evaluate the safety of monotherapy with ALG-000184 versus TDF
2. To evaluate the antiviral activity/efficacy of monotherapy with ALG-000184 versus TDF as measured by changes HBV DNA and RNA
3. To evaluate the efficacy of monotherapy with ALG-000184 versus TDF as measured by biochemical response (as measured by ALT levels)
4. To evaluate the emergence and persistence of viral variants during and after monotherapy with ALG-000184 versus TDF
5. To evaluate steady-state plasma pharmacokinetics of ALG-001075

Conditions and MedDRA coding

Chronic Hepatitis B Virus Infection

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

No

IPD plan description

The sharing of individual participant data (IPD) is currently undecided. Any future decision to share IPD will be subject to strict compliance with applicable data protection regulations, including the General Data Protection Regulation (GDPR).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2.
2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
3. HBsAg ≥ LLOQ
4. HBV DNA ≥20,000 IU/mL.
5. A history of a clinical diagnosis of chronic HBV infection AND a serum ALT values of ≤8×ULN during screening.
6. Must have the following chronic hepatitis B virus infection treatment status at screening: a. 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 b. 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).

Exclusion criteria 8

1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
2. Positive for anti-HBs antibodies.
3. History or current evidence of cirrhosis.
4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
5. History of, or current evidence of, hepatic decompensation.
6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
7. 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
8. Exclusionary screening laboratory values include: a. Aspartate aminotransferase (AST) >8×ULN, b. Bilirubin (total, direct) >1.2×ULN (unless Gilbert's syndrome is suspected) c. International Normalization Ratio (INR) >1.2×ULN

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1 (HBeAg positive): Plasma HBV DNA < LLOQ (10 IU/mL, TD [target detected] or target not detected [TND])at Week 48
2. Part 2 (HBeAg negative): Plasma HBV DNA < LLOQ (10 IU/mL, TND) at Week 48

Secondary endpoints 13

1. Safety will be assessed by monitoring treatment-emergent adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory results (including chemistry, blood coagulation, hematology, and urinalysis).
2. Plasma HBV DNA level at Week 48 categorized according to one of the following ordinal categories: HBV DNA ≥ LLOQ, HBV DNA < LLOQ (TD), and HBV DNA < LLOQ (TND)
3. Plasma HBV DNA < LLOQ (TD or TND) at various time points during the 48-week dosing period (Part 1 only)
4. Plasma HBV DNA < LLOQ (TND) at various time points during the 48-week dosing period (Part 2 only)
5. Change from baseline in plasma HBV DNA at various time points during the 48-week dosing period
6. Time to plasma HBV DNA < LLOQ (TD or TND) (Part 1 only)
7. Time to plasma HBV DNA < LLOQ (TND) (Part 2 only)
8. Serum HBV RNA < LLOQ at various time points during the 48-week dosing period
9. Change from baseline in serum HBV RNA at various time points during the 48-week dosing period
10. Time to serum HBV RNA < LLOQ
11. Subjects with abnormal ALT at baseline who have normal ALT at Week 48
12. Emergence of treatment-associated mutations in the HBV genome during the 48-week dosing period and the 48- to 96-week dosing period
13. PK parameters of ALG-001075 in plasma, including, but not limited to: Ctrough (predose), Tmax, Cmax, AUCss, and half-life, as applicable.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aligos Therapeutics Inc.

Sponsor organisation

Aligos Therapeutics Inc.

Address

1 Corporate Drive, 2nd Floor 2nd Floor

City

South San Francisco

Postcode

94080-7043

Country

United States

Scientific contact point

Organisation

Aligos Therapeutics Inc.

Contact name

Stanley Wang

Public contact point

Organisation

Aligos Therapeutics Inc.

Contact name

Anthony Lee

Third parties 9

Locations

5 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 50 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications