A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients

Chronic Hepatitis b Clinical Trial

Official title:

Phase IIa Single Dose and Phase IIb Mutiple Dose Clinical Studies to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneously Injected PD-L1 Antibody ASC22 in Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04465890
• Other study ID #: ASC-ASC22-II-CTP-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 17, 2020
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and efficacy of ASC22 in the treatment of chronic hepatitis B after single and multiple drug administration.

Description:

The study consists of two parts: the ASC22 single-dose IIa study and the ASC22 multi-dose IIb study. The IIa study consists of 3 cohorts of 0.3mg/kg, 1.0mg/kg and 2.5mg/kg, and the IIb study consists of 2 cohorts of 1.0mg/kg and 2.5mg/kg. The objective is to evaluate the safety, tolerance and efficacy of ASC22 in patients with chronic hepatitis B (CHB), and to provide a guidance for the determination of dosage regimen.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 207
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 18-65 years old (including boundary value), gender unlimited;

2. Chronic hepatitis B patients with clear diagnosis of Hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);

3. HBV-DNA turns negative after treatment with nucleoside (acid) drugs;

4. cohort1-5:HBsAg= 10000 IU/mL; cohort6: HBsAg= 100 IU/mL;

5. HBeAg negative;

6. The fertile female subjects or the fertile male subjects agreed to take contraceptive measures from 7 days before the first administration until 24 weeks after the end of the administration cycle of ASC22. The serum pregnancy test of fertile female subjects must be negative within 7 days before the first administration.

Exclusion Criteria:

1. Patients with hepatitis a, hepatitis c (HCV RNA>15IU/L), hepatitis d or HIV infection; Patients with other active infections (e.g., respiratory tract infection, urinary tract infection and herpes simplex, cytomegalovirus, epstein-barr virus);

2. Fibrosis stage: Cirrhosis, portal hypertension, or advanced fibrosis (defined as Fibroscan=9.5kPa or ARFI=1.81m/sec or Fibrosis-4 (FIB-4)=3.25 or METAVIR F=3);

3. Liver cancer patients or blood AFP>1×ULN;

4. cohort1-5:Patients who received interferon therapy within 6 months before the first administration; cohort6: Patients who received interferon therapy before the first administration;

5. Patients receiving immunosuppressive therapy within 3 months before the first administration (except interferon);

6. The investigator judges that the participants are not suitable for this study.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ASC22
200mg/1ml/1bottle
• sodium chloride
90mg/10ml/1 bottle

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.	Beijing Clinical Service Center, Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the decreased HBsAg levels at 12 or 24 weeks of treatment or at 4, 12, or 24 weeks of follow-up visits compared with baseline.	Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).	48 weeks
Primary	Evaluate the number of patients with =0.5log reduction in HBsAg log10IU/ mL at 12 or 24 weeks of treatment, or at 4, 12, or 24 weeks of follow-up visits compared with baseline.	Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).	48 weeks
Secondary	Evaluate the decline value of HBsAg level.	Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).	48 weeks
Secondary	Evaluate the propotion's change of HBsAg < 0.05IU/ml in each cohort.	Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).	48 weeks
Secondary	Evaluate the changes of cytokines (IL-2, IFN-?) in each cohort.	Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).	48 weeks
Secondary	Evaluate the changes of peripheral blood lymphocyte subsets in each cohort.	Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).	48 weeks