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

November 27, 2024 updated by: Ascletis Pharmaceuticals Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cohort1: Single dose ASC22 injection 0.3mg/kg
Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,0.3mg/kg dose of the drug once.
Drug: ASC22
200mg/1ml/1bottle
Experimental: cohort2:Single dose ASC22 injection 1.0mg/kg
Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,1.0mg/kg dose of the drug once.
Drug: ASC22
200mg/1ml/1bottle
Experimental: cohort3:Single dose ASC22 injection 2.5mg/kg
Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,2.5mg/kg dose of the drug once.
Drug: ASC22
200mg/1ml/1bottle
Experimental: cohort4: Multiple dose ASC22 injection 1.0mg/kg
Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks
Drug: ASC22
200mg/1ml/1bottle
Experimental: cohort5: Multiple dose ASC22 injection 2.5mg/kg
Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 2.5mg/kg, up to 24 weeks
Drug: ASC22
200mg/1ml/1bottle
Placebo Comparator: cohort4: Placebo sodium chloride injection A
Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg).
Drug: sodium chloride
90mg/10ml/1 bottle
Placebo Comparator: cohort5: Placebo sodium chloride injection B
Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (2.5mg/kg).
Drug: sodium chloride
90mg/10ml/1 bottle
Experimental: cohort6: Multiple dose ASC22 injection 1.0mg/kg
Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks
Drug: ASC22
200mg/1ml/1bottle
Placebo Comparator: cohort6: Placebo sodium chloride injection A
Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg).
Drug: sodium chloride
90mg/10ml/1 bottle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 48 weeks
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
48 weeks
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.
Time Frame: 48 weeks
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the decline value of HBsAg level.
Time Frame: 48 weeks
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
48 weeks
Evaluate the propotion's change of HBsAg < 0.05IU/ml in each cohort.
Time Frame: 48 weeks
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
48 weeks
Evaluate the changes of cytokines (IL-2, IFN-γ) in each cohort.
Time Frame: 48 weeks
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
48 weeks
Evaluate the changes of peripheral blood lymphocyte subsets in each cohort.
Time Frame: 48 weeks
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

Collaborators

Peking University First Hospital
Beijing Clinical Service Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2020

Primary Completion (Actual)

August 9, 2024

Study Completion (Actual)

August 9, 2024

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC-ASC22-II-CTP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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