Study to Evaluate Safety, Tolerance and Efficacy of ASC22... | NCT05330143

Studies
Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV

NCT05330143

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

Status

Completed

Last Update Posted

Nov 25, 2024Actual

Enrollment

19Actual

Phase

Phase 2

Conditions

HIV-1-infection
HIV Infections
PD-L1 Gene Mutation

Interventions

ASC22 1mg/kg
ASC22 2.5mg/kg
Antiretroviral Therapy
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2022Actual

Primary Completion Date

May 15, 2024Actual

Completion Date

May 15, 2024Actual

First Submitted Date

Mar 17, 2022

First Submission Date that Met QC Criteria

Apr 8, 2022

First Posted Date

Apr 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2024

Last Update Posted Date

Nov 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a phase II, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of ASC22 injection in combination with anti-retroviral therapy to treat subjects living with human immunodeficiency virus type 1.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASC22 1mg/kg	Experimental	ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks	Drug: ASC22 1mg/kg Drug: Antiretroviral Therapy
ASC22 2.5mg/kg	Experimental	ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks	Drug: ASC22 2.5mg/kg Drug: Antiretroviral Therapy
Placebo	Placebo Comparator	0.9% Saline and anti-retroviral therapy for 12 weeks	Drug: Antiretroviral Therapy Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASC22 1mg/kg	Drug	ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.	ASC22 1mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CD4/CD8 ratio changes compared with baseline		Week 4\Week 8\Week 12

Secondary Outcomes

Measure	Description	Time Frame
HIV-DNA copy changes compared with baselnie		Week 12
CD4+ count changes compared with baseline		Week 12
CD8+ count changes compared with baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 and ≤ 60 years old at screening.
Treated with anti-retroviral medicine continuously for at least 12 months within 6 months of diagnosis of HIV-1 infection.
Treated with anti-retroviral medicine continuously, contain integrase inhibitor, for at least months before screening.
CD4+ Cell count ≥300 cells/μL and CD4+/ CD8+ratio ≤ 0.9 at screening.
Weight ≥ 50 kg at screening.

Exclusion Criteria:

Known allergy to the drug or excipients used in this trial.
HIV-associated opportunistic infections in the past 5 years.
Co-sensors of HBV, HCV, syphilis, etc.
With bleeding disorders or on anticoagulant therapy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Fifth Medical Center of the General Hospital of the Peoples Liberation Army		Beijing	Beijing Municipality	100071	China

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000718749	envafolimab
D023241	Antiretroviral Therapy, Highly Active

Ancestor Terms

ID	Term
D004359	Drug Therapy, Combination
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided