Efficacy and Safety Phase III Clinical Study of VC005 Tab... | NCT07172360

Studies
Efficacy and Safety Phase III Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.

NCT07172360

Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Status

Recruiting

Last Update Posted

Jan 2, 2026Actual

Enrollment

420Estimated

Phase

Phase 3

Conditions

Active Ankylosing Spondylitis

Interventions

VC005 tablets
VC005 Tablets 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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 26, 2025Actual

Primary Completion Date

Aug 30, 2027Estimated

Completion Date

Aug 30, 2027Estimated

First Submitted Date

Sep 8, 2025

First Submission Date that Met QC Criteria

Sep 8, 2025

First Posted Date

Sep 15, 2025Actual

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

Dec 29, 2025

Last Update Posted Date

Jan 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

420Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
VC005 Tablets Low Dose groups	Experimental	Drug: VC005 tablets
VC005 Tablets High Dose groups	Experimental	Drug: VC005 tablets
VC005 Tablets Placebo groups	Placebo Comparator	Drug: VC005 Tablets Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VC005 tablets	Drug	VC005 groups repeat administration for 48 weeks	VC005 Tablets High Dose groups VC005 Tablets Low Dose groups

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients achieving an Assessment of disease activity (signs and symptoms) in ankylosing spondylitis 20% improvement (ASAS20) in response at week 12 of treatment.		week 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject understands and voluntarily signs the informed consent form (ICF) and is willing and able to comply with the study protocol;
The subject is between 18 and 70 years of age (including borderline values) at the time of signing the ICF, regardless of gender;
The subject has been diagnosed with AS according to the 1984 New York Revised Criteria for Ankylosing Spondylitis

Exclusion Criteria:

Those who may be allergic to VC005, similar drugs or their excipients.
Individuals who have undergone organ transplantation in the past and require continuous use of immunosuppressants.
Those who, for any reason, are considered by the investigator to be unsuitable for participation in this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xiaojuan lai	Contact	15358160458		lai_xiaojuan@vcarepharmatech.com

Overall Officials

Name	Affiliation	Role
Zhanguo Li	Peking University People's Hospital	Principal Investigator
Xu Liu	Peking University People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital	Recruiting	Beijing	Beijing Municipality		China