NCT07172360

Brief Summary

This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for phase_3

Timeline
16mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Aug 2027

First Submitted

Initial submission to the registry

September 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 26, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

September 8, 2025

Last Update Submit

December 29, 2025

Conditions

Active Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

VC005 tabletsDRUG

VC005 groups repeat administration for 48 weeks

VC005 Tablets High Dose groupsVC005 Tablets Low Dose groups
VC005 Tablets PlaceboDRUG

VC005 placebo groups repeat administration for 48 weeks

VC005 Tablets Placebo groups

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

  • Zhanguo Li

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

  • Xu Liu

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaojuan lai

CONTACT

15358160458lai_xiaojuan@vcarepharmatech.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 15, 2025

Study Start

December 26, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

CN(1)