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

A Multicenter, Randomized, Double-blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Subjects With Active Ankylosing Spondylitis

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

Study Overview

• Status: Recruiting
• Conditions: Active Ankylosing Spondylitis
• Intervention / Treatment: Drug: VC005 tablets; Drug: VC005 Tablets Placebo

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: xiaojuan lai; Phone Number: 15358160458; Email: lai_xiaojuan@vcarepharmatech.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University People's Hospital
      • Contact: Zhanguo Li; Phone Number: 13910713924; Email: Zgli99@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VC005 Tablets Low Dose groups	Drug: VC005 tablets; VC005 groups repeat administration for 48 weeks
Experimental: VC005 Tablets High Dose groups	Drug: VC005 tablets; VC005 groups repeat administration for 48 weeks
Placebo Comparator: VC005 Tablets Placebo groups	Drug: VC005 Tablets Placebo; VC005 placebo groups repeat administration for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
• Investigators: Principal Investigator: Zhanguo Li, Peking University People's Hospital; Principal Investigator: Xu Liu, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: September 8, 2025
• First Submitted That Met QC Criteria: September 8, 2025
• First Posted (Estimated): September 15, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: VC005-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No