RecruitingPhase 3NCT07172360

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


Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Enrollment

420 participants

Start Date

Dec 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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Interventions

DRUGVC005 tablets

VC005 groups repeat administration for 48 weeks

DRUGVC005 Tablets Placebo

VC005 placebo groups repeat administration for 48 weeks


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT07172360


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