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NCT Number: NCT07172360

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

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

Recruiting

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Key information

Conditions

Active Ankylosing Spondylitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Zhanguo Li

CONTACT

[email protected]

13910713924

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VC005 tablets

Drug

VC005 groups repeat administration for 48 weeks

VC005 Tablets Placebo

Drug

VC005 placebo groups repeat administration for 48 weeks

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.

    Time frame: week 12

Study contacts

Contact information is provided by the study sponsor or research team.

xiaojuan lai

CONTACT

[email protected]

15358160458

Sponsors and collaborators

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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