VC005 tablets for adults 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 Phase III trial will test whether VC005 tablets are safe and help reduce symptoms in adults with active ankylosing spondylitis.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07172360 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase III trial comparing VC005 tablets to placebo in adults with active ankylosing spondylitis. Eligible participants aged 18–70 who meet the 1984 New York Revised Criteria are randomized to receive VC005 or matching placebo and followed for safety and efficacy endpoints. The trial uses standardized clinical assessments and safety monitoring to measure symptom improvement and adverse events. The study is sponsored by Jiangsu vcare pharmaceutical technology and includes at least one site at Peking University People's Hospital.

Who should consider this trial

Good fit: Adults aged 18–70 diagnosed with active ankylosing spondylitis by the 1984 New York criteria who can consent and follow study procedures are ideal candidates.

Not a fit: People with known allergy to VC005 or its ingredients, those who need ongoing immunosuppressants after organ transplant, or individuals the investigator deems unsuitable are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, VC005 could offer an additional oral treatment option that reduces inflammation and symptoms in people with active ankylosing spondylitis.

How similar studies have performed: Other oral agents and biologic therapies have shown benefit in ankylosing spondylitis, but VC005 itself has not yet published phase III results to confirm similar success.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Zhanguo Li — Peking University People's Hospital
• Study coordinator: xiaojuan lai

Conditions: Active Ankylosing Spondylitis