Recruiting NCT07172360
Efficacy and Safety Phase III Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VC005 tablets, VC005 Tablets Placebo.
- Who it may be relevant to
- Registry conditions: Active Ankylosing Spondylitis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study.
Interventions
- Drug VC005 tablets
VC005 groups repeat administration for 48 weeks - Drug VC005 Tablets Placebo
VC005 placebo groups repeat administration for 48 weeks
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07172360 · VC005-301