Active Ankylosing Spondylitis
Conditions
Brief summary
This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study.
Interventions
DRUGVC005 tablets
VC005 groups repeat administration for 48 weeks
VC005 placebo groups repeat administration for 48 weeks
Sponsors
Jiangsu vcare pharmaceutical technology co., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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 |
Countries
China
Contacts
Primary Contactxiaojuan lai
Outcome results
None listed