Efficacy and Safety Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Study ID
- NCT05814939
- Phase
- PHASE2
- Status
- Completed
Conditions
- Active Ankylosing Spondylitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- VC005 tablets — DRUGVC005 groups repeat administration for 12 weeks
- Tofacitinib Citrate Tablets — DRUGTofacitinib Citrate groups repeat administration for 12 weeks
- VC005 Tablets Placebo — DRUGVC005 placebo groups repeat administration for 12 weeks
Study Details
This clinical trial is a multicenter, randomized, double-blind, controlled phase II clinical study.
Key Dates
- Start date
- Apr 26, 2023
- Status verified
- Jul 2024
- Primary completion
- May 11, 2024
- Completion
- May 11, 2024
Study Design
- Enrollment
- 180 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: VC005 Tablets Low Dose groups
- Experimental: VC005 Tablets Medium Dose groups
- Experimental: VC005 Tablets High Dose groups
- Active Comparator: Tofacitinib Citrate Tablets groups
- Placebo Comparator: VC005 Tablets Placebo groups
Primary Outcome Measure
Percentage of patients achieving ASAS20 [ Time Frame: Week 12 ]