Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active AS
NCT07498634 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 323
Last updated 2026-03-27
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, and parallel grouping study.
Study procedures: The screening period does not exceed 4 weeks, including 16 weeks for initial treatment, 28 weeks for maintenance treatment and 8 weeks for safety follow-up.
Conditions
- Phase III
Interventions
- DRUG
-
XKH004
Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection
- DRUG
-
Placebo
Sponsors & Collaborators
-
Zhejiang Kanova Biopharmaceutical Co., LTD
lead INDUSTRY
Principal Investigators
-
Huji Xu, PHD · Shanghai Changzheng Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-21
- Primary Completion
- 2025-08-01
- Completion
- 2025-11-14
Countries
- China
Study Locations
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