NCT07498634

Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active AS

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active Ankylosing Spondylitis (AS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Zhejiang Kanova Biopharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Eligible patients are randomized at a ratio of 1:1 (stratification factors include: TNFi-incomplete response vs. TNFi-naive; weight ≥ 70 kg vs. weight \< 70 kg) to the following 2 groups (Group 1 and Group 2). During the initial treatment period, patients in Group 1 shall be treated with XKH004(160 mg, Q4W) by subcutaneous injection while those in Group 2 shall receive a placebo. During the maintenance treatment period, starting at Week 16 (W16), patients in Group 1 shall maintain the original treatment (continue 160 mg, Q4W) and patients in Group 2 shall switch from placebo to XKH004 (160 mg, Q4W). Patients who have received TNFi therapy in the initial treatment period will account for approximately 20% of the total sample size to make this population representative. All patients will undergo the efficacy/safety/immunogenicity assessment procedures specified in the protocol at visit points such as W1, W2, W4 and every 4 weeks thereafter until W44 and W52.

Conditions

• Phase III

Interventions

Type	Name	Description
DRUG	XKH004	Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-09-21
• Primary completion: 2025-08-01
• Completion: 2025-11-14
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China