NCT06378697

A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis.

Detailed description

The study consists of 3 parts. Part 1 is screening period, Part 2 is Placebo control period and part 3 is Long term treatment follow-up period. The research period is 61 weeks in total.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	AK111	Drug: AK111 subcutaneous injection at week 0,1, 4 and 4-weekly thereafter until week 48.
DRUG	Placebo+AK111	Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.

Timeline

• Start date: 2023-11-22
• Primary completion: 2025-02-19
• Completion: 2025-11-07
• First posted: 2024-04-22
• Last updated: 2026-03-18

Locations

54 sites across 1 country: China