NCT05467995

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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of AK111 in subjects with active ankylosing spondylitis.

Detailed description

The purpose of this study is to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis. Subjects will be randomized to receive AK111 or placebo following subcutaneous injection. The study period for each subject will be 25 weeks, including a screening period of up to 35 days, followed by a treatment period of 12 weeks and a follow up period of 8 weeks.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
BIOLOGICAL	AK111	AK111 administered subcutaneously at Week 0, 1, and 4, then every 4 weeks
BIOLOGICAL	Placebo	Placebo administered subcutaneously at Week 0, 1, and 4, then every 4 weeks

Timeline

• Start date: 2021-06-02
• Primary completion: 2022-04-25
• Completion: 2022-05-19
• First posted: 2022-07-21
• Last updated: 2024-03-06

Locations

15 sites across 1 country: China