drugset / Trial / NCT06378697

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

NCT06378697 ↗

Phase 3 Completed 510 enrolled Akeso
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-11-22
Primary completion
2025-02-19
Completion
2025-11-07

Outcome

Met primary endpoint

release “在治疗活动性强直性脊柱炎(AS)的关键注册性Ⅲ期临床研究中取得阳性结果,主要疗效终点ASAS20” akesobio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject GUMOKIMAB Monoclonal antibody 150 mg Subcutaneous