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

NCT06378697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06378697 on ClinicalTrials.gov