NCT07047196

Evaluating the Efficacy and Safety of Intra-articular Injection of HS-20116 in Patients With Knee Osteoarthritis

A Randomized, Single-Blind, Active-controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Intra-articular Injection of HS-20116 in Patients With Knee Osteoarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the efficacy and safety of HS-20116 for intra-articular use in patients with symptomatic knee osteoarthritis.

Detailed description

This is a prospective, randomized, single-blind, active-controlled, multicenter clinical study to evaluate the efficacy and safety of intra-articular injection of HS-20116 in patients with knee osteoarthritis. Eligible subjects after screening will be randomized in a 1:1 ratio into the test group and the control group. Test group subjects will receive a single intra-articular injection of HS-20116 (3 mL) into the treated knee on Day 0. Control group subjects will receive 2-3 intra-articular injections of chitosan (2-3 mL each) on Day 0 and Day 14, with an optional injection on Day 28. The primary endpoint is the change from baseline in WOMAC pain score at Week 12 after the first injection. Each subject may choose to participate in an optional long-term follow-up visit between Weeks 22 and 28.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	HS-20116	Innovative chitosan-based biomaterial intended for intra-articular injection
DEVICE	Medical Chitosan (for intra-articular injection)	Medical chitosan for intra-articular injection

Timeline

• Start date: 2024-08-13
• Primary completion: 2025-02-26
• Completion: 2025-04-27
• First posted: 2025-07-02
• Last updated: 2025-07-09

Locations

1 site across 1 country: China