Clinical Trial of YYD302 (Phase3) for Treatment of Osteoarthritis of the Knee

Phase 3 Completed 184 enrolled Yooyoung Pharmaceutical Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, active-controlled, multi-center, phase 3 study to evaluate the safety and efficacy of intraarticular hyaluronic acid(YYD302) for osteoarthritis of the knee after 12 weeks of treatment and retreatment

Timeline

Start: 2018-02-21
Primary completion: 2019-06-14
Completion: 2019-10-04

Outcome

Met primary endpoint

paper proving noninferiority of the YYD302 group to the Synovian group PMID 34736768 ↗

paper the lower bound of the 95% CI (-4.3 to 8.3) was well above the predefined margin (-10 mm). PMID 34736768 ↗

Publications

Park YG, Ha CW, Yoo JH, Lee WS, Lee HJ, In Y, Bae KC, Shon OJ, Kim YM, Seon JK, Song SJ, Chang CB, Kim JM, Kim CW, Kim DH, Bae JH. Intra-Articular Injection of a Novel DVS Cross-Linked Hyaluronic Acid Manufactured by Biological Fermentation (YYD302) in Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Multicenter, Noninferiority Study. Clin Ther. 2021 Nov;43(11):1843-1860. doi: 10.1016/j.clinthera.2021.09.005. Epub 2021 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Synovian	Other / unclassified	3 ml	Other
Subject	YYD302	Other / unclassified	2 ml	Other