NCT04333160

Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis

A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 746 (actual)
• Sponsor: Bone Therapeutics S.A · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis is a degenerative, chronic, and progressive joint disease considered as the most common joint disorder worldwide. In healthy joints, there is a continuous process of natural breakdown and repair of cartilage. This process becomes disrupted in OA, leading to degeneration and loss of articular cartilage, along with other joint changes, including subchondral bone remodeling, osteophyte formation, thickening of the capsule and sometimes inflammation of the synovia. JTA-004 is a plasma protein solution supplemented with HA and clonidine developed as a single IA injection for the treatment of knee OA. Local administration of JTA-004 into the joint cavity is intended to relieve chronic pain in subjects suffering from knee OA and discomfort associated with the IA administration. The JTA-004 Phase III study is a placebo and active-controlled, randomized, double-blind study to evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee at 3 months compared to placebo or active comparator. The study is expected to enrol 742 patients with mild to moderate symptomatic knee osteoarthritis in 22 centres in 6 European countries and Hong Kong SAR.

Conditions

• Symptomatic Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	JTA-004	Patients will undergo a single intra-articular injection of JTA-004 into the knee joint
DEVICE	Hylan G-F 20	Patients will undergo a single intra-articular injection of Hylan G-F 20 into the knee joint
OTHER	placebo	Patients will undergo a single intra-articular injection of placebo into the knee joint

Timeline

• Start date: 2020-03-10
• Primary completion: 2021-03-31
• Completion: 2021-12-09
• First posted: 2020-04-03
• Last updated: 2022-03-02

Locations

22 sites across 7 countries: Belgium, Czechia, Denmark, Hong Kong, Moldova, Poland, United Kingdom