JTA-KOA2 Initial submission
Research type
Research Study
Full title
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
IRAS ID
277158
Contact name
Petrina Ayertey-Gbeve
Contact email
Sponsor organisation
Bone Therapeutics SA
Eudract number
2019-000796-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 16 days
Research 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 breakdown and repair of cartilage. This process becomes disrupted in OA, leading to degeneration and loss of articular cartilage, along with other joint changes. Symptoms consist of fluctuating joint pain, swelling, loss of mobility, stiffness after immobility, and crepitus in the joint increasing in severity as the disease progresses.
JTA-004 is an IMP whose active substances are human plasma (blood from which cells are removed), hyaluronic acid and clonidine. Human plasma enables JTA-004 to form a gel. Hyaluronic acid is found naturally in the body, particularly in joints and joint fluid. This substance acts as a lubricant and a shock absorber. In joints affected by osteoarthritis, the presence of hyaluronic acid and its ability to lubricate and provide shock protection is reduced. Therefore, the administration of hyaluronic acid directly into the joint enables the hyaluronic acid to better fulfil its functions of lubricating and absorbing shocks, thus alleviating the pain related to osteoarthritis. Clonidine, a medication usually used in the treatment of hypertension, is used here for its painkilling properties mainly just after the injection into the knee.
Worldwide, the study will recruit around 676 subjects with OA in the knee. Subjects will be randomly assigned to receive a single injection of either the investigational treatment, JTA-004, or a reference treatment, Synvisc-One®, or placebo, saline solution, into the knee joint.
The randomization scheme is 2:1:1, which means that there is a 2 out of 4 chance of receiving JTA-004, a 1 out of 4 chance of receiving Synvisc-One®, and a 1 out of 4 chance of receiving placebo.REC name
London - Brent Research Ethics Committee
REC reference
20/LO/0188
Date of REC Opinion
25 Jun 2020
REC opinion
Further Information Favourable Opinion