Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JTA-004 · 1 trial · 1 indication
Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 3 using the Western Ontario McMaster University (WOMAC®) Visual Analogue 3.1 pain subscale (subscale A; score 0 (no-pain)-100 (worst imaginable pain) mm).
| Arm | Type | Description |
|---|---|---|
| JTA-004 | EXPERIMENTAL | single knee intra-articular injection of JTA-004 solution (2ml) |
| placebo | PLACEBO_COMPARATOR | single knee intra-articular injection of saline solution (2ml) |
| Hylan G-F 20 | ACTIVE_COMPARATOR | single knee intra-articular injection of Hylan G-F 20 (6ml) |
| Name | Type | Description |
|---|---|---|
| JTA-004 | DRUG | Patients will undergo a single intra-articular injection of JTA-004 into the knee joint |
| Hylan G-F 20 | DEVICE | Patients will undergo a single intra-articular injection of Hylan G-F 20 into the knee joint |
| placebo | OTHER | Patients will undergo a single intra-articular injection of placebo into the knee joint |
Inclusion Criteria: * Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one) is allowed if already used at screening but should be avoided during the study up to the 6-month follow-up visit) * Diagnosed with primary knee OA, fulfilling the following American College ...
JTA-004 is being developed for the treatment of symptomatic osteoarthritis of the knee. It is a small molecule therapy administered as a single intra-articular injection into the knee joint. The program is led by Bone Biologics Corp and is currently in Phase 3 clinical development.
JTA-004 is being developed by Bone Biologics Corp, which trades under the ticker symbol BBLG. The company is advancing the candidate for symptomatic osteoarthritis of the knee, a musculoskeletal condition, and has completed a Phase 3 clinical trial of the therapy.
JTA-004 has completed a Phase 3 clinical trial and is an investigational therapy, meaning it is still in clinical development and has not been approved by the FDA. The Phase 3 study was a randomized, double-blind, placebo-controlled trial.
JTA-004 has been studied in one clinical trial, NCT04333160, titled "Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis." The trial is completed and enrolled 746 participants across Belgium, Czechia, Denmark, Hong Kong, Moldova, Poland, and the United Kingdom.
The Phase 3 trial NCT04333160 was a randomized, double-blind, placebo-controlled study evaluating a single intra-articular administration of JTA-004 in adults with symptomatic knee osteoarthritis. It enrolled 746 participants aged 40 years and older, across seven countries, and the study is now completed.