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 an investigational small molecule being developed for symptomatic osteoarthritis of the knee. It is administered as a single intra-articular injection directly into the knee joint. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
JTA-004 is being developed by Bone Biologics Corp, a company traded on the NASDAQ under the ticker symbol BBLG. The company is conducting clinical trials to evaluate the safety and efficacy of JTA-004 for the treatment of symptomatic knee osteoarthritis.
JTA-004 is in Phase 3 clinical development. A Phase 3 study has been completed, evaluating the safety and efficacy of a single intra-articular administration of JTA-004 in patients with symptomatic knee osteoarthritis. The drug remains investigational and has not received FDA approval.
JTA-004 has one completed Phase 3 clinical trial registered as NCT04333160. This randomized, double-blind, placebo-controlled study enrolled 746 participants with symptomatic knee osteoarthritis across multiple countries, including Belgium, Czechia, Denmark, Hong Kong, Moldova, Poland, and the United Kingdom.
JTA-004 is administered as a single intra-articular injection, meaning it is injected directly into the knee joint. This route of administration is designed to deliver the drug locally to the site of osteoarthritis. The completed Phase 3 trial evaluated this single-dose approach in patients with symptomatic knee osteoarthritis.