Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JTA-004 intra-articular · 1 trial · 1 indication
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
| Arm | Type | Description |
|---|---|---|
| Reference product | ACTIVE_COMPARATOR | Hylan G-F 20 |
| JTA-004 50 (2 ml) | EXPERIMENTAL | Sodium hyaluronate, plasma proteins and clonidine |
| JTA-004 50 (4 ml) | EXPERIMENTAL | Sodium hyaluronate, plasma proteins and clonidine |
| JTA-004 100 (2 ml) | EXPERIMENTAL | Sodium hyaluronate, plasma proteins and clonidine |
| Name | Type | Description |
|---|---|---|
| JTA-004 intra-articular injection | DRUG | Each patient will undergo a single injection of JTA-004 into the knee joint |
| Reference product intra-articular injection | DEVICE | Each patient will undergo a single injection of Reference product into the knee joint |
Inclusion Criteria: * Ambulatory * Diagnosed with primary knee osteoarthritis, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee: * Pain ≥ 40 mm on a 0-100 mm VAS during the 3 days preceding the date of the screening visit * Morning stiffness not excee...
JTA-004 intra-articular is an investigational small molecule being developed for the treatment of knee osteoarthritis. It is administered directly into the joint. The drug is currently in Phase 2 clinical development and has completed a randomized, double-blind, active-controlled trial in patients with symptomatic knee osteoarthritis.
JTA-004 intra-articular is being developed by Bone Biologics Corp, a company traded on the Nasdaq under the ticker symbol BBLG. The company is advancing this investigational therapy for knee osteoarthritis through clinical development.
JTA-004 intra-articular is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial for the drug has been completed, involving 173 patients with knee osteoarthritis.
JTA-004 intra-articular has been studied in one completed Phase 2 clinical trial, registered as NCT02740231. The trial, titled "A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis," enrolled 173 patients aged 50 years and older with knee osteoarthritis.
JTA-004 intra-articular refers to the intra-articular formulation of JTA-004, which is administered directly into the joint. The drug is being studied specifically for knee osteoarthritis, and the completed Phase 2 trial used this route of administration.