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Also known as JTA-004 intra-articular injection
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...
Top 5 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
JTA-004 intra-articular is an investigational small molecule therapy being developed for knee osteoarthritis. It is administered by intra-articular injection directly into the knee joint. Bone Biologics Corp (ticker BBLG) is developing the asset, which has completed a Phase 2 clinical trial in symptomatic knee osteoarthritis.
JTA-004 intra-articular is being studied for the treatment of knee osteoarthritis. Its only recorded clinical trial enrolled patients with symptomatic knee osteoarthritis, aged 50 years and older, of all sexes. The trial excluded healthy volunteers, meaning participants had to have the condition being studied.
JTA-004 intra-articular is being developed by Bone Biologics Corp, which trades under the ticker BBLG. The company is the sponsor of the clinical program for this intra-articular knee osteoarthritis candidate.
JTA-004 intra-articular has completed a Phase 2 clinical trial and remains an investigational therapy. It is not described as approved by the FDA. The Phase 2 study has a completed status, and no active trials for this asset are currently listed.
JTA-004 intra-articular has been evaluated in one clinical trial, NCT02740231, titled A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis. That Phase 2 trial is completed, enrolled 173 participants, was randomized, double blind, and used an active control design.
Yes. JTA-004 intra-articular and JTA-004 intra-articular injection refer to the same investigational product from Bone Biologics Corp. The injection wording reflects the intra-articular route of administration used in its Phase 2 knee osteoarthritis trial, NCT02740231.