Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PTP-001 · 1 trial · 1 indication
To evaluate the change from pretreatment baseline in the WOMAC pain sub-score in the target knee on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized on scales of 0-100.
To assess the long-term (6 months) incidence of local and systemic AEs, and consists of physical examination, laboratory values, AEs, AESI, and immunogenicity testing.
| Arm | Type | Description |
|---|---|---|
| PTP-001 200 mg | EXPERIMENTAL | A single intra-articular injection in the target knee of PTP-001 200 mg. |
| PTP-001 100 mg | EXPERIMENTAL | A single intra-articular injection in the target knee of PTP-001 100 mg. |
| Placebo/saline | PLACEBO_COMPARATOR | A single intra-articular injection in the target knee of 4mL of placebo control - physiological saline (0.9% sodium chloride injection, USP). |
| Name | Type | Description |
|---|---|---|
| PTP-001 | BIOLOGICAL | Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline. |
| Placebo control | OTHER | The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee. |
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: 1. Male or female, aged 40 to 80 years 2. Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3 (mild or moderate) as assessed by the central read...