Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06884865 | A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee | PHASE2 | ACTIVE NOT_RECRUITING | 135 | — | — | Feb 26, 2025 | Jul 1, 2032 | Mar 24, 2026 | 17 | United States |
| Arm | Type | Description |
|---|---|---|
| Part A Dose A | EXPERIMENTAL | Single Intra-Articular injection |
| Part A, Placebo | PLACEBO_COMPARATOR | Single Intra-Articular injection |
| Part B Dose A | EXPERIMENTAL | Single Intra-Articular injection |
| Part B Dose B | EXPERIMENTAL | Single Intra-Articular injection |
| Part B Placebo | PLACEBO_COMPARATOR | Part B Placebo |
| Part A, Dose B | EXPERIMENTAL | Single Intra-Articular injection |
| Name | Type | Description |
|---|---|---|
| Enekinragene Inzadenovec (PCRX-201) | BIOLOGICAL | Enekinragene Inzadenovec (PCRX-201) injection |
| Placebo | BIOLOGICAL | Placebo injection |
Inclusion Criteria: * Subjects must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions. * Subjects must be male or female and 45 to 80 years old, inclusive, at Screening. * Subjects must exhibit symptoms associated with oste...