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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04129944 | A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee | PHASE2 | COMPLETED | 183 | — | — | Oct 30, 2019 | Aug 7, 2020 | Dec 29, 2021 | 20 | United States |
| NCT03513016 | A Safety and Tolerability Study of UBX0101 in Patients With Osteoarthritis of the Knee | PHASE1 | COMPLETED | 78 | — | — | May 16, 2018 | Apr 12, 2019 | Apr 20, 2020 | 7 | United States |
WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| UBX0101 0.5 mg | EXPERIMENTAL | - |
| UBX0101 2.0 mg | EXPERIMENTAL | - |
| UBX0101 4.0 mg | EXPERIMENTAL | - |
| Part A: UBX0101 | EXPERIMENTAL | Part A: UBX0101, single intra-articular injection, ascending dose |
| Part A: Placebo | PLACEBO_COMPARATOR | Part A: Placebo, single intra-articular injection, ascending dose |
| Part B: UBX0101 | EXPERIMENTAL | Part B: UBX0101, single intra-articular injection, fixed dose |
| Part B: Placebo | PLACEBO_COMPARATOR | Part B: Placebo, single intra-articular injection, fixed dose |
| Name | Type | Description |
|---|---|---|
| UBX0101 | DRUG | Investigational drug intra-articular injection |
| Placebo | OTHER | Placebo intra-articular injection |
Key Inclusion Criteria: * Patients who are ambulatory with a diagnosis of OA of the knee and who have baseline pain with a mean of ≥ 4 and ≤ 9 on the 11-point (0-10) average daily pain NRS for at least five of seven days during the Screening period. * Kellgren-Lawrence grade of 1-4 on a weight-bear...