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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03529942 | Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee | PHASE3 | COMPLETED | 129 | — | — | Apr 24, 2018 | Mar 9, 2020 | Jan 24, 2024 | 10 | United States, United Kingdom |
Synovial volume (mm\^3) as measured by MRI and read by a central imaging vendor. Standardization was performed by dividing the model-derived least squares means and corresponding confidence intervals by the adjusted standard deviation (SD). Therefore, the mean standardized change represents the change in synovial volume expressed in standard deviation units.
| Arm | Type | Description |
|---|---|---|
| FX006 32 mg | EXPERIMENTAL | Single intra-articular (IA) injection of FX006 32 mg |
| Name | Type | Description |
|---|---|---|
| FX006 32 mg | DRUG | Extended-release 32 mg FX006 IA injection |
Inclusion Criteria: * Written consent to participate in the study * Male or female ≥ 40 years of age * Body mass index (BMI) ≤ 40 kg/m\^2 * Ambulatory and in good general health * Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instruct...