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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04097379 | Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OA | PHASE2 | COMPLETED | 45 | — | — | Jul 20, 2020 | Jan 17, 2025 | Jan 30, 2026 | 1 | Netherlands |
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in the volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee. Change from baseline in cartilage volume was analyzed using the mixed effects model for repeated measures (MMRM). The model included baseline, treatment, timepoint and treatment-timepoints as fixed effects, and participant as random effect. Missing data was assumed to be Missing at Random (MAR).
| Arm | Type | Description |
|---|---|---|
| LRX712 15 mg | EXPERIMENTAL | LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations. |
| LRX712 25 mg | EXPERIMENTAL | LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations. |
| LRX712 75 mg | EXPERIMENTAL | LRX712 75 mg was administered i.a. every four weeks, for a total of three administrations. |
| Placebo | PLACEBO_COMPARATOR | Placebo was administered i.a. every four weeks, for a total of three administrations. |
| Name | Type | Description |
|---|---|---|
| LRX712 | DRUG | LRX712 intra-articular injections |
| Placebo | OTHER | Placebo intra-articular injections |
Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. To be eligible for inclusion in this study patients must meet all of the following criteria: * Patient must have a BMI between 18 -35 kg/m2 * Patient must have symptomatic knee osteoarthritis predomi...