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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04120402 | Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee | PHASE2 | COMPLETED | 318 | — | — | Sep 10, 2021 | Jun 1, 2023 | Jun 25, 2024 | 12 | Czechia, Denmark +1 |
| NCT02609126 | Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis | PHASE1 | COMPLETED | 32 | — | — | Apr 1, 2016 | Dec 28, 2017 | Sep 1, 2021 | 3 | Canada |
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst). Least squares mean from a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC pain score.
| Arm | Type | Description |
|---|---|---|
| EP-104IAR 25 mg | EXPERIMENTAL | A single use intra-articular injection containing 25 mg of EP-104IAR |
| Placebo (vehicle) | PLACEBO_COMPARATOR | A single use intra-articular injection containing no active ingredients |
| EP-104IAR | EXPERIMENTAL | 15mg EP-104IAR in 4 mL carrier fluid |
| Vehicle | PLACEBO_COMPARATOR | 4 mL carrier fluid |
| Name | Type | Description |
|---|---|---|
| EP-104IAR 25 mg | DRUG | Single 5 mL intra-articular injection |
| Vehicle | DRUG | Single 5 mL intra-articular injection |
| EP-104IAR | DRUG | Single, ultrasound-guided injection of EP-104IAR into the knee |
Key Inclusion Criteria: * Males or females, aged ≥40 years * Body Mass Index (BMI) ≤ 40.0 kg/m2 * Diagnosis of primary OA of the Index knee, with symptoms present for at least 6 months * OA severity Grade 2 or 3 (based on Kellgren Lawrence Grading Scale) * Unsatisfactory pain relief from at least 2...