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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01291914 | Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee | PHASE1 | COMPLETED | 140 | — | — | Dec 1, 2010 | Mar 1, 2012 | Jan 24, 2024 | 13 | Austria, Canada +2 |
| Arm | Type | Description |
|---|---|---|
| FX005 | EXPERIMENTAL | - |
| Placebo 1 (Carrier) | PLACEBO_COMPARATOR | - |
| Placebo 2 (Diluent) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| FX005 | DRUG | Single Ascending Dose (SAD) Phase Cohorts: 1, 10 or 45 mg intra-articular injection; Proof of Concept Phase: Maximum, well-tolerated dose intra-articular injection (determined during SAD Phase) |
| Placebo 1 (Carrier) | DRUG | Single intra-articular injection |
| Placebo 2 (Diluent) | DRUG | Single intra-articular injection |
Inclusion Criteria: * Male or female ≥40 years of age * Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological) * Kellgren-Lawrence grades II or III * Mea...