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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04119687 | Study to Evaluate the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee | PHASE1 | ACTIVE NOT_RECRUITING | 72 | — | — | Mar 2, 2020 | Nov 28, 2026 | Mar 17, 2025 | 6 | United States |
Incidence of treatment emergent adverse events after a single intra-articular (IA) injection of FX201
| Arm | Type | Description |
|---|---|---|
| Low Dose FX201 | EXPERIMENTAL | Single low dose FX201 injection |
| Mid Dose FX201 | EXPERIMENTAL | Single mid dose FX201 injection |
| High Dose FX201 | EXPERIMENTAL | Single high dose FX201 injection |
| Name | Type | Description |
|---|---|---|
| FX201 | BIOLOGICAL | FX201, humantakinogene hadenovec, is a novel interleukin-1 receptor antagonist (IL-1Ra) gene therapy for IA administration that is being developed for the treatment of patients with OAK. |
Inclusion Criteria: * Written consent to participate in the study * Male or female 30 to 80 years of age, inclusive, on the day of enrollment (Day 1) * Body mass index (BMI) ≤ 40 kilograms per meters squared (kg/m2) * Clinical diagnosis of OA of the knee on the American College of Rheumatology crit...