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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03816891 | Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis | PHASE2 | COMPLETED | 240 | — | — | Mar 11, 2019 | Aug 24, 2023 | Jan 13, 2026 | 86 | United States, Australia +11 |
Participants rated pruritus daily on the Worst Itch \[pruritis\] Numeric Rating Scale (WI-NRS: 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place.
| Arm | Type | Description |
|---|---|---|
| Phase 2a - Vixarelimab 360 mg SC Weekly (QW) | EXPERIMENTAL | Vixarelimab 720 mg loading dose followed by 360 mg weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2) |
| Phase 2a - Placebo SC QW | PLACEBO_COMPARATOR | Placebo loading dose followed by placebo weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2) |
| Phase 2b - Vixarelimab 540 mg SC Every 4 Weeks (Q4W; DBL) | EXPERIMENTAL | Vixarelimab 540 mg SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period |
| Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | EXPERIMENTAL | Vixarelimab 360 mg SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period |
| Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL) | EXPERIMENTAL | Vixarelimab 120 mg SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period |
| Phase 2b - Placebo SC, Q4W (DBL) | PLACEBO_COMPARATOR | Placebo SC, every 4 weeks (Q4W) for 16 weeks during Double Blind Period |
| Phase 2b - Vixarelimab 360 mg SC, Every 2 Weeks (Q2W; OLE) | EXPERIMENTAL | Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension |
| Name | Type | Description |
|---|---|---|
| Vixarelimab | DRUG | solution for injection |
| Placebo | DRUG | solution for injection |
Inclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified): 1. Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b) 2. Have clinical diagnosis of prurigo nodularis for at least 6 months 3. Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the...