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Vixarelimab · 1 trial · 2 indications
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...
Vixarelimab is an investigational drug being studied for the treatment of prurigo nodularis, a skin condition characterized by intense itching and nodular lesions. It is being evaluated for its ability to reduce pruritus, or itching, in patients with this condition. The drug is currently in clinical development and is not yet approved.
Vixarelimab is being developed by Kiniksa Pharmaceuticals International, plc, a biopharmaceutical company traded on the Nasdaq under the ticker symbol KNSA. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with prurigo nodularis.
Vixarelimab is in Phase 2 clinical development. It has completed a Phase 2 trial, which was a randomized, double-blind, placebo-controlled study involving 240 participants with prurigo nodularis. The drug remains investigational and has not received regulatory approval.
Vixarelimab has been studied in one completed Phase 2 clinical trial, identified as NCT03816891. This trial assessed the efficacy, safety, and tolerability of Vixarelimab in reducing pruritus in patients with prurigo nodularis. The study enrolled 240 participants across multiple countries, including the United States, Australia, and several European and Asian nations.
Vixarelimab is not FDA approved. It is an investigational drug currently in clinical development for prurigo nodularis. The drug has completed a Phase 2 trial, but it has not yet received regulatory approval from the FDA or any other health authority.