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Also known as KPL-716, RG6536
Vixarelimab · 2 trials · 7 indications
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
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 |
|---|---|---|
| KPL-716 | EXPERIMENTAL | Weekly for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Weekly for 8 weeks |
| 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 |
|---|---|---|
| KPL-716 | DRUG | A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection. |
| Placebo | DRUG | Placebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection. |
| Vixarelimab | DRUG | solution for injection |
Inclusion Criteria: 1. Male or female aged 18 to 75 years 2. Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months 3. Moderate to severe pruritus 4. Female...
Vixarelimab is an investigational monoclonal antibody being developed for the treatment of prurigo nodularis, a chronic skin condition characterized by intensely itchy nodules. It is also being studied for pruritus, or itch. It has not been approved for any indication and remains in clinical development.
Vixarelimab targets OSMR, the oncostatin M receptor. It is an inhibitor of this receptor. By binding OSMR, vixarelimab is designed to block signaling pathways associated with itch and inflammation in prurigo nodularis. The target class is an inhibitor of the oncostatin M receptor.
Vixarelimab is being developed by Kiniksa Pharmaceuticals International, plc, which trades under the ticker KNSA. Kiniksa is the sponsor of the clinical program evaluating vixarelimab in prurigo nodularis and pruritus.
Vixarelimab is in Phase 2 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The completed Phase 2 trial evaluated its efficacy, safety, and tolerability in reducing pruritus in prurigo nodularis.
Vixarelimab has been studied in one clinical trial, NCT03816891, titled a study to assess the efficacy, safety, and tolerability of vixarelimab in reducing pruritus in prurigo nodularis. The Phase 2 trial is completed and enrolled 240 participants across the United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Poland, South Korea, Taiwan, and the United Kingdom.
Yes. The Phase 2 trial NCT03816891 was randomized, double blind, and placebo controlled. It enrolled 240 participants aged 18 years and older of all sexes, and it did not use biomarker selection. The study evaluated vixarelimab in prurigo nodularis and pruritus and is now completed.