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Also known as Vixarelimab, RG6536
KPL-716 · 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...
KPL-716 is an investigational monoclonal antibody developed by Kiniksa Pharmaceuticals International, plc for chronic idiopathic urticaria, a dermatologic condition involving persistent hives. It has completed a Phase 2 clinical trial and is not approved for commercial use. Kiniksa trades under the ticker KNSA.
KPL-716 targets the oncostatin M receptor beta, also known as OSMR. OSMR is a protein receptor involved in inflammatory signaling pathways. By binding this receptor, KPL-716 is designed to interfere with oncostatin M mediated signaling that contributes to itch and inflammation in chronic pruritic diseases.
KPL-716 is being developed by Kiniksa Pharmaceuticals International, plc, which trades on the Nasdaq under the ticker KNSA. Kiniksa is the sponsor of the clinical program evaluating KPL-716 in chronic idiopathic urticaria and related pruritic conditions.
KPL-716 is in Phase 2 development. Its single clinical trial, NCT03858634, has been completed. The drug is investigational and has not been approved by the FDA for any indication. No active trials of KPL-716 are currently listed.
KPL-716 has been studied in one Phase 2 trial, NCT03858634, titled A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases. The trial enrolled 58 participants in the United States and has been completed. It was randomized, double-blind, and placebo-controlled.
KPL-716 is being evaluated for chronic idiopathic urticaria, a condition characterized by recurring hives and itching. The Phase 2 trial NCT03858634 assessed KPL-716 for reducing pruritus across chronic pruritic diseases, including chronic idiopathic urticaria, chronic idiopathic pruritus, lichen planus, lichen simplex chronicus, and plaque psoriasis.