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KPL-716 · 1 trial · 5 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.
| Arm | Type | Description |
|---|---|---|
| KPL-716 | EXPERIMENTAL | Weekly for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Weekly for 8 weeks |
| 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. |
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 small molecule being developed for chronic idiopathic urticaria, a condition characterized by recurrent hives of unknown cause. It is also being studied for other chronic pruritic conditions, including chronic idiopathic pruritus, lichen planus, lichen simplex chronicus, and plaque psoriasis, based on a completed Phase 2 trial.
The specific molecular target of KPL-716 has not been disclosed in available information. It is a small molecule being evaluated for its ability to reduce pruritus, or itching, in chronic pruritic diseases. Its mechanism of action is not publicly detailed.
KPL-716 is being developed by Kiniksa Pharmaceuticals International, plc, a biopharmaceutical company traded on the Nasdaq under the ticker symbol KNSA. The company is responsible for the clinical development and regulatory strategy for this investigational drug.
KPL-716 is in Phase 2 clinical development. It has completed one Phase 2 trial, NCT03858634, which assessed its efficacy, safety, and tolerability in reducing pruritus in chronic pruritic diseases. The drug is investigational and has not been approved by regulatory authorities.
KPL-716 has been studied in one completed Phase 2 clinical trial, registered as NCT03858634. This randomized, double-blind, placebo-controlled study enrolled 58 participants in the United States and evaluated the drug in chronic idiopathic urticaria, chronic idiopathic pruritus, lichen planus, lichen simplex chronicus, and plaque psoriasis.
No alternative names for KPL-716 have been reported. It is identified solely by its code name KPL-716 in clinical trial registries and company communications. No other brand or generic names have been associated with this investigational drug.