A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Summary
Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study. The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).
Timeline
- Start
- 2019-05-29
- Primary completion
- 2020-04-01
- Completion
- 2020-06-08
Outcome
Mixed primary results
registry analysis (superiority test); KPL-716: PPs Cohort vs Placebo: PPs Cohort; p = 0.0186; LS mean difference -3.1 (80% CI -4.70 to -1.51); NCT03858634 ↗
registry analysis (superiority test); KPL-716: CIU Cohort vs Placebo: CIU Cohort; p = 0.3980; Least squares (LS) mean difference -3.3 (80% CI -8.68 to 2.17); NCT03858634 ↗
registry analysis (superiority test); KPL-716: PPs Cohort vs Placebo: PPs Cohort; p = 0.0122; LS mean difference -37.5 (80% CI -55.48 to -19.61); NCT03858634 ↗
registry analysis (superiority test); KPL-716: CIP Cohort vs Placebo: CIP Cohort; p = 0.8130; LS mean difference -3.6 (80% CI -23.33 to 16.18); NCT03858634 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vixarelimab | Monoclonal antibody | 360 mg | Subcutaneous |