This Study is a Phase 2 randomized, double-blind, placebo-controlled, pilot study to investigate the efficacy, safety, and tolerability of KPL-716 in reducing pruritus in diseases characterized by chronic pruritus.
Objectives of this Study
Screening period (up to 4 weeks)
Potential patients will meet with the study doctor to determine if they are eligible to participate in the clinical study.
Treatment period (8 weeks)
This period will be broken up into two parts.
- Pre-dose: Eligibility must be confirmed prior to dosing on Day 1. Subjects will have the multiple procedures performed prior to dosing on Day 1.
- Dosing: A loading dose of KPL-716 720 mg (2x maintenance dose) or matching placebo will be administered via 2 SC injections within 30 minutes on Day 1 by the Investigator or qualified designee at the study sites. All subsequent doses of KPL-716 360 mg (1x maintenance dose) or matching placebo will be administered by the Investigator or qualified designee at the study sites via a single SC injection.
Follow-up period (10 weeks)
Subjects will undergo vital signs measurement, review of concomitant medications, therapies and procedure, review of adverse events, and monitoring of compliance at every visit.
Start the conversation early
This clinical study has the potential to offer a step forward in providing much needed relief for people with moderate to severe pruritus. This study is currently open and actively enrolling patients. We are looking for physicians to review their patient's charts to see if any of them may be eligible for participation. Please consider referring patients:
Patients can either visit this website to learn more and screen or call to speak to a study nurse at (1-855-277-3149)