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Working to provide relief for chronic pruritus

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.

  • To evaluate the efficacy of subcutaneous (SC) KPL-716 in reducing pruritus in subjects with chronic pruritus experiencing moderate to severe pruritus.
  • KPL-716 is an injectable medication whose active substance is a fully-human monoclonal antibody against Oncostatin M Receptor beta (OSMR β).

Objectives of this 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).
  • Change from baseline in weekly average Worst Itch-Numeric Rating Scale (WI-NRS) at Week 8

Study Design At-A-Glance

The planned study duration per subject is approximately 20 to 22 weeks and is divided up into three sections:

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:

  • Who are 18 to 75 years old
  • Who have a physician-documented diagnosis of pruritus for at least 6 months
  • Whose pruritus associated with these diagnoses has been refractory to treatment with H1 antihistamines and must have been present for at least 6 weeks prior to Day 1
  • Who have had pruritus and hives for at least 6 consecutive weeks prior to Day 1 if they are subjects with CIU. In subjects with CIU, urticarial eruptions must typically last less than 24 hours

Discussing the study opportunity with your patients

Here are some simple ways to discuss this clinical study with your patients: The study is examining an investigational drug (KPL-716) as a potential way to reduce pruritus in subjects experiencing moderate to severe pruritus.

  • The study is comprised of multiple cohorts for a different study population. They are Chronic Idiopathic Urticaria (CIU), Chronic Idiopathic Pruritus (CIP), Lichen Planus (LP), Lichen Simplex Chronicus (LSC), and Plaque Psoriasis (PPs). Each cohort will be enrolled and analyzed independently.
  • Each cohort will enroll approximately 26 subjects and contain three periods: Screening Period (Day-28 to Day-1, minimum 14 days and maximum 28 days), Treatment Period (Day 1 [Baseline] to Week 8), and Follow-up Period (After week 8 to Week 18).
  • All study participants will receive all study-related care and all study-related drugs at no cost.
  • This clinical study may be an appealing choice for patients with moderate to severe pruritus who are looking for additional options.

Patients can either visit this website to learn more and screen or call to speak to a study nurse at (1-855-277-3149)