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A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases

KPL-716-C202: 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

NCT03858634•Genentech, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 10 weeks after final study drug administration
•5. Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study

Exclusion Criteria

•1. Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
•2. Is currently using medication known to cause pruritus
•3. Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
•4. Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
•5. Has an active infection, including skin infection
•6. Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the participant at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results

Locations (14)

Site 106

Anniston, Alabama, United States

Site 110

Phoenix, Arizona, United States

Site 114

Hot Springs, Arkansas, United States

Site 103

Los Angeles, California, United States

Site 113

Sweetwater, Florida, United States

Site 105

Normal, Illinois, United States

Site 112

Plainfield, Indiana, United States

Site 119

New Orleans, Louisiana, United States

Site 109

Fort Gratiot, Michigan, United States

Site 123

New York, New York, United States

Key Dates

Start Date

May 29, 2019

Primary Completion Date

April 1, 2020

Completion Date

June 8, 2020

Last Updated

March 18, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Idiopathic UrticariaChronic Idiopathic PruritusLichen PlanusLichen Simplex ChronicusPlaque Psoriasis

Interventions

KPL-716

DRUG

Placebo

DRUG

Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus

NCT07131813

Oral Lichen Planus

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RECRUITING

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

NCT06321003

Oral Squamous Cell CarcinomaOral Potentially Malignant Disorder+10 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases

Inclusion Criteria

Exclusion Criteria

Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

Vaginal Ecosystem and Network in the United States Study

Thyme Honey for Management of Oral Lichen Planus

Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP

Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders