Psoriasis Clinical Trial
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).
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 to 75 years
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
Moderate to severe pruritus
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
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:
Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
Is currently using medication known to cause pruritus
Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
Has an active infection, including skin infection
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
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There are 19 Locations for this study
Anniston Alabama, 36207, United States
Phoenix Arizona, 85032, United States
Hot Springs Arkansas, 71913, United States
Los Angeles California, 90045, United States
Clearwater Florida, 33756, United States
Gainesville Florida, 32610, United States
Sweetwater Florida, 33172, United States
Sandy Springs Georgia, 30328, United States
Normal Illinois, 61761, United States
Plainfield Indiana, 46168, United States
New Orleans Louisiana, 70115, United States
Fort Gratiot Michigan, 48059, United States
Omaha Nebraska, 68144, United States
New York New York, 10012, United States
Johnston Rhode Island, 02919, United States
Houston Texas, 77004, United States
Pflugerville Texas, 78660, United States
San Antonio Texas, 78213, United States
Spokane Washington, 99202, United States
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