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).

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT03858634

Recruitment Status:

Completed

Sponsor:

Kiniksa Pharmaceuticals, Ltd.

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There are 19 Locations for this study

See Locations Near You

Site 106
Anniston Alabama, 36207, United States
Site 110
Phoenix Arizona, 85032, United States
Site 114
Hot Springs Arkansas, 71913, United States
Site 103
Los Angeles California, 90045, United States
Site 108
Clearwater Florida, 33756, United States
Site 120
Gainesville Florida, 32610, United States
Site 113
Sweetwater Florida, 33172, United States
Site 116
Sandy Springs Georgia, 30328, United States
Site 105
Normal Illinois, 61761, United States
Site 112
Plainfield Indiana, 46168, United States
Site 119
New Orleans Louisiana, 70115, United States
Site 109
Fort Gratiot Michigan, 48059, United States
Site 121
Omaha Nebraska, 68144, United States
Site 123
New York New York, 10012, United States
Site 115
Johnston Rhode Island, 02919, United States
Site 102
Houston Texas, 77004, United States
Site 104
Pflugerville Texas, 78660, United States
Site 101
San Antonio Texas, 78213, United States
Site 122
Spokane Washington, 99202, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT03858634

Recruitment Status:

Completed

Sponsor:


Kiniksa Pharmaceuticals, Ltd.

How clear is this clinincal trial information?

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