A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
NCT ID: NCT03858634
Last Updated: 2025-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2019-05-29
2020-06-08
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KPL-716
Weekly for 8 weeks
KPL-716
A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection.
Placebo
Weekly for 8 weeks
Placebo
Placebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection.
Interventions
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KPL-716
A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection.
Placebo
Placebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Kiniksa Pharmaceuticals, Ltd.
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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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
Site 115
Johnston, Rhode Island, United States
Site 104
Pflugerville, Texas, United States
Site 101
San Antonio, Texas, United States
Site 122
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GX45045
Identifier Type: OTHER
Identifier Source: secondary_id
KPL-716-C202
Identifier Type: -
Identifier Source: org_study_id
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