A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Idiopathic Urticaria, Chronic Idiopathic Pruritus, Lichen Planus, Lichen Simplex Chronicus, Plaque Psoriasis
In brief
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).
Key facts
- Study ID
- NCT03858634
- Run by
- Genentech, Inc.
- People needed
- 58
- Starts
- 2019-05-29
- Expected to finish
- 2020-06-08
- Last updated by the study team
- 2025-03-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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