Status:
COMPLETED
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Kiniksa Pharmaceuticals, Ltd.
Conditions:
Chronic Idiopathic Urticaria
Chronic Idiopathic Pruritus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 inve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2020
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03858634
Start Date
May 29 2019
End Date
June 8 2020
Last Update
March 18 2025
Active Locations (14)
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1
Site 106
Anniston, Alabama, United States, 36207
2
Site 110
Phoenix, Arizona, United States, 85032
3
Site 114
Hot Springs, Arkansas, United States, 71913
4
Site 103
Los Angeles, California, United States, 90045