Clinical trial NCT03858634: A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Official title: KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Idiopathic Urticaria
Chronic Idiopathic Pruritus
Lichen Planus
Lichen Simplex Chronicus
Plaque Psoriasis
Keywords: pruritus, chronic pruritus, moderate to severe
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kiniksa Pharmaceuticals, Ltd.
First posted: 2019-03-01
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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:

1. Male or female aged 18 to 75 years
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:

1. Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
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

Primary outcomes:
measure: Change From Baseline in Weekly Average WI-NRS at Week 8
timeFrame: Baseline, Week 8
measure: Percent Change From Baseline in Weekly Average WI-NRS at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in Weekly Average WI-NRS Over Time
timeFrame: Baseline, Weeks 1-18
measure: Percent Change From Baseline in Weekly Average WI-NRS Over Time
timeFrame: Baseline, Weeks 1-18
measure: Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time
timeFrame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
measure: Percent Change From Baseline in Pruritus VAS Over Time
timeFrame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
measure: Change From Baseline in 5-D Pruritus Total Score Over Time
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
measure: Percent Change From Baseline in 5-D Pruritus Total Score Over Time
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
measure: Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time
timeFrame: Baseline, Weeks 1-18
measure: Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
timeFrame: Baseline, Weeks 1-18
measure: Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
timeFrame: Baseline, Weeks 1-18
measure: Change From Baseline in Sleep Loss VAS Over Time
timeFrame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
measure: Percent Change From Baseline in Sleep Loss VAS Over Time
timeFrame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
measure: Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time
timeFrame: Baseline, Weeks 1-18
measure: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
timeFrame: Baseline, Weeks 1-18
measure: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
timeFrame: Baseline, Weeks 1-18
measure: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
timeFrame: Baseline, Weeks 1-18
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 18
measure: Percent Change From Baseline in DLQI Total Score Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 18
measure: Change From Baseline in ItchyQoL Total Score Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 18
measure: Percent Change From Baseline in ItchyQoL Total Score Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 18
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Site 106
state: Alabama
city: Phoenix
country: United States
facility: Site 110
state: Arizona
city: Hot Springs
country: United States
facility: Site 114
state: Arkansas
city: Los Angeles
country: United States
facility: Site 103
state: California
city: Sweetwater
country: United States
facility: Site 113
state: Florida
city: Normal
country: United States
facility: Site 105
state: Illinois
city: Plainfield
country: United States
facility: Site 112
state: Indiana
city: New Orleans
country: United States
facility: Site 119
state: Louisiana
city: Fort Gratiot
country: United States
facility: Site 109
state: Michigan
city: New York
country: United States
facility: Site 123
state: New York
city: Johnston
country: United States
facility: Site 115
state: Rhode Island
city: Pflugerville
country: United States
facility: Site 104
state: Texas
city: San Antonio
country: United States
facility: Site 101
state: Texas
city: Spokane
country: United States
facility: Site 122
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: