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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03858634
Other study ID # KPL-716-C202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 29, 2019
Est. completion date June 8, 2020

Study information

Verified date November 2021
Source Kiniksa Pharmaceuticals, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date June 8, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
United States Site 106 Anniston Alabama
United States Site 108 Clearwater Florida
United States Site 109 Fort Gratiot Michigan
United States Site 120 Gainesville Florida
United States Site 114 Hot Springs Arkansas
United States Site 102 Houston Texas
United States Site 115 Johnston Rhode Island
United States Site 103 Los Angeles California
United States Site 119 New Orleans Louisiana
United States Site 123 New York New York
United States Site 105 Normal Illinois
United States Site 121 Omaha Nebraska
United States Site 104 Pflugerville Texas
United States Site 110 Phoenix Arizona
United States Site 112 Plainfield Indiana
United States Site 101 San Antonio Texas
United States Site 116 Sandy Springs Georgia
United States Site 122 Spokane Washington
United States Site 113 Sweetwater Florida

Sponsors (1)

Lead Sponsor Collaborator
Kiniksa Pharmaceuticals, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Weekly Average WI-NRS at Week 8 WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. Baseline, Week 8
Primary Percent Change From Baseline in Weekly Average WI-NRS at Week 8 WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. Baseline, Week 8
Secondary Change From Baseline in Weekly Average WI-NRS Over Time WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. Baseline, Weeks 1-18
Secondary Percent Change From Baseline in Weekly Average WI-NRS Over Time WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. Baseline, Weeks 1-18
Secondary Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Secondary Percent Change From Baseline in Pruritus VAS Over Time Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Secondary Change From Baseline in 5-D Pruritus Total Score Over Time This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus). Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Secondary Percent Change From Baseline in 5-D Pruritus Total Score Over Time This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus). Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Secondary Percentage of Participants Achieving =4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. Baseline, Weeks 1-18
Secondary Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort. Baseline, Weeks 1-18
Secondary Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort Baseline, Weeks 1-18
Secondary Change From Baseline in Sleep Loss VAS Over Time Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit. Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Secondary Percent Change From Baseline in Sleep Loss VAS Over Time Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit. Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Secondary Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult. Baseline, Weeks 1-18
Secondary Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult. Baseline, Weeks 1-18
Secondary Change From Baseline in Weekly Average of Sleep Quality NRS Over Time Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep. Baseline, Weeks 1-18
Secondary Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep. Baseline, Weeks 1-18
Secondary Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect. Baseline, Weeks 4, 8, 12, 16, 18
Secondary Percent Change From Baseline in DLQI Total Score Over Time The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect. Baseline, Weeks 4, 8, 12, 16, 18
Secondary Change From Baseline in ItchyQoL Total Score Over Time ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). Baseline, Weeks 4, 8, 12, 16, 18
Secondary Percent Change From Baseline in ItchyQoL Total Score Over Time ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). Baseline, Weeks 4, 8, 12, 16, 18
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