A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
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| ClinicalTrials.gov Identifier: NCT03858634 |
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Recruitment Status :
Completed
First Posted : March 1, 2019
Results First Posted : December 28, 2021
Last Update Posted : December 28, 2021
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Sponsor:
Kiniksa Pharmaceuticals, Ltd.
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd.
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Idiopathic Urticaria Chronic Idiopathic Pruritus Lichen Planus Lichen Simplex Chronicus Plaque Psoriasis | Drug: KPL-716 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 58 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 29, 2019 |
| Actual Primary Completion Date : | April 1, 2020 |
| Actual Study Completion Date : | June 8, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: KPL-716
Weekly for 8 weeks
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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.
Other Name: vixarelimab |
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Placebo Comparator: Placebo
Weekly for 8 weeks
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Drug: 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. |
Primary Outcome Measures :
- Change From Baseline in Weekly Average WI-NRS at Week 8 [ Time Frame: Baseline, 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.
- Percent Change From Baseline in Weekly Average WI-NRS at Week 8 [ Time Frame: Baseline, 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.
Secondary Outcome Measures :
- Change From Baseline in Weekly Average WI-NRS Over Time [ Time Frame: Baseline, Weeks 1-18 ]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.
- Percent Change From Baseline in Weekly Average WI-NRS Over Time [ Time Frame: Baseline, Weeks 1-18 ]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.
- Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time [ Time Frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18 ]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.
- Percent Change From Baseline in Pruritus VAS Over Time [ Time Frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18 ]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.
- Change From Baseline in 5-D Pruritus Total Score Over Time [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 ]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).
- Percent Change From Baseline in 5-D Pruritus Total Score Over Time [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 ]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).
- Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time [ Time Frame: Baseline, Weeks 1-18 ]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.
- Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only [ Time Frame: Baseline, Weeks 1-18 ]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.
- Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only [ Time Frame: Baseline, Weeks 1-18 ]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
- Change From Baseline in Sleep Loss VAS Over Time [ Time Frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18 ]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.
- Percent Change From Baseline in Sleep Loss VAS Over Time [ Time Frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18 ]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.
- Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time [ Time Frame: Baseline, Weeks 1-18 ]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.
- Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time [ Time Frame: Baseline, Weeks 1-18 ]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.
- Change From Baseline in Weekly Average of Sleep Quality NRS Over Time [ Time Frame: Baseline, Weeks 1-18 ]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.
- Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time [ Time Frame: Baseline, Weeks 1-18 ]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.
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 18 ]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.
- Percent Change From Baseline in DLQI Total Score Over Time [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 18 ]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.
- Change From Baseline in ItchyQoL Total Score Over Time [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 18 ]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).
- Percent Change From Baseline in ItchyQoL Total Score Over Time [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 18 ]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).
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858634
Locations
Show 19 study locations
Sponsors and Collaborators
Kiniksa Pharmaceuticals, Ltd.
Investigators
| Study Director: | John Paolini, M.D. | Kiniksa Pharmaceuticals, Ltd. |
Study Documents (Full-Text)
Documents provided by Kiniksa Pharmaceuticals, Ltd.:
Documents provided by Kiniksa Pharmaceuticals, Ltd.:
Study Protocol [PDF] January 28, 2019
Statistical Analysis Plan [PDF] April 13, 2020
| Responsible Party: | Kiniksa Pharmaceuticals, Ltd. |
| ClinicalTrials.gov Identifier: | NCT03858634 |
| Other Study ID Numbers: |
KPL-716-C202 |
| First Posted: | March 1, 2019 Key Record Dates |
| Results First Posted: | December 28, 2021 |
| Last Update Posted: | December 28, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Kiniksa Pharmaceuticals, Ltd.:
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pruritus, chronic pruritus, moderate to severe |
Additional relevant MeSH terms:
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Psoriasis Pruritus Urticaria Lichen Planus Chronic Urticaria Neurodermatitis Skin Diseases, Papulosquamous Skin Diseases |
Skin Manifestations Skin Diseases, Vascular Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Lichenoid Eruptions Dermatitis Skin Diseases, Eczematous |