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Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis

Primary Purpose

Prurigo Nodularis, Pruritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
vixarelimab
Placebo
Sponsored by
Kiniksa Pharmaceuticals, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prurigo Nodularis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified):

  1. Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b)
  2. Have clinical diagnosis of prurigo nodularis for at least 6 months
  3. Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the Screening Visit and Day 1
  4. Moderate to severe pruritus (Phase 2a); severe pruritus (Phase 2b)
  5. Female subjects of childbearing potential must have a negative pregnancy test, be nonlactating, and having agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 16 weeks after final study drug administration
  6. 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 (apply to both Phase 2a and Phase 2b unless otherwise specified):

  1. Use of prohibited medications within the indicated timeframe from Day 1
  2. Is currently using medication known to cause pruritus
  3. Presence of any inflammatory, pruritic, and/or fibrotic skin condition other than moderate to severe prurigo nodularis or atopic dermatitis unless approved by the Sponsor
  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 subject 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

Sites / Locations

  • Site 104
  • Site 125
  • Site 1127
  • Site 1132
  • Site 137
  • Site 1116
  • Site 1154
  • Site 1102
  • Site 1167
  • Site 1165
  • Site 122
  • Site 1139
  • Site 1151
  • Site 1107
  • Site 1135
  • Site 111
  • Site 1163
  • Site 117
  • Site 1166
  • Site 114
  • Site 105
  • Site 123
  • Site 1155
  • Site 1110
  • Site 1159
  • Site 1113
  • Site 1118
  • Site 130
  • Site 108
  • Site 1150
  • Site 1158
  • Site 1121
  • Site 1133
  • Site 101
  • Site 106
  • Site 128
  • Site 1115
  • Site 4106
  • Site 4105
  • Site 4104
  • Site 2102
  • Site 2101
  • Site 2702
  • Site 2701
  • Site 1308
  • Site 1301
  • Site 1306
  • Site 1307
  • Site 1305
  • Site 1309
  • Site 303
  • Site 2301
  • Site 2302
  • Site 2503
  • Site 2502
  • Site 2504
  • Site 2001
  • Site 2003
  • Site 2011
  • Site 2008
  • Site 2002
  • Site 2005
  • Site 2604
  • Site 2603
  • Site 4304
  • Site 4303
  • Site 4302
  • Site 2207
  • Site 2204
  • Site 2201
  • Site 4203
  • Site 4207
  • Site 4201
  • Site 4204
  • Site 2901
  • Site 2903

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Phase 2a - Vixarelimab 360 mg SC QW

Phase 2a - Placebo SC QW

Phase 2b - Vixarelimab 540 mg SC Q4W (DBL)

Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL)

Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL)

Phase 2b - Placebo SC, Q4W (DBL)

Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE)

Arm Description

Vixarelimab 720 mg loading dose followed by 360 mg weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)

Placebo loading dose followed by placebo weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)

Vixarelimab 540 mg SC, every 4 weeks for 16 weeks during Double Blind Period

Vixarelimab 360 mg SC, every 4 weeks for 16 weeks during Double Blind Period

Vixarelimab 120 mg SC, every 4 weeks for 16 weeks during Double Blind Period

Placebo SC, every 4 weeks for 16 weeks during Double Blind Period

Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension

Outcomes

Primary Outcome Measures

Phase 2a & 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS)
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)

Secondary Outcome Measures

*Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2a: Percent change from baseline in pruritus visual analog scale (VAS)
At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
Phase 2a: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2a: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2a: Change from baseline in pruritis visual analog scale (VAS) over time
At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
Phase 2a: Percent change from baseline in pruritis visual analog scale (VAS) over time
At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
Phase 2a: Change from baseline in 5-D Pruritus total score over time
Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. 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)
Phase 2a: Percent change from baseline in 5-D Pruritus total score over time
Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. 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)
Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2a: Change from baseline in Sleep Loss VAS over time
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
Phase 2a: Percent change from baseline in Sleep Loss VAS over time
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
Phase 2a: Change from baseline in weekly average of difficulty falling asleep NRS over time
Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)
Phase 2a: Percent change from baseline in weekly average of difficulty falling asleep NRS over time
Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)
Phase 2a: Change from baseline in weekly average of sleep quality NRS over time
Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)
Phase 2a: Percent change from baseline in weekly average of sleep quality NRS over time
Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)
Phase 2a: Change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time
QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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)
Phase 2a: Percent change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time
QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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)
Phase 2a: Change from baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) over time
PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area.
Phase 2a: Proportion of subjects with improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 categories over time
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis)
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis)
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2b: Proportion of subjects achieving 0 or 1 from baseline in PN-IGA
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
Phase 2b: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2b: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Phase 2b: Proportion of subjects achieving 0 or 1 in PN-IGA over time
PN-IGA is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in PN-IGA over time
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
Phase 2b: Proportion of subjects achieving 0 or 1 in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) over time
IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.
Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in IGA-CNPG-S over time
IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.
Phase 2b: Change from baseline in weekly average of Sleep Loss VAS over time
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
Phase 2b: Percent change from baseline in weekly average of Sleep Loss VAS over time
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
Phase 2b: Change from baseline in ItchyQoL over time
Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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)
Phase 2b: Percent change from baseline in ItchyQoL over time
Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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)

Full Information

First Posted
January 23, 2019
Last Updated
September 22, 2023
Sponsor
Kiniksa Pharmaceuticals, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03816891
Brief Title
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
Official Title
A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects With Prurigo Nodularis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kiniksa Pharmaceuticals, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis.
Detailed Description
This is a Phase 2a/b randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, PK and immunogenicity of Vixarelimab administered subcutaneously (SC) in subjects with prurigo nodularis experiencing pruritus. Phase 2a portion (completed): Forty-nine subjects with moderate to severe PN experiencing moderate to severe pruritus were treated in the Phase 2a portion of the study. At Baseline, subjects were randomized 1:1 to receive double-blind Vixarelimab or placebo: Vixarelimab 720 mg loading dose followed by 360 mg every week; Placebo loading dose followed by placebo every week. The treatment Period was 8 weeks or 16 weeks (treatment duration was reduced from 16 weeks to 8 weeks in a protocol amendment [Protocol Version 3]). Phase 2b portion (enrolling): The Phase 2b study (Figure 1) will consist of a 4-week Screening Period and a 16-week Double-Blind Period, followed by a 36-week Open-Label-Extension (OLE) Period. Approximately 180 subjects with PN, experiencing severe pruritus, will be randomized (at 1:1:1:1 ratio) into one of 4 arms (3 active arms and one placebo arm). A total of 4 doses of study drug will be administered during the Double-Blind Period to measure the efficacy, safety, and PK of Vixarelimab. After the Double-Blind Period, all subjects will have the option to receive Vixarelimab during the OLE Period to evaluate the long-term safety and PK.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prurigo Nodularis, Pruritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase 2a (completed): 2 arms; Phase 2b (enrolling): 5 arms (4 arms during Double Blind Period and 1 arm during Open Label Extension)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 2a - Vixarelimab 360 mg SC QW
Arm Type
Experimental
Arm Description
Vixarelimab 720 mg loading dose followed by 360 mg weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)
Arm Title
Phase 2a - Placebo SC QW
Arm Type
Placebo Comparator
Arm Description
Placebo loading dose followed by placebo weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)
Arm Title
Phase 2b - Vixarelimab 540 mg SC Q4W (DBL)
Arm Type
Experimental
Arm Description
Vixarelimab 540 mg SC, every 4 weeks for 16 weeks during Double Blind Period
Arm Title
Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL)
Arm Type
Experimental
Arm Description
Vixarelimab 360 mg SC, every 4 weeks for 16 weeks during Double Blind Period
Arm Title
Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL)
Arm Type
Experimental
Arm Description
Vixarelimab 120 mg SC, every 4 weeks for 16 weeks during Double Blind Period
Arm Title
Phase 2b - Placebo SC, Q4W (DBL)
Arm Type
Placebo Comparator
Arm Description
Placebo SC, every 4 weeks for 16 weeks during Double Blind Period
Arm Title
Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE)
Arm Type
Experimental
Arm Description
Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension
Intervention Type
Drug
Intervention Name(s)
vixarelimab
Other Intervention Name(s)
KPL-716
Intervention Description
solution for injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
solution for injection
Primary Outcome Measure Information:
Title
Phase 2a & 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS)
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
at Week 8 (Phase 2a); at Week 16 (Phase 2b)
Secondary Outcome Measure Information:
Title
*Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
at Week 8
Title
Phase 2a: Percent change from baseline in pruritus visual analog scale (VAS)
Description
At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
Time Frame
at Week 8
Title
Phase 2a: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Change from baseline in pruritis visual analog scale (VAS) over time
Description
At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Percent change from baseline in pruritis visual analog scale (VAS) over time
Description
At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Change from baseline in 5-D Pruritus total score over time
Description
Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. 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)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Percent change from baseline in 5-D Pruritus total score over time
Description
Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. 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)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Change from baseline in Sleep Loss VAS over time
Description
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Percent change from baseline in Sleep Loss VAS over time
Description
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Change from baseline in weekly average of difficulty falling asleep NRS over time
Description
Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Percent change from baseline in weekly average of difficulty falling asleep NRS over time
Description
Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Change from baseline in weekly average of sleep quality NRS over time
Description
Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Percent change from baseline in weekly average of sleep quality NRS over time
Description
Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time
Description
QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Percent change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time
Description
QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Change from baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) over time
Description
PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area.
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2a: Proportion of subjects with improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 categories over time
Description
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
Time Frame
to end of treatment, assessed up to 24 weeks
Title
Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis)
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis)
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
at Week 16
Title
Phase 2b: Proportion of subjects achieving 0 or 1 from baseline in PN-IGA
Description
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
Time Frame
at Week 16
Title
Phase 2b: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time
Description
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Proportion of subjects achieving 0 or 1 in PN-IGA over time
Description
PN-IGA is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in PN-IGA over time
Description
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Proportion of subjects achieving 0 or 1 in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) over time
Description
IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in IGA-CNPG-S over time
Description
IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state.
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Change from baseline in weekly average of Sleep Loss VAS over time
Description
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Percent change from baseline in weekly average of Sleep Loss VAS over time
Description
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Change from baseline in ItchyQoL over time
Description
Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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)
Time Frame
to end of treatment, assessed up to 52 weeks
Title
Phase 2b: Percent change from baseline in ItchyQoL over time
Description
Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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)
Time Frame
to end of treatment, assessed up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified): Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b) Have clinical diagnosis of prurigo nodularis for at least 6 months Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the Screening Visit and Day 1 Moderate to severe pruritus (Phase 2a); severe pruritus (Phase 2b) Female subjects of childbearing potential must have a negative pregnancy test, be nonlactating, and having agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 16 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 (apply to both Phase 2a and Phase 2b unless otherwise specified): Use of prohibited medications within the indicated timeframe from Day 1 Is currently using medication known to cause pruritus Presence of any inflammatory, pruritic, and/or fibrotic skin condition other than moderate to severe prurigo nodularis or atopic dermatitis unless approved by the Sponsor 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 subject 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Paolini, M.D.
Organizational Affiliation
Kiniksa Pharmaceuticals, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Site 104
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Site 125
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Site 1127
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Site 1132
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Site 137
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Site 1116
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Site 1154
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Site 1102
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Site 1167
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Facility Name
Site 1165
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Site 122
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Site 1139
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Site 1151
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Site 1107
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Site 1135
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site 111
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Site 1163
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Site 117
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Site 1166
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Site 114
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Site 105
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Site 123
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Site 1155
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Site 1110
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Site 1159
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Site 1113
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Site 1118
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Site 130
City
Warren
State/Province
Michigan
ZIP/Postal Code
08088
Country
United States
Facility Name
Site 108
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Site 1150
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
Site 1158
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Site 1121
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Site 1133
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Site 101
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Site 106
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Site 128
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Site 1115
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Site 4106
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Site 4105
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Site 4104
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Site 2102
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Site 2101
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Site 2702
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Site 2701
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Site 1308
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
Site 1301
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N6V7
Country
Canada
Facility Name
Site 1306
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Site 1307
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Site 1305
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Site 1309
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Site 303
City
Saint-Jérôme
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
Site 2301
City
Pardubice
ZIP/Postal Code
53 002
Country
Czechia
Facility Name
Site 2302
City
Praha 10
ZIP/Postal Code
10000
Country
Czechia
Facility Name
Site 2503
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Site 2502
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Site 2504
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Site 2001
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Facility Name
Site 2003
City
Bielefeld
State/Province
NRW
ZIP/Postal Code
33647
Country
Germany
Facility Name
Site 2011
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Site 2008
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Site 2002
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Site 2005
City
Witten
ZIP/Postal Code
58453
Country
Germany
Facility Name
Site 2604
City
Catania
State/Province
Sicily
ZIP/Postal Code
95123
Country
Italy
Facility Name
Site 2603
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Site 4304
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Site 4303
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Site 4302
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Site 2207
City
Kraków
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Site 2204
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Site 2201
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Site 4203
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Site 4207
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Site 4201
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Site 4204
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Site 2901
City
Leytonstone
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Site 2903
City
Liverpool
ZIP/Postal Code
L14 3AB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis

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