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

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 of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis.

Study Overview

• Status: Completed
• Conditions: Prurigo Nodularis; Pruritis
• Intervention / Treatment: Drug: Placebo; Drug: vixarelimab

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.

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Site 4106
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Site 4105
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Site 4104
• Austria
  • Graz, Austria, 8036
    • Site 2102
  • Wien, Austria, 1090
    • Site 2101
• Belgium
  • Brussels, Belgium, 1200
    • Site 2702
  • Liège, Belgium, 4000
    • Site 2701
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Site 1308
    • Red Deer, Alberta, Canada, T4N6V7
      • Site 1301
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Site 1306
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Site 1307
    • London, Ontario, Canada, N6H 5L5
      • Site 1305
    • Markham, Ontario, Canada, L3P 1X2
      • Site 1309
  • Quebec
    • Saint-Jérôme, Quebec, Canada, J7Z 7E2
      • Site 303
• Czechia
  • Pardubice, Czechia, 53 002
    • Site 2301
  • Praha 10, Czechia, 10000
    • Site 2302
• France
  • Bordeaux, France, 33075
    • Site 2503
  • Brest, France, 29609
    • Site 2502
  • Nantes, France, 44093
    • Site 2504
• Germany
  • Dresden, Germany, 01307
    • Site 2011
  • Göttingen, Germany, 37075
    • Site 2008
  • Münster, Germany, 48149
    • Site 2002
  • Witten, Germany, 58453
    • Site 2005
  • NRW
    • Bielefeld, NRW, Germany, 33647
      • Site 2003
  • Niedersachsen
    • Bad Bentheim, Niedersachsen, Germany, 48455
      • Site 2001
• Italy
  • Brescia, Italy, 25123
    • Site 2603
  • Sicily
    • Catania, Sicily, Italy, 95123
      • Site 2604
• Korea, Republic of
  • Incheon, Korea, Republic of, 21431
    • Site 4304
  • Seoul, Korea, Republic of, 03722
    • Site 4303
  • Seoul, Korea, Republic of, 05505
    • Site 4302
• Poland
  • Kraków, Poland, 30-033
    • Site 2207
  • Rzeszów, Poland, 35-055
    • Site 2204
  • Wrocław, Poland, 50-367
    • Site 2201
• Taiwan
  • New Taipei City, Taiwan, 23561
    • Site 4203
  • Taipei, Taiwan, 10002
    • Site 4207
  • Taipei, Taiwan, 11217
    • Site 4201
  • Taoyuan City, Taiwan, 333
    • Site 4204
• United Kingdom
  • Leytonstone, United Kingdom, E11 1NR
    • Site 2901
  • Liverpool, United Kingdom, L14 3AB
    • Site 2903
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Site 104
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Site 125
    • Scottsdale, Arizona, United States, 85255
      • Site 1127
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Site 1132
  • California
    • Colton, California, United States, 92324
      • Site 137
    • Fountain Valley, California, United States, 92708
      • Site 1116
    • Fremont, California, United States, 94538
      • Site 1154
    • Los Angeles, California, United States, 90045
      • Site 1102
    • Los Angeles, California, United States, 90056
      • Site 1167
    • North Hollywood, California, United States, 91606
      • Site 1165
    • San Francisco, California, United States, 94115
      • Site 122
  • Colorado
    • Centennial, Colorado, United States, 80111
      • Site 1139
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Site 1151
    • Largo, Florida, United States, 33770
      • Site 1107
    • Miami, Florida, United States, 33136
      • Site 1135
    • Pembroke Pines, Florida, United States, 33028
      • Site 111
    • Tampa, Florida, United States, 33607
      • Site 1163
    • Tampa, Florida, United States, 33614
      • Site 117
    • Tampa, Florida, United States, 33615
      • Site 1166
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Site 114
  • Idaho
    • Boise, Idaho, United States, 83712
      • Site 105
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Site 123
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Site 1155
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Site 1110
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Site 1159
    • Fort Gratiot, Michigan, United States, 48059
      • Site 1113
    • Troy, Michigan, United States, 48084
      • Site 1118
    • Warren, Michigan, United States, 08088
      • Site 130
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Site 108
  • New York
    • New York, New York, United States, 10012
      • Site 1150
    • Rochester, New York, United States, 14620
      • Site 1158
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Site 1121
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Site 1133
  • Texas
    • Houston, Texas, United States, 77004
      • Site 101
    • Pflugerville, Texas, United States, 78660
      • Site 106
    • San Antonio, Texas, United States, 78213
      • Site 128
  • Washington
    • Spokane, Washington, United States, 99202
      • Site 1115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2a - Vixarelimab 360 mg SC QW; Vixarelimab 720 mg loading dose followed by 360 mg weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)	Drug: vixarelimab; solution for injection; Other Names: KPL-716
Placebo Comparator: Phase 2a - Placebo SC QW; Placebo loading dose followed by placebo weekly for 8 weeks (Protocol Version 3) or 16 weeks (Protocol Version 2)	Drug: Placebo; solution for injection
Experimental: Phase 2b - Vixarelimab 540 mg SC Q4W (DBL); Vixarelimab 540 mg SC, every 4 weeks for 16 weeks during Double Blind Period	Drug: vixarelimab; solution for injection; Other Names: KPL-716
Experimental: Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL); Vixarelimab 360 mg SC, every 4 weeks for 16 weeks during Double Blind Period	Drug: vixarelimab; solution for injection; Other Names: KPL-716
Experimental: Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL); Vixarelimab 120 mg SC, every 4 weeks for 16 weeks during Double Blind Period	Drug: vixarelimab; solution for injection; Other Names: KPL-716
Placebo Comparator: Phase 2b - Placebo SC, Q4W (DBL); Placebo SC, every 4 weeks for 16 weeks during Double Blind Period	Drug: Placebo; solution for injection
Experimental: Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE); Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension	Drug: vixarelimab; solution for injection; Other Names: KPL-716

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at Week 8 (Phase 2a); at Week 16 (Phase 2b)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
*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)	at Week 8
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)	at Week 8
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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.	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 24 weeks
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)	to end of treatment, assessed up to 52 weeks
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)	at Week 16
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)	at Week 16
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)	to end of treatment, assessed up to 52 weeks
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)	to end of treatment, assessed up to 52 weeks
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)	to end of treatment, assessed up to 52 weeks
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)	to end of treatment, assessed up to 52 weeks
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)	to end of treatment, assessed up to 52 weeks
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)	to end of treatment, assessed up to 52 weeks
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.	to end of treatment, assessed up to 52 weeks
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.	to end of treatment, assessed up to 52 weeks
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)	to end of treatment, assessed up to 52 weeks
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)	to end of treatment, assessed up to 52 weeks
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)	to end of treatment, assessed up to 52 weeks
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)	to end of treatment, assessed up to 52 weeks

Collaborators and Investigators

• Sponsor: Kiniksa Pharmaceuticals, Ltd.
• Investigators: Study Director: John Paolini, M.D., Kiniksa Pharmaceuticals, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): December 28, 2022
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Dermatitis; Skin Diseases, Eczematous; Pruritus; Prurigo; Neurodermatitis
• Other Study ID Numbers: KPL-716-C201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No