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

• ClinicalTrials.gov Identifier: NCT03816891
• Recruitment Status: Active, not recruiting
• First Posted: January 25, 2019
• Last Update Posted: May 10, 2023
• Sponsor: Kiniksa Pharmaceuticals, Ltd.
• Information provided by (Responsible Party): Kiniksa Pharmaceuticals, Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Prurigo Nodularis; Pruritis	Drug: vixarelimab; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 11, 2019
• Actual Primary Completion Date: December 28, 2022
• Estimated Study Completion Date: August 2023

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: KPL-716

Outcome Measures

Primary Outcome Measures :

1. Phase 2a & 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS) [ Time Frame: at Week 8 (Phase 2a); at Week 16 (Phase 2b) ]
   Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)

Secondary Outcome Measures :

1. *Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS [ Time Frame: at Week 8 ]
   Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
2. Phase 2a: Percent change from baseline in pruritus visual analog scale (VAS) [ Time Frame: at Week 8 ]
   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)
3. 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 [ Time Frame: to end of treatment, assessed up to 24 weeks ]
   Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
4. 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 [ Time Frame: to end of treatment, assessed up to 24 weeks ]
   Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
5. Phase 2a: Change from baseline in pruritis visual analog scale (VAS) over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
   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)
6. Phase 2a: Percent change from baseline in pruritis visual analog scale (VAS) over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
   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)
7. Phase 2a: Change from baseline in 5-D Pruritus total score over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
   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)
8. Phase 2a: Percent change from baseline in 5-D Pruritus total score over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
   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)
9. 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 [ Time Frame: to end of treatment, assessed up to 24 weeks ]
   Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
10. Phase 2a: Change from baseline in Sleep Loss VAS over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    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)
11. Phase 2a: Percent change from baseline in Sleep Loss VAS over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    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)
12. Phase 2a: Change from baseline in weekly average of difficulty falling asleep NRS over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)
13. Phase 2a: Percent change from baseline in weekly average of difficulty falling asleep NRS over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult)
14. Phase 2a: Change from baseline in weekly average of sleep quality NRS over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)
15. Phase 2a: Percent change from baseline in weekly average of sleep quality NRS over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep)
16. Phase 2a: Change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    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)
17. Phase 2a: Percent change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    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)
18. Phase 2a: Change from baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    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.
19. Phase 2a: Proportion of subjects with improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 categories over time [ Time Frame: to end of treatment, assessed up to 24 weeks ]
    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)
20. 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) [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
21. 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) [ Time Frame: at Week 16 ]
    Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
22. Phase 2b: Proportion of subjects achieving 0 or 1 from baseline in PN-IGA [ Time Frame: at Week 16 ]
    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)
23. 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 [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
24. 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 [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
25. 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 [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
26. 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 [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)
27. Phase 2b: Proportion of subjects achieving 0 or 1 in PN-IGA over time [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    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)
28. Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in PN-IGA over time [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    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)
29. Phase 2b: Proportion of subjects achieving 0 or 1 in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) over time [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    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.
30. Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in IGA-CNPG-S over time [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    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.
31. Phase 2b: Change from baseline in weekly average of Sleep Loss VAS over time [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    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)
32. Phase 2b: Percent change from baseline in weekly average of Sleep Loss VAS over time [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    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)
33. Phase 2b: Change from baseline in ItchyQoL over time [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    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)
34. Phase 2b: Percent change from baseline in ItchyQoL over time [ Time Frame: to end of treatment, assessed up to 52 weeks ]
    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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Site 104

Anniston, Alabama, United States, 36207

United States, Arizona

Site 125

Phoenix, Arizona, United States, 85053

Site 1127

Scottsdale, Arizona, United States, 85255

United States, Arkansas

Site 1132

Little Rock, Arkansas, United States, 72205

United States, California

Site 137

Colton, California, United States, 92324

Site 1116

Fountain Valley, California, United States, 92708

Site 1154

Fremont, California, United States, 94538

Site 1102

Los Angeles, California, United States, 90045

Site 1167

Los Angeles, California, United States, 90056

Site 1165

North Hollywood, California, United States, 91606

Site 122

San Francisco, California, United States, 94115

United States, Colorado

Site 1139

Centennial, Colorado, United States, 80111

United States, Florida

Site 1151

Fort Lauderdale, Florida, United States, 33316

Site 1107

Largo, Florida, United States, 33770

Site 1135

Miami, Florida, United States, 33136

Site 111

Pembroke Pines, Florida, United States, 33028

Site 1163

Tampa, Florida, United States, 33607

Site 117

Tampa, Florida, United States, 33614

Site 1166

Tampa, Florida, United States, 33615

United States, Georgia

Site 114

Sandy Springs, Georgia, United States, 30328

United States, Idaho

Site 105

Boise, Idaho, United States, 83712

United States, Indiana

Site 123

New Albany, Indiana, United States, 47150

United States, Kentucky

Site 1155

Louisville, Kentucky, United States, 40241

United States, Massachusetts

Site 1110

Beverly, Massachusetts, United States, 01915

United States, Michigan

Site 1159

Clinton Township, Michigan, United States, 48038

Site 1113

Fort Gratiot, Michigan, United States, 48059

Site 1118

Troy, Michigan, United States, 48084

Site 130

Warren, Michigan, United States, 08088

United States, Nebraska

Site 108

Omaha, Nebraska, United States, 68144

United States, New York

Site 1150

New York, New York, United States, 10012

Site 1158

Rochester, New York, United States, 14620

United States, Ohio

Site 1121

Fairborn, Ohio, United States, 45324

United States, South Carolina

Site 1133

Charleston, South Carolina, United States, 29425

United States, Texas

Site 101

Houston, Texas, United States, 77004

Site 106

Pflugerville, Texas, United States, 78660

Site 128

San Antonio, Texas, United States, 78213

United States, Washington

Site 1115

Spokane, Washington, United States, 99202

Australia, New South Wales

Site 4106

Kogarah, New South Wales, Australia, 2217

Australia, Queensland

Site 4105

Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

Site 4104

Parkville, Victoria, Australia, 3050

Austria

Site 2102

Graz, Austria, 8036

Site 2101

Wien, Austria, 1090

Belgium

Site 2702

Brussels, Belgium, 1200

Site 2701

Liège, Belgium, 4000

Canada, Alberta

Site 1302

Edmonton, Alberta, Canada, T5K 1X3

Site 1308

Edmonton, Alberta, Canada, T6G 1C3

Site 1301

Red Deer, Alberta, Canada, T4N6V7

Canada, New Brunswick

Site 1306

Fredericton, New Brunswick, Canada, E3B 1G9

Canada, Ontario

Site 1307

Barrie, Ontario, Canada, L4M 7G1

Site 1305

London, Ontario, Canada, N6H 5L5

Site 1309

Markham, Ontario, Canada, L3P 1X2

Canada, Quebec

Site 303

Saint-Jérôme, Quebec, Canada, J7Z 7E2

Czechia

Site 2301

Pardubice, Czechia, 53 002

Site 2302

Praha 10, Czechia, 10000

France

Site 2503

Bordeaux, France, 33075

Site 2502

Brest, France, 29609

Site 2504

Nantes, France, 44093

Germany

Site 2001

Bad Bentheim, Niedersachsen, Germany, 48455

Site 2003

Bielefeld, NRW, Germany, 33647

Site 2011

Dresden, Germany, 01307

Site 2008

Göttingen, Germany, 37075

Site 2002

Münster, Germany, 48149

Site 2005

Witten, Germany, 58453

Italy

Site 2604

Catania, Sicily, Italy, 95123

Site 2603

Brescia, Italy, 25123

Korea, Republic of

Site 4304

Incheon, Korea, Republic of, 21431

Site 4303

Seoul, Korea, Republic of, 03722

Site 4302

Seoul, Korea, Republic of, 05505

Poland

Site 2207

Kraków, Poland, 30-033

Site 2204

Rzeszów, Poland, 35-055

Site 2201

Wrocław, Poland, 50-367

Taiwan

Site 4203

New Taipei City, Taiwan, 23561

Site 4207

Taipei, Taiwan, 10002

Site 4201

Taipei, Taiwan, 11217

Site 4204

Taoyuan City, Taiwan, 333

United Kingdom

Site 2901

Leytonstone, United Kingdom, E11 1NR

Site 2903

Liverpool, United Kingdom, L14 3AB

Sponsors and Collaborators

Kiniksa Pharmaceuticals, Ltd.

Investigators

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

More Information

• Responsible Party: Kiniksa Pharmaceuticals, Ltd.
• ClinicalTrials.gov Identifier: NCT03816891
• Other Study ID Numbers: KPL-716-C201
• First Posted: January 25, 2019
• Last Update Posted: May 10, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pruritus; Prurigo; Neurodermatitis; Skin Diseases; Skin Manifestations; Dermatitis; Skin Diseases, Eczematous