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

Sponsor
Kiniksa Pharmaceuticals, Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03816891
Collaborator
(none)
230
Enrollment
90
Locations
7
Arms
52.6
Anticipated Duration (Months)
2.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

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
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
Anticipated Enrollment :
230 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)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 :
Mar 11, 2019
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Jul 30, 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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Phase 2a & 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS) [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 [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Site 104 Anniston Alabama United States 36207
    2 Site 125 Phoenix Arizona United States 85053
    3 Site 1127 Scottsdale Arizona United States 85255
    4 Site 1132 Little Rock Arkansas United States 72205
    5 Site 137 Colton California United States 92324
    6 Site 1116 Fountain Valley California United States 92708
    7 Site 1154 Fremont California United States 94538
    8 Site 1102 Los Angeles California United States 90045
    9 Site 1167 Los Angeles California United States 90056
    10 Site 1165 North Hollywood California United States 91606
    11 Site 122 San Francisco California United States 94115
    12 Site 1139 Centennial Colorado United States 80111
    13 Site 1141 Washington District of Columbia United States 20037
    14 Site 1151 Fort Lauderdale Florida United States 33316
    15 Site 1126 Gainesville Florida United States 32610
    16 Site 1107 Largo Florida United States 33770
    17 Site 1157 Miami Lakes Florida United States 33014
    18 Site 1135 Miami Florida United States 33136
    19 Site 111 Pembroke Pines Florida United States 33028
    20 Site 1163 Tampa Florida United States 33607
    21 Site 1169 Tampa Florida United States 33609
    22 Site 117 Tampa Florida United States 33614
    23 Site 1166 Tampa Florida United States 33615
    24 Site 1131 West Palm Beach Florida United States 33406
    25 Site 114 Sandy Springs Georgia United States 30328
    26 Site 105 Boise Idaho United States 83712
    27 Site 1160 Downers Grove Illinois United States 60515
    28 Site 123 New Albany Indiana United States 47150
    29 Site 1155 Louisville Kentucky United States 40241
    30 Site 1138 Baton Rouge Louisiana United States 70808
    31 Site 1110 Beverly Massachusetts United States 01915
    32 Site 1159 Clinton Township Michigan United States 48038
    33 Site 1113 Fort Gratiot Michigan United States 48059
    34 Site 1118 Troy Michigan United States 48084
    35 Site 130 Warren Michigan United States 08088
    36 Site 108 Omaha Nebraska United States 68144
    37 Site 1120 Lebanon New Hampshire United States 03756
    38 Site 1150 New York New York United States 10012
    39 Site 1158 Rochester New York United States 14620
    40 Site 1121 Fairborn Ohio United States 45324
    41 Site 1161 Philadelphia Pennsylvania United States 19103
    42 Site 1133 Charleston South Carolina United States 29425
    43 Site 101 Houston Texas United States 77004
    44 Site 106 Pflugerville Texas United States 78660
    45 Site 128 San Antonio Texas United States 78213
    46 Site 1115 Spokane Washington United States 99202
    47 Site 4102 Kogarah New South Wales Australia 2217
    48 Site 4106 Kogarah New South Wales Australia 2217
    49 Site 4105 Woolloongabba Queensland Australia 4102
    50 Site 4104 Parkville Victoria Australia 3050
    51 Site 2102 Graz Austria 8036
    52 Site 2101 Wien Austria 1090
    53 Site 2702 Brussels Belgium 1200
    54 Site 2701 Liège Belgium 4000
    55 Site 1302 Edmonton Alberta Canada T5K 1X3
    56 Site 1308 Edmonton Alberta Canada T6G 1C3
    57 Site 1301 Red Deer Alberta Canada T4N6V7
    58 Site 1306 Fredericton New Brunswick Canada E3B 1G9
    59 Site 1307 Barrie Ontario Canada L4M 7G1
    60 Site 1305 London Ontario Canada N6H 5L5
    61 Site 1309 Markham Ontario Canada L3P 1X2
    62 Site 303 Saint-Jérôme Quebec Canada J7Z 7E2
    63 Site 2301 Pardubice Czechia 53 002
    64 Site 2302 Praha 10 Czechia 10000
    65 Site 2503 Bordeaux France 33075
    66 Site 2502 Brest France 29609
    67 Site 2504 Nantes France 44093
    68 Site 2505 Paris France 75010
    69 Site 2501 Toulouse France 31059
    70 Site 2001 Bad Bentheim Niedersachsen Germany 48455
    71 Site 2003 Bielefeld NRW Germany 33647
    72 Site 2006 Erlangen Germany 91054
    73 Site 2002 Münster Germany 48149
    74 Site 2005 Witten Germany 58453
    75 Site 2604 Catania Sicily Italy 95123
    76 Site 2603 Brescia Italy 25123
    77 Site 4304 Incheon Korea, Republic of 21431
    78 Site 4301 Seoul Korea, Republic of 03080
    79 Site 4303 Seoul Korea, Republic of 03722
    80 Site 4302 Seoul Korea, Republic of 05505
    81 Site 2207 Kraków Poland 30-033
    82 Site 2205 Kraków Poland 30-510
    83 Site 2204 Rzeszów Poland 35-055
    84 Site 2201 Wrocław Poland 50-367
    85 Site 4203 New Taipei City Taiwan 23561
    86 Site 4207 Taipei Taiwan 10002
    87 Site 4201 Taipei Taiwan 11217
    88 Site 4204 Taoyuan City Taiwan 333
    89 Site 2903 Liverpool United Kingdom L14 3AB
    90 Site 2904 Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Kiniksa Pharmaceuticals, Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kiniksa Pharmaceuticals, Ltd.
    ClinicalTrials.gov Identifier:
    NCT03816891
    Other Study ID Numbers:
    • KPL-716-C201
    First Posted:
    Jan 25, 2019
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    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

    Study Results

    No Results Posted as of Jun 13, 2022