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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03816891




Registration number
NCT03816891
Ethics application status
Date submitted
23/01/2019
Date registered
25/01/2019

Titles & IDs
Public title
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
Scientific 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
Secondary ID [1] 0 0
KPL-716-C201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prurigo Nodularis 0 0
Pruritis 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - vixarelimab
Treatment: Drugs - Placebo

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)

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)

Experimental: Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) - Vixarelimab 540 mg SC, every 4 weeks for 16 weeks during Double Blind Period

Experimental: Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) - Vixarelimab 360 mg SC, every 4 weeks for 16 weeks during Double Blind Period

Experimental: Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL) - Vixarelimab 120 mg SC, every 4 weeks for 16 weeks during Double Blind Period

Placebo comparator: Phase 2b - Placebo SC, Q4W (DBL) - Placebo SC, every 4 weeks for 16 weeks during Double Blind Period

Experimental: Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE) - Vixarelimab 360 mg SC, every 2 weeks for 36 weeks during Open Label Extension


Treatment: Drugs: vixarelimab
solution for injection

Treatment: Drugs: Placebo
solution for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2a & 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS)
Timepoint [1] 0 0
at Week 8 (Phase 2a); at Week 16 (Phase 2b)
Secondary outcome [1] 0 0
*Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS
Timepoint [1] 0 0
at Week 8
Secondary outcome [2] 0 0
Phase 2a: Percent change from baseline in pruritus visual analog scale (VAS)
Timepoint [2] 0 0
at Week 8
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [5] 0 0
Phase 2a: Change from baseline in pruritis visual analog scale (VAS) over time
Timepoint [5] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [6] 0 0
Phase 2a: Percent change from baseline in pruritis visual analog scale (VAS) over time
Timepoint [6] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [7] 0 0
Phase 2a: Change from baseline in 5-D Pruritus total score over time
Timepoint [7] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [8] 0 0
Phase 2a: Percent change from baseline in 5-D Pruritus total score over time
Timepoint [8] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [10] 0 0
Phase 2a: Change from baseline in Sleep Loss VAS over time
Timepoint [10] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [11] 0 0
Phase 2a: Percent change from baseline in Sleep Loss VAS over time
Timepoint [11] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [12] 0 0
Phase 2a: Change from baseline in weekly average of difficulty falling asleep NRS over time
Timepoint [12] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [13] 0 0
Phase 2a: Percent change from baseline in weekly average of difficulty falling asleep NRS over time
Timepoint [13] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [14] 0 0
Phase 2a: Change from baseline in weekly average of sleep quality NRS over time
Timepoint [14] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [15] 0 0
Phase 2a: Percent change from baseline in weekly average of sleep quality NRS over time
Timepoint [15] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [16] 0 0
Phase 2a: Change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time
Timepoint [16] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [17] 0 0
Phase 2a: Percent change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time
Timepoint [17] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [18] 0 0
Phase 2a: Change from baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) over time
Timepoint [18] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [19] 0 0
Phase 2a: Proportion of subjects with improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 categories over time
Timepoint [19] 0 0
to end of treatment, assessed up to 24 weeks
Secondary outcome [20] 0 0
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)
Timepoint [20] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [21] 0 0
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)
Timepoint [21] 0 0
at Week 16
Secondary outcome [22] 0 0
Phase 2b: Proportion of subjects achieving 0 or 1 from baseline in PN-IGA
Timepoint [22] 0 0
at Week 16
Secondary outcome [23] 0 0
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
Timepoint [23] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [24] 0 0
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
Timepoint [24] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [25] 0 0
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
Timepoint [25] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [26] 0 0
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
Timepoint [26] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [27] 0 0
Phase 2b: Proportion of subjects achieving 0 or 1 in PN-IGA over time
Timepoint [27] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [28] 0 0
Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in PN-IGA over time
Timepoint [28] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [29] 0 0
Phase 2b: Proportion of subjects achieving 0 or 1 in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) over time
Timepoint [29] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [30] 0 0
Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in IGA-CNPG-S over time
Timepoint [30] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [31] 0 0
Phase 2b: Change from baseline in weekly average of Sleep Loss VAS over time
Timepoint [31] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [32] 0 0
Phase 2b: Percent change from baseline in weekly average of Sleep Loss VAS over time
Timepoint [32] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [33] 0 0
Phase 2b: Change from baseline in ItchyQoL over time
Timepoint [33] 0 0
to end of treatment, assessed up to 52 weeks
Secondary outcome [34] 0 0
Phase 2b: Percent change from baseline in ItchyQoL over time
Timepoint [34] 0 0
to end of treatment, assessed up to 52 weeks

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/08/2023
Sample size
Target
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Site 4106 - Kogarah
Recruitment hospital [2] 0 0
Site 4105 - Woolloongabba
Recruitment hospital [3] 0 0
Site 4104 - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Austria
State/province [19] 0 0
Graz
Country [20] 0 0
Austria
State/province [20] 0 0
Wien
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Liège
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
New Brunswick
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Czechia
State/province [27] 0 0
Pardubice
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 10
Country [29] 0 0
France
State/province [29] 0 0
Bordeaux
Country [30] 0 0
France
State/province [30] 0 0
Brest
Country [31] 0 0
France
State/province [31] 0 0
Nantes
Country [32] 0 0
Germany
State/province [32] 0 0
Niedersachsen
Country [33] 0 0
Germany
State/province [33] 0 0
NRW
Country [34] 0 0
Germany
State/province [34] 0 0
Dresden
Country [35] 0 0
Germany
State/province [35] 0 0
Göttingen
Country [36] 0 0
Germany
State/province [36] 0 0
Münster
Country [37] 0 0
Germany
State/province [37] 0 0
Witten
Country [38] 0 0
Italy
State/province [38] 0 0
Sicily
Country [39] 0 0
Italy
State/province [39] 0 0
Brescia
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Incheon
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Poland
State/province [42] 0 0
Kraków
Country [43] 0 0
Poland
State/province [43] 0 0
Rzeszów
Country [44] 0 0
Poland
State/province [44] 0 0
Wroclaw
Country [45] 0 0
Taiwan
State/province [45] 0 0
New Taipei City
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taipei
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taoyuan City
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Leytonstone
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kiniksa Pharmaceuticals, Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Paolini, M.D.
Address 0 0
Kiniksa Pharmaceuticals, Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03816891