Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
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

Study Design

Phase
Phase 2
Study Type
Interventional
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)
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Site 1127
Scottsdale, Arizona 85255
Contact:
Principal Investigator

Site 1132
Little Rock, Arkansas 72205
Contact:
Principal Investigator

Site 1116
Fountain Valley, California 92708
Contact:
Principal Investigator

Site 1154
Fremont, California 94538
Contact:
Principal Investigator

Site 1102
Los Angeles, California 90045
Contact:
Principal Investigator

Site 1167
Los Angeles, California 90056
Contact:
Principal Investigator

Site 1165
North Hollywood, California 91606
Contact:
Principal Investigator

Site 1139
Centennial, Colorado 80111
Contact:
Principal Investigator

Site 1141
Washington, District of Columbia 20037
Contact:
Principal Investigator

Site 1151
Fort Lauderdale, Florida 33316
Contact:
Principal Investigator

Site 1126
Gainesville, Florida 32610
Contact:
Principal Investigator

Site 1107
Largo, Florida 33770
Contact:
Principal Investigator

Site 1157
Miami Lakes, Florida 33014
Contact:
Principal Investigator

Site 1135
Miami, Florida 33136
Contact:
Principal Investigator

Site 1163
Tampa, Florida 33607
Contact:
Principal Investigator

Site 1166
Tampa, Florida 33615
Contact:
Principal Investigator

Site 1131
West Palm Beach, Florida 33406
Contact:
Principal Investigator

Site 1160
Downers Grove, Illinois 60515
Contact:
Principal Investigator

Site 1155
Louisville, Kentucky 40241
Contact:
Principal Investigator

Site 1138
Baton Rouge, Louisiana 70808
Contact:
Principal Investigator

Site 1110
Beverly, Massachusetts 01915
Contact:
Principal Investigator

Site 1159
Clinton Township, Michigan 48038
Contact:
Principal Investigator

Site 1113
Fort Gratiot, Michigan 48059
Contact:
Prinicpal Investigator

Site 1118
Troy, Michigan 48084
Contact:
Principal Investigator

Site 1120
Lebanon, New Hampshire 03756
Contact:
Principal Investigator

Site 1150
New York, New York 10012
Contact:
Principal Investigator

Site 1158
Rochester, New York 14620
Contact:
Principal Investigator

Site 1121
Fairborn, Ohio 45324
Contact:
Principal Investigator

Site 1161
Philadelphia, Pennsylvania 19103
Contact:
Principal Investigator

Site 1133
Charleston, South Carolina 29425
Contact:
Principal Investigator

Site 1115
Spokane, Washington 99202
Contact:
Principal Investigator

More Details

NCT ID
NCT03816891
Status
Recruiting
Sponsor
Kiniksa Pharmaceuticals, Ltd.

Study Contact

Sponsor Clinical Project Manager
17814319100
studyinfo@kiniksa.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.