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

  • STATUS
    Recruiting
  • End date
    Mar 15, 2023
  • participants needed
    230
  • sponsor
    Kiniksa Pharmaceuticals, Ltd.
Updated on 16 May 2021
Investigator
Sponsor Clinical Project Manager
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Site 113 (6.6 mi away) Contact
+60 other location
prurigo

Summary

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

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 moderate to severe 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.

Details
Condition Pruritus, Prurigo Nodularis
Treatment Placebo, KPL-716, vixarelimab
Clinical Study IdentifierNCT03816891
SponsorKiniksa Pharmaceuticals, Ltd.
Last Modified on16 May 2021

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