Trial intelligence / Profile preview

Gevokizumab in Pyoderma Gangrenosum

NCT02326740Phase 3

Key facts

Status
Terminated
Start
Dec 2014
Primary completion
Mar 2016
Countries
3
Sponsor
XOMA
Modality
Monoclonal Antibodies
Conditions
pyoderma gangrenosum (PG)
01

Overview

Phase 3, randomised, double-blind trial of gevokizumab in pyoderma gangrenosum (PG) (3 arms), sponsored by XOMA. Primary endpoint: Proportion of subjects with complete closure of the PG target ulcer at Day 126. Started Dec 2014; status: terminated.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Gevokizumab

    Gevokizumab subcutaneous injection (Part 1)

  • Placebo

    Placebo subcutaneous injection (Part 1)

  • Gevokizumab Open-Label

    Gevokizumab open-label treatment (Part 2)

03

Who it enrols

Patients with a clinical diagnosis of classic pyoderma gangrenosum and an active ulcer. Excludes patients with acutely infected PG, history of recurrent systemic infections, or allergy to monoclonal antibodies.

04

Endpoints

Primary

  • Proportion of subjects with complete closure of the PG target ulcer

Secondary

  • Proportion of subjects with reduction in target ulcer area

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