ClinicalTrials.gg
TerminatedNCT02315417Updated Apr 27, 2016

An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

A Phase 3 interventional study of gevokizumab and Placebo in Pyoderma Gangrenosum, sponsored by XOMA (US) LLC. Terminated at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-27.

Sponsored by XOMA (US) LLC (part of Ligand Pharmaceuticals Incorporated) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).

02

Conditions studied

  • Pyoderma Gangrenosum

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Keywords

  • Pyoderma Gangrenosum
  • Classic Pyoderma Gangrenosum
03

In context

Pyoderma Gangrenosum

36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.

This study's enrollment of 16 is above the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.

Browse Pyoderma Gangrenosum studies →

Lead sponsor

XOMA (US) LLC is the lead sponsor of 25 studies on the registry; none are open to participants now.

First submitted before XOMA (US) LLC became part of Ligand Pharmaceuticals Incorporated.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A clinical diagnosis of classic pyoderma gangrenosum
  • An active pyoderma gangrenosum ulcer
  • measures adequate to prevent pregnancy during the study

Exclusion criteria

Exclusion Criteria:

  • Clinical evidence of acutely infected pyoderma gangrenosum
  • History of allergic or anaphylactic reactions to monoclonal antibodies
  • History of recurrent or chronic systemic infections
  • Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    gevokizumab

    Solution for subcutaneous injection (Part 1, Group B)

    Drug: gevokizumab

  • Placebo comparator
    Placebo

    Solution for subcutaneous injection (Part 1, Group A)

    Drug: Placebo

  • Experimental
    gevokizumab open-label

    Solution for subcutaneous injection (Part 2, Open-label)

    Drug: gevokizumab open-label

Interventions

06

What researchers measure

Primary outcomes

  1. The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment

    Time frame: Day 126

Secondary outcomes

  1. The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.

    Time frame: Day 126

07

Study locations

12 sites
  • Coral Gables, Florida, United States
  • North Miami Beach, Florida, United States
  • Ann Arbor, Michigan, United States
  • St. Louis, Missouri, United States
  • Lebanon, New Hampshire, United States
  • New York, New York, United States
  • Winston-Salem, North Carolina, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Lubbock, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02315417
Lead sponsor
XOMA (US) LLC
Responsible party
Sponsor
First posted
Dec 11, 2014
Start date
Nov 2014
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Apr 27, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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