ClinicalTrials.gg
CompletedNCT01882504Updated Feb 3, 2016

Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum

A Phase 2 interventional study of gevokizumab in Pyoderma Gangrenosum, sponsored by XOMA (US) LLC. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-03.

Sponsored by XOMA (US) LLC (part of Ligand Pharmaceuticals Incorporated) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.

02

Conditions studied

  • Pyoderma Gangrenosum

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Keywords

  • Pyoderma Gangrenosum
  • Classic Pyoderma Gangrenosum
  • Atypical Pyoderma Gangrenosum
  • Peristomal 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 8 is below 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

  • An established diagnosis of pyoderma gangrenosum
  • Currently experiencing an inflammatory episode of pyoderma gangrenosum
  • 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    gevokizumab

    Solution for subcutaneous injection

    Drug: gevokizumab

Interventions

06

What researchers measure

Primary outcomes

  1. Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer

    Time frame: Day 1 through Day 84

07

Study locations

19 sites
  • Birmingham, Alabama, United States
  • Miami Shores, Florida, United States
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Ann Arbor, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Verona, New Jersey, United States
  • New York, New York, United States
  • Winston-Salem, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Knoxville, Tennessee, United States
  • Arlington, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Norfolk, Virginia, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2013, a primary completion of Oct 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2013
First posted
Jun 20, 2013
Start
May 2013
Primary completionActual
Oct 2015
CompletionActual
Oct 2015
Last update
Feb 3, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01882504
Lead sponsor
XOMA (US) LLC
Responsible party
Sponsor
First posted
Jun 20, 2013
Start date
May 2013
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Feb 3, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Discussion

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Studies of the drug tested here: Gevokizumab

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