ClinicalTrials.gg
TerminatedNCT02318914Updated Apr 27, 2016

A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum

A Phase 3 interventional study of gevokizumab in Pyoderma Gangrenosum, sponsored by XOMA (US) LLC. Terminated at 40 sites in 3 countries. 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
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers

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 15 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

  • Individuals who participated in a previous study of gevokizumab in PG
  • A clinical diagnosis of classic 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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    gevokizumab

    Solution for subcutaneous injection

    Drug: gevokizumab

Interventions

06

What researchers measure

Primary outcomes

  1. Evaluation of treatment-emergent adverse events;

    Time frame: Up to 2 years

  2. Changes from baseline vital signs, physical examination results, and laboratory test results

    Time frame: Up to 2 years

  3. Changes from baseline concomitant medications use

    Time frame: Up to 2 years

07

Study locations

40 sites
  • Birmingham, Alabama, United States
  • Scottsdale, Arizona, United States
  • Oceanside, California, United States
  • San Diego, California, United States
  • Farmington, Connecticut, United States
  • Coral Gables, Florida, United States
  • Miami, Florida, United States
  • North Miami Beach, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Macon, Georgia, United States
  • Chicago, Illinois, United States
  • Springfield, Illinois, United States
  • New Orleans, Louisiana, United States
  • Ann Arbor, Michigan, United States
  • Minneapolis, Minnesota, United States
  • St. Louis, Missouri, United States
  • Henderson, Nevada, United States
  • Lebanon, New Hampshire, United States
  • Bronx, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Lubbock, Texas, United States
  • Salt Lake City, Utah, United States
  • Benowa, Queensland, Australia
  • Woolloongabba, Queensland, Australia
  • Parkville, Victoria, Australia
  • Fremantle, Australia
  • St. Leonards, Australia
  • Sydney, Australia
  • Westmead, Australia
  • Markham, Ontario, Canada
  • Richmond Hill, Ontario, Canada
08

Timeline

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

The record gives a start of Nov 2014, a primary completion of Feb 2016 and a completion of Feb 2016. 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
Dec 8, 2014
First posted
Dec 17, 2014
Start
Nov 2014
Primary completionActual
Feb 2016
CompletionActual
Feb 2016
Last update
Apr 27, 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 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
NCT02318914
Lead sponsor
XOMA (US) LLC
Responsible party
Sponsor
First posted
Dec 17, 2014
Start date
Nov 2014
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Apr 27, 2016

Oversight

Data monitoring committee
No
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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