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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02326740
Other study ID # X052173
Secondary ID
Status Terminated
Phase Phase 3
First received December 22, 2014
Last updated April 25, 2016
Start date December 2014
Est. completion date March 2016

Study information

Verified date April 2016
Source XOMA (US) LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- A clinical diagnosis of classic pyoderma gangrenosum

- An active pyoderma gangrenosum ulcer

- Contraceptive measures adequate to prevent pregnancy during the study

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
gevokizumab

Placebo

gevokizumab open-label


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
XOMA (US) LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 126 No
Secondary The proportions of subjects at Day 126 with a reduction in the target ulcer area of = 75% or = 90% from baseline. Day 126 No
See also
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Recruiting NCT05120726 - A Novel Therapeutic Treatment of Pyoderma Gangrenosum Phase 4
Withdrawn NCT00690846 - Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum Phase 2
Completed NCT01965613 - A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum Phase 2
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