Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
9 May 2016 |
Main ID: |
NCT02318914 |
Date of registration:
|
08/12/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum
|
Scientific title:
|
A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Patients With Pyoderma Gangrenosum |
Date of first enrolment:
|
November 2014 |
Target sample size:
|
15 |
Recruitment status: |
Terminated |
URL:
|
https://clinicaltrials.gov/show/NCT02318914 |
Study type:
|
Interventional |
Study design:
|
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
Phase:
|
Phase 3
|
|
Countries of recruitment
|
Australia
|
Canada
|
United States
| | | | | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Individuals who participated in a previous study of gevokizumab in PG
- A clinical diagnosis of classic pyoderma gangrenosum
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Pyoderma Gangrenosum
|
Intervention(s)
|
Drug: gevokizumab
|
Primary Outcome(s)
|
Evaluation of treatment-emergent adverse events;
[Time Frame: Up to 2 years]
|
Changes from baseline concomitant medications use
[Time Frame: Up to 2 years]
|
Changes from baseline vital signs, physical examination results, and laboratory test results
[Time Frame: Up to 2 years]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|