Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02318914




Registration number
NCT02318914
Ethics application status
Date submitted
8/12/2014
Date registered
17/12/2014
Date last updated
27/04/2016

Titles & IDs
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
Secondary ID [1] 0 0
X052171
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pyoderma Gangrenosum 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - gevokizumab

Experimental: gevokizumab - Solution for subcutaneous injection


Treatment: Drugs: gevokizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of treatment-emergent adverse events;
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Changes from baseline vital signs, physical examination results, and laboratory test results
Timepoint [2] 0 0
Up to 2 years
Primary outcome [3] 0 0
Changes from baseline concomitant medications use
Timepoint [3] 0 0
Up to 2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
- Benowa
Recruitment hospital [2] 0 0
- Woolloongabba
Recruitment hospital [3] 0 0
- Parkville
Recruitment hospital [4] 0 0
- Fremantle
Recruitment hospital [5] 0 0
- St. Leonards
Recruitment hospital [6] 0 0
- Sydney
Recruitment hospital [7] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Benowa
Recruitment postcode(s) [2] 0 0
- Woolloongabba
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment postcode(s) [4] 0 0
- Fremantle
Recruitment postcode(s) [5] 0 0
- St. Leonards
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment postcode(s) [7] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Hampshire
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
XOMA (US) LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers
Trial website
https://clinicaltrials.gov/ct2/show/NCT02318914
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02318914