Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02326740




Registration number
NCT02326740
Ethics application status
Date submitted
22/12/2014
Date registered
29/12/2014
Date last updated
27/04/2016

Titles & IDs
Public title
An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Secondary ID [1] 0 0
X052173
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
Experimental: gevokizumab - Solution for subcutaneous injection (Part 1, Group B)

Placebo comparator: Placebo - Solution for subcutaneous injection (Part 1, Group A)

Experimental: gevokizumab open-label - Solution for subcutaneous injection (Part 2, Open-label)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Day 126
Secondary outcome [1] 0 0
The proportions of subjects at Day 126 with a reduction in the target ulcer area of = 75% or = 90% from baseline.
Timepoint [1] 0 0
Day 126

Eligibility
Key inclusion criteria
* A clinical diagnosis of classic pyoderma gangrenosum
* An active pyoderma gangrenosum ulcer
* 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
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
9
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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
Canada
State/province [7] 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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02326740