Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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/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
Treatment: Drugs - gevokizumab
Treatment: Drugs - Placebo
Treatment: Drugs - gevokizumab open-label

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)


Treatment: Drugs: gevokizumab


Treatment: Drugs: Placebo


Treatment: Drugs: gevokizumab open-label
Intervention code [1] 0 0
Treatment: Drugs
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
Terminated
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
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of
pyoderma gangrenosum (PG).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02326740
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/NCT02326740