An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

• Register: ClinicalTrials.gov
• Last refreshed on: 2 March 2015
• Main ID: NCT02366260
• Date of registration: 11/02/2015
• Prospective Registration: No
• Primary sponsor: MedDerm Associates
• 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
• Date of first enrolment: February 2015
• Target sample size: 5
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02366260
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Karla Anselmo, CRC

• Name: XOMA

• Name: Michelle Pelle, M.D.
• Affiliation: MedDerm Associates

Key inclusion & exclusion criteria

Inclusion Criteria:

- A clinical diagnosis of classic pyoderma gangrenosum

- An active pyoderma gangrenosum ulcer

- A willingness to use contraceptive methods to prevent pregnancy during the study

Exclusion Criteria:

- A clinical evidence of acute infected pyoderma gangrenosum

- Active Hepatitis B, C, and postive Quantiferon TB test result

- History of HIV

- History of malignancy, clinically significant recurrent or chronic systemic infection

- History of severe allergic or anaphylactic reaction to monoclonal antibodies

- Washout periods for certain treatments applies. 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: Placebo

Drug: Gevokizumab

Primary Outcome(s)

The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later and without the need for rescue treatment. [Time Frame: 126 days]

Secondary Outcome(s)

The proportion of subjects at Day 126 with a reduction in target ulcer area of 50% or more had a baseline target ulcer area greater or equal to 25cm and less than 50cm. [Time Frame: 126 days]

Secondary ID(s)

X052172

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

XOMA (US) LLC