Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XOMA (US) LLC

Criteria

Inclusion Criteria:

• Diagnosis of moderate to severe acne vulgaris

• Acne vulgaris unresponsive to oral antibiotics

• Willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study

Exclusion Criteria:

• Use of medications or treatments from specified pre-treatment time periods through the end of the study

• Beard, moustache, sideburns or other facial hair that may interfere with evaluation

• Other forms of acne

• History of malignancy within 5 years

• History of allergic or anaphylactic reactions to monoclonal antibodies

• History of tuberculosis

• History of chronic systemic infections

• Female subjects who are pregnant, planning to become pregnant

Other protocol-defined inclusion/exclusion criteria may apply