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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris

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

Detailed Summary:
Sponsor: XOMA (US) LLC

Current Primary Outcome: The mean absolute change from baseline in inflammatory facial lesion count at Day 84 [ Time Frame: Baseline and Day 84 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The proportion of subjects with a successful treatment outcome at Day 84 [ Time Frame: Baseline and Day 84 ]

Successful treatment outcome is defined as an improvement of >= 2 grades from the baseline grade on the dichotomized facial Investigator's Global Assessment scale.


Original Secondary Outcome: Same as current

Information By: XOMA (US) LLC

Dates:
Date Received: December 21, 2011
Date Started: December 2011
Date Completion:
Last Updated: March 3, 2014
Last Verified: March 2014