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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Placebo; Drug: gevokizumab

• Registration Number: NCT01498874
• Lead Sponsor: XOMA (US) LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-26
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
high dose gevokizumab	gevokizumab	-
low dose gevokizumab	gevokizumab	-

Primary Outcome Measures

Name	Time	Method
The mean absolute change from baseline in inflammatory facial lesion count at Day 84	Baseline and Day 84

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects with a successful treatment outcome at Day 84	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.