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