Status:
COMPLETED
Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris
Lead Sponsor:
XOMA (US) LLC
Conditions:
Acne Vulgaris
Eligibility:
All Genders
17+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01498874
Start Date
December 1 2011
End Date
June 1 2013
Last Update
March 4 2014
Active Locations (19)
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1
Hot Springs, Arkansas, United States
2
Riverside, California, United States
3
San Diego, California, United States
4
Denver, Colorado, United States