Acne Vulgaris
Conditions
Keywords
Acne, 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.
Interventions
DRUGPlacebo
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
DRUGgevokizumab
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
Sponsors
XOMA (US) LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean absolute change from baseline in inflammatory facial lesion count at Day 84 | Baseline and Day 84 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed