Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris
NCT ID: NCT01498874
Last Updated: 2014-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2011-12-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
low dose gevokizumab
gevokizumab
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
high dose gevokizumab
gevokizumab
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
Interventions
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Placebo
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
gevokizumab
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
gevokizumab
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
17 Years
ALL
No
Sponsors
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XOMA (US) LLC
INDUSTRY
Responsible Party
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Locations
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Hot Springs, Arkansas, United States
Riverside, California, United States
San Diego, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Bay City, Michigan, United States
Fridley, Minnesota, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
South Euclid, Ohio, United States
Portland, Oregon, United States
Arlington, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Countries
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Other Identifiers
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X052120
Identifier Type: -
Identifier Source: org_study_id
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