Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris
1 other identifier
interventional
127
1 country
19
Brief Summary
The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2011
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
December 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMarch 4, 2014
March 1, 2014
1.3 years
December 21, 2011
March 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mean absolute change from baseline in inflammatory facial lesion count at Day 84
Baseline and Day 84
Secondary Outcomes (1)
The proportion of subjects with a successful treatment outcome at Day 84
Baseline and Day 84
Study Arms (3)
Placebo
PLACEBO COMPARATORlow dose gevokizumab
EXPERIMENTALhigh dose gevokizumab
EXPERIMENTALInterventions
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XOMA (US) LLClead
Study Sites (19)
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Bay City, Michigan, United States
Unknown Facility
Fridley, Minnesota, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
South Euclid, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Richmond, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2011
First Posted
December 26, 2011
Study Start
December 1, 2011
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
March 4, 2014
Record last verified: 2014-03