Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris
This study is ongoing, but not recruiting participants.
Sponsor:
XOMA (US) LLC
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01498874
First received: December 21, 2011
Last updated: February 28, 2013
Last verified: September 2012
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Purpose
The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Placebo Drug: gevokizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris |
Resource links provided by NLM:
Further study details as provided by XOMA (US) LLC:
Primary Outcome Measures:
- The mean absolute change from baseline in inflammatory facial lesion count at Day 84 [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The proportion of subjects with a successful treatment outcome at Day 84 [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]Successful treatment outcome is defined as an improvement of >= 2 grades from the baseline grade on the dichotomized facial Investigator's Global Assessment scale.
| Estimated Enrollment: | 171 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
|
| Experimental: low dose gevokizumab |
Drug: gevokizumab
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
|
| Experimental: high dose gevokizumab |
Drug: gevokizumab
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
|
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498874
Locations
| United States, Arkansas | |
| Hot Springs, Arkansas, United States | |
| United States, California | |
| Riverside, California, United States | |
| San Diego, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| New Haven, Connecticut, United States | |
| United States, Michigan | |
| Bay City, Michigan, United States | |
| United States, Minnesota | |
| Fridley, Minnesota, United States | |
| United States, Nevada | |
| Las Vegas, Nevada, United States | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States | |
| High Point, North Carolina, United States | |
| Raleigh, North Carolina, United States | |
| United States, Ohio | |
| South Euclid, Ohio, United States | |
| United States, Oregon | |
| Portland, Oregon, United States | |
| United States, Texas | |
| Arlington, Texas, United States | |
| Austin, Texas, United States | |
| Houston, Texas, United States | |
| United States, Utah | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Richmond, Virginia, United States | |
Sponsors and Collaborators
XOMA (US) LLC
More Information
No publications provided
| Responsible Party: | XOMA (US) LLC |
| ClinicalTrials.gov Identifier: | NCT01498874 History of Changes |
| Other Study ID Numbers: | X052120 |
| Study First Received: | December 21, 2011 |
| Last Updated: | February 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by XOMA (US) LLC:
|
Acne Acne Vulgaris |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
ClinicalTrials.gov processed this record on May 19, 2013