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Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01498874
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC

Tracking Information
First Submitted Date  ICMJE December 21, 2011
First Posted Date  ICMJE December 26, 2011
Last Update Posted Date March 4, 2014
Study Start Date  ICMJE December 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
The mean absolute change from baseline in inflammatory facial lesion count at Day 84 [ Time Frame: Baseline and Day 84 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01498874 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
The proportion of subjects with a successful treatment outcome at Day 84 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Placebo
    Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
  • Drug: gevokizumab
    Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: low dose gevokizumab
    Intervention: Drug: gevokizumab
  • Experimental: high dose gevokizumab
    Intervention: Drug: gevokizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2014)
127
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2011)
171
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01498874
Other Study ID Numbers  ICMJE X052120
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party XOMA (US) LLC
Study Sponsor  ICMJE XOMA (US) LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account XOMA (US) LLC
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP