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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01498874
First received: December 21, 2011
Last updated: March 3, 2014
Last verified: March 2014
  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.


Enrollment: 127
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 3, 2014
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 September 29, 2014