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

March 3, 2014 updated by: XOMA (US) LLC

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris

The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States
    • California
      • Riverside, California, United States
      • San Diego, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Michigan
      • Bay City, Michigan, United States
    • Minnesota
      • Fridley, Minnesota, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • High Point, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • South Euclid, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Texas
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean absolute change from baseline in inflammatory facial lesion count at Day 84
Time Frame: Baseline and Day 84
Baseline and Day 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XOMA (US) LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

December 21, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (ESTIMATE)

December 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X052120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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