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Completed

NCT Number: NCT01498874

Efficacy and Safety Study of Gevokizumab to Treat 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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hot Springs, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56

gevokizumab

Drug

Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56

Primary outcomes

  1. The mean absolute change from baseline in inflammatory facial lesion count at Day 84

    Time frame: Baseline and Day 84

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 26, 2011
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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