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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498874
• Other study ID #: X052120
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2011
• Last updated: March 3, 2014
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Placebo
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
• gevokizumab
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
• gevokizumab
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean absolute change from baseline in inflammatory facial lesion count at Day 84		Baseline and Day 84	No
Secondary	The proportion of subjects with a successful treatment outcome at 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	No