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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
gevokizumab
gevokizumab
Sponsored by
XOMA (US) LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, Acne Vulgaris

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

low dose gevokizumab

high dose gevokizumab

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 21, 2011
Last Updated
March 3, 2014
Sponsor
XOMA (US) LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01498874
Brief Title
Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XOMA (US) LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
low dose gevokizumab
Arm Type
Experimental
Arm Title
high dose gevokizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
Intervention Type
Drug
Intervention Name(s)
gevokizumab
Intervention Description
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
Intervention Type
Drug
Intervention Name(s)
gevokizumab
Intervention Description
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
Primary Outcome Measure Information:
Title
The mean absolute change from baseline in inflammatory facial lesion count at Day 84
Time Frame
Baseline and Day 84
Secondary Outcome Measure Information:
Title
The proportion of subjects with a successful treatment outcome at Day 84
Description
Successful treatment outcome is defined as an improvement of >= 2 grades from the baseline grade on the dichotomized facial Investigator's Global Assessment scale.
Time Frame
Baseline and Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Hot Springs
State/Province
Arkansas
Country
United States
City
Riverside
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
New Haven
State/Province
Connecticut
Country
United States
City
Bay City
State/Province
Michigan
Country
United States
City
Fridley
State/Province
Minnesota
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
South Euclid
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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