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

XOMA

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: gevokizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01498874

X052120

Details and patient eligibility

About

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

Enrollment: 127 patients

Sex: All

Ages: 17+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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127 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

low dose gevokizumab

Experimental group

Treatment:

Drug: gevokizumab

Drug: gevokizumab

high dose gevokizumab

Experimental group

Treatment:

Drug: gevokizumab

Drug: gevokizumab