A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
Inclusion Criteria:
Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least
1 year prior to Baseline
Stable HS for at least 2 months prior to Screening and also at the Baseline Visit
Inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS
Total abscess and inflammatory nodule count >=3 at the Baseline Visit
Subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified over-the-counter topical antiseptics on their HS lesions
Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
Male subjects must be willing to use a method of contraception when sexually active, up till 20 weeks after the last administration of study medication
Exclusion Criteria: