A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.

• Status: Completed
• Trial end date: 2019-02-21
• Target enrollment: 0
• Participant gender: All

Summary

Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.
• Treatments: Adalimumab

Criteria

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:

• Prior treatment with anti-IL17s or participation in an anti-IL17 study

• Previously received anti-TNFs

• Subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol)

• Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline Visit

• Subject received systemic non-biologic therapies for HS with potential therapeutic impact for HS less than 28 days prior to Baseline Visit

• Draining fistula count >20 at the Baseline Visit

• Diagnosis of inflammatory conditions other than HS