A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Status: | Completed |
---|---|
Conditions: | Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 3/24/2019 |
Start Date: | September 22, 2017 |
End Date: | February 20, 2019 |
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.
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:
- 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
We found this trial at
12
sites
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