Status:
COMPLETED
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03248531
Start Date
September 22 2017
End Date
February 21 2019
Last Update
April 11 2022
Active Locations (31)
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1
Hs0001 121
Los Angeles, California, United States, 90033
2
Hs0001 119
Coral Gables, Florida, United States, 33134
3
Hs0001 111
Orange, Florida, United States, 32073
4
Hs0001 117
Tampa, Florida, United States, 33624