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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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

Key facts

Study ID

NCT03248531

Run by

UCB Biopharma SRL

People needed

90

Starts

2017-09-22

Expected to finish

2019-02-21

Last updated by the study team

2022-04-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hs0001 121 — Los Angeles, California, United States
• Hs0001 119 — Coral Gables, Florida, United States
• Hs0001 111 — Orange, Florida, United States
• Hs0001 117 — Tampa, Florida, United States
• Hs0001 112 — Sandy Springs, Georgia, United States
• Hs0001 113 — Boston, Massachusetts, United States
• Hs0001 115 — Las Vegas, Nevada, United States
• Hs0001 126 — Manhasset, New York, United States
• Hs0001 125 — Chapel Hill, North Carolina, United States
• Hs0001 123 — Hershey, Pennsylvania, United States
• Hs0001 120 — Nashville, Tennessee, United States
• Hs0001 103 — East Melbourne, Australia
• Hs0001 101 — Fremantle, Australia
• Hs0001 104 — Saint Leonards, Australia
• Hs0001 100 — Westmead, Australia
• Hs0001 102 — Woolloongabba, Australia
• Hs0001 203 — Brussels, Belgium
• Hs0001 202 — Liège, Belgium
• Hs0001 300 — Copenhagen, Denmark
• Hs0001 408 — Berlin, Germany
• Hs0001 405 — Bochum, Germany
• Hs0001 407 — Darmstadt, Germany
• Hs0001 400 — Dessau, Germany
• Hs0001 404 — Erlangen, Germany
• Hs0001 406 — Würzburg, Germany

Full record on ClinicalTrials.gov

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