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

UCB

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Adalimumab; Other: Placebo; Drug: Bimekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03248531

2017-000892-10 (EudraCT Number)

HS0001

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Bimekizumab

Experimental group

Description:

Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.

Treatment:

Drug: Bimekizumab

Adalimumab

Active Comparator group

Description:

Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.

Treatment:

Drug: Adalimumab

Placebo

Placebo Comparator group

Description:

Subjects will receive several placebo applications to keep the blinding.

Treatment:

Other: Placebo