Hidradenitis Suppurativa
Conditions
Sponsors
UCB Japan Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be at least 18 years of age, at the time of signing the informed consent. If a study participant is _5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits - Study participant must have had an inadequate response to a course of a systemic antibiotic for treatment of HS as assessed by the Investigator through study participant interview and review of medical history - A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) OR b) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 20 weeks after the last dose of investigational medicinal product (IMP)
Exclusion criteria
Exclusion criteria: - Draining tunnel count of >20 at the Baseline Visit - Any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS) - Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD) - Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy - Female who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP) - Active infection or history of certain infection(s) - Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection - Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured - History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease - Known hypersensitivity to any components of bimekizumab or comparative drugs as stated in this protocol - Concomitant and prior medication restrictions - Myocardial infarction or stroke within the 6 months prior to the Screening Visit - Presence of active suicidal ideation, or moderately severe major depression or severe major depression - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 2. Percentage of participants with Flare by Week 16 3. Absolute change from Baseline in Skin Pain score at Week 16 4. Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 5. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study 6. Percentage of participants with serious adverse events (SAEs) during the study 7. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study | — |
Countries
Japan, North America
Outcome results
None listed