A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa

Ki vehet részt

• Study participant must be 12 to <18 years of age at the time of informed consent/assent, at Tanner stage 2 or more, for the first 8 participants only, followed by also including participants ≥9 to <18 years of age at Tanner stage 2 or more
• Study participant must have a diagnosis of HS for at least 6 months prior to the Baseline Visit
• Study participant must have moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, the sum of abscesses and inflammatory nodules), as assessed at both the Screening and Baseline Visits
• Study participant must have HS lesions present in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or III, as assessed at both the Screening and Baseline Visits
• Study participant must have had a history of inadequate response to a course of a systemic antibiotic for treatment of HS
• Study participant must weigh ≥30kg at the Screening Visit

Ki nem vehet részt

• Study participant has previously participated in this study or has received previous therapy with bimekizumab
• Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
• Study participant diagnosed with severe depression in the past 6 months prior to the Screening Visit
• Study participant has experienced primary failure (no response within 12 weeks) to 1 or more IL 17 biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier
• Study participant has a history of IBD or symptoms suggestive of IBD
• History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
• Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
• Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study
• Study participant has a draining tunnel count of >20 at either the Screening or Baseline Visits
• Study participant has the presence of active suicidal ideation, or positive suicide behavior,