Acne Inversa Clinical Study (9-17 yrs)

A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa

Study Description

Brief Summary

The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)

Condition or Disease

Hidradenitis Suppruativa

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	40
Primary Outcome Measures	1. Geometric Mean Plasma bimekizumab concentrations at Week 16
Actual Study Start Date:	April 2025
Estimated Primary Completion Date:	March 2027

Eligibility Criteria

Ages Eligible for Study:	9 – 17 years old
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Hidradenitis Supurativa

Inclusion Criteria

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.

Exclusion Criteria

Study participant has a draining tunnel count of >20 at either the Screening or Baseline Visits
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 previously participated in this study or has received previous therapy with bimekizumab
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 received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments

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Moderate-to-Severe Hidradenitis Suppruativa Study (9-17 Years)