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

Launched by UCB BIOPHARMA SRL · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called bimekizumab to see how it works and how safe it is for children and adolescents with moderate to severe hidradenitis suppurativa (HS). HS is a painful skin condition that causes bumps and abscesses, often in areas like the armpits and groin. The trial will include participants aged 9 to 17 who have had HS for at least six months and have not responded well to antibiotics. To qualify, they need to have a certain number of painful lesions and have them in more than one area of the body.

Participants in this trial can expect to receive the medication through an injection under the skin. The study is designed to gather important information about how the body processes bimekizumab and its overall safety. It’s important to note that there are some health conditions that would exclude someone from participating, such as certain infections or a history of severe depression. Currently, the trial is not yet recruiting participants, but it will be an opportunity for eligible young people to contribute to research that could help improve treatment options for HS in the future.

Gender

ALL

Eligibility criteria

• 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
• • Study participant has the presence of active suicidal ideation, or positive suicide behavior,
• • Study participant diagnosed with severe depression in the past 6 months prior to the Screening Visit.
• • Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study.