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

UCB

Status and phase

Enrolling

Phase 3

Conditions

Hidradenitis Suppurativa

Treatments

Drug: Bimekizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06921850

HS0006

2023-505323-31 (Registry Identifier)

U1111-1316-5308 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment

40 estimated patients

Sex

All

Ages

9 to 17 years old

Volunteers

No Healthy Volunteers

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.