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

Phase 3RecruitingNCT06921850

UCB Biopharma SRL40 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

BimekizumabDRUG

Bimekizumab will be administered at pre-specified timepoints.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (16)

Hs0006 50175

Phoenix, Arizona, United States

RECRUITING

Hs0006 50708

Roseville, California, United States

Outcomes

Primary Outcomes

Geometric Mean Plasma bimekizumab concentrations at Week 16

Plasma samples will be collected prior to dosing for measurement of plasma concentrations of bimekizumab at the specified timepoint.

Time frame: At Week 16

Secondary Outcomes

Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) during the Initial Treatment Period

The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to IMP.

Time frame: From Baseline until end of the Initial Treatment Period (up to 16 weeks)

Exposure-adjusted incidence rate of Serious TEAEs during the Initial Treatment Period

The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. A SAE is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly/birth defect * Important medical events

Time frame: From Baseline until end of the Initial Treatment Period (up to 16 weeks)

Exposure-adjusted incidence rate of TEAEs leading to withdrawal during the Initial Treatment Period

The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to IMP.

Central Contacts

UCB Cares

CONTACT

+18445992273 ucbcares@ucb.com

UCB Cares

CONTACT

001 844 599 2273

Data from ClinicalTrials.gov

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