A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa
3 other identifiers
interventional
40
3 countries
18
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2025
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2025
CompletedStudy Start
First participant enrolled
April 7, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 6, 2029
March 27, 2026
March 1, 2026
1.7 years
April 3, 2025
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At Week 16
Secondary Outcomes (14)
Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) during the Initial Treatment Period
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
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
From Baseline until end of the Initial Treatment Period (up to 16 weeks)
Exposure-adjusted incidence rate of Selected Safety Topics of Interest (including incidence of infections [serious, opportunistic, fungal, and TB], IBD, and injection site reactions) over the Initial Treatment Period
Up to Week 16
Mean Change from Baseline in vital signs (Systolic Blood Pressure and Diastolic Blood Pressure) at Week 16
Baseline and Week 16
- +9 more secondary outcomes
Study Arms (1)
Bimekizumab
EXPERIMENTALStudy participants will receive a bimekizumab dose which is weight-dependent.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Hs0006 50175
Phoenix, Arizona, 85006, United States
Hs0006 50708
Roseville, California, 95661, United States
Hs0006 50684
Sacramento, California, 95815, United States
Hs0006 50707
Washington D.C., District of Columbia, 20010, United States
Hs0006 50199
Miami, Florida, 33136, United States
Hs0006 50178
Clarkston, Michigan, 48346, United States
Hs0006 50710
Fort Gratiot, Michigan, 48059, United States
Hs0006 50711
Troy, Michigan, 48084, United States
Hs0006 50712
New York, New York, 10023, United States
Hs0006 50706
Chapel Hill, North Carolina, 27516, United States
Hs0006 50202
Fairborn, Ohio, 45324, United States
Hs0006 50201
Arlington, Texas, 76011, United States
Hs0006 40326
Berlin, Germany
Hs0006 40747
Mainz, Germany
Hs0006 40625
Warsaw, Poland
Hs0006 40761
Warsaw, Poland
Hs0006 40095
Wroclaw, Poland
Hs0006 40845
Wroclaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2025
First Posted
April 10, 2025
Study Start
April 7, 2025
Primary Completion (Estimated)
December 21, 2026
Study Completion (Estimated)
March 6, 2029
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.