NCT06921850 · UCB Biopharma SRL
A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
What this study is about
The purpose of the study is to assess the PK of bimekizumab following injected under the skin (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)
View original scientific description
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)
Interventions
DRUG
Bimekizumab
Bimekizumab will be administered at pre-specified timepoints.
Primary outcome measures
Geometric Mean Plasma bimekizumab concentrations at Week 16
Time frame: At Week 16
Plasma samples will be collected prior to dosing for measurement of plasma concentrations of bimekizumab at the specified timepoint.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Roseville, California
- Sacramento, California
- Washington D.C., District of Columbia
- Miami, Florida
- Bowling Green, Kentucky
- Clarkston, Michigan
- Fort Gratiot, Michigan
- Troy, Michigan
- Chapel Hill, North Carolina
- Fairborn, Ohio
- Arlington, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations