Actively Recruiting
A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa
Led by UCB Biopharma SRL · Updated on 2026-06-05
40
Participants Needed
18
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics and safety of bimekizumab in children and adolescents aged 9 to 17 years with moderate to severe hidradenitis suppurativa (HS). This study focuses on understanding how the drug behaves in the body when given by subcutaneous injection and aims to gather important safety information in this younger population. Participants must have had HS for at least six months and show certain disease severity and characteristics to join the study. Participants will receive bimekizumab doses adjusted based on their weight, administered at specific scheduled times during the study. This is an open-label trial where all participants receive the drug, and no placebo or comparator group is used. The study primarily measures the concentration of bimekizumab in the blood at Week 16 to understand drug exposure. Throughout the study, participants will undergo various assessments including monitoring for side effects, vital signs, and detailed laboratory tests such as blood chemistry and hematology at multiple time points up to Week 16. Researchers will also check for anti-drug antibodies and track safety events related to infections and other concerns. The total study duration extends up to about four years, ending in 2029, with careful safety follow-up and data collection to evaluate the treatment's profile in this population.
CONDITIONS
Brief Title
A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Study participant must be 12 to under 18 years of age at the time of informed consent/assent, at Tanner stage 2 or more, for the first 8 participants only, then including participants 9 to under 18 years at Tanner stage 2 or more
- Diagnosis of hidradenitis suppurativa for at least 6 months prior to Baseline Visit
- Moderate to severe hidradenitis suppurativa with at least 5 inflammatory lesions (abscesses and nodules) at Screening and Baseline Visits
- Hidradenitis suppurativa lesions in at least 2 distinct body areas, with one area at Hurley Stage II or III at Screening and Baseline Visits
- History of inadequate response to systemic antibiotic course for hidradenitis suppurativa
- Weight of 30 kg or more at Screening Visit
You will not qualify if you...
- Draining tunnel count greater than 20 at Screening or Baseline Visits
- Primary failure to one or more IL-17 biologic response modifiers or to more than one biologic response modifier other than IL-17
- Previous participation in this study or prior bimekizumab therapy
- History or symptoms suggestive of inflammatory bowel disease
- Active tuberculosis unless successfully treated, or latent tuberculosis unless treated prophylactically
- Active infection or history of serious, chronic, opportunistic, or severe infections
- Use of prohibited drugs outside specified timeframes relative to Baseline Visit
- Presence of active suicidal ideation or positive suicide behavior
- Diagnosis of severe depression within 6 months prior to Screening Visit
- Psychiatric inpatient hospitalization within 1 year before enrolling in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive weight-dependent doses of bimekizumab at pre-specified timepoints to treat moderate to severe hidradenitis suppurativa.
Visits at Baseline, and Weeks 4, 12, and 16
Trial Site Locations
Total: 18 locations
1
Hs0006 50175
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Hs0006 50708
Roseville, California, United States, 95661
Actively Recruiting
3
Hs0006 50684
Sacramento, California, United States, 95815
Active, Not Recruiting
4
Hs0006 50707
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Hs0006 50199
Miami, Florida, United States, 33136
Actively Recruiting
6
Hs0006 50178
Clarkston, Michigan, United States, 48346
Actively Recruiting
7
Hs0006 50710
Fort Gratiot, Michigan, United States, 48059
Actively Recruiting
8
Hs0006 50711
Troy, Michigan, United States, 48084
Actively Recruiting
9
Hs0006 50712
New York, New York, United States, 10023
Actively Recruiting
10
Hs0006 50706
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
11
Hs0006 50202
Fairborn, Ohio, United States, 45324
Actively Recruiting
12
Hs0006 50201
Arlington, Texas, United States, 76011
Actively Recruiting
13
Hs0006 40326
Berlin, Germany
Actively Recruiting
14
Hs0006 40747
Mainz, Germany
Actively Recruiting
15
Hs0006 40625
Warsaw, Poland
Actively Recruiting
16
Hs0006 40761
Warsaw, Poland
Actively Recruiting
17
Hs0006 40095
Wroclaw, Poland
Actively Recruiting
18
Hs0006 40845
Wroclaw, Poland
Actively Recruiting
Research Team
U
UCB Cares
U
UCB Cares
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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