Active, not recruitingPhase 3
A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
Key facts
- Who runs it
- UCB Biopharma SRL
- Where
- Arlington, Bowling Green, Chapel Hill, Clarkston, Fairborn, Fort Gratiot, Miami, Roseville, Sacramento, Troy, and Washington D.C., United StatesSee the 11 sitesAlso in 2 other countries, 9 sites
- Trial code
- NCT06921850
- EU 2023-505323-31-00
- U1111-1316-5308
- Status
- Active, not recruiting
- Phase
- Phase 3
- People taking part
- 43 people enrolled
- Started
- 7 Apr 2025
- Expected to end
- 6 Mar 2029
- Type of study
- Interventional
- Treatments tested
- Bimekizumab
- Record updated
- 25 September 2026
Who can take part
- Age
- 9 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Study participant has previously participated in this study or has received previous therapy with bimekizumab
- Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
- Study participant diagnosed with severe depression in the past 6 months prior to the Screening Visit
- 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 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 a history of psychiatric inpatient hospitalization within the past year before enrolling into the study
- Study participant has a draining tunnel count of >20 at either the Screening or Baseline Visits
- Study participant has the presence of active suicidal ideation, or positive suicide behavior,
Where in United States
Also in 2 other countries, 9 sites
- Hs0006 50201Arlington, United StatesNo longer taking part
- Hs0006 50712Bowling Green, United StatesNo longer taking part
- Hs0006 50706Chapel Hill, United StatesNo longer taking part
- Hs0006 50178Clarkston, United StatesNo longer taking part
- Hs0006 50202Fairborn, United StatesNo longer taking part
- Hs0006 50710Fort Gratiot, United StatesNo longer taking part
- Hs0006 50199Miami, United StatesNo longer taking part
- Hs0006 50708Roseville, United StatesNo longer taking part
- Hs0006 50684Sacramento, United StatesNo longer taking part
- Hs0006 50711Troy, United StatesNo longer taking part
- Hs0006 50707Washington D.C., United StatesNo longer taking part
About the trial
What the trial wants to find out
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)
The group in the trial
- BimekizumabTreatment being tested
Study participants will receive a bimekizumab dose which is weight-dependent.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa
- Record updated
- 25 September 2026