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Clinical Trials in the USA / NCT06921850
Active, not recruiting Phase 3

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

NCT06921850 · tracked via the Priya Life Science USA tracker
Sponsor
UCB Biopharma SRL
Phase
Phase 3
Started
2025-04-07
Last updated
2026-09-11

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

Bimekizumab

Bimekizumab: Bimekizumab will be administered at pre-specified timepoints.

Study 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)

Eligibility

Sex
ALL
Min age
9 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Hs0006 50175 Phoenix Arizona
Hs0006 50708 Roseville California
Hs0006 50684 Sacramento California
Hs0006 50707 Washington D.C. District of Columbia
Hs0006 50199 Miami Florida
Hs0006 50712 Bowling Green Kentucky
Hs0006 50178 Clarkston Michigan
Hs0006 50710 Fort Gratiot Michigan
Hs0006 50711 Troy Michigan
Hs0006 50706 Chapel Hill North Carolina
Hs0006 50202 Fairborn Ohio
Hs0006 50201 Arlington Texas
Hs0006 40326 Berlin Germany
Hs0006 40747 Mainz Germany
Hs0006 40625 Lodz Poland
Hs0006 40761 Warsaw Poland
Hs0006 40095 Wroclaw Poland
Hs0006 40845 Wroclaw Poland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06921850 on ClinicalTrials.gov ↗ ← All trials in the USA