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

Running, not enrolling · Phase 3

Conditions studied: Hidradenitis Suppurativa

In brief

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)

Key facts

Study ID

NCT06921850

Run by

UCB Biopharma SRL

People needed

43

Starts

2025-04-07

Expected to finish

2029-03-06

Last updated by the study team

2026-07-31

Who can join

Age: 9 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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