A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT06921850
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
40 participants
INTERVENTIONAL
2025-04-07
2029-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bimekizumab
Study participants will receive a bimekizumab dose which is weight-dependent.
Bimekizumab
Bimekizumab will be administered at pre-specified timepoints.
Interventions
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Bimekizumab
Bimekizumab will be administered at pre-specified timepoints.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
9 Years
17 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Hs0006 50175
Phoenix, Arizona, United States
Hs0006 50708
Roseville, California, United States
Hs0006 50199
Miami, Florida, United States
Hs0006 50178
Clarkston, Michigan, United States
Hs0006 50710
Fort Gratiot, Michigan, United States
Hs0006 50711
Troy, Michigan, United States
Hs0006 50712
Brooklyn, New York, 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
Countries
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Central Contacts
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UCB Cares
Role: CONTACT
Other Identifiers
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2023-505323-31
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1316-5308
Identifier Type: OTHER
Identifier Source: secondary_id
HS0006
Identifier Type: -
Identifier Source: org_study_id
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