RECRUITING

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

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Conditions

Hidradenitis SuppurativaBimekizumabHS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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

Quick Facts

Study Start:2025-04-07
Study Completion:2030-11-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06921850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Study participant must have a diagnosis of HS for at least 6 months prior to the Baseline Visit.
  3. * 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.
  4. * 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.
  5. * Study participant must have had a history of inadequate response to a course of a systemic antibiotic for treatment of HS
  6. * Study participant must weigh ≥30kg at the Screening Visit.
  1. * Study participant has a draining tunnel count of \>20 at either the Screening or Baseline Visits.
  2. * 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.
  3. * Study participant has previously participated in this study or has received previous therapy with bimekizumab.
  4. * Study participant has a history of IBD or symptoms suggestive of IBD.
  5. * History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
  6. * Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
  7. * Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
  8. * Study participant has the presence of active suicidal ideation, or positive suicide behavior,
  9. * Study participant diagnosed with severe depression in the past 6 months prior to the Screening Visit.
  10. * Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study.

Contacts and Locations

Study Contact

UCB Cares
CONTACT
+18445992273
ucbcares@ucb.com
UCB Cares
CONTACT
001 844 599 2273

Principal Investigator

UCB Cares
STUDY_DIRECTOR
001 844 599 2273

Study Locations (Sites)

Hs0006 50708
Roseville, California, 95661
United States
Hs0006 50178
Clarkston, Michigan, 48346
United States
Hs0006 50710
Fort Gratiot, Michigan, 48059
United States
Hs0006 50711
Troy, Michigan, 48084
United States
Hs0006 50201
Arlington, Texas, 76011
United States

Collaborators and Investigators

Sponsor: UCB Biopharma SRL

  • UCB Cares, STUDY_DIRECTOR, 001 844 599 2273

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-07
Study Completion Date2030-11-11

Study Record Updates

Study Start Date2025-04-07
Study Completion Date2030-11-11

Terms related to this study

Keywords Provided by Researchers

  • Bimekizumab
  • HS
  • Hidradenitis Suppurativa

Additional Relevant MeSH Terms

  • Hidradenitis Suppurativa