A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa
UCB Biopharma SRL
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
- Age range
- 9–17 years
- Sex
- All
- 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 hav…
Interventions
- DrugBimekizumab
Bimekizumab will be administered at pre-specified timepoints.
Locations (18)
- Hs0006 50175Phoenix, Arizona
- Hs0006 50708Roseville, California
- Hs0006 50684Sacramento, California
- Hs0006 50707Washington D.C., District of Columbia
- Hs0006 50199Miami, Florida
- Hs0006 50178Clarkston, Michigan