A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
Phase 3
40
about 4.1 years
9–17
12 sites in AZ, CA, DC +6
What this study is about
Researchers are testing a treatment called bimekizumab in children and adolescents with moderate to severe hidradenitis suppurativa. The trial will examine how well this medication works (pharmacokinetics) and its safety.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Bimekizumab
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
bimekizumab
Secondary: Exposure-adjusted incidence rate of Serious TEAEs during the Initial Treatment Period, Exposure-adjusted incidence rate of TEAEs leading to withdrawal during the Initial Treatment Period, Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) during the Initial Treatment Period, Mean Change from Baseline in Biochemistry Laboratory Analyses (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Weeks 4,12, and 16, Mean Change from Baseline in Biochemistry Laboratory Analyses (glucose, potassium, sodium, calcium) at Weeks 4,12, and 16, Mean Change from Baseline in Biochemistry Laboratory Analyses (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) at Weeks 4,12, and 16, Mean Change from Baseline in Hematology Laboratory Analyses (erythrocytes), Mean Change from Baseline in Hematology Laboratory Analyses (hematocrit) at Weeks 4,12, and 16