A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa

Conditions

Hidradenitis Suppurativa

Brief summary

• Geometric mean plasma bimekizumab concentration at Week 16

Detailed description

1. Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) over the Initial Treatment Period, 2. Exposure-adjusted incidence rate of Serious TEAEs over the Initial Treatment Period, 3. Exposure-adjusted incidence rate of TEAEs leading to withdrawal from study over the Initial Treatment Period, 4. Exposure-adjusted incidence rate of selected Safety Topics of Interest (including incidence of infections [serious, opportunistic, fungal, and TB], IBD, and injection site reactions) over the Initial Treatment Period, 5. Mean Change from Baseline in Systolic Blood Pressure, Diastolic Blood Pressure, and Pulse over the Initial Treatment Period, 6. Mean Change from Baseline in Biochemistry Laboratory Analyses over the Initial Treatment Period, 7. Mean Change from Baseline in Hematology Laboratory Analyses over the Initial Treatment Period, 8. Incidence rate for Positive, Negative, Missing Plasma Anti-Bimekizumab Antibodies during the Initial Treatment Period

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Interventions

DRUGbimekizumab

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
• Geometric mean plasma bimekizumab concentration at Week 16	—

Secondary

Measure	Time frame
1. Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) over the Initial Treatment Period, 2. Exposure-adjusted incidence rate of Serious TEAEs over the Initial Treatment Period, 3. Exposure-adjusted incidence rate of TEAEs leading to withdrawal from study over the Initial Treatment Period, 4. Exposure-adjusted incidence rate of selected Safety Topics of Interest (including incidence of infections [serious, opportunistic, fungal, and TB], IBD, and injection site reactions) over the Initial Treatment Period, 5. Mean Change from Baseline in Systolic Blood Pressure, Diastolic Blood Pressure, and Pulse over the Initial Treatment Period, 6. Mean Change from Baseline in Biochemistry Laboratory Analyses over the Initial Treatment Period, 7. Mean Change from Baseline in Hematology Laboratory Analyses over the Initial Treatment Period, 8. Incidence rate for Positive, Negative, Missing Plasma Anti-Bimekizumab Antibodies during the Initial Treatment Period	—

Measure

Time frame

1. Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) over the Initial Treatment Period, 2. Exposure-adjusted incidence rate of Serious TEAEs over the Initial Treatment Period, 3. Exposure-adjusted incidence rate of TEAEs leading to withdrawal from study over the Initial Treatment Period, 4. Exposure-adjusted incidence rate of selected Safety Topics of Interest (including incidence of infections [serious, opportunistic, fungal, and TB], IBD, and injection site reactions) over the Initial Treatment Period, 5. Mean Change from Baseline in Systolic Blood Pressure, Diastolic Blood Pressure, and Pulse over the Initial Treatment Period, 6. Mean Change from Baseline in Biochemistry Laboratory Analyses over the Initial Treatment Period, 7. Mean Change from Baseline in Hematology Laboratory Analyses over the Initial Treatment Period, 8. Incidence rate for Positive, Negative, Missing Plasma Anti-Bimekizumab Antibodies during the Initial Treatment Period

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Countries

Germany, Poland

Outcome results

None listed