NCT06921850进行中（未招募）3 期
A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 18
- 主要终点
- Geometric Mean Plasma bimekizumab concentrations at Week 16
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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.
排除标准
- •Study participant has a draining tunnel count of >20 at either the Screening or Baseline Visits.
- •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.
研究组 & 干预措施
Bimekizumab
Experimental
Study participants will receive a bimekizumab dose which is weight-dependent.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Geometric Mean Plasma bimekizumab concentrations at Week 16
时间窗: At Week 16
Plasma samples will be collected prior to dosing for measurement of plasma concentrations of bimekizumab at the specified timepoint.
次要结局
- Mean Change from Baseline in Biochemistry Laboratory Analyses (glucose, potassium, sodium, calcium) at Weeks 4,12, and 16(Baseline, Weeks 4, 12, and 16)
- Mean Change from Baseline in Hematology Laboratory Analyses (hematocrit) at Weeks 4,12, and 16(Baseline, Weeks 4, 12, and 16)
- Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) during the Initial Treatment Period(From Baseline until end of the Initial Treatment Period (up to 16 weeks))
- Mean Change from Baseline in vital sign (Pulse rate) at Week 16(Baseline and Week 16)
- Incidence rate for Positive, Negative, Missing Plasma Anti-Bimekizumab Antibodies at Baseline and Week 16(Baseline and Week 16)
- Exposure-adjusted incidence rate of Serious TEAEs during the Initial Treatment Period(From Baseline until end of the Initial Treatment Period (up to 16 weeks))
- Exposure-adjusted incidence rate of TEAEs leading to withdrawal during the Initial Treatment Period(From Baseline until end of the Initial Treatment Period (up to 16 weeks))
- 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(Up to Week 16)
- Mean Change from Baseline in vital signs (Systolic Blood Pressure and Diastolic Blood Pressure) at Week 16(Baseline and Week 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(Baseline, Weeks 4, 12, and 16)
- Mean Change from Baseline in Biochemistry Laboratory Analyses (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Weeks 4,12, and 16(Baseline, Weeks 4, 12, and 16)
- Mean Change from Baseline in Hematology Laboratory Analyses (hemoglobin) at Weeks 4,12, and 16(Baseline, Weeks 4, 12, and 16)
- Mean Change from Baseline in Hematology Laboratory Analyses (platelets, leukocytes, neutrophils, lymphocytes, eosinophils, basophils, and monocytes) at Weeks 4, 12, and 16(Baseline, Weeks 4, 12, and 16)
- Mean Change from Baseline in Hematology Laboratory Analyses (erythrocytes)(Baseline, Week 4, 12, and 16)
研究者
研究点 (18)
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