A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 15
- 主要终点
- Plasma concentration of bimekizumab at Week 1
研究概览
简要总结
The purpose of the study is to assess th pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥12 to less than 18 years of age at the time of signing the informed consent/assent according to local regulation
- •Participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit and:
- •Body surface area (BSA) affected by PSO ≥10%
- •Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
- •Psoriasis Area and Severity Index (PASI) score ≥12 OR
- •PASI score ≥10 plus at least 1 of the following:
- •i. Clinically relevant facial involvement ii. Clinically relevant genital involvement iii. Clinically relevant hand and foot involvement
- •Participant must be candidate for systemic PSO therapy and/or photo/chemotherapy
- •Body weight ≥30 kg and body mass index for age percentile of ≥5 at Baseline
- •Male or female A female participant will be eligible to participate if she is not pregnant, not breastfeeding, and a woman of childbearing potential (WOCBP) agrees to follow the contraceptive guidance
- •Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate)
排除标准
- •Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO
- •Participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD
- •History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
- •Participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
- •Participant has laboratory abnormalities at Screening
- •Participant has experienced primary failure to one or more interleukin-17 (IL-17) biologic response modifier OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier
- •Presence of active suicidal ideation, or positive suicide behavior
- •Participant has been diagnosed with severe depression in the past 6 months
研究组 & 干预措施
Bimekizumab Dose A
Study participants randomized to this arm will receive bimekizumab (BKZ) Dose A at pre-specified time points during the study.
干预措施: bimekizumab (Drug)
Bimekizumab Dose B
Study participants randomized to this arm will receive bimekizumab (BKZ) Dose B at pre-specified time points during the study.
干预措施: bimekizumab (Drug)
结局指标
主要结局
Plasma concentration of bimekizumab at Week 1
时间窗: Week 1
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 1.
Plasma concentration of bimekizumab at Week 64
时间窗: Week 64
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 64.
Plasma concentration of bimekizumab at safety follow up (SFU)
时间窗: Week 140 (SFU)
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 140 (SFU).
Plasma concentration of bimekizumab at Week 4
时间窗: Week 4
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 4.
Plasma concentration of bimekizumab at Week 8
时间窗: Week 8
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 8.
Plasma concentration of bimekizumab at Week 12
时间窗: Week 12
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 12.
Plasma concentration of bimekizumab at Week 16
时间窗: Week 16
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 16.
Plasma concentration of bimekizumab at Week 112
时间窗: Week 112
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 112.
Plasma concentration of bimekizumab at Week 0
时间窗: Baseline (Week 0)
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 0.
Plasma concentration of bimekizumab at Week 36
时间窗: Week 36
Blood samples will be collected at pre-specified time points at Week 36 to determine the bimekizumab plasma concentration, if participant is not eligible for the Open-label Extension (OLE) Period at Week 20 or does not wish to continue into the OLE Period.
Plasma concentration of bimekizumab at Week 20
时间窗: Week 20
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 20.
Plasma concentration of bimekizumab at Week 88
时间窗: Week 88
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 88.
Plasma concentration of bimekizumab at Week 40
时间窗: Week 40
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 40.
Plasma concentration of bimekizumab at Week 124
时间窗: Week 124
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 124.
次要结局
- Change from Baseline in physical examination findings reported as TEAEs with onset occurring from day of first dose through 20 weeks after final dose of IMP(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Percentage of participants with serious TEAEs(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Percentage of participants with TEAEs leading to discontinuation of investigational medicinal product (IMP)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in vital signs (temperature)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in hematology parameters (platelet count)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in hematology parameters (mean corpuscular hemoglobin)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in clinical chemistry parameters (calcium, potassium, sodium, blood urea nitrogen, glucose (nonfasting))(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in vital signs (heart rate or pulse rate)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in hematology parameters (mean corpuscular volume)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in hematology parameters (erythrocytes)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in hematology parameters (hemoglobin)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in clinical chemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in clinical chemistry parameters (total protein)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in height(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in vital signs (systolic and diastolic blood pressure)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Percentage of participants with Psoriasis Area and Severity Index (PASI) 90 response at Week 16(Week 16)
- Percentage of participants with anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration(Baseline (Week 0))
- Percentage of participants with anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration(From Week 1 through 20 weeks after final dose of IMP (up to Week 140))
- Percentage of participants with treatment-emergent adverse events (TEAEs)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)])
- Percentage of participants with selected safety topics of interest(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in hematology parameters (hematocrit)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in clinical chemistry parameters (creatinine, total and direct bilirubin)(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Change from Baseline in weight(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Percentage of participants with Investigator's Global Assessment (IGA) 0/1 (Clear [0]/Almost Clear [1] with at least 2-category improvement from Baseline) response at Week 16(Week 16)
- Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) response at Week 16(Week 16, compared to Baseline)
- Percentage of participants with Psoriasis Area and Severity Index (PASI) 75 response at Week 4(Week 4)