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
- 11
- 主要终点
- Plasma Concentration of Bimekizumab at Week 0
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 0
时间窗: Baseline (Week 0)
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 0. PK-PPS = Pharmacokinetic per-protocol set, IMP = investigational medicinal product.
Plasma Concentration of Bimekizumab at Week 1
时间窗: Week 1
Blood samples were collected to determine the bimekizumab plasma concentration at Week 1.
Plasma Concentration of Bimekizumab at Week 4
时间窗: Week 4
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 4.
Plasma Concentration of Bimekizumab at Week 8
时间窗: Week 8
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 8.
Plasma Concentration of Bimekizumab at Week 12
时间窗: Week 12
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 12.
Plasma Concentration of Bimekizumab at Week 16
时间窗: Week 16
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 16.
Plasma Concentration of Bimekizumab at Week 20
时间窗: Week 20
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 20.
Plasma Concentration of Bimekizumab at Week 40
时间窗: Week 40
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 40.
Plasma Concentration of Bimekizumab at Week 64
时间窗: Week 64
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 64.
Plasma Concentration of Bimekizumab at Week 88
时间窗: Week 88
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 88.
Plasma Concentration of Bimekizumab at Week 112
时间窗: Week 112
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 112.
Plasma Concentration of Bimekizumab at Week 124
时间窗: Week 124
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 124.
Plasma Concentration of Bimekizumab at Safety Follow up (SFU)
时间窗: Week 140 (SFU)
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 140 (SFU).
次要结局
- 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 Serious Treatment-emergent Adverse Events(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Percentage of Participants With Treatment-emergent Adverse Events (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))
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study(From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140))
- Exposure-adjusted Incidence Rates (EAIR) of 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 Vital Signs (Systolic and Diastolic Blood Pressure)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Vital Signs (Pulse Rate)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Vital Signs (Temperature)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Hematology Parameters (Platelet Count)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Hematology Parameters (Mean Corpuscular Hemoglobin)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Hematology Parameters (Mean Corpuscular Volume)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Hematology Parameters (Erythrocytes)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Hematology Parameters (Hemoglobin)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Hematology Parameters (Hematocrit)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Clinical Chemistry Parameters (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Hematology Parameters (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Clinical Chemistry Parameters (Calcium, Potassium, Sodium, Blood Urea Nitrogen, Glucose (Nonfasting)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Clinical Chemistry Parameters (Creatinine, Total and Direct Bilirubin)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Clinical Chemistry Parameters (Total Protein)(Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140))
- Change From Baseline in Height(Baseline (Week 0), Weeks 16, 124)
- Change From Baseline in Weight(Baseline (Week 0), Weeks 16, 124)
- Percentage of Participants With Psoriasis Area and Severity Index (PASI) 90 Response at Week 16(Week 16)
- 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)
- Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 Response at Week 4(Week 4)
- 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 Baseline (Week 0, post-first dose) to Safety Follow-Up (Week 140))
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Response at Week 16(Baseline, Week 16)