2023-509832-24-00已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- Plasma concentration of bimekizumab at Week 124
研究概览
简要总结
Assess the pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- Participant must be ≥12 to <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: a) Body surface area (BSA) affected by PSO ≥10% b) Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4) c) Psoriasis Area and Severity Index (PASI) score ≥12 OR d) 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
Experimental
Participants receiving bimekizumab
干预措施: bimekizumab (Drug)
结局指标
主要结局
Plasma concentration of bimekizumab at Week 124
Plasma concentration of bimekizumab at Week 124
Plasma concentration of bimekizumab at Week 0
Plasma concentration of bimekizumab at Week 0
Plasma concentration of bimekizumab at Week 1
Plasma concentration of bimekizumab at Week 1
Plasma concentration of bimekizumab at Week 4
Plasma concentration of bimekizumab at Week 4
Plasma concentration of bimekizumab at Week 8
Plasma concentration of bimekizumab at Week 8
Plasma concentration of bimekizumab at Week 12
Plasma concentration of bimekizumab at Week 12
Plasma concentration of bimekizumab at Week 16
Plasma concentration of bimekizumab at Week 16
Plasma concentration of bimekizumab at Week 20
Plasma concentration of bimekizumab at Week 20
Plasma concentration of bimekizumab at Week 36
Plasma concentration of bimekizumab at Week 36
Plasma concentration of bimekizumab at Week 40
Plasma concentration of bimekizumab at Week 40
Plasma concentration of bimekizumab at Week 64
Plasma concentration of bimekizumab at Week 64
Plasma concentration of bimekizumab at Week 88
Plasma concentration of bimekizumab at Week 88
Plasma concentration of bimekizumab at Week 112
Plasma concentration of bimekizumab at Week 112
Plasma concentration of bimekizumab at safety follow up (SFU)
Plasma concentration of bimekizumab at safety follow up (SFU)
次要结局
- Percentage of participants with treatment-emergent adverse events (TEAEs)
- Percentage of participants with serious TEAEs
- Percentage of participants with TEAEs leading to discontinuation of investigational medicinal product (IMP)
- Percentage of participants with selected safety topics of interest
- Change from Baseline in vital signs (systolic and diastolic blood pressure)
- Change from Baseline in vital signs (heart rate or pulse rate)
- Change from Baseline in vital signs (temperature)
- 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
- Change from Baseline in hematology parameters (platelet count)
- Change from Baseline in hematology parameters (mean corpuscular hemoglobin)
- Change from Baseline in hematology parameters (mean corpuscular volume)
- Change from Baseline in hematology parameters (erythrocytes)
- Change from Baseline in hematology parameters (hemoglobin)
- Change from Baseline in hematology parameters (hematocrit)
- Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)
- Change from Baseline in clinical chemistry parameters (calcium, potassium, sodium, blood urea nitrogen, glucose (nonfasting))
- Change from Baseline in clinical chemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase)
- Change from Baseline in clinical chemistry parameters (creatinine, total and direct bilirubin)
- Change from Baseline in clinical chemistry parameters (total protein)
- Change from Baseline in height
- Change from Baseline in weight
- Percentage of participants with Psoriasis Area and Severity Index (PASI) 90 response at 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
- Percentage of participants with Psoriasis Area and Severity Index (PASI) 75 response at Week 4
- Percentage of participants with anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration
- Percentage of participants with anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration
- Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) response at Week 16
研究者
研究点 (7)
Loading locations...
标识符
- 欧盟试验编号
- 2023-509832-24-00
- 其他研究编号
- PS0020, EUCTR2020-001724-34-PL, EUCTR2020-001724-34-DE, NCT04718896
日期
- 首次发布
- (2年前)
- 最近更新
- (去年)
监管与共享
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
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