此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

一项评估两剂 Bimekizumab 在患有中度至重度斑块状银屑病的青少年研究参与者中的药代动力学、安全性和有效性的研究 (BE CONNECTED)

2026年7月30日 更新者：UCB Biopharma SRL

一项多中心、开放标签、随机研究，以评估两剂 Bimekizumab 在患有中度至重度斑块状银屑病的青少年研究参与者中的药代动力学、安全性和有效性

该研究的目的是评估在患有中度至重度斑块状银屑病 (PSO) 的青少年中皮下 (sc) 给药的 bimekizumab 的药代动力学 (PK)。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

41

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
      • Calgary、加拿大
        • Ps0020 50354
      • St. John's、加拿大
        • Ps0020 50357
  • 德国
      • Frankfurt、德国
        • Ps0020 40645
  • 波兰
      • Bialystok、波兰
        • Ps0020 40626
      • Lodz、波兰
        • Ps0020 40625
      • Rzeszów、波兰
        • Ps0020 40396
      • Warsaw、波兰
        • Ps0020 40335
      • Wroclaw、波兰
        • Ps0020 40333
      • Wroclaw、波兰
        • Ps0020 40334
  • 美国
    • Indiana
      • Indianapolis、Indiana、美国、46250
        • Ps0020 50344
    • Texas
      • Cypress、Texas、美国、77433
        • Ps0020 50359

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 17年 (孩子)

接受健康志愿者

不

描述

纳入标准：

  • 根据当地法规，参与者在签署知情同意书/同意书时必须年满 12 岁至 <18 岁

  • 参与者在筛选访视前至少 3 个月被诊断为中度至重度斑块状银屑病 (PSO)，并且：

    1. 受 PSO 影响的体表面积 (BSA) ≥10%
    2. 研究者的整体评估 (IGA) 分数≥3（从 0 到 4 分）
    3. 银屑病面积和严重程度指数 (PASI) 评分≥12 或
    4. PASI 分数≥10 加上至少以下一项：

    我。临床相关的面部受累 ii. 临床相关的生殖器受累 iii. 临床相关的手足受累

  • 参与者必须是全身 PSO 治疗和/或光/化疗的候选人
  • 基线时体重 ≥ 30 kg 且年龄百分位数的体重指数 ≥ 5
  • 男性或女性 如果女性参与者未怀孕、未哺乳且有生育潜力的女性 (WOCBP) 同意遵循避孕指南，则她将有资格参加
  • 能够给予/让父母或法定代表提供签署的知情同意/同意（如适用）

排除标准：

  • 参与者存在点滴状、逆向、脓疱性或红皮病性 PSO 或其他可能影响 PSO 临床评估的皮肤病
  • 参与者有炎症性肠病 (IBD) 病史或提示 IBD 的症状
  • 活动性结核病史，除非成功治疗，潜伏性结核病，除非预防性治疗
  • 参与者有活动性感染或感染史（如严重感染、慢性感染、机会性感染、异常严重感染）
  • 参与者在筛选时有实验室异常
  • 参与者经历过一种或多种白细胞介素 17 (IL-17) 生物反应调节剂的原发性失败或 IL-17 生物反应调节剂以外的超过 1 种生物反应调节剂的原发性失败
  • 存在积极的自杀意念或积极的自杀行为
  • 参与者在过去 6 个月内被诊断出患有严重抑郁症

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Bimekizumab 剂量 A
随机分配到该组的研究参与者将在研究期间的预先指定时间点接受 bimekizumab (BKZ) 剂量 A。
药品：比美珠单抗
研究参与者将在研究期间的预定时间点接受皮下注射的 bimekizumab (BKZ)。
其他名称：
  • UCB4940
  • BKZ
实验性的：Bimekizumab 剂量 B
随机分配到该组的研究参与者将在研究期间的预先指定时间点接受 bimekizumab (BKZ) 剂量 B。
药品：比美珠单抗
研究参与者将在研究期间的预定时间点接受皮下注射的 bimekizumab (BKZ)。
其他名称：
  • UCB4940
  • BKZ

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Plasma Concentration of Bimekizumab at Week 0
大体时间：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.
Baseline (Week 0)
Plasma Concentration of Bimekizumab at Week 1
大体时间：Week 1
Blood samples were collected to determine the bimekizumab plasma concentration at Week 1.
Week 1
Plasma Concentration of Bimekizumab at Week 4
大体时间：Week 4
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 4.
Week 4
Plasma Concentration of Bimekizumab at Week 8
大体时间：Week 8
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 8.
Week 8
Plasma Concentration of Bimekizumab at Week 12
大体时间：Week 12
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 12.
Week 12
Plasma Concentration of Bimekizumab at Week 16
大体时间：Week 16
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 16.
Week 16
Plasma Concentration of Bimekizumab at Week 20
大体时间：Week 20
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 20.
Week 20
Plasma Concentration of Bimekizumab at Week 40
大体时间：Week 40
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 40.
Week 40
Plasma Concentration of Bimekizumab at Week 64
大体时间：Week 64
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 64.
Week 64
Plasma Concentration of Bimekizumab at Week 88
大体时间：Week 88
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 88.
Week 88
Plasma Concentration of Bimekizumab at Week 112
大体时间：Week 112
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 112.
Week 112
Plasma Concentration of Bimekizumab at Week 124
大体时间：Week 124
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 124.
Week 124
Plasma Concentration of Bimekizumab at Safety Follow up (SFU)
大体时间：Week 140 (SFU)
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 140 (SFU).
Week 140 (SFU)

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
大体时间：From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. The last dose was given 4 weeks prior end of extension period.
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
大体时间：From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
An serious adverse event (SAE) must meet 1 or more of the following criteria: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. The data was rounded to one decimal place. The last dose was given 4 weeks prior end of extension period.
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)
大体时间：From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. The last dose was given 4 weeks prior end of extension period.
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
大体时间：From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. This measure considers any TEAEs leading to withdrawal from the study. The last dose was given 4 weeks prior end of extension period.
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
大体时间：From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Selected safety topics of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions) with onset occurring from day of first dose through 20 weeks after final dose of IMP adjusted by duration of participant exposure to IMP. The exposure-adjusted incidence rate (EAIR) is defined as the number of participants (n) with a specific AE adjusted for the exposure and was scaled to 100 participant-years. The last dose was given 4 weeks prior end of extension period.
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)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Blood pressure was measured in millimeters of mercury (mmHg).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Vital Signs (Pulse Rate)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Pulse rate was measured in beats per minute (beats/min).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Vital Signs (Temperature)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Temperature (oral, axillary, otic or non-contact forehead) was measured in degrees Celsius (°C).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Platelet Count)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Platelets was measured in number of platelets per liter (10^9/L).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Mean Corpuscular Hemoglobin)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Mean Corpuscular Volume)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Mean corpuscular volume was measured in femtolitres.
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Erythrocytes)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Hemoglobin)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Hemoglobin was measured in grams per liter.
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Hematocrit)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Hematocrit was measured in volume percentage (%) of red blood cells in the blood.
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)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase was measured in units per liter.
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)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes was measured in number of white blood cells per liter (10^9/L).
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)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Calcium, potassium, sodium, blood urea nitrogen, and glucose (non fasting) was measured in millimoles per liter (mmol/L).
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)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Creatinine and bilirubin was measured in micromols per liter (μmol/L).
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Total Protein)
大体时间：Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Total protein was measured in gram per liter (g/L)
Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Height
大体时间：Baseline (Week 0), Weeks 16, 124
Growth assessment, as assessed by the change from Baseline in height.
Baseline (Week 0), Weeks 16, 124
Change From Baseline in Weight
大体时间：Baseline (Week 0), Weeks 16, 124
Growth assessment, as assessed by the 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
大体时间：Week 16
Percentage of participants with PASI 90 response at Week 16 is reported. PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. This is scoring system that averages redness, thickness, and scaliness of psoriatic lesions(on a 0-4 scale), and weights resulting score by area of skin involved. Body divided into 4 areas:head, arms, trunk to groin, and legs to top of buttocks. Assignment of average score for redness, thickness, and scaling for each of 4 body areas with score of 0(none) to 4(very marked). Determining percentage of skin covered with psoriasis(PSO) for each of body areas and converting to 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved PSO area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum possible PASI score is 0=no disease, maximum score is 72=maximal disease. Data was rounded to one decimal place.
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
大体时间：Week 16
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline. The data was rounded to one decimal place.
Week 16
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 Response at Week 4
大体时间：Week 4
Percentage of participants with PASI75 response at Week 4 is reported. PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. This is scoring system that averages redness, thickness, and scaliness of psoriatic lesions (on a 0-4 scale), and weights resulting score by area of skin involved. Body divided into 4 areas:head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum possible PASI score is 0=no disease, maximum score is 72=maximal disease. Data was rounded to one decimal place.
Week 4
Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Prior to Investigational Medicinal Product (IMP) Administration
大体时间：Baseline (Week 0)
Anti-bimekizumab antibody (AbAb) detection prior to IMP administration. Anti-bimekizumab antibodies was measured using 3-tiered assay approach: screening assay, confirmatory assay, and titration assay. Antidrug antibody (ADAb) positive status: any sample that is positive screen and positive immunodepletion (regardless of availability of a titer value). ADAb negative status: any sample that is either negative screen, or positive screen and negative immunodepletion, and where the bimekizumab concentration is less than or equal to the drug tolerance limit of the validated ADAb assay. ADAb missing status: any sample that is either negative screen or positive screen and negative immunodepletion and where the bimekizumab concentration exceeds the validated ADAb assay drug tolerance limit.
Baseline (Week 0)
Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Following Investigational Medicinal Product (IMP) Administration
大体时间：From Baseline (Week 0, post-first dose) to Safety Follow-Up (Week 140)
Anti-bimekizumab antibody (AbAb) detection following IMP administration. Overall ADAb positive is defined as having at least one sample that is confirmed positive following the 1st dose of IMP to SFU (regardless of missing data). Overall ADAb negative is defined as having all samples reported as negative, or has only one missing/inconclusive sample, following the 1st dose of IMP to SFU. Overall ADAb missing if the study participant has more than one missing ADAb sample for any reason and all other available ADAb samples are negative. The data was rounded to one decimal place.
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
大体时间：Baseline, Week 16
The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week, (ie, over the last 7 days). The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol).
Baseline, Week 16

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UCB Biopharma SRL

调查人员

  • 研究主任：UCB Cares、001 844 599 2273

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月6日

初级完成 (实际的)

2025年3月12日

研究完成 (实际的)

2025年3月12日

研究注册日期

首次提交

2021年1月18日

首先提交符合 QC 标准的

2021年1月18日

首次发布 (实际的)

2021年1月22日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PS0020
  • 2020-001724-34 (EudraCT编号)
  • 2023-509832-24 (注册表标识符：EU Clinical Trials)
  • U1111-1303-1875 (其他标识符：World Health Organization (WHO))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

在产品在美国和/或欧洲获得批准或全球开发停止后六个月，以及试验完成后 18 个月，合格的研究人员可能会要求提供来自该试验的数据。 调查人员可能会要求访问匿名的个体患者数据和编辑过的试验文件，其中可能包括：分析就绪数据集、研究方案、带注释的病例报告表、统计分析计划、数据集规范和临床研究报告。 在使用数据之前，提案需要通过 www.Vivli.org 上的独立审查小组批准 并且需要执行已签署的数据共享协议。 所有文件仅提供英文版本，并在预先指定的时间内（通常为 12 个月）在受密码保护的门户网站上提供。 如果在试验完成后确定重新识别试验参与者的风险过高，则该计划可能会改变；在这种情况下，为了保护参与者，将不会提供个人患者层面的数据。

IPD 共享时间框架

在美国和/或欧洲的产品批准或全球开发停止六个月后，以及试验完成后 18 个月，合格的研究人员可能会要求获得该试验的数据。

IPD 共享访问标准

合格的研究人员可以请求访问匿名 IPD 和编辑的研究文件，其中可能包括：原始数据集、分析就绪数据集、研究协议、空白病例报告表、带注释的病例报告表、统计分析计划、数据集规范和临床研究报告。 在使用数据之前，提案需要通过 www.Vivli.org 上的独立审查小组批准 并且需要执行已签署的数据共享协议。所有文档仅提供英文版本，并在预先指定的时间内（通常为 12 个月）在受密码保护的门户网站上提供。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅