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Sonelokimab 治疗活动性银屑病关节炎患者的评价

2026年8月17日 更新者：MoonLake Immunotherapeutics AG

Sonelokimab 在活动性银屑病关节炎患者中的第 2 期、随机、平行组、双盲、安慰剂对照研究

这项研究旨在证明皮下 (sc) 纳米抗体® sonelokimab 与安慰剂相比在治疗患有活动性银屑病关节炎的成年参与者中的临床疗效和安全性。 该研究包括阿达木单抗治疗作为主动参考组。

研究概览

地位

完全的

条件

干预/治疗

详细说明

患者将随机接受三种 sonelokimab 治疗方案、阿达木单抗或安慰剂中的一种。 主要疗效评估将在第 12 周进行。根据第 12 周的反应评估，患者将被分配到另外 12 周的 sonelokimab 或阿达木单抗治疗。 在某些国家/地区，治疗将在第 12 周结束。

研究类型

介入性

注册 (实际的)

207

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

  • 保加利亚
      • Pleven、保加利亚、5800
        • Clinical Site
      • Pleven、保加利亚、5803
        • Clinical Site
      • Plovdiv、保加利亚、4002
        • Clinical Site
      • Plovdiv、保加利亚、4003
        • Clinical Site
      • Rousse、保加利亚、7002
        • Clinical Site
      • Sofia、保加利亚、1336
        • Clinical Site
      • Stara Zagora、保加利亚、6000
        • Clinical Site
      • Varna、保加利亚、9000
        • Clinical Site
  • 匈牙利
      • Budapest、匈牙利、1023
        • Clinical Site
      • Budapest、匈牙利、1027
        • Clinical Site
      • Budapest、匈牙利、1036
        • Clinical Site
      • Szentes、匈牙利、6600
        • Clinical Site
      • Székesfehérvár、匈牙利、8000
        • Clinical Site
      • Veszprém、匈牙利、8200
        • Clinical Site
  • 德国
      • Hamburg、德国、20095
        • Clinical Site
      • Herne、德国、44649
        • Clinical Site
  • 捷克语
      • Ostrava、捷克语、702 00
        • Clinical Site
  • 波兰
      • Bialystok、波兰、15-879
        • Clinical Site
      • Bialystok、波兰、15-077
        • Clinical Site
      • Bialystok、波兰、15-351
        • Clinical Site
      • Bydgoszcz、波兰、85-065
        • Clinical Site
      • Bydgoszcz、波兰、85-168
        • Clinical Site
      • Elblag、波兰、82-300
        • Clinical Site
      • Gdynia、波兰、81-338
        • Clinical Site
      • Krakow、波兰、30-727
        • Clinical Site
      • Lodz、波兰、90-242
        • Clinical Site
      • Nadarzyn、波兰、05-830
        • Clinical Site
      • Nowa Sól、波兰、67-100
        • Clinical Site
      • Olsztyn、波兰、10-117
        • Clinical Site
      • Poznan、波兰、61-113
        • Clinical Site
      • Sochaczew、波兰、96-500
        • Clinical Site
      • Swidnica、波兰、58-100
        • Clinical Site
      • Warsaw、波兰、02-665
        • Clinical Site
      • Wroclaw、波兰、52-416
        • Clinical Site
  • 爱沙尼亚
      • Tallinn、爱沙尼亚、10128
        • Clinical Site
      • Tartu、爱沙尼亚、20708
        • Clinical Site
  • 美国
    • California
      • Rancho Mirage、California、美国、92260
        • Clinical Site
    • Pennsylvania
      • Duncansville、Pennsylvania、美国、16635
        • Clinical Site
  • 西班牙
      • Madrid、西班牙、28100
        • Clinical Site
      • Sabadell、西班牙、8208
        • Clinical Site
      • Santiago de Compostela、西班牙、15702
        • Clinical Site
      • Seville、西班牙、41010
        • Clinical Site

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 参与者年满 18 岁；
  2. 参与者根据 2006 年银屑病关节炎分类标准 (CASPAR) 确诊为 PsA，且在筛选访视前症状持续 ≥ 6 个月；
  3. 参与者患有活动性疾病（定义为 TJC68 ≥3 和 SJC66 ≥3）；
  4. 参与者目前有活动性 PsO 或皮肤科医生确认有 PsO 病史；
  5. 参与者在筛选访视时类风湿因子 (RF) 测试呈阴性；
  6. 参与者在筛选访视时抗环瓜氨酸肽 (CCP) 抗体测试呈阴性；
  7. 根据经批准的当地产品信息，研究者认为参与者必须是阿达木单抗治疗的合适人选。

排除标准：

  1. 已知对 sonelokimab 或其任何赋形剂过敏的参与者；
  2. 已知对阿达木单抗或其任何赋形剂过敏的参与者；
  3. 先前抗白细胞介素 (IL)-17 治疗失败的参与者；
  4. 先前抗肿瘤坏死因子α (TNFα) 治疗失败的参与者；
  5. 在筛选访问之前曾接触过超过 2 种任何类型的生物制剂以治疗 PsA 的参与者；
  6. 被诊断患有 PsO 或 PsA 以外的慢性炎症的参与者；
  7. 诊断为关节炎 mutilans 的参与者

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：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：sonelokimab 给药方案 1
随机分配到该组的受试者将接受分配的 sonelokimab 剂量方案 1
药品：索奈洛基单抗
随机化治疗；平行组
其他名称：
  • M1095
实验性的：sonelokimab 剂量方案 2
随机分配到该组的受试者将接受分配的 sonelokimab 剂量方案 2
药品：索奈洛基单抗
随机化治疗；平行组
其他名称：
  • M1095
实验性的：sonelokimab 给药方案 3
随机分配到该组的受试者将接受分配的 sonelokimab 剂量方案 3
药品：索奈洛基单抗
随机化治疗；平行组
其他名称：
  • M1095
安慰剂比较：安慰剂
随机分配到该组的受试者将接受安慰剂
药品：安慰剂
随机化治疗；平行组
有源比较器：阿达木单抗
随机分配到该组的受试者将接受阿达木单抗
药品：阿达木单抗
随机化治疗；平行组

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
Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
大体时间：At Week 12
The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) participant's assessment of arthritis pain (PtAAP) on a Visual Analog Scale (VAS, no pain =0 to severe pain =100); 2) participant's global assessment of disease activity (PtGADA) on a VAS (very well =0 to very poor =100); 3) physician's global assessment of disease activity (phGADA) on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) high sensitivity C-reactive protein (hs-CRP, decrease indicates improvement). A non-responder imputation (NRI) method was used for missing data.
At Week 12

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, and 8 and 12
大体时间：At Weeks 2, 4, 8, and 12
The ACR20 response criteria was a response of at least 20% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 20% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data. ACR20 response rate at Week 12 was analyzed as a key secondary outcome measure.
At Weeks 2, 4, 8, and 12
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 4, 8 and 12, in Participants With Psoriasis Involving at Least 3% Body Surface Area (BSA) at Baseline
大体时间：At Weeks 4, 8, and 12
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI90 response was defined as greater than or equal to 90% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data. PASI90 response at Week 12 was analyzed as a key secondary outcome measure.
At Weeks 4, 8, and 12
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, and 8
大体时间：At Weeks 2, 4, and 8
The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data.
At Weeks 2, 4, and 8
Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 2, 4, 8, and 12
大体时间：At Weeks 2, 4, 8, and 12
The ACR70 response criteria was a response of at least 70% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 70% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data.
At Weeks 2, 4, 8, and 12
Percentage of Participants Achieving Minimal Disease Activity at Week 12
大体时间：At Week 12
Minimal disease activity was defined as meeting 5 of the following 7 criteria: tender joint count (68 joints) ≤1; swollen joint count (66 joints) ≤1; psoriasis area and severity index ≤1 or psoriasis affecting ≤1% of body surface area; PtAAP ≤15 on a VAS (0 = no pain to 100 = severe pain); PtGADA ≤20 on a VAS (0 = very well to 100 = very poor); HAQ-DI ≤0.5 (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and Leeds Enthesitis Index (LEI) ≤1 (overall score ranging from 0 to 6, with higher scores indicating greater disease severity). An NRI method was used for missing data.
At Week 12
Percentage of Participants Who Achieved a PASI75 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
大体时间：At Week 12
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI75 response was defined as greater than or 75% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data.
At Week 12
Percentage of Participants Achieving a PASI100 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
大体时间：At Week 12
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI100 response was defined as 100% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data.
At Week 12
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 12
大体时间：Baseline and Week 12
The mNAPSI is a tool to assess psoriatic nail involvement. Three groups of features (pitting, onycholysis, and oil-drop dyshromia and crumbling) for each fingernail are graded on a scale from 0 to 3. Four features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula) are graded as either present (1) or absent (0) in each fingernail. The total score was calculated by summing the score for each feature and each fingernail and ranged from 0 to 130, with higher scores indicating greater nail disease. A negative change from baseline indicated an improvement in nail disease.
Baseline and Week 12

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

MoonLake Immunotherapeutics AG

调查人员

  • 研究主任：MD、MoonLake Immunotherapeutics AG

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2022年12月13日

初级完成 (实际的)

2023年9月5日

研究完成 (实际的)

2024年1月15日

研究注册日期

首次提交

2022年11月28日

首先提交符合 QC 标准的

2022年11月28日

首次发布 (实际的)

2022年12月7日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8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

  • M1095-PSA-201

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

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.

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