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A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies (VERANDA™-IIM)

2026年9月14日 更新者：Boehringer Ingelheim

A Phase III, Parallel Design, Double-blind, Randomised, Placebo-controlled, Multi-centre Trial to Evaluate the Efficacy and Safety of Nerandomilast Oral Therapy Added to Standard Background Therapy Over 52 Weeks in Adult Trial Participants With Active Idiopathic Inflammatory Myopathies (VERANDA™-IIM)

This study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis. The purpose of this study is to find out whether a medicine called nerandomilast improves IIM symptoms.

Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take nerandomilast or placebo twice a day for 1 year.

Participants are in the study for about 1 year and 2 months. During this time, they visit the study site at least 16 times. During this time, doctors regularly check the participant's health, IIM symptoms, and take note of any unwanted effects. Participants fill in questionnaires about their IIM symptoms and how IIM impacts their quality of life. The results are compared between the 2 groups to see whether the treatment works.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

270

阶段

  • 第三阶段

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。

学习联系方式

学习地点

  • 中国
      • Beijing、中国、100730
        • Peking Union Medical College Hospital
        • 接触：
      • Beijing、中国、100029
        • China-Japan Friendship Hospital
        • 接触：
      • Chongqing、中国、400010
        • Second Affiliated Hospital Chongqing Medical University
        • 接触：
      • Dongguan、中国、523059
      • Guangzhou、中国、510080
        • Guangdong Provincial People's Hospital
        • 接触：
      • Guangzhou、中国、510630
        • The third affiliated hospital of Sun Yat-Sen University
        • 接触：
      • Hefei、中国、230001
      • Luoyang、中国、471003
        • The First Affiliated Hospital of Henan University of Science and Technology
        • 接触：
      • Nanchang、中国、330038
        • The Second Affiliated Hospital to Nanchang University
        • 接触：
      • Nanjing、中国、210008
        • Nanjing Drum Tower Hospital
        • 接触：
      • Shanghai、中国、200040
        • Huashan Hospital, Fudan University
        • 接触：
      • Shanghai、中国、200025
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • 接触：
      • Shanghai、中国、201112
        • Renji Hospital Shanghai Jiaotong University School of Medicine
        • 接触：
      • Wenzhou、中国、325000
        • The First Affiliated Hospital of Wenzhou Medical University
        • 接触：
      • Wuhan、中国、430030
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • 接触：
      • Xi'an、中国、710061
        • First Affiliated Hospital of Xi'an JiaoTong University
        • 接触：
  • 保加利亚
      • Haskovo、保加利亚、6304
      • Sofia、保加利亚、1431
      • Sofia、保加利亚、1612
        • University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
        • 接触：
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4Z6
    • Quebec
      • Sherbrooke、Quebec、加拿大、J1E 0N8
        • Diex Recherche (Sherbrooke Est)
        • 接触：
  • 匈牙利
  • 台湾
      • Kaohsiung City、台湾、80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • 接触：
      • Taichung、台湾、40705
        • Taichung Veterans General Hospital
        • 接触：
      • Taichung、台湾、402
        • Chung Shan Medical University Hospital
        • 接触：
      • Taipei、台湾、11217
        • Taipei Veterans General Hospital
        • 接触：
  • 塞尔维亚
      • Belgrade、塞尔维亚、11000
      • Belgrade、塞尔维亚、11040
      • Kragujevac、塞尔维亚、34000
        • University Clinical Center of Kragujevac
        • 接触：
  • 墨西哥
      • Chihuahua City、墨西哥、31203
        • Mediadvance Clinical S.A.P.I de C.V.
        • 接触：
      • Guadalajara、墨西哥、44670
        • Panamerican Clinical Research Mexico
        • 接触：
      • Guadalajara、墨西哥、44160
        • Centro Integral en Reumatologia, SA. de CV.
        • 接触：
      • León、墨西哥、37000
      • Mexico City、墨西哥、14080
        • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
        • 接触：
      • Mexico City、墨西哥、06700
        • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
        • 接触：
      • Mérida、墨西哥、97070
        • Medical Care & Research SA de CV
        • 接触：
  • 巴西
      • Juiz de Fora、巴西、36010-570
        • Centro Mineiro de Pesquisa (CMIP)
        • 接触：
      • Porto Alegre - RS、巴西、CEP 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
        • 接触：
      • Salvador、巴西、40221-500
      • São Paulo、巴西、01246-903
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
        • 接触：
      • Valinhos、巴西、13271-130
        • Azidus Centro de Pesquisa Clinica Avancada
        • 接触：
  • 希腊
      • Thessaloniki、希腊、546 42
        • General Hospital of Thessaloniki "Ippokrateio"
        • 接触：
  • 德国
      • Bad Bramstedt、德国、24576
      • Berlin、德国、13125
      • Cologne、德国、51149
      • Erlangen、德国、91054
      • Freiburg im Breisgau、德国、79106
      • Halle、德国、06120
      • Jena、德国、07747
      • Kirchheim unter Teck、德国、73230
      • Tübingen、德国、72076
      • Ulm、德国、89081
      • Würzburg、德国、97080
  • 意大利
      • Bari、意大利、70124
        • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
        • 接触：
      • Catania、意大利、95121
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
        • 接触：
      • Padova、意大利、35100
      • Pavia、意大利、27100
        • Fondazione IRCCS Policlinico S. Matteo
        • 接触：
      • Pisa、意大利、56126
        • Azienda Ospedaliera Universitaria Pisana
        • 接触：
      • Torino、意大利、10126
        • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
        • 接触：
  • 日本
      • Aichi, Nagoya、日本、457-8510
        • Japan Community Healthcare Organization Chukyo Hospital
        • 接触：
      • Fukuoka, Kitakyushu、日本、807-8556
        • Hospital of the University of Occupational and Environmental Health
        • 接触：
      • Fukushima, Fukushima、日本、960-1295
        • Fukushima Medical University Hospital
        • 接触：
      • Hokkaido, Sapporo、日本、060-8648
      • Kanagawa, Kawasaki、日本、216-8511
        • St. Marianna University Hospital
        • 接触：
      • Kanagawa, Yokohama、日本、236-0004
        • Yokohama City University Hospital
        • 接触：
      • Kyoto, Kyoto、日本、606-8507
      • Miyagi, Sendai、日本、983-8512
        • Tohoku Medical and Pharmaceutical University Hospital
        • 接触：
      • Nara, Kashihara、日本、634-8522
        • Nara Medical University Hospital
        • 接触：
      • Okayama, Okayama、日本、700-8558
      • Osaka, Suita、日本、565-0871
        • The University of Osaka Hospital
        • 接触：
      • Tokyo, Bunkyo-ku、日本、113-8431
      • Tokyo, Bunkyo-ku、日本、113-8603
        • Nippon Medical School Hospital
        • 接触：
      • Tokyo, Bunkyo-ku、日本、113-8519
        • Institute of Science Tokyo Hospital
        • 接触：
      • Tokyo, Ota-ku、日本、143-8541
        • Toho University Omori Medical Center
        • 接触：
      • Tokyo, Shinjuku-ku、日本、160-0023
        • Tokyo Medical University Hospital
        • 接触：
      • Tokyo, Shinjuku-ku、日本、162-8666
        • Tokyo Women's Medical University Hospital
        • 接触：
      • Tokyo, Shinjuku-ku、日本、160-8582
  • 比利时
      • Ghent、比利时、9000
      • Jette、比利时、1090
      • Leuven、比利时、3000
      • Liège、比利时、4000
        • Centre Hospitalier Universitaire de Liege
        • 接触：
  • 法国
      • Angers、法国、49933
      • Bordeaux、法国、33076
      • Caen、法国、14000
      • Lyon、法国、69437
      • Paris、法国、75010
      • Paris、法国、75013
        • Hôpital de la Pitié Salpêtrière
        • 接触：
      • Strasbourg、法国、67091
      • Toulouse、法国、31059
        • Hôpital Rangueil - CHU de Toulouse
        • 接触：
  • 波兰
      • Bialystok、波兰、15-707
        • Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fizjoterapeuty
        • 接触：
      • Bydgoszcz、波兰、85-168
        • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
        • 接触：
      • Katowice、波兰、40635
        • Gornoslaskie Centrum Medyczne im prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego W Katowicach
        • 接触：
  • 泰国
      • Bangkok、泰国、10700
      • Chiang Mai、泰国、50200
        • Maharaj Nakom Chiangmai Hospital
        • 接触：
      • Hat Yai、泰国、90110
        • Songklanagarind Hospital
        • 接触：
      • Ratchathewi、泰国、10400
  • 澳大利亚
    • New South Wales
      • Wollongong、New South Wales、澳大利亚、2500
    • Victoria
      • Ivanhoe、Victoria、澳大利亚、3079
  • 罗马尼亚
      • Bucharest、罗马尼亚、020475
      • Bucharest、罗马尼亚、020983
        • Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
        • 接触：
      • Cluj-Napoca、罗马尼亚、400006
        • Spitalul Clinic Judetean de urgenta Cluj
        • 接触：
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85028
      • Scottsdale、Arizona、美国、85259
    • California
      • Irvine、California、美国、92697
      • Los Angeles、California、美国、90095
      • San Francisco、California、美国、94115
    • Colorado
      • Aurora、Colorado、美国、80045
    • Florida
      • Orlando、Florida、美国、32819
    • Kansas
      • Fairway、Kansas、美国、66205
    • Maryland
      • Baltimore、Maryland、美国、21224
    • Massachusetts
      • Boston、Massachusetts、美国、02115
    • Michigan
      • Ann Arbor、Michigan、美国、48109-5314
    • Minnesota
      • Rochester、Minnesota、美国、55905
    • Missouri
      • St Louis、Missouri、美国、63110
    • New York
      • Great Neck、New York、美国、11021
    • Ohio
      • Cleveland、Ohio、美国、44195
      • Middleburg Heights、Ohio、美国、44130
    • Oregon
      • Portland、Oregon、美国、97239
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
    • Tennessee
      • Jackson、Tennessee、美国、38305
    • Texas
      • Dallas、Texas、美国、75231
      • Houston、Texas、美国、77030
  • 荷兰
      • Amsterdam、荷兰、1105 AZ
  • 葡萄牙
      • Aveiro、葡萄牙、3814-501
      • Coimbra、葡萄牙、3004-561
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
        • 接触：
      • Lisbon、葡萄牙、1649-035
  • 西班牙
      • Barcelona、西班牙、08036
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron
        • 接触：
      • Barcelona、西班牙、08041
      • Madrid、西班牙、28041
        • Hospital Universitario 12 de Octubre
        • 接触：
      • Madrid、西班牙、28006
        • Hospital Universitario de La Princesa
        • 接触：
      • Málaga、西班牙、29010
        • Hospital Universitario Virgen de la Victoria
        • 接触：
      • Valencia、西班牙、46017
  • 阿根廷
      • C.a.b.a、阿根廷、C1426BOD
      • CABA、阿根廷、C1405BFN
      • CABA、阿根廷、C1113
        • Centro Argentino de Investigacion (CADI)-Diagnostico Medico
        • 接触：
      • Capital Federal、阿根廷、C1405BCH
      • La Plata、阿根廷、B1902COS
      • Quilmes、阿根廷、B1878DVB
      • Rosario、阿根廷、S2000ORE
      • San Miguel de Tucumán、阿根廷、4000
        • Centro de Investigaciones Médicas Tucuman
        • 接触：
      • Villa Nueva、阿根廷、M5526DRW
  • 韩国
      • Gwangju、韩国、61469
        • Chonnam National University Hospital
        • 接触：
      • Seoul、韩国、03080
        • Seoul National University Hospital
        • 接触：
      • Seoul、韩国、02447
      • Seoul、韩国、04763
        • Hanyang University Medical Center
        • 接触：

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion criteria:

  1. Male or female adult individuals from ≥18 years of age (or alternative age for adults based on local regulations) on the date of signing the informed consent.
  2. A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 American college of rheumatology (ACR)/European alliance of associations of rheumatology (EULAR) classification criteria.
  3. Participants with overlap myositis (OM) must have IIM as the predominant disease.
  4. Participants ≥18 years of age (or alternative age for adults based on local regulations) with juvenile dermatomyositis (JDM) can only be included if they were 15 years old or older at first onset of DM symptoms.
  5. Disease activity defined by moderate to severe myopathy.
  6. The participant must be on background therapy for IIM.
  7. Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control for a period of 28 days before treatment initiation, throughout the trial, and for a period of at least 5 days after the last dose of investigational medicinal product (IMP). WOCBP taking oral contraceptives also have to use one barrier method.
  8. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 9. Further inclusion criteria apply.

Exclusion criteria:

  1. Major surgery (major according to the investigator's assessment, e.g. hip replacement) performed within 6 weeks prior to randomisation or planned during the trial period.
  2. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
  3. Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  4. Participants diagnosed with advanced interstitial lung disease (ILD).
  5. Severe muscle damage.
  6. Further exclusion criteria apply.

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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Nerandomilast
药品：Nerandomilast
Nerandomilast
安慰剂比较：Placebo
Placebo matching nerandomilast
药品：Placebo
Placebo-matching nerandomilast

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
Total improvement score (TIS) score (continuous) at Week 52
大体时间：At Week 52.
The TIS composite score includes 6 core set measures: manual muscle testing (MMT8), extra-muscular disease activity (MDAAT), patient global disease activity (PtGA), physician global disease activity (PhGA), health assessment questionnaire disability index (HAQ-DI), and muscle enzymes. An improvement score for each core set measure will be assigned using the absolute percent change, based on predetermined ranges. The TIS will be the sum of the all core set measure, scoring from 0 to 100, with higher scores corresponding to a greater degree of improvement.
At Week 52.

次要结果测量

结果测量
措施说明
大体时间
Achievement of a TIS-40 response (yes/no; defined as TIS ≥40) at Week 52
大体时间：At Week 52.
Number of participants with 40 TIS points or higher.
At Week 52.
Achievement of a successful tapering of oral corticosteroids (OCS) (yes/no) at Week 52
大体时间：At Week 52.
Number of participants achieving a TIS-40 response at Week 52 and ≤5 mg/day of prednisone (or equivalent) at Week 52
At Week 52.
Change from baseline in cutaneous dermatomyositis disease area and severity index activity score (CDASI-A) at Week 52 (in participants with baseline CDASI-A ≥6)
大体时间：At baseline and at Week 52.
The Cutaneous Dermatomyositis Disease Area and Severity Index activity score (CDASI-A) is a questionnaire assessing skin disease activity and damage in patients with dermatomyositis (DM). It ranges from 0 to 100, with higher values indicating more severe active skin involvement.
At baseline and at Week 52.
Change from baseline in extra-muscular disease activity as per myositis disease activity assessment tool (MDAAT) at Week 52
大体时间：At baseline and at Week 52.
Myositis Disease Activity Assessment Tool (MDAAT) is a questionnaire assessing the disease activity of extra-muscular organ systems and muscle in participants with IIM. It is a combined tool with two parallel scores: the MYOACT VAS and the MITAX. The Myositis disease activity assessment (MYOACT) visual analogue scale (VAS) scores the overall severity of disease activity. The sum of the individual scores ranges from 0 to 70, The higher the more severe. For the Myositis Intention-to-Treat Activity Index (MITAX), each question is answered with either: 0 = not present; 1 = improving; 2 = the same; 3 = worse; 4 = new. The summed scores are summed to obtain a total MITAX score with a range of 0 to 63, the higher the more severe.
At baseline and at Week 52.
Change from baseline in PtGA at Week 52
大体时间：At baseline and at Week 52.
Patient global disease activity (PtGA) measures the participant's self-assessment of the disease. It is composed of a 100 mm visual analogue scale. Patients will mark their assessment between "extremely poor" (0) and "excellent" (100). The difference between 0 (extremely poor) and the patient assessment is the PtGA, where higher distances indicate a better health status.
At baseline and at Week 52.
Change from baseline in PhGA at Week 52
大体时间：At baseline and at Week 52.
Physician global activity (PhGA) captures the physician's assessment of the participant's overall health. It is composed of a 100 mm visual analogue scale. Physicians will mark their assessment between "extremely poor" (0) and "excellent" (100). The difference between 0 (extremely poor) and the physician assessment is the PhGA, where higher distances indicate a better health status.
At baseline and at Week 52.
Change from baseline in HAQ-DI at Week 52
大体时间：At baseline and at Week 52.
The health assessment questionnaire disability index (HAQ-DI) assesses difficulties in performing activities of daily living across 8 domains. Each domain is rated on a scale of 0-3. The higher the score, the higher the disability.
At baseline and at Week 52.
Change from baseline in MMT-8 score at Week 52
大体时间：At baseline and at Week 52.
Manual Muscle Testing (MMT-8) assesses the muscle strength of 8 proximal, distal, and axial muscle groups. Each item is rated from 0 to 10, with the total score ranging from 0 to 150, where higher scores mean better muscle strength condition.
At baseline and at Week 52.
Achievement of a TIS-60 response (yes/no; defined as TIS ≥60) at Week 52
大体时间：At baseline and at Week 52.
At baseline and at Week 52.
Change from baseline in the most abnormal baseline muscle enzymes (aldolase, CK, AST, ALT, or LDH) at Week 52
大体时间：At baseline and at Week 52.
CK means creatine kinase, AST means aspartate aminotransferase, ALT means alanine aminotransferase, and LDH means lactate dehydrogenase.
At baseline and at Week 52.
Change from baseline in clinical-reported outcome 1 at Week 12
大体时间：At baseline and at Week 12.
At baseline and at Week 12.
Change from baseline in clinical-reported outcome 2 at Week 12
大体时间：At baseline and at Week 12.
At baseline and at 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

Boehringer Ingelheim

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。

有用的网址

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 (估计的)

2026年11月9日

初级完成 (估计的)

2030年3月21日

研究完成 (估计的)

2030年3月26日

研究注册日期

首次提交

2026年8月24日

首先提交符合 QC 标准的

2026年8月24日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1305-0146
  • U1111-1338-2454 (注册表标识符：WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-526365-24-00 (注册表标识符：CTIS)

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

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

IPD 共享时间框架

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD 共享访问标准

For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

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

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