이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 9월 14일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

270

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Nerandomilast
의약품: Nerandomilast
Nerandomilast
위약 비교기: Placebo
Placebo matching nerandomilast
의약품: Placebo
Placebo-matching nerandomilast

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Total improvement score (TIS) score (continuous) at Week 52
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Achievement of a TIS-40 response (yes/no; defined as TIS ≥40) at Week 52
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: At baseline and at Week 12.
At baseline and at Week 12.
Change from baseline in clinical-reported outcome 2 at Week 12
기간: At baseline and at Week 12.
At baseline and at Week 12.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 9일

기본 완료 (추정된)

2030년 3월 21일

연구 완료 (추정된)

2030년 3월 26일

연구 등록 날짜

최초 제출

2026년 8월 24일

QC 기준을 충족하는 최초 제출

2026년 8월 24일

처음 게시됨 (실제)

2026년 8월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 14일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1305-0146
  • U1111-1338-2454 (레지스트리 식별자: WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-526365-24-00 (레지스트리 식별자: CTIS)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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