Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

14 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

270

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Nerandomilast
Médicament: Nerandomilast
Nerandomilast
Comparateur placebo: Placebo
Placebo matching nerandomilast
Médicament: Placebo
Placebo-matching nerandomilast

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Total improvement score (TIS) score (continuous) at Week 52
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Achievement of a TIS-40 response (yes/no; defined as TIS ≥40) at Week 52
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: At baseline and at Week 12.
At baseline and at Week 12.
Change from baseline in clinical-reported outcome 2 at Week 12
Délai: At baseline and at Week 12.
At baseline and at Week 12.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boehringer Ingelheim

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

9 novembre 2026

Achèvement primaire (Estimé)

21 mars 2030

Achèvement de l'étude (Estimé)

26 mars 2030

Dates d'inscription aux études

Première soumission

24 août 2026

Première soumission répondant aux critères de contrôle qualité

24 août 2026

Première publication (Réel)

27 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner