Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

14 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

270

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
      • Bad Bramstedt, Alemania, 24576
        • Auenlandklinik Bad Bramstedt GmbH
        • Contacto:
      • Berlin, Alemania, 13125
      • Cologne, Alemania, 51149
        • Krankenhaus Porz am Rhein gGmbH
        • Contacto:
      • Erlangen, Alemania, 91054
      • Freiburg im Breisgau, Alemania, 79106
      • Halle, Alemania, 06120
        • Martin-Luther-Universität Halle-Wittenberg
        • Contacto:
      • Jena, Alemania, 07747
      • Kirchheim unter Teck, Alemania, 73230
      • Tübingen, Alemania, 72076
      • Ulm, Alemania, 89081
      • Würzburg, Alemania, 97080
        • Universitätsklinikum Würzburg AÖR
        • Contacto:
  • Argentina
      • C.a.b.a, Argentina, C1426BOD
      • CABA, Argentina, C1405BFN
        • Instituto de Investigación Clínica TyT
        • Contacto:
      • CABA, Argentina, C1113
        • Centro Argentino de Investigacion (CADI)-Diagnostico Medico
        • Contacto:
      • Capital Federal, Argentina, C1405BCH
        • Instituto Medico Especializado
        • Contacto:
      • La Plata, Argentina, B1902COS
        • Framingham Centro Medico
        • Contacto:
      • Quilmes, Argentina, B1878DVB
      • Rosario, Argentina, S2000ORE
      • San Miguel de Tucumán, Argentina, 4000
        • Centro de Investigaciones Médicas Tucuman
        • Contacto:
      • Villa Nueva, Argentina, M5526DRW
        • Alto Dorrego Consultorios
        • Contacto:
  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
    • Victoria
      • Ivanhoe, Victoria, Australia, 3079
  • Brasil
      • Juiz de Fora, Brasil, 36010-570
        • Centro Mineiro de Pesquisa (CMIP)
        • Contacto:
      • Porto Alegre - RS, Brasil, CEP 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
        • Contacto:
      • Salvador, Brasil, 40221-500
        • Hospital Mater Dei BA
        • Contacto:
      • São Paulo, Brasil, 01246-903
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
        • Contacto:
      • Valinhos, Brasil, 13271-130
        • Azidus Centro de Pesquisa Clinica Avancada
        • Contacto:
  • Bulgaria
      • Haskovo, Bulgaria, 6304
        • Medical Center MedTech Services Ltd.
        • Contacto:
      • Sofia, Bulgaria, 1431
        • Alexandrovska University Hospital
        • Contacto:
      • Sofia, Bulgaria, 1612
        • University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
        • Contacto:
  • Bélgica
      • Ghent, Bélgica, 9000
        • Universitair Ziekenhuis Gent
        • Contacto:
      • Jette, Bélgica, 1090
        • Universitair Ziekenhuis Brussel
        • Contacto:
      • Leuven, Bélgica, 3000
      • Liège, Bélgica, 4000
        • Centre Hospitalier Universitaire de Liege
        • Contacto:
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4Z6
        • South Health Campus (Calgary)
        • Contacto:
    • Quebec
      • Sherbrooke, Quebec, Canadá, J1E 0N8
        • Diex Recherche (Sherbrooke Est)
        • Contacto:
  • Corea del Sur
      • Gwangju, Corea del Sur, 61469
        • Chonnam National University Hospital
        • Contacto:
      • Seoul, Corea del Sur, 03080
        • Seoul National University Hospital
        • Contacto:
      • Seoul, Corea del Sur, 02447
        • Kyung Hee University Hospital
        • Contacto:
      • Seoul, Corea del Sur, 04763
        • Hanyang University Medical Center
        • Contacto:
  • España
      • Barcelona, España, 08036
        • Hospital Clinic de Barcelona
        • Contacto:
      • Barcelona, España, 08035
        • Hospital Universitari Vall d'Hebron
        • Contacto:
      • Barcelona, España, 08041
        • Hospital Santa Creu i Sant Pau
        • Contacto:
      • Madrid, España, 28041
        • Hospital Universitario 12 de Octubre
        • Contacto:
      • Madrid, España, 28006
        • Hospital Universitario de La Princesa
        • Contacto:
      • Málaga, España, 29010
        • Hospital Universitario Virgen de la Victoria
        • Contacto:
      • Valencia, España, 46017
        • Hospital Dr. Peset
        • Contacto:
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85028
        • Arizona Neuromuscular Research Center
        • Contacto:
      • Scottsdale, Arizona, Estados Unidos, 85259
    • California
      • Irvine, California, Estados Unidos, 92697
      • Los Angeles, California, Estados Unidos, 90095
        • University of California Los Angeles
        • Contacto:
      • San Francisco, California, Estados Unidos, 94115
        • University of California San Francisco
        • Contacto:
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
    • Florida
      • Orlando, Florida, Estados Unidos, 32819
    • Kansas
      • Fairway, Kansas, Estados Unidos, 66205
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21224
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109-5314
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine
        • Contacto:
    • New York
      • Great Neck, New York, Estados Unidos, 11021
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
      • Middleburg Heights, Ohio, Estados Unidos, 44130
        • Paramount Medical Research and Consulting
        • Contacto:
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health and Sciences University
        • Contacto:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
    • Tennessee
      • Jackson, Tennessee, Estados Unidos, 38305
    • Texas
      • Dallas, Texas, Estados Unidos, 75231
      • Houston, Texas, Estados Unidos, 77030
  • Francia
      • Angers, Francia, 49933
        • HOP d'Angers
        • Contacto:
      • Bordeaux, Francia, 33076
        • HOP Pellegrin
        • Contacto:
      • Caen, Francia, 14000
        • HOP CHU Caen
        • Contacto:
      • Lyon, Francia, 69437
        • Hôpital Edouard Herriot
        • Contacto:
      • Paris, Francia, 75010
        • HOP Saint-Louis
        • Contacto:
      • Paris, Francia, 75013
        • Hôpital de la Pitié Salpêtrière
        • Contacto:
      • Strasbourg, Francia, 67091
      • Toulouse, Francia, 31059
        • Hôpital Rangueil - CHU de Toulouse
        • Contacto:
  • Grecia
      • Thessaloniki, Grecia, 546 42
        • General Hospital of Thessaloniki "Ippokrateio"
        • Contacto:
  • Hungría
      • Debrecen, Hungría, 4032
      • Pécs, Hungría, 7634
  • Italia
      • Bari, Italia, 70124
        • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
        • Contacto:
      • Catania, Italia, 95121
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
        • Contacto:
      • Padova, Italia, 35100
        • Azienda Ospedaliera di Padova
        • Contacto:
      • Pavia, Italia, 27100
        • Fondazione IRCCS Policlinico S. Matteo
        • Contacto:
      • Pisa, Italia, 56126
        • Azienda Ospedaliera Universitaria Pisana
        • Contacto:
      • Torino, Italia, 10126
        • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
        • Contacto:
  • Japón
      • Aichi, Nagoya, Japón, 457-8510
        • Japan Community Healthcare Organization Chukyo Hospital
        • Contacto:
      • Fukuoka, Kitakyushu, Japón, 807-8556
        • Hospital of the University of Occupational and Environmental Health
        • Contacto:
      • Fukushima, Fukushima, Japón, 960-1295
        • Fukushima Medical University Hospital
        • Contacto:
      • Hokkaido, Sapporo, Japón, 060-8648
        • Hokkaido University Hospital
        • Contacto:
      • Kanagawa, Kawasaki, Japón, 216-8511
        • St. Marianna University Hospital
        • Contacto:
      • Kanagawa, Yokohama, Japón, 236-0004
        • Yokohama City University Hospital
        • Contacto:
      • Kyoto, Kyoto, Japón, 606-8507
        • Kyoto University Hospital
        • Contacto:
      • Miyagi, Sendai, Japón, 983-8512
        • Tohoku Medical and Pharmaceutical University Hospital
        • Contacto:
      • Nara, Kashihara, Japón, 634-8522
        • Nara Medical University Hospital
        • Contacto:
      • Okayama, Okayama, Japón, 700-8558
        • Okayama University Hospital
        • Contacto:
      • Osaka, Suita, Japón, 565-0871
        • The University of Osaka Hospital
        • Contacto:
      • Tokyo, Bunkyo-ku, Japón, 113-8431
        • Juntendo University Hospital
        • Contacto:
      • Tokyo, Bunkyo-ku, Japón, 113-8603
        • Nippon Medical School Hospital
        • Contacto:
      • Tokyo, Bunkyo-ku, Japón, 113-8519
        • Institute of Science Tokyo Hospital
        • Contacto:
      • Tokyo, Ota-ku, Japón, 143-8541
        • Toho University Omori Medical Center
        • Contacto:
      • Tokyo, Shinjuku-ku, Japón, 160-0023
        • Tokyo Medical University Hospital
        • Contacto:
      • Tokyo, Shinjuku-ku, Japón, 162-8666
        • Tokyo Women's Medical University Hospital
        • Contacto:
      • Tokyo, Shinjuku-ku, Japón, 160-8582
        • Keio University Hospital
        • Contacto:
  • México
      • Chihuahua City, México, 31203
        • Mediadvance Clinical S.A.P.I de C.V.
        • Contacto:
      • Guadalajara, México, 44670
        • Panamerican Clinical Research Mexico
        • Contacto:
      • Guadalajara, México, 44160
        • Centro Integral en Reumatologia, SA. de CV.
        • Contacto:
      • León, México, 37000
        • CIMOVA (Consultorio anexo)
        • Contacto:
      • Mexico City, México, 14080
        • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contacto:
      • Mexico City, México, 06700
        • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
        • Contacto:
      • Mérida, México, 97070
        • Medical Care & Research SA de CV
        • Contacto:
  • Países Bajos
      • Amsterdam, Países Bajos, 1105 AZ
        • Amsterdam UMC Locatie AMC
        • Contacto:
  • Polonia
      • Bialystok, Polonia, 15-707
        • Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fizjoterapeuty
        • Contacto:
      • Bydgoszcz, Polonia, 85-168
        • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
        • Contacto:
      • Katowice, Polonia, 40635
        • Gornoslaskie Centrum Medyczne im prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego W Katowicach
        • Contacto:
  • Porcelana
      • Beijing, Porcelana, 100730
        • Peking Union Medical College Hospital
        • Contacto:
      • Beijing, Porcelana, 100029
        • China-Japan Friendship Hospital
        • Contacto:
      • Chongqing, Porcelana, 400010
        • Second Affiliated Hospital Chongqing Medical University
        • Contacto:
      • Dongguan, Porcelana, 523059
        • Dongguan People's Hospital
        • Contacto:
      • Guangzhou, Porcelana, 510080
        • Guangdong Provincial People's Hospital
        • Contacto:
      • Guangzhou, Porcelana, 510630
        • The third affiliated hospital of Sun Yat-Sen University
        • Contacto:
      • Hefei, Porcelana, 230001
        • Anhui Provincial Hospital
        • Contacto:
      • Luoyang, Porcelana, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contacto:
      • Nanchang, Porcelana, 330038
        • The Second Affiliated Hospital to Nanchang University
        • Contacto:
      • Nanjing, Porcelana, 210008
        • Nanjing Drum Tower Hospital
        • Contacto:
      • Shanghai, Porcelana, 200040
        • Huashan Hospital, Fudan University
        • Contacto:
      • Shanghai, Porcelana, 200025
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contacto:
      • Shanghai, Porcelana, 201112
        • Renji Hospital Shanghai Jiaotong University School of Medicine
        • Contacto:
      • Wenzhou, Porcelana, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contacto:
      • Wuhan, Porcelana, 430030
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • Contacto:
      • Xi'an, Porcelana, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contacto:
  • Portugal
      • Aveiro, Portugal, 3814-501
        • ULS da Região de Aveiro
        • Contacto:
      • Coimbra, Portugal, 3004-561
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
        • Contacto:
      • Lisbon, Portugal, 1649-035
        • ULS de Santa Maria, E.P.E
        • Contacto:
  • Rumania
      • Bucharest, Rumania, 020475
        • Spitalul Clinic Dr. I. Cantacuzino
        • Contacto:
      • Bucharest, Rumania, 020983
        • Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
        • Contacto:
      • Cluj-Napoca, Rumania, 400006
        • Spitalul Clinic Judetean de urgenta Cluj
        • Contacto:
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Rheumatology
        • Contacto:
      • Belgrade, Serbia, 11040
        • Military Medical Academy
        • Contacto:
      • Kragujevac, Serbia, 34000
        • University Clinical Center of Kragujevac
        • Contacto:
  • Tailandia
      • Bangkok, Tailandia, 10700
        • Siriraj Hospital
        • Contacto:
      • Chiang Mai, Tailandia, 50200
        • Maharaj Nakom Chiangmai Hospital
        • Contacto:
      • Hat Yai, Tailandia, 90110
        • Songklanagarind Hospital
        • Contacto:
      • Ratchathewi, Tailandia, 10400
        • Ramathibodi Hospital
        • Contacto:
  • Taiwán
      • Kaohsiung City, Taiwán, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contacto:
      • Taichung, Taiwán, 40705
        • Taichung Veterans General Hospital
        • Contacto:
      • Taichung, Taiwán, 402
        • Chung Shan Medical University Hospital
        • Contacto:
      • Taipei, Taiwán, 11217
        • Taipei Veterans General Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Nerandomast
Droga: Nerandomast
Nerandomast
Comparador de placebos: Placebo
Placebo matching nerandomilast
Droga: Placebo
Placebo-matching nerandomilast

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total improvement score (TIS) score (continuous) at Week 52
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Achievement of a TIS-40 response (yes/no; defined as TIS ≥40) at Week 52
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At baseline and at Week 12.
At baseline and at Week 12.
Change from baseline in clinical-reported outcome 2 at Week 12
Periodo de tiempo: At baseline and at Week 12.
At baseline and at Week 12.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

9 de noviembre de 2026

Finalización primaria (Estimado)

21 de marzo de 2030

Finalización del estudio (Estimado)

26 de marzo de 2030

Fechas de registro del estudio

Enviado por primera vez

24 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de agosto de 2026

Publicado por primera vez (Actual)

27 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir