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

14. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

270

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Nerandomilast
Legemiddel: Nerandomilast
Nerandomilast
Placebo komparator: Placebo
Placebo matching nerandomilast
Legemiddel: Placebo
Placebo-matching nerandomilast

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total improvement score (TIS) score (continuous) at Week 52
Tidsramme: 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.

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

9. november 2026

Primær fullføring (Antatt)

21. mars 2030

Studiet fullført (Antatt)

26. mars 2030

Datoer for studieregistrering

Først innsendt

24. august 2026

Først innsendt som oppfylte QC-kriteriene

24. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere