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A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
Sponsor: Boehringer Ingelheim
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2026-12-14
Completion Date
2030-04-04
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo-matching nerandomilast
Nerandomilast
Nerandomilast
Locations (158)
Arizona Neuromuscular Research Center
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
University of California Irvine
Irvine, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Kansas University Medical Center
Fairway, Kansas, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Northwell Health
Great Neck, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Paramount Medical Research and Consulting
Middleburg Heights, Ohio, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Helios CR, Inc - Dallas
Dallas, Texas, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
Bioclinic Research
C.a.b.a, Argentina
Centro Argentino de Investigacion (CADI)-Diagnostico Medico
CABA, Argentina
Instituto de Investigacion Clinica TyT
CABA, Argentina
Instituto Medico Especializado
Capital Federal, Argentina
Framingham Centro Medico
La Plata, Argentina
Instituto Medico CER
Quilmes, Argentina
Sanatorio de la Mujer
Rosario, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
Alto Dorrego Consultorios
Villa Nueva, Argentina
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Austin Health
Ivanhoe, Victoria, Australia
Perron Institute
Nedlands, Western Australia, Australia
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitair Ziekenhuis Brussel
Jette, Belgium
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Centro Mineiro de Pesquisa (CMIP)
Juiz de Fora, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre - RS, Brazil
Hospital Mater Dei BA
Salvador, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, Brazil
A2Z Clinical Centro Avançado de Pesquisa Clinica
Valinhos, Brazil
Medical Center MedTech Services Ltd.
Haskovo, Bulgaria
Alexandrovska University Hospital
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia, Bulgaria
University of Calgary
Calgary, Alberta, Canada
Gordon & Leslie Diamond Health Care Centre (UBC)
Vancouver, British Columbia, Canada
Diex Recherche (Sherbrooke Est)
Sherbrooke, Quebec, Canada
China-Japan Friendship Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Second Affiliated Hospital Chongqing Medical University
Chongqing, China
Dongguan People's Hospital
Dongguan, China
Guangdong Provincial People's Hospital
Guangzhou, China
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, China
Anhui Provincial Hospital
Hefei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
The Second Affiliated Hospital to Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital
Nanjing, China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
Huashan Hospital, Fudan University
Shanghai, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, China
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, China
Revmatologicky Ustav
Prague, Czechia
HOP d'Angers
Angers, France
HOP Pellegrin
Bordeaux, France
HOP CHU Caen
Caen, France
Hôpital Edouard Herriot
Lyon, France
HOP Saint-Louis
Paris, France
Hôpital de la Pitié Salpêtrière
Paris, France
HOP Civil
Strasbourg, France
Hôpital Rangueil - CHU de Toulouse
Toulouse, France
Auenlandklinik Bad Bramstedt GmbH
Bad Bramstedt, Germany
Immanuel-Krankenhaus GmbH
Berlin, Germany
Krankenhaus Porz am Rhein gGmbH
Cologne, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
Universitätsklinikum Jena
Jena, Germany
medius Kliniken gGmbH
Kirchheim unter Teck, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, Germany
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, Greece
University of Debrecen
Debrecen, Hungary
University of Pecs
Pécs, Hungary
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, Italy
Azienda Ospedaliera di Padova
Padova, Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Torino, Italy
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, Japan
Yokohama City University Hospital
Kanagawa, Yokohama, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan