Idiopathic Inflammatory MyopathiesPhase 3VERANDA™-IIMNCT07789015
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
A Phase 3 study testing Nerandomilast in people with Idiopathic Inflammatory Myopathies, run by Boehringer Ingelheim at 158 sites in 26 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Inflammatory Myopathies
- What is being tested?
- Nerandomilast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 158 sitesin 26 countries
- Study dates
- 14 Dec 2026to 4 Apr 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Participants with overlap myositis (OM) must have IIM as the predominant disease.
- 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.
- Disease activity defined by moderate to severe myopathy.
- The participant must be on background therapy for IIM.
- 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.
- 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.
Who cannot join
- 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.
- 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.
- 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.
- Participants diagnosed with advanced interstitial lung disease (ILD).
- Severe muscle damage.
- Further exclusion criteria apply.
Trial locations and contacts
158 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
158 sites in 26 countries
United States21 sites
University of Michigan
Ann Arbor, Michigan, 48109-5314
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
University of Colorado Denver
Aurora, Colorado, 80045
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Cleveland Clinic
Cleveland, Ohio, 44195
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Helios CR, Inc - Dallas
Dallas, Texas, 75231
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Kansas University Medical Center
Fairway, Kansas, 66205
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Northwell Health
Great Neck, New York, 11021
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Nerve and Muscle Center of Texas
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
University of California Irvine
Irvine, California, 92697
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
West Tennessee Research Institute
Jackson, Tennessee, 38305
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
University of California Los Angeles
Los Angeles, California, 90095
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Paramount Medical Research and Consulting
Middleburg Heights, Ohio, 44130
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Arizona Neuromuscular Research Center
Phoenix, Arizona, 85028
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Oregon Health and Sciences University
Portland, Oregon, 97239
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
University of California San Francisco
San Francisco, California, 94115
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Mayo Clinic
Scottsdale, Arizona, 85259
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Washington University School of Medicine
St Louis, Missouri, 63110
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Japan18 sites
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, 457-8510
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
St. Marianna University Hospital
Kanagawa, Kawasaki, 216-8511
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Yokohama City University Hospital
Kanagawa, Yokohama, 236-0004
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai, 983-8512
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Nara Medical University Hospital
Nara, Kashihara, 634-8522
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Okayama University Hospital
Okayama, Okayama, 700-8558
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
The University of Osaka Hospital
Osaka, Suita, 565-0871
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8519
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Toho University Omori Medical Center
Tokyo, Ota-ku, 143-8541
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, 162-8666
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
China16 sites
China-Japan Friendship Hospital
Beijing, 100029
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Peking Union Medical College Hospital
Beijing, 100730
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Second Affiliated Hospital Chongqing Medical University
Chongqing, 400010
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Dongguan People's Hospital
Dongguan, 523059
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Guangdong Provincial People's Hospital
Guangzhou, 510080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, 510630
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Anhui Provincial Hospital
Hefei, 230001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
The Second Affiliated Hospital to Nanchang University
Nanchang, 330038
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Nanjing Drum Tower Hospital
Nanjing, 210008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Huashan Hospital, Fudan University
Shanghai, 200040
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 201112
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710061
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Germany10 sites
Auenlandklinik Bad Bramstedt GmbH
Bad Bramstedt, 24576
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Immanuel-Krankenhaus GmbH
Berlin, 13125
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Krankenhaus Porz am Rhein gGmbH
Cologne, 51149
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Universitätsklinikum Erlangen
Erlangen, 91054
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Martin-Luther-Universität Halle-Wittenberg
Halle, 06120
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Universitätsklinikum Jena
Jena, 07747
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
medius Kliniken gGmbH
Kirchheim unter Teck, 73230
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Universitätsklinikum Tübingen
Tübingen, 72076
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Universitätsklinikum Würzburg AÖR
Würzburg, 97080
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Argentina9 sites
Bioclinic Research
C.a.b.a, C1426BOD
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Centro Argentino de Investigacion (CADI)-Diagnostico Medico
CABA, C1113
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Instituto de Investigacion Clinica TyT
CABA, C1405BFN
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Instituto Medico Especializado
Capital Federal, C1405BCH
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Framingham Centro Medico
La Plata, B1902COS
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Instituto Medico CER
Quilmes, B1878DVB
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Sanatorio de la Mujer
Rosario, S2000ORE
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, 4000
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Alto Dorrego Consultorios
Villa Nueva, M5526DRW
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
France8 sites
HOP d'Angers
Angers, 49933
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
HOP Pellegrin
Bordeaux, 33076
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
HOP CHU Caen
Caen, 14000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Hôpital Edouard Herriot
Lyon, 69437
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
HOP Saint-Louis
Paris, 75010
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Hôpital de la Pitié Salpêtrière
Paris, 75013
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
HOP Civil
Strasbourg, 67091
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
United Kingdom8 sites
City Health Campus
Birmingham, B18 7QH
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Southmead Hospital
Bristol, BS10 5NB
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Doncaster Royal Infirmary
Doncaster, DN2 5LT
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Western General Hospital
Edinburgh, EH4 2XU
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Northwick Park Hospital
Harrow, HA1 3UJ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Aintree University Hospital
Liverpool, L9 7AL
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Salford Royal Hospital
Salford, M6 8HD
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
New Cross Hospital
Wolverhampton, WV10 0QP
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Mexico7 sites
Mediadvance Clinical S.A.P.I de C.V.
Chihuahua City, 31203
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Centro Integral en Reumatologia, SA. de CV.
Guadalajara, 44160
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Panamerican Clinical Research Mexico
Guadalajara, 44670
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
CIMOVA (Consultorio anexo)
León, 37000
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Medical Care & Research SA de CV
Mérida, 97070
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
Mexico City, 06700
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Hospital Clínic de Barcelona
Barcelona, 08036
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Hospital Santa Creu i Sant Pau
Barcelona, 08041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Hospital Universitario De La Princesa
Madrid, 28006
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Hospital Dr. Peset
Valencia, 46017
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Italy6 sites
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, 70124
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, 95121
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Azienda Ospedaliera di Padova
Padova, 35100
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Torino, 10126
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Brazil5 sites
Centro Mineiro de Pesquisa (CMIP)
Juiz de Fora, 36010-570
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre - RS, CEP 90020-090
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Hospital Mater Dei BA
Salvador, 40221-500
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 01246-903
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
A2Z Clinical Centro Avançado de Pesquisa Clinica
Valinhos, 13271-130
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Australia4 sites
Campbelltown Hospital
Campbelltown, New South Wales, 2560
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Austin Health
Ivanhoe, Victoria, 3079
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Perron Institute
Nedlands, Western Australia, 6009
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Wollongong Hospital
Wollongong, New South Wales, 2500
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Belgium4 sites
Universitair Ziekenhuis Gent
Ghent, 9000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Universitair Ziekenhuis Brussel
Jette, 1090
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Centre Hospitalier Universitaire de Liège
Liège, 4000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
South Korea4 sites
Chonnam National University Hospital
Gwangju, 61469
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Kyung Hee University Hospital
Seoul, 02447
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Hanyang University Medical Center
Seoul, 04763
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Chung Shan Medical University Hospital
Taichung, 402
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Taichung Veterans General Hospital
Taichung, 40705
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Taipei Veterans General Hospital
Taipei, 11217
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Thailand4 sites
Siriraj Hospital
Bangkok, 10700
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
Maharaj Nakom Chiangmai Hospital
Chiang Mai, 50200
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
Songklanagarind Hospital
Hat Yai, 90110
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
Ramathibodi Hospital
Ratchathewi, 10400
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
Bulgaria3 sites
Medical Center MedTech Services Ltd.
Haskovo, 6304
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Alexandrovska University Hospital
Sofia, 1431
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia, 1612
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Canada3 sites
University of Calgary
Calgary, Alberta, T2N 4N1
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Diex Recherche (Sherbrooke Est)
Sherbrooke, Quebec, J1E 0N8
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Gordon & Leslie Diamond Health Care Centre (UBC)
Vancouver, British Columbia, V5Z 1M9
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Poland3 sites
Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fizjoterapeuty
Bialystok, 15-707
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, 85-168
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Gornoslaskie Centrum Medyczne im prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego W Katowicach
Katowice, 40635
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Portugal3 sites
ULS da Região de Aveiro
Aveiro, 3814-501
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3004-561
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
Romania3 sites
Spitalul Clinic Dr. I. Cantacuzino
Bucharest, 020475
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
Bucharest, 020983
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Spitalul Clinic Judetean de urgenta Cluj
Cluj-Napoca, 400006
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Serbia3 sites
Institute of Rheumatology
Belgrade, 11000
Boehringer Ingelheim, 0800800636, srbija@bitrialsupport.com
Military Medical Academy
Belgrade, 11040
Boehringer Ingelheim, 0800800636, srbija@bitrialsupport.com
University Clinical Center of Kragujevac
Kragujevac, 34000
Boehringer Ingelheim, 0800800636, srbija@bitrialsupport.com
Hungary2 sites
University of Debrecen
Debrecen, 4032
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
University of Pecs
Pécs, 7634
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
Czechia1 site
Revmatologicky Ustav
Prague, 128 00
Boehringer Ingelheim, 800142046, cesko@bitrialsupport.com
Greece1 site
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, 546 42
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
Netherlands1 site
Amsterdam UMC Locatie AMC
Amsterdam, 1105 AZ
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
About this study
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)
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.
- Conditions
- Idiopathic Inflammatory Myopathies
- Being tested
- Placebo, Nerandomilast
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo-matching nerandomilast
NerandomilastDrug
Nerandomilast
| Study group | Role | What they receive |
|---|---|---|
| Nerandomilast | Experimental | Not described Receives: Drug: Nerandomilast |
| Placebo | Placebo comparator | Placebo matching nerandomilast Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total improvement score (TIS) score (continuous) 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.
Measured: At Week 52.
Secondary outcomes (12)
Achievement of a TIS-40 response (yes/no; defined as TIS ≥40) at Week 52
Number of participants with 40 TIS points or higher.
Measured: At Week 52.
Achievement of a successful tapering of oral corticosteroids (OCS) (yes/no) 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
Measured: 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)
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.
Measured: 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
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.
Measured: At baseline and at Week 52.
Change from baseline in PtGA 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.
Measured: At baseline and at Week 52.
Change from baseline in clinical-reported outcome 1 at Week 12
Measured: At baseline and at Week 12.
Change from baseline in PhGA 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.
Measured: At baseline and at Week 52.
Change from baseline in HAQ-DI 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.
Measured: At baseline and at Week 52.
Change from baseline in MMT-8 score 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.
Measured: At baseline and at Week 52.
Achievement of a TIS-60 response (yes/no; defined as TIS ≥60) at Week 52
Measured: At baseline and at Week 52.
Change from baseline in clinical-reported outcome 2 at Week 12
Measured: At baseline and at Week 12.
Change from baseline in the most abnormal baseline muscle enzymes (aldolase, CK, AST, ALT, or LDH) at Week 52
CK means creatine kinase, AST means aspartate aminotransferase, ALT means alanine aminotransferase, and LDH means lactate dehydrogenase.
Measured: At baseline and at Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start14 Dec 2026 (estimated)
- Primary completion21 Mar 2030 (estimated)
- Study completion4 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Inflammatory MyopathiesStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789015
- Sponsor's protocol ID
- 1305-0146
- Other IDs
- U1111-1338-2454, 2026-526365-24-00
- Acronym
- VERANDA™-IIM
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07789015
- Acronym / sponsor ID
- VERANDA™-IIM / 1305-0146
- Conditions
- Idiopathic Inflammatory Myopathies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2026 (estimated)
- Primary completion
- 21 Mar 2030 (estimated)
- Study completion
- 4 Apr 2030 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerandomilast | Experimental | Drug: Nerandomilast |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching nerandomilast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
- Participants with overlap myositis (OM) must have IIM as the predominant disease.
- 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.
- Disease activity defined by moderate to severe myopathy.
Key exclusion criteria (6 listed)
- 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.
- 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.
- 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.
- Participants diagnosed with advanced interstitial lung disease (ILD).
- Severe muscle damage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo-matching nerandomilast | Drug | Placebo |
| NerandomilastNerandomilast | Drug | Nerandomilast |
Primary outcome
Total improvement score (TIS) score (continuous) at Week 52
Time frame: 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.
12 secondary outcomes
Achievement of a TIS-40 response (yes/no; defined as TIS ≥40) at Week 52
Time frame: At Week 52.
Achievement of a successful tapering of oral corticosteroids (OCS) (yes/no) at Week 52
Time frame: 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)
Time frame: 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
Time frame: At baseline and at Week 52.
Change from baseline in PtGA at Week 52
Time frame: At baseline and at Week 52.
Change from baseline in clinical-reported outcome 1 at Week 12
Time frame: At baseline and at Week 12.
Change from baseline in PhGA at Week 52
Time frame: At baseline and at Week 52.
Change from baseline in HAQ-DI at Week 52
Time frame: At baseline and at Week 52.
Change from baseline in MMT-8 score at Week 52
Time frame: At baseline and at Week 52.
Achievement of a TIS-60 response (yes/no; defined as TIS ≥60) at Week 52
Time frame: At baseline and at Week 52.
Change from baseline in clinical-reported outcome 2 at Week 12
Time frame: At baseline and at Week 12.
Change from baseline in the most abnormal baseline muscle enzymes (aldolase, CK, AST, ALT, or LDH) at Week 52
Time frame: At baseline and at Week 52.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
158 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nerandomilast in people with Idiopathic Inflammatory Myopathies, run by Boehringer Ingelheim at 158 sites in 26 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 158 sites in United States, Japan, China, Germany, Argentina and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total improvement score (TIS) score (continuous) at Week 52 (time frame: At Week 52.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.