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NCT07789015

PHASE3

A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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

2026-11-09

Completion Date

2030-03-26

Last Updated

2026-08-27

Healthy Volunteers

Conditions

Idiopathic Inflammatory Myopathies

Interventions

DRUG

Placebo

Placebo-matching nerandomilast

DRUG

Nerandomilast

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. For participants diagnosed with DM Disease activity defined by moderate to severe myopathy with manual muscle testing-8 (MMT-8) of ≥80 and ≤142/150 and cutaneous dermatomyositis disease area and severity index activity score (CDASI-A) ≥6 at screening and baseline and at least 2 of the following core set measures (CSM) abnormalities at screening: * Patient global assessment (PtGA) ≥2 cm * Physician global activity (PhGA) derived from myositis disease activity assessment tool (MDAAT) ≥2 cm * Extramuscular disease activity as per MDAAT ≥2 cm * At least 1 muscle enzyme (aldolase, creatine kinase (CK), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or lactate dehydrogenase (LDH)) ≥1.5× upper limit of normal (ULN), * Health assessment questionnaire-disability index (HAQ-DI) ≥0.25. 6. For participants diagnosed with anti-synthetase syndrome (ASyS)\* and OM\*: 1. Active disease based on at least 1 of the following criteria: * CK ≥4× ULN at screening * Muscle biopsy indicative of active IIM within up to 6 months prior to screening * Evidence of active myositis by electromyography (EMG) within up to 6 months prior to screening * Magnetic resonance imaging with evidence of active myositis within up to 6 months prior to screening AND 2. Minimum disease activity defined by moderate to severe myopathy with MMT-8 of ≥ 80 and ≤142/150 at screening and baseline and at least 2 of the following CSM abnormalities at screening: * PtGA ≥2 cm * PhGA derived from MDAAT ≥2 cm * Extramuscular disease activity as per MDAAT ≥2 cm * At least 1 muscle enzyme ≥1.5× ULN * HAQ-DI ≥0.25. \* Note: Inclusion Criteria #6a and #6b must be reviewed by the central eligibility committee. 7. The participant must be on background therapy for IIM. The standard treatments that are allowed as background therapy for IIM include: 1. Oral corticosteroid (OCS) monotherapy in doses ≤20 mg prednisone (or prednisone equivalent), OR 2. One of the following immunosuppressants/immunomodulators: azathioprine, mycophenolate mofetil or mycophenolic acid, methotrexate, 6 mercaptopurine, sulfasalazine, leflunomide, mizoribine, cyclosporine, tacrolimus in doses as per local guidelines (combinations of these treatments are not allowed), OR 3. One of the following antimalarials: hydroxychloroquine quinacrine, chloroquine, OR 4. Any combination of OCS in doses ≤20 mg prednisone (or prednisone equivalent), 1 of the above immunosuppressants/immunomodulators, and/or 1 of the above antimalarials * If using OCS for IIM, the participant must be introduced ≥4 weeks prior to screening. the dose must be stable and not exceed 20 mg/day of prednisone (or equivalent) 2 weeks prior to screening * If using immunosuppressants/immunomodulators and/or antimalarials the participant must have been on the same medication for ≥12 weeks before randomisation and on a stable dose for ≥4 weeks prior to randomisation 8. 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. 9. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 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 with uncontrolled IIM manifestations that, in the opinion of the investigator, would be likely to require treatment with restricted medications (e.g. cyclophosphamide) during the trial. 5. Participants diagnosed with advanced interstitial lung disease (ILD), with: 1. Forced vital capacity (FVC) \<70% of predicted at screening OR 2. A history of any of the following up to 12 months prior to screening: * Diffusing capacity of the lung for carbon monoxide (DLCO) \<70% of predicted * Hypoxemia requiring supplemental oxygen therapy, not attributable to sleep apnoea OR * Recent ILD exacerbation or respiratory hospitalisation related to ILD within the last 3 months. 6. Participants with Immune-mediated necrotizing myositis (IMNM); Inclusion body myositis (IBM), cancer-associated polymyositis (PM) or DM, and non-inflammatory myopathies (e.g. muscular dystrophies), antibody-negative PM, or amyopathic dermatomyositis (ADM) with a CDASI-A score ≤14. 7. Participants who experience improvement in MMT-8 (\>10%) or PhGA (≥2 cm) from screening (Visit 1) to randomisation (Visit 2). 8. Severe muscle damage defined as a global muscle damage score of \>5 on a 10-centimetre visual analogue scale (VAS) scale on the myositis damage Index (MDI). 9. Further exclusion criteria apply.

Locations (138)

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

Heuer M.D. Research, Inc

Orlando, Florida, United States

Kansas University Medical Center

Fairway, Kansas, United States

Johns Hopkins Hospital

Baltimore, Maryland, 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

Cleveland Clinic

Cleveland, Ohio, United States

Paramount Medical Research and Consulting

Middleburg Heights, Ohio, United States

University of Pennsylvania

Philadelphia, 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

Wollongong Hospital

Wollongong, New South Wales, Australia

Austin Health

Ivanhoe, Victoria, Australia

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 Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil

Azidus Centro de Pesquisa Clinica Avancada

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

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

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

medius Kliniken gGmbH

Kirchheim unter Teck, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, 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

Tohoku Medical and Pharmaceutical University Hospital

Miyagi, Sendai, Japan

Nara Medical University Hospital

Nara, Kashihara, Japan

Okayama University Hospital

Okayama, Okayama, Japan

The University of Osaka Hospital

Osaka, Suita, Japan

Juntendo University Hospital

Tokyo, Bunkyo-ku, Japan

Institute of Science Tokyo Hospital

Tokyo, Bunkyo-ku, Japan

Nippon Medical School Hospital

Tokyo, Bunkyo-ku, Japan

Toho University Omori Medical Center

Tokyo, Ota-ku, Japan

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, Japan

Keio University Hospital

Tokyo, Shinjuku-ku, Japan

Tokyo Women's Medical University Hospital

Tokyo, Shinjuku-ku, Japan

Mediadvance Clinical S.A.P.I de C.V.

Chihuahua City, Mexico

Centro Integral en Reumatologia, SA. de CV.

Guadalajara, Mexico

Panamerican Clinical Research Mexico

Guadalajara, Mexico

CIMOVA (Consultorio anexo)

León, Mexico

CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV

Mexico City, Mexico

Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico

Medical Care & Research SA de CV

Mérida, Mexico

Amsterdam UMC Locatie AMC

Amsterdam, Netherlands

Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fizjoterapeuty

Bialystok, Poland

Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy

Bydgoszcz, Poland

Gornoslaskie Centrum Medyczne im prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego W Katowicach

Katowice, Poland

ULS da Região de Aveiro

Aveiro, Portugal

CHUC - Centro Hospitalar e Universitario de Coimbra, EPE

Coimbra, Portugal

ULS de Santa Maria, E.P.E

Lisbon, Portugal

Spitalul Clinic Dr. I. Cantacuzino

Bucharest, Romania

Centrul Clinic De Boli Reumatismale Dr. Ion Stoia

Bucharest, Romania

Spitalul Clinic Judetean de urgenta Cluj

Cluj-Napoca, Romania

Institute of Rheumatology

Belgrade, Serbia

Military Medical Academy

Belgrade, Serbia

University Clinical Center of Kragujevac

Kragujevac, Serbia

Chonnam National University Hospital

Gwangju, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hanyang University Medical Center

Seoul, South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario De La Princesa

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Dr. Peset

Valencia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Siriraj Hospital

Bangkok, Thailand

Maharaj Nakom Chiangmai Hospital

Chiang Mai, Thailand

Songklanagarind Hospital

Hat Yai, Thailand

Ramathibodi Hospital

Ratchathewi, Thailand

Clinical Research Directory

A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (138)