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Can a new pill ease muscle weakness in myositis?

NCT ID NCT07789015

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This phase III trial tests whether the oral drug nerandomilast can improve symptoms of idiopathic inflammatory myopathies, a group of rare autoimmune diseases that cause muscle weakness and inflammation. Adults with active myositis are randomly assigned to take nerandomilast or a placebo twice a day for a year, alongside their usual treatment. Researchers compare symptom scores and quality of life between the two groups to see if the drug helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nerandomilast
What this could lead to
If it works, nerandomilast could become a new treatment option to ease muscle weakness and other symptoms of myositis, potentially reducing the need for steroids.
What could go wrong
This is an early test in a relatively small group, and the drug may not prove more effective than placebo. Side effects are possible, and results may not apply to all types of myositis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy antisynthetase syndrome dermatomyositis idiopathic inflammatory myopathy myositis disease overlap myositis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic inflammatory myopathies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    141 sites in 24 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alexandrovska University Hospital

    Sofia, 1431, Bulgaria

  • Alto Dorrego Consultorios

    Villa Nueva, M5526DRW, Argentina

  • Amsterdam UMC Locatie AMC

    Amsterdam, 1105 AZ, Netherlands

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Arizona Neuromuscular Research Center

    Phoenix, Arizona, 85028, United States

  • Auenlandklinik Bad Bramstedt GmbH

    Bad Bramstedt, 24576, Germany

  • Austin Health

    Ivanhoe, Victoria, 3079, Australia

  • Azidus Centro de Pesquisa Clinica Avancada

    Valinhos, 13271-130, Brazil

  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

    Torino, 10126, Italy

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Ospedaliera di Padova

    Padova, 35100, Italy

  • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania

    Catania, 95121, Italy

  • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari

    Bari, 70124, Italy

  • Bioclinic Research

    C.a.b.a, C1426BOD, Argentina

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE

    Coimbra, 3004-561, Portugal

  • CIMOVA (Consultorio anexo)

    León, 37000, Mexico

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

    Mexico City, 06700, Mexico

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000, Belgium

  • Centro Argentino de Investigacion (CADI)-Diagnostico Medico

    CABA, C1113, Argentina

  • Centro Integral en Reumatologia, SA. de CV.

    Guadalajara, 44160, Mexico

  • Centro Mineiro de Pesquisa (CMIP)

    Juiz de Fora, 36010-570, Brazil

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, 4000, Argentina

  • Centrul Clinic De Boli Reumatismale Dr. Ion Stoia

    Bucharest, 020983, Romania

  • China-Japan Friendship Hospital

    Beijing, 100029, China

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Chung Shan Medical University Hospital

    Taichung, 402, Taiwan

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Diex Recherche (Sherbrooke Est)

    Sherbrooke, Quebec, J1E 0N8, Canada

  • Dongguan People's Hospital

    Dongguan, 523059, China

  • First Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710061, China

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100, Italy

  • Framingham Centro Medico

    La Plata, B1902COS, Argentina

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • General Hospital of Thessaloniki "Ippokrateio"

    Thessaloniki, 546 42, Greece

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

    Katowice, 40635, Poland

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • HOP CHU Caen

    Caen, 14000, France

  • HOP Civil

    Strasbourg, 67091, France

  • HOP Pellegrin

    Bordeaux, 33076, France

  • HOP Saint-Louis

    Paris, 75010, France

  • HOP d'Angers

    Angers, 49933, France

  • Hanyang University Medical Center

    Seoul, 04763, South Korea

  • Helios CR, Inc - Dallas

    Dallas, Texas, 75231, United States

  • Heuer M.D. Research, Inc

    Orlando, Florida, 32819, United States

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648, Japan

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Dr. Peset

    Valencia, 46017, Spain

  • Hospital Mater Dei BA

    Salvador, 40221-500, Brazil

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario De La Princesa

    Madrid, 28006, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, 01246-903, Brazil

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8556, Japan

  • Huashan Hospital, Fudan University

    Shanghai, 200040, China

  • Hôpital Edouard Herriot

    Lyon, 69437, France

  • Hôpital Rangueil - CHU de Toulouse

    Toulouse, 31059, France

  • Hôpital de la Pitié Salpêtrière

    Paris, 75013, France

  • Immanuel-Krankenhaus GmbH

    Berlin, 13125, Germany

  • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080, Mexico

  • Institute of Rheumatology

    Belgrade, 11000, Serbia

  • Institute of Science Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8519, Japan

  • Instituto Medico CER

    Quilmes, B1878DVB, Argentina

  • Instituto Medico Especializado

    Capital Federal, C1405BCH, Argentina

  • Instituto de Investigacion Clinica TyT

    CABA, C1405BFN, Argentina

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre - RS, CEP 90020-090, Brazil

  • Japan Community Healthcare Organization Chukyo Hospital

    Aichi, Nagoya, 457-8510, Japan

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21224, United States

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 113-8431, Japan

  • Kansas University Medical Center

    Fairway, Kansas, 66205, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Keio University Hospital

    Tokyo, Shinjuku-ku, 160-8582, Japan

  • Krankenhaus Porz am Rhein gGmbH

    Cologne, 51149, Germany

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507, Japan

  • Kyung Hee University Hospital

    Seoul, 02447, South Korea

  • Maharaj Nakom Chiangmai Hospital

    Chiang Mai, 50200, Thailand

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06120, Germany

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

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

    Chihuahua City, 31203, Mexico

  • Medical Care & Research SA de CV

    Mérida, 97070, Mexico

  • Medical Center MedTech Services Ltd.

    Haskovo, 6304, Bulgaria

  • Military Medical Academy

    Belgrade, 11040, Serbia

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • Nara Medical University Hospital

    Nara, Kashihara, 634-8522, Japan

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030, United States

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku, 113-8603, Japan

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

    Bialystok, 15-707, Poland

  • Okayama University Hospital

    Okayama, Okayama, 700-8558, Japan

  • Panamerican Clinical Research Mexico

    Guadalajara, 44670, Mexico

  • Paramount Medical Research and Consulting

    Middleburg Heights, Ohio, 44130, United States

  • Peking Union Medical College Hospital

    Beijing, 100730, China

  • Ramathibodi Hospital

    Ratchathewi, 10400, Thailand

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 201112, China

  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025, China

  • Sanatorio de la Mujer

    Rosario, S2000ORE, Argentina

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing, 400010, China

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Songklanagarind Hospital

    Hat Yai, 90110, Thailand

  • South Health Campus (Calgary)

    Calgary, Alberta, T2N 4Z6, Canada

  • Spitalul Clinic Dr. I. Cantacuzino

    Bucharest, 020475, Romania

  • Spitalul Clinic Judetean de urgenta Cluj

    Cluj-Napoca, 400006, Romania

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511, Japan

  • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy

    Bydgoszcz, 85-168, Poland

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, 471003, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000, China

  • The Second Affiliated Hospital to Nanchang University

    Nanchang, 330038, China

  • The University of Osaka Hospital

    Osaka, Suita, 565-0871, Japan

  • The third affiliated hospital of Sun Yat-Sen University

    Guangzhou, 510630, China

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541, Japan

  • Tohoku Medical and Pharmaceutical University Hospital

    Miyagi, Sendai, 983-8512, Japan

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023, Japan

  • Tokyo Women's Medical University Hospital

    Tokyo, Shinjuku-ku, 162-8666, Japan

  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

    Wuhan, 430030, China

  • ULS da Região de Aveiro

    Aveiro, 3814-501, Portugal

  • ULS de Santa Maria, E.P.E

    Lisbon, 1649-035, Portugal

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Brussel

    Jette, 1090, Belgium

  • University Clinical Center of Kragujevac

    Kragujevac, 34000, Serbia

  • University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD

    Sofia, 1612, Bulgaria

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of California San Francisco

    San Francisco, California, 94115, United States

  • University of Debrecen

    Debrecen, 4032, Hungary

  • University of Michigan

    Ann Arbor, Michigan, 48109-5314, United States

  • University of Pecs

    Pécs, 7634, Hungary

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

  • Wollongong Hospital

    Wollongong, New South Wales, 2500, Australia

  • Yokohama City University Hospital

    Kanagawa, Yokohama, 236-0004, Japan

  • medius Kliniken gGmbH

    Kirchheim unter Teck, 73230, Germany

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