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New pill aims to halt lung scarring in thousands

NCT ID NCT07540988

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 10 times

Summary

This study tests a drug called nerandomilast in 466 adults with fibrosing interstitial lung disease (ILD) who are at risk of worsening. Participants take either the drug or a placebo for at least 52 weeks. Doctors measure lung function and use CT scans to see if the drug slows disease progression.

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, this could provide a new treatment option to slow lung function decline in people with fibrosing interstitial lung disease.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The drug may not prove better than placebo, and side effects are possible.

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 466 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 and female individuals ≥18 years of age at the time of first signed informed consent at Visit 1a 2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial 3. Diagnosis of fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF) as established by the investigator 4. Presence of fibrotic lung disease on high resolution computed tomography (HRCT), defined as reticulation with traction bronchiectasis/ bronchiolectasis and/or honeycombing, and extent of fibrosis ≥10%, as assessed by central review prior to randomization 5. Time since ILD diagnosis ≤3 years before randomization 6. FVC ≥45% of predicted normal at Visit 1 7. Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1 8. Patients treated with permitted immunosuppressive/immunomodulatory agents for an underlying systemic disease (e.g. methotrexate (MTX), azathioprine (AZA)) need to be on stable treatment for at least 12 weeks prior to Visit 1 and during screening period 9. Further inclusion criteria apply. Exclusion criteria : 1. Known diagnosis of idiopathic pulmonary fibrosis (IPF) based on multidisciplinary discussion (MDD) and according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2022 guidelines 2. Known diagnosis of autoimmune-ILDs other than rheumatoid arthritis-associated ILD (RA-ILD) 3. Known diagnosis of sarcoidosis 4. Patients with predominant features of organizing pneumonia on HRCT, as assessed by central review 5. Patients who developed ILD due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/Coronavirus Disease 2019 (COVID-19) (based on investigators judgement) 6. Meeting criteria for progressive pulmonary fibrosis (PPF), as assessed by investigator 7. Meeting criteria for treatment with currently approved therapies for the fibrosing ILD (e.g. PPF), as assessed by investigator 8. Prior or current use of nerandomilast, nintedanib, or pirfenidone 9. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

interstitial lung disease pulmonary fibrosis

As listed by the trial registrant

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

Interstitial lung diseases

How to take part

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

  1. The places running it

    163 sites in 19 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

  • A.O. San Gerardo di Monza

    Monza, 20900, Italy

  • AZ Delta

    Roeselare, 8800, Belgium

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida, 33470, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Avanza Medical Research Center

    Pensacola, Florida, 32503, United States

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128, Italy

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

    Catania, 95124, Italy

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Beijing Chao-Yang Hospital

    Beijing, 100020, China

  • CIC Mauricie (Trois Rivieres)

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • CLARE - Clinica de Pneumologia

    Goiânia, 74110-030, Brazil

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000, Belgium

  • Centro de Investigacion Farmacologica del Bajío, S.C.

    León, 37160, Mexico

  • Centro de Investigacion Integral MEDIVEST S.C

    Chihuahua City, 31203, Mexico

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • China Medical University Hospital

    Taichung, 404, Taiwan

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Clinical Research Specialists LLC - Kissimmee

    Kissimmee, Florida, 34746, United States

  • Clinical Trials Center of Middle Tennessee, LLC

    Franklin, Tennessee, 37067, United States

  • Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine

    New Bern, North Carolina, 28562, United States

  • Coastal Pulmonary & Critical Care

    St. Petersburg, Florida, 33704, United States

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Consultorios Medicos del Buen Ayre

    Capital Federal, 1425, Argentina

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD, Netherlands

  • Essence MD Research

    Naples, Florida, 34102, United States

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510000, China

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

  • Fundacion Innovaciencia

    Rosario, 2000, Argentina

  • Fundacion NIBA Neurologia Infantil Buenos Aires

    CABA, 1182, Argentina

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, 15090-000, Brazil

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004, China

  • Glenfield Hospital

    Leicester, LE3 9QP, United Kingdom

  • HOP Avicenne

    Bobigny, 93000, France

  • HOP Bichat

    Paris, 75018, France

  • HOP CHU Caen

    Caen, 14033, France

  • HOP CHU de Grenoble

    La Tronche, 38700, France

  • HOP Nord

    Marseille, 13015, France

  • HOP Pontchaillou

    Rennes, 35033, France

  • HOP d'Angers

    Angers, 49933, France

  • HYKS Keuhkosairauksien tutkimusyksikkö

    Helsinki, 000290, Finland

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192, Japan

  • Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Henan Provincial People's Hospital

    Zhengzhou, 450003, China

  • Henderson Clinical Trials

    Henderson, Nevada, 89052, United States

  • Hiroshima Prefectural Hospital

    Hiroshima, Hiroshima, 734-8530, Japan

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hopital Louis Pradel

    Bron, 69677, France

  • Hopital Pasteur

    Nice, 06000, France

  • Hospital Aleman

    CABA, 1118, Argentina

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Elisabethinen Linz

    Linz, 4020, Austria

  • Hospital General de Granollers

    Granollers, 08402, Spain

  • Hospital Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari de Bellvitge

    Hospitalet Llobregat, 08907, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460, Mexico

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, 14004, Spain

  • Hospital de Galdakao

    Galdakao, 48960, Spain

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8556, Japan

  • IMIP Pernambuco

    Recife, 50070902, Brazil

  • INCOR e Hospital das Clínicas da Universidade de São Paulo

    São Paulo, 05403-000, Brazil

  • INS Coeur Poumon

    Lille, 59037, France

  • INSARES

    Mendoza, M5500CCG, Argentina

  • Indiana University Health Enterprise Clinical Research Operation

    Indianapolis, Indiana, 46202, United States

  • Inje University Busan Paik Hospital

    Busan, 47392, South Korea

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

    Québec, G1V 4G5, Canada

  • Instituto Ave Pulmo - Fundacion Enfisema

    Mar del Plata, 7600, Argentina

  • Instituto de Medicina Respiratoria (IMeR)

    Alberdi Sur, X5003DCE, Argentina

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90050-170, Brazil

  • Johannes Kepler University Linz

    Linz, 4020, Austria

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 113-8431, Japan

  • Kagawa University Hospital

    Kagawa, Kita-gun, 761-0793, Japan

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • Keio University Hospital

    Tokyo, Shinjuku-ku, 160-8582, Japan

  • Kelowna Respirology & Allergy Research

    Kelowna, British Columbia, V1Y 3H5, Canada

  • Kindai University Hospital

    Osaka, Sakai, 590-0197, Japan

  • Klinikum Region Hannover GmbH

    Hanover, 30459, Germany

  • Klinikum der Universität München AÖR

    München, 81377, Germany

  • Kyung Hee University Hospital

    Seoul, 02447, South Korea

  • Lakeland Regional Medical Center - Lakeland

    Lakeland, Florida, 33805, United States

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406, United States

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376, Germany

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

  • Medical University of Graz

    Graz, 8036, Austria

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Metroplex Pulmonary & Sleep Center

    McKinney, Texas, 75069, United States

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, 02-637, Poland

  • National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655, Japan

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555, Japan

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563, Japan

  • National Institute Of Tuberculosis And Lung Diseases

    Warsaw, 01-138, Poland

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Newport Native MD, Inc

    Newport Beach, California, 92663, United States

  • Ospedale Classificato San Giuseppe

    Milan, 20123, Italy

  • Ospedale Colonnello D Avanzo

    Foggia, 71100, Italy

  • Ospedale G.B. Morgagni

    Forlì, 47121, Italy

  • Oulun yliopistollinen keskussairaala

    Oulu, 90220, Finland

  • People's Hospital of Sichuan Province

    Chengdu, 610072, China

  • Pol. Universitario Tor Vergata

    Roma, 00133, Italy

  • Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.

    Świdnik, 21-040, Poland

  • Robert Bosch Gesellschaft für medizinische Forschung mbH

    Stuttgart, 70376, Germany

  • Royal Brompton Hospital

    London, SW3 6HP, United Kingdom

  • Royal Devon and Exeter Hospital, Wonford

    Exeter, EX2 5DW, United Kingdom

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239, Germany

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sapporo Medical University Hospital

    Hokkaido, Sapporo, 060-8543, Japan

  • Second Affiliated Hospital of medical college of Xi'an JiaoTong University

    Xi'an, 710004, China

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, 310016, China

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggi-do, 14584, South Korea

  • Southeastern Research Center-Winston-Salem-61365

    Winston-Salem, North Carolina, 27103, United States

  • St George's Hospital

    London, SW17 0RE, United Kingdom

  • St James's University Hospital

    Leeds, LS9 7TF, United Kingdom

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM, Netherlands

  • St. Paul's Hospital (Vancouver)

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Synergy Respiratory Care

    Sherwood Park, Alberta, T8H 0N2, Canada

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006, China

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011, China

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126, Germany

  • Tianjin Medical University General Hospital

    Tianjin, 300052, China

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503, Japan

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

    Wuhan, 430030, China

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • Tosei General Hospital

    Aichi, Seto, 489-8642, Japan

  • Turku University Hospital / TYKS

    Turku, 20521, Finland

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022, China

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84108, United States

  • Universitätsklinikum Bonn AöR

    Bonn, 53127, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

    Poznan, 60-569, Poland

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 12351, Germany

  • Weill Cornell Medicine-New York-60569

    New York, New York, 10021, United States

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Wiener Gesundheitsverbund

    Vienna, 1140, Austria

  • Wiener Gesundheitsverbund

    Vienna, 1210, Austria

  • Wuxi People's Hospital

    Wuxi, 214043, China

  • Wythenshawe Hospital

    Manchester, M23 9LT, United Kingdom

  • Yale University School of Medicine

    New Haven, Connecticut, 06520, United States

  • Zhejiang Hospital

    Hangzhou, 310013, China

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