New drug aims to halt lung damage in autoimmune patients

NCT ID NCT06806592

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

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 6 times

Summary

This study tests whether the drug nerandomilast can slow lung scarring in people with autoimmune diseases like rheumatoid arthritis or scleroderma. About 400 adults whose lung function hasn't improved with standard treatment will take either nerandomilast or a placebo twice daily for at least 26 weeks. Researchers will measure changes in lung scarring using CT scans and lung function tests.

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 scarring in people with autoimmune-related lung disease.
What could go wrong: This is a Phase 3 trial, but results are not guaranteed. The drug may not improve lung function or could cause side effects. Participants continue standard immunosuppressants, so benefits may be modest.

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

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Conditions

The condition(s) this trial relates to.

idiopathic inflammatory myopathy interstitial lung disease mixed connective tissue disease pulmonary systemic sclerosis rheumatoid arthritis rheumatoid arthritis-associated interstitial lung disease Sjogren syndrome systemic sclerosis

As listed by the trial registrant

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

INTERSTITIAL LUNG DISEASES SYSTEMIC AUTOIMMUNE RHEUMATIC DISEASES ASSOCIATED INTERSTITIAL LUNG DISEASES

Contacts and locations

Locations

A. O. Universitaria Careggi
RECRUITING

Florence, 50134, Italy
AKH - Medical University of Vienna
NOT_YET_RECRUITING

Vienna, 1090, Austria
AOU Policlinico Umberto I
RECRUITING

Roma, 00161, Italy
ASST degli Spedali Civili di Brescia
RECRUITING

Brescia, 25123, Italy
Akershus Universitetssykehus HF
RECRUITING

Nordbyhagen, 1478, Norway
Altnagelvin Area Hospital
RECRUITING

Londonderry, BT47 6SB, United Kingdom
Antrim Area Hospital
RECRUITING

Antrim, BT41 2RL, United Kingdom
Augusta University
RECRUITING

Augusta, Georgia, 30912, United States
Austin Hospital
RECRUITING

Heidelberg, Victoria, 3084, Australia
Azienda Ospedaliera Universitaria di Padova
RECRUITING

Padova, 35128, Italy
Beijing Chao-Yang Hospital
RECRUITING

Beijing, 100020, China
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
RECRUITING

Mexico City, 06700, Mexico
Cantonal Hospital of Aarau
RECRUITING

Aarau, CH-5001, Switzerland
Centro Integral en Reumatologia, SA. de CV.
RECRUITING

Guadalajara, 44160, Mexico
Chapel Allerton Hospital
RECRUITING

Leeds, LS7 4SA, United Kingdom
Charité - Universitätsmedizin Berlin
RECRUITING

Berlin, 10117, Germany
China-Japan Friendship Hospital
RECRUITING

Beijing, 100029, China
Cleveland Clinic
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
Columbia University Medical Center-New York Presbyterian Hospital
RECRUITING

New York, New York, 10032, United States
Complejo Hospitalario Universitario de Vigo
RECRUITING

Vigo, 36312, Spain
Erasmus Medisch Centrum-ROTTERDAM-50697
RECRUITING

Rotterdam, 3015, Netherlands
Fiona Stanley Hospital
RECRUITING

Murdoch, Western Australia, 6150, Australia
First Affiliated Hospital of Xiamen University
RECRUITING

Xiamen, 361003, China
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
RECRUITING

Milan, 20122, Italy
Fondazione IRCCS Policlinico S. Matteo
RECRUITING

Pavia, 27100, Italy
Fujita Health University Hospital
RECRUITING

Aichi, Toyoake, 470-1192, Japan
Fundación Jiménez Díaz
RECRUITING

Madrid, 28040, Spain
GCM Medical Group, PSC
RECRUITING

San Juan, 00917, Puerto Rico
Gesundheit Nord gGmbH | Klinikverbund Bremen
COMPLETED

Bremen, 28325, Germany
Guangdong Provincial People's Hospital
RECRUITING

Guangzhou, 510080, China
HOP Bichat
RECRUITING

Paris, 75018, France
HOP Civil
RECRUITING

Strasbourg, 67091, France
HOP Pellegrin
RECRUITING

Bordeaux, 33076, France
HOP Sud
RECRUITING

Rennes, 35203, France
HOP d'Angers
RECRUITING

Angers, 49933, France
Heartlands Hospital
RECRUITING

Birmingham, B9 5SS, United Kingdom
Helios Fachklinik Vogelsang-Gommern GmbH
RECRUITING

Gommern, 39245, Germany
Hiroshima University Hospital
RECRUITING

Hiroshima, Hiroshima, 734-8551, Japan
Hokkaido University Hospital
RECRUITING

Hokkaido, Sapporo, 060-8648, Japan
Hopitaux Universitaires de Geneve (HUG)
RECRUITING

Geneva, 1205, Switzerland
Hospital Clínico de Santiago
RECRUITING

Santiago de Compostela, 15706, Spain
Hospital Dr. Peset
RECRUITING

Valencia, 46017, Spain
Hospital Juan Ramón Jimenez
RECRUITING

Huelva, 21005, Spain
Hospital Santa Creu i Sant Pau
RECRUITING

Barcelona, 08026, Spain
Hospital Universitari Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain
Hospital Universitari de Bellvitge
RECRUITING

L'Hospitalet de Llobregat, 08907, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Dr Jose Eleuterio Gonzalez
RECRUITING

Monterrey, 64460, Mexico
Hospital Universitario Ramon Y Cajal
RECRUITING

Madrid, 28034, Spain
Hospital Universitario Reina Sofía
RECRUITING

Córdoba, 14004, Spain
Hospital Universitario Virgen De La Macarena
RECRUITING

Seville, 41009, Spain
Hospital Virgen del Rocío
RECRUITING

Seville, 41013, Spain
Hospital de Basurto
RECRUITING

Bilbao, 48013, Spain
Hospital of the University of Occupational and Environmental Health
RECRUITING

Fukuoka, Kitakyushu, 807-8556, Japan
Huashan Hospital, Fudan University
RECRUITING

Shanghai, 200040, China
Hôpital Claude Huriez
RECRUITING

Lille, 59037, France
Hôpital Cochin
RECRUITING

Paris, 75014, France
Hôpital Rangueil - CHU de Toulouse
RECRUITING

Toulouse, 31059, France
Immanuel-Krankenhaus GmbH
RECRUITING

Berlin, 13125, Germany
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
RECRUITING

Mexico City, 14080, Mexico
Investigacion y Biomedicina de Chihuahua S.C.
RECRUITING

Chihuahua City, 31020, Mexico
Johannes Wesling Klinikum Minden
RECRUITING

Minden, 32429, Germany
Juntendo University Hospital
RECRUITING

Tokyo, Bunkyo-Ku, 113-8431, Japan
Kagawa University Hospital
COMPLETED

Kagawa, Kita-gun, 761-0793, Japan
Kantonsspital St.Gallen
RECRUITING

Sankt Gallen, 9007, Switzerland
Keio University Hospital
RECRUITING

Tokyo, Shinjuku-ku, 160-8582, Japan
Kitasato University Hospital
RECRUITING

Kanagawa, Sagamihara, 252-0375, Japan
Klinikum Konstanz
RECRUITING

Konstanz, 78464, Germany
Klinikum Wels - Grieskirchen GmbH
RECRUITING

Wels, 4600, Austria
Klinikum der Universität München AÖR
NOT_YET_RECRUITING

München, 80336, Germany
Krankenhaus Barmherzige Brüder Regensburg
RECRUITING

Regensburg, 93049, Germany
Krankenhaus Porz am Rhein gGmbH
RECRUITING

Cologne, 51149, Germany
Krems University Hospital
RECRUITING

Krems, 3500, Austria
Kyoto University Hospital
RECRUITING

Kyoto, Kyoto, 606-8507, Japan
Kyung Hee University Hospital
RECRUITING

Seoul, 02447, South Korea
LSU Health Sciences Center
NOT_YET_RECRUITING

New Orleans, Louisiana, 70112, United States
Luton & Dunstable University Hospital
RECRUITING

Luton, LU4 8RB, United Kingdom
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic, Rochester
RECRUITING

Rochester, Minnesota, 55902, United States
Mayo Clinic-Arizona
RECRUITING

Scottsdale, Arizona, 85259, United States
Medical Care & Research SA de CV
RECRUITING

Mérida, 97070, Mexico
Medizinische Hochschule Hannover
RECRUITING

Hanover, 30625, Germany
Meris Clinical Research-Brandon-69466
RECRUITING

Brandon, Florida, 33511, United States
Miami VA Healthcare System
RECRUITING

Miami, Florida, 33125, United States
NIHR Lancashire Clinical Research Facility
RECRUITING

Preston, PR2 9HT, United Kingdom
NYU Langone Health
RECRUITING

New York, New York, 10017, United States
Nagasaki University Hospital
RECRUITING

Nagasaki, Nagasaki, 852-8501, Japan
National Jewish Health
RECRUITING

Denver, Colorado, 80206, United States
Neuchatel Hospital Network
RECRUITING

Neuchâtel, 2000, Switzerland
Nippon Medical School Hospital
RECRUITING

Tokyo, Bunkyo-ku, 113-8603, Japan
Northern General Hospital
RECRUITING

Sheffield, S5 7AU, United Kingdom
Northshore University Health System
RECRUITING

Evanston, Illinois, 60201, United States
Northwell Health
RECRUITING

Great Neck, New York, 11021, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States
Onsite Clinical Solutions
RECRUITING

Salisbury, North Carolina, 28144, United States
Osaka Medical and Pharmaceutical University Hospital
RECRUITING

Osaka, Takatsuki, 569-8686, Japan
Ospedale San Raffaele S.r.l.
RECRUITING

Milan, 20132, Italy
Paradigm Clinical Research - San Diego
RECRUITING

San Diego, California, 92108, United States
Peking Union Medical College Hospital
RECRUITING

Beijing, 100730, China
People's Hospital of Sichuan Province
RECRUITING

Chengdu, 610072, China
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
RECRUITING

Atlanta, Georgia, 30309, United States
Rheumatology and Pulmonary Clinic
RECRUITING

Beckley, West Virginia, 25801, United States
Royal Cornwall Hospital
RECRUITING

Truro, TR1 3LJ, United Kingdom
Royal Free Hospital
RECRUITING

London, NW3 2QG, United Kingdom
Royal Prince Alfred Hospital
RECRUITING

Camperdown, Sydney, New South Wales, 2050, Australia
Royal United Hospital, Bath
RECRUITING

Bath, BA1 3NG, United Kingdom
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
RECRUITING

Essen, 45239, Germany
Saitama Medical University Hospital
RECRUITING

Saitama, Iruma-gun, 350-0495, Japan
Sapporo Medical University Hospital
RECRUITING

Hokkaido, Sapporo, 060-8543, Japan
Seoul National University Bundang Hospital
RECRUITING

Seongnam, 13620, South Korea
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Soltmed Smo
RECRUITING

Mexico City, 03650, Mexico
Soonchunhyang University Hospital Seoul
RECRUITING

Seoul, 04401, South Korea
Southeastern Research Center-Winston Salem-69289
RECRUITING

Winston-Salem, North Carolina, 27103, United States
Southend University Hospital
RECRUITING

Westcliffe-on-Sea, SS0 0RY, United Kingdom
St George's Hospital
RECRUITING

London, SW17 0QT, United Kingdom
St Vincent's Hospital Sydney
RECRUITING

Darlinghurst, New South Wales, 2010, Australia
St. Antonius Ziekenhuis
RECRUITING

Nieuwegein, 3435 CM, Netherlands
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
RECRUITING

Herne, 44649, Germany
St. Marianna University Hospital
RECRUITING

Kanagawa, Kawasaki, 216-8511, Japan
Städtisches Klinikum Braunschweig gGmbH
RECRUITING

Braunschweig, 38126, Germany
Sykehuset Telemark HF, Avd. Skien
RECRUITING

Skien, N-3710, Norway
Temple Lung Center
RECRUITING

Philadelphia, Pennsylvania, 19140, United States
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING

Luoyang, 471000, China
The First Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, 330006, China
The First Affiliated Hospital, Zhejiang University
RECRUITING

Hangzhou, 310003, China
The Prince Charles Hospital
RECRUITING

Chermside, Queensland, 4032, Australia
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING

Hangzhou, 310009, China
The University of Chicago Medical Center
RECRUITING

Chicago, Illinois, 60637, United States
The University of Texas Health Science Center at Houston
RECRUITING

Houston, Texas, 77030, United States
Tianjin Medical University General Hospital
RECRUITING

Tianjin, 30052, China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
RECRUITING

Wuhan, 430030, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING

Wuhan, 430022, China
University College Hospital
RECRUITING

London, WC1E 6BT, United Kingdom
University Hospital Zurich
RECRUITING

Zurich, 8091, Switzerland
University Hospital_Macau University of Science and Technology
RECRUITING

Macau, 999078, China
University of Alabama at Birmingham
RECRUITING

Birmingham, Alabama, 35205, United States
University of California Los Angeles
RECRUITING

Los Angeles, California, 90095, United States
University of Kansas Medical Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Minnesota
RECRUITING

Minneapolis, Minnesota, 55455, United States
University of Nebraska Medical Center
RECRUITING

Omaha, Nebraska, 68198-1230, United States
University of Pittsburgh Medical Center
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
University of Texas Health Science Center at San Antonio
RECRUITING

San Antonio, Texas, 78229, United States
University of Utah Health Sciences Center
RECRUITING

Salt Lake City, Utah, 84108, United States
University of Wisconsin
RECRUITING

Madison, Wisconsin, 53792, United States
Universitätsklinikum Bonn AöR
RECRUITING

Bonn, 53127, Germany
Universitätsklinikum Düsseldorf
RECRUITING

Düsseldorf, 40225, Germany
Universitätsklinikum Freiburg
RECRUITING

Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
RECRUITING

Lübeck, 23538, Germany
Universitätsspital Basel
RECRUITING

Basel, 4031, Switzerland
West China Hospital, Sichuan University
RECRUITING

Chengdu, 610041, China
Yale University School of Medicine
RECRUITING

New Haven, Connecticut, 06510, United States
Zhuzhou Central Hospital
RECRUITING

Zhuzhou, 412007, China
Zuyderland Medisch Centrum
RECRUITING

Heerlen, 6419 PC, Netherlands
medius Kliniken gGmbH
RECRUITING

Kirchheim unter Teck, 73230, Germany

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