A Study to Test Whether Nerandomilast Helps People With Lung Fibrosis Related to Rheumatic Diseases
A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over at Least 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)
3 other identifiers
interventional
413
15 countries
151
Brief Summary
Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. 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 a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2025
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2025
CompletedFirst Posted
Study publicly available on registry
February 4, 2025
CompletedStudy Start
First participant enrolled
September 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
October 2, 2026
September 1, 2026
1.8 years
January 28, 2025
September 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26
QILD will be assessed via quantitative high-resolution computed tomography (qHRCT). QILD are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung. QHC is a measure of HC within the lung. QILD is the sum of QLF, QGGO, and QHC. Quantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD \[%\] is the QILD volume \[mL\] as a percent of the total lung volume. A higher QILD percentage or volume indicates a higher extent of disease.
At baseline and at Week 26
Secondary Outcomes (7)
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
At baseline and at Week 26
Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26
At baseline and at Week 26
Absolute change from baseline in vascular volume [%] on HRCT at Week 26
At baseline and at Week 26
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26
At baseline and at Week 26
Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at baseline
At baseline and at Week 52
- +2 more secondary outcomes
Study Arms (2)
Nerandomilast
EXPERIMENTALParticipants with SARD-ILDs will receive nerandomilast.
Placebo
PLACEBO COMPARATORParticipants with SARD-ILDs will receive placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as
- Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or mixed connective tissue disease (MCTD) (participants must be anti-U1-ribonucleoprotein particle (RNP) auto-antibody positive)
- Presence of fibrotic interstitial lung disease (ILD) on high-resolution computed tomography (HRCT), defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent \>10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review
- No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:
- No clinically significant improvement in ILD based on clinician's judgement (including symptoms, imaging/HRCT, or other assessments as considered relevant and documented by the Investigator)
- FVC ≥45% of predicted normal at Visit 1
- Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1
- Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) prior to visit 2, with the following specifications:
- If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2
- If using rituximab, participants must have completed their first cycle \>6 months prior to Visit 2
- If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2
- In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned
You may not qualify if:
- Organising pneumonia as predominant pattern in the HRCT
- Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) \<0.7 at Visit 1
- Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement
- Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period
- Any suicidal behaviour in the past 2 years
- Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2
- Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (153)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Mayo Clinic-Arizona
Scottsdale, Arizona, 85259, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Paradigm Clinical Research - San Diego
San Diego, California, 92108, United States
National Jewish Health
Denver, Colorado, 80206, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Meris Clinical Research-Brandon-69466
Brandon, Florida, 33511, United States
Miami VA Healthcare System
Miami, Florida, 33125, United States
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, 30309, United States
Augusta University
Augusta, Georgia, 30912, United States
Northwestern University
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55902, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-1230, United States
Northwell Health
Great Neck, New York, 11021, United States
NYU Langone Health
New York, New York, 10017, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032, United States
Onsite Clinical Solutions
Salisbury, North Carolina, 28144, United States
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina, 27103, United States
Temple Lung Center
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Royal Prince Alfred Hospital
Camperdown, Sydney, New South Wales, 2050, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Krems University Hospital
Krems, 3500, Austria
Klinikum Wels - Grieskirchen GmbH
Wels, 4600, Austria
Beijing Chao-Yang Hospital
Beijing, 100020, China
China-Japan Friendship Hospital
Beijing, 100029, China
Peking Union Medical College Hospital
Beijing, 100730, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000, China
University Hospital_Macau University of Science and Technology
Macau, 999078, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
Tianjin Medical University General Hospital
Tianjin, 30052, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030, China
First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
Zhuzhou Central Hospital
Zhuzhou, 412007, China
HOP d'Angers
Angers, 49933, France
HOP Pellegrin
Bordeaux, 33076, France
Hôpital Claude Huriez
Lille, 59037, France
Hôpital Cochin
Paris, 75014, France
HOP Bichat
Paris, 75018, France
HOP Sud
Rennes, 35203, France
HOP Civil
Strasbourg, 67091, France
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059, France
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Immanuel-Krankenhaus GmbH
Berlin, 13125, Germany
Universitätsklinikum Bonn AöR
Bonn, 53127, Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126, Germany
Gesundheit Nord gGmbH | Klinikverbund Bremen
Bremen, 28325, Germany
Krankenhaus Porz am Rhein gGmbH
Cologne, 51149, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Helios Fachklinik Vogelsang-Gommern GmbH
Gommern, 39245, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Herne, 44649, Germany
medius Kliniken gGmbH
Kirchheim unter Teck, 73230, Germany
Klinikum Konstanz
Konstanz, 78464, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Klinikum der Universität München AÖR
München, 80336, Germany
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, 93049, Germany
ASST degli Spedali Civili di Brescia
Brescia, 25123, Italy
A. O. Universitaria Careggi
Florence, 50134, Italy
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale San Raffaele S.r.l.
Milan, 20132, Italy
Azienda Ospedaliera Universitaria di Padova
Padova, 35128, Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100, Italy
AOU Policlinico Umberto I
Roma, 00161, Italy
Fujita Health University Hospital
Aichi, Toyoake, 470-1192, Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793, Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, 216-8511, Japan
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, Takatsuki, 569-8686, Japan
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495, Japan
Juntendo University Hospital
Tokyo, Bunkyo-Ku, 113-8431, Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603, Japan
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582, Japan
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, 31020, Mexico
Centro Integral en Reumatologia, SA. de CV.
Guadalajara, 44160, Mexico
Soltmed Smo
Mexico City, 03650, Mexico
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
Mexico City, 06700, Mexico
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
Medical Care & Research SA de CV
Mérida, 97070, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Zuyderland Medisch Centrum
Heerlen, 6419 PC, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM, Netherlands
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015, Netherlands
Akershus Universitetssykehus HF
Nordbyhagen, 1478, Norway
Sykehuset Telemark HF, Avd. Skien
Skien, N-3710, Norway
GCM Medical Group, PSC
San Juan, 00917, Puerto Rico
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Soonchunhyang University Hospital Seoul
Seoul, 04401, South Korea
Hospital Santa Creu i Sant Pau
Barcelona, 08026, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital de Basurto
Bilbao, 48013, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Juan Ramón Jimenez
Huelva, 21005, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clínico de Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009, Spain
Hospital Virgen del Rocio
Seville, 41013, Spain
Hospital Dr. Peset
Valencia, 46017, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, 36312, Spain
Cantonal Hospital of Aarau
Aarau, CH-5001, Switzerland
Universitätsspital Basel
Basel, 4031, Switzerland
Hopitaux Universitaires de Geneve (HUG)
Geneva, 1205, Switzerland
Neuchatel Hospital Network
Neuchâtel, 2000, Switzerland
Kantonsspital St.Gallen
Sankt Gallen, 9007, Switzerland
University Hospital Zurich
Zurich, 8091, Switzerland
Antrim Area Hospital
Antrim, BT41 2RL, United Kingdom
Royal United Hospital, Bath
Bath, BA1 3NG, United Kingdom
Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Chapel Allerton Hospital
Leeds, LS7 4SA, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
University College Hospital
London, WC1E 6BT, United Kingdom
Altnagelvin Area Hospital
Londonderry, BT47 6SB, United Kingdom
Luton & Dunstable University Hospital
Luton, LU4 8RB, United Kingdom
NIHR Lancashire Clinical Research Facility
Preston, PR2 9HT, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
Southend University Hospital
Westcliffe-on-Sea, SS0 0RY, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2025
First Posted
February 4, 2025
Study Start
September 13, 2025
Primary Completion (Estimated)
July 17, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
October 2, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents -upon signing of a "Document Sharing Agreement". For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "time frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.