A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases

May 28, 2026 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Camperdown, Sydney, New South Wales, Australia, 2050
      • Darlinghurst, New South Wales, Australia, 2010
        • Not yet recruiting
        • St Vincent's Hospital Sydney
        • Contact:
    • Queensland
      • Chermside, Queensland, Australia, 4032
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • Austria
      • Krems, Austria, 3500
      • Vienna, Austria, 1090
      • Wels, Austria, 4600
  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, China, 100020
        • Recruiting
        • Beijing Chao-Yang Hospital
        • Contact:
      • Chengdu, China, 610041
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Chengdu, China, 610072
        • Recruiting
        • People's Hospital of Sichuan Province
        • Contact:
      • Guangzhou, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Hangzhou, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Luoyang, China, 471000
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Macau, China, 999078
        • Not yet recruiting
        • University Hospital_Macau University of Science and Technology
        • Contact:
      • Nanchang, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
      • Tianjin, China, 30052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Wuhan, China, 430022
        • Not yet recruiting
        • Wuhan Union Hospital
        • Contact:
      • Wuhan, China, 430030
        • Recruiting
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • Contact:
      • Xiamen, China, 361003
        • Not yet recruiting
        • First Affiliated Hospital of Xiamen University
        • Contact:
      • Zhuzhou, China, 412007
        • Recruiting
        • Zhuzhou Central Hospital
        • Contact:
  • France
      • Angers, France, 49933
      • Bordeaux, France, 33076
      • Lille, France, 59037
        • Not yet recruiting
        • Hôpital Claude Huriez
        • Contact:
      • Paris, France, 75014
      • Paris, France, 75018
      • Rennes, France, 35203
      • Strasbourg, France, 67091
      • Toulouse, France, 31059
        • Recruiting
        • Hôpital Rangueil - CHU de Toulouse
        • Contact:
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charite - Universitatsmedizin Berlin
        • Contact:
      • Berlin, Germany, 13125
      • Bonn, Germany, 53127
      • Braunschweig, Germany, 38126
        • Not yet recruiting
        • Städtisches Klinikum Braunschweig gGmbH
        • Contact:
      • Bremen, Germany, 28325
        • Completed
        • Gesundheit Nord gGmbH | Klinikverbund Bremen
      • Cologne, Germany, 51149
      • Düsseldorf, Germany, 40225
      • Erlangen, Germany, 91054
      • Essen, Germany, 45239
        • Recruiting
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
        • Contact:
      • Freiburg im Breisgau, Germany, 79106
      • Gommern, Germany, 39245
        • Not yet recruiting
        • Helios Fachklinik Vogelsang-Gommern GmbH
        • Contact:
      • Hanover, Germany, 30625
      • Herne, Germany, 44649
        • Not yet recruiting
        • St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
        • Contact:
      • Kirchheim unter Teck, Germany, 73230
      • Konstanz, Germany, 78464
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
        • Contact:
      • Minden, Germany, 32429
      • München, Germany, 80336
        • Not yet recruiting
        • Klinikum der Universität München AÖR
        • Contact:
      • Regensburg, Germany, 93049
        • Not yet recruiting
        • Krankenhaus Barmherzige Brüder Regensburg
        • Contact:
  • Italy
      • Brescia, Italy, 25123
        • Not yet recruiting
        • ASST degli Spedali Civili di Brescia
        • Contact:
      • Florence, Italy, 50134
        • Not yet recruiting
        • A. O. Universitaria Careggi
        • Contact:
      • Milan, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele S.r.l.
        • Contact:
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Contact:
      • Modena, Italy, 41124
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria di Modena
        • Contact:
      • Padova, Italy, 35128
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria di Padova
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico S. Matteo
        • Contact:
      • Roma, Italy, 00161
        • Not yet recruiting
        • AOU Policlinico Umberto I
        • Contact:
  • Japan
      • Aichi, Toyoake, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
      • Fukuoka, Kitakyushu, Japan, 807-8556
        • Recruiting
        • Hospital of the University of Occupational and Environmental Health
        • Contact:
      • Hiroshima, Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8543
        • Not yet recruiting
        • Sapporo Medical University Hospital
        • Contact:
      • Kagawa, Kita-gun, Japan, 761-0793
        • Completed
        • Kagawa University Hospital
      • Kanagawa, Kawasaki, Japan, 216-8511
        • Not yet recruiting
        • St. Marianna University Hospital
        • Contact:
      • Kanagawa, Sagamihara, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital
        • Contact:
      • Kyoto, Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
        • Contact:
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Not yet recruiting
        • Nagasaki University Hospital
        • Contact:
      • Osaka, Takatsuki, Japan, 569-8686
        • Not yet recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
      • Saitama, Iruma-gun, Japan, 350-0495
        • Recruiting
        • Saitama Medical University Hospital
        • Contact:
      • Tokyo, Bunkyo-Ku, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-8582
        • Recruiting
        • Keio University Hospital
        • Contact:
  • Mexico
      • Chihuahua City, Mexico, 31020
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua S.C.
        • Contact:
      • Guadalajara, Mexico, 44160
        • Recruiting
        • Centro Integral en Reumatologia, SA. de CV.
        • Contact:
      • Mexico City, Mexico, 06700
        • Not yet recruiting
        • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
        • Contact:
      • Mexico City, Mexico, 14080
        • Not yet recruiting
        • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
      • Mexico City, Mexico, 03650
      • Monterrey, Mexico, 64460
        • Recruiting
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
        • Contact:
      • Mérida, Mexico, 97070
        • Recruiting
        • Medical Care & Research SA de CV
        • Contact:
  • Netherlands
      • Heerlen, Netherlands, 6419 PC
      • Nieuwegein, Netherlands, 3435 CM
      • Rotterdam, Netherlands, 3015
        • Not yet recruiting
        • Erasmus Medisch Centrum-ROTTERDAM-50697
        • Contact:
  • Norway
      • Nordbyhagen, Norway, 1478
        • Not yet recruiting
        • Akershus Universitetssykehus HF
        • Contact:
      • Skien, Norway, N-3710
        • Not yet recruiting
        • Sykehuset Telemark HF, Avd. Skien
        • Contact:
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
  • South Korea
      • Seongnam, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 02447
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
      • Seoul, South Korea, 04401
        • Recruiting
        • Soonchunhyang University Hospital Seoul
        • Contact:
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08026
        • Recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
      • Bilbao, Spain, 48013
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofía
        • Contact:
      • Huelva, Spain, 21005
        • Recruiting
        • Hospital Juan Ramón Jimenez
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Fundación Jiménez Díaz
        • Contact:
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hospital Clínico de Santiago
        • Contact:
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Virgen del Rocío
        • Contact:
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen De La Macarena
        • Contact:
      • Valencia, Spain, 46017
      • Vigo, Spain, 36312
        • Recruiting
        • Complejo Hospitalario Universitario de Vigo
        • Contact:
  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Recruiting
        • Cantonal Hospital of Aarau
        • Contact:
      • Basel, Switzerland, 4031
        • Recruiting
        • Universitätsspital Basel
        • Contact:
      • Geneva, Switzerland, 1205
        • Not yet recruiting
        • Hopitaux Universitaires de Geneve (HUG)
        • Contact:
      • Neuchâtel, Switzerland, 2000
        • Recruiting
        • Neuchatel Hospital Network
        • Contact:
      • Sankt Gallen, Switzerland, 9007
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:
  • United Kingdom
      • Antrim, United Kingdom, BT41 2RL
      • Bath, United Kingdom, BA1 3NG
      • Birmingham, United Kingdom, B9 5SS
      • Leeds, United Kingdom, LS7 4SA
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, SW17 0QT
      • London, United Kingdom, WC1E 6BT
      • Londonderry, United Kingdom, BT47 6SB
      • Luton, United Kingdom, LU4 8RB
      • Preston, United Kingdom, PR2 9HT
      • Sheffield, United Kingdom, S5 7AU
      • Truro, United Kingdom, TR1 3LJ
      • Westcliffe-on-Sea, United Kingdom, SS0 0RY
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • California
      • Los Angeles, California, United States, 90095
      • San Diego, California, United States, 92108
    • Colorado
      • Denver, Colorado, United States, 80206
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Florida
      • Brandon, Florida, United States, 33511
      • Miami, Florida, United States, 33125
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
        • Contact:
      • Augusta, Georgia, United States, 30912
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • The University of Chicago Medical Center
        • Contact:
      • Evanston, Illinois, United States, 60201
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
      • Rochester, Minnesota, United States, 55902
    • Nebraska
      • Omaha, Nebraska, United States, 68198-1230
    • New York
      • Great Neck, New York, United States, 11021
      • New York, New York, United States, 10017
      • New York, New York, United States, 10024
        • Not yet recruiting
        • Columbia University Medical Center-New York Presbyterian Hospital
        • Contact:
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Southeastern Research Center-Winston Salem-69289
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Pittsburgh, Pennsylvania, United States, 15213
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Not yet recruiting
        • University of Utah Health Sciences Center
        • Contact:
    • West Virginia
      • Beckley, West Virginia, United States, 25801
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 improvement in absolute forced vital capacity (FVC) % predicted >5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart. (Note: 1: In the case of multiple PFTs over the 15 months prior to screening, exceptional values of absolute change in FVC % predicted >5% are acceptable if the overall trend of FVC % predicted is declining or stable; note 2: Visit 1 spirometry may be used to fulfill the inclusion criterion if there is only 1 spirometry reading in the 15 months prior to Visit 1)
    • 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
  • Further inclusion criteria apply

Exclusion Criteria:

  • 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
  • Further exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nerandomilast
Participants with SARD-ILDs will receive nerandomilast.
Drug: Nerandomilast
Nerandomilast
Other Names:
  • JASCAYD®
Placebo Comparator: Placebo
Participants with SARD-ILDs will receive placebo.
Drug: Placebo matching nerandomilast
Placebo matching nerandomilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26
Time Frame: At baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26
Time Frame: At baseline and at Week 26
FVC will be assessed using standardised spirometry equipment which will be provided centrally with supplies of precalibrated disposable flow sensors. Spirometry will be conducted with the participant in a seated position. It is preferable that the same trained individual (i.e. PFT specialist or pulmonologist) performs the PFTs for a given participant. The best of 3 efforts will be defined as the highest FVC obtained on any of three blows meeting the 2019 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria (with a maximum of eight attempts). Predicted normal values will be calculated according to global lung function initiative (GLI).
At baseline and at Week 26
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
Time Frame: At baseline and at Week 26

QLF will be assessed via qHRCT. QLF are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion.

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
Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26
Time Frame: At baseline and at Week 26

QGGO will be assessed via qHRCT. QGGO are quantitative measures of different radiological patterns associated with lung fibrosis. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung.

Quantification of HRCT scans will be performed centrally via a machine learning algorithm.

A higher QGGO percentage or volume indicates a higher extent of disease.
At baseline and at Week 26
Absolute change from baseline in vascular volume [%] on HRCT at Week 26
Time Frame: At baseline and 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
Time Frame: At baseline and at Week 52
At baseline and at Week 52
Time to first supplemental oxygen use during the trial for oxygen non-users at baseline
Time Frame: Up to Week 52
Up to Week 52
Occurrence of infection-related adverse events (AEs) from baseline over the duration of the trial
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2025

Primary Completion (Estimated)

July 17, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1305-0046
  • 2024-512849-17-00 (Registry Identifier: CTIS)
  • U1111-1305-5857 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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