Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug aims to halt lung damage in autoimmune patients

NCT ID NCT06806592

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 study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Updated 12 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.

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 400 people

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

Started

Sep 2025

Expected to finish

Jul 2027

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: * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Idiopathic inflammatory myopathy-associated interstitial lung disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

How to take part

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

  1. The places running it

    136 sites in 16 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. Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • 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

    ACTIVE_NOT_RECRUITING

    Londonderry, BT47 6SB, United Kingdom

  • Antrim Area Hospital

    ACTIVE_NOT_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

    ACTIVE_NOT_RECRUITING

    Leeds, LS7 4SA, United Kingdom

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, 100029, China

  • 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)

    COMPLETED

    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 Rocio

    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

    COMPLETED

    München, 80336, Germany

  • Krankenhaus Barmherzige Brüder Regensburg

    RECRUITING

    Regensburg, 93049, Germany

  • Krankenhaus Porz am Rhein gGmbH

    RECRUITING

    Cologne, 51149, Germany

  • Krems University Hospital

    COMPLETED

    Krems, 3500, Austria

  • Kyoto University Hospital

    RECRUITING

    Kyoto, Kyoto, 606-8507, Japan

  • Kyung Hee University Hospital

    RECRUITING

    Seoul, 02447, South Korea

  • Luton & Dunstable University Hospital

    ACTIVE_NOT_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

    ACTIVE_NOT_RECRUITING

    Preston, PR2 9HT, United Kingdom

  • NYU Langone Health

    RECRUITING

    New York, New York, 10017, United States

  • Nagasaki University Hospital

    COMPLETED

    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

    ACTIVE_NOT_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

    COMPLETED

    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

    ACTIVE_NOT_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

    ACTIVE_NOT_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

    ACTIVE_NOT_RECRUITING

    Westcliffe-on-Sea, SS0 0RY, United Kingdom

  • St George's Hospital

    ACTIVE_NOT_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

More trials for these conditions

Other studies related to the condition(s) this trial covers.