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NCT06806592PHASE3Recruiting

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

Boehringer Ingelheim

Start Date

9/13/2025

Completion Date

7/30/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Nerandomilast

DRUG

Placebo matching nerandomilast

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Conditions

Interstitial Lung DiseasesSystemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

Locations

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

LSU Health Sciences Center

New Orleans, Louisiana 70112

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

Cleveland Clinic

Cleveland, Ohio 44195

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

AKH - Medical University of Vienna

Vienna, 1090

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

People's Hospital of Sichuan Province

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

Wuhan Union Hospital

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 Rocío

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