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)

Status: Recruiting
Location: See all (153) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as

‣ Diagnosis by a rheumatologist 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)

⁃ 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: 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) 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

Locations
United States
Alabama
University of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
Arizona
Mayo Clinic-Arizona
NOT_YET_RECRUITING
Scottsdale
California
University of California Los Angeles
NOT_YET_RECRUITING
Los Angeles
Paradigm Clinical Research - San Diego
NOT_YET_RECRUITING
San Diego
Colorado
National Jewish Health
RECRUITING
Denver
Connecticut
Yale University School of Medicine
NOT_YET_RECRUITING
New Haven
Florida
Meris Clinical Research-Brandon-69466
NOT_YET_RECRUITING
Brandon
Miami VA Healthcare System
NOT_YET_RECRUITING
Miami
Georgia
Piedmont Hospital
NOT_YET_RECRUITING
Atlanta
Augusta University
NOT_YET_RECRUITING
Augusta
Illinois
Northwestern University
NOT_YET_RECRUITING
Chicago
University of Chicago
NOT_YET_RECRUITING
Chicago
Evanston Hospital
NOT_YET_RECRUITING
Evanston
Kansas
University of Kansas Medical Center
NOT_YET_RECRUITING
Kansas City
Louisiana
LSU Health Sciences Center
NOT_YET_RECRUITING
New Orleans
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Minnesota
University of Minnesota
NOT_YET_RECRUITING
Minneapolis
Mayo Clinic
NOT_YET_RECRUITING
Rochester
North Carolina
Onsite Clinical Solutions
NOT_YET_RECRUITING
Salisbury
Southeastern Research Center-Winston Salem-69289
NOT_YET_RECRUITING
Winston-salem
Nebraska
University of Nebraska Medical Center
NOT_YET_RECRUITING
Omaha
New York
Northwell Health
NOT_YET_RECRUITING
Great Neck
Columbia University Medical Center-New York Presbyterian Hospital
NOT_YET_RECRUITING
New York
NYU Langone Health
NOT_YET_RECRUITING
New York
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
Pennsylvania
Temple Lung Center
NOT_YET_RECRUITING
Philadelphia
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
Texas
The University of Texas Health Science Center at Houston
NOT_YET_RECRUITING
Houston
University of Texas Health Science Center at San Antonio
NOT_YET_RECRUITING
San Antonio
Utah
University of Utah Health Sciences Center
NOT_YET_RECRUITING
Salt Lake City
Wisconsin
University of Wisconsin
NOT_YET_RECRUITING
Madison
West Virginia
Rheumatology and Pulmonary Clinic
NOT_YET_RECRUITING
Beckley
Other Locations
Australia
Royal Prince Alfred Hospital
NOT_YET_RECRUITING
Camperdown, Sydney
The Prince Charles Hospital
NOT_YET_RECRUITING
Chermside
St Vincent's Hospital Sydney
NOT_YET_RECRUITING
Darlinghurst
Austin Hospital
NOT_YET_RECRUITING
Heidelberg
Fiona Stanley Hospital
NOT_YET_RECRUITING
Murdoch
Austria
Krems University Hospital
NOT_YET_RECRUITING
Krems
AKH - Medical University of Vienna
NOT_YET_RECRUITING
Vienna
Klinikum Wels - Grieskirchen GmbH
NOT_YET_RECRUITING
Wels
China
Beijing Chao-Yang Hospital
NOT_YET_RECRUITING
Beijing
China-Japan Friendship Hospital
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
People's Hospital of Sichuan Province
NOT_YET_RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
University Hospital_Macau University of Science and Technology
NOT_YET_RECRUITING
Macau
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Huashan Hospital, Fudan University
NOT_YET_RECRUITING
Shanghai
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
NOT_YET_RECRUITING
Wuhan
Wuhan Union Hospital
NOT_YET_RECRUITING
Wuhan
First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Zhuzhou Central Hospital
NOT_YET_RECRUITING
Zhuzhou
France
HOP d'Angers
NOT_YET_RECRUITING
Angers
HOP Pellegrin
NOT_YET_RECRUITING
Bordeaux
HOP Claude Huriez
NOT_YET_RECRUITING
Lille
HOP Bichat
NOT_YET_RECRUITING
Paris
HOP Cochin
NOT_YET_RECRUITING
Paris
HOP Sud
NOT_YET_RECRUITING
Rennes
HOP Civil
NOT_YET_RECRUITING
Strasbourg
HOP Rangueil
NOT_YET_RECRUITING
Toulouse
Germany
Immanuel-Krankenhaus GmbH
NOT_YET_RECRUITING
Berlin
Universitätsklinikum Bonn AöR
NOT_YET_RECRUITING
Bonn
Städtisches Klinikum Braunschweig gGmbH
NOT_YET_RECRUITING
Braunschweig
Gesundheit Nord gGmbH | Klinikverbund Bremen
NOT_YET_RECRUITING
Bremen
Krankenhaus Porz am Rhein gGmbH
NOT_YET_RECRUITING
Cologne
Universitätsklinikum Düsseldorf
NOT_YET_RECRUITING
Düsseldorf
Universitätsklinikum Erlangen
NOT_YET_RECRUITING
Erlangen
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
NOT_YET_RECRUITING
Essen
Universitätsklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
Helios Fachklinik Vogelsang-Gommern GmbH
NOT_YET_RECRUITING
Gommern
Medizinische Hochschule Hannover
NOT_YET_RECRUITING
Hanover
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
NOT_YET_RECRUITING
Herne
medius Kliniken gGmbH
NOT_YET_RECRUITING
Kirchheim Unter Teck
Klinikum Konstanz
NOT_YET_RECRUITING
Konstanz
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
NOT_YET_RECRUITING
Lübeck
Johannes Wesling Klinikum Minden
NOT_YET_RECRUITING
Minden
Klinikum der Universität München AÖR
NOT_YET_RECRUITING
München
Krankenhaus Barmherzige Brüder Regensburg
NOT_YET_RECRUITING
Regensburg
Italy
ASST degli Spedali Civili di Brescia
NOT_YET_RECRUITING
Brescia
A. O. Universitaria Careggi
NOT_YET_RECRUITING
Frienze
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
IRCCS San Raffaele
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera Policlinico di Modena
NOT_YET_RECRUITING
Modena
Università degli Studi Padova
NOT_YET_RECRUITING
Padua
Fondazione IRCCS Policlinico S. Matteo
NOT_YET_RECRUITING
Pavia
AOU Policlinico Umberto I
NOT_YET_RECRUITING
Roma
Japan
Fujita Health University Hospital
NOT_YET_RECRUITING
Aichi, Toyoake
Hospital of the University of Occupational and Environmental Health
NOT_YET_RECRUITING
Fukuoka, Kitakyushu
Hiroshima University Hospital
NOT_YET_RECRUITING
Hiroshima, Hiroshima
Hokkaido University Hospital
NOT_YET_RECRUITING
Hokkaido, Sapporo
Sapporo Medical University Hospital
NOT_YET_RECRUITING
Hokkaido, Sapporo
Kagawa University Hospital
NOT_YET_RECRUITING
Kagawa, Kita-gun
St. Marianna University Hospital
NOT_YET_RECRUITING
Kanagawa, Kawasaki
Kitasato University Hospital
NOT_YET_RECRUITING
Kanagawa, Sagamihara
Kyoto University Hospital
NOT_YET_RECRUITING
Kyoto, Kyoto
Nagasaki University Hospital
NOT_YET_RECRUITING
Nagasaki, Nagasaki
Osaka Medical and Pharmaceutical University Hospital
NOT_YET_RECRUITING
Osaka, Takatsuki
Saitama Medical University Hospital
NOT_YET_RECRUITING
Saitama, Iruma-gun
Juntendo University Hospital
NOT_YET_RECRUITING
Tokyo, Bunkyo-ku
Nippon Medical School Hospital
NOT_YET_RECRUITING
Tokyo, Bunkyo-ku
Keio University Hospital
NOT_YET_RECRUITING
Tokyo, Shinjuku-ku
Mexico
Investigacion y Biomedicina de Chihuahua S.C.
NOT_YET_RECRUITING
Chihuahua City
Centro Integral en Reumatologia, SA. de CV.
NOT_YET_RECRUITING
Guadalajara
Medical Care & Research SA de CV
NOT_YET_RECRUITING
Mérida
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
NOT_YET_RECRUITING
Mexico City
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
NOT_YET_RECRUITING
Mexico City
Soltmed Smo
NOT_YET_RECRUITING
Mexico City
Hospital Universitario Dr Jose Eleuterio Gonzalez
NOT_YET_RECRUITING
Monterrey
Netherlands
Zuyderland Medisch Centrum
NOT_YET_RECRUITING
Heerlen
St. Antonius ziekenhuis, locatie Nieuwegein
NOT_YET_RECRUITING
Nieuwegein
Erasmus Medisch Centrum-ROTTERDAM-50697
NOT_YET_RECRUITING
Rotterdam
Norway
Akershus Universitetssykehus HF
NOT_YET_RECRUITING
Nordbyhagen
Sykehuset Telemark HF, Avd. Skien
NOT_YET_RECRUITING
Skien
Puerto Rico
GCM Medical Group, PSC
NOT_YET_RECRUITING
San Juan
Republic of Korea
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam
Kyung Hee University Hospital
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Soonchunhyang University Hospital Seoul
NOT_YET_RECRUITING
Seoul
Spain
Hospital Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall D Hebron
NOT_YET_RECRUITING
Barcelona
Hospital de Basurto
NOT_YET_RECRUITING
Bilbao
Hospital Universitario Reina Sofía-Córdoba-40500
NOT_YET_RECRUITING
Córdoba
Hospital Juan Ramón Jimenez
NOT_YET_RECRUITING
Huelva
Hospital de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Fundación Jiménez Díaz
NOT_YET_RECRUITING
Madrid
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramon Y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Clínico de Santiago
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Virgen del Rocío
NOT_YET_RECRUITING
Seville
Hospital Virgen Macarena
NOT_YET_RECRUITING
Seville
Hospital Dr. Peset
NOT_YET_RECRUITING
Valencia
Complejo Hospitalario Universitario de Vigo
NOT_YET_RECRUITING
Vigo
Switzerland
Cantonal Hospital of Aarau
NOT_YET_RECRUITING
Aarau
Universitätsspital Basel
NOT_YET_RECRUITING
Basel
Hopitaux Universitaires de Geneve (HUG)
NOT_YET_RECRUITING
Geneva
Neuchatel Hospital Network
NOT_YET_RECRUITING
Neuchâtel
Kantonsspital St.Gallen
NOT_YET_RECRUITING
Sankt Gallen
University Hospital Zurich
NOT_YET_RECRUITING
Zurich
United Kingdom
Antrim Area Hospital
NOT_YET_RECRUITING
Antrim
Heartlands Hospital
NOT_YET_RECRUITING
Birmingham
Royal Brompton Hospital
NOT_YET_RECRUITING
London
St George's Hospital-London-26733
NOT_YET_RECRUITING
London
University College Hospital
NOT_YET_RECRUITING
London
Altnagelvin Area Hospital
NOT_YET_RECRUITING
Londonderry
NIHR Lancashire Clinical Research Facility
NOT_YET_RECRUITING
Preston
Royal Hallamshire Hospital
NOT_YET_RECRUITING
Sheffield
Royal Cornwall Hospital
NOT_YET_RECRUITING
Truro
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2025-09-13
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 400
Treatments
Experimental: Nerandomilast
Participants with SARD-ILDs will receive nerandomilast.
Placebo_comparator: Placebo
Participants with SARD-ILDs will receive placebo.
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov