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Набира участници Фаза 3 NCT06806592

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Interstitial Lung Diseases Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

Спонсор: Boehringer Ingelheim

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
Nerandomilast
DRUG
Placebo matching nerandomilast
DRUG
Места на провеждане 158
Австралия (5)
Royal Prince Alfred Hospital
Camperdown, Sydney , New South Wales
NOT_YET_RECRUITING
The Prince Charles Hospital
Chermside , Queensland
St Vincent's Hospital Sydney
Darlinghurst , New South Wales
NOT_YET_RECRUITING
Austin Hospital
Heidelberg , Victoria
Fiona Stanley Hospital
Murdoch , Western Australia
Австрия (3)
Krems University Hospital
Krems
NOT_YET_RECRUITING
AKH - Medical University of Vienna
Vienna
NOT_YET_RECRUITING
Klinikum Wels - Grieskirchen GmbH
Wels
Китай (17)
Beijing Chao-Yang Hospital
Beijing
China-Japan Friendship Hospital
Beijing
Peking Union Medical College Hospital
Beijing
West China Hospital, Sichuan University
Chengdu
NOT_YET_RECRUITING
People's Hospital of Sichuan Province
Chengdu
Guangdong Provincial People's Hospital
Guangzhou
The First Affiliated Hospital, Zhejiang University
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
University Hospital_Macau University of Science and Technology
Macau
NOT_YET_RECRUITING
The First Affiliated Hospital of Nanchang University
Nanchang
NOT_YET_RECRUITING
Huashan Hospital, Fudan University
Shanghai
Tianjin Medical University General Hospital
Tianjin
Wuhan Union Hospital
Wuhan
NOT_YET_RECRUITING
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan
First Affiliated Hospital of Xiamen University
Xiamen
NOT_YET_RECRUITING
Zhuzhou Central Hospital
Zhuzhou
Франция (8)
HOP d'Angers
Angers
HOP Pellegrin
Bordeaux
NOT_YET_RECRUITING
Hôpital Claude Huriez
Lille
NOT_YET_RECRUITING
Hôpital Cochin
Paris
HOP Bichat
Paris
NOT_YET_RECRUITING
HOP Sud
Rennes
NOT_YET_RECRUITING
HOP Civil
Strasbourg
NOT_YET_RECRUITING
Hôpital Rangueil - CHU de Toulouse
Toulouse
Германия (19)
Charité - Universitätsmedizin Berlin
Berlin
NOT_YET_RECRUITING
Immanuel-Krankenhaus GmbH
Berlin
Universitätsklinikum Bonn AöR
Bonn
Städtisches Klinikum Braunschweig gGmbH
Braunschweig
NOT_YET_RECRUITING
Gesundheit Nord gGmbH | Klinikverbund Bremen
Bremen
COMPLETED
Krankenhaus Porz am Rhein gGmbH
Cologne
NOT_YET_RECRUITING
Universitätsklinikum Düsseldorf
Düsseldorf
NOT_YET_RECRUITING
Universitätsklinikum Erlangen
Erlangen
NOT_YET_RECRUITING
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen
Universitätsklinikum Freiburg
Freiburg im Breisgau
NOT_YET_RECRUITING
Helios Fachklinik Vogelsang-Gommern GmbH
Gommern
NOT_YET_RECRUITING
Medizinische Hochschule Hannover
Hanover
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Herne
NOT_YET_RECRUITING
medius Kliniken gGmbH
Kirchheim unter Teck
Klinikum Konstanz
Konstanz
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck
Johannes Wesling Klinikum Minden
Minden
NOT_YET_RECRUITING
Klinikum der Universität München AÖR
München
NOT_YET_RECRUITING
Krankenhaus Barmherzige Brüder Regensburg
Regensburg
NOT_YET_RECRUITING
Италия (8)
ASST degli Spedali Civili di Brescia
Brescia
NOT_YET_RECRUITING
A. O. Universitaria Careggi
Florence
NOT_YET_RECRUITING
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan
Ospedale San Raffaele S.r.l.
Milan
NOT_YET_RECRUITING
Azienda Ospedaliero-Universitaria di Modena
Modena
NOT_YET_RECRUITING
Azienda Ospedaliera Universitaria di Padova
Padova
NOT_YET_RECRUITING
Fondazione IRCCS Policlinico S. Matteo
Pavia
AOU Policlinico Umberto I
Roma
NOT_YET_RECRUITING
Япония (15)
Fujita Health University Hospital
Aichi, Toyoake
NOT_YET_RECRUITING
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu
Hiroshima University Hospital
Hiroshima, Hiroshima
Sapporo Medical University Hospital
Hokkaido, Sapporo
NOT_YET_RECRUITING
Hokkaido University Hospital
Hokkaido, Sapporo
Kagawa University Hospital
Kagawa, Kita-gun
COMPLETED
St. Marianna University Hospital
Kanagawa, Kawasaki
NOT_YET_RECRUITING
Kitasato University Hospital
Kanagawa, Sagamihara
Kyoto University Hospital
Kyoto, Kyoto
Nagasaki University Hospital
Nagasaki, Nagasaki
NOT_YET_RECRUITING
Osaka Medical and Pharmaceutical University Hospital
Osaka, Takatsuki
NOT_YET_RECRUITING
Saitama Medical University Hospital
Saitama, Iruma-gun
Juntendo University Hospital
Tokyo, Bunkyo-Ku
NOT_YET_RECRUITING
Nippon Medical School Hospital
Tokyo, Bunkyo-ku
Keio University Hospital
Tokyo, Shinjuku-ku
Mexico (7)
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City
Centro Integral en Reumatologia, SA. de CV.
Guadalajara
Medical Care & Research SA de CV
Mérida
Soltmed Smo
Mexico City
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
Mexico City
NOT_YET_RECRUITING
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City
NOT_YET_RECRUITING
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey
Нидерландия (3)
Zuyderland Medisch Centrum
Heerlen
St. Antonius Ziekenhuis
Nieuwegein
NOT_YET_RECRUITING
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam
NOT_YET_RECRUITING
Норвегия (2)
Akershus Universitetssykehus HF
Nordbyhagen
NOT_YET_RECRUITING
Sykehuset Telemark HF, Avd. Skien
Skien
NOT_YET_RECRUITING
Puerto Rico (1)
GCM Medical Group, PSC
San Juan
NOT_YET_RECRUITING
Южна Корея (4)
Seoul National University Bundang Hospital
Seongnam
Kyung Hee University Hospital
Seoul
Seoul National University Hospital
Seoul
NOT_YET_RECRUITING
Soonchunhyang University Hospital Seoul
Seoul
Испания (14)
Hospital Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital de Basurto
Bilbao
Hospital Universitario Reina Sofía
Córdoba
Hospital Juan Ramón Jimenez
Huelva
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Hospital Universitario Ramon Y Cajal
Madrid
Fundación Jiménez Díaz
Madrid
NOT_YET_RECRUITING
Hospital Universitario 12 de Octubre
Madrid
Hospital Clínico de Santiago
Santiago de Compostela
Hospital Universitario Virgen De La Macarena
Seville
NOT_YET_RECRUITING
Hospital Virgen del Rocío
Seville
Hospital Dr. Peset
Valencia
Complejo Hospitalario Universitario de Vigo
Vigo
Швейцария (6)
Cantonal Hospital of Aarau
Aarau
NOT_YET_RECRUITING
Universitätsspital Basel
Basel
Hopitaux Universitaires de Geneve (HUG)
Geneva
NOT_YET_RECRUITING
Neuchatel Hospital Network
Neuchâtel
Kantonsspital St.Gallen
Sankt Gallen
University Hospital Zurich
Zurich
SUSPENDED
Великобритания (13)
Antrim Area Hospital
Antrim
Royal United Hospital, Bath
Bath
NOT_YET_RECRUITING
Heartlands Hospital
Birmingham
Chapel Allerton Hospital
Leeds
Royal Free Hospital
London
St George's Hospital
London
University College Hospital
London
Altnagelvin Area Hospital
Londonderry
Luton & Dunstable University Hospital
Luton
NIHR Lancashire Clinical Research Facility
Preston
NOT_YET_RECRUITING
Northern General Hospital
Sheffield
NOT_YET_RECRUITING
Royal Cornwall Hospital
Truro
Southend University Hospital
Westcliffe-on-Sea
САЩ (33)
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta , Georgia
Augusta University
Augusta , Georgia
NOT_YET_RECRUITING
Rheumatology and Pulmonary Clinic
Beckley , West Virginia
University of Alabama at Birmingham
Birmingham , Alabama
Massachusetts General Hospital
Boston , Massachusetts
NOT_YET_RECRUITING
Brigham and Women's Hospital
Boston , Massachusetts
Meris Clinical Research-Brandon-69466
Brandon , Florida
NOT_YET_RECRUITING
Northwestern University
Chicago , Illinois
The University of Chicago Medical Center
Chicago , Illinois
NOT_YET_RECRUITING
Cleveland Clinic
Cleveland , Ohio
NOT_YET_RECRUITING
National Jewish Health
Denver , Colorado
Northshore University Health System
Evanston , Illinois
Northwell Health
Great Neck , New York
NOT_YET_RECRUITING
The University of Texas Health Science Center at Houston
Houston , Texas
University of Kansas Medical Center
Kansas City , Kansas
University of California Los Angeles
Los Angeles , California
NOT_YET_RECRUITING
University of Wisconsin
Madison , Wisconsin
Miami VA Healthcare System
Miami , Florida
University of Minnesota
Minneapolis , Minnesota
Yale University School of Medicine
New Haven , Connecticut
LSU Health Sciences Center
New Orleans , Louisiana
NOT_YET_RECRUITING
NYU Langone Health
New York , New York
Columbia University Medical Center-New York Presbyterian Hospital
New York , New York
NOT_YET_RECRUITING
University of Nebraska Medical Center
Omaha , Nebraska
Temple Lung Center
Philadelphia , Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh , Pennsylvania
Mayo Clinic, Rochester
Rochester , Minnesota
Onsite Clinical Solutions
Salisbury , North Carolina
University of Utah Health Sciences Center
Salt Lake City , Utah
NOT_YET_RECRUITING
University of Texas Health Science Center at San Antonio
San Antonio , Texas
NOT_YET_RECRUITING
Paradigm Clinical Research - San Diego
San Diego , California
Mayo Clinic-Arizona
Scottsdale , Arizona
Southeastern Research Center-Winston Salem-69289
Winston-Salem , North Carolina
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
13.09.2025
Крайна дата
30.07.2027
Регистрационен номер
NCT06806592
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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