Clinical trial NCT06806592: A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Official title: A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Interstitial Lung Diseases
Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-02-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 26 weeks. Participants continue immunosuppressant treatment for their underlying rheumatic disease.

Participants are in the study for about 7.5 months. During this time, they visit the study site 8 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: Inclusion Criteria :

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

  * Diagnosis by a rheumatologist with 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

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

Primary outcomes:
measure: Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] at Week 26.
timeFrame: At baseline and at Week 26
Secondary outcomes:
measure: Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] at Week 26
timeFrame: At baseline and at Week 26
measure: Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] at Week 26
timeFrame: At baseline and at Week 26
measure: Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26
timeFrame: At baseline and at Week 26
measure: Absolute change from baseline in living with pulmonary fibrosis (L-PF) Symptoms Dyspnoea domain score at Week 26
timeFrame: At baseline and at Week 26
measure: Absolute change from baseline in living with pulmonary fibrosis (L-PF) Symptoms Cough domain score at Week 26
timeFrame: At baseline and at Week 26
measure: Occurrence of infection-related adverse events (AEs) from baseline to Week 26
timeFrame: At baseline and at Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic-Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: San Diego
country: United States
facility: Paradigm Clinical Research - San Diego
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Brandon
country: United States
facility: Meris Clinical Research-Brandon-69466
state: Florida
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center-New York Presbyterian Hospital
state: New York
city: Salisbury
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center-Winston Salem-69289
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Temple Lung Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Camperdown, Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Krems
country: Austria
facility: Krems University Hospital
city: Vienna
country: Austria
facility: AKH - Medical University of Vienna
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen GmbH
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chengdu
country: China
facility: West China Hospital
city: Chengdu
country: China
facility: People's Hospital of Sichuan Province
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Macau
country: China
facility: University Hospital_Macau University of Science and Technology
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Wuhan
country: China
facility: Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
city: Xiamen
country: China
facility: First Affiliated Hospital of Xiamen University
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
city: Angers
country: France
facility: HOP d'Angers
city: Bordeaux
country: France
facility: HOP Pellegrin
city: Lille
country: France
facility: HOP Claude Huriez
city: Paris
country: France
facility: HOP Cochin
city: Paris
country: France
facility: HOP Bichat
city: Rennes
country: France
facility: HOP Sud
city: Strasbourg
country: France
facility: HOP Civil
city: Toulouse
country: France
facility: HOP Rangueil
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin KöR
city: Berlin
country: Germany
facility: Immanuel-Krankenhaus GmbH
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH
city: Bremen
country: Germany
facility: Gesundheit Nord gGmbH | Klinikverbund Bremen
city: Dresden
country: Germany
facility: Technische Universität Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Gommern
country: Germany
facility: Helios Fachklinik Vogelsang-Gommern GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Herne
country: Germany
facility: St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
city: Kirchheim unter Teck
country: Germany
facility: medius Kliniken gGmbH
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: Köln
country: Germany
facility: Krankenhaus Porz am Rhein gGmbH
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: München
country: Germany
facility: Klinikum der Universität München AÖR
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Frienze
country: Italy
facility: A. O. Universitaria Careggi
city: Milano
country: Italy
facility: Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS San Raffaele
city: Modena
country: Italy
facility: Azienda Ospedaliera Policlinico di Modena
city: Padova
country: Italy
facility: Università degli Studi Padova
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Aichi, Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Fukuoka, Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health
city: Hiroshima, Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Kagawa, Kita-gun
country: Japan
facility: Kagawa University Hospital
city: Kanagawa, Kawasaki
country: Japan
facility: St. Marianna University Hospital
city: Kanagawa, Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Kyoto, Kyoto
country: Japan
facility: Kyoto University Hospital
city: Nagasaki, Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Osaka, Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Saitama, Iruma-gun
country: Japan
facility: Saitama Medical University Hospital
city: Tokyo, Bunkyo-Ku
country: Japan
facility: Juntendo University Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Keio University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital Seoul
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua S.C.
city: Ciudad de Mexico
country: Mexico
facility: Soltmed Smo
city: Ciudad de Mexico
country: Mexico
facility: CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia, SA. de CV.
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
city: Mexico City
country: Mexico
facility: Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis, locatie Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum-ROTTERDAM-50697
city: Nordbyhagen
country: Norway
facility: Akershus Universitetssykehus HF
city: Skien
country: Norway
facility: Sykehuset Telemark HF, Avd. Skien
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía-Córdoba-40500
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Dr. Peset
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Aarau
country: Switzerland
facility: Cantonal Hospital of Aarau
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve (HUG)
city: Neuchatel
country: Switzerland
facility: Neuchatel Hospital Network
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zürich
country: Switzerland
facility: University Hospital Zurich
city: Antrim
country: United Kingdom
facility: Antrim Area Hospital
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: London
country: United Kingdom
facility: St George's Hospital-London-26733
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: Preston
country: United Kingdom
facility: NIHR Lancashire Clinical Research Facility
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
References: