Last updated 11 days ago
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
400 patients around the world
Available in Puerto Rico, Mexico
Boehringer Ingelheim
19Research sites
400Patients around the world
This study is for people with
Interstitial Lung Disease
Collagenopathy-associated Interstitial Lung Disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.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.
- 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.
Sites
Instituto Nacional de Ciencias Médicas y Nutrición Dr. Salvador Zubirán
Hospital Universitario Dr. José Eleuterio González
Investigación y Biomedicina de Chihuahua
Medical Care & Research SA de CV
SOLTMED SMO
Clínica para el Diagnostico y Tratamiento de las Enfermedades Reumáticas - CITER
Centro Integral en Reumatología S.A. de C.V. - CIRSA
Centro Reumatológico Caguas
Hospital Universitario Reina Sofía
Hospital Universitario Basurto
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Collagenopathy-associated Interstitial Lung Disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06806592
