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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)

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

Kutsunai Mitsuru

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Yamada Nobuko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Recruiting

Aug. 21, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as:
a) 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), Sjogren's disease, or Mixed connective tissue disease (MCTD)
b) 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
2. No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:
a) 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 or more 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)
b) 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)

1. Organising pneumonia as predominant pattern in the HRCT
2. 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
3. Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period
4. Any suicidal behaviour in the past 2 years
5. 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
6. Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1

Both

Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

Nerandomilast/ Placebo matching nerandomilast

Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] at Week 26.

Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] at Week 26
Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] at Week 26
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26
Absolute change from baseline in living with pulmonary fibrosis (L-PF) Symptoms Dyspnoea domain score at Week 26
Absolute change from baseline in living with pulmonary fibrosis (L-PF) Symptoms Cough domain score at Week 26
Occurrence of infection-related adverse events (AEs) from baseline to Week 26

+81-93-691-7503

Dec. 11, 2024

Yes

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