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)

Boehringer Ingelheim0 个研究点目标入组 400 人开始时间: 待定最近更新: 2025年2月21日

试验速览

暂无简介。

•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
•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)

•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

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

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