2024-512849-17-00招募中3 期
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)
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.57 个研究点 分布在 5 个国家目标入组 161 人开始时间: 2025年3月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 161
- 试验地点
- 57
- 主要终点
- Absolute change from baseline in QILD score [%] on HRCT at Week 26
研究概览
简要总结
The primary objective is to investigate the effect of nerandomilast on the extent of pulmonary involvement from baseline to Week 26 as assessed with quantitative interstitial lung disease (QILD) score in quantitative high-resolution computed tomography (qHRCT). The primary treatment comparison is as randomised, including all data collected until Week 26 regardless of treatment discontinuation, start of restricted medication, changes in background IS therapies, or initiation of nintedanib.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •"Participant has SARD-ILD, defined as - Diagnosis by a rheumatologist with at least 1 of the following SARDs: RA, SSc (participants must be anticentromere auto-antibody negative), IIM, Sjögren’s disease, or MCTD - Presence of fibrotic ILD on 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 IS therapy according to both criteria: - No improvement in absolute 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 SoC treatment with IS, IM, or nintedanib is planned
- •Further inclusion criteria apply
排除标准
- •Organising pneumonia as predominant pattern in the HRCT
- •Prebronchodilator FEV1/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
结局指标
主要结局
Absolute change from baseline in QILD score [%] on HRCT at Week 26
Absolute change from baseline in QILD score [%] on HRCT at Week 26
次要结局
- Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
- Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26
- Absolute change from baseline in vascular volume [%] on HRCT at Week 26
- Absolute change from baseline in FVC [mL] at Week 26
- Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at Week 26 at baseline
- "Time to first supplemental oxygen use during the trial for oxygen non-users at baseline"
- Occurrence of infection-related AEs from baseline over the duration of the trial
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (57)
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