jRCT2011240027招募中不适用
A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults with Interstitial Lung Disease (ILD) Associated with Connective Tissue Disease (CTD) (BEconneCTD-ILD (BElimumab for conneCtive Tissue Disease ILD))
GlaxoSmithKline K.K.0 个研究点目标入组 30 人开始时间: 2024年10月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM; including polymyositis, dermatomyositis, anti-synthetase syndrome), Sjogren's syndrome (pSS), or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria
- •Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extent of greater than or equal to (>-) 10% of the whole lung (WLILD), as confirmed by central reader at screening.
- •Evidence of ILD progression in the previous 24 months
- •Must be currently receiving stable standard therapy to manage ILD and/or underlying CTD, or to have failed or failed to tolerate first line standard therapy.
- •Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- •Is a woman of nonchildbearing potential (WONCBP)
- •Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%
- •Capable of giving signed informed consent
排除标准
- •Diagnosis of ILD other than CTD-ILD.
- •Primary diagnosis of Systemic Sclerosis (SSc)
- •Participants with rapidly progressive disease.(absolute drop of 10% or more of FVC between screening and baseline visit and/or recent pulmonary hospitalisation).
- •FVC <- 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) <- 40% of predicted at screening.
- •History or presence of diffuse alveolar haemorrhage (DAH) or other confounding pulmonary disease, signs, or symptoms
- •Pulmonary arterial hypertension requiring therapy, as determined by the investigator at, or prior to first day of dosing (Day 1)
- •Dependence on continuous oxygen supplementation
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
- •Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC <0.7).
- •Significant emphysema on screening or historical HRCT (extent of emphysema exceeds extent of ILD)
- •Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms
- •Participants with PHQ-9 score >-10 that in the opinion of a mental healthcare professional pose a serious suicide risk, or have any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk
- •Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •Breast cancer within the past 10 years
- •Major surgery (including joint surgery) within 3 months prior to screening or planned during the duration of the study
- •An active infection, or a history of infections
结局指标
主要结局
-
Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52.
次要结局
- Absolute Change from Baseline in FVC percent (%) Predicted(At Week 52)
- Time to ILD progression or death
- Absolute Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score(at Week 52)
- Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score(at Week 52)
- Absolute Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL)(At Week 52)
- Absolute Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung(At Week 52)
- Achieving Greater than or Equal (>-)2% Decrease in QILD-WL Score(at Week 52)
- Achieving Relative Decline from Baseline in FVC (mL) >- 5 %(at Week 52)
- Achieving Relative Decline from Baseline in FVC (mL) >- 10 %(at Week 52)
- Absolute Change from Baseline in Steroid Dose (Prednisone Equivalent Dose)(at Week 52)
- Time to Connective Tissue Disease Progression
- Absolute Change from Baseline in Transition Dyspnea Index (TDI)(at Week 52)
- Absolute Change from Baseline in Short Form Health Survey 36-Item Version 2 (SF36-v2)(atWeek 52)
- Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Impacts Total Score(at Week 52)
- Absolute Change from Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD)(at Week 52)
- Absolute Change from Baseline in Physician Global Assessment (PhGA)(at Week 52)
- Absolute Change in Patient Global Impression of Change (PGIC)-ILD(at week 52)
- Absolute Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) % Predicted(at Week 52)
- Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Serious Adverse Events (SAEs)
- Number of Participants with Respiratory Related Hospitalizations(up to Week 52)
研究者
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