Last updated 3 months ago
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
440 patients around the world
Available in Spain, Brazil, Argentina, United States, Mexico, Panama
GlaxoSmithKline
1Research sites
440Patients around the world
This study is for people with
Interstitial Lung Disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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).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 less than (<)1%.Capable of giving signed informed consent.
- 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 or requiring supplemental oxygen 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 HRCT (extent of emphysema exceeds extent of ILD).Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms.Have evidence of moderate to severe depression, defined as PHQ-9 score ≥10, or serious current suicide risk, or 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.
Sites
STAT Research - CABA
Recruiting
StudyBEconneCTD-ILD
SponsorGlaxoSmithKline
Conditions
Interstitial Lung Disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06572384
