Belimumab for Interstitial Lung Disease Associated with Connective Tissue Disease
This study is investigating belimumab to see if it can help adults with interstitial lung disease (ILD), a condition that causes inflammation and stiffening of the lungs, when it's linked to connective tissue diseases (CTDs). You might be able to join if you're 18 or older and your ILD is still active or getting worse despite standard treatments. The main goal is to see if belimumab can improve your lung function, specifically by measuring changes in your Forced Vital Capacity (FVC) after 52 weeks. The study aims to enroll 440 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 440 participants. Some participants will receive belimumab, while others will receive a placebo (an inactive substance).
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at Week 52, indicating follow-up for at least that duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06572384
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
Recruiting
PHASE3Ages 18+InterventionalTreatmentGlaxoSmithKline
~440 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:BelimumabPlacebo
At a glance
Recruiting sites
130 of 131 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52
Measured over Baseline and Week 52
Conditions
Where it's being run
131 sites across 26 statesChina17
Japan14
Italy12
Spain10
Argentina9
Brazil7
France6
Mexico6
Study leadership
- GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants with persistent/worsening active inflammatory disease who have failed to achieve their treatment goal, i. e., those who have experience lack of expected treatment benefit (clinically meaningful improvement in FVC), fail to demonstrate sustained lung function stability or continue to experience worsening of ILD despite initiation of standard therapy or failed to tolerate standard therapy.
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 inflammatory and/or fibrotic ILD on High Resolution Computed Tomography (HRCT) with a total disease extent of greater than or equal to (≥) 10% of the whole lung
Evidence of persistent active/worsening ILD
Must be currently receiving stable standard therapy to manage ILD and/or underlying CTD, or to have failed or failed to tolerate 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) OR
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
Exclusion
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 hospitalization).
FVC ≤ 45% of predicted, or a Diffusing Capacity of the lung for Carbon Monoxide (DLco) (corrected for hemoglobin) ≤ 40% of predicted at screening as confirmed by central reader
History or presence of diffuse alveolar hemorrhage (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) as confirmed by central reader
Significant emphysema on screening or historical HRCT (extent of emphysema exceeds extent of ILD) as confirmed by central reader
Confirmed Progressive multifocal leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms
Participants with patient health questionnaire (PHQ-9) score ≥10, that in the opinion of a mental healthcare professional pose a serious suicide risk, have 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
What this trial measures
- Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52Baseline and Week 52
Forced vital capacity is the total amount of air exhaled during the lung function test. Low FVC (mL) reflects more impaired lung function. Absolute Change from Baseline in FVC will be reported.