Emapalumab for MDA5 Rapidly Progressive Interstitial Lung Disease
This study is looking at whether Emapalumab, a medication currently used for a severe immune system problem, might help people with a condition called anti-MDA5 antibody positive rapidly progressive interstitial lung disease (MDA5 RP-ILD). This condition causes scarring in the lungs. You might be able to join if you are 18 or older, have worsening lung symptoms, and have MDA5 antibodies present in your blood. Researchers will give Emapalumab intravenously (through a vein) over several weeks. They will measure changes in your oxygen needs and lung function (like how much air you can breathe in and out) to see if the treatment is effective. This is a small study, planning to enroll 5 participants.
- Study design
- This is a proof-of-concept study, meaning it's an early look at whether Emapalumab might be effective. It plans to enroll 5 participants.
- What's involved
- You would receive Emapalumab intravenously on a specific schedule over several weeks. Researchers will measure your oxygen requirements and lung function at different times.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure your oxygen requirements and lung function at 4 weeks and 12 weeks after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kelly Corbitt, D.O. · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in oxygen requirementBaseline, 4 weeks, 12 weeks
Supplemental oxygen requirement assessed as the oxygen flow rate (reported in liters per minute \[L/min\]) while the participant is at rest and, when feasible, while the participant is ambulating during the 6-Minute Walk Test (6MWT). Values are compared with baseline to assess change over time.
- Forced Vital Capacity (FVC)Baseline, 12 weeks
Pulmonary function assessed using forced vital capacity (FVC) measured by standard pulmonary function testing (spirometry). The outcome is expressed as percent change from baseline (%) in FVC.
- Diffusing capacity of the lungs for carbon monoxide (DLCO)Baseline, 12 weeks
Pulmonary gas exchange capacity assessed using diffusing capacity of the lungs for carbon monoxide (DLCO) measured by standard pulmonary function testing. The outcome is expressed as percent change from baseline (%) in DLCO
- Change in chest computed tomography (CT) consolidationsBaseline, 4 weeks, 12 weeks
Pulmonary consolidations assessed on chest computed tomography (CT) scans. CT images are reviewed by a radiologist and pulmonologist, and percentage of lung affected by consolidations will be documented. Percentage change of affected lung will be evaluated.