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Recruiting
NCT07486869
Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study
Conditions: Dermatomyositis, Dermatomyositis Sine Myositis, Dermatomyositis With Myopathy, Dermatomyositis With Respiratory Involvement, Dermatomyositis With Organ Involvement, Interstitial Lung Disease, Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 5
Sponsor: University of Miami
Location: University of Miami Hospital and Clinics Miami Florida
Summary
This is a proof of concept study to determine if Emapalumab appears effective for the treatment of anti-MDA5 antibody positive rapidly progressive interstitial lung disease (MDA5 RP-ILD). Emapalumab is a medication that is currently used for a severe problem with the immune system, called macrophage activation syndrome, and this disease shares some similar features with MDA5 RP-ILD.
Eligibility Criteria
Inclusion Criteria:
* Progressive interstitial lung disease as determined by at least 2/4 of the following:
1. worsening respiratory symptoms;
2. worsening or new oxygen requirement;
3. worsening disease on CT chest;
4. worsening Forced Vital Capacity (FVC1) or Diffusing Capacity for Carbon Monoxide (DLCO) on pulmonary function tests
* MDA5 antibodies present
* Elevated ferritin above the upper limit of normal (ULN)
* Participant at least 18 years old
Exclusion Criteria:
* Active, untreated bacterial, mycobacterial or fungal infection
* Active herpes zoster infection
* Currently requiring extracorporeal membrane oxygenation (ECMO)
* Participant refusal to participate in the study
* Pregnant women
* Prisoners
Source: ClinicalTrials.gov (NCT07486869). StuddyBuddy aggregates publicly available trial information.
