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RECRUITING Phase 2 ClinicalTrials.gov

Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study

Sponsor: University of Miami • ClinicalTrials.gov ID: NCT07486869

Registry updated: 2026-08-25
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Description

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.

Interventions

  • Emapalumab (Drug)
    Emapalumab administered intravenously according to the following dosing regimen: 6 mg/kg on Day 1, followed by 3 mg/kg every 3 days for 2 weeks, and then 3 mg/kg twice weekly for 2 weeks.

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

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)

Locations

  • University of Miami Hospital and Clinics — Miami, Florida, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record