Health Trials

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

ConditionsDermatomyositisDermatomyositis Sine MyositisDermatomyositis With MyopathyDermatomyositis With Respiratory InvolvementDermatomyositis With Organ InvolvementInterstitial Lung DiseaseInterstitial Lung Disease Due to Connective Tissue Disease (Disorder)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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

Qualifiers

worsening respiratory symptoms;

worsening or new oxygen requirement;

worsening disease on CT chest;

worsening Forced Vital Capacity (FVC1) or Diffusing Capacity for Carbon Monoxide (DLCO) on pulmonary function tests

Disqualifiers

Active, untreated bacterial, mycobacterial or fungal infection

Active herpes zoster infection

Currently requiring extracorporeal membrane oxygenation (ECMO)

Participant refusal to participate in the study

Trial design

Treatments tested in this trial

  • Emapalumab

Treatment groups

5 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Miami

Lead sponsor

Swedish Orphan Biovitrum

Collaborator

Source ClinicalTrials.gov