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

ConditionsDermatomyositis 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)

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

Locations

University of Miami Hospital and Clinics33136, MiamiFlorida, United States

Sponsors and collaborators

University of Miami

Lead sponsor

Swedish Orphan Biovitrum

Collaborator

Source ClinicalTrials.gov