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Not yet recruiting NCT07486869

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

Phase II Interventional Dermatomyositis Dermatomyositis Sine Myositis Dermatomyositis With Myopathy Dermatomyositis With Respiratory Involvement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emapalumab.
Who it may be relevant to
Registry conditions: Dermatomyositis, Dermatomyositis Sine Myositis, Dermatomyositis With Myopathy, Dermatomyositis With Respiratory Involvement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Emapalumab for the Treatment of Anti-MDA5 Antibody Positive Rapidly Progressive Interstitial Lung Disease

Overview

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

  • Drug Emapalumab
    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.

Primary outcome measures

  • Change in oxygen requirement [Time frame: Baseline, 4 weeks, 12 weeks]
  • Forced Vital Capacity (FVC) [Time frame: Baseline, 12 weeks]
  • Diffusing capacity of the lungs for carbon monoxide (DLCO) [Time frame: Baseline, 12 weeks]
  • Change in chest computed tomography (CT) consolidations [Time frame: Baseline, 4 weeks, 12 weeks]
Secondary outcome measures (3)
  • Change in Ferritin level [Time frame: Baseline, 4 weeks, 12 weeks]
  • Change in MDA5 antibody level [Time frame: Baseline, 12 weeks]
  • New infections during treatment [Time frame: Baseline, 12 weeks]

Eligibility criteria

Inclusion criteria

  • Progressive interstitial lung disease as determined by at least 2/4 of the following:
  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami Hospital and Clinics — Miami

Identifiers

NCT: NCT07486869 · 20241227

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗