Emapalumab for MDA5-positive RP-ILD in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, proof-of-concept interventional study evaluating emapalumab for anti-MDA5 antibody–positive rapidly progressive interstitial lung disease associated with dermatomyositis. Eligible participants are adults with progressive ILD and evidence of MDA5 antibodies, including worsening respiratory status or imaging/functional decline, and elevated ferritin. The trial will monitor response to emapalumab and safety in a small, focused cohort at the University of Miami with collaboration from Swedish Orphan Biovitrum. Primary outcomes will reflect changes in respiratory status and lung function, with safety assessments throughout treatment. Enrollment is limited to patients without active uncontrolled infections and without pregnancy or other exclusions described.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Miami Hospital and Clinics
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Kelly Corbitt, D.O. — University of Miami
• Study coordinator: Kelly Corbitt, D.O.
• Email: KKC51@miami.edu
• Phone: 305-243-7545

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.