ClinicalTrials.gov record NCT07486869
Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study
Emapalumab for the Treatment of Anti-MDA5 Antibody Positive Rapidly Progressive Interstitial Lung Disease
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This phase 2, proof-of-concept, single-group interventional study evaluates intravenous emapalumab in adults with anti‑MDA5 antibody–positive rapidly progressive interstitial lung disease (RP‑ILD). Participants receive emapalumab on a set dosing schedule during a 12‑week treatment period. The study measures oxygen needs, lung function, chest CT findings, ferritin and anti‑MDA5 antibody levels.
What it is studying. Tests emapalumab treatment and measures changes in oxygen requirement, lung function (FVC and DLCO), chest CT consolidations, ferritin, anti‑MDA5 antibody levels, and new infections.
What the researchers hope to learn. To collect early evidence on how emapalumab affects oxygen requirement, lung function, chest CT consolidations, ferritin and anti‑MDA5 antibody levels, and the occurrence of new infections in adults with anti‑MDA5 RP‑ILD.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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 being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Emapalumab
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive intravenous emapalumab over a 12-week treatment period. The registry lists an initial regimen (6 mg/kg on Day 1, then 3 mg/kg every 3 days for 2 weeks, then 3 mg/kg twice weekly for 2 weeks) but does not detail dosing for the remaining weeks. They will have chest CT scans, lung function tests including FVC and DLCO, and a 6-minute walk test with assessment of oxygen needs at baseline and at planned follow-up times (including about 4 and 12 weeks), plus blood tests for ferritin and anti‑MDA5 levels. Study staff will monitor for new infections and other safety measures during the study. Visits, infusions, imaging, and blood tests are scheduled by the study team.
How the study is structured. Interventional phase 2, single-group, open-label study. All participants receive intravenous emapalumab: 6 mg/kg on Day 1, then 3 mg/kg every 3 days for 2 weeks, then 3 mg/kg twice weekly for an additional 2 weeks, with total treatment duration 12 weeks. Key assessments occur at baseline, 4 weeks and 12 weeks and include oxygen flow at rest and during a 6‑minute walk, pulmonary function tests (FVC and DLCO), chest CT, blood tests (including ferritin and anti‑MDA5 antibody levels), and monitoring for new infections.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on dermatomyositis
This trial is also listed on this site under polymyositis.
Important dates
- Study start
- Jul 23, 2026
- Primary completion
- July 2027 (estimated)
- Study completion
- July 2027 (estimated)
- Target enrollment
- 5 participants (estimated)
- Last updated on registry
- Aug 25, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University of Miami
- Principal investigator
- Kelly Corbitt, Assistant Professor of Clinical Medicine
University of Miami - Collaborators
- Swedish Orphan Biovitrum
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Kelly Corbitt, D.O. 📞 305-243-7545 ✉ KKC51@miami.edu
Participating sites (1)
- University of Miami Hospital and ClinicsRecruiting
Miami, Florida, 33136 · United States
- Kelly Corbitt, D.O. · 305-243-7545 · KKC51@miami.edu
Terms used on this page · explanations by MedicalUpdates.ai
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- Forced Vital Capacity
- A breathing test that measures the total amount of air a person can blow out after a full breath in. It is often given as a percentage of what is expected for a person's age and size.
- Diffusing Capacity
- A breathing test that measures how well the lungs pass oxygen from the air into the blood.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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