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Experimental drug takes aim at deadly lung complication

NCT ID NCT07486869

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This small study will test a drug called emapalumab in 5 adults with a rare, rapidly worsening lung disease linked to dermatomyositis. The drug is already used for a similar immune overreaction condition. Researchers will check if it improves oxygen needs, lung function, and CT scans over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Emapalumab
What this could lead to
If it works, this could point toward a treatment for a rare, life-threatening lung condition that currently has few options.
What could go wrong
This is a very small, early proof-of-concept study with only 5 people. It may not show clear benefit, and emapalumab can have serious side effects like infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

amyopathic dermatomyositis anti-MDA5 dermatomyositis dermatomyositis interstitial lung disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dermatomyositis Dermatomyositis sine myositis Dermatomyositis with myopathy Dermatomyositis with organ involvement Dermatomyositis with respiratory involvement Interstitial lung disease Interstitial lung disease due to connective tissue disease (disorder)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Miami Hospital and Clinics

    RECRUITING

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.