Recruiting
Phase 2

Emapalumab with Medication

Sponsor:

University of Miami

Code:

NCT07486869

Conditions

Dermatomyositis

Dermatomyositis Sine Myositis

Dermatomyositis With Myopathy

Dermatomyositis With Respiratory Involvement

Dermatomyositis With Organ Involvement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Emapalumab

Study Details

Brief summary:

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.

Conditions

Dermatomyositis

Dermatomyositis Sine Myositis

Dermatomyositis With Myopathy

Dermatomyositis With Respiratory Involvement

Dermatomyositis With Organ Involvement

Study ID

NCT07486869

Start date

Jul 23, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Emapalumab

Participants will receive emapalumab administered intravenously at a dose of 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 an additional 2 weeks. Total treatment duration is 12 weeks.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kelly Corbitt, D.O.

305-243-7545KKC51@miami.edu

Locations

University of Miami Hospital and Clinics

Recruiting

Miami, Florida, United States, 33136

Contacts

Kelly Corbitt, D.O.

305-243-7545KKC51@miami.edu

More Information

Sponsor

University of Miami

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-25.