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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07486869
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • 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)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Emapalumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in oxygen requirement [ Time Frame: Baseline, 4 weeks, 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Hospital and ClinicsMiamiFlorida33136
Kelly Corbitt, D.O.
[email protected]
305-243-7545

Find similar trials in Miami, FL

By research site
University of Miami Hospital and Clinics· Miami, FL

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