Emapalumab for Interstitial Lung Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Emapalumab, a medication, to determine its effectiveness for people with a fast-progressing lung disease called MDA5 RP-ILD, linked to certain antibodies. Emapalumab is already used for another immune system issue, and researchers believe it might also help with this lung problem. The trial seeks participants with worsening lung issues, such as increased breathing troubles or a greater need for oxygen, who have the MDA5 antibodies. Participants will receive the treatment through IV for 12 weeks. As a Phase 2 trial, this research measures how well Emapalumab works in an initial, smaller group, offering participants a chance to potentially benefit from this treatment.
Is there any evidence suggesting that Emapalumab is likely to be safe for humans?
A previous study used emapalumab to help people with macrophage activation syndrome, a severe immune condition. The treatment was generally well-tolerated, though some patients experienced serious side effects. Specifically, 31% of patients had serious side effects, with pneumonia being the most common, affecting 5%.
Emapalumab is already approved for use in some conditions, indicating that its safety has been studied. However, individual responses can vary, and side effects may differ. It is crucial to discuss potential risks and benefits with a doctor before joining a trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for interstitial lung disease, which often involve corticosteroids or immunosuppressive drugs, Emapalumab offers a novel approach by specifically targeting interferon-gamma, a key cytokine involved in inflammation. This targeted mechanism could potentially reduce inflammation more precisely, with fewer side effects than broad-spectrum immunosuppressants. Researchers are excited about Emapalumab because it presents a more focused way to manage the disease, possibly leading to improved outcomes for patients with fewer complications.
What evidence suggests that Emapalumab might be an effective treatment for MDA5 RP-ILD?
Research has shown that emapalumab can effectively treat immune-related conditions, such as macrophage activation syndrome. In one study, 63% of patients with primary HLH, a serious immune disorder, responded well to emapalumab. Additionally, emapalumab has been used successfully in cases of rapidly worsening lung disease linked to MDA-5 dermatomyositis. This suggests that it may help by targeting interferon gamma, a protein involved in inflammation, which can cause problems in certain lung diseases. While more research is needed, these findings offer hope for its potential use in treating MDA5 RP-ILD. Participants in this trial will receive emapalumab to evaluate its effectiveness for interstitial lung disease.24678
Who Is on the Research Team?
Kelly Corbitt, D.O.
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive emapalumab 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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of oxygen requirement, pulmonary function, and antibody levels.
What Are the Treatments Tested in This Trial?
Interventions
- Emapalumab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Swedish Orphan Biovitrum AB
Collaborator
Citations
Low-dose emapalumab treatment in refractory macrophage ...
In a real-world study for rheumatologic disease-associated HLH, the 12-month survival probability from emapalumab initiation was 86.7% and 90.0% ...
Emapalumab MDA5 Rapidly Progressive Interstitial Lung ...
This is a proof of concept study to determine if Emapalumab appears effective for the treatment of anti-MDA5 antibody positive rapidly progressive interstitial ...
Targeting Interferon Gamma With Emapalumab to Lung ...
This study is testing a medication called emapalumab to see if it can help people who have had a lung transplant and are experiencing a ...
4.
researchgate.net
researchgate.net/publication/388560205_Refractory_MDA-5_dermatomyositis_rapidly_progressive_interstitial_lung_disease_successfully_treated_with_emapalumabRefractory MDA-5 dermatomyositis rapidly progressive ...
Refractory MDA-5 dermatomyositis rapidly progressive interstitial lung disease successfully treated with emapalumab ... outcomes; severe acute interstitial lung ...
Emapalumab MDA5 Rapidly Progressive Interstitial Lung ...
This is a proof of concept study to determine if Emapalumab appears effective for the treatment of anti-MDA5 antibody positive rapidly progressive interstitial ...
Efficacy and safety of emapalumab in macrophage activation ...
The objective of this study was to confirm the adequacy of an emapalumab dosing regimen in relation to interferon-γ (IFNγ) activity by assessing efficacy and ...
Safety Data | Gamifant® (emapalumab-lzsg) For HCPs
Serious adverse reactions were reported in 12 patients (31%), with the most common serious adverse reaction being pneumonia (5%). Fatal adverse reactions ...
Efficacy and Safety of Emapalumab in Children and Adults ...
Emapalumab achieved sustained control of MAS in a phase 2 trial (NCT03311854). This report presents data from an expanded population of patients ...
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