What side effects are associated with this type of intervention?

Common treatments for Interstitial Lung Disease (ILD) that modulate the immune response, such as nintedanib and pirfenidone, have known side effects. Nintedanib often causes diarrhea, nausea, and elevated liver enzymes, while pirfenidone can lead to nausea, rash, and photosensitivity. Immunosuppressive therapies like prednisone and azathioprine are associated with increased risks of infections, gastrointestinal issues, and potential cardiac events. Treatments similar to Efzofitimod, which modulate the immune response to reduce inflammation and fibrosis, are likely to have side effects related to immune suppression, including infections and gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved pirfenidone and nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF), a type of interstitial lung disease (ILD). Pirfenidone works by reducing fibrosis and inflammation, while nintedanib inhibits multiple pathways involved in fibrosis. Both drugs aim to slow disease progression. Other treatments explored for ILD include immunomodulatory therapies like corticosteroids and investigational drugs targeting specific inflammatory and fibrotic pathways, similar to the mechanism of action being studied for Efzofitimod.

What other types of research exist?

Promising novel alternatives to Efzofitimod for ILD patients include: 1) Nintedanib, a tyrosine kinase inhibitor that has shown efficacy in reducing disease progression by targeting multiple pathways involved in fibrosis. 2) Pirfenidone, an antifibrotic agent that slows the decline in lung function and reduces mortality in IPF patients. 3) BI 1015550, a phosphodiesterase 4B inhibitor that has demonstrated antifibrotic and immunomodulatory effects in clinical trials. 4) Recombinant human pentraxin 2, which inhibits monocyte differentiation and reduces TGF-beta1 production, showing promise in slowing lung function decline.

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Efzofitimod for Scleroderma-Related Lung Disease

Phase 2

Recruiting

Research Sponsored by aTyr Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new drug called efzofitimod to see if it can help people with a lung disease linked to systemic sclerosis. The goal is to find out if the drug can improve their breathing and skin health.

Who is the study for?

This trial is for patients with a specific lung condition called SSc-ILD, linked to systemic sclerosis. Participants must have been diagnosed within the last 4 years and show significant lung involvement. They should be on a stable dose of mycophenolate and can have limited or diffuse skin disease. Smokers, those with severe lung function decline, other rheumatic diseases, or recent use of certain medications are excluded.

What is being tested?

The study tests efzofitimod at two different doses (450 mg and 270 mg) against a placebo in people with SSc-ILD. It's double-blind meaning neither doctors nor participants know who gets what treatment. The main goal is to see if it improves lung disease and skin changes over time.

What are the potential side effects?

While the side effects of efzofitimod in this context aren't detailed here, similar drugs often cause immune system reactions, infections due to lowered immunity, infusion-related responses like fever or chills, possible liver issues, and gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: efzofitimod 450 mgExperimental Treatment1 Intervention

Administered IV infusion

Group II: efzofitimod 270 mgExperimental Treatment1 Intervention

Administered IV infusion

Group III: PlaceboPlacebo Group1 Intervention

Administered IV infusion

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Interstitial Lung Disease (ILD) often target the underlying mechanisms of inflammation and fibrosis. Nintedanib and pirfenidone are antifibrotic agents that slow disease progression by inhibiting pathways involved in fibrogenesis. Nintedanib is a tyrosine kinase inhibitor that blocks multiple growth factors, while pirfenidone reduces fibroblast proliferation and collagen synthesis. Immunomodulatory treatments like rituximab and tocilizumab target specific immune pathways to reduce inflammation and fibrosis. Rituximab depletes B-cells, which are involved in autoimmune responses, and tocilizumab inhibits the IL-6 receptor, reducing inflammatory signaling. These mechanisms are crucial for ILD patients as they help manage disease progression and improve quality of life by addressing both inflammation and fibrosis.

Acute exacerbation of idiopathic pulmonary fibrosis: who to treat, how to treat.