drugset / Trial / NCT07299695

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis

NCT07299695

Phase 3 Recruiting 196 enrolled Argyrios Tzouvelekis
RandomizedParallel-groupOpen-labelTreatment

Summary

Acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) are sudden and severe worsening episodes that can be life-threatening. Currently, no treatment has been proven to clearly improve outcomes during these events. Inflammation and immune system imbalance are thought to play an important role in causing AE-IPF. Early clinical experience suggests that intravenous immunoglobulin (IVIG) can be beneficial for patients suffering from AE-IPF. This clinical trial aims to determine whether adding IVIG to usual treatment can improve outcomes for patients hospitalized with AE-IPF.

Timeline

Start
2026-01-25
Primary completion
2028-06
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 1 g/kg Intravenous
Comparator Fondaparinux Other / unclassified
Comparator Methylprednisolone Other / unclassified 250 mg Intravenous
Comparator Nerandomilast Small molecule
Comparator Nintedanib Small molecule
Comparator Pirfenidone Small molecule