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

Recruiting now · Phase 3

Conditions studied: Idiopathic Pulmonary Fibrosis, Acute Exacerbation of Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT07299695

Run by

Argyrios Tzouvelekis

People needed

196

Starts

2026-01-25

Expected to finish

2028-12-01

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥ 18 years of age
• Patients with IPF diagnosis that fulfils ATS/ERS Consensus Criteria.
• Patients hospitalised with a definite or suspected AE-IPF diagnosis, as defined by the international working group criteria and as ascertained by the responsible Primary Investigator.
• The criteria of IPF-AE are as follows:
• Previous or concurrent diagnosis of IPF
• Acute worsening or development of dyspnoea typically < 1 month duration
• Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern
• Deterioration not fully explained by cardiac failure or fluid overload Patients who fail to meet all 4 criteria due to missing computed tomography should be considered as having "suspected Acute Exacerbation".
• A) If the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and/or histopathologic changes consistent with usual interstitial pneumonia pattern on the current evaluation.
• B) If no previous computed tomography is available, the qualifier "new" can be dropped from the third AE-IPF criterion.
• Patient able to understand and sign a written informed consent form. In case of incapacity of the patient, the written informed consent form will be signed by the patients' legally authorized representative.

You may not qualify if…

• Patients with acute worsening due to uncontrolled heart failure or pulmonary embolism.
• Patients with known hypersensitivity to corticosteroids, IVIG or any component of the study treatment.
• Patients with known IgA deficiency (IgA level <7 mg/dL)- to preclude IVIG reactions.
• Patients without a definite diagnosis of IPF or AE-IPF based on clinical, radiological, laboratory evaluation, and multidisciplinary discussion.
• Patients with active malignancy or currently receiving cancer treatment, except for basal cell or squamous cell skin cancer or low-risk prostate cancer (T1 or T2a stage with PSA <10 ng/dL). These criteria are aligned with current guidelines.
• Patients that have received treatment for >14 days within the preceding month with >20mg daily prednisone (or equivalent) or any treatment during the last month with immunosuppressants (e.g., cyclophosphamide, mycophenolate etc.) according to already published therapeutic protocols or > 1 mg/kg/d from more than 7 days in the last 15 days.
• Patients participating to another interventional clinical trial.
• Patients with documented pregnancy or lactation.
• Patients under tutorship or curatorship.
• Patients deprived of liberty or under court protection.
• Patients who refuse to participate or decline to provide written informed consent.

Where it is running

• Department of Respiratory Medicine, University Hospital of Patras — Pátrai, Greece (enrolling)

Full record on ClinicalTrials.gov

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