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RECRUITING

NCT07299695

PHASE3

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

Sponsor: Argyrios Tzouvelekis

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multicenter, Randomized, Open-Label Clinical Trial Evaluating the Efficacy of Intravenous Immunoglobulin in Patients Hospitalized for Acute Exacerbations of Idiopathic Pulmonary Fibrosis.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2026-01-25

Completion Date

2028-12

Last Updated

2026-03-16

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Interventions

DRUG

Intravenous immunoglobulin (IVIG)

Total dose of 1 g/kg, divided over three consecutive days. The infusion will start at a rate of 0.5 mg/kg/hour for the first 15 minutes and, if no adverse reaction occurs, the rate will then be gradually increased step-wise as tolerated. Premedication with acetaminophen and levocetirizine. Usual treatment will be co-administered, as described.

DRUG

Usual treatment

1. Corticosteroids: A pulse regimen of IV methylprednisolone at 250 mg daily (days 1 to 3), with no additional corticosteroids thereafter. 2. Antibiotics: Empirical broad-spectrum antibiotics starting from the first 24 hours of hospitalization - respiratory quinolone and/or an antipseudomonal penicillin. Duration or escalation of antibiotics may be adjusted based on available antibiograms or treating physician's clinical judgment. 3. Anticoagulation: Prophylactic-dose anticoagulation - low molecular weight heparin or fondaparinux - throughout hospitalization. Patients with an established indication for therapeutic anticoagulation will be maintained on their therapeutic regimen. 4. Antifibrotic therapy: Antifibrotics (nintedanib, pirfenidone, or nerandomilast) will be continued during hospitalization if already prescribed and not contraindicated. No new antifibrotic treatment will be initiated during the study period.

Inclusion Criteria: 1. Patients ≥ 18 years of age 2. Patients with IPF diagnosis that fulfils ATS/ERS Consensus Criteria. 3. 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. 4. 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. Exclusion Criteria: 1. Patients with acute worsening due to uncontrolled heart failure or pulmonary embolism. 2. Patients with known hypersensitivity to corticosteroids, IVIG or any component of the study treatment. 3. Patients with known IgA deficiency (IgA level \<7 mg/dL)- to preclude IVIG reactions. 4. Patients without a definite diagnosis of IPF or AE-IPF based on clinical, radiological, laboratory evaluation, and multidisciplinary discussion. 5. 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. 6. 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. 7. Patients participating to another interventional clinical trial. 8. Patients with documented pregnancy or lactation. 9. Patients under tutorship or curatorship. 10. Patients deprived of liberty or under court protection. 11. Patients who refuse to participate or decline to provide written informed consent.

Locations (1)

Department of Respiratory Medicine, University Hospital of Patras

Pátrai, Greece