Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis
United States52 participantsStarted 2026-10-01
Plain-language summary
This Phase IIb trial will compare effectiveness and safety of a multi-component autoantibody reduction therapy (AART), consisting of therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIg) for treatment of patients with progressive idiopathic pulmonary fibrosis (IPF).
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age between 40-85 years old.
. A diagnosis of IPF that fulfills latest ATS/ERS Consensus Criteria.
. A diagnosis of Progressive IPF (P-IPF), defined as a relative decrease of FVC%p \>10% during the preceding twelve months, and substantiated by replicate values at least three weeks apart.
. Ability and willingness to give informed consent (no surrogates) and adhere to requirements.
. Have eligibility confirmed by a consensus of trial investigators.
. Is not now or has been in experimental regimen for at least 2 weeks (or 5 half-lives of agent) and agrees to not become participants in other experimental regimens (other than solely observational registries) for the duration of their participation in this trial (180 days).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Forced Vital Capacity (FVC)
Timeframe: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
. Has been immunized with 2025-2026 COVID-19 vaccine (and later versions as they become available) between 1 and 26 weeks prior to randomization.
. IPF duration \<10 years, based on the date of definitive diagnosis.
Exclusion criteria
. Diagnoses of current infection by clinical or microbial assessments.
. Diagnoses of an additional or alternative etiology for lung dysfunction based upon clinical assessment, including sepsis, congestive heart failure, thromboembolism, worsened pulmonary artery hypertension, etc. using routine clinical evaluations under direction of the attending physician.
. History or serologic evidence of hepatitis B or C infection. Positive serology for Hepatitis C will not exclude patients if their circulating HC virus RNA test is negative.
. Coagulopathy, defined as an INR \>1.6, PTT \>2x control, fibrinogen \<100 mg/dL, or platelet count \<50,000 unless these abnormalities can be reversed.
. Uncontrolled diabetes or hypertension (systolic BP \>160 mm Hg and diastolic BP \>100 mm Hg) that would contraindicate use of corticosteroids.
. Hemodynamic instability, defined as an inotrope or vasopressor requirement.
. History of reactions to blood products, murine-derived products, or prior rituximab use within the last six months.
. History of malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer, the latter defined as stage T1 or T2a, with prostate specific antigen \<10 ng/dl. AART is not known to promote cancer, and these criteria are within current guidelines.