Triple attack on lung scarring: could plasma exchange and immune therapy slow IPF?
NCT ID NCT07674745
First seen Jun 30, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This Phase II trial tests whether a combination of therapeutic plasma exchange (filtering the blood), rituximab (a drug that targets certain immune cells), and intravenous immunoglobulin (IVIg) can slow lung decline in people with progressive idiopathic pulmonary fibrosis (IPF). The study enrolls 52 adults aged 40–85 with worsening IPF. Participants receive either this triple therapy plus usual care, or usual care alone, and researchers track changes in lung function, oxygen needs, and walking distance over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- therapeutic plasma exchange, rituximab, and intravenous immunoglobulin
- What this could lead to
- If successful, this combination could offer a new way to slow lung function decline in people with progressive IPF, potentially delaying the need for oxygen or transplant.
- What could go wrong
- This is a mid-stage trial with only 52 participants, so results may not apply to all IPF patients. The treatment involves multiple procedures and carries risks like infection or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 40-85 years old. 2. A diagnosis of IPF that fulfills latest ATS/ERS Consensus Criteria. 3. 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. 4. Ability and willingness to give informed consent (no surrogates) and adhere to requirements. 5. Have eligibility confirmed by a consensus of trial investigators. 6. 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). 7. Has been immunized with 2025-2026 COVID-19 vaccine (and later versions as they become available) between 1 and 26 weeks prior to randomization. 8. IPF duration \<10 years, based on the date of definitive diagnosis. 9. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>0.70 Exclusion Criteria: 1. Diagnoses of current infection by clinical or microbial assessments. 2. 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. 3. 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. 4. 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. 5. Uncontrolled diabetes or hypertension (systolic BP \>160 mm Hg and diastolic BP \>100 mm Hg) that would contraindicate use of corticosteroids. 6. Hemodynamic instability, defined as an inotrope or vasopressor requirement. 7. History of reactions to blood products, murine-derived products, or prior rituximab use within the last six months. 8. 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. 9. Unwillingness to accept blood product transfusion. 10. Diagnosis of major comorbidities expected to interfere with study participation. 11. Treatment for \>14 days within the preceding month with \>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immuno-suppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, etc.), or with rituximab (or other anti-B-cell biological agents) within the last 6 months. 12. Current treatment with an angiotensin converting enzyme inhibitor that cannot be discontinued and/or substituted (to obviate hemodynamic lability during TPE). 13. Fertile women who do not agree to contraception or abstinence. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration. 14. An alternative, concordant or historical diagnosis of interstitial lung diseases other than IPF, including idiopathic fibrosis with autoimmune features (IPAF) per clinical domain.1 15. IgA deficiency, to preclude IVIg reactions. 16. Listed with the United Network for Organ Sharing (UNOS) for lung transplant at the time of enrollment, to minimize the number of censoring due to very early transplants. 17. Ongoing suspected or known acute exacerbations of IPF (AE-IPF), defined as new onset (within the last 30 days) of dyspnea with increased hypoxemia or oxygen requirement, and new radiographic infiltrates especially with ground glass opacities (GGO). 18. Patients taking antifibrotic agents at randomization who have not been on a stable dose for at least 6 weeks: these therapies could be initiated, at the discretion of their attending physicians, at or after the midpoint of their participation in STRIVE II (i.e., three months after randomization). 19. Patients whose oxygen requirements at rest (per an arterial oxygen saturation \[SaO2\] \>0.92) cannot be met with simple nasal cannula at \<10L/min. 20. Patients who are not expected to survive 180 days or, in the opinion of the local attending physician, have a high likelihood of not tolerating the trial interventions due to underlying comorbidities or frailties. 21. \>10% of whole lung images are emphysematous on High Resolution CT scan \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Loyola University
Chicago, Illinois, 60153, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Temple University
Philadelphia, Pennsylvania, 19140, United States
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35216, United States
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University of Kansas
Kansas City, Kansas, 60611, United States
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University of North Carolina
Chapel Hill, North Carolina, 27599, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 60611, United States
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University of Utah
Salt Lake City, Utah, 84132, United States
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