Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis (NCT07674745)
Study of Therapeutic Plasma Exchange, Rituximab, and Intravenous Immunoglobulin for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (22 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 40 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
- Unwillingness to accept blood product transfusion.
- Diagnosis of major comorbidities expected to interfere with study participation.
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (9 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Loyola University — Chicago, Illinois
- Northwestern University — Chicago, Illinois
- University of Kansas — Kansas City, Kansas
- University of North Carolina — Chapel Hill, North Carolina
- Thomas Jefferson University — Philadelphia, Pennsylvania
- Temple University — Philadelphia, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania
- University of Utah — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (412) 215-6977
Email: srduncan@uabmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Idiopathic Pulmonary Fibrosis
- Atezolizumab for Idiopathic Pulmonary Fibrosis — Los Angeles, California
- Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis — Windsor, Ontario
- Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis — Worcester, Massachusetts
- A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) — Quilmes, Buenos Aires
- Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF — St John's,
Explore by condition: All Idiopathic Pulmonary Fibrosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.