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Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)

29 juni 2026 uppdaterad av: Steven R. Duncan, MD, University of Alabama at Birmingham

Study of Therapeutic Plasma Exchange, Rituximab, and Intravenous Immunoglobulin for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)

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).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Patients with progressive pulmonary fibrosis, identified at any of nine participating leading U.S. medical centers, will be randomized (by computer) in a 1:1 ratio to either AART or treatment as usual (TAU). Stratification factors for randomization are sex (self-identified) and whether or not patients are taking any IPF-approved medication. Patients will be observed for six (6) months, with observations and assessments made at baseline, 30 days after randomization, and 90 and 180 days after randomization.

Data will be electronically submitted via electronic case report forms (eCRF) to a Data Coordinating Center.

The University of Alabama Medical Center Institutional Review Board (IRB) will be the central IRB for all sites.

Specimens collected will also be used in experimental B-cell studies conducted in the laboratory of the Principal Investigator.

Studietyp

Interventionell

Inskrivning (Beräknad)

52

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35216
        • University of Alabama at Birmingham
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Steven R Duncan, MD
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
      • Chicago, Illinois, Förenta staterna, 60153
        • Loyola University
        • Huvudutredare:
          • Daniel Dilling, MD
        • Kontakt:
    • Kansas
      • Kansas City, Kansas, Förenta staterna, 60611
        • University of Kansas
        • Huvudutredare:
          • Mark Hamblin, MD
        • Kontakt:
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • University of North Carolina
        • Huvudutredare:
          • Sean Callahan, MD
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • Thomas Jefferson University
        • Huvudutredare:
          • Ross Summer, MD
        • Kontakt:
      • Philadelphia, Pennsylvania, Förenta staterna, 19140
      • Pittsburgh, Pennsylvania, Förenta staterna, 60611
        • University of Pittsburgh
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Dan Kass, MD
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84132
        • University of Utah
        • Huvudutredare:
          • Mary Beth Scholand, MD
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

    -

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Autoantibody Reduction Therapy (AART)
Patients will be treated with combination of five (5) therapeutic plasma exchanges, followed by one dose of rituximab and then followed with four infusions of intravenous immunoglobulin (IVIg)
Övrig: Therapeutic Plasma Exchange
Removal of patient's plasma by mechanical means and replacement with saline and albumin or normal plasma
Andra namn:
  • Plasmaferes
Läkemedel: Rituximab
Infusion of humanized mouse monoclonal antibody with specificity for human CD20
Andra namn:
  • ritux
Läkemedel: Intravenous immunoglobulin
intravenous infusions of normal human immunoglobulin
Andra namn:
  • IVIg
Aktiv komparator: Treatment as Usual (TAU)
Patients will continue treatment(s) with optimized approved medications for idiopathic pulmonary fibrosis (IPF)
Läkemedel: Treatment as Usual
Continued therapy with conventional, approved, specific IPF medications

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Forced Vital Capacity (FVC)
Tidsram: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Intergroup comparisons of FVC changes over duration of observations
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Supplemental Oxygen Requirements (O2)
Tidsram: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Intergroup comparisons of changing O2 requirements over duration of observations
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Six-minute walk distances (6MWD)
Tidsram: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Intergroup comparisons of changes of 6MWD over duration of observations
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Durations of progression-free survival
Tidsram: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Intergroup comparisons of number who survive without >5% decrements of FVC as percent of predicted normal values
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Composite outcome measure
Tidsram: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Absolute numbers of acute IPF exacerbations or all cause deaths or unscheduled hospitalizations
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Alabama at Birmingham

Utredare

  • Huvudutredare: Steven R Duncan, MD, University of Alabama at Birmingham

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

30 september 2030

Avslutad studie (Beräknad)

31 mars 2031

Studieregistreringsdatum

Först inskickad

24 juni 2026

Först inskickad som uppfyllde QC-kriterierna

24 juni 2026

Första postat (Faktisk)

30 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB-300016700
  • PR251064 (Annat bidrag/finansieringsnummer: U.S. Department of Defense)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

Any shared data would need to be de-identified, shared only with qualified researchers and otherwise be sanctioned by university regulations.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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