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

29 juin 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

52

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35216
        • University of Alabama at Birmingham
        • Contact:
        • Contact:
        • Chercheur principal:
          • Steven R Duncan, MD
    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Northwestern University
        • Contact:
        • Chercheur principal:
          • Anthony Esposito, MD
      • Chicago, Illinois, États-Unis, 60153
        • Loyola University
        • Chercheur principal:
          • Daniel Dilling, MD
        • Contact:
    • Kansas
      • Kansas City, Kansas, États-Unis, 60611
        • University of Kansas
        • Chercheur principal:
          • Mark Hamblin, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, États-Unis, 27599
        • University of North Carolina
        • Chercheur principal:
          • Sean Callahan, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Thomas Jefferson University
        • Chercheur principal:
          • Ross Summer, MD
        • Contact:
      • Philadelphia, Pennsylvania, États-Unis, 19140
      • Pittsburgh, Pennsylvania, États-Unis, 60611
        • University of Pittsburgh
        • Contact:
          • Dan Kass, MD
          • Numéro de téléphone: 917-687-4592
          • E-mail: kassd2@upmc.edu
        • Contact:
          • Dan Kass, MD
          • Numéro de téléphone: 917-887-4592
          • E-mail: kassd2@upmc.edu
        • Chercheur principal:
          • Dan Kass, MD
    • Utah
      • Salt Lake City, Utah, États-Unis, 84132
        • University of Utah
        • Chercheur principal:
          • Mary Beth Scholand, MD
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

    -

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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)
Autre: Therapeutic Plasma Exchange
Removal of patient's plasma by mechanical means and replacement with saline and albumin or normal plasma
Autres noms:
  • Plasmaphérèse
Médicament: Rituximab
Infusion of humanized mouse monoclonal antibody with specificity for human CD20
Autres noms:
  • ritux
Médicament: Intravenous immunoglobulin
intravenous infusions of normal human immunoglobulin
Autres noms:
  • IgIV
Comparateur actif: Treatment as Usual (TAU)
Patients will continue treatment(s) with optimized approved medications for idiopathic pulmonary fibrosis (IPF)
Médicament: Treatment as Usual
Continued therapy with conventional, approved, specific IPF medications

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Forced Vital Capacity (FVC)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Supplemental Oxygen Requirements (O2)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Alabama at Birmingham

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

30 septembre 2030

Achèvement de l'étude (Estimé)

31 mars 2031

Dates d'inscription aux études

Première soumission

24 juin 2026

Première soumission répondant aux critères de contrôle qualité

24 juin 2026

Première publication (Réel)

30 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB-300016700
  • PR251064 (Autre subvention/numéro de financement: U.S. Department of Defense)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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