Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07674745
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Therapeutic Plasma Exchange — OTHER
    Removal of patient's plasma by mechanical means and replacement with saline and albumin or normal plasma
  • Rituximab — DRUG
    Infusion of humanized mouse monoclonal antibody with specificity for human CD20
  • Intravenous immunoglobulin — DRUG
    intravenous infusions of normal human immunoglobulin
  • Treatment as Usual — DRUG
    Continued therapy with conventional, approved, specific IPF medications

Study Details

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).

Key Dates

Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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)
  • Active Comparator: Treatment as Usual (TAU)
    Patients will continue treatment(s) with optimized approved medications for idiopathic pulmonary fibrosis (IPF)

Primary Outcome Measure

Forced Vital Capacity (FVC) [ Time Frame: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35216
Steven R. Duncan, MD
[email protected]
412-215-6977
Steven R Duncan, MD
[email protected]
4122156977
Steven R Duncan, MD (PRINCIPAL_INVESTIGATOR)
Loyola UniversityChicagoIllinois60153
Dan Dilling, MD
[email protected]
773-793-3594
Daniel Dilling, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Anthony Esposito, MD
[email protected]
256-231-0022
Anthony Esposito, MD (PRINCIPAL_INVESTIGATOR)
University of KansasKansas CityKansas60611
Mark Hamblin, MD
[email protected]
913-588-6045
Mark Hamblin, MD (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599
Sean Callahan, MD
[email protected]
919-966-2531
Sean Callahan, MD (PRINCIPAL_INVESTIGATOR)
Temple UniversityPhiladelphiaPennsylvania19140
Gerald R. Criner, MD
[email protected]
215-510-6570
Gerald R Criner, MD
[email protected]
215-510-6570
Gerald R Criner, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Ross Summer, MD
[email protected]
617-680-8966
Ross Summer, MD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania60611
Dan Kass, MD
[email protected]
917-687-4592
Dan Kass, MD
[email protected]
917-887-4592
Dan Kass, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Mary Beth Scholand, MD
[email protected]
801-657-2370
Mary Beth Scholand, MD (PRINCIPAL_INVESTIGATOR)

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