Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis
NCT07674745 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2026-07-01
Summary
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).
Conditions
Interventions
- OTHER
-
Therapeutic Plasma Exchange
Removal of patient's plasma by mechanical means and replacement with saline and albumin or normal plasma
- DRUG
-
Infusion of humanized mouse monoclonal antibody with specificity for human CD20
- DRUG
-
intravenous infusions of normal human immunoglobulin
- DRUG
-
Treatment as Usual
Continued therapy with conventional, approved, specific IPF medications
Sponsors & Collaborators
-
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Steven R Duncan, MD · University of Alabama at Birmingham
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-01
- Primary Completion
- 2030-09-30
- Completion
- 2031-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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