Autoantibody Reduction Therapy for Idiopathic Pulmonary Fibrosis

(STRIVE II Trial)

Not yet recruiting at 8 trial locations
SR
TK
Overseen ByTeja Kulakarni, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

SR

Steven R Duncan, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults with progressive idiopathic pulmonary fibrosis (IPF), a lung disease that gets worse over time. Participants should not have other major health problems or conditions that could interfere with the study.

Inclusion Criteria

I was diagnosed with IPF less than 10 years ago.
Ratio of FEV1/FVC >0.70
I am between 40 and 85 years old.
See 6 more

Exclusion Criteria

Coagulopathy defined as INR >1.6, PTT >2x control, fibrinogen <100 mg/dL, or platelet count <50,000 unless reversible
I have not recently taken high-dose steroids or strong immune-suppressing drugs.
Major comorbidities expected to interfere with study participation
See 18 more

What Are the Treatments Tested in This Trial?

Interventions

  • Intravenous immunoglobulin
  • Rituximab
  • Therapeutic Plasma Exchange

Trial Overview

The study compares a combination therapy—plasma exchange, rituximab, and intravenous immunoglobulin—to standard treatment in people with worsening IPF to see if it helps slow down the disease.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Autoantibody Reduction Therapy (AART)Experimental Treatment3 Interventions
Group II: Treatment as Usual (TAU)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+