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 trial tests a new combination treatment for idiopathic pulmonary fibrosis (IPF), a lung disease that makes breathing difficult. The treatment combines three components: therapeutic plasma exchange (a blood filtering process), rituximab (a medication targeting certain immune cells), and intravenous immunoglobulin (a therapy using antibodies). The goal is to determine if this combination can slow lung damage more effectively than standard treatments. Individuals who have had IPF for less than ten years and have experienced worsening symptoms might be suitable for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in IPF treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that intravenous immunoglobulin (IVIg) is usually well-tolerated, though some studies mention risks like lung injury related to transfusions. Studies indicate that rituximab can help maintain or improve lung function in some patients, but there is a risk of serious infections or reactions during infusion, such as breathing problems. Therapeutic plasma exchange (TPE) is considered safe when performed by experienced professionals, although low blood pressure commonly occurs as a side effect. Each treatment carries different risks, so prospective participants should consider these when deciding to join a trial.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for idiopathic pulmonary fibrosis, which generally focus on managing symptoms with medications like pirfenidone and nintedanib, Autoantibody Reduction Therapy (AART) offers a fresh approach. This treatment works by reducing harmful autoantibodies through a combination of therapeutic plasma exchange, rituximab, and intravenous immunoglobulin (IVIg). Researchers are excited about AART because it directly targets the immune system's faulty response, potentially slowing disease progression more effectively than current options. Additionally, the combination of plasma exchange and immunotherapy might provide a more comprehensive attack on the underlying causes of the disease, offering hope for improved outcomes.

What evidence suggests that this trial's treatments could be effective for idiopathic pulmonary fibrosis?

Research has shown that combining different treatments in Autoantibody Reduction Therapy (AART), which participants in this trial may receive, may benefit people with idiopathic pulmonary fibrosis (IPF). Rituximab, one of these treatments, improved lung function by 6.7% in some patients. Another treatment in the AART arm, therapeutic plasma exchange, has been linked to better survival rates; one study showed a 70% survival rate compared to 20% in past cases. While intravenous immunoglobulin (IVIg) is commonly used for immune-related issues, its exact role in treating IPF remains unclear, though it supports the immune system. Overall, these treatments aim to reduce harmful proteins called autoantibodies that attack the body's own tissues, potentially slowing the progression of IPF.678910

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of five therapeutic plasma exchanges, followed by one dose of rituximab and four infusions of intravenous immunoglobulin (IVIg)

6 months
Visits at baseline, 30, 90, and 180 days after randomization

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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+

Citations

1.

pulmonaryfibrosis.org

pulmonaryfibrosis.org/

Pulmonary Fibrosis Foundation

Dedicated to finding a cure for pulmonary fibrosis through leading research and clinical trials. Learn more about our work to create a world without PF.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/15831842/

Severe pulmonary hypertension and chronic obstructive ...

Exertional dyspnea was more severe (p < 0.01) and survival was shorter (p = 0.0026) than in the control subjects. idiopathic pulmonary hypertension.

Definition of pulmonary - NCI Dictionary of Cancer Terms

NCI's Dictionary of Cancer Terms provides easy-to-understand definitions for words and phrases related to cancer and medicine.

Understanding Pulmonary Function Tests

Pulmonary Function Tests use Z-scores to help determine if your breathing test results are within a normal range. Core IM Pulmonary Function ...

Chronic obstructive pulmonary disease (COPD)

COPD is not curable but symptoms can improve if one avoids smoking and exposure to air pollution and gets vaccines to prevent infections.

Idiopathic Pulmonary Fibrosis: Current Clinical Trials ...

Bexotegrast-treated participants demonstrated reduced FVC decline at Week 12, with 50% of Bexotegrast participants still showing improvement at Week 24. 89% of ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34743710/

Clinical outcomes of intravenous immunoglobulin therapy ...

Overall ICU mortality in the study population was 27.1%, and in the matched cohort, it was 25.8%. Mortality was higher among IVIG-treated ...

https://clinicaltrials.gov/search?cond=IPF

No information is available for this page.

Safety and Efficacy Confirmed for Idiopathic Pulmonary ...

The safety and tolerability profile seen in the studies was further confirmed by 1-year data from post-marketing surveillance, including real ...

IPF Treatment - Idiopathic Pulmonary Fibrosis

Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, ...