What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include antifibrotic medications such as nintedanib and pirfenidone. Nintedanib is often associated with gastrointestinal side effects, particularly diarrhea, as well as liver enzyme elevations. Pirfenidone commonly causes nausea, rash, and photosensitivity. Both medications have been shown to slow disease progression and reduce the frequency of acute exacerbations, but they do not cure the disease. Other treatments, like immunosuppressive therapies, can have side effects such as increased risk of infections and liver toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for Idiopathic Pulmonary Fibrosis (IPF), including nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis, while pirfenidone is an antifibrotic agent that reduces fibroblast proliferation and collagen synthesis. These treatments aim to slow the progression of lung function decline in IPF patients. While Vixarelimab, an Anti-OX40 Ligand Monoclonal Antibody, is being studied for its efficacy in IPF, it represents a different therapeutic approach compared to the currently approved antifibrotic agents.

What other types of research exist?

Promising alternatives to Vixarelimab for IPF patients include: 1) Tacrolimus, which has shown improved survival rates in combination with methylprednisolone; 2) Hemoperfusion with polymyxin-B immobilized fiber, which has demonstrated improved oxygenation and survival rates; and 3) Rituximab, which has shown effectiveness in treating various interstitial lung diseases, including those related to connective tissue diseases. These treatments have shown potential in clinical studies and may be considered as alternatives in 2024.

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Vixarelimab for Pulmonary Fibrosis

Verified Trial

Phase 2

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum 6-MWT distance of 150 m with maximum use of 6 liters per minute (L/min) at sea-level and up to 8 L/min at altitude (> 5000 feet [1524 m] above sea level) of supplemental oxygen while maintaining oxygen saturation of >83% during the 6MWT during screening

Age 40-85 years

Must not have

Resting oxygen saturation of <89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (5000 feet [1524 m] above sea level) during screening

History of lung transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to week 52

Summary

This trial is testing vixarelimab, a medication that may help improve lung function, in people with IPF and SSc-ILD. It works by reducing inflammation and scarring in the lungs to help with breathing.

Who is the study for?

Adults aged 18-85 with idiopathic pulmonary fibrosis or systemic sclerosis-associated interstitial lung disease, who have a certain level of lung function and are considering all treatment options including possible lung transplantation. Excluded are those with active infections, significant emphysema, history of lung transplant or malignancy within the past 5 years, among other criteria.

What is being tested?

The trial is testing Vixarelimab's effectiveness on improving lung function compared to a placebo in patients with specific types of lung diseases over a period of one year. Those completing this phase can continue for another year in an open-label extension to receive Vixarelimab.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical drug reactions such as injection site reactions, allergic responses, gastrointestinal issues, fatigue and possibly impact on liver enzymes or blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk at least 150 meters with up to 6L/min of oxygen, or 8L/min if I'm at a high altitude, and keep my oxygen level above 83%.

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I am between 40 and 85 years old.

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I have been diagnosed with IPF or it's likely I have IPF.

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My lung scans and any lung biopsies confirm I have idiopathic pulmonary fibrosis.

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I have been on a stable dose of pirfenidone or nintedanib for my IPF for at least 4 weeks.

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I am between 18 and 85 years old.

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I have been diagnosed with systemic sclerosis according to ACR/EULAR criteria.

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My lung scarring is getting worse.

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I have completed 52 weeks of treatment in a previous study phase.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My oxygen levels are below 89% even with extra oxygen.

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I have had a lung transplant.

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I have been treated with vixarelimab before.

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I am being treated for high blood pressure in my lungs.

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I have had cancer within the last 5 years.

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I have active or untreated latent tuberculosis.

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More than half of my lung scan shows emphysema, more than fibrosis.

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I have an autoimmune disease that is not systemic sclerosis.

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I haven't developed any new lung diseases since starting the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC)

Secondary study objectives

Cohort 2: Change From Baseline in Pruritus Measured Using the Five-Dimension Itch Scale (5-D Itch) Total Score

Cohort 2: Change From Baseline in Skin Sclerosis Assessed Using Modified Rodnan Skin Score (mRSS)

Cohorts 1 and 2: Absolute Change From Baseline in 6-Minute Walk Test (6MWT) Distance

+7 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: OLE Period: Cohort 2: VixarelimabExperimental Treatment1 Intervention

Participants with SSC-ILD who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.

Group II: OLE Period: Cohort 1: VixarelimabExperimental Treatment1 Intervention

Participants with IPF who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.

Group III: DBT: Cohort 2: VixarelimabExperimental Treatment1 Intervention

Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.

Group IV: DBT: Cohort 1: VixarelimabExperimental Treatment1 Intervention

Participants with IPF will receive vixarelimab, subcutaneously (SC), once every two weeks (Q2W) for 52 weeks in the DBT period.

Group V: DBT: Cohort 1: PlaceboPlacebo Group1 Intervention

Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.

Group VI: DBT: Cohort 2: PlaceboPlacebo Group1 Intervention

Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include antifibrotic agents like nintedanib and pirfenidone. Nintedanib works by inhibiting multiple tyrosine kinases involved in the pathways that lead to fibrosis, thereby slowing the decline in lung function. Pirfenidone exerts its effects by reducing fibroblast proliferation, production of fibrosis-associated proteins, and cytokine release, which collectively help to slow disease progression. Vixarelimab, an investigational anti-OX40 ligand monoclonal antibody, targets the OX40-OX40L pathway, which is involved in the immune response and fibrosis. By modulating this pathway, vixarelimab aims to reduce inflammation and fibrotic processes in the lungs. These mechanisms are vital for IPF patients as they help to manage symptoms and potentially extend survival by slowing the progression of lung fibrosis.