Vixarelimab for Pulmonary Fibrosis

Recruiting at 120 trial locations

Overseen By Reference Study ID Number: GB44496 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Must be taking: Pirfenidone, Nintedanib, Tocilizumab

Must not be taking: Pirfenidone, Nintedanib, Tocilizumab

Disqualifiers: Lung transplant, Malignancy, Immunodeficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 26

320 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking pirfenidone or nintedanib for IPF, or tocilizumab or nintedanib for SSc-ILD, you can continue these medications during the study as long as your dose has been stable for at least 4 weeks before screening. The trial does not specify about other medications, so it's best to discuss with the study team.

What makes the drug Vixarelimab unique for treating pulmonary fibrosis?

Vixarelimab is unique because it targets a specific pathway involved in inflammation and fibrosis, which may offer a new approach compared to existing treatments for pulmonary fibrosis that primarily focus on slowing disease progression. This drug is also known by several other names, including KPL-716 and BIIB069, and its novel mechanism of action could provide additional benefits for patients with this condition. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

Your lung function is between 30% and 90% of what is expected for someone your age and size.

I have considered all medical treatments and/or lung transplant before joining this study.

I am between 40 and 85 years old.

Exclusion Criteria

Significant non-compliance in the double-blinded treatment period, per investigator's judgment

I have had cancer within the last 5 years.

You have tested positive for hepatitis C virus and have a positive RNA test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive vixarelimab or placebo subcutaneously every two weeks for 52 weeks

52 weeks

26 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label Extension (optional)

Participants may opt into continuation of treatment with vixarelimab for another 52 weeks

52 weeks

Treatment Details

Interventions

• Placebo
• Vixarelimab

Trial Overview 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.

Participant Groups

Group I: OLE Period: Cohort 2: Vixarelimab Experimental Treatment 1 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: Vixarelimab Experimental Treatment 1 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: Vixarelimab Experimental Treatment 1 Intervention

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

Group IV: DBT: Cohort 1: Vixarelimab Experimental Treatment 1 Intervention

Participants with IPF will receive vixarelimab, subcutaneously (SC), once every two weeks (Q2W) for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.

Group V: DBT: Cohort 1: Placebo Placebo Group 1 Intervention

Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.

Group VI: DBT: Cohort 2: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Findings from Research

A 71-year-old man with rheumatoid arthritis and progressive pulmonary fibrosis showed significant improvement in respiratory symptoms and joint pain after one year of treatment with the TNF-alpha inhibitor infliximab.

The patient's pulmonary function tests indicated stabilization of lung function, suggesting that targeting TNF-alpha may be a beneficial treatment strategy for managing pulmonary fibrosis associated with rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical response of rheumatoid arthritis-associated pulmonary fibrosis to tumor necrosis factor-alpha inhibition. Vassallo, R., Matteson, E., Thomas, CF.[2019]

In a phase 2 trial involving 505 patients with idiopathic pulmonary fibrosis (IPF), lebrikizumab, an IL-13 monoclonal antibody, did not significantly reduce the decline in lung function (measured by FVC) compared to placebo, indicating it may not be effective as a treatment for IPF.

Despite the lack of efficacy in improving lung function, lebrikizumab was well tolerated and had a safety profile consistent with previous studies, suggesting it may be safe for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 trial to assess lebrikizumab in patients with idiopathic pulmonary fibrosis. Maher, TM., Costabel, U., Glassberg, MK., et al.[2021]

The INBUILD trial demonstrated that nintedanib significantly reduces the rate of decline in forced vital capacity (FVC) in patients with progressive fibrosing interstitial lung diseases (ILDs), particularly in those with a relative decline in FVC of 10% or more.

The trial effectively identified patients with progressive ILDs using specific criteria related to FVC decline and worsening symptoms, showing that nintedanib's efficacy was consistent across different subgroups, regardless of the severity of FVC decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nintedanib by inclusion criteria for progression of interstitial lung disease. Maher, TM., Brown, KK., Kreuter, M., et al.[2022]

The phase III trial (FIBRONEER-IPF) is investigating the efficacy of BI 1015550, a phosphodiesterase 4B inhibitor, in preventing decline in lung function (measured by forced vital capacity) in patients with idiopathic pulmonary fibrosis (IPF) over at least 52 weeks.

The study is designed to compare two doses of BI 1015550 (9 mg and 18 mg) against a placebo, with a primary focus on lung function change and secondary outcomes including acute exacerbations, hospitalizations, or death, ensuring a comprehensive assessment of the drug's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF). Richeldi, L., Azuma, A., Cottin, V., et al.[2023]

In a study of 56 patients with rheumatoid arthritis-related interstitial lung disease (RA-ILD) treated with rituximab (RTX), over half (52%) remained stable and 16% showed improvement in lung function after treatment, indicating RTX can be effective for managing RA-ILD.

The study found that patients with more severe ILD before starting RTX were more likely to experience disease progression or death, suggesting that RTX is safe and does not worsen lung disease in patients with RA-ILD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of rituximab on the progression of rheumatoid arthritis-related interstitial lung disease: 10 years' experience at a single centre. Md Yusof, MY., Kabia, A., Darby, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical response of rheumatoid arthritis-associated pulmonary fibrosis to tumor necrosis factor-alpha inhibition. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Phase 2 trial to assess lebrikizumab in patients with idiopathic pulmonary fibrosis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effects of nintedanib by inclusion criteria for progression of interstitial lung disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF). [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effect of rituximab on the progression of rheumatoid arthritis-related interstitial lung disease: 10 years' experience at a single centre. [2022]