Vixarelimab for Pulmonary Fibrosis

Recruiting at 144 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if vixarelimab can improve breathing in individuals with lung problems. It focuses on two groups: those with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs, and those with systemic sclerosis-associated interstitial lung disease (SSc-ILD), where similar scarring occurs due to another condition. The trial will compare vixarelimab with a placebo (a look-alike treatment with no active ingredients) to assess which is more effective for lung function. It seeks participants with SSc-ILD who have tried other treatments but still experience worsening lung problems. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

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.

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

Research shows that vixarelimab is under study to determine its safety and effectiveness for treating lung diseases like idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). Detailed safety information is still being collected, but this is a Phase 2 study, indicating that vixarelimab has already demonstrated some safety in earlier tests.

In past studies, most patients tolerated vixarelimab well. However, like any new treatment, it may cause side effects. Participants often report mild skin reactions at the injection site or other minor issues. Serious side effects are less common but can occur.

By joining these studies, participants help researchers learn more about vixarelimab's safety. Those considering joining the trial should discuss any concerns with the study team, who can provide more detailed information based on the latest research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Vixarelimab is unique because it targets a specific protein called OSMRβ, which is involved in the development of pulmonary fibrosis. Unlike traditional treatments like antifibrotic medications, which generally slow disease progression, Vixarelimab's mechanism aims to directly interrupt the signaling pathways that lead to lung tissue scarring. Researchers are excited about this treatment because it offers a novel approach that could potentially halt or reverse fibrosis, providing significant hope for improved outcomes in patients with conditions like idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSC-ILD).

What evidence suggests that vixarelimab could be an effective treatment for idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease?

Research shows that vixarelimab is under investigation in this trial for its potential to help people with idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD) breathe better. Participants in this trial will receive either vixarelimab or a placebo. Previous studies have explored how vixarelimab might improve these lung conditions by targeting specific pathways that lead to inflammation and scarring. Early results suggest that vixarelimab may help reduce lung damage by affecting certain biological processes involved in these diseases. While researchers continue to gather detailed information from human studies, this approach offers hope for those dealing with these difficult conditions. ^{1 3 5 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05785624

NCT05785624 | A Study Evaluating the Efficacy and Safety ...

The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary ...

2.

atsjournals.org

atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A1778

American Journal of Respiratory and Critical Care Medicine

RATIONALE More effective treatments are needed for patients with idiopathic pulmonary fibrosis (IPF) ... efficacy and safety of vixarelimab in patients with IPF ...

3.

ucla.clinicaltrials.researcherprofiles.org

ucla.clinicaltrials.researcherprofiles.org/fibrosis

UCLA Fibrosis Clinical Trials for 2025 — Los Angeles

The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic ...

4.

trials.arthritis.org

trials.arthritis.org/trials/NCT05785624

A Study Evaluating the Efficacy and Safety of Vixarelimab in ...

The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary ...

5.

genentech-clinicaltrials.com

genentech-clinicaltrials.com/en/trials/respiratory-disorder/ipf/a-study-evaluating-the-efficacy-and-safety-of-vixarelim-89139.html

Clinical trial for Idiopathic Pulmonary Fibrosis (IPF), S...

The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary ...

6.

atsjournals.org

atsjournals.org/doi/10.1164/ajrccm.2025.211.Abstracts.A1778

American Journal of Respiratory and Critical Care Medicine

CONCLUSIONS Moonscape will provide evidence for the efficacy and safety of vixarelimab in patients with IPF and SSc-ILD. Interim patient baseline data ...

7.

sigma.larvol.com

sigma.larvol.com/product.php?e1=778943&tab=newstrac

vixarelimab (RG6536) News

CONCLUSIONS Moonscape will provide evidence for the efficacy and safety of vixarelimab in patients with IPF and SSc-ILD. Interim patient baseline data ...