Vixarelimab for Pulmonary Fibrosis
Recruiting in Palo Alto (17 mi)
+119 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Genentech, Inc.
Prior Safety Data
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.
12345Eligibility 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
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%.
I am between 40 and 85 years old.
I have been diagnosed with IPF or it's likely I have IPF.
My lung scans and any lung biopsies confirm I have idiopathic pulmonary fibrosis.
I have been on a stable dose of pirfenidone or nintedanib for my IPF for at least 4 weeks.
I am between 18 and 85 years old.
I have been diagnosed with systemic sclerosis according to ACR/EULAR criteria.
My lung scarring is getting worse.
I have completed 52 weeks of treatment in a previous study phase.
Exclusion Criteria
My oxygen levels are below 89% even with extra oxygen.
I have had a lung transplant.
I have been treated with vixarelimab before.
I am being treated for high blood pressure in my lungs.
I have had cancer within the last 5 years.
I have active or untreated latent tuberculosis.
More than half of my lung scan shows emphysema, more than fibrosis.
I have an autoimmune disease that is not systemic sclerosis.
I haven't developed any new lung diseases since starting the treatment.
Participant Groups
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.
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Banner University Medicine Lung InstitutePhoenix, AZ
IntraCare Health Center ? PrestigeDallas, TX
Pulmonix LLCGreensboro, NC
Southern Arizona VA Health Care System NAVREF PPDSTucson, AZ
More Trial Locations
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Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
References
Clinical response of rheumatoid arthritis-associated pulmonary fibrosis to tumor necrosis factor-alpha inhibition. [2019]Treatment options for patients with pulmonary fibrosis associated with rheumatoid disease are limited. We report a case of a 71-year-old man with a 3-year history of seropositive rheumatoid arthritis (RA) referred to the pulmonary clinic because of progressive pulmonary symptoms associated with radiographic fibrosis that was progressive in spite of corticosteroid treatment. In an attempt to control his articular symptoms and alter the course of his pulmonary fibrosis, treatment with IV infusion of the tumor necrosis factor (TNF)-alpha inhibitor infliximab was initiated. Following 1 year of therapy with this agent, the patient reported sustained improvement in dyspnea, cough, and exercise tolerance, in addition to improvement in joint symptoms. Stabilization of pulmonary function was indicated by repeat pulmonary function test findings. This report suggests that inhibition of TNF-alpha may be of significant benefit to patients with fibrosing lung conditions in the setting of RA.
Phase 2 trial to assess lebrikizumab in patients with idiopathic pulmonary fibrosis. [2021]This phase 2, randomised, double-blind, placebo-controlled trial evaluated the efficacy and safety of lebrikizumab, an interleukin (IL)-13 monoclonal antibody, alone or with background pirfenidone therapy, in patients with idiopathic pulmonary fibrosis (IPF).Patients with IPF aged ≥40 years with forced vital capacity (FVC) of 40%-100% predicted and diffusing capacity for carbon monoxide of 25%-90% predicted and who were treatment-naïve (cohort A) or receiving pirfenidone (2403 mg·day-1; cohort B) were randomised 1:1 to receive lebrikizumab 250 mg or placebo subcutaneously every 4 weeks. The primary endpoint was annualised rate of FVC % predicted decline over 52 weeks.In cohort A, 154 patients were randomised to receive lebrikizumab (n=78) or placebo (n=76). In cohort B, 351 patients receiving pirfenidone were randomised to receive lebrikizumab (n=174) or placebo (n=177). Baseline demographics were balanced across treatment arms in both cohorts. The primary endpoint (annualised rate of FVC % predicted decline) was not met in cohort A (lebrikizumab versus placebo, -5.2% versus -6.2%; p=0.456) or cohort B (lebrikizumab versus placebo, -5.5% versus -6.0%; p=0.557). In cohort B, a non-statistically significant imbalance in mortality favouring combination therapy was observed (hazard ratio 0.42 (95% CI 0.17-1.04)). Pharmacodynamic biomarkers indicated lebrikizumab activity. The safety profile was consistent with that in previous studies of lebrikizumab and pirfenidone as monotherapies.Lebrikizumab alone or with pirfenidone was not associated with reduced FVC % predicted decline over 52 weeks despite evidence of pharmacodynamic activity. Lebrikizumab was well tolerated with a favourable safety profile. These findings suggest that blocking IL-13 may not be sufficient to achieve a lung function benefit in patients with IPF.
Effects of nintedanib by inclusion criteria for progression of interstitial lung disease. [2022]Label="BACKGROUND">The INBUILD trial investigated nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs). We investigated the decline in forced vital capacity (FVC) in subgroups based on the inclusion criteria for ILD progression.
Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF). [2023]IntroductionThere is an unmet need for new treatments for idiopathic pulmonary fibrosis (IPF). The oral preferential phosphodiesterase 4B inhibitor, BI 1015550, prevented a decline in forced vital capacity (FVC) in a phase II study in patients with IPF. This study design describes the subsequent pivotal phase III study of BI 1015550 in patients with IPF (FIBRONEER-IPF).
Effect of rituximab on the progression of rheumatoid arthritis-related interstitial lung disease: 10 years' experience at a single centre. [2022]To evaluate the effect of rituximab (RTX) in patients with RA-related interstitial lung disease (RA-ILD) and identify factors associated with outcome after treatment.