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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights
Study Summary
This trial will assess if vixarelimab can improve lung function in people with IPF or SSc-ILD over a period of up to one year.
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.Check my eligibility
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.See study design
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 belowSelect...
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%.
Select...
I am between 40 and 85 years old.
Select...
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.
Select...
I have been on a stable dose of pirfenidone or nintedanib for my IPF for at least 4 weeks.
Select...
I am between 18 and 85 years old.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC)
Secondary outcome measures
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
+12 moreTrial 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.
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Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
567,853 Total Patients Enrolled
10 Trials studying Idiopathic Pulmonary Fibrosis
2,560 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,588 Total Patients Enrolled
16 Trials studying Idiopathic Pulmonary Fibrosis
4,504 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer within the last 5 years.You have tested positive for hepatitis C virus and have a positive RNA test.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.I have skin thick enough for a biopsy, especially on my upper arms.I have completed 52 weeks of treatment in a previous study phase.I have been on a stable dose of pirfenidone or nintedanib for my IPF for at least 4 weeks.Your breathing test shows that you can exhale a certain amount of air in one second.I have active or untreated latent tuberculosis.More than half of my lung scan shows emphysema, more than fibrosis.You have other known reasons for lung disease.I have had a lung transplant.I haven't developed any new lung diseases since starting the treatment.I am between 18 and 85 years old.My oxygen levels are below 89% even with extra oxygen.I have not had any unresolved infections in the month before my screening.I am being treated for high blood pressure in my lungs.I have been treated with vixarelimab before.Your chest scan shows more than 10% fibrosis, as confirmed by a central review of the scan.Your lung function improves significantly after using a bronchodilator.Your lung function test shows that you can breathe out a certain amount of air.I have been diagnosed with IPF or it's likely I have IPF.My lung scarring is getting worse.I have been on a stable dose of tocilizumab for my SSc-ILD for at least 3 months.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 have an autoimmune disease that is not systemic sclerosis.Your lung function has improved in the six months before screening.My lung scans and any lung biopsies confirm I have idiopathic pulmonary fibrosis.You have a weakened immune system.I have been treated with anti-fibrotic medication within the last 4 weeks.I have been diagnosed with systemic sclerosis according to ACR/EULAR criteria.
Research Study Groups:
This trial has the following groups:- Group 1: DBT: Cohort 1: Vixarelimab
- Group 2: DBT: Cohort 1: Placebo
- Group 3: DBT: Cohort 2: Vixarelimab
- Group 4: DBT: Cohort 2: Placebo
- Group 5: OLE Period: Cohort 1: Vixarelimab
- Group 6: OLE Period: Cohort 2: Vixarelimab
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation welcome people aged 85 or older to participate?
"As stated in the trial's inclusion criteria, participants must be aged 18-85. 146 studies are available for minors and 993 trials focus on elderly patients."
Answered by AI
Is my eligibility sufficient to partake in this research endeavor?
"Prospective participants must be afflicted with idiopathic pulmonary fibrosis, have a maximum age of 85, and meet the minimum age requirement. This clinical trial is currently looking for approximately 290 patients to enrol in the study."
Answered by AI
Has Vixarelimab been sanctioned by the FDA to be used in DBT Cohort 1?
"While the clinical efficacy of DBT: Cohort 1: Vixarelimab has not been conclusively established, there is a sufficient body of evidence to rate its safety at 2 out of 3."
Answered by AI
Is there currently availability for volunteers to participate in this experiment?
"Indeed, clinicaltrials.gov specifies that this current medical trial is actively seeking volunteers for enrollment. It was first posted on March 30th 2023 and recently updated on the 14th of March; 290 patients are needed from a single site."
Answered by AI
What is the current intake capacity of this investigation?
"Affirmative. Clinicaltrials.gov details that this investigation, which was launched on March 30th 2023, is presently enrolling new participants. The research requires 290 individuals to sign up from a single medical centre."
Answered by AI
Who else is applying?
What site did they apply to?
University of Alabama at Birmingham
University of California, San Francisco Medical Center
Pulmonix LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
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