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A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease

A Two-Cohort, Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vixarelimab Compared With Placebo in Patients With Idiopathic Pulmonary Fibrosis and in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease

NCT05785624•Genentech, Inc.

View on ClinicalTrials.gov

Summary

The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•FVC ≥45% predicted during screening as determined by the over-reader
•Forced expiratory volume in 1 second (FEV1)/FVC ratio \>0.70 during screening as determined by the over-reader
•DLco ≥30% and ≤90% of predicted during screening (Hgb corrected) as determined by the over-reader
•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
•Participant and investigator consideration of all medicinal treatment options and/or possibly lung transplantation prior to consideration of participation in the study
•Age 40-85 years
•Documented diagnosis of IPF or IPF (likely)
•HRCT pattern consistent with the diagnosis of IPF, confirmed by central review of chest HRCT and central review of any available lung biopsy
•For participants receiving pirfenidone or nintedanib treatment for IPF: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with plans to continue treatment during the study period
•Age 18-85 years
+8 more criteria

Exclusion Criteria

•Percentage of predicted FVC value showing improvement in the 6-month period prior to screening and including screening value
•Known post-bronchodilator response in FEV1 and/or FVC (defined as an increase in percent predicted values by ≥ 10)
•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
•Previous treatment with vixarelimab
•Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening not successfully resolved by 4 weeks prior to screening visit
•Presence of pulmonary hypertension requiring treatment
•History of malignancy within the 5 years prior to screening
•Positive hepatitis C virus (HCV) antibody test result accompanied by a positive HCV ribonucleic acid (RNA) test at screening
•Known immunodeficiency
+9 more criteria

Locations (114)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner University Medicine Lung Institute

Phoenix, Arizona, United States

Southern Arizona VA Health Care System NAVREF PPDS

Tucson, Arizona, United States

University of California, San Francisco-Fresno

Fresno, California, United States

University of Southern California Keck School of Medicine

Los Angeles, California, United States

UCLA Rheumatology

Los Angeles, California, United States

University of California, San Francisco Medical Center

San Francisco, California, United States

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente

Torrance, California, United States

Renstar Medical Research

Ocala, Florida, United States

Coastal Pulmonary and Critical Care PLC

St. Petersburg, Florida, United States

Key Dates

Start Date

May 26, 2023

Primary Completion Date

January 12, 2026

Completion Date

January 12, 2026

Last Updated

February 9, 2026

Enrollment

286

ACTUAL participants

Conditions

Idiopathic Pulmonary FibrosisSystemic Sclerosis With Lung Involvement

Interventions

Vixarelimab

DRUG

Placebo

DRUG

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

NCT06238622

Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis

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RECRUITINGPHASE3

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis

NCT07299695

Idiopathic Pulmonary FibrosisAcute Exacerbation of Idiopathic Pulmonary Fibrosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease

Inclusion Criteria

Exclusion Criteria

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis

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