Last updated 27 days ago

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

320 patients around the world

Available in United States, Chile

Genentech, Inc.

320Patients around the world

This study is for people with

Pulmonary fibrosis

Idiopathic pulmonary fibrosis

Rare diseases

Systemic sclerosis

Requirements for the patient

To 85 Years

All Gender

Medical requirements

: for all Participants: FVC ≥45% predicted during screening as determined by the over-reader
for all Participants: Forced expiratory volume in 1 second (FEV1)/FVC ratio >0.70 during screening as determined by the over-reader
for all Participants: DLco ≥30% and ≤90% of predicted during screening (Hgb corrected) as determined by the over-reader
for all Participants: 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
for all Participants: Participant and investigator consideration of all medicinal treatment options and/or possibly lung transplantation prior to consideration of participation in the study
for Cohort 1: Age 40-85 years
for Cohort 1: Documented diagnosis of IPF or IPF (likely)
for Cohort 1: HRCT pattern consistent with the diagnosis of IPF, confirmed by central review of chest HRCT and central review of any available lung biopsy
for Cohort 1: 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
for Cohort 2: Age 18-85 years
for Cohort 2: Diagnosis of SSc as defined using the American College of Rheumatology/European Alliance of Associations for Rheumatology (EULAR) criteria
for Cohort 2: HRCT demonstrating ≥10% extent of fibrosis, confirmed by central review of Chest HRCT
for Cohort 2: Evidence of progressive pulmonary fibrosis
for Cohort 2: For participants receiving tocilizumab treatment for SSc-ILD: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with no contraindications according to local prescribing information, and no intention to change or modify their treatment regimen for the duration of the study
for Cohort 2: Availability of skin for biopsy preferably on proximal forearms having Modified Rodnan Skin Score (mRSS) ≥2 at the biopsy location
for OLE Period: Completion of 52 weeks of treatment in the double-blinded treatment period

: for all Participants: Percentage of predicted FVC value showing improvement in the 6-month period prior to screening and including screening value
for all Participants: Known post-bronchodilator response in FEV1 and/or FVC (defined as an increase by 12% and 200 milliliters [mL])
for all Participants: 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
for all Participants: History of lung transplant
for all Participants: Previous treatment with vixarelimab
for all Participants: 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
for all Participants: Presence of pulmonary hypertension requiring treatment
for all Participants: History of malignancy within the 5 years prior to screening
for all Participants: Positive hepatitis C virus (HCV) antibody test result accompanied by a positive HCV ribonucleic acid (RNA) test at screening
for all Participants: Known immunodeficiency
for all Participants: Known evidence of active or untreated latent tuberculosis
for Cohort 1: Evidence of other known causes of ILD
for Cohort 1: Emphysema present on ≥50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
for Cohort 2: Evidence of other known causes of ILD
for Cohort 2: Rheumatic autoimmune disease other than SSc
for Cohort 2: Receiving anti-fibrotic treatment (e.g., nintedanib) within 4 weeks prior to screening
for OLE Period: Significant non-compliance in the double-blinded treatment period, per investigator's judgment
for OLE Period: Any new clinically significant pulmonary disease other than IPF or SSc-ILD since enrolling in the double-blinded treatment period

SponsorGenentech, Inc.

Conditions

Idiopathic pulmonary fibrosisSystemic sclerosis

Requirements

To 85 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05785624