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

STUDY OVERVIEW

The study by Genentech, Inc. aims to assess the effectiveness of vixarelimab versus placebo in improving lung function in individuals diagnosed with idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants completing the initial 52-week Double-blind Treatment (DBT) period may opt to continue in a subsequent 52-week Open-label Extension (OLE) period receiving vixarelimab.

STUDY GOALS

The goal of this study is to compare the impact of vixarelimab versus placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD), with an optional extension phase to evaluate long-term treatment effects.

LOCATION

El Paso, Texas: El Paso Pulmonary Association

INCLUSION CRITERIA for all participants

  • FVC ≥45% predicted

  • FEV1/FVC ratio >0.70

  • DLco ≥30% and ≤90% predicted (Hgb corrected)

  • Minimum 6-minute walk test (6MWT) distance of 150 m with oxygen supplementation per protocol

  • Consideration of all medicinal treatment options and/or lung transplantation prior to study participation

Inclusion criteria cohort 1

  • Age 40-85 years

  • Diagnosis of IPF or IPF (likely) with confirmed HRCT pattern

  • Stable treatment with pirfenidone or nintedanib for ≥3 months

inclusion criteria cohort 2

  • Age 18-85 years

  • Diagnosis of SSc as per ACR/EULAR criteria

  • HRCT showing ≥10% extent of fibrosis

  • Stable treatment with tocilizumab or nintedanib for ≥3 months

inclusion criteria for ole period

  • Completion of 52 weeks of double-blinded treatment

  • Investigator's favorable benefit-risk assessment

exclusion criteria for all participants

  • Improvement in predicted FVC in the 6-month period prior to screening

  • Post-bronchodilator response in FEV1 and/or FVC ≥10%

  • Resting oxygen saturation <89% with specified oxygen supplementation

  • History of lung transplant or certain medical conditions

exclusion criteria for cohort 1

  • Evidence of other causes of ILD

  • Extensive emphysema on HRCT

exclusion criteria for cohort 2

  • Evidence of other causes of ILD or autoimmune diseases

  • Recent use of pirfenidone or specific combination treatments

EXCLUSION CRITERIA for ole period

  • Significant non-compliance during double-blinded treatment

  • New clinically significant pulmonary disease

For more information, visit ClinicalTrials.gov.