Southeastern Research Center | Winston-Salem, NC
Status and phase
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Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria for all Participants:
Inclusion Criteria for Cohort 1:
Inclusion Criteria for Cohort 2:
Inclusion Criteria for OLE Period:
Exclusion Criteria for all Participants:
Exclusion Criteria for Cohort 1:
Exclusion Criteria for Cohort 2:
Exclusion Criteria for OLE Period:
Primary purpose
Allocation
Interventional model
Masking
320 participants in 6 patient groups, including a placebo group
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Central trial contact
Reference Study ID Number: GB44496 https://forpatients.roche.com/
Data sourced from clinicaltrials.gov
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