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
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Idiopathic Pulmonary Fibrosis, Systemic Sclerosis With Lung Involvement
In brief
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.
Key facts
- Study ID
- NCT05785624
- Run by
- Genentech, Inc.
- People needed
- 286
- Starts
- 2023-05-26
- Expected to finish
- 2026-01-12
- Last updated by the study team
- 2026-02-09
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Rambam Medical Center — Haifa, Israel
- Lady Davis Carmel Medical Center — Haifa, Israel
- Hadassah Medical Center — Jerusalem, Israel
- Rabin Medical Center — Petah Tikva, Israel
- 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
- Weston Hospital — Weston, Florida, United States
- Piedmont Pulmonary and Sleep Medicine Buckhead — Atlanta, Georgia, United States
- GenHarp Clinical Solutions — Evergreen Park, Illinois, United States
- Northwestern Medicine - Northwestern Medicine Glen — Glenview, Illinois, United States
- IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine — Muncie, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- University of Michigan Hospital — Ann Arbor, Michigan, United States
- Hannibal Regional Healthcare System HRMG Hannibal — Hannibal, Missouri, United States
- Pulmonix LLC — Greensboro, North Carolina, United States
- Southeastern Research Center — Winston-Salem, North Carolina, United States
- Emory Clinic — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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