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Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis
Sponsor: aTyr Pharma, Inc.
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
268
Start Date
2022-09-15
Completion Date
2025-08-31
Last Updated
2025-05-20
Healthy Volunteers
No
Conditions
Interventions
Efzofitimod 3 mg/kg
EfzofitimodIV infusion every 4 weeks for a total of 12 doses
Efzofitimod 5 mg/kg
EfzofitimodIV infusion every 4 weeks for a total of 12 doses
Placebo
Placebo IV infusion every 4 weeks for a total of 12 doses
Locations (91)
aTyr Investigative Site
Birmingham, Alabama, United States
aTyr Investigative Site
Phoenix, Arizona, United States
aTyr Investigative Site
Los Angeles, California, United States
aTyr Investigative Site
Sacramento, California, United States
aTyr Investigative Site
Denver, Colorado, United States
aTyr Investigative Site
Washington D.C., District of Columbia, United States
aTyr Investigative Site
Gainesville, Florida, United States
aTyr Investigative Site
Tampa, Florida, United States
aTyr Investigative Site
Weston, Florida, United States
aTyr Investigative Site
Atlanta, Georgia, United States
aTyr Investigative Site
Chicago, Illinois, United States
aTyr Investigative Site
Chicago, Illinois, United States
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Louisville, Kentucky, United States
aTyr Investigative Site
New Orleans, Louisiana, United States
aTyr Investigative Site
Baltimore, Maryland, United States
aTyr Investigative Site
Boston, Massachusetts, United States
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Ada, Michigan, United States
aTyr Investigative Site
Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
aTyr Investigative Site
Rochester, Minnesota, United States
aTyr Investigative Site
Jackson, Mississippi, United States
aTyr Investigative Site
St Louis, Missouri, United States
aTyr Investigative Site
Albany, New York, United States
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Middletown, New York, United States
aTyr Investigative Site
Durham, North Carolina, United States
aTyr Investigative Site
Greenville, North Carolina, United States
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Cincinnati, Ohio, United States
aTyr Investigative Site
Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
aTyr Investigative Site
Charleston, South Carolina, United States
aTyr Investigative Site
Dickson, Tennessee, United States
aTyr Investigative Site
Dallas, Texas, United States
aTyr Investigative Site
Dallas, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Falls Church, Virginia, United States
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Richmond, Virginia, United States
aTyr Investigative Site
Salvador, Estado de Bahia, Brazil
aTyr Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
aTyr Investigative Site
São Bernardo do Campo, Brazil
aTyr Investigative Site
São Paulo, Brazil
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São Paulo, Brazil
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Bobigny, France
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La Tronche, France
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Montpellier, France
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Paris, France
aTyr Investigative Site
Toulouse, France
aTyr Investigative Site
Essen, Germany
aTyr Investigative Site
Freiburg im Breisgau, Germany
aTyr Investigative Site
Hanover, Germany
aTyr Investigative Site
Heidelberg, Germany
aTyr Investigative Site
Catania, Italy
aTyr Investigative Site
Florence, Italy
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Forlì, Italy
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Milan, Italy
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Naples, Italy
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Padua, Italy
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Rome, Italy
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Siena, Italy
aTyr Investigative Site
Trieste, Italy
Kyorin Investigative Site
Aomori, Japan
Kyorin Investigative Site
Fukuoka, Japan
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Fukushima, Japan
Kyorin Investigative Site
Hokkaido, Japan
Kyorin Investigative Site
Hokkaido, Japan
Kyorin Investigative Site
Hyōgo, Japan
Kyorin Investigative Site
Kanagawa, Japan
Kyorin Investigative Site
Kanagawa, Japan
aTyr Investigative Site
Kumamoto, Japan
Kyorin Investigative Site
Miyagi, Japan
Kyorin Investigative Site
Okayama, Japan
Kyorin Investigative Site
Osaka, Japan
Kyorin Investigative Site
Shimane, Japan
Kyorin Investigative Site
Shizuoka, Japan
Kyorin Investigative Site
Tokyo, Japan
Kyorin Investigative Site
Tokyo, Japan
aTyr Investigative Site
Nieuwegein, Netherlands
aTyr Investigative Site
Barcelona, Spain
aTyr Investigative Site
Barcelona, Spain
aTyr Investigative Site
Madrid, Spain
aTyr Investigative Site
Madrid, Spain
aTyr Investigative Site
Santander, Spain
aTyr Investigative Site
Valencia, Spain
aTyr Investigative Site
Birmingham, United Kingdom
aTyr Investigative Site
Cambridge, United Kingdom
aTyr Investigative Site
Cottingham, United Kingdom
aTyr Investigative Site
Coventry, United Kingdom
aTyr Investigative Site
London, United Kingdom
aTyr Investigative Site
London, United Kingdom