Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis
NCT ID: NCT05415137
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
268 participants
INTERVENTIONAL
2022-09-15
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Efzofitimod 3 mg/kg
Efzofitimod 3 mg/kg
EfzofitimodIV infusion every 4 weeks for a total of 12 doses
Efzofitimod 5 mg/kg
Efzofitimod 5 mg/kg
EfzofitimodIV infusion every 4 weeks for a total of 12 doses
Placebo
Placebo
Placebo IV infusion every 4 weeks for a total of 12 doses
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70
* Patients must be receiving treatment with OCS of ≥ 3 months at Day 1 with a starting dose between ≥ 7.5 and ≤ 25 mg/day ≥ 4 weeks prior to Day 1.
* Body weight ≥ 40 kg and \< 160 kg
Exclusion Criteria
* Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-α) inhibitors or antifibrotics or interleukin inhibitors
* Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: High resolution CT fibrosis \> 20% within the last 12 months; FVC percent predicted (FVCPP) \< 50% and KSQ-Lung score \< 30
* In the opinion of the investigator, clinically significant pulmonary hypertension
* Patients with active cardiac, neuro, or renal sarcoidosis requiring organ-specific therapy in the past 2 years
* Patients with cutaneous or ocular sarcoidosis, which in the opinion of the Investigator, are at risk for exacerbation, necessitating OCS rescue or other systemic therapy
* History of Addisonian symptoms that precluded previous OCS taper attempts
* Is an active, heavy smoker of tobacco/nicotine-containing products
* History of anti-synthetase syndrome or Jo-1 positive at Screening
* Patients with active tuberculosis or those currently undergoing treatment for tuberculosis
18 Years
ALL
No
Sponsors
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Kyorin Pharmaceutical Co.,Ltd
INDUSTRY
aTyr Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Carey
Role: STUDY_DIRECTOR
aTyr Pharma, Inc.
Locations
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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
aTyr Investigative Site
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
aTyr Investigative Site
Ada, Michigan, United States
aTyr Investigative Site
Detroit, Michigan, United States
aTyr Investigative Site
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
aTyr Investigative Site
Middletown, New York, United States
aTyr Investigative Site
Durham, North Carolina, United States
aTyr Investigative Site
Greenville, North Carolina, United States
aTyr Investigative Site
Cincinnati, Ohio, United States
aTyr Investigative Site
Cleveland, Ohio, United States
aTyr Investigative Site
Oklahoma City, Oklahoma, United States
aTyr Investigative Site
Portland, Oregon, United States
aTyr Investigative Site
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
aTyr Investigative Site
Houston, Texas, United States
aTyr Investigative Site
Salt Lake City, Utah, United States
aTyr Investigative Site
Falls Church, Virginia, United States
aTyr Investigative Site
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
aTyr Investigative Site
São Paulo, , Brazil
aTyr Investigative Site
Bobigny, , France
aTyr Investigative Site
La Tronche, , France
aTyr Investigative Site
Montpellier, , France
aTyr Investigative Site
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
aTyr Investigative Site
Forlì, , Italy
aTyr Investigative Site
Milan, , Italy
aTyr Investigative Site
Napoli, , Italy
aTyr Investigative Site
Padua, , Italy
aTyr Investigative Site
Rome, , Italy
aTyr Investigative Site
Siena, , Italy
aTyr Investigative Site
Trieste, , Italy
Kyorin Investigative Site
Aomori, , Japan
Kyorin Investigative Site
Fukuoka, , Japan
Kyorin Investigative Site
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
Countries
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References
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Forster S, Chong YE, Siefker D, Becker Y, Bao R, Escobedo E, Qing Y, Rauch K, Burman L, Burkart C, Kainz P, Cubitt A, Muders M, Nangle LA. Development and Characterization of a Novel Neuropilin-2 Antibody for Immunohistochemical Staining of Cancer and Sarcoidosis Tissue Samples. Monoclon Antib Immunodiagn Immunother. 2023 Oct;42(5):157-165. doi: 10.1089/mab.2023.0007.
Other Identifiers
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ATYR1923-C-004
Identifier Type: -
Identifier Source: org_study_id
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