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| Name | Class |
|---|---|
| Kyorin Pharmaceutical Co.,Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efzofitimod 3 mg/kg | Experimental |
| |
| Efzofitimod 5 mg/kg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efzofitimod 3 mg/kg | Drug | Efzofitimod IV infusion every 4 weeks for a total of 12 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean daily oral corticosteroid (OCS) dose at Week 48 | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in KSQ-Lung score at Week 48 | Baseline to Week 48 | |
| Steroid withdrawal rate | Baseline to Week 48 | |
| Change from baseline in absolute value of FVC at Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Carey | aTyr Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| aTyr Investigative Site | Birmingham | Alabama | 35294 | United States | ||
| aTyr Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37902990 | Derived | 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. |
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| Efzofitimod 5 mg/kg | Drug | Efzofitimod IV infusion every 4 weeks for a total of 12 doses |
|
|
| Placebo | Drug | Placebo IV infusion every 4 weeks for a total of 12 doses |
|
| Baseline to Week 48 |
| Phoenix |
| Arizona |
| 85027 |
| United States |
| aTyr Investigative Site | Los Angeles | California | 90033 | United States |
| aTyr Investigative Site | Sacramento | California | 95817 | United States |
| aTyr Investigative Site | Denver | Colorado | 80206 | United States |
| aTyr Investigative Site | Washington D.C. | District of Columbia | 20060 | United States |
| aTyr Investigative Site | Gainesville | Florida | 32610 | United States |
| aTyr Investigative Site | Tampa | Florida | 33606 | United States |
| aTyr Investigative Site | Weston | Florida | 33331 | United States |
| aTyr Investigative Site | Atlanta | Georgia | 30308 | United States |
| aTyr Investigative Site | Chicago | Illinois | 60611 | United States |
| aTyr Investigative Site | Chicago | Illinois | 60612 | United States |
| aTyr Investigative Site | Louisville | Kentucky | 40202 | United States |
| aTyr Investigative Site | New Orleans | Louisiana | 70115 | United States |
| aTyr Investigative Site | Baltimore | Maryland | 21224 | United States |
| aTyr Investigative Site | Boston | Massachusetts | 02114 | United States |
| aTyr Investigative Site | Ada | Michigan | 49301 | United States |
| aTyr Investigative Site | Detroit | Michigan | 48202 | United States |
| aTyr Investigative Site | Minneapolis | Minnesota | 55455 | United States |
| aTyr Investigative Site | Rochester | Minnesota | 55905 | United States |
| aTyr Investigative Site | Jackson | Mississippi | 39216 | United States |
| aTyr Investigative Site | St Louis | Missouri | 63110 | United States |
| aTyr Investigative Site | Albany | New York | 12208 | United States |
| aTyr Investigative Site | Middletown | New York | 10941 | United States |
| aTyr Investigative Site | Durham | North Carolina | 27710 | United States |
| aTyr Investigative Site | Greenville | North Carolina | 27834 | United States |
| aTyr Investigative Site | Cincinnati | Ohio | 45219 | United States |
| aTyr Investigative Site | Cleveland | Ohio | 44195 | United States |
| aTyr Investigative Site | Oklahoma City | Oklahoma | 73104 | United States |
| aTyr Investigative Site | Portland | Oregon | 97220 | United States |
| aTyr Investigative Site | Philadelphia | Pennsylvania | 19140 | United States |
| aTyr Investigative Site | Charleston | South Carolina | 29425-0630 | United States |
| aTyr Investigative Site | Dickson | Tennessee | 37055 | United States |
| aTyr Investigative Site | Dallas | Texas | 75246 | United States |
| aTyr Investigative Site | Dallas | Texas | 75390 | United States |
| aTyr Investigative Site | Houston | Texas | 77030 | United States |
| aTyr Investigative Site | Salt Lake City | Utah | 84132 | United States |
| aTyr Investigative Site | Falls Church | Virginia | 22042 | United States |
| aTyr Investigative Site | Richmond | Virginia | 23298 | United States |
| aTyr Investigative Site | Salvador | Estado de Bahia | 40220-005 | Brazil |
| aTyr Investigative Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| aTyr Investigative Site | São Bernardo do Campo | 09780-000 | Brazil |
| aTyr Investigative Site | São Paulo | 04039-901 | Brazil |
| aTyr Investigative Site | São Paulo | 05403-900 | Brazil |
| aTyr Investigative Site | Bobigny | 93000 | France |
| aTyr Investigative Site | La Tronche | 38700 | France |
| aTyr Investigative Site | Montpellier | 34295 | France |
| aTyr Investigative Site | Paris | 75015 | France |
| aTyr Investigative Site | Toulouse | 31000 | France |
| aTyr Investigative Site | Essen | 45122 | Germany |
| aTyr Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| aTyr Investigative Site | Hanover | 30625 | Germany |
| aTyr Investigative Site | Heidelberg | 69126 | Germany |
| aTyr Investigative Site | Catania | 95124 | Italy |
| aTyr Investigative Site | Florence | 50134 | Italy |
| aTyr Investigative Site | Forlì | 47121 | Italy |
| aTyr Investigative Site | Milan | 20123 | Italy |
| aTyr Investigative Site | Naples | 80131 | Italy |
| aTyr Investigative Site | Padua | 35128 | Italy |
| aTyr Investigative Site | Rome | 00168 | Italy |
| aTyr Investigative Site | Siena | 53100 | Italy |
| aTyr Investigative Site | Trieste | 34149 | Italy |
| Kyorin Investigative Site | Aomori | 036-8563 | Japan |
| Kyorin Investigative Site | Fukuoka | 814-0180 | Japan |
| Kyorin Investigative Site | Fukushima | 960-1295 | Japan |
| Kyorin Investigative Site | Hokkaido | 060-0033 | Japan |
| Kyorin Investigative Site | Hokkaido | 060-8648 | Japan |
| Kyorin Investigative Site | Hyōgo | 653-0013 | Japan |
| Kyorin Investigative Site | Kanagawa | 236-0004 | Japan |
| Kyorin Investigative Site | Kanagawa | 236-0051 | Japan |
| aTyr Investigative Site | Kumamoto | 860-8556 | Japan |
| Kyorin Investigative Site | Miyagi | 980-8574 | Japan |
| Kyorin Investigative Site | Okayama | 700-8558 | Japan |
| Kyorin Investigative Site | Osaka | 591-8025 | Japan |
| Kyorin Investigative Site | Shimane | 693-8501 | Japan |
| Kyorin Investigative Site | Shizuoka | 431-3192 | Japan |
| Kyorin Investigative Site | Tokyo | 150-8935 | Japan |
| Kyorin Investigative Site | Tokyo | 151-8528 | Japan |
| aTyr Investigative Site | Nieuwegein | 3435CM | Netherlands |
| aTyr Investigative Site | Barcelona | 08036 | Spain |
| aTyr Investigative Site | Barcelona | 08907 | Spain |
| aTyr Investigative Site | Madrid | 28006 | Spain |
| aTyr Investigative Site | Madrid | 28031 | Spain |
| aTyr Investigative Site | Santander | 39008 | Spain |
| aTyr Investigative Site | Valencia | 46010 | Spain |
| aTyr Investigative Site | Birmingham | B15 2TH | United Kingdom |
| aTyr Investigative Site | Cambridge | CB233RE | United Kingdom |
| aTyr Investigative Site | Cottingham | HU16 5JQ | United Kingdom |
| aTyr Investigative Site | Coventry | CV2 2DX | United Kingdom |
| aTyr Investigative Site | London | SE59RS | United Kingdom |
| aTyr Investigative Site | London | SW3 6NP | United Kingdom |
| ID | Term |
|---|---|
| D017565 | Sarcoidosis, Pulmonary |
| D012507 | Sarcoidosis |
| D006099 | Granuloma |
| D007249 | Inflammation |
| D008232 | Lymphoproliferative Disorders |
| D017563 | Lung Diseases, Interstitial |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007160 | Immunoproliferative Disorders |
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