Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
NCT ID: NCT06932263
Last Updated: 2026-01-16
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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RECRUITING
PHASE2
540 participants
INTERVENTIONAL
2025-03-26
2028-03-16
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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Tozorakimab Dose 1
Dosing subcutaneously tozorakimab Dose 1
Tozorakimab
The drug will be administered subcutaneously.
Tozorakimab Dose 2
Dosing subcutaneously tozorakimab Dose 2 and placebo
Tozorakimab
The drug will be administered subcutaneously.
Placebo
Dosing subcutaneously with equivalent volume to tozorakimab
Placebo
Placebo will be administered subcutaneously.
Interventions
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Tozorakimab
The drug will be administered subcutaneously.
Placebo
Placebo will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
2. Adults aged 18-75, inclusive when signing the informed consent.
3. Documented physician-diagnosis of asthma for at least 12 months.
4. Treated with medium or high dose ICS in combination with LABA.
5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
7. Documented exacerbation history in the last 12 months and biomarker requirements of:
1. 2 severe exacerbations OR
2. 1 severe exacerbation and:
(i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
2. Clinically significant pulmonary disease other than asthma .
3. Current smokers, former smokers with \>10 pack-years history.
4. Clinically significant aortic stenosis or pulmonary arterial hypertension.
5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
6. Unstable cardiovascular disorders.
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Bakersfield, California, United States
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Huntington Beach, California, United States
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La Mesa, California, United States
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Newport Beach, California, United States
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San Jose, California, United States
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Wilmington, Delaware, United States
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Cutler Bay, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palmetto Bay, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Boise, Idaho, United States
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Indianapolis, Indiana, United States
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West Des Moines, Iowa, United States
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Louisville, Kentucky, United States
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White Marsh, Maryland, United States
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Farmington Hills, Michigan, United States
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Warren, Michigan, United States
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St Louis, Missouri, United States
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Bellevue, Nebraska, United States
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Grand Island, Nebraska, United States
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Omaha, Nebraska, United States
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Toms River, New Jersey, United States
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Maspeth, New York, United States
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Asheville, North Carolina, United States
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Huntersville, North Carolina, United States
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Kings Mountain, North Carolina, United States
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Toledo, Ohio, United States
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Edmond, Oklahoma, United States
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Grants Pass, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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DuBois, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Smithfield, Pennsylvania, United States
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Rock Hill, South Carolina, United States
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Knoxville, Tennessee, United States
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Austin, Texas, United States
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Forney, Texas, United States
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Kingwood, Texas, United States
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Tyler, Texas, United States
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Victoria, Texas, United States
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Roy, Utah, United States
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Bellingham, Washington, United States
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Kingwood, West Virginia, United States
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Milwaukee, Wisconsin, United States
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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La Plata, , Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Caxias do Sul, , Brazil
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Criciúma, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Salvador, , Brazil
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Santo André, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Sorocaba, , Brazil
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Curicó, , Chile
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Quillota, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Viña del Mar, , Chile
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Baotou, , China
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Changchun, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Haikou, , China
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Hefei, , China
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Hohhot, , China
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Huizhou, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenzhen, , China
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Wenzhou, , China
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Xuzhou, , China
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Brest, , France
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Créteil, , France
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Lyon, , France
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Marseille, , France
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Pessac, , France
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Strasbourg, , France
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Suresnes, , France
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Athens, , Greece
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Athens, , Greece
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Ioannina, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Gödöllő, , Hungary
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Pécs, , Hungary
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Törökbálint, , Hungary
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Belagavi, , India
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Coimbatore, , India
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Dehradun, , India
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Delhi, , India
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Faridabad, , India
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Gurgaon, , India
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Kochi, , India
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Lucknow, , India
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New Delhi, , India
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Vadodara, , India
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Catania, , Italy
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Foggia, , Italy
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Genoa, , Italy
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Roma, , Italy
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Fukuoka, , Japan
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Ginowan-shi, , Japan
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Hiroshima, , Japan
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Ishinomaki, , Japan
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Kawaguchi-shi, , Japan
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Kiyose-shi, , Japan
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Kobe, , Japan
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Meguro-ku, , Japan
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Miura, , Japan
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Neyagawa, , Japan
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Sapporo, , Japan
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Sapporo, , Japan
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Takamatsu, , Japan
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Ube, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Iloilo City, , Philippines
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Las Piñas, , Philippines
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Lipa City, , Philippines
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Manadaluyong City, , Philippines
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Quezon City, , Philippines
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Roxas City, , Philippines
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Benoni, , South Africa
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Brackenfell, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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eMkhomazi, , South Africa
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Somerset West, , South Africa
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Tygervalley, , South Africa
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Cheongju-si, , South Korea
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Daegu, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Mérida, , Spain
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Patraix, , Spain
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Santander, , Spain
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Chanthaburi, , Thailand
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Chiang Rai, , Thailand
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Chon Buri, , Thailand
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Khon Kaen, , Thailand
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Nakhon Sri Thammarat, , Thailand
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Da Nang, , Vietnam
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Haiphong, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Huế, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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2024-519116-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D9181C00002
Identifier Type: -
Identifier Source: org_study_id
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