A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
NCT ID: NCT06015737
Last Updated: 2025-11-13
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
PHASE3
302 participants
INTERVENTIONAL
2024-06-29
2027-08-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Anifrolumab
Participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to Week 51.
Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Placebo
Participants will receive placebo as a SC injection from Week 0/Day 1 up to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.
Placebo
Matching placebo solution for injection in aPFS.
Interventions
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Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Placebo
Matching placebo solution for injection in aPFS.
Eligibility Criteria
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Inclusion Criteria
* CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
* Inadequate response or intolerant to antimalarial therapy.
* Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
* 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
* Severe or life-threatening Systemic lupus erythematosus (SLE).
* Active SLE or Sjögren's Syndrome.
* Any active skin conditions other than CLE that may interfere with the study.
* History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS).
* History of recurrent infection requiring hospitalization and IV antibiotics.
* COVID-19 infection.
* Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
* At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.
18 Years
70 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Covina, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Plantation, Florida, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Murray, Kentucky, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Ann Arbor, Michigan, United States
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Bloomfield Hills, Michigan, United States
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Rochester, Minnesota, United States
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Omaha, Nebraska, United States
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Midland Park, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Statesville, North Carolina, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Summerville, South Carolina, United States
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Dallas, Texas, United States
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Galveston, Texas, United States
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Mesquite, Texas, United States
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Charlottesville, Virginia, United States
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Roanoke, Virginia, United States
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Seattle, Washington, United States
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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San Miguel, , Argentina
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Box Hill, , Australia
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Clayton, , Australia
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Kogarah, , Australia
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Malvern, , Australia
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Melbourne, , Australia
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Westmead, , Australia
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Woolloongabba, , Australia
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Belo Horizonte, , Brazil
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Belo Horizonte, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Osorno, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Baotou, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Heilongjiang, , China
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Jinan, , China
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Kunming, , China
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Nanchang, , China
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Nanjing, , China
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Shanghai, , China
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Shanghai, , China
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Shenzhen, , China
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Shenzhen, , China
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Shenzhen, , China
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Shijiazhuang, , China
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Ürümqi, , China
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Wuhan, , China
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Zhuzhou, , China
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Barranquilla, , Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Chía, , Colombia
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Aarhus, , Denmark
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Copenhagen, , Denmark
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Bois-Guillaume, , France
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Bordeaux, , France
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Chambray-lès-Tours, , France
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Dijon, , France
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Lille, , France
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Lyon, , France
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Montivilliers, , France
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Nantes, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Poitiers, , France
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Toulouse, , France
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Berlin, , Germany
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Bochum, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Marburg, , Germany
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Regensburg, , Germany
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Wuppertal, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Brescia, , Italy
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Cona, , Italy
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Florence, , Italy
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Marche, , Italy
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Milan, , Italy
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Napoli, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Rome, , Italy
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Bunkyō City, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Kanazawa, , Japan
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Kita-gun, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Omura-shi, , Japan
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Ono, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Suita, , Japan
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tabashi City, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yotsukaido-shi, , Japan
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Cuernavaca, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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San Luis Potosí City, , Mexico
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Veracruz, , Mexico
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Zapopan, , Mexico
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Hamilton, , New Zealand
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Papatoetoe, , New Zealand
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Iloilo City, , Philippines
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Lipa, , Philippines
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Manila, , Philippines
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Gdynia, , Poland
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Katowice, , Poland
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Kielce, , Poland
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Olsztyn, , Poland
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Ossy, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Braga, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Bucharest, , Romania
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Bucharest, , Romania
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Craiova, , Romania
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Iași, , Romania
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Târgu Mureş, , Romania
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Belgrade, , Serbia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kragujevac, , Serbia
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Košice, , Slovakia
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Piešťany, , Slovakia
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Piešťany, , Slovakia
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Svidník, , Slovakia
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Cape Town, , South Africa
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Johannesburg, , South Africa
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Stellenbosch, , South Africa
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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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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Castellon, , Spain
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Granada, , Spain
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L'Hospitalet de Llobregat, , Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Salamanca, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Vigo, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Khlong Luang, , Thailand
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Khon Kaen, , Thailand
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Cambridge, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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2021-003698-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D346BC00001
Identifier Type: -
Identifier Source: org_study_id