An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
NCT ID: NCT05513001
Last Updated: 2025-07-31
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
696 participants
INTERVENTIONAL
2022-12-09
2027-08-02
Brief Summary
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This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
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Detailed Description
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Epoch 1 is the initial study period and includes participants from preceding Phase 3 studies. It consists of a 24-week randomized withdrawal period where participants receive either remibrutinib 25 mg b.i.d. or placebo if their UAS7 score is less than 16. For those with a UAS7 score of 16 or higher, there is a 24-week open-label treatment period with remibrutinib 25 mg b.i.d. Participants are randomized 1:1 to the double-blind placebo-controlled withdrawal phase. All participants will continue their background H1-AH treatment. If participants relapse (UAS7 ≥ 16) in the blinded group, they enter the (Re-)treatment period of Epoch 1 and receive 24 weeks of open-label treatment with remibrutinib 25 mg b.i.d. After this period, they move to Epoch 2.
Epoch 2 is the second subsequent study period and consists of 24-week cycles that may include treatment-free observation and/or open-label (Re-)treatment periods with remibrutinib 25 mg b.i.d., with or without background H1-AH, at the investigator's discretion. Participants from future Phase 3 remibrutinib studies may also join Epoch 2 if approved. If participants relapse (UAS7 ≥ 16) during an observation period, they enter the next (Re-)treatment period for 24 weeks of treatment with remibrutinib 25 mg b.i.d. Participants completing an observation period with a UAS7 ≤ 6 will complete the study with an end-of-study (EOS) visit. Those with a UAS7 \> 6 but \< 16 can enter the next (Re-)treatment period if continuous treatment is deemed necessary. Participants with a UAS7 \< 16 in the previous treatment period will receive remibrutinib monotherapy (without background H1-AH). If treatment continuation is not necessary, they complete the EOS visit and leave the study. Participants with a UAS7 ≥ 16 during the observation period will enter the corresponding (Re-)treatment period to continue treatment.
Throughout Epoch 2, the use of background H1-AH is at the investigator's discretion, except for participants with a UAS7 \< 16 in the previous treatment period, who will be treated with remibrutinib monotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: LOU064 (blinded)
LOU064 (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
LOU064 (blinded)
LOU064 (blinded) active treatment
LOU064 (open label)
LOU064 (open-label) active treatment
Arm 2: LOU064 Placebo (blinded)
LOU064 placebo (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
Placebo
Placebo
LOU064 (open label)
LOU064 (open-label) active treatment
Arm 3: LOU064 (Open Label)
LOU064 (open-label) taken orally for 24 weeks per treatment cycle (Arm 3)
LOU064 (open label)
LOU064 (open-label) active treatment
Interventions
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LOU064 (blinded)
LOU064 (blinded) active treatment
Placebo
Placebo
LOU064 (open label)
LOU064 (open-label) active treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female, adult participants ≥18 years of age.
* Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
* Willing and able to adhere to the study protocol and visit schedule.
Exclusion Criteria
* History of gastrointestinal bleeding.
* Requirement for anti-platelet medication.
* Requirement for anticoagulant medication.
* History or current hepatic disease.
* Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Allervie Clinical Research
Birmingham, Alabama, United States
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, United States
Research Solutions of Arizona
Litchfield Park, Arizona, United States
Acuro Research Inc
Little Rock, Arkansas, United States
Arkansas Research Trials
North Little Rock, Arkansas, United States
Kern Research
Bakersfield, California, United States
Antelope Valley Clinical Trials
Lancaster, California, United States
Allergy and Asthma Consultants
Redwood City, California, United States
Asthma and Allergy Associates P C
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Ctr PC
Denver, Colorado, United States
UCONN Health Dermatology
Farmington, Connecticut, United States
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States
Finlay Medical Research
Greenacres City, Florida, United States
Miami Dade Medical Research
Miami, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
Allergy and Asthma Diagnostic Treatment Center
Tallahassee, Florida, United States
AeroAllergy Research Laboratories of Savannah Inc
Savannah, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Endeavor Health
Glenview, Illinois, United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, United States
Deaconess Clin Allerg Res Inst
Evansville, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, United States
John Hopkins University
Baltimore, Maryland, United States
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, United States
The Clinical Research Center
St Louis, Missouri, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
Allergy Asthma Assoc Monmouth
Little Silver, New Jersey, United States
Oakview Dermatology
Athens, Ohio, United States
Optimed Research LLC
Columbus, Ohio, United States
CR Services Acquisition US
Dublin, Ohio, United States
Toledo Institute of Clinical Research
Toledo, Ohio, United States
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina, United States
Orion Clinical Research
Austin, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
RFSA Dermatology
San Antonio, Texas, United States
Allergy Associates of Utah
Sandy City, Utah, United States
Bellingham Asthma Allergy and Immunology
Bellingham, Washington, United States
Seattle Allergy and Asthma Rsch
Seattle, Washington, United States
Allergy Asthma and amp Sinus Ctr S C
Greenfield, Wisconsin, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Buenos Aires, Nueve De Julio, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Bahía Blanca, , Argentina
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Capital Federal, , Argentina
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Santa Fe, , Argentina
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East Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Santo André, São Paulo, Brazil
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Fredericton, New Brunswick, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Verdun, Quebec, Canada
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Guangdong, Guangzhou, China
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Wuhan, Hubei, China
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Wuxi, Jiangsu, China
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Changchun, Jilin, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Tianjin, , China
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Barranquilla, Atlántico, Colombia
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Bogotá, , Colombia
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Brno, , Czechia
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Olomouc, , Czechia
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Plzen Bory, , Czechia
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Prague, , Czechia
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Hellerup, , Denmark
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Kobenhavn N V, , Denmark
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Angers, , France
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Antony, , France
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Bordeaux, , France
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Brest, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Pierre-Bénite, , France
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Reims, , France
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Rouen, , France
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Saint-Mandé, , France
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Toulouse, , France
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Bramsche, Lower Saxony, Germany
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Göttingen, Lower Saxony, Germany
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Merzig, Saarland, Germany
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Leipzig, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Halle, Saxony-Anhalt, Germany
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Bad Bentheim, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Hanover, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Marburg, , Germany
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München, , Germany
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München, , Germany
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Debrecen, Hajdú-Bihar, Hungary
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Debrecen, , Hungary
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Belagavi, Karnataka, India
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Ancona, AN, Italy
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Milan, MI, Italy
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Nagoya, Aichi-ken, Japan
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Urayasu, Chiba, Japan
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Obihiro, Hokkaido, Japan
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Yokohama, Kanagawa, Japan
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Kamimashi-gun, Kumamoto, Japan
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Izumiōtsu, Osaka, Japan
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Neyagawa, Osaka, Japan
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Sakai, Osaka, Japan
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Takatsuki, Osaka, Japan
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Takatsuki, Osaka, Japan
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Izumo, Shimane, Japan
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Itabashi-ku, Tokyo, Japan
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Koto, Tokyo, Japan
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Minato, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Hiroshima, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Muar town, Johor, Malaysia
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Ipoh, Perak, Malaysia
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George Town, Pulau Pinang, Malaysia
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Wilayah Persekutuan, , Malaysia
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Bialystok, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Warsaw, , Poland
Alma Cruz-Santana Private Practice
Carolina, , Puerto Rico
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Izhevsk, , Russia
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Ryazan, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Stavropol, , Russia
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Singapore, , Singapore
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Kežmarok, , Slovakia
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Komárno, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Nové Zámky, , Slovakia
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Svidník, , Slovakia
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Pretoria, Gauteng, South Africa
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Cape Town, Western Province, South Africa
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Daegu, Dalseo Gu, South Korea
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Hwaseong-si, Gyeonggi-do, South Korea
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Suwon, Gyeonggi-do, South Korea
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Gwangju, , South Korea
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Incheon, , 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, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Alicante, , 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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Valencia, , Spain
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Valencia, , Spain
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Bern, , Switzerland
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Zurich, , Switzerland
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Zurich, , Switzerland
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Khon Kaen, THA, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Aydin, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Sakarya, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Talas Kayseri, , Turkey (Türkiye)
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Cardiff, , United Kingdom
Countries
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Other Identifiers
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2022-001034-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLOU064A2303B
Identifier Type: -
Identifier Source: org_study_id
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