This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 70 Years |
Gender | All |
Key
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06015737 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AstraZeneca |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, France, Germany, Greece, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Cutaneous Lupus Erythematosus |
The primary objectives of the study are to evaluate the efficacy of anifrolumab compared with placebo in reducing skin disease in participants with active chronic and/or subacute CLE who are refractory and/or intolerant to antimalarial therapy. The secondary objectives of the study are to evaluate additional efficacy parameters of anifrolumab, safety, tolerability, quality of life, pharmacokinetics, pharmacodynamics, and immunogenicity. Stage 1 and Stage 2 of the study will have broadly identical study designs with the exception of sample size. Both Stages of the study will have a randomized, double-blind, placebo-controlled design, followed by an open-label treatment period.
Experimental: Stage 1: Anifrolumab
The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.
Placebo Comparator: Stage 1: Placebo
The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.
Experimental: Stage 2: Anifrolumab
The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.
Placebo Comparator: Stage 2: Placebo
The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.
Combination Product: - Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Other: - Placebo
Matching placebo solution for injection in aPFS.
Combination Product: - Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Other: - Placebo
Matching placebo solution for injection in aPFS.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Research Site
Glendale, Arizona, 85306
Status
Not yet recruiting
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Phoenix, Arizona, 85028
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Not yet recruiting
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Covina, California, 91722
Status
Withdrawn
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Fountain Valley, California, 92708
Status
Recruiting
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La Jolla, California, 92037
Status
Recruiting
Address
Research Site
Los Angeles, California, 90045
Status
Not yet recruiting
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Los Angeles, California, 90089
Status
Recruiting
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Orange, California, 92868
Status
Recruiting
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San Francisco, California, 94143
Status
Not yet recruiting
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Aurora, Colorado, 80045
Status
Recruiting
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Denver, Colorado, 80230
Status
Recruiting
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New Haven, Connecticut, 06519
Status
Not yet recruiting
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Washington, District of Columbia, 20037
Status
Not yet recruiting
Address
Research Site
Fort Lauderdale, Florida, 33309
Status
Withdrawn
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Miami, Florida, 33136
Status
Recruiting
Address
Research Site
Miami, Florida, 33174
Status
Recruiting
Address
Research Site
Plantation, Florida, 33324
Status
Recruiting
Address
Research Site
Chicago, Illinois, 60611
Status
Not yet recruiting
Address
Research Site
Chicago, Illinois, 60637
Status
Recruiting
Address
Research Site
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Research Site
Murray, Kentucky, 42071
Status
Not yet recruiting
Address
Research Site
Baltimore, Maryland, 21287
Status
Recruiting
Address
Research Site
Boston, Massachusetts, 02115-5817
Status
Withdrawn
Address
Research Site
Ann Arbor, Michigan, 48103
Status
Recruiting
Address
Research Site
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Research Site
Bloomfield Hills, Michigan, 48302
Status
Not yet recruiting
Address
Research Site
Rochester, Minnesota, 55905
Status
Recruiting
Address
Research Site
Omaha, Nebraska, 68198-5885
Status
Not yet recruiting
Address
Research Site
Midland Park, New Jersey, 07432
Status
Not yet recruiting
Address
Research Site
Brooklyn, New York, 11201
Status
Not yet recruiting
Address
Research Site
New York, New York, 10016
Status
Recruiting
Address
Research Site
New York, New York, 10028
Status
Recruiting
Address
Research Site
Rochester, New York, 14642
Status
Withdrawn
Address
Research Site
Chapel Hill, North Carolina, 27516
Status
Recruiting
Address
Research Site
Charlotte, North Carolina, 28207
Status
Recruiting
Address
Research Site
Statesville, North Carolina, 28625
Status
Recruiting
Address
Research Site
Cleveland, Ohio, 44195
Status
Recruiting
Address
Research Site
Portland, Oregon, 97239
Status
Not yet recruiting
Address
Research Site
Philadelphia, Pennsylvania, 19104
Status
Not yet recruiting
Address
Research Site
Providence, Rhode Island, 02903
Status
Recruiting
Address
Research Site
Charleston, South Carolina, 29425
Status
Withdrawn
Address
Research Site
Summerville, South Carolina, 29486
Status
Recruiting
Address
Research Site
Dallas, Texas, 75390-8843
Status
Not yet recruiting
Address
Research Site
Galveston, Texas, 77555
Status
Recruiting
Address
Research Site
Mesquite, Texas, 75150
Status
Recruiting
Address
Research Site
Charlottesville, Virginia, 22903
Status
Recruiting
Address
Research Site
Roanoke, Virginia, 24016
Status
Not yet recruiting
Address
Research Site
Seattle, Washington, 98105
Status
Not yet recruiting
Address
Research Site
Ciudad de Buenos Aires, , 1221
Status
Not yet recruiting
Address
Research Site
Córdoba, , 5000
Status
Not yet recruiting
Address
Research Site
Córdoba, , X5004BAL
Status
Not yet recruiting
Address
Research Site
Quilmes, , 1878
Status
Not yet recruiting
Address
Research Site
Rosario, , S2000PBJ
Status
Not yet recruiting
Address
Research Site
San Miguel, , 1663
Status
Recruiting
Address
Research Site
Box Hill, , 3128
Status
Withdrawn
Address
Research Site
Clayton, , 3168
Status
Recruiting
Address
Research Site
Kogarah, , 3168
Status
Withdrawn
Address
Research Site
Malvern, , 3144
Status
Recruiting
Address
Research Site
Melbourne, , 3004
Status
Recruiting
Address
Research Site
Westmead, , 2145
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Not yet recruiting
Address
Research Site
Woolloongabba, , 04102
Status
Recruiting
Address
Research Site
Innsbruck, , 6020
Status
Recruiting
Address
Research Site
Sankt Pölten, , 3100
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Not yet recruiting
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Wien, , 1130
Status
Not yet recruiting
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Bruxelles, , 1200
Status
Not yet recruiting
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Leuven, , 3000
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Not yet recruiting
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Liège, , 4000
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Not yet recruiting
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Belo Horizonte, , 30150-221
Status
Not yet recruiting
Address
Research Site
Porto Alegre, , 90035903
Status
Recruiting
Address
Research Site
Rio de Janeiro, , 22470-220
Status
Not yet recruiting
Address
Research Site
Salvador, , 40150-150
Status
Recruiting
Address
Research Site
Sao Paulo, , 05403-000
Status
Withdrawn
Address
Research Site
Edmonton, Alberta, T6G 2G3
Status
Not yet recruiting
Address
Research Site
Vancouver, British Columbia, V5Z 1M9
Status
Not yet recruiting
Address
Research Site
Hamilton, Ontario, L8N 3Z5
Status
Not yet recruiting
Address
Research Site
Toronto, Ontario, M5T 2S8
Status
Not yet recruiting
Address
Research Site
Osorno, , 200025
Status
Recruiting
Address
Research Site
Santiago, , 130021
Status
Recruiting
Address
Research Site
Santiago, , 7500571
Status
Withdrawn
Address
Research Site
Santiago, , 8420383
Status
Not yet recruiting
Address
Research Site
Baotou, , 14010
Status
Recruiting
Address
Research Site
Beijing, , 100029
Status
Not yet recruiting
Address
Research Site
Beijing, , 100043
Status
Withdrawn
Address
Research Site
Beijing, , 100050
Status
Not yet recruiting
Address
Research Site
Changchun, , 130021
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Not yet recruiting
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Research Site
Changsha, , 410011
Status
Recruiting
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Research Site
Chengdu, , 610021
Status
Not yet recruiting
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Research Site
Chongqing, , 400016
Status
Not yet recruiting
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Research Site
Guangzhou, , 510120
Status
Not yet recruiting
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Research Site
Hangzhou, , 310003
Status
Not yet recruiting
Address
Research Site
Heilongjiang, , 150086
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Not yet recruiting
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Jinan, , 250022
Status
Not yet recruiting
Address
Research Site
Kunming, , 650101
Status
Not yet recruiting
Address
Research Site
Nanchang, , 330006
Status
Not yet recruiting
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Research Site
Nanjing, , 210042
Status
Recruiting
Address
Research Site
Shanghai, , 200025
Status
Not yet recruiting
Address
Research Site
Shanghai, , 200443
Status
Recruiting
Address
Research Site
Shenzhen, , 518020
Status
Not yet recruiting
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Research Site
Shenzhen, , 518052
Status
Not yet recruiting
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Research Site
Shenzhen, , 518053
Status
Recruiting
Address
Research Site
Shijiazhuang, , 050000
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Not yet recruiting
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Research Site
Urumqi, , CN-830004
Status
Not yet recruiting
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Research Site
Wuhan, , 430060
Status
Withdrawn
Address
Research Site
Barranquilla, , 01800
Status
Recruiting
Address
Research Site
Barranquilla, , 080020
Status
Recruiting
Address
Research Site
Bogota, , 110221
Status
Not yet recruiting
Address
Research Site
Aarhus, , 641-8510
Status
Not yet recruiting
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Research Site
København, , 2100
Status
Not yet recruiting
Address
Research Site
Bois Guillaume, , 76031
Status
Not yet recruiting
Address
Research Site
Bordeaux, , 33075
Status
Withdrawn
Address
Research Site
Chambray Les Tours, , 37170
Status
Not yet recruiting
Address
Research Site
Dijon, , 21000
Status
Suspended
Address
Research Site
Lille Cedex, , 59037
Status
Not yet recruiting
Address
Research Site
Lyon, , 69437
Status
Not yet recruiting
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Research Site
Montivilliers, , 76290
Status
Not yet recruiting
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Research Site
Nantes, , 44000
Status
Not yet recruiting
Address
Research Site
Paris, , 75010
Status
Not yet recruiting
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Research Site
Paris, , 75013
Status
Not yet recruiting
Address
Research Site
Paris, , 75014
Status
Not yet recruiting
Address
Research Site
Paris, , 75970
Status
Not yet recruiting
Address
Research Site
Poitiers, , 86000, FR
Status
Not yet recruiting
Address
Research Site
Toulouse Cedex 9, , 31059
Status
Recruiting
Address
Research Site
Berlin, , 10117
Status
Recruiting
Address
Research Site
Bochum, , 44791
Status
Recruiting
Address
Research Site
Dresden, , 01307
Status
Not yet recruiting
Address
Research Site
Erlangen, , 91054
Status
Recruiting
Address
Research Site
Essen, , 45147
Status
Withdrawn
Address
Research Site
Hamburg, , 20251
Status
Recruiting
Address
Research Site
Hannover, , 30625
Status
Recruiting
Address
Research Site
Leipzig, , 04103
Status
Recruiting
Address
Research Site
Mainz, , 55131
Status
Not yet recruiting
Address
Research Site
Marburg, , 35043
Status
Not yet recruiting
Address
Research Site
Regensburg, , 93053
Status
Recruiting
Address
Research Site
Wuppertal, , 42283
Status
Withdrawn
Address
Research Site
Athens, , 11525
Status
Not yet recruiting
Address
Research Site
Athens, , 11527, GR
Status
Recruiting
Address
Research Site
Athens, , 12462
Status
Not yet recruiting
Address
Research Site
Athens, , 15125
Status
Recruiting
Address
Research Site
Athens, , 16121
Status
Recruiting
Address
Research Site
Brescia, , 25123
Status
Recruiting
Address
Research Site
Florence, , 50121
Status
Not yet recruiting
Address
Research Site
Marche, , 60126
Status
Recruiting
Address
Research Site
Milano, , 20132
Status
Not yet recruiting
Address
Research Site
Napoli, , 80138
Status
Not yet recruiting
Address
Research Site
Reggio Emilia, , 42123
Status
Not yet recruiting
Address
Research Site
Bunkyo-ku, , 113-8431
Status
Recruiting
Address
Research Site
Chuo-ku, , 104-8560
Status
Not yet recruiting
Address
Research Site
Fukuoka-Shi, , 812-8582
Status
Not yet recruiting
Address
Research Site
Itabashi, , 173-8606
Status
Not yet recruiting
Address
Research Site
Kita-gun, , 761-0793
Status
Not yet recruiting
Address
Research Site
Nagasaki-shi, , 852-8501
Status
Not yet recruiting
Address
Research Site
Nagoya-shi, , 467-8602
Status
Recruiting
Address
Research Site
Nagoya, , 457-8510
Status
Recruiting
Address
Research Site
Okayama-shi, , 700-8558
Status
Withdrawn
Address
Research Site
Omura-shi, , 856-8562
Status
Not yet recruiting
Address
Research Site
Ono, , 675-1392
Status
Recruiting
Address
Research Site
Osaka-shi, , 545-8586
Status
Not yet recruiting
Address
Research Site
Sapporo, , 060-8648
Status
Not yet recruiting
Address
Research Site
Suita, , 565-0871
Status
Not yet recruiting
Address
Research Site
Wakayama, , 641-8510
Status
Not yet recruiting
Address
Research Site
Yokohama-shi, , 232-0024
Status
Recruiting
Address
Research Site
Yokohama, , 245-8575
Status
Not yet recruiting
Address
Research Site
Yotsukaido-shi, , 284-0003
Status
Recruiting
Address
Research Site
Seoul, , 06591
Status
Recruiting
Address
Research Site
Seoul, , 06973
Status
Not yet recruiting
Address
Research Site
Ciudad de Mexico, , 07760
Status
Withdrawn
Address
Research Site
Cuernavaca, , 62170
Status
Not yet recruiting
Address
Research Site
Guadalajara, , 44340
Status
Not yet recruiting
Address
Research Site
Guadalajara, , 44610
Status
Not yet recruiting
Address
Research Site
Guadalajara, , 44638
Status
Not yet recruiting
Address
Research Site
Guadalajara, , 44690
Status
Not yet recruiting
Address
Research Site
San Luis Potosi, , 78213
Status
Not yet recruiting
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Research Site
Veracruz, , 91910
Status
Not yet recruiting
Address
Research Site
Zapopan, , 45070
Status
Withdrawn
Address
Research Site
Amsterdam, , 1105 AZ
Status
Recruiting
Address
Research Site
Breda, , 4818 CK
Status
Not yet recruiting
Address
Research Site
Nijmegen, , 6525 GA
Status
Recruiting
Address
Research Site
Rotterdam, , 3015 GD
Status
Recruiting
Address
Research Site
Hamilton, , 3204
Status
Not yet recruiting
Address
Research Site
Papatoetoe, , 2025
Status
Recruiting
Address
Research Site
Iloilo City, , 5000
Status
Recruiting
Address
Research Site
Manila, , 1000
Status
Recruiting
Address
Research Site
Gdynia, , 10-229
Status
Recruiting
Address
Research Site
Katowice, , 40-851
Status
Recruiting
Address
Research Site
Kielce, , 25-316
Status
Recruiting
Address
Research Site
Olsztyn, , 30-229
Status
Recruiting
Address
Research Site
Ossy, , 40-027
Status
Withdrawn
Address
Research Site
Poznan, , 60-529
Status
Recruiting
Address
Research Site
Warszawa, , 01-157
Status
Recruiting
Address
Research Site
Warszawa, , 02-507
Status
Recruiting
Address
Research Site
Warszawa, , 02-953
Status
Not yet recruiting
Address
Research Site
Braga, , 4710-243
Status
Not yet recruiting
Address
Research Site
Coimbra, , 3004-561
Status
Not yet recruiting
Address
Research Site
Lisboa, , 1649-035
Status
Not yet recruiting
Address
Research Site
Porto, , 4099-001
Status
Not yet recruiting
Address
Research Site
Bucharest, , 020125
Status
Not yet recruiting
Address
Research Site
Bucuresti, , 011774
Status
Not yet recruiting
Address
Research Site
Craiova, , 200061
Status
Not yet recruiting
Address
Research Site
Iasi, , 700291
Status
Not yet recruiting
Address
Research Site
Targu Mures, , 540342
Status
Withdrawn
Address
Research Site
Belgrade, , 11000
Status
Not yet recruiting
Address
Research Site
Belgrade, , 11000
Status
Recruiting
Address
Research Site
Kragujevac, , 34000
Status
Not yet recruiting
Address
Research Site
Košice, , 04001
Status
Withdrawn
Address
Research Site
Piestany, , 92101
Status
Not yet recruiting
Address
Research Site
Piestany, , 92101
Status
Withdrawn
Address
Research Site
Svidnik, , 089 01
Status
Recruiting
Address
Research Site
Cape Town, , 7500
Status
Recruiting
Address
Research Site
Johannesburg, , 2193
Status
Withdrawn
Address
Research Site
Stellenbosch, , 7600
Status
Not yet recruiting
Address
Research Site
Barcelona, , 08025
Status
Recruiting
Address
Research Site
Barcelona, , 8035
Status
Not yet recruiting
Address
Research Site
Castellon de la Plana, , 12004
Status
Recruiting
Address
Research Site
Granada, , 18012
Status
Recruiting
Address
Research Site
L'Hospitalet de Llobregat, , 08907
Status
Not yet recruiting
Address
Research Site
La Coruña, , 15006
Status
Not yet recruiting
Address
Research Site
Las Palmas de Gran Canaria, , 35010
Status
Recruiting
Address
Research Site
Madrid, , 28006
Status
Recruiting
Address
Research Site
Madrid, , 28034
Status
Not yet recruiting
Address
Research Site
Madrid, , 28040
Status
Not yet recruiting
Address
Research Site
Madrid, , 28041
Status
Not yet recruiting
Address
Research Site
Majadahonda, , 28222
Status
Recruiting
Address
Research Site
Salamanca, , 37007
Status
Not yet recruiting
Address
Research Site
Sevilla, , 41014
Status
Recruiting
Address
Research Site
Valencia, , 46017
Status
Recruiting
Address
Research Site
València, , 46014
Status
Not yet recruiting
Address
Research Site
Kaohsiung, , 83301
Status
Recruiting
Address
Research Site
Taichung, , 404
Status
Not yet recruiting
Address
Research Site
Taipei, , 10449
Status
Not yet recruiting
Address
Research Site
Taipei, , 11217
Status
Not yet recruiting
Address
Research Site
Bangkok, , 10330
Status
Not yet recruiting
Address
Research Site
Bangkok, , 10700
Status
Not yet recruiting
Address
Research Site
Hat Yai, , 90110
Status
Not yet recruiting
Address
Research Site
Khlong Luang, , 12120
Status
Not yet recruiting
Address
Research Site
Khon-Kaen, , 40002
Status
Not yet recruiting
Address
Research Site
Istanbul, , 34098
Status
Not yet recruiting
Address
Research Site
Istanbul, , 34668
Status
Not yet recruiting
Address
Research Site
Karsiyaka, , 35575
Status
Not yet recruiting
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Research Site
Kayseri, , 38039
Status
Not yet recruiting
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Samsun, , 55270
Status
Not yet recruiting
Address
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Cambridge, , CB2 0QQ
Status
Not yet recruiting
Address
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Leeds, , LS2 9JT
Status
Not yet recruiting
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Research Site
London, , NW1 2PG
Status
Not yet recruiting
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Research Site
London, , NW3 2QG
Status
Not yet recruiting
Address
Research Site
London, , SE1 7EH
Status
Recruiting
Address
Research Site
London, , SE5 9RS
Status
Recruiting
Address
Research Site
Newcastle upon Tyne, , NE1 4LP