Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

ClinicalTrials.gov Identifier: NCT04181762

Novartis Reference Number: CAIN457Q12301

Last Update: Feb 01, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this trial is to evaluate the efficacy and safety of subcutaneous secukinumab 300 mg compared to placebo, in combination with standard of care therapy (SoC), in subjects with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features).

Condition 
Lupus Nephritis
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jul 07, 2020
Completion date 
Jan 08, 2026
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
secukinumab
STUDY DRUG

Eligibility Criteria

Inclusion Criteria:

Adult male and female subjects aged 18 - 75 years old at the time of Baseline.

Confirmed diagnosis of:

SLE as defined by the American College of Rheumatology (ACR), OR
LN as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies.

Active lupus nephritis:

International Society of Neurology/Renal Pathology Society (ISN/RPS) Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)]; subjects are permitted to have co-existing Class V.
UPCR ≥1 at Screening.
Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2.
Active urinary sediment.

Exclusion Criteria:

Severe renal impairment and subjects requiring dialysis dialysis within the previous 12 months before Screening.
Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE).
Cyclophosphamide (CYC) use (i.v. or oral) or more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the month prior to Baseline.
Active ongoing inflammatory diseases.
Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor.
Ongoing infections or malignant process.
Pregnant or lactating women.

Other inclusion and exclusion criteria may apply.

Study Locations

United States
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Birmingham, 35294
Alabama
United States
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Fontana, 92335
California
United States
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La Mesa, 91942
California
United States
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Loma Linda, 92354
California
United States
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San Diego, 92037
California
United States
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Upland, 91786
California
United States
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Van Nuys, 91405
California
United States
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Hartford, 06106
Connecticut
United States
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Aventura, 33180
Florida
United States
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Miami, 33173
Florida
United States
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Plantation, 33324
Florida
United States
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Evansville, 47715
Indiana
United States
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Boston, 02111
Massachusetts
United States
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Boston, 02215
Massachusetts
United States
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Grand Blanc, 48439
Michigan
United States
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Brooklyn, 11201
New York
United States
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Manhasset, 11030
New York
United States
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Syracuse, 13210
New York
United States
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Statesville, 28625
North Carolina
United States
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Oklahoma City, 73104
Oklahoma
United States
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Philadelphia, 19140
Pennsylvania
United States
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Amarillo, 79016
Texas
United States
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Colleyville, 76034
Texas
United States
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Houston, 77054
Texas
United States
Argentina
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Caba, C1280AEB
Buenos Aires
Argentina
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Buenos Aires, C1012AAR
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Argentina
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Ciudad Autonoma de Bs As, C1015ABO
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Argentina
Australia
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Westmead, 2145
New South Wales
Australia
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Woolloongabba, 4102
Queensland
Australia
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Murdoch, 6150
Western Australia
Australia
Brazil
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Fortaleza, 60430 370
CE
Brazil
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Porto Alegre, 90020-090
RS
Brazil
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Santo Andre, 09060-870
SP
Brazil
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Sao Paulo, 05403 000
SP
Brazil
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São Paulo, 04038-002
SP
Brazil
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Sao Jose do Rio Preto, 15090 000
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Brazil
Canada
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Toronto, M5T 2S8
Ontario
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Chile
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Valdivia, 5100238
Los Rios
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Concepcion,
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Chile
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Santiago, 7500710
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Chile
China
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Nanning, 530021
Guangxi
China
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Shijiazhuang, 050000
Hebei
China
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Chengdu, 610072
Sichuan
China
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Beijing, 100029
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China
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Beijing, 100034
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China
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Beijing, 100191
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China
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Beijing, 100730
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China
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Chongqing, 400037
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China
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Shanghai, 200025
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China
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Shanghai, 200040
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China
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Tianjin, 300052
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China
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Wuhan, 430022
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Colombia
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Medellin, 050001
Antioquia
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Barranquilla,
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Cali,
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Cundinamarca, 111121
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Colombia
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Split, 21000
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Zagreb, 10000
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Croatia
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Prague 2, 128 50
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Praha 5, 150 06
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Praha, 12808
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Czech Republic
Denmark
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Aalborg, 9000
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Denmark
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Arhus N, DK-8200
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Odense, 5000
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France
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Bordeaux Cedex, 33067
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France
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Grenoble, 38043
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Marseille, 13385
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France
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Paris Cedex 13, 75651
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France
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Toulouse Cedex 4, 31054
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Germany
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Berlin, 13353
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Freiburg, 79106
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Kiel, 24105
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Mainz, 55131
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Heraklion Crete, 711 10
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Guatemala City, 01011
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Guatemala
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Guatemala, 01009
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Guatemala, 01010
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New Delhi, 110 017
Delhi
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New Delhi, 110 060
Delhi
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Gandhinagar, 387001
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Pune, 411013
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Cona, 44100
FE
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Milano, 20122
MI
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Padova, 35128
PD
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Roma, 00161
RM
Italy
Japan
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Toyoake city, 470 1192
Aichi
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Kitakyushu-city, 807-8556
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Hokkaido
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Kanazawa-city, 920-8641
Ishikawa
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Sendai city, 980 8574
Miyagi
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Kurashiki, 701-0192
Okayama
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Tokyo
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Chuo ku, 104-8560
Tokyo
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Shinjuku-ku, 160 8582
Tokyo
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Niigata, 951 8520
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Japan
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Osaka, 545-8586
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Korea, Republic of
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Seoul, 06591
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Seoul, 04763
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Korea, Republic of
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Seoul, 05030
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Korea, Republic of
Latvia
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Riga, LV 1002
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Latvia
Mauritius
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Solferino Phoenix, 1772
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Mexico
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Mexicali, 21200
Baja California Norte
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Ciudad de Mexico, 14080
Mexico CP
Mexico
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Merida, 97070
Yucatan
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Mexico City, 06726
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Mexico
Norway
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Oslo, 0372
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Norway
Peru
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Santiago de Surco, 33
Lima
Peru
Philippines
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Lipa City, 4217
Batangas
Philippines
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Iloilo,
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Philippines
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Manila, 1008
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Philippines
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Quezon City, 1102
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Philippines
Portugal
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Coimbra, 3000-075
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Portugal
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Guimaraes, 4835 044
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Portugal
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Lisbon, 1069-166
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Portugal
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Porto, 4099 001
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Romania
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Oradea, 410469
Bihor
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Ramnicu Valcea, 240672
Valcea
Romania
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Brasov, 500283
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Romania
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Bucharest, 022328
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Romania
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Bucuresti, 010 731
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Romania
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Bucuresti, 011172
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Romania
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Cluj Napoca, 400006
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Romania
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Timisoara, 300736
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Romania
Russian Federation
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Kazan, 420012
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Russian Federation
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Kemerovo, 650070
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Russian Federation
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Petrozavodsk, 185019
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Russian Federation
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Rostov on Don, 344022
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Russian Federation
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Saint Petersburg, 197022
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Russian Federation
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Tyumen, 625023
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Russian Federation
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Yaroslavl, 150062
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Russian Federation
Slovakia
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Piestany, 92101
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Slovakia
South Africa
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Panorama, 7500
Western Cape
South Africa
Spain
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Cordoba, 14004
Andalucia
Spain
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Sevilla, 41013
Andalucia
Spain
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Sabadell, 08208
Barcelona
Spain
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Barcelona, 08036
Catalunya
Spain
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Santiago de Compostela, 15706
Galicia
Spain
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Vigo, 36200
Pontevedra
Spain
Sweden
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Linkoping, SE 581 85
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Sweden
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Stockholm, 171 76
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Sweden
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Uppsala, 751 85
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Sweden
Switzerland
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Bern, 3010
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Switzerland
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Lausanne, 1005
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Switzerland
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St Gallen, CH 9007
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Switzerland
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Zuerich, 8091
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Switzerland
Taiwan
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Kaohsiung, 81346
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Taiwan
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Taichung, 40447
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Taiwan
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Taichung, 40705
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Taiwan
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Tao Yuan, 333
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Taiwan
Thailand
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Khon Kaen, 40002
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Thailand
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Bangkok, 10400
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Thailand
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Bangkok, 10700
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Thailand
Turkey
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Istanbul, 34093
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Turkey
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Istanbul, 34300
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Turkey
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Kocaeli, 41380
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Turkey
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Zuhuratbaba / Istanbul, 34147
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Turkey
United Kingdom
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London, W12 0NN
UK
United Kingdom
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London, SE1 7EH
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United Kingdom
Vietnam
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Ho Chi Minh, 700000
VNM
Vietnam
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Hanoi, 100000
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Vietnam
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Ho Chi Minh,
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Vietnam

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