A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
NCT ID: NCT05985915
Last Updated: 2026-02-04
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
612 participants
INTERVENTIONAL
2023-10-27
2030-07-18
Brief Summary
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* The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe (PFS) or in a 2 mL autoinjector (AI) for injection. All participants will receive ianalumab either monthly or every 3 months.
* The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years.
* The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up.
Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding.
Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study.
Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens:
* ianalumab 300 mg monthly or
* ianalumab 300 mg once every 3 months
Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study.
Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe or a 2 mL autoinjector. Participants will be given the opportunity to self-inject at home on some visits after receiving training.
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Detailed Description
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Trial Design: This is a multicenter, randomized, double-blind, phase 3 study to assess the long-term safety and tolerability of four treatment regimens of ianalumab in participants with Sjogrens syndrome who have taken part in and completed one of two NEPTUNUS core studies, NEPTUNUS-1 (CVAY736A2301) or NEPTUNUS-2 (CVAY736A2302). There will be no screening period in this trial. From week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. Eligible participants will continue their assigned treatment to receive ianalumab 300 mg either monthly or every 3 months for up to 3 additional years of treatment beyond the 1-year core study period. After the treatment period, all participants will enter a follow-up period to be monitored for at least 20 weeks and then a conditional (if B-cell recovery criteria have not been met) follow-up period. The total post treatment follow-up period is up to 2 years.
Study Population: Participants with Sjogrens syndrome who have completed treatment in one of two NEPTUNUS core studies.
Study treatment assignment method: Participants randomized to ianalumab 300 mg monthly or every 3 months in one of the NEPTUNUS core studies will continue their assigned treatment. Participants randomized to placebo in the NEPTUNUS core studies will be randomized in a 1:1 ratio to either ianalumab 300 mg monthly or every 3 months.
Participants randomized to ianalumab 300 mg every 3 months will receive placebo (a dummy treatment) once monthly between doses.
Committees: An independent Data Monitoring Committee (DMC) will be utilized for safety review throughout the study. A steering committee will be formed to ensure overview of the study conduct.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ianalumab Monthly
Ianalumab 300 mg s.c. monthly
Ianalumab (VAY736)
Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use
Ianalumab 3 Monthly
Ianalumab 300 mg s.c. every three months and placebo once monthly between doses
Ianalumab (VAY736)
Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use
Placebo
Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use
Interventions
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Ianalumab (VAY736)
Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use
Placebo
Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants must have participated in either one of the two NEPTUNUS core studies, CVAY736A2301 or CVAY736A2302, and must have completed the entire treatment up to Week 48 without treatment discontinuation in core NEPTUNUS studies.
3. In the judgement of the Investigator, participants must be expected to clinically benefit from continued ianalumab therapy.
Exclusion Criteria
3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.
4. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment during dosing and for 6 months after stopping of investigational drug. Highly effective contraception methods include:
* Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
* Female bilateral tubal ligation, female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or total hysterectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
* Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
* Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception.
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
Contraception should be used in accordance with locally approved prescribing information of concomitant medications administered.
Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women are considered of not child-bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential.
If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF).
5. United States (and other countries, if male contraception is locally required): Sexually active males, unless they agree to use barrier protection during intercourse with a woman of child-bearing potential, while taking study treatment. As condom use alone has a reported failure rate exceeding 1% per year, it is recommended that female partners of male study participants use a second method of birth control. Although ianalumab is not teratogenic and/or genotoxic, and not transferred to semen, male contraception is required, as requested by FDA.
Globally, for all sexually active males, contraception should be used in accordance with the locally approved prescribing information of concomitant medications administered.
18 Years
75 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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Providence Medical Foundation
Fullerton, California, United States
Advanced Medical Research
La Palma, California, United States
Medvin Clinical Research
Van Nuys, California, United States
Bay Area Arthritis And Osteoporosis
Brandon, Florida, United States
GNP Research
Cooper City, Florida, United States
Sarasota Arthritis Res Ctr
Sarasota, Florida, United States
West Broward Rheumatology Associates Inc
Tamarac, Florida, United States
Augusta University Georgia
Augusta, Georgia, United States
North GA Rheumatology Group PC
Suwanee, Georgia, United States
Clin Invest Specialists Inc
Orland Park, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Ochsner Health System
Baton Rouge, Louisiana, United States
The John Hopkins Jerome L Greene Sjogren
Baltimore, Maryland, United States
Tufts School of Dental Medicine
Boston, Massachusetts, United States
Arthritis Osteoporosis Assoc of NM
Las Cruces, New Mexico, United States
Winthrop University Hospital
Mineola, New York, United States
St Lawrence Health System
Potsdam, New York, United States
On Site Clinical Solutions Llc
Charlotte, North Carolina, United States
Arthritis and Osteoporosis
Charlotte, North Carolina, United States
Carolina Arthritis Associates
Wilmington, North Carolina, United States
STAT Research Inc
Dayton, Ohio, United States
RAO Research LLC
Oklahoma City, Oklahoma, United States
Altoona Center for Clin Res
Duncansville, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Shelby Research LLC
Memphis, Tennessee, United States
Precision Comprehensive Research
Colleyville, Texas, United States
Baylor College Of Medicine
Houston, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Houston Rheumatology & Arthrit
Katy, Texas, United States
First Outpatient Research Unit
San Antonio, Texas, United States
Advanced Rheumatology of Houston
Spring, Texas, United States
Arthritis Northwest PLLC
Spokane, Washington, United States
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CABA, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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San Miguel Tucuman, Tucumán Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Maroochydore, Queensland, Australia
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Woodville South, South Australia, Australia
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Hobart, Tasmania, Australia
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Graz, , Austria
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Leuven, , Belgium
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Vitória, Espírito Santo, Brazil
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Salvador, Estado de Bahia, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Burgas, , Bulgaria
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Sofia, , Bulgaria
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Vancouver, British Columbia, Canada
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Sydney, Nova Scotia, Canada
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Rimouski, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Concepción, Bio Bio, Chile
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Valdivia, Los Ríos Region, Chile
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Santiago, RM, Chile
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Hefei, Anhui, China
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Chongqing, Chongqing Municipality, China
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Guangzhou, Guangdong, China
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Shenzhen, Guangdong, China
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Wuhan, Hubei, China
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Baotou, Inner Mongolia, China
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Nanjing, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Shenyang, Liaoning, China
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Linyi, Shandong, China
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Taiyuan, Shanxi, China
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Taiyuan, Shanxi, China
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Xian, Shanxi, China
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Chengdu, Sichuan, China
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Yinchuan, The Ningxia Hui Autonomous Reg, 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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Bogota, Cundinamarca, Colombia
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Bucaramanga, Santander Department, Colombia
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Brno, , Czechia
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Uherské Hradiště, , Czechia
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Angers, , France
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Brest, , France
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Le Kremlin-Bicêtre, , France
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Paris, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Würzburg, Bavaria, Germany
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Cologne, North Rhine-Westphalia, Germany
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Dresden, Saxony, Germany
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Herne, , Germany
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Ludwigshafen, , Germany
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Athens, , Greece
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Guatemala City, , Guatemala
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Quetzaltenango, , Guatemala
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Székesfehérvár, Fejér, Hungary
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Debrecen, Hajdu Bihar Megye, Hungary
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Eger, , Hungary
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Gyula, , Hungary
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Szeged, , Hungary
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Ahmedabad, Gujarat, India
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Ahmedabad, Gujarat, India
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New Delhi, , India
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Ancona, AN, Italy
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Milan, MI, Italy
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Salerno, SA, Italy
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Napoli, , Italy
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Kitakyushu, Fukuoka, Japan
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Sapporo, Hokkaido, Japan
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Yokohama, Kanagawa, Japan
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Kuwana, Mie-ken, Japan
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Sasebo, Nagasaki, Japan
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Kurashiki, Okayama-ken, Japan
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Bunkyo Ku, Tokyo, Japan
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Chuo Ku, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Vilnius, , Lithuania
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Culiacán, Sinaloa, Mexico
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Mérida, Yucatán, Mexico
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México, , Mexico
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Poznan, Greater Poland Voivodeship, Poland
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Krakow, Lesser Poland Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Bydgoszcz, , Poland
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Krakow, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Braga, , Portugal
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Guarda, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Cluj-Napoca, Cluj, Romania
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Brasov, , Romania
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Bucharest, , Romania
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Singapore, , Singapore
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Bratislava, , Slovakia
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Košice, , Slovakia
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Zvolen, , Slovakia
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Cape Town, Western Cape, South Africa
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Stellenbosch, Western Cape, South Africa
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Gwangju, , South Korea
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Seoul, , South Korea
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Badalona, Barcelona, Spain
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Sabadell, Barcelona, Spain
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Bilbao, Bizkaia, Spain
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Santander, Cantabria, Spain
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Vigo, Pontevedra, Spain
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A Coruña, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Stockholm, SE, Sweden
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Ankara, Bilkent Cankaya, Turkey (Türkiye)
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Ankara, Sihhiye-Altindag, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Doncaster, , United Kingdom
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Leeds, , United Kingdom
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Liverpool, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Swindon, , United Kingdom
Countries
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Other Identifiers
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2022-502966-26-01
Identifier Type: REGISTRY
Identifier Source: secondary_id
CVAY736A2301E1
Identifier Type: -
Identifier Source: org_study_id
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