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ACTIVE NOT RECRUITING

NCT05985915

PHASE3

A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren's syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]).

Official title: A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjögren's Syndrome

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

612

Start Date

2023-10-27

Completion Date

2033-04-22

Last Updated

2026-03-23

Healthy Volunteers

Conditions

Sjogrens Syndrome

Interventions

DRUG

Ianalumab (VAY736)

Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use

OTHER

Placebo

Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use

Inclusion Criteria: 1. Signed informed consent prior to participation in the extension study. 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: 1. Use of therapies excluded by the NEPTUNUS-1 and NEPTUNUS-2 study protocols (see NEPTUNUS studies protocols exclusion criteria in Section 5.2 for details). 2. Plans for administration of live vaccines during the study period. 3. Pregnant or nursing (breastfeeding) 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, from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). WOCBP are excluded unless they are using highly effective methods of contraception (failure rate \< 1% per year) 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. * Bilateral tubal occlusion or bilateral tubal ligation (at least six weeks before taking study treatment). * Sterilization (vasectomy) of male partner (s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical confirmation of surgical process. * Use of hormonal contraception methods: * Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal. * Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable. * Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) 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. If local regulations are more stringent than the contraception methods listed above, 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.

Locations (197)

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

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

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San Miguel Tucuman, Tucumán Province, Argentina

Novartis Investigative Site

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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São Paulo, São Paulo, Brazil

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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

Novartis Investigative Site

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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Pingxiang, 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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Beijing, China

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Shanghai, China

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Tianjin, China

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Xinxiang, 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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Dijon, France

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Le Kremlin-Bicêtre, France

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Le Mans, France

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Lille, France

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Paris, France

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Paris, France

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Saint-Priest-en-Jarez, 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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Berlin, Germany

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Berlin, Germany

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Erlangen, Germany

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Hanover, Germany

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Herne, Germany

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Ludwigshafen, Germany

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Athens, Greece

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Athens, Greece

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Guatemala City, Guatemala

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Guatemala City, Guatemala

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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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Naples, 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

Clinical Research Directory

A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (197)