Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NCT05349214 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CVAY736A23022024-511068-10-00
• Study Type: interventional
• Target: 506
• Locations: 26 countries
• Sites: 146

Brief Summary

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

Conditions

Sjogren Syndrome

Keywords

Sjogren's syndrome, B-cell depleting, BAFF-R, VAY736, ianalumab, NEPTUNUS

Outcome Measures

Primary Outcomes (1)

• Plan A and B - Change from baseline in ESSDAI score at Week 48

  * Plan A - United States of America and US reference countries * Plan B - EU, China, other non-US Regions and EU reference countries Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status.

  48 weeks

Secondary Outcomes (10)

• Change from baseline in SSSD score at Week 48

  48 weeks

• Percentage of participants achieving ESSDAI response at Week 48**

  48 weeks

• Percentage of participants achieving ESSDAI score <5 at Week 48

  48 weeks

• Percentage of participants achieving SSSD response at Week 48**

  48 weeks

• Change from baseline in stimulated whole salivary flow rate at Week 48

  48 weeks

Other Outcomes (3)

• Incidence of Treatment-emergent AEs (TEAEs) /SAEs (Serious Adverse Event) upto the end of the study

  Through study completion up to two years

• Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay to end of study

  through study completion up to 2 years

• Ianalumab concentration in serum during the treatment and follow-up (up to the end of study)

  throughout study completion up to 2 years

Study Arms (3)

Arm A

EXPERIMENTAL

ianalumab exposure level 1

Biological: VAY736

Arm B

EXPERIMENTAL

ianalumab exposure level 2

Biological: VAY736

Arm C

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

VAY736 BIOLOGICAL

ianalumab s.c.

Arm A; Arm B

Placebo OTHER

placebo s.c.

Arm C

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study
• Women and men ≥ 18 years of age
• Classification of Sjögren's syndrome according to the ACR/EULAR 2016 criteria
• Time since diagnosis of Sjögren's of ≤ 7.5 years at screening
• Positive anti-Ro/SSA antibody at screening
• Patients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review
• Enrollment of anti-Ro/SSA-negative patients will be limited up to ≤10% of the study population
• Screening ESSDAI score of ≥ 5 within the following 8 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological and biologic.
• Stimulated whole salivary flow (sSF) rate of ≥ 0.05 mL/min at screening
• Ability to communicate well with the Investigator, understand and agree to comply with the requirements of the study
• Patients taking hydroxychloroquine (≤ 400 mg/day), methotrexate (≤ 25 mg/week) or azathioprine (≤ 150 mg/day) alone or in combination, are allowed to continue their medication, and must have been on a stable dose for at least 30 days prior to randomization.
• Patients taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day predniso(lo)ne or equivalent for at least 30 days before randomization.
• Patients taking
• the following Traditional Chinese Medicines: Total glucoside of peony (TGP) or Tripterium glycosides (TG) must discontinue these medications at least 30 days prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.

You may not qualify if:

• Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness
• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer3. Prior treatment with ianalumab
• Prior use of a B-cell depleting therapy other than ianalumab within 36 weeks prior to randomization or as long as B-cell count is less than the lower limit of normal or baseline value prior to receipt of previous B cell-depleting therapy (whichever is lower)
• Prior treatment with any of the following:
• Within 24 weeks prior to randomization: iscalimab (anti CD-40 mAb), belimumab , abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins plasmapheresis;
• Within 12 weeks prior to randomization: i.v. or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors) unless explicitly allowed by protocol
• Use of corticosteroids (predniso(lo)ne or equivalent corticosteroid) at dose \>10 mg/day
• Any one of the following laboratory values at screening:
• Hemoglobin levels \< 8.0 g/dL
• White blood cells (WBC) count \< 2.0 x 10E3/µL
• Platelet count \< 80 x 10E3/µL
• Absolute neutrophil count (ANC) \< 0.8 x 10E3/µL
• Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms
• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/ L-histidine, polysorbate 20)
• History of major organ, hematopoietic stem cell or bone marrow transplant

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (146)

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

Advanced Medical Research

La Palma, California, 90623, United States

Location

Bay Area Arthritis And Osteoporosis

Brandon, Florida, 33511, United States

Location

GNP Research

Cooper City, Florida, 33024, United States

Location

Sarasota Arthritis Res Ctr

Sarasota, Florida, 34239, United States

Location

Augusta University Georgia

Augusta, Georgia, 30912, United States

Location

North Georgia Rheumatology Group

Lawrenceville, Georgia, 30046, United States

Location

Clin Invest Specialists Inc

Orland Park, Illinois, 60467, United States

Location

Clinic of Robert Hozman

Skokie, Illinois, 60176, United States

Location

Clinical Investigation Specialists, Inc.

Wauconda, Illinois, 60084, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Tufts School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Arthritis Osteoporosis Assoc of NM

Las Cruces, New Mexico, 88011, United States

Location

St Lawrence Health System

Potsdam, New York, 13676, United States

Location

On Site Clinical Solutions Llc

Charlotte, North Carolina, 28202, United States

Location

Arthritis and Osteoporosis

Charlotte, North Carolina, 28207, United States

Location

RAO Research LLC

Oklahoma City, Oklahoma, 73116, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Ramesh C Gupta MD Memphis TN

Memphis, Tennessee, 38119, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

First Outpatient Research Unit

San Antonio, Texas, 78229, United States

Location

Advanced Rheumatology of Houston

Spring, Texas, 77382, United States

Location

Arthritis Northwest PLLC

Spokane, Washington, 99204, United States

Location

Novartis Investigative Site

CABA, Buenos Aires, C1405BCH, Argentina

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Novartis Investigative Site

Quilmes, Buenos Aires, 1878, Argentina

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Novartis Investigative Site

San Miguel Tucuman, Tucumán Province, T4000DPK, Argentina

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Novartis Investigative Site

Buenos Aires, 1646, Argentina

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Novartis Investigative Site

Buenos Aires, C1055AAF, Argentina

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Novartis Investigative Site

Buenos Aires, C1428DQG, Argentina

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Novartis Investigative Site

Maroochydore, Queensland, 4558, Australia

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Woodville South, South Australia, 5011, Australia

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Novartis Investigative Site

Hobart, Tasmania, 7000, Australia

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Novartis Investigative Site

Salvador, Estado de Bahia, 40150 150, Brazil

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Curitiba, Paraná, 80030-110, Brazil

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Novartis Investigative Site

São Paulo, São Paulo, 04266 010, Brazil

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Novartis Investigative Site

Burgas, 8000, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1606, Bulgaria

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Vancouver, British Columbia, V5Z 1L7, Canada

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Sydney, Nova Scotia, B1P 1P3, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Rimouski, Quebec, G5L 5T1, Canada

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Sherbrooke, Quebec, J1G 2E8, Canada

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Novartis Investigative Site

Trois-Rivières, Quebec, G9A 3Y2, Canada

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Novartis Investigative Site

Concepción, Bio Bio, 4070280, Chile

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Novartis Investigative Site

Valdivia, Los Ríos Region, 5110683, Chile

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Novartis Investigative Site

Santiago, RM, 7500588, Chile

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Novartis Investigative Site

Hefei, Anhui, 230001, China

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Chongqing, Chongqing Municipality, 400010, China

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Nanjing, Jiangsu, 210008, China

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Nanchang, Jiangxi, 330006, China

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Pingxiang, Jiangxi, 337000, China

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Changchun, Jilin, 130021, China

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Taiyuan, Shanxi, 030001, China

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Chengdu, Sichuan, 610041, China

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Yinchuan, The Ningxia Hui Autonomous Reg, 750000, China

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Ürümqi, Xinjiang, 830001, China

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Hangzhou, Zhejiang, 310006, China

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Beijing, 100029, China

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Beijing, 100730, China

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Shanghai, 200011, China

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Shanghai, 200040, China

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Novartis Investigative Site

Tianjin, 300052, China

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Xinxiang, 453099, China

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Medellín, Antioquia, 050001, Colombia

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Barranquilla, Atlántico, 080002, Colombia

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Bogota, Cundinamarca, 110221, Colombia

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Bucaramanga, Santander Department, 680003, Colombia

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Angers, 49933, France

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Brest, 29200, France

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Le Kremlin-Bicêtre, 94275, France

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Le Mans, 72000, France

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Strasbourg, 67000, France

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Cologne, North Rhine-Westphalia, 50937, Germany

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Dresden, Saxony, 01307, Germany

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Berlin, 13125, Germany

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Hanover, 30625, Germany

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Herne, 44649, Germany

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Athens, 115 21, Greece

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Athens, 115 27, Greece

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Székesfehérvár, Fejér, 8000, Hungary

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Debrecen, Hajdu Bihar Megye, 4032, Hungary

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Eger, 3300, Hungary

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Gyula, 5700, Hungary

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Szeged, 6725, Hungary

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Ahmedabad, Gujarat, 380013, India

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Ahmedabad, Gujarat, 380015, India

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Bangalore, Karnataka, 560 002, India

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Pune, Maharashtra, 411001, India

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New Delhi, 110029, India

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Kfar Saba, 4428164, Israel

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Ramat Gan, 5265601, Israel

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Ancona, AN, 60126, Italy

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Milan, MI, 20100, Italy

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Salerno, SA, 84131, Italy

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Udine, UD, 33100, Italy

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Naples, 80131, Italy

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Nagoya, Aichi-ken, 455-8530, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, 4578510, Japan

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Nagoya, Aichi-ken, 4578511, Japan

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Kitakyushu, Fukuoka, 8078556, Japan

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Sapporo, Hokkaido, 0608543, Japan

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Sapporo, Hokkaido, 0608648, Japan

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Yokohama, Kanagawa, 2458575, Japan

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Kuwana, Mie-ken, 511-0061, Japan

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Sasebo, Nagasaki, 857-1195, Japan

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Kurashiki, Okayama-ken, 7100824, Japan

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Bunkyo Ku, Tokyo, 1138431, Japan

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Chuo Ku, Tokyo, 1048560, Japan

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Itabashi-ku, Tokyo, 1738610, Japan

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Meguro-ku, Tokyo, 152-8902, Japan

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Shinjuku-ku, Tokyo, 1608582, Japan

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Culiacán, Sinaloa, 80000, Mexico

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Mérida, Yucatán, 97070, Mexico

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México, 07029, Mexico

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Poznan, Greater Poland Voivodeship, 61-397, Poland

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Krakow, Lesser Poland Voivodeship, 30-727, Poland

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Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

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Warsaw, 00-874, Poland

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Wroclaw, 50367, Poland

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Cluj-Napoca, Cluj, 400006, Romania

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Brasov, 500283, Romania

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Bucharest, 010825, Romania

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Bucharest, 011172, Romania

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Bratislava, 811 08, Slovakia

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Košice, 040 11, Slovakia

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Novartis Investigative Site

Partizánske, 958 01, Slovakia

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Novartis Investigative Site

Zvolen, 960 01, Slovakia

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Panorama, Western Cape, 7500, South Africa

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Stellenbosch, Western Cape, 7600, South Africa

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Santander, Cantabria, 39008, Spain

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Novartis Investigative Site

Vigo, Pontevedra, 36214, Spain

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Novartis Investigative Site

Barcelona, 08041, Spain

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Córdoba, 14004, Spain

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Madrid, 28009, Spain

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Valencia, 46026, Spain

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Stockholm, SE, 113 65, Sweden

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Kaohsiung City, 81346, Taiwan

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Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

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Novartis Investigative Site

Taichung, 40447, Taiwan

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Novartis Investigative Site

Taichung, 407219, Taiwan

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Novartis Investigative Site

Doncaster, DN2 5LT, United Kingdom

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Novartis Investigative Site

Leeds, LS1 3EX, United Kingdom

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Novartis Investigative Site

Liverpool, L9 7AL, United Kingdom

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Newcastle upon Tyne, NE1 4LP, United Kingdom

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Novartis Investigative Site

Swindon, SN3 6BB, United Kingdom

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MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, investigator staff, persons performing the assessments and Novartis Clinical Trial Team will remain blinded to the identity of the treatment from the time of randomization until the final database lock
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 27, 2022
• Study Start: August 4, 2022
• Primary Completion: May 13, 2025
• Study Completion (Estimated): May 13, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (5); GB (5); ZA (2); BR (3); CO (4); JP (15); GR (2); ME (3); AU (3); PL (5); SL (4); CA (6); IN (5); AR (6); CN (17); DE (5); HU (5); RO (4); FR (5); ES (6); US (23); CL (3); IL (2); SE (1); TW (4); BU (3)