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. (NEPTUNUS-Ext)

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

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]).

Study Overview

• Status: Active, not recruiting
• Conditions: Sjogrens Syndrome
• Intervention / Treatment: Drug: Ianalumab (VAY736); Other: Placebo

Detailed Description

This is a multicenter, randomized, double-blind, followed by an open-label, phase 3 study to assess the long-term safety and tolerability of of 300 mg ianalumab s.c. injection in participants with Sjögren's 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 enter the double blind treatment period and receive ianalumab 300 mg either monthly or every three months, consistent with their prior treatment assignment. Participants previously randomized to placebo in the core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every three months, starting at Week 60. Participants assigned to every three month dosing will receive monthly placebo injections between active doses to maintain blinding.

The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe (PFS) in needle safety device for injection or ianalumab via 2 mL autoinjector (AI). An AI is a device constituent of a single integral, or single entity, drug-device combination product, with drug primary mode of action. Participants already enrolled into the study (before AI approval and implementation) will continue receiving the treatment via PFS and will not be switched to AI.

All participants, including those previously on ianalumab 300 mg every three months or monthly in the double-blind treatment period will switch to open-label treatment and receive ianalumab 300 mg monthly. The treatment duration including both double-blind and open-label treatment periods will be 6 years. 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. The total duration of this extension study will be up to 8 years.

• Study Type: Interventional
• Enrollment (Actual): 612
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1646
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1055AAF
    • Novartis Investigative Site
  • CABA, Argentina, C1428DZF
    • Novartis Investigative Site
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1405BCH
      • Novartis Investigative Site
    • Quilmes, Buenos Aires, Argentina, 1878
      • Novartis Investigative Site
  • Tucumán Province
    • San Miguel Tucuman, Tucumán Province, Argentina, T4000DPK
      • Novartis Investigative Site
• Australia
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Novartis Investigative Site
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • Novartis Investigative Site
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Novartis Investigative Site
• Austria
  • Graz, Austria, 8036
    • Novartis Investigative Site
• Belgium
  • Leuven, Belgium, 3000
    • Novartis Investigative Site
• Brazil
  • São Paulo, Brazil, 01409-902
    • Novartis Investigative Site
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055 450
      • Novartis Investigative Site
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40150 150
      • Novartis Investigative Site
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36010 570
      • Novartis Investigative Site
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Novartis Investigative Site
    • São Paulo, São Paulo, Brazil, 04266 010
      • Novartis Investigative Site
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1606
    • Novartis Investigative Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L7
      • Novartis Investigative Site
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • Novartis Investigative Site
  • Quebec
    • Rimouski, Quebec, Canada, G5L 5T1
      • Novartis Investigative Site
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Novartis Investigative Site
    • Trois-Rivières, Quebec, Canada, G9A 3Y2
      • Novartis Investigative Site
• Chile
  • Biobio
    • Concepción, Biobio, Chile, 4070280
      • Novartis Investigative Site
  • Los Ríos Region
    • Valdivia, Los Ríos Region, Chile, 5110683
      • Novartis Investigative Site
  • RM
    • Santiago, RM, Chile, 7500588
      • Novartis Investigative Site
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 7500571
      • Novartis Investigative Site
    • Santiago, Santiago Metropolitan, Chile, 7500710
      • Novartis Investigative Site
• China
  • Beijing, China, 100730
    • Novartis Investigative Site
  • Beijing, China, 100029
    • Novartis Investigative Site
  • Beijing, China, 100050
    • Novartis Investigative Site
  • Shanghai, China, 200011
    • Novartis Investigative Site
  • Tianjin, China, 300052
    • Novartis Investigative Site
  • Xinxiang, China, 453099
    • Novartis Investigative Site
  • Anhui
    • Hefei, Anhui, China, 230001
      • Novartis Investigative Site
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400010
      • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Novartis Investigative Site
    • Shenzhen, Guangdong, China, 518020
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Novartis Investigative Site
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • Novartis Investigative Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Novartis Investigative Site
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Novartis Investigative Site
    • Pingxiang, Jiangxi, China, 337000
      • Novartis Investigative Site
  • Jilin
    • Changchun, Jilin, China, 130021
      • Novartis Investigative Site
  • Liaoning
    • Shenyang, Liaoning, China, 110011
      • Novartis Investigative Site
  • Shandong
    • Linyi, Shandong, China, 276000
      • Novartis Investigative Site
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Novartis Investigative Site
    • Taiyuan, Shanxi, China, 030000
      • Novartis Investigative Site
    • Xian, Shanxi, China, 710061
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
  • The Ningxia Hui Autonomous Reg
    • Yinchuan, The Ningxia Hui Autonomous Reg, China, 750000
      • Novartis Investigative Site
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050001
      • Novartis Investigative Site
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080002
      • Novartis Investigative Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Novartis Investigative Site
  • Santander Department
    • Bucaramanga, Santander Department, Colombia, 680003
      • Novartis Investigative Site
• Czechia
  • Brno, Czechia, 638 00
    • Novartis Investigative Site
  • Uherské Hradiště, Czechia, 686 01
    • Novartis Investigative Site
• France
  • Angers, France, 49933
    • Novartis Investigative Site
  • Brest, France, 29200
    • Novartis Investigative Site
  • Dijon, France, 21000
    • Novartis Investigative Site
  • Le Kremlin-Bicêtre, France, 94275
    • Novartis Investigative Site
  • Le Mans, France, 72000
    • Novartis Investigative Site
  • Lille, France, 59037
    • Novartis Investigative Site
  • Paris, France, 75013
    • Novartis Investigative Site
  • Paris, France, 75010
    • Novartis Investigative Site
  • Saint-Priest-en-Jarez, France, 42270
    • Novartis Investigative Site
• Germany
  • Berlin, Germany, 13125
    • Novartis Investigative Site
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Erlangen, Germany, 91056
    • Novartis Investigative Site
  • Hanover, Germany, 30625
    • Novartis Investigative Site
  • Herne, Germany, 44649
    • Novartis Investigative Site
  • Ludwigshafen, Germany, 67063
    • Novartis Investigative Site
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Novartis Investigative Site
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Novartis Investigative Site
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Novartis Investigative Site
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Novartis Investigative Site
• Greece
  • Athens, Greece, 115 27
    • Novartis Investigative Site
  • Athens, Greece, 115 21
    • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01011
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01009
    • Novartis Investigative Site
  • Quetzaltenango, Guatemala, 9001
    • Novartis Investigative Site
• Hungary
  • Eger, Hungary, 3300
    • Novartis Investigative Site
  • Gyula, Hungary, 5700
    • Novartis Investigative Site
  • Szeged, Hungary, 6725
    • Novartis Investigative Site
  • Fejér
    • Székesfehérvár, Fejér, Hungary, 8000
      • Novartis Investigative Site
  • Hajdu Bihar Megye
    • Debrecen, Hajdu Bihar Megye, Hungary, 4032
      • Novartis Investigative Site
• India
  • New Delhi, India, 110029
    • Novartis Investigative Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380013
      • Novartis Investigative Site
    • Ahmedabad, Gujarat, India, 380015
      • Novartis Investigative Site
• Israel
  • Kfar Saba, Israel, 4428164
    • Novartis Investigative Site
  • Ramat Gan, Israel, 5265601
    • Novartis Investigative Site
• Italy
  • Naples, Italy, 80131
    • Novartis Investigative Site
  • AN
    • Ancona, AN, Italy, 60126
      • Novartis Investigative Site
  • MI
    • Milan, MI, Italy, 20100
      • Novartis Investigative Site
  • SA
    • Salerno, SA, Italy, 84131
      • Novartis Investigative Site
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 455-8530
      • Novartis Investigative Site
    • Nagoya, Aichi-ken, Japan, 4578511
      • Novartis Investigative Site
    • Nagoya, Aichi-ken, Japan, 4578510
      • Novartis Investigative Site
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 8078556
      • Novartis Investigative Site
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Novartis Investigative Site
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 245-8575
      • Novartis Investigative Site
  • Mie-ken
    • Kuwana, Mie-ken, Japan, 511-0061
      • Novartis Investigative Site
  • Nagasaki
    • Sasebo, Nagasaki, Japan, 857-1195
      • Novartis Investigative Site
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 7100824
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo Ku, Tokyo, Japan, 1138431
      • Novartis Investigative Site
    • Chuo Ku, Tokyo, Japan, 104-8560
      • Novartis Investigative Site
    • Itabashi-ku, Tokyo, Japan, 1738610
      • Novartis Investigative Site
    • Meguro-ku, Tokyo, Japan, 152-8902
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 1608582
      • Novartis Investigative Site
• Lithuania
  • Vilnius, Lithuania, 08406
    • Novartis Investigative Site
• Mexico
  • México, Mexico, 07029
    • Novartis Investigative Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Novartis Investigative Site
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06700
      • Novartis Investigative Site
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80000
      • Novartis Investigative Site
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Novartis Investigative Site
• Poland
  • Bydgoszcz, Poland, 85-168
    • Novartis Investigative Site
  • Krakow, Poland, 30-002
    • Novartis Investigative Site
  • Warsaw, Poland, 00-874
    • Novartis Investigative Site
  • Wroclaw, Poland, 50367
    • Novartis Investigative Site
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-397
      • Novartis Investigative Site
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-727
      • Novartis Investigative Site
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
      • Novartis Investigative Site
    • Wroclaw, Lower Silesian Voivodeship, Poland, 52-416
      • Novartis Investigative Site
• Portugal
  • Braga, Portugal, 4710243
    • Novartis Investigative Site
  • Guarda, Portugal, 6301-858
    • Novartis Investigative Site
  • Lisbon, Portugal, 1649-035
    • Novartis Investigative Site
  • Lisbon, Portugal, 1050-034
    • Novartis Investigative Site
  • Lisbon, Portugal, 1349-019
    • Novartis Investigative Site
• Romania
  • Brasov, Romania, 500283
    • Novartis Investigative Site
  • Bucharest, Romania, 011172
    • Novartis Investigative Site
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, S308433
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, 811 08
    • Novartis Investigative Site
  • Košice, Slovakia, 040 11
    • Novartis Investigative Site
  • Zvolen, Slovakia, 960 01
    • Novartis Investigative Site
• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
      • Novartis Investigative Site
    • Stellenbosch, Western Cape, South Africa, 7600
      • Novartis Investigative Site
• South Korea
  • Gwangju, South Korea, 61469
    • Novartis Investigative Site
  • Seoul, South Korea, 06591
    • Novartis Investigative Site
• Spain
  • A Coruña, Spain, 15006
    • Novartis Investigative Site
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Córdoba, Spain, 14004
    • Novartis Investigative Site
  • Madrid, Spain, 28034
    • Novartis Investigative Site
  • Valencia, Spain, 46026
    • Novartis Investigative Site
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Novartis Investigative Site
    • Sabadell, Barcelona, Spain, 08208
      • Novartis Investigative Site
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48013
      • Novartis Investigative Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Novartis Investigative Site
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36214
      • Novartis Investigative Site
• Sweden
  • SE
    • Stockholm, SE, Sweden, 113 65
      • Novartis Investigative Site
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Novartis Investigative Site
  • Kaohsiung City, Taiwan, 81346
    • Novartis Investigative Site
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taichung, Taiwan, 407219
    • Novartis Investigative Site
• Turkey (Türkiye)
  • Kocaeli, Turkey (Türkiye), 41380
    • Novartis Investigative Site
  • Bilkent Cankaya
    • Ankara, Bilkent Cankaya, Turkey (Türkiye), 06800
      • Novartis Investigative Site
  • Sihhiye-Altindag
    • Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
      • Novartis Investigative Site
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06500
      • Novartis Investigative Site
• United Kingdom
  • Doncaster, United Kingdom, DN2 5LT
    • Novartis Investigative Site
  • Leeds, United Kingdom, LS1 3EX
    • Novartis Investigative Site
  • Liverpool, United Kingdom, L9 7AL
    • Novartis Investigative Site
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Novartis Investigative Site
  • Swindon, United Kingdom, SN3 6BB
    • Novartis Investigative Site
• United States
  • California
    • Fullerton, California, United States, 92835
      • Providence Medical Foundation
    • La Palma, California, United States, 90623
      • Advanced Medical Research
    • Van Nuys, California, United States, 91405
      • Medvin Clinical Research
  • Florida
    • Brandon, Florida, United States, 33511
      • Bay Area Arthritis And Osteoporosis
    • Cooper City, Florida, United States, 33024
      • GNP Research
    • Sarasota, Florida, United States, 34239
      • Sarasota Arthritis Res Ctr
    • Tamarac, Florida, United States, 33321
      • West Broward Rheumatology Associates Inc
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Georgia
    • Suwanee, Georgia, United States, 30024
      • North GA Rheumatology Group PC
  • Illinois
    • Orland Park, Illinois, United States, 60467
      • Clin Invest Specialists Inc
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Ochsner Health System
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • The John Hopkins Jerome L Greene Sjogren
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts School of Dental Medicine
  • New Mexico
    • Las Cruces, New Mexico, United States, 88011
      • Arthritis Osteoporosis Assoc of NM
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • Potsdam, New York, United States, 13676
      • St Lawrence Health System
  • North Carolina
    • Charlotte, North Carolina, United States, 28202
      • On Site Clinical Solutions Llc
    • Charlotte, North Carolina, United States, 28202
      • Arthritis and Osteoporosis
    • Wilmington, North Carolina, United States, 28401
      • Carolina Arthritis Associates
  • Ohio
    • Dayton, Ohio, United States, 45402
      • STAT Research Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • RAO Research LLC
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clin Res
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
    • Memphis, Tennessee, United States, 38119
      • Shelby Research LLC
  • Texas
    • Colleyville, Texas, United States, 76034
      • Precision Comprehensive Research
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77054
      • Prolato Clinical Research Center
    • Katy, Texas, United States, 77494
      • Houston Rheumatology and Arthrit
    • San Antonio, Texas, United States, 78229
      • First Outpatient Research Unit
    • Spring, Texas, United States, 77382
      • Advanced Rheumatology of Houston
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ianalumab Monthly; Ianalumab 300 mg s.c. monthly during initial double-blind treatment period. Open-label treatment and receive ianalumab 300 mg monthly.	Drug: Ianalumab (VAY736); Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use; Other Names: VAY736
Experimental: Ianalumab 3 Monthly; Ianalumab 300 mg s.c. every three months and placebo once monthly between doses during initial double-blind treatment period. Open-label treatment and receive ianalumab 300 mg monthly.	Drug: Ianalumab (VAY736); Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use; Other Names: VAY736; Other: Placebo; Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-emergent AEs (TEAEs)/SAEs	Assessment of safety and tolerability of ianalumab (VAY736) in patients with active Sjogrens syndrome	Week 52 to Week 464

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B-cell count measurement	To assess impact of long-term treatment on B-cell depletion.	Week 52 to Week 304
Pre-dose Ianalumab serum concentrations	To show comparability of ianalumab Ctrough between 2x 1 mL PFS (from the NEPTUNUS core studies) and 1x 2 mL PFS for participants on continuous monthly treatment.	pre-dose at Week 48 (from core study) and Week 64
On-treatment Ianalumab serum concentrations	To further assess the pharmacokinetics of ianalumab.	During treatment (from Week 52 to Week 204) and follow-up (From Week 208 to Week 304)
Percentage of participants achieving ≥ 5 points reduction from baseline in ESSDAI	EULAR Sjogren's syndrome disease activity index (ESSDAI) is a validated clinical disease outcome measure for Sjogrens that will be used in the study The instrument contains 12 organ-specific domains contributing to assessment of disease activity. For each domain, features of disease activity are scored by a clinician in 3 or 4 (Level 0=No disease activity to Level 3= high disease activity) levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The maximum possible score is 123.To calculate ESSDAI, all 12 organ domains must be individually assessed by a trained assessor (study Investigator) at every scheduled timepoint. This is to evaluate the long-term efficacy of VAY736 300 mg administered monthly or every 3 months.	Over time up to Week 360
Percentage of participants achieving ≥2.3 points reduction from baseline in ESSPRI among participants with baseline ESSPRI ≥3 score over time	The EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) questionnaire consists of three items to be given an activity level score between 0-10: pain (joint and/or muscle pain), fatigue and dryness (0 = no symptom at all and 10 = worst symptom imaginable ESSPRI is an established disease outcome measure for Sjogrens. It consists of three domains of dryness, pain and fatigue. The participant will assess severity of symptoms they experience on a single 0-10 numerical scale for each of the three domains. The ESSPRI score is defined as a mean of scores from the three scales: (dryness + pain + fatigue) /3.	Over time up to Week 360
Percentage of participants achieving ≥2.0 points reduction from baseline in SSSD among participants with baseline SSSD ≥3	The Sjogrens Syndrome Symptom Diary (SSSD) questionnaire consists of five (six for females) questions about symptoms of Sjögren's syndrome, each question given a score of 0-10 (0=no symptoms, 10=worst possible symptoms) where patient choose the one response that best describes how severe the symptom was at its worst in the PAST 24 HOURS. It includes six symptom items (eye dryness, mouth dryness, skin dryness, physical fatigue, muscle and/or joint pain, genital dryness), and applies a recall period of 24 hrs. The aim of the SSSD is to establish patient reported endpoints for the treatment of Sjogrens syndrome. Participants will complete the diary daily for 7 days prior to the scheduled dosing.	Over time up to Week 360

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): April 22, 2033
• Study Completion (Estimated): April 22, 2033

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: VAY736; Sjogrens Syndrome; ianalumab; NEPTUNUS
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome; ianalumab
• Other Study ID Numbers: CVAY736A2301E1; 2022-502966-26 (Registry Identifier: EU CT NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No