Sjogrens SyndromePhase 3NEPTUNUS-ExtNCT05985915
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.
A Phase 3 study testing Ianalumab (VAY736) in people with Sjogrens Syndrome, run by Novartis Pharmaceuticals at 198 sites in 35 countries.
Trial 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]). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjogrens Syndrome
- What is being tested?
- Ianalumab (VAY736)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 612 participants
- Where
- 198 sitesin 35 countries
- Study dates
- 27 Oct 2023to 22 Apr 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to participation in the extension study.
- 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.
- In the judgement of the Investigator, participants must be expected to clinically benefit from continued ianalumab therapy.
Who cannot join
- 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).
- Plans for administration of live vaccines during the study period.
- 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.
- 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.
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- 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).
- 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.
Trial locations and contacts
198 sites in 35 countries.
198 sites in 35 countries
United States32 sites
Augusta University Georgia
Augusta, Georgia, 30912
The John Hopkins Jerome L Greene Sjogren
Baltimore, Maryland, 21224
Ochsner Health System
Baton Rouge, Louisiana, 70809
Tufts School of Dental Medicine
Boston, Massachusetts, 02111
Bay Area Arthritis And Osteoporosis
Brandon, Florida, 33511
Arthritis and Osteoporosis
Charlotte, North Carolina, 28202
On Site Clinical Solutions Llc
Charlotte, North Carolina, 28202
Precision Comprehensive Research
Colleyville, Texas, 76034
GNP Research
Cooper City, Florida, 33024
STAT Research Inc
Dayton, Ohio, 45402
Altoona Center for Clin Res
Duncansville, Pennsylvania, 16635
Providence Medical Foundation
Fullerton, California, 92835
Baylor College Of Medicine
Houston, Texas, 77030
Prolato Clinical Research Center
Houston, Texas, 77054
West Tennessee Research Institute
Jackson, Tennessee, 38305
University of Kansas Hospital
Kansas City, Kansas, 66160
Houston Rheumatology and Arthrit
Katy, Texas, 77494
Advanced Medical Research
La Palma, California, 90623
Arthritis Osteoporosis Assoc of NM
Las Cruces, New Mexico, 88011
Shelby Research LLC
Memphis, Tennessee, 38119
NYU Langone Hospital - Long Island
Mineola, New York, 11501
RAO Research LLC
Oklahoma City, Oklahoma, 73116
Clin Invest Specialists Inc
Orland Park, Illinois, 60467
St Lawrence Health System
Potsdam, New York, 13676
First Outpatient Research Unit
San Antonio, Texas, 78229
Sarasota Arthritis Res Ctr
Sarasota, Florida, 34239
Arthritis Northwest PLLC
Spokane, Washington, 99216
North GA Rheumatology Group PC
Suwanee, Georgia, 30024
West Broward Rheumatology Associates Inc
Tamarac, Florida, 33321
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382
Medvin Clinical Research
Van Nuys, California, 91405
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
China23 sites
Novartis Investigative Site
Baotou, Inner Mongolia, 014010
Novartis Investigative Site
Beijing, 100029
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Chengdu, Sichuan, 610041
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Chongqing, Chongqing Municipality, 400010
Novartis Investigative Site
Guangzhou, Guangdong, 510630
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Hefei, Anhui, 230001
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Linyi, Shandong, 276000
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Nanchang, Jiangxi, 330006
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Nanjing, Jiangsu, 210008
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Pingxiang, Jiangxi, 337000
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Shanghai, 200011
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Shenyang, Liaoning, 110011
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Shenzhen, Guangdong, 518020
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Taiyuan, Shanxi, 030000
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Taiyuan, Shanxi, 030001
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Tianjin, 300052
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Wuhan, Hubei, 430030
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Xian, Shanxi, 710061
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Xinxiang, 453099
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Yinchuan, The Ningxia Hui Autonomous Reg, 750000
Japan14 sites
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138431
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Chuo Ku, Tokyo, 1048560
Novartis Investigative Site
Itabashi-ku, Tokyo, 1738610
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Kitakyushu, Fukuoka, 8078556
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Kurashiki, Okayama-ken, 7100824
Novartis Investigative Site
Kuwana, Mie-ken, 5110061
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Meguro-ku, Tokyo, 1528902
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Nagoya, Aichi-ken, 4558530
Novartis Investigative Site
Nagoya, Aichi-ken, 4578510
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Nagoya, Aichi-ken, 4578511
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Sapporo, Hokkaido, 0608648
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Sasebo, Nagasaki, 8571195
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Shinjuku-ku, Tokyo, 1608582
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Yokohama, Kanagawa, 2458575
Germany10 sites
Novartis Investigative Site
Berlin, 13125
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Berlin, 13353
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Cologne, North Rhine-Westphalia, 50937
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Dresden, Saxony, 01307
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Erlangen, 91056
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Freiburg im Breisgau, Baden-Wurttemberg, 79106
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Hanover, 30625
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Herne, 44649
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Ludwigshafen, Germany, 67063
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Würzburg, Bavaria, 97080
Spain10 sites
Novartis Investigative Site
A Coruña, 15006
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Badalona, Barcelona, 08916
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Barcelona, 08041
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Bilbao, Bizkaia, 48013
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Córdoba, 14004
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Madrid, 28034
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Sabadell, Barcelona, 08208
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Santander, Cantabria, 39008
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Valencia, 46026
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Vigo, Pontevedra, 36214
France9 sites
Novartis Investigative Site
Angers, France, 49933
Novartis Investigative Site
Brest, 29200
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Dijon, 21000
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Le Kremlin-Bicêtre, 94275
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Le Mans, 72000
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Lille, 59037
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75013
Novartis Investigative Site
Saint-Priest-en-Jarez, 42270
Poland8 sites
Novartis Investigative Site
Bydgoszcz, 85-168
Novartis Investigative Site
Krakow, Lesser Poland Voivodeship, 30-727
Novartis Investigative Site
Krakow, 30-002
Novartis Investigative Site
Poznan, Greater Poland Voivodeship, 61-397
Novartis Investigative Site
Warsaw, 00-874
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, 52-210
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, 52-416
Novartis Investigative Site
Wroclaw, 50-367
Argentina6 sites
Novartis Investigative Site
Buenos Aires, C1055AAF
Novartis Investigative Site
Buenos Aires, C1437FFC
Novartis Investigative Site
CABA, Buenos Aires, C1405BCH
Novartis Investigative Site
CABA, C1428DZF
Novartis Investigative Site
Quilmes, Buenos Aires, 1878
Novartis Investigative Site
San Miguel Tucuman, Tucumán Province, T4000DPK
Brazil6 sites
Novartis Investigative Site
Juiz de Fora, Minas Gerais, 36010-570
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14048-900
Novartis Investigative Site
Salvador, Estado de Bahia, 40150-150
Novartis Investigative Site
São Paulo, São Paulo, 04266-010
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São Paulo, 01409-902
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Vitória, Espírito Santo, 29055-450
Canada5 sites
Novartis Investigative Site
Rimouski, Quebec, G5L 5T1
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Sherbrooke, Quebec, J1G 2E8
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Sydney, Nova Scotia, B1P 1P3
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Trois-Rivières, Quebec, G9A 3Y2
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Vancouver, British Columbia, V5Z 1L7
Chile5 sites
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Concepción, Biobio, 4070280
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Santiago, RM, 7500588
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Santiago, Santiago Metropolitan, 7500571
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Santiago, Santiago Metropolitan, 7500710
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Valdivia, Los Ríos Region, 5110683
Guatemala5 sites
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010
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Guatemala City, Departamento de Guatemala, 01011
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Guatemala City, 01009
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Guatemala City, 01010
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Quetzaltenango, Departamento de Quetzaltenango, 09001
Hungary5 sites
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
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Eger, 3300
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Gyula, 5700
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Szeged, 6725
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Székesfehérvár, Fejér, 8000
Mexico5 sites
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Culiacán, Sinaloa, 80000
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Guadalajara, Jalisco, 44650
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Mérida, Yucatán, 97070
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Mexico City, Mexico City, 06700
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Mexico City, Mexico City, 07369
Portugal5 sites
Novartis Investigative Site
Braga, 4710-243
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Guarda, 6301-858
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Lisbon, 1050-034
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Lisbon, 1349-019
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Lisbon, 1649-035
United Kingdom5 sites
Novartis Investigative Site
Doncaster, DN2 5LT
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Leeds, LS1 3EX
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Liverpool, L9 7AL
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Newcastle upon Tyne, NE1 4LP
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Swindon, SN3 6BB
Colombia4 sites
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Barranquilla, Atlántico, 080002
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Bogota, Cundinamarca, 110221
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Bucaramanga, Santander Department, 680003
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Medellín, Antioquia, 050001
Italy4 sites
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Ancona, AN, 60020
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Milan, MI, 20100
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Naples, 80131
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Salerno, SA, 84131
Taiwan4 sites
Novartis Investigative Site
Kaohsiung City, 81346
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Kaohsiung City, 833
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Taichung, 40447
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Taichung, 407219
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara, Bilkent Cankaya, 06800
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Ankara, Sihhiye Altindag, 06230
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Ankara, Yenimahalle, 06500
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Köseköy, Kocaeli, 41380
Australia3 sites
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Hobart, Tasmania, 7000
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Maroochydore, Queensland, 4558
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Woodville South, South Australia, 5011
India3 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380013
Novartis Investigative Site
Ahmedabad, Gujarat, 380015
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New Delhi, New Delhi, 110029
Romania3 sites
Novartis Investigative Site
Brasov, 500283
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Bucharest, 011172
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Cluj-Napoca, Cluj, 400006
Slovakia3 sites
Novartis Investigative Site
Bratislava, 811 08
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Košice, 040 11
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Zvolen, 960 01
Bulgaria2 sites
Novartis Investigative Site
Burgas, Bulgaria, 8000
Novartis Investigative Site
Sofia, 1431
Czechia2 sites
Novartis Investigative Site
Brno, 638 00
Novartis Investigative Site
Uherské Hradiště, 686 01
Greece2 sites
Novartis Investigative Site
Athens, 115 21
Novartis Investigative Site
Athens, 115 27
Israel2 sites
Novartis Investigative Site
Kfar Saba, 4428164
Novartis Investigative Site
Ramat Gan, 5265601
South Africa2 sites
Novartis Investigative Site
Cape Town, Western Cape, 7500
Novartis Investigative Site
Somerset West, Western Cape, 7130
South Korea2 sites
Novartis Investigative Site
Gwangju, 61469
Novartis Investigative Site
Seoul, 06591
About this study
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
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]).
Read the 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.
- Conditions
- Sjogrens Syndrome
- Being tested
- Ianalumab (VAY736), Placebo
- Keywords
- Sjogrens Syndrome, ianalumab, VAY736, NEPTUNUS
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ianalumab (VAY736)Drug
Also called VAY736
Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use
PlaceboOther
Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use
| Study group | Role | What they receive |
|---|---|---|
| Ianalumab Monthly | Experimental | Ianalumab 300 mg s.c. monthly during initial double-blind treatment period. Open-label treatment and receive ianalumab 300 mg monthly. Receives: Drug: Ianalumab (VAY736) |
| Ianalumab 3 Monthly | Experimental | 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. Receives: Drug: Ianalumab (VAY736); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent AEs (TEAEs)/SAEs
Assessment of safety and tolerability of ianalumab (VAY736) in patients with active Sjogrens syndrome
Measured: Week 52 to Week 464
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: Over time up to Week 360
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.
Measured: pre-dose at Week 48 (from core study) and Week 64
On-treatment Ianalumab serum concentrations
To further assess the pharmacokinetics of ianalumab.
Measured: During treatment (from Week 52 to Week 204) and follow-up (From Week 208 to Week 304)
B-cell count measurement
To assess impact of long-term treatment on B-cell depletion.
Measured: Week 52 to Week 304
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start27 Oct 2023
- Primary completion22 Apr 2033 (estimated)
- Study completion22 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogrens SyndromeStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985915
- Sponsor's protocol ID
- CVAY736A2301E1
- Other IDs
- 2022-502966-26-01
- Acronym
- NEPTUNUS-Ext
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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