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AzTrials

Sjogren SyndromePhase 3NEPTUNUS-2NCT05349214

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

A Phase 3 study testing VAY736 in people with Sjogren Syndrome, run by Novartis Pharmaceuticals at 146 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Sjogren Syndrome
What is being tested?
VAY736
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
506 participants
Where
146 sitesin 26 countries
Study dates
4 Aug 2022to 15 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • disease-modifying antirheumatic drugs (DMARDs) other than specifically allowed in inclusion criterion #9 or
  • 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.

Who cannot join

  • 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
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  • 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
  • Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect, and which have not been on a stable dose for at least 30 days prior to Screening, or any anticipated change in the treatment regimen during the course of the study.
  • Use of topical ocular prescription medications (excluding artificial tears, gels, lubricants) that have not been on a stable dose for at least 90 days prior to randomization, or any anticipated change in the treatment regimen during the course of the study
  • Receipt of live/attenuated vaccine within a 4-week period prior to randomization
  • History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer or Sjögren's related lymphoma), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • History of sarcoidosis
  • Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes mellitus), psychiatric or additional physical condition that the Investigator feels may jeopardize the patient in case of participation in this study
  • Chronic infection with hepatitis B (HBV) or hepatitis C (HCV) virus. Positive serology for hepatitis B surface antigen (HBsAg) excludes the subject.
  • HBsAg negative subjects who are hepatitis B core antibody (HBcAb) positive are also excluded unless all of the following criteria are met:
  • HBV DNA is negative
  • hepatitis B monitoring is implemented - in these subjects, monthly testing of HBsAg and HBV DNA must be performed while on study treatment and at least every 12 weeks after end of treatment for the entire duration of safety follow-up.
  • Antiviral prophylaxis must be implemented before the first administration of the study treatment, and continued up to 12 months after end of study treatment. If antiviral therapy cannot be given or if the patient is not willing to comply with the antiviral treatment requirement, the patient is not eligible for the study.
  • Hepatitis C: patients with positive hepatitis C antibody and HCV-RNA at screening are excluded. Chronic hepatitis C patients who have completed HCV anti-viral treatment must be HCV-RNA negative at least 12 weeks after treatment before randomization to be eligible. Cases of spontaneous HCV clearance should be discussed with sponsor before enrollment.
  • Evidence of active tuberculosis (TB) infection is exclusionary. Patient with previously treated TB and previously treated or newly diagnosed latent TB may be eligible.
  • Pregnant or nursing (lactating) women,
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational medication.
  • Patients with a known history of non-compliance to medication, or who were unable or unwilling to complete PRO questionnaires, or who are unable or unwilling to use the device for collection of PROs.
  • United States (and other countries, if locally required): Sexually active males, unless they agree to use barrier protection during intercourse with a woman of childbearing 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 locally approved prescribing information of concomitant medications administered.

Trial locations and contacts

146 sites in 26 countries.

146 sites in 26 countries

United States23 sites

  • Augusta University Georgia

    Augusta, Georgia, 30912

  • 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

  • GNP Research

    Cooper City, Florida, 33024

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Advanced Medical Research

    La Palma, California, 90623

  • Arthritis Osteoporosis Assoc of NM

    Las Cruces, New Mexico, 88011

  • North Georgia Rheumatology Group

    Lawrenceville, Georgia, 30046

  • Ramesh C Gupta MD Memphis TN

    Memphis, Tennessee, 38119

  • 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

  • Clinic of Robert Hozman

    Skokie, Illinois, 60176

  • Arthritis Northwest PLLC

    Spokane, Washington, 99216

  • Advanced Rheumatology of Houston

    Spring, Texas, 77382

  • Clinical Investigation Specialists, Inc.

    Wauconda, Illinois, 60084

Other trials in United States

China17 sites

  • Novartis Investigative Site

    Beijing, 100029

  • Novartis Investigative Site

    Beijing, 100730

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Chongqing, Chongqing Municipality, 400010

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006

  • Novartis Investigative Site

    Hefei, Anhui, 230001

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008

  • Novartis Investigative Site

    Pingxiang, Jiangxi, 337000

  • Novartis Investigative Site

    Shanghai, 200011

  • Novartis Investigative Site

    Shanghai, 200040

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001

  • Novartis Investigative Site

    Xinxiang, 453099

  • Novartis Investigative Site

    Yinchuan, The Ningxia Hui Autonomous Reg, 750000

Other trials in China

Japan15 sites

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-8560

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 8078556

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 7100824

  • Novartis Investigative Site

    Kuwana, Mie-ken, 511-0061

  • Novartis Investigative Site

    Meguro-ku, Tokyo, 152-8902

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 455-8530

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578510

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578511

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608543

  • Novartis Investigative Site

    Sasebo, Nagasaki, 857-1195

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1608582

  • Novartis Investigative Site

    tabashi City, Tokyo, 1738610

  • Novartis Investigative Site

    Yokohama, Kanagawa, 245-8575

Other trials in Japan

Argentina6 sites

  • Novartis Investigative Site

    Buenos Aires, 1646

  • Novartis Investigative Site

    Buenos Aires, C1055AAF

  • Novartis Investigative Site

    Buenos Aires, C1428DQG

  • Novartis Investigative Site

    CABA, Buenos Aires, C1405BCH

  • Novartis Investigative Site

    Quilmes, Buenos Aires, 1878

  • Novartis Investigative Site

    San Miguel Tucuman, Tucumán Province, T4000DPK

Other trials in Argentina

Canada6 sites

  • Novartis Investigative Site

    Rimouski, Quebec, G5L 5T1

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1G 2E8

  • Novartis Investigative Site

    Sydney, Nova Scotia, B1P 1P3

  • Novartis Investigative Site

    Toronto, Ontario, M5T 2S8

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G9A 3Y2

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1L7

Other trials in Canada

Spain6 sites

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Córdoba, 14004

  • Novartis Investigative Site

    Madrid, 28009

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Valencia, 46026

  • Novartis Investigative Site

    Vigo, Pontevedra, 36214

Other trials in Spain

France5 sites

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Brest, 29200

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275

  • Novartis Investigative Site

    Le Mans, 72000

  • Novartis Investigative Site

    Strasbourg, 67000

Other trials in France

Germany5 sites

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Herne, 44649

Other trials in Germany

Hungary5 sites

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

  • Novartis Investigative Site

    Eger, 3300

  • Novartis Investigative Site

    Gyula, 5700

  • Novartis Investigative Site

    Szeged, 6725

  • Novartis Investigative Site

    Székesfehérvár, Fejér, 8000

Other trials in Hungary

India5 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380013

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380015

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 002

  • Novartis Investigative Site

    New Delhi, 110029

  • Novartis Investigative Site

    Pune, Maharashtra, 411001

Other trials in India

Italy5 sites

  • Novartis Investigative Site

    Ancona, AN, 60126

  • Novartis Investigative Site

    Milan, MI, 20100

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Salerno, SA, 84131

  • Novartis Investigative Site

    Udine, UD, 33100

Other trials in Italy

Poland5 sites

  • Novartis Investigative Site

    Krakow, Lesser Poland Voivodeship, 30-727

  • Novartis Investigative Site

    Poznan, Greater Poland Voivodeship, 61-397

  • Novartis Investigative Site

    Warsaw, 00-874

  • Novartis Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 52-416

  • Novartis Investigative Site

    Wroclaw, 50367

Other trials in Poland

United Kingdom5 sites

  • Novartis Investigative Site

    Doncaster, DN2 5LT

  • Novartis Investigative Site

    Leeds, LS1 3EX

  • Novartis Investigative Site

    Liverpool, L9 7AL

  • Novartis Investigative Site

    Newcastle upon Tyne, NE1 4LP

  • Novartis Investigative Site

    Swindon, SN3 6BB

Other trials in United Kingdom

Colombia4 sites

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 680003

  • Novartis Investigative Site

    Medellín, Antioquia, 050001

Other trials in Colombia

Romania4 sites

  • Novartis Investigative Site

    Brasov, 500283

  • Novartis Investigative Site

    Bucharest, 010825

  • Novartis Investigative Site

    Bucharest, 011172

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400006

Other trials in Romania

Slovakia4 sites

  • Novartis Investigative Site

    Bratislava, 811 08

  • Novartis Investigative Site

    Košice, 040 11

  • Novartis Investigative Site

    Partizánske, 958 01

  • Novartis Investigative Site

    Zvolen, 960 01

Other trials in Slovakia

Taiwan4 sites

  • Novartis Investigative Site

    Kaohsiung City, 81346

  • Novartis Investigative Site

    Kaohsiung City, 83301

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Taichung, 407219

Other trials in Taiwan

Australia3 sites

  • Novartis Investigative Site

    Hobart, Tasmania, 7000

  • Novartis Investigative Site

    Maroochydore, Queensland, 4558

  • Novartis Investigative Site

    Woodville South, South Australia, 5011

Other trials in Australia

Brazil3 sites

  • Novartis Investigative Site

    Curitiba, Paraná, 80030-110

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40150 150

  • Novartis Investigative Site

    São Paulo, São Paulo, 04266 010

Other trials in Brazil

Bulgaria3 sites

  • Novartis Investigative Site

    Burgas, 8000

  • Novartis Investigative Site

    Plovdiv, 4002

  • Novartis Investigative Site

    Sofia, 1606

Other trials in Bulgaria

Chile3 sites

  • Novartis Investigative Site

    Concepción, Biobio, 4070280

  • Novartis Investigative Site

    Santiago, RM, 7500588

  • Novartis Investigative Site

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Mexico3 sites

  • Novartis Investigative Site

    Culiacán, Sinaloa, 80000

  • Novartis Investigative Site

    Mérida, Yucatán, 97070

  • Novartis Investigative Site

    México, 07029

Other trials in Mexico

Greece2 sites

  • Novartis Investigative Site

    Athens, 115 21

  • Novartis Investigative Site

    Athens, 115 27

Other trials in Greece

Israel2 sites

  • Novartis Investigative Site

    Kfar Saba, 4428164

  • Novartis Investigative Site

    Ramat Gan, 5265601

Other trials in Israel

South Africa2 sites

  • Novartis Investigative Site

    Panorama, Western Cape, 7500

  • Novartis Investigative Site

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

Sweden1 site

  • Novartis Investigative Site

    Stockholm, SE, 113 65

Other trials in Sweden

About this study

Official title: 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)

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)

Read the detailed description

Three-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly or every 3 months compared to placebo in patients with active Sjogren's syndrome.

Being tested
VAY736, Placebo
Keywords
Sjogren's syndrome, B-cell depleting, BAFF-R, VAY736, ianalumab, 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.

  • VAY736Biological

    ianalumab s.c.

  • PlaceboOther

    placebo s.c.

Study groups in NCT05349214
Study groupRoleWhat they receive
Arm AExperimentalianalumab exposure level 1
Receives: Biological: VAY736
Arm BExperimentalianalumab exposure level 2
Receives: Biological: VAY736
Arm CPlacebo comparatorplacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48 weeks

Secondary outcomes (10)

  1. Change from baseline in SSSD score at Week 48

    Efficacy (Plan A and B)

    The Sjogrens Syndrome Symptom Diary (SSSD) is 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: 48 weeks

  2. Percentage of participants achieving ESSDAI response at Week 48**

    Efficacy (Plan A and B)

    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

    Measured: 48 weeks

  3. Percentage of participants achieving ESSDAI score <5 at Week 48

    Efficacy (Plan A and B)

    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

    Measured: 48 weeks

  4. Percentage of participants achieving SSSD response at Week 48**

    Efficacy (Plan A and B)

    The Sjogrens Syndrome Symptom Diary (SSSD) is 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: 48 weeks

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

    Efficacy (Plan A and B)

    Both the amount and composition of saliva has been shown to reflect the glandular damage caused by the disease process of Sjögren's (Pijpe et al 2007). Unstimulated and stimulated salivary secretions are collected over 5 minutes. As much as possible the assessments are to be performed at a fixed time of the day to minimize fluctuations related to the circadian rhythm of salivary flow and composition (Dawes 1972).

    Measured: 48 weeks

  6. Change from baseline in PhGA at Week 48

    Efficacy (Plan A and B)

    Physician global assessment of disease activity is made with relation to Sjögren's syndrome. Physician's global assessment (PhGA) of disease activity for Sjögren's syndrome is performed using 3 separate scales:

    • Visual Analog Scale (VAS) - an unnumbered 100 mm long horizontal line ranging from "no disease activity' to "maximal disease activity". The assessment of patient's condition on the day is made by placing a vertical mark across the line.
    • Numerical Rating Scale (NRS) - a segmented numeric version of the VAS. A respondent needs to select a whole number (0-10 integers), with 0 being "no disease activity" and 10 being "maximal disease activity".
    • 4-point Likert scale - The level of disease activity is assessed on a scale from "inactive" to "high activity".

    Measured: 48 weeks

  7. Change from baseline in PaGA at Week 48

    Efficacy (Plan A and B)

    Patient's global assessment (PaGA) of disease activity for Sjögren's syndrome is performed using 3 separate scales:

    • Visual Analog Scale (VAS) - an unnumbered 100 mm long horizontal line ranging from "very good' to "very poor". The assessment is made by placing a vertical mark across the line.
    • Numerical Rating Scale - a segmented numeric version of the VAS. A respondent needs to select a whole number (0-10 integers), with 0 being "very poor" and 10 being "very good".
    • 4-point Likert scale - The level of symptom severity is assessed on a scale from "none to severe".

    Measured: 48 weeks

  8. Change from baseline in FACIT-F score at Week 48

    Efficacy (Plan A and B)

    The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F version 4) is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the past week (Webster et al 2003). The level of fatigue is measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much).

    Measured: 48 weeks

  9. Change from baseline in ESSPRI score at Week 48

    Efficacy (Plan B)

    ESSPRI is an established disease outcome measure for Sjögren's (Seror et al 2011, Seror et al 2015). It consists of three domains of dryness, pain and fatigue.

    The subject assesses severity of symptoms they experience on a single 0-10 numerical scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. ESSPRI will be applied to the study patients at during runin period, at baseline and during study treatment.

    Measured: 48 weeks

  10. Percentage of participants achieving ESSPRI response at Week 48**

    Efficacy (Plan B)

    ESSPRI is an established disease outcome measure for Sjögren's (Seror et al 2011, Seror et al 2015). It consists of three domains of dryness, pain and fatigue.

    The subject assesses severity of symptoms they experience on a single 0-10 numerical scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. ESSPRI will be applied to the study patients at during run-in period, at baseline and during study treatment.

    Measured: 48 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2022
  2. Study start4 Aug 2022
  3. Primary completion13 May 2025
  4. Study completion15 Apr 2027 (estimated)

Resources

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
506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05349214
Sponsor's protocol ID
CVAY736A2302
Other IDs
2024-511068-10-00
Acronym
NEPTUNUS-2
Status last verified
Jun 2026
First submitted
8 Apr 2022
Last updated
17 Jun 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

Publications

  • Mariette X, Grader-Beck T, Finzel S, Schiopu E, Papas A, Devauchelle-Pensec V, Sopala M, Zeng X, Noaiseh G, Takeuchi T, Kumar U, Hermann J, Ozawa H, Fox R, Zong S, Narayanswamy D, Li X, Luo WL, Woznicki J, Debonnett L, Zhu X, He L, Matzkies F, Jahreis A, Jain DK, Porter B, Lau C, Dorner T, McCoy SS, Bowman SJ, Hueber W; NEPTUNUS-1 and NEPTUNUS-2 Investigators; NEPTUNUS-1 Investigators; NEPTUNUS-2 Investigators. Ianalumab for the Treatment of Patients with Sjogren's Disease. N Engl J Med. 2026 Oct 22;395(16):1585-1599. doi: 10.1056/NEJMoa2601088.

    PubMed 42906087

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VAY736 in people with Sjogren Syndrome, run by Novartis Pharmaceuticals at 146 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, China, Japan, Argentina, Canada and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plan A and B - Change from baseline in ESSDAI score at Week 48 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05349214, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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