Sjogren SyndromePhase 3NEPTUNUS-1NCT05350072
Two-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 77 sites in 18 countries.
Trial summary
A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1) 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
- 275 participants
- Where
- 77 sitesin 18 countries
- Study dates
- 28 Jul 2022to 2 Jun 2026
- 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 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 by protocol
- 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 and 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 the 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. Patients 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
77 sites in 18 countries.
77 sites in 18 countries
United States13 sites
The John Hopkins Jerome L Greene Sjogren
Baltimore, Maryland, 21224
Ochsner Health System
Baton Rouge, Louisiana, 70809
Precision Comprehensive Research
Colleyville, Texas, 76034
Metroplex Clinical Research
Dallas, Texas, 75231
STAT Research Inc
Dayton, Ohio, 45402
Altoona Center for Clin Res
Duncansville, Pennsylvania, 16635
Baylor College Of Medicine
Houston, Texas, 77030
Indiana Univ School of Dentistry
Indianapolis, Indiana, 46202
Houston Rheumatology and Arthrit
Katy, Texas, 77494
NYU Langone Hospital - Long Island
Mineola, New York, 11501
West Broward Rheumatology Associates Inc
Tamarac, Florida, 33321
Medvin Clinical Research
Van Nuys, California, 91405
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
China11 sites
Novartis Investigative Site
Baotou, Inner Mongolia, 014010
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Guangzhou, Guangdong, 510630
Novartis Investigative Site
Hohhot, Inner Mongolia, 010050
Novartis Investigative Site
Linyi, Shandong, 276000
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Novartis Investigative Site
Shenyang, Liaoning, 110011
Novartis Investigative Site
Shenzhen, Guangdong, 518020
Novartis Investigative Site
Taiyuan, Shanxi, 030000
Novartis Investigative Site
Wuhan, Hubei, 430030
Novartis Investigative Site
Xian, Shanxi, 710061
France7 sites
Novartis Investigative Site
Caen, 14033
Novartis Investigative Site
Dijon, 21000
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Marseille, 13005
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75013
Novartis Investigative Site
Saint-Priest-en-Jarez, 42270
Germany6 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Erlangen, 91056
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Novartis Investigative Site
Gommern, 39245
Novartis Investigative Site
Ludwigshafen, 67063
Novartis Investigative Site
Würzburg, Bavaria, 97080
Portugal5 sites
Novartis Investigative Site
Braga, 4710243
Novartis Investigative Site
Guarda, 6301-858
Novartis Investigative Site
Lisbon, 1050-034
Novartis Investigative Site
Lisbon, 1349-019
Novartis Investigative Site
Lisbon, 1649-035
Spain5 sites
Novartis Investigative Site
A Coruña, 15006
Novartis Investigative Site
Badalona, Barcelona, 08916
Novartis Investigative Site
Bilbao, Bizkaia, 48013
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Sabadell, Barcelona, 08208
Brazil4 sites
Novartis Investigative Site
Juiz de Fora, Minas Gerais, 36010 570
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14048-900
Novartis Investigative Site
São Paulo, 01409-902
Novartis Investigative Site
Vitória, Espírito Santo, 29055 450
Guatemala4 sites
Novartis Investigative Site
Guatemala City, 01009
Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 01011
Novartis Investigative Site
Quetzaltenango, 9001
Poland4 sites
Novartis Investigative Site
Bydgoszcz, 85-168
Novartis Investigative Site
Krakow, 30-002
Novartis Investigative Site
Lublin, 20-090
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, 52-210
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara, Bilkent Cankaya, 06800
Novartis Investigative Site
Ankara, Sihhiye-Altindag, 06230
Novartis Investigative Site
Ankara, Yenimahalle, 06500
Novartis Investigative Site
Kocaeli, 41380
Czechia3 sites
Novartis Investigative Site
Brno, 638 00
Novartis Investigative Site
Prague, 148 00
Novartis Investigative Site
Uherské Hradiště, 686 01
Austria2 sites
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Stockerau, 2000
Chile2 sites
Novartis Investigative Site
Santiago, Santiago Metropolitan, 7500571
Novartis Investigative Site
Santiago, Santiago Metropolitan, 7500710
Mexico2 sites
Novartis Investigative Site
Guadalajara, Jalisco, 44650
Novartis Investigative Site
Mexico City, Mexico City, 06700
South Korea2 sites
Novartis Investigative Site
Gwangju, 61469
Novartis Investigative Site
Seoul, 06591
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1)
A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)
Read the detailed description
Two-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of the study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly compared to placebo in patients with active Sjogren's syndrome.
- Conditions
- Sjogren 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 group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | ianalumab Receives: Biological: VAY736 |
| Arm B | Placebo comparator | placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in EULAR Sjogren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo
Efficacy (Plan A: US and US reference countries and 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 (9)
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
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
Achieving ESSDAI response at Week 24
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: 24 weeks
Achieving SSSD response at Week 48
Efficacy (Plan 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
Change from baseline in stimulated whole salivary flow rate at Week 48
Efficacy (Plan A and B)
Measured: 48 weeks
Change from baseline in Physician's Global Assessment (PhGA) of disease activity at Week 48
Efficacy (Plan A and B)
Measured: 48 weeks
Change from baseline in Patient's Global Assessment (PaGA) of disease activity at Week 48
Efficacy (Plan A and B)
Measured: 48 weeks
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
Efficacy (Plan A and B)
Measured: 48 weeks
Achieving EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) response at Week 48
Efficacy (Plan B)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start28 Jul 2022
- Primary completion7 May 2025
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren 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
- 275 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
- NCT05350072
- Sponsor's protocol ID
- CVAY736A2301
- Other IDs
- 2024-511069-12-00
- Acronym
- NEPTUNUS-1
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2022
- Last updated
- 7 Jul 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