Last Update: Feb 21, 2024
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)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CVAY736A2301
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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)

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.

Sjogren Syndrome
Phase 3
Recruiting
268
Jul 28, 2022
Mar 09, 2028
All
18 Years - (Adult, Older Adult)

Interventions

Other

Placebo

placebo s.c.
Biological

VAY736

ianalumab s.c.

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Women and men ≥ 18 years of age
Classification of Sjögren's syndrome according to the ACR/EULAR 2016 criteria
Time since diagnosis of Sjögren's of ≤ 7.5 years at screening

Positive anti-Ro/SSA antibody at screening

Patients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review
Enrollment of anti-Ro/SSA-negative patients will be limited up to ≤10% of the study population
Screening ESSDAI score of ≥ 5 within the following 8 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological and biologic.
Stimulated whole salivary flow (sSF) rate of ≥ 0.05 mL/min at screening
Ability to communicate well with the Investigator, understand and agree to comply with the requirements of the study
Patients taking hydroxychloroquine (≤ 400 mg/day), methotrexate (≤ 25 mg/week) or azathioprine (≤ 150 mg/day) alone or in combination, are allowed to continue their medication, and must have been on a stable dose for at least 30 days prior to randomization.
Patients taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day predniso(lo)ne or equivalent for at least 30 days before randomization.

Patients taking

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.

Exclusion Criteria:

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
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.

Study Location

Novartis Investigative Site

Recruiting

Stockerau,2000,Austria

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Graz,8036,Austria

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Gent,9000,Belgium

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Leuven,3000,Belgium

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Rio de Janeiro,22061-080,Brazil

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Sao Paulo,01409-902,Brazil

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Vitoria,ES,29055 450,Brazil

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Juiz de Fora,MG,36010 570,Brazil

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Santiago,7500571,Chile

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Santiago,7500710,Chile

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Baotou,Inner Mongolia,014010,China

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Nanchang,Jiangxi,330006,China

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Beijing,100050,China

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Wuhan,Hubei,430030,China

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Taiyuan,Shanxi,030000,China

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Shanxi,710063,China

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Shenyang,Liaoning,110011,China

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Shenzhen,Guangdong,518020,China

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Guangzhou,510630,China

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Linyi,Shandong,276000,China

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Uherske Hradiste,686 01,Czech Republic

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Praha 11,14900,Czech Republic

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Brno,63800,Czech Republic

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Marseille,13385,France

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Caen Cedex 9,14033,France

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Saint Etienne,42100,France

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Paris 13,75651,France

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Paris cedex 10,75010,France

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Grenoble,38043,France

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Dijon,21034,France

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Paris,75014,France

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Lille,59000,France

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Wuerzburg,97080,Germany

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Gommern,39245,Germany

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Berlin,13353,Germany

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Ludwigshafen,67063,Germany

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Erlangen,91056,Germany

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Freiburg,79106,Germany

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Guatemala,01010,Guatemala

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Guatemala City,01011,Guatemala

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Guatemala,01009,Guatemala

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Quetzaltenango,9001,Guatemala

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Seoul,04763,Korea, Republic of

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Seoul,Seocho Gu,06591,Korea, Republic of

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Daegu,705 718,Korea, Republic of

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Gwangju,61469,Korea, Republic of

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Seoul,03080,Korea, Republic of

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Vilnius,08406,Lithuania

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Ciudad de Mexico,Distrito Federal,06700,Mexico

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Guadalajara,Jalisco,44650,Mexico

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Bydgoszcz,85 168,Poland

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Krakow,30 002,Poland

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Lublin,20-954,Poland

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Wroclaw,Dolnoslaskie,52-210,Poland

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Guarda,6300 858,Portugal

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Lisboa,1050-034,Portugal

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Lisboa,1349 019,Portugal

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Lisboa,1649-035,Portugal

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Braga,4710243,Portugal

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Singapore,308433,Singapore

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Sabadell,Barcelona,08208,Spain

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Sevilla,Andalucia,41013,Spain

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La Coruna,Galicia,15006,Spain

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Bilbao,Pais Vasco,48013,Spain

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Madrid,28034,Spain

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Badalona,Catalunya,08916,Spain

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Kocaeli,41380,Turkey

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Ankara,06100,Turkey

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Ankara,06560,Turkey

Rush University Medical Center Suite 300

Recruiting

Chicago,(312-432-2352) -- Joel A Block,60612 - Illinois,United States

Houston Rheumatology & Arthrit Houston Rheum and Arthritis

Recruiting

Katy,Eliana Prada (346-257-4299) email: [email protected] -- Tara Jabeen Rizvi,77494 - Texas,United States

STAT Research Inc .

Recruiting

Dayton,Aby Madrigal (937-223-4229) email: [email protected] -- Sanford Wolfe,45402 - Ohio,United States

Indiana University School of Dentistry

Recruiting

Indianapolis,Eymi Pinales (317-274-8822) email: [email protected] -- Domenick Zero,46202 - Indiana,United States

The John Hopkins Jerome L Greene Sjogren

Recruiting

Baltimore,(410-550-1887) -- Thomas Grader Beck,21224 - Maryland,United States

Ochsner Health System

Recruiting

Baton Rouge,(225-761-5375) -- Saravanan Thiagarajan,70809 - Louisiana,United States

Medvin Clinical Research .

Recruiting

Van Nuys,Griselda Encarnacion (213-281-5146) email: [email protected] -- Dan La,91405 - California,United States

West Broward Rheumatology Associates Inc

Recruiting

Tamarac,Jennifer Perez (954-545-8400) email: [email protected] -- Alan R Alberts,33321 - Florida,United States

Altoona Center for Clinical Research

Recruiting

Duncansville,Mary Beyer (814-693-0300) email: [email protected] -- Alan J Kivitz,16635 - Pennsylvania,United States

Precision Comprehensive Research

Recruiting

Colleyville,Alma Torres (972-299-8399) email: [email protected] -- Dhiman Basu,76034 - Texas,United States

Winthrop University Hospital

Recruiting

Mineola,(516-663-2929) -- Steven Carsons,11501 - New York,United States

Arizona Arthritis and Rheumatology Associates PLLC .

Recruiting

Paradise Valley,Tanya Alderete (480-626-6650) email: [email protected] -- Nehad Soloman,85253 - Arizona,United States

Private Practice

Recruiting

Dallas,Shreeja Sainju (972-288-2600) email: [email protected] -- Scott J Zashin,75231 - Texas,United States

Baylor College Of Medicine .

Recruiting

Houston,Claudell Montano (713-798-7862) email: [email protected] -- Rashmi Maganti,77030 - Texas,United States

Reciomed Clinical Research

Recruiting

Boynton Beach,Joseph Romero email: [email protected] -- Juan Maya,33472 - Florida,United States

Carolina Arthritis Associates

Recruiting

Wilmington,(910-762-1182) -- Mark Harris,28401 - North Carolina,United States

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals