Last Update: Apr 22, 2024
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)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CVAY736A2302
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, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

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.

Sjogren Syndrome
Phase 3
Recruiting
489
Aug 04, 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 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.

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, 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 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.

Study Location

Novartis Investigative Site

Recruiting

Caba,Buenos Aires,C1405BCH,Argentina

Novartis Investigative Site

Recruiting

Tucuman,San Miguel De Tucuman,4000,Argentina

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San Nicolas,Buenos Aires,B2900DMH,Argentina

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Quilmes,Buenos Aires,1878,Argentina

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Ciudad Autonoma de Bs As,Buenos Aires,C1055AAF,Argentina

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Buenos Aires,1646,Argentina

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Buenos Aires,C1428DQG,Argentina

Novartis Investigative Site

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Hobart,Tasmania,7000,Australia

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Maroochydore,Queensland,4558,Australia

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Woodville,South Australia,5011,Australia

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Belo Horizonte,MG,30150-221,Brazil

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Curitiba,PR,80030-110,Brazil

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Salvador,BA,40150 150,Brazil

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Sao Paulo,SP,04266 010,Brazil

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Sydney,Nova Scotia,B1P 1P3,Canada

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Sherbrooke,Quebec,J1G 2E8,Canada

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Vancouver,British Columbia,V5Z 1L7,Canada

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Toronto,Ontario,M5T 2S8,Canada

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Rimouski,Quebec,G5L 5T1,Canada

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Trois Rivieres,Quebec,G8Z 1Y2,Canada

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Valdivia,Los Rios,5110683,Chile

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Santiago,RM,7500588,Chile

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Concepcion,6740,Chile

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Xian,Shanxi,710004,China

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Hefei,Anhui,230001,China

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Xinxiang,453099,China

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Chang Chun,Jilin,130021,China

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Pingxiang,Jiangxi,337000,China

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Shanghai,200011,China

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Urumqi,Xinjiang,830001,China

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Yinchuan City,The Ningxia Hui Autonomous Reg,750000,China

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Chengdu,Sichuan,610041,China

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Shanghai,200040,China

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Tianjin,300052,China

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Beijing,100029,China

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Beijing,100730,China

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Bogota,110221,Colombia

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Barranquilla,Atlantico,080002,Colombia

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Bucaramanga,Santander,0001,Colombia

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Medellin,Antioquia,050001,Colombia

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Koeln,50937,Germany

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Herne,44649,Germany

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Berlin,13125,Germany

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Dresden,01307,Germany

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Luebeck,23538,Germany

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Hannover,30625,Germany

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Ahmedabad,Gujarat,380013,India

Novartis Investigative Site

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Ahmedabad,Gujarat,380015,India

Novartis Investigative Site

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Bangalore,Karnataka,560 002,India

Novartis Investigative Site

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Pune,Maharashtra,411001,India

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New Delhi,110029,India

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Vellore,Tamil Nadu,632004,India

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Tel Aviv,6423906,Israel

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Ramat Gan,52621,Israel

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Haifa,3109601,Israel

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Kfar Saba,4428164,Israel

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Roma,RM,00161,Italy

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Kitakyushu-city,Fukuoka,807-8556,Japan

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Sasebo-city,Nagasaki,857-1165,Japan

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Chuo ku,Tokyo,104-8560,Japan

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Nagoya,Aichi,457 8510,Japan

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Shinjuku-ku,Tokyo,160 8582,Japan

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Sapporo city,Hokkaido,060 8648,Japan

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Recruiting

Sapporo,Hokkaido,060-8543,Japan

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Beirut,1107 2020,Lebanon

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Merida,Yucatan,97070,Mexico

Novartis Investigative Site

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Mexico,07029,Mexico

Novartis Investigative Site

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Culiacan,Sinaloa,CP 80000,Mexico

Novartis Investigative Site

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Panorama,Western Cape,7500,South Africa

Novartis Investigative Site

Recruiting

Stellenbosch,7600,South Africa

Novartis Investigative Site

Recruiting

Stockholm,SE,113 65,Sweden

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Recruiting

Kaohsiung,81346,Taiwan

Novartis Investigative Site

Recruiting

Kaohsiung,83301,Taiwan

Novartis Investigative Site

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Swindon,SN3 6BB,United Kingdom

Novartis Investigative Site

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Doncaster,DN2 5LT,United Kingdom

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Recruiting

Leeds,LS1 3EX,United Kingdom

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Liverpool,L9 7AL,United Kingdom

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Glasgow-Scotland,G12 OYN,United Kingdom

Novartis Investigative Site

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Newcastle Upon Tyme,NE4 4LP,United Kingdom

Clinical Investigation Special Inc .

Recruiting

Wauconda,Marina Hanna (847-599-2492) email: [email protected] -- Kamran Chaudhary,60084 - Illinois,United States

Western Kentucky Rheumatology

Recruiting

Hopkinsville,Hope Widrick (931-542-9124) email: [email protected] -- Kishorkumar Desai,42240 - Kentucky,United States

RAO Research LLS

Recruiting

Oklahoma City,Ashley Johnson (405-608-8060) email: [email protected] -- Latisha Heinlen,73116 - Oklahoma,United States

Arthritis and Osteoporosis

Recruiting

Charlotte,Audrey Droppelman (+1 704 342 0252#1170) email: [email protected] -- Gordon K W Lam,28207 - North Carolina,United States

First Outpatient Research Unit

Recruiting

San Antonio,(210-567-0450) -- Agustin Escalante,78229 - Texas,United States

Sarasota Arthritis Research Center

Recruiting

Sarasota,Katie Decker (941-366-1244) email: [email protected] -- Kimberly Lyn Shue,34239 - Florida,United States

Arthritis Northwest PLLC .

Recruiting

Spokane,Corine Nguyen (+1 509 838 6500#307) email: [email protected] -- Christopher C Wright,99204 - Washington,United States

GNP Research

Recruiting

Hollywood,Gina Peralta (754-248-3538) email: [email protected] -- Mark Jaffe,33024 - Florida,United States

St Lawrence Health System .

Recruiting

Potsdam,Caryn Harrington (315-261-5611) email: [email protected] -- Eyal Kedar,13676 - New York,United States

Augusta University Georgia .

Recruiting

Augusta,Jessica Johnson (706-723-0106) email: [email protected] -- Elena Schiopu,30912 - Georgia,United States

Achieve Clinical Research

Recruiting

Vestavia Hills,Darianne Mitchell (205-757-8212) email: [email protected] -- Hayes T Williams,35216 - Alabama,United States

OnSite Clinical Solutions Llc .

Recruiting

Charlotte,Angie Price (608-855-9161) email: [email protected] -- Rakesh C Patel,28202 - North Carolina,United States

Integral Rheumatology and Immunology Specialists IRIS

Recruiting

Plantation,Ana Santana (954-476-2338) email: [email protected] -- Guillermo Valenzuela,33324 - Florida,United States

Bay Area Arthritis and Osteoporosis

Recruiting

Brandon,(813-651-4441) -- Vipul Joshi,33511 - Florida,United States

Tufts School of Dental Medicine

Recruiting

Boston,Christian Mastroianni (617-636-2408) email: [email protected] -- Athena Papas,02111 - Massachusetts,United States

Advanced Medical Research Medical Research

Recruiting

La Palma,Andy Hodgson (562-867-8195) email: [email protected] -- Gerald Ho,90623 - California,United States

Prolato Clinical Research Center

Recruiting

Houston,Armanda Mandy Silguero (+1 832 338 9118) email: [email protected] -- Sreedhar Mandayam,77054 - Texas,United States

Medvin Clinical Research .

Recruiting

Van Nuys,Nereyda Negrete email: [email protected] -- Tien I Karleen Karleen Su,91405 - California,United States

Clin Invest Specialists Inc

Recruiting

Orland Park,Marina Hanna (847-599-2492) email: [email protected] -- Cory Conniff,60467 - Illinois,United States

University of Pennsylvania

Recruiting

Philadelphia,Wren Catrillo (215-614-4408) email: [email protected] -- Nora Sandorfi,19104 - Pennsylvania,United States

Advanced Rheumatology of Houston .

Recruiting

Spring,(281-766-7886) -- Tamar Brionez,77382 - Texas,United States

Providence Medical Foundation

Recruiting

Fullerton,Angela Gonzalez (714-992-3000) email: [email protected] -- Shirley Pang,92835 - California,United States

North Georgia Rheumatology Group

Recruiting

Lawrenceville,Mierra Robinson (770-822-1090) email: [email protected] -- Theresa Lawrence Ford,30046 - Georgia,United States

Clinic of Robert Hozman

Recruiting

Skokie,Marina Hanna (847-727-2743) email: [email protected] -- Robert Hozman,60176 - Illinois,United States

West Tennessee Research Institute

Recruiting

Jackson,Kim Smith (731-664-7824) email: [email protected] -- Jacob A. Aelion,38305 - Tennessee,United States

Alliance for Multispecialty Resrch

Recruiting

Wichita,Keitiza Bakhtiar (316-684-5469) email: [email protected] -- Shadi Shahouri,67207 - Kansas,United States

Ramesh C Gupta MD Memphis TN

Recruiting

Memphis,Anita Das (901-681-9670) email: [email protected] -- Ramesh C Gupta,38119 - Tennessee,United States

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