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.
Interventions
Placebo
VAY736
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
Buenos Aires,C1428DQG,Argentina
Novartis Investigative Site
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Caba,Buenos Aires,C1405BCH,Argentina
Novartis Investigative Site
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San Nicolas,Buenos Aires,B2900DMH,Argentina
Novartis Investigative Site
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Tucuman,San Miguel De Tucuman,4000,Argentina
Novartis Investigative Site
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Quilmes,Buenos Aires,1878,Argentina
Novartis Investigative Site
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Ciudad Autonoma de Bs As,Buenos Aires,C1055AAF,Argentina
Novartis Investigative Site
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Buenos Aires,1646,Argentina
Novartis Investigative Site
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Woodville,South Australia,5011,Australia
Novartis Investigative Site
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Hobart,Tasmania,7000,Australia
Novartis Investigative Site
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Maroochydore,Queensland,4558,Australia
Novartis Investigative Site
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Curitiba,PR,80030-110,Brazil
Novartis Investigative Site
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Salvador,BA,40150 150,Brazil
Novartis Investigative Site
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Belo Horizonte,MG,30150-221,Brazil
Novartis Investigative Site
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Sao Paulo,SP,04266 010,Brazil
Novartis Investigative Site
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Vancouver,British Columbia,V5Z 1L7,Canada
Novartis Investigative Site
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Toronto,Ontario,M5T 2S8,Canada
Novartis Investigative Site
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Sherbrooke,Quebec,J1G 2E8,Canada
Novartis Investigative Site
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Trois Rivieres,Quebec,G8Z 1Y2,Canada
Novartis Investigative Site
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Sydney,Nova Scotia,B1P 1P3,Canada
Novartis Investigative Site
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Rimouski,Quebec,G5L 5T1,Canada
Novartis Investigative Site
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Santiago,RM,7500588,Chile
Novartis Investigative Site
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Concepcion,6740,Chile
Novartis Investigative Site
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Valdivia,Los Rios,5110683,Chile
Novartis Investigative Site
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Hefei,Anhui,230001,China
Novartis Investigative Site
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Tianjin,300052,China
Novartis Investigative Site
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Shanghai,200040,China
Novartis Investigative Site
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Pingxiang,Jiangxi,337000,China
Novartis Investigative Site
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Chang Chun,Jilin,130021,China
Novartis Investigative Site
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Chengdu,Sichuan,610041,China
Novartis Investigative Site
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Xian,Shanxi,710004,China
Novartis Investigative Site
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Xinxiang,453099,China
Novartis Investigative Site
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Urumqi,Xinjiang,830001,China
Novartis Investigative Site
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Beijing,100029,China
Novartis Investigative Site
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Yinchuan City,The Ningxia Hui Autonomous Reg,750000,China
Novartis Investigative Site
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Beijing,100730,China
Novartis Investigative Site
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Shanghai,200011,China
Novartis Investigative Site
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Bogota,110221,Colombia
Novartis Investigative Site
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Barranquilla,Atlantico,080002,Colombia
Novartis Investigative Site
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Bucaramanga,Santander,0001,Colombia
Novartis Investigative Site
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Medellin,Antioquia,050001,Colombia
Novartis Investigative Site
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Koeln,50937,Germany
Novartis Investigative Site
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Herne,44649,Germany
Novartis Investigative Site
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Berlin,13125,Germany
Novartis Investigative Site
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Dresden,01307,Germany
Novartis Investigative Site
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Luebeck,23538,Germany
Novartis Investigative Site
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Hannover,30625,Germany
Novartis Investigative Site
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Ahmedabad,Gujarat,380013,India
Novartis Investigative Site
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Vellore,Tamil Nadu,632004,India
Novartis Investigative Site
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Ahmedabad,Gujarat,380015,India
Novartis Investigative Site
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New Delhi,110029,India
Novartis Investigative Site
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Pune,Maharashtra,411001,India
Novartis Investigative Site
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Bangalore,Karnataka,560 002,India
Novartis Investigative Site
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Ramat Gan,52621,Israel
Novartis Investigative Site
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Haifa,3109601,Israel
Novartis Investigative Site
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Kfar Saba,4428164,Israel
Novartis Investigative Site
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Tel Aviv,6423906,Israel
Novartis Investigative Site
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Roma,RM,00161,Italy
Novartis Investigative Site
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Sasebo-city,Nagasaki,857-1165,Japan
Novartis Investigative Site
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Kitakyushu-city,Fukuoka,807-8556,Japan
Novartis Investigative Site
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Beirut,1107 2020,Lebanon
Novartis Investigative Site
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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
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Stellenbosch,7600,South Africa
Novartis Investigative Site
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Kaohsiung,81346,Taiwan
Novartis Investigative Site
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Kaohsiung,83301,Taiwan
Novartis Investigative Site
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Doncaster,DN2 5LT,United Kingdom
Novartis Investigative Site
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Leeds,LS1 3EX,United Kingdom
Novartis Investigative Site
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Liverpool,L9 7AL,United Kingdom
Novartis Investigative Site
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Glasgow-Scotland,G12 OYN,United Kingdom
Novartis Investigative Site
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Swindon,SN3 6BB,United Kingdom
Novartis Investigative Site
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Newcastle Upon Tyme,NE4 4LP,United Kingdom
Tufts School of Dental Medicine
Recruiting
Boston,Christian Mastroianni (617-636-2408) email: [email protected] -- Athena Papas,02111 - Massachusetts,United States
Clinic of Robert Hozman
Recruiting
Skokie,Marina Hanna (847-727-2743) email: [email protected] -- Robert Hozman,60176 - Illinois,United States
Prolato Clinical Research Center
Recruiting
Houston,Armanda Mandy Silguero (+1 832 338 9118) email: [email protected] -- Sreedhar Mandayam,77054 - Texas,United States
Alliance for Multispecialty Resrch
Recruiting
Wichita,Keitiza Bakhtiar (316-684-5469) email: [email protected] -- Shadi Shahouri,67207 - Kansas,United States
University of Pennsylvania
Recruiting
Philadelphia,Wren Catrillo (215-614-4408) email: [email protected] -- Nora Sandorfi,19104 - Pennsylvania,United States
Clinical Investigation Special Inc .
Recruiting
Wauconda,Marina Hanna (847-599-2492) email: [email protected] -- Kamran Chaudhary,60084 - Illinois,United States
Arthritis and Osteoporosis
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Charlotte,Audrey Droppelman (+1 704 342 0252#1170) email: [email protected] -- Gordon K W Lam,28207 - North Carolina,United States
Providence Medical Foundation
Recruiting
Fullerton,Angela Gonzalez (714-992-3000) email: [email protected] -- Shirley Pang,92835 - California,United States
First Outpatient Research Unit
Recruiting
San Antonio,(210-567-0450) -- Agustin Escalante,78229 - Texas,United States
West Tennessee Research Institute
Recruiting
Jackson,Kim Smith (731-664-7824) email: [email protected] -- Jacob A. Aelion,38305 - Tennessee,United States
Arthritis Northwest PLLC .
Recruiting
Spokane,Corine Nguyen (+1 509 838 6500#307) email: [email protected] -- Christopher C Wright,99204 - Washington,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
GNP Research
Recruiting
Hollywood,Gina Peralta (754-248-3538) email: [email protected] -- Mark Jaffe,33024 - Florida,United States
Western Kentucky Rheumatology
Recruiting
Hopkinsville,Hope Widrick (931-542-9124) email: [email protected] -- Kishorkumar Desai,42240 - Kentucky,United States
Augusta University Georgia .
Recruiting
Augusta,Jessica Johnson (706-723-0106) email: [email protected] -- Elena Schiopu,30912 - Georgia,United States
RAO Research LLS
Recruiting
Oklahoma City,Ashley Johnson (405-608-8060) email: [email protected] -- Latisha Heinlen,73116 - Oklahoma,United States
Achieve Clinical Research
Recruiting
Vestavia Hills,Darianne Mitchell (205-757-8212) email: [email protected] -- Hayes T Williams,35216 - Alabama,United States
Integral Rheumatology and Immunology Specialists IRIS
Recruiting
Plantation,Ana Santana (954-476-2338) email: [email protected] -- Guillermo Valenzuela,33324 - Florida,United States
Sarasota Arthritis Research Center
Recruiting
Sarasota,Katie Decker (941-366-1244) email: [email protected] -- Kimberly Lyn Shue,34239 - Florida,United States
Bay Area Arthritis and Osteoporosis
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Brandon,(813-651-4441) -- Vipul Joshi,33511 - Florida,United States
Advanced Medical Research Medical Research
Recruiting
La Palma,Andy Hodgson (562-867-8195) email: [email protected] -- Gerald Ho,90623 - California,United States
Medvin Clinical Research .
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Van Nuys,Nereyda Negrete email: [email protected] -- Tien I Karleen Karleen Su,91405 - California,United States
St Lawrence Health System .
Recruiting
Potsdam,Caryn Harrington (315-261-5611) email: [email protected] -- Eyal Kedar,13676 - New York,United States
Clin Invest Specialists Inc
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Orland Park,Marina Hanna (847-599-2492) email: [email protected] -- Cory Conniff,60467 - Illinois,United States
OnSite Clinical Solutions Llc .
Recruiting
Charlotte,Angie Price (608-855-9161) email: [email protected] -- Rakesh C Patel,28202 - North Carolina,United States
Advanced Rheumatology of Houston .
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Spring,(281-766-7886) -- Tamar Brionez,77382 - Texas,United States
North Georgia Rheumatology Group
Recruiting
Lawrenceville,Mierra Robinson (770-822-1090) email: [email protected] -- Theresa Lawrence Ford,30046 - Georgia,United States
Worldwide Contacts
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