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)
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05350072 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Novartis Pharmaceuticals |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Novartis Pharmaceuticals |
Principal Investigator Affiliation | Novartis Pharmaceuticals |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Austria, Belgium, Brazil, Chile, China, Czechia, France, Germany, Guatemala, Korea, Republic of, Lithuania, Mexico, Poland, Portugal, Singapore, Spain, Turkey, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Sjogren Syndrome |
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.
Experimental: Arm A
ianalumab
Placebo Comparator: Arm B
placebo
Biological: - VAY736
ianalumab s.c.
Other: - Placebo
placebo s.c.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
Arizona Arthritis and Rheumatology Associates PLLC .
Paradise Valley, Arizona, 85253
Status
Active, not recruiting
Address
Medvin Clinical Research .
Van Nuys, California, 91405
Status
Withdrawn
Address
Reciomed Clinical Research
Boynton Beach, Florida, 33472
Status
Recruiting
Address
West Broward Rheumatology Assoc Inc
Tamarac, Florida, 33321
Status
Recruiting
Address
Rush University Medical Center Suite 300
Chicago, Illinois, 60612
Status
Recruiting
Address
Indiana Univ School of Dentistry
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Ochsner Health System
Baton Rouge, Louisiana, 70809
Status
Recruiting
Address
The John Hopkins Jerome L Greene
Baltimore, Maryland, 21224
Status
Active, not recruiting
Address
Winthrop University Hospital
Mineola, New York, 11501
Status
Active, not recruiting
Address
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
Status
Active, not recruiting
Address
STAT Research Inc .
Dayton, Ohio, 45402
Status
Recruiting
Address
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Status
Recruiting
Address
Prisma Health Rheumatology
Columbia, South Carolina, 29203
Status
Active, not recruiting
Address
Precision Comprehensive Research
Colleyville, Texas, 76034
Status
Completed
Address
Novartis Investigative Site
Dallas, Texas, 75231
Status
Withdrawn
Address
Novartis Investigative Site
Dallas, Texas, 75231
Status
Recruiting
Address
Baylor College Of Medicine .
Houston, Texas, 77030
Status
Recruiting
Address
Houston Rheumatology & Arthrit Houston Rheum and Arthritis
Katy, Texas, 77494
Status
Recruiting
Address
Novartis Investigative Site
Graz, , 8036
Status
Recruiting
Address
Novartis Investigative Site
Stockerau, , 2000
Status
Recruiting
Address
Novartis Investigative Site
Gent, , 9000
Status
Recruiting
Address
Novartis Investigative Site
Leuven, , 3000
Status
Recruiting
Address
Novartis Investigative Site
Vitoria, ES, 29055 450
Status
Recruiting
Address
Novartis Investigative Site
Juiz de Fora, MG, 36010 570
Status
Recruiting
Address
Novartis Investigative Site
Ribeirao Preto, SP, 14048-900
Status
Recruiting
Address
Novartis Investigative Site
Rio de Janeiro, , 22061-080
Status
Recruiting
Address
Novartis Investigative Site
Sao Paulo, , 01409-902
Status
Recruiting
Address
Novartis Investigative Site
Santiago, , 7500571
Status
Recruiting
Address
Novartis Investigative Site
Santiago, , 7500710
Status
Active, not recruiting
Address
Novartis Investigative Site
Shenzhen, Guangdong, 518020
Status
Active, not recruiting
Address
Novartis Investigative Site
Wuhan, Hubei, 430030
Status
Active, not recruiting
Address
Novartis Investigative Site
Baotou, Inner Mongolia, 014010
Status
Completed
Address
Novartis Investigative Site
Hohhot, Inner Mongolia, 10050
Status
Active, not recruiting
Address
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Status
Active, not recruiting
Address
Novartis Investigative Site
Shenyang, Liaoning, 110011
Status
Recruiting
Address
Novartis Investigative Site
Linyi, Shandong, 276000
Status
Active, not recruiting
Address
Novartis Investigative Site
Taiyuan, Shanxi, 030000
Status
Active, not recruiting
Address
Novartis Investigative Site
Beijing, , 100050
Status
Withdrawn
Address
Novartis Investigative Site
Beijing, , 100730
Status
Active, not recruiting
Address
Novartis Investigative Site
Guangzhou, , 510630
Status
Active, not recruiting
Address
Novartis Investigative Site
Shanxi, , 710063
Status
Recruiting
Address
Novartis Investigative Site
Brno, , 63800
Status
Recruiting
Address
Novartis Investigative Site
Praha 11, , 14900
Status
Recruiting
Address
Novartis Investigative Site
Uherske Hradiste, , 686 01
Status
Active, not recruiting
Address
Novartis Investigative Site
Caen Cedex 9, , 14033
Status
Active, not recruiting
Address
Novartis Investigative Site
Dijon, , 21034
Status
Withdrawn
Address
Novartis Investigative Site
Grenoble, , 38043
Status
Active, not recruiting
Address
Novartis Investigative Site
Lille, , 59000
Status
Active, not recruiting
Address
Novartis Investigative Site
Marseille, , 13385
Status
Active, not recruiting
Address
Novartis Investigative Site
Paris 13, , 75651
Status
Active, not recruiting
Address
Novartis Investigative Site
Paris cedex 10, , 75010
Status
Recruiting
Address
Novartis Investigative Site
Paris, , 75014
Status
Active, not recruiting
Address
Novartis Investigative Site
Saint Etienne, , 42100
Status
Active, not recruiting
Address
Novartis Investigative Site
Berlin, , 13353
Status
Active, not recruiting
Address
Novartis Investigative Site
Erlangen, , 91056
Status
Active, not recruiting
Address
Novartis Investigative Site
Freiburg, , 79106
Status
Active, not recruiting
Address
Novartis Investigative Site
Gommern, , 39245
Status
Active, not recruiting
Address
Novartis Investigative Site
Ludwigshafen, , 67063
Status
Active, not recruiting
Address
Novartis Investigative Site
Wuerzburg, , 97080
Status
Recruiting
Address
Novartis Investigative Site
Guatemala City, , 01010
Status
Recruiting
Address
Novartis Investigative Site
Guatemala City, , 01011
Status
Recruiting
Address
Novartis Investigative Site
Guatemala, , 01009
Status
Recruiting
Address
Novartis Investigative Site
Guatemala, , 01010
Status
Recruiting
Address
Novartis Investigative Site
Quetzaltenango, , 9001
Status
Active, not recruiting
Address
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Status
Withdrawn
Address
Novartis Investigative Site
Daegu, , 705 718
Status
Active, not recruiting
Address
Novartis Investigative Site
Gwangju, , 61469
Status
Withdrawn
Address
Novartis Investigative Site
Seoul, , 03080
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 04763
Status
Recruiting
Address
Novartis Investigative Site
Vilnius, , 08406
Status
Recruiting
Address
Novartis Investigative Site
Ciudad de Mexico, Distrito Federal, 06700
Status
Recruiting
Address
Novartis Investigative Site
Guadalajara, Jalisco, 44650
Status
Recruiting
Address
Novartis Investigative Site
Wroclaw, Dolnoslaskie, 52-210
Status
Recruiting
Address
Novartis Investigative Site
Bydgoszcz, , 85 168
Status
Recruiting
Address
Novartis Investigative Site
Krakow, , 30 002
Status
Recruiting
Address
Novartis Investigative Site
Lublin, , 20-954
Status
Active, not recruiting
Address
Novartis Investigative Site
Braga, , 4710243
Status
Active, not recruiting
Address
Novartis Investigative Site
Guarda, , 6300 858
Status
Active, not recruiting
Address
Novartis Investigative Site
Lisboa, , 1050-034
Status
Active, not recruiting
Address
Novartis Investigative Site
Lisboa, , 1349 019
Status
Active, not recruiting
Address
Novartis Investigative Site
Lisboa, , 1649-035
Status
Active, not recruiting
Address
Novartis Investigative Site
Singapore, , 308433
Status
Recruiting
Address
Novartis Investigative Site
Sevilla, Andalucia, 41013
Status
Active, not recruiting
Address
Novartis Investigative Site
Sabadell, Barcelona, 08208
Status
Active, not recruiting
Address
Novartis Investigative Site
Badalona, Catalunya, 08916
Status
Active, not recruiting
Address
Novartis Investigative Site
La Coruna, Galicia, 15006
Status
Active, not recruiting
Address
Novartis Investigative Site
Bilbao, Pais Vasco, 48013
Status
Active, not recruiting
Address
Novartis Investigative Site
Madrid, , 28034
Status
Recruiting
Address
Novartis Investigative Site
Ankara, , 06100
Status
Recruiting
Address
Novartis Investigative Site
Ankara, , 06560
Status
Recruiting
Address
Novartis Investigative Site
Kocaeli, , 41380