A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)
Status: Recruiting
Location: See all (124) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 100
Healthy Volunteers: f
View:
• Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
• Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
• In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.
Locations
United States
Alabama
Pinnacle Research Group Llc
RECRUITING
Anniston
California
Providence Medical Center
RECRUITING
Burbank
Advanced Medical Research
RECRUITING
La Palma
Millennium Clinical Trials
RECRUITING
Westlake Village
Colorado
University of Colorado Denver
RECRUITING
Aurora
Florida
Clinical Res Of W Florida
RECRUITING
Clearwater
GNP Research
RECRUITING
Cooper City
IRIS Research and Development
RECRUITING
Plantation
Georgia
Parris and Associates Rheumatology
RECRUITING
Lawrenceville
Illinois
Robert A Hozman MD SC
RECRUITING
Skokie
Willow Rheumatology Wellness
RECRUITING
Willowbrook
Louisiana
Accurate Clinical Research
RECRUITING
Lake Charles
Maryland
University Of Maryland
RECRUITING
Baltimore
Michigan
Henry Ford Health
RECRUITING
Detroit
Ahmed Arif Medical Research Center
RECRUITING
Grand Blanc
Ohio
Paramount Med Rsrch and Consult LLC
RECRUITING
Middleburg Heights
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Shelby Research LLC
RECRUITING
Memphis
Texas
Novel Research LLC
RECRUITING
Bellaire
Accurate Clinical Research
RECRUITING
League City
Epic Medical Research
RECRUITING
Red Oak
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
San Miguel
Novartis Investigative Site
RECRUITING
San Miguel
Novartis Investigative Site
RECRUITING
San Miguel De Tucumán
Australia
Novartis Investigative Site
RECRUITING
Maroochydore
Brazil
Novartis Investigative Site
RECRUITING
Barretos
Novartis Investigative Site
RECRUITING
Belo Horizonte
Novartis Investigative Site
RECRUITING
Rio De Janeiro
Novartis Investigative Site
RECRUITING
Salvador
Novartis Investigative Site
RECRUITING
Salvador
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
Bulgaria
Novartis Investigative Site
RECRUITING
Plovdiv
Novartis Investigative Site
RECRUITING
Sofia
Canada
Novartis Investigative Site
RECRUITING
Rimouski
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Vancouver
Chile
Novartis Investigative Site
RECRUITING
Santiago
Novartis Investigative Site
RECRUITING
Santiago
Novartis Investigative Site
RECRUITING
Valdivia
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Changchun
Novartis Investigative Site
RECRUITING
Chengdu
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Linyi
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nanchang
Novartis Investigative Site
RECRUITING
Nanjing
Novartis Investigative Site
RECRUITING
Ningbo
Novartis Investigative Site
RECRUITING
Pingxiang
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shantou
Novartis Investigative Site
RECRUITING
Suzhou
Novartis Investigative Site
RECRUITING
Ürümqi
Colombia
Novartis Investigative Site
RECRUITING
Barranquilla
Novartis Investigative Site
RECRUITING
Bogotá
Novartis Investigative Site
RECRUITING
Bucaramanga
Novartis Investigative Site
RECRUITING
Chía
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Medellín
France
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Toulouse
Novartis Investigative Site
RECRUITING
Toulouse
Germany
Novartis Investigative Site
RECRUITING
Cologne
Novartis Investigative Site
RECRUITING
Leipzig
Guatemala
Novartis Investigative Site
RECRUITING
Guatemala City
Hungary
Novartis Investigative Site
RECRUITING
Gyula
Novartis Investigative Site
RECRUITING
Székesfehérvár
India
Novartis Investigative Site
RECRUITING
Ahmedabad
Novartis Investigative Site
RECRUITING
Ahmedabad
Novartis Investigative Site
RECRUITING
Kozhikode
Novartis Investigative Site
RECRUITING
Nagpur
Novartis Investigative Site
RECRUITING
Nashik
Novartis Investigative Site
RECRUITING
New Delhi
Novartis Investigative Site
RECRUITING
New Delhi
Novartis Investigative Site
RECRUITING
Pune
Israel
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Ramat Gan
Italy
Novartis Investigative Site
RECRUITING
Pisa
Novartis Investigative Site
RECRUITING
Torino
Japan
Novartis Investigative Site
RECRUITING
Chuo Ku
Novartis Investigative Site
RECRUITING
Nagoya
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Yokohama
Malaysia
Novartis Investigative Site
RECRUITING
Ipoh
Mexico
Novartis Investigative Site
RECRUITING
Guadalajara
Novartis Investigative Site
RECRUITING
León
Novartis Investigative Site
RECRUITING
Mérida
Novartis Investigative Site
RECRUITING
México
Novartis Investigative Site
RECRUITING
Mexico City
Novartis Investigative Site
RECRUITING
Morelia
Poland
Novartis Investigative Site
RECRUITING
Bydgoszcz
Novartis Investigative Site
RECRUITING
Bydgoszcz
Novartis Investigative Site
RECRUITING
Bytom
Novartis Investigative Site
RECRUITING
Warsaw
Novartis Investigative Site
RECRUITING
Warsaw
Novartis Investigative Site
RECRUITING
Wroclaw
Portugal
Novartis Investigative Site
RECRUITING
Braga
Republic of Korea
Novartis Investigative Site
RECRUITING
Gwangju Gwangyeoksi
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Romania
Novartis Investigative Site
RECRUITING
Brasov
Novartis Investigative Site
RECRUITING
Bucharest
Novartis Investigative Site
RECRUITING
Cluj-napoca
South Africa
Novartis Investigative Site
RECRUITING
Cape Town
Novartis Investigative Site
RECRUITING
Cape Town
Novartis Investigative Site
RECRUITING
Pretoria
Novartis Investigative Site
RECRUITING
Stellenbosch
Spain
Novartis Investigative Site
RECRUITING
Badalona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
San Sebastian Reyes
Novartis Investigative Site
RECRUITING
Santander
Novartis Investigative Site
RECRUITING
Santiago Compostela
Novartis Investigative Site
RECRUITING
Valencia
Taiwan
Novartis Investigative Site
RECRUITING
Kaohsiung City
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taoyuan
Thailand
Novartis Investigative Site
RECRUITING
Bangkok
Novartis Investigative Site
RECRUITING
Bangkok
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2024-05-21
Estimated Completion Date: 2032-04-05
Participants
Target number of participants: 550
Treatments
Experimental: Ianalumab monthly
Ianalumab s.c. monthly
Experimental: Ianalumab quarterly
Ianalumab s.c. quarterly
Placebo_comparator: Placebo monthly
Placebo s.c. monthly
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals