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Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
NCT06133972 · Novartis
In plain English
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Official title
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)
About this study
The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.
Eligibility criteria
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* Use of prohibited therapies.
* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
* Plans for administration of live vaccines during the study period.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
* United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.
Other protocol-defined inclusion/exclusion criteria may apply.
Study design
Enrollment target: 550 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2024-05-21
Estimated completion: 2032-04-05
Last updated: 2026-03-13
Interventions
Drug: PlaceboDrug: Ianalumab
Primary outcomes
- • Number of treatment-emergent Adverse events/Serious Adverse events (through study completion, up to approximately 91 months)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (127)
Pinnacle Research Group LlcRecruiting
Anniston, Alabama, United States
Providence Medical CenterRecruiting
Burbank, California, United States
Advanced Medical ResearchRecruiting
La Palma, California, United States
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Westlake Village, California, United States
University of Colorado DenverRecruiting
Aurora, Colorado, United States
Clinical Res Of W FloridaRecruiting
Clearwater, Florida, United States
GNP ResearchRecruiting
Cooper City, Florida, United States
IRIS Research and DevelopmentRecruiting
Plantation, Florida, United States
Parris and Associates RheumatologyRecruiting
Lawrenceville, Georgia, United States
Robert A Hozman MD SCRecruiting
Skokie, Illinois, United States
Willow Rheumatology WellnessRecruiting
Willowbrook, Illinois, United States
Accurate Clinical ResearchRecruiting
Lake Charles, Louisiana, United States
University Of MarylandRecruiting
Baltimore, Maryland, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
Ahmed Arif Medical Research CenterRecruiting
Grand Blanc, Michigan, United States
Paramount Med Rsrch and Consult LLCRecruiting
Middleburg Heights, Ohio, United States
West Tennessee Research InstituteRecruiting
Jackson, Tennessee, United States
Shelby Research LLCRecruiting
Memphis, Tennessee, United States
Novel Research LLCRecruiting
Bellaire, Texas, United States
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League City, Texas, United States
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Red Oak, Texas, United States
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San Miguel, Buenos Aires, Argentina
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San Miguel, Tucumán Province, Argentina
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Caba, Argentina
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San Miguel de Tucumán, Argentina
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Maroochydore, Queensland, Australia
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Salvador, Estado de Bahia, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Salvador, Brazil
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Vancouver, British Columbia, Canada
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Rimouski, Quebec, Canada
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Valdivia, Los Ríos Region, Chile
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Santiago, RM, Chile
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Santiago, Santiago Metropolitan, Chile
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Guangzhou, Guangdong, China
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Shantou, Guangdong, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Nanchang, Jiangxi, China
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Pingxiang, Jiangxi, China
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Changchun, Jilin, China
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Linyi, Shandong, China
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Chengdu, Sichuan, China
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Ürümqi, Xinjiang, China
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Ningbo, Zhejiang, China
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Beijing, China
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Beijing, China
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Shanghai, China
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Chía, Cundinamarca, Colombia
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Bucaramanga, Santander Department, Colombia
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Bogotá, Colombia
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Brno, Czechia
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Prague, Czechia
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Uherské Hradiště, Czechia
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Montpellier, France
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Paris, France
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Paris, France
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Toulouse, France
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Toulouse, France
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Cologne, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Guatemala City, Guatemala
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Székesfehérvár, Fejér, Hungary
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Gyula, Hungary
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Ahmedabad, Gujarat, India
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Ahmedabad, Gujarat, India
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Kozhikode, Kerala, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, India
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New Delhi, India
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Haifa, Israel
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Ramat Gan, Israel
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Pisa, PI, Italy
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Torino, TO, Italy
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Nagoya, Aichi-ken, Japan
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Sapporo, Hokkaido, Japan
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Yokohama, Kanagawa-ku, Japan
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Chuo Ku, Tokyo, Japan
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Ipoh, Perak, Malaysia
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León, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Morelia, Michoacán, Mexico
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Mérida, Yucatán, Mexico
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México, Mexico
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Wroclaw, Lower Silesian Voivodeship, Poland
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Bydgoszcz, Poland
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Bydgoszcz, Poland
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Bytom, Poland
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Warsaw, Poland
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Warsaw, Poland
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Braga, Portugal
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Cluj-Napoca, Cluj, Romania
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Brasov, Romania
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Bucharest, Romania
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Pretoria, Gauteng, South Africa
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Cape Town, Western Cape, South Africa
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Cape Town, Western Cape, South Africa
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Stellenbosch, Western Cape, South Africa
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Gwangju Gwangyeoksi, Gwangju, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Santiago Compostela, A Coruna, Spain
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Badalona, Barcelona, Spain
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Santander, Cantabria, Spain
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Barcelona, Catalonia, Spain
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San Sebastian Reyes, Madrid, Spain
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Barcelona, Spain
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Madrid, Spain
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Valencia, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand