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O estudo clínico NCT06133972 (SIRIUS-SLE LTE) para Lúpus eritematoso sistêmico está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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NovartisPhase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). (SIRIUS-SLE LTE) Fase III 550
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06133972 (SIRIUS-SLE LTE) procura avaliar tratamento para Lúpus eritematoso sistêmico. Este é um estudo intervencionista de Fase III. Seu status atual é: em recrutamento. O estudo começou em 21 de maio de 2024 e pretende incluir 550 participantes. Coordenado por Novartis e deve ser concluído em 5 de abril de 2032. Essas informações foram atualizadas no ClinicalTrials.gov em 13 de março de 2026.
Resumo
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).
Descrição detalhada
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.
Título oficial
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)
Condições médicas
Lúpus eritematoso sistêmicoOutros IDs do estudo
- SIRIUS-SLE LTE
- CVAY736F12301E1
- 2023-505929-14-00 (Identificador de registro) (EU CT NUMBER)
Número NCT
Data de início (real)
2024-05-21
Última atualização postada
2026-03-13
Data de conclusão (estimada)
2032-04-05
Inscrição (estimada)
550
Tipo de estudo
Intervencionista
FASE
Fase III
Status
Em recrutamento
Palavras-chave
Systemic Lupus Erythematosus
SLE
B cell depletion
SLEDAI-2K
BILAG-2004
SRI-4, ANA
ianalumab
VAY736
SLE
B cell depletion
SLEDAI-2K
BILAG-2004
SRI-4, ANA
ianalumab
VAY736
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Quádruplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalIanalumab monthly Ianalumab s.c. monthly | Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly |
ExperimentalIanalumab quarterly Ianalumab s.c. quarterly | Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly |
Comparador placeboPlacebo monthly Placebo s.c. monthly | PLACEBO Placebo s.c. monthly |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Number of treatment-emergent Adverse events/Serious Adverse events | Assessment of long-term safety and tolerability of ianalumab | through study completion, up to approximately 91 months |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response | SRI-4 response is defined as:
* Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points
* No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline
* No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale | up to Week 216 |
Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index | SLICC/ACR Damage Index is a measure of cumulative damage due to SLE | up to Week 216 |
Average daily dose of oral corticosteroids administered | Evaluating the effect of ianalumab on corticosteroids intake | up to Week 216 |
Annualized BILAG moderate or severe flare rate | Annualized BILAG moderate or severe flare rate where moderate BILAG flare is defined as 2 or more new BILAG-2004 B items, and severe BILAG flare is defined as 1 or more new BILAG-2004 A items, compared to the previous visit | up to Week 216 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto, Idoso
Idade mínima
12 Years
Sexos elegíveis
Todos
- 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.
- 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.
NovartisContato central do estudo
Contato: Novartis Pharmaceuticals, 1-888-669-6682, [email protected]
Contato: Novartis Pharmaceuticals, +41613241111, [email protected]
127 Locais do estudo em 28 países
Estado de Bahia
Novartis Investigative Site, Salvador, Estado de Bahia, 40150 150, Brazil
Em recrutamento
Minas Gerais
Novartis Investigative Site, Belo Horizonte, Minas Gerais, 30150-221, Brazil
Em recrutamento
Rio de Janeiro
Novartis Investigative Site, Rio de Janeiro, Rio de Janeiro, 22211-230, Brazil
Em recrutamento
São Paulo
Novartis Investigative Site, Barretos, São Paulo, 14784 400, Brazil
Em recrutamento
Novartis Investigative Site, São Paulo, São Paulo, 01244-030, Brazil
Em recrutamento
Novartis Investigative Site, São Paulo, São Paulo, 04038-002, Brazil
Em recrutamento
Novartis Investigative Site, Salvador, 40323-010, Brazil
Em recrutamento
Novartis Investigative Site, Braga, 4710243, Portugal
Em recrutamento
Alabama
Pinnacle Research Group Llc, Anniston, Alabama, 36207, United States
Ruby Fields, Contato, 256-236-0055, [email protected]
Vishala L Chindalore, Investigador principal
Em recrutamento
California
Providence Medical Center, Burbank, California, 91505, United States
Sandra Figueroa, Contato, 818-869-7067, [email protected]
Sue Chung, Investigador principal
Em recrutamento
Advanced Medical Research, La Palma, California, 90623, United States
Andy Hodgson, Contato, 714-752-6587, [email protected]
Gerald Ho, Investigador principal
Em recrutamento
Millennium Clinical Trials, Westlake Village, California, 91361, United States
Michelle Nielsen, Contato, [email protected]
Razmig Krumian, Investigador principal
Em recrutamento
Colorado
University of Colorado Denver, Aurora, Colorado, 80045, United States
Chong Pedrick, Contato, [email protected]
Christopher Striebich, Investigador principal
Em recrutamento
Florida
Clinical Res Of W Florida, Clearwater, Florida, 33765, United States
Jessica Mayfield, Contato, 727-466-0078, [email protected]
Robert Levin, Investigador principal
Em recrutamento
GNP Research, Cooper City, Florida, 33024, United States
Elisabeth Rivera, Contato, 754-248-3589, [email protected]
Mark Jaffe, Investigador principal
Em recrutamento
IRIS Research and Development, Plantation, Florida, 33324, United States
Jhon Galindo, Contato, 954-476-2338, [email protected]
Guillermo Valenzuela, Investigador principal
Em recrutamento
Georgia
Parris and Associates Rheumatology, Lawrenceville, Georgia, 30044, United States
Mannai Coutermarsh, Contato, +17709621616#8334, [email protected]
Glenn Parris, Investigador principal
Em recrutamento
Illinois
Robert A Hozman MD SC, Skokie, Illinois, 60076, United States
Patrycja Kalwajtys, Contato, 847-727-2743, [email protected]
Robert Hozman, Investigador principal
Em recrutamento
Willow Rheumatology Wellness, Willowbrook, Illinois, 60527, United States
Lubna Ali, Contato, [email protected]
Angela R Crowley, Investigador principal
Em recrutamento
Louisiana
Accurate Clinical Research, Lake Charles, Louisiana, 70601, United States
Machell Broussard, Contato, [email protected]
Enrique Mendez, Investigador principal
Em recrutamento
Maryland
University Of Maryland, Baltimore, Maryland, 21201, United States
Vinh Nguyen, Contato, [email protected]
Violeta Rus, Investigador principal
Em recrutamento
Michigan
Henry Ford Health, Detroit, Michigan, 48202, United States
Jenna Hudy, Contato, [email protected]
Alireza Meysami, Investigador principal
Em recrutamento
Ahmed Arif Medical Research Center, Grand Blanc, Michigan, 48439, United States
Iman Abdelrahman, Contato, 810-953-8700, [email protected]
Ali Karrar, Investigador principal
Em recrutamento
Ohio
Paramount Med Rsrch and Consult LLC, Middleburg Heights, Ohio, 44130, United States
Denine Ryan, Contato, 440-891-9395, [email protected]
Isam Diab, Investigador principal
Em recrutamento
Tennessee
West Tennessee Research Institute, Jackson, Tennessee, 38305, United States
Abbie Hinton, Contato, 731-664-7824, [email protected]
Jacob A Aelion, Investigador principal
Em recrutamento
Shelby Research LLC, Memphis, Tennessee, 38119, United States
Tanuja Katiki, Contato, 901-681-9670, [email protected]
Ramesh C Gupta, Investigador principal
Em recrutamento
Texas
Novel Research LLC, Bellaire, Texas, 77401, United States
Hassan Khan, Contato, [email protected]
Wajeeha Yousaf, Investigador principal
Em recrutamento
Accurate Clinical Research, League City, Texas, 77573, United States
Mariela Martinez, Contato, [email protected]
Sabeen Najam, Investigador principal
Em recrutamento
Epic Medical Research, Red Oak, Texas, 75154, United States
Harshini Potluri, Contato, 469-206-2642, [email protected]
Sunny Patel, Investigador principal
Em recrutamento
Buenos Aires
Novartis Investigative Site, San Miguel, Buenos Aires, B1663GKT, Argentina
Em recrutamento
Tucumán Province
Novartis Investigative Site, San Miguel, Tucumán Province, T4000CBC, Argentina
Em recrutamento
Novartis Investigative Site, Caba, C1015ABO, Argentina
Em recrutamento
Novartis Investigative Site, San Miguel de Tucumán, 4000, Argentina
Em recrutamento
Queensland
Novartis Investigative Site, Maroochydore, Queensland, 4558, Australia
Em recrutamento
Novartis Investigative Site, Plovdiv, 4002, Bulgaria
Em recrutamento
Novartis Investigative Site, Sofia, 1431, Bulgaria
Em recrutamento
British Columbia
Novartis Investigative Site, Vancouver, British Columbia, V5Z 1L7, Canada
Ativo, não recrutando
Quebec
Novartis Investigative Site, Rimouski, Quebec, G5L 5T1, Canada
Em recrutamento
Los Ríos Region
Novartis Investigative Site, Valdivia, Los Ríos Region, 5110683, Chile
Em recrutamento
RM
Novartis Investigative Site, Santiago, RM, 7500588, Chile
Em recrutamento
Santiago Metropolitan
Novartis Investigative Site, Santiago, Santiago Metropolitan, 7500710, Chile
Em recrutamento
Guangdong
Novartis Investigative Site, Guangzhou, Guangdong, 510080, China
Em recrutamento
Novartis Investigative Site, Shantou, Guangdong, 515000, China
Em recrutamento
Jiangsu
Novartis Investigative Site, Nanjing, Jiangsu, 210008, China
Em recrutamento
Novartis Investigative Site, Suzhou, Jiangsu, 215004, China
Em recrutamento
Jiangxi
Novartis Investigative Site, Nanchang, Jiangxi, 330006, China
Ativo, não recrutando
Novartis Investigative Site, Pingxiang, Jiangxi, 337000, China
Em recrutamento
Jilin
Novartis Investigative Site, Changchun, Jilin, 130021, China
Em recrutamento
Shandong
Novartis Investigative Site, Linyi, Shandong, 276000, China
Em recrutamento
Sichuan
Novartis Investigative Site, Chengdu, Sichuan, 610041, China
Em recrutamento
Xinjiang
Novartis Investigative Site, Ürümqi, Xinjiang, 830001, China
Em recrutamento
Zhejiang
Novartis Investigative Site, Ningbo, Zhejiang, 315016, China
Em recrutamento
Novartis Investigative Site, Beijing, 100069, China
Em recrutamento
Novartis Investigative Site, Beijing, 100730, China
Em recrutamento
Novartis Investigative Site, Shanghai, 200127, China
Em recrutamento
Antioquia
Novartis Investigative Site, Medellín, Antioquia, 050001, Colombia
Ativo, não recrutando
Atlántico
Novartis Investigative Site, Barranquilla, Atlántico, 080020, Colombia
Em recrutamento
Cundinamarca
Novartis Investigative Site, Chía, Cundinamarca, 250001, Colombia
Em recrutamento
Santander Department
Novartis Investigative Site, Bucaramanga, Santander Department, 680003, Colombia
Em recrutamento
Novartis Investigative Site, Bogotá, 111211, Colombia
Em recrutamento
Novartis Investigative Site, Brno, 638 00, Czechia
Em recrutamento
Novartis Investigative Site, Prague, 128 00, Czechia
Em recrutamento
Novartis Investigative Site, Uherské Hradiště, 686 01, Czechia
Em recrutamento
Novartis Investigative Site, Montpellier, 34295, France
Em recrutamento
Novartis Investigative Site, Paris, 75013, France
Em recrutamento
Novartis Investigative Site, Paris, 75014, France
Em recrutamento
Novartis Investigative Site, Toulouse, 31054, France
Em recrutamento
Novartis Investigative Site, Toulouse, 31059, France
Em recrutamento
North Rhine-Westphalia
Novartis Investigative Site, Cologne, North Rhine-Westphalia, 50937, Germany
Em recrutamento
Saxony
Novartis Investigative Site, Leipzig, Saxony, 04103, Germany
Em recrutamento
Novartis Investigative Site, Guatemala City, 01010, Guatemala
Em recrutamento
Fejér
Novartis Investigative Site, Székesfehérvár, Fejér, 8000, Hungary
Em recrutamento
Novartis Investigative Site, Gyula, 5700, Hungary
Em recrutamento
Gujarat
Novartis Investigative Site, Ahmedabad, Gujarat, 380006, India
Em recrutamento
Novartis Investigative Site, Ahmedabad, Gujarat, 380015, India
Em recrutamento
Kerala
Novartis Investigative Site, Kozhikode, Kerala, 673008, India
Em recrutamento
Maharashtra
Novartis Investigative Site, Nagpur, Maharashtra, 441108, India
Em recrutamento
Novartis Investigative Site, Nashik, Maharashtra, 422101, India
Em recrutamento
Novartis Investigative Site, Pune, Maharashtra, 411001, India
Em recrutamento
Novartis Investigative Site, New Delhi, 110029, India
Em recrutamento
Novartis Investigative Site, New Delhi, 110075, India
Em recrutamento
Novartis Investigative Site, Haifa, 3109601, Israel
Ativo, não recrutando
Novartis Investigative Site, Ramat Gan, 5265601, Israel
Em recrutamento
PI
Novartis Investigative Site, Pisa, PI, 56126, Italy
Em recrutamento
TO
Novartis Investigative Site, Torino, TO, 10128, Italy
Em recrutamento
Aichi-ken
Novartis Investigative Site, Nagoya, Aichi-ken, 4578510, Japan
Em recrutamento
Hokkaido
Novartis Investigative Site, Sapporo, Hokkaido, 0608648, Japan
Em recrutamento
Kanagawa-ku
Novartis Investigative Site, Yokohama, Kanagawa-ku, 236-0004, Japan
Em recrutamento
Tokyo
Novartis Investigative Site, Chuo Ku, Tokyo, 1048560, Japan
Em recrutamento
Perak
Novartis Investigative Site, Ipoh, Perak, 30450, Malaysia
Em recrutamento
Guanajuato
Novartis Investigative Site, León, Guanajuato, 37160, Mexico
Em recrutamento
Jalisco
Novartis Investigative Site, Guadalajara, Jalisco, 44160, Mexico
Em recrutamento
Mexico City
Novartis Investigative Site, Mexico City, Mexico City, 06700, Mexico
Em recrutamento
Michoacán
Novartis Investigative Site, Morelia, Michoacán, 58000, Mexico
Em recrutamento
Yucatán
Novartis Investigative Site, Mérida, Yucatán, 97070, Mexico
Em recrutamento
Novartis Investigative Site, México, 07760, Mexico
Em recrutamento
Lower Silesian Voivodeship
Novartis Investigative Site, Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
Em recrutamento
Novartis Investigative Site, Bydgoszcz, 85-065, Poland
Em recrutamento
Novartis Investigative Site, Bydgoszcz, 85-168, Poland
Em recrutamento
Novartis Investigative Site, Bytom, 41 902, Poland
Em recrutamento
Novartis Investigative Site, Warsaw, 00-874, Poland
Em recrutamento
Novartis Investigative Site, Warsaw, 04-141, Poland
Em recrutamento
Cluj
Novartis Investigative Site, Cluj-Napoca, Cluj, 400006, Romania
Em recrutamento
Novartis Investigative Site, Brasov, 500283, Romania
Em recrutamento
Novartis Investigative Site, Bucharest, 011172, Romania
Em recrutamento
Gauteng
Novartis Investigative Site, Pretoria, Gauteng, 0002, South Africa
Em recrutamento
Western Cape
Novartis Investigative Site, Cape Town, Western Cape, 7405, South Africa
Em recrutamento
Novartis Investigative Site, Cape Town, Western Cape, 7500, South Africa
Em recrutamento
Novartis Investigative Site, Stellenbosch, Western Cape, 7600, South Africa
Em recrutamento
Gwangju
Novartis Investigative Site, Gwangju Gwangyeoksi, Gwangju, 61748, South Korea
Em recrutamento
Novartis Investigative Site, Seoul, 04763, South Korea
Em recrutamento
Novartis Investigative Site, Seoul, 06591, South Korea
Em recrutamento
A Coruna
Novartis Investigative Site, Santiago Compostela, A Coruna, 15706, Spain
Em recrutamento
Barcelona
Novartis Investigative Site, Badalona, Barcelona, 08916, Spain
Em recrutamento
Cantabria
Novartis Investigative Site, Santander, Cantabria, 39008, Spain
Em recrutamento
Catalonia
Novartis Investigative Site, Barcelona, Catalonia, 08003, Spain
Em recrutamento
Madrid
Novartis Investigative Site, San Sebastian Reyes, Madrid, 28702, Spain
Em recrutamento
Novartis Investigative Site, Barcelona, 08035, Spain
Em recrutamento
Novartis Investigative Site, Madrid, 28034, Spain
Em recrutamento
Novartis Investigative Site, Valencia, 46014, Spain
Em recrutamento
Novartis Investigative Site, Kaohsiung City, 83301, Taiwan
Em recrutamento
Novartis Investigative Site, Taichung, 40447, Taiwan
Em recrutamento
Novartis Investigative Site, Taichung, 407219, Taiwan
Em recrutamento
Novartis Investigative Site, Taipei, 11217, Taiwan
Em recrutamento
Novartis Investigative Site, Taoyuan District, 33305, Taiwan
Em recrutamento
Novartis Investigative Site, Bangkok, 10400, Thailand
Em recrutamento
Novartis Investigative Site, Bangkok, 10700, Thailand
Em recrutamento