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Lo studio clinico NCT06133972 (SIRIUS-SLE LTE) per Lupus eritematoso sistemico è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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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
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06133972 (SIRIUS-SLE LTE) è uno studio interventistico di Fase III volto a esaminare il trattamento per Lupus eritematoso sistemico, attualmente in arruolamento. Avviato il 21 maggio 2024, prevede di arruolare 550 partecipanti. Sotto la guida di Novartis, dovrebbe concludersi entro il 5 aprile 2032. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 13 marzo 2026.
Sommario breve
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).
Descrizione dettagliata
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.
Titolo ufficiale
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)
Patologie
Lupus eritematoso sistemicoAltri ID dello studio
- SIRIUS-SLE LTE
- CVAY736F12301E1
- 2023-505929-14-00 (Identificativo del registro) (EU CT NUMBER)
Numero NCT
Data di inizio (effettiva)
2024-05-21
Ultimo aggiornamento pubblicato
2026-03-13
Data di completamento (stimata)
2032-04-05
Arruolamento (previsto)
550
Tipo di studio
Interventistico
FASE
Fase III
Stato
In arruolamento
Parole chiave
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
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleIanalumab monthly Ianalumab s.c. monthly | Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly |
SperimentaleIanalumab quarterly Ianalumab s.c. quarterly | Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly |
Comparatore placeboPlacebo monthly Placebo s.c. monthly | PLACEBO Placebo s.c. monthly |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
12 Years
Sessi idonei
Tutti
- 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.
NovartisContatti principali dello studio
Contatto: Novartis Pharmaceuticals, 1-888-669-6682, [email protected]
Contatto: Novartis Pharmaceuticals, +41613241111, [email protected]
127 Centri dello studio in 28 paesi
PI
Novartis Investigative Site, Pisa, PI, 56126, Italy
In arruolamento
TO
Novartis Investigative Site, Torino, TO, 10128, Italy
In arruolamento
Alabama
Pinnacle Research Group Llc, Anniston, Alabama, 36207, United States
Ruby Fields, Contatto, 256-236-0055, [email protected]
Vishala L Chindalore, Investigatore principale
In arruolamento
California
Providence Medical Center, Burbank, California, 91505, United States
Sandra Figueroa, Contatto, 818-869-7067, [email protected]
Sue Chung, Investigatore principale
In arruolamento
Advanced Medical Research, La Palma, California, 90623, United States
Andy Hodgson, Contatto, 714-752-6587, [email protected]
Gerald Ho, Investigatore principale
In arruolamento
Millennium Clinical Trials, Westlake Village, California, 91361, United States
Michelle Nielsen, Contatto, [email protected]
Razmig Krumian, Investigatore principale
In arruolamento
Colorado
University of Colorado Denver, Aurora, Colorado, 80045, United States
Chong Pedrick, Contatto, [email protected]
Christopher Striebich, Investigatore principale
In arruolamento
Florida
Clinical Res Of W Florida, Clearwater, Florida, 33765, United States
Jessica Mayfield, Contatto, 727-466-0078, [email protected]
Robert Levin, Investigatore principale
In arruolamento
GNP Research, Cooper City, Florida, 33024, United States
Elisabeth Rivera, Contatto, 754-248-3589, [email protected]
Mark Jaffe, Investigatore principale
In arruolamento
IRIS Research and Development, Plantation, Florida, 33324, United States
Jhon Galindo, Contatto, 954-476-2338, [email protected]
Guillermo Valenzuela, Investigatore principale
In arruolamento
Georgia
Parris and Associates Rheumatology, Lawrenceville, Georgia, 30044, United States
Mannai Coutermarsh, Contatto, +17709621616#8334, [email protected]
Glenn Parris, Investigatore principale
In arruolamento
Illinois
Robert A Hozman MD SC, Skokie, Illinois, 60076, United States
Patrycja Kalwajtys, Contatto, 847-727-2743, [email protected]
Robert Hozman, Investigatore principale
In arruolamento
Willow Rheumatology Wellness, Willowbrook, Illinois, 60527, United States
Lubna Ali, Contatto, [email protected]
Angela R Crowley, Investigatore principale
In arruolamento
Louisiana
Accurate Clinical Research, Lake Charles, Louisiana, 70601, United States
Machell Broussard, Contatto, [email protected]
Enrique Mendez, Investigatore principale
In arruolamento
Maryland
University Of Maryland, Baltimore, Maryland, 21201, United States
Vinh Nguyen, Contatto, [email protected]
Violeta Rus, Investigatore principale
In arruolamento
Michigan
Henry Ford Health, Detroit, Michigan, 48202, United States
Jenna Hudy, Contatto, [email protected]
Alireza Meysami, Investigatore principale
In arruolamento
Ahmed Arif Medical Research Center, Grand Blanc, Michigan, 48439, United States
Iman Abdelrahman, Contatto, 810-953-8700, [email protected]
Ali Karrar, Investigatore principale
In arruolamento
Ohio
Paramount Med Rsrch and Consult LLC, Middleburg Heights, Ohio, 44130, United States
Denine Ryan, Contatto, 440-891-9395, [email protected]
Isam Diab, Investigatore principale
In arruolamento
Tennessee
West Tennessee Research Institute, Jackson, Tennessee, 38305, United States
Abbie Hinton, Contatto, 731-664-7824, [email protected]
Jacob A Aelion, Investigatore principale
In arruolamento
Shelby Research LLC, Memphis, Tennessee, 38119, United States
Tanuja Katiki, Contatto, 901-681-9670, [email protected]
Ramesh C Gupta, Investigatore principale
In arruolamento
Texas
Novel Research LLC, Bellaire, Texas, 77401, United States
Hassan Khan, Contatto, [email protected]
Wajeeha Yousaf, Investigatore principale
In arruolamento
Accurate Clinical Research, League City, Texas, 77573, United States
Mariela Martinez, Contatto, [email protected]
Sabeen Najam, Investigatore principale
In arruolamento
Epic Medical Research, Red Oak, Texas, 75154, United States
Harshini Potluri, Contatto, 469-206-2642, [email protected]
Sunny Patel, Investigatore principale
In arruolamento
Buenos Aires
Novartis Investigative Site, San Miguel, Buenos Aires, B1663GKT, Argentina
In arruolamento
Tucumán Province
Novartis Investigative Site, San Miguel, Tucumán Province, T4000CBC, Argentina
In arruolamento
Novartis Investigative Site, Caba, C1015ABO, Argentina
In arruolamento
Novartis Investigative Site, San Miguel de Tucumán, 4000, Argentina
In arruolamento
Queensland
Novartis Investigative Site, Maroochydore, Queensland, 4558, Australia
In arruolamento
Estado de Bahia
Novartis Investigative Site, Salvador, Estado de Bahia, 40150 150, Brazil
In arruolamento
Minas Gerais
Novartis Investigative Site, Belo Horizonte, Minas Gerais, 30150-221, Brazil
In arruolamento
Rio de Janeiro
Novartis Investigative Site, Rio de Janeiro, Rio de Janeiro, 22211-230, Brazil
In arruolamento
São Paulo
Novartis Investigative Site, Barretos, São Paulo, 14784 400, Brazil
In arruolamento
Novartis Investigative Site, São Paulo, São Paulo, 01244-030, Brazil
In arruolamento
Novartis Investigative Site, São Paulo, São Paulo, 04038-002, Brazil
In arruolamento
Novartis Investigative Site, Salvador, 40323-010, Brazil
In arruolamento
Novartis Investigative Site, Plovdiv, 4002, Bulgaria
In arruolamento
Novartis Investigative Site, Sofia, 1431, Bulgaria
In arruolamento
British Columbia
Novartis Investigative Site, Vancouver, British Columbia, V5Z 1L7, Canada
Attivo, non in arruolamento
Quebec
Novartis Investigative Site, Rimouski, Quebec, G5L 5T1, Canada
In arruolamento
Los Ríos Region
Novartis Investigative Site, Valdivia, Los Ríos Region, 5110683, Chile
In arruolamento
RM
Novartis Investigative Site, Santiago, RM, 7500588, Chile
In arruolamento
Santiago Metropolitan
Novartis Investigative Site, Santiago, Santiago Metropolitan, 7500710, Chile
In arruolamento
Guangdong
Novartis Investigative Site, Guangzhou, Guangdong, 510080, China
In arruolamento
Novartis Investigative Site, Shantou, Guangdong, 515000, China
In arruolamento
Jiangsu
Novartis Investigative Site, Nanjing, Jiangsu, 210008, China
In arruolamento
Novartis Investigative Site, Suzhou, Jiangsu, 215004, China
In arruolamento
Jiangxi
Novartis Investigative Site, Nanchang, Jiangxi, 330006, China
Attivo, non in arruolamento
Novartis Investigative Site, Pingxiang, Jiangxi, 337000, China
In arruolamento
Jilin
Novartis Investigative Site, Changchun, Jilin, 130021, China
In arruolamento
Shandong
Novartis Investigative Site, Linyi, Shandong, 276000, China
In arruolamento
Sichuan
Novartis Investigative Site, Chengdu, Sichuan, 610041, China
In arruolamento
Xinjiang
Novartis Investigative Site, Ürümqi, Xinjiang, 830001, China
In arruolamento
Zhejiang
Novartis Investigative Site, Ningbo, Zhejiang, 315016, China
In arruolamento
Novartis Investigative Site, Beijing, 100069, China
In arruolamento
Novartis Investigative Site, Beijing, 100730, China
In arruolamento
Novartis Investigative Site, Shanghai, 200127, China
In arruolamento
Antioquia
Novartis Investigative Site, Medellín, Antioquia, 050001, Colombia
Attivo, non in arruolamento
Atlántico
Novartis Investigative Site, Barranquilla, Atlántico, 080020, Colombia
In arruolamento
Cundinamarca
Novartis Investigative Site, Chía, Cundinamarca, 250001, Colombia
In arruolamento
Santander Department
Novartis Investigative Site, Bucaramanga, Santander Department, 680003, Colombia
In arruolamento
Novartis Investigative Site, Bogotá, 111211, Colombia
In arruolamento
Novartis Investigative Site, Brno, 638 00, Czechia
In arruolamento
Novartis Investigative Site, Prague, 128 00, Czechia
In arruolamento
Novartis Investigative Site, Uherské Hradiště, 686 01, Czechia
In arruolamento
Novartis Investigative Site, Montpellier, 34295, France
In arruolamento
Novartis Investigative Site, Paris, 75013, France
In arruolamento
Novartis Investigative Site, Paris, 75014, France
In arruolamento
Novartis Investigative Site, Toulouse, 31054, France
In arruolamento
Novartis Investigative Site, Toulouse, 31059, France
In arruolamento
North Rhine-Westphalia
Novartis Investigative Site, Cologne, North Rhine-Westphalia, 50937, Germany
In arruolamento
Saxony
Novartis Investigative Site, Leipzig, Saxony, 04103, Germany
In arruolamento
Novartis Investigative Site, Guatemala City, 01010, Guatemala
In arruolamento
Fejér
Novartis Investigative Site, Székesfehérvár, Fejér, 8000, Hungary
In arruolamento
Novartis Investigative Site, Gyula, 5700, Hungary
In arruolamento
Gujarat
Novartis Investigative Site, Ahmedabad, Gujarat, 380006, India
In arruolamento
Novartis Investigative Site, Ahmedabad, Gujarat, 380015, India
In arruolamento
Kerala
Novartis Investigative Site, Kozhikode, Kerala, 673008, India
In arruolamento
Maharashtra
Novartis Investigative Site, Nagpur, Maharashtra, 441108, India
In arruolamento
Novartis Investigative Site, Nashik, Maharashtra, 422101, India
In arruolamento
Novartis Investigative Site, Pune, Maharashtra, 411001, India
In arruolamento
Novartis Investigative Site, New Delhi, 110029, India
In arruolamento
Novartis Investigative Site, New Delhi, 110075, India
In arruolamento
Novartis Investigative Site, Haifa, 3109601, Israel
Attivo, non in arruolamento
Novartis Investigative Site, Ramat Gan, 5265601, Israel
In arruolamento
Aichi-ken
Novartis Investigative Site, Nagoya, Aichi-ken, 4578510, Japan
In arruolamento
Hokkaido
Novartis Investigative Site, Sapporo, Hokkaido, 0608648, Japan
In arruolamento
Kanagawa-ku
Novartis Investigative Site, Yokohama, Kanagawa-ku, 236-0004, Japan
In arruolamento
Tokyo
Novartis Investigative Site, Chuo Ku, Tokyo, 1048560, Japan
In arruolamento
Perak
Novartis Investigative Site, Ipoh, Perak, 30450, Malaysia
In arruolamento
Guanajuato
Novartis Investigative Site, León, Guanajuato, 37160, Mexico
In arruolamento
Jalisco
Novartis Investigative Site, Guadalajara, Jalisco, 44160, Mexico
In arruolamento
Mexico City
Novartis Investigative Site, Mexico City, Mexico City, 06700, Mexico
In arruolamento
Michoacán
Novartis Investigative Site, Morelia, Michoacán, 58000, Mexico
In arruolamento
Yucatán
Novartis Investigative Site, Mérida, Yucatán, 97070, Mexico
In arruolamento
Novartis Investigative Site, México, 07760, Mexico
In arruolamento
Lower Silesian Voivodeship
Novartis Investigative Site, Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
In arruolamento
Novartis Investigative Site, Bydgoszcz, 85-065, Poland
In arruolamento
Novartis Investigative Site, Bydgoszcz, 85-168, Poland
In arruolamento
Novartis Investigative Site, Bytom, 41 902, Poland
In arruolamento
Novartis Investigative Site, Warsaw, 00-874, Poland
In arruolamento
Novartis Investigative Site, Warsaw, 04-141, Poland
In arruolamento
Novartis Investigative Site, Braga, 4710243, Portugal
In arruolamento
Cluj
Novartis Investigative Site, Cluj-Napoca, Cluj, 400006, Romania
In arruolamento
Novartis Investigative Site, Brasov, 500283, Romania
In arruolamento
Novartis Investigative Site, Bucharest, 011172, Romania
In arruolamento
Gauteng
Novartis Investigative Site, Pretoria, Gauteng, 0002, South Africa
In arruolamento
Western Cape
Novartis Investigative Site, Cape Town, Western Cape, 7405, South Africa
In arruolamento
Novartis Investigative Site, Cape Town, Western Cape, 7500, South Africa
In arruolamento
Novartis Investigative Site, Stellenbosch, Western Cape, 7600, South Africa
In arruolamento
Gwangju
Novartis Investigative Site, Gwangju Gwangyeoksi, Gwangju, 61748, South Korea
In arruolamento
Novartis Investigative Site, Seoul, 04763, South Korea
In arruolamento
Novartis Investigative Site, Seoul, 06591, South Korea
In arruolamento
A Coruna
Novartis Investigative Site, Santiago Compostela, A Coruna, 15706, Spain
In arruolamento
Barcelona
Novartis Investigative Site, Badalona, Barcelona, 08916, Spain
In arruolamento
Cantabria
Novartis Investigative Site, Santander, Cantabria, 39008, Spain
In arruolamento
Catalonia
Novartis Investigative Site, Barcelona, Catalonia, 08003, Spain
In arruolamento
Madrid
Novartis Investigative Site, San Sebastian Reyes, Madrid, 28702, Spain
In arruolamento
Novartis Investigative Site, Barcelona, 08035, Spain
In arruolamento
Novartis Investigative Site, Madrid, 28034, Spain
In arruolamento
Novartis Investigative Site, Valencia, 46014, Spain
In arruolamento
Novartis Investigative Site, Kaohsiung City, 83301, Taiwan
In arruolamento
Novartis Investigative Site, Taichung, 40447, Taiwan
In arruolamento
Novartis Investigative Site, Taichung, 407219, Taiwan
In arruolamento
Novartis Investigative Site, Taipei, 11217, Taiwan
In arruolamento
Novartis Investigative Site, Taoyuan District, 33305, Taiwan
In arruolamento
Novartis Investigative Site, Bangkok, 10400, Thailand
In arruolamento
Novartis Investigative Site, Bangkok, 10700, Thailand
In arruolamento