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Die klinische Studie NCT06133972 (SIRIUS-SLE LTE) für Systemischer Lupus erythematodes ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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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) Phase 3 550
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06133972 (SIRIUS-SLE LTE) untersucht Behandlung im Zusammenhang mit Systemischer Lupus erythematodes. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 21. Mai 2024. Es ist geplant, 550 Teilnehmer aufzunehmen. Durchgeführt von Novartis wird der Abschluss für 5. April 2032 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 13. März 2026 aktualisiert.
Kurzbeschreibung
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).
Ausführliche Beschreibung
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.
Offizieller Titel
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)
Erkrankungen
Systemischer Lupus erythematodesWeitere Studien-IDs
- SIRIUS-SLE LTE
- CVAY736F12301E1
- 2023-505929-14-00 (Registerkennung) (EU CT NUMBER)
NCT-Nummer
Studienbeginn (tatsächlich)
2024-05-21
Zuletzt aktualisiert
2026-03-13
Studienende (vorauss.)
2032-04-05
Geplante Rekrutierung
550
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Stichwörter
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
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellIanalumab monthly Ianalumab s.c. monthly | Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly |
ExperimentellIanalumab quarterly Ianalumab s.c. quarterly | Ianalumab Ianalumab s.c. monthly Ianalumab s.c. quarterly |
Placebo-VergleichspräparatPlacebo monthly Placebo s.c. monthly | PLACEBO Placebo s.c. monthly |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
12 Years
Zugelassene Geschlechter
Alle
- 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.
NovartisZentrale Studienkontakte
Kontakt: Novartis Pharmaceuticals, 1-888-669-6682, [email protected]
Kontakt: Novartis Pharmaceuticals, +41613241111, [email protected]
127 Studienstandorte in 28 Ländern
North Rhine-Westphalia
Novartis Investigative Site, Cologne, North Rhine-Westphalia, 50937, Germany
Offene Rekrutierung
Saxony
Novartis Investigative Site, Leipzig, Saxony, 04103, Germany
Offene Rekrutierung
Alabama
Pinnacle Research Group Llc, Anniston, Alabama, 36207, United States
Ruby Fields, Kontakt, 256-236-0055, [email protected]
Vishala L Chindalore, Hauptprüfer
Offene Rekrutierung
California
Providence Medical Center, Burbank, California, 91505, United States
Sandra Figueroa, Kontakt, 818-869-7067, [email protected]
Sue Chung, Hauptprüfer
Offene Rekrutierung
Advanced Medical Research, La Palma, California, 90623, United States
Andy Hodgson, Kontakt, 714-752-6587, [email protected]
Gerald Ho, Hauptprüfer
Offene Rekrutierung
Millennium Clinical Trials, Westlake Village, California, 91361, United States
Michelle Nielsen, Kontakt, [email protected]
Razmig Krumian, Hauptprüfer
Offene Rekrutierung
Colorado
University of Colorado Denver, Aurora, Colorado, 80045, United States
Chong Pedrick, Kontakt, [email protected]
Christopher Striebich, Hauptprüfer
Offene Rekrutierung
Florida
Clinical Res Of W Florida, Clearwater, Florida, 33765, United States
Jessica Mayfield, Kontakt, 727-466-0078, [email protected]
Robert Levin, Hauptprüfer
Offene Rekrutierung
GNP Research, Cooper City, Florida, 33024, United States
Elisabeth Rivera, Kontakt, 754-248-3589, [email protected]
Mark Jaffe, Hauptprüfer
Offene Rekrutierung
IRIS Research and Development, Plantation, Florida, 33324, United States
Jhon Galindo, Kontakt, 954-476-2338, [email protected]
Guillermo Valenzuela, Hauptprüfer
Offene Rekrutierung
Georgia
Parris and Associates Rheumatology, Lawrenceville, Georgia, 30044, United States
Mannai Coutermarsh, Kontakt, +17709621616#8334, [email protected]
Glenn Parris, Hauptprüfer
Offene Rekrutierung
Illinois
Robert A Hozman MD SC, Skokie, Illinois, 60076, United States
Patrycja Kalwajtys, Kontakt, 847-727-2743, [email protected]
Robert Hozman, Hauptprüfer
Offene Rekrutierung
Willow Rheumatology Wellness, Willowbrook, Illinois, 60527, United States
Lubna Ali, Kontakt, [email protected]
Angela R Crowley, Hauptprüfer
Offene Rekrutierung
Louisiana
Accurate Clinical Research, Lake Charles, Louisiana, 70601, United States
Machell Broussard, Kontakt, [email protected]
Enrique Mendez, Hauptprüfer
Offene Rekrutierung
Maryland
University Of Maryland, Baltimore, Maryland, 21201, United States
Vinh Nguyen, Kontakt, [email protected]
Violeta Rus, Hauptprüfer
Offene Rekrutierung
Michigan
Henry Ford Health, Detroit, Michigan, 48202, United States
Jenna Hudy, Kontakt, [email protected]
Alireza Meysami, Hauptprüfer
Offene Rekrutierung
Ahmed Arif Medical Research Center, Grand Blanc, Michigan, 48439, United States
Iman Abdelrahman, Kontakt, 810-953-8700, [email protected]
Ali Karrar, Hauptprüfer
Offene Rekrutierung
Ohio
Paramount Med Rsrch and Consult LLC, Middleburg Heights, Ohio, 44130, United States
Denine Ryan, Kontakt, 440-891-9395, [email protected]
Isam Diab, Hauptprüfer
Offene Rekrutierung
Tennessee
West Tennessee Research Institute, Jackson, Tennessee, 38305, United States
Abbie Hinton, Kontakt, 731-664-7824, [email protected]
Jacob A Aelion, Hauptprüfer
Offene Rekrutierung
Shelby Research LLC, Memphis, Tennessee, 38119, United States
Tanuja Katiki, Kontakt, 901-681-9670, [email protected]
Ramesh C Gupta, Hauptprüfer
Offene Rekrutierung
Texas
Novel Research LLC, Bellaire, Texas, 77401, United States
Hassan Khan, Kontakt, [email protected]
Wajeeha Yousaf, Hauptprüfer
Offene Rekrutierung
Accurate Clinical Research, League City, Texas, 77573, United States
Mariela Martinez, Kontakt, [email protected]
Sabeen Najam, Hauptprüfer
Offene Rekrutierung
Epic Medical Research, Red Oak, Texas, 75154, United States
Harshini Potluri, Kontakt, 469-206-2642, [email protected]
Sunny Patel, Hauptprüfer
Offene Rekrutierung
Buenos Aires
Novartis Investigative Site, San Miguel, Buenos Aires, B1663GKT, Argentina
Offene Rekrutierung
Tucumán Province
Novartis Investigative Site, San Miguel, Tucumán Province, T4000CBC, Argentina
Offene Rekrutierung
Novartis Investigative Site, Caba, C1015ABO, Argentina
Offene Rekrutierung
Novartis Investigative Site, San Miguel de Tucumán, 4000, Argentina
Offene Rekrutierung
Queensland
Novartis Investigative Site, Maroochydore, Queensland, 4558, Australia
Offene Rekrutierung
Estado de Bahia
Novartis Investigative Site, Salvador, Estado de Bahia, 40150 150, Brazil
Offene Rekrutierung
Minas Gerais
Novartis Investigative Site, Belo Horizonte, Minas Gerais, 30150-221, Brazil
Offene Rekrutierung
Rio de Janeiro
Novartis Investigative Site, Rio de Janeiro, Rio de Janeiro, 22211-230, Brazil
Offene Rekrutierung
São Paulo
Novartis Investigative Site, Barretos, São Paulo, 14784 400, Brazil
Offene Rekrutierung
Novartis Investigative Site, São Paulo, São Paulo, 01244-030, Brazil
Offene Rekrutierung
Novartis Investigative Site, São Paulo, São Paulo, 04038-002, Brazil
Offene Rekrutierung
Novartis Investigative Site, Salvador, 40323-010, Brazil
Offene Rekrutierung
Novartis Investigative Site, Plovdiv, 4002, Bulgaria
Offene Rekrutierung
Novartis Investigative Site, Sofia, 1431, Bulgaria
Offene Rekrutierung
British Columbia
Novartis Investigative Site, Vancouver, British Columbia, V5Z 1L7, Canada
Aktiv, nicht rekrutierend
Quebec
Novartis Investigative Site, Rimouski, Quebec, G5L 5T1, Canada
Offene Rekrutierung
Los Ríos Region
Novartis Investigative Site, Valdivia, Los Ríos Region, 5110683, Chile
Offene Rekrutierung
RM
Novartis Investigative Site, Santiago, RM, 7500588, Chile
Offene Rekrutierung
Santiago Metropolitan
Novartis Investigative Site, Santiago, Santiago Metropolitan, 7500710, Chile
Offene Rekrutierung
Guangdong
Novartis Investigative Site, Guangzhou, Guangdong, 510080, China
Offene Rekrutierung
Novartis Investigative Site, Shantou, Guangdong, 515000, China
Offene Rekrutierung
Jiangsu
Novartis Investigative Site, Nanjing, Jiangsu, 210008, China
Offene Rekrutierung
Novartis Investigative Site, Suzhou, Jiangsu, 215004, China
Offene Rekrutierung
Jiangxi
Novartis Investigative Site, Nanchang, Jiangxi, 330006, China
Aktiv, nicht rekrutierend
Novartis Investigative Site, Pingxiang, Jiangxi, 337000, China
Offene Rekrutierung
Jilin
Novartis Investigative Site, Changchun, Jilin, 130021, China
Offene Rekrutierung
Shandong
Novartis Investigative Site, Linyi, Shandong, 276000, China
Offene Rekrutierung
Sichuan
Novartis Investigative Site, Chengdu, Sichuan, 610041, China
Offene Rekrutierung
Xinjiang
Novartis Investigative Site, Ürümqi, Xinjiang, 830001, China
Offene Rekrutierung
Zhejiang
Novartis Investigative Site, Ningbo, Zhejiang, 315016, China
Offene Rekrutierung
Novartis Investigative Site, Beijing, 100069, China
Offene Rekrutierung
Novartis Investigative Site, Beijing, 100730, China
Offene Rekrutierung
Novartis Investigative Site, Shanghai, 200127, China
Offene Rekrutierung
Antioquia
Novartis Investigative Site, Medellín, Antioquia, 050001, Colombia
Aktiv, nicht rekrutierend
Atlántico
Novartis Investigative Site, Barranquilla, Atlántico, 080020, Colombia
Offene Rekrutierung
Cundinamarca
Novartis Investigative Site, Chía, Cundinamarca, 250001, Colombia
Offene Rekrutierung
Santander Department
Novartis Investigative Site, Bucaramanga, Santander Department, 680003, Colombia
Offene Rekrutierung
Novartis Investigative Site, Bogotá, 111211, Colombia
Offene Rekrutierung
Novartis Investigative Site, Brno, 638 00, Czechia
Offene Rekrutierung
Novartis Investigative Site, Prague, 128 00, Czechia
Offene Rekrutierung
Novartis Investigative Site, Uherské Hradiště, 686 01, Czechia
Offene Rekrutierung
Novartis Investigative Site, Montpellier, 34295, France
Offene Rekrutierung
Novartis Investigative Site, Paris, 75013, France
Offene Rekrutierung
Novartis Investigative Site, Paris, 75014, France
Offene Rekrutierung
Novartis Investigative Site, Toulouse, 31054, France
Offene Rekrutierung
Novartis Investigative Site, Toulouse, 31059, France
Offene Rekrutierung
Novartis Investigative Site, Guatemala City, 01010, Guatemala
Offene Rekrutierung
Fejér
Novartis Investigative Site, Székesfehérvár, Fejér, 8000, Hungary
Offene Rekrutierung
Novartis Investigative Site, Gyula, 5700, Hungary
Offene Rekrutierung
Gujarat
Novartis Investigative Site, Ahmedabad, Gujarat, 380006, India
Offene Rekrutierung
Novartis Investigative Site, Ahmedabad, Gujarat, 380015, India
Offene Rekrutierung
Kerala
Novartis Investigative Site, Kozhikode, Kerala, 673008, India
Offene Rekrutierung
Maharashtra
Novartis Investigative Site, Nagpur, Maharashtra, 441108, India
Offene Rekrutierung
Novartis Investigative Site, Nashik, Maharashtra, 422101, India
Offene Rekrutierung
Novartis Investigative Site, Pune, Maharashtra, 411001, India
Offene Rekrutierung
Novartis Investigative Site, New Delhi, 110029, India
Offene Rekrutierung
Novartis Investigative Site, New Delhi, 110075, India
Offene Rekrutierung
Novartis Investigative Site, Haifa, 3109601, Israel
Aktiv, nicht rekrutierend
Novartis Investigative Site, Ramat Gan, 5265601, Israel
Offene Rekrutierung
PI
Novartis Investigative Site, Pisa, PI, 56126, Italy
Offene Rekrutierung
TO
Novartis Investigative Site, Torino, TO, 10128, Italy
Offene Rekrutierung
Aichi-ken
Novartis Investigative Site, Nagoya, Aichi-ken, 4578510, Japan
Offene Rekrutierung
Hokkaido
Novartis Investigative Site, Sapporo, Hokkaido, 0608648, Japan
Offene Rekrutierung
Kanagawa-ku
Novartis Investigative Site, Yokohama, Kanagawa-ku, 236-0004, Japan
Offene Rekrutierung
Tokyo
Novartis Investigative Site, Chuo Ku, Tokyo, 1048560, Japan
Offene Rekrutierung
Perak
Novartis Investigative Site, Ipoh, Perak, 30450, Malaysia
Offene Rekrutierung
Guanajuato
Novartis Investigative Site, León, Guanajuato, 37160, Mexico
Offene Rekrutierung
Jalisco
Novartis Investigative Site, Guadalajara, Jalisco, 44160, Mexico
Offene Rekrutierung
Mexico City
Novartis Investigative Site, Mexico City, Mexico City, 06700, Mexico
Offene Rekrutierung
Michoacán
Novartis Investigative Site, Morelia, Michoacán, 58000, Mexico
Offene Rekrutierung
Yucatán
Novartis Investigative Site, Mérida, Yucatán, 97070, Mexico
Offene Rekrutierung
Novartis Investigative Site, México, 07760, Mexico
Offene Rekrutierung
Lower Silesian Voivodeship
Novartis Investigative Site, Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
Offene Rekrutierung
Novartis Investigative Site, Bydgoszcz, 85-065, Poland
Offene Rekrutierung
Novartis Investigative Site, Bydgoszcz, 85-168, Poland
Offene Rekrutierung
Novartis Investigative Site, Bytom, 41 902, Poland
Offene Rekrutierung
Novartis Investigative Site, Warsaw, 00-874, Poland
Offene Rekrutierung
Novartis Investigative Site, Warsaw, 04-141, Poland
Offene Rekrutierung
Novartis Investigative Site, Braga, 4710243, Portugal
Offene Rekrutierung
Cluj
Novartis Investigative Site, Cluj-Napoca, Cluj, 400006, Romania
Offene Rekrutierung
Novartis Investigative Site, Brasov, 500283, Romania
Offene Rekrutierung
Novartis Investigative Site, Bucharest, 011172, Romania
Offene Rekrutierung
Gauteng
Novartis Investigative Site, Pretoria, Gauteng, 0002, South Africa
Offene Rekrutierung
Western Cape
Novartis Investigative Site, Cape Town, Western Cape, 7405, South Africa
Offene Rekrutierung
Novartis Investigative Site, Cape Town, Western Cape, 7500, South Africa
Offene Rekrutierung
Novartis Investigative Site, Stellenbosch, Western Cape, 7600, South Africa
Offene Rekrutierung
Gwangju
Novartis Investigative Site, Gwangju Gwangyeoksi, Gwangju, 61748, South Korea
Offene Rekrutierung
Novartis Investigative Site, Seoul, 04763, South Korea
Offene Rekrutierung
Novartis Investigative Site, Seoul, 06591, South Korea
Offene Rekrutierung
A Coruna
Novartis Investigative Site, Santiago Compostela, A Coruna, 15706, Spain
Offene Rekrutierung
Barcelona
Novartis Investigative Site, Badalona, Barcelona, 08916, Spain
Offene Rekrutierung
Cantabria
Novartis Investigative Site, Santander, Cantabria, 39008, Spain
Offene Rekrutierung
Catalonia
Novartis Investigative Site, Barcelona, Catalonia, 08003, Spain
Offene Rekrutierung
Madrid
Novartis Investigative Site, San Sebastian Reyes, Madrid, 28702, Spain
Offene Rekrutierung
Novartis Investigative Site, Barcelona, 08035, Spain
Offene Rekrutierung
Novartis Investigative Site, Madrid, 28034, Spain
Offene Rekrutierung
Novartis Investigative Site, Valencia, 46014, Spain
Offene Rekrutierung
Novartis Investigative Site, Kaohsiung City, 83301, Taiwan
Offene Rekrutierung
Novartis Investigative Site, Taichung, 40447, Taiwan
Offene Rekrutierung
Novartis Investigative Site, Taichung, 407219, Taiwan
Offene Rekrutierung
Novartis Investigative Site, Taipei, 11217, Taiwan
Offene Rekrutierung
Novartis Investigative Site, Taoyuan District, 33305, Taiwan
Offene Rekrutierung
Novartis Investigative Site, Bangkok, 10400, Thailand
Offene Rekrutierung
Novartis Investigative Site, Bangkok, 10700, Thailand
Offene Rekrutierung