Checks long-term safety of ianalumab in people with lupus
Tests ianalumab against placebo for long-term safety in people with lupus.
Plain-language title generated from the registry record
Registry title: Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Key facts
- Where
- Badalona, Barcelona, Elche, La Laguna, Madrid, Pamplona, San Sebastián de los Reyes, Santander, Santiago de Compostela, Valencia, Valladolid, Vigo, and Vitoria, SpainSee the 14 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 100 years old?
Source: NCT06133972, who can take part
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainTaking people
- Hospital del MarBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital General Universitario de ElcheElche, SpainTaking people
- Hospital Universitario De CanariasLa Laguna, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Hospital Universitario Infanta SofiaSan Sebastián de los Reyes, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- Hospital General Universitario de ValenciaValencia, SpainTaking people
- Hospital Universitario Rio HortegaValladolid, SpainTaking people
- Complexo Hospitalario Universitario De VigoVigo, SpainTaking people
- Hospital Universitario ArabaVitoria, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06133972EU 2023-505929-14-00
- Record updated
- 9 November 2026
- Original description
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).Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)
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).
Inclusion: 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.
Exclusion: Use of prohibited therapies; Plans for administration of live vaccines during the study period; 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; Pregnant or nursing (lactating) women; Other protocol-defined inclusion/exclusion criteria may apply.