Ireland
--:--IST
Recruiting Phase 3

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

NCT06133972 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2024-05-21
Last updated
2026-10-13

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

PlaceboIanalumab →

Placebo: Placebo s.c. monthly

Ianalumab: Ianalumab s.c. monthly Ianalumab s.c. quarterly

Study summary

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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
100 Years
Healthy volunteers
No
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. Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

  • Number of treatment-emergent Adverse events/Serious Adverse events — through study completion, up to approximately 324 weeks
    Assessment of long-term safety and tolerability of ianalumab

Trial sites (164)

FacilityCityRegionStatus
Pinnacle Research Group Llc Anniston Alabama Recruiting
Providence Medical Center Burbank California Recruiting
Advanced Medical Research La Palma California Recruiting
Millennium Clinical Trials Westlake Village California Active Not Recruiting
University of Colorado Denver Aurora Colorado Recruiting
Clinical Res Of W Florida Clearwater Florida Recruiting
GNP Research Cooper City Florida Recruiting
Homestead Assoc In Research Inc Homestead Florida Recruiting
IRIS Research and Development Plantation Florida Recruiting
Clinical Research of West Florida Inc Tampa Florida Recruiting
Parris and Associates Rheumatology Lawrenceville Georgia Recruiting
Robert A Hozman MD SC Skokie Illinois Completed
Willow Rheumatology Wellness Willowbrook Illinois Recruiting
Accurate Clinical Research Lake Charles Louisiana Recruiting
UMC New Orleans New Orleans Louisiana Active Not Recruiting
University Of Maryland Baltimore Maryland Active Not Recruiting
Henry Ford Health Detroit Michigan Recruiting
Ahmed Arif Medical Research Center Grand Blanc Michigan Recruiting
Paramount Med Rsrch and Consult LLC Middleburg Heights Ohio Recruiting
University Of Pittsburgh Pittsburgh Pennsylvania Recruiting
West Tennessee Research Institute Jackson Tennessee Recruiting
Shelby Research LLC Memphis Tennessee Recruiting
Novel Research LLC Bellaire Texas Recruiting
Accurate Clinical Research League City Texas Recruiting
Epic Medical Research Red Oak Texas Recruiting
Novartis Investigative Site La Plata Buenos Aires Recruiting
Novartis Investigative Site Quilmes Buenos Aires Recruiting
Novartis Investigative Site San Miguel Buenos Aires Active Not Recruiting
Novartis Investigative Site San Miguel Tucumán Province Active Not Recruiting
Novartis Investigative Site Caba Argentina Active Not Recruiting
Novartis Investigative Site Caba Argentina Recruiting
Novartis Investigative Site San Miguel de Tucumán Argentina Active Not Recruiting
Novartis Investigative Site Maroochydore Queensland Recruiting
Novartis Investigative Site Vitória Espírito Santo Recruiting
Novartis Investigative Site Salvador Estado de Bahia Recruiting
Novartis Investigative Site Belo Horizonte Minas Gerais Active Not Recruiting
Novartis Investigative Site Niterói Rio de Janeiro Active Not Recruiting
Novartis Investigative Site Rio de Janeiro Rio de Janeiro Recruiting
Novartis Investigative Site Barretos São Paulo Recruiting
Novartis Investigative Site São Paulo São Paulo Active Not Recruiting

+ 124 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06133972 on ClinicalTrials.gov ↗ ← All trials in Japan