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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Pinnacle Research Group Llc, Anniston, Alabama, United States
• Providence Medical Center, Burbank, California, United States
• Advanced Medical Research, La Palma, California, United States
• Millennium Clinical Trials, Westlake Village, California, United States
• University of Colorado Denver, Aurora, Colorado, United States
• Clinical Res Of W Florida, Clearwater, Florida, United States
• GNP Research, Cooper City, Florida, United States
• IRIS Research and Development, Plantation, Florida, United States
• Clinical Research of West Florida Inc, Tampa, Florida, United States
• Parris and Associates Rheumatology, Lawrenceville, Georgia, United States
• Robert A Hozman MD SC, Skokie, Illinois, United States
• Willow Rheumatology Wellness, Willowbrook, Illinois, United States

+ 131 more sites.

Who to contact

Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06133972.