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RECRUITINGPhase 3INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Key Who May Qualify: - Signed willing to sign a consent form prior to participation in the extension study. Parent or legal guardian's signed willing to sign a consent form 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. * 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.

Treatments Being Tested

DRUG

Placebo

Placebo s.c. monthly

DRUG

Ianalumab

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

Locations (20)

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
Parris and Associates Rheumatology
Lawrenceville, Georgia, United States
Robert A Hozman MD SC
Skokie, Illinois, United States
Willow Rheumatology Wellness
Willowbrook, Illinois, United States
Accurate Clinical Research
Lake Charles, Louisiana, United States
University Of Maryland
Baltimore, Maryland, United States
Henry Ford Health
Detroit, Michigan, United States
Ahmed Arif Medical Research Center
Grand Blanc, Michigan, United States
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Shelby Research LLC
Memphis, Tennessee, United States
Novel Research LLC
Bellaire, Texas, United States
Accurate Clinical Research
League City, Texas, United States