Study 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). 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.
Interventions
Ianalumab
Placebo
Eligibility Criteria
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.
Worldwide Contacts
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