Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 100
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
550 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for people with systemic lupus erythematosus who have completed a previous study using ianalumab. Participants will be monitored for long-term safety and tolerance of the treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have signed an informed consent form to participate.
I completed the treatment period in one of the previous SIRIUS-SLE studies.
I am expected to benefit from continued treatment as judged by the doctor.
You may not be able to join if
I am using any prohibited therapies.
I have an active serious infection that needs intravenous treatment.
I plan to have live vaccines during this study.
I am pregnant or nursing.
I am a woman who can get pregnant and I cannot or refuse to use effective contraception.
I am a sexually active male and I do not agree to use barrier protection during sex.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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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 rea…
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.
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