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Ianalumab for Lupus (SIRIUS-SLE LTE Trial)
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Must not have
Women of child-bearing potential who refuse or are unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping the study drug (or longer if required by concomitant medications)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to approximately 91 months
Awards & highlights
Pivotal Trial
Summary
"This trial aims to assess the safety and tolerability of ianalumab over a long period in individuals with lupus who have finished treatment in one of two previous studies."
Who is the study for?
This trial is for people with systemic lupus erythematosus who finished a previous SIRIUS-SLE study without stopping treatment. They must consent to participate and, if under 18, have guardian consent plus their own assent. Participants should be expected to benefit from continued treatment.
What is being tested?
The trial is testing the long-term safety of Ianalumab in individuals with lupus who completed prior SIRIUS-SLE studies. It compares ongoing Ianalumab use against a placebo to see how well patients tolerate it over an extended period.
What are the potential side effects?
While specific side effects are not listed here, generally, drugs like Ianalumab may cause immune system changes leading to infections or allergic reactions and could affect blood counts or liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I completed one of the SIRIUS-SLE studies without stopping the treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am a woman able to have children and agree to use effective birth control during and 6 months after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to approximately 91 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to approximately 91 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of treatment-emergent Adverse events/Serious Adverse events
Secondary study objectives
Annualized BILAG moderate or severe flare rate
Average daily dose of oral corticosteroids administered
Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ianalumab quarterlyExperimental Treatment1 Intervention
Ianalumab s.c. quarterly
Group II: Ianalumab monthlyExperimental Treatment1 Intervention
Ianalumab s.c. monthly
Group III: Placebo monthlyPlacebo Group1 Intervention
Placebo s.c. monthly
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,919 Previous Clinical Trials
4,253,957 Total Patients Enrolled