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Ianalumab for Lupus (SIRIUS-SLE 1 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36 to week 60
Awards & highlights
Pivotal Trial
Summary
This trial tests if two new treatments for systemic lupus erythematosus (SLE) are safe, effective & tolerable when given as monthly or quarterly injections.
Who is the study for?
Adults and children aged 12+ (18+ in some regions) diagnosed with systemic lupus erythematosus for at least 6 months, meeting specific disease activity criteria. Participants must weigh over 35 kg and be on stable lupus medications. Excluded are those with certain other health conditions, women who could get pregnant not using effective contraception, recent recipients of live vaccines or certain treatments, and individuals with severe organ dysfunction or infections.
What is being tested?
The trial is testing the effectiveness of Ianalumab against a placebo when given monthly or quarterly as an injection alongside standard lupus treatments. It aims to see if Ianalumab can better control lupus symptoms compared to the usual treatment alone.
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infections due to immune system alteration by Ianalumab, possible blood disorders, fatigue, and possibly other unknown risks that often come with new immunomodulating drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 36 to week 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36 to week 60
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants on monthly ianalumab achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
Secondary study objectives
Ianalumab concentration in serum during the treatment and follow-up
Number of participants with adverse events
Proportion of participants on monthly or quarterly ianalumab achieving BILAG-based Composite Lupus Assessment (BICLA)
+10 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 s.c. quarterlyExperimental Treatment1 Intervention
Ianalumab s.c. quarterly
Group II: Ianalumab s.c. monthlyExperimental Treatment1 Intervention
Ianalumab s.c. monthly
Group III: Placebo s.c. monthlyPlacebo Group1 Intervention
placebo s.c. monthly
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,297 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood test shows high levels of specific antibodies related to an autoimmune condition.I am 12 years or older, or 18 and older in certain countries.I don't have any serious health issues that could affect my participation.I have severe lupus affecting at least one organ.I have had specific treatments within certain time frames before screening.I have not received a live vaccine in the last 4 weeks.I do not have any health issues that could affect my participation in the study.I have a chronic hepatitis B or C infection.I am currently receiving IV or IM treatment for a serious infection.My lupus affects at least two organ systems moderately.I have conditions like asthma or gout needing ongoing steroid treatment.I am currently on treatment for arthritis with specific drugs.I have been treated with ianalumab before.I have had cancer before, but it was not skin cancer or cervical cancer that stayed in one place.I weigh at least 35 kg.My lupus has caused severe kidney problems.I have an active tuberculosis infection.I was diagnosed with lupus at least 6 months ago, according to EULAR/ACR criteria.I was diagnosed with lupus at least 6 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Ianalumab s.c. monthly
- Group 2: Ianalumab s.c. quarterly
- Group 3: Placebo s.c. monthly
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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