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Monoclonal Antibodies
Ianalumab for Lupus (SIRIUS-SLE 2 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
SIRIUS-SLE 2 Trial Summary
This trial will test a new drug to treat lupus, given as monthly injections, to see if it is safe, effective, and tolerable.
Who is the study for?
This trial is for people aged 12+ (or 18+ in certain countries) with active systemic lupus erythematosus diagnosed at least 6 months ago. They must have specific antibodies, be on current treatments like steroids or DMARDs, and meet disease activity criteria. Exclusions include prior ianalumab use, recent other treatments, infections including hepatitis and HIV, severe organ dysfunction or life-threatening diseases.Check my eligibility
What is being tested?
The study tests the effectiveness of Ianalumab versus a placebo when given monthly as an injection alongside standard lupus care. It aims to see if Ianalumab can better manage symptoms compared to usual treatment alone.See study design
What are the potential side effects?
While not specified here, potential side effects may include reactions at the injection site, increased risk of infection due to immune system alteration by Ianalumab, and any common side effects associated with medications that modulate the immune system.
SIRIUS-SLE 2 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
Secondary outcome measures
Ianalumab concentration in serum during the treatment and follow-up
Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time
Proportion of participants achieving BILAG-based Composite Lupus Assessment (BICLA)
+8 moreSIRIUS-SLE 2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ianalumab s.c. monthlyExperimental Treatment1 Intervention
ianalumab s.c. monthly
Group II: placebo s.c. monthlyPlacebo Group1 Intervention
placebo s.c. monthly
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,860 Previous Clinical Trials
4,198,029 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health issues that could affect my participation in the study.I have an active tuberculosis infection.I have not received a live vaccine in the last 4 weeks.I have been treated with ianalumab before.I am on steroids for a condition other than lupus.I do not have any serious health conditions that could affect my participation.I do not have severe organ problems or a life-threatening condition.I weigh at least 35 kg.I have had specific treatments within certain time frames before screening.I was diagnosed with lupus at least 6 months ago, according to EULAR/ACR criteria.I have had cancer in the past, but it was not skin cancer or cervical cancer that stayed in one place.I am a woman who can have children and am not using effective birth control.I am at least 12 years old, or 18 in certain countries.My blood test shows high levels of specific antibodies.I am currently on treatment for rheumatism as outlined in the study.My lupus is active in at least one major or two minor organ systems.I have a chronic hepatitis B or C infection.I have severe kidney problems due to lupus.I do not have any active infections requiring strong antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: placebo s.c. monthly
- Group 2: ianalumab 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any vacancies in this clinical trial?
"Affirmative. Clinicaltrials.gov attests that the clinical trial, published on April 21st 2023, is still in search of participants. 280 patients need to be recruited from 8 distinct medical facilities."
Answered by AI
How many healthcare centers in North America are conducting this clinical experiment?
"The current study is being conducted at 8 different sites, spanning from Jackson to Maroochydore. To reduce the need for travel, it is best to select a clinic close by should you choose to participate in this trial."
Answered by AI
Has the FDA sanctioned ianalumab s.c. monthly as an effective treatment?
"Our assessment team at Power scored ianalumab s.c monthly with a 3 out of 3, as it has been tested extensively in clinical trials and there is significant evidence demonstrating its safety."
Answered by AI
What is the aggregate enrollment rate of this clinical trial?
"Affirmative. The details hosted on clinicaltrials.gov reveals that this experiment, which was initially published on April 21st 2023, is actively accepting volunteers. Presently there are 8 trial sites looking to enlist 280 participants in total."
Answered by AI
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