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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

SIRIUS-SLE 1 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.Check my eligibility
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.See study design
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.

SIRIUS-SLE 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36 to week 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 to week 60 for reporting.

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 on monthly ianalumab achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
Secondary outcome measures
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 more

SIRIUS-SLE 1 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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,860 Previous Clinical Trials
4,197,903 Total Patients Enrolled

Media Library

Ianalumab s.c. monthly Clinical Trial Eligibility Overview. Trial Name: NCT05639114 — Phase 3
Lupus Research Study Groups: Ianalumab s.c. monthly, Ianalumab s.c. quarterly, Placebo s.c. monthly
Lupus Clinical Trial 2023: Ianalumab s.c. monthly Highlights & Side Effects. Trial Name: NCT05639114 — Phase 3
Ianalumab s.c. monthly 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639114 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many settings are being utilized to conduct this clinical trial?

"This medical trial currently has 10 different sites, located in the cities of Chengdu, Beijing and Wuhan. To make it more convenient for participants to join this study, we suggest selecting one of the nearby clinics."

Answered by AI

Is enrollment for this experiment currently available to the public?

"The data from clinicaltrials.gov confirms that recruitment for this trial is ongoing, having been initially posted on March 2nd 2023 and most recently revised on the 28th of same month."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to Ianalumab s.c. administered on a quarterly basis?

"Our team determined that ianalumab s.c. quarterly has a safety rating of 3 due to the numerous rounds of clinical testing confirming both efficacy and safety."

Answered by AI

How many participants can this clinical trial feasibly accept?

"Affirmative, based on the information provided by clinicaltrials.gov it appears that this medical trial is still accepting patients. The study was initially posted on March 2nd 2023 and most recently updated 28 days later. 406 individuals are needed to be enrolled at 10 different sites for this research endeavour."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Epic Medical Research
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
2023. "Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639114.
All > Systemic Lupus Erythematosus > Lupus
~271 spots leftby Jan 2027
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