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Monoclonal Antibodies
Ianalumab + Standard Therapy for Lupus Nephritis (SIRIUS-LN 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
Adult male and female participants aged 18 years or older at the time of screening
Weigh at least 35 kg at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 72
Awards & highlights
SIRIUS-LN Trial Summary
This trial will compare how well two different doses of ianalumab work in combination with standard of care (SoC) to treat active lupus nephritis (LN), as well as how safe and tolerable the doses are.
Who is the study for?
Adults with active Lupus Nephritis (LN) who have started or are willing to start standard treatment, including high-dose corticosteroids and MPA. They must weigh at least 35 kg, have a positive ANA test, and meet specific criteria for active LN. Excluded are those with severe kidney damage, recent heavy steroid use, certain infections or immunodeficiencies, cancer history within 5 years, or women who could become pregnant not using effective contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Ianalumab administered under the skin every 4 weeks or every 12 weeks versus a placebo. All treatments will be given in combination with standard-of-care therapy for LN. The goal is to see how well Ianalumab works and how safe it is compared to just receiving the usual treatment without this additional drug.See study design
What are the potential side effects?
While specific side effects of Ianalumab aren't listed here, similar medications can cause injection site reactions, increased risk of infections due to immune system suppression, possible allergic reactions if there's a sensitivity to ingredients in the medication as well as general symptoms like fatigue and nausea.
SIRIUS-LN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I weigh at least 35 kg.
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I am willing to switch from azathioprine to MPA before the study starts.
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I have been diagnosed with SLE according to EULAR/ACR criteria.
SIRIUS-LN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 72
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 72
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and percentage of participants achieving stable Complete Renal Response (CRR)
Secondary outcome measures
Change in British Isles Lupus Activity Group (BILAG) score
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score
Ianalumab concentration in serum
+6 moreSIRIUS-LN Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 2 - ianalumab s.c. q12wExperimental Treatment1 Intervention
ianalumab s.c. q12w in addition to SoC
Group II: Arm 1 - ianalumab s.c. q4wExperimental Treatment1 Intervention
ianalumab s.c. q4w in addition to standard of care (SoC)
Group III: Arm 3 - placebo s.c. q4wPlacebo Group1 Intervention
Placebo s.c. q4w in addition to SoC
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,197,824 Total Patients Enrolled
7 Trials studying Lupus Nephritis
771 Patients Enrolled for Lupus Nephritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I agree to use barrier protection during sex while on the study treatment.I have had cancer in any part of my body in the last 5 years.I have an active TB infection.I have severe kidney problems.I am using effective birth control and will continue for 6 months after my treatment ends.You have a positive anti-nuclear antibody (ANA) test result with a certain level of ANA in your blood.I weigh at least 35 kg.I am newly diagnosed or previously treated for LN and open to starting standard treatment with MPA.I am on a stable dose of anti-malarial medication with no contraindications.I have not received more than 3000 mg of IV pulse steroids in the last 3 months.I am willing to switch from azathioprine to MPA before the study starts.I have not received a live vaccine in the last 4 weeks.I have been diagnosed with SLE according to EULAR/ACR criteria.I started treatment with high dose steroids and MPA before or on the day I joined the study.I have had or am scheduled for a major organ or bone marrow transplant.Your lab test results are not within the normal range.I've received a strong steroid treatment for my kidney inflammation within the last 2 months.I do not have any current infections needing treatment or a history of serious infections.You have a history of a weak immune system, including testing positive for HIV.I have a chronic hepatitis B or C infection.I have not used certain medications within the restricted time.More than half of the kidney samples show scarring.You have active lymph nodes at the time of screening.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2 - ianalumab s.c. q12w
- Group 2: Arm 1 - ianalumab s.c. q4w
- Group 3: Arm 3 - placebo s.c. q4w
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 similar ongoing or completed experiments to ianalumab s.c. q12w?
"As of right now, there are seven ongoing clinical trials researching ianalumab s.c. q12w with two phase three trials underway. The majority of these research studies are based in Aachen, Michigan; however, there are a total of 152 locations running trials for this treatment across the globe."
Answered by AI
Has this medical experiment been attempted before?
"Novartis Pharmaceuticals sponsored the initial study for ianalumab s.c. q12w in 2018, which completed its Phase 2 & 3 drug approval stage that year. This involved 65 patients across 28 countries and 65 cities. Since then, 4 more studies have been conducted."
Answered by AI
How many subjects are required for this research project?
"That is correct, the online clinicaltrial.gov registry shows that this study is open and recruiting patients. The trial was first announced on July 14th, 2020 with the most recent update being October 14th, 2020. The aim is to recruit 420 individuals from a single location."
Answered by AI
Does the FDA endorse ianalumab s.c. q12w treatments?
"ianalumab s.c. q12w is estimated to be a 3 on Power's safety scale because it is Phase 3, which means that efficacy has been supported by some data and multiple rounds support safety."
Answered by AI
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