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Ianalumab for Lupus (SIRIUS-SLE 2 Trial)
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.
SIRIUS-SLE 2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SIRIUS-SLE 2 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: placebo s.c. monthly
- Group 2: ianalumab s.c. monthly
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
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."
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."
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."
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."
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