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Tests treatment safety and results for Systemic Lupus Erythematosus
Official title Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
ClinicalTrials.gov ID: NCT06133972
What this study is testing
What is Ianalumab?
Ianalumab is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as VAY736.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 100
You may be able to join if
- Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if...
- Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the...
- In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment. Key
You likely can't join if
- Use of prohibited therapies.
- Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the...
- Plans for administration of live vaccines during the study period.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective...
- United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with...
The study team makes the final eligibility decision.
Where it's taking place
- Anniston, Alabama, United States
- Burbank, California, United States
- La Palma, California, United States
- Westlake Village, California, United States
- Aurora, Colorado, United States
- Clearwater, Florida, United States
- Cooper City, Florida, United States
- Plantation, Florida, United States
- Tampa, Florida, United States
- Lawrenceville, Georgia, United States
- Skokie, Illinois, United States
- Willowbrook, Illinois, United States
- Lake Charles, Louisiana, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- Grand Blanc, Michigan, United States
- Middleburg Heights, Ohio, United States
- Jackson, Tennessee, United States
- Memphis, Tennessee, United States
- Bellaire, Texas, United States
+ 109 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anniston, Alabama, United States; Burbank, California, United States; La Palma, California, United States; Westlake Village, California, United States; Aurora, Colorado, United States; Clearwater, Florida, United States and 123 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.