Systemic Lupus Erythematosus study: Ianalumab
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 (VAY736)?
An investigational once‑monthly or once‑quarterly injectable medicine being studied 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 study aims to see how safe and tolerable ianalumab is over a long period.
- Who it's for
- People with systemic lupus erythematosus who have already completed one of the two core SIRIUS‑SLE studies.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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.
- 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. Other protocol-defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Anniston, Alabama, United States
- Burbank, California, United States
- La Palma, California, United States
- Aurora, Colorado, United States
- Clearwater, Florida, United States
- Cooper City, Florida, United States
- Homestead, Florida, United States
- Plantation, Florida, United States
- Tampa, Florida, United States
- Lawrenceville, Georgia, United States
- Willowbrook, Illinois, United States
- Lake Charles, Louisiana, United States
- Detroit, Michigan, United States
- Grand Blanc, Michigan, United States
- Middleburg Heights, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Jackson, Tennessee, United States
- Memphis, Tennessee, United States
- Bellaire, Texas, United States
- League City, Texas, United States
+ 97 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, but 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?
This study is enrolling now at Anniston, Alabama, United States; Burbank, California, United States; La Palma, California, United States; Aurora, Colorado, United States; Clearwater, Florida, United States; Cooper City, Florida, United States and 111 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.