A randomized, double-blind, placebo-controlled extension study to assess the long-term safety and tolerability of ianalumab in patients with systemic lupus erythematosus (SIRIUS-SLE extension)
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 550
- Locations
- 12
- Primary Endpoint
- What adverse events do participants have during the trial?
Study Overview
Brief Summary
The purpose of this trial is to learn if continued treatment with the trial drug VAY736 (ianalumab) can help adolescent and adult patients with systemic lupus erythematosus (also called SLE). This is an extension study offered to participants who have completed the treatment period in one of the SIRIUS-SLE core trials (CVAY736F12301/CVAY736F12302).
Ianalumab belongs to a class of drugs called monoclonal antibodies which are able to recognize and stick to specific proteins on specific cells. By attaching to a protein on B cells, ianalumab causes the elimination of the B cell. B cells are a group of white blood cells which play a role in the development of SLE. By removing such B cells, ianalumab may be able to improve SLE disease activity.
This trial is designed to find out if longer treatment with ianalumab improves participants’ lupus symptoms over time, and if it does better than the standard of care (SoC) treatment. This trial is also designed to learn more about the safety of ianalumab.
A treatment duration of three years in this extension study will allow for an overall assessment of four-year safety and efficacy data when taking into account the data from the two SIRIUS-SLE core studies (SIRIUS-SLE 1 and SIRIUS-SLE 2). This is to learn more about how ianalumab affects patient’s well-being and how effective is ianalumab in reducing SLE disease activity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults and adolescents (where allowed) aged 12 years or older who are diagnosed with SLE and had previously completed the treatment period in one of the SIRIUS-SLE core studies without treatment discontinuation.
Exclusion Criteria
- •Use of prohibited therapies.
- •Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
- •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 methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
Outcomes
Primary Outcomes
What adverse events do participants have during the trial?
Time Frame: What adverse events do participants have during the trial?
Secondary Outcomes
- What is the long-term effect of ianalumab on disease activity?
- What is the long-term effect of ianalumab on organ damage?(Every 20 weeks from week 84 until week 180)
Investigators
Murugananthan K
Novartis Healthcare Private Limited