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Phase 3 extension study to evaluate long-term safety of two regimens of ianalumab in participants with systemic lupus erythematosus (SIRIUS-SLE extension).
EU CTIS ID: 2023-505929-14-00
What this study is testing
To evaluate long-term safety and tolerability of ianalumab XXX mg administered XXX XXX or XXX in participants with active systemic lupus erythematosus (SLE)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 appropriate, are required before any assessment is performed for participants below18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
- Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
- In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.
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 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 (breastfeeding) 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).
- United States (and other countries, where male contraception is locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Australia
- Malaysia
- Turkey
- Mexico
- India
- China
- United States
- Japan
- Israel
- Argentina
- Taiwan
- Singapore
- United Kingdom
- Canada
- Korea, Republic of
- Colombia
- Guatemala
- Thailand
- South Africa
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Australia; Malaysia; Turkey; Mexico; India and 14 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 EU CTIS; the study team decides eligibility.