BridgeMD
Phase 3 study to evaluate ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2)
EU CTIS ID: 2023-508499-12-00
What this study is testing
To demonstrate superiority of xxx ianalumab XXX mg xxx XXX, compared to placebo, in achieving Systemic Lupus Erythematosus Responder Index (SRI-4) at Week 60
- 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
- Male and Female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed.
- Diagnosis of systemic lupus erythematosus (SLE) meeting the EULAR/ACR SLE classification criteria at least 6 months prior to screening
- Elevated serum titers at screening of Antinuclear Antibodies (≥1:80) as determined by a central laboratory with a SLE typical fluorescence pattern.
- Currently receiving corticosteroids and/or anti-malarial treatment and/or another Disease-modifying antirheumatic drug (DMARD) as specified in the protocol.
- SLEDAI-2K Criteria at screening: SLEDAI-2K score ≥6 points, excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome" British Isles Lupus Assessment Group-2004 disease activity level at screening of at least 1 of the following: British Isles Lupus Assessment Group-2004 level A disease in ≥1 organ system, Or British Isles Lupus Assessment Group-2004 level B disease in ≥2 organ systems
- Weigh at least 35 kg at screening
You likely can't join if
- Prior treatment with Ianalumab
- Receipt of live/attenuated vaccine within a 4-week period before first dosing
- Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms
- Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CS
- History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer
- Pregnant or nursing (lactating) women.
See the full eligibility criteria
Who can join
- Male and Female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed.
- Diagnosis of systemic lupus erythematosus (SLE) meeting the EULAR/ACR SLE classification criteria at least 6 months prior to screening
- Elevated serum titers at screening of Antinuclear Antibodies (≥1:80) as determined by a central laboratory with a SLE typical fluorescence pattern.
- Currently receiving corticosteroids and/or anti-malarial treatment and/or another Disease-modifying antirheumatic drug (DMARD) as specified in the protocol.
- SLEDAI-2K Criteria at screening: SLEDAI-2K score ≥6 points, excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome" British Isles Lupus Assessment Group-2004 disease activity level at screening of at least 1 of the following: British Isles Lupus Assessment Group-2004 level A disease in ≥1 organ system, Or British Isles Lupus Assessment Group-2004 level B disease in ≥2 organ systems
- Weigh at least 35 kg at screening
What rules you out
- Prior treatment with Ianalumab
- Receipt of live/attenuated vaccine within a 4-week period before first dosing
- Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms
- Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CS
- History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer
- Pregnant or nursing (lactating) women.
- History of receiving following treatment I) high dose corticosteroids, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) 12 weeks prior to screening II) Cyclophosphamide or biologics such as immunoglobulins (i.v. or XXX), plasmapheresis, anti-type I interferon receptor biologic agents, anti- CD40 agents, CTLA4-Fc Ig or B-cell activating factor-targeting agents administered within 24 weeks prior to screening; belimumab administered within 12 weeks prior to screening. III) Any B-cell depleting therapies, other than ianalumab administered within 36 weeks prior to randomization or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower) IV) Traditional Chinese medicines administered within 30 days prior to randomization
- Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection
- Chronic infection with hepatitis B (HBV) or hepatitis C (HCV)
- Evidence of active tuberculosis infection
- History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening
- Any one of the following laboratory values prior to randomization: Platelets <25000/mm^3 (<25 x 10^3/μL) Hemoglobin (Hgb) <8.0 g/dL (<5 mmol/L), or <7.0 g/dL (<4.3 mmol/L) if related to participant's SLE such as in active hemolytic anemia Absolute neutrophil count (ANC) (<0.8 x 10^3/ μL)
- Severe organ dysfunction or life-threatening disease at screening
- Presence of severe lupus kidney disease as defined by proteinuria above 2g/day or equivalent using spot urine protein creatinine ratio
- XXX
- Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Australia
- Colombia
- Chile
- Argentina
- Korea, Republic of
- Mexico
- United Kingdom
- India
- United States
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, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Australia; Colombia; Chile; Argentina; Korea, Republic of and 4 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.