Systemic Lupus Erythematosus MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) according to 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 Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 326 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Prior treatment with Ianalumab 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 s.c.), 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) Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization or history of recurrent 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/Lg), 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 History of major organ, hematopoietic stem cell or bone marrow transplant Presence of severe lupus kidney disease as defined by proteinuria above 2g/day or equivalent using spot urine protein creatinine ratio 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 History of hypersensitivity to drugs of similar class or oral CS or to any of the constituents of the study drugs (sucrose, L-histidine hydrochloride, L-histidine, polysorbate 20) History of non-compliance with medical regiments or considered potentially unreliable Use of other investigational drugs within 5 half lives of enrollment or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer, or longer if required by local regulations Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic corticosteroids 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. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational drug. US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse while taking study treatment Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of subcutaneous (s.c.) ianalumab 300 mg monthly, compared to placebo, in achieving Systemic Lupus Erythematosus Responder Index (SRI-4) at Week 60;Secondary Objective: To demonstrate superiority of s.c. ianalumab 300 mg monthly compared to placebo in: Reducing moderate or severe British Isles Lupus Assessment Group flares up to Week(Wk) 60; Maintaining corticosteroid dose =5 mg/day or =baseline dose, whichever is lower, b/w Wk 36 & Wk 60; Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Wk 60; Achieving Lupus Low Disease Activity State at Wk 60; Time to first occurrence of SRI-4 from baseline up to Wk 60; Achieving SRI-4 at Wk 60 while maintaining reduced corticosteroid dose =5 mg/day or =baseline dose, whichever is lower, b/w Wk 36 & Wk 60; Achieving SRI-6 at Wk 60; Maintaining corticosteroid dose =5mg/day or =baseline dose, whichever is lower, b/w Wk 24 & Wk 60 To demonstrate superiority of ianalumab 300 mg s.c. quarterly compared to placebo for SRI-4 & secondary objectives listed above To evaluate: safety & tolerability, immunogenicity& characterize the PK of ianalumab 300 mg s.c (monthly or quarterly);Primary end point(s): Proportion of participants achieving SRI-4 at Week 60;Timepoint(s) of evaluation of this end point: Week 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of participants with no moderate or severe British Isles Lupus Assessment Group flare up to Week 60 2. Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne =5 mg/day or =baseline dose, whichever is lower. 3. Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Week 60 4. Proportion of participants achieving Lupus Low Disease Activity State at Week 60 5. Time to first occurrence of SRI-4 from baseline to Week 60 6. Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced corticosteroiddose of predniso(lo)ne =5 mg/day or =baseline dose, whichever is lower 7. Proportion of participants achieving SRI-6 at Week 60 8. Proportion of participants maintaining between Week 24 and Week 60 a reduced corticosteroid dose of predniso(lo)ne =5 mg/day, or =baseline dose, whichever is lower Proportion of participants with Adverse Events and Serious Adverse Events Clinical laboratory measurements Vital signs Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time Ianalumab concentration in serum during the treatment and follow-up (up to the end of study);Timepoint(s) of evaluation of this end point: 1,3,4,6,7 - Week 60 2 - Between Week 36 and Week 60 5 - from baseline to Week 60 8 - Between Week 24 and Week 60 | — |
Countries
Brazil, Bulgaria, Canada, China, Czechia, Czech Republic, Guatemala, Hungary, Israel, Japan, Poland, Portugal, Slovakia, South Africa, Spain, Thailand, Turkey, United States
Contacts
Public ContactDRA information desk
Novartis Slovakia s.r.o.
Outcome results
None listed