Last updated 32 days ago

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

406 patients around the world

Available in Guatemala, Spain, United States, Brazil

A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)

Novartis Pharmaceuticals

406Patients around the world

This study is for people with

Lupus

Systemic lupus erythematosus

Requirements for the patient

From 12 Years

All Gender

Medical requirements

: 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 according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria at least 6 months prior to screening.
Elevated serum titers at screening of anti-nuclear antibodies ≥ 1:80 as determined by a central laboratory with a SLE-typical fluorescence pattern.
Currently receiving CS 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"
BILAG-2004 disease activity level at screening of at least 1 of the following:
BILAG-2004 level 'A' disease in ≥ 1 organ system, Or
BILAG-2004 level 'B' disease in ≥ 2 organ systems
Weigh at least 35 kg at screening

: Prior treatment with ianalumab
History of receiving following treatment I) high dose CS, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) administered within 12 weeks prior to screening II) cyclophosphamide or biologics such as immunoglobulins (intravenous or s.c.), plasmapheresis, anti-type I interferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cell activating factor (BAFF)-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 virus (HBV) or hepatitis C virus (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 abnormal 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 anaemia
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 2 g/day or equivalent using spot urine protein creatinine ratio, or serum creatinine greater than 2.0 mg/dL (176.84 µmol/L), or requiring immune-suppressive induction or maintenance treatment exceeding protocol-defined limits prior to randomization
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.
Women of child-bearing potential (WOCBP), 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.
Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study

StudySIRIUS-SLE 1

SponsorNovartis Pharmaceuticals

Conditions

Systemic lupus erythematosus

Requirements

From 12 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05639114