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)

Study Purpose

The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years and Over
Gender	All

More Inclusion & Exclusion 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 meeting the 2019 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.

Exclusion Criteria:

- 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). 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 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 at screening.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05639114
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Guatemala, Hungary, Israel, Japan, Poland, Portugal, Singapore, Slovakia, South Africa, Spain, Thailand, Turkey (Türkiye), United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus

Additional Details

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)

Arms & Interventions

Arms

Experimental: Ianalumab s.c. monthly

Ianalumab s.c. monthly

Experimental: Ianalumab s.c. quarterly

Ianalumab s.c. quarterly

Placebo Comparator: Placebo s.c. monthly

placebo s.c. monthly

Interventions

Drug: - Ianalumab

ianalumab s.c. monthly or quarterly

Drug: - Placebo

placebo s.c. monthly

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona, Tucson 5318313, Arizona 5551752

Status

Recruiting

Address

University of Arizona

Tucson 5318313, Arizona 5551752, 85724

Site Contact

Fernanda Camargo

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