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)
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).
Condition
- Systemic Lupus Erythematosus
Eligibility
- Eligible Ages
- Between 12 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The trial is designed to 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).
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Providence Medical Center
Burbank, California 91505
Burbank, California 91505
University of California San Diego
La Jolla, California 92093
La Jolla, California 92093
Contact:
+1 858 657 7040
+1 858 657 7040
Keck School of Medicine
Los Angeles, California 90033
Los Angeles, California 90033
Millennium Clinical Trials
Westlake Village, California 91361
Westlake Village, California 91361
Yale University School Of Medicine
New Haven, Connecticut 06520
New Haven, Connecticut 06520
Clinical Res Of W Florida
Clearwater, Florida 33765
Clearwater, Florida 33765
GNP Research
Hollywood, Florida 33024
Hollywood, Florida 33024
Clinical Research of West Florida Inc
Tampa, Florida 33603
Tampa, Florida 33603
Parris and Associates Rheumatology
Lawrenceville, Georgia 30044
Lawrenceville, Georgia 30044
Contact:
+17709621616#8334
+17709621616#8334
Robert A Hozman MD SC
Skokie, Illinois 60076
Skokie, Illinois 60076
Lake Cumberland Rheumatology and In
New Albany, Indiana 47150
New Albany, Indiana 47150
Ochsner Clinic Foundation
Baton Rouge, Louisiana 70836
Baton Rouge, Louisiana 70836
Henry Ford Health
Detroit, Michigan 48202
Detroit, Michigan 48202
Univ of Nevada School of Med
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Sahni Rheumatology and Therapy
West Long Branch, New Jersey 07764
West Long Branch, New Jersey 07764
Medical Center Main Campus
Cleveland, Ohio 44109
Cleveland, Ohio 44109
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio 44130
Middleburg Heights, Ohio 44130
Prisma Health
Columbia, South Carolina 29203
Columbia, South Carolina 29203
Accurate Clinical Research Research
Baytown, Texas 77521
Baytown, Texas 77521
Texas Arthritis Center
El Paso, Texas 79902
El Paso, Texas 79902
Epic Medical Research
Red Oak, Texas 75154
Red Oak, Texas 75154
More Details
- NCT ID
- NCT05639114
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
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)