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Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

PHASE3RECRUITING

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

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Study details:

A randomized, double-blind, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-04-21

Primary completion: 2027-01-26

Study completion finish: 2029-01-23

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05624749

Intervention or treatment

DRUG: ianalumab

DRUG: placebo

Conditions

• Systemic Lupus Erythematosus

Image related to Systemic Lupus Erythematosus

Condition: Systemic Lupus Erythematosus
DRUG: ianalumab and other drugs
Maroochydore, Queensland, Australia
Sponsor: Novartis Pharmaceuticals

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Find a site

Closest Location:

Novartis Investigative Site

Research sites nearby

Select from list below to view details:

Novartis Investigative Site
Maroochydore, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ianalumab s.c. monthly ianalumab s.c. monthly	DRUG: ianalumab ianalumab s.c. monthly
PLACEBO_COMPARATOR: placebo s.c. monthly placebo s.c. monthly	DRUG: placebo placebo s.c. monthly

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)	SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale	Week 60

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of participants with no moderate or severe BILAG flare	Moderate BILAG flare is defined as 2 or more new BILAG-2004 B items compared to the previous visit; severe BILAG flare is defined as 1 or more new BILAG-2004 A items compared to the previous visit	Baseline to Week 60
Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid (CS) dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower	Maintaining reduced CS dose from Week 36 to Week 60	Week 36 to Week 60
Proportion of participants achieving BILAG-based Composite Lupus Assessment (BICLA)	BICLA response is defined as: * Reduction of all baseline BILAG-2004 A to B/C/D and baseline B to C/D and no worsening in other organ systems defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening from baseline in SLEDAI-2K defined as an increase from baseline of \> 0 points * No worsening in PhGA defined as an increase of ≥ 0.3 from baseline on a 0 to 3 PhGA visual analog scale	Week 60
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)	LLDAS response is defined as: * SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) (Golder et al 2019) * No new lupus disease activity compared with the previous assessment, defined as any new SLEDAI-2K component that was not present at the previous assessment * PhGA (scale 0-3) ≤ 1 * Current predniso(lo)ne (or equivalent) dose ≤ 7.5 mg daily * Well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents	Week 60
Time to first occurrence of SRI-4	Time to first occurrence of SRI-4 from baseline to Week 60	Baseline to Week 60
Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced CS dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower	Achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced CS dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower	Week 36 to Week 60
Proportion of participants achieving SRI-6	SRI-6 response is defined as: * SLEDAI-2K reduction from baseline of ≥ 6 points * No BILAG-2004 worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in PhGA, defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale	Week 60
Proportion of participants achieving SF-36 Bodily Pain response	Achieving Short Form 36 (SF-36) Bodily Pain response	Week 60
Proportion of participants with Adverse Events (AEs)	To evaluate safety and tolerability of ianalumab s.c. monthly	Baseline to Week 60
Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time	To evaluate immunogenicity of ianalumab s.c. monthly	Baseline to Week 164
Ianalumab concentration in serum during the treatment and follow-up	Concentration of Ianalumab in serum	Baseline to Week 164

Frequently Asked Questions

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References

Clinical Trials Gov: Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)