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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05624749




Registration number
NCT05624749
Ethics application status
Date submitted
7/11/2022
Date registered
22/11/2022

Titles & IDs
Public title
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
Scientific title
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)
Secondary ID [1] 0 0
2022-002690-29
Secondary ID [2] 0 0
CVAY736F12302
Universal Trial Number (UTN)
Trial acronym
SIRIUS-SLE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ianalumab
Treatment: Drugs - placebo

Experimental: ianalumab s.c. monthly - ianalumab s.c. monthly

Placebo comparator: placebo s.c. monthly - placebo s.c. monthly


Treatment: Drugs: ianalumab
ianalumab s.c. monthly

Treatment: Drugs: placebo
placebo s.c. monthly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
Timepoint [1] 0 0
Week 60
Secondary outcome [1] 0 0
Proportion of participants with no moderate or severe BILAG flare
Timepoint [1] 0 0
Baseline to Week 60
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 36 to Week 60
Secondary outcome [3] 0 0
Proportion of participants achieving BILAG-based Composite Lupus Assessment (BICLA)
Timepoint [3] 0 0
Week 60
Secondary outcome [4] 0 0
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)
Timepoint [4] 0 0
Week 60
Secondary outcome [5] 0 0
Time to first occurrence of SRI-4
Timepoint [5] 0 0
Baseline to Week 60
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Week 36 to Week 60
Secondary outcome [7] 0 0
Proportion of participants achieving SRI-6
Timepoint [7] 0 0
Week 60
Secondary outcome [8] 0 0
Proportion of participants achieving SF-36 Bodily Pain response
Timepoint [8] 0 0
Week 60
Secondary outcome [9] 0 0
Proportion of participants with Adverse Events (AEs)
Timepoint [9] 0 0
Baseline to Week 60
Secondary outcome [10] 0 0
Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time
Timepoint [10] 0 0
Baseline to Week 164
Secondary outcome [11] 0 0
Ianalumab concentration in serum during the treatment and follow-up
Timepoint [11] 0 0
Baseline to Week 164

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/01/2029
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - St Leonards
Recruitment hospital [2] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [3] 0 0
Novartis Investigative Site - Victoria Park
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Tucuman
Country [16] 0 0
Chile
State/province [16] 0 0
Los Rios
Country [17] 0 0
Chile
State/province [17] 0 0
RM
Country [18] 0 0
Chile
State/province [18] 0 0
Concepcion
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago
Country [20] 0 0
Colombia
State/province [20] 0 0
Antioquia
Country [21] 0 0
Colombia
State/province [21] 0 0
Atlantico
Country [22] 0 0
Colombia
State/province [22] 0 0
Santander
Country [23] 0 0
Colombia
State/province [23] 0 0
Barranquilla
Country [24] 0 0
Colombia
State/province [24] 0 0
Bogota
Country [25] 0 0
Colombia
State/province [25] 0 0
Cundinamarca
Country [26] 0 0
France
State/province [26] 0 0
Angers Cedex 9
Country [27] 0 0
France
State/province [27] 0 0
Grenoble
Country [28] 0 0
France
State/province [28] 0 0
Montpellier Cedex 5
Country [29] 0 0
France
State/province [29] 0 0
Paris 13
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Toulouse 4
Country [32] 0 0
France
State/province [32] 0 0
Toulouse
Country [33] 0 0
France
State/province [33] 0 0
Tours
Country [34] 0 0
Germany
State/province [34] 0 0
Aachen
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Erlangen
Country [37] 0 0
Germany
State/province [37] 0 0
Freiburg
Country [38] 0 0
Germany
State/province [38] 0 0
Herne
Country [39] 0 0
Germany
State/province [39] 0 0
Koeln
Country [40] 0 0
Germany
State/province [40] 0 0
Leipzig
Country [41] 0 0
Germany
State/province [41] 0 0
Mainz
Country [42] 0 0
India
State/province [42] 0 0
Gujarat
Country [43] 0 0
India
State/province [43] 0 0
Kerala
Country [44] 0 0
India
State/province [44] 0 0
Maharashtra
Country [45] 0 0
India
State/province [45] 0 0
Telangana
Country [46] 0 0
India
State/province [46] 0 0
New Delhi
Country [47] 0 0
India
State/province [47] 0 0
Puducherry
Country [48] 0 0
India
State/province [48] 0 0
Visakhapatnam
Country [49] 0 0
Italy
State/province [49] 0 0
AN
Country [50] 0 0
Italy
State/province [50] 0 0
CE
Country [51] 0 0
Italy
State/province [51] 0 0
FE
Country [52] 0 0
Italy
State/province [52] 0 0
PD
Country [53] 0 0
Italy
State/province [53] 0 0
PI
Country [54] 0 0
Italy
State/province [54] 0 0
RM
Country [55] 0 0
Italy
State/province [55] 0 0
TO
Country [56] 0 0
Italy
State/province [56] 0 0
Milano
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Korea
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Seocho Gu
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Gwangju Gwangyeoksi
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Seoul
Country [61] 0 0
Malaysia
State/province [61] 0 0
Negeri Sembilan
Country [62] 0 0
Malaysia
State/province [62] 0 0
Perak
Country [63] 0 0
Malaysia
State/province [63] 0 0
Sarawak
Country [64] 0 0
Malaysia
State/province [64] 0 0
Selangor Darul Ehsan
Country [65] 0 0
Malaysia
State/province [65] 0 0
Kuala Lumpur
Country [66] 0 0
Mexico
State/province [66] 0 0
Distrito Federal
Country [67] 0 0
Mexico
State/province [67] 0 0
Guanajuato
Country [68] 0 0
Mexico
State/province [68] 0 0
Jalisco
Country [69] 0 0
Mexico
State/province [69] 0 0
Michoacan
Country [70] 0 0
Mexico
State/province [70] 0 0
Yucatan
Country [71] 0 0
Mexico
State/province [71] 0 0
Mexico
Country [72] 0 0
Romania
State/province [72] 0 0
Brasov
Country [73] 0 0
Romania
State/province [73] 0 0
Bucuresti
Country [74] 0 0
Romania
State/province [74] 0 0
Cluj-Napoca
Country [75] 0 0
Taiwan
State/province [75] 0 0
Kaohsiung
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taichung
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei
Country [78] 0 0
Taiwan
State/province [78] 0 0
Taoyuan
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Leeds
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05624749