IANALUMAB for Systemic lupus erythematosus

Inclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Elevated serum titers at screening of Antinuclear Antibodies (≥1:80) as determined by a central laboratory with a SLE typical fluorescence pattern."}
• {"criterion_text":"- Currently receiving corticosteroids and/or anti-malarial treatment and/or another Disease-modifying antirheumatic drug (DMARD) as specified in the protocol."}
• {"criterion_text":"- SLEDAI-2K Criteria at screening: SLEDAI-2K score ≥6 points, excluding points attributed to \"fever\", \"lupus headache\", \"alopecia\", and \"organic brain syndrome\"; British Isles Lupus Assessment Group-2004 disease activity level at screening of at least 1 of the following: British Isles Lupus Assessment Group-2004 level A disease in ≥1 organ system, Or British Isles Lupus Assessment Group-2004 level B disease in ≥2 organ systems"}
• {"criterion_text":"- Weigh at least 35 kg at screening"}

Exclusion criteria

• {"criterion_text":"- Prior treatment with ianalumab"}
• {"criterion_text":"- Evidence of active tuberculosis infection"}
• {"criterion_text":"- History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening"}
• {"criterion_text":"- Any one of the following 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 anemia Absolute neutrophil count (ANC) (<0.8 x 10^3/ μL)"}
• {"criterion_text":"- Severe organ dysfunction or life-threatening disease at screening"}
• {"criterion_text":"- Presence of severe lupus kidney disease as defined by proteinuria above 2g/day or equivalent using spot urine protein creatinine ratio"}
• {"criterion_text":"- XXX"}
• {"criterion_text":"- XXX"}
• {"criterion_text":"- Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study"}
• {"criterion_text":"- Receipt of live/attenuated vaccine within a 4-week period before first dosing"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CS"}
• {"criterion_text":"- History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer"}
• {"criterion_text":"- Pregnant or nursing (lactating) women."}
• {"criterion_text":"- History of receiving following treatment I) high dose corticosteroids, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) 12 weeks prior to screening II) Cyclophosphamide or biologics such as immunoglobulins (i.v. or s.c.), plasmapheresis, anti-type I interferon receptor biologic agents, anti- CD40 agents, CTLA4-Fc Ig or B-cell activating factor-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"}
• {"criterion_text":"- Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection"}
• {"criterion_text":"- Chronic infection with hepatitis B (HBV) or hepatitis C (HCV)"}

Primary endpoints

• {"endpoint_text":"- Proportion of participants achieving SRI-4 at Week 60","definition_or_measurement_approach":"Proportion achieving Systemic Lupus Erythematosus Responder Index (SRI-4) at Week 60; per main objective this is measured as achieving SRI-4 at Week 60 (primary clinical question also specifies without treatment discontinuation or use of restricted/rescue medications)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants with no moderate or severe British Isles Lupus Assessment Group flare up to Week 60","definition_or_measurement_approach":"Measured using BILAG-2004 flare definitions up to Week 60."}
• {"endpoint_text":"- Proportion of participants maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower","definition_or_measurement_approach":"Measured as maintenance of predniso(lo)ne ≤5 mg/day or ≤baseline dose between Weeks 36 and 60."}
• {"endpoint_text":"- Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment at Week 60","definition_or_measurement_approach":"Measured as BICLA response at Week 60 using BILAG-based composite criteria."}
• {"endpoint_text":"- Proportion of participants achieving Lupus Low Disease Activity State at Week 60","definition_or_measurement_approach":"Measured as achievement of LLDAS at Week 60 per defined LLDAS criteria."}
• {"endpoint_text":"- Time to first occurrence of SRI-4 from baseline to Week 60","definition_or_measurement_approach":"Time-to-event analysis from baseline to first achievement of SRI-4 up to Week 60."}
• {"endpoint_text":"- Proportion of participants achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤5 mg/day or ≤baseline dose, whichever is lower","definition_or_measurement_approach":"Composite endpoint combining SRI-4 at Week 60 and corticosteroid maintenance between Weeks 36 and 60."}
• {"endpoint_text":"- Proportion of participants achieving SRI-6 at Week 60","definition_or_measurement_approach":"Measured as achievement of SRI-6 at Week 60."}
• {"endpoint_text":"- Proportion of participants achieving SF-36 Bodily Pain response at Week 60","definition_or_measurement_approach":"Measured using SF-36 Bodily Pain response criteria at Week 60."}
• {"endpoint_text":"- Proportion of participants with AEs and SAEs","definition_or_measurement_approach":"Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study period."}
• {"endpoint_text":"- Clinical laboratory measurements","definition_or_measurement_approach":"Standard clinical laboratory safety and efficacy lab assessments per schedule."}
• {"endpoint_text":"- Vital Signs","definition_or_measurement_approach":"Recorded vital signs per study schedule."}
• {"endpoint_text":"- Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time","definition_or_measurement_approach":"ADA assay measuring incidence and titers of anti-ianalumab antibodies longitudinally."}
• {"endpoint_text":"- Ianalumab concentration in serum during the treatment and followup (up to the end of study)","definition_or_measurement_approach":"Pharmacokinetic measurements of serum ianalumab concentrations during treatment and follow-up."}

Methods

• Country-specific recruitment arrangements documents (K1_Recruitment Arrangements) submitted per country
• Advertisements (K2_Advertisements) / recruitment advertisements submitted per country
• Use of patient-facing materials developed by third party (Jumo Health) as documented in sponsor third-party roles

Bulgaria

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

603

Number Of Sites

3

Number Of Participants

9

Czechia

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

595

Number Of Sites

3

Number Of Participants

11

Hungary

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

18-03-2026

Processing Time Days

596

Number Of Sites

5

Number Of Participants

10

Poland

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

601

Number Of Sites

9

Number Of Participants

32

Portugal

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

594

Number Of Sites

6

Number Of Participants

10

Slovakia

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

594

Number Of Sites

6

Number Of Participants

14

Spain

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

19-03-2026

Processing Time Days

597

Number Of Sites

15

Number Of Participants

36

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Iqvia Holdings Inc.

Responsibilities

Management of drug supply logistics, dispensing and unblinding. Develop IRT system; code:3

Name

Syneos Health Inc.

Responsibilities

Operational CRO responsibilities (code:1)

Name

Parexel International (IRL) Limited

Responsibilities

Study-related CRO activities (code:12)

Third parties

• {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patient Facing Materials","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Licensing and Translations of Patient Reported Outcomes and Clinician Reported outcomes","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"Management of drug supply logistics, dispensing and unblinding. Develop IRT system; code:3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}