Phase 3 study to evaluate ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2)

Phase 1

• Conditions: Systemic Lupus Erythematosus; MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2022-002690-29-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-28
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

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 (SLE) according to EULAR/ACR SLE classification criteria at least 6 months prior to screening

Elevated serum titers at screening of Antinuclear Antibodies (=1:80) as determined by a central laboratory with a SLE typical fluorescence pattern.

Currently receiving corticosteroids 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”
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

Weigh at least 35 kg at screening

Are the trial subjects under 18? yes
Number of subjects for this age range: 28
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 224
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

Prior treatment with Ianalumab

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)

Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization or history of recurrent clinically significant infection

Chronic infection with hepatitis B (HBV) or hepatitis C (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 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)

Severe organ dysfunction or life-threatening disease at screening

History of major organ, hematopoietic stem cell or bone marrow transplant

Presence of severe lupus kidney disease as defined by proteinuria above 2g/day or equivalent using spot urine protein creatinine ratio

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

History of hypersensitivity to drugs of similar chemical class (e.g., IgG1 biologics) or oral
CS or to any of the constituents of the study drugs (sucrose, L-histidine hydrochloride, Lhistidine,
polysorbate 20)

History of non-compliance with medical regimens or considered potentially unreliable

Use of other investigational drugs within 5 half-lives of enrollment or within 30 days or
until the expected pharmacodynamic effect has returned to baseline, whichever is longer,
or longer if required by local regulations

Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic corticosteroids

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, 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.

US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse while taking study treatment

Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified