ianalumab s.c. q4w: ianalumab s.c. q4w in addition to SoC
ianalumab s.c. q12w: ianalumab s.c. q12w in addition to SoC
placebo s.c.: placebo s.c. q4w in addition to SoC
Study summary
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria:
* Adult male and female participants aged 18 years or older at the time of screening
* Weigh at least 35 kg at screening
* Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria
* Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result
* Active LN at screening, as defined by meeting the 3 following criteria:
* Renal biopsy within 6 months prior to screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous LN. If no biopsy was performed within 6 months prior to screening period, a biopsy will need to be performed during the screening period after having met all other inclusion/exclusion criteria.
* UPCR ≥ 1.0 g/g on 24h urine collection at Screening
* eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR \< 30 mL/min/1.73 m2 require renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli
* Newly diagnosed participants as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA
* Induction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization
* Anti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications
* Participants on azathioprine treatment at Screening must be switched to MPA prior to randomization
* Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior randomization. Participant who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day) oral predniso(lo)ne.
* Able to communicate well with the Investigator to understand and comply with the requirements of the study
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this study:
* Severe renal impairment as defined by i.) presence of oliguria (defined as a documented urine volume \<400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation
* Sclerosis in \> 50% of glomeruli on renal biopsy
* 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. Use of certain Traditional Chinese Medicines
* Prior use of ianalumab (ever); or prior use other B cell depleting therapy within 36 weeks prior to randomization or if therapy was administered \< 36 weeks prior to randomization, B cell count less than the lower limit of normal or patient's own baseline value prior to having received an earlier B cell-depleting therapy
* Prior treatment with any of the following within 12 weeks prior to randomization
* Belimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.) plasmapheresis
* Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors)
* Thalidomide treatment and/or methotrexate
* Combination of DMARDs
* Imidazole derivative (e.g., azathioprine, mizoribine) must be discontinued prior to starting treatment with MPA
* Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12 weeks prior to randomization
* History of major organ transplant or hematopoietic stem cell/bone marrow transplant or are due to receive transplantation
* Any one of the following laboratory values at screening:
* Hemoglobin levels \< 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
* Platelet count \< 25 x 1000/µL
* Absolute neutrophil count (ANC) \< 0.8 x 1000/µL
* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection or history of recurrent clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
* History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any component of the study drug(s) or its excipients
* Receipt of live/attenuated vaccine within a 4-week period prior to randomization
* History of primary or secondary immunodeficiency, including a positive HIV test result
* History of malignancy of any organ system (other than localized basal cell carcinoma or squamous cell carcinoma of the skin or or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
* Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes), psychiatric or additional physical condition that the Investigator feels may jeopardize the participants in case of participation in this study
* Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the participant
* Evidence of active tuberculosis (TB) infection (after anti-TB treatment, participants with history of TB may become eligible according to national local guidelines)
* 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 during dosing and for 6 months after stopping of investigational medication
* Sexually active male participants, who do not agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment
Other protocol -defined Inclusion/Exclusion may apply.
Primary outcome measure(s)
Frequency and percentage of participants achieving stable Complete Renal Response (CRR) — Week 72 The primary objective is to demonstrate superiority of ianalumab compared to placebo, in achieving stable CRR (defined as estimated glomerular filtration rate (eGFR) ≥90 ml/min/1.73 m2 or no less than 85% of baseline, AND, 24-hour UPCR \<0.5 g/g) at Week 72 in active lupus nephritis (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous) participants on background SoC therapy.
Trial sites (147)
Facility
City
Region
Status
University Of Alabama
Birmingham
Alabama
Advanced Medical Research
La Palma
California
University of California Irvine
Orange
California
School Of Medicine
Sacromento
California
University of California San Diego
San Deigo
California
Kaiser Permanente
San Diego
California
Mayo Clinic Jacksonville
Jacksonville
Florida
University Of Miami
Miami
Florida
Emory University School of Medicine
Atlanta
Georgia
Fides Clinical Research
Atlanta
Georgia
Parris and Associates Rheumatology
Lawrenceville
Georgia
Accurate Clinical Research
Lake Charles
Louisiana
UMC New Orleans
New Orleans
Louisiana
Wayne State University
Detroit
Michigan
Univ of Nevada School of Med
Las Vegas
Nevada
NY Nephrology
Clifton Park
New York
Hospital for Special Surgery
New York
New York
Northwell Health
New York
New York
Circuit Clinical
Orchard Park
New York
University Of Cincinnati
Cincinnati
Ohio
Univ of Pennsylvania Medical Center
Philadelphia
Pennsylvania
Precision Comprehensive Research
Colleyville
Texas
Univof Texas Southwestern Med Cntr
Dallas
Texas
Uni of Texas Health Science Center
San Antonio
Texas
Uni Wisconsin School Med Pub Health
Madison
Wisconsin
Novartis Investigative Site
CABA
Buenos Aires
Novartis Investigative Site
La Plata
Buenos Aires
Novartis Investigative Site
Caba
Argentina
Novartis Investigative Site
CABA
Argentina
Novartis Investigative Site
San Miguel de Tucumán
Argentina
Novartis Investigative Site
Vitória
Espírito Santo
Novartis Investigative Site
Salvador
Estado de Bahia
Novartis Investigative Site
Belo Horizonte
Minas Gerais
Novartis Investigative Site
Juiz de Fora
Minas Gerais
Novartis Investigative Site
Recife
Pernambuco
Novartis Investigative Site
Porto Alegre
Rio Grande do Sul
Novartis Investigative Site
Porto Alegre
Rio Grande do Sul
Novartis Investigative Site
Santo André
São Paulo
Novartis Investigative Site
Salvador
Brazil
Novartis Investigative Site
Calgary
Alberta
+ 107 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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