Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

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

Key facts

Study ID: NCT05126277
Run by: Novartis Pharmaceuticals
People needed: 452
Starts: 2022-07-14
Expected to finish: 2031-02-11
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Advanced Medical Research — La Palma, California, United States
University of California Irvine — Orange, California, United States
School Of Medicine — Sacramento, California, United States
University of California San Diego — San Diego, California, United States
Kaiser Permanente — San Diego, California, United States
Mayo Clinic Jacksonville — Jacksonville, Florida, United States
University Of Miami — Miami, Florida, United States
Emory University School of Medicine — Atlanta, Georgia, United States
Fides Clinical Research — Atlanta, Georgia, United States
Parris and Associates Rheumatology — Lawrenceville, Georgia, United States
Accurate Clinical Research — Lake Charles, Louisiana, United States
UMC New Orleans — New Orleans, Louisiana, United States
Wayne State University — Detroit, Michigan, United States
Univ of Nevada School of Med — Las Vegas, Nevada, United States
NY Nephrology — Clifton Park, New York, United States
Hospital for Special Surgery — New York, New York, United States
Northwell Health — New York, New York, United States
Circuit Clinical — Orchard Park, New York, United States
James J Peters VA Medical Center — The Bronx, New York, United States
University Of Cincinnati — Cincinnati, Ohio, United States
Univ of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
Precision Comprehensive Research — Colleyville, Texas, United States
Univof Texas Southwestern Med Cntr — Dallas, Texas, United States
Uni of Texas Health Science Center — San Antonio, Texas, United States
University Of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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