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
This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous). using the 2003 International Society for Nephrology (ISN)/Renal Pathology Society (RPS) criteria).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
452
ianalumab s.c. q4w in addition to SoC
ianalumab s.c. q12w in addition to SoC
placebo s.c. q4w in addition to SoC
Frequency and percentage of participants achieving stable Complete Renal Response (CRR)
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.
Time frame: Week 72
Time to first occurrence of stable urine protein-to-creatinine ratio (UPCR) <0.5 g/g or ≥50% reduction from baseline
To demonstrate superiority of ianalumab, compared to placebo, in time to first occurrence of stable urine protein-to-creatinine ratio (UPCR) \<0.5 g/g or ≥50% reduction from baseline up to Week 72
Time frame: Week 72
Percentage of participants achieving stable Overall Renal Response (ORR), defined as achievement as either Complete Renal Response (CRR) or Partial Renal Response (PRR)
To demonstrate superiority of ianalumab, compared to placebo, in achieving stable Overall Renal Response (ORR) at Week 48
Time frame: Week 48
Incidence of stable Complete Renal Response (CRR) while maintaining daily corticosteroid dose ≤5 mg/day
To demonstrate superiority of ianalumab, compared to placebo, in achieving stable Complete Renal Response (CRR) at Week 72 while maintaining daily corticosteroid dose ≤5 mg/day between Week 24 and Week 72
Time frame: Week 72
Incidence of renal-related event or death
To demonstrate superiority of ianalumab, compared to placebo, in preventing renal-related event or death through Week 72
Time frame: Week 72
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University Of Alabama
Birmingham, Alabama, United States
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
...and 146 more locations
Change in British Isles Lupus Activity Group (BILAG) score
To demonstrate superiority of ianalumab, compared to placebo in BILAG-2004 at Week 72
Time frame: Week 72
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score
To demonstrate superiority of ianalumab, compared to placebo, in FACIT-Fatigue at Week 72
Time frame: Week 72
Number of participants with treatment-emergent Adverse Events (AEs)
AEs are any untoward sign or symptom that occurs during the study treatment
Time frame: Week 72
Ianalumab concentration in serum
To characterize the pharmacokinetics (PK) of ianalumab mean, median, minimum and maximum concentrations will be provided
Time frame: Week 72
Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time
To evaluate immunogenicity of ianalumab
Time frame: Week 72