The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Taken for 52 Weeks
Taken for 52 Weeks
Taken for 52 Weeks
Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares
Part 1: To evaluate the proportion of patients achieving complete renal response with iptacopan treatment "A" plus standard of care, compared to treatment alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "B" plus standard of care, compared to treatment "D" alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "C" plus standard of care, compared to treatment "D" alone Complete Renal Response is defined as meeting the following criteria: estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2 or no less than 85% of baseline value, and 24h urine protein-to-creatinine ratio (UPCR) ≤ 0.5 g/g.
Time frame: Baseline and week 24
Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares
Proportion of patients achieving complete renal response or partial renal response
Time frame: Baseline, week 24, week 52
Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24
Frequency of renal flares between weeks 24 and 52
Time frame: Baseline, week 24 week 52
Log-transformed ratio to baseline of 24h UPCR at week 24
Dose exposure response for reduction in proteinurea. (each 24h urine protein-to-creatinine ratio value will based on two 24 urine collections sampled within 10 days before the respective study visit)
Time frame: Baseline week 24
Change from baseline FACIT-Fatigue Score
Measure fatigue in patients
Time frame: Weeks 24 and 52
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Taken for 52 Weeks
AKDHC Medical Research ServicesLLC
Phoenix, Arizona, United States
WITHDRAWNKaiser Permanente Fontana
Fontana, California, United States
WITHDRAWNUniv Calif Irvine
Irvine, California, United States
ACTIVE_NOT_RECRUITINGRonald Reagan UCLA Medical Center
Los Angeles, California, United States
RECRUITINGLoma Linda University
San Bernardino, California, United States
ACTIVE_NOT_RECRUITINGOlive View UCLA Medical Center
Sylmar, California, United States
ACTIVE_NOT_RECRUITINGUniversity of Colorado Denver
Aurora, Colorado, United States
RECRUITINGRoyal Research Corp
Hollywood, Florida, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
RECRUITINGNephrology Associates Of Central FL
Orlando, Florida, United States
ACTIVE_NOT_RECRUITING...and 93 more locations
Change from baseline in SLEDAI-2K score at weeks 24 and 52
Measure disease activity in SLE
Time frame: Weeks 24 and 52
Change from baseline in BILAG-2004 score at weeks 24 and 52
Measure disease activity
Time frame: Weeks 24 and 52
Time-to-Complete Renal Response (CRR) based on first morning void(FMV) urine samples
Measurement of time to complete renal response based on urine samples
Time frame: Week 24 and Week 52