Lupus Nephritis Class III-IV, +/- V MedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Iptacopan
Product Code: LNP023
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: iptacopan
CAS Number: 2447007-60-3
Current Sponsor code: LNP023
Other descriptive name: LNP023 HY
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Unequivocally positive ANA test result and/or a positive anti dsDNA at screening ? Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis. ? Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS. ? eGFR = 30 ml/min/1.73 m2 ? Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections ? Vaccination against Haemophilus influenzae infection ? Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study. ? First presentation or flare of lupus nephritis Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: ? Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to screening ? Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening. ? Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy. ? Participants being treated with systemic corticosteroids (>5 mg/day prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease. ? Participants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 10 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 20 mg/day in the previous 1 week ? Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment) Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?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/1.73m2 or no less than 85% of baseline value, and 24h urine protein-to-creatine ratio (UPCR) < 0.5 g/g.;Secondary Objective: ?Proportion of patients achieving complete renal response or partial renal response ? Frequency of renal flares between weeks 24 and 52 ? Dose exposure response for reduction in proteinurea. (each 24h urine protein-to-creatine ratio value will based on two 24 urine collections samples within 10 days before the respective study visit) ?Measure fatigue in patients ?Measure disease activity in SLE ?Measure disease activity ?Measurement of time to complete renal response based on urine samples;Primary end point(s): ?Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares ;Timepoint(s) of evaluation of this end point: Baseline and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares ? Proportion of patients achieving >25% UPCR reduction in the absence of renal flares compared to baseline at week 24 ? Log-transformed ratio to baseline of 24h UPCR at week 24 ? Change from baseline FACIT-Fatigue Score ? Change from baseline in SLEDAI-2K score at weeks 24 and 52 ? Change from baseline in BILAG-2004 score at weeks 24 and 52 ? Time-to-Complete Renal Response (CRR) based on first morning void (FMV) urine samples;Timepoint(s) of evaluation of this end point: ?Baseline, week 24, week 52 ? Baseline, week 24, week 52 ?Baseline week 24 ?Weeks 24 and 52 ?Weeks 24 and 52 ?Weeks 24 and 52 ?Week 24 and Week 52 | — |
Countries
Argentina, Brazil, Bulgaria, China, Colombia, France, Germany, Hong Kong, Hungary, India, Israel, Malaysia, Mexico, Panama, Philippines, Portugal, Russian Federation, Singapore, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactInformation&Communication Médicales
Novartis Pharma S.A.S
Outcome results
None listed