Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)

  • STATUS
    Recruiting
  • End date
    Oct 7, 2025
  • participants needed
    470
  • sponsor
    Novartis Pharmaceuticals
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Updated on 9 September 2023
See if I qualify
treatment regimen
nephropathy
adrenaline
fibrosis
proteinuria
mammogram
hbeag

Summary

The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

Description

The purpose of the study is to evaluate the efficacy and safety of iptacopan (LNP023) compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients. The study will be the pivotal trial for registration of LNP023 in IgA Nephropathy patients with the aim to demonstrate a clinically meaningful reduction in proteinuria by LNP023 vs. placebo as assessed by reduction in urine protein to creatinine ratio (UPCR) sampled from a 24 hour urine collection at an IA at 9 months. The trial will continue in a blinded fashion to confirm long-term efficacy based on annualized total slope of eGFR decline over 24 months to provide confirmatory evidence of LNP023 efficacy and safety in treating patients with IgAN. The trial will enroll approximately 470 participants; 430 biopsy-proven IgAN participants with eGFR ≥30 mL /min/1.73m2 (main study population) and up to approximately 40 participants with eGFR 20 to <30 mL/min/1.73m2 (severe renal impairment (SRI) population).

Details
Condition IgA Nephropathy
Treatment Placebo, LNP023
Clinical Study IdentifierNCT04578834
SponsorNovartis Pharmaceuticals
Last Modified on9 September 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male and female patients ≥ 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy as follows
For patients eGFR ≥ 45ml/min/1.73m2, a qualifying biopsy performed within the last 5 years is required
For patients with eGFR 30 to <45ml/min/1.73m2, a qualifying biopsy performed within 2 years with < 50% tubulointerstitial fibrosis is required
For patients with eGFR 20 to <30ml/min/1.73m2, a qualifying biopsy performed at any time
In all cases, if a historical biopsy is not available, one may be performed during
screening. eGFR calculated using the CKD-EPI formula (or modified MDRD formula according
to specific ethnic groups and local practice guidelines)
Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by
UPCR ≥1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the
completion of the run-in period by UPCR ≥1 g/g (113 mg/mmol) calculated as the
(geometric) mean of two 24h urine collections obtained within 14 days of each other at
baseline
Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is
required prior to the start of study treatment. If the patient has not been previously
vaccinated, or if a booster is required, vaccine should be given according to local
regulations at least 2 weeks prior to first study drug administration. If study
If not previously vaccinated, vaccination against Haemophilus influenzae infections
should be given, if available and according to local regulations, at least 2 weeks
treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic
prior to first study drug administration
treatment should be initiated
All patients must have been on supportive care including stable dose regimen of ACEi
or ARB at either the locally approved maximal daily dose or the maximally tolerated
dose (per investigators' judgment) for approximately 90 days before first study drug
administration. In addition, if patients are taking diuretics, other antihypertensive
medication, or other background medication for IgAN, the doses should also be
stabilized for approximately 90 days prior to the first dosing of study treatment

Exclusion Criteria

Sitting office SBP >140 mmHg or DBP >90 mmHg at the randomization visit
Other protocol-defined inclusion/exclusion criteria may apply
Any secondary IgAN as defined by the investigator; secondary IgAN can be associated
with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection
dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma
disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease
familial mediterranean fever, etc
Patients previously treated with immunosuppressive or other immunomodulatory agents
such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab
canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine
tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>7.5 mg/d
prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior
to first study drug administration. Participants previously or currently treated with
oral budesonide. Participants treated with endothelin (receptor) antagonists within 90
days prior to first study drug administration
Prior use of iptacopan (LNP023) or prior enrollment in any other LNP023 clinical trial
History of recurrent invasive infections caused by encapsulated organisms, such as
where study drug was taken, including matching placebo
meningococcus and pneumococcus
Active systemic bacterial, viral (including COVID-19) or fungal infection within 14
days prior to study drug administration
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