A multi-center, randomized, double-blind, placebocontrolled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Phase 3

Recruiting

• Conditions: IgA kidney disease; IgAN; 10029149

• Registration Number: NL-OMON56184
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

• Male and female patients >= 18 years of age with an eGFR level and
biopsy-confirmed IgA nephropathy as follows
o For patients eGFR* >= 45mL/min/1.73m2, a qualifying biopsy performed within
the last 5 years is required
o For patients with eGFR* 30 to <45mL/min/1.73m2, a qualifying biopsy performed
within 2 years with < 50% tubulointerstitial fibrosis is required
o 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.
• 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 treatment has to start earlier than 2 weeks post
vaccination, prophylactic antibiotic treatment should be initiated.
• If not previously vaccinated, vaccination against Haemophilus influenzae
infection should be given, if available and according to local regulations, at
least 2 weeks prior to first study drug administration.
• 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

• 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.
• Sitting office SBP >140 mmHg or DBP >90 mmHg at the randomization visit
• Patients previously treated with immunosuppressive or other immunmodulatory
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 LNP023 or prior enrollment in any other LNP023 clinical trial
where study drug was taken, including matching placebo
• History of recurrent invasive infections caused by encapsulated organisms,
such as meningococcus and pneumococcus.
• Active systemic bacterial, viral (including COVID-19) or fungal infection
within 14 days prior to study drug administration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified