A randomized, open-label, parallel group, two arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.
- Conditions
- 10029149Ideopathic membranous nephropathyMembranous nephropathy
- Registration Number
- NL-OMON52636
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
• Female or male adult (>=18 years) subjects at screening visit with a diagnosis
of idiopathic (primary) MN confirmed by renal biopsy within 36 months prior to
screening. A renal biopsy may be taken at any time during the run-in period to
confirm the diagnosis of MN and facilitate subject eligibility, if the most
recent biopsy was performed greater than 36 months prior to the screening visit.
• Anti-PLA2R antibody titer of >= 60 RU/mL at screening visit (based on the
EuroImmun ELISA test)
• Urine protein >= 3.5 g/24h at run-in and baseline visits
• <=50% reduction in both anti-PLA2R level and 24h urine protein between first
measurement at screening or run-in visit and baseline
• Estimated GFR (using the CKD-EPI formula) >= 30 mL/min per 1.73 m2 at
screening visit
• Receiving stable dose at the maximum recommended dose according to local
guidelines or maximum tolerated dose of ACEi and/or ARB and/or statins and/or
diuretics for at least 8 weeks prior to Day 1
• Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and
Haemophilus influenzae (in accordance with local guidelines) at least 28 days
prior to Day 1 and no longer than 5 years prior to Day 1
• Secondary causes of MN, e.g. systemic autoimmune diseases, solid or
haematological malignancies, infections or chronic intake of drugs (e.g. gold
salts, NSAIDs, penicillamines)
• Diagnostic renal biopsy showing evidence of crescent formation in glomeruli,
suggestive of an alternative or additional diagnosis to primary idiopathic MN
• Previous treatment with B-cell depleting or B-cell modifying agents such as,
but not limited to rituximab, belimumab, daratumomab or bortezomib
• Previous treatment with immunosuppressive agents such as cyclophosphamide,
chlorambucil, mycophenolate mofetil (or equivalent), cyclosporine, tacrolimus
or azathioprine within 90 days prior to Day 1. Low dose systemic corticosteroid
therapy is permitted, though the subject should have been on stable dose
equivalent to <=10 mg prednisolone for at least 90 days prior to Day 1
• Previous treatment with gemfibrozil or strong CYP2C8 inhibitors such as
clopidogrel within 7 days prior to Day 1
• Presence or suspicion (based on judgment of the investigator) of active
infection within 30 days prior to Day 1, or history of severe recurrent
bacterial infections
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the efficacy of LNP023 compared with rituximab</p><br>
- Secondary Outcome Measures
Name Time Method <p>Objective 1: To assess the safety and tolerability of dose of LNP023<br /><br>Objective 2: To assess the relationship between LNP023 systemic<br /><br>drug exposure and pharmacodynamics, mode-of-action markers<br /><br>and clinical efficacy<br /><br>Objective 3: To assess the effect of LNP023 compared with<br /><br>rituximab on proteinuria remission and renal function<br /><br>Objective 4: To assess the pharmacokinetics of LNP023</p><br>