Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. =18 to =80 years (at date of signing ICF)
2. Urine protein to creatinine ratio (UPCR) of = 3.0 g/g (as measured from a 24 hour urine collection)
3. MN diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
4. Estimated glomerular filtration rate (eGFR) =50 ml/min/1.73m² or >30 and <50 ml/min/1.73m², and IFTA (interstitial fibrosis and tub-ular atrophy) score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening. If a subject falls into the latter range without availability of an adequate biopsy, a biopsy at screening should be performed for IFTA assessment.
5. The subject is on supportive treatment with an ACEI or an ARB for at least 4 weeks prior to screening. The ACEI or ARB treatment should have reached a stable dose according to best local practice.
6. Systolic BP = 150 mmHg and diastolic BP = 100 mmHg after a period of 5 minutes of rest as measured at screening
7. Subject vaccinated against Pneumococcus within the last 3 years prior to date of signing ICF (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days (1)).
8. Cohort 1: Serum anti-PLA2R antibodies = 150.0 RU/mL as determined at screening by Euroimmun ELISA
9. Cohort 1: Serum anti-PLA2R antibodies before screening ris-ing or stable as judged by the investigator
10. Cohort 1, relapse subjects only: Must have had complete remission of proteinuria, or a combination of partial remission of proteinuria (demonstrating at least 50 % decrease) with a remission of serum anti-PLA2R anti-body titer to less than 20.0 RU/mL (Euroimmun ELISA) or negative Immunfluorescence Test (IFT). Remission must have lasted for at least 6 months according to clinical judgement.
11. Cohort 2: Failure of previous therapy, i.e. subject never achieved a reduction of serum anti-PLA2R antibody titers to below 20.0 RU/ml (Euroimmun ELISA) during or after completion of a recognized IST contain-ing CSA, tacrolimus, MMF, ACTH or alkylating agents (e.g. cy-clophosphamide), or RTX determined after at least 6 months after start of this IST.
12. Cohort 2: Subjects may have received a maximum of two prior treatment lines of immunosuppressive therapy (retreatment for re-lapse with the same regimen is considered a line of its own). A planned, fixed sequence of different therapeutic agents (e. g. STARMEN regimen) is considered as one regimen.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Hemoglobin < 90 g/L
2. Thrombocytopenia: Platelets < 100.0x10^9/L
3. Neutropenia: Neutrophils < 1.5x10^9/L
4. Leukopenia: Leukocytes < 3.0x10^9/L
5. Hypogammaglobulinemia: Serum immunoglobulins =5.0 g/L
6. Secondary cause of MN (e.g. SLE, medications, malignancies) as determined by the investigator
7. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of MOR202 treatment in subjects with anti-PLA2R antibody positive membranous nephropathy (aMN);Primary end point(s): Incidence and severity of treatment-emergent adverse events (TEAE);<br> Secondary Objective: To assess the effect of MOR202 on serum anti-PLA2R antibodies in subjects with aMN<br> To assess immunogenicity of MOR202 (anti-MOR202 antibody formation)<br> To assess the pharmacokinetic (PK) profile of MOR202<br> To assess safety in the follow-up phase<br> ;Timepoint(s) of evaluation of this end point: Throughout the study

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): KEY SECONDARY ENDPOINT: Best Immunological Response: rate of sICR, ICR and IPR based on re-duction of serum anti-PLA2R antibody titer<br> SECONDARY ENDPOINTS:<br> 1. Number and antibody titers of subjects tested positive for anti-MOR202 antibodies<br> 2. MOR202 serum concentrations after multiple i.v. administrations<br> 3. Incidence and severity of AEs in the follow-up phase<br> ;Timepoint(s) of evaluation of this end point: Throughout the study

Updated 9/4/2023

Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy

Recruitment & Eligibility

Study & Design

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