Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1 Level: LLT Classification code 10027170 Term: Membranous nephropathy System Organ Class: 100000004857
Conditions
Interventions
Product Name: MOR202
Product Code: MOR202
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: No INN assigned yet
CAS Number: 2197112-39-1
Current Sponsor code:
Sponsors
MorphoSys AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 to =80 years (at date of signing ICF) 2. Urine protein to creatinine ratio (UPCR) of = 3.0000 g/g OR proteinuria = 3.500 g/24 h from 24-hr urine at screening 3. Active and anti-PLA2R antibody positive MN in need for IST according to investigator judgement and with diagnostic 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 =65 years) yes F.1.3.1 Number of subjects for this age
Exclusion criteria
Exclusion criteria: 1. Hemoglobin 20 mg prednisone/day), within 30 days prior to screening OR b.Alkylating agents (e.g. cyclophosphamide [CYC]) or CNIs (e.g. tacrolimus, cyclosporine A [CSA]) within 90 days OR c.Biologic drugs including RTX within 180 days d.Any other oral/parenteral IST within 180 days. 13. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator 14. Clinically relevant findings on a 12 lead ECG as determined by the investigator at screening 15. History of significant cerebrovascular disease or sensory or motor neuropathy of tox-icity = grade 3 16. Total bilirubin, aspartate aminotransferase and alanine aminotransferase >1.5 x ULN, alkaline phosphatase >2.0 x ULN 17. Treatment within five terminal half-lives (if known) or within the last 30 days prior to baseline (whatever is longer) with investigational drugs. 18. Known or suspected hypersensitivity to MOR202 and its excipients (L-histidine, su-crose, polysorbate 20) 19. Serologic or virologic markers positive for HIV, hepatitis C (subjects with positive anti hepatitis C virus [anti-HCV] antibody but negative HCV RNA polymerase chain reaction [PCR] may enroll) or active or latent hepatitis B (subjects with positive hepatitis B surface antigen [HBsAg] are excluded, subjects with isolated positive hepatitis B core antibody [anti-HBc] but non-detectable hepatitis B virus (HBV) DNA by PCR may be enrolled). 20. For any other pre-existing symptoms and impairments of health classified or any re-sidual toxicity from prior therapy = grade 3 (NCICTCAE, see 3.2): these subjects may be included upon confirmation by the medical department of the sponsor 21. Pregnancy or breast feeding 22.Any active infection (viral, fungal, bacterial) requiring systemic therapy. 23.Any malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of MOR202 treatment in subjects with anti-PLA2R antibody positive membranous nephropathy (aMN);Secondary Objective: To assess the effect of MOR202 on serum anti-PLA2R antibodies in subjects with aMN To assess immunogenicity of MOR202 (anti-MOR202 antibody formation) To assess the pharmacokinetic (PK) profile of MOR202 To assess safety in subjects with aMN after MOR202 treatment and during follow-up phase;Primary end point(s): Incidence and severity of treatment-emergent adverse events (TEAE);Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 SECONDARY ENDPOINTS: 1. Number and antibody titers of subjects tested positive for anti-MOR202 antibodies 2. MOR202 serum concentrations after multiple i.v. administrations 3. Incidence and severity of AEs in the follow-up phase;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Australia, European Union, France, Italy, Korea, Republic of, Netherlands, Poland, Spain, United States
Contacts
Public ContactSenior Global Program Medical Direc
MorphoSys AG
Outcome results
None listed