This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)
After treatment subjects will be observed for up to 1 year. Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Patients received 9 doses of MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occured weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
Number of Participants With Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 1 to Week 24
Percentage of Participants With Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 1 to Week 24
Best Immunological Response Rate (BIRR)
The BIRR was defined as the percentage of participants with a best immunological response of stringent immunological complete response (sICR), immunological complete response (ICR), or immunological partial response (IPR) prior to the start of prohibited treatment or progression, based on reduction of serum anti-PLA2R antibody titer.
Time frame: Up to 52 weeks
Number of Participants Tested Positive for Anti-felzartamab Antibodies
Time frame: Baseline; Up to 52 weeks
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North America Research Institute
Azusa, California, United States
UCSF Medical Center
San Francisco, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
University of Miami Division of Nephrology & Hypertension
Miami, Florida, United States
GA Nephrology Associates
Lawrenceville, Georgia, United States
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, United States
Kidney Care and Transplant Services of New England, PC
Springfield, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
MedResearch, Inc
El Paso, Texas, United States
...and 35 more locations
Percentage of Participants Tested Positive for Anti-felzartamab Antibodies
Time frame: Baseline; Up to 52 weeks
Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies
Time frame: Baseline; Up to 52 weeks
Felzartamab Serum Concentrations After Multiple Intravenous Administrations
Time frame: Pre Dose and Post Dose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C1D22, C2D1, C3D1, C4D1, C5D1, C6D1, End of Treatment (week 24), Follow-up visit (week 38), End of Study (up to 52 weeks)
Number of Participants With AEs During the Follow-up Period
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 25 to Week 52
Percentage of Participants With AEs During the Follow-up Period
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 25 to Week 52