Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA... | NCT04145440

Label	Type	Description	Intervention Names
Cohort 1 (newly diagnosed or relapsed participants)	Experimental	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.	Drug: MOR202
Cohort 2 (refractory participants)	Experimental	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.	Drug: MOR202

Name	Type	Description	Arm Group Labels	Other Names
MOR202	Drug	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.

Measure	Description	Time Frame
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.	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.	Week 1 to Week 24

Measure	Description	Time Frame
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.	Up to 52 weeks

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

> 18 to < 80 years (at date of signing informed consent form [ICF]).
Urine protein to creatinine ratio (UPCR) of ≥ 3.000 g/g OR proteinuria ≥ 3.500 g/24 h from 24-h urine at screening
Active anti-PLA2R antibody positive MN in need of immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
Estimated glomerular filtration rate ≥ 50 ml/min/1.73m² or ≥ 30 and <50 ml/min/1.73m², and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening.
Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained prior to enrolment.
Systolic blood pressure BP ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest
Vaccinated against Pneumococcus within the last 5 years prior to date of signing informed consent (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days).
Cohort 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies ≥50.0 RU/mL
Cohort 2 comprises therapy refractory subjects: a Subject did not achieve immunological remission after prior IST(s) as documented by the investigator AND b Subject is without promising standard therapeutic options as documented by the investigator (i.e. investigator expects efficacy or safety issues with remaining IST options) AND c Serum anti-PLA2R antibodies ≥ 20.0 RU/mL measured at screening

Note: France will only enroll patients in Cohort 2.

Key Exclusion Criteria:

Hemoglobin < 80 g/L.
Thrombocytopenia: Platelets < 100.0 x 109/L.
Neutropenia: Neutrophils < 1.5 x 109/L.
Leukopenia: Leukocytes < 3.0 x 109/L.
Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.

Subjects may receive supportive therapies to meet the above criteria

B-cells < 5 x 106/L.
Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies)
Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy).

Name	Affiliation	Role
Medical Director	HI-Bio, A Biogen Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
North America Research Institute		Azusa	California	91702	United States
UCSF Medical Center

PubMed Identifier	Type	Citation	Retractions
40465397	Derived	Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.

ID	Title	Description
FG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
FG001	Cohort 2 (Refractory Participants)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 1, 2020	Nov 20, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

The Safety Analysis Set included all participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

Week 1 to Week 24

ID	Title	Description
OG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
OG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Units	Counts
Participants	OG00018 OG00113

Title

Denominators

Categories

Title	Measurements
	OG00015 OG00112

Primary

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.

The Safety Analysis Set included all participants who received at least one dose of study drug.

Posted

Number

percentage of participants

Week 1 to Week 24

ID	Title	Description
OG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
OG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Secondary

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.

The FAS included all participants who received at least one dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 52 weeks

ID	Title	Description
OG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
OG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Units	Counts

Secondary

Number of Participants Tested Positive for Anti-felzartamab Antibodies

The Immunogenicity Analysis Set (IAS) included all participants with at least one antidrug antibody (ADA) result available.

Posted

Count of Participants

Participants

Baseline; Up to 52 weeks

ID	Title	Description
OG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
OG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Tested Positive for Anti-felzartamab Antibodies

The IAS included all participants with at least one ADA result available.

Posted

Number

percentage of participants

Baseline; Up to 52 weeks

ID	Title	Description
OG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
OG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Units	Counts
Participants	OG000

Secondary

Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies

The IAS included all participants with at least one ADA result available. Here, the "Overall Number of Participants Analyzed" equals the number of participants with positive ADA titers and "Number Analyzed" is the number of participants evaluable at each time point.

Posted

Mean

Standard Deviation

anti-felzartamab antibody titers

Baseline; Up to 52 weeks

ID	Title	Description
OG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
OG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Units	Counts
Participants

Secondary

Felzartamab Serum Concentrations After Multiple Intravenous Administrations

The Pharmacokinetic Analysis Set (PKAS) included all participants with evaluable felzartamab serum concentration data. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and the "Number Analyzed" shows the number of participants evaluated at each time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram(s)/millilitre (ng/mL)

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)

ID	Title	Description
OG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
OG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Units

Secondary

Number of Participants With AEs During the Follow-up Period

The Safety Analysis Set included all participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

Week 25 to Week 52

ID	Title	Description
OG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
OG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Secondary

Percentage of Participants With AEs During the Follow-up Period

The Safety Analysis Set included all participants who received at least one dose of study drug

Posted

Number

percentage of participants

Week 25 to Week 52

ID	Title	Description
OG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
OG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Aortic aneurysm	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG0030 affected13 at risk
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected18 at risk EG0014 affected13 at risk EG0020 affected18 at risk EG003
Chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0012 affected13 at risk EG0021 affected18 at risk EG003
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0012 affected13 at risk EG0020 affected18 at risk EG003
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Infusion site phlebitis	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Malaise	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Vaccination site pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Generalised oedema	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0007 affected18 at risk EG0011 affected13 at risk EG0021 affected18 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Immunisation reaction	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Pruritus genital	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0012 affected13 at risk EG0020 affected18 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Euphoric mood	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Lipase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Lymphocyte percentage decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Blood immunoglobulin G decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Haematocrit decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Monocyte count increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Neutrophil count increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0018 affected13 at risk EG0020 affected18 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Eye contusion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Lethargy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Presyncope	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Decreased appetite	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected13 at risk EG0021 affected18 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Dry eye	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Vision blurred	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Gastroenteritis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0012 affected13 at risk EG0020 affected18 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Bronchitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0014 affected13 at risk EG0021 affected18 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0012 affected13 at risk EG0022 affected18 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Gastrointestinal bacterial infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Oral herpes	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Hypoferritinaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Steroid diabetes	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Cohort 1 (Newly Diagnosed or Relapsed Participants)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
BG001	Cohort 2 (Refractory Participants)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1 (Newly Diagnosed or Relapsed Participants) Treatment Period (Weeks 1-24)	Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.	18	2	18	15	18
EG001	Cohort 2 (Refractory Participants) Treatment Period (Weeks 1-24)	Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.	13	3	13	12	13
EG002	Cohort 1 (Newly Diagnosed or Relapsed Participants) Follow-up Period (Weeks 25-52)	Participants with newly diagnosed or relapsed membranous nephropathy.	18	1	18	8	18
EG003	Cohort 2 (Refractory Participants) Follow-up Period (Weeks 25-52)	Participants with membranous nephropathy refractory to immunosuppressive treatment.	13	1	13	5	13

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Foot fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG0030 affected13 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0021 affected18 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
Type I hypersensitivity	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected13 at risk EG0020 affected18 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected13 at risk EG0020 affected18 at risk EG003