Clinical trial NCT04145440
Conditions: Glomerulonephritis, Membranous antiPLA2R Positive
Sponsor: HI-Bio, A Biogen Company
Start date: 2019-10-15; Completion date: 2022-08-02
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
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)

Detailed description:
After treatment subjects will be observed for up to 1 year.

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: MOR202
Intervention descriptions: intervention 1: 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.

Protocol documents:
Prot_000.pdf: 
CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
CLINICAL TRIAL PROTOCOL
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and 
Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R 
Antibody Positive Membranous Nephropathy (aMN) - M-PLACE
Brief Description of 
Clinical Trial
Open-Label, Two-Cohort, Multicenter Clinical Trial to 
assess Safety and Efficacy of MOR202 in anti-PLA2R 
antibody positive Membranous Nephropathy (aMN)
Clinical Trial Phase:
Ib/IIa
Product Name:
MOR202
Sponsor:
MorphoSys AG
Sponsor’s Address:
Semmelweisstrasse 7 
D-82152 Planegg
GERMANY
Clinical Trial Protocol No.:
MOR202C103
EudraCT No.:
2019-000780-24
IND No.:
142840
Effective Date:
07-Jul-2020
Protocol Version:
Version 7.0, dated 01-Jul-2020
Previous Versions of the 
Clinical Trial Protocol:
6.0, 31-Oct-2019
5.0, 26-Jul-2019
4.0, 11-Jul-2019, US only
3.0, 01-Jul-2019, France only
2.0, 29-Mar-2019
Author:
This confidential document is the property of the sponsor. No unpublished information in 
this document may be disclosed without prior written approval of the sponsor.
MorphoSys AG
Confidential
Page 1 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
I CLINICAL TRIAL PROTOCOL 
A Phase lb/Ila, Open-Label, Multicenter Clinical Trial to Assess Safety and 
Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R 
Antibody Positive Membranous Nephropathy (aMN)- M-PLACE 
Brief Description of 
Clinical Trial 
Clinical Trial Phase: 
Product Name: 
Sponsor: 
Sponsor's Address: 
Clinical Trial Protocol No.: 
EudraCT No.: 
IND No.: 
Effective Date: 
Protocol Version: 
Previous Versions of the 
Clinical Trial Protocol: 
Author: 
Open-Label, Two-Cohort, Multicenter Clinical Trial to 
assess Safety and Efficacy ofMOR202 in anti-PLA2R 
antibody positive Membranous Nephropathy (aMN) 
lb/Ila 
MOR202 
MorphoSys AG 
Semmelweisstrasse 7 
D-82152 Planegg 
GERMANY 
MOR202Cl03 
2019-000780-24 
142840 
07-Jul-2020 
Version 7.0, dated 01-Jul-2020 
6.0, 31-0ct-2019 
5.0, 26-Jul-2019 
4.0, 11-Jul-2019, US only 
3.0, 01-Jul-2019, France only 
2.0, 29-Mar-2019 
 
This confidential document is the property of the sponsor. No unpublished information in 
this document may be disclosed without prior written approval of the sponsor. 
MorphoSys AG 
Confidential 
Page 1 of73 
NCT #: NCT04145440
PPD


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Sponsor Signatory:
MorphoSys AG
Confidential
Page 2 of 73
CTP v7.0, 01-Jul-2020 
Sponsor Signatory: 
MorphoSys AG 
Protocol Number: MOR202C103 M-PLACE 
Confidential 
Page 2 of73 
PPD


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Principal Investigator’s Signature
I have read and understood all pages of this clinical trial protocol. I agree that this protocol 
contains all the information required to conduct this clinical trial. I agree to conduct the clinical 
trial as outlined in the clinical trial protocol and to comply with all the terms and conditions set 
out therein. I confirm that I will conduct the clinical trial in accordance with ICH GCP 
guidelines and the principles which have their origin in the Declaration of Helsinki, copies of 
both documents have been given to me by the sponsor, and I will also ensure that sub- 
investigator(s) and other relevant members of my staff have access to copies of this protocol, 
the ICH GCP guidelines and the Declaration of Helsinki to enable them to work in accordance 
with these documents.
Signature: 
Date:
(DD, Mmm, YYYY)
Printed Name:
Address:
<Insert name and qualifications of
the Investigator>
MorphoSys AG
Confidential
Page 3 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
Principal Investigator's Signature 
I have read and understood all pages of this clinical trial protocol. I agree that this protocol 
contains all the information required to conduct this clinical trial. I agree to conduct the clinical 
trial as outlined in the clinical trial protocol and to comply with all the terms and conditions set 
out therein. I confirm that I will conduct the clinical trial in accordance with ICH GCP 
guidelines and the principles which have their origin in the Declaration of Helsinki, copies of 
both documents have been given to me by the sponsor, and I will also ensure that sub-
investigator(s) and other relevant members of my staff have access to copies of this protocol, 
the ICH GCP guidelines and the Declaration of Helsinki to enable them to work in accordance 
with these documents. 
Signature: 
Printed Name: 
Address: 
MorphoSys AG 
<Insert name and qualifications of 
the Investigator> 
Confidential 
Date: 
(DD, Mmm, YYYY) 
Page 3 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Contact Details of Key Trial Personnel
24h-Contact for Medical 
Emergencies:
Refer to Investigator Site File.
IQVIA Medical Monitor
Refer to Investigator Site File.
Sponsor’s Medical Monitor
Refer to Investigator Site File.
MorphoSys AG
Confidential
Page 4 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
Contact Details of Key Trial Personnel 
24h-Contact for Medical 
Refer to Investigator Site File. 
Emergencies: 
IQVIA Medical Monitor 
Refer to Investigator Site File. 
Sponsor's Medical Monitor 
Refer to Investigator Site File. 
MorphoSys AG 
Confidential 
Page 4 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
SUMMARY OF CHANGES
Amendment 5 (global), 01-Jul-2020, CTP v7.0,
Section
Change
Reason / Comment
Section 1, 7.1, and 
7.2
several inclusion (IC) and exclusion criteria 
(EC) were updated:
IC 2: proteinuria determination from 24h urine 
collection added 
IC 3, 4,: rephrased
IC 5: possibility added to include patients not 
tolerating ACEI/ARB 
IC 7: pneumococcus vaccination period 
extended from 3 to 5 years 
IC 8 and 9 combined to abolish cohort 1 
subgroups, cohort 1 now comprises all patients 
with antiPLA2R antibodies > 50.0 RU/mL 
IC 10 and 11 combined and cohort 2 definition 
revised to enable the participation of subjects 
refractory to previous therapy without limiting 
the number of such previous therapies 
EC 1: updated to enable the participation of 
subjects with hemoglobin levels below 80 
(formerly 90 g/L)
EC 5: hypogammaglobulinemia threshold 
revised to 4 g/L
EC 10 and 11 combined due to abolished 
cohort 1 subgroups (see above), wash out 
period for previous therapies revised 
EC 19: hepatitis diagnostics clarified to ensure 
to exclude subjects with latent hepatitis 
new EC 21 added: pregnancy 
new EC 22 added: active infection 
new EC 23 added: malignancy
Inclusion and exclusion 
criteria were updated
• to expand the patient 
population
• to align with clinical 
practice, international 
guidelines, and clinical 
research standards and 
further improve the 
quality of the CTP
• for better 
understanding
• EC 5: most commonly 
accepted threshold, be-
fore hypogammaglo-
bulinemia leads to 
immunocompromised 
state
Section 1 and 7.2
new EC 6 added to exclude patients with B-cell 
levels below 5 x 106/L ....
To avoid including 
patients with prolonged 
B-cell depletion after 
previous B-cell depleting 
therapy (e.g. rituximab)
Section 1, 5, 6.2, 
8.3.2, 8.7, 10, 10.1 
10.8.1, 12.5
sections updated according to revised in- and 
exclusion criteria
to assure consistency of 
the CTP
MorphoSys AG
Confidential
Page 5 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
SUMMARY OF CHANGES 
Amendment 5 (global), 01-Jul-2020, CTP v7.0, 
Section 
Change 
Section 1, 7.1, and several inclusion (IC) and exclusion criteria 
7.2 
(EC) were updated: 
IC 2: proteinuria determination from 24h urine 
collection added 
IC 3, 4,: rephrased 
IC 5: possibility added to include patients not 
tolerating ACEI/ ARB 
IC 7: pneumococcus vaccination period 
extended from 3 to 5 years 
IC 8 and 9 combined to abolish cohort I 
subgroups, cohort I now comprises all patients 
with antiPLA2R antibodies 2: 50.0 RU/mL 
IC IO and 11 combined and cohort 2 definition 
revised to enable the participation of subjects 
refractory to previous therapy without limiting 
the number of such previous therapies 
EC I: updated to enable the participation of 
subjects with hemoglobin levels below 80 
(formerly 90 g/L) 
EC 5: hypogammaglobulinemia threshold 
revised to 4 g/L 
EC IO and 11 combined due to abolished 
cohort I subgroups (see above), wash out 
period for previous therapies revised 
EC 19: hepatitis diagnostics clarified to ensure 
to exclude subjects with latent hepatitis 
new EC 21 added: pregnancy 
new EC 22 added: active infection 
new EC 23 added: malignancy 
Section I and 7.2 
new EC 6 added to exclude patients with B-cell 
levels below 5 x 106/L .... 
Section 1, 5, 6.2, 
sections updated according to revised in- and 
8.3.2, 8.7, 10, IO.I exclusion criteria 
10.8.1, 12.5 
MorphoSys AG 
Confidential 
Reason / Comment 
Inclusion and exclusion 
criteria were updated 
• to expand the patient 
population 
• to align with clinical 
practice, international 
guidelines, and clinical 
research standards and 
further improve the 
quality of the CTP 
• for better 
understanding 
• EC 5: most commonly 
accepted threshold, be-
fore hypogammaglo-
bulinemia leads to 
immunocompromised 
state 
To avoid including 
patients with prolonged 
B-cell depletion after 
previous B-cell depleting 
therapy ( e.g. rituximab) 
to assure consistency of 
the CTP 
Page 5 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Section 1 and 5
revised wording for exploratory endpoint on 
renal function rate deterioration
to assure consistency 
within study protocol
Section 1
planned total number of clinical trial sites and 
locations updated
increasing sites and geo-
graphic spread to mitigate 
recruitment challenge due 
to COVID-19
Section 3.2
definition of progressive disease updated to 
clarify that only UPCR from 24 h urine 
collection will be used as criterion
no comment
Section 4.2
information about other clinical trials updated 
with current information
no comment
Section 8.4
plasmapheresis and immunoadsorption added 
as prohibited therapies
since they influence 
outcome parameters
Section 8.2.2 and 
10
maximum interval for body weight determina-
tion applicable for IMP preparation defined, 
increased frequency of body weight assessment
to provide more accurate 
information for dosing and 
PK analysis
Section 10 and 
10.1
Hba1c added a parameter to be tested in central 
laboratory for subjects with diabetes mellitus 
type II
to ensure accurate Hba1c 
is available at screening to 
check eligibility
Section 10 and 
10.1
requirement for kidney ultrasound deleted in 
schedule of assessments
deleted to align with 
clinical practice and to 
simplify CTP
Section 10 and 
Section 10.1
minimum creatinine amount in collected urine 
revised in footnote of schedule of assessments, 
as well as in Section 10.1
recalculated reflecting 
creatinine excretion of 
elderly, on low protein 
diet, or with infrequent 
physical activity
Section 10.4
added time window for assessment of CBC
to further improve patient 
safety
Section 10.8.7 and 
12.12.1
Additional AESIs added: 
neutropenia 
thrombocytopenia 
major bleeds
to ensure timely reporting 
of such events
Section 14
Updated list of references, now presented in 
alphabetical order
no comment
All sections
editorial changes: corrections of inconsisten- 
cies/ erroneous wording, moving wording to 
different positions, adding definitions, con-
sistent use of American spelling, reference to 
cited literature corrected
no comment
MorphoSys AG
Confidential
Page 6 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
Section I and 5 
revised wording for exploratory endpoint on 
to assure consistency 
renal function rate deterioration 
within study protocol 
Section I 
planned total number of clinical trial sites and 
increasing sites and geo-
locations updated 
graphic spread to mitigate 
recruitment challenge due 
to COVID-19 
Section 3.2 
definition of progressive disease updated to 
no comment 
clarify that only UPCR from 24 h urine 
collection will be used as criterion 
Section 4.2 
information about other clinical trials updated 
no comment 
with current information 
Section 8.4 
plasmapheresis and immunoadsorption added 
since they influence 
as prohibited therapies 
outcome parameters 
Section 8.2.2 and 
maximum interval for body weight determina-
to provide more accurate 
10 
tion applicable for IMP preparation defined, 
information for dosing and 
increased frequency of body weight assessment PK analysis 
Section 10 and 
Hbalc added a parameter to be tested in central to ensure accurate Hbal c 
10.1 
laboratory for subjects with diabetes mellitus 
is available at screening to 
type II 
check eligibility 
Section 10 and 
requirement for kidney ultrasound deleted in 
deleted to align with 
10.1 
schedule of assessments 
clinical practice and to 
simplify CTP 
Section 10 and 
minimum creatinine amount in collected urine recalculated reflecting 
Section 10.1 
revised in footnote of schedule of assessments, creatinine excretion of 
as well as in Section 10.1 
elderly, on low protein 
diet, or with infrequent 
physical activity 
Section 10.4 
added time window for assessment of CBC 
to further improve patient 
safety 
Section 10.8.7 and Additional AESis added: 
to ensure timely reporting 
12.12.1 
neutropenia 
of such events 
thrombocytopenia 
major bleeds 
Section 14 
Updated list of references, now presented in 
no comment 
alphabetical order 
All sections 
editorial changes: corrections of inconsisten-
no comment 
cies/ erroneous wording, moving wording to 
different positions, adding definitions, con-
sistent use of American spelling, reference to 
cited literature corrected 
MorphoSys AG 
Confidential 
Page 6 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Amendment 4 (global), 31-Oct-2019, CTP v6.0,
Section
Change
Reason / Comment
Sections 1, 6.2 and 7.1
Previous inclusion criteria 10 
and 11 revised, inclusion 
criterion 9 deleted, inclusion 
criterion 3 expanded.
Criteria changed to enable the 
participations of subjects 
historically monitored with 
different anti-PLA2R assays, 
subgroups a + b for Cohort 1 with 
minimum of 10 subjects for 1a 
introduced
Sections 1, 3, 6.1.2, 6.7, 
7.1,7.2, 8.2.2, 8.3.1, 10 
and 12
Editorial changes
Corrections of inconsistencies/ 
erroneous wording, moving 
wording to different positions, 
adding definitions
Section 10
Description for one blood 
sample added to clarify the 
sampling purpose for future 
research
Correction to highlight optional 
sample
Sections 1 and 10
BAFF added as additional 
biomarker
Enrichment of the research 
biomarker panel
Amendment 3, 26-Jul-2019, CTP v5.0, European countries, United States of America
Section
Change
Reason / Comment
Table 2 (Schedule of 
Assessments)
Serum pregnancy test added at 
Follow Up Visit (FUV), Day 
267
Request of German Competent 
Authority, PEI
Section 10.1
Wording added to address the 
recommendation of the CTFG 
related to the pregnancy 
testing in case of delayed 
menstrual cycle in women of 
childbearing potential
Request of German Competent 
Authority, PEI
Sections 1, 6.2 and 7
Patients in France excluded 
from enrolment in Cohort 1
Request from French Competent 
Authority ANSM
MorphoSys AG
Confidential
Page 7 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
Amendment 4 (global), 31-0ct-2019, CTP v6.0, 
Section 
Change 
Reason / Comment 
Sections 1, 6.2 and 7.1 
Previous inclusion criteria I 0 
Criteria changed to enable the 
and 11 revised, inclusion 
participations of subjects 
criterion 9 deleted, inclusion 
historically monitored with 
criterion 3 expanded. 
different anti-PLA2R assays, 
subgroups a + b for Cohort I with 
minimum of IO subjects for I a 
introduced 
Sections 1, 3, 6.1.2, 6.7, Editorial changes 
Corrections of inconsistencies/ 
7.1,7.2, 8.2.2, 8.3.1, 10 
erroneous wording, moving 
and 12 
wording to different positions, 
adding definitions 
Section 10 
Description for one blood 
Correction to highlight optional 
sample added to clarify the 
sample 
sampling purpose for future 
research 
Sections I and 10 
BAFF added as additional 
Enrichment of the research 
biomarker 
biomarker panel 
Amendment 3, 26-Jul-2019, CTP v5.0, European countries, United States of America 
Section 
Change 
Reason / Comment 
Table 2 (Schedule of 
Serum pregnancy test added at Request of German Competent 
Assessments) 
Follow Up Visit (FUV), Day 
Authority, PEI 
267 
Section 10.1 
Wording added to address the Request of German Competent 
recommendation of the CTFG Authority, PEI 
related to the pregnancy 
testing in case of delayed 
menstrual cycle in women of 
childbearing potential 
Sections 1, 6.2 and 7 
Patients in France excluded 
Request from French Competent 
from enrolment in Cohort I 
Authority ANSM 
MorphoSys AG 
Confidential 
Page 7 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Section 7.1
Wording related to the 
contraception methods in 
females of childbearing 
potential revised in Inclusion 
criterion 14.
Request of US FDA
Sections 1, 5, 7.2, 8.2.2, 
8.7 and 10.1
Editorial changes
Corrections of inconsistencies/ 
erroneous wording
Amendment 2, 11-Jul-2019, CTP v4.0 United States of America
Section
Change
Reason / Comment
Section 6.3
Added wording “Safety 
Review Panel” to name the 
respective safety review board 
appropriately
Request of US FDA
Section 9.1
Revised wording in order to 
introduce stricter rules for 
triggering the safety review by 
the Safety Review Panel and 
decisions about pausing 
recruitment and pausing of 
MOR202 dosing in all 
subjects.
Request of US FDA
Amendment 1, 01-Jul-2019, CTP v3.0 France
Section
Change
Reason / Comment
Section 10.1
Table 2 (Schedule of
Assessments)
Wording revised in order to 
make blood typing mandatory 
(previously recommended) 
before treatment with 
MOR202 in order to mitigate 
the risk of possible 
interference of CD38 
antibodies with blood bank 
serologic tests
Request of the French Competent 
Authority ANSM
MorphoSys AG
Confidential
Page 8 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
Section 7.1 
Wording related to the 
Request of US FDA 
contraception methods in 
females of childbearing 
potential revised in Inclusion 
criterion 14. 
Sections 1, 5, 7.2, 8.2.2, Editorial changes 
Corrections of inconsistencies/ 
8.7 and 10.1 
erroneous wording 
Amendment 2, 11-Jul-2019, CTP v4.0 United States of America 
Section 
Change 
Reason / Comment 
Section 6.3 
Added wording "Safety 
Request of US FDA 
Review Panel" to name the 
respective safety review board 
appropriate! y 
Section 9.1 
Revised wording in order to 
Request of US FDA 
introduce stricter rules for 
triggering the safety review by 
the Safety Review Panel and 
decisions about pausing 
recruitment and pausing of 
MOR202 dosing in all 
subjects. 
Amendment 1, 01-Jul-2019, CTP v3.0 France 
Section 
Change 
Reason / Comment 
Section 10.1 
Wording revised in order to 
Request of the French Competent 
Table 2 (Schedule of 
make blood typing mandatory Authority ANSM 
Assessments) 
(previously recommended) 
before treatment with 
MOR202 in order to mitigate 
the risk of possible 
interference of CD3 8 
antibodies with blood bank 
serologic tests 
MorphoSys AG 
Confidential 
Page 8 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
1. 
SYNOPSIS
Title of Clinical Trial
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess 
Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in 
antiPLA2R antibody positive Membranous Nephropathy (aMN) - 
M-PLACE
Investigational Medicinal 
Product
MOR202 (compound code: MOR03087)
Clinical Trial Protocol 
Number
MOR202C103
Sponsor
Sponsor:
MorphoSys AG 
SemmelweisstraBe 7 
D-82152 Planegg 
GERMANY
Clinical Trial Phase
Ib/IIa
Background / Rationale
The purpose of the trial is to assess the safety and efficacy of the human 
anti-CD38 antibody MOR202 (compound code MOR03087) in patients 
with anti-PLA2R antibody positive membranous nephropathy (aMN) 
eligible for immunosuppressive therapy (IST) or who have failed to 
respond to previous IST.
The main treatment rationale is the reduction of membranous 
nephropathy (MN) specific anti-PLA2R autoantibodies through 
MOR202 mediated targeted depletion of autoantibody producing 
plasma cells.
Autoantibodies binding to the PLA2R antigen are highly specific to 
primary MN. They are present in approximately 70% of patients 
diagnosed with this condition.
It is clinically observed that anti-PLA2R antibody titers correlate tightly 
with disease activity. Taken together with the fact that the disease 
defining glomerular basement changes contain both PLA2R protein as 
well as antibody complex deposits, indirect evidence is provided that 
indeed anti-PLA2R antibodies play a causative role in MN.
Patients diagnosed with MN and proteinuria >3.5 g per day initially 
receive supportive therapy with a combination of angiotensin 
converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers 
(ARBs), statins and diuretics as per current clinical standard. If not 
responding with a significant decrease of proteinuria within months, 
escalation to IST is indicated with usage of cyclophosphamide, 
calcineurin inhibitors (CNIs) or mycophenolate mofetil (MMF), even 
though none of these drugs is approved for use in MN. Recently 
introduced off-label use therapy with anti-CD20 therapeutic antibody 
rituximab (RTX) allows for a more targeted IST approach by depleting
MorphoSys AG
Confidential
Page 9 of 73
CTP v7.0, 01-Jul-2020 
1. 
SYNOPSIS 
Title of Clinical Trial 
Investigational Medicinal 
Product 
Clinical Trial Protocol 
Number 
Sponsor 
Clinical Trial Phase 
Background / Rationale 
MorphoSys AG 
Protocol Number: MOR202Cl03 M-PLACE 
A Phase lb/Ila, Open-Label, Multicenter Clinical Trial to Assess 
Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in 
antiPLA2R antibody positive Membranous Nephropathy (aMN) -
M-PLACE 
MOR202 (compound code: MOR03087) 
MOR202Cl03 
Sponsor: 
MorphoSys AG 
Semmelweisstra.13e 7 
D-82152 Planegg 
GERMANY 
lb/Ila 
The purpose of the trial is to assess the safety and efficacy of the human 
anti-CD38 antibody MOR202 (compound code MOR03087) in patients 
with anti-PLA2R antibody positive membranous nephropathy (aMN) 
eligible for immunosuppressive therapy (1ST) or who have failed to 
respond to previous 1ST. 
The main treatment rationale is the reduction of membranous 
nephropathy (MN) specific anti-PLA2R autoantibodies through 
MOR202 mediated targeted depletion of autoantibody producing 
plasma cells. 
Autoantibodies binding to the PLA2R antigen are highly specific to 
primary MN. They are present in approximately 70% of patients 
diagnosed with this condition. 
It is clinically observed that anti-PLA2R antibody titers correlate tightly 
with disease activity. Taken together with the fact that the disease 
defining glomerular basement changes contain both PLA2R protein as 
well as antibody complex deposits, indirect evidence is provided that 
indeed anti-PLA2R antibodies play a causative role in MN. 
Patients diagnosed with MN and proteinuria >3.5 g per day initially 
receive supportive therapy with a combination of angiotensin 
converting enzyme inhibitors (ACEls) or angiotensin receptor blockers 
(ARBs), statins and diuretics as per current clinical standard. If not 
responding with a significant decrease of proteinuria within months, 
escalation to 1ST is indicated with usage of cyclophosphamide, 
calcineurin inhibitors (CNis) or mycophenolate mofetil (MMF), even 
though none of these drugs is approved for use in MN. Recently 
introduced off-label use therapy with anti-CD20 therapeutic antibody 
rituximab (RTX) allows for a more targeted 1ST approach by depleting 
Confidential 
Page 9 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
B cell populations involved in producing autoantibodies. However, in 
MN patients with high anti-PLA2R antibody titers, response rates with 
RTX seem to be low. One reason could be that a substantial amount of 
anti-PLA2R antibodies are produced by a mature, long-lived plasma 
cell pool with a CD20 negative, but CD38 positive immuno-phenotype, 
potentially limiting the efficacy of an anti-CD20 therapeutic approach.
Thus, an anti-CD38 directed specific plasma cell depletion approach 
employing the monoclonal antibody MOR202 may provide a viable 
therapeutic option sparing patients of significant toxicity of broader 
acting immunosuppressive agents, and that is possibly effective in 
patients with limited benefits from anti-CD20 directed therapy.
Clinical Trial Objectives
(Key Primary and 
Secondary)
PRIMARY OBJECTIVE:
To assess the safety and tolerability of MOR202 treatment in subjects 
with aMN.
KEY SECONDARY OBJECTIVE:
To assess the effect of MOR202 on serum anti-PLA2R antibodies in 
subjects with aMN.
SECONDARY OBJECTIVES:
1. To assess the immunogenicity of MOR202 (anti-MOR202 
antibody formation).
2. To assess the pharmacokinetic (PK) profile of MOR202.
3. To assess the safety in subjects with aMN after MOR202 
treatment and during the follow-up phase.
 
Clinical Trial Endpoints 
(Key Primary and 
Secondary)
PRIMARY ENDPOINT:
Incidence and severity of treatment-emergent adverse events (TEAEs). 
KEY SECONDARY ENDPOINT:
Best immunological response: rate of stringent immunological complete 
response (sICR), immunological complete response (ICR) and 
immunological partial response (IPR) based on reduction of serum 
anti-PLA2R antibody titer.
MorphoSys AG
Confidential
Page 10 of 73
CTP v7.0, 01-Jul-2020 
Clinical Trial Objectives 
(Key Primary and 
Secondary) 
Clinical Trial Endpoints 
(Key Primary and 
Secondary) 
MorphoSys AG 
Protocol Number: MOR202Cl03 M-PLACE 
B cell populations involved in producing autoantibodies. However, in 
MN patients with high anti-PLA2R antibody titers, response rates with 
RTX seem to be low. One reason could be that a substantial amount of 
anti-PLA2R antibodies are produced by a mature, long-lived plasma 
cell pool with a CD20 negative, but CD38 positive immuno-phenotype, 
potentially limiting the efficacy of an anti-CD20 therapeutic approach. 
Thus, an anti-CD38 directed specific plasma cell depletion approach 
employing the monoclonal antibody MOR202 may provide a viable 
therapeutic option sparing patients of significant toxicity of broader 
acting immunosuppressive agents, and that is possibly effective in 
patients with limited benefits from anti-CD20 directed therapy. 
PRIMARY OBJECTIVE: 
To assess the safety and tolerability of MOR202 treatment in subjects 
withaMN. 
KEY SECONDARY OBJECTIVE: 
To assess the effect ofMOR202 on serum anti-PLA2R antibodies in 
subjects with aMN. 
SECONDARY OBJECTIVES: 
1. To assess the immunogenicity ofMOR202 (anti-MOR202 
antibody formation). 
2. To assess the pharmacokinetic (PK) profile ofMOR202. 
3. To assess the safety in subjects with aMN after MOR202 
treatment and during the follow-up phase. 
 
PRIMARY ENDPOINT: 
Incidence and severity of treatment-emergent adverse events (TEAEs). 
KEY SECONDARY ENDPOINT: 
Best immunological response: rate of stringent immunological complete 
response (slCR), immunological complete response (ICR) and 
immunological partial response (IPR) based on reduction of serum 
anti-PLA2R antibody titer. 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
SECONDARY ENDPOINTS:
1. Number and antibody titers of subjects tested positive for 
antiMOR202 antibodies.
2. MOR202 serum concentrations after multiple 
i.v. administrations.
3. Incidence and severity of adverse events (AEs) in the 
follow-up phase.
EXPLORATORY ENDPOINTS:
Design and Methodology
Phase Ib/IIa, open-label, two-cohort, multicenter clinical trial to assess 
safety and efficacy of MOR202 in aMN
Cohorts/Patient Population
Cohort 1 will consist of approximately 20 aMN newly diagnosed or 
relapsing subjects stable on supportive care treatment with ACEI/ARB
MorphoSys AG
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Page 11 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
SECONDARY ENDPOINTS: 
1. Number and antibody titers of subjects tested positive for 
antiMOR202 antibodies. 
2. 
MOR202 serum concentrations after multiple 
i.v. administrations. 
3. 
Incidence and severity of adverse events (AEs) in the 
follow-up phase. 
EXPLORATORY ENDPOINTS: 
 
Design and Methodology 
Phase lb/Ila, open-label, two-cohort, multicenter clinical trial to assess 
safety and efficacy ofMOR202 in aMN 
Cohorts/Patient Population 
Cohort 1 will consist of approximately 20 aMN newly diagnosed or 
relapsing subjects stable on supportive care treatment with ACEI/ARB 
MorphoSys AG 
Confidential 
Page 11 of73 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
at screening with proteinuria and medium/high serum titers of 
anti-PLA2R antibodies, eligible for IST.
Cohort 2 will consist of approximately 10 subjects with aMN refractory 
to IST and requiring other forms of IST.
Intervention
MOR202 monotherapy within a 24-week treatment phase followed by 
a 28-week observational follow-up phase.
Population
Adult subjects with biopsy proven MN, positive for serum anti-PLA2R 
antibodies
Key Inclusion Criteria
1. > 18 to < 80 years (at date of signing informed consent form [ICF]).
2. 
Urine protein to creatinine ratio (UPCR) o f > 3.000 g/g OR 
proteinuria > 3.500 g/24 h from  24-h urine at screening.
3. Anti-PLA2R antibody positive MN in need of IST according to the 
investigator’s judgment. The diagnosis of MN should be 
histologically documented with a diagnostic biopsy; for this 
purpose, a biopsy at screening or an archival biopsy acquired within 
5 years prior to screening is acceptable.
4. Estimated glomerular filtration rate (eGFR) > 50 mL/min/1.73m2. 
Alternatively eGFR >30 and <50 mL/min/1.73m2 and interstitial 
fibrosis and tubular atrophy (IFTA) score < 25% in a renal biopsy 
obtained within the last 6 months prior to start of screening (if not 
available, a biopsy should be performed at screening to obtain the 
IFTA assessment).
5. Not in spontaneous remission despite proper treatment with ACEIs, 
ARBs (sufficient dose and treatment duration) as per clinical 
practice and scientific guidelines. If the Principal Investigator 
determines that a subject is intolerant to an ACEI or ARB, the 
reason must be documented and approval obtained from the 
Medical Monitor prior to enrolment.
6. Systolic blood pressure BP < 150 mmHg and diastolic BP < 100 
mmHg after 5 minutes of rest.
7. Subject vaccinated against Pneumococcus within the last 5 years 
prior to date of signing ICF (subjects may be vaccinated to meet 
this criterion during screening; interval to first dose of MOR202 
must be at least 14 days [MSD SmPC]).
8. Cohort 1 comprises newly diagnosed or relapsed subjects: Serum 
anti-PLA2R antibodies > 50.0 RU/mL determined by Euroimmun 
ELISA at central laboratory.
MorphoSys AG
Confidential
Page 12 of 73
CTP v7.0, 01-Jul-2020 
Population 
Key Inclusion Criteria 
MorphoSys AG 
Protocol Number: MOR202Cl03 M-PLACE 
at screemng with proteinuria and medium/high serum titers of 
anti-PLA2R antibodies, eligible for IST. 
Cohort 2 will consist of approximately 10 subjects with aMN refractory 
to IST and requiring other forms ofIST. 
Intervention 
MOR202 monotherapy within a 24-week treatment phase followed by 
a 28-week observational follow-up phase. 
Adult subjects with biopsy proven MN, positive for serum anti-PLA2R 
antibodies 
1. 
18 to S 80 years ( at date of signing informed consent form [I CF]). 
2. 
Urine protein to creatinine ratio (UPCR) of ~ 3.000 gig OR 
proteinuria ?. 3.500 g/24 hfrom 24-h urine at screening. 
3. Anti-PLA2R antibody positive MN in need of IST according to the 
investigator's judgment. The diagnosis of MN should be 
histologically documented with a diagnostic biopsy; for this 
purpose, a biopsy at screening or an archival biopsy acquired within 
5 years prior to screening is acceptable. 
4. Estimated glomerular .filtration rate (eGFR) ?. 50 mL/min/1. 73m 2. 
Alternatively eGFR ?_30 and <50 mL/min/1. 73m 2 and interstitial 
_fibrosis and tubular atrophy (IFTA) score < 25% in a renal biopsy 
obtained within the last 6 months prior to start of screening (if not 
available, a biopsy should be performed at screening to obtain the 
IFTA assessment). 
5. Not in spontaneous remission despite proper treatment with ACEis, 
ARBs (sufficient dose and treatment duration) as per clinical 
practice and scientific guidelines. If the Principal Investigator 
determines that a subject is intolerant to an ACEI or ARB, the 
reason must be documented and approval obtained from the 
Medical Monitor prior to enrolment. 
6. 
Systolic blood pressure BP S 150 mmHg and diastolic BP S 100 
mmHg after 5 minutes of rest. 
7. Subject vaccinated against Pneumococcus within the last 5 years 
prior to date of signing ICF (subjects may be vaccinated to meet 
this criterion during screening; interval to first dose of MOR202 
must be at least 14 days [MSD SmPC]). 
8. Cohort 1 comprises newly diagnosed or relapsed subjects: Serum 
anti-PLA2R antibodies ?. 50.0 RU/mL determined by Euroimmun 
ELISA at central laboratory. 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
9. 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 by the Euroimmun ELISA at central laboratory.
Note: France will only enroll patients in Cohort 2.
Parameters in italics are measured in a central laboratory.
Key Exclusion Criteria
1. Hemoglobin < 80 g/L.f
2. Thrombocytopenia: Platelets < 100.0 x 109/L. *
3. Neutropenia: Neutrophils < 1.5 x 109/L.#
4. Leukopenia: Leukocytes < 3.0 x 109/L.#
5. Hypogammaglobulinemia: Serum immunoglobulins < 4.0 g/L.f
f Subjects may receive blood transfusions or erythropoietin to meet the 
criterion.
* Subjects may receive thrombopoietin to meet the criterion.
# Subjects may receive colony stimulating factors to meet the criterion.
{ Subjects may receive immunoglobulin substitution to meet the criterion.
6. B-cells < 5 x 106/L.
7. Secondary cause of MN (e.g. systemic lupus erythematosus (SLE), 
medications, malignancies) as determined by the investigator.
8. Concomitant renal disease other than MN (e.g., diabetic renal 
disease, lupus nephritis, IgA nephropathy).
Sample Size, Planned total 
number of Clinical Trial 
Sites and Locations
Approximately 20 subjects in Cohort 1 and approximately 10 subjects 
in Cohort 2 will be enrolled and receive MOR202.
As this is a Phase Ib/IIa trial primarily conducted to explore safety 
endpoints, no formal statistical hypothesis has been established for the 
sample size calculation of this trial.
It is expected that approximately 10% of the subjects will prematurely 
discontinue the trial prior to completion of the last treatment cycle (i.e. 
end of Week 24).
Approximately 55 clinical trial sites in the US, Asia Pacific and Europe 
will participate in the trial.
Investigational and Control 
Drug(s) (Name, Description)
MOR202 antibody (compound MOR03087). No comparator drug.
Dose, Route of 
Administration, 
Treatment Regimen
9 doses of MOR202 will be administered as an intravenous infusion at 
16 mg/kg over 6 treatment cycles of 28-days each. Dosing will occur 
QW in Cycle 1 and Q4W in Cycle 2 to 6.
MorphoSys AG
Confidential
Page 13 of 73
CTP v7.0, 01-Jul-2020 
Key Exclusion Criteria 
Sample Size, Planned total 
number of Clinical Trial 
Sites and Locations 
Protocol Number: MOR202Cl03 M-PLACE 
9. 
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 1ST 
options) AND 
c 
Serum anti-PLA2R antibodies~ 20.0 RU/mL measured at 
screening by the Euroimmun ELISA at central laboratory. 
Note: France will only enroll patients in Cohort 2. 
Parameters in italics are measured in a central laboratory. 
1. Hemoglobin < 80 g/L. f 
2. Thrombocytopenia: Platelets< 100.0 x 109/L. * 
3. Neutropenia: Neutrophils < 1.5 x 109/L.# 
4. Leukopenia: Leukocytes< 3.0 x 109/L.# 
5. Hypogammaglobulinemia: Serum immunoglobulins :S 4.0 g/L.f 
t Subjects may receive blood transfusions or erythropoietin to meet the 
criterion. 
* Subjects may receive thrombopoietin to meet the criterion. 
# Subjects may receive colony stimulating factors to meet the criterion. 
t Subjects may receive immunoglobulin substitution to meet the criterion. 
6. B-cells < 5 x 106/L. 
7. Secondary cause of MN (e.g. systemic lupus erythematosus (SLE), 
medications, malignancies) as determined by the investigator. 
8. Concomitant renal disease other than MN (e.g., diabetic renal 
disease, lupus nephritis, IgA nephropathy). 
Approximately 20 subjects in Cohort 1 and approximately 10 subjects 
in Cohort 2 will be enrolled and receive MOR202. 
As this is a Phase lb/Ila trial primarily conducted to explore safety 
endpoints, no formal statistical hypothesis has been established for the 
sample size calculation of this trial. 
It is expected that approximately 10% of the subjects will prematurely 
discontinue the trial prior to completion of the last treatment cycle (i.e. 
end ofWeek 24). 
Approximately 55 clinical trial sites in the US, Asia Pacific and Europe 
will participate in the trial. 
Investigational and Control MOR202 antibody (compound MOR03087). No comparator drug. 
Drug(s) (Name, Description) 
Dose, Route of 
Administration, 
Treatment Regimen 
MorphoSys AG 
9 doses of MOR202 will be administered as an intravenous infusion at 
16 mg/kg over 6 treatment cycles of 28-days each. Dosing will occur 
QW in Cycle 1 and Q4W in Cycle 2 to 6. 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Supply, Preparation and 
Administration
MOR202 is supplied as a lyophilized powder for reconstitution in 
labelled glass vials. MOR202 must be stored at 2-8°C until use. For 
administration, MOR202 will be reconstituted in water for injection 
(WFI) and diluted into a commercially available 0.9% (w/v) sodium 
chloride solution.
MOR202 will be administered by slow i.v. infusion. Premedication of 
subjects with antihistamines and antipyretic drugs is recommended. For 
the first 3 administrations, glucocorticoid premedication is mandatory.
Visit Schedule and 
Assessments
Screening: 1 visit
Treatment phase: 10 visits, EOT planned after 24 weeks. 
Follow-up phase: 2 visits, EOS planned 28 weeks after EOT. 
For details see Figure 1.
Efficacy Assessments
Proteinuria assessed by UPCR in 24-hour urine and spot urine, 
anti-PLA2R titer, eGFR.
Special Safety Assessments
Adverse events will be graded according to National Cancer Institute 
Common Terminology Criteria for Adverse Events (NCI CTCAE), 
version 5.
Subject Reported 
Outcomes / QoL
 
Pharmacokinetics
Serum concentrations of MOR202 at selected time points will be 
assessed for all subjects treated with MOR202 during the course of the 
trial.
Immunogenicity
The presence of potential anti-drug antibodies and corresponding titers 
will be assessed at selected time points for all subjects treated with 
MOR202 during the course of the trial.
Biomarker Assessments
At selected time points assessments may include:
Peripheral blood immune cell populations 
 
 
 
Serum concentrations of antigen specific antibodies (e.g. anti-tetanus 
toxoid titer),
 
 
 
 
 
MorphoSys AG
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CTP v7.0, 01-Jul-2020 
Supply, Preparation and 
Administration 
Visit Schedule and 
Assessments 
Efficacy Assessments 
Protocol Number: MOR202Cl03 M-PLACE 
MOR202 is supplied as a lyophilized powder for reconstitution in 
labelled glass vials. MOR202 must be stored at 2-8°C until use. For 
administration, MOR202 will be reconstituted in water for injection 
(WFI) and diluted into a commercially available 0.9% (w/v) sodium 
chloride solution. 
MOR202 will be administered by slow i.v. infusion. Premedication of 
subjects with antihistamines and antipyretic drugs is recommended. For 
the first 3 administrations, glucocorticoid premedication is mandatory. 
Screening: 1 visit 
Treatment phase: 10 visits, EOT planned after 24 weeks. 
Follow-up phase: 2 visits, EOS planned 28 weeks after EOT. 
For details see Figure 1. 
Proteinuria assessed by UPCR in 24-hour urine and spot urine, 
anti-PLA2R titer, eGFR. 
Special Safety Assessments Adverse events will be graded according to National Cancer Institute 
Common Terminology Criteria for Adverse Events (NCI CTCAE), 
version 5. 
Subject Reported 
Outcomes I QoL 
Pharmacokinetics 
Immunogenicity 
Biomarker Assessments 
MorphoSys AG 
 
 
Serum concentrations of MOR202 at selected time points will be 
assessed for all subjects treated with MOR202 during the course of the 
trial. 
The presence of potential anti-drug antibodies and corresponding titers 
will be assessed at selected time points for all subjects treated with 
MOR202 during the course of the trial. 
At selected time points assessments may include: 
Peripheral blood immune cell populations 
 
 
 
Serum concentrations of antigen specific antibodies (e.g. anti-tetanus 
toxoid titer),
 
 
 
 
 
 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Safety run-in
The safety run-in period consists of the following:
The first three subjects dosed in this trial (regardless of cohort) will be 
treated and observed until Cycle 2, Day 1 (C2D1) or until they 
demonstrate a toxicity leading to discontinuation of treatment, 
whichever is earlier.
Treatment initiation of further subjects will be paused and re-started 
after completion of the safety run-in period, unless any grade 4/5 
adverse drug reaction (ADR) (i.e. AE at least suspected to be possibly 
related to MOR202) occurs.
If a MOR202 related grade 4/5 ADR occurs, then a safety review must 
take place and treatment initiation for further patients will be 
contingent on safety review outcome. Subjects involved in the safety 
run-in will continue the trial as per protocol. The safety review consists 
of an evaluation based on the number and type of AEs occurring 
during the first cycle as well as laboratory values (biochemistry and 
hematology). It will entail a recommendation either to keep the current 
dose of MOR202 or to adapt the dose for the remainder of the trial or 
to terminate the trial because of unacceptable toxicity. The evaluation 
will be performed within two weeks after completion of the safety 
run-in phase.
Statistical Methods and 
Data Analysis
All data in this Phase Ib/IIa trial will be summarized descriptively 
using appropriate tabular overviews. Summary statistics for continuous 
variables will include number of subjects, mean, median, Q1, Q3, 
standard deviation, minimum, and maximum. For categorical 
variables, frequencies and percentages will be provided. When 
required for the analysis of a particular variable, the baseline value will 
be the last recorded value prior to first treatment. For trial endpoints 
point estimates and 95% confidence limits will be presented. 
Time-to-event endpoints will be analyzed using the Kaplan-Meier 
methodology. No formal statistical hypothesis testing will be 
performed.
MorphoSys AG
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CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
Safety run-in 
The safety run-in period consists of the following: 
The first three subjects dosed in this trial (regardless of cohort) will be 
treated and observed until Cycle 2, Day 1 (C2D 1) or until they 
demonstrate a toxicity leading to discontinuation of treatment, 
whichever is earlier. 
Treatment initiation of further subjects will be paused and re-started 
after completion of the safety run-in period, unless any grade 4/5 
adverse drug reaction (ADR) (i.e. AE at least suspected to be possibly 
related to MOR202) occurs. 
If a MOR202 related grade 4/5 ADR occurs, then a safety review must 
take place and treatment initiation for further patients will be 
contingent on safety review outcome. Subjects involved in the safety 
run-in will continue the trial as per protocol. The safety review consists 
of an evaluation based on the number and type of AEs occurring 
during the first cycle as well as laboratory values (biochemistry and 
hematology). It will entail a recommendation either to keep the current 
dose ofMOR202 orto adapt the dose for the remainder of the trial or 
to terminate the trial because of unacceptable toxicity. The evaluation 
will be performed within two weeks after completion of the safety 
run-in phase. 
Statistical Methods and 
All data in this Phase lb/lla trial will be summarized descriptively 
Data Analysis 
using appropriate tabular overviews. Summary statistics for continuous 
variables will include number of subjects, mean, median, Q 1, Q3, 
standard deviation, minimum, and maximum. For categorical 
variables, frequencies and percentages will be provided. When 
required for the analysis of a particular variable, the baseline value will 
be the last recorded value prior to first treatment. For trial endpoints 
point estimates and 95% confidence limits will be presented. 
Time-to-event endpoints will be analyzed using the Kaplan-Meier 
methodology. No formal statistical hypothesis testing will be 
performed. 
MorphoSys AG 
Confidential 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
2. 
Table of contents
SUMMARY OF CHANGES................................................................................................................... 5
1. 
SYNOPSIS................................................................................................................................. 9
2. 
Table of contents.................................................................................................................... 16
2.1. 
List of tables.............................................................................................................................. 19
2.2. 
List of figures............................................................................................................................19
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF
TERMS.....................................................................................................................................20
3.1. 
List of Abbreviations...............................................................................................................20
3.2. 
List of Definitions specific to nephrology, membranous
nephropathy and this clinical trial protocol......................................................................... 25
4. 
INTRODUCTION.................................................................................................................27
4.1. 
Background - nonclinical studies...........................................................................................28
4.1.1. 
............................................................................................28
4.1.2. 
........................................................................................... 29
4.1.3. 
Toxicology................................................................................................................................29
4.2. 
Background - clinical studies.................................................................................................. 30
4.2.1. 
Clinical pharmacokinetics and immunogenicity..................................................................30
4.2.2. 
Clinical safety...........................................................................................................................30
4.2.3. 
Clinical efficacy....................................................................................................................... 31
4.2.4. 
Other anti-CD38 antibodies....................................................................................................31
5. 
CLINICAL TRIAL PURPOSE AND OBJECTIVES...................................................31
6. 
CLINICAL TRIAL DESIGN ............................................................................................. 33
6.1. 
Rationale................................................................................................................................... 33
6.1.1. 
Rationale for this Clinical Trial............................................................................................. 33
6.1.2. 
Dosing Rationale...................................................................................................................... 33
6.2. 
Overall Clinical Trial Design and Investigational Plan......................................................34
6.3. 
Safety Run-in............................................................................................................................35
6.4. 
Screening Phase....................................................................................................................... 36
6.5. 
Treatment Phase....................................................................................................................... 36
6.6. 
Foll ow-up Phase...................................................................................................................... 36
6.7. 
Clinical Trial Duration............................................................................................................ 36
6.8. 
Risks and Benefits to Subjects............................................................................................... 36
7. 
SELECTION OF SUBJECTS ............................................................................................ 37
7.1. 
Inclusion Criteria..................................................................................................................... 37
7.2. 
Exclusion Criteria....................................................................................................................38
8. 
TREATMENT OF SUBJECTS..........................................................................................40
8.1. 
Prior Therapy............................................................................................................................40
8.2. 
Investigational Medicinal Product (IM P).............................................................................40
8.2.1. 
MOR202 ................................................................................................................................... 40
8.2.2. 
Preparation and application of MOR202 including prophylaxis of
infusion reactions.....................................................................................................................40
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CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
2. 
Table of contents 
SUMMARY OF CHANGES ........................................................................................................... 5 
1. 
SYNOPSIS ....................................................................................................................... 9 
2. 
Table of contents ........................................................................................................... 16 
2.1. 
List of tables .................................................................................................................... 19 
2.2. 
List of figures .................................................................................................................. 19 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF 
TERMS .......................................................................................................................... 20 
3 .1. 
List of Abbreviations ..................................................................................................... .20 
3.2. 
List of Definitions specific to nephrology, membranous 
nephropathy and this clinical trial protocol ................................................................... .25 
4. 
INTRODUCTION ........................................................................................................ 27 
4.1. 
Background - nonclinical studies ................................................................................... .28 
4.1.1. 
.................................................................................... .28 
4.1.2. 
.................................................................................... .29 
4.1.3. 
Toxicology ..................................................................................................................... .29 
4.2. 
Background - clinical studies .......................................................................................... 30 
4.2.1. 
Clinical pharmacokinetics and immunogenicity ............................................................. 30 
4.2.2. 
Clinical safety ................................................................................................................. 30 
4.2.3. 
Clinical efficacy .............................................................................................................. 31 
4.2.4. 
Other anti-CD38 antibodies ............................................................................................ 31 
5. 
CLINICAL TRIAL PURPOSE AND OBJECTIVES ............................................... 31 
6. 
CLINICAL TRIAL DESIGN ...................................................................................... 33 
6.1. 
Rationale ......................................................................................................................... 33 
6.1.1. 
Rationale for this Clinical Trial ...................................................................................... 33 
6.1.2. 
Dosing Rationale ............................................................................................................. 33 
6.2. 
Overall Clinical Trial Design and Investigational Plan .................................................. 34 
6.3. 
Safety Run-in .................................................................................................................. 35 
6.4. 
Screening Phase .............................................................................................................. 36 
6.5. 
Treatment Phase .............................................................................................................. 36 
6.6. 
Follow-up Phase ............................................................................................................. 36 
6.7. 
Clinical Trial Duration .................................................................................................... 36 
6.8. 
Risks and Benefits to Subjects ........................................................................................ 36 
7. 
SELECTION OF SUBJECTS ..................................................................................... 37 
7 .1. 
Inclusion Criteria ............................................................................................................ 3 7 
7.2. 
Exclusion Criteria ........................................................................................................... 38 
8. 
TREATMENT OF SUBJECTS ................................................................................... 40 
8.1. 
Prior Therapy .................................................................................................................. 40 
8.2. 
Investigational Medicinal Product (IMP) ...................................................................... .40 
8.2.1. 
MOR202 ........................................................................................................................ .40 
8.2.2. 
Preparation and application of MOR202 including prophylaxis of 
infusion reactions ............................................................................................................ 40 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
8.3. 
C oncomitant Therapy............................................................................................................. 41
8.3.1 
Management of Infusion Related Reactions (IRRs)........................................................... 41
8.3.2 
Infection Prophylaxis...............................................................................................................43
8.4. 
Prohibited Therapy: Immunosuppressive therapies (IST)................................................. 43
8.5. 
Treatment Adherence...............................................................................................................43
8.6. 
Overdose................................................................................................................................... 43
8.7. 
Treatment management of subjects with toxicity................................................................43
8.8. 
Subject Discontinuation of IMP and Subject Withdrawal................................................. 44
8.8.1. 
Discontinuation due to toxicity.............................................................................................. 44
8.8.2. 
Discontinuation due to other reasons.................................................................................... 44
8.8.3. 
Discontinuation due to efficacy - stringent immunological
complete remission..................................................................................................................44
8.8.4. 
Withdrawal due to Subject Decision..................................................................................... 44
8.8.5. 
Withdrawal due to Use of Prohibited Therapy
[Immunosuppressive Therapy].............................................................................................. 45
8.9. 
Subject replacement.................................................................................................................45
8.10. 
IMP Accountability..................................................................................................................45
9. 
TRIAL PAUSING OR TERMINATION.........................................................................45
9.1. 
Safety Review Triggers and Decision M aking..................................................................... 45
9.2. 
Clinical Trial (Site) Termination...........................................................................................45
10. 
CLINICAL TRIAL ASSESSMENTS............................................................................... 46
10.1. 
Screening Phase....................................................................................................................... 49
10.1.1. 
Screening Failures....................................................................................................................51
10.2. 
Re-screening Procedures......................................................................................................... 51
10.3. 
Baseline -  Cycle 1 Day 1 immediate pre-dose assessments.............................................. 52
10.4. 
Treatment Phase....................................................................................................................... 52
10.5. 
Follow-up Phase...................................................................................................................... 52
10.6. 
Early Discontinuation and Withdrawal................................................................................. 52
10.7. 
Efficacy Assessments..............................................................................................................53
10.8. 
Safety Assessments..................................................................................................................53
10.8.1. 
Clinical Safety Laboratory Evaluation.................................................................................. 53
10.8.2. 
Vital Signs................................................................................................................................. 54
10.8.3. 
Electrocardiograms..................................................................................................................54
10.8.4. 
Physical Examination...............................................................................................................54
10.8.5. 
Adverse Events (AEs)..............................................................................................................55
10.8.6. 
Serious Adverse Events (SAEs)............................................................................................. 56
10.8.7. 
Adverse Events of Special Interest (AESI)...........................................................................56
10.8.8. 
Pregnancy.................................................................................................................................. 57
10.8.9. 
Assessment of AEs, SAEs and AESIs.................................................................................. 57
10.8.10. Reporting of AEs, SAEs and AESIs......................................................................................58
10.9. 
Pharmacokinetics and Immunogenicity................................................................................ 58
10.10. 
Pharmacodynamic Biomarkers.............................................................................................. 58
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CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
8.3. 
8.3.1 
8.3.2 
8.4. 
8.5. 
8.6. 
8.7. 
8.8. 
8.8.1. 
8.8.2. 
8.8.3. 
8.8.4. 
8.8.5. 
8.9. 
8.10. 
9. 
9.1. 
9.2. 
10. 
10.1. 
IO.I.I. 
10.2. 
10.3. 
10.4. 
10.5. 
10.6. 
10.7. 
10.8. 
10.8.1. 
10.8.2. 
10.8.3. 
10.8.4. 
10.8.5. 
10.8.6. 
10.8.7. 
10.8.8. 
10.8.9. 
10.8.10. 
10.9. 
10.10. 
Concomitant Therapy ..................................................................................................... 41 
Management of Infusion Related Reactions (IRRs) ....................................................... 41 
Infection Prophylaxis ..................................................................................................... .43 
Prohibited Therapy: Immunosuppressive therapies (1ST) ............................................. .43 
Treatment Adherence ..................................................................................................... .43 
Overdose ......................................................................................................................... 43 
Treatment management of subjects with toxicity .......................................................... .43 
Subject Discontinuation of IMP and Subject Withdrawal ............................................. .44 
Discontinuation due to toxicity ....................................................................................... 44 
Discontinuation due to other reasons .............................................................................. 44 
Discontinuation due to efficacy - stringent immunological 
complete remission ......................................................................................................... 44 
Withdrawal due to Subject Decision ............................................................................... 44 
Withdrawal due to Use of Prohibited Therapy 
[Immunosuppressive Therapy] ...................................................................................... .45 
Subject replacement ....................................................................................................... .45 
IMP Accountability ......................................................................................................... 45 
TRIAL PAUSING OR TERMINATION ................................................................... 45 
Safety Review Triggers and Decision Making .............................................................. .45 
Clinical Trial (Site) Termination ................................................................................... .45 
CLINICAL TRIAL ASSESSMENTS ......................................................................... 46 
Screening Phase .............................................................................................................. 49 
Screening Failures ........................................................................................................... 51 
Re-screening Procedures ................................................................................................. 51 
Baseline - Cycle I Day I immediate pre-dose assessments ........................................... 52 
Treatment Phase .............................................................................................................. 52 
Follow-up Phase ............................................................................................................. 52 
Early Discontinuation and Withdrawal.. ......................................................................... 52 
Efficacy Assessments ..................................................................................................... 53 
Safety Assessments ......................................................................................................... 53 
Clinical Safety Laboratory Evaluation ............................................................................ 53 
Vital Signs ....................................................................................................................... 54 
Electrocardiograms ......................................................................................................... 54 
Physical Examination ...................................................................................................... 54 
Adverse Events (AEs) ..................................................................................................... 55 
Serious Adverse Events (SAEs) ...................................................................................... 56 
Adverse Events of Special Interest (AESI) ..................................................................... 56 
Pregnancy ........................................................................................................................ 5 7 
Assessment of AEs, SAEs and AESis ............................................................................ 57 
Reporting of AEs, SAEs and AESis ............................................................................... 58 
Pharmacokinetics and Immunogenicity .......................................................................... 58 
Pharmacodynamic Biomarkers ....................................................................................... 58 
MorphoSys AG 
Confidential 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
11. 
DATA HANDLING AND QUALITY ASSURANCE...................................................59
11.1. 
Completing and Signing Case Report Form s...................................................................... 59
11.2. 
Clinical Monitoring..................................................................................................................59
11.3. 
Audit and Inspection................................................................................................................59
11.4. 
Clinical Data Management.....................................................................................................59
11.5. 
Archiving.................................................................................................................................. 59
12. 
STATISTICAL METHODS AND PLANNED ANALYSIS........................................59
12.1. 
Timing of Analysis..................................................................................................................59
12.1.1. 
Primary Completion Analysis................................................................................................ 59
12.1.2. 
Final Analysis...........................................................................................................................60
12.2. 
Population for Analysis.......................................................................................................... 60
12.2.1. 
Full Analysis Set (FAS).......................................................................................................... 60
12.2.2. 
Per Protocol Set........................................................................................................................ 60
12.2.3. 
Pharmacokinetic Analysis Set (PKAS)................................................................................. 60
12.2.4. 
Immunogenicity Analysis Set (IAS)..................................................................................... 60
12.3. 
General Statistical Considerations.........................................................................................60
12.4. 
Subject Disposition, Demographics and other Baseline
Characteristics...........................................................................................................................61
12.5. 
Sample Size...............................................................................................................................61
12.6. 
Procedures for Missing, Unused and Spurious D ata.......................................................... 61
12.7. 
Procedures for Reporting Deviations from Original Statistical
Plan............................................................................................................................................62
12.8. 
Primary Objective Analysis....................................................................................................62
12.9. 
Key Secondary Objective Analysis.......................................................................................62
12.10. 
Secondary Objective Analysis............................................................................................... 62
12.10.1. Immunogenicity of MOR202..................................................................................................62
12.10.2. Pharmacokinetic (PK) profile of MOR202...........................................................................62
12.10.3. Safety in subjects with aMN during the follow-up Phase...................................................63
12.11. 
Exploratory Objective Analysis............................................................................................. 63
12.11.1. Efficacy Analysis..................................................................................................................... 63
12.11.2. 
....................................................................................................... 64
12.11.3. 
....................................................................................................... 65
12.11.4. Pharmacodynamic Biomarkers.............................................................................................. 65
12.12. 
Safety Analysis........................................................................................................................ 65
12.12.1. Adverse Events........................................................................................................................ 65
12.12.2. New Abnormalities..................................................................................................................66
12.12.3. Clinical Laboratory Evaluation.............................................................................................. 67
12.12.4. Vital Signs................................................................................................................................. 67
12.12.5. Electrocardiograms..................................................................................................................67
13. 
SPECIAL REQUIREMENTS AND PROCEDURES...................................................68
13.1. 
Regulatory and Ethical Considerations................................................................................. 68
13.2. 
Publication of Trial Protocol and Results.............................................................................68
13.3. 
Investigator’s Responsibilities............................................................................................... 68
13.3.1. 
Overall Responsibilities.......................................................................................................... 68
13.3.2. 
Subject Informed Consent.......................................................................................................68
MorphoSys AG
Confidential
Page 18 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
11. 
11.1. 
11.2. 
11.3. 
11.4. 
11.5. 
12. 
12.1. 
12.1.1. 
12.1.2. 
12.2. 
12.2.1. 
12.2.2. 
12.2.3. 
12.2.4. 
12.3. 
12.4. 
12.5. 
12.6. 
12.7. 
12.8. 
12.9. 
12.10. 
12.10.1. 
12.10.2. 
12.10.3. 
12.11. 
12.11.1. 
12.11.2. 
12.11.3. 
DATA HANDLING AND QUALITY ASSURANCE ............................................... 59 
Completing and Signing Case Report Forms ................................................................. 59 
Clinical Monitoring ......................................................................................................... 59 
Audit and Inspection ....................................................................................................... 59 
Clinical Data Management ............................................................................................. 59 
Archiving ........................................................................................................................ 59 
STATISTICAL METHODS AND PLANNED ANALYSIS ..................................... 59 
Timing of Analysis ......................................................................................................... 59 
Primary Completion Analysis ......................................................................................... 59 
Final Analysis ................................................................................................................. 60 
Population for Analysis .................................................................................................. 60 
Full Analysis Set (FAS) .................................................................................................. 60 
Per Protocol Set. .............................................................................................................. 60 
Pharmacokinetic Analysis Set (PKAS) ........................................................................... 60 
Immunogenicity Analysis Set (IAS) ............................................................................... 60 
General Statistical Considerations .................................................................................. 60 
Subject Disposition, Demographics and other Baseline 
C haracteri sti cs ................................................................................................................. 61 
Sample Size ..................................................................................................................... 61 
Procedures for Missing, Unused and Spurious Data ...................................................... 61 
Procedures for Reporting Deviations from Original Statistical 
................................................................................................................................. 
Primary Objective Analysis ............................................................................................ 62 
Key Secondary Objective Analysis ................................................................................ 62 
Secondary Objective Analysis ........................................................................................ 62 
Immunogenicity ofMOR202 .......................................................................................... 62 
Pharmacokinetic (PK) profile ofMOR202 ..................................................................... 62 
Safety in subjects with aMN during the follow-up Phase ............................................... 63 
Exploratory Objective Analysis ...................................................................................... 63 
Efficacy Analysis ............................................................................................................ 63 
............................................................................................... 64 
............................................................................................... 65 
12.11 .4. Pharmacodynamic Biomarkers ....................................................................................... 65 
12.12. 
Safety Analysis ............................................................................................................... 65 
12.12.1. Adverse Events ............................................................................................................... 65 
12.12.2. New Abnormalities ......................................................................................................... 66 
12.12.3. Clinical Laboratory Evaluation ....................................................................................... 67 
12.12.4. Vital Signs ....................................................................................................................... 67 
12.12.5. Electrocardiograms ......................................................................................................... 67 
13. 
13.1. 
13.2. 
13.3. 
13.3.1. 
13.3.2. 
SPECIAL REQUIREMENTS AND PROCEDURES ............................................... 68 
Regulatory and Ethical Considerations ........................................................................... 68 
Publication of Trial Protocol and Results ....................................................................... 68 
Investigator's Responsibilities ........................................................................................ 68 
Overall Responsibilities .................................................................................................. 68 
Subject Informed Consent. .............................................................................................. 68 
MorphoSys AG 
Confidential 
Page 18 of73 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
13.3.3. 
Direct Access to Source Data/Documents............................................................................69
13.3.4. 
Confidentiality..........................................................................................................................69
13.4. 
F inancial Disclosure................................................................................................................69
13.5. 
Publication Policy....................................................................................................................69
14. 
REFERENCES.......................................................................................................................70
2.1. 
List of tables
Table 1 
...............................................................................41
Table 2 
Schedule of Assessments...........................................................................................46
Table 3 
Clinical safety laboratory parameters....................................................................... 53
2.2. 
List of figures
Figure 1 
Clinical Trial Schedule...............................................................................................35
MorphoSys AG
Confidential
Page 19 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
13.3.3. 
13.3.4. 
13.4. 
13.5. 
14. 
2.1. 
Table I 
Table 2 
Table 3 
2.2. 
Figure I 
Direct Access to Source Data/Documents ...................................................................... 69 
Confidentiality ................................................................................................................ 69 
Financial Disclosure ....................................................................................................... 69 
Publication Policy ........................................................................................................... 69 
REFERENCES .............................................................................................................. 70 
List of tables 
........................................................................ 41 
Schedule of Assessments .................................................................................. 46 
Clinical safety laboratory parameters ................................................................ 53 
List of figures 
Clinical Trial Schedule ...................................................................................... 3 5 
MorphoSys AG 
Confidential 
Page 19 of73 
CCI


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
3.
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
3.1.
List of Abbreviations
ACEI
Angiotensin Converting Enzyme Inhibitor
ACTH
Adrenocorticotropic hormone
ADA
Anti drug antibody
ADCC
antibody-dependent cell-mediated cytotoxicity
ADCP
antibody-dependent cell-mediated phagocytosis
ADR
Adverse drug reaction
AE
Adverse event, for definition see 10.8.6
AESI
Adverse Event of Special Interest
ALT
Alanine-Aminotransferase
aMN
Anti-PLA2R antibody positive membranous nephropathy
Anti-PLA2R
Anti phospholipase A2 receptor antibodies
ANSM
Agence Nationale de Securite du Medicament et des Produits de Sante
ARB
Angiotensin II Receptor Blocker
AST
aspartate aminotransferase
ATC
Anatomical Therapeutic Chemical Classification
AUC
Area under the curve
BAFF
B-Cell Activating Factor
P-hCG
P human Chorionic Gonadotropin
BIR
best overall immunological response
BIRR
best overall immunological response rate
BL
Baseline
BP
Blood pressure
BPR
Best proteinuria response
CBC
Complete blood cell count
CD
Cluster of differentiation
CD20
B-lymphocyte antigen CD20
CD38
B-lymphocyte antigen CD38
Cm a x
Maximum concentration
CI
Confidence Interval
CNI
Calcineurin inhibitor
MorphoSys AG
Confidential
Page 20 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
3. 
3.1. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
List of Abbreviations 
ACEI 
ACTH 
ADA 
ADCC 
ADCP 
ADR 
AE 
AESI 
ALT 
aMN 
Anti-PLA2R 
ANSM 
ARB 
AST 
ATC 
AUC 
BAFF 
~-hCG 
BIR 
BIRR 
BL 
BP 
BPR 
CBC 
CD 
CD20 
CD38 
Cmax 
CI 
CNI 
MorphoSys AG 
Angiotensin Converting Enzyme Inhibitor 
Adrenocorticotropic hormone 
Anti drug antibody 
antibody-dependent cell-mediated cytotoxicity 
antibody-dependent cell-mediated phagocytosis 
Adverse drug reaction 
Adverse event, for definition see 10.8.6 
Adverse Event of Special Interest 
Alanine-Aminotransferase 
Anti-PLA2R antibody positive membranous nephropathy 
Anti phospholipase A2 receptor antibodies 
Agence Nationale de Securite du Medicament et des Produits de Sante 
Angiotensin II Receptor Blocker 
aspartate aminotransferase 
Anatomical Therapeutic Chemical Classification 
Area under the curve 
B-Cell Activating Factor 
human Chorionic Gonadotropin 
best overall immunological response 
best overall immunological response rate 
Baseline 
Blood pressure 
Best proteinuria response 
Complete blood cell count 
Cluster of differentiation 
B-lymphocyte antigen CD20 
B-lymphocyte antigen CD38 
Maximum concentration 
Confidence Interval 
Calcineurin inhibitor 
Confidential 
Page 20 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
CKD-EPI
Chronic Kidney Disease Epidemiology Collaboration
CR
Complete response
CRF
Case Report Form
CRO
Contract research organization
CSA
Cyclosporin A
Ctro u g h
Minimum concentration
CTFG
Clinical Trial Facilitation Group
CX
Various fractions of complement, C1q, C5a, ....
CXDY
Cycle X Day Y (eg C1D1 is the 1s t day of the 1st cycle)
DEX
Dexamethasone
DMC
Data Monitoring Committee
DTT
Dithiothreitol
ECG
Electrocardiogram
eCRF
Electronic Case Report Form
EDTA
Ethylenediaminetetraacetic acid
eGFR
estimated glomerular filtration rate
ELISA
Enzyme-linked immunosorbent assay
EOS
End of study visit (28 weeks after EOT)
EOT
End of therapy visit (28 days after last dose)
ESA
Erythropoiesis stimulating agent
ESRD
End stage renal disease
EudraCT
European Union Drug Regulating Authorities Clinical Trials
FAS
Full analysis set
FCBP
Female of childbearing potential
FDA
Food and Drug Administration
FiH
First in Human
FSH
Follicle stimulating hormone
FUV
Follow up visit (14 weeks after EOT)
GCP
Good Clinical Practice
GFR
Glomerular Filtration Rate
GGT
Gamma-Glutamyltransferase
Hba1c
Glycated hemoglobin
MorphoSys AG
Confidential
Page 21 of 73
CTP v7.0, 01-Jul-2020 
CKD-EPI 
CR 
CRF 
CRO 
CSA 
Ctrough 
CTFG 
ex 
CXDY 
DEX 
DMC 
DTT 
ECG 
eCRF 
EDTA 
eGFR 
ELISA 
EOS 
EOT 
ESA 
ESRD 
EudraCT 
FAS 
FCBP 
FDA 
FiH 
FSH 
FUV 
GCP 
GFR 
GGT 
Hbalc 
MorphoSys AG 
Protocol Number: MOR202Cl03 M-PLACE 
Chronic Kidney Disease Epidemiology Collaboration 
Complete response 
Case Report Form 
Contract research organization 
Cyclosporin A 
Minimum concentration 
Clinical Trial Facilitation Group 
Various fractions of complement, Clq, C5a, .... 
Cycle X Day Y (eg ClDl is the 1st day of the 1st cycle) 
Dexamethasone 
Data Monitoring Committee 
Dithiothreitol 
Electrocardiogram 
Electronic Case Report Form 
Ethylenediaminetetraacetic acid 
estimated glomerular filtration rate 
Enzyme-linked immunosorbent assay 
End of study visit (28 weeks after EOT) 
End of therapy visit (28 days after last dose) 
Erythropoiesis stimulating agent 
End stage renal disease 
European Union Drug Regulating Authorities Clinical Trials 
Full analysis set 
Female of childbearing potential 
Food and Drug Administration 
First in Human 
Follicle stimulating hormone 
Follow up visit ( 14 weeks after EOT) 
Good Clinical Practice 
Glomerular Filtration Rate 
Gamma-Glutamyltransferase 
Glycated hemoglobin 
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Page 21 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
HBcAg
Hepatitis B core antigen
HBsAb
Hepatitis B surface antibody
HBsAg
Hepatitis B surface antigen
HCV
Hepatitis C virus
HIV
Human Immunodeficiency Virus
IAS
Immunological analysis set
IB
Investigator Brochure
ICF
Informed Consent Form
ICH
International Council for Harmonisation
ICR
Immunological complete response
IEC
Independent Ethics Committee
IFN
Interferon
IFT
Immunfluorescence Test
IFTA score
Interstitial fibrosis and tubular atrophy score
Ig
Immunoglobulin
IL
Interleukin
IMP
Investigational medicinal product
IPR
immunological partial response
IRB
Institutional/Independent Review Board
IRR
infusion related reaction
IST
Immunosuppressive therapy
IU
International Units
IUD
Intra Uterine Device
i.v.
intravenously
LEN
Lenalidomide
LDH
L-Lactate dehydrogenase
mAbs
Monoclonal antibodies
MAC
Membrane attack complex
MedDRA
Medical Dictionary for Regulatory Activities
mg
Milligram
mL
Milliliter
MorphoSys AG
Confidential
Page 22 of 73
CTP v7.0, 01-Jul-2020 
HBcAg 
HBsAb 
HBsAg 
HCV 
HIV 
IAS 
1B 
ICF 
ICH 
ICR 
IEC 
IFN 
IFT 
IFTA score 
lg 
IL 
IMP 
IPR 
IRB 
IRR 
1ST 
IU 
IUD 
1.V. 
LEN 
LDH 
mAbs 
MAC 
MedDRA 
mg 
mL 
MorphoSys AG 
Protocol Number: MOR202Cl03 M-PLACE 
Hepatitis B core antigen 
Hepatitis B surface antibody 
Hepatitis B surface antigen 
Hepatitis C virus 
Human Immunodeficiency Virus 
Immunological analysis set 
Investigator Brochure 
Informed Consent Form 
International Council for Harmonisation 
Immunological complete response 
Independent Ethics Committee 
Interferon 
Immunfluorescence Test 
Interstitial fibrosis and tubular atrophy score 
Immunoglobulin 
Interleukin 
Investigational medicinal product 
immunological partial response 
Institutional/Independent Review Board 
infusion related reaction 
Immunosuppressive therapy 
International Units 
Intra Uterine Device 
intravenously 
Lenalidomide 
L-Lactate dehydrogenase 
Monoclonal antibodies 
Membrane attack complex 
Medical Dictionary for Regulatory Activities 
Milligram 
Milliliter 
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Page 22 of73 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
MM
Multiple myeloma
MMF
Mycophenolat-Mofetil
MN
Membranous nephropathy
mPBPK
minimal physiologically-based PK model
MTD
Maximum tolerated dose
ng
nanogram
NCI CTCAE 5.0
National Cancer Institute Common Terminology Criteria for Adverse 
Events, version 5.0
NK
Natural killer
NMRI
US Naval Medical Research Institute, strain of outbred laboratory mice
NS
Nephrotic syndrome
NYHA
New York Heart Association
OPR
Overall Proteinuria Response
OR
Overall response [complete CR or partial PR response]
ORR
Overall response rate
PBMC
Peripheral blood mononuclear cell
PE
Physical examination
PEI
Paul-Ehrlich Institute
PFS
Progression free survival
PK
Pharmacokinetics
PKAS
Pharmacokinetic Analysis Set
PK/PD
pharmacokinetic/pharmacodynamic
PLA2R
Phospholipase A2 receptor
POM
Pomalidomide
PR
Partial response
Prot-CR
Proteinuria Complete Response
Prot-PR
Proteinuria Partial Response
QW
Once every week
QTcB
QT interval corrected for heart rate according to Bazett
QTcF
QT interval corrected for heart rate according to Fridericia
Q1
25th Percentile
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CTP v7.0, 01-Jul-2020 
MM 
MMF 
MN 
mPBPK 
MTD 
ng 
NCI CTCAE 5.0 
NK 
NMRI 
NS 
NYHA 
OPR 
OR 
ORR 
PBMC 
PE 
PEI 
PFS 
PK 
PKAS 
PK/PD 
PLA2R 
POM 
PR 
Prot-CR 
Prot-PR 
QW 
QTcB 
QTcF 
Ql 
MorphoSys AG 
Protocol Number: MOR202Cl03 M-PLACE 
Multiple myeloma 
Mycophenolat-Mofetil 
Membranous nephropathy 
minimal physiologically-based PK model 
Maximum tolerated dose 
nanogram 
National Cancer Institute Common Terminology Criteria for Adverse 
Events, version 5.0 
Natural killer 
US Naval Medical Research Institute, strain of outbred laboratory mice 
Nephrotic syndrome 
New York Heart Association 
Overall Proteinuria Response 
Overall response [ complete CR or partial PR response] 
Overall response rate 
Peripheral blood mononuclear cell 
Physical examination 
Paul-Ehrlich Institute 
Progression free survival 
Pharmacokinetics 
Pharmacokinetic Analysis Set 
pharmacokinetic/pharmacodynamic 
Phospholipase A2 receptor 
Pomalidomide 
Partial response 
Proteinuria Complete Response 
Proteinuria Partial Response 
Once every week 
QT interval corrected for heart rate according to Bazett 
QT interval corrected for heart rate according to Fridericia 
25th Percentile 
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Page 23 of73 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Q3
75 th  Percentile
Q4W
Once every 4 weeks
RTX
Rituximab
RU
Relative Unit
SAE
Serious adverse event, for definition see Section 10.8.6
SAP
Statistical analysis plan
SCR
Screening
Scr
Serum creatinine
sICR
Stringent immunological complete response
SLE
Systemic lupus erythematosus
SmPC
Summary of product characteristics
SOC
Standard of Care
SOP
Standard Operating Procedure
TEAE
Treatment emergent adverse event
TNF
Tumor necrosis factor
TSH
Thyroid stimulating hormone
TTP
Time to progression
11/2
Terminal elimination half-life
UP
Urine protein
UPCR
Urine protein to creatinine ratio
WFI
Water for Injection
WHO
World Health Organization
MorphoSys AG
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CTP v7.0, 01-Jul-2020 
Q3 
Q4W 
RTX 
RU 
SAE 
SAP 
SCR 
Ser 
sICR 
SLE 
SmPC 
soc 
SOP 
TEAE 
TNF 
TSH 
TIP 
UP 
UPCR 
WFI 
WHO 
MorphoSys AG 
Protocol Number: MOR202Cl03 M-PLACE 
75th Percentile 
Once every 4 weeks 
Rituximab 
Relative Unit 
Serious adverse event, for definition see Section 10.8.6 
Statistical analysis plan 
Screening 
Serum creatinine 
Stringent immunological complete response 
Systemic lupus erythematosus 
Summary of product characteristics 
Standard of Care 
Standard Operating Procedure 
Treatment emergent adverse event 
Tumor necrosis factor 
Thyroid stimulating hormone 
Time to progression 
Terminal elimination half-life 
Urine protein 
Urine protein to creatinine ratio 
Water for Injection 
World Health Organization 
Confidential 
Page 24 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
3.2. 
List of Definitions specific to nephrology, membranous nephropathy
and this clinical trial protocol
Clinically relevant
Practical importance of a treatment effect or abnormality -  
whether it has a genuine, noticeable effect on daily life of a 
subject.
End of study
Date of the last visit of the last subject.
End-stage renal disease 
(ESRD)
For the purpose of this protocol ESRD is defined as decrement in 
the subject’s kidney function to a level at which renal 
replacement therapy is required to sustain life meeting one of the 
following criteria:
1. 
Was on dialysis therapy for more than 30 days 
continuously.
2. 
Received a kidney transplant.
3. 
A physician recommended renal replacement therapy. 
[dialysis or transplant] and the subject refused therapy.
4. 
Began dialysis and died < 30 days later.
5. 
Confirmed eGFR < 10 mL/min/1.73 m2
Estimated glomerular 
filtration rate (eGFR)
eGFR will be calculated as per the Chronic Kidney Disease 
Epidemiology Collaboration (CKD-EPI) equation 
(Levey et al 2007, Levey et al 2009): eGFR =
141xm in(Scr/K , 1)axm ax(Scr/K ,1)-1-209x0 .9 9 3 Agex1 .0 1 8 [if fem a le]x 1.159 
[if black] where:
- 
Scr is serum creatinine in pmol/L,
-  
k  is 61.9 for females and 79.6 for males,
- 
a is -0.329 for females and -0.411 for males,
- 
min indicates the minimum of Scr/K or 1, and
- 
max indicates the maximum of Scr/K or 1 eGFR as a 
measure of kidney function
Immunological
Responses
Immunological responses are reflected by the reduction of 
antiPLA2R antibody titers as measured by ELISA. Based on the 
immunological responses, the following response categories are 
defined for this protocol (the baseline value is the last 
measurement obtained prior to treatment start):
- Immunological partial 
response (IPR)
Reduction of anti-PLA2R antibody titers by at least 50% 
compared to baseline
- Immunological 
complete response 
(ICR)
Reduction of anti-PLA2R antibody titers to less than 14.0 RU/mL
MorphoSys AG
Confidential
Page 25 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
3.2. 
List of Definitions specific to nephrology, membranous nephropathy 
and this clinical trial protocol 
Clinically relevant 
Practical importance of a treatment effect or abnormality -
whether it has a genuine, noticeable effect on daily life of a 
subject. 
End of study 
Date of the last visit of the last subject. 
End-stage renal disease 
For the purpose of this protocol ESRD is defined as decrement in 
(ESRD) 
the subject's kidney function to a level at which renal 
replacement therapy is required to sustain life meeting one of the 
following criteria: 
1. 
Was on dialysis therapy for more than 30 days 
continuous! y. 
2. 
Received a kidney transplant. 
3. 
A physician recommended renal replacement therapy. 
[dialysis or transplant] and the subject refused therapy. 
4. 
Began dialysis and died < 30 days later. 
5. 
Confirmed eGFR < 10 mL/min/1.73 m2. 
Estimated glomerular 
eGFR will be calculated as per the Chronic Kidney Disease 
filtration rate ( eGFR) 
Epidemiology Collaboration (CKD-EPI) equation 
(Levey et al 2007, Levey et al 2009): eGFR = 
141 xmin(Scr/K, Itxmax(Scr/K,1)·1209xo.993Agex l.018[if female] x 1.159 
[if black] where: 
-
Ser is serum creatinine in µmol/L, 
-
K is 61.9 for females and 79.6 for males, 
-
a is -0.329 for females and -0.411 for males, 
-
min indicates the minimum of Scr/K or 1, and 
-
max indicates the maximum of Scr/K or 1 eGFR as a 
measure of kidney function 
Immunological 
Immunological responses are reflected by the reduction of 
Responses 
antiPLA2R antibody titers as measured by ELISA Based on the 
immunological responses, the following response categories are 
defined for this protocol (the baseline value is the last 
measurement obtained prior to treatment start): 
- Immunological partial Reduction of anti-PLA2R antibody titers by at least 50% 
response (IPR) 
compared to baseline 
- Immunological 
Reduction of anti-PLA2R antibody titers to less than 14.0 RU/mL 
complete response 
(ICR) 
MorphoSys AG 
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- Stringent 
immunological 
complete response 
(sICR)
ICR and a negative result in anti-PLA2R immunofluorescence 
test
Progressive disease
Decrease of eGFR by more than 30% of baseline eGFR, or 
increase in UPCR determined from 24 h urine collection by more 
than 50% from baseline value and less than 10% decline of anti- 
PLA2R antibody titers compared to baseline.
Proteinuria
Proteinuria will be assessed by UPCR from 24 h urine throughout 
this clinical trial.
Proteinuria Responses
Proteinuria responses are reflected by the reduction of proteinuria 
as measured by UPCR. Based on the proteinuria responses, the 
following response categories are defined by this protocol 
(baseline proteinuria value is defined as the mean of the values 
determined at screening and prior to Cycle 1 Day 1 pre-dose 
[UPCR from 24 h urine]):
- Proteinuria complete 
response (Prot-CR)
Reduction of proteinuria to less than 0.5 g/g, serum albumin 
within the reference range and stable eGFR (at least 80% of 
baseline).
- Proteinuria partial 
response (Prot-PR)
Reduction by at least 50% of UPCR at a given visit compared to 
baseline, proteinuria below 3.0 g/g and stable eGFR (at least 80% 
of baseline), but not meeting Prot-CR.
- Overall proteinuria 
response (OPR)
The sum of Prot-CR and Prot-PR
Treatment emergent 
adverse event (TEAE)
TEAEs are defined as any adverse event reported within the 
following time interval: start of first administration of trial drug 
until date of last administration of MOR202 + 28 days
Toxicity and symptoms for adverse event reporting and medical history are graded according 
to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 
5.0 (NCI-CTCAE 5.0) throughout this Clinical Trial Protocol unless otherwise stated. A copy 
will be provided in the Investigator Site File.
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- Stringent 
ICR and a negative result in anti-PLA2R immunofluorescence 
immunological 
test 
complete response 
(sICR) 
Progressive disease 
Decrease of eGFR by more than 30% of baseline eGFR, or 
increase in UPCR determined from 24 h urine collection by more 
than 50% from baseline value and less than 10% decline of anti-
PLA2R antibody titers compared to baseline. 
Proteinuria 
Proteinuria will be assessed by UPCR from 24 h urine throughout 
this clinical trial. 
Proteinuria Responses 
Proteinuria responses are reflected by the reduction of proteinuria 
as measured by UPCR. Based on the proteinuria responses, the 
following response categories are defined by this protocol 
(baseline proteinuria value is defined as the mean of the values 
determined at screening and prior to Cycle I Day I pre-dose 
[UPCR from 24 h urine]): 
- Proteinuria complete 
Reduction of proteinuria to less than 0.5 gig, serum albumin 
response (Prot-CR) 
within the reference range and stable eGFR (at least 80% of 
baseline). 
- Proteinuria partial 
Reduction by at least 50% of UPCR at a given visit compared to 
response (Prot-PR) 
baseline, proteinuria below 3.0 gig and stable eGFR (at least 80% 
of baseline), but not meeting Prot-CR. 
- Overall proteinuria 
The sum of Prot-CR and Prot-PR 
response (OPR) 
Treatment emergent 
TEAEs are defined as any adverse event reported within the 
adverse event (TEAE) 
following time interval: start of first administration of trial drug 
until date of last administration ofMOR202 + 28 days 
Toxicity and symptoms for adverse event reporting and medical history are graded according 
to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 
5.0 (NCI-CTCAE 5.0) throughout this Clinical Trial Protocol unless otherwise stated. A copy 
will be provided in the Investigator Site File. 
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4. 
INTRODUCTION
The purpose of the trial is to assess safety and efficacy of the human anti-CD38 antibody MOR202 
(compound MOR03087) in subjects with anti-PLA2R antibody positive membranous nephropathy 
(aMN) eligible for immunosuppressive therapy (IST) or who have failed to respond to previous 
IST.
Membranous nephropathy (MN) is the leading cause of nephrotic syndrome (NS) in adults 
(Medawar et al 1990). About 80% of MN cases are idiopathic, 20% are related to other diseases 
or exposures (Couser et al 2017). The overall global incidence is estimated at 1.2 per 100,000 per 
year (Mc Grogan et al 2011).
Although up to 30% of patients experience spontaneous remissions, and although the disease 
usually progresses slowly, approximately 30% to 40% of patients eventually develop end-stage 
renal disease (ESRD) (Ruggenenti et al 2003, Troyanov et al 2004). Patients with MN remaining 
nephrotic are at increased risk for thromboembolic (Wagoner et al 1983) and cardiovascular events 
(Lee et al 2016). Currently, there is no approved standard treatment for MN and there is no 
predictive test available that identifies patients who will undergo spontaneous remission. The 
current treatment regimen mainly comprises off-label use of various non-immunosuppressive and 
immunosuppressive drugs (Couser et al 2017, Bomback et al 2018).
Commonly, patients presenting with proteinuria and an established (histological) diagnosis of MN 
receive supportive, non-immunosuppressive therapy. Typically, this consists of a combination of 
angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), 
statins and diuretics. Evidence of a direct therapeutic effect of ACEIs and/or ARBs either 
immunologically or on proteinuria directly is lacking, particularly in light of the aforementioned 
underlying rate of spontaneous remissions.
Should supportive therapy not lead to reduction of proteinuria within months, treatment is 
escalated by employing IST with the most common IST regimens being cyclophosphamide 
combined with steroids, calcineurin inhibitors (CNIs: cyclosporine [CSA] or tacrolimus), 
mycophenolate-mofetil (MMF) or rituximab (RTX). To a lesser extent, adrenocorticotropic 
hormone (ACTH) has been used. Treatment effects of these combinations appear to be similar: 
remission of proteinuria can be expected in about 50 to 60% of patients in the first year and 70 to 
80% at 2 to 3 years (Couser et al 2017).
Out of all patients with primary MN not receiving IST, 30% to 40% progress to ESRD in 10 years 
after disease onset. IST reduces the progression rate to 10% or less (Bomback et al 2018). Relapses 
in proteinuria are seen in about 25% of patients previously treated with IST. The cases are usually 
re-treated with a different IST combinations (Couser et al 2017, Bomback et al 2018).
Autoantibodies binding to the PLA2R antigen are highly specific to primary MN. They are present 
in approximately 70% of patients diagnosed with this condition (Beck et al 2009). It is clinically 
observed that anti-PLA2R antibody titers correlate tightly with disease activity (Bomback et al 
2018). Taken together with the fact that the disease defining glomerular basement changes contain 
both PLA2R protein as well as antibody complex deposits, indirect evidence is provided that 
indeed anti-PLA2R antibodies play a causative role in MN. This in consequence currently leads 
to a change of previously established therapy algorithms, i.e. to an IST guided by anti-PLA2R 
titers in patients where these antibodies are detectable. Nowadays, patients with elevated
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4. 
INTRODUCTION 
The purpose of the trial is to assess safety and efficacy of the human anti-CD38 antibody MOR202 
(compound MOR03087) in subjects with anti-PLA2R antibody positive membranous nephropathy 
(aMN) eligible for immunosuppressive therapy (1ST) or who have failed to respond to previous 
1ST. 
Membranous nephropathy (MN) is the leading cause of nephrotic syndrome (NS) in adults 
(Medawar et al 1990). About 80% of MN cases are idiopathic, 20% are related to other diseases 
or exposures (Couser et al 2017). The overall global incidence is estimated at 1.2 per 100,000 per 
year (Mc Grogan et al 2011 ). 
Although up to 30% of patients experience spontaneous remissions, and although the disease 
usually progresses slowly, approximately 30% to 40% of patients eventually develop end-stage 
renal disease (ESRD) (Ruggenenti et al 2003, Troyanov et al 2004). Patients with MN remaining 
nephrotic are at increased risk for thromboembolic (Wagoner et al 1983) and cardiovascular events 
(Lee et al 2016). Currently, there is no approved standard treatment for MN and there is no 
predictive test available that identifies patients who will undergo spontaneous remission. The 
current treatment regimen mainly comprises off-label use of various non-immunosuppressive and 
immunosuppressive drugs (Couser et al 2017, Bomback et al 2018). 
Commonly, patients presenting with proteinuria and an established (histological) diagnosis of MN 
receive supportive, non-immunosuppressive therapy. Typically, this consists of a combination of 
angiotensin converting enzyme inhibitors (ACEis) or angiotensin receptor blockers (ARBs), 
statins and diuretics. Evidence of a direct therapeutic effect of ACEis and/or ARBs either 
immunologically or on proteinuria directly is lacking, particularly in light of the aforementioned 
underlying rate of spontaneous remissions. 
Should supportive therapy not lead to reduction of proteinuria within months, treatment is 
escalated by employing 1ST with the most common 1ST regimens being cyclophosphamide 
combined with steroids, calcineurin inhibitors (CNis: cyclosporine [CSA] or tacrolimus), 
mycophenolate-mofetil (MMF) or rituximab (RTX). To a lesser extent, adrenocorticotropic 
hormone (ACTH) has been used. Treatment effects of these combinations appear to be similar: 
remission of proteinuria can be expected in about 50 to 60% of patients in the first year and 70 to 
80% at 2 to 3 years (Couser et al 2017). 
Out of all patients with primary MN not receiving 1ST, 30% to 40% progress to ESRD in 10 years 
after disease onset. 1ST reduces the progression rate to 10% or less (Bomback et al 2018). Relapses 
in proteinuria are seen in about 25% of patients previously treated with 1ST. The cases are usually 
re-treated with a different 1ST combinations (Couser et al 2017, Bomback et al 2018). 
Autoantibodies binding to the PLA2R antigen are highly specific to primary MN. They are present 
in approximately 70% of patients diagnosed with this condition (Beck et al 2009). It is clinically 
observed that anti-PLA2R antibody titers correlate tightly with disease activity (Bomback et al 
2018). Taken together with the fact that the disease defining glomerular basement changes contain 
both PLA2R protein as well as antibody complex deposits, indirect evidence is provided that 
indeed anti-PLA2R antibodies play a causative role in MN. This in consequence currently leads 
to a change of previously established therapy algorithms, i.e. to an 1ST guided by anti-PLA2R 
titers in patients where these antibodies are detectable. Nowadays, patients with elevated 
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circulating levels of anti-PLA2R antibodies and proteinuria >3.5 g per day are candidates for early 
IST (Couser et al 2017, Bomback et al 2018, Vriese et al 2017).
The above described ISTs exhibit considerable toxicity: 25% of patients treated with 
cyclophosphamide demonstrate adverse events (AEs) such as infections, infertility, hematologic 
toxicity and malignancy later in life (Couser et al 2017). Disadvantages of CNIs include long-term 
nephrotoxicity, the need to closely monitor drug levels and the increased risk for hypertension and 
diabetes. Relapse rates with CNIs seem to be higher than with cyclophosphamide [40 to 50 % 
versus 25%] (Cattran and Brenchley 2017, Tran et al 2015, van de Logt et al 2016).
Therapy with RTX, an anti-CD20 therapeutic antibody, allows for a more targeted IST approach 
by depleting B cell populations involved in producing autoantibodies. RTX response rates seem 
to be similar to alkylating agents and CNIs, whereas side effects seem to be less than for other 
drugs used in IST (Ruggenenti et al 2012, Fervenza et al 2017, Fervenza et al 2015). A prospective 
randomized trial testing RTX versus Cyclosporin A found RTX to be non-inferior (Fervenza et al 
2017).
Interestingly, CD20 is not expressed on mature antibody producing plasma cells, the main source 
of endogenous immunoglobulins. Indeed, a variable but essential amount of the circulating 
antiPLA2R antibodies may be produced by a mature, long-lived plasma cell pool with a CD20 
negative but CD38 positive immunophenotype. Residual long-lived plasma cells could be a 
possible explanation for RTX non-responders as well as data indicating a trend towards lower 
response rate of RTX in MN for subjects with high anti-PLA2R antibody titers (Ruggenenti et al 
2012, van de Logt et al 2018).
Thus, an anti-CD38 directed specific plasma cell depletion by MOR202 may provide a viable 
emerging therapeutic option sparing patients of significant toxicity of broader acting 
immunosuppressive agents, possibly effective in patients with limited benefit of an anti-CD20 
directed therapy.
4.1. 
Background - nonclinical studies
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circulating levels of anti-PLA2R antibodies and proteinuria >3.5 g per day are candidates for early 
IST (Couser et al 2017, Bomback et al 2018, Vriese et al 2017). 
The above described ISTs exhibit considerable toxicity: 25% of patients treated with 
cyclophosphamide demonstrate adverse events (AEs) such as infections, infertility, hematologic 
toxicity and malignancy later in life (Couser et al 2017). Disadvantages of CNis include long-term 
nephrotoxicity, the need to closely monitor drug levels and the increased risk for hypertension and 
diabetes. Relapse rates with CNis seem to be higher than with cyclophosphamide [ 40 to 50 % 
versus 25%] (Cattran and Brenchley 2017, Tran et al 2015, van de Logt et al 2016). 
Therapy with RTX, an anti-CD20 therapeutic antibody, allows for a more targeted IST approach 
by depleting B cell populations involved in producing autoantibodies. RTX response rates seem 
to be similar to alkylating agents and CNis, whereas side effects seem to be less than for other 
drugs used in IST (Ruggenenti et al 2012, Fervenza et al 2017, Fervenza et al 2015). A prospective 
randomized trial testing RTX versus Cyclosporin A found RTX to be non-inferior (Fervenza et al 
2017). 
Interestingly, CD20 is not expressed on mature antibody producing plasma cells, the main source 
of endogenous immunoglobulins. Indeed, a variable but essential amount of the circulating 
antiPLA2R antibodies may be produced by a mature, long-lived plasma cell pool with a CD20 
negative but CD38 positive immunophenotype. Residual long-lived plasma cells could be a 
possible explanation for RTX non-responders as well as data indicating a trend towards lower 
response rate ofRTX in MN for subjects with high anti-PLA2R antibody titers (Ruggenenti et al 
2012, van de Logt et al 2018). 
Thus, an anti-CD38 directed specific plasma cell depletion by MOR202 may provide a viable 
emerging therapeutic option sparing patients of significant toxicity of broader acting 
immunosuppressive agents, possibly effective in patients with limited benefit of an anti-CD20 
directed therapy. 
4.1. 
Background - nonclinical studies 
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4.1.3. 
Toxicology
Based on the high sequence identity between marmoset monkey and human CD38 protein, the 
comparable binding affinity and expression levels of CD38 on blood cells as well as the similar 
activity to induce ADCC by PBMCs, the marmoset monkey was selected as the relevant species 
for the non-clinical safety assessment of MOR202.
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4.1.3. 
Toxicology 
Based on the high sequence identity between marmoset monkey and human CD38 protein, the 
comparable binding affinity and expression levels of CD38 on blood cells as well as the similar 
activity to induce ADCC by PBMCs, the marmoset monkey was selected as the relevant species 
for the non-clinical safety assessment of MOR202. 
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4.2. 
Background - clinical studies
To date, MOR202 has been administered in the first-in-human (FIH) study MOR202C101 in 
91 subjects with MM. This study is a combined dose escalation and dose confirmation study with 
a maximum dose of 16 mg/kg administered i.v. once weekly (including a loading dose on Cycle 
1, Day 4). MOR202 was applied either as a single agent or in combination with dexamethasone 
(DEX), lenalidomide (LEN)/DEX or pomalidomide (POM)/DEX. The overall treatment duration 
was based on clinical response with a continuous treatment for up to 3 years. The maximum 
tolerated dose (MTD) was not reached in this trial and the recommended dose was defined at 16 
mg/kg once weekly (i.e. the highest dose tested). As of 30-Nov-2019, 21 subjects were treated at 
this dose level for more than 6 months (13 subjects for more than 12 months and 9 subjects for 
more than 24 months) (Jarutat 2018, Raab et al 2020). 
 
 
4.2.1. 
Clinical pharmacokinetics and immunogenicity
The PK of MOR202 administered i.v. to MM patients has been well characterized by a 
2-compartment population PK model. The volume of distribution was found to be increased at 
lower MOR202 doses most likely reflecting the impact of target-mediated drug disposition 
(TMDD) effects. So far, anti-drug antibody (ADA) samples from 85 MM subjects with a treatment 
duration up to a maximum of 3 years have been analyzed. No ADA has been detected to date.
4.2.2. 
Clinical safety
The most commonly reported treatment-emergent adverse events (TEAEs) in the FIH study 
(MOR202C101) in MM were hematological AEs, such as lymphocytopenia, leukocytopenia, 
thrombocytopenia, and anemia.
The combination drugs for MM used in the FIH study are intrinsically myelosuppressive when 
administered as single agents. Anti-CD38 monoclonal antibodies (mAbs) may further deteriorate 
cytopenias induced by such background therapy. Cytopenic effects are well known and 
manageable via treatment with colony stimulating factors and blood transfusions.
Non-hematological TEAEs related to MOR202 reported in more than 5% of subjects overall in the 
FIH study were fatigue, infusion-related reactions, respiratory and urinary tract infections, diarrhea, 
nausea, hypokalemia, C-reactive protein increased, cough, constipation, hypophosphatemia, 
pyrexia, nasopharyngitis, and oral herpes.
Please refer to the Investigator Brochure for MOR202 for further details.
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4.2. 
Background - clinical studies 
To date, MOR202 has been administered in the first-in-human (FIH) study MOR202Cl01 in 
91 subjects with MM. This study is a combined dose escalation and dose confirmation study with 
a maximum dose of 16 mg/kg administered i.v. once weekly (including a loading dose on Cycle 
1, Day 4). MOR202 was applied either as a single agent or in combination with dexamethasone 
(DEX), lenalidomide (LEN)/DEX or pomalidomide (POM)/DEX. The overall treatment duration 
was based on clinical response with a continuous treatment for up to 3 years. The maximum 
tolerated dose (MTD) was not reached in this trial and the recommended dose was defined at 16 
mg/kg once weekly (i.e. the highest dose tested). As of 30-Nov-2019, 21 subjects were treated at 
this dose level for more than 6 months (13 subjects for more than 12 months and 9 subjects for 
more than 24 months) (Jarutat 2018, Raab et al 2020). 
 
 
4.2.1. 
Clinical pharmacokinetics and immunogenicity 
The PK of MOR202 administered i.v. to MM patients has been well characterized by a 
2-compartment population PK model. The volume of distribution was found to be increased at 
lower MOR202 doses most likely reflecting the impact of target-mediated drug disposition 
(TMDD) effects. So far, anti-drug antibody (ADA) samples from 85 MM subjects with a treatment 
duration up to a maximum of 3 years have been analyzed. No ADA has been detected to date. 
4.2.2. 
Clinical safety 
The most commonly reported treatment-emergent adverse events (TEAEs) in the FIH study 
(MOR202Cl01) in MM were hematological AEs, such as lymphocytopenia, leukocytopenia, 
thrombocytopenia, and anemia. 
The combination drugs for MM used in the FIH study are intrinsically myelosuppressive when 
administered as single agents. Anti-CD38 monoclonal antibodies (mAbs) may further deteriorate 
cytopenias induced by such background therapy. Cytopenic effects are well known and 
manageable via treatment with colony stimulating factors and blood transfusions. 
Non-hematological TEAEs related to MOR202 reported in more than 5% of subjects overall in the 
FIH study were fatigue, infusion-related reactions, respiratory and urinary tract infections, diarrhea, 
nausea, hypokalemia, C-reactive protein increased, cough, constipation, hypophosphatemia, 
pyrexia, nasopharyngitis, and oral herpes. 
Please refer to the Investigator Brochure for MOR202 for further details. 
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4.2.3. 
Clinical efficacy
In the MM studies, MOR202 has demonstrated clinical activity comparable to other CD38 
targeting agents in MM in terms of overall response rates (Raab et al 2020). 
 
 
4.2.4. 
Other anti-CD38 antibodies
Daratumumab and isatuximab have been approved for the therapy of different types of MM. 
TAK-079 is currently in mid stage clinical development for MM, systemic lupus erythematosus 
(SLE), myasthenia gravis and immune thrombocytopenic purpura.
There is no information available, whether these compounds were tested in patients with MN.
5. 
CLINICAL TRIAL PURPOSE AND OBJECTIVES
The purpose of the trial is to assess the safety and efficacy of the human anti-CD38 antibody 
MOR202 in subjects with aMN in two cohorts with subjects:
• 
Presenting with medium/high anti-PLA2R titer either newly diagnosed or after relapse 
and eligible for IST (Cohort 1) or
• 
With aMN refractory to IST (Cohort 2).
Objective
Endpoint
Primary
To assess the safety and tolerability 
of MOR202 treatment in subjects 
with aMN.
Incidence and severity of TEAEs.
Key
Secondary
To assess the effect of MOR202 on 
serum antiPLA2R antibodies in 
subjects with aMN.
Best immunological response: rate of 
sICR, ICR and IPR based on reduction of 
serum anti-PLA2R antibody titer.
Secondary
To assess the immunogenicity of 
MOR202 (anti-MOR202 antibody 
formation) in subjects with aMN.
Number and antibody titers of subjects 
tested positive for anti-MOR202 
antibodies.
To assess the PK profile of 
MOR202 in subjects with aMN.
MOR202 serum concentrations after 
multiple i.v. administrations.
To assess the safety in subjects with 
aMN after MOR202 treatment and 
during the follow-up phase.
Incidence and severity of AEs in the 
follow-up phase.
Exploratory
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4.2.3. 
Clinical efficacy 
In the MM studies, MOR202 has demonstrated clinical act1v1ty comparable to other CD38 
targeting agents in MM in terms of overall response rates (Raab et al 2020).
 
 
 
 
4.2.4. 
Other anti-CD38 antibodies 
Daratumumab and isatuximab have been approved for the therapy of different types of MM. 
TAK-079 is currently in mid stage clinical development for MM, systemic lupus erythematosus 
(SLE), myasthenia gravis and immune thrombocytopenic purpura. 
There is no information available, whether these compounds were tested in patients with MN. 
5. 
CLINICAL TRIAL PURPOSE AND OBJECTIVES 
The purpose of the trial is to assess the safety and efficacy of the human anti-CD38 antibody 
MOR202 in subjects with aMN in two cohorts with subjects: 
• 
Presenting with medium/high anti-PLA2R titer either newly diagnosed or after relapse 
and eligible for IST (Cohort 1) or 
• 
With aMN refractory to IST (Cohort 2). 
Objective 
Endpoint 
Primary 
To assess the safety and tolerability Incidence and severity of TEAEs. 
ofMOR202 treatment in subjects 
with aMN. 
Key 
To assess the effect of MOR202 on 
Best immunological response: rate of 
Secondary 
serum antiPLA2R antibodies in 
sICR, ICR and IPR based on reduction of 
subjects with aMN. 
serum anti-PLA2R antibody titer. 
Secondary 
To assess the immunogenicity of 
Number and antibody titers of subjects 
MOR202 (anti-MOR202 antibody 
tested positive for anti-MOR202 
formation) in subjects with aMN. 
antibodies. 
To assess the PK profile of 
MOR202 serum concentrations after 
MOR202 in subjects with aMN. 
multiple i.v. administrations. 
To assess the safety in subjects with Incidence and severity of AEs in the 
aMN after MOR202 treatment and 
follow-up phase. 
during the follow-up phase. 
Exploratory 
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Additional exploratory analyses 
may be performed to characterize 
further potential pharmacodynamic 
biomarkers under MOR202 
treatment.
• 
Changes in peripheral blood immune 
cell populations.
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Additional exploratory analyses 
 
may be performed to characterize 
• 
Changes in peripheral blood immune 
further potential pharmacodynamic 
cell populations. 
biomarkers under MQR202 
treatment. 
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6. 
CLINICAL TRIAL DESIGN
6.1. 
Rationale
6.1.1. 
Rationale for this Clinical Trial
This trial primarily seeks to assess the safety and tolerability of MOR202 therapy in aMN subjects. 
As a key further objective, the immunological response under MOR202 therapy will be assessed. 
Reduction in proteinuria as an early clinical efficacy parameter will be measured as well.
The monoclonal anti-CD38 antibody MOR202 selectively binds to the CD38 antigen and thereby 
depletes antibody producing cells such as plasmablasts and plasma cells mainly via ADCC and 
ADCP.
Plasma cells and plasmablasts are the source of pathogenic anti-PLA2R antibodies. Published 
evidence shows a tight correlation of the clinical course of MN with PLA2R autoantibody titers: 
high titers and sustained or re-emerging positivity of anti-PLA2R antibody titers during therapy 
have been demonstrated as negative predictors for outcome. Here, MOR202’s mode of action 
provides a compelling rationale for hard-to-treat aMN subjects, i.e. those presenting with high 
autoantibody titers, or subjects with insufficient immunological response to prior therapy.
6.1.2. 
Dosing Rationale
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6. 
6.1. 
6.1.1. 
CLINICAL TRIAL DESIGN 
Rationale 
Rationale for this Clinical Trial 
Protocol Number: MOR202Cl03 M-PLACE 
This trial primarily seeks to assess the safety and tolerability ofMOR202 therapy in aMN subjects. 
As a key further objective, the immunological response under MOR202 therapy will be assessed. 
Reduction in proteinuria as an early clinical efficacy parameter will be measured as well. 
The monoclonal anti-CD38 antibody MOR202 selectively binds to the CD38 antigen and thereby 
depletes antibody producing cells such as plasmablasts and plasma cells mainly via ADCC and 
ADCP. 
Plasma cells and plasmablasts are the source of pathogenic anti-PLA2R antibodies. Published 
evidence shows a tight correlation of the clinical course of MN with PLA2R autoantibody titers: 
high titers and sustained or re-emerging positivity of anti-PLA2R antibody titers during therapy 
have been demonstrated as negative predictors for outcome. Here, MOR202's mode of action 
provides a compelling rationale for hard-to-treat aMN subjects, i.e. those presenting with high 
autoantibody titers, or subjects with insufficient immunological response to prior therapy. 
6.1.2. 
Dosing Rationale 
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6.2. 
Overall Clinical Trial Design and Investigational Plan
T h is 
phase 
Ib/IIa 
m ulticenter 
trial 
enrolls 
subjects 
w ith  
a n ti-P L A 2 R  
an tibody 
p o sitive 
m em branous nephropathy (a M N ) in dicated for IS T  into tw o  cohorts:
C o h ort 1 w ill con sist o f approxim ately 20 a M N  n e w ly  d iagn osed or relapsin g subjects stable on 
supportive care treatm ent w ith  A C E I / A R B  at screen ing w ith  proteinuria and m edium /high serum 
titers o f  a n ti-P L A 2 R  antibodies elig ib le for IS T . (Note: Patients in France will not be enrolled 
in Cohort 1.)
C o h ort 2 w ill consist o f  approxim ately 10 subjects w ith  a M N  refractory to IS T  and requiring other 
form s o f  IS T .
F or detailed description o f the subjects in C o h ort 1 and 2 and the respective in - and exclu sion  
criteria refer to Section 7 .1  and Section  7 .2 .
T h e trial d esign  in cludes a S a fety R un -in , w h ich  in the initial stage o f  the trial intends to lim it drug 
exposure to the first three subjects (see Section  6 .3 ) . T h e rem ainder o f  planned subjects m a y on ly 
start treatm ent con tin gent on a p o sitive ou tcom e o f the safety observation s in these initial three 
subjects.
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6.2. 
Overall Clinical Trial Design and Investigational Plan 
This phase lb/Ila multicenter trial enrolls subjects with anti-PLA2R antibody positive 
membranous nephropathy (aMN) indicated for IST into two cohorts: 
Cohort 1 will consist of approximately 20 aMN newly diagnosed or relapsing subjects stable on 
supportive care treatment with ACEI/ ARB at screening with proteinuria and medium/high serum 
titers of anti-PLA2R antibodies eligible for IST. (Note: Patients in France will not be enrolled 
in Cohort 1.) 
Cohort 2 will consist of approximately 10 subjects with aMN refractory to IST and requiring other 
forms of IS T. 
For detailed description of the subjects in Cohort 1 and 2 and the respective in- and exclusion 
criteria refer to Section 7 .1 and Section 7.2. 
The trial design includes a Safety Run-in, which in the initial stage of the trial intends to limit drug 
exposure to the first three subjects (see Section 6.3). The remainder of planned subjects may only 
start treatment contingent on a positive outcome of the safety observations in these initial three 
subjects. 
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All trial subjects, including the safety run-in subjects, will follow the clinical trial schedule (Figure 
1) consisting of a
- 
Screening Phase
- 
Treatment Phase
- 
Follow-up Phase
Figure 1 
Clinical Trial Schedule
6.3. 
Safety Run-in
As this is the first time that MOR202 is tested in subjects with aMN, a safety-run-in is planned. 
The safety run-in period consists of the following:
The first three subjects dosed in this trial (regardless of cohort) will be treated and observed until 
C2D1 or until they have demonstrated a toxicity leading to discontinuation of treatment, whichever 
is earlier. In order to ensure sufficient exposure of three safety run-in subj ects to MOR202, subj ects 
will be replaced if within their first treatment cycle (C1) they
• 
Missed more than two doses of MOR202, or
• 
Discontinued treatment for reasons other than toxicities.
The safety run-in continues until three subjects are treated with sufficient exposure to MOR202. 
Replaced subjects may remain on trial and continue trial treatment as per protocol.
After the safety run-in, further subjects may start treatment unless any grade 4/5 ADR (related to 
MOR202) has occurred. If a grade 4/5 ADR occurs during the safety run-in, then a safety review 
must take place and start of treatment for further subjects will be contingent on the safety review 
outcome. The safety review will consist of an evaluation based on the number and type of all AEs 
occurring during the first cycle and laboratory values (biochemistry and hematology) and will be
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CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
All trial subjects, including the safety run-in subjects, will follow the clinical trial schedule (Figure 
I) consisting of a 
Screening Phase 
Treatment Phase 
Follow-up Phase 
Figure 1 
Clinical Trial Schedule 
Screening Phase of up to 6 weeks 
Cohort 1 
Newly diagnosed or 
relapsed MN 
subjects eligible for 
1ST (n=20) 
Cohort 2 
MN subjects 
refractory to 1ST 
(n=10) 
6.3. 
Safety Run-in 
MOR202 administration 
u 
c 
"' 
u 
24-week Treatment Phase 
MOR202 for 24 weeks 
c 
"' 
u 
EOT 
(D169) 
Primary Completion 
FUV 
(D267) 
28-week Follow-up Phase 
Observation for up to 1 year 
from C1D1 
EOS 
(D366) 
As this is the first time that MOR202 is tested in subjects with aMN, a safety-run-in is planned. 
The safety run-in period consists of the following: 
The first three subjects dosed in this trial (regardless of cohort) will be treated and observed until 
C2D I or until they have demonstrated a toxicity leading to discontinuation of treatment, whichever 
is earlier. In order to ensure sufficient exposure of three safety run-in subjects to MOR202, subjects 
will be replaced if within their first treatment cycle (Cl) they 
• 
Missed more than two doses ofMOR202, or 
• 
Discontinued treatment for reasons other than toxicities. 
The safety run-in continues until three subjects are treated with sufficient exposure to MOR202. 
Replaced subjects may remain on trial and continue trial treatment as per protocol. 
After the safety run-in, further subjects may start treatment unless any grade 4/5 ADR (related to 
MOR202) has occurred. If a grade 4/5 ADR occurs during the safety run-in, then a safety review 
must take place and start of treatment for further subjects will be contingent on the safety review 
outcome. The safety review will consist of an evaluation based on the number and type of all AEs 
occurring during the first cycle and laboratory values (biochemistry and hematology) and will be 
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perform ed b y  representatives o f  the participating in vestigators and the sponsor (S a fety R e v ie w  
Panel) as defin ed in a respective charter. T h e safety review  w ill b e h eld after C 2 D 1  o f  the third 
subject.
T h e  ou tcom e o f  this safety review  w ill also provide a confirm ation on the dose and d osin g schedule 
for M O R 2 0 2  or recom m endation for an adapted dose and/or d osin g schedule to b e used in the 
fo llo w in g  part o f  the trial or recom m endation for term ination o f  the trial because o f  u n acceptable 
to xicity. S a fety run-in subjects w ill continue the trial as per protocol during the safety review . 
A fterw ard s, their M O R 2 0 2  dose m ay b e altered as w e ll.
6.4. 
Screening Phase
See Section 10 .1 and Section  10 .2 .
6.5. 
Treatment Phase
A ll subjects enrolled in the trial w ill b e treated for 24 w eek s across six 2 8 -d a y treatm ent cycles.
In total, 9 doses o f  M O R 2 0 2  w ill b e adm inistered on the fo llo w in g  treatm ent days: C y c le  1 D a y  1, 
8, 15 and 22, and on D a y  1 o f  C y c le  2 to 6 (for details see F igu re 1 and T a b le 2 ) .
T h e  Treatm ent P h ase ends w ith  the E O T  visit, scheduled b etw een  28 and 42 days after the last 
adm inistration o f  M O R 2 0 2 . F o r details see Section  10 .4 .
6.6. 
Follow-up Phase
T h e fo llo w -u p  phase consists o f  28 w eek s o f  post-treatm ent fo llo w -u p  starting from  the E O T  visit. 
It con sists o f  tw o  visits at an interval o f  14 w eek s each.
T h e  fo llo w -u p  phase ends w ith  the E O S  visit, scheduled 28 w eek s after the E O T  visit. F o r details 
see Section  10 .5 .
6.7. 
Clinical Trial Duration
T h e  duration o f  this trial is planned to b e approxim ately 2 years from  first subject sign in g the 
inform ed consent form  (IC F ) until trial com pletion.
Su bjects w ill b e on the clin ical trial from  sign in g o f  IC F  until the E O S  v isit (i.e. a planned 
m axim u m  tim e period o f  58 w eeks: up to 6 -w e e k  screening phase, 2 4 -w e e k  treatm ent phase and 
2 8 -w e e k  fo llo w -u p  phase).
6.8. 
Risks and Benefits to Subjects
Sim ilar safety fin d in gs w ere also observed in the F iH  trial M O R 2 0 2 C 1 0 1  (see Section  4.2 and 
Section  6 .1 .2 ) . In this trial adm inistering M O R 2 0 2  to M M  subjects the m ost frequent M O R 2 0 2  
related treatm ent em ergent 
adverse 
events 
( T E A E s ) w ere throm bocytopenia, 
neutropenia, 
lym phopenia, and in fections. N o  A D A s  w ere detected in this trial until the prim ary com pletion 
date (sam ples an alyzed  from  85 subj ects treated for up to 29 m onths at a m axim u m ) (Jarutat 2 0 18 ) .
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performed by representatives of the participating investigators and the sponsor (Safety Review 
Panel) as defined in a respective charter. The safety review will be held after C2D I of the third 
subject. 
The outcome of this safety review will also provide a confirmation on the dose and dosing schedule 
for MQR202 or recommendation for an adapted dose and/or dosing schedule to be used in the 
following part of the trial or recommendation for termination of the trial because of unacceptable 
toxicity. Safety run-in subjects will continue the trial as per protocol during the safety review. 
Afterwards, their MQR202 dose may be altered as well. 
6.4. 
Screening Phase 
See Section 10. 1 and Section 10.2. 
6.5. 
Treatment Phase 
All subjects enrolled in the trial will be treated for 24 weeks across six 28-day treatment cycles. 
In total, 9 doses ofMQR202 will be administered on the following treatment days: Cycle I Day 1, 
8, 15 and 22, and on Day I of Cycle 2 to 6 (for details see Figure I and Table 2). 
The Treatment Phase ends with the EQT visit, scheduled between 28 and 42 days after the last 
administration ofMQR202. For details see Section 10.4. 
6.6. 
Follow-up Phase 
The follow-up phase consists of 28 weeks of post-treatment follow-up starting from the EQT visit. 
It consists of two visits at an interval of 14 weeks each. 
The follow-up phase ends with the EQS visit, scheduled 28 weeks after the EQT visit. For details 
see Section 10.5. 
6. 7. 
Clinical Trial Duration 
The duration of this trial is planned to be approximately 2 years from first subject signing the 
informed consent form (ICF) until trial completion. 
Subjects will be on the clinical trial from signing of ICF until the EQS visit (i.e. a planned 
maximum time period of 58 weeks: up to 6-week screening phase, 24-week treatment phase and 
28-week follow-up phase). 
6.8. 
Risks and Benefits to Subjects 
Similar safety findings were also observed in the FiH trial MQR202Cl01 (see Section 4.2 and 
Section 6.1.2). In this trial administering MQR202 to MM subjects the most frequent MQR202 
related treatment emergent adverse events (TEAEs) were thrombocytopenia, neutropenia, 
lymphopenia, and infections. No ADAs were detected in this trial until the primary completion 
date (samples analyzed from 85 subjects treated for up to 29 months at a maximum) (Jarutat 201 8). 
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It is exp ected  that the potential risks as described ab o ve w ill be ad equately controlled b y  the design 
o f  this trial (e.g. b y  the in clusion and exclu sio n  criteria) as w ell as b y  frequent m onitorin g for 
potential A D R s . S in ce a m ajor ph arm aco lo gical effect o f  M O R 2 0 2  is depletion o f  plasm a cells 
and plasm ablasts, the risk for a p oten tially reduced fun ction o f  the ad aptive im m une system  w as 
further 
addressed. 
T h is 
com prises 
m onitorin g 
and 
potential 
substitution 
o f  total 
serum 
im m u n oglo bu lin  as w e ll as vaccin a tio n  before trial start (see Section  7 .1 and Section  7 .2 ) .
M O R 2 0 2  offers a n o vel m echanism  o f  action that m ay h ave the potential to em erge as an im portant 
treatm ent option for a M N  patients com pared to current (o ff-lab el) treatm ent options. Particularly 
w ith  calcineurin inhibitors (C N Is) b ein g in trin sically nephrotoxic and cyclo p h o sp h a m id e as an 
alk ylatin g 
cy to to x ic 
drug 
b e in g  
associated 
w ith  
kn ow n  
h em atotoxicity, 
risk 
o f  ovarian 
in su fficien cy and second ary m align an cy, n ew  therapeutic options are needed for the treatm ent o f 
M N . R ecen t literature su ggests that R T X , although m ore favo rable in the safety profile com pared 
to the aforem entioned drugs, m igh t h ave decreased a ctivity in h igh  a n tiP L A 2 R  an tibody titer 
subjects (R u ggen en ti et al 2 0 1 5 ) . T h is patient population is sp ecifica lly addressed b y  C o h ort 1 o f 
this trial.
N o n  response to an im m un osuppressive regim en m ay b e caused b y  survival o f  lo n g -liv e d  plasm a 
cells produ cing a n ti-P L A 2 R  antibodies. T h ese cells dem onstrate a h igh  expression o f  M O R 2 0 2 ’ s 
target C D 3 8 . T h is patient population is sp ecifica lly addressed b y  C o h ort 2 o f  this trial.
In this con text and tak in g into accou nt the existin g clin ical experien ce w ith  M O R 2 0 2 , the overall 
risk/benefit ratio for the trial subjects is regarded as acceptable.
7. 
SELECTION OF SUBJECTS
A ll subjects m ust sign  the I C F  and m ust m eet the fo llo w in g  selection  criteria at screening to 
participate in the trial.
7.1. 
Inclusion Criteria
Sin ce deviations from  in clu sion  criteria can h ave a n egative im pact on subject safety or the 
scien tific in tegrity and regulatory accep tab ility o f  the clin ical trial, the Sponsor w ill not provid e 
w a ivers to them  (p a ra m eters in  ita lics w ill be te ste d  a t screen in g ; p a ra m e te rs n o t in  ita lics w ill be 
d e te rm in e d  lo ca lly) :
C o h ort 1 and 2:
1. 
>  18 to <  80 years (at date o f  sign in g IC F ).
2. 
U rine p ro te in  to cre a tin in e ra tio  (U P C R ) o f  > 3 .0 0 0  g /g  O R  p ro te in u ria  > 3 .5 0 0  g /2 4  h 
fr o m  2 4  h  u rin e a t screening.
3. 
A n ti-P L A 2 R  an tibody p o sitive M N  in need o f  1S T  accord in g to the in vestigato r’ s 
jud gm en t. T h e diagn osis o f  M N  should b e h isto lo g ica lly docum en ted w ith  a diagn ostic 
b iop sy; for this purpose, a b io p sy at screen ing or an archival b io p sy acquired w ith in  5 years 
prior to screening is acceptable.
4. 
E stim a te d  g lo m e ru la r filtr a tio n  ra te (eG F R ) > 5 0  m L /m in /1 .7 3  m 2. A lte rn a tiv e ly  eG F R  
> 30 a n d  < 5 0  m L /m in /1 .7 3 m 2 a n d  in te rstitia lfib ro sis a n d  tu b u la r a tro p h y (IF T A ) sco re < 
2 5 %  in a  re n a l b io p sy o b ta in e d  w ith in  the la st 6 m o n th s p r io r  to sta rt o f  sc re e n in g  ( if not 
available, a b io p sy should b e perform ed at screening to obtain the I F T A  assessm ent).
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It is expected that the potential risks as described above will be adequately controlled by the design 
of this trial (e.g. by the inclusion and exclusion criteria) as well as by frequent monitoring for 
potential ADRs. Since a major pharmacological effect of MOR202 is depletion of plasma cells 
and plasmablasts, the risk for a potentially reduced function of the adaptive immune system was 
further addressed. This comprises monitoring and potential substitution of total serum 
immunoglobulin as well as vaccination before trial start (see Section 7.1 and Section 7.2). 
MOR202 offers a novel mechanism of action that may have the potential to emerge as an important 
treatment option for aMN patients compared to current ( off-label) treatment options. Particularly 
with calcineurin inhibitors (CNls) being intrinsically nephrotoxic and cyclophosphamide as an 
alkylating cytotoxic drug being associated with known hematotoxicity, risk of ovarian 
insufficiency and secondary malignancy, new therapeutic options are needed for the treatment of 
MN. Recent literature suggests that RTX, although more favorable in the safety profile compared 
to the aforementioned drugs, might have decreased activity in high antiPLA2R antibody titer 
subjects (Ruggenenti et al 201 5). This patient population is specifically addressed by Cohort 1 of 
this trial. 
Non response to an immunosuppressive regimen may be caused by survival of long-lived plasma 
cells producing anti-PLA2R antibodies. These cells demonstrate a high expression of MOR202's 
target CD38. This patient population is specifically addressed by Cohort 2 of this trial. 
In this context and taking into account the existing clinical experience with MOR202, the overall 
risk/benefit ratio for the trial subjects is regarded as acceptable. 
7. 
SELECTION OF SUBJECTS 
All subjects must sign the ICF and must meet the following selection criteria at screening to 
participate in the trial. 
7.1. 
Inclusion Criteria 
Since deviations from inclusion criteria can have a negative impact on subject safety or the 
scientific integrity and regulatory acceptability of the clinical trial, the Sponsor will not provide 
waivers to them (parameters in italics will be tested at screening; parameters not in italics will be 
determined locally): 
Cohort 1 and 2: 
1. 
18 to :S: 80 years (at date of signing ICF). 
2. Urine protein to creatinine ratio (UPCR) of~ 3. 000 gig OR proteinuria 
3.500 g/24 h 
from 2 4 h urine at screening. 
3. Anti-PLA2R antibody positive MN in need of 1ST according to the investigator's 
judgment. The diagnosis of MN should be histologically documented with a diagnostic 
biopsy; for this purpose, a biopsy at screening or an archival biopsy acquired within 5 years 
prior to screening is acceptable. 
4. Estimated glomerular filtration rate (eGFR) 
50 mL/min/1. 73 m 2• Alternatively eGFR 
30 and< 50 mL/min/1. 73m 2 and interstitial fibrosis and tubular atrophy (IFTA) score< 
25% in a renal biopsy obtained within the last 6 months prior to start of screening (if not 
available, a biopsy should be performed at screening to obtain the IFTA assessment). 
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5. 
N o t in spontaneous rem ission despite proper treatm ent w ith  A C E Is , A R B s  (su fficien t dose 
and treatm ent duration) as per clin ical practice and scien tific gu idelines. I f  the Principal 
Investigator determ ines that a subject is intolerant to an A C E I  or A R B , the reason m ust be 
docum en ted and approval obtained from  the M ed ica l M o n ito r prior to enrolm ent.
6. 
S y sto lic b lo o d  pressure (B P ) <  150  m m H g  and d iasto lic B P  <  100 m m H g  after 5 m inutes 
o f  rest.
7. 
Su b ject vaccin a ted  again st P n eu m o co ccu s w ith in  the last 5 years prior to date o f  sign in g 
IC F  (subjects m a y b e vaccin a ted  to m eet this criterion during screening; interval to first 
dose o f  M O R 2 0 2  m ust b e at least 14 days [M S D  S m P C ]).
8. 
C o h ort 1 com prises n e w ly  diagn osed or relapsed subjects: S eru m  a n ti-P L A 2 R  a n tib o d ies 
> 5 0 .0  R U /m L  d e te rm in e d  a t sc re e n in g  b y E u ro im m u n  E L IS A  a t c e n tra l laboratory.
9. 
C o h ort 2 com prises therapy refractory subjects:
a. 
Su b ject did not ach ieve im m u n ological rem ission after prior IS T (s) as 
docum en ted b y  the in vestigator A N D
b. 
Su b ject is w ith ou t prom isin g standard therapeutic options as docum en ted b y  the 
in vestigator (i.e. in vestigato r exp ects e ffica cy  or safety issues w ith  rem aining IS T  
options) A N D
c. 
S eru m  a n ti-P L A 2 R  a n tib o d ie s > 2 0 .0  R U /m L  m e a su re d  a t sc re e n in g  b y the 
E u ro im m u n  E L IS A  a t c e n tra l laboratory.
N ote: Fran ce w ill o n ly enroll patients in C o h ort 2.
7.2. 
Exclusion Criteria
Sin ce deviations from  exclu sio n  criteria can h ave a n egative im pact on subject safety or the 
scien tific in tegrity and regulatory accep tab ility o f  the clin ical trial, the sponsor w ill not provide 
w a ivers to them . Subjects m ust b e exclu d ed  from  participating in this clin ical trial i f  th ey m eet any 
o f  the fo llo w in g  criteria at screen ing (p a ra m eters in  ita lics w ill be te ste d  a t screen in g ; param eters 
not in italics w ill b e determ ined locally):
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5. Not in spontaneous remission despite proper treatment with ACEls, ARBs (sufficient dose 
and treatment duration) as per clinical practice and scientific guidelines. If the Principal 
Investigator determines that a subject is intolerant to an ACEI or ARB, the reason must be 
documented and approval obtained from the Medical Monitor prior to enrolment. 
6. Systolic blood pressure (BP) .S 150 mmHg and diastolic BP .S 100 mmHg after 5 minutes 
of rest. 
7. Subject vaccinated against Pneumococcus within the last 5 years prior to date of signing 
ICF (subjects may be vaccinated to meet this criterion during screening; interval to first 
dose ofMOR202 must be at least 14 days [MSD SmPC]). 
8. Cohort 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies 
50. 0 RU/mL determined at screening by Euroimmun ELISA at central laboratory. 
9. 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 1ST 
options) AND 
c. Serum anti-PLA2R antibodies ~ 20.0 RU/mL measured at screening by the 
Euroimmun ELISA at central laboratory. 
Note: France will only enroll patients in Cohort 2. 
7.2. 
Exclusion Criteria 
Since deviations from exclusion criteria can have a negative impact on subject safety or the 
scientific integrity and regulatory acceptability of the clinical trial, the sponsor will not provide 
waivers to them. Subjects must be excluded from participating in this clinical trial if they meet any 
of the following criteria at screening (parameters in italics will be tested at screening; parameters 
not in italics will be determined locally): 
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1. 
H e m o g lo b in  < 8 0  g /L f
2. 
T h ro m b o cyto p en ia : P la te le ts < 1 00 .0  x 109/L *
3. 
N eu tro p en ia : N e u tro p h ils < 1.5 x 109/L#
4. 
L eu ko p e n ia : L e u k o c y te s < 3.0 x 109/L #
5. 
H y p o g a m m a g lo b u lin e m ia  d e fin e d  a s seru m  im m u n o g lo b u lin  < 4.0 g / L f
f Subjects may receive blood transfusions or erythropoietin to meet the criterion.
* Subjects may receive thrombopoietin to meet the criterion.
# Subjects may receive colony stimulating factors to meet the criterion.
{ Subjects may receive immunoglobulin substitution to meet the criterion.
6. 
B -c e lls < 5 x 1 0 6/L.
7. Secondary cause of MN (e.g. SLE, medications, malignancies) as determined by the 
investigator.
8. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA 
nephropathy).
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1. Hemoglobin< 80 g/Lt 
2. Thrombocytopenia: Platelets< 100.0 x 109/L* 
3. Neutropenia: Neutrophils < 1.5 x 109/L# 
4. Leukopenia: Leukocytes < 3. 0 x 109 /L# 
5. Hypogammaglobulinemia defined as serum immunoglobulin :'S 4. 0 g/Lf 
t Subjects may receive blood transfusions or erythropoietin to meet the criterion. 
* Subjects may receive thrombopoietin to meet the criterion. 
# Subjects may receive colony stimulating factors to meet the criterion. 
t Subjects may receive immunoglobulin substitution to meet the criterion. 
6. B-cells < 5 x 106/L. 
7. Secondary cause of MN (e.g. SLE, medications, malignancies) as determined by the 
investigator. 
8. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA 
nephropathy). 
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8. 
TREATMENT OF SUBJECTS
8.1. 
Prior Therapy
The following prior therapy will be recorded in the eCRF:
• 
All prior medications/non-drug procedures given for MN.
• 
All prior immunosuppressive medications.
• 
All other medication and other therapy (including non-drug procedure) taken 
by/administered to the subject within 30 days prior to signature of ICF.
The entry must include the dose, regimen, route of administration, indication, and dates of use 
(start, end).
8.2. 
Investigational Medicinal Product (IMP)
Each Investigator is responsible for ensuring that deliveries of IMP(s) and other clinical trial 
materials from the sponsor are completely and correctly received, recorded, handled and stored 
safely and properly in accordance with all applicable regulatory guidelines, and used in accordance 
with this clinical trial protocol.
The IMP must be stored in a secure area under the appropriate physical conditions for the product. 
Access to and administration of the IMP will be limited to the Investigator or designee. The IMP 
must be dispensed or administered only to subjects enrolled in the clinical trial and in accordance 
with the protocol. After the clinical trial and overall drug accountability, all unused IMP must be 
returned to the sponsor or destroyed on site following the Drug Handling Manual.
8.2.1. 
MOR202
MOR202 antibody (i.e. compound MOR03087, this protocol refers to as MOR202) will be 
supplied by the sponsor as a lyophilized powder for reconstitution in labelled glass vials. MOR202 
must be stored at 2-8°C until use.
MOR202 will be labelled according to applicable regulatory requirements. All chemical, physical 
and pharmaceutical characteristics are summarized in the Investigator’s Brochure.
8.2.2. 
Preparation and application of MOR202 including prophylaxis of infusion 
reactions
MOR202 will be administered i.v. at a dose of 16 mg/kg. Preferably, body weight data will be 
collected in the morning of the dosing day. In case this is not possible, the MOR202 dose must be 
based on a weight determined within 14 days prior to dosing.
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8. 
TREATMENT OF SUBJECTS 
8.1. 
Prior Therapy 
The following prior therapy will be recorded in the eCRF: 
• 
All prior medications/non-drug procedures given for MN. 
• 
All prior immunosuppressive medications. 
• 
All other medication and other therapy (including non-drug procedure) taken 
by/administered to the subject within 30 days prior to signature ofICF. 
The entry must include the dose, regimen, route of administration, indication, and dates of use 
(start, end). 
8.2. 
Investigational Medicinal Product (IMP) 
Each Investigator is responsible for ensuring that deliveries of IMP(s) and other clinical trial 
materials from the sponsor are completely and correctly received, recorded, handled and stored 
safely and properly in accordance with all applicable regulatory guidelines, and used in accordance 
with this clinical trial protocol. 
The IMP must be stored in a secure area under the appropriate physical conditions for the product. 
Access to and administration of the IMP will be limited to the Investigator or designee. The IMP 
must be dispensed or administered only to subjects enrolled in the clinical trial and in accordance 
with the protocol. After the clinical trial and overall drug accountability, all unused IMP must be 
returned to the sponsor or destroyed on site following the Drug Handling Manual. 
8.2.1. 
MOR202 
MOR202 antibody (i.e. compound MOR03087, this protocol refers to as MOR202) will be 
supplied by the sponsor as a lyophilized powder for reconstitution in labelled glass vials. MOR202 
must be stored at 2-8°C until use. 
MOR202 will be labelled according to applicable regulatory requirements. All chemical, physical 
and pharmaceutical characteristics are summarized in the Investigator's Brochure. 
8.2.2. 
Preparation and application of MOR202 including prophylaxis of infusion 
reactions 
MOR202 will be administered i.v. at a dose of 16 mg/kg. Preferably, body weight data will be 
collected in the morning of the dosing day. In case this is not possible, the MOR202 dose must be 
based on a weight determined within 14 days prior to dosing. 
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For administration, 
 
 
 The individual MOR202 infusion will be prepared under aseptic 
conditions and administered at the trial site according to the directions of the Drug Handling 
Manual.
8.3. 
Concomitant Therapy
Subjects are allowed to continue medications that they are taking at baseline, particularly, 
supportive therapy for MN and therapy initiated at screening such as immunoglobulin substitution 
or erythropoiesis stimulating agent (ESA) therapy. Subjects are allowed to receive concomitant 
medications that are medically indicated as standard of care for the treatment of symptoms and 
intercurrent illnesses, unless they fall under prohibited medications. Subjects may also receive 
therapy to mitigate side effects of the trial medication as clinically indicated, as well as best 
supportive care as per institutional guidelines. This may include medications such as diuretics, 
anti-lipid-medication, anti-hypertensive (e.g. ACEI), anticoagulation, antiemetics, antidiarrheals, 
anticholinergics, antispasmodics, antipyretics, antihistamines, analgesics, or antibiotics. The 
Investigator should instruct the subject not to take any additional medications (including over-the- 
counter products) during the trial without prior consultation.
Investigators should document all medication and other therapy (including non-drug procedure) 
taken by/administered to the subject during the entire course of the trial including the screening 
and the follow-up phase. The entry must include the dose, regimen, route of administration, 
indication, and dates of use (start, end).
8.3.1 
Management of Infusion Related Reactions (IRRs)
If a subject presents with a grade 1 or 2 infusion reaction:
• 
The infusion should be stopped immediately.
• 
The subject should receive appropriate further treatment with an antihistamine, 
paracetamol (acetaminophen), and glucocorticoids as clinically indicated.
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For administration, 
 
 
 The individual MOR202 infusion will be prepared under aseptic 
conditions and administered at the trial site according to the directions of the Drug Handling 
Manual. 
8.3. 
Concomitant Therapy 
Subjects are allowed to continue medications that they are taking at baseline, particularly, 
supportive therapy for MN and therapy initiated at screening such as immunoglobulin substitution 
or erythropoiesis stimulating agent (ESA) therapy. Subjects are allowed to receive concomitant 
medications that are medically indicated as standard of care for the treatment of symptoms and 
intercurrent illnesses, unless they fall under prohibited medications. Subjects may also receive 
therapy to mitigate side effects of the trial medication as clinically indicated, as well as best 
supportive care as per institutional guidelines. This may include medications such as diuretics, 
anti-lipid-medication, anti-hypertensive (e.g. ACEI), anticoagulation, antiemetics, antidiarrheals, 
anticholinergics, antispasmodics, antipyretics, antihistamines, analgesics, or antibiotics. The 
Investigator should instruct the subject not to take any additional medications (including over-the-
counter products) during the trial without prior consultation. 
Investigators should document all medication and other therapy (including non-drug procedure) 
taken by/administered to the subject during the entire course of the trial including the screening 
and the follow-up phase. The entry must include the dose, regimen, route of administration, 
indication, and dates of use (start, end). 
8.3.1 
Management of Infusion Related Reactions (IRRs) 
If a subject presents with a grade 1 or 2 infusion reaction: 
• 
The infusion should be stopped immediately. 
• 
The subject should receive appropriate further treatment with an antihistamine, 
paracetamol (acetaminophen), and glucocorticoids as clinically indicated. 
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• 
Once the symptoms have been resolved or reduced to “mild” according to the investigator’s 
assessment, the infusion can be continued at an infusion rate of 50% of the initial rate. If, 
after 1 hour, the subject is symptom-free and vital signs are stable, the infusion rate may 
be increased every 30 minutes by approximately 25% of the reduced rate as tolerated.
• 
If a subject who developed a grade 1 or 2 IRR will receive further infusions, then 
premedication with glucocorticoids either as mandated by this protocol or by local 
guidelines should be given before start of any subsequent MOR202 infusion. The infusion 
rate should be slowed down and the duration of infusion should exceed that of the last prior 
infusion by at least 30 minutes.
If a subject exhibits a grade 3 IRR:
• 
The infusion should be stopped immediately.
• 
The subject must receive appropriate treatment with an antihistamine, paracetamol 
(acetaminophen), and glucocorticoids and, as necessary, further medications (i.e. 
epinephrine, bronchodilator).
• 
Only after the resolution of all symptoms to < grade 1, and after having received 
appropriate prophylactic medication(s) as described above, the infusion may be resumed 
at an infusion rate of 25% of the initial rate. If, after 1 hour, the subject’s symptoms do not 
return and vital signs are stable, the infusion rate may be increased to a maximum of 50% 
of the initial rate.
• 
If, after the resumption of the infusion, symptoms return (irrespective of grade), the 
infusion must be discontinued for that visit date and the infusion tubing should be 
disconnected. Based on the investigator’s decision, the subject may receive further 
MOR202 at the next scheduled visit provided clinically appropriate precautions were 
taken.
• 
If a subj ect who developed a grade 3 IRR will receive further infusions, then premedication 
with glucocorticoids either as mandated by this protocol or by local guidelines should be 
given before start of any subsequent MOR202 infusion. The infusion rate should be slowed 
down and the duration of infusion should exceed that of the last prior infusion by at least 
30 minutes.
If a subject presents with a grade 4 IRR:
• 
The infusion must be discontinued immediately and the infusion tubing should be 
disconnected.
• 
The subject must receive appropriate treatment with an antihistamine, paracetamol 
(acetaminophen), and glucocorticoids and, if necessary, further medications (i.e. 
epinephrine, bronchodilator).
• 
The subject must not receive any further MOR202 infusion and must discontinue trial 
treatment, subject may enter the follow-up phase.
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• 
Once the symptoms have been resolved or reduced to "mild" according to the investigator's 
assessment, the infusion can be continued at an infusion rate of 50% of the initial rate. If, 
after I hour, the subject is symptom-free and vital signs are stable, the infusion rate may 
be increased every 30 minutes by approximately 25% of the reduced rate as tolerated. 
• If a subject who developed a grade I or 2 IRR will receive further infusions, then 
premedication with glucocorticoids either as mandated by this protocol or by local 
guidelines should be given before start of any subsequent MOR202 infusion. The infusion 
rate should be slowed down and the duration of infusion should exceed that of the last prior 
infusion by at least 30 minutes. 
If a subject exhibits a grade 3 IRR: 
• 
The infusion should be stopped immediately. 
• 
The subject must receive appropriate treatment with an antihistamine, paracetamol 
(acetaminophen), and glucocorticoids and, as necessary, further medications (i.e. 
epinephrine, bronchodilator). 
• 
Only after the resolution of all symptoms to :S grade 1, and after having received 
appropriate prophylactic medication(s) as described above, the infusion may be resumed 
at an infusion rate of 25% of the initial rate. If, after I hour, the subject's symptoms do not 
return and vital signs are stable, the infusion rate may be increased to a maximum of 50% 
of the initial rate. 
• 
If, after the resumption of the infusion, symptoms return (irrespective of grade), the 
infusion must be discontinued for that visit date and the infusion tubing should be 
disconnected. Based on the investigator's decision, the subject may receive further 
MOR202 at the next scheduled visit provided clinically appropriate precautions were 
taken. 
• If a subject who developed a grade 3 IRR will receive further infusions, then premedication 
with glucocorticoids either as mandated by this protocol or by local guidelines should be 
given before start of any subsequent MOR202 infusion. The infusion rate should be slowed 
down and the duration of infusion should exceed that of the last prior infusion by at least 
30 minutes. 
If a subject presents with a grade 4 IRR: 
• 
The infusion must be discontinued immediately and the infusion tubing should be 
disconnected. 
• 
The subject must receive appropriate treatment with an antihistamine, paracetamol 
(acetaminophen), and glucocorticoids and, if necessary, further medications (i.e. 
epinephrine, bronchodilator). 
• 
The subject must not receive any further MOR202 infusion and must discontinue trial 
treatment, subject may enter the follow-up phase. 
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8.3.2 
Infection Prophylaxis
The immunoglobulin level will be monitored throughout the trial. If this level drops below 4 g/L, 
initiating substitution therapy with a polyvalent immunoglobulin according to local institutional 
guidelines is advised. Generally, a trough level of at least 5 g/L shall be targeted, with a 
substitution of 0.2 g per kg body weight every 3 to 4 weeks.
Furthermore, investigators may follow institutional guidelines on infection prophylaxis for 
subjects regarded to be at high risk of infection.
8.4. 
Prohibited Therapy: Immunosuppressive therapies (IST)
The use of ISTs other than MOR202 is prohibited during the entire trial. This includes, but is not 
limited to ACTH, chemotherapies, immunotherapy, biological response modifiers, mAbs with or 
without conjugation, CNIs (e.g. cyclosporine, tacrolimus), plasmapheresis and immuno- 
adsorption. MOR202 treatment of subjects in need of immunosuppressive therapies must be 
discontinued and the subject must be discontinued from the trial (see Section 8.8.5).
Subjects in need of systemic corticosteroid therapy other than for prophylaxis and treatment of 
IRR for more than 7 days may continue being treated with MOR202, but will be excluded from 
the Per Protocol Analysis Set and the Immunological Analysis Set (IAS).
8.5. 
Treatment Adherence
Subjects will receive MOR202 under the direct supervision of site personnel. Each administration 
volume or dose will be checked.
The vial/outer package code and volume or dose per administration will be recorded in each 
subject’s eCRF as well as in the source data. At each visit after initiation of treatment, site staff 
will record adherence of subjects to their assigned regimen.
Non-adherence is defined as administering < 70% or > 
 of a MOR202 dose.
Any MOR202 dose missed without a medical reason is considered a non-adherence.
8.6. 
Overdose
In this clinical trial, an overdose of MOR202 is defined as a dose exceeding 
 of the planned dose.
In clinical trial MOR202C101, four incidents of doses exceeding the calculated dose were noted, 
all of these doses exceeded the planned dose by no more than 10.5% and affected subjects 
remained asymptomatic.
In case of overdose, infusion should be discontinued immediately and subjects should be closely 
monitored for signs or symptoms of AEs for 24 hours, and appropriate symptomatic treatment 
instituted immediately if needed. No specific antidote is available. Overdose with clinical 
symptoms will be reported as AE (non-serious or serious) in accordance to Section 10.8.10.
8.7. 
Treatment management of subjects with toxicity
For the first dosing of MOR202, subjects should exhibit hemoglobin, leucocyte, neutrophil and 
platelet counts meeting the eligibility criteria. They should not have an active infection > grade 2.
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8.3.2 
Infection Prophylaxis 
The immunoglobulin level will be monitored throughout the trial. If this level drops below 4 g/L, 
initiating substitution therapy with a polyvalent immunoglobulin according to local institutional 
guidelines is advised. Generally, a trough level of at least 5 g/L shall be targeted, with a 
substitution of 0.2 g per kg body weight every 3 to 4 weeks. 
Furthermore, investigators may follow institutional guidelines on infection prophylaxis for 
subjects regarded to be at high risk of infection. 
8.4. 
Prohibited Therapy: Immunosuppressive therapies (1ST) 
The use of IS Ts other than MOR202 is prohibited during the entire trial. This includes, but is not 
limited to ACTH, chemotherapies, immunotherapy, biological response modifiers, mAbs with or 
without conjugation, CNis (e.g. cyclosporine, tacrolimus), plasmapheresis and immuno-
adsorption. MOR202 treatment of subjects in need of immunosuppressive therapies must be 
discontinued and the subject must be discontinued from the trial (see Section 8.8.5). 
Subjects in need of systemic corticosteroid therapy other than for prophylaxis and treatment of 
IRR for more than 7 days may continue being treated with MOR202, but will be excluded from 
the Per Protocol Analysis Set and the Immunological Analysis Set (IAS). 
8.5. 
Treatment Adherence 
Subjects will receive MOR202 under the direct supervision of site personnel. Each administration 
volume or dose will be checked. 
The vial/outer package code and volume or dose per administration will be recorded in each 
subject's eCRF as well as in the source data. At each visit after initiation of treatment, site staff 
will record adherence of subjects to their assigned regimen. 
Non-adherence is defined as administering :S 70% or> 
 of a MOR202 dose. 
Any MOR202 dose missed without a medical reason is considered a non-adherence. 
8.6. 
Overdose 
In this clinical trial, an overdose ofMOR202 is defined as a dose exceeding 
 of the planned dose. 
In clinical trial MOR202C 101, four incidents of doses exceeding the calculated dose were noted, 
all of these doses exceeded the planned dose by no more than 10.5% and affected subjects 
remained asymptomatic. 
In case of overdose, infusion should be discontinued immediately and subjects should be closely 
monitored for signs or symptoms of AEs for 24 hours, and appropriate symptomatic treatment 
instituted immediately if needed. No specific antidote is available. Overdose with clinical 
symptoms will be reported as AE (non-serious or serious) in accordance to Section 10.8.10. 
8. 7. 
Treatment management of subjects with toxicity 
For the first dosing of MOR202, subjects should exhibit hemoglobin, leucocyte, neutrophil and 
platelet counts meeting the eligibility criteria. They should not have an active infection ?. grade 2. 
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For subsequent doses, in case a subject shows laboratory values as listed below, further treatment 
of the subject has to be interrupted:
• 
Hemoglobin level < 60 g/L (grade 3): interruption until resolved to > 80 g/L.
• 
Platelet count < 75.0 x 109/L (grade 2): interruption until resolved to > 100.0 x 109/L.
• 
Neutrophil count < 1.000 x 109/L (grade 3): interruption until resolved to > 1.500 x 109/L.
If the subject exhibits any other clinically relevant adverse drug reaction > grade 3, MOR202 
administration has to be interrupted until the toxicity has resolved to grade 2 or better.
8.8. 
Subject Discontinuation of IMP and Subject Withdrawal
8.8.1. 
Discontinuation due to toxicity
MOR202 treatment must be permanently discontinued, if:
• 
Needing platelet transfusion.
• 
Not recovering to < grade 2 from > grade 3 ADRs related to MOR202 within 21 days 
despite adequate treatment of the ADR.
• 
Experiencing grade 4 IRR.
Subjects discontinuing MOR202 treatment will have their EOT visit (earliest after 28 days after 
last dose of MOR202) and enter the follow-up phase.
8.8.2. 
Discontinuation due to other reasons
MOR202 treatment must be permanently discontinued for subjects:
• 
With progressive disease as defined in Section 3.2
• 
Wishing to discontinue MOR202 treatment
• 
With pregnancy
Investigator(s) have the right to discontinue subjects from MOR202 treatment in the event of 
illness, AEs, or other reasons putting a risk to the health or well-being of the subject, or in case of 
lack of subject’s co-operation.
The reason for discontinuing MOR202 treatment must be noted in the eCRF.
Subjects discontinuing MOR202 treatment will have their EOT visit (earliest after 28 days after 
last dose of MOR202) and enter the follow-up phase.
8.8.3. 
Discontinuation due to efficacy - stringent immunological complete remission
Furthermore, treatment may be discontinued for subjects with stringent immunological complete 
remission (sICR) confirmed by repeat measurement at least 25 days apart. These subjects will 
follow their planned schedule, but will not be treated at the following Cx D1 visits, unless a subject 
turns positive again during the treatment phase.
8.8.4. 
Withdrawal due to Subject Decision
Each subject is free to withdraw from the clinical trial at any time. All efforts will be made to 
complete and report the observations up to the time of withdrawal as thoroughly as possible. A 
complete final evaluation at the time of the subject’s withdrawal should be made (all assessments 
scheduled for EOT/EOS visit depending on time of withdrawal). An explanation why the subject
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For subsequent doses, in case a subject shows laboratory values as listed below, further treatment 
of the subject has to be interrupted: 
• 
Hemoglobin level< 60 g/L (grade 3): interruption until resolved to 2: 80 g/L. 
• 
Platelet count< 75.0 x 109/L (grade 2): interruption until resolved to 2: 100.0 x 109/L. 
• 
Neutrophil count< 1.000 x 109/L (grade 3): interruption until resolved to 2: 1.500 x 109/L. 
If the subject exhibits any other clinically relevant adverse drug reaction 2: grade 3, MQR202 
administration has to be interrupted until the toxicity has resolved to grade 2 or better. 
8.8. 
8.8.1. 
Subject Discontinuation of IMP and Subject Withdrawal 
Discontinuation due to toxicity 
MQR202 treatment must be permanently discontinued, if: 
• 
Needing platelet transfusion. 
• 
Not recovering to :S grade 2 from 2: grade 3 ADRs related to MQR202 within 21 days 
despite adequate treatment of the ADR. 
• 
Experiencing grade 4 IRR. 
Subjects discontinuing MQR202 treatment will have their EQT visit (earliest after 28 days after 
last dose ofMQR202) and enter the follow-up phase. 
8.8.2. 
Discontinuation due to other reasons 
MQR202 treatment must be permanently discontinued for subjects: 
• 
With progressive disease as defined in Section 3 .2 
• 
Wishing to discontinue MQR202 treatment 
• 
With pregnancy 
Investigator(s) have the right to discontinue subjects from MQR202 treatment in the event of 
illness, AEs, or other reasons putting a risk to the health or well-being of the subject, or ·n case of 
lack of subject's co-operation. 
The reason for discontinuing MQR202 treatment must be noted in the eCRF. 
Subjects discontinuing MQR202 treatment will have their EQT visit (earliest after 28 days after 
last dose ofMQR202) and enter the follow-up phase. 
8.8.3. 
Discontinuation due to efficacy - stringent immunological complete remission 
Furthermore, treatment may be discontinued for subjects with stringent immunological complete 
remission (sICR) confirmed by repeat measurement at least 25 days apart. These subjects will 
follow their planned schedule, but will not be treated at the following CxD 1 visits, unless a subject 
turns positive again during the treatment phase. 
8.8.4. 
Withdrawal due to Subject Decision 
Each subject is free to withdraw from the clinical trial at any time. All efforts will be made to 
complete and report the observations up to the time of withdrawal as thoroughly as possible. A 
complete final evaluation at the time of the subject's withdrawal should be made (all assessments 
scheduled for EQT/EQS visit depending on time of withdrawal). An explanation why the subject 
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is withdrawing from the clinical trial should be provided. If withdrawn in the treatment phase, 
these subjects will not enter the follow-up phase.
8.8.5. 
Withdrawal due to Use of Prohibited Therapy [Immunosuppressive Therapy]
Subjects starting on prohibited IST other than MOR202 will be withdrawn from the clinical trial. 
If withdrawn in the treatment phase, these subjects will immediately be scheduled for their EOT 
visit (at least 28 days after the last MOR202 dose) and will not enter the follow-up phase.
8.9. 
Subject replacement
After safety run-in, withdrawn or discontinued subjects will not be replaced.
8.10. 
IMP Accountability
The assigned pharmacist or other designated individual at the site will maintain up-to-date records:
• 
Of IMP delivered to the site
• 
The dispensation to and use by each subject
• 
And the return of unused IMP to the sponsor or disposal
9. 
TRIAL PAUSING OR TERMINATION
9.1. 
Safety Review Triggers and Decision Making
After completion of the safety run-in, toxicities leading to discontinuation will be continuously 
monitored. Recruitment into the MOR202C103 clinical trial will be paused in the following 
situation until a safety review by the Safety Review Panel consisting of representatives of the 
participating investigators and the sponsor (as defined in Section 6.3) is performed:
• 
If at any time treatment with MOR202 had to be discontinued due to the reasons listed in 
Section 8.8.1 in at least 2 subjects treated.
The safety review will consist of an evaluation based on the number and type of AEs and 
laboratory values (biochemistry and hematology) and will be performed by representatives of the 
participating investigators and the sponsor as defined in a respective charter. Based on the 
assessment, the Safety Review Panel (see Section 6.3) will decide on further steps, e.g. pause of 
dosing in all subjects, introduction of any required protocol changes or trial termination due to 
unacceptable toxicity.
Additional safety review may be triggered at any time if any of the following occur:
• 
Thrombocytopenia > grade 3 in at least 4 subjects
• 
IRR > grade 3 in at least 4 subjects
• 
A single patient is not recovering to < grade 2 from > grade 3 ADRs related to MOR202 
within 21 days despite adequate treatment of the ADR.
The Safety Review Panel will convene, perform a safety review and make recommendations as 
outlined above.
9.2. 
Clinical Trial (Site) Termination
The sponsor can terminate this clinical trial for any reason at any time.
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is withdrawing from the clinical trial should be provided. If withdrawn in the treatment phase, 
these subjects will not enter the follow-up phase. 
8.8.5. 
Withdrawal due to Use of Prohibited Therapy [Immunosuppressive Therapy] 
Subjects starting on prohibited 1ST other than MOR202 will be withdrawn from the clinical trial. 
If withdrawn in the treatment phase, these subjects will immediately be scheduled for their EQT 
visit (at least 28 days after the last MOR202 dose) and will not enter the follow-up phase. 
8.9. 
Subject replacement 
After safety run-in, withdrawn or discontinued subjects will not be replaced. 
8.10. 
IMP Accountability 
The assigned pharmacist or other designated individual at the site will maintain up-to-date records: 
• 
Of IMP delivered to the site 
• 
The dispensation to and use by each subject 
• 
And the return of unused IMP to the sponsor or disposal 
9. 
TRIAL PAUSING OR TERMINATION 
9.1. 
Safety Review Triggers and Decision Making 
After completion of the safety run-in, toxicities leading to discontinuation will be continuously 
monitored. Recruitment into the MOR202C 103 clinical trial will be paused in the following 
situation until a safety review by the Safety Review Panel consisting of representatives of the 
participating investigators and the sponsor (as defined in Section 6.3) is performed: 
If at any time treatment with MOR202 had to be discontinued due to the reasons listed in 
Section 8.8. 1 in at least 2 subjects treated. 
The safety review will consist of an evaluation based on the number and type of AEs and 
laboratory values (biochemistry and hematology) and will be performed by representatives of the 
participating investigators and the sponsor as defined in a respective charter. Based on the 
assessment, the Safety Review Panel (see Section 6.3) will decide on further steps, e.g. pause of 
dosing in all subjects, introduction of any required protocol changes or trial termination due to 
unacceptable toxicity. 
Additional safety review may be triggered at any time if any of the following occur: 
Thrombocytopenia ?. grade 3 in at least 4 subjects 
IRR ?. grade 3 in at least 4 subjects 
A single patient is not recovering to :S grade 2 from ?. grade 3 ADRs related to MOR202 
within 21 days despite adequate treatment of the ADR. 
The Safety Review Panel will convene, perform a safety review and make recommendations as 
outlined above. 
9.2. 
Clinical Trial (Site) Termination 
The sponsor can terminate this clinical trial for any reason at any time. 
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10. 
CLINICAL TRIAL ASSESSMENTS
The Schedule of Assessments is presented in Table 2. All examinations or assessments to be 
performed at a specific visit are indicated with an X. Results obtained from these assessments need 
to be documented in the hospital record of the subject unless they are generated in a central 
laboratory.
Visits maybe postponed due to AEs as described above (see Section 8.7), but in all other situations 
conducting visits as scheduled is important.
Each treatment cycle (C) consist of 28 days (D). Allowed visit windows are
• 
± 2 days for C1D8 to C2D1,
• 
± 7 days for C3D1 to C6D1,
• 
+ 14 days for EOT visit, and
• 
± 14 days for FUV and EOS visit.
Further excursions from the timing of assessments will be considered protocol deviations and 
should be recorded in the source documents along with the reason.
The date of the next visit will always be recalculated based on the actual date of the previous IMP 
administration.
Subjects missing a treatment visit within the specified visit window for reasons other than toxicity 
will get the next dose at the next scheduled visit and thus receive less than the planned 9 MOR202 
applications.
Table 2 
Schedule of Assessments
Clinical Trial
SC
BL
C1D
C1D
C1D
C2D
C3D
C4D
C5D1
C6D1
EOT
FUV
EOS
Schedule of
R
C1D1
8
15
22
1
1
1
Assessments
Day6
-42
1
8
15
22
29
57
85
113
141
169
267
366
to -1
±2
±2
±2
±2
±7
±7
±7
±7 days
+14 days
±14
±14
days
days
days
days
days
days
days
days
days
T ests/assessments
Informed consent
X
Medical history/ 
demography/ disease 
therapy history/ allergies 
and hypersensitivities
X
Inclusion/exclusion
X
Recording of
prior/concomitant
medication
X
X
X
X
X
X
X
X
X
X
X
X
X
12-lead ECG
X
X3
X
Kidney biopsy
X4
X5
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10. 
CLINICAL TRIAL ASSESSMENTS 
The Schedule of Assessments is presented in Table 2. All examinations or assessments to be 
performed at a specific visit are indicated with an X. Results obtained from these assessments need 
to be documented in the hospital record of the subject unless they are generated in a central 
laboratory. 
Visits maybe postponed due to AEs as described above (see Section 8.7), but in all other situations 
conducting visits as scheduled is important. 
Each treatment cycle (C) consist of 28 days (D). Allowed visit windows are 
• 
± 2 days for ClD8 to C2Dl, 
• 
± 7 days for C3Dl to C6Dl, 
• + 14 days for EQT visit, and 
• 
± 14 days for FUV and EOS visit. 
Further excursions from the timing of assessments will be considered protocol deviations and 
should be recorded in the source documents along with the reason. 
The date of the next visit will always be recalculated based on the actual date of the previous IMP 
administration. 
Subjects missing a treatment visit within the specified visit window for reasons other than toxicity 
will get the next dose at the next scheduled visit and thus receive less than the planned 9 MOR202 
applications. 
Table 2 
Schedule of Assessments 
Oinical Trial 
SC 
BL 
cm cm cm C2D C3D C4D 
C5D1 
C6D1 
E0T 
FUV 
E0S 
Cml 
Schedule of 
R 
8 
15 
22 
1 
1 
1 
Assessments 
Day• 
-42 
1 
8 
15 
22 
29 
57 
85 
113 
141 
169 
267 
366 
to -1 
±2 
±2 
±2 
±2 
±7 
±7 
±7 
±7 days 
+14 days 
±14 
±14 
days days 
days days days days 
days 
days 
days 
Tests/assessments 
Informed consent 
X 
Medical history/ 
demography/ disease 
X 
therapy history/ allergies 
and hypersensitivities 
Inclusion/ exclusion 
X 
Recording of 
prior/concomitant 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
medication 
12-lead ECG 
X 
X3 
X 
Kidney biopsy 
X4 
XS 
MorphoSys AG 
Confidential 
Page 46 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Clinical Trial
SC
BL
C1D
C1D
C1D
C2D
C3D
C4D
C5D1
C6D1
EOT
FUV
EOS
Schedule of
R
C1D1
8
15
22
1
1
1
Assessments
Day6
-42
1
8
15
22
29
57
85
113
141
169
267
366
to -1
±2
±2
±2
±2
±7
±7
±7
±7 days
+14 days
±14
±14
days
days
days
days
days
days
days
days
days
T ests/assessments
Blood typing and 
screening for irregular 
antibodies at local blood 
bank
X6
Full physical examination 
(Limited)
X
L
L
L
L
L
L
L
L
L
X
L
X
Height
X
Body weight
X
X2
X2
X2
X2
X2
X2
X2
X2
X2
X
X
X
Vital signs
X
X2
X2
X2
X2
X2
X2
X2
X2
X2
X
X
X
Adverse event assessment
X
X
X
X
X
X
X
X
X
X
X
X
Serum pregnancy
(in FCBP)
X
X
X
X
Urine pregnancy 
(in FCBP)
X2
X2
X2
X2
X2
X2
X2
X2
X2
Pregnancy and risk 
counselling
X
Hepatitis B/C, HIV 
Serology/Vi rology
X
Urine analysis
X
X2
X2
X2
X2
X
X
24 h urine collection for 
UPCR ratio, Na+
X
X2
X2
X
X
X
Single urine sample:
UPCR ratio#
X
X2
X2
X2
X2
X
X
X
Anti-PLA2R antibodies
X
X2
X2
X2
X2
X2
X2
X2
X2
X2
X
X
X
CBC with differential 
blood
X
X2
X2
X2
X2
X2
X2
X2
X2
X2
X
X
X
Serum Biochemistry, 
Immunoglobulins
X
X2
X2
X2
X2
X2
X2
X2
X2
X2
X
X
X
Hba1c
X9
Coagulation
X2
X
X
X
Lipid panel
X
X
X
On site hematology
X2
X2
X2
X2
X2
X2
X2
X2
X2
MorphoSys AG
Confidential
Page 47 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
Oinical Trial 
SC 
BL 
cm cm cm C2D C3D C4D 
C5D1 
C6D1 
E0T 
FUV 
E0S 
Cml 
Schedule of 
R 
8 
15 
22 
1 
1 
1 
Assessments 
Day• 
-42 
1 
8 
15 
22 
29 
57 
85 
113 
141 
169 
267 
366 
to -1 
±2 
±2 
±2 
±2 
±7 
±7 
±7 
±7 days 
+14 days 
±14 
±14 
days days 
days days days days 
days 
days 
days 
Tests/assessments 
Blood typing and 
screening for irregular 
X6 
antibodies at local blood 
bank 
Full physical examination 
X 
L 
L 
L 
L 
L 
L 
L 
L 
L 
X 
L 
X 
(Limited) 
Height 
X 
Bodyweight 
X 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X 
X 
X 
Vital signs 
X 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X 
X 
X 
Adverse event assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serum pregnancy 
X 
X 
X 
X 
(inFCBP) 
Urine pregnancy 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
(in FCBP) 
Pregnancy and risk 
X 
counselling 
Hepatitis EiC, HIV 
X 
Serology/Virology 
Urine analysis 
X 
X2 
X2 
X2 
X2 
X 
X 
24 h urine collection for 
X 
X2 
X2 
X 
X 
X 
UPCR ratio, Na+ 
Single urine sample: 
X 
X2 
X2 
X2 
X2 
X 
X 
X 
UPCR ratio#4 
Anti-PIA2R antibodies 
X 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X 
X 
X 
CBC with differential 
X 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X 
X 
X 
blood 
Serum Biochemistry, 
X 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X 
X 
X 
Jmmunoglobulins 
Hbalc 
X9 
Coagulation 
X2 
X 
X 
X 
Lipid panel 
X 
X 
X 
On site hematology 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
MorphoSys AG 
Confidential 
Page 47 of73 
CCI


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Clinical Trial
SC
BL
C1D
C1D
C1D
C2D
C3D
C4D
C5D1
C6D1
EOT
FUV
EOS
Schedule of
R
C1D1
8
15
22
1
1
1
Assessments
Day6
-42
1
8
15
22
29
57
85
113
141
169
267
366
to -1
±2
±2
±2
±2
±7
±7
±7
±7 days
+14 days
±14
±14
days
days
days
days
days
days
days
days
days
T ests/assessments
MOR 202 infusion with 
pre-infusion medication
X
X
X
X
X
X
X
X
X
PK sampling MGR202 
(serum)
X1
X1
X1
X1
X1
X2
X2
X2
X2
X
X
X
PK sampling MGR202
X2
X2
X2
X2
X2
X2
X2
X2
X
X
X
(urine) (spot check) 4
ADA sampling
X2
X2
X2
X2
X
X
X
Biomarker sampling 
(blood)
X8
X2
X2
X2
X2
X2
X
X
X
Biomarker sampling 
(serum)2
X1
X1
X1
X2
X2
X
X
X
Biomarker sampling 
(urine) (spot check)3 4
X2
X2
X2
X2
X2
X
X
X
X1: predose and 30 min after end of infusion;
X2: predose, MOR202 may not be applied without baseline UPCR value from 24 h urine collection,
X3: postdose;
X4: mandatory for all subjects if not done within the last 5 years before start of screening, mandatory for subjects with eGFR 
< 50ml/min/1.73m2 or with diabetes mellitus type 2 if not done within the last 6 months before start of screening, optional for all other patients; 
X5 optional for subjects who had a kidney biopsy at screening,
X6: see Section 10.1 of clinical trial protocol,
X7: predose during treatment phase, only for subjects who provided optional consent for future research,
X8: Only B-cell, T-cell, and natural killer (NK) cell counts,
X9: only in subjects with diabetes mellitus type II
SCR: screening, BL: baseline; EOT: end of treatment; FUV: follow-up visit, EOS: end of study
1Immune cell counts 
 
2Antigen specific immunoglobulin levels 
6The date of the next visit will always be recalculated based on the actual date of the previous IMP administration. Thus, the actual number of 
days from baseline visit (C1D1) for an individual subject might differ from the standard scheme as shown in the Schedule of Assessments in 
the protocol.
For screening, subjects will be given supplies for collection of a 24-hour urine sample at screening and will return with the collected sample 
within the screening phase. For other visits, the sample will be collected 24 hours immediately prior to the visit. Subjects who forget to collect 
this sample prior to the visit, start a 24-hour urine sample at the same visit day and return it the next working day. If the collected urine does 
not contain at least 5 mg creatinine/kg/day for females and 6 mg creatinine/kg/day for males, urine collection needs to be repeated.
MorphoSys AG
Confidential
Page 48 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
Oinical Trial 
SC 
BL 
cm cm cm C2D C3D C4D 
C5D1 
C6D1 
E0T 
FUV 
E0S 
Cml 
Schedule of 
R 
8 
15 
22 
1 
1 
1 
Assessments 
Day• 
-42 
1 
8 
15 
22 
29 
57 
85 
113 
141 
169 
267 
366 
to -1 
±2 
±2 
±2 
±2 
±7 
±7 
±7 
±7 days 
+14 days 
±14 
±14 
days days 
days days days days 
days 
days 
days 
Tests/assessments 
MOR 202 infusion with 
X 
X 
X 
X 
X 
X 
X 
X 
X 
pre-infusion medication 
PK samplingMOR202 
XI 
XI 
XI 
XI 
XI 
X2 
X2 
X2 
X2 
X 
X 
X 
(serum) 
PK samplingMOR202 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X 
X 
X 
(urine) (spot check) 4 
ADA sampling 
X2 
X2 
X2 
X2 
X 
X 
X 
Biomarker sampling 
X8 
X2 
X2 
X2 
X2 
X2 
X 
X 
X 
(blood/ 
Biomarker sampling 
XI 
XI 
XI 
X2 
X2 
X 
X 
X 
(serum)2 
Biomarker sampling 
X2 
X2 
X2 
X2 
X2 
X 
X 
X 
(urine) (spot check) 3• 4 
XI: predose and 30 min after end of infusion; 
X2: predose, MOR202 may not be applied without baseline UPCR value from 24 h urine collection, 
X3: postdose; 
X4: mandatory for all subjects if not done within the last S years before start of screening, mandatory for subjects with eGFR 
< S0ml/min/l .73m2 or with diabetes mellitus type 2 if not done within the last 6 months before start of screening, optional for all other patients; 
XS optional for subjects mio had a kidney biopsy at screening, 
X6: see Section IO .I of clinical trial protocol, 
X7: predose during treatment phase, only for subjects mio provided optional consent for future research, 
X8: Only B-cell, T-cell, and natural killer (NK) cell counts, 
X9: only in subjects with diabetes mellitus type II 
SCR: screening, BL: baseline; EOT: end of treatment; FUV: follow-up visit, EOS: end of study 
1 Immune cell counts 
 
 
2Antigen specific immunoglobulin levels 
 
6The date of the next visit will always be recalculated based on the actual date of the previous IMP administration. Thus, the actual number of 
days from baseline visit (CID!) for an individual subject might differ from the standard scheme as shown in the Schedule of Assessments in 
the protocol. 
For screening, subjects will be given supplies for collection of a 24-hour urine sample at screening and will return with the collected sample 
within the screening phase. For other visits, the sample will be collected 24 hours immediately prior to the visit. Subjects mio forget to collect 
this sample prior to the visit, start a 24-hour urine sample at the same visit day and return it the next working day. If the collected urine does 
not contain at least S mg creatinine/kg/day for females and 6 mg creatinine/kg/day for males, urine collection needs to be repeated. 
MorphoSys AG 
Confidential 
Page 48 of73 
CCI
CCI
CCI
CCI


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Clinical Trial 
Schedule of
Assessments
SC
R
BL
C1D1
C1D
8
C1D
15
C1D
22
C2D
1
C3D
1
C4D
1
C5D1
C6D1
EOT
FUV
EOS
Day6
T ests/assessments
-42 
to -1
1
8
±2
days
15
±2
days
22
±2
days
29
±2
days
57
±7
days
85
±7
days
113
±7
days
141
±7 days
169
+14 days
267
±14
days
366
±14
days
Limited PEs must include vital signs and general appearance and may be focused on clinical symptoms observed. If clinically indicated, a full 
PE must be performed at any trial visit.
Parameters in italics are measured in a central laboratory.
10.1. 
Screening Phase
All subjects must meet all inclusion criteria and none of the exclusion criteria listed in 
Section 7.1 and Section 7.2. Signed and dated informed consent must be obtained from all 
subjects prior to their entering the clinical trial.
The Screening Phase begins on the date when the ICF is signed; it will last for up to 42 days and 
is followed by treatment start (Cycle 1 Day 1, C1D1).
The assessments to be performed at screening are:
Documentation of
• 
Informed consent
• 
Medical history including results of biopsies and disease therapy history
• 
Laboratory values including
o proteinuria
o 
all available historic anti-PLA2R titers and IFT results
• 
Demography (age, gender, race)
• 
Prior and concomitant medications
• 
Allergies and hypersensitivities
Assessment of
• 
In- and exclusion criteria
• 
Physical examination
• 
Electrocardiogram (ECG)
• 
Vital signs (blood pressure, heart rate, body temperature)
• 
Weight (in kg without decimals with 1st decimal rounding in case of higher precision 
scales; e.g. 67.4 rounded to 67; 67.5 rounded up to 68)
• 
Height (in centimeter without decimals)
Laboratory
• 
Complete blood count with differential white blood cell count (CBC)
• 
B-cell count
• 
HbA1c
• 
Serum biochemistry including immunoglobulins
MorphoSys AG
Confidential
Page 49 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
Oinical Trial 
SC 
BL 
cm cm cm C2D C3D C4D 
C5D1 
C6D1 
E0T 
FUV 
E0S 
Cml 
Schedule of 
R 
8 
15 
22 
1 
1 
1 
Assessments 
Day• 
-42 
1 
8 
15 
22 
29 
57 
85 
113 
141 
169 
267 
366 
to -1 
±2 
±2 
±2 
±2 
±7 
±7 
±7 
±7 days 
+14 days 
±14 
±14 
days days 
days days days days 
days 
days 
days 
Tests/assessments 
Limited PEs must include vital signs and general appearance and may be focused on clinical symptoms observed. If clinically indicated, a full 
PE must be performed at any trial visit. 
Parameters in italics are measured in a central laboratory. 
10.1. 
Screening Phase 
All subjects must meet all inclusion criteria and none of the exclusion criteria listed in 
Section 7.1 and Section 7.2. Signed and dated informed consent must be obtained from all 
subjects prior to their entering the clinical trial. 
The Screening Phase begins on the date when the ICF is signed; it will last for up to 42 days and 
is followed by treatment start (Cycle 1 Day 1, ClDl). 
The assessments to be performed at screening are: 
Documentation of 
• 
Informed consent 
• 
Medical history including results of biopsies and disease therapy history 
• 
Laboratory values including 
o proteinuria 
o all available historic anti-PLA2R titers and IFT results 
• 
Demography (age, gender, race) 
• 
Prior and concomitant medications 
• 
Allergies and hypersensitivities 
Assessment of 
• 
In- and exclusion criteria 
• 
Physical examination 
• 
Electrocardiogram (ECG) 
• 
Vital signs (blood pressure, heart rate, body temperature) 
• 
Weight (in kg without decimals with 1st decimal rounding in case of higher precision 
scales; e.g. 67.4 rounded to 67; 67.5 rounded up to 68) 
• 
Height (in centimeter without decimals) 
Laboratory 
• 
Complete blood count with differential white blood cell count (CBC) 
• 
B-cell count 
• 
HbAlc 
• 
Serum biochemistry including immunoglobulins 
MorphoSys AG 
Confidential 
Page 49 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
• 
Hepatitis B/C, HIV Serology/Virology (incl. PCR confirmation)
• 
Lipid panel
• 
Urine analysis
• 
eGFR
• 
Liver function tests (AST, ALT, gamma-GT, bilirubin)
• 
24 hour urine for urine protein, creatinine, and sodium
An abnormal laboratory value may be reanalyzed during the screening phase.
Substitution with immunoglobulins before or during screening is permitted. Data on immuno-
globulin administration should be entered in the eCRF as concomitant medication.
24 hour urine:
For screening, subjects will be given supplies for collection of 24-hour urine and will return the 
collected sample within the visit window. For visits C4D1, EOT, FUV, and EOS the sample will 
be collected prior to the visit. Subjects who forget to collect this sample prior to the visit, start a 
24-hour urine sample at the visit day and return it the next working day after completion. If the 
collected urine does not contain at least 5 mg creatinine/kg/day for females and 6 mg 
creatinine/kg/day for males, urine collection needs to be repeated immediately without undue 
delay.
Kidney biopsy
• 
Mandatory:
o 
For all subjects if not done within the last 5 years before start of screening.
o 
For subjects with eGFR < 50 mL/min/1.73m2 if not done within the last 6 months 
before start of screening.
o 
For subjects with diabetes mellitus type 2 if not done within the last 6 months 
before start of screening.
• 
Optional:
o 
For all other subjects.
The histological assessment of a fresh kidney biopsy obtained under this clinical trial protocol 
should include a confirmation of the diagnosis of MN as well as the grade of any existing 
interstitial fibrosis. Biopsies will further be subject to biomarker studies as outlined in the 
exploratory objectives, theses analyses will be retrospective in nature.
Females of child bearing potential (FCBP, for definition see above Section 7.1) will be tested for 
pregnancy (serum or urine analysis at different visits). Of note, in each case of delayed menstrual 
period (over one month between menstruations during the study) confirmation of absence of 
pregnancy with pregnancy test (urine or serum on discretion of investigator) is strongly 
recommended. This recommendation also applies to FCBP with infrequent or irregular menstrual 
cycles.
FCBPs and non-vasectomized males will be counselled for pregnancy risks.
The assessments performed during screening may substitute as baseline data if for any reason 
baseline values from the baseline period (Section 10.3 and Table 2) are missing.
MorphoSys AG
Confidential
Page 50 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
• 
Hepatitis B/C, HIV Serology/Virology (incl. PCR confirmation) 
• 
Lipid panel 
• 
Urine analysis 
• 
eGFR 
• 
Liver function tests (AST, ALT, gamma-GT, bilirubin) 
• 
24 hour urine for urine protein, creatinine, and sodium 
An abnormal laboratory value may be reanalyzed during the screening phase. 
Substitution with immunoglobulins before or during screening is permitted. Data on immuno-
globulin administration should be entered in the eCRF as concomitant medication. 
24 hour urine: 
For screening, subjects will be given supplies for collection of 24-hour urine and will return the 
collected sample within the visit window. For visits C4Dl, EOT, FUV, and EOS the sample will 
be collected prior to the visit. Subjects who forget to collect this sample prior to the visit, start a 
24-hour urine sample at the visit day and return it the next working day after completion. If the 
collected urine does not contain at least 5 mg creatinine/kg/day for females and 6 mg 
creatinine/kg/day for males, urine collection needs to be repeated immediately without undue 
delay. 
Kidney biopsy 
• 
Mandatory: 
o 
For all subjects if not done within the last 5 years before start of screening. 
o 
For subjects with eGFR < 50 mL/min/1.73m2 if not done within the last 6 months 
before start of screening. 
o 
For subjects with diabetes mellitus type 2 if not done within the last 6 months 
before start of screening. 
• 
Optional: 
o 
For all other subjects. 
The histological assessment of a fresh kidney biopsy obtained under this clinical trial protocol 
should include a confirmation of the diagnosis of MN as well as the grade of any existing 
interstitial fibrosis. Biopsies will further be subject to biomarker studies as outlined in the 
exploratory objectives, theses analyses will be retrospective in nature. 
Females of child bearing potential (FCBP, for definition see above Section 7.1) will be tested for 
pregnancy (serum or urine analysis at different visits). Of note, in each case of delayed menstrual 
period (over one month between menstruations during the study) confirmation of absence of 
pregnancy with pregnancy test (urine or serum on discretion of investigator) is strongly 
recommended. This recommendation also applies to FCBP with infrequent or irregular menstrual 
cycles. 
FCBPs and non-vasectomized males will be counselled for pregnancy risks. 
The assessments performed during screening may substitute as baseline data if for any reason 
baseline values from the baseline period (Section 10.3 and Table 2) are missing. 
MorphoSys AG 
Confidential 
Page 50 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
On a single occasion during screening, it is permitted to repeat the central laboratory assessments 
of serum chemistry and hematology if out-of-range laboratory results might have been caused by 
a transient, medically plausible event, e.g. dehydration. The repeat procedure and the rationale 
behind must be documented in the source data. Such repeated assessment will not be counted as 
“re screening” for that subject.
For all screening failure subjects data on demographics and inclusion/exclusion criteria will be 
documented in the eCRF. Serious adverse events will be reported in accordance with 
Section 10.8.10.
For subjects requiring blood transfusions the presence of high levels of therapeutic anti-CD38 
antibodies in host serum like MOR202 most likely interferes with blood bank serologic tests, 
particularly the indirect Coombs test (Oostendorp et al 2015, Weinig 2017 [MOR202L069]).
Therefore, subjects must be typed and screened for the eventual presence of irregular antibodies 
before the first administration of MOR202. Phenotyping may be considered prior to starting 
MOR202 treatment as per local practice. Red blood cell genotyping is not impacted by CD38 
antibodies and may be performed at any time.
In the event of a planned transfusion blood transfusion centers should be notified of the 
interference with indirect antiglobulin tests.
If an emergency transfusion is required, non-cross-matched ABO/RhD-compatible RBCs can be 
given per local blood bank practices.
Further technical guidance to mitigate this interference is published in the AABB bulletin #16-02 
(AABB), e.g. a baseline typing and screening for irregular antibodies before starting MOR202 
treatment and/or the use of dithiothreitol (DTT)-treated cells for antibody detection (screening) 
and identification during MOR202 treatment as well as at least 6 months after the last MOR202 
administration (Chapuy et al 2016, Chapuy et al 2015).
10.1.1. 
Screening Failures
Subjects who sign an informed consent but fail to start treatment for any reason will be considered 
a screen failure. Minimum data requirements for the eCRF are: the reason for not starting 
treatment, demographic information, and SAEs.
10.2. 
Re-screening Procedures
Subjects can be re-screened at the discretion of the investigator under certain circumstances. 
Rescreening is restricted to one attempt per subject and can only be performed if one of the 
following criteria is met:
• 
The subject has already consented and met all of the inclusion and none of the exclusion 
criteria and his or her enrollment was delayed due to an unexpected change in the subject’s 
personal situation (e.g., family issues).
• 
The subject previously failed to be eligible due to a circumstance (e.g., planned surgery, 
pathological laboratory test result) that has resolved.
• 
The subject previously failed screening but has become eligible for the trial based on a 
change in the inclusion and exclusion criteria as a result of a protocol amendment.
MorphoSys AG
Confidential
Page 51 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
On a single occasion during screening, it is permitted to repeat the central laboratory assessments 
of serum chemistry and hematology if out-of-range laboratory results might have been caused by 
a transient, medically plausible event, e.g. dehydration. The repeat procedure and the rationale 
behind must be documented in the source data. Such repeated assessment will not be counted as 
"re screening" for that subject. 
For all screening failure subjects data on demographics and inclusion/exclusion criteria will be 
documented in the eCRF. Serious adverse events will be reported in accordance with 
Section 10.8.10. 
For subjects requiring blood transfusions the presence of high levels of therapeutic anti-CD38 
antibodies in host serum like MOR202 most likely interferes with blood bank serologic tests, 
particularly the indirect Coombs test (Oostendorp et al 2015, Weinig 2017 [MOR202L069]). 
Therefore, subjects must be typed and screened for the eventual presence of irregular antibodies 
before the first administration of MOR202. Phenotyping may be considered prior to starting 
MOR202 treatment as per local practice. Red blood cell genotyping is not impacted by CD3 8 
antibodies and may be performed at any time. 
In the event of a planned transfusion blood transfusion centers should be notified of the 
interference with indirect antiglobulin tests. 
If an emergency transfusion is required, non-cross-matched ABO/RhD-compatible RBCs can be 
given per local blood bank practices. 
Further technical guidance to mitigate this interference is published in the AABB bulletin #16-02 
(AABB), e.g. a baseline typing and screening for irregular antibodies before starting MOR202 
treatment and/or the use of dithiothreitol (DTT)-treated cells for antibody detection (screening) 
and identification during MOR202 treatment as well as at least 6 months after the last MOR202 
administration (Chapuy et al 2016, Chapuy et al 2015). 
10.1.1. 
Screening Failures 
Subjects who sign an informed consent but fail to start treatment for any reason will be considered 
a screen failure. Minimum data requirements for the eCRF are: the reason for not starting 
treatment, demographic information, and SAEs. 
10.2. 
Re-screening Procedures 
Subjects can be re-screened at the discretion of the investigator under certain circumstances. 
Rescreening is restricted to one attempt per subject and can only be performed if one of the 
following criteria is met: 
• 
The subject has already consented and met all of the inclusion and none of the exclusion 
criteria and his or her enrollment was delayed due to an unexpected change in the subject's 
personal situation (e.g., family issues). 
• 
The subject previously failed to be eligible due to a circumstance (e.g., planned surgery, 
pathological laboratory test result) that has resolved. 
• 
The subject previously failed screening but has become eligible for the trial based on a 
change in the inclusion and exclusion criteria as a result of a protocol amendment. 
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• 
The subject was successfully screened but could not start treatment within the screening 
phase.
The following procedures apply:
• 
The subject must sign and date a new ICF as part of the rescreening procedure.
• 
The subject will receive a new unique identification number via the interactive response 
technology.
• 
A new electronic case report form (eCRF) should be completed.
• 
The subject will be documented as rescreened in the source documents.
• 
All screening procedures must be completed again.
A rescreened subject can be enrolled, if all of the inclusion criteria are met and none of the 
exclusion criteria are met.
10.3. 
Baseline -  Cycle 1 Day 1 immediate pre-dose assessments
Before administration of MOR202, any missing data from screening shall be obtained. For 
assessments refer to the Schedule of Assessments (Table 2). MOR202 may not be applied without 
baseline UPCR value from 24 h urine collection.
Subjects who forget to collect a 24-hour urine sample prior to the baseline visit must not be dosed. 
The subject must complete a 24-hour urine sample on the day of the rescheduled baseline visit 
before dosing.
10.4. 
Treatment Phase
In the first treatment cycle MOR202 will be administered at 16 mg/kg once weekly (i.e. 4 doses 
for cycle 1 in total). In treatment cycle 2-6 MOR202 will be administered at 16 mg/kg once every 
4 weeks on the first day of each cycle (i.e. C2D1, C3D1, ...; 5 doses for Cycle 2 to 6 in total). For 
assessments refer to the Schedule of Assessments (Table 2).
Before each dose of MOR202, the complete blood count (CBC) needs to be determined at the 
local laboratory. The time window from blood draw to MOR 202 application should not exceed 
48 hours. The values need to be recorded in the eCRF.
10.5. 
Follow-up Phase
Safety measurements will be performed in the Follow-Up Phase which spans from the EOT Visit 
until the EOS Visit: EOT takes place 28 days after the last administration of MOR202. The
visit window is + 14 days, thus up to 42 days after the last administration of MOR202. After the 
EOT visit subjects will be followed up for further 28 weeks at two visits with an interval of 
14 weeks each: FUV and EOS. For assessments refer to the Schedule of Assessments (Table 2).
10.6. 
Early Discontinuation and Withdrawal
See Section 8.8.
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Protocol Number: MOR202Cl03 M-PLACE 
• 
The subject was successfully screened but could not start treatment within the screening 
phase. 
The following procedures apply: 
• 
The subject must sign and date a new ICF as part of the rescreening procedure. 
• 
The subject will receive a new unique identification number via the interactive response 
technology. 
• 
A new electronic case report form ( eCRF) should be completed. 
• 
The subject will be documented as rescreened in the source documents. 
• 
All screening procedures must be completed again. 
A rescreened subject can be enrolled, if all of the inclusion criteria are met and none of the 
exclusion criteria are met. 
10.3. 
Baseline - Cycle 1 Day 1 immediate pre-dose assessments 
Before administration of MOR202, any missing data from screening shall be obtained. For 
assessments refer to the Schedule of Assessments (Table 2). MOR202 may not be applied without 
baseline UPCR value from 24 h urine collection. 
Subjects who forget to collect a 24-hour urine sample prior to the baseline visit must not be dosed. 
The subject must complete a 24-hour urine sample on the day of the rescheduled baseline visit 
before dosing. 
10.4. 
Treatment Phase 
In the first treatment cycle MOR202 will be administered at 16 mg/kg once weekly (i.e. 4 doses 
for cycle 1 in total). In treatment cycle 2-6 MOR202 will be administered at 16 mg/kg once every 
4 weeks on the first day of each cycle (i.e. C2Dl, C3Dl, ... ; 5 doses for Cycle 2 to 6 in total). For 
assessments refer to the Schedule of Assessments (Table 2). 
Before each dose of MOR202, the complete blood count (CBC) needs to be determined at the 
local laboratory. The time window from blood draw to MOR 202 application should not exceed 
48 hours. The values need to be recorded in the eCRF. 
10.5. 
Follow-up Phase 
Safety measurements will be performed in the Follow-Up Phase which spans from the EQT Visit 
until the EOS Visit: EOT takes place 28 days after the last administration of MOR202. The 
visit window is + 14 days, thus up to 42 days after the last administration of MOR202. After the 
EQT visit subjects will be followed up for further 28 weeks at two visits with an interval of 
14 weeks each: FUV and EOS. For assessments refer to the Schedule of Assessments (Table 2). 
10.6. 
Early Discontinuation and Withdrawal 
See Section 8.8. 
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10.7. 
Efficacy Assessments
For details refer to the Schedule of Assessments (Table 2).
10.8. 
Safety Assessments
Safety monitoring for all subjects enrolled will include laboratory safety assessments (e.g., 
hematology, serum biochemistry, urinalysis and coagulation) and clinical evaluations (e.g., 
physical examinations, vital signs, 12-lead ECG) as detailed in the Schedule of Assessments 
(Table 2).
Laboratory and AE toxicities will be graded according to NCI-CTCAE, version 5.0. Subjects who 
experience any toxicity should be followed until the toxicity has stabilized, the toxicity has 
returned to the baseline level, or a new treatment has commenced.
10.8.1. 
Clinical Safety Laboratory Evaluation
Blood and urine samples for safety assessment will be obtained for various parameters as displayed 
in Table 3 as described in the Schedule of Assessments (Table 2). The collection time will be 
documented in the eCRF.
Table 3 
Clinical safety laboratory parameters
Evaluation
Analysis
On site hematology
(EDTA blood)
CBC with differential count 
Erythrocyte sedimentation rate
Hematology
(EDTA blood)
CBC with differential count 
B-cell count
Serum biochemistry
(serum sample)
ALT, total albumin, alkaline phosphatase, amylase, AST, 
bicarbonate, bilirubin (total), urea, total calcium, chloride, 
creatinine, creatinine kinase, GGT, glucose, LDH, lipase, phosphate, 
potassium, protein (total), sodium, uric acid, magnesium, [ 2- 
microglobulin, C-reactive protein, immunoglobulins, Hba1c in 
subjects with diabetes mellitus type II
Coagulation parameters
(sodium citrate blood)
Activated partial thromboplastin time, prothrombin time, 
international normalization ratio, D-dimers
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10.7. 
Efficacy Assessments 
For details refer to the Schedule of Assessments (Table 2). 
10.8. 
Safety Assessments 
Safety monitoring for all subjects enrolled will include laboratory safety assessments (e.g., 
hematology, serum biochemistry, urinalysis and coagulation) and clinical evaluations (e.g., 
physical examinations, vital signs, 12-lead ECG) as detailed in the Schedule of Assessments 
(Table 2). 
Laboratory and AE toxicities will be graded according to NCI-CTCAE, version 5.0. Subjects who 
experience any toxicity should be followed until the toxicity has stabilized, the toxicity has 
returned to the baseline level, or a new treatment has commenced. 
10.8.1. 
Clinical Safety Laboratory Evaluation 
Blood and urine samples for safety assessment will be obtained for various parameters as displayed 
in Table 3 as described in the Schedule of Assessments (Table 2). The collection time will be 
documented in the eCRF. 
Table 3 
Clinical safety laboratory parameters 
Evaluation 
Analysis 
On site hematology 
CBC with differential count 
(EDT A blood) 
Erythrocyte sedimentation rate 
Hematology 
CBC with differential count 
(EDTA blood) 
B-cell count 
ALT, total albumin, alkaline phosphatase, amylase, AST, 
bicarbonate, bilirubin (total), urea, total calcium, chloride, 
Serum biochemistry 
creatinine, creatinine kinase, GGT, glucose, LDH, lipase, phosphate, 
(serum sample) 
potassium, protein (total), sodium, uric acid, magnesium, /32-
microglobulin, C-reactive protein, immunoglobulins, Hbal c in 
subjects with diabetes mellitus type II 
Coagulation parameters 
Activated partial thromboplastin time, prothrombin time, 
(sodium citrate blood) 
international normalization ratio, D-dimers 
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CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
Serology parameters
(serum sample)
HIV-1/2 antibodies;
HCV antibody (if positive HCVRNA PCR)
HBs antigen (qualitative), HBs antibody, HBc antibody 
(if isolated positive, HBV DNA PCR)
Pregnancy test
(serum sample)
FCBP only: serum fi-HCG
Pregnancy test
(urine)
FCBP only: P-HCG urine, Test assay should have a minimum 
sensitivity of 25 IU/mL (urine sticks will be provided centrally).
Urinalysis
Appearance, color, urine bilirubin, glucose, hemoglobin, ketones, pH, 
protein, specific gravity, urobilinogen.
Microscopy will only be performed if clinically indicated.
Parameters in italics are measured in a central laboratory.
T h e valu es o f  the central laboratory w ill be transferred electro n ically to the e C R F  w ith  the 
corresponding norm al ranges.
T h e in vestigator needs to sp ecify for an y abnorm al laboratory fin d in gs w hether clin ica lly relevant 
or not. I f  the fin d in g is considered clin ica lly relevant, it constitutes an A E  and should b e recorded 
as such in the e C R F . A d d itio n a l d iagn ostic tests are at the discretion o f the in vestigator.
10.8.2. 
Vital Signs
V ita l signs w ill b e m easured as described in the S ch ed u le o f A ssessm en ts ( T a b le 2 ). V ita l sign 
param eters in clud e m easurem ents o f  heart rate, b o d y  tem perature, and systolic/d iastolic B P . B P  
and heart rate are m easured after a period o f  5 m inutes o f  rest. T h e subject should take the sam e 
position each tim e heart rate and b lo o d  pressure are m easured. B P  should b e m easured from  the 
arm contra-lateral to the site o f  IM P  adm inistration w h en ever possible.
10.8.3. 
Electrocardiograms
A  standard 12 -le a d  E C G  w ill be obtained as described in the S ch ed u le o f A ssessm en ts ( T ab le 2 ) . 
A ll E C G  recordings w ill be read at the site accord in g to local practice.
10.8.4. 
Physical Examination
P h ysical exam ination (P E ) w ill be perform ed accord in g to the Sch edu le o f  A ssessm en ts (T ab le 
2 ) . A  full P E  w ill b e perform ed at the screening, E O T  and E O S  visit.
F u ll P E  should in clud e at least vital signs, general appearance, skin, head, eyes, ears, nose, throat 
in clu d in g W a ld eyer lym p h atic structures, lun gs, breasts and axillae, lym p h  nodes, card iovascular 
system , b a ck  and spine, abdom en (if applicable in clu d in g spleen size b e lo w  the costal m argin), 
extrem ities, in fu sion site, and a b asic n eu rological exam ination (if an y n eu rological abnorm alities 
are noted, a full n eu rological exam ination w ill b e perform ed).
L im ited  P E s  m ust in clud e at least vital signs and general appearance and should b e fo cu sed  on 
clin ical sym ptom s observed. I f  clin ica lly indicated, a full P E  m ust b e perform ed at an y trial visit.
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CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
HIV-1/2 antibodies; 
Serology parameters 
HCV antibody (if positive HCV RNA PCR) 
(serum sample) 
HBs antigen (qualitative), HBs antibody, HBc antibody 
(if isolated positive, HBV DNA PCR) 
Pregnancy test 
FCBP only: serum /3-HCG 
(serum sample) 
Pregnancy test 
FCBP only: ~-HCG urine, Test assay should have a minimum 
(urine) 
sensitivity of 25 IU/mL (urine sticks will be provided centrally). 
Appearance, color, urine bilirubin, glucose, hemoglobin, ketones, pH, 
Urinalysis 
protein, specific gravity, urobilinogen. 
Microscopy will only be performed if clinically indicated. 
Parameters in italics are measured in a central laboratory. 
The values of the central laboratory will be transferred electronically to the eCRF with the 
corresponding normal ranges. 
The investigator needs to specify for any abnormal laboratory findings whether clinically relevant 
or not. If the finding is considered clinically relevant, it constitutes an AE and should be recorded 
as such in the eCRF. Additional diagnostic tests are at the discretion of the investigator. 
10.8.2. 
Vital Signs 
Vital signs will be measured as described in the Schedule of Assessments (Table 2). Vital sign 
parameters include measurements of heart rate, body temperature, and systolic/diastolic BP. BP 
and heart rate are measured after a period of 5 minutes of rest. The subject should take the same 
position each time heart rate and blood pressure are measured. BP should be measured from the 
arm contra-lateral to the site of IMP administration whenever possible. 
10.8.3. 
Electrocardiograms 
A standard 12-lead ECG will be obtained as described in the Schedule of Assessments (Table 2). 
All ECG recordings will be read at the site according to local practice. 
10.8.4. 
Physical Examination 
Physical examination (PE) will be performed according to the Schedule of Assessments (Table 
2). A full PE will be performed at the screening, EQT and EOS visit. 
Full PE should include at least vital signs, general appearance, skin, head, eyes, ears, nose, throat 
including Waldeyer lymphatic structures, lungs, breasts and axillae, lymph nodes, cardiovascular 
system, back and spine, abdomen (if applicable including spleen size below the costal margin), 
extremities, infusion site, and a basic neurological examination (if any neurological abnormalities 
are noted, a full neurological examination will be performed). 
Limited PEs must include at least vital signs and general appearance and should be focused on 
clinical symptoms observed. If clinically indicated, a full PE must be performed at any trial visit. 
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CTP v7.0, 01-Jul-2020
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10.8.5. 
Adverse Events (AEs)
Site personnel must remain vigilant for the occurrence of AEs. It is their responsibility to detect, 
document and report (S)AEs.
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical 
product and which does not necessarily have a causal relationship with this treatment. An AE can 
therefore be any unfavorable and unintended sign (including a clinically significant abnormal 
laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether 
or not considered related to that product.
Generally, the diagnosis instead of the individual symptoms should be reported as the AE term. If 
a diagnosis has been reported as an AE, it is not necessary to report each individual sign and 
symptom of that AE as a separate AE. For example, if a febrile neutropenia is reported as an AE, 
there is no need to report neutrophil count decrease and fever above 38°C, or other related signs, 
symptoms, or laboratory values as separate AEs. However, if such events occur in isolation, and 
febrile neutropenia is not diagnosed, then each event should be reported as an AE.
Death should be considered an outcome and not a distinct event. The event or condition that caused 
the fatal outcome should be recorded as the single medical concept on the Adverse Event eCRF. 
Generally, only one such event should be reported.
AEs include any clinically significant deterioration of a subject’s medical status after signing of 
the ICF. Also an increase in the frequency or intensity of a pre-existing episodic event or conditions 
and events resulting from protocol mandated procedure (e.g. invasive procedures) fall under the 
definition of AE.
The following events do not meet the AE definition:
• Medical procedures will not be reported as AE. The underlying condition being the reason to 
perform the medical procedure will be reported as AE.
• Events without an untoward medical occurrence (e.g. planned surgery with hospitalization for 
conditions already existing at screening).
• Progression of underlying disease will not be reported as AE.
• Pre-existing diseases or pre-existing medical conditions known or detected before ICF signature 
and not increasing in severity.
All serious and non-serious AEs must be followed up for a final outcome until the end of the 
follow-up phase. Subjects prematurely withdrawn from the clinical trial will be followed up at 
least until 28 days after last IMP treatment. A final outcome of “unknown” is not considered 
acceptable. A final outcome of “not yet resolved” is acceptable.
The subjects will be closely observed and questioned for any kind of AE during the clinical trial 
procedures and at follow-up appointments throughout the clinical trial period with non-leading 
questioning (e.g. “How do you feel?”). The subjects will be instructed to immediately report any 
symptoms and signs to the site personnel (i.e. between formal observations).
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10.8.5. 
Adverse Events (AEs) 
Site personnel must remain vigilant for the occurrence of AEs. It is their responsibility to detect, 
document and report (S)AEs. 
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical 
product and which does not necessarily have a causal relationship with this treatment. An AE can 
therefore be any unfavorable and unintended sign (including a clinically significant abnormal 
laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether 
or not considered related to that product. 
Generally, the diagnosis instead of the individual symptoms should be reported as the AE term. If 
a diagnosis has been reported as an AE, it is not necessary to report each individual sign and 
symptom of that AE as a separate AE. For example, if a febrile neutropenia is reported as an AE, 
there is no need to report neutrophil count decrease and fever above 38°C, or other related signs, 
symptoms, or laboratory values as separate AEs. However, if such events occur in isolation, and 
febrile neutropenia is not diagnosed, then each event should be reported as an AE. 
Death should be considered an outcome and not a distinct event. The event or condition that caused 
the fatal outcome should be recorded as the single medical concept on the Adverse Event eCRF. 
Generally, only one such event should be reported. 
AEs include any clinically significant deterioration of a subject's medical status after signing of 
the ICF. Also an increase in the frequency or intensity of a pre-existing episodic event or conditions 
and events resulting from protocol mandated procedure ( e.g. invasive procedures) fall under the 
definition of AE. 
The following events do not meet the AE definition: 
• Medical procedures will not be reported as AE. The underlying condition being the reason to 
perform the medical procedure will be reported as AE. 
• Events without an untoward medical occurrence ( e.g. planned surgery with hospitalization for 
conditions already existing at screening). 
• Progression of underlying disease will not be reported as AE. 
• Pre-existing diseases or pre-existing medical conditions known or detected before ICF signature 
and not increasing in severity. 
All serious and non-serious AEs must be followed up for a final outcome until the end of the 
follow-up phase. Subjects prematurely withdrawn from the clinical trial will be followed up at 
least until 28 days after last IMP treatment. A final outcome of "unknown" is not considered 
acceptable. A final outcome of "not yet resolved" is acceptable. 
The subjects will be closely observed and questioned for any kind of AE during the clinical trial 
procedures and at follow-up appointments throughout the clinical trial period with non-leading 
questioning (e.g. "How do you feel?"). The subjects will be instructed to immediately report any 
symptoms and signs to the site personnel (i.e. between formal observations). 
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CTP v7.0, 01-Jul-2020
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10.8.6. 
Serious Adverse Events (SAEs)
An SAE is defined as any AE that:
• 
Results in death
• 
Is life threatening (immediate risk)
• 
Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization 
signifies that the subject was an inpatient for at least one overnight stay) unless hospitalization 
is for:
- 
Routine treatment or monitoring of the studied indication, not associated with deterioration 
of symptoms related to aMN.
- 
Elective or pre-planned treatment for a pre-existing condition that is unrelated to aMN and 
has not worsened since signing of the ICF.
- 
Social reason and respite care in the absence of any deterioration in the subject’s general 
condition.
• 
Results in persistent or significant disability or incapacity.
• 
Is a congenital anomaly or birth defect.
• 
Is another important medical event. Based upon appropriate medical judgment, the event may 
jeopardize the subject and may require medical intervention to prevent one of the outcomes 
listed above (e.g. emergency treatment at home).
NOTE: The term “life threatening” refers to an event in which the subject was, in the view of the 
reporting investigator, at immediate risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it was more severe. Medical judgment should 
be exercised in deciding whether an AE is serious in other situations: Important AEs that are not 
immediately life threatening or do not result in death or hospitalization but may jeopardize the 
subject or may require intervention to prevent one of the other outcomes listed in the previous 
definitions should also be considered serious.
10.8.7. 
Adverse Events of Special Interest (AESI)
AEs of special interest (AESI) in this clinical trial should be reported along with their respective 
symptoms (e.g. hives, chills, and fever for infusion reaction) using the trial specific SAE report 
form.
AESIs include:
• 
Infusion related reactions to MOR202 > grade 3
• 
Cytokine release syndrome
• 
Allergic reactions to MOR202
• 
Infections > grade 3
• 
Neutropenia > grade 3 (< 1.0 x 109/L)
• 
Thrombocytopenia > grade 3 (< 50.0 x 109/L)
• 
Major bleeds (defined as critical organ bleed or hemoglobin decrease of more than 20 g/L 
within 24 h)
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10.8.6. 
Serious Adverse Events (SAEs) 
An SAE is defined as any AE that: 
• 
Results in death 
• 
Is life threatening (immediate risk) 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization 
signifies that the subject was an inpatient for at least one overnight stay) unless hospitalization 
is for: 
-
Routine treatment or monitoring of the studied indication, not associated with deterioration 
of symptoms related to aMN. 
-
Elective or pre-planned treatment for a pre-existing condition that is unrelated to aMN and 
has not worsened since signing of the ICF. 
Social reason and respite care in the absence of any deterioration in the subject's general 
condition. 
• 
Results in persistent or significant disability or incapacity. 
• 
Is a congenital anomaly or birth defect. 
• 
Is another important medical event. Based upon appropriate medical judgment, the event may 
jeopardize the subject and may require medical intervention to prevent one of the outcomes 
listed above (e.g. emergency treatment at home). 
NOTE: The term "life threatening" refers to an event in which the subject was, in the view of the 
reporting investigator, at immediate risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it was more severe. Medical judgment should 
be exercised in deciding whether an AE is serious in other situations: Important AEs that are not 
immediately life threatening or do not result in death or hospitalization but may jeopardize the 
subject or may require intervention to prevent one of the other outcomes listed in the previous 
definitions should also be considered serious. 
10.8.7. 
Adverse Events of Special Interest (AESI) 
AEs of special interest (AESI) in this clinical trial should be reported along with their respective 
symptoms (e.g. hives, chills, and fever for infusion reaction) using the trial specific SAE report 
form. 
AESis include: 
• 
Infusion related reactions to MOR202 2: grade 3 
• 
Cytokine release syndrome 
• 
Allergic reactions to MOR202 
• 
Infections 2: grade 3 
• 
Neutropenia 2: grade 3 (< 1.0 x 109/L) 
• 
Thrombocytopenia 2: grade 3 (< 50.0 x 109/L) 
• 
Major bleeds ( defined as critical organ bleed or hemoglobin decrease of more than 20 g/L 
within 24 h) 
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10.8.8. 
Pregnancy
All pregnancies detected during the clinical trial will be reported in the trial specific pregnancy 
form and will be followed up until delivery or abortion.
Each pregnancy of a clinical trial subject or a female partner of a male clinical trial subject must 
be reported within 24 hours.
Female clinical trial subjects who become pregnant must be withdrawn from treatment.
Pregnancy in a subject or female partner of a male clinical trial subject who has received trial 
medication is not considered an AE unless the pregnancy results in complications in mother or 
child. AEs meeting seriousness criteria have to be reported as SAE of mother or child respectively. 
For example, if the child is born with a birth defect, this should be reported as a SAE of the child.
The pregnancy should be followed up to determine outcome, including spontaneous or voluntary 
termination, details of birth, and the presence or absence of any birth defects or congenital 
abnormalities or maternal and newborn complications. Every infant has to be followed up for 
3 months after delivery.
10.8.9. 
Assessment of AEs, SAEs and AESIs
As far as possible, each AE should be evaluated to determine the following:
• 
Relationship to trial drug (suspected/not suspected).
• 
Duration (start and end date or if continuing at EOS).
• 
Intensity: The intensity of all AEs will be graded as mild, moderate, or severe using the 
following definitions:
o 
Mild: 
Tolerable
o 
Moderate: 
Interferes with normal activity
o 
Severe: 
Incapacitating (causes inability to perform usual activity or work).
• 
Toxicity grade (severity): The toxicity grade of AEs will be graded according to the 
NCI-CTCAE version 5.0 of November 27, 2017 using the following definitions:
o 
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated.
o 
Grade 2: Moderate; minimal, local or non-invasive intervention indicated; limiting age- 
appropriate instrumental activities of daily living (refers to preparing meals, shopping 
for groceries or clothes, using the telephone, managing money, etc.)
o 
Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-
care activities of daily living.
o 
Grade 4: Life-threatening consequences; urgent intervention indicated. 
o 
Grade 5: Death related to AE.
• 
Seriousness
• 
Outcome
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10.8.8. 
Pregnancy 
All pregnancies detected during the clinical trial will be reported in the trial specific pregnancy 
form and will be followed up until delivery or abortion. 
Each pregnancy of a clinical trial subject or a female partner of a male clinical trial subject must 
be reported within 24 hours. 
Female clinical trial subjects who become pregnant must be withdrawn from treatment. 
Pregnancy in a subject or female partner of a male clinical trial subject who has received trial 
medication is not considered an AE unless the pregnancy results in complications in mother or 
child. AEs meeting seriousness criteria have to be reported as SAE of mother or child respectively. 
For example, if the child is born with a birth defect, this should be reported as a SAE of the child. 
The pregnancy should be followed up to determine outcome, including spontaneous or voluntary 
termination, details of birth, and the presence or absence of any birth defects or congenital 
abnormalities or maternal and newborn complications. Every infant has to be followed up for 
3 months after delivery. 
10.8.9. 
Assessment of AEs, SAEs and AESis 
As far as possible, each AE should be evaluated to determine the following: 
• 
Relationship to trial drug (suspected/not suspected). 
• 
Duration (start and end date or if continuing at EOS). 
• 
Intensity: The intensity of all AEs will be graded as mild, moderate, or severe using the 
following definitions: 
o Mild: 
Tolerable 
o Moderate: 
Interferes with normal activity 
o Severe: 
Incapacitating (causes inability to perform usual activity or work). 
• 
Toxicity grade (severity): The toxicity grade of AEs will be graded according to the 
NCI-CTCAE version 5.0 of November 27, 2017 using the following definitions: 
o Grade I: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated. 
o Grade 2: Moderate; minimal, local or non-invasive intervention indicated; limiting age-
appropriate instrumental activities of daily living (refers to preparing meals, shopping 
for groceries or clothes, using the telephone, managing money, etc.) 
o Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-
care activities of daily living. 
o Grade 4: Life-threatening consequences; urgent intervention indicated. 
o Grade 5: Death related to AE. 
• 
Seriousness 
• 
Outcome 
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• 
Action taken (no action taken; trial drug temporarily interrupted; trial drug permanently 
discontinued due to this AE; concomitant medication taken; non-drug therapy given; 
hospitalization/prolonged hospitalization).
10.8.10. 
Reporting of AEs, SAEs and AESIs
All AEs and SAEs will be collected from the signing of the ICF until the EOS visit. For screening 
failure patients only SAEs will be collected.
All SAEs and AESI must be reported to IQVIA Pharmacovigilance within 24 hours of investigator 
awareness. The investigator will submit any updated (follow-up) SAE data within 24 hours of 
investigator awareness.
Investigators are not obligated to actively seek AEs or SAEs after conclusion of the study 
participation. However, if the investigator learns of any SAE, including AEs resulting in death, at 
any time after a participant has been discontinued from the study, and he/she considers the event 
to be reasonably related to the study intervention or study participation, the investigator must 
promptly notify IQVIA Pharmacovigilance.
All AEs, including SAEs will be reported in eCRF. SAEs and AESIs will automatically be 
transmitted to IQVIA Pharmacovigilance via the eCRF. If the eCRF is not available, a paper SAE 
Report Form should be sent to IQVIA Pharmacovigilance via email or fax or the Investigator 
should call the IQVIA SAE hotline within 24 hours of being made aware of the SAE/AESI. When 
the eCRF system becomes available again, the SAE/AESI information must be entered as soon as 
possible of the system becoming available. Refer for contact information to the site reference 
manual for contact details.
The sponsor or designee will report all SAEs to local health authorities, Independent Ethics 
Committees (IECs) or Institutional/Independent Review Boards (IRBs) and investigators as 
required by local regulations.
10.9. 
Pharmacokinetics and Immunogenicity
Blood samples for pharmacokinetics (PK; MOR202) and Immunogenicity (ADA; antiMOR202) 
should be collected on the visits specified in the Schedule of Assessments (Table 2).
The details of blood sample handling and shipment instructions will be provided in a separate 
laboratory manual.
The actual dates and times of PK and ADA blood sampling will be recorded in the eCRF.
10.10. 
Pharmacodynamic Biomarkers
Blood and urine samples for biomarkers should be collected on the visits specified in the Schedule 
of Assessments (Table 2).
The details of sample handling and shipment instructions will be provided in a separate laboratory 
manual.
The actual dates and times of biomarker sampling will be recorded in the eCRF.
Due to the exploratory nature of some assays, the sponsor may decide at any point during the trial 
to terminate these assessments, in which case the sites will be informed accordingly.
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• 
Action taken (no action taken; trial drug temporarily interrupted; trial drug permanently 
discontinued due to this AE; concomitant medication taken; non-drug therapy given; 
hospi talizati on/prolonged hospitalization). 
10.8.10. 
Reporting of AEs, SAEs and AESis 
All AEs and SAEs will be collected from the signing of the ICF until the EOS visit. For screening 
failure patients only SAEs will be collected. 
All SAEs and AESI must be reported to IQ VIA Pharmacovigilance within 24 hours ofinvestigator 
awareness. The investigator will submit any updated (follow-up) SAE data within 24 hours of 
investigator awareness. 
Investigators are not obligated to actively seek AEs or SAEs after conclusion of the study 
participation. However, if the investigator learns of any SAE, including AEs resulting in death, at 
any time after a participant has been discontinued from the study, and he/she considers the event 
to be reasonably related to the study intervention or study participation, the investigator must 
promptly notify IQVIA Pharmacovigilance. 
All AEs, including SAEs will be reported in eCRF. SAEs and AESis will automatically be 
transmitted to IQVIA Pharmacovigilance via the eCRF. If the eCRF is not available, a paper SAE 
Report Form should be sent to IQVIA Pharmacovigilance via email or fax or the Investigator 
should call the IQVIA SAE hotline within 24 hours of being made aware of the SAE/AESI. When 
the eCRF system becomes available again, the SAE/ AESI information must be entered as soon as 
possible of the system becoming available. Refer for contact information to the site reference 
manual for contact details. 
The sponsor or designee will report all SAEs to local health authorities, Independent Ethics 
Committees (IECs) or Institutional/Independent Review Boards (IRBs) and investigators as 
required by local regulations. 
10.9. 
Pharmacokinetics and Immunogenicity 
Blood samples for pharmacokinetics (PK; MOR202) and Immunogenicity (ADA; antiMOR202) 
should be collected on the visits specified in the Schedule of Assessments (Table 2). 
The details of blood sample handling and shipment instructions will be provided in a separate 
laboratory manual. 
The actual dates and times of PK and ADA blood sampling will be recorded in the eCRF. 
10.10. 
Pharmacodynamic Biomarkers 
Blood and urine samples for biomarkers should be collected on the visits specified in the Schedule 
of Assessments (Table 2). 
The details of sample handling and shipment instructions will be provided in a separate laboratory 
manual. 
The actual dates and times of biomarker sampling will be recorded in the eCRF. 
Due to the exploratory nature of some assays, the sponsor may decide at any point during the trial 
to terminate these assessments, in which case the sites will be informed accordingly. 
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11. 
DATA HANDLING AND QUALITY ASSURANCE
11.1. 
Completing and Signing Case Report Forms
Trained clin ical trial site personnel w ill enter the data into the e C R F . F or any m issin g data a reason 
should b e given . A n y  errors should be corrected w ith in  the electronic system  and source 
docum ents. T h e audit trail w ill record all ch an ges m ade, the date and tim e o f  the correction, and 
the person correcting the error.
11.2. 
Clinical Monitoring
T h e Spon sor or d esign ee w ill m onitor the clin ical trial con du ct at the clin ical trial sites to ensure 
data qu ality (accurate and com plete data collection ), and protection o f  su b jects’ safety and rights.
11.3. 
Audit and Inspection
T h e sponsor or regulatory authorities m a y audit the in vestigation al site. T h e sponsor’ s or I Q V I A ’ s 
Q u a lity  A ssu ran ce U n it, independent o f  the C lin ica l R esearch  and D e ve lo p m en t D epartm ent, is 
responsible for auditing the trial.
T h e in vestigator(s) m ust accept that regulatory authorities con du ct an in spection to v e rify  
com p lian ce o f  the trial w ith  G C P .
11.4. 
Clinical Data Management
T h e sponsor or design ee w ill b e responsible for p rocessin g and qu ality control o f  the data. T h e 
h an dling o f  data, in clu d in g data qu ality control, w ill co m p ly w ith  all applicable regulatory 
guidelines. A d v e rse  events and con com itant m edication term s w ill b e cod ed w ith  the current 
M e d D R A  version  and W H O  m ed ication dictionary. A t  the end o f  the trial all M e d D R A  cod es w ill 
b e updated to the n ew est versions.
11.5. 
Archiving
A ll trial docum entation at the sites and Spon sor site w ill be archived in accord ance w ith  
International 
C o u n cil for H arm on ization (IC H ) E 6 -G o o d  C lin ica l Practice (G C P ) and the 
sponsor’ s qu ality standards and SO P s.
12. 
STATISTICAL METHODS AND PLANNED ANALYSIS
T h e data w ill b e an alyzed  b y  the sponsor and/or designated C R O . A n y  data an alysis carried out 
in depen dently b y  the in vestigator should b e subm itted to the sponsor b efore publication  or 
presentation.
It is planned that the data from  participating centers in this protocol w ill b e com bin ed, so that an 
adequate num ber o f  subjects w ill b e availab le for analysis.
12.1. 
Timing of Analysis
12.1.1. 
Primary Completion Analysis
T h e prim ary com pletion  an alysis w ill b e perform ed after the last subject com pletes C y c le  6 o f 
treatm ent, i.e. after the E O T  visit, or 28 days after the last subject received  the last dose o f 
M O R 2 0 2 .
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11. 
DATA HANDLING AND QUALITY ASSURANCE 
11.1. 
Completing and Signing Case Report Forms 
Trained clinical trial site personnel will enter the data into the eCRF. For any missing data a reason 
should be given. Any errors should be corrected within the electronic system and source 
documents. The audit trail will record all changes made, the date and time of the correction, and 
the person correcting the error. 
11.2. 
Clinical Monitoring 
The Sponsor or designee will monitor the clinical trial conduct at the clinical trial sites to ensure 
data quality (accurate and complete data collection), and protection of subjects' safety and rights. 
11.3. 
Audit and Inspection 
The sponsor or regulatory authorities may audit the investigational site. The sponsor's or IQ VIA' s 
Quality Assurance Unit, independent of the Clinical Research and Development Department, is 
responsible for auditing the trial. 
The investigator(s) must accept that regulatory authorities conduct an inspection to verify 
compliance of the trial with GCP. 
11.4. 
Clinical Data Management 
The sponsor or designee will be responsible for processing and quality control of the data. The 
handling of data, including data quality control, will comply with all applicable regulatory 
guidelines. Adverse events and concomitant medication terms will be coded with the current 
MedDRA version and WHO medication dictionary. At the end of the trial all MedDRA codes will 
be updated to the newest versions. 
11.5. 
Archiving 
All trial documentation at the sites and Sponsor site will be archived in accordance with 
International Council for Harmonization (ICH) E6-Good Clinical Practice (GCP) and the 
sponsor's quality standards and SOPs. 
12. 
STATISTICAL METHODS AND PLANNED ANALYSIS 
The data will be analyzed by the sponsor and/or designated CRO. Any data analysis carried out 
independently by the investigator should be submitted to the sponsor before publication or 
presentation. 
It is planned that the data from participating centers in this protocol will be combined, so that an 
adequate number of subjects will be available for analysis. 
12.1. 
Timing of Analysis 
12.1.1. 
Primary Completion Analysis 
The primary completion analysis will be performed after the last subject completes Cycle 6 of 
treatment, i.e. after the EQT visit, or 28 days after the last subject received the last dose of 
MOR202. 
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I f  the enrolm ent for one o f  the cohorts needs sign ifican tly longer, the prim ary com pletion  analysis 
m ay be perform ed b y  cohort, otherw ise at the sam e tim e for both cohorts.
Prim ary, k e y  secondary and selected exploratory endpoints w ill b e an alyzed at the tim e o f  prim ary 
com pletion. D eta ils w ill b e p rovid ed in the Statistical A n a ly sis P lan  (S A P ).
12.1.2. 
Final Analysis
A fte r the last subject com p leted  the last visit, a final an alysis w ill be perform ed.
A d d itio n al safety and fo llo w -u p  an alyses m ay b e perform ed b y  the Sponsor as and w h en  deem ed 
necessary.
12.2. 
Population for Analysis
Su bjects w h o  w ere screened but n ever started M O R 2 0 2  treatm ent w ill b e listed. Screenin g failures 
w ill not be in clud ed in any o f  the sum m ary tables.
12.2.1. 
Full Analysis Set (FAS)
A ll subjects w h o  received  at least one dose o f  M O R 2 0 2 . E ffic a c y  and safety an alyses w ill be 
perform ed on F A S .
12.2.2. 
Per Protocol Set
Su bjects in clud ed in F A S  w ith ou t any im portant protocol deviation  that cou ld im pact e ffica cy  
endpoints.
12.2.3. 
Pharmacokinetic Analysis Set (PKAS)
A ll subjects w ith  evalu able M O R 2 0 2  serum concentration data.
12.2.4. 
Immunogenicity Analysis Set (IAS)
A ll subjects w ith  at least one M O R 2 0 2  A D A  sam ple.
12.3. 
General Statistical Considerations
T abu lation s o f  sum m ary statistics, graphical presentations, 
and statistical an alyses w ill be 
perform ed u sin g SA S®  softw are version  9.3 or higher.
C on tin u ou s, quan titative variable sum m aries w ill in clu d e the num ber o f  subjects (N ) (w ith 
non m issin g valu es/valid  cases), m ean, standard deviation, m inim um , 2 5 th quartile (Q 1), m edian, 
7 5 th quartile (Q 3 ) and m axim u m , excep t for P K  m etrics, w here additional statistics m ay be used.
C a tego rical, 
qu alitative variable 
sum m aries w ill in clu d e the freq u en cy and percentage o f 
subjects/entries in the particular category.
D efin itio n  o f  baseline va lu e: the last pre-adm inistration observation w ill b e used as the baseline 
valu e for calcu latin g post-adm inistration changes from  baseline.
A ll data obtained v ia  the e C R F  and entered into the database w ill b e p rovid ed in separate data 
listin gs sh ow in g in divid ual subject valu es. A  S A P  detailin g the statistical an alyses w ill b e fin alized 
prior to first subject first visit.
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If the enrolment for one of the cohorts needs significantly longer, the primary completion analysis 
may be performed by cohort, otherwise at the same time for both cohorts. 
Primary, key secondary and selected exploratory endpoints will be analyzed at the time of primary 
completion. Details will be provided in the Statistical Analysis Plan (SAP). 
12.1.2. 
Final Analysis 
After the last subject completed the last visit, a final analysis will be performed. 
Additional safety and follow-up analyses may be performed by the Sponsor as and when deemed 
necessary. 
12.2. 
Population for Analysis 
Subjects who were screened but never started MOR202 treatment will be listed. Screening failures 
will not be included in any of the summary tables. 
12.2.1. 
Full Analysis Set (FAS) 
All subjects who received at least one dose of MOR202. Efficacy and safety analyses will be 
performed on FAS. 
12.2.2. 
Per Protocol Set 
Subjects included in FAS without any important protocol deviation that could impact efficacy 
endpoints. 
12.2.3. 
Pharmacokinetic Analysis Set (PKAS) 
All subjects with evaluable MOR202 serum concentration data. 
12.2.4. 
Immunogenicity Analysis Set (IAS) 
All subjects with at least one MOR202 ADA sample. 
12.3. 
General Statistical Considerations 
Tabulations of summary statistics, graphical presentations, and statistical analyses will be 
performed using SAS® software version 9.3 or higher. 
Continuous, quantitative variable summaries will include the number of subjects (N) (with 
nonmissing values/valid cases), mean, standard deviation, minimum, 25th quartile (QI), median, 
75th quartile (Q3) and maximum, except for PK metrics, where additional statistics may be used. 
Categorical, qualitative variable summaries will include the frequency and percentage of 
subjects/entries in the particular category. 
Definition of baseline value: the last pre-administration observation will be used as the baseline 
value for calculating post-administration changes from baseline. 
All data obtained via the eCRF and entered into the database will be provided in separate data 
listings showing individual subject values. A SAP detailing the statistical analyses will be finalized 
prior to first subject first visit. 
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12.4. 
Subject Disposition, Demographics and other Baseline 
Characteristics
A table will be provided with the following information:
• 
Number of subjects included in each analysis set.
• 
Number of subjects screened, enrolled, received at least one dose of trial treatment, 
discontinued treatment within first 24 weeks, discontinued trial during the 28-week follow-
up phase after treatment phase and finished complete follow-up and had their scheduled 
last-visit.
• 
Number of subjects withdrawn from the clinical trial and the reason for withdrawal.
Demographic information will be summarized using descriptive statistics for the FAS. Gender and 
race will be summarized by counts and percentages.
Medical history will be summarized by counts and percentages using MedDRA system organ class 
(SOC) and preferred term classifications. Concomitant medications will be recorded and coded 
using the WHO Drug Dictionary enhanced and grouped by anatomical therapeutic chemical 
(ATC) classes. Tabulations with counts/percentages will show the number of medications/percen- 
tage used in each class.
The medical history related to MN will be summarized displaying the
• 
Duration of disease since initial diagnosis,
• 
Number and type of prior therapies, and
• 
Best response during or following previous therapy.
12.5. 
Sample Size
Three evaluable subjects will be enrolled in the safety run-in phase. These subjects can belong to 
either Cohort 1 or Cohort 2.
Once the Safety run-in is completed successfully, additional subjects will be enrolled in Cohort 1 
and Cohort 2 in parallel. Approximately 20 subjects will be enrolled in Cohort 1 and 
approximately 10 subjects will be enrolled in Cohort 2.
With a sample size of 20 subjects in Cohort 1, there is an 88% probability to observe at least one 
occurrence of a particular AE if the natural incidence of this AE in Cohort 1 is 10%.
Cohort 2 includes subjects with aMN refractory to IST. Thus it is expected that incidence of AEs 
will be higher in Cohort 2 than in Cohort 1. With a sample size of 10 subjects in Cohort 2, there is 
an 80% probability to observe at least one occurrence of a particular AE if the incidence of this 
AE is 15%.
12.6. 
Procedures for Missing, Unused and Spurious Data
Missing values will not be substituted by estimated values, but treated as missing in the statistical 
evaluation. All data from all subjects dosed in the clinical trial will be included in all listings, plots, 
summary tables, and statistical analyses when appropriate.
If a subject in the safety run-in phase discontinues the trial for any reason other than treatment 
related toxicity, this subject will be replaced.
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12.4. 
Subject Disposition, Demographics and other Baseline 
Characteristics 
A table will be provided with the following information: 
• 
Number of subjects included in each analysis set. 
• 
Number of subjects screened, enrolled, received at least one dose of trial treatment, 
discontinued treatment within first 24 weeks, discontinued trial during the 28-week follow-
up phase after treatment phase and finished complete follow-up and had their scheduled 
last-visit. 
• 
Number of subjects withdrawn from the clinical trial and the reason for withdrawal. 
Demographic information will be summarized using descriptive statistics for the FAS. Gender and 
race will be summarized by counts and percentages. 
Medical history will be summarized by counts and percentages using MedDRA system organ class 
(SOC) and preferred term classifications. Concomitant medications will be recorded and coded 
using the WHO Drug Dictionary enhanced and grouped by anatomical therapeutic chemical 
(ATC) classes. Tabulations with counts/percentages will show the number of medications/percen-
tage used in each class. 
The medical history related to MN will be summarized displaying the 
• 
Duration of disease since initial diagnosis, 
• 
Number and type of prior therapies, and 
• 
Best response during or following previous therapy. 
12.5. 
Sample Size 
Three evaluable subjects will be enrolled in the safety run-in phase. These subjects can belong to 
either Cohort 1 or Cohort 2. 
Once the Safety run-in is completed successfully, additional subjects will be enrolled in Cohort 1 
and Cohort 2 in parallel. Approximately 20 subjects will be enrolled in Cohort 1 and 
approximately 10 subjects will be enrolled in Cohort 2. 
With a sample size of 20 subjects in Cohort 1, there is an 88% probability to observe at least one 
occurrence of a particular AE if the natural incidence of this AE in Cohort 1 is 10%. 
Cohort 2 includes subjects with aMN refractory to 1ST. Thus it is expected that incidence of AEs 
will be higher in Cohort 2 than in Cohort 1. With a sample size of 10 subjects in Cohort 2, there is 
an 80% probability to observe at least one occurrence of a particular AE if the incidence of this 
AE is 15%. 
12.6. 
Procedures for Missing, Unused and Spurious Data 
Missing values will not be substituted by estimated values, but treated as missing in the statistical 
evaluation. All data from all subjects dosed in the clinical trial will be included in all listings, plots, 
summary tables, and statistical analyses when appropriate. 
If a subject in the safety run-in phase discontinues the trial for any reason other than treatment 
related toxicity, this subject will be replaced. 
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In the even t o f  a sign ifican t v o lu m e o f  m issin g data, sen sitivity an alyses for e ffica cy  and biom arker 
endpoints m a y b e perform ed u sin g the principle o f  m u ltiple im putation.
12.7. 
Procedures for Reporting Deviations from Original Statistical Plan
D eta ils o f  the an alyses to b e perform ed on data from  this trial w ill be provid ed in a separate S A P .
A n y  deviations from  the statistical an alysis outlined in this protocol and reasons for the deviations 
listed w ill be described in the clin ical trial report.
12.8. 
Primary Objective Analysis
T h e  prim ary o b jective o f  this trial is to assess the safety and tolerability o f  M O R 2 0 2  in subjects 
w ith  a M N  during the treatm ent phase. F o r details o f  the safety an alysis see Section  1 2 .1 2 .
12.9. 
Key Secondary Objective Analysis
T h e k e y  secondary o b jective is to assess the effect o f  M O R 2 0 2  on serum a n ti-P L A 2 R  antibodies 
in subjects w ith  aM N .
T h e k e y  secondary endpoint for this o b jective is b est overall im m u n ological response (B IR ).
B IR  is defin ed w h en  a subject is classified  as h a vin g a IP R , I C R  or s IC R  based on the definitions 
provid ed in Section  3.2 o f  this protocol ach ieved  at an y tim e during the trial.
T h e best overall im m u n ological response rate (B IR R ) is defin ed as the proportion o f  subjects w ith  
best overall im m u n ological response. B IR R  alo n g w ith  its 9 5 %  C Is (C lopper-P earso n ) w ill be 
presented b y  cohort.
In addition, for each v isit available, the num ber (counts and percentages) o f  subjects in each o f  the 
fo llo w in g  categories w ill b e presented in a table: IP R , I C R  or sIC R . M issin g  response evaluations 
w ill also be presented.
F or prim ary com pletion  analyses, the ab o ve an alyses w ill be perform ed based on the visits during 
the safety run-in phase and treatm ent phase.
F or final analyses, the a b o ve an alyses w ill be perform ed based on all the visits during the trial. 
T h is an alyses w ill be perform ed on F A S . Further details w ill b e sp ecified  in the S A P .
12.10. 
Secondary Objective Analysis
12.10.1. 
Immunogenicity of MOR202
Im m u n ogen icity o f  M O R 2 0 2  (a n ti-M O R 2 0 2  an tibody form ation) in subjects w ith  a M N  w ill be 
assessed b y  presenting A D A  status (positive/n egative), A D A  titer (w hen A D A  status w as 
positive), and potential drug interference in the assay (yes/no w h en  A D A  status w a s negative). 
T h e results w ill be sum m arized d escrip tively for each cohort and visit.
T h is an alysis w ill b e perform ed on the IA S .
12.10.2. 
Pharmacokinetic (PK) profile of MOR202
F or subjects in the P K A S , in divid ual serum  concentrations o f  M O R 2 0 2  w ill be listed.
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In the event of a significant volume of missing data, sensitivity analyses for efficacy and biomarker 
endpoints may be performed using the principle of multiple imputation. 
12.7. 
Procedures for Reporting Deviations from Original Statistical Plan 
Details of the analyses to be performed on data from this trial will be provided in a separate SAP. 
Any deviations from the statistical analysis outlined in this protocol and reasons for the deviations 
listed will be described in the clinical trial report. 
12.8. 
Primary Objective Analysis 
The primary objective of this trial is to assess the safety and tolerability of MOR202 in subjects 
with aMN during the treatment phase. For details of the safety analysis see Section 12.12. 
12.9. 
Key Secondary Objective Analysis 
The key secondary objective is to assess the effect of MOR202 on serum anti-PLA2R antibodies 
in subjects with aMN. 
The key secondary endpoint for this objective is best overall immunological response (BIR). 
BIR is defined when a subject is classified as having a IPR, ICR or slCR based on the definitions 
provided in Section 3 .2 of this protocol achieved at any time during the trial. 
The best overall immunological response rate (BIRR) is defined as the proportion of subjects with 
best overall immunological response. BIRR along with its 95% Cis (Clopper-Pearson) will be 
presented by cohort. 
In addition, for each visit available, the number ( counts and percentages) of subjects in each of the 
following categories will be presented in a table: IPR, ICR or slCR. Missing response evaluations 
will also be presented. 
For primary completion analyses, the above analyses will be performed based on the visits during 
the safety run-in phase and treatment phase. 
For final analyses, the above analyses will be performed based on all the visits during the trial. 
This analyses will be performed on FAS. Further details will be specified in the SAP. 
12.10. 
Secondary Objective Analysis 
12.10.1. 
Immunogenicity of MOR202 
lmmunogenicity of MOR202 (anti-MOR202 antibody formation) in subjects with aMN will be 
assessed by presenting ADA status (positive/negative), ADA titer (when ADA status was 
positive), and potential drug interference in the assay (yes/no when ADA status was negative). 
The results will be summarized descriptively for each cohort and visit. 
This analysis will be performed on the IAS. 
12.10.2. 
Pharmacokinetic (PK) profile of MOR202 
For subjects in the PKAS, individual serum concentrations of MOR202 will be listed. 
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Descriptive statistics will be calculated by day for serum concentrations and for the listed PK 
parameters. Mean (± standard error) serum concentrations of MOR202 vs. time will be plotted 
using both linear and semi-logarithmic scales.
The following PK parameters, where appropriate, will be determined for MOR202 serum 
concentrations by non-compartmental analysis using individual concentration-time profiles:
• 
t.1/2 : terminal elimination half-life (h)
MOR202 serum levels may be further analyzed performing population PK analyses, which will 
be reported separately.
Further details will be specified in the SAP.
12.10.3. 
Safety in subjects with aMN during the follow-up Phase
The incidence and severity of AEs during the post-treatment follow-up phase until the EOS will 
be presented. For details see Section 12.12.
12.11. 
Exploratory Objective Analysis
12.11.1. 
Efficacy Analysis
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Descriptive statistics will be calculated by day for serum concentrations and for the listed PK 
parameters. Mean(± standard error) serum concentrations of MQR202 vs. time will be plotted 
using both linear and semi-logarithmic scales. 
The following PK parameters, where appropriate, will be determined for MQR202 serum 
concentrations by non-compartmental analysis using individual concentration-time profiles: 
• 
t112: terminal elimination half-life (h) 
MQR202 serum levels may be further analyzed performing population PK analyses, which will 
be reported separately. 
Further details will be specified in the SAP. 
12.10.3. 
Safety in subjects with aMN during the follow-up Phase 
The incidence and severity of AEs during the post-treatment follow-up phase until the EQS will 
be presented. For details see Section 12.12. 
12.11. 
Exploratory Objective Analysis 
12.11.1. 
Efficacy Analysis 
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12.11.2. 
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12.11.2. 
 
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12.11.3. 
12.11.4. 
Pharmacodynamic Biomarkers
Additional PD biomarkers may be identified by assessing the effect of MOR202 on the 
following biomarkers:
i. 
Peripheral blood immune cell populations.
These biomarkers will be assessed and characterized using descriptive statistics of the following:
• 
Absolute levels by visit.
• 
Absolute and relative change from baseline to each visit until EOS.
• 
Post EOT samples only: Absolute and relative change from EOT visit to each subsequent 
visits until EOS.
These analyses will be performed on FAS by cohort. Further details will be specified in the SAP.
12.12. 
Safety Analysis
The primary and one of the secondary objectives of this trial is to assess the safety and tolerability 
of MOR202 in subjects with aMN.
Primary Objective:
Incidence and severity of TEAEs.
Secondary Objective:
To assess the safety of subjects with aMN after MOR202 treatment and during the follow-up phase.
12.12.1. 
Adverse Events
All AEs which start after the first dose of trial medication until 28 days after last treatment will be 
considered as TEAEs. Adverse events that start during the trial but before the time of the first dose
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12.11.3. 
 
12.11.4. 
Pharmacodynamic Biomarkers 
Additional PD biomarkers may be identified by assessing the effect of MQR202 on the 
following biomarkers: 
1. 
Peripheral blood immune cell populations. 
 
These biomarkers will be assessed and characterized using descriptive statistics of the following: 
• 
Absolute levels by visit. 
• 
Absolute and relative change from baseline to each visit until EQS. 
• 
Post EQT samples only: Absolute and relative change from EQT visit to each subsequent 
visits until EQS. 
These analyses will be performed on FAS by cohort. Further details will be specified in the SAP. 
12.12. 
Safety Analysis 
The primary and one of the secondary objectives of this trial is to assess the safety and tolerability 
ofMQR202 in subjects with aMN. 
Primary Objective: 
Incidence and severity of TEAEs. 
Secondary Objective: 
To assess the safety of subjects with aMN after MQR202 treatment and during the follow-up phase. 
12.12.1. 
Adverse Events 
All AEs which start after the first dose of trial medication until 28 days after last treatment will be 
considered as TEAEs. Adverse events that start during the trial but before the time of the first dose 
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of MOR202 (e.g. screening phase) will be classified as non-treatment emergent adverse events 
and will be presented in a separate AE listing.
Adverse events will be coded according to Medical Dictionary for Regulatory Activities 
(MedDRA), system organ class (SOC) and preferred term. Incidence and frequency of all AEs 
will be summarized by SOC, preferred term, relationship to treatment, severity and seriousness.
An AE summary table will be presented showing the number of events, number of subjects and 
the percentage of subjects in each cohort and overall having:
• 
All TEAEs
• 
TEAEs by maximum severity
• 
SAEs
• 
Drug-related TEAEs
• 
Drug-related TEAEs in each severity/toxicity grading
• 
TEAEs that led to treatment discontinuation
• 
IRRs by grade
Adverse events of special interest (AESI) in this trial are:
• 
Infusion related reactions to MOR202 > grade 3
• 
Cytokine release syndrome
• 
Allergic reactions to MOR202
• 
Infections > grade 3
• 
Neutropenia > grade 3 (< 1.0 x 109/L)
• 
Thrombocytopenia > grade 3 (< 50.0 x 109/L)
• 
Major bleeds (defined as critical organ bleed or hemoglobin decrease of more than 20 g/L 
within 24 h)
The sponsor will describe AESI, in addition to those reported as SAEs. AESI tabulations will be 
analogous to the tabulation of TEAEs.
As part of one of the secondary endpoint, the sponsor will analyze the incidences and severity of 
AEs of MOR202 during the follow-up phase until EOS. Post-treatment AE tabulations will be 
analogous to the tabulation of TEAEs.
The sponsor will discuss other significant AEs as appropriate, e.g. laboratory abnormalities that 
qualify as AEs (other than those meeting the definition for serious) and any events that led to an 
intervention (including premature discontinuation of IMP, increase of dose interval, or significant 
additional concomitant therapy) in addition to those reported as SAEs.
12.12.2. 
New Abnormalities
The sponsor will internally evaluate each clinical laboratory result, vital sign result, and ECG 
result to assess if it reflects a new abnormality, and for numeric data, to assess if it reflects a 
significant worsening from baseline or an outlying result or extreme value. These terms are defined 
for clinical laboratory results, vital sign results, and ECG results as follows:
• 
A new abnormality will be any abnormal post baseline result for a subject whose baseline 
value was within normal limits.
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of MOR202 (e.g. screening phase) will be classified as non-treatment emergent adverse events 
and will be presented in a separate AE listing. 
Adverse events will be coded according to Medical Dictionary for Regulatory Activities 
(MedDRA), system organ class (SOC) and preferred term. Incidence and frequency of all AEs 
will be summarized by SOC, preferred term, relationship to treatment, severity and seriousness. 
An AE summary table will be presented showing the number of events, number of subjects and 
the percentage of subjects in each cohort and overall having: 
• 
All TEAEs 
• 
TEAEs by maximum severity 
• 
SAEs 
• 
Drug-related TEAEs 
• 
Drug-related TEAEs in each severity/toxicity grading 
• 
TEAEs that led to treatment discontinuation 
• 
IRRs by grade 
Adverse events of special interest (AESI) in this trial are: 
• 
Infusion related reactions to MOR202 2: grade 3 
• 
Cytokine release syndrome 
• 
Allergic reactions to MOR202 
• 
Infections 2: grade 3 
• 
Neutropenia 2: grade 3 (< 1.0 x 109/L) 
• 
Thrombocytopenia 2: grade 3 (< 50.0 x 109/L) 
• 
Maj or bleeds ( defined as critical organ bleed or hemoglobin decrease of more than 20 g/L 
within 24 h) 
The sponsor will describe AESI, in addition to those reported as SAEs. AESI tabulations will be 
analogous to the tabulation of TEAEs. 
As part of one of the secondary endpoint, the sponsor will analyze the incidences and severity of 
AEs of MOR202 during the follow-up phase until EOS. Post-treatment AE tabulations will be 
analogous to the tabulation of TEAEs. 
The sponsor will discuss other significant AEs as appropriate, e.g. laboratory abnormalities that 
qualify as AEs ( other than those meeting the definition for serious) and any events that led to an 
intervention (including premature discontinuation of IMP, increase of dose interval, or significant 
additional concomitant therapy) in addition to those reported as SAEs. 
12.12.2. 
New Abnormalities 
The sponsor will internally evaluate each clinical laboratory result, vital sign result, and ECG 
result to assess if it reflects a new abnormality, and for numeric data, to assess if it reflects a 
significant worsening from baseline or an outlying result or extreme value. These terms are defined 
for clinical laboratory results, vital sign results, and ECG results as follows: 
• 
A new abnormality will be any abnormal post baseline result for a subject whose baseline 
value was within normal limits. 
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• 
A significant worsening will be any numeric clinical laboratory result, vital sign result, or 
ECG interval measurement that represents a change from baseline by >25% of the baseline 
value, in the direction away from normal (i.e., in the direction that is clinically significant).
• 
An outlying result for any numeric laboratory result, vital sign result, or ECG interval 
measurement will be any post-administration change from baseline that meets either of the 
following criteria:
< 25th Percentile (Q1) - 1.5 * (interquartile range) OR
> 75th Percentile (Q3) + 1.5 * (interquartile range).
• 
An extreme value for any numeric laboratory result, vital sign result, or ECG interval 
measurement will be any post-administration change from baseline that meets either of the 
following criteria:
< 25th Percentile (Q1) -  3 * (interquartile range) OR
> 75th Percentile (Q3) + 3 * (interquartile range).
Subjects who demonstrate new abnormal results will be noted in data listings and reviewed by the 
sponsor. All results showing a significant worsening will be noted in data listings and reviewed by 
the sponsor. Outlying results or extreme values will be identified and reviewed in the context of 
the subject’s other abnormal results.
12.12.3. 
Clinical Laboratory Evaluation
The analysis of central laboratory parameters for each treatment arm will be presented, separated 
into blood parameters (e.g., hematology, serum chemistry, coagulation) and urine parameters 
(urinalysis). All data collected in the course of the trial will be listed.
The analyses will be performed on FAS. Further details will be specified in the SAP.
12.12.4. 
Vital Signs
Descriptive summaries of actual values and changes from baseline will be calculated for vital 
signs. These summaries will be presented for the FAS at all time points. Each abnormal value 
will be flagged to show whether it is a value below or above the normal limit.
12.12.5. 
Electrocardiograms
Summary ECG assessment (categories: ‘normal’; ‘abnormal’, ‘clinically significant’; ‘abnormal’, 
‘not clinically significant’) will be tabulated by time point using frequency tabulations.
Each result of the 12-lead ECG (PR, QRS, RR and QT interval values) will be flagged to show 
whether it is a value below or above the normal limit.
Summary statistics for all time points will be displayed for QT and both QTc correction methods. 
The Bazett’s correction method for QTc (Bazett 1920) will be applied as follows:
Bazett’s Correction (QTcB) = QT/RR12
The Fridericia correction method for QTc (Fridericia 1920) will be applied as follows:
Fridericia’s Correction (QTcF) = QT/RR13 
where relative rate (RR) = 60/heart rate
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• 
A significant worsening will be any numeric clinical laboratory result, vital sign result, or 
ECG interval measurement that represents a change from baseline by > 25% of the baseline 
value, in the direction away from normal (i.e., in the direction that is clinically significant). 
• 
An outlying result for any numeric laboratory result, vital sign result, or ECG interval 
measurement will be any post-administration change from baseline that meets either of the 
following criteria: 
< 25th Percentile (QI) - 1.5 * (interquartile range) OR 
> 75th Percentile (Q3) + 1.5 * (interquartile range). 
• 
An extreme value for any numeric laboratory result, vital sign result, or ECG interval 
measurement will be any post-administration change from baseline that meets either of the 
following criteria: 
< 25th Percentile (QI) - 3 * (interquartile range) OR 
> 75th Percentile (Q3) + 3 * (interquartile range). 
Subjects who demonstrate new abnormal results will be noted in data listings and reviewed by the 
sponsor. All results showing a significant worsening will be noted in data listings and reviewed by 
the sponsor. Outlying results or extreme values will be identified and reviewed in the context of 
the subject's other abnormal results. 
12.12.3. 
Clinical Laboratory Evaluation 
The analysis of central laboratory parameters for each treatment arm will be presented, separated 
into blood parameters (e.g., hematology, serum chemistry, coagulation) and urine parameters 
(urinalysis). All data collected in the course of the trial will be listed. 
The analyses will be performed on FAS. Further details will be specified in the SAP. 
12.12.4. 
Vital Signs 
Descriptive summaries of actual values and changes from baseline will be calculated for vital 
signs. These summaries will be presented for the FAS at all time points. Each abnormal value 
will be flagged to show whether it is a value below or above the normal limit. 
12.12.5. 
Electrocardiograms 
Summary ECG assessment (categories: 'normal'; 'abnormal', 'clinically significant'; 'abnormal', 
'not clinically significant') will be tabulated by time point using frequency tabulations. 
Each result of the 12-lead ECG (PR, QRS, RR and QT interval values) will be flagged to show 
whether it is a value below or above the normal limit. 
Summary statistics for all time points will be displayed for QT and both QTc correction methods. 
The Bazett's correction method for QTc (Bazett 1920) will be applied as follows: 
Bazett's Correction (QTcB) = QT/RR112 
The Fridericia correction method for QTc (Fridericia 1920) will be applied as follows: 
Fridericia's Correction (QTcF) = QT/RR1'3 
where relative rate (RR) = 60/heart rate 
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A lso , the num ber and percentage o f  subjects w ith  Q T c  valu es ab o ve the norm al lim it (> 450 ms,
>  480 m s, >  500 m s) and the num ber and percentage o f  subjects w h o  experien ced a change
>  30 m s or a ch an ge >  60 m s w ill b e presented b y  tim e point.
13. 
SPECIAL REQUIREMENTS AND PROCEDURES
13.1. 
Regulatory and Ethical Considerations
T h is trial w a s designed and shall be im plem ented, execu ted and reported in accordance w ith  the 
I C H  H arm on ized Tripartite G u id elin es for G o o d  C lin ica l P ractice (IC H -G C P ), w ith  applicable 
local regulations and w ith  the ethical principles laid do w n  in the D eclaration  o f  H elsinki.
B efo re starting this trial, the clin ical trial protocol w ill be subm itted to the IE C /IR B  and/or 
regulatory authorities (in accordance w ith  local regulations) for evalu ation . T h e  trial w ill not start 
before the IE C /IR B  and/or regulatory authorities g iv e  w ritten approval or a favo rable opinion as 
required. A n y  am endm ents to the protocol w ill require IE C /IR B  and/or regulatory authority 
approval as required before im plem entation, excep t for changes necessary to elim inate an 
im m ediate hazard to subjects.
13.2. 
Publication of Trial Protocol and Results
Inform ation 
on 
the 
protocol 
w ill 
b e 
posted 
in 
a 
p u b licly 
accessib le 
database 
such 
as 
clin icaltrials.go v and/or the E U  C lin ica l Trials R egister. In addition, the results o f  this trial w ill be 
subm itted for publication and/or posted in a p u b licly accessib le database in accordance w ith  local 
regulations.
13.3. 
Investigator’s Responsibilities
13.3.1. 
Overall Responsibilities
B efo re in itiatin g a trial, the investigator/institution m ust ensure approval/favorable opinion is 
obtained from  the IE C /IR B  for the protocol, w ritten IC F , 
consent form  updates, 
subject 
recruitm ent procedures (e.g., advertisem ents) and any other w ritten inform ation to be p rovid ed to 
subjects. Prior to study start, the in vestigator is required to sign a protocol signature p age 
con firm in g his/her agreem ent to con du ct the study in accord ance w ith  the protocol, I C H -G C P , 
applicable local regulations and the ethical principles laid do w n  in the D eclaration  o f  H elsin ki.
T h e in vestigator is responsible to provid e oversigh t o f  the con du ct o f  the study at their site. 
Investigators w ill ap p ly due d iligen ce to avo id  protocol deviations. I f  the in vestigator feels a 
protocol am endm ent is n ecessary to im prove the con du ct o f  the study, such an am endm ent is 
required to b e agreed upon b y  the sponsor and approved b y  the IE C /IR B  and/or regulatory 
authorities as required prior to im plem entation. N o tw ith stan d in g the need for approval o f  protocol 
am endm ents, the in vestigator is exp ected  to take an y im m ediate action required for the safety o f 
an y subject in clu d ed in this trial, even  i f  this action represents a deviation  from  the protocol. In 
such cases, the sponsor m ust be n otified o f  this action, as w e ll as the IE C /IR B  and/or regulatory 
authorities as required.
13.3.2. 
Subject Informed Consent
T h e in vestigator or his/her representative is responsible for exp la in in g the nature o f  the study to 
the subject or his/her le g a lly  authorized representative and answ er all questions regarding the 
study. S u b jects m ust b e inform ed that their participation is volu ntary. S u b jects or their le g a lly
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Also, the number and percentage of subjects with QTc values above the normal limit(> 450 ms, 
> 480 ms, > 500 ms) and the number and percentage of subjects who experienced a change 
2: 30 ms or a change 2: 60 ms will be presented by time point. 
13. 
13.1. 
SPECIAL REQUIREMENTS AND PROCEDURES 
Regulatory and Ethical Considerations 
This trial was designed and shall be implemented, executed and reported in accordance with the 
ICH Harmonized Tripartite Guidelines for Good Clinical Practice (ICH-GCP), with applicable 
local regulations and with the ethical principles laid down in the Declaration of Helsinki. 
Before starting this trial, the clinical trial protocol will be submitted to the IEC/IRB and/or 
regulatory authorities (in accordance with local regulations) for evaluation. The trial will not start 
before the IEC/IRB and/or regulatory authorities give written approval or a favorable opinion as 
required. Any amendments to the protocol will require IEC/IRB and/or regulatory authority 
approval as required before implementation, except for changes necessary to eliminate an 
immediate hazard to subjects. 
13.2. 
Publication of Trial Protocol and Results 
Information on the protocol will be posted in a publicly accessible database such as 
clinicaltrials.gov and/or the EU Clinical Trials Register. In addition, the results of this trial will be 
submitted for publication and/or posted in a publicly accessible database in accordance with local 
regulations. 
13.3. 
13.3.1. 
Investigator's Responsibilities 
Overall Responsibilities 
Before initiating a trial, the investigator/institution must ensure approval/favorable opinion is 
obtained from the IEC/IRB for the protocol, written ICF, consent form updates, subject 
recruitment procedures ( e.g., advertisements) and any other written information to be provided to 
subjects. Prior to study start, the investigator is required to sign a protocol signature page 
confirming his/her agreement to conduct the study in accordance with the protocol, ICH-GCP, 
applicable local regulations and the ethical principles laid down in the Declaration of Helsinki. 
The investigator is responsible to provide oversight of the conduct of the study at their site. 
Investigators will apply due diligence to avoid protocol deviations. If the investigator feels a 
protocol amendment is necessary to improve the conduct of the study, such an amendment is 
required to be agreed upon by the sponsor and approved by the IEC/IRB and/or regulatory 
authorities as required prior to implementation. Notwithstanding the need for approval of protocol 
amendments, the investigator is expected to take any immediate action required for the safety of 
any subject included in this trial, even if this action represents a deviation from the protocol. In 
such cases, the sponsor must be notified of this action, as well as the IEC/IRB and/or regulatory 
authorities as required. 
13.3.2. 
Subject Informed Consent 
The investigator or his/her representative is responsible for explaining the nature of the study to 
the subject or his/her legally authorized representative and answer all questions regarding the 
study. Subjects must be informed that their participation is voluntary. Subjects or their legally 
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authorized representative w ill b e required to sign the IC F  prior to an y stu d y-sp ecific procedures 
b ein g perform ed. T h e original IC F  m ust be kept as part o f  the study records at the site, and a co p y 
m ust b e p rovid ed to the subjects or their le g a lly  authorized representative. S u b jects m ust be re-
consented to the m ost current version o f  the IC F (s ) during their participation in the study. T he 
process o f  obtain in g inform ed consent m ust b e docum en ted in the su b ject’ s source docum ents.
13.3.3. 
Direct Access to Source Data/Documents
T h e in vestigator m ust g iv e  access to all relevant data and records to m onitors, auditors, other 
designated agents o f  the sponsor, IE C /IR B , and regulatory authorities as required. Personal 
m ed ical inform ation w ill alw a ys b e treated as con fiden tial. I f  an in spection o f  the clin ical site is 
requested b y  a regulatory authority, the in vestigato r m ust inform  the sponsor im m ed iately that this 
request has been m ade.
13.3.4. 
Confidentiality
S u b jects w ill b e assigned a unique iden tifier b y  the sponsor. T h e in vestigato r m ust ensure that any 
su b ject’ s data that are transferred to the sponsor w ill contain the iden tifier on ly; subject nam es or 
an y inform ation that w o u ld  m ake the subject iden tifiable w ill not b e transferred.
13.4. 
Financial Disclosure
Investigators and sub-in vestigators w ill p rovid e the sponsor w ith  sufficient, accurate financial 
inform ation as requested to a llo w  the sponsor to subm it com plete and accurate financial 
certification or disclosure statem ents to the appropriate regulatory authorities. Investigators and 
sub-in vestigators are responsible for p ro vid in g inform ation on financial interests during the course 
o f  the study and for 1 year after com pletion  o f  the study.
13.5. 
Publication Policy
A n y  presentation or publication  o f  data from  this trial w ill be intended as a jo in t publication  b y  the 
investigator(s)/appropriate trial site personnel and appropriate sponsor personnel. A uthorship w ill 
fo llo w  the International C o m m ittee o f  M ed ica l Journal E ditors U n iform  R equirem en ts for 
M an u scripts Subm itted to B io m ed ica l Journals and w ill be defin ed prior to the first publication.
F or m ulticenter studies, it is m andatory that the first publication  b e based on data from  all centers, 
and that the data are an alyzed  and subm itted as stipulated in the protocol b y  a statistician assigned 
b y  the sponsor.
Thus, no in vestigator or institution m a y publish an y results o f  the trial con du cted at their site, 
before such a first m ulticenter publication  is m ade w h ich  covers the data from  all sites. T h e authors 
h ave the final respo n sibility for the d ecision  to subm it their m anuscript and shall be g iv e n  full 
access to  the data resulting from  the trial.
T h e coordinatin g in vestigator and/or authors shall coordinate any intended publication  o f  trial 
results w ith  the sponsor, to enable the sponsor to ensure that results are presented in a responsible 
and coherent m anner.
T h e sponsor reserves the right to review  all m anuscripts and abstracts at least 60 days before their 
subm ission for publication or presentation. T h is is not intended to restrict or hinder publication  or 
presentation, but is to a llo w  the sponsor to protect the con fid en tiality o f  inform ation and to provid e 
com m ents that m ay not y e t be availab le to the investigator.
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authorized representative will be required to sign the ICF prior to any study-specific procedures 
being performed. The original ICF must be kept as part of the study records at the site, and a copy 
must be provided to the subjects or their legally authorized representative. Subjects must be re-
consented to the most current version of the ICF(s) during their participation in the study. The 
process of obtaining informed consent must be documented in the subject's source documents. 
13.3.3. 
Direct Access to Source Data/Documents 
The investigator must give access to all relevant data and records to monitors, auditors, other 
designated agents of the sponsor, IEC/IRB, and regulatory authorities as required. Personal 
medical information will always be treated as confidential. If an inspection of the clinical site is 
requested by a regulatory authority, the investigator must inform the sponsor immediately that this 
request has been made. 
13.3.4. 
Confidentiality 
Subjects will be assigned a unique identifier by the sponsor. The investigator must ensure that any 
subject's data that are transferred to the sponsor will contain the identifier only; subject names or 
any information that would make the subject identifiable will not be transferred. 
13.4. 
Financial Disclosure 
Investigators and sub-investigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators and 
sub-investigators are responsible for providing information on financial interests during the course 
of the study and for I year after completion of the study. 
13.5. 
Publication Policy 
Any presentation or publication of data from this trial will be intended as a joint publication by the 
investigator(s)/appropriate trial site personnel and appropriate sponsor personnel. Authorship will 
follow the International Committee of Medical Journal Editors Uniform Requirements for 
Manuscripts Submitted to Biomedical Journals and will be defined prior to the first publication. 
For multicenter studies, it is mandatory that the first publication be based on data from all centers, 
and that the data are analyzed and submitted as stipulated in the protocol by a statistician assigned 
by the sponsor. 
Thus, no investigator or institution may publish any results of the trial conducted at their site, 
before such a first multi center publication is made which covers the data from all sites. The authors 
have the final responsibility for the decision to submit their manuscript and shall be given full 
access to the data resulting from the trial. 
The coordinating investigator and/or authors shall coordinate any intended publication of trial 
results with the sponsor, to enable the sponsor to ensure that results are presented in a responsible 
and coherent manner. 
The sponsor reserves the right to review all manuscripts and abstracts at least 60 days before their 
submission for publication or presentation. This is not intended to restrict or hinder publication or 
presentation, but is to allow the sponsor to protect the confidentiality of information and to provide 
comments that may not yet be available to the investigator. 
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At the sponsor’s request, any confidential information (other than trial results) will be deleted and 
all reasonable comments made by the sponsor will be incorporated prior to the submission for 
publication or presentation. In the rare event that such publication would affect the patentability 
of any invention to which the sponsor has rights, the sponsor has the right to request an additional 
delay to the proposed publication of no more than 90 days so as to allow the sponsor to protect its 
intellectual property rights.
The results of the trial may be used by the sponsor for the purposes of national and international 
registration, publication, and information for medical professionals. If necessary, the authorities 
will be notified of the investigators’ names, addresses, qualifications, and extent of involvement.
14. 
REFERENCES
External references
• 
AABB. AB#16-02 Mitigating the Anti-CD38 Interference with Serologic Testing.
• 
Bazett HC. An analysis of the time relationships or time-relations of electrocardiograms. 
Heart 1920; 7:353-80.
• 
Beck LH, Bonegio RGB, Lambeau G, Beck DM, Powell DW, Cummins TD et al. M-type 
phospholipase A2 receptor as target antigen in idiopathic membranous nephropathy. N 
Engl J Med 2009; 361(1):11-21.
• 
Bomback AS, Fervenza FC. Membranous Nephropathy: Approaches to Treatment. Am J 
Nephrol 2018; 47 Suppl 1:30-42.
• 
Cao Y, Jusko WJ. Incorporating target-mediated drug disposition in a minimal 
physiologically-based pharmacokinetic model for monoclonal antibodies. J 
Pharmacokinet Pharmacodyn 2014; 41(4):375-87.
• 
Cattran DC, Brenchley PE. Membranous nephropathy: integrating basic science into 
improved clinical management. Kidney Int 2017; 91(3):566-74.
• 
Chapuy CI, Aguad MD, Nicholson RT, AuBuchon JP, Cohn CS, Delaney M et al. 
International validation of a dithiothreitol (DTT)-based method to resolve the 
daratumumab interference with blood compatibility testing. Transfusion 2016; 
56(12):2964-72.
• 
Chapuy CI, Nicholson RT, Aguad MD, Chapuy B, Laubach JP, Richardson PG et al. 
Resolving the daratumumab interference with blood compatibility testing. Transfusion 
2015; 55(6 Pt 2):1545-54.
• 
Couser WG. Primary Membranous Nephropathy. Clin J Am Soc Nephrol 2017; 
12(6):983-97.
• 
Fervenza F. A Multi-Center Randomized Controlled Trial of Rituximab versus 
Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (MENTOR).
New Orleans; 2017. (Kidney Week) [cited 2018 Nov 29]. Available from: URL:
https://www.asn-online.org/education/kidneyweek/2017/programabstract.aspx?
controlId=2831149.
MorphoSys AG
Confidential
Page 70 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
At the sponsor's request, any confidential information ( other than trial results) will be deleted and 
all reasonable comments made by the sponsor will be incorporated prior to the submission for 
publication or presentation. In the rare event that such publication would affect the patentability 
of any invention to which the sponsor has rights, the sponsor has the right to request an additional 
delay to the proposed publication of no more than 90 days so as to allow the sponsor to protect its 
intellectual property rights. 
The results of the trial may be used by the sponsor for the purposes of national and international 
registration, publication, and information for medical professionals. If necessary, the authorities 
will be notified of the investigators' names, addresses, qualifications, and extent of involvement. 
14. 
REFERENCES 
External references 
• 
AABB. AB#l6-02 Mitigating the Anti-CD38 Interference with Serologic Testing. 
• 
Bazett HC. An analysis of the time relationships or time-relations of electrocardiograms. 
Heart 1920; 7:353-80. 
• 
Beck LH, Bonegio RGB, Lambeau G, Beck DM, Powell DW, Cummins TD et al. M-type 
phospholipase A2 receptor as target antigen in idiopathic membranous nephropathy. N 
Engl J Med 2009; 361(1): 11-21. 
• 
Bomback AS, Fervenza FC. Membranous Nephropathy: Approaches to Treatment. Am J 
Nephrol 2018; 47 Suppl 1 :30-42. 
• 
Cao Y, Jusko WJ. Incorporating target-mediated drug disposition in a minimal 
physiologically-based pharmacokinetic model for monoclonal antibodies. J 
Pharmacokinet Pharmacodyn 2014; 41(4):375-87. 
• 
Cattran DC, Brenchley PE. Membranous nephropathy: integrating basic science into 
improved clinical management. Kidney Int 2017; 91(3):566-74. 
• 
Chapuy CI, Aguad MD, Nicholson RT, AuBuchon JP, Cohn CS, Delaney Met al. 
International validation of a dithiothreitol (DTT)-based method to resolve the 
daratumumab interference with blood compatibility testing. Transfusion 2016; 
56(12):2964-72. 
• 
Chapuy CI, Nicholson RT, Aguad MD, Chapuy B, Laubach JP, Richardson PG et al. 
Resolving the daratumumab interference with blood compatibility testing. Transfusion 
2015; 55(6 Pt 2): 1545-54. 
• 
Couser WG. Primary Membranous Nephropathy. Clin J Am Soc Nephrol 2017; 
12(6):983-97. 
• 
Fervenza F. A Multi-Center Randomized Controlled Trial ofRituximab versus 
Cyclosporine in the Treatment ofldiopathic Membranous Nephropathy (MENTOR). 
New Orleans; 2017. (Kidney Week) [cited 2018 Nov 29]. Available from: URL: 
https ://www.asn-online.org/ educati on/ki dneyweek/201 7 /programab stract. aspx? 
controlld=283 l l 49. 
MorphoSys AG 
Confidential 
Page 70 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
• 
Fervenza FC, Canetta PA, Barbour SJ, Lafayette RA, Rovin BH, Aslam N et al. A 
Multicenter Randomized Controlled Trial of Rituximab versus Cyclosporine in the 
Treatment of Idiopathic Membranous Nephropathy (MENTOR). Nephron 2015; 
130(3):159-68.
• 
Fridericia LS. Die Systolendauer im Elektrokardiogramm bei normalen Menschen und 
bei Herzkranken. [The duration of systole in the electrocardiogram of normal subjects 
and of patients with heart disease. Acta Medica Scandinavica 1920; 53:469-86.
• 
Jarutat T. Preliminary Efficacy of the Human Anti-CD38 Antibody MOR03087 as 
Monotherapy and in Combination with Standard Therapy in Subjects with Relapsed or 
Refractory Multiple Myeloma; A Phase I/IIa, Open-Label, Multicenter, Dose-Escalation 
Study to Evaluate the Safety and Study: MOR202C101 EudraCT Number: 2009-015942-
50; 2018.
• 
Lee T, Derebail VK, Kshirsagar AV, Chung Y, Fine JP, Mahoney S et al. Patients with 
primary membranous nephropathy are at high risk of cardiovascular events. Kidney Int 
2016; 89(5):1111-8.
• 
Levey AS, Coresh J, Greene T, Marsh J, Stevens LA, Kusek JW et al. Expressing the 
Modification of Diet in Renal Disease Study equation for estimating glomerular filtration 
rate with standardized serum creatinine values. Clin Chem 2007; 53(4):766-72.
• 
Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF, Feldman HI et al. A new 
equation to estimate glomerular filtration rate. Ann Intern Med 2009; 150(9):604-12.
• 
McGrogan A, Franssen CFM, Vries CS de. The incidence of primary glomerulonephritis 
worldwide: a systematic review of the literature. Nephrol Dial Transplant 2011; 
26(2):414-30.
• 
Medawar W, Green A, Campbell E, Carmody M, Donohoe J, Doyle G et al. Clinical and 
histopathologic findings in adults with the nephrotic syndrome. Ir J Med Sci 1990; 
159(5):137-40.
• 
Merck Sharp and Dohme Ltd (UK). Pneumococcal polysaccharide Vaccine: SmPC 
Summary of Product Characteristics.
• 
Niederalt C, Kuepfer L, Solodenko J, Eissing T, Siegmund H-U, Block M et al. A generic 
whole body physiologically based pharmacokinetic model for therapeutic proteins in PK- 
Sim. J Pharmacokinet Pharmacodyn 2018; 45(2):235-57.
• 
Oostendorp M, van Lammerts Bueren JJ, Doshi P, Khan I, Ahmadi T, Parren PWHI et al. 
When blood transfusion medicine becomes complicated due to interference by 
monoclonal antibody therapy. Transfusion 2015; 55(6 Pt 2):1555-62.
• 
Raab, Marc S.; Engelhardt, M; Blank, A; Goldschmidt, H; Agis, H; Blau, IW et al.
(2020): MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or 
refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial. In The 
Lancet Haematology. DOI: 10.1016/S2352-3026(19)30249-2
• 
Ruggenenti P, Cravedi P, Chianca A, Perna A, Ruggiero B, Gaspari F et al. Rituximab in 
idiopathic membranous nephropathy. J Am Soc Nephrol 2012; 23(8):1416-25.
MorphoSys AG
Confidential
Page 71 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
• 
F ervenza FC, Canetta PA, Barbour SJ, Lafayette RA, Rovin BH, Aslam N et al. A 
Multicenter Randomized Controlled Trial of Rituximab versus Cyclosporine in the 
Treatment ofldiopathic Membranous Nephropathy (MENTOR). Nephron 2015; 
130(3): 159-68. 
• 
Fridericia LS. Die Systolendauer im Elektrokardiogramm bei normalen Menschen und 
bei Herzkranken. [The duration of systole in the electrocardiogram of normal subjects 
and of patients with heart disease. Acta Medi ca Scandinavica 1920; 53 :469-86. 
• 
Jarutat T. Preliminary Efficacy of the Human Anti-CD38 Antibody MOR03087 as 
Monotherapy and in Combination with Standard Therapy in Subjects with Relapsed or 
Refractory Multiple Myeloma; A Phase I/Ila, Open-Label, Multicenter, Dose-Escalation 
Study to Evaluate the Safety and Study: MOR202Cl01 EudraCT Number: 2009-015942-
50; 2018. 
• 
Lee T, Derebail VK, Kshirsagar AV, Chung Y, Fine JP, Mahoney Set al. Patients with 
primary membranous nephropathy are at high risk of cardiovascular events. Kidney Int 
2016; 89(5):1111-8. 
• 
Levey AS, Coresh J, Greene T, Marsh J, Stevens LA, Kusek JW et al. Expressing the 
Modification of Diet in Renal Disease Study equation for estimating glomerular filtration 
rate with standardized serum creatinine values. Clin Chem 2007; 53( 4):766-72. 
• 
Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF, Feldman HI et al. A new 
equation to estimate glomerular filtration rate. Ann Intern Med 2009; 150(9):604-12. 
• 
McGrogan A, Franssen CFM, Vries CS de. The incidence of primary glomerulonephritis 
worldwide: a systematic review of the literature. Nephrol Dial Transplant 2011; 
26(2):414-30. 
• 
Medawar W, Green A, Campbell E, Carmody M, Donohoe J, Doyle G et al. Clinical and 
histopathologic findings in adults with the nephrotic syndrome. Ir J Med Sci 1990; 
159(5): 137-40. 
• 
Merck Sharp and Dohme Ltd (UK). Pneumococcal polysaccharide Vaccine: SmPC 
Summary of Product Characteristics. 
• 
Niederalt C, Kuepfer L, Solodenko J, Eissing T, Siegmund H-U, Block Met al. A generic 
whole body physiologically based pharmacokinetic model for therapeutic proteins in PK-
Sim. J Pharmacokinet Pharmacodyn 2018; 45(2):235-57. 
• 
Oostendorp M, van Lammerts Bueren JJ, Doshi P, Khan I, Ahmadi T, Parren PWHI et al. 
When blood transfusion medicine becomes complicated due to interference by 
monoclonal antibody therapy. Transfusion 2015; 55(6 Pt 2):1555-62. 
• 
Raab, Marc S.; Engelhardt, M; Blank, A; Goldschmidt, H; Agis, H; Blau, IW et al. 
(2020): MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or 
refractory multiple myeloma: a first-in-human, multicentre, phase l-2a trial. In The 
Lancet Haematology. DOI: 10.1016/S2352-3026(19)30249-2 
• 
Ruggenenti P, Cravedi P, Chianca A, Perna A, Ruggiero B, Gaspari Fetal. Rituximab in 
idiopathic membranous nephropathy. J Am Soc Nephrol 2012; 23(8): 1416-25. 
MorphoSys AG 
Confidential 
Page 71 of73 


CTP v7.0, 01-Jul-2020
Protocol Number: MOR202C103 M-PLACE
• 
Ruggenenti P, Debiec H, Ruggiero B, Chianca A, Pelle T, Gaspari F et al. Anti-
Phospholipase A2 Receptor Antibody Titer Predicts Post-Rituximab Outcome of 
Membranous Nephropathy. J Am Soc Nephrol 2015; 26(10):2545-58.
• 
Ruggenenti P, Chiurchiu C, Brusegan V, Abbate M, Perna A, Filippi C et al. Rituximab 
in idiopathic membranous nephropathy: a one-year prospective study. J Am Soc Nephrol 
2003; 14(7):1851-7.
• 
Tran TH, J Hughes G, Greenfeld C, Pham JT. Overview of current and alternative 
therapies for idiopathic membranous nephropathy. Pharmacotherapy 2015; 35(4):396- 
411.
• 
Troyanov S, Wall CA, Miller JA, Scholey JW, Cattran DC. Idiopathic membranous 
nephropathy: definition and relevance of a partial remission. Kidney Int 2004; 
66(3):1199-205.
• 
van de Logt A-E, Hofstra JM, Wetzels JF. Pharmacological treatment of primary 
membranous nephropathy in 2016. Expert Rev Clin Pharmacol 2016; 9(11):1463—78.
• 
van de Logt A-E, Dahan K, Rousseau A, van der Molen R, Debiec H, Ronco P et al. 
Immunological remission in PLA2R-antibody-associated membranous nephropathy: 
cyclophosphamide versus rituximab. Kidney Int 2018; 93(4):1016-7.
• 
Vriese AS de, Glassock RJ, Nath KA, Sethi S, Fervenza FC. A Proposal for a Serology- 
Based Approach to Membranous Nephropathy. J Am Soc Nephrol 2017; 28(2):421-30.
• 
Wagoner RD, Stanson AW, Holley KE, Winter CS. Renal vein thrombosis in idiopathic 
membranous glomerulopathy and nephrotic syndrome: Incidence and significance. 
Kidney Int 1983; 23(2):368-74.
MorphoSys AG
Confidential
Page 72 of 73
CTP v7.0, 01-Jul-2020 
Protocol Number: MOR202Cl03 M-PLACE 
• 
Ruggenenti P, Debiec H, Ruggiero B, Chianca A, Pelle T, Gaspari Fetal. Anti-
Phospholipase A2 Receptor Antibody Titer Predicts Post-Rituximab Outcome of 
Membranous Nephropathy. J Am Soc Nephrol 2015; 26(10):2545-58. 
• 
Ruggenenti P, Chiurchiu C, Brusegan V, Abbate M, Perna A, Filippi C et al. Rituximab 
in idiopathic membranous nephropathy: a one-year prospective study. J Am Soc Nephrol 
2003; 14(7):1851-7. 
• 
Tran TH, J Hughes G, Greenfeld C, Pham JT. Overview of current and alternative 
therapies for idiopathic membranous nephropathy. Pharmacotherapy 2015; 35(4):396-
411. 
• 
Troyanov S, Wall CA, Miller JA, Scholey JW, Cattran DC. Idiopathic membranous 
nephropathy: definition and relevance of a partial remission. Kidney Int 2004; 
66(3): 1199-205. 
• 
van de Logt A-E, Hofstra JM, Wetzels JF. Pharmacological treatment of primary 
membranous nephropathy in 2016. Expert Rev Clin Pharmacol 2016; 9(11): 1463-78. 
• 
van de Logt A-E, Dahan K, Rousseau A, van der Molen R, Debiec H, Ronco Pet al. 
Immunological remission in PLA2R-antibody-associated membranous nephropathy: 
cyclophosphamide versus rituximab. Kidney Int 2018; 93(4):1016-7. 
• 
Vriese AS de, Glassock RJ, Nath KA, Sethi S, Fervenza FC. A Proposal for a Serology-
Based Approach to Membranous Nephropathy. J Am Soc Nephrol 2017; 28(2):421-30. 
• 
Wagoner RD, Stanson AW, Holley KE, Winter CS. Renal vein thrombosis in idiopathic 
membranous glomerulopathy and nephrotic syndrome: Incidence and significance. 
Kidney Int 1983; 23(2):368-74. 
MorphoSys AG 
Confidential 
Page 72 of73 
CCI


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Protocol Number: MOR202Cl03 M-PLACE 
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SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN 
MorphoSys AG 
MOR202C103 
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STATISTICAL ANALYSIS PLAN 
Version 6 
MorphoSys AG 
Semmelweisstr. 7 
D-82152 Planegg 
GERMANY 
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess 
Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in 
Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN) M-
PLACE 
Protocol No: MOR202C103 
IND Number: 
142840 
EudraCT Number: 
2019-000780-24 
Sponsor: 
MorphoSys AG 
Author: 
 
SAP Version: 
Final Version 6 
Version Dates: 
20-SEP-2022
This document contains confidential information of MorphoSys AG.  Any viewing or 
disclosure of such information that is not authorized in writing by MorphoSys AG is strictly 
prohibited.  Such information may be used solely for the purpose of reviewing or performing 
this study. 
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STATISTICAL ANALYSIS PLAN 
SIGNATURE PAGE 
MorphoSys AG 
Semmelweisstr. 7 
D-82152 Planegg 
GERMANY 
 
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the 
Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous 
Nephropathy (aMN) M-PLACE  
Protocol No: MOR202C103 
 
 
 
 
 
 
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1. 
TABLE OF CONTENTS 
1. 
TABLE OF CONTENTS ............................................................................. iii 
2. 
DOCUMENT HISTORY .............................................................................. 7 
3. 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .................. 16 
4. 
INTRODUCTION ...................................................................................... 18 
5. 
STUDY OBJECTIVES AND ENDPOINTS ................................................ 18 
6. 
STUDY DESIGN ........................................................................................ 20 
6.1. 
General study design ........................................................................................ 20 
6.2. 
Schedule of assessments ................................................................................... 21 
6.3. 
Determination of sample size............................................................................ 21 
6.4. 
Timing of analyses............................................................................................ 22 
6.4.1. 
Safety run-in analyses .................................................................................................. 22 
6.4.2. 
Primary completion analysis ....................................................................................... 22 
6.4.3. 
Final analysis ................................................................................................................ 22 
7. 
DEFINITIONS AND GENERAL METHODOLOGY ................................. 22 
7.1. 
Treatment cycle ............................................................................................... 22 
7.2. 
Study drug/treatment ....................................................................................... 23 
7.3. 
Study drug administration ............................................................................... 23 
7.3.1. 
Date of first administration of study drug.................................................................. 23 
7.3.2. 
Date of last administration of study drug ................................................................... 23 
7.4. 
Reference start date and study day .................................................................. 23 
7.5. 
Screening failure .............................................................................................. 23 
7.6. 
Time unit ......................................................................................................... 24 
7.7. 
Baseline ............................................................................................................ 24 
7.8. 
On treatment assessment/event ........................................................................ 25 
7.9. 
End of treatment .............................................................................................. 25 
7.10. 
Analysis visits ............................................................................................... 25 
7.11. 
Selection of data in the event of multiple records in a window ...................... 25 
7.12. 
Analysis populations ..................................................................................... 26 
7.12.1. 
Screened population (SCR) ......................................................................................... 26 
7.12.2. 
Full analysis set (FAS) .................................................................................................. 26 
7.12.3. 
Per protocol set (PPS) .................................................................................................. 26 
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7.12.4. 
PK analysis set (PKAS) ................................................................................................ 26 
7.12.5. 
Immunogenicity analysis set (IAS).............................................................................. 26 
7.12.6. 
Biomarker analysis set (BAS) ...................................................................................... 26 
7.12.7. 
Planned analyses for the different populations .......................................................... 26 
7.12.8. 
Withdrawal of informed consent ................................................................................ 27 
7.13. 
Implementation of efficacy assessments ........................................................ 28 
7.13.1. 
Renal function ............................................................................................................... 28 
7.13.2. 
 .................................................................................................................... 28 
7.13.3. 
Overall response for subjects ...................................................................................... 28 
7.13.4. 
Disease progression ...................................................................................................... 30 
7.13.5. 
Start and end date for time to event variables ........................................................... 30 
7.13.6. 
Prohibited medication .................................................................................................. 31 
8. 
STATISTICAL METHODOLOGY ............................................................. 32 
8.1. 
General principles of statistical programming ................................................. 32 
8.2. 
Variable types and descriptive statistics ........................................................... 32 
8.3. 
Convention on missing data ............................................................................. 32 
8.4. 
Data included in the analysis and cut-off date .................................................. 33 
8.5. 
Specifications and analysis database ................................................................ 33 
8.6. 
Pooling of investigative sites ............................................................................. 34 
9. 
SUBJECT DISPOSITION, BACKGROUND AND BASELINE 
CHARACTERISTICS ........................................................................................... 34 
9.1. 
Subject disposition - Screened subjects ............................................................ 34 
9.2. 
Subject disposition – Treatment and follow-up phase ...................................... 34 
9.3. 
Protocol deviations ........................................................................................... 35 
9.4. 
Demographic characteristics ............................................................................ 35 
9.5. 
Medical history and current medical conditions ............................................... 36 
9.5.1. 
Coding ........................................................................................................................... 36 
9.5.2. 
Medical history and current medical conditions summaries .................................... 36 
9.5.3. 
aMN-specific medical history and diagnosis .............................................................. 36 
9.6. 
Study treatment ............................................................................................... 37 
9.6.1. 
Exposure........................................................................................................................ 37 
9.6.2. 
Dose reduction .............................................................................................................. 38 
9.6.3. 
Dose interruption.......................................................................................................... 38 
9.6.4. 
Permanent treatment discontinuations ...................................................................... 38 
9.6.5. 
Compliance ................................................................................................................... 38 
9.7. 
Prior and concomitant medications and non-drug treatments/procedures ....... 39 
9.7.1. 
Coding ........................................................................................................................... 39 
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9.7.2. 
Definitions ..................................................................................................................... 39 
9.7.3. 
Data presentation ......................................................................................................... 40 
9.7.4. 
aMN-specific prior therapies ....................................................................................... 40 
10. 
EFFICACY ANALYSIS ............................................................................. 41 
10.1. 
Analysis of best immunological response rate ............................................... 41 
10.2. 
Analysis of 24 hour urine .............................................................................. 42 
10.3. 
........................................... 42 
10.4. 
........................................... 43 
10.5. 
........................................... 43 
10.6. 
 
 ................................................................... 44 
10.7. 
........................................... 44 
10.8. 
........................................... 45 
10.9. 
........................................... 46 
10.10. 
Sensitivity analysis ........................................................................................ 46 
11. 
SAFETY ANALYSES ................................................................................. 47 
11.1. 
Adverse events .............................................................................................. 47 
11.1.1. 
Dictionary coding of adverse events ........................................................................... 48 
11.1.2. 
Grading of adverse events ........................................................................................... 49 
11.1.3. 
General Rules for AE reporting .................................................................................. 49 
11.1.4. 
Adverse Event summaries and listings ....................................................................... 49 
11.1.5. 
Specific safety evaluation ............................................................................................. 52 
11.1.6. 
General rules for specific safety evaluation ............................................................... 52 
11.1.7. 
Time to onset and duration of selected AE ................................................................ 52 
11.2. 
Definition of new abnormalities .................................................................... 53 
11.3. 
Vital signs ..................................................................................................... 53 
11.3.1. 
Vital signs variables ..................................................................................................... 53 
11.3.2. 
Vital signs analysis ....................................................................................................... 53 
11.4. 
Physical examination .................................................................................... 54 
11.5. 
Electrocardiogram (ECG) ............................................................................ 54 
11.5.1. 
ECG variables ............................................................................................................... 54 
11.5.2. 
ECG analysis ................................................................................................................. 55 
11.6. 
Laboratory data ........................................................................................... 55 
11.6.1. 
Laboratory variables .................................................................................................... 56 
11.6.2. 
Grading of laboratory results ...................................................................................... 56 
11.6.3. 
Laboratory analysis ...................................................................................................... 57 
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12. 
PHARMACOKINETIC (PK) ANALYSES ................................................... 58 
12.1. 
Available Data .............................................................................................. 58 
12.2. 
PK Parameters ............................................................................................. 58 
12.3. 
PK Parameter Derivation Rules ................................................................... 58 
12.4. 
Summary Statistics ....................................................................................... 59 
13. 
IMMUNOGENICITY ANALYSES ............................................................. 59 
14. 
BIOMARKERS ANALYSES ....................................................................... 60 
15. 
GENERAL GUIDANCE ON REPORTING ................................................ 69 
15.1. 
Document headers and footers ..................................................................... 69 
15.2. 
Presentation of output numbering and titles within this document ............... 69 
15.3. 
Presentation of analysis sets.......................................................................... 69 
15.4. 
General rules for presenting frequencies and percentages ............................ 70 
15.5. 
General rule for tables/listings ...................................................................... 70 
15.6. 
Format of tables/listings and displays with no data ...................................... 71 
15.7. 
Precision rules .............................................................................................. 71 
15.8. 
General rules for presenting listings ............................................................. 71 
15.9. 
Presentation of dates .................................................................................... 72 
16. 
 
 
73 
17. 
REFERENCES .......................................................................................... 76 
 
 
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2. 
DOCUMENT HISTORY 
Document History – Changes compared to the previous finalized version 
Version 
Date 
Changes 
Rationale for Change 
1.0 
06-09-2019 
Original 
 
2.0 
05-06-2020 
Section 4: 
Description of subjects in accordance with 
Clinical Trial Protocol (CTP) v.6 
Section 5: 
Re-wording of study endpoints to match 
wording in CTP v.6 
Section 6.1:  
Description of Cohort 1a and Cohort 1b in 
accordance with CTP v.6 
Section 6.3:  
Description of Cohort 1a and Cohort 1b in 
accordance with CTP v.6 
Section 15.4 
Modification of table shell to display 
results for Cohort 1a and Cohort 1b 
As per CTP v.6.0 Cohort 1 is split 
into Cohort 1a and Cohort 1b 
3.0 
30-11-2020 
Section 6.1, Section 6.3:  
Description of Cohort 1 and Cohort 2 in 
accordance with CTP v.7 
As per CTP v7.0 Cohort 1a and 
Cohort 1b are combined to Cohort 
1, and Cohort 2 definition is 
updated.  
Section 6.4.2: 
Time point of primary analysis definition 
extended in order to provide a clearer 
guidance.   
Addition of “selected” exploratory 
endpoints to the analysis to be performed 
at primary analysis. 
 
To provide a more detailed 
definition of the time point of the 
primary completion analysis. 
Some exploratory endpoints are 
not mature enough at the time of 
primary completion analysis and 
will be analysed at the time of 
final analysis. 
Section 7.9 
Addition of “subjects lost to follow-up” to 
the derivation of date of last contact.  
To provide a more detailed 
definition of the use of date of last 
contact.  
Section 7.13.7 
Listing of subjects in each analysis sets 
added. 
Listing added in order to provide 
more details.  
Section 7.14.3 
 
Response assessments after start 
of prohibited treatment or 
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Version 
Date 
Changes 
Rationale for Change 
Addition of “prior to start of prohibited 
treatment or progression” to the definition 
of response variables 
 
Addition of duration of response variable. 
progression should not be 
included in the derivation of 
responses. 
Analysis of duration of response 
will provide more information on 
efficacy.   
Section 7.14.5 
Addition of “Time to BIR” and “Time to 
BPR” to the censoring table.  
Addition of censoring rules for subjects 
receiving prohibited treatment.  
 
Censoring rule for subjects discontinuing 
from study without event modified to 
“date of last response assessment prior to 
study discontinuation” 
 
To provide censoring rules for 
“Time to BIR” and “Time to 
BPR”.  
Response assessments after start 
of prohibited treatment should not 
be included in the derivation of 
responses.  
Censoring rule adapted according 
to FDA guidance. 
Section 8.2 
Percentage calculation for categorical 
variables changed to include percentage 
for missing categories. 
 
To provide percentage of missing 
categories for more information. 
Section 8.4 
Incidence and severity of AEs in follow-up 
phase added to analysis at the time of 
primary analysis. 
To provide more information at 
the time of primary analysis as 
some patients may have entered 
follow-up phase at this time point 
already.   
Section 9.4 
Removed the specification of “important 
and non important protocol deviations” for 
the analysis of protocol deviation and refer 
to the protocol deviation specification 
form.  
 
Frequency table for missed visits added, 
including missed visits in the context of 
COVID-19. 
 
To not limit the deviation 
categories to “important and non 
important” but use all categories 
as specified in the protocol 
deviation specification form. 
To provide an analysis on the 
impact of missed visits in the 
context of COVID-19 
Section 9.5, Section 9.7.1, Section 11.6.1, 
Section 9.6.3  
Details to the categorical variables added.  
 
To display the categories from the 
categorical variables.  
Section 9.6.3 
Removed several anti-PLA2R summaries 
and kidney ultrasounds.  
Removed IFTA score summaries. 
 
As per CTP v7.0 these summaries 
are not needed. 
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Version 
Date 
Changes 
Rationale for Change 
IFTA score is collected as free 
text, thus listing of IFTA score 
will be provided instead. 
Section 9.7.4 
Summary by infusion number replaced by 
cycle and day. 
 
Display infusion by cycle and day 
will provide clearer information.  
Section 9.8.4 
Re-categorized prior immunosuppressive 
medications. 
Removed summary on remission as 
entered in the eCRF during or following 
the last therapy.  
 
To provide more information.  
 
Summary is already presented in 
section 9.6.3. 
Section 10.1 and Section 10.3 
Subjects with PD and non-responder added 
to the summary tables of response 
assessments 
 
To provide more information in 
the context of response 
assessments.  
 
Section 10.6 
Analysis of duration of response added. 
Analysis of duration of response 
will provide more information on 
efficacy.   
Section 10.8 
Details on the KDQOL-36 scores added. 
Summary of subscales added. 
 
To provide more information on 
the subscales of the total score.  
Section 10.9 
Summary of change from baseline until 
EOS added. 
Mean and 95%CI for percentage change 
plot added. 
Waterfall plot per subjects added. 
Analyses for the PPS may be generated.  
 
To provide more information on 
the kinetics of anti-PLA2R.  
 
 
As FAS and PPS may be similar, 
repeating of the analyses based on 
PPS is optional.  
Section 11.1 
Definition of SAE and AESI removed. 
 
 
Reference to the protocol is 
provided.  
Section 11.1.4 
Summary of non-serious TEAEs 
regardless of study drug relationship, and 
summary of TEAEs related to COVID-19 
added. 
 
Newly added summaries will be 
needed for trial results reporting. 
To provide a more detailed 
definition.  
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Version 
Date 
Changes 
Rationale for Change 
Definition of IRR summary table 
extended. 
 
Removed several special AE listings. 
 
Information of AE listing is 
present in the remaining listings. 
Section 11.1.4 
Summary of non-serious TEAEs 
regardless of study drug relationship, and 
summary of TEAEs related to COVID-19 
added. 
Definition of IRR summary table 
extended. 
 
Removed several special AE listings. 
 
Newly added summaries will be 
needed for trial results reporting. 
To provide a more detailed 
definition.  
 
Information of AE listing is 
present in the remaining listings. 
Section 11.6.3 
Summary of absolute and change from 
baseline of cytokines added.  
 
To provide more information on 
cytokines. 
Section 13 
Summary of ADA over all visits added.   
 
To provide more on information 
as ADA. 
Section 14 
Summary of change from EOT for 
biomarkers added.  
 
Added as per clinical protocol 
wording.  
Throughout the document: 
Editorial changes 
 
4.0 
 
 
 
 
 
 
 
 
 
 
 
17-11-2021 
 
 
 
 
 
 
 
 
 
 
 
Section 7.9 (old) and section 9.3 (old) 
Removed definition of date of last contact 
and duration of follow-up. 
Information is available in the 
exposure and disposition table.  
Section 7.10 and section 7.11 
Added information on pre-/post dose 
collection for analysis visit mapping. 
Information is needed for 
mapping algorithm 
Section 7.12.7 
Removed PPS analysis for kinetics of anti-
PLA2R titres. 
Analyses will be performed on 
FAS. Due to the small sample 
size, SAF and FAS will not differ 
substantially. 
Section 9.2 
Added the number of subjects ongoing in 
follow-up phase. 
Information relevant for primary 
analysis 
Section 9.5.3 
Information will be present in 
section 9.7.4, section 10.1  
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Version 
Date 
Changes 
Rationale for Change 
 
 
 
 
 
 
 
 
 
 
 
 
Removed information on prior IST 
treatment, baseline proteinuria value, and 
anti-PLA2R titres from aMN-specific 
medical history table. 
Removed kidney biopsy outputs. 
Kidney biopsy information can be 
found in listings. 
Section 9.6.5 
Removed boxplots of compliance. 
Information is already available in 
table 
Section 9.7.2 and section 9.7.3 
Merging of concomitant medication and 
prior and concomitant medication. 
A separate category of prior and 
concomitant medication is not 
required. 
Section 10.1 
Removed sensitivity analysis of excluding 
subjects with no post-baseline assessment. 
All patients have at least one post-
baseline assessment.  
Section 10.2 
Replace boxplot with waterfall plot.  
Waterfall plot is of higher 
interest.  
Section 10.4, Section 10.5 
Removed plots. 
For this exploratory endpoint, no 
figures are needed.  
Section 10.7 
Added cumulative hazard plot.  
Plot will provide a different view 
on the time to event endpoint.  
Section 10.8 
Added the information on the norm used 
for KDQOL. 
Since two versions of the 
questionnaires are used, the 
specification of the norm provides 
comparability of the two versions. 
Section 10.9 
Removed the boxplot and plots by best 
response. Replaced confidence interval 
with standard error for the plot.  
Due to small number of subjects, 
spaghetti plots over time can 
present all patients and a wide 
confidence interval may not be 
meaningful. 
Section 11.1.4 
Added ≥ 5% to non-serious TEAE output.  
Removed AE tables of grade 5.  
SAE table including death cases added. 
Death table removed. IRR table removed. 
Replaced IRR by SMQ Hypersensitivity in 
bar chart. Removed special listings. 
Removed pre-treatment AE listing 
Requirement added for trial result 
posting.  
Information of grade 5 is 
available in by grade AE tables.  
Table added for EudraCT posting. 
Information on death cases 
available in listings and SAE 
table including death cases.  
Information on IRR already 
available in AE tables.  
To broaden the AE event 
categories.  
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Version 
Date 
Changes 
Rationale for Change 
Information available in AE 
listing already.  
Information not relevant for CSR 
writing. 
Section 11.6.3 
Removed tables for pregnancy results and 
categorical urinalysis variables. 
Information will be present in 
listings. 
Section 12.4 
Replaced MOR202 concentration ratio by 
normalized MOR202 concentration ratio. 
Analysis of normalized 
concentration ratio is more 
meaningful. 
Section 14 
Detailed specification of biomarkers.  
To provide more information. 
Throughout the document: 
Editorial changes 
 
5.0 
08.03.2022 
Section 7.3.16 
The definition of Prohibited medication 
was added in the SAP 
Prohibited medications make part 
of the analyses and should be 
defined in the SAP 
Section 7.10 
The ‘Assessment windows and analysis 
visits’ section was substituted by ‘Analysis 
visits’ section. Assessment windows are 
disregarded in current version and the 
main difference in analysis windows 
approach is that: 
nominal (actual) visit dates will be used as 
per eCRF, 
unscheduled visits for visit-based analyses 
will be disregarded, except baseline 
assessment 
unscheduled visits will be considered only 
for patient data listings and spaghetti plots 
 
Applying the assessment 
windows clarifies the approach 
for using unscheduled visit data. 
Section 9.6.1 
Categories of exposure duration and the 
cumulative exposure duration were 
defined based on study days  
This approach enables an easier 
interpretation of the results 
Section 10.2  
Spaghetti plots for % change from baseline 
for each subject were added 
These plots will allow detailed 
exploration of the results 
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Version 
Date 
Changes 
Rationale for Change 
All plots will be produced also for Urine 
creatinine parameter  
Section 10.3 
Analysis of Proteinuria response will be 
evaluated also on PPS population 
UPCR is an important efficacy 
endpoint and the analyses done on 
PPS population will allow 
detailed interpretation of the 
results 
Section 10.4 
Analysis of Renal Function assessed by 
eGFR will be evaluated also on PPS 
population 
Renal Function is an important 
efficacy endpoint and the analyses 
done on PPS population will 
allow detailed interpretation of 
the results 
Section 10.4 
The eGFR will be evaluated as % change 
from baseline to each visit until End of 
Study.  
No sense from clinical point of 
view doing the evaluation from 
EOT until EOS 
Section 10.5 
The serum albumin levels will be 
evaluated as % change from baseline to 
each visit until End of Study.  
No sense from clinical point of 
view doing the evaluation from 
EOT until EOS 
Section 10.7 
Number (%) of subjects with doubling of 
serum creatinine either vs. baseline or any 
nadir measured during the trial was 
removed from the analyses 
Is not needed per Protocol  
Section 10.8 
The kidney specific subscales will be 
derived using additional SAS code 
(Appendix 1).  
The evaluation of kidney specific 
subscales is not included in core 
scoring software provided by 
Optum 
Section 10.9 
The kinetics of anti-PLA2R titers will be 
evaluated as % change from baseline to 
each visit until End of Study.  
No sense from clinical point of 
view doing the evaluation from 
EOT until EOS 
Section 10.9  
Spaghetti plots for % change from baseline 
for each subject were added 
These plots will allow detailed 
exploration of the results 
Section 10.10 
Sensitivity analysis will be performed on 
FAS population excluding subjects with 
less than 70% of the MOR202 doses 
These analyses will allow detailed 
interpretation of the efficacy of 
study treatment 
Section 11.1.4 
Tables of Treatment-emergent SAEs by 
primary SOC and PT, regardless of study 
Previously these 3 tables were 
defined as a single table which is 
not possible 
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Version 
Date 
Changes 
Rationale for Change 
treatment relationship, suspected to be 
related to study treatment and death cases 
for Final analyses were split to 3 different 
tables  
Section 14 
Spaghetti plots for individual 
pharmacodynamic biomarker level (time 
vs. parameter value) were removed 
Boxplots for absolute 
pharmacodynamic biomarker 
levels at each visit will be used 
 
 
Section 15 
Some rules were adapted to Metronomia 
standards 
Better display of the results 
Throughout the document: 
Editorial changes 
 
6.0 
19.09.2022 
Section 5 
The definition of Proteinuria endpoint was 
updated, ie ‘end of cycle 6’ and ‘after 12 
months’ were removed from its definition 
It is in accordance with the 
Protocol section 5 and FAS 
includes all patients with EOT 
and EOS data.  
 
 
Section 7.13.3 
In the Proteinuria Response section, the 
definition of the reference range of serum 
albumin was added in accordance with Q2 
laboratory manual 
This reference range is necessary 
in programming of Proteinuria 
Complete Response 
 
 
Section 10.10 
Sensitivity Analysis was updated with new 
conditions: 
1)excluding subjects who received at least 
one dose of relevant IST therapies 
2)Visit windows approach was 
implemented to evaluate main efficacy 
endpoints in accordance with Protocol visit 
assessments. 
1)From clinical point of view 
these subjects have negative 
impact on different endpoints and 
the sensitivity analysis should be 
done excluding them 
2)This approach enables 
assigning data in accordance with 
calendar days when the actual 
visits were done by subjects. 
Moreover, this approach enables 
not losing any subject data 
collected. 
 
 
 
 
Section 14 
Bullet ‘Post EOT samples only: Absolute 
and relative change from EOT visit to each 
This analysis is covered in the 
analysis of change from baseline 
at FU and EOS visits 
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Version 
Date 
Changes 
Rationale for Change 
subsequent visits until end of study’ was 
removed 
 
 
Throughout the document: 
Editorial changes 
 
 
 
 
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3. 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
ACEI 
Angiotensin Converting Enzyme Inhibitor 
ADA 
Anti drug antibody  
ADaM 
Analysis Data Model 
ADS 
Analysis Dataset specification 
ADR 
Adverse drug reaction 
AE 
Adverse event, for definition see 10.8.6 
AESI 
Adverse Event of Special Interest 
ALT 
Alanine-Aminotransferase 
aMN 
Anti-PLA2R antibody positive membranous nephropathy 
Anti-PLA2R 
Anti phospholipase A2 receptor antibodies 
ATC 
Anatomical Therapeutic Chemical Classification 
BAS 
Biomarker Analysis Set 
BIR 
Best overall immunological response  
BIRR 
Best overall immunological response rate 
BLOQ 
Below Limit of Quantification 
BPR 
Best proteinuria response 
CDISC 
Clinical Data Interchange Standards Consortium 
CI 
Confidence Interval 
CKD-EPI 
Chronic Kidney Disease Epidemiology Collaboration 
CR 
Complete response 
CRF 
Case Report Form 
CRO 
Contract research organization 
CSR 
CTP 
Clinical study report 
Clinical trial protocol 
CxDy 
Cycle x Day y (e.g. C1D1 is the 1st day of the 1st cycle) 
CV 
Coefficient of variation 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
eGFR 
estimated glomerular filtration rate 
ELISA 
Enzyme-linked immunosorbent assay 
EMA 
European Medicines Agency 
EOS 
End of study visit (28 weeks after EOT) 
EOT 
End of therapy visit (28 days after last dose) 
ESRD 
End stage renal disease 
EudraCT  
European Union Drug Regulating Authorities Clinical Trials 
FA 
Final analysis 
FAS 
Full analysis set 
FDA 
Food and Drug Administration 
FCBP 
Female of childbearing potential 
FUV 
Follow up visit (14 weeks after EOT) 
GCP 
Good Clinical Practice 
GFR 
Glomerular Filtration Rate 
IAS 
Immunological analysis set 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
ICR 
Immunological complete response 
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IFTA score 
Interstitial fibrosis and tubular atrophy score 
IMP 
Investigational medicinal product 
IPR 
immunological partial response 
IRR 
infusion related reaction 
IST 
Immunosuppressive therapy 
i.v. 
intravenously 
LLOQ 
Lower Limit of Quantification 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
mL 
Milliliter 
Max 
maximum 
Min 
minimum 
MM 
Multiple myeloma 
MN 
Membranous nephropathy 
NCI CTCAE 5.0 
National Cancer Institute Common Terminology Criteria for Adverse 
Events, version 5.0  
PA 
Primary analysis 
PD 
Progressive disease 
PE  
Physical examination 
PK 
Pharmacokinetics  
PKAS 
Pharmacokinetic Analysis Set 
PK/PD 
pharmacokinetic/pharmacodynamic 
PKAS 
Pharmacokinetic Analysis Set 
PLA2R 
Phospholipase A2 receptor 
PPS 
Per protocol set 
PR 
Partial response 
Prot-CR 
Proteinuria Complete Response 
Prot-PR 
Proteinuria Partial Response  
PT 
Preferred term 
QoL 
Quality of Life 
QTcB 
QT interval corrected for heart rate according to Bazett 
QTcF 
QT interval corrected for heart rate according to Fridericia 
Q1 
25th Percentile 
Q3 
75th Percentile 
RU 
Response unit 
SAE 
Serious adverse event, for definition see 10.8.6 
SAP 
Statistical analysis plan 
Scr 
Serum creatinine 
SDTM 
Study data tabulation model 
sICR 
Stringent immunological complete response 
SOC 
Standard of Care 
SOP 
Standard Operating Procedure 
StD 
Standard deviation 
TEAE 
Treatment emergent adverse event 
t1/2 
Terminal elimination half-life 
UPCR 
Urine protein to creatinine ratio 
WHO 
World Health Organization 
 
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4. 
INTRODUCTION 
This Statistical Analysis Plan (SAP) describes the planned analysis and reporting of data collected from 
MorphoSys protocol MOR202C103, Version 7.0, dated 07-Jul-2020. Any amendments to the protocol, 
which do not affect the statistical aspects of the trial will not necessitate a SAP update. 
 
This study is a two-cohort, non-randomized, open-label, multicenter clinical trial to assess safety and 
efficacy of the human anti-CD38 antibody MOR202 in anti-PLA2R antibody positive membranous 
nephropathy (aMN) subjects eligible for immunosuppressive therapy (IST) or who have failed to 
respond to previous IST. The structure and content of this SAP are specified to give detailed and 
comprehensive description of the endpoints in the study and the corresponding analyses in accordance 
with the requirements identified by the Food and Drug Administration (FDA), European Medicines 
Agency (EMA), and International Conference on Harmonization (ICH) of Technical Requirements for 
Registration of Pharmaceuticals for Human Use: Guidance on Statistical Principles in Clinical Trials. 
All work planned and reported from this SAP will follow internationally accepted guidelines, published 
by the American Statistical Association and the Royal Statistical Society, for statistical practice. 
 
The planned analyses identified in this SAP may be included in clinical study report (CSRs) and/or in 
relevant summary report documents (e.g. regulatory submissions, or future manuscripts). Also, post-hoc 
exploratory analyses not necessarily identified in this SAP may be performed to further examine study 
data and will not require updating the final SAP. Any post-hoc, or unplanned, exploratory analysis 
performed will be clearly identified as such and described in the final CSR. 
The SAP is based on the following documents:  
 
Clinical Research Protocol MOR202C103 
 
ICH Guidance on Statistical Principles for Clinical Trials (E9) 
 
The reader of this SAP is encouraged to also read the clinical protocol, and other identified documents, 
for details on the planned conduct of this study. Operational aspects related to collection and timing of 
planned clinical assessments are not repeated in this SAP unless relevant to the planned analysis. 
 
5. 
STUDY OBJECTIVES AND ENDPOINTS 
An overview of the study objectives and endpoints is depicted in Table 5-1. 
Table 5-1: Study objectives and endpoints 
Study objective 
Endpoint 
Analysis 
Primary objective: 
Primary endpoint: 
 
To assess the safety and 
tolerability of MOR202 treatment 
in subjects with anti-PLA2R 
antibody positive 
membranous nephropathy 
(aMN) 
Incidence and severity of TEAEs 
Section 11.1 
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Study objective 
Endpoint 
Analysis 
Key secondary objective: 
Key secondary endpoint: 
 
To assess the effect of 
MOR202 on serum anti- 
PLA2R antibodies in subjects 
with aMN 
Best Immunological response: rate of sICR, 
ICR and IPR based on reduction of serum 
anti-PLA2R antibody titer 
Section 10.1 
Secondary objectives: 
Secondary endpoints: 
 
1. To assess immunogenicity 
of MOR202 (anti-MOR202 
antibody formation) in subjects 
with aMN 
Number and antibody titers of subjects tested 
positive for anti-MOR202 antibodies 
Section 13 
2. To assess the pharmacokinetic 
(PK) profile of MOR202 in 
subjects with 
aMN 
MOR202 serum concentrations after multiple 
i.v. administrations 
Section 12 
3. To assess the safety in subjects 
with aMN after 
MOR202 treatment and during 
the follow-up phase. 
Incidence and severity of adverse events (AEs) in 
the follow-up phase. 
Section 11.1 
Exploratory objectives: 
Exploratory endpoints: 
 
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Study objective 
Endpoint 
Analysis 
 
6. 
STUDY DESIGN  
6.1. 
General study design 
This phase Ib/IIa multicenter trial enrolls subjects with anti-PLA2R antibody positive membranous 
nephropathy (aMN) indicated for immunosuppressive therapy (IST) into two cohorts: 
 
 
Cohort 1 consists of approximately 20 aMN subjects newly diagnosed or relapsing subjects 
stable on supportive care treatment with ACEI/ARB at screening with proteinuria and 
medium/high serum titers of anti-PLA2R antibodies eligible for immunosuppressive therapy 
(IST).  
 
Cohort 2 consists of approximately 10 subjects with aMN refractory to IST and requiring 
other forms of IST. 
 
The trial design includes a Safety Run-in, which in the initial stage of the trial intends to limit 
drug exposure to the first three subjects. All trial subjects, including the safety run-in subjects, will 
follow the clinical trial schedule in Figure 6-1. Each treatment cycle (C) consists of 28 days (D). 
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Please refer to section 6.2 of the clinical trial protocol for more details on the screening phase, 
treatment phase and follow-up phase.  
 
6.2. 
Schedule of assessments 
Please refer to section 10 of the clinical trial protocol for the full schedule of assessments.  
6.3. 
Determination of sample size 
As this is a Phase Ib/IIa trial primarily conducted to explore safety endpoints, no formal statistical 
hypothesis has been established for the sample size calculation of this trial. 
 
Three evaluable subjects will be enrolled in the safety run-in phase. These subjects can belong to either 
Cohort 1 or Cohort 2.   
Once the safety run-in is completed successfully, additional subjects will be enrolled in Cohort 1 and 
Cohort 2 in parallel. Approximately 20 subjects will be enrolled in Cohort 1 and approximately 10 
subjects will be enrolled in Cohort 2.  
 
With a sample size of 20 subjects in Cohort 1, there is an 88% probability to observe at least one 
occurrence of a particular adverse event if the natural incidence of this adverse event in Cohort 1 is 10%. 
 
Cohort 2 includes subjects refractory to IST with up to 2 prior lines of treatment. Thus it is expected that 
incidence of AEs will be higher in Cohort 2 than in Cohort 1. With a sample size of 10 subjects in Cohort 
2, there is a 80% probability to observe at least one occurrence of a particular adverse event if the 
incidence of this adverse event is 15%. 
 
 
Figure 6-1 Clinical Trial Schedule 
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6.4. 
Timing of analyses 
6.4.1. 
Safety run-in analyses 
The first three subjects dosed in this trial (regardless of cohort) will be treated and observed until Cycle 
2 Day 1 or until having demonstrated a toxicity leading to discontinuation of treatment, whichever is 
earlier. If a grade 4/5 adverse drug reaction (ADR) occurs during the safety run-in, then a safety review 
will take place and start of treatment for further subjects will be contingent on safety review outcome.  
 
The safety review will consist of an evaluation based on the number and type of all AEs occurring during 
the first cycle and laboratory values (biochemistry and hematology) and will be performed by 
representatives of the Safety Review Panel consisting of representatives of the participating 
investigators and the sponsor. The safety review will be held after C2D1 of the 3rd subject. For more 
details refer to section 6.3 of the clinical trial protocol. 
 
6.4.2. 
Primary completion analysis 
The primary completion analysis will be performed after the last subject completes Cycle 6 of treatment 
(after the EOT visit), or 28 days after the last subject received the last dose of MOR202 (only for early 
termination).  
 
If the enrolment for one of the cohorts is significantly longer (approximately two months difference 
between the enrolment of the last subject in Cohort 1 and the last subject in Cohort 2), the Primary 
Completion Analysis may be performed by cohort. In this case, no overall summary of both cohorts will 
be presented in the analysis. Otherwise the analyses will be performed for both cohorts at the same time. 
 
Primary, key secondary and selected exploratory endpoints will be analysed at the time of Primary 
Completion. For more details, see Table 8-1 in section 8.4. 
 
6.4.3. 
Final analysis 
The final analysis will be performed after all subjects completed either their EOS visit or completed 
the “Early study discontinuation” eCRF page. 
 
7. 
DEFINITIONS AND GENERAL METHODOLOGY 
 
7.1. 
Treatment cycle 
The subjects will be administered study treatment according to cycles. Each treatment cycle (C) 
consists of 28 days (D).  
The planned administration of MOR202 is as follows: 
Cycle 1: Day 1, Day 8, Day 15, Day 22 
Cycle 2 to Cycle 6: Day 1 
 
 
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7.2. 
Study drug/treatment 
Study drug and study treatment refer to the individual drug MOR202. In the rest of the SAP we will 
refer to it only as “study drug”.  
 
7.3. 
Study drug administration 
7.3.1. 
Date of first administration of study drug  
The date of first administration of study drug for a subject is the first date when a non-zero dose of 
study drug is administered and is referred to as “start date of study drug”.  
 
7.3.2. 
Date of last administration of study drug 
The date of last administration of study drug for a subject is the last date when a non-zero dose of 
study drug is administered and is referred to as “end date of study drug”.  
 
7.4. 
Reference start date and study day 
The reference start date will be defined as the start date of study drug for all 
Safety assessments (e.g. adverse event onset, laboratory abnormality occurrence, etc.) 
Efficacy assessments (e.g. response assessments, etc.) 
Non-safety screening assessments, baseline disease characteristics, medical history that 
occurred prior to start date of study treatment 
 
The study day describes the day of the event or assessment, relative to the reference start date. The 
reference start date is designated as Study Day 1. Study Day -1 is the day that precedes Study Day 1. 
Study Day 0 is not defined.  
The study day will be calculated as: 
The date of the event (visit date, assessment date, etc.) – reference start date + 1 day, if the event 
is on or after the reference start date 
The date of the event (visit date, assessment date, etc.) – reference start date, if the event 
precedes the reference start date 
 
The study day will be displayed in the data listings.  
 
7.5. 
Screening failure 
Screening failures are subjects who have signed informed consent and failed screening criteria. Subjects 
who signed informed consent and fulfilled screening criteria, but have never received treatment are not 
considered as screening failures. These subjects are referred to as “Not treated subjects”. 
   
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7.6. 
Time unit 
A month-length is 30.4375 days (365.25/12). If duration is to be reported in months, duration in days is 
divided by 30.4375. If duration is to be reported in years, duration in days will be divided by 365.25. 
 
7.7. 
Baseline 
Baseline is the result of an investigation describing the “true” uninfluenced state of the subject, defined 
as the period from the date of signing any informed consent document to the start date of study drug.  
Unless otherwise stated in the respective sections, the last non-missing assessment, including 
unscheduled assessments, on or before the start date of study drug prior to the first dosing of the study 
drug will be used as “baseline” value or “baseline” assessment. Assessments collected post-dose on the 
first date of treatment are not considered as baseline values. 
Baseline values for proteinuria responses are defined in the respective section. 
If a subject has no value as defined above, the baseline value will be considered as missing. 
Data listings will include baseline flags. 
Change from baseline calculation 
Absolute change from baseline will be calculated as  
[visit value – baseline value] 
and percentage change from baseline will be calculated as  
[ 
visit value−baseline value
baseline value
 × 100 ]. 
 
 
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7.8. 
On treatment assessment/event 
On-treatment assessment/event 
An on-treatment assessment/event is defined as any assessment/event happening after the start date of 
study treatment, i.e. assessments/events happening in the following time interval (including the lower 
and upper limits): 
[Start date of study drug +1 day; End date of study drug + 28 days]. 
Assessments collected post-dose on the start date of study drug are also considered as on-treatment 
assessments. Data listings will include all assessments/events, flagging those which are not on-treatment 
assessments/events. 
Post-treatment assessment/event 
A post-treatment assessment/event is defined as any assessment happening after the completion of the 
on-treatment phase, i.e. assessments/events happening in the following time interval (including the 
lower and upper limits): 
[End date of study drug + 28 days + 1 day; Date of study discontinuation]. 
The date of study discontinuation is defined as the date of the End of Study Visit, or the date entered in 
the “Early study discontinuation” eCRF page, whichever is later. 
 
7.9. 
End of treatment 
End of treatment (EOT) is defined as the assessment obtained on the EOT visit date.  
Change from EOT will be calculated similarly to change from baseline as described in section 7.7, 
replacing baseline value with the value obtained at EOT. 
7.10. 
Analysis visits 
For parameters that will be summarized by visit, the nominal visit as recorded in the eCRF (i.e. actual 
visit date) will be used (disregarding the allowed assessment windows). Data collected in unscheduled 
visits will be displayed in patient data listings and spaghetti plots only, except Baseline assessment (refer 
to section 7.7). The unscheduled visit results will be flagged in the listings accordingly and will be 
highlighted by asterisks on spaghetti plots.  
 
In the case of multiple records for one visit, selection rules are described in section 7.11 (below). 
7.11. 
Selection of data in the event of multiple records in a window 
Depending on the statistical analysis method, single values may be required for each visit. For example, 
change from baseline by visit usually requires a single value per visit, whereas a time-to-event analysis 
would not require on value per visit but rather one value for the study.  
Unless otherwise noted in the respective sections, when a single value is needed, the following rules 
will be used: 
 
If more than one assessment is assigned to the same nominal visit, select the record closest to 
the nominal day for that particular visit day 
 
If there are two assessments that are equidistant from the nominal visit day, the data of the 
assessment after the scheduled study day will be used 
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 
If more than one assessment is collected on the same day, the latest assessment on that day  will 
be used. 
 
7.12. 
Analysis populations 
7.12.1. Screened population (SCR) 
The screened population consists of all subjects who signed informed consent. 
 
7.12.2. Full analysis set (FAS) 
All subjects belonging to the screened population who received at least one dose of study drug. Efficacy 
and Safety analyses will be performed on FAS. 
 
7.12.3. Per protocol set (PPS) 
All subjects included in FAS without any protocol deviation, which could impact the efficacy outcome. 
Those protocol deviations leading to exclusion from FAS and creating the PPS will be listed including 
the subject number and specified in the Protocol Deviation specification form. 
 
7.12.4. PK analysis set (PKAS) 
All subjects included in FAS with at least one evaluable MOR202 serum concentration data. 
 
7.12.5. Immunogenicity analysis set (IAS) 
All subjects included in SCR with at least one anti-drug antibody (ADA) result available. 
 
7.12.6. Biomarker analysis set (BAS) 
All subjects included in FAS with at least one biomarker assessment available.  
 
7.12.7. Planned analyses for the different populations 
The number of subjects in each analysis set will be summarized. A listing of all analysis sets for each 
subject will be prepared. 
Table 7-1 gives an overview of the assessments performed on the different analysis sets. 
Table 7-1 Planned analyses for different populations 
Analysis 
SCR 
FAS 
PPS 
PKAS 
IAS 
BAS 
Subject disposition 
X 
X 
 
 
 
 
Background and demographic 
characteristics 
 
X 
 
 
 
 
Medical history and aMN-specific medical 
history 
 
X 
 
 
 
 
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Analysis 
SCR 
FAS 
PPS 
PKAS 
IAS 
BAS 
Study treatment 
 
X 
 
 
 
 
Prior and concomitant medications and 
aMN-specific medical history 
 
X 
 
 
 
 
Safety analysis during and after MOR202 
treatment 
 
X 
 
 
 
 
Best immunological response 
 
X 
X 
 
 
 
Immunogenicity of MOR202 
 
 
 
 
X 
 
PK profile of MOR202 
 
 
 
X 
 
 
Summary of 24 hour urine 
 
X 
 
 
 
 
 
X 
X 
 
 
 
 
X 
X 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
Summary of vital signs, physical 
examination and ECG 
 
X 
 
 
 
 
Summary of laboratory data 
 
X 
 
 
 
 
 
 
7.12.8. Withdrawal of informed consent 
The date on which a subject signs the main informed consent, additional informed consent for kidney 
biopsy at screening, additional informed consent for kidney biopsy at last study visit or additional 
informed consent for future research is recorded in the eCRF. 
Any data collected in the clinical database after a subject withdraws the main informed consent from 
further participation in the trial, will not be included in the analysis data sets.  
If a subject withdraws only any of the additional informed consents, the related data collected in the 
clinical database after the withdrawal, will not be included in the analysis data sets. 
Exceptions are the information entered to close a page after the date of withdrawal of consent, e.g. End 
of Treatment or End of Study information.  
 
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7.13. 
Implementation of efficacy assessments 
7.13.1. Renal function 
Renal function will be assessed by the estimated glomerular filtration rate (eGFR). eGFR in 
ml/min/1.73𝑚2 will be calculated as per the Chronic Kidney Disease Epidemiology Collaboration 
(CKD-EPI) equation ( (1), (2)):  
𝑒𝐺𝐹𝑅= 141 × min (𝑆𝑐𝑟
𝜅, 1)
𝛼
× max (𝑆𝑐𝑟
𝜅, 1)
−1.209
× 0.993𝐴𝑔𝑒× 1.018[𝑖𝑓 𝑓𝑒𝑚𝑎𝑙𝑒] 
× 1.159[𝑖𝑓 𝑏𝑙𝑎𝑐𝑘], 
Where: 
Scr is serum creatinine in µmol/L, 
𝜅 is 61.9 for females and 79.6 for males (if Scr is measured in µmol/L), 
(𝜅 is 0.7 for females and 0.9 for males (if Scr is measured in mg/dL)), 
α is -0.329 for females and -0.411 for males, 
min indicates the minimum of 
𝑆𝑐𝑟
𝜅 or 1, and  
max indicates the maximum of 
𝑆𝑐𝑟
𝜅 or 1. 
 
Stable renal function is defined in this trial by eGFR as an eGFR of at least 80% of baseline. 
 
7.13.2. 
 
 
7.13.3. Overall response for subjects 
Immunological Response 
Immunological responses are reflected by the reduction of anti-PLA2R antibody titres as measured by 
ELISA (Euroimmun). Based on the immunological responses, the following response categories are 
defined for this clinical trial (the baseline value is the last measurement obtained prior to treatment start): 
 
Immunological Partial Response (IPR): Reduction of anti-PLA2R antibody titres by at least 
50% compared to baseline 
 
Immunological Complete Response (ICR): Reduction of anti-PLA2R antibody titres to less 
than 14.0 RU/mL 
 
Stringent Immunological Complete Response (sICR): ICR and a negative result in anti-
PLA2R immunofluorescence test 
 
The following variables related to immunological responses are defined as follows. 
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 
Time to First Immunological Response (in months) prior to start of prohibited treatment (see 
definition in section 7.13.6) or progression, defined as  
[Date of first documented response of IPR, ICR or sICR (whichever is earlier) – Start date of 
study drug + 1 day]/30.4375  
 
Best overall immunological response (BIR) is defined when a subject is classified as having a 
IPR, ICR, or sIRC at any time during the trial but prior to start of prohibited treatment or 
progression. Responses for BIR are ordered as IPR < ICR < sICR. If a subject meets the 
criteria for more than one response category, the subject will be classified in the highest 
category.  
 
Time to BIR (in months), defined as  
[Date of BIR – Start date of study drug + 1 day]/30.4375 
 
Duration of Immunological response (in months), defined as  
[Date of death, PD or start of prohibited treatment (whichever is earlier) – Date of first 
documented response of IPR, ICR or sICR (whichever is earlier) + 1 day]/30.4375. Subjects 
with a response but no date of death, PD or start of prohibited treatment at the time of analysis 
cut-off will be censored at the date of last response assessment. Subjects without a response of 
IPR, ICR or sICR are assigned a duration time of zero. 
 
Proteinuria Response 
Proteinuria responses are reflected by the reduction of proteinuria as measured by UPCR. Based on the 
proteinuria responses, the following response categories are defined by this clinical trial: 
 
Proteinuria Complete Response (Prot-CR): Reduction of proteinuria to less than 0.5 g/g, 
serum albumin within the reference range (3.5 – 5.2 g/dL) and stable eGFR (at least 80% of 
baseline) 
 
Proteinuria Partial Response (Prot-PR): Reduction by at least 50% of UPCR at a given visit 
compared to baseline, proteinuria below 3.0 g/g and stable eGFR (at least 80% of baseline), 
but not meeting Prot-CR 
The following variables related to proteinuria responses are defined as follows. 
Overall Proteinuria Response (OPR), defined as subjects achieving either Prot-CR or Prot-PR 
as a response (irrespective of start of prohibited medication or progressive disease prior to the 
proteinuria response).   
Time to First Proteinuria Response (in months) prior to start of prohibited treatment or 
progression, defined as  
[Date of first documented response of Prot-CR or Prot-PR (whichever is earlier) – Start of 
study drug + 1 day]/30.4375    
Best Proteinuria Response (BPR) for a subject is defined when a subject is classified as having 
a Prot-CR or Prot-PR at any time during the trial but prior to start of prohibited treatment or 
progression. Responses for BPR are ordered as Prot-PR < Prot-CR. If a subject meets the 
criteria for more than one response category, the subject will be classified in the highest 
category. 
Time to BPR (in months), defined as 
[Date of BPR – Start date of study drug + 1 day]/30.4375  
Duration of Proteinuria Response, defined as  
[Date of death, PD or start of prohibited treatment (whichever is earlier) – Date of first 
documented response of Prot-CR or Prot-PR (whichever is earlier) + 1 day]/30.4375. Subjects 
with a response but no date of death, PD or start of prohibited treatment at the time of analysis 
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cut-off will be censored at the date of last response assessment. Subjects without a response of 
Prot-CR or Prot-PR are assigned a duration time of zero. 
 
7.13.4. Disease progression 
Progressive Disease 
Progressive Disease (PD) is defined as a decrease of eGFR by more than 30% of baseline eGFR, or 
increase in UPCR by more than 50% from baseline value and less than 10% decline of anti-PLA2R 
antibody titres compared to baseline. 
End Stage Renal Disease 
End Stage Renal Disease (ESRD) is defined as decrement in the subject’s kidney function to a level at 
which renal replacement therapy is required to sustain life meeting one of the following criteria: 
Was on dialysis therapy for more than 30 days continuously 
Received a kidney transplant 
A physician recommended renal replacement therapy (dialysis or transplant) and the subject refused 
therapy 
Began dialysis and died < 30 days later 
Confirmed eGFR < 10 ml/min/1.73𝑚2 
 
7.13.5. Start and end date for time to event variables 
Start Date 
For all efficacy “time to event” variables, the start date of study drug will be used as the start date.  
End Date 
For all efficacy “time to event” variables, the end dates are defined as follows: 
Date of first documented response IPR, ICR or sICR (for immunological response) 
Date of first documented Prot-CR or Prot-PR (for proteinuria response) 
Date of first documented PD 
 
Subjects not experiencing either response or PD defined above will be censored at the time of trial 
discontinuation, or the date of cut-off, whichever is earlier.  
Calculation of “time to event” variables: 
Time to event (days) = End date – Start Date + 1 day 
 
Censoring rules  
For the analysis of time to event variables using the Kaplan-Meier method, the following censoring 
rules are defined. 
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Situation 
Time to event variable 
Date of event 
or censoring 
Outcome 
Censoring 
Reason 
Ongoing and no 
event until data 
cut-off 
Time to first immunological 
response, Time to BIR, Time 
to first proteinuria response, 
Time to BPR, Time to PD 
Date of cut-off 
Censored 
Ongoing 
Discontinued the 
study with no event 
Time to first immunological 
response, Time to BIR, Time 
to first proteinuria response, 
Time to BPR, Time to PD 
Date of last 
response 
assessment 
prior to study 
discontinuation 
Censored 
Discontinued 
without event 
No baseline 
assessment for the 
time to event 
variable 
Time to first immunological 
response, Time to BIR, Time 
to first proteinuria response, 
time to BPR, Time to PD 
Date of C1D1 
Censored 
No baseline 
assessment 
Subject received 
prohibited 
treatment before 
event 
Time to first immunological 
response, Time to BIR,  
Time to proteinuria 
response, Time to BPR 
Date of last 
response 
assessment 
prior to 
prohibited 
treatment 
Censored 
Start of 
prohibited 
treatment 
Subject with 
progressive disease 
(PD) before event 
Time to first immunological 
response, Time to BIR, Time 
to first proteinuria response, 
Time to BPR 
Date of 
documented 
PD 
Censored 
Start of PD 
No post-baseline 
assessment for the 
event variable 
Time to first immunological 
response, Time to BIR, Time 
to first proteinuria response, 
time to BPR, Time to PD 
Date of C1D1 
Censored 
No post-baseline 
assessment 
 
7.13.6. Prohibited medication 
Prohibited medication will be identified on a case-by-case basis by a medical review of the concomitant 
medication. For the definition of response and time to event variables as described above the first 
administration of prohibited medication will be relevant. If the day of any prohibited medication is 
missing, it will be imputed by the first of the month. If day and month are missing, it will be imputed by 
1-Jan of the corresponding year.  
Subjects in need of systemic corticosteroid therapy other than for prophylaxis and treatment of IRR for 
more than 7 days may continue being treated with MOR202 but will be excluded from the Per Protocol 
Analysis Set and the Immunological Analysis Set (IAS). These subjects will be selected on the basis of 
concomitant medication listing as described above. The ATC level 3 ‘CORTICOSTEROIDS FOR 
SYSTEMIC USE, PLAIN’ will be selected for individuating patients in systemic use of corticosteroids. 
Out of these patients, only those who was on therapy for more than 7 days will be excluded from the 
PPS and IAS. 
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8. 
STATISTICAL METHODOLOGY 
8.1. 
General principles of statistical programming 
The statistical analysis will be performed on the analysis study database with appropriate software, 
SAS Software version 9.4 or above (SAS Institute, Cary, N.C.). 
 
8.2. 
Variable types and descriptive statistics 
Descriptive statistics will be calculated using as reference the number of subjects in the relevant analysis 
population (any exception will be specified) according to the nature of the data as follows: 
 
Continuous variables (e.g. age, body weight): number of non-missing observations, number of missing 
observations, arithmetic mean, standard deviation (StD), minimum and maximum values, quartiles 
(median, Q1 and Q3).  
 
If there are less than 5 observations, only the number of non-missing observations, arithmetic mean, 
median, minimum and maximum will be presented. 
 
Descriptive statistics of plasma concentrations and PK parameters will include number of observations, 
arithmetic mean, geometric mean, StD, median, coefficient of variation CV (%), geometric CV (%), 
minimum and maximum. Geometric mean and the geometric CV (%) will be derived from non-zero 
values. For plasma concentrations, the number of non-zero values (m) will also be reported. 
 
Categorical variables: (e.g. gender) number of non-missing observations, the number of missing and 
the relevant percentage on the analysis population, number and relative frequencies. 
 
In case of subcategories, the relative frequencies will be calculated on the basis of the subjects in the 
respective category, in this case a footnote will be added explaining the different denominators. 
 
Time variables (durations): Will be summarized using arithmetic mean, StD, minimum and maximum 
values, median and quartiles (Q1, Q3) and will be presented in months (unless otherwise stated). 
 
Time to event variables: (e.g. Time to Response) Unless otherwise stated, Kaplan Meier estimates of 
Q1, Median, and Q3 along with their 95% Confidence Intervals will be presented. 
 
The majority of data obtained on the eCRF and entered into the database will be provided in separate 
data listings showing individual subject values. The planning and reporting of statistical analyses will 
be carried out as described in the CROs standard operating procedures (SOPs). 
 
8.3. 
Convention on missing data 
Unless otherwise specified, missing data will not be imputed. Details on missing data imputation are 
present in the respective sections.  
 
In all listings, imputed values will be flagged.  
 
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8.4. 
Data included in the analysis and cut-off date 
All the analyses will be performed using data collected in the database up to the data cut-off date. A cut-
off date will be defined for each of these analyses and will be specified in the outputs.  
Any data collected beyond the cut-off date will not be included in the analysis. Only data with an 
assessment date or event start date prior to or on the cut-off date will be included in the analysis.  
All events with an event start date either before or on the cut-off date and an event end date after the 
cut-off date will be reported as “continuing at the cut-off date”. The same rule will be applied to events 
starting either before or on the cut-off date and not having a documented end date. This approach applies, 
in particular, to adverse event and concomitant medication reports. For these events, the end date will 
not be imputed and therefore will appear as missing in listings. 
If it is required to impute an end date to be able to perform a specific analysis, the cut-off date needs to 
be imputed as an end date. The imputed date will be displayed and flagged in the listings. 
Any data collected beyond a subject’s withdrawal of consent will not be included in the analysis; except 
for SAEs and the date of death provided by a confirmed public registry and subject status entered after 
the date of withdrawal of consent on e.g. early treatment discontinuation eCRF page.  
The data before cut-off for the primary analysis includes all data until the last subject completes Cycle 6 
of treatment, i.e. after the EOT visit, or 28 days after the last subject received the last dose of MOR202 
for early terminated subjects.  
Table 8-1 below indicates the analyses performed for the primary and final analyses. 
Table 8-1 Analysis included in primary and final analysis 
Analysis 
Primary 
Analysis 
Final 
Analysis 
Incidence and severity of TEAEs 
X 
X 
Immunological response 
X 
X 
Anti-MOR202 antibodies 
X 
X 
MOR202 serum concentration 
X 
X 
Incidence and severity of AEs in follow-up phase 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X  
 
8.5. 
Specifications and analysis database 
Based on dataset in SDTM format, analysis datasets adhering to CDISC ADaM standard will be 
generated with SAS software, version 9.4 or above, after the soft lock of data for the primary completion 
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analysis or hard lock of complete study database for the final analysis and according to agreed Analysis 
Dataset specifications (ADS). 
 
8.6. 
Pooling of investigative sites 
Data will be pooled from all investigative sites for the analyses. The justification for this is based on the 
following: 
The sites will follow protocol harmonized across the countries in the sense of study population and 
outcome measures (in case of country specific protocol amendments). 
The sponsor will provide close monitoring of study procedures and compliance for all sites. 
Each site is expected to recruit a few subjects only. 
The study sites must use unified data collection procedures. 
 
9. 
SUBJECT DISPOSITION, BACKGROUND AND BASELINE 
CHARACTERISTICS 
 
9.1. 
Subject disposition - Screened subjects 
The number (%) of subjects who were  
Screened 
Screen failure 
Not treated subjects, i.e. successfully screened but never treated 
In the FAS population, i.e. received at least one dose of MOR202 
 
will be summarized and listed by cohort, country, and overall based on SCR. Percentages will be 
calculated based on the number of subjects screened.  
The reason for screen failures (i.e. the violated inclusion or exclusion criteria) will be listed by cohort 
on SCR. 
Subjects who were successfully screened but never started MOR202 treatment will be listed on SCR.  
 
9.2. 
Subject disposition – Treatment and follow-up phase 
The following summaries and listings by cohort and overall will be provided, based on the number of 
subjects in FAS: 
 
Number (%) of subjects treated with study drug 
 
Number (%) of subjects successfully completed treatment phase (without early treatment 
discontinuation) 
 
Number (%) of subjects, who discontinued treatment early in the treatment phase 
 
Reason for early treatment discontinuation  
 
Number (%) of subjects, who discontinued study early in the treatment phase 
 
Reason for early study discontinuation in the treatment phase 
 
Number (%) of subjects entered the follow-up phase  
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 
Number (%) of subjects ongoing in follow-up phase 
 
Number (%) of subjects completed the follow-up phase (i.e. having their scheduled last visit) 
 
Number (%) of subjects discontinued study early in the follow-up phase  
 
Reason for early study discontinuation in the follow-up phase 
 
 
 
9.3. 
Protocol deviations 
The number (%) of subjects in the FAS with any protocol deviation as well as the protocol deviations 
will be tabulated by deviation category (as specified in the Protocol deviation specification form) and 
will be summarized by cohort, overall and by site, and tabulated according to the categories in the 
Protocol deviation specification form. 
Only protocol deviations directly affecting the subject will be reported. Protocol deviations pertaining 
to the study centers will not be considered.  
In a table, for each protocol deviation, the number (%) of events (incidence) and the number (%) of 
subjects experiencing the protocol deviation will be displayed by cohort and overall on FAS.  
A frequency table by visit will be produced for the number (%) of subjects with missed visits in the FAS 
with the reason for the missed visit (including missed visits in the context of COVID-19).  
Protocol deviations will be listed by cohort on FAS. 
 
9.4. 
Demographic characteristics 
All summaries will be presented by cohort and overall for the FAS. Listings for demographic data will 
be produced by cohort on FAS. 
The following continuous variables will be summarized by cohort and overall:  
 
Age at screening (Year of screening – Year of birth, in years) 
 
Height at screening (cm) 
 
Weight at screening (kg) 
 
Body Mass Index (BMI) (
𝑘𝑔
𝑚2) at screening, calculated as BMI = 
𝑊𝑒𝑖𝑔ℎ𝑡 (𝑘𝑔)
𝐻𝑒𝑖𝑔ℎ𝑡 (𝑚)^2 
 
Body Surface Area (BSA) (𝑚2) at screening, calculated as  
BSA (𝑚2) =  √𝐻𝑒𝑖𝑔ℎ𝑡 (𝑐𝑚)×𝑊𝑒𝑖𝑔ℎ𝑡 (𝑘𝑔)
3600
                  (3) 
 
 
 
The following categorical variables will be summarized by cohort and overall:  
Age categorized: 18 – 64 years, 65 – 84 years, ≥ 85 years 
Gender 
Race (White, Black or African American, Asian, American Indian or Alaska Native, Native 
Hawaiian or other Pacific Islander, or Other) 
Female Subjects of child bearing potential: Yes or No 
Male Subject Vasectomized: Yes or No  
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9.5. 
Medical history and current medical conditions 
9.5.1. 
Coding  
Medical history and current medical conditions will be summarised using the current Medical Dictionary 
for Regulatory Activities MedDRA (MedDRA Version 25.0 or higher) system organ class (SOC) and 
preferred term classifications. At the end of the trial, all MedDRA codes will be updated with the latest 
MedDRA version. 
 
9.5.2. 
Medical history and current medical conditions summaries 
The relevant medical history and current medical conditions, including allergies or hypersensitivities 
(except aMN-related) will be summarised by counts and percentages by primary SOC, PT and toxicity 
grade for each cohort and overall in FAS. The relevant medical history and current medical conditions 
will be listed for subjects in FAS.  
 
9.5.3. 
aMN-specific medical history and diagnosis 
The medical history related to membranous nephropathy will be summarized by cohort and overall 
including the following summaries  
Disease status at screening (newly diagnosed, relapsed or refractory) 
Time since initial aMN diagnosis (months) defined as: [Date of screening – Date of initial 
diagnosis of aMN + 1 day]/30.4375 
o If the date of initial diagnosis of aMN is completely missing, the date will not be 
imputed and the subject will have a missing time since initial aMN diagnosis 
o If only the day is missing, then it will be replaced by the first day of the month 
o If both the day and month are missing, then it will be replaced by the first day of the 
year 
Proteinuria remission 
Number (%) of subjects with a Proteinuria remission during or following previous therapy 
before starting MOR202 treatment (overall and split by complete vs. partial remission) 
Duration of remission during or following previous therapy (months) (overall and split by 
complete remission vs. partial remission) 
Number (%) of subjects with a remission for ≥ 6 months vs. < 6 months during or following 
previous therapy according to the clinical judgement (months) as entered in the eCRF (overall 
and split by complete vs. partial remission) 
Immunofluorescence test results for anti-PLA2R  
Number (%) of subjects with positive/negative immunofluorescence test during remission 
(overall and by remission categories for complete vs. partial remission)  
Anti-PLA2R titre 
Number (%) of subjects with anti-PLA2R titre of less than 20.0 RU/ml during remission 
(overall and split by complete vs. partial remission) 
 
The following calculations will be defined:  
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 
Duration of remission to previous therapy (months): [End date of last remission – start date of 
remission + 1 day]/30.4375 
o If start or end date is completely missing, then duration of response will not be 
imputed and is missing. 
o If both day and month are missing, the date will not be imputed 
o If only day is missing for the start date, it will be replaced by the first day of the 
month 
o If only day is missing for end date, it will be replaced by the last day of the month 
 
If after imputation, the end date of last remission is after the date of screening, the end date of 
last remission will be replaced by the date of screening 
 
If after imputation, the duration of remission is < 6 months, and the result of “Duration of 
remission during or following previous therapy according to the clinical judgement” in the 
eCRF is ≥ 6 months, the start date will be replaced by [End date – 6 months - 1 day]  
 
If after imputation, the duration of remission is ≥ 6 months, and the result of “Duration of 
remission during or following previous therapy according to the clinical judgement” in the 
eCRF is < 6 months, the start date will be replaced by [End date – 6 months + 1 day] 
 
 
9.6. 
Study treatment 
9.6.1. 
Exposure 
Duration of exposure to study drug 
Exposure to study treatment will be summarized for the FAS population. The duration of exposure will 
be calculated as follows: 
Duration of exposure (days) = [end date of study drug – start date of study drug + 1 day] 
Cumulative Dose 
The MOR202 dose for each infusion can be calculated following the drug handling manual as follows: 
 
MOR202 infusion dose (mg)  = 
𝐴𝑐𝑡𝑢𝑎𝑙 𝑡𝑜𝑡𝑎𝑙 𝑖𝑛𝑓𝑢𝑠𝑖𝑜𝑛 𝑣𝑜𝑙𝑢𝑚𝑒 𝑎𝑑𝑚𝑖𝑛𝑖𝑠𝑡𝑒𝑟𝑒𝑑 (𝑚𝑙)
𝑇𝑜𝑡𝑎𝑙 𝑣𝑜𝑙𝑢𝑚𝑒 𝑖𝑛 𝑡ℎ𝑒 𝑝𝑟𝑒𝑝𝑎𝑟𝑒𝑑 𝑖𝑛𝑓𝑢𝑠𝑖𝑜𝑛 𝑏𝑎𝑔 (𝑚𝑙)  
                                              ×   𝑉𝑜𝑙𝑢𝑚𝑒 𝑜𝑓 𝑟𝑒𝑐𝑜𝑛𝑠𝑡𝑖𝑡𝑢𝑡𝑒𝑑 𝑑𝑟𝑢𝑔 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛 𝑎𝑑𝑑𝑒𝑑 𝑖𝑛𝑡𝑜 𝑡ℎ𝑒 𝑖𝑛𝑓𝑢𝑠𝑖𝑜𝑛 𝑏𝑎𝑔 (𝑚𝑙) 
                                           × 65 (
𝑚𝑔
𝑚𝑙) 
 
The cumulative dose is defined as the sum of total doses that the subject received from the first study 
treatment administration until the last study treatment administration. 
 
A summary table with the following information will be presented by cohort and overall on FAS: 
 
Duration of exposure (months) 
 
Duration of exposure categorized as follows: 
 
Days of exposure  
    >0 to <7 days 
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    >=7 to <14 days 
    >=14 to <21 days 
    >=21 to <30 days 
    >=30 to <60 days 
    >=60 to <90 days 
    >=90 to <120 days 
    >=120 to <183 days 
    >=183 days 
In addition, the cumulative exposure duration will be displayed as described above. 
 
Number (%) of subjects completing each cycle (Cycle 1, 2, 3, 4, 5, and 6) 
 
Total number of MOR202 infusions per subject (categorized: 1-2 infusions, 3-4 infusions, 
etc.) 
 
Cumulative Dose (mg) per subject 
 
Individual study drug administration data will be listed by subject and cohort on FAS, including the 
information on start and end times of administration, including the study day, infusion volume, and 
reason(s) for dose interruptions, if applicable. 
Listings of the vial numbers for each subjects per administration will be provided.  
 
9.6.2. 
Dose reduction 
Not applicable. 
 
9.6.3. 
Dose interruption 
The number (%) of subjects with at least one temporary interruption (during infusion and interruptions 
due to toxicity) and the associated reasons will be summarized by cohort, cycle and day on FAS.  
 
9.6.4. 
Permanent treatment discontinuations 
The number (%) of subjects who discontinued MOR202 permanently and the associated reasons will be 
summarized and listed by cohort, cycle and day on FAS.  
 
9.6.5. 
Compliance 
Compliance for a MOR202 infusion (based on infusion volumes) will be calculated by dividing the 
actual MOR202 infusion dose with the planned MOR202 infusion dose and multiplied by 100 (refer to 
the drug handling manual for the calculation of the planned MOR202 infusion dose).  
Overall compliance for MOR202 per subject (based on cumulative infusion volumes) will be calculated 
by dividing the sum of actual MOR202 infusion doses with the sum of planned MOR202 infusion doses 
and multiplied by 100. 
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A subject is non-compliant for each infusion if the MOR202 dose administered is ≤ 70% or > 130% of 
the planned MOR202 dose. Such non-compliance is recorded in the eCRF. Subjects with overall 
compliance ≤ 70% are excluded from the FAS in the Sensitivity Analysis, refer to section 10.10. 
Any MOR202 dose missed without medical reason is considered as non-compliance.  
The following information will be displayed by cohort and on FAS: 
 
Number (%) of subjects in the following compliance categories per single infusion: 
o  ≤ 70% 
o > 70% - ≤ 130% 
o > 130% 
 
Summary statistics of compliance per infusion visit 
 
Number (%) of subjects in the following compliance categories for the overall compliance: 
o ≤ 70% 
o > 70% - ≤ 130% 
o > 130% 
 
Summary statistics of the overall compliance 
 
 
9.7. 
Prior and concomitant medications and non-drug treatments/procedures 
9.7.1. 
Coding 
Concomitant medications will be recorded and coded using the WHO Drug Dictionary Enhanced and 
grouped by Anatomical Therapeutic Chemical (ATC) classes; non-drug treatments/procedures will be 
coded using the MedDRA (MedDRA Version 25.0 or higher). Tabulations with counts and percentages 
will show the number of medications and non-drug treatments /percentage used in each class  / preferred 
term by cohorts and overall. 
 
9.7.2. 
Definitions 
Pre-medication: Medication given prior to MOR202 infusion to mitigate potential infusion-related 
reactions. Pre-medication encompasses antihistamine, antipyretic and glucocorticoids.  
Prior medication/non-drug treatment: If the treatment start and stop dates are both before the start of 
study drug, the medication/non-drug treatment will be classified as prior medication/non-drug treatment. 
Subjects will only be counted once for multiple drug use by preferred drug name. 
Concomitant medication/non-drug treatment: If the medication start date is on or after start of study 
drug, the medication will be considered as concomitant medication. If the medication start date If before 
start date of study treatment but ongoing or with stop date after the start of study treatment, the 
medication will be considered as concomitant medication. Subjects will only be counted once for 
multiple drug use by preferred drug name. If the medication start and stop date are incomplete, the 
following algorithm will apply to exclude the medication from the category concomitant medication. If 
the start date is missing and  
 
If stop day is missing but month is complete, medication will only be excluded from 
concomitant medication if stop month is before month of treatment start. 
 
If stop day and month are missing but year is complete, medication will only be excluded 
from concomitant medication if stop year is before year of treatment start. 
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 
If stop date is completely missing, medication will not be excluded. 
 
9.7.3. 
Data presentation 
Summary tables (excluding aMN-specific prior therapies) will be presented by cohort and overall for: 
Prior medications  
Concomitant medications  
Prior non-drug treatments/procedures  
Concomitant non-drug treatments/procedures  
Pre-medications  
 
All summaries will be conducted on FAS. Listings will be shown for pre-medication, prior 
medication/non-drug treatments or procedures and concomitant medication/non-drug treatments or 
procedures (excluding aMN-specific prior therapies). 
 
9.7.4. 
aMN-specific prior therapies 
A summary table will be presented by cohort and overall on FAS for the following aMN-specific 
therapies: 
Prior medications/non-drug procedures given for aMN (= medication with indication given as 
“Primary disease (aMN)” and end date prior or equal to date of screening) 
Number of subjects (%) with at least one prior medication 
Number of subjects (%) with at least one non-drug procedure 
Time since last prior anti-aMN medication/non-drug procedure (months) (see calculation 
below) 
 
Prior immunosuppressive medications (= medication recorded on prior IST eCRF page with latest 
end date prior or equal to screening) 
 
Number of subjects (%) treated with no, one, two and more than two immunosuppressive 
medication categorized and continuous. Different recordings of the same preferred term 
according to the WHO Drug Dictionary are not counted as separate immunosuppressive 
medications.  
 
 
Duration of last prior IST (months) (see calculation below)  
 
Separate listings will be presented on prior aMN medications/non-drug procedures and 
immunosuppressive medications. Listings on IST therapy will include information on: 
 
Medication name 
 
Number of the particular IST therapy line 
 
Therapy start date 
 
Therapy end date 
 
Route and dosing regimen 
 
Date and type of the remission during or following the last IST therapy before start of MOR202 
treatment 
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The following calculations are defined: 
 
Time since last prior anti-aMN medication/non-drug procedure: [Date of screening – End date 
of last prior anti-aMN medication/non-drug procedure + 1 day]/30.4375 
If the end date of last prior aMN medication/non-drug procedure is completely missing, the date 
will not be imputed 
If only the day of the end date is missing, then it will be replaced by the day 15 of the month 
If both the day and month, or year are missing, the date will not be imputed 
If after imputation, the end date of last prior anti-aMN medication/non-drug procedure is after 
the date of screening, the end date will be replaced by the date of screening 
Duration of last prior IST: [End date of last prior IST – Start date of last prior IST + 1 
day]/30.4375 
If the end date or the start date is completely missing, the date will not be imputed 
If both the day and month, or year of the start or end date is missing, the date will not be imputed 
If the day of the start date is missing, it will be replaced by the first day of the month 
If the day of the end date is missing, it will be replaced by the last day of the month, or the date 
of screening, whichever is first 
 
 
10. 
EFFICACY ANALYSIS 
For the primary completion analysis, the analyses will be performed based on the visits during the safety 
run-in phase and treatment phase.  
For the final analysis, the analyses will be performed based on all the visits during the trial. 
 
10.1. 
Analysis of best immunological response rate 
The key secondary objective in this trial is to assess the effect of MOR202 on serum anti-PLA2R 
antibodies in subjects with aMN in terms of best overall immunological response rate (BIRR). 
The best overall immunological response (BIR) is defined as achieving any response of IPR, ICR or 
sICR at any time during the trial but prior to start of prohibited medication or progression based on the 
definitions in section 7.13.3.  
The best overall immunological response rate (BIRR) is defined as the proportion of subjects with a best 
overall immunological response. The denominator will be the total number of subjects included in the 
analysis population.  
Main Analysis 
The main analysis will be conducted on FAS. The following information will be presented by cohort 
and overall: 
Number (%) of subjects achieving a BIR of IPR at any time during the trial 
Number (%) of subjects achieving a BIR of ICR at any time during the trial 
Number (%) of subjects achieving a BIR of sICR at any time during the trial 
BIRR along with the 95% confidence interval (CI, using the Clopper-Pearson exact method)  
Number (%) of subjects with a BIR of PD at any time during the trial 
Number (%) of subjects classified as Non-responder  
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For each visit available, the number and percentages of subjects in each of the response categories will 
be tabulated, including missing response evaluations and subjects with a progressive disease. Subjects, 
who are not classified in either response category or progressive disease will be tabulated as “Non-
Responders”. Subjects with no post-baseline assessment of response will be included as “Non-
Responders”. 
If a subject achieves several responses, the subject will be tabulated in the highest achieved response 
category.  
No formal hypothesis testing will be conducted.  
Sensitivity Analysis 
The main analysis as described above will be conducted using the PPS population. 
 
Listings of individual responses per visit will be generated on FAS.  
 
10.2. 
Analysis of 24 hour urine  
24 hour urine will be collected to assess the following parameters:  
 
Urine protein 
 
Urine creatinine 
 
Urine sodium 
 
 
 
The following information will be summarized for each 24 hour urine parameter above by cohort and 
overall on FAS: 
Absolute levels by visit 
Absolute and percentage change from baseline to each visit until end of study  
 
Listings with individual urine parameter levels will be generated by visit on FAS. 
 
The following plots will be generated by cohort on FAS for UPCR and Urine creatinine: 
Spaghetti plots (time vs. parameter value for each subject) 
Spaghetti plots (time starting from baseline vs. % change from baseline for each subject) – 
please add dotted reference lines for upper (50%) and lower (-50%) thresholds. 
Waterfall plot for relative change from baseline at EOT, FUV and EOS – please add study days 
under the corresponding subject IDs 
 
 
10.3. 
  
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10.4. 
 
 
10.5. 
 
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10.6. 
 
 
10.7. 
  
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10.8. 
 
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10.9. 
 
 
10.10. Sensitivity analysis 
The sensitivity analysis will be performed on the FAS excluding subjects who received ≤ 70% of the 
MOR202 doses overall (please see section 9.6.5 for the details) or who received at least one dose of 
relevant IST therapies at any timepoint of the study in accordance with the visit windows defined in 
Table 3. The relevant IST therapies will be identified on a case-by-case basis by a medical review of the 
concomitant medication listing (please refer to section 7.13.6 for the details) and documented in the data 
review meeting minutes.  
Table 3. Allowed assessment windows. 
Visit 
Target day 
Analysis Window 
1 week 
Day 7 
Day 2 to Day 10 
2 weeks 
Day 14 
Day 11 to Day 17 
3 weeks 
Day 21 
Day 18 to Day 26 
1 month 
Day 30 
Day 27 to Day 45 
2 months 
Day 61 
Day 46 to Day 75 
3 months 
Day 92 
Day 76 to Day 107 
4 months 
Day 122 
Day 108 to Day 138 
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6 months 
Day 183 
Day 139 to Day 229 
9 months 
Day 274 
Day 230 to Day 320 
12 months 
Day 366 
≥ Day 321  
 
The closest value to the target day should be taken into analysis. If there are two values equidistant from 
the target date, then the latest value will be taken in the analysis. Unscheduled visits are considered in 
sensitivity analysis. 
The sensitivity analyses will be applied to the following endpoints: 
 
Best immunological response rate, section 10.1 
 
 
 
 
 
Renal Function assessed by eGFR, section 10.4 
 
Serum Albumin Levels, section 10.5 
 
Kinetics of anti-PLA2R titres, section 10.9 
 
11. 
SAFETY ANALYSES 
The analysis of safety assessments in this trial will include the evaluation of: 
 
Adverse Events  
 
Vital signs 
 
Physical Examination 
 
Electrocardiogram 
 
Laboratory evaluations 
 
11.1. 
Adverse events 
Adverse Event (AE) 
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical 
product and which does not necessarily have to have a causal relationship with this treatment.  
An AE can therefore be any unfavourable and unintended sign (including a clinically relevant abnormal 
laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not 
considered related to that product. For more details, refer to study protocol section 10.8.5.  
All AEs will be recorded with information regarding onset, start and end date/time, relationship to study 
drug, intensity, toxicity grade, action taken with study drug, treatment of event and outcome. 
Treatment Emergent Adverse Event (TEAE) 
TEAEs are defined as any adverse event reported within the following time interval (including the lower 
and upper limits), which is referred to as the treatment-emergent period:  
[Start date of study drug, End date of study drug + 28 days]. 
The analysis of TEAEs will serve as primary endpoint of this trial. 
If the start date and time of an AE are partially or completely missing, the AE will be assumed to be a 
TEAE if it cannot be definitely shown that the AE did not occur during the treatment emergent period 
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(worst case approach).  Missing dates and times will not be replaced. The following approach will be 
followed: 
 
If the start time of an AE is missing but the start date is complete, an AE will only be excluded 
from TEAE if the start day is before the day of first study drug administration or the start date 
is after the end date of the treatment-emergent period 
 
If the start time and day are missing but the start month is complete, an AE will only excluded 
from TEAE if the start month is before the month of first study drug administration or the start 
month is after the end month of the treatment-emergent period or if the stop date and time is 
before the start of first study drug administration 
 
If the start day and months are missing but the start year is complete, an AE will only be 
excluded from TEAE if the start year is before the year of first study drug administration or if 
the start year is after the end year of the treatment-emergent period or if the stop date and time 
is before the start of first study drug administration 
 
If the start date is completely missing, an AE will not be excluded from TEAE unless the stop 
date and time is before the start of first study drug administration 
 
AEs starting during the study but before the first date of study drug administration will be classified as 
pre-treatment adverse events and will be presented in a separate adverse events listing.  
An AE present prior to first study drug administration but increased in severity after treatment start, will 
also be included as TEAE.  
 
Post-Treatment Adverse Event 
Post-treatment AEs are defined as any adverse event reported within the following time interval 
(including the lower and upper limits), which is referred to as the post-treatment period: 
[End date of study drug + 28 days + 1 day; Date of study discontinuation]. 
The analysis of post-treatment AEs will serve as one of the secondary endpoints. 
 
Serious Adverse Events (SAE) 
SAEs are defined in the protocol section 10.8.6.  
 
Adverse Events of Special Interest (AESI) 
AESIs in this clinical trial are defined in the protocol section 10.8.7. 
 
11.1.1. Dictionary coding of adverse events 
AEs will be coded according to the current Medical Dictionary for Regulatory Activities (MedDRA) 
version and will be reported by primary system organ class (SOC) and preferred term (PT). At the end 
of the trial all MedDRA codes will be updated to the newest version.  
  
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11.1.2. Grading of adverse events 
The toxicity grade of AEs will be graded according to the NCI-CTCAE version 5.0 of November 27, 
2017 using the following definitions: 
 
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated 
 
Grade 2: Moderate; minimal, local or non-invasive intervention indicated; limiting age-
appropriate instrumental activities of daily living (refers to preparing meals, shopping for 
groceries or clothes, using the telephone, managing money, etc.) 
 
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily 
living 
 
Grade 4: Life-threatening consequences; urgent intervention indicated 
 
Grade 5: Death related to AE 
 
11.1.3. General Rules for AE reporting 
AE tables 
 
All safety analyses will be done using the FAS by cohort and overall.  
 
AEs will be summarised by SOC and PT. The SOCs and PTs will be used for tabulation 
 
AE frequency tables will display the number of events (incidence), the number of subjects 
experiencing an event and the percentage of subjects with the event by SOC and PT 
 
If a subject reported more than one AE with the same PT, the AE with greatest severity and the 
closest association with the study drug will be presented   
 
If a subject reported more than one AE with the same PT, the AE with the maximum toxicity 
grade will be presented 
 
If a subject reported more than one AE within the same SOC, the subject will be counted only 
once with the maximum toxicity grade at the SOC level, where applicable 
 
AE listings 
 
All AEs will be listed by subject and cohort, along with information regarding onset, start and 
end date, relationship to study drug, intensity, toxicity grade, action taken with study drug, 
treatment of event, and outcomes based on FAS.  
 
In the AE listings, AEs that started prior to the administration of study drug will be flagged as 
pre-treatment AEs. AEs that start 28 days after the last date of study drug administration will be 
flagged as post-treatment AEs 
 
 
11.1.4. Adverse Event summaries and listings 
Overall Summary of AEs 
An AE summary table will be presented showing the number of events, number of subjects and the 
percentage of subjects in each cohort and overall having: 
 
TEAEs 
 
Post-treatment AEs 
 
TEAEs by maximum intensity 
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 
Post-treatment AEs by maximum intensity 
 
TEAEs by maximum grade 
 
Post-treatment AEs by maximum grade 
 
Treatment-emergent SAEs 
 
Post-treatment SAEs 
 
On-treatment deaths 
 
Post-treatment deaths 
 
TEAEs suspected to be related to study drug 
 
TEAEs suspected to be related to study drug in each intensity/toxicity grading 
 
Post-treatment AEs suspected to be related to study drug 
 
Post-treatment AEs suspected to be related to study drug in each intensity/toxicity grading 
 
All AEs suspected to be related to study drug 
 
All AEs suspected to be related to study drug in each intensity/toxicity grading 
 
TEAEs leading to discontinuation of study drug 
 
IRRs by grade 
 
Treatment-emergent AESIs by grade 
 
Post-treatment AESIs by grade 
 
TEAEs (serious and non-serious) 
The following summary tables will be provided: 
TEAEs regardless of study drug relationship by primary SOC, PT and grade 
Non-serious TEAEs in ≥ 5% of subjects regardless of study drug relationship by primary SOC 
and PT  
TEAEs regardless of study drug relationship by primary SOC, PT and intensity 
TEAEs regardless of study treatment relationship of ≥ grade 3 by primary SOC, PT and grade. 
TEAEs suspected to be related to study drug by primary SOC, PT and grade 
TEAEs suspected to be related to study drug by primary SOC, PT and intensity 
TEAEs suspected to be related to study drug of ≥ grade 3 by primary SOC, PT and grade. 
TEAEs leading to any action on study drug by primary SOC, PT and grade (any action includes: 
Drug withdrawn, drug interrupted) 
TEAEs related to COVID-19 by primary SOC, PT and grade 
 
Post-treatment AEs (serious and non-serious) 
The following summary tables will be provided: 
Post-treatment AEs regardless of study drug relationship by primary SOC, PT and grade 
Post-treatment AEs regardless of study drug relationship by primary SOC, PT and intensity 
Post-treatment AEs regardless of study treatment relationship of ≥ grade 3 by primary SOC, PT 
and grade 
Post-treatment AEs suspected to be related to study drug by primary SOC, PT and grade 
Post-treatment AEs suspected to be related to study drug by primary SOC, PT and intensity 
Post-treatment AEs suspected to be related to study drug of ≥ grade 3 by primary SOC, PT and 
grade 
 
Treatment-emergent and post-treatment SAE 
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The following summary tables will be provided: 
Treatment-emergent SAEs regardless of study drug relationship by primary SOC, PT and grade 
Treatment-emergent SAEs regardless of study drug relationship ≥ grade 3 by primary SOC, PT 
and grade 
Treatment-emergent SAEs suspected to be related to study drug by primary SOC, PT and grade 
Treatment-emergent SAEs suspected to be related to study drug ≥ grade 3 by primary SOC, PT 
and grade 
 
Post-treatment SAEs regardless of study drug relationship by primary SOC, PT and grade 
Post-treatment SAEs regardless of study drug relationship ≥ grade 3 by primary SOC, PT and 
grade 
Post-treatment SAEs suspected to be related to study drug by primary SOC, PT and grade 
Post-treatment SAEs suspected to be related to study drug ≥ grade 3 by primary SOC, PT and 
grade 
 
For the final analysis, the following tables of treatment-emergent SAEs by primary SOC and PT will be 
produced in addition:  
 regardless of study treatment relationship;  
suspected to be related to study treatment; 
death cases. 
 
Treatment-emergent and post-treatment AESIs 
The following summary tables will be provided: 
 
Treatment-emergent AESIs regardless of study drug relationship by primary SOC, PT and grade 
 
Treatment-emergent AESIs suspected to be related to study drug by primary SOC, PT and grade 
 
Post-treatment AESIs regardless of study drug relationship by primary SOC, PT and grade 
 
Post-treatment AESIs suspected to be related to study drug by primary SOC, PT and grade 
 
All AEs suspected to be related to study drug (TEAEs and post-treatment AEs) 
The following summary tables will be provided: 
All AEs suspected to be related to study drug by primary SOC, PT and grade 
All AEs suspected to be related to study drug by primary SOC, PT and intensity 
All AEs suspected to be related to study drug of ≥ grade 3 by primary SOC, PT and grade 
All SAEs suspected to be related to study drug by primary SOC, PT and grade 
All SAEs suspected to be related to study drug ≥ grade 3 by primary SOC, PT and grade 
All AESIs suspected to be related to study drug by primary SOC, PT and grade 
 
All TEAEs (irrespective of causality) and post-treatment AEs suspected to be related to study 
drug  
The following summary tables will be provided: 
All TEAEs (irrespective of causality) and post-treatment AEs suspected to be related to study 
drug by primary SOC, PT and grade 
All TEAEs (irrespective of causality) and post-treatment AEs suspected to be related to study 
drug by primary SOC, PT and intensity 
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All TEAEs (irrespective of causality) and post-treatment AEs suspected to be related to study 
drug of ≥ grade 3 by primary SOC, PT and grade 
 
Deaths 
Information on death is captured on “Adverse Events” and “Early study discontinuation” page in the 
eCRF.  
All deaths including those that occurred on-treatment and post-treatment, will be listed along with the 
primary cause of death. Post-treatment deaths will be flagged in listings.  
 
Infusion related reactions (IRRs) 
A bar chart will be generated, showing the number of infusions (e.g. 1st infusion, 2nd infusion, etc.) (x-
axis) vs. the number of subjects with at least one event of SMQ “Hypersensitivity” (narrow version) (y-
axis) during or in the context of this infusion. The number of subjects receiving the respective infusion 
will be displayed in the bar chart as well. This analysis would be useful to identify the trend of IRR over 
consecutive infusions. 
 
Special AE listings 
Special AE listings for TEAEs and post-treatment AEs by cohort on FAS, displaying details of the 
event(s) captured on the eCRF, will be provided for: 
 
Serious adverse events  
 
AEs leading to discontinuation of study drug 
 
AEs of special interest 
 
AEs leading to death 
 
AEs related to Covid-19 as assessed by the investigator in the eCRF 
 
AEs that start 28 days after the last date of study drug administration will be flagged as post-treatment 
AEs. 
 
11.1.5. Specific safety evaluation 
Not applicable for this trial. 
11.1.6. General rules for specific safety evaluation 
Not applicable for this trial. 
11.1.7. Time to onset and duration of selected AE 
  
For TEAEs in the following categories:  
AESIs 
Hematological AEs (AEs pertaining to the SOC “Blood and lymphatic system disorders” and 
AEs pertaining to the HLGT “Haematology investigations”) 
SAEs 
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a plot for each category will be generated by subject (y-axis) vs. time on study (months, x-axis) showing 
the start and end time of an AE. Ongoing AEs and grading information will be marked for each subject.  
 
11.2. 
Definition of new abnormalities 
For the evaluation of clinical laboratory results, vital sign results and ECG results the following terms 
are defined: 
 
A new abnormality will be any abnormal post baseline result for a subject whose baseline was 
within normal limits 
 
A significant worsening will be any numeric measurement that represents a change from 
baseline by ≥ 25% of the baseline value, in the direction away from normal (i.e., in the direction 
that is clinically significant) 
 
An outlying result for any numeric measurement will be any post administration change from 
baseline that meets either of the following criteria: 
o < 25th percentile (Q1) – 1.5 * interquartile range 
o > 75th percentile (Q3) + 1.5 * interquartile range 
 
An extreme value for any numeric measurement will be any post administration change from 
baseline that meets either of the following criteria: 
o < 25th percentile (Q1) – 3 * interquartile range 
o > 75th percentile (Q3) + 3* interquartile range 
Q1, Q3 and the interquartile range will be calculated for each visit in summary statistics. 
11.3. 
Vital signs 
11.3.1. Vital signs variables 
The Vital Signs captured in the eCRF for each subject at each visit are the following: 
Weight (Screening Visit, C1D1 and C2D1 onwards) 
Height (only Screening Visit) 
Systolic Blood Pressure (all visits) 
Diastolic Blood Pressure (all visits) 
Heart Rate (all visits) 
Body Temperature (all visits) 
 
11.3.2. Vital signs analysis 
The following information will be summarized by cohort on FAS: 
 
Absolute values and percentage changes from baseline for all time points available 
 
Number (%) of subjects with at least one post-baseline abnormal value below or above the 
normal limit by vital signs variables 
 
Number (%) of subjects with at least one post-baseline significant worsening by vital sign 
variables 
 
Number (%) of subjects with at least one post-baseline outlying value by vital sign variables 
 
Number (%) of subjects with at least one post-baseline extreme value by vital sign variables 
 
Normal limits are defined as follows: 
Systolic blood pressure: 90-120 mmHg 
Diastolic blood pressure: 60-80 mmHg 
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Heart rate: 60-100 beats per minute 
Body temperature: 
35.9-37.1 °C axillary temperature 
35.9-37.5 °C oral, ear, forehead, rectal temperature 
 
All collected data on vital signs will be listed by visit. Each abnormal value will be flagged to show 
whether it is a value below or above the normal limit and whether the value is a significant worsening, 
an outlying value or an extreme value as defined in section 11.2. 
 
11.4. 
Physical examination 
At Screening, End of Treatment and End of Study full physical examinations will be performed. Limited 
physical examinations will include at least vital signs and general appearance. If clinically indicated, a 
full PE must be performed. New and worsening clinically relevant abnormal physical examination 
findings during the study will be entered as AEs and analysed within the AE tables.  
Physical examination summaries and listings will be presented for each cohort on FAS. 
 
The number (%) of subjects at screening, EOT visit, EOS visit and any visit with a full physical 
examination assessment by body system of the following categories: 
 
Normal 
Abnormal, clinically relevant 
Abnormal, not clinically relevant 
 
For all other visits, the number (%) of subjects with abnormal findings (clinically relevant or not 
clinically relevant) by body system and cohort will be displayed.   
 
Listings on individual full and limited physical examination will be presented by visit and cohort, 
including the assessments and description of the abnormalities.  
 
11.5. 
Electrocardiogram (ECG) 
ECG recordings will be obtained by a standard 12-lead ECG.  
 
11.5.1. ECG variables 
The Electrocardiogram variables captured in the eCRF for each subject at each visit are the following: 
 
 
QRS Interval 
 
RR Interval 
 
PR Interval 
 
QT Interval 
 
Heart Rate 
 
In addition to the QT interval, QTc corrections will be calculated as follows 
Bazett’s Correction (QTcB) (5): 𝑄𝑇𝑐𝐵= 
𝑄𝑇𝑚𝑠𝑒𝑐
√𝑅𝑅 
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Friderica’s Correction (QTcF) (6): 𝑄𝑇𝑐𝐹= 
𝑄𝑇𝑚𝑠𝑒𝑐
√𝑅𝑅
3
 
Where relative rate (RR) = 60/heart rate. 
 
11.5.2. ECG analysis 
The following information will be summarized by cohort on FAS: 
 
Absolute values and percentage changes from baseline for all time points 
 
Number (%) of subjects with at least one post-baseline abnormal value below or above the 
normal limit by ECG variables 
 
Number (%) of subjects with at least one post-baseline significant worsening by ECG variables, 
as defined in section 11.2 
 
Number (%) of subjects with at least one post-baseline outlying value by ECG variables, as 
defined in section 11.2 
 
Number (%) of subjects with at least one post-baseline extreme value by ECG variables, as 
defined in section 11.2 
 
Number (%) of subjects at each time point with an ECG assessment of the following categories 
o Normal 
o Abnormal, clinically relevant 
o Abnormal, not clinically relevant 
 
Number (%) of subjects at each time point experienced a QTcF change from baseline of  
o < 30 ms 
o ≥ 30 ms and < 60 ms 
o ≥ 60 ms 
 
Number (%) of subjects at each time point experienced a QTcF prolongation of  
o QTcF: <= 450 ms 
o QTcF: > 450 ms and ≤ 480 ms 
o QTcF: > 480 ms and ≤ 500 ms 
o QTcF: > 500 ms  
 
 
Normal limits are defined as follows: 
PR interval: 120-200 ms 
QRS interval: 80-100 ms 
RR interval: 600-1200 ms 
QT interval: 400-440 ms 
 
All individual ECG data will be listed by visit and cohort, including the assessments and description of 
abnormalities. Each abnormal value will be flagged to show whether it is a value below or above the 
normal limit and whether the value is a significant worsening, an outlying value or an extreme value as 
defined in section 11.2. 
 
11.6. 
Laboratory data 
Local and central laboratory assessments will be collected in the eCRF.  
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11.6.1. Laboratory variables 
Laboratory parameters measured in the central laboratory can be classified into 
 
Blood parameters from 
o Haematology 
o Serum biochemistry  
o Coagulation parameters 
o Serology parameters for HBV (HBsAg, HBsAb and HBcAb), HCV (anti-HCV Ab) and 
HIV (anti HIV 1/2 Ab)  
o Cytokines (samples collected due to IRR) 
 
Urine parameters from 
 
24 hour urine 
 
Spot urine 
 
Pregnancy tests (from serum and urine sample): B-hCG (only for female of childbearing 
potential) 
 
Local laboratory parameters include  
 
Blood parameters from haematology 
 
Urine parameters from urinalysis, urine microscopy 
 
11.6.2. Grading of laboratory results 
Laboratory data grades of severity will be derived according to the Common Terminology Criteria for 
Adverse Events (CTCAE), version 5.0. A severity grade of 0 will be assigned when the value is within 
normal limits. Grade 5 will not be used.  
Laboratory values having hyper or hypo shifts will be classified as a particular CTCAE grade 
irrespective of the shift direction (no differentiation between CTCAE grades due to increased, or 
decreased lab values).  
Laboratory test results will also be flagged in listings by the low/normal/high classifications based on 
laboratory normal ranges. 
For duplicate laboratory measurements with grades taken at the last assessment date on or before the 
start date of study treatment, the value of lower CTCAE grade will be considered as the baseline value. 
For non-gradable laboratory values with duplicate measurements taken at the last assessment date on or 
before the start date of study treatment, the following rules apply: 
 
If both within normal range, use the average value 
 
If one within normal range and the other outside, use the one within normal range 
 
If both outside normal range, use the one closest to the normal range 
 
Laboratory values with missing units or normal range may not be included in laboratory tables.  
 
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11.6.3. Laboratory analysis 
Laboratory data that are continuous in nature but are less than the lower limit of quantitation or above 
the upper limit of quantitation will be imputed. The limit of quantitation will be used for calculation of 
descriptive statistics if the data is reported in the form of “≤ x” or “< x” or “≥ x” or “>x” (x is considered 
as the limit of quantitation).  
The following analysis on laboratory parameters by cohort and overall on FAS will be performed: 
Laboratory Tables 
 
Central haematology, coagulation and serum biochemistry parameters 
o Descriptive summaries of absolute values and absolute change from baseline values 
will be presented for continuous parameters for FAS by visit 
o Number (%) of subjects at each time point having clinical relevant findings of 
laboratory parameters will be tabulated by visit for each clinical laboratory parameter  
o For each laboratory parameter shifts in assessments from baseline (low, normal or high) 
to worst-post baseline will be presented based on classifications relative to the 
laboratory reference ranges (low/normal/high) for laboratory parameters where NCI-
CTCAE grades are not defined. If a subject experiences both “low” and “high” 
assessments in the course of the trial, the worst post-baseline will be defined as “Low 
and High” 
o If NCI-CTCAE grades are available for a clinical laboratory parameter, frequency and 
shift tables based on grades will be created as follows: 
 
Number (%) of subjects with worst post-baseline grade. Each subject will be 
counted only for the worst grade observed on-treatment. 
 
Shift tables to compare baseline to the worst post-baseline value using CTCAE 
grades for laboratory parameters where grades are defined 
 
Central serology parameters 
o Descriptive summaries of absolute values and change from baseline values will be 
presented for FAS by visit 
 
Cytokine (due to IRR ≥ grade 3) 
o Descriptive summaries of absolute values will be presented for FAS on visits where the 
IRR was observed (split by samples taken at time of IRR and 24 hours after IRR) 
o Absolute and relative change from baseline, if the baseline values are available  
 
24 hour urine 
o Analysis of parameters from 24h urine is described in section 10.2 
 
Spot Urine 
o Descriptive summaries of absolute values and change from baseline values for UPCR 
from spot urine will be presented for FAS by visit 
 
The tables will include only assessment on-treatment.  
 
Laboratory Listings 
 
Listings of subjects with laboratory values outside the reference ranges will be produced, 
including the information of the laboratory result with the corresponding CTCAE grade and the 
classifications relative to the laboratory reference ranges, including the indication whether  
o the value is below or above the reference range  
o the investigator assessed the abnormal value as clinically relevant 
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o the value is a significant worsening, an outlying value or an extreme value as defined 
in section 11.2 
 
Listings on individual laboratory results will be presented by visit on FAS 
 
12. 
PHARMACOKINETIC (PK) ANALYSES 
12.1. 
Available Data 
MOR202 concentrations in serum (free drug levels). 
 
12.2. 
PK Parameters 
The following PK parameter will be determined by non-compartmental analysis using individual 
concentration-time profiles:  
 
t1/2: terminal elimination half-life (h) 
 
The analyses will be performed on the PKAS population for the final analysis.  
 
12.3. 
PK Parameter Derivation Rules  
Time deviation:  
The actual sampling time will be used for PK parameter calculation and graphical presentation of 
individual data. 
 
Handling of Below Lower Limit of Quantification (BLOQ) values: 
Concentration BLOQ will be imputed by 0 for the calculation of descriptive statistics, PK analyses and 
graphical presentation except for the geometric mean and the geometric CV, where it will be imputed 
as Lower Limit of Quantification (LLOQ)/2 
If the concentrations before the first quantifiable concentration time point is BLOQ, the concentration 
will be set to 0. 
If the concentrations after the last quantifiable concentration time point is BLOQ, the concentration will 
be set to missing. 
If there are embedded BLOQ values between quantifiable concentrations, these BLOQ values will be 
set to missing. 
If there is a quantifiable concentration after 2 consecutive BLOQ values at the end of the profile, this 
quantifiable concentration and any further quantifiable concentration will be set to missing. 
 
PK parameters: 
 
Terminal elimination half-life estimate:  
At least three time points (post-last study drug administration) should be used for determination of the 
elimination rate constant (𝑧);  
The adjusted correlation coefficient of the linear regression should be ≥ 0.90.  
If these two criteria are not met the terminal elimination half-life will not be reported.  
Handling of other potential anomalies in the serum PK profiles will be discussed with the sponsor before 
PK parameter derivation.  
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12.4. 
Summary Statistics 
Summary statistics include n, arithmetic mean, standard deviation (StD), geometric mean, coefficient 
of variation (CV), median, minimum and maximum. The CV will be expressed as a percentage and 
calculated as follows: 
CV of the arithmetic mean (%): 
StD
mean×100 
CV of the geometric mean (%): √exp (variance for log transformed data) −1 × 100 
 
A table with summaries by cohort and overall, and by study visit will be presented with the following 
information: 
 
MOR202 serum concentrations 
 
A table with summaries by cohort and overall will be presented with the following information: 
 
Terminal elimination half-life (days) 
 
Individual plots of MOR202 serum concentrations over actual sample time with all subjects on the same 
plot will be generated using linear and semi-logarithmic scales (i.e. log y-axis) by cohort and sampling 
time (pre-and post-dose). 
Figures of mean (± standard error) serum concentrations of MOR202 versus nominal days by cohort 
will be generated using both linear and semi-logarithmic scales (i.e. log y-axis) and split by pre-dose 
and 30 minutes post-dose.  
MOR202 serum levels may be further analysed performing population PK analyses, which will be 
reported separately. 
Listings of individual serum concentrations and sampling time of MOR202 and individual terminal 
elimination half-life values will be presented by cohort on PKAS.  
The following information will be summarized by arm and overall on PKAS: 
Absolute normalized urine levels (i.e. MOR202 urine level/CREA frozen level, both values 
derived from the same frozen urine sample) by visit 
 
Listings with individual frozen Creatinine values, MOR202 PK samples, and CREA frozen normalized 
urine levels will be generated by visit on FAS. 
 
13. 
IMMUNOGENICITY ANALYSES 
ADA status (positive/negative), the ADA titre when ADA positive and potential drug interference in the 
assay when ADA negative (yes/no) will be summarized descriptively, by treatment group and time point. 
The analyses will be performed using the IAS population.  
The following results will be tabulated for each cohort and by visit and overall (across all visits): 
Number (%) of subjects with ADA status positive/negative 
For ADA status positive subjects: summary (n, mean, median, SD, min, max) of ADA titre 
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For ADA status negative subjects: number (%) of subjects with potential drug interference in 
the assay (yes/no) 
 
Listings of individual ADA results incl. titre values when ADA positive and potential drug interference 
in the assay when ADA negative (yes/no) will be presented by cohort and on IAS.  
 
14. 
BIOMARKERS ANALYSES 
Additional pharmacodynamic biomarkers may include the following:  
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15. 
GENERAL GUIDANCE ON REPORTING 
15.1. 
Document headers and footers 
The following header will be used for all tables, listings and figures outlined in this document: 
 
MorphoSys AG 
Tables, Version for Reporting Event 
MOR202C103 
Database status: Draft, DD-Mmm-YYYY (Cut-off date: DD-Mmm-YYYY) 
MOR202 
Page x of X 
The following labels of reporting event will be used for all outputs: 
 
Primary Analysis 
 
Final Analysis 
Version could be Dry-Run, Draft v0x, Final v01. 
 
The following display will be used for outputs: 
- footnote 1 
- footnote 2 
- footnote 3 
Created on date by program.  
For example:  
Created on 11-Jan-2022 / 12:18 by program T14_1.sas  
In the applicable outputs, the MedDRA version and WHO-DDE version used for reporting the study 
will be specified as a footnote. 
- MedDRA Version <xx.x> has been used for the reporting  
- WHO-DDE Version <xx.x> has been used for the reporting 
The latest available version of dictionaries at the time of reporting will be used. 
 
15.2. 
Presentation of output numbering and titles within this document 
In practice, the numbering and title for all tables, figures and listings defined in this document will be 
formatted as follows, respectively: 
 
Table XX.X Title Title Title Title Title Title - Population 
 
Listing XX.X Title Title Title Title Title Title - Population 
 
15.3. 
Presentation of analysis sets 
The outputs to be produced based on this document will use ‘SCR’, ‘FAS’, “PPS’, ‘PKAS’, ‘IAS”, 
“BAS” in the table/figure/listing titles. 
 
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15.4. 
General rules for presenting frequencies and percentages 
If a summary table displays only categorical variables then the convention illustrated in the following 
example will be used: 
 
However, if a summary table displays both continuous and categorical variables, then the convention 
illustrated in the following example will be used: 
 
 
15.5. 
General rule for tables/listings 
All data as documented in the eCRF will be listed and/or tabulated using descriptive statistics or 
counts/percentages depending on the nature of data. All the data derived in the trial will be presented in 
subject data listings. 
 
Preferred Term 
Cohort 1 
(newly 
diagnosed 
subjects) 
 N=xx 
  n (%) 
Cohort 1 
(relapsed 
subjects) 
 N=xx 
  n (%) 
Cohort 2 
(refractory 
subjects) 
 N=xx 
  n (%) 
Total 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Fatigue 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Nausea 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Anemia 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
Cohort 
1(newly 
diagnosed 
subjects) 
 N=xx 
Cohort 1 
(relapsed 
subjects) 
 N=xx 
Cohort 2 
(refractory 
subjects) 
 N=xx 
All Subjects 
 N=xx 
Sex, n  (%) 
 
 
 
 
  Male 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Female 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Age (Years) 
 
 
 
 
   n 
xx 
xx 
xx 
xx 
   Mean (StD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
   Median 
xx.x 
xx.x 
xx.x 
xx.x 
   Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
   Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
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15.6. 
Format of tables/listings and displays with no data 
Where a listing or table has been planned, but no data meet the criteria, then a single line stating ‘No 
data meeting the criteria are present’ will be provided in the output. The default tables, listings and 
figures (TLF) layout will be as follows. 
Orientation 
Landscape 
Paper Size 
A4 
Margins 
Top: 2 cm  
Bottom: 1.5 cm 
Left: 1.5 cm 
Right: 1.5 cm 
Font 
Arial 9pt 
Headers 
 
see section 15.1 
Footers 
 
see section 15.1 
 
The font size may be reduced as necessary to allow additional columns to be presented, but not at the 
expense of clarity. Also the orientation may be changed to portrait if appropriate. 
 
15.7. 
Precision rules 
For continuous variables, minimum and maximum will be presented to the same precision as the raw 
data. Mean, median, 25th and 75th percentiles will be presented to one more decimal place and standard 
deviation to two more decimal places than the raw data. An exception will be made for biomarker 
representing cell counts where mean and median will be presented without a decimal place. Geometric 
mean will be presented to one more decimal place than the raw data. CV of mean and CV of geometric 
mean will be shown to one decimal place. 
For concentrations and PK parameters 3 significant digits apply for mean, geometric mean, median, StD, 
min and max.  
For categorical variables, the number (n) and percentage (%) of subjects per category will be presented. 
If the count is zero in a cell, then only ‘0’ count will be presented and not ‘0.0 (0.0)’. The number of 
missing values will be presented as a “Missing” category. Percentage values are to be rounded and 
presented to one decimal place. If percentages are equal to 100, then no decimal places will be presented 
‘xx (100)’. 
The confidence intervals of a percentage will be presented to the same precision as the percentage. 
Hazard ratios and respective confidence intervals will be presented to two decimal places. 
 
15.8. 
General rules for presenting listings 
The following general rules for presenting listings should be applied by default for all listings. 
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For listings, the default sorting order is by subject number and event/assessment date unless otherwise 
stated. 
The first column of the listing will always be “Subject identifier” field.  
Where a listing or table has been planned, but no data meet the criteria, then a single line stating ‘No 
data meeting the criteria are present’ will be provided in the output. 
The study day will always be displayed in the listings if applicable. It will be printed under the label 
‘Study Day’ in all listings. The definition of study day is: 
The reference start date for all safety assessments (e.g. adverse event onset, laboratory abnormality 
occurrence, vital sign measurement, dose interruption, etc.) and for all efficacy assessments (e.g. death, 
disease progression, response) will be the start date of study treatment. The following footnote will be 
added in all safety listings: “Study Day is relative to the first date of study treatment (Day 1)”. 
For data collected at the visit level: ‘Visit’ column will be displayed in the listings. Unscheduled visits 
will appear as “U0X” (or similar) in all the listings, if any. 
For all laboratory parameters, SI units are used as default. 
When a variable collected in the eCRF is linked to another variable, one or both variables will be 
presented in the same column of the listing or in adjacent columns if space permits this.  
For example: 
 ‘Setting’=’OTHER’ and ‘Other, specify’=’Lung’ 
“OTHER: Lung” will be displayed in the column as ‘Setting’. 
 ‘Dose’=’120’ and Dose unit =’mg’ 
‘120 mg’ will be displayed in the column as ‘dose (unit)’. 
 
Date = “12-05-2012” and Study day =”5”. 
“12MAY2012 (5)” will be displayed in the column as ‘Date (Study Day)’. 
 
End date = “22-05-2012” and Study day =”15”   
“22MAY2012 (15)” will be displayed in the column as ‘End date (Study Day)’ 
 
End date = “ ” and ongoing is ticked  
“Ongoing” will be displayed in the column as ‘End date / Study Day’ 
 
15.9. 
Presentation of dates 
Calendar dates and times (optional) in all the listings will be displayed in the format:  
YYYY-MM-DD hh:mm e.g. 2012-01-15 00:20.  
Note: If time is not collected, calendar dates will be displayed as: YYYY-MM-DD. 
 
 
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16. 
 
 
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17. 
REFERENCES 
1. Expressing the Modification of Diet in Renal Disease Study equation for estimating glomerular 
filtration rate with standardized serum creatinine values. Levey AS, Coresh J, Greene T, Marsh J, 
Stevens LA, Kusek JW et al. 2007, Clin Chem, pp. 53 (4): 766-72. 
2. A new equation to estimate glomerular filtration rate. Levey AS, Stevens LA, Schmid CH, Zhang 
YL, Castro AF, Feldmann HI et al. 2009, Ann Intern Med, pp. 150(9): 604-12. 
3. Simplified calculation of body-surface area. Mosteller, RD. s.l. : New English Journal of Medicine, 
1987, Vol. 317:1098. 
4. Optum Smart Measurement System ("SMS") Scoring Solution. Sciences, OptumInsight Life. 2019. 
5. An analysis of the time relationships or time-relations of electrocardiograms. Bazett HC. 1920, 
Heart, pp. 7:353-80. 
6. Die Systolendauer im Elektrokardiogramm bei normalen Menschen und bei Herzkranken. [The 
duration of systole in the elctrocardiogram of normal subjects and of patients with heart disease.]. 
Fridericia LS. 1920, Acta Medica Scandinavica, pp. 53: 469-86. 
 
 
  
 
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