An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Phase: PHASE3
Conditions: Generalized Myasthenia Gravis
Sponsor: UCB Biopharma SRL

UCB 
 
03 Oct 2022 
Clinical Study Protocol Amendment 3 
Rozanolixizumab 
MG0007 
 
 
 
Confidential 
Page 1 of 140 
AN OPEN-LABEL EXTENSION STUDY TO EVALUATE 
ROZANOLIXIZUMAB IN STUDY PARTICIPANTS WITH 
GENERALIZED MYASTHENIA GRAVIS 
PROTOCOL MG0007 AMENDMENT 3 
PHASE 3 
 
SHORT TITLE: 
A Phase 3, open-label extension (OLE) study to evaluate 6-week treatment cycles of 
rozanolixizumab in study participants with gMG. 
Sponsor: 
UCB Biopharma SRL 
Allée de la Recherche 60 
1070 Brussels 
BELGIUM 
 
Regulatory agency identifying number(s): 
 
Eudra CT Number: 
2020-003230-20 
IND Number: 
132407 
NCT Number:  
NCT04650854 
Confidential Material 
Confidential 
This document is the property of UCB and may not – in full or in part – be passed on, 
reproduced, published, or otherwise used without the express permission of UCB. 
 
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Clinical Study Protocol Amendment 3 
Rozanolixizumab 
MG0007 
Confidential 
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PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE 
Document History 
Document 
Date 
Type of amendment 
Protocol Amendment 3 
03 Oct 2022 
Substantial 
Protocol Amendment 2 
30 Jun 2022 
Substantial 
Protocol Amendment 1 
03 Mar 2021 
Substantial 
Protocol Amendment 0.2 
(France) 
28 Jan 2021 
Substantial 
Protocol Amendment 0.1 
(France) 
25 Jan 2021 
Substantial 
Original Protocol Addendum A 
(UK) 
19 Oct 2020 
Not applicable 
Original Protocol 
31 Jul 2020 
Not applicable 
Amendment 3 (03 Oct 2022) 
Overall Rationale for the Amendment 
The primary reason for this protocol amendment is to provide an update on the safety 
information in line with the updated Investigator’s Brochure (IB) dated Sep 2022 and updates on 
the adverse events of special monitoring (AESM). The criteria for study medication 
discontinuation due to coronavirus disease 2019 (COVID-19) and the requirements for male 
contraception were also updated. 
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union. 
Section # and Name 
Description of Change 
Brief Rationale 
Global 
Minor editorial and formatting 
changes have been made. 
To provide clarity and remain 
consistent with remainder of 
protocol. 
1.3 Schedule of activities, 
Table 1-2, 
Table 1-3 
New footnotes “k” (Table 1-2) 
and “h” (Table 1-3): Added to 
clarify that a full neurological 
examination should be performed 
in the event of severe and/or 
serious headache or suspected 
aseptic meningitis. Subsequent 
footnotes have been reordered. 
The accumulated safety data on 
rozanolixizumab led to an 
update of the adverse events 
requiring special monitoring. 
As of the cut-off date of the IB 
(13 Jul 2022), the following 
serious adverse events (SAEs) 
Headache and Meningitis 
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03 Oct 2022 
Clinical Study Protocol Amendment 3 
Rozanolixizumab 
MG0007 
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Section # and Name 
Description of Change 
Brief Rationale 
1.3 Schedule of activities, 
Table 1-2, 
Table 1-3 
8.9 Biomarkers 
Footnote q (now r, Table 1-2), 
footnote m (now n, Table 1-3), 
and text (Section 8.9): Updated to 
remove the former AESM of 
severe GI disorders, to add the 
new AESM of suspected aseptic 
meningitis, and to further detail 
the sampling time. 
Aseptic (PT terms) suggest a 
possible causal relationship to 
rozanolixizumab; based on both 
their temporal association with 
investigational medicinal 
product (IMP) infusion 
(primarily initial infusion) and 
given the events have occurred 
more than once in the 
rozanolixizumab clinical 
development program. 
1.3.1 Additional study 
assessments 
New section added to detail 
additional study assessments in 
case of AESM of severe and/or 
serious headache or the new 
AESM of suspected aseptic 
meningitis. 
2.3 Benefit/Risk assessment 
Revised text on most common 
adverse drug reactions, safety 
concerns, and other safety topics 
of interest. 
8.3.7 Adverse events of 
special monitoring 
The AESM have been updated to 
delete severe GI disorders and 
opportunistic infections and to 
add suspected aseptic meningitis. 
10.2 Appendix 2: Clinical 
Laboratory Tests, 
Table 10-1 
Added cross-reference to 
Table 1-6 for additional 
assessments that may be required 
in case of AESM. 
1.1 Synopsis, Objectives and 
endpoints 
3 Objectives and endpoints 
The other endpoint specific to 
Change from Baseline (Day 1) in 
 has been 
updated to delete “AESM of 
severe headache”. 
The sampling of complement for 
severe headache was removed to 
align with a new guidance on 
biomarker collection. 
1.3 Schedule of activities, 
Table 1-2, 
Table 1-3 
8.9.1 Immunological 
assessments 
9.4.2.3 Immunological 
analyses 
Footnote s (now t, Table 1-2), 
footnote n (now o, Table 1-3), and 
text (Section 8.9.1 and 
Section 9.4.2.3): Updated to 
delete “severe headache”. 
1.1 Synopsis, Objectives and 
endpoints 
The collection and analysis of 
cytokines has been removed from 
the protocol. 
The endpoint was removed as 
the analysis of cytokines is not 
required in this protocol as 
samples have been collected in 
other rozanolixizumab studies 
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Clinical Study Protocol Amendment 3 
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MG0007 
 
 
 
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Section # and Name 
Description of Change 
Brief Rationale 
1.3 Schedule of activities, 
Table 1-2, 
Table 1-3 
3 Objectives and endpoints 
9.4.2.3 Immunological 
analyses 
and no additional information is 
expected from this study, and 
the scientific value is limited. 
1.3 Schedule of activities, 
Table 1-2 
Scheduled visits have been 
removed from the full physical 
activity and additional visits have 
been added to the brief physical 
activities. 
Updated to match the correct 
procedures at sites. 
1.3 Schedule of activities, 
Table 1-3 
For QMG scale, visits specific to 
treatment with no 
rozanolixizumab (every 12 
weeks) was updated to replace 
footnote "m" with "o" (now p). 
Updated to correct an error in 
protocol amendment 2. 
Footnote b: Updated to remove 
“minus (-)” from the visit 
window. 
To provide clarity and remain 
consistent with the study design. 
2.2 Background 
Text on the other studies with 
rozanolixizumab has been 
updated in line with the current 
studies status at the time of this 
amendment. 
Updated in line with studies 
status at the time of this 
amendment.  
5.1 Inclusion criteria 
10.12 Appendix 12: Gap 
Period Eligibility Criteria 
(Gap Period Inclusion 
Criteria) 
Criterion #3a (now 3b, 
Section 5.1) and criterion #2 (now 
2a, Section 10.12) have been 
updated to delete the requirements 
for male contraception. 
To update male contraception 
requirements with current 
guidelines, after completion of 
the required reproductive 
toxicity studies and considering 
that rozanolixizumab has not 
genotoxic potential and potential 
exposure through seminal fluid 
is expected to be negligible. 
10.4 Appendix 4: 
Contraceptive Guidance and 
Collection of Pregnancy 
Information 
Contraception guidance for male 
participants has been deleted. 
7.1.3 Temporary IMP 
discontinuation 
The temporary IMP 
discontinuation criteria in relation 
to COVID-19 infection have been 
updated. 
To adapt the withdrawal criteria 
to the evolution of the medical 
practices and local guidelines 
with regards to COVID-19 
management. 
7.1.3 Temporary IMP 
discontinuation 
Added a new criterion (#3) on the 
temporary discontinuation of IMP 
in the event of suspected drug-
induced aseptic meningitis. 
The accumulated safety data on 
rozanolixizumab led to an 
update of the discontinuation 
criteria which is in line with the 
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Clinical Study Protocol Amendment 3 
Rozanolixizumab 
MG0007 
 
 
 
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Section # and Name 
Description of Change 
Brief Rationale 
7.1.4 Study medication 
permanent discontinuation 
criteria 
Added a new criterion (#10) on 
the permanent discontinuation of 
study medication in the event of 
recurrence of aseptic meningitis. 
revisions to adverse events 
requiring special monitoring. 
Deleted criterion #7 on the 
permanent discontinuation of 
study medication in the event of 
serious or recurrent (ie, second 
occurrence) severe AE of 
headache which is considered 
related to the study medication. 
8.2.1 Physical examination 
The text has been updated to add 
the details of the full neurological 
assessment in the event of severe 
and/or serious headache or 
suspected aseptic meningitis. 
Added to provide clear guidance 
to Investigators on the 
management of AESM. 
8.2.2 Vital signs 
Wording on the requirement to 
collect vital signs for participants 
switching to manual push has 
been updated to replace “3 
infusions” with “2 infusions”. 
Updated to be consistent with 
the study design and schedule of 
activities. 
10.6 Appendix 6: Liver 
Safety – Suggested Actions 
and Follow-up Assessments 
The literature reference Le Gal et 
al, 2005 has been moved to 
Section 11 References. 
General update. 
10.8 Appendix 8: Country-
specific Requirements, 
Japan 
Clarified that country-specific 
requirements for Japan aligned 
with Japan GCP will be provided 
separately in Protocol Exhibit. 
Clarification. 
10.9 Appendix 9: 
Abbreviations and 
Trademarks 
Additions have been made to the 
list of abbreviations. 
General update. 
10.10 Appendix 10: Protocol 
Amendment History 
Details of the previous 
amendment (protocol 
amendment 2) have been added. 
Some updates and corrections 
have been made to the summary 
of changes table. 
General update. 
10.13 Appendix 13: 
Management of headaches, 
diarrhea, and infections and 
hypogammaglobulinemia  
The title of Appendix 13 has been 
updated to Management of 
infections and 
hypogammaglobulinemia and 
infusion reactions or 
hypersensitivity reactions. 
The accumulated safety data on 
rozanolixizumab led to an 
update of the adverse events 
requiring special monitoring and 
to a revision of protocol 
guidance.  
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03 Oct 2022 
Clinical Study Protocol Amendment 3 
Rozanolixizumab 
MG0007 
 
 
 
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Section # and Name 
Description of Change 
Brief Rationale 
10.13.1 Management of 
headache 
The protocol guidance for the 
management of headache has 
been updated and moved to 
Section 10.14 (Appendix 14).  
10.13.2 Management of 
diarrhea 
The protocol guidance for the 
management of diarrhea has been 
deleted. Subsequent subsections 
have been renumbered. 
10.14 Appendix 14: 
Management of adverse 
event of special monitoring 
New appendix: Added to provide 
guidance on the management of 
AESM. Subsequent appendix has 
been renumbered. 
10.13.1 Management of 
infections and 
hypogammaglobulinemia 
The text has been updated to add 
“during a treatment period”.  
Clarification. 
11 References 
Additions have been made to the 
list of references. 
General update.  
 
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Clinical Study Protocol Amendment 3 
Rozanolixizumab 
MG0007 
 
 
 
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SERIOUS ADVERSE EVENT REPORTING 
 
Serious adverse event reporting (24h) 
Fax 
Europe and Rest of the World: +32 2 386 24 21 
US and Canada: +1 800 880 6949 or +1 866 890 3175 
Email 
Global: DS_ICT@ucb.com (for interventional clinical studies) 
 
Serious adverse event (investigational device) and  
device deficiency reporting (24h)  
Fax: 
Japan: +81 3 6864 7400 
Email: 
Japan: UCBJ-Safety@ucb.com 
  
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Clinical Study Protocol Amendment 3 
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MG0007 
 
 
 
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TABLE OF CONTENTS 
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ...................................... 2 
1 
PROTOCOL SUMMARY ............................................................................................... 13 
1.1 
Synopsis ....................................................................................................................... 13 
1.2 
Schema ......................................................................................................................... 20 
1.3 
Schedule of activities ................................................................................................... 21 
1.3.1 
Additional study assessments .............................................................................. 31 
2 
INTRODUCTION ........................................................................................................... 32 
2.1 
Study rationale ............................................................................................................. 33 
2.2 
Background .................................................................................................................. 33 
2.3 
Benefit/Risk assessment............................................................................................... 34 
3 
OBJECTIVES AND ENDPOINTS ................................................................................. 36 
4 
STUDY DESIGN ............................................................................................................. 39 
4.1 
Overall design .............................................................................................................. 39 
4.1.1 
Study population .................................................................................................. 41 
4.1.2 
Dosing .................................................................................................................. 41 
4.2 
Scientific rationale for study design ............................................................................ 42 
4.3 
Justification for dose .................................................................................................... 42 
4.4 
End of study definition................................................................................................. 44 
5 
STUDY POPULATION .................................................................................................. 44 
5.1 
Inclusion criteria .......................................................................................................... 44 
5.2 
Exclusion criteria ......................................................................................................... 45 
5.3 
Lifestyle restrictions..................................................................................................... 46 
5.4 
Screen failures .............................................................................................................. 46 
6 
STUDY TREATMENTS ................................................................................................. 47 
6.1 
Treatments administered .............................................................................................. 47 
6.2 
Preparation, handling, storage, and accountability requirements ................................ 48 
6.2.1 
Drug accountability ............................................................................................. 48 
6.3 
Measures to minimize bias: randomization and blinding ............................................ 49 
6.3.1 
Procedures for maintaining and breaking the treatment blind ............................. 49 
6.3.1.1 
Maintenance of study treatment blind ....................................................... 49 
6.3.1.2 
Breaking the treatment blind in an emergency situation ........................... 49 
6.4 
Treatment compliance .................................................................................................. 49 
6.5 
Concomitant medication(s)/treatment(s) ..................................................................... 50 
6.5.1 
Permitted concomitant treatments (medications and therapies) .......................... 50 
6.5.2 
Prohibited concomitant treatments (medications and therapies) ......................... 50 
6.5.3 
Treatments specific to NMJ interference ............................................................. 51 
6.5.4 
Rescue medication ............................................................................................... 51 
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6.6 
Dose modification ........................................................................................................ 52 
6.7 
Home (or Virtual) visits ............................................................................................... 52 
6.8 
Treatment after the end of the study ............................................................................ 52 
7 
DISCONTINUATION OF STUDY MEDICATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ........................................................................ 53 
7.1 
Discontinuation of study medication ........................................................................... 53 
7.1.1 
Liver chemistry stopping criteria ......................................................................... 53 
7.1.2 
QTc stopping criteria ........................................................................................... 54 
7.1.3 
Temporary IMP discontinuation .......................................................................... 55 
7.1.4 
Study medication permanent discontinuation criteria ......................................... 56 
7.2 
Participant discontinuation/Withdrawal from the study .............................................. 57 
7.3 
Lost to follow up .......................................................................................................... 58 
8 
STUDY ASSESSMENTS AND PROCEDURES ........................................................... 59 
8.1 
Efficacy assessments .................................................................................................... 60 
8.1.1 
MGFA Classification ........................................................................................... 60 
8.1.2 
Quantitative Myasthenia Gravis scale ................................................................. 60 
8.1.3 
MG-Composite scale ........................................................................................... 60 
8.1.4 
Patient-reported outcomes ................................................................................... 60 
8.1.4.1 
MG-Activities of Daily Living .................................................................. 61 
8.1.4.2 
MG Symptoms PRO .................................................................................. 61 
8.1.4.3 
EQ-5D-5L .................................................................................................. 62 
8.1.4.4 
MG-QOL15r .............................................................................................. 62 
8.2 
Safety assessments ....................................................................................................... 62 
8.2.1 
Physical examination ........................................................................................... 62 
8.2.2 
Vital signs ............................................................................................................ 63 
8.2.3 
Electrocardiograms .............................................................................................. 63 
8.2.4 
Clinical safety laboratory assessments ................................................................ 63 
8.2.5 
Suicidal risk monitoring ...................................................................................... 64 
8.2.6 
Assessment and management of TB and TB risk factors .................................... 64 
8.3 
Adverse events and serious adverse events ................................................................. 67 
8.3.1 
Time period and frequency for collecting AE and SAE information .................. 67 
8.3.2 
Method of detecting AEs and SAEs .................................................................... 68 
8.3.3 
Follow-up of AEs and SAEs ................................................................................ 68 
8.3.4 
Regulatory reporting requirements for SAEs ...................................................... 68 
8.3.5 
Pregnancy ............................................................................................................ 68 
8.3.6 
Adverse events of special interest ........................................................................ 69 
8.3.7 
Adverse events of special monitoring .................................................................. 69 
8.3.8 
Treatment-emergent adverse events .................................................................... 69 
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8.4 
Safety signal detection ................................................................................................. 70 
8.5 
Treatment of overdose ................................................................................................. 70 
8.6 
Pharmacokinetics and antidrug antibodies................................................................... 70 
8.7 
Genetics........................................................................................................................ 71 
8.8 
Pharmacodynamics ...................................................................................................... 71 
8.9 
Biomarkers ................................................................................................................... 71 
8.9.1 
Immunological assessments ................................................................................. 71 
8.10 
Medical resource utilization and health economics ..................................................... 72 
9 
STATISTICAL CONSIDERATIONS ............................................................................. 72 
9.1 
Definition of analysis sets ............................................................................................ 72 
9.2 
General statistical considerations ................................................................................. 72 
9.2.1 
Intercurrent event handling rationale and impact on the study ............................ 73 
9.3 
Planned safety analyses................................................................................................ 73 
9.3.1 
Analysis of the primary safety endpoint .............................................................. 73 
9.3.2 
Other safety analyses ........................................................................................... 74 
9.4 
Planned efficacy and other analyses ............................................................................ 74 
9.4.1 
Efficacy analyses ................................................................................................. 74 
9.4.2 
Other analyses ...................................................................................................... 74 
9.4.2.1 
Pharmacokinetic analyses .......................................................................... 74 
9.4.2.2 
Pharmacodynamic analyses ....................................................................... 75 
9.4.2.3 
Immunological analyses ............................................................................ 75 
9.4.2.4 
Anti-drug antibodies analyses ................................................................... 75 
9.5 
Handling of protocol deviations................................................................................... 76 
9.6 
Handling of dropouts or missing data .......................................................................... 76 
9.7 
Planned interim analysis and data monitoring ............................................................. 76 
9.8 
Determination of sample size ....................................................................................... 76 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS... 77 
10.1 
Appendix 1: Regulatory, ethical, and study oversight considerations ......................... 77 
10.1.1 
Regulatory and ethical considerations ................................................................. 77 
10.1.2 
Financial disclosure ............................................................................................. 77 
10.1.3 
Informed consent process .................................................................................... 78 
10.1.4 
Data protection ..................................................................................................... 78 
10.1.5 
Committees structure ........................................................................................... 79 
10.1.6 
Data quality assurance ......................................................................................... 79 
10.1.6.1 
Case Report form completion .................................................................... 79 
10.1.7 
Source documents ................................................................................................ 80 
10.1.8 
Study and Site Closure ......................................................................................... 80 
10.1.9 
Publication Policy ................................................................................................ 81 
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10.2 
Appendix 2: Clinical Laboratory Tests ........................................................................ 82 
10.3 
Appendix 3: Adverse Events – Definitions and Procedures for Recording, Evaluating, 
Follow-up, and Reporting ............................................................................................ 84 
10.4 
Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information ....... 89 
10.5 
Appendix 5: Genetics ................................................................................................... 92 
10.6 
Appendix 6: Liver Safety – Suggested Actions and Follow-up Assessments ............. 93 
Phase 3-4 liver Chemistry Stopping Criteria and Follow-Up assessments ......................... 93 
Phase 3-4 Liver Chemistry Increased Monitoring Criteria with Continued Study 
medication ............................................................................................................ 95 
10.7 
Appendix 7: Rapid Alert Procedures ........................................................................... 96 
10.8 
Appendix 8: Country-specific Requirements............................................................... 97 
Japan…………………………………………………………………………………..97 
Denmark……………………………………………………………………………...103 
France………………………………………………………………………………...103 
UK……………………………………………………………………………………104 
10.9 
Appendix 9: Abbreviations and Trademarks ............................................................. 105 
10.10 Appendix 10: Protocol Amendment History ............................................................. 108 
10.11 Appendix 11: Gap Period Screening Assessments .................................................... 126 
10.12 Appendix 12: Gap Period Eligibility Criteria ............................................................ 127 
10.13 Appendix 13: Management of infections and hypogammaglobulinemia and infusion 
reactions or hypersensitivity reactions ....................................................................... 133 
10.13.1 
Management of infections and hypogammaglobulinemia ................................. 133 
10.13.2 
Management of infusion reactions or hypersensitivity reactions ...................... 134 
10.14 Appendix 14: Management of adverse event of special monitoring ......................... 136 
Aseptic meningitis (suspected) .................................................................................... 136 
Severe and/or serious headache ................................................................................... 137 
10.15 Appendix 15: Sampson Criteria Questionnaire ......................................................... 138 
11 REFERENCES .............................................................................................................. 139 
SPONSOR DECLARATION ................................................................................................ 140 
 
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LIST OF TABLES 
Table 1-1: 
MG0007 dose levels and weight tiers .............................................................. 19 
Table 1-2: 
Schedule of activities (initial fixed cycle) ....................................................... 21 
Table 1-3: 
Schedule of activities (subsequent cycles) ....................................................... 26 
Table 1-4: 
Schedule of activities (initial fixed cycle - study participants who receive 
fulla COVID-19 vaccination before or during the study) ................................ 29 
Table 1-5: 
Schedule of activities (subsequent cycles - study participants who receive 
fulla COVID-19 vaccination before or during the study) ................................ 30 
Table 1-6: 
Additional study assessments .......................................................................... 31 
Table 6-1: 
Study treatments administered ......................................................................... 47 
Table 6-2: 
MG0007 dose levels and weight tiers .............................................................. 48 
Table 6-3: 
Permitted concomitant treatments .................................................................... 50 
Table 10-1: 
Protocol-Required Safety Laboratory Assessments ......................................... 82 
Table 10-2: 
Treatment-free Period for Exclusionary Immunosuppressants, Biologics, 
and Other Therapies Prior to Baseline (Visit 1)............................................. 129 
Table 10-3: 
Suggested management guidelines for infusion reactions or anaphylaxis..... 134 
 
LIST OF FIGURES 
Figure 1-1: 
MG0007 entry schema ..................................................................................... 18 
Figure 1-2: 
MG0007 study schema .................................................................................... 20 
Figure 7-1: 
Liver Chemistry Stopping Criteria and Increased Monitoring Algorithm ....... 53 
Figure 7-2: 
Liver Chemistry Increased Monitoring Algorithm with Continued Study 
Intervention for Participants with ALT ≥3xULN but <8xULN....................... 54 
 
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1 
PROTOCOL SUMMARY 
1.1 
Synopsis 
Protocol title:  
An open-label extension study to evaluate rozanolixizumab in study participants with 
generalized myasthenia gravis. 
Short Title: 
A Phase 3 open-label extension study to evaluate 6-week treatment cycles of rozanolixizumab in 
study participants with generalized myasthenia gravis (gMG). 
Rationale: 
Myasthenia gravis (MG) is a serious, sometimes life threatening, debilitating condition 
associated with numerous symptoms including muscular weakness and fatigue. The major 
pathophysiology leading to MG is the abnormal production of immunoglobulin (Ig)G 
autoantibodies directed toward nicotinic acetylcholine receptor (AChR), or muscle-specific 
kinase (MuSK) protein. Several commonly prescribed treatments act, at least in part, by reducing 
the quantity of such circulating IgG autoantibodies. While the standard of care for MG involves 
the utilization of a variety of therapeutic agents including cholinesterase inhibitors, 
immunomodulators, corticosteroid, biologics, high dose intravenous immunoglobulin (IVIg), 
plasmapheresis or immunoadsorption, there remains a need for a safe and effective treatment 
devoid of significant side effects to conveniently treat patients with MG. 
By blocking the activity of neonatal Fc receptor (FcRn), rozanolixizumab accelerates the 
catabolism of antibodies and reduces the serum IgG concentration, including pathogenic IgG in 
MG patients, thus offering a potentially 
, effective, and convenient alternative to existing 
treatments. This Phase 3 study will provide the required data to establish the safety and efficacy 
of rozanolixizumab in anti-AChR or anti-MuSK autoantibody-positive patients with generalized 
MG who experience moderate to severe symptoms and are being considered for additional 
treatment such as IVIg or plasma exchange (PEX). 
MG0007 is a Phase 3, 2-arm, randomized, open-label extension (OLE) study to evaluate the 
long-term safety, tolerability, and efficacy of repeated 6-week treatment cycles of 
rozanolixizumab based on MG worsening in study participants with gMG. This OLE study will 
provide the opportunity for study participants who participated in MG0003 and MG0004 to 
benefit from long-term rozanolixizumab treatment based on their MG symptom needs. 
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Objectives and Endpoints 
Objectives 
Endpoints/Estimands 
Primary 
• To assess the safety and tolerability of 
additional 6-week treatment cycles with 
rozanolixizumab in study participants 
with gMG 
The primary safety endpoints are: 
• Occurrence of treatment-emergent adverse 
events (TEAEs) 
• TEAEs leading to withdrawal of 
investigational medicinal product (IMP) 
The other safety endpoints are: 
• Occurrence of serious TEAEs 
• Occurrence of treatment-emergent adverse 
events of special monitoring (AESM) 
• Vital sign values and changes from 
Baseline (Day 1) (systolic and diastolic 
blood pressure [BP] and pulse rate at each 
scheduled assessment during Treatment 
and Observation Periods) 
• 12-lead electrocardiogram (ECG) values 
and change from Baseline at each 
scheduled assessment during the 
Treatment and Observation Periods 
• Laboratory values and changes from 
Baseline at each scheduled assessment 
during the Treatment and Observation 
Periods (hematology, clinical chemistry, 
and urinalysis) 
Secondary 
• To assess the efficacy of 6-week treatment 
cycles with rozanolixizumab in study 
participants with gMG 
The secondary efficacy endpoints are:  
For each of the first 3 x 6-week treatment 
cycle, change from Baseline (Day 1) to 
Day 43a:  
• In MG-Activities of Daily Living (ADL) 
score within one treatment cycle 
• In Quantitative MG (QMG) score within 
one treatment cycle 
• In MG-Composite (MG-C) score within 
one treatment cycle 
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• In MG Symptoms patient-reported 
outcomes (PRO) ‘Muscle Weakness 
Fatigability’ score within one treatment 
cycle 
• In MG Symptoms PRO ‘Physical Fatigue’ 
score within one treatment cycle 
• In MG Symptoms PRO ‘Bulbar 
symptoms’ score within one treatment 
cycle 
• In MG-ADL responder (≥2.0-point 
improvement within one treatment cycle 
• Time to MG-ADL response (≥2.0-point 
improvement from Baseline [Day 1]) 
within one treatment cycle 
For consecutive treatment cycles:  
• Time between consecutive treatment 
cycles 
The other efficacy endpoints are: 
For each 6-week treatment cycle and 
Observation Period (where applicable), 
improvement from Baseline (Day 1)] to each 
scheduled assessment: 
• MG-ADL responder (≥2.0-point) within 
one treatment cycle 
• QMG responder rate (≥3.0-point) within 
one treatment cycle 
• MG-C responder rate (≥3.0-point) within 
one treatment cycle 
• Time to MG-ADL response (≥2.0-point) 
within one treatment cycle 
• Minimal symptom expression (MG-ADL 
score of 0 or 1) at any time during 
Treatment and Observation Periods 
For each 6-week treatment cycle and 
Observation Period (where applicable), 
change from Baseline (Day 1) to each 
scheduled assessment: 
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• In MG-ADL score within one treatment 
cycle 
• In QMG score within one treatment cycle 
• In MG-C score within one treatment cycle 
• In MG Symptoms PRO ‘Muscle 
Weakness Fatigability’ score within one 
treatment cycle 
• In MG Symptoms PRO ‘Physical Fatigue’ 
score within one treatment cycle 
• In MG Symptoms PRO ‘Bulbar 
symptoms’ score within one treatment 
cycle 
For each 6-week treatment cycle and 
Observation Period (where applicable), 
change from Baseline (Day 1) to Day 43a: 
• In 5-level European quality of life 5 
dimension (EQ-5D-5L) within one 
treatment cycle 
• In Myasthenia Gravis-Quality of Life 
(MG-QOL)15r within one treatment cycle 
Other 
• To assess the pharmacokinetics (PK) of 
rozanolixizumab 
• Plasma concentrations of rozanolixizumab 
at each scheduled assessment 
• To evaluate the incidence and emergence 
of antidrug antibody (ADA) of 
rozanolixizumab 
• ADA at each scheduled assessment  
• To assess the pharmacodynamics (PD) of 
rozanolixizumab 
For each 6-week treatment cycle and 
Observation Period (where applicable): 
• Minimum value and maximum decrease 
from Baseline (Day 1) in total serum 
immunoglobulin (Ig) G and IgG 
subclasses concentration over time 
• Change from Baseline (Day 1) in serum 
IgG subclasses concentration over time 
• Change (absolute and percentage) from 
Baseline (Day 1) in MG-specific 
autoantibodies at each scheduled 
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assessment during the Treatment and 
Observation Periods   
• To assess the effects of rozanolixizumab 
on the concentration of 
 
 and 
 
 
• Change from Baseline (Day 1)b in 
 
 
 
in participants experiencing infusion 
reactions 
For initial fixed treatment cycle only: 
• Change from Baseline (Day 1) in serum Ig 
concentrations (
 
at each scheduled assessment during 
Treatment and Observation Periods 
• To assess the need for gMG medications 
including changes in type and doses 
• Use of rescue therapy (yes/no) 
• Time to rescue therapy 
• Healthcare resource utilization, including 
hospitalization (type: intensive care unit 
[ICU]/non-ICU and duration) 
• To assess the effect of rozanolixizumab 
on
 
 
 
• Change in 
 
 
  
a Day 43 = Visit 8 for the initial fixed cycle and Visit 7 for the subsequent cycles. 
b Baseline will be used from the sample collected at Day 1 (Visit 2) in MG0003. Other exploratory safety 
biomarkers may be assessed (Section 8.9). 
Overall Design 
This is a Phase 3, multicenter, 2-arm, OLE study to evaluate 6-week treatment cycles of 
rozanolixizumab in study participants with gMG. MG0007 is an extension study of MG0003.  
Eligible study participants from the lead-in study, MG0003, will be randomized to receive an 
initial fixed 6-week treatment cycle of a subcutaneous (sc) dose of rozanolixizumab equivalent to 
approximately 7mg/kg or 10mg/kg weekly (QW) (Table 1-1 and Figure 1-2), followed by an 
Observation Period that begins after the last dose of the current treatment cycle as per 
assessments described in the Schedule of Activities (Section 1.3).  
Eligible study participants from MG0004 who have completed at least 6 scheduled visits in the 
Treatment Period and the premature end of treatment (PEOT) visit can move directly into the 
Observation Period in MG0007 of the initial fixed cycle. Additionally, eligible study participants 
from MG0004 who are in the Observation Period and have completed the EOS visit can move 
directly into the Observation Period in MG0007 of the initial fixed cycle (Figure 1-1 and 
Figure 1-2). If IMP treatment was withheld for low IgG in MG0004, study participant's missed 
dose(s) can be counted as part of the total 6 visits for completion of MG0004 and meet eligibility 
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requirements for MG0007. These study participants will undergo their first MG0007 treatment 
with rozanolixizumab upon worsening of gMG symptoms. For the first MG0007 treatment with 
rozanolixizumab, participants will continue on their last treatment dose from MG0004. Dose 
adjustments may be applied in future cycles as per description below.  
The rollover into MG0007 must be completed within 4 weeks after the End of Study (EOS) visit 
from MG0003, or the PEOT or EOS (as appropriate) visit from MG0004. In the event a study 
participant has a gap period (>4 weeks) between the EOS or PEOT visit from the lead-in study 
and the start of MG0007, a Screening Period (see Appendix 11 [Section 10.11]) of up to 4 weeks 
will be applicable to confirm that the study participant still meets the eligibility criteria for entry 
into MG0007 (see Appendix 12 [Section 10.12]). 
Figure 1-1: MG0007 entry schema 
 
 
MG=myasthenia gravis 
In case of symptom worsening (eg, an increase of 2.0 points on the MG-ADL or 3.0 points on 
the QMG scale) between assessments, resulting in a need for additional treatment, study 
participants will undergo another 6-week treatment cycle followed by an Observation Period, 
based on the Investigator's discretion. The dose may be adjusted to 7mg/kg or 10mg/kg at the 
beginning of each treatment cycle based on the Investigator's discretion. The minimal time to 
start the next treatment cycle is 4 weeks following the last dose of the Treatment Period of the 
previous cycle. If a study participant requires treatment earlier than 4 weeks, IgG levels from the 
previous cycle should be considered and discussed with the Medical Monitor. A new treatment 
cycle should not be initiated until total IgG level is ≥2g/L. 
Participants in MG0007 will remain on their gMG background medications. With the exception 
of steroids and acetylcholinesterase (AChE) inhibitors, all gMG medication doses should be 
maintained during each respective 6-week treatment cycle and efforts should be made to 
maintain a stable dose during the first 8 weeks of the Observation Period. 
Study participants who receive rescue therapy (intravenous immunoglobulin [IVIg], plasma 
exchange [PEX], subcutaneous immunoglobulin [SCIg], or iv corticosteroid) during the 
Treatment Period are not eligible to receive any further treatment with rozanolixizumab. Study 
participants must complete the first 8 weeks of the Observation Period after the last dose of 
rozanolixizumab prior to completing the EOS visit assessments, and subsequently will be 
withdrawn from the study (Section 4.4).  
Those patients who received rescue therapy (IVIg, PEX, SCIg, or iv corticosteroid) during the 
observation or no treatment with rozanolixizumab periods may continue in the study at the 
Investigator’s discretion and after discussion with Medical Monitor and/or UCB Study 
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Physician. The following cycle of rozanolixizumab should in general not start earlier than 4 
weeks following the last dose of IVIg, SCIg, or iv corticosteroids or the last PEX session, unless 
there is a medical reason, and an earlier treatment initiation is being considered 
 for the study 
participant as agreed upon with the Medical Monitor and/or UCB Study physician. 
Study participants (not withdrawn from the study) will continue in MG0007 until product 
approval or until transition to a managed access program (MAP), if available, as indicated per 
the Sponsor, and according to local guidance. For country-specific requirements, see Appendix 
8, Section 10.8.  
Number of Participants 
No formal sample size calculation can be performed. All eligible study participants from 
MG0003 and MG0004 will be invited to participate in MG0007. It will be assumed that 
approximately 200 study participants will be enrolled into MG0007.  
Treatment Groups and Duration 
Fixed unit doses across body weight tiers and study arms will be employed in MG0007. This 
OLE study will continue treatment with rozanolixizumab sc fixed doses equivalent to 
approximately 7mg/kg and 10mg/kg administered QW for 6-week treatment cycles.  
Table 1-1: 
MG0007 dose levels and weight tiers  
 
 
Bodyweight 
Rozanolixizumab dose eqv 
7mg/kg 
Dose 1 
10mg/kg 
Dose 2 
≥35 to <50kg 
280mg 
420mg 
≥50 to <70kg 
420mg 
560mg 
≥70 to <100kg 
560mg 
840mg 
≥100kg 
840mg 
1120mg 
eqv=equivalent 
If a dose arm is determined to be futile and is discontinued after the interim analysis in MG0003, 
then that dose arm will be dropped from MG0007, and study participants in the affected dose 
arm will be transferred to the continuing dose arm. An independent Data Monitoring Committee 
(IDMC) will monitor the ongoing safety and efficacy of the study. Further details of the IDMC 
will be provided in an IDMC charter.
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1.2 
Schema 
Figure 1-2: MG0007 study schema 
 
 
MG=myasthenia gravis
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1.3 
Schedule of activities 
Table 1-2: 
Schedule of activities (initial fixed cycle) 
Procedure 
Gap 
Period a 
Treatment Period 
Observation Period 
No treatment with 
rozanolixizumab 
 
Visit 
Scr a 
V1 
(BL)b,c 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
(PEOT) 
V9 
V10 
V11 
V12 
- 
- 
EOS 
Visit type 
S 
S 
Hd 
S 
S 
S 
Hd 
S 
S 
S 
S 
VR 
S 
VR 
S 
S 
Day (visit window)e  
-28 to -1 
1 
3 
(±1) 
8 
(±2) 
15 
(±2) 
22 
(±2) 
29 
(±2) 
36 
(±2) 
43  
(±2) 
71 
(±7) 
99 
(±7) 
127 
(±7) 
155 
(±7) 
Every 4 
weeks 
(±7) 
Every 12 
weeks 
(±7) 
- 
(±2) 
Written informed consent  
X 
X  
 
 
 
 
 
 
 
Xf 
 
 
 
 
 
 
Demographic and Baseline 
characteristics  
X 
X 
 
 
 
 
 
 
 
Xf 
 
 
 
 
 
 
Verification of 
inclusion/exclusion criteria 
Xg 
 Xh 
 
 
 
 
 
 
 
Xf 
 
 
 
 
 
 
Medical history update 
 
X 
 
 
 
 
 
 
 
Xf 
 
 
 
 
 
 
Prior and concomitant 
medications and medical 
procedures 
X 
X 
X  
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
X 
Body weight 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Psychiatric history/C-SSRS 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Query for suicidalityi 
 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
IGRA TB testj 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
TB Signs and Symptoms 
questionnaire 
X 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
X 
X 
12-lead ECG 
X 
X 
 
X  
 
 
 
 
  
 
 
 
 
 
 
X 
Full physical examinationk 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Brief physical 
examinationk 
 
 
 
X 
X 
X 
 
X 
X 
X 
 
 
X 
 
X 
X 
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Procedure 
Gap 
Period a 
Treatment Period 
Observation Period 
No treatment with 
rozanolixizumab 
 
Visit 
Scr a 
V1 
(BL)b,c 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
(PEOT) 
V9 
V10 
V11 
V12 
- 
- 
EOS 
Visit type 
S 
S 
Hd 
S 
S 
S 
Hd 
S 
S 
S 
S 
VR 
S 
VR 
S 
S 
Day (visit window)e  
-28 to -1 
1 
3 
(±1) 
8 
(±2) 
15 
(±2) 
22 
(±2) 
29 
(±2) 
36 
(±2) 
43  
(±2) 
71 
(±7) 
99 
(±7) 
127 
(±7) 
155 
(±7) 
Every 4 
weeks 
(±7) 
Every 12 
weeks 
(±7) 
- 
(±2) 
Vital signsl 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
  
X 
X 
Call or enter IRT to 
register the visit 
X 
X 
 
X 
X 
X 
X 
X 
Xm 
  
 
 
 
 
 
Xn 
Study participants 
identification card assigned 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recording of AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pregnancy test (serum) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy test (urine)o 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
PTT and INR 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematology, serum 
chemistry 
X 
X 
 
X 
 
X 
 
X 
X 
 
X 
 
X 
 
X 
X 
Serology (HIV, Hepatitis 
B, and Hepatitis C) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis 
X 
X 
 
 
 
X 
 
 
X 
 
 
 
X 
 
 
 
Blood sampling for PKp 
 
X 
Xq 
 
 
X 
 
 
X 
 
X 
 
 
 
 
X 
Blood sampling for ADA 
 
X 
 
 
 
X 
 
 
X 
 
X 
 
 
 
 
X 
Blood sampling for total 
IgG and IgG subclasses 
X 
X 
 
X 
X 
X 
Xq 
X 
X 
 
X 
 
 
 
 
X 
Blood sampling for 
exploratory safety 
biomarker analysis 
 
Xr 
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Procedure 
Gap 
Period a 
Treatment Period 
Observation Period 
No treatment with 
rozanolixizumab 
 
Visit 
Scr a 
V1 
(BL)b,c 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
(PEOT) 
V9 
V10 
V11 
V12 
- 
- 
EOS 
Visit type 
S 
S 
Hd 
S 
S 
S 
Hd 
S 
S 
S 
S 
VR 
S 
VR 
S 
S 
Day (visit window)e  
-28 to -1 
1 
3 
(±1) 
8 
(±2) 
15 
(±2) 
22 
(±2) 
29 
(±2) 
36 
(±2) 
43  
(±2) 
71 
(±7) 
99 
(±7) 
127 
(±7) 
155 
(±7) 
Every 4 
weeks 
(±7) 
Every 12 
weeks 
(±7) 
- 
(±2) 
MG-specific 
autoantibodiess 
 
X 
 
 
  
X 
 
 
X 
 
X 
 
 
 
 
X 
MGFA classification 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
QMG scale  
X 
X 
 
X 
X 
X 
 
Xu 
X 
Xu 
X 
 
X 
 
Xu 
X 
MG-C scale  
X 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
 
X 
 
X 
X 
MG-ADL 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
MG Symptoms PRO 
X 
X 
 
 
 
X 
 
 
X 
 
X 
 
 
 
X 
X 
EQ-5D-5L 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
X 
MG-QOL15r 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
X 
Study drug administrationv 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Study drug discontinuation 
criteria 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Study withdrawal criteria  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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Procedure 
Gap 
Period a 
Treatment Period 
Observation Period 
No treatment with 
rozanolixizumab 
 
Visit 
Scr a 
V1 
(BL)b,c 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
(PEOT) 
V9 
V10 
V11 
V12 
- 
- 
EOS 
Visit type 
S 
S 
Hd 
S 
S 
S 
Hd 
S 
S 
S 
S 
VR 
S 
VR 
S 
S 
Day (visit window)e  
-28 to -1 
1 
3 
(±1) 
8 
(±2) 
15 
(±2) 
22 
(±2) 
29 
(±2) 
36 
(±2) 
43  
(±2) 
71 
(±7) 
99 
(±7) 
127 
(±7) 
155 
(±7) 
Every 4 
weeks 
(±7) 
Every 12 
weeks 
(±7) 
- 
(±2) 
AChR=acetylcholine receptor; ADA=antidrug antibody; AE=adverse event; BL=Baseline; C-SSRS=Columbia Suicide Severity Rating Scale; 
ECG=electrocardiogram; EQ-5D-5L=5-level European quality of life 5 dimension; EOS=End of Study; H=home; HIV=human immunodeficiency virus; 
; IgG=immunoglobulin G; 
 IGRA=interferon-gamma release assay; 
IMP=investigational medicinal product; INR=international normalized ratio; IRT=interactive response technology; MG=myasthenia gravis; MG-
ADL=myasthenia gravis-Activities of Daily Living; MG-C=Myasthenia Gravis Composite; MG-QOL15r=Myasthenia Gravis Quality of Life; 
MuSK=muscle-specific kinase; PEOT=premature end of treatment; PK=pharmacokinetics; PRO=patient-reported outcome; PTT=partial thromboplastin 
time; QMG=Quantitative Myasthenia Gravis; S=site; TB=tuberculosis; V=visit; VR=virtual 
 a Only applicable to study participants with a gap period, defined as any study participant who does not enroll in MG0007 within 4 weeks (or ≤32 days) of the 
EOS or PEOT visit from the lead-in study (see gap period screening assessments, Appendix 11, Section 10.11).  
b For any study participant enrolling from MG0003, the EOS visit in MG0003 (Visit 14) will serve as the Baseline Visit in MG0007. All activities should be 
completed predose at Visit 1 (+1 week). For any activities not completed at the EOS or PEOT visit in the lead-in study, these activities should be completed at 
V1. For study participants with a gap period (>4 weeks), see footnote a and Section 4.1. For any study participant enrolling from MG0004, see footnote b in 
Table 1-3 (subsequent cycle). 
c All MG0003 study participants will be assessed for worsening of MG symptoms (eg, an increase of 2.0 points on the MG-ADL or 3.0 points on the QMG 
scale) prior to first dose at the initial Baseline. 
d For all study participants, home visits are optional and can be conducted at the site as deemed necessary by site personnel and/or the study participant 
(Section 6.7). 
e A visit window of ±1 day is allowed for V2. A visit window of ±2 days is allowed for all other dosing visits. The visit window of ±2 days is relative to the first 
dosing visit date. However, there should be a minimum interval of 5 days and maximum interval of 9 days as compared to the previous dose. A visit window of 
±7 days is allowed for V9 to V12. 
f Only applicable to study participants enrolling from MG0004. 
g Only applicable to study participants with a gap period (see gap period eligibility criteria, Appendix 12, Section 10.12).  
h For criteria pertaining to laboratory measures, the last value from MG0003, or MG0004 will be used for evaluation of study participant eligibility, as long as 
the measurement was taken within the last 4 weeks prior to MG0007 Baseline (Day 1). 
i A full C-SSRS assessment will be performed only when a study participant has a positive response to Question 1 of the suicidal ideation query. If a study 
participant has active suicidal ideation as confirmed by the answer ‘Yes’ to Question 4 or Question 5 of the C-SSRS assessments, the study participant will be 
excluded or withdrawn from the study and immediately referred to a Mental Healthcare Professional. 
j The Screening visit in MG0003, and the final visit in MG0004 (Visit 52 [PEOT] or Visit 53 [EOS]) will serve as Baseline in MG0007. An IGRA test will be 
performed in a central laboratory. Study participant should not be dosed in case of any positive IGRA or two indeterminate (Section 8.2.6). 
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k A full neurological examination should be performed for any study participant who experiences severe and/or serious headache and for any study participant 
who experiences suspected aseptic meningitis. For details of the assessments included in these examinations see Section 8.2.1. For additional assessments that 
may be required in case of AESM, see Section 1.3.1 (Table 1-6). 
l In case of switching to manual push administration, for the first 2 infusions vital signs will be measured prior to IMP administration, at the end of the infusion 
(±15 minutes), and 1 hour after the end of the infusion (±15 minutes). For the subsequent infusions all assessments will be performed prior to any blood 
sampling and IMP administration (see Section 8.2.2). 
m Only applicable if study participants require PEOT. 
n Required for study withdrawal or study completion visit (Section 4.4). 
o For UK-specific requirements on additional pregnancy test, see Appendix 8, Section 10.8. 
p At dosing visits, PK samples should be taken predose for all study participants. 
q Blood samples may be collected by a healthcare professional visiting the study participant at their home. Alternately, home visits can be conducted at the site as 
deemed necessary by site personnel and/or the study participant or if home visits are not feasible.  
r Baseline (Day 1, Visit 2) from MG0003 will serve as Baseline in MG0007. In study participants who experience severe and/or serious headaches or suspected 
aseptic meningitis, samples should be collected 4 hours after the onset of the event, or otherwise as soon as possible within 72 hours after the onset of the event. 
For additional assessments that may be required in case of AESM, see Section 1.3.1 (Table 1-6). 
s For study participants entering from MG0003, MuSK and AChR antibodies will be tested at Baseline. All subsequent testing will be limited to the positive 
antibody. 
 
 
 
 
u This assessment is optional; however, every effort should be made to capture the study participant’s QMG score.  
v Study participants must be observed at site postdose for at least 4 hours following the first 2 infusions, and then 1 hour thereafter for subsequent infusions of 
the initial cycle (see Section 8.2.2). 
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All study participants will be assessed for the worsening of gMG symptoms during the Observation Period and the no treatment with 
rozanolixizumab visits. In case of symptom worsening (eg, an increase of 2.0 points on the MG-ADL or 3.0 points on the QMG scale) 
between assessments, resulting in a need for additional treatment, study participants will undergo another 6-week treatment cycle 
followed by an Observation Period, based on the Investigator's discretion. 
Table 1-3: 
Schedule of activities (subsequent cycles) 
Procedure 
Treatment Period 
Observation Period 
No treatment with 
rozanolixizumab 
 
Visit 
V1 
(BL)a,b 
V2 
V3 
V4 
V5 
V6 
V7 (PEOT) 
V8 
V9 
V10 
V11 
- 
- 
EOS 
Visit type 
S 
Hc 
S 
Hc 
S 
Hc 
S 
VR 
S 
VR 
S 
VR 
S 
S 
Day (visit window) d 
1 
8 (±2) 
15 (±2) 
22 (±2) 
29 (±2) 
36 (±2) 
43  
(±2) 
71 
(±7) 
99 
(±7) 
127 
(±7) 
155 
(±7) 
Every 4 
weeks 
(±7) 
Every 12 
weeks 
(±7) 
-  
(±2) 
Concomitant medications and 
medical procedures 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
Medical history update 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Query for suicidality e 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
IGRA TB test f 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
TB Signs and Symptoms 
questionnaire 
X 
 
 
 
 
 
X 
 
 
 
  
 
X 
X 
Body weight g 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG  
X 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
Full physical examination h 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Brief physical examination h 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Vital signs i 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
Call or enter IRT to register the 
visit 
X 
X 
X 
X 
X 
X 
X j 
 
 
 
 
 
 
Xk 
Recording of AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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Procedure 
Treatment Period 
Observation Period 
No treatment with 
rozanolixizumab 
 
Visit 
V1 
(BL)a,b 
V2 
V3 
V4 
V5 
V6 
V7 (PEOT) 
V8 
V9 
V10 
V11 
- 
- 
EOS 
Visit type 
S 
Hc 
S 
Hc 
S 
Hc 
S 
VR 
S 
VR 
S 
VR 
S 
S 
Day (visit window) d 
1 
8 (±2) 
15 (±2) 
22 (±2) 
29 (±2) 
36 (±2) 
43  
(±2) 
71 
(±7) 
99 
(±7) 
127 
(±7) 
155 
(±7) 
Every 4 
weeks 
(±7) 
Every 12 
weeks 
(±7) 
-  
(±2) 
Pregnancy test (urine) l 
X 
 
 
 
  
 
 
 
 
 
 
 
 
X 
Hematology, serum chemistry 
X 
 
X 
 
 
 
X 
 
X 
 
X 
 
X 
X 
Urinalysis 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
Blood sampling for PK m 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
Blood sampling for ADA 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
Blood sampling for total IgG 
and IgG subclasses  
X 
  
 
X 
 
 
X 
 
X 
 
 
 
 
X 
Blood sampling for exploratory 
safety biomarker analysis 
X n 
MG-specific autoantibodies 
X 
 
  
 
 
 
X 
 
 
 
 
 
 
X 
MGFA classification 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
QMG scale  
X 
  
X p 
 
X p 
  
X 
 
X 
 
X 
 
X p 
X 
MG-C scale  
X 
  
X 
  
X 
  
X 
  
X 
  
X 
 
X 
X 
MG-ADL 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
MG Symptoms PRO 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
X 
EQ-5D-5L 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
X 
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Procedure 
Treatment Period 
Observation Period 
No treatment with 
rozanolixizumab 
 
Visit 
V1 
(BL)a,b 
V2 
V3 
V4 
V5 
V6 
V7 (PEOT) 
V8 
V9 
V10 
V11 
- 
- 
EOS 
Visit type 
S 
Hc 
S 
Hc 
S 
Hc 
S 
VR 
S 
VR 
S 
VR 
S 
S 
Day (visit window) d 
1 
8 (±2) 
15 (±2) 
22 (±2) 
29 (±2) 
36 (±2) 
43  
(±2) 
71 
(±7) 
99 
(±7) 
127 
(±7) 
155 
(±7) 
Every 4 
weeks 
(±7) 
Every 12 
weeks 
(±7) 
-  
(±2) 
MG-QOL15r 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
X 
Study drug administration q 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Study drug discontinuation 
criteria 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Study withdrawal criteria  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ADA=antidrug antibody; AE=adverse event; BL=Baseline; ECG=electrocardiogram; EQ-5D-5L=5-level European quality of life 5 dimension; EOS=End of 
Study; H=home; IgG=immunoglobulin G; IGRA= interferon-gamma release assay; IMP=investigational medicinal product; IRT=interactive response 
technology; MG=myasthenia gravis; MG-ADL=myasthenia gravis-Activities of Daily Living; MG-C=Myasthenia Gravis Composite; MG-
QOL15r=Myasthenia Gravis Quality of Life; PEOT=premature end of treatment; PK=pharmacokinetics; PRO=patient-reported outcome; QMG=Quantitative 
Myasthenia Gravis; S=site; TB=tuberculosis; V=visit; VR=virtual 
a All study participant will be assessed for worsening of MG symptoms. In case of symptom worsening (eg, an increase of 2.0 points on the MG-ADL or 3.0 
points on the QMG scale) between assessments, resulting to additional treatment, study participants will undergo another 6-week treatment cycle followed by 
an Observation Period, based on the Investigator's discretion. 
b For any study participant enrolling from MG0004, the final visit in MG0004 (Visit 52 [PEOT] or Visit 53 [EOS]) will serve as the Baseline Visit in MG0007. 
All activities should be completed at Visit 1 (+1 week). For study participants with a gap period (>4 weeks), see Section 4.1. 
c For all study participants, home visits are optional and can be conducted at the site as deemed necessary by site personnel and/or the study participant 
(Section 6.7). 
d A visit window of ±2 days is allowed for V2 to V7. The visit window of ±2 days is relative to the first dosing visit date. However, there should be a minimum 
interval of 5 days and maximum interval of 9 days as compared to the previous dose. A visit window of ±7 days is allowed for Visit 8 to Visit 11. 
e A full C-SSRS assessment will be performed only when a study participant has a positive response to Question 1 of the suicidal ideation query. If a study 
participant has active suicidal ideation as confirmed by the answer ‘Yes’ to Question 4 or Question 5 of the C-SSRS assessments, the study participant will be 
excluded or withdrawn from the study and immediately referred to a Mental Healthcare Professional. 
f An IGRA test will be performed in a central laboratory. Additional IGRA TB testing will be done at least 12 months since last test. Study participant should not 
be dosed in case of any positive IGRA or two indeterminate IGRAs. 
g Weight-based dose adjustments are limited to a maximum of every 6 months. 
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h A full neurological examination should be performed for any study participant who experiences severe and/or serious headache and for any study participant 
who experiences suspected aseptic meningitis. For details of the assessments included in these examinations see Section 8.2.1. For additional assessments that 
may be required in case of AESM, see Section 1.3.1 (Table 1-6). 
i In case of switching to manual push administration, for the first 2 infusions vital signs will be measured prior to IMP administration, at the end of the infusion 
(±15 minutes), and 1 hour after the end of the infusion (±15 minutes). For the subsequent infusions all assessments will be performed prior to any blood 
sampling and IMP administration (see Section 8.2.2). 
j Only applicable if study participants require PEOT.  
k Required for study withdrawal or study completion visit (Section 4.4). 
l For UK-specific requirements on additional pregnancy test, see Appendix 8, Section 10.8. 
m At dosing visits, PK samples should be taken predose for all study participants. 
n In study participants who experience severe and/or serious headaches or suspected aseptic meningitis, additional samples should be collected 4 hours after the 
onset of the event, or otherwise as soon as possible within 72 hours after the onset of the event. For additional assessments that may be required in case of 
AESM, see Section 1.3.1 (Table 1-6). 
 
 
 
p After the first subsequent cycle, this assessment is optional, however every effort should be made to capture the study participant’s QMG score. 
q Study participants must be observed at site or home postdose for at least 1 hour following the first 2 infusions, and then a minimum 15 minutes thereafter for 
subsequent infusions. The observation time should be prolonged for the individual participants if required (see Section 8.2.2). 
 
Table 1-4: 
Schedule of activities (initial fixed cycle - study participants who receive fulla COVID-19 vaccination 
before or during the study) 
Procedure 
 
Treatment Period 
Observation Period 
No treatment with 
rozanolixizumab 
 
Visit 
Scr 
V1 (BL)  
V2 
V3 
V4 
V5 
V6 
V7 
V8 
(PEOT) 
V9 
V10 
V11 
V12 
- 
- 
EOS 
Visit type 
S 
S 
H 
S 
S 
S 
H 
S 
S 
S 
S 
VR 
S 
VR 
S 
S 
Day (visit window)  
-28 to -
1 
1 
3 
(±1) 
8 
(±2) 
15 
(±2) 
22 
(±2) 
29 
(±2) 
36 
(±2) 
43  
(±2) 
71 
(±7) 
99 
(±7) 
127 
(±7) 
155 
(±7) 
Every 4 
weeks 
(±7) 
Every 12 
weeks 
(±7) 
- 
(±2) 
COVID-19 post-
vaccination biomarkers 
sampling a 
 
Xb 
 
 
 
 
 
 
X 
 
Xc 
 
 
 
 
X 
BL=Baseline; COVID-19=coronavirus disease 2019; EOS=end of study; H=home; PEOT=premature end of treatment; S=site; V=visit; VR=virtual 
a A full COVID-19 vaccination should be defined according to current regional recommendations.  
b To be collected prior to study drug administration. 
c If subsequent treatment cycle starts before Visit 9, or any time during the Observation period, the sample must be collected prior to study drug administration. 
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Table 1-5: 
Schedule of activities (subsequent cycles - study participants who receive fulla COVID-19 
vaccination before or during the study) 
Procedure 
Treatment Period 
Observation Period 
No treatment with 
rozanolixizumab 
 
Visit 
V1 (BL) 
V2 
V3 
V4 
V5 
V6 
V7 (PEOT) 
V8 
V9 
V10 
V11 
- 
- 
EOS 
Visit type 
S 
H 
S 
H 
S 
H 
S 
VR 
S 
VR 
S 
VR 
S 
S 
Day (visit window)  
1 
8 (±2) 
15 (±2) 
22 (±2) 
29 (±2) 
36 (±2) 
43  
(±2) 
71 
(±7) 
99 
(±7) 
127 
(±7) 
155 
(±7) 
Every 4 
weeks 
(±7) 
Every 12 
weeks 
(±7) 
-  
(±2) 
COVID-19 post-
vaccination biomarkers 
sampling a 
Xb 
 
 
 
 
 
X 
 
Xc 
 
 
 
 
X 
BL=Baseline; COVID-19=coronavirus disease 2019; EOS=end of study; H=home; PEOT=premature end of treatment; S=site; V=visit; VR=virtual 
a A full COVID-19 vaccination should be defined according to current regional recommendations.  
b To be collected prior to study drug administration.  
c If subsequent treatment cycle starts before Visit 8, or any time during the Observation Period, the sample must be collected prior to study drug 
administration. 
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1.3.1 
Additional study assessments  
In addition to those detailed in Table 1-2 to Table 1-5, the assessments in Table 1-6 may be 
required in case of adverse events of special monitoring (AESM) (severe and/or serious 
headache, or suspected aseptic meningitis, see Section 8.3.7). Note that additional vital sign 
measurements and/or additional investigations may be taken at the discretion of the Investigator. 
Table 1-6: 
Additional study assessments 
Assessment 
When applicable 
For study participants who experience severe and/or serious headache and for study participants 
with suspected aseptic meningitis 
Headache or 
suspected 
aseptic 
meningitis 
follow-up 
questionnaire 
Headache follow-up questionnaire which sites will receive after reporting AESM of 
severe and/or serious headache should be completed promptly and returned to the 
Sponsor via the SAE reporting process. 
Suspected aseptic meningitis follow-up questionnaire which sites will receive after 
reporting AESM of suspected aseptic meningitis should be completed promptly and 
returned to the Sponsor via the SAE reporting process. 
Full neurological 
examination 
In study participants who report/are diagnosed with severe and/or serious headache or 
with a suspected aseptic meningitis at the clinic visit, a full neurological examination 
(including fundoscopy) should be performed (see Appendix 14 [Section 10.14]).  
In study participants who report a severe and/or serious headache while at home or 
features suggestive of aseptic meningitis, a visit to the site for the full neurological 
examination should be arranged for as soon as is practically possible. 
Blood analysis 
Blood sample collection for exploratory analysis. 
Other 
In study participants who report severe and/or serious headache, other diagnostic 
procedures including but not limited to CT scan, MRI (Gadolinium-enhanced 
preferred) and/or lumbar puncture for CSF collection are to be performed if indicated 
at the discretion of the Investigator. 
For study participants who experience suspected aseptic meningitis 
Lumbar 
puncture 
In study participants who reported signs and/or symptoms of meningitis which 
required a lumbar puncture, results of the CSF analysis should be recorded in the 
eCRF, and preliminary data should be included on the SAE form used for reporting 
the event as an AESM within 24 hours (ie, preliminary data reported on the first 
reporting may not have CSF results yet, but the reporting should occur as soon as 
there is a suspected diagnosis. Full results should be communicated in subsequent 
exchanges with UCB).  
Additional 
analysis 
Results of all investigations should be recorded in the eCRF, and preliminary data 
should be included on the SAE form used for reporting the event as an AESM. 
Please include details on all investigations results including but not limited to blood or 
CSF cultures and analysis/ PCR test (including list of microorganisms tested) / MRI 
scans +/- gadolinium. 
AESM=adverse event of special monitoring; CSF=cerebrospinal fluid; CT=computed tomography; eCRF=electronic 
case report form; MRI=magnetic resonance imaging; PCR=polymerase chain reaction; SAE=serious adverse event 
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The frequency of the collection of samples for exploratory biomarker sample collection after 
severe and/or serious headache or suspected aseptic meningitis are described in Table 1-2 
(footnote r) and Table 1-3 (footnote n). 
2 
INTRODUCTION 
Rozanolixizumab is a humanized IgG4 monoclonal antibody that is being developed as an 
inhibitor of the activity of the FcRn for IgG. 
By blocking the activity of FcRn, rozanolixizumab accelerates the catabolism of IgG antibodies, 
including IgG pathogenic autoantibodies. The aim is to reduce the concentration of pathogenic 
IgG in patients with autoimmune diseases mediated by the action of IgG autoantibodies. 
The FcRn recycles IgG and albumin and transports it bidirectionally across epithelial barriers. 
Recent studies have shown that FcRn rescues both IgG and albumin from intracellular lysosomal 
degradation by recycling it from the sorting endosome to the cell surface (Roopenian and 
Akilesh, 2007). FcRn may also mediate transcytosis of IgG to facilitate its distribution within 
tissues. Rozanolixizumab has been specifically designed to block IgG binding to FcRn without 
blocking the binding and recycling of albumin. 
Rozanolixizumab binds with high affinity to FcRn at both neutral and acidic pH. 
Immunoglobulin G that is constitutively taken up by pinocytosis into cells fails to bind to FcRn, 
even at the acidic pH found in the endosome. It is therefore not recycled and is trafficked to the 
lysosomes for degradation. 
Production of pathogenic IgG autoantibodies is the major pathophysiology leading to a number 
of autoimmune diseases, which include MG, pemphigus vulgaris,
 
, Goodpasture’s syndrome, neuromyelitis optica, Guillain-Barré Syndrome, and chronic 
inflammatory demyelinating polyradiculoneuropathy. 
As individual disease entities, IgG autoantibody-mediated conditions are relatively rare. 
Treatment of these disorders remains a difficult clinical problem, requiring in many of these 
conditions the long-term use of corticosteroids alone or combined with other immunomodulatory 
therapy. These therapeutic approaches are not effective in all patients and conditions and have 
broad immunosuppressive effects causing considerable toxicity and treatment-related morbidity. 
Treatments aimed at reducing the quantity of circulating IgG autoantibodies, including 
plasmapheresis, immunoadsorption, or high dose IVIg, are being used for primary and secondary 
therapy of autoimmune diseases. The therapeutic approach of these treatments is thought in part 
to be based on lowering levels of pathogenic autoantibodies, which represents rational and 
effective treatment modalities of autoimmune diseases. 
Therefore, specific removal of the IgG autoantibodies by FcRn blockade may provide an 
effective therapeutic option for IgG autoantibody-mediated autoimmune disorders. 
More detailed information regarding the nonclinical and clinical development programs for 
rozanolixizumab, including all completed and ongoing studies, can be found in the latest version 
of the Investigator’s Brochure (IB). 
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2.1 
Study rationale 
 
MG0007 will complement the ongoing Phase 3 study, MG0003, and replace the open-label 
extension (OLE) study, MG0004. The study will evaluate the safety, tolerability, and efficacy of 
rozanolixizumab over the initial 6-week treatment cycle and subsequent treatment cycles when 
given as needed based on worsening of gMG symptoms. The study will gather information on 
the efficacy response of subsequent treatment cycles and the duration until next treatment is 
needed. The study will support the intended use of rozanolixizumab in study participants with 
gMG, (ie, repeated 6-week treatment cycles based on worsening of symptoms).  
MG0003 is a Phase 3 study of rozanolixizumab in anti-acetylcholine receptor (AChR) or 
anti-muscle-specific kinase (MuSK) autoantibody-positive participants with gMG who 
experience moderate to severe symptoms and are being considered for additional treatment such 
as IVIg or PEX. The primary objective is to demonstrate the clinical efficacy of rozanolixizumab 
in study participants with gMG. The study consists of a Screening Period of up to 4 weeks, 
followed by a 6-week double blind Treatment Period, and a blinded Observation Period of 8 
weeks. MG0003 will provide the core data to support marketing authorization application 
globally. The current OLE study, MG0004, is a Phase 3, randomized study to evaluate the long-
term safety, tolerability, and efficacy of rozanolixizumab in study participants with gMG.  
The MG0007 study has been designed with the following considerations:   
1. Double-blind placebo-controlled data will be collected on a single cycle as part of the 
MG0003 study. MG0007 will provide data on subsequent treatment cycles when given as 
needed based on worsening of gMG symptoms.  
2. An open-label design is deemed appropriate since a placebo controlled long-term extension 
study may raise ethical concerns 
3. The dose and treatment regimen for rozanolixizumab (equivalent to approximately 7mg/kg or 
10mg/kg QW for 6-week treatment cycle) in MG0007 are identical to that used in MG0003. 
4. For comprehensive data collection, an extended 16-week Observation Period was chosen to 
investigate maintenance of effect after a 6-week treatment cycle. 
2.2 
Background 
Rozanolixizumab is a humanized anti-FcRn monoclonal antibody that has been specifically 
designed to inhibit IgG binding to FcRn without inhibiting albumin binding to FcRn. 
Rozanolixizumab is being developed as an inhibitor of FcRn activity with the aim to reduce the 
concentration of pathogenic IgG in patients with IgG autoantibody-mediated diseases. 
To date, rozanolixizumab has been administered to human study participants in 8 completed 
clinical studies (UP0018, UP0060, MG0002, MG0003, MG0004, CIDP01, CIDP04, TP0001) 
and 6 ongoing studies (UP0106, TP0003, TP0006, TP0004, MOG001, and AIE001). UP0018 is 
a completed first-in-human study, MG0002 is a completed Phase 2 study in study participants 
with gMG, and 
 is a completed Phase 2 study in study participants with primary 
, and 
UP0060 is a completed Phase 1 study comparing the safety, tolerability, pharmacokinetics (PK), 
and pharmacodynamics (PD) of rozanolixizumab in Chinese, Japanese and Caucasian healthy 
volunteers. 
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In MG0002, clinically relevant improvements in day-to-day functioning, as measured by change 
from Baseline to Day 29 in myasthenia gravis-activities of daily living (MG-ADL) (secondary 
endpoint), were observed following treatment with rozanolixizumab 7mg/kg compared with 
placebo (p=0.036). Numerical differences numerical in favor of rozanolixizumab 7mg/kg 
compared with placebo were observed in reductions from Baseline in quantitative myasthenia 
gravis (QMG) (p=0.221) and MG-C score (p=0.089). Overall, repeated administrations of 
rozanolixizumab at dose levels of 7mg/kg and 4mg/kg sc have been generally well tolerated, 
with an acceptable safety profile. No new safety concerns were identified. The treatment-
emergent adverse event (TEAE) profile was similar between rozanolixizumab and placebo 
except for headaches where increased frequency and severity was observed in the 
rozanolixizumab study participants. 
Final data from the proof-of-concept 
 demonstrated that rozanolixizumab was 
tolerated with an acceptable safety profile after multiple (4, 7, and 10mg/kg) and single (15 and 
20mg/kg) doses. 
MG0003 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the 
efficacy and safety of 2 doses of rozanolixizumab (equivalent to approximately 7mg/kg and 
10mg/kg) in study participants with gMG who experience moderate to severe symptoms and are 
being considered for additional treatment such as IVIg or PEX. 
MG0004 is an open-label extension study for the lead-in study, MG0003, evaluating the long-
term safety, tolerability, and efficacy of rozanolixizumab in study participants with gMG. Study 
participants in MG0004 are randomized to receive weekly doses of rozanolixizumab (equivalent 
to approximately 7mg/kg and 10mg/kg, respectively) over a 52-week Treatment Period. 
MG0007 is a Phase 3 OLE study to evaluate the long-term safety, tolerability, and efficacy of 
repeated 6-week treatment cycles of rozanolixizumab based on MG worsening in study 
participants with gMG. This OLE study will provide the opportunity for study participants from 
the MG0003 and MG0004 to receive long-term rozanolixizumab treatment based on their MG 
symptom needs. 
Once the OLE study MG0007 is activated at sites and ongoing study participants have had the 
opportunity to rollover into MG0007, MG0004 will be closed. 
2.3 
Benefit/Risk assessment 
Generalized MG is a rare, debilitating, chronic autoimmune disease driven by, in large part, IgG 
autoantibodies that target neuromuscular junctions (NMJs). Most current treatment approaches 
are not targeted treatments to the specific underlying pathology of IgG autoantibody formation, 
but rather they produce a broad cascade of immune suppression, which results in undesirable 
side effects such as those seen with high-dose chronic steroid use. Many treatments of choice 
often require invasive, expensive, and time-consuming inpatient procedures such as PEX, or 
intravenous (IV) administration of immunoglobulins at a healthcare facility. 
Rozanolixizumab represents an innovative, subcutaneous (sc) anti-FcRn monoclonal antibody 
that may provide a novel and specific targeted therapeutic approach for the treatment of patients 
with MG. Data show that rozanolixizumab markedly lowers serum IgG and IgG autoantibody 
levels in patients with generalized MG. The completed Phase 2 study MG0002 established 
supportive evidence of efficacy for the treatment of MG, achieving significant and clinically 
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meaningful improvements to Day 29 in MG-ADL with rozanolixizumab 7mg/kg compared with 
placebo (p=0.036). Repeated administrations of rozanolixizumab were generally 
and well 
tolerated, with an acceptable safety profile and in line with sc dosing in the Phase 1 program and 
the safety profile observed in TP0001. 
In MG0003, a Phase 3 study evaluating efficacy and safety of sc rozanolixizumab in adult study 
participants with gMG, the 
 clinical efficacy of rozanolixizumab was demonstrated by 
improvements versus placebo in all efficacy endpoints tested in the study. There were clinically 
meaningful and statistically significant reductions from Baseline in the primary endpoint, 
MG-ADL score, at Day 43 for both rozanolixizumab dose groups versus placebo. 
The identified adverse drug reactions (ADRs) associated with sc administration of 
rozanolixizumab are headaches, diarrhoea, pyrexia, nausea, upper respiratory tract infections, 
arthralgia, rash, injections site reactions, vomiting, myalgia, and herpes simplex infections. 
Headache is the most commonly reported ADR. Headaches were mostly mild to moderate and 
easily managed with over-the-counter medications. Serious infections and hypersensitivity 
reactions are the safety concerns with rozanolixizumab. Other safety topics of interest include 
effects on vaccination response, effects on the kidney, reductions in albumin and plasma 
proteins, drug-induced aseptic meningitis (DIAM), and 
. These risks can 
be mitigated by careful monitoring, exclusion of at-risk study participants, and appropriate 
protocol withdrawal and stopping criteria. Additionally, protocol guidance for management of 
severe and/or serious headaches (AESM), suspected aseptic meningitis (AESM), hypersensitivity 
reactions, and infection is also provided as well as expedited reporting requirements of AESM to 
UCB. 
Restrictions on use of live vaccines have been defined in the exclusion criterion 6 (Section 5.2) 
(exclusion criteria 7 in Gap Period Eligibility Criteria [Section 10.12]). If vaccination with non-
live vaccines (including COVID-19 vaccines) is considered necessary once a study participant 
has started therapy with IMP, the degree of protection afforded with a vaccine may be 
compromised while the participant is being treated with IMP. 
Based on its mechanism of action, rozanolixizumab will reduce total IgG levels including 
vaccine specific IgG. However, it is unlikely that the immunogenicity of the vaccine will be 
compromised by FcRn inhibition. Given the study population characteristics (eg, status of the 
underlying disease, concomitant immunosuppressive therapies, etc.) it is recommended to 
perform individualized benefit risk assessment for vaccination and specifically vaccination 
against COVID-19 infection. If COVID-19 vaccination is planned, information regarding 
vaccine should be recorded (Section 6.5.1). Coronavirus Disease 2019 vaccination should be 
scheduled, if at all possible, to allow differentiation of safety profiles of IMP and vaccine (eg, a 
minimum window of 72 hours between COVID-19 vaccination and IMP administration). If any 
AEs were to occur, they should be handled as described in (Section 8.3) with causality 
assessment provided for both IMP and vaccine. Additionally, to further characterize the effect of 
rozanolixizumab on COVID-19 vaccination response, measurement of vaccine titers are being 
tested in rozanolixizumab development programs. 
More detailed information about the known safety profile and expected adverse events (AEs) of 
rozanolixizumab may be found in the IB. 
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3 
OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints/Estimands 
Primary 
• To assess the safety and tolerability of 
additional 6-week treatment cycles with 
rozanolixizumab in study participants 
with gMG 
The primary safety endpoints are: 
• Occurrence of treatment-emergent adverse 
events (TEAEs) 
• TEAEs leading to withdrawal of 
investigational medicinal product (IMP) 
The other safety endpoints are: 
• Occurrence of serious TEAEs 
• Occurrence of treatment-emergent adverse 
events of special monitoring (AESM) 
• Vital sign values and changes from 
Baseline (Day 1) (systolic and diastolic 
blood pressure [BP] and pulse rate at each 
scheduled assessment during Treatment 
and Observation Periods) 
• 12-lead electrocardiogram (ECG) values 
and change from Baseline at each 
scheduled assessment during the 
Treatment and Observation Periods 
• Laboratory values and changes from 
Baseline at each scheduled assessment 
during the Treatment and Observation 
Periods (hematology, clinical chemistry, 
and urinalysis) 
Secondary 
• To assess the efficacy of 6-week treatment 
cycles with rozanolixizumab in study 
participants with gMG 
The secondary efficacy endpoints are:  
For each of the first 3 x 6-week treatment 
cycle, change from Baseline (Day 1) to 
Day 43a:  
• In MG-Activities of Daily Living (ADL) 
score within one treatment cycle 
• In Quantitative MG (QMG) score within 
one treatment cycle 
• In MG-Composite (MG-C) score within 
one treatment cycle 
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• In MG Symptoms patient-reported 
outcomes (PRO) ‘Muscle Weakness 
Fatigability’ score within one treatment 
cycle 
• In MG Symptoms PRO ‘Physical Fatigue’ 
score within one treatment cycle 
• In MG Symptoms PRO ‘Bulbar 
symptoms’ score within one treatment 
cycle 
• In MG-ADL responder (≥2.0-point 
improvement within one treatment cycle 
• Time to MG-ADL response (≥2.0-point 
improvement from Baseline [Day 1]) 
within one treatment cycle 
For consecutive treatment cycles:  
• Time between consecutive treatment 
cycles 
The other efficacy endpoints are: 
For each 6-week treatment cycle and 
Observation Period (where applicable), 
improvement from Baseline (Day 1)] to each 
scheduled assessment: 
• MG-ADL responder (≥2.0-point) within 
one treatment cycle 
• QMG responder rate (≥3.0-point) within 
one treatment cycle 
• MG-C responder rate (≥3.0-point) within 
one treatment cycle 
• Time to MG-ADL response (≥2.0-point) 
within one treatment cycle 
• Minimal symptom expression (MG-ADL 
score of 0 or 1) at any time during 
Treatment and Observation Periods 
For each 6-week treatment cycle and 
Observation Period (where applicable), 
change from Baseline (Day 1) to each 
scheduled assessment: 
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• In MG-ADL score within one treatment 
cycle 
• In QMG score within one treatment cycle 
• In MG-C score within one treatment cycle 
• In MG Symptoms PRO ‘Muscle 
Weakness Fatigability’ score within one 
treatment cycle 
• In MG Symptoms PRO ‘Physical Fatigue’ 
score within one treatment cycle 
• In MG Symptoms PRO ‘Bulbar 
symptoms’ score within one treatment 
cycle 
For each 6-week treatment cycle and 
Observation Period (where applicable), 
change from Baseline (Day 1) to Day 43a: 
• In 5-level European quality of life 5 
dimension (EQ-5D-5L) within one 
treatment cycle 
• In Myasthenia Gravis-Quality of Life 
(MG-QOL)15r within one treatment cycle 
Other 
• To assess the pharmacokinetics (PK) of 
rozanolixizumab 
• Plasma concentrations of rozanolixizumab 
at each scheduled assessment 
• To evaluate the incidence and emergence 
of antidrug antibody (ADA) of 
rozanolixizumab 
• ADA at each scheduled assessment  
• To assess the pharmacodynamics (PD) of 
rozanolixizumab 
For each 6-week treatment cycle and 
Observation Period (where applicable): 
• Minimum value and maximum decrease 
from Baseline (Day 1) in total serum 
immunoglobulin (Ig) G and IgG 
subclasses concentration over time 
• Change from Baseline (Day 1) in serum 
IgG subclasses concentration over time 
• Change (absolute and percentage) from 
Baseline (Day 1) in MG-specific 
autoantibodies at each scheduled 
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assessment during the Treatment and 
Observation Periods   
• To assess the effects of rozanolixizumab 
on the concentration of 
 
 
 
• Change from Baseline (Day 1)b in 
 
 
 
in participants experiencing infusion 
reactions 
For initial fixed treatment cycle only: 
• Change from Baseline (Day 1) in serum Ig 
concentrations 
) 
at each scheduled assessment during 
Treatment and Observation Periods 
• To assess the need for gMG medications 
including changes in type and doses 
• Use of rescue therapy (yes/no) 
• Time to rescue therapy 
• Healthcare resource utilization, including 
hospitalization (type: intensive care unit 
[ICU]/non-ICU and duration) 
• To assess the effect of rozanolixizumab 
on 
 
 
 
• Change in 
 
 
  
a Day 43 = Visit 8 for the initial fixed cycle and Visit 7 for the subsequent cycles. 
b Baseline will be used from the sample collected at Day 1 (Visit 2) in MG0003. Other exploratory safety 
biomarkers may be assessed (Section 8.9). 
 
4 
STUDY DESIGN 
4.1 
Overall design 
This is a Phase 3, multicenter, 2-arm, OLE study to evaluate 6-week treatment cycles of 
rozanolixizumab in study participants with gMG. MG0007 is an extension study of MG0003 and 
will be open for study participants from MG0003and MG0004 (see Section 4.1.1).  
Eligible study participants from MG0003 will be randomized to receive an initial fixed 6-week 
treatment cycle of a subcutaneous dose of rozanolixizumab equivalent to approximately 7mg/kg 
or 10mg/kg QW (see Figure 1-1 and Figure 1-2), followed by an Observation Period that begins 
after the last dose of that treatment cycle as per assessments described in the Schedule of 
Activities (Section 1.3). 
Eligible study participants from MG0004 who have completed at least 6 scheduled visits for 
rozanolixizumab treatment and the PEOT visit can move directly into the Observation Period in 
MG0007. Additionally, eligible study participants from MG0004 who are in the Observation 
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Period can complete the EOS visit and move directly into the Observation Period in MG0007 
(see Figure 1-1 and Figure 1-2). If IMP treatment was withheld for low IgG in MG0004, study 
participant's missed dose(s) can be counted as part of the total 6 visits for completion of MG0004 
and meet eligibility requirements for MG0007. These study participants will undergo their first 
MG0007 treatment with rozanolixizumab upon worsening of gMG symptoms. Participants will 
continue on their last treatment dose from MG0004. Dose adjustments may be applied in future 
cycles as per description below. 
The rollover into MG0007 must be completed within 4 weeks after the EOS visit from MG0003, 
or the PEOT or EOS (as appropriate) visit from MG0004. In the event a study participant has a 
gap period (>4 weeks) between the EOS or PEOT visit from the lead-in study and the start of 
MG0007, a Screening Period (see Appendix 11, Section 10.11) of up to 4 weeks will be 
applicable to confirm that the study participant still meets the eligibility criteria for entry into 
MG0007 (see Appendix 12, Section 10.12). 
In case of symptom worsening (eg, an increase of 2.0 points on the MG-ADL or 3.0 points on 
the QMG scale) between assessments, resulting in a need for additional treatment, study 
participants will undergo another 6-week treatment cycle followed by an Observation Period, 
based on the Investigator's discretion. 
The dose may be adjusted to 7mg/kg or 10mg/kg at the beginning of each treatment cycle based 
on the Investigator's discretion. Rules for dose modification and temporary treatment hold are 
described in Section 6.6 and Section 6.7. The minimal time to start the next treatment cycle is 4 
weeks following the last dose of the treatment period of the previous cycle. If a study participant 
requires treatment earlier than 4 weeks, IgG levels from the previous cycle should be considered 
and discussed with the Medical Monitor. A new treatment cycle should not be initiated until total 
IgG level is ≥2g/L. 
Participants in MG0007 will remain on their gMG background medications (Table 6-3). With the 
exception of corticosteroids and AChE inhibitors, all gMG medication doses should be 
maintained during each respective 6-week treatment cycle and efforts should be made to 
maintain a stable dose during the first 8 weeks of the Observation Period. 
Study participants who receive rescue therapy (IVIg, PEX, SCIg, or iv corticosteroid) during the 
Treatment Period are not eligible to receive any further treatment with rozanolixizumab, must 
complete an additional 8 weeks of follow up after the last dose of rozanolixizumab. Study 
participants must complete the first 8 weeks of the Observation Period after the last dose of 
rozanolixizumab prior to completing the EOS visit assessments, and subsequently will be 
withdrawn from the study (Section 4.4).  
Those patients who received rescue therapy (IVIg, PEX, SCIg, or iv corticosteroid) during the 
observation or no treatment with rozanolixizumab periods may continue in the study at the 
Investigator’s discretion and after discussion with Medical Monitor and/or UCB Study 
Physician. The following cycle of rozanolixizumab should in general not start earlier than 4 
weeks following the last dose of IVIg, SCIg, or iv corticosteroids or the last PEX session, unless 
there is a medical reason, and an earlier treatment initiation is being considered
 for the study 
participant as agreed upon with the Medical Monitor and/or UCB Study physician. 
Study participants (not withdrawn from the study; criteria outlined in Section 7.2) will continue 
in the study and until product approval or until transition to a managed access program (MAP), if 
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available, as indicated per the Sponsor, and according to local guidance. For country-specific 
requirements, see Appendix 8 (Section 10.8). 
In exceptional circumstances (eg, pandemic, hurricanes, etc) where study-specific investigations 
may not be conducted according to study protocol, contingency measures will be in place (see 
Section 8). 
4.1.1 
Study population 
Study participants will enter from MG0003, or MG0004. Participants eligible for enrollment in 
this study completed MG0003, required rescue therapy during the Observation Period in 
MG0003 (except for study participants who opted to receive IVIg or PEX in MG0003), or 
completed at least 6 treatment visits in MG0004.  
Study participants directly enrolling from MG0003 can use the EOS assessments as the Baseline 
(Day 1) in MG0007.   
Study participants directly enrolling from MG0004 who have completed at least 6 visits 
regardless of the number of infusions (due to low IgG resulting in IMP treatment hold) will 
complete the PEOT visit (if entering from Treatment Period of MG0004) or EOS visit (if 
entering from Observation Period of MG0004) assessments from MG0004 and will directly enter 
the Observation Period (Visit 9 [Day 71]) of the initial fixed cycle. 
A study participant who had to discontinue receiving treatment under the MG0003, or MG0004 
due to the coronavirus disease 2019 (COVID-19) pandemic (ie, due to logistic reasons, 
resolution of suspected or confirmed COVID-19 infection, or fulfillment of quarantine period 
due to exposure) and provided no parameter(s) meeting the protocol-defined study drug 
discontinuation criteria can potentially enter MG0007. The Investigator should assess all 
available medical information prior to the study participant joining MG0007. The Investigator 
must discuss the eligibility for the study participant to join the MG0007 study based on a 
thorough individualized benefit-risk evaluation (ie, disease status, alternative options, AE profile, 
laboratory assessments), the regional situation, and protocol criteria and treatment schema with 
the Sponsor’s Study Physician. Study participants with a gap of >4 weeks between the EOS visit 
from the lead-in study and the start of MG0007 must have an eligibility assessment performed 
during a 4-week Screening Period (see Section 10.11). 
No formal sample size calculation can be performed. Approximately 200 study participants will 
be enrolled at approximately 130 sites from North America, Europe, and Asia (including Japan). 
4.1.2 
Dosing 
The doses and regimen selected for the rozanolixizumab Phase 3 study, MG0003, was based on 
data from the Phase 2 studies in the MG and 
), and Phase 1 data 
in healthy study participants. To date, there has not been any data to indicate that the doses used 
in MG0003 should be modified. Therefore, this OLE study will continue treatment with 
rozanolixizumab sc fixed doses across body weight tiers equivalent to approximately 7mg/kg and 
10mg/kg administered QW for 6 weeks (Table 1-1). Weight-based dose adjustments should be 
limited to a maximum of every 6 months during the study.  
If one of the doses described in Table 1-1 is determined to be futile and is discontinued in 
MG0003, then that dose arm will be dropped from MG0007, and study participants in the 
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affected dose arm will be transferred to an adjusted dose. Dose modifications are allowed in this 
study (see Section 6.6). 
4.2 
Scientific rationale for study design 
MG0007 will complement the ongoing Phase 3 study, MG0003, and replace the chronic 
treatment OLE study, MG0004. The study will evaluate the safety, tolerability, and efficacy of 
rozanolixizumab over the initial 6-week treatment cycle and subsequent treatment cycles when 
given as needed based on worsening of gMG symptoms. The study will gather information on 
the efficacy response of subsequent treatment cycles and the duration until next treatment is 
needed. The study will support the intended use of rozanolixizumab in study participants with 
gMG, (ie, repeated 6-week treatment cycles based on worsening of symptoms).  
MG0003 is a Phase 3 study of rozanolixizumab in anti-acetylcholine receptor (AChR) or 
anti-muscle-specific kinase (MuSK) autoantibody-positive participants with gMG who 
experience moderate to severe symptoms and are being considered for additional treatment such 
as IVIg or PEX. The primary objective is to demonstrate the clinical efficacy of rozanolixizumab 
in study participants with gMG. The study consists of a Screening Period of up to 4 weeks, 
followed by a 6-week double blind Treatment Period, and a blinded Observation Period of 8 
weeks. MG0003 will provide the core data to support marketing authorization application 
globally. The OLE study, MG0004, is a Phase 3, randomized study to evaluate the long-term 
safety, tolerability, and efficacy of rozanolixizumab in study participants with gMG.  
The MG0007 study has been designed with the following considerations:   
1. Double-blind placebo-controlled data will be collected on a single cycle as part of MG0003. 
MG0007 will provide data on subsequent treatment cycles when given as needed based on 
worsening of gMG symptoms.  
2. An open-label design is deemed appropriate since a placebo controlled long-term extension 
study may raise ethical concerns 
3. The dose and treatment regimen for rozanolixizumab (equivalent to approximately 7mg/kg or 
10mg/kg QW and for 6-week treatment cycle) in MG0007 are identical to that used in 
MG0003. 
4. For comprehensive data collection, a 16-week Observation Period was chosen to investigate 
maintenance of effect after the 6-week treatment cycle. 
4.3 
Justification for dose 
The dose and regimen of rozanolixizumab (equivalent to approximately 10mg/kg or 7mg/kg, 
administered sc QW) is selected based on the results from first-in-human study UP0018, the 
Phase 2 clinical studies in MG and 
 (MG0002 and 
) as well as the doses selected for 
use in the pivotal Phase 3 study, MG0003; fixed-unit doses equivalent to approximately 7mg/kg 
or 10mg/kg QW. UP0018 was a randomized, investigator- and study participant-blind, placebo-
controlled, single dose-escalating study to evaluate the safety and PK and to explore the PD of 
rozanolixizumab doses of 1mg/kg, 4mg/kg, and 7mg/kg administered as an iv or sc infusion over 
 in 49 healthy male and female volunteers. Data indicate that mean absolute decreases 
in IgG and mean percent change from Baseline IgG were greater in the active dose groups (n=6 
each) compared to the pooled iv and sc placebo group (n=12) with median maximum decreases 
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of 42.8% (range: 39.6% to 48.6%) observed on Day 9 postdose for a rozanolixizumab 7mg/kg sc 
dose. Rozanolixizumab was tolerated with an acceptable safety profile after the single 
administration of a 7mg/kg sc dose, and all participant reported TEAEs were mild or moderate in 
severity. 
MG0002 was a Phase 2, multicenter, randomized, investigator- and study participant-blind, 
placebo-controlled, 2-arm repeat dose, treatment sequence study evaluating the safety and 
efficacy of rozanolixizumab sc (4mg/kg and 7mg/kg) in 43 study participants with generalized 
MG. Marked improvements in patient-reported MG symptoms and disability, as measured by 
change from Baseline to Day 29 in MG-ADL, were observed following treatment with 
rozanolixizumab 7mg/kg compared with placebo. The least squares (LS) mean (standard error 
[SE]) change from Baseline was -1.8 (0.5) for the Rozanolixizumab 7mg/kg Group and -0.4 (0.5) 
for the Placebo Group. The difference between treatment groups was -1.4 (p=0.036 [95% upper 
confidence interval (CI): -0.4]). Smaller but numerical differences in favor of rozanolixizumab 
7mg/kg vs placebo were observed in reductions from Baseline in QMG on Day 29 with the LS 
mean (SE) change from Baseline of -1.8 (0.6) for the Rozanolixizumab 7mg/kg Group and -1.2 
(0.6) for the Placebo Group. The LS mean (SE) change from Baseline in MG-C score to Day 29 
was -3.1 (0.9) for the Rozanolixizumab 7mg/kg Group and -1.2 (0.9) for the Placebo Group. In 
general, responder rates for QMG score, MG-C score, and MG-ADL score were higher for the 
rozanolixizumab 7mg/kg group than the placebo group. Serum total IgG concentrations and 
AChR autoantibodies rapidly decreased from Baseline in the rozanolixizumab 7mg/kg group in 
Dosing Period 1 and continued to decline on further dosing with 7mg/kg to a mean nadir of 
3.3g/L for total IgG (
 reduction from Baseline). Overall, repeated administrations of 
rozanolixizumab at dose levels of 7mg/kg and 4mg/kg sc have been generally 
 and well 
tolerated, with an acceptable safety profile. The TEAE profile was similar between 
rozanolixizumab and placebo, except for headaches where increased frequency and severity was 
observed in the rozanolixizumab-treated study participants.  
Consistent with the mechanism of action of rozanolixizumab, an increased catabolism of IgG 
will reduce disease-specific autoantibodies with corresponding improvements in clinical signs 
and symptoms. Two sc treatment arms, equivalent to individual 7mg/kg and 10mg/kg dosing, 
have been selected to provide maximal reduction in autoantibody concentration and result in 
clinically significant improvements in the primary endpoint. A dose of 7mg/kg has demonstrated 
clinical improvements in MG-ADL in MG0002 (as described above). Additional data from the 
Phase 2 study in study participants with 
 demonstrated that rozanolixizumab was 
well tolerated at 2 doses of 10mg/kg with further IgG reduction achieved. An individual 
equivalent dose of 10mg/kg has been included to assess if further improvements in MG-ADL 
(magnitude of response and time to onset of symptom relief) can be achieved at a higher dose 
level with greater and more rapid IgG reduction. 
A population PKPD model that characterizes the dose-exposure-IgG relationship was used to 
guide, through simulation, the choice of fixed-unit doses at each weight bracket that achieved 
equivalent IgG reductions (mean and 90% prediction interval) to the weight-based (mg/kg) 
dosing regimens studied previously. These models-based simulations demonstrate that the 
proposed weekly doses of rozanolixizumab for 6 consecutive weeks are expected to produce 
mean maximum IgG reductions of 
. These reductions will be achieved rapidly and 
maintained consistently over the Treatment Period. 
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4.4 
End of study definition 
A study participant is considered to have completed the study if he/she has completed all phases 
of the study including the first 8 weeks of the Observation Period and the EOS visit assessments.  
At the time of product approval or the availability of a MAP, or study participant early 
withdrawal the following scenarios need to be considered: 
• if the study participant is still in a treatment cycle, he/she will need to complete that cycle 
and the first 8 weeks of the Observation Period before completing the EOS visit assessments. 
• if a study participant is in the first 8 weeks of the Observation Period in, he/she must 
complete the 8 weeks before completing the EOS visit assessments  
• if a study participant is in the beyond the first 8 weeks of the Observation Period or in the no 
treatment period, he/she can complete EOS visit assessments 
The end of the study is defined as the date of the last visit of the last participant in the study. 
5 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1 
Inclusion criteria 
Study participants are eligible to be included in the study only if all of the following criteria 
apply: 
Type of participant and disease characteristics 
1a. Study participant must meet one of the following: 
− completed MG0003, 
− required rescue therapy (except IVIg or PEX) during the Observation Period in MG0003 
or  
− completed at least 6 visits in MG0004. 
Weight 
2. Body weight ≥35kg at Baseline (Day 1). 
Sex 
3b. Study participants may be male or female: 
− Removed. 
− A female participant is eligible to participate if she is not pregnant (see Appendix 4), not 
breastfeeding, and at least one of the following conditions applies: 
◦ 
Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 
OR 
◦ 
A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the 
treatment period and for at least for at least 90 days after the last dose of study 
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treatment. The study participant must have a negative urine pregnancy test prior to the 
first dose of study medication at Baseline (Day 1) of the initial and subsequent 
treatment cycles. 
Informed consent 
4. Capable of giving signed informed consent as described in Appendix 1 which includes 
compliance with the requirements and restrictions listed in the informed consent form (ICF) 
and in this protocol. For Japan-specific regulations, see Appendix 8 (Section 10.8). 
5. Study participant is considered reliable and capable of adhering to the protocol visit schedule, 
or medication intake according to the judgment of the Investigator. 
For France-specific inclusion criteria (criterion #6), see Appendix 8 (Section 10.8). 
5.2 
Exclusion criteria 
For criteria pertaining to laboratory measures, the last value from MG0003, or MG0004 will be 
used for evaluation of study participant eligibility, as long as the measurement was taken within 
the last 4 weeks prior to MG0007 Baseline (Day 1). 
Study participants are excluded from the study if any of the following criteria apply: 
Medical conditions 
1. Study participant has any medical or psychiatric condition that, in the opinion of the 
Investigator, could jeopardize or would compromise the study participant’s ability to 
participate in this study. 
2. Study participant has a history of alcohol use disorder or other substance use disorder (as per 
Diagnostic and Statistical Manual of Mental Disorders-5 [American Psychiatric Association, 
2013]) within the previous 12 months. 
3a. Study participant has a known hypersensitivity to any components of the study medication or 
other anti-FcRn medications. 
4a. Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB 
infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous 
mycobacterial infection (NTMBI).  
5a. Study participant met any mandatory withdrawal or mandatory study drug discontinuation 
criteria in MG0003, or MG0004, or permanently discontinued study drug in either study. 
Prior/Concomitant therapy 
6. Study participant intends to have a live vaccination during the course of the study or within 
8 weeks following the final dose of rozanolixizumab. 
Diagnostic assessments 
7. Study participant has absolute neutrophil count <1500 cells/mm3. 
8. Study participant with severe (defined as Grade 3 on the MG-ADL scale) weakness affecting 
oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis. 
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9. Study participant has any laboratory abnormality that, in the opinion of the Investigator, is 
clinically significant, has not resolved at randomization, and could jeopardize or compromise 
the study participant's ability to participate in this study. 
10. Study participant has renal impairment, defined as GFR less than 45mL/min/1.73m2. 
11.Study participant has 12-lead ECG with findings considered to be clinically significant upon 
medical review. The clinical significance of the findings needs to be assessed by the 
Investigator to determine eligibility, and any queries regarding continuation of the study 
participants will have to be addressed with the Medical Monitor. 
12. Alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase 
(ALP) are >3.0x upper limit of normal (ULN). 
13. Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated 
and direct bilirubin <35%). 
14a.If study participant has >ULN ALT, AST, or ALP that does not meet the exclusion limit at 
Baseline (Day 1), repeat the tests, if possible, prior to dosing to ensure there is no further 
ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the 
participant must be discussed with the Medical Monitor (tests that result in ALT, AST, or 
ALP up to 25% above the exclusion limit may be repeated once for confirmation).  Current 
unstable liver or biliary disease per Investigator assessment defined by the presence of 
ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, 
persistent jaundice, or cirrhosis. NOTE: Stable chronic hepatobiliary disease (including 
Gilbert’s syndrome, and asymptomatic gallstones) is acceptable of the study participant 
otherwise meets entry criteria. For UK-specific requirements, see Appendix 8, Section 10.8. 
15a.Study participant has corrected QT interval (QTcF) >450msec (for male participants) or 
QTc >470msec (for female participants) or QTc >480msec in participants with bundle branch 
block. 
Other 
16.A female study participant, who plans to get pregnant during the participation in the study. 
17. Study participant has a lifetime history of suicide attempt (including an 
 
), or had suicidal ideation since the last visit in 
MG0003 or MG0004 as indicated by a positive response (Yes) to either Question 4 or 
Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS). 
For France-specific exclusion criteria (criterions #18 and #19), see Appendix 8 (Section 10.8). 
5.3 
Lifestyle restrictions 
There are no lifestyle restrictions during the study unless deemed to interfere with compliance 
with the protocol as deemed by the Investigator. 
The use of medicinal cannabidiols and medicinal marijuana (prescribed by a Physician) is 
permitted. For Japan-specific regulations, see Appendix 8 (Section 10.8). 
5.4 
Screen failures 
Applicable to study participants with a gap period only (see Section 10.11). 
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Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently entered in the study. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure participants to meet the Consolidated Standards of 
Reporting Trials (CONSORT) publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes demography, screen failure details, eligibility criteria, 
and any serious adverse event (SAE). 
For study participants otherwise fully eligible but not able to enter the study as planned for 
nonclinical reasons, rescreening may be allowed at the discretion of the Investigator, following 
discussion with the sponsor's Medical Monitor and/or Study Physician. 
If a study participant has 1 isolated test result in the exclusionary range that is deemed not being 
clinically significant by the Investigator, retesting may be allowed at the discretion of the 
Investigator, following discussion with the sponsor's Medical Monitor and/or Study Physician. If 
the normalization of the test result occurs within the Screening Period, then no other screening 
procedures need to be repeated. 
6 
STUDY TREATMENTS 
Study treatment is defined as any investigational treatment(s), intended to be administered to a 
study participant according to the study protocol. 
6.1 
Treatments administered 
A description of the IMP to be administered in MG0007 is provided in Table 6-1. 
Table 6-1: 
Study treatments administered 
Intervention name 
Rozanolixizumab 
Type 
Drug 
Dose formulation 
Solution for injection 
A glass vial, containing rozanolixizumab at a concentration of 
 
 
Dosage level(s) 
See Table 6-2 
Route of administration 
Subcutaneous infusion via syringe driver or manual push method 
Use 
Experimental 
IMP and NIMP 
IMP  
Sourcing 
Provided centrally by the Sponsor or locally by the study site, 
subsidiary, or designee 
Packaging and labelling 
Rozanolixizumab is manufactured, packaged, and labeled according 
to Good Manufacturing Practice guidelines and applicable laws or 
regulations 
Current/Former name(s) or 
alias(es) 
UCB7665 
IMP=investigational medicinal product; NIMP=non investigational medicinal product 
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Details on the preparation of study treatment for infusion, rate of infusion, administration, 
appropriate records handling, and site personnel roles are provided in the IMP Handling Manual. 
The optional onsite manual push route of administration performed by a healthcare professional 
should only be introduced at the beginning of a treatment cycle and may be reverted back to the 
standard syringe driver administration at any time. All site personnel delegated to handle study 
treatment storage, preparation and administration must be trained to IMP Handling Manual. 
Rozanolixizumab sc doses across body weight tiers to be used in MG0007 are presented in 
Table 6-2. 
Table 6-2: 
MG0007 dose levels and weight tiers 
 
 
Bodyweight 
Rozanolixizumab dose eqv 
7mg/kg 
Dose 1 
10mg/kg 
Dose 2 
≥35 to <50kg 
280mg 
420mg 
≥50 to <70kg 
420mg 
560mg 
≥70 to <100kg 
560mg 
840mg 
≥100kg 
840mg 
1120mg 
eqv=equivalent 
6.2 
Preparation, handling, storage, and accountability requirements 
The Investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatment received and any discrepancies are reported and 
resolved before use of the study treatment. 
Only participants enrolled in the study may receive study treatment and only authorized site staff 
may supply or administer study treatment. All study treatments must be stored in a secure, 
environmentally controlled, and monitored (manual or automated) area in accordance with the 
labeled storage conditions with access limited to the Investigator and authorized site staff. 
The Investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study treatment accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records). 
In case an out-of-range temperature is noted, it must be immediately reported as per instructions 
contained in the IMP Handling Manual. 
Further guidance and information for the final disposition of unused study treatment are provided 
in the IMP Handling Manual.  
6.2.1 
Drug accountability  
A Drug Accountability form will be used to record study medication dispensing and return 
information on a by-participant basis and will serve as source documentation during the course 
of the study. Details of any study medication lost, damaged (due to breakage or wastage), not 
used, partially used, disposed of at the study site, or returned to the Sponsor or designee must 
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also be recorded on the appropriate forms. All supplies and pharmacy documentation must be 
made available throughout the study for UCB (or designee) to review. 
The Investigator (or designee) is responsible for retaining all used, unused, and partially used 
containers of study medication until returned or destroyed. 
The Investigator may assign some of the Investigator’s duties for drug accountability at the study 
site to an appropriate pharmacist/designee. 
The Investigator must ensure that the study medication is used only in accordance with the 
protocol. 
Periodically, and/or after completion of the clinical phase of the study, all used (including empty 
containers)/partially used, unused, damaged, and/or expired study medication must be reconciled 
and either destroyed at the site according to local laws, regulations, and UCB and/or site SOPs or 
returned to UCB (or designee). Investigational medicinal product intended for the study cannot 
be used for any other purpose than that described in this protocol. 
6.3 
Measures to minimize bias: randomization and blinding 
An interactive response technology (IRT) will be used for assigning eligible participants to a 
treatment regimen (as applicable) based on a predetermined production randomization and/or 
packaging schedule provided by UCB (or designee). The randomization schedule will be 
produced by the IRT vendor. The IRT will generate individual assignments for kits of study 
medication, as appropriate, according to the visit schedule. Study participants from MG0003 
who complete the EOS visit will be rerandomized in MG0007. Randomization in MG0007 is to a 
ratio of 1:1. Study participants from MG0004 will not be rerandomized upon entering MG0007, 
but will continue their last treatment regimen received in MG0004 for their first treatment cycle 
in MG0007. 
To enroll a study participant (Visit 1), the Investigator or designee will contact the IRT and 
provide brief details about the participant to be enrolled. Study participants will retain the same 
5-digit number assigned at Screening in MG0003 that serves as the participant identifier 
throughout the study. The participant number will be required in all communication between the 
Investigator or designee and the IRT regarding a particular participant. Participant numbers and 
kit numbers will be tracked via the IRT. 
6.3.1 
Procedures for maintaining and breaking the treatment blind 
6.3.1.1 
Maintenance of study treatment blind 
This is an OLE study and treatment details (ie, dose arm) will not be blinded. 
To maintain study integrity, IgG level will remain blinded to the study sites and the UCB study 
team for the first 4 weeks of the study. 
6.3.1.2 
Breaking the treatment blind in an emergency situation 
Not applicable. 
6.4 
Treatment compliance 
Drug accountability must be recorded on the Drug Accountability form (Section 6.2.1). 
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Details regarding treatment compliance are outlined in the Important Protocol Deviation 
Specification document.  
6.5 
Concomitant medication(s)/treatment(s) 
6.5.1 
Permitted concomitant treatments (medications and therapies) 
Concomitant medications listed in Table 6-3 are permitted during the study for the treatment of 
gMG, and dose adjustments are allowed between treatment cycles. With the exception of 
corticosteroids and AChE inhibitors, the dose of permitted concomitant medications should be 
maintained during each 6-week treatment cycle and every effort should be made to maintain a 
stable dose during the first 8 weeks of each Observation Period. Any violation of the permitted 
treatment criteria would lead to prohibited treatment and should be discussed with the 
Investigator, Sponsor, and Medical Monitor.  
If a study participant receives a COVID-19 vaccine, the product name and date of 
administration(s) should be captured in the eCRF as a concomitant medication.  
Table 6-3: 
Permitted concomitant treatments 
Permitted Medications 
Dose 
Oral corticosteroids (eg, prednisolone) 
No specific requirements 
Methotrexate 
≤30mg/week 
Mycophenolate mofetil  
≤3g/day 
Cyclosporinea 
≤5mg/kg/day for unmodified 
≤4mg/kg/day for modified 
(microemulsion) 
Azathioprine 
≤3mg/kg/day 
Cholinesterase inhibitors 
≤600mg pyridostigmine/day 
Tacrolimusb 
≤5mg/day 
a Doses higher than listed are permissible if trough level is ≤300ng/mL. 
b If the total daily weight-based dose is >5mg, then a plasma trough level should be checked  
to ensure study participant is not above the recommended therapeutic range. 
6.5.2 
Prohibited concomitant treatments (medications and therapies) 
The following concomitant medications are prohibited during the study: 
• All biologics, including rituximab 
• Cyclophosphamide 
• Pimecrolimus 
• IPP-201101 (Lupuzor™) 
• Immunoadsorption 
• Vinca alkaloids (vincristine, vinblastine) 
Study participants can enroll in MG0007 irrespective of their background gMG medications. 
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If a study participant needs or takes any prohibited medication or therapy, the Investigator will 
(where possible) discuss with the Medical Monitor and/or the Sponsor’s Study Physician and a 
decision will be made whether the study participant can continue in the study or be withdrawn. 
6.5.3 
Treatments specific to NMJ interference 
Treatments could interfere with the function of the NMJ (and which therefore could impair study 
participants with MG), such as, but not limited to, include the following medications: 
− botulinum toxin 
− aminoglycoside antibiotics  
− tetracycline antibiotics  
− penicillamine 
− magnesium 
For a more detailed list please refer to the Myasthenia Gravis Foundation of America (MGFA) 
medication list (https://myasthenia.org/What-is-MG/MG-Management/Cautionary-Drugs). The 
benefit-risk of starting these medications should be carefully considered by the Investigator, and 
where possible, the Investigator will discuss with the Medical Monitor and/or sponsor’s Study 
Physician prior to initiating therapy that can affect the NMJ. 
6.5.4 
Rescue medication 
The study site will supply rescue therapy that will be obtained locally. Rescue therapy will be 
given as per standard of care and at the discretion of the Investigator. Study participants who 
continue to experience moderate to severe symptoms despite treatment with rozanolixizumab 
may be treated with the following as rescue therapy: 
• IVIg 
• SCIg 
• PEX, or plasmapheresis 
• iv corticosteroids at a higher dose than previous oral dose 
Participants who are treated with rescue therapy during the Treatment Period are not eligible to 
receive any further treatment with rozanolixizumab. Study participants must complete the first 8 
weeks of the Observation Period after the last dose of rozanolixizumab prior to completing the 
EOS visit assessments, and subsequently will be withdrawn from the study (Section 4.4).  
Those patients who received rescue therapy during the observation or no treatment with 
rozanolixizumab periods may continue in the study at the Investigator’s discretion and after 
discussion with Medical Monitor and/or UCB Study Physician. The following cycle of 
rozanolixizumab should in general not start earlier than 4 weeks following the last dose of IVIg, 
SCIg, or iv corticosteroids or the last PEX session, unless there is a medical reason, and an 
earlier treatment initiation is being considered 
 for the study participant as agreed upon with 
the Medical Monitor and/or UCB Study physician. 
The date and time of rescue medication administration as well as the name and dosage regimen 
of the rescue medication must be recorded.  
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6.6 
Dose modification 
Dose modifications from 10mg/kg to 7mg/kg equivalent and vice versa is permitted at the 
beginning of the treatment cycles at the Investigator’s discretion, and if the benefit-risk remains 
favorable for the study participant. Recommended dose modifications from 10mg/kg to 7mg/kg 
equivalent due to drug-related adverse events which may include but not limited to: 
• Moderate to severe headaches that are considered to be related to rozanolixizumab  
• Moderate to severe GI disturbances that are considered to be related to rozanolixizumab  
• Moderate to severe toxicities (≥Grade 2 as defined by Common Terminology Criteria for 
Adverse Events [CTCAE], version 5.0) for which rozanolixizumab cannot be excluded as a 
cause 
• Recurrent hypogammaglobulinemia with a serum total IgG level of <2g/L. 
6.7 
Home (or Virtual) visits 
During the Treatment Period, the at-home visits will be conducted by fully trained healthcare 
professional visiting the study participant at his or her home. Alternatively, these visits can be 
conducted at the site as deemed necessary by site personnel and/or the study participant. For 
home dosing, the same safety monitoring schedule will be followed as per onsite dosing. The 
home nurse will be present during the full duration of the visit. Home visits can be conducted if 
the following conditions are met: 
• The study participant is willing to be dosed and monitored at home by a home nurse. 
• The study participant has shown good acute tolerability to previous administrations of IMP 
(namely, he or she must have had no moderate or severe infusion reactions or other AEs that 
the Investigator considers could increase the risk of home administration). 
The Investigator should complete a checklist to confirm that criteria for home nurse and/or self- 
administration have been fully evaluated. 
Virtual visits will be conducted with study participants during the Observation Period and 
between cycles (see Schedule of Activities (Section 1.3); no treatment with rozanolixizumab) by 
site personnel. Alternatively, these visits can be conducted at the site as deemed necessary by site 
personnel and/or the study participant. 
6.8 
Treatment after the end of the study 
Study participants who complete participation in MG0007 may have the possibility to continue 
receiving rozanolixizumab through a MAP if available, as indicated per the Sponsor and 
applicable per local regulations. 
In the case of prolonged hypogammaglobulinemia after treatment discontinuation, study 
participants must be followed up until IgG levels return to values within the normal range or to 
individual Baseline values. 
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7 
DISCONTINUATION OF STUDY MEDICATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
Discontinuation of study medication 
7.1.1 
Liver chemistry stopping criteria 
Discontinuation of study treatment for abnormal liver function should be considered by the 
Investigator when a participant meets one of the conditions outlined Figure 7-1 and Figure 7-2 or 
if the Investigator believes that it is in best interest of the participant.  
Figure 7-1: Liver Chemistry Stopping Criteria and Increased Monitoring 
Algorithm 
 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; INR=international normalized ratio; SAE=serious 
adverse event; ULN=upper limit of normal 
Treatment with study medication may be continued with increased monitoring if a study 
participant meets one of the criteria outlined in Figure 7-2. 
 
Continue Study Treatment 
Discontinue Study Treatment 
Plus 
Bilirubin≥2x
ULN (>35% 
direct) or plus
INR>1.5, if 
measured*
Possible  
Hy’s Law
ALT≥3xULN
ALT
≥8xULN
Plus
Symptoms of 
liver injury
or 
hypersensitivity
No
Yes
Yes
Yes
No
No
No
See algorithm 
for continued 
therapy with 
increased liver 
chemistry 
monitoring
Yes
ALT 
≥3xULN 
but 
<8xULN
Yes
Refer to the Liver Safety Required Actions and Follow up Assessments section in 
Appendix 6. 
Report as an SAE if possible Hy’s Law case: AST/ALT ≥3xULN and Bilirubin 
≥2xULN (>35% direct) or INR>1.5, if measured 
(Note: INR value not applicable to patients on anticoagulants) 
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Figure 7-2: Liver Chemistry Increased Monitoring Algorithm with Continued 
Study Intervention for Participants with ALT ≥3xULN but <8xULN 
 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; bili=bilirubin; INR=international normalized 
ratio; SAE=serious adverse event; ULN=upper limit of normal 
Specific assessments and follow up actions for potential drug-induced liver injury are provided 
in Appendix 6 (Section 10.6).  
7.1.2 
QTc stopping criteria 
If a clinically significant finding is identified (including, but not limited to changes from baseline 
in QT interval corrected using Fridericia’s formula [QTcF]) after enrollment, the Investigator or 
qualified designee will determine if the participant can continue in the study and if any change in 
participant management is needed. This review of the ECG printed at the time of collection must 
be documented. Any new clinically relevant finding should be reported as an AE. 
A study participant who meets either bulleted criterion based on the average of triplicate ECG 
readings will be withdrawn from study medication and move into the Observation Period. The 
study participant should be referred to a specialist (ie, cardiologist) and managed as per local 
guidance. 
• QTc >500 msec OR uncorrected QT >600msec 
• Change from baseline of QTc >60msec 
 
Continue Study Treatment   and   Monitor Liver Chemistry
Discontinue Study Treatment 
ALT≥5xULN 
but <8xULN
+ bili <2xULN +
no symptoms
No
➢Must refer to Liver Safety Required Actions and Follow up Assessments section in the Appendix
Yes
ALT ≥3xULN 
but <5xULN
+ bili <2xULN  +
no symptoms
Able to 
monitor  
weekly 
for  ≥2 
weeks
Persists for 
≥2 weeks  
or other 
stopping 
criteria  
met
No
Yes
Yes
Yes
No
No
Able to 
monitor  
weekly 
for  ≥4 
weeks
Persists for 
≥4 weeks  
or other 
stopping 
criteria  
met
No
Yes
Yes
Yes
Yes
ALT ≥5xULN 
ALT <5xULN 
Yes
Yes
Refer to the Liver Safety Required Actions and Follow up Assessments section in 
Appendix 6. 
Report as an SAE if possible Hy’s Law case: AST/ALT ≥3xULN and Bilirubin 
≥2xULN (>35% direct) or INR>1.5, if measured 
(Note: INR value not applicable to patients on anticoagulants) 
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For participants with underlying bundle branch block, follow the discontinuation criteria listed 
below: 
Baseline QTc with Bundle Branch Block 
Discontinuation QTc Threshold with Bundle 
Branch Block 
<450msec 
>500msec 
450 to 480msec 
≥530msec 
See the Schedule of Activities for data to be collected at the time of treatment discontinuation 
and follow-up and for any further evaluations that need to be completed. 
7.1.3 
Temporary IMP discontinuation  
Study participant must be TEMPORARILY discontinued from the IMP if any of the following 
events occur: 
1. The study participant develops an event of hypogammaglobulinemia with a serum total IgG 
of <1g/L irrespective of infection. When the IgG level reaches ≥2g/L, the study participant 
may be allowed to continue treatment with IMP (see Appendix 13; Section 10.13.1). 
2. Symptomatic cases of confirmed COVID-19 infection. The IMP may be restarted if clinically 
appropriate when signs and symptoms have resolved and in agreement with local guidelines. 
3. Study participant has a suspected DIAM. The IMP may be restarted if clinically appropriate 
when signs and symptoms have resolved. Refer to Section 7.1.4 for permanent 
discontinuation criteria (criterion #10). 
Study participants may be TEMPORARILY discontinued from the IMP if the following events 
occur: 
1. The study participant develops a nonserious persisting or recurrent infection with serum total 
IgG level between ≥1 and <2g/L. Upon resolution of infection and the IgG returning to level 
of ≥2g/L, the study participant may be allowed to resume treatment with the IMP (see 
Appendix 13; Section 10.13.1).  
2. Asymptomatic or suspected cases of COVID-19 infection. The IMP may be restarted when 
clinically appropriate as deemed by the Investigator and in agreement with local guidelines.  
3. Study participant has a moderate to severe infection (Grade 2 to 3) that may or may not result 
in hospitalization, unless the discontinuation criterion #3 is met. Decision to start a new 
treatment cycle should be based on careful evaluation by the Principal Investigator of the 
Benefit-Risk for the individual study participant and provided a full recovery from infection 
has occurred, an acceptable level of total IgG (≥2g/L) has been reached and no other 
discontinuation criteria were met. 
The Investigator should discuss with the Medical Monitor and/or Sponsor’s study physician prior 
to reinitiating the IMP. As appropriate, virtual assessments could continue (eg, AE collection, 
patient-reported outcome [PRO] assessments as per contingency measures described in 
Section 8). 
If IMP treatment is resumed, continue the next dose as previously scheduled. No “make up” dose 
is permitted.  
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The participant should subsequently follow the visit schedule as described in the protocol, and 
the eCRF should be completed accordingly, including the information if the visit was impacted 
by COVID-19 infection.  
The date and reason for dose modification/hold of rozanolixizumab is to be recorded on each 
study participant’s eCRF. 
7.1.4 
Study medication permanent discontinuation criteria 
Study participants must permanently discontinue study medication if any of the following events 
occur: 
1. Study participant develops an illness that would interfere with his or her continued 
participation. 
2. Study participant has new onset or recurrent neoplastic disease (except for superficial basal 
or squamous cell carcinoma of the skin not requiring targeted biological therapy, 
chemotherapy or radiation). 
3. Study participant experiences a significant infective episode including but not limited to 
bacteremia/sepsis, infectious meningitis, septic arthritis, osteomyelitis, complicated 
pneumonia, or visceral abscess, which may or may not result in hospitalization during a 
treatment period. This list is not intended to be all inclusive and the investigator is expected 
to apply his/her judgement on continuing IMP based on the clinical situation. 
However, if a significant infective episode is reported during observation and no treatment 
with rozanolixizumab period, the decision to start a new treatment cycle should be based on 
careful evaluation by the Principal Investigator of the Benefit-Risk for the individual study 
participant and provided a full recovery from infection, an acceptable level of total IgG 
(≥2g/L) and no other discontinuation criteria were met. 
4. Study participant meets potential drug-induced liver injury (PDILI) permanent 
discontinuation criteria. 
5. Study participant has a TB test that is confirmed positive or any further evidence suggestive 
of potential TB infection (ie, exposure) and further examinations result in a diagnosis of 
active TB or latent TB infection (LTBI). 
6. If a nontuberculosis mycobacterium infection (NTMBI) is identified during a study, the same 
withdrawal procedures as those used for an active TB infection identified during the study 
should be followed. 
7. Removed. 
8. Study participant has an AE of severe or serious infusion or anaphylactic reaction requiring 
corticosteroid and/or epinephrine therapy (Sampson et al, 2006). 
9. Study participant is treated with rescue therapy (IVIg, SCIg, PEX, or iv corticosteroids; see 
Section 6.5.4) during the Treatment Period. Those patients who received rescue therapy 
during the observation or no treatment with rozanolixizumab periods may continue in the 
study at the investigator’s discretion and after discussion with Medical Monitor and/or UCB 
Study Physician. The following cycle of rozanolixizumab should in general not start earlier 
than 4 weeks following the last dose of IVIg, SCIg, or iv corticosteroids or the last PEX 
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session, unless there is a medical reason, and an earlier treatment initiation is being 
considered 
 for the study participant as agreed upon with the Medical Monitor and/or 
UCB Study physician. 
10. Study participant has a recurrence of aseptic meningitis (see also Appendix 14 
[Section 10.14]). 
Study participants may permanently discontinue rozanolixizumab and move into the 
Observation Period at the discretion of the Investigator, Medical Monitor, and Study Physician if 
any of the following events occur: 
1. Study participant is noncompliant with the study procedures or medications in the opinion of 
the Investigator.  
2. Study participant takes prohibited concomitant medications as defined in this protocol.  
Investigators should contact the Medical Monitor, whenever possible, to discuss the withdrawal 
of a participant in advance. Investigators should attempt to obtain information on study 
participants in the event of withdrawal (eg, reason for withdrawal, any safety information). 
In the event of study participant early withdrawal, the scenarios as described in Section 4.4 need 
to be considered. 
7.2 
Participant discontinuation/Withdrawal from the study 
Participants are free to withdraw from the study at any time, without prejudice to their continued 
care. 
Study participants must be withdrawn from the study if any of the following events occur: 
1. Study participant withdraws his/her consent. 
2. The Sponsor or a regulatory agency requests withdrawal of the study participant. 
3. There is confirmation of a pregnancy during the study, as evidenced by a positive pregnancy 
test. 
4. Study participant has active suicidal ideation as indicated by a positive response (Yes) to 
either Question 4 or Question 5 of the "Since Last Visit" version of the C-SSRS. The study 
participants should be referred immediately to a Mental Healthcare Professional. 
A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the Investigator for safety, behavioral, compliance, or 
administrative reasons. 
If the study participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
If a study participant withdraws from the study, he/she may request destruction of any samples 
taken and not tested, and the Investigator must document this in the site study records. 
See the Schedule of Activities (Section 1.3) and Section 4.4 for data to be collected at the time of 
study discontinuation and follow-up and for any further evaluations that need to be completed. 
Investigators should contact the Medical Monitor, whenever possible, to discuss the withdrawal 
of a study participant in advance. 
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7.3 
Lost to follow up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site.  
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the participant wishes to and/or should continue in the 
study. 
• Before a participant is deemed lost to follow up, the Investigator or designee must make 
every effort to regain contact with the participant (at least 1 phone call and 1 written message 
to the participant), and document his/her effort (date and summary of the phone call and copy 
of the written message in the source documents), to complete the final evaluation. All results 
of these evaluations and observations, together with a narrative description of the reason(s) 
for removing the participant, must be recorded in the source documents. The eCRF must 
document the primary reason for withdrawal. 
Should the participant continue to be unreachable, he/she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up documented in the eCRF.  
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8 
STUDY ASSESSMENTS AND PROCEDURES 
Study procedures and their timing are summarized in the Schedule of Activities (Section 1.3).  
Protocol waivers or exemptions are not allowed. 
Immediate safety concerns should be discussed with the Sponsor immediately upon occurrence 
or awareness to determine if the participant should continue or discontinue study treatment. 
Adherence to the study design requirements, including those specified in the Schedule of 
Activities (Section 1.3), is essential and required for study conduct. 
All screening evaluations must be completed and reviewed to confirm that potential participants 
meet all eligibility criteria. The Investigator will maintain a screening log to record details of all 
participants screened and to confirm eligibility or record reasons for screening failure, as 
applicable.  
Procedures conducted as part of the participant’s routine clinical management (eg, blood count) 
and obtained before signing of the ICF may be utilized for Screening or Baseline purposes 
provided the procedures met the protocol-specified criteria and were performed within the time 
frame defined in the Schedule of Activities (Section 1.3). 
An Unscheduled Visit can be conducted at the discretion of the Investigator (eg, due to an AE). 
During the Unscheduled Visit, the following assessments will be performed: 
• AE reporting 
• Concomitant medications  
• Review of withdrawal criteria 
• Physical examination 
• Vital signs 
Blood samples for PK, IgG, hematology, biochemistry, other laboratory testing and assessments 
may be performed as clinically indicated at the discretion of the Investigator. 
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples. 
Some study-specific investigations may not be conducted according to the study protocol during 
a pandemic or other exceptional circumstances (eg, hurricanes) due to the need to implement 
safety measures and guidance from regulatory authorities. In such a situation, which may be 
accompanied by local or global containment or other measures, sites may need to prohibit access 
to study participants and study-related personnel. Study participants visits to the study site may 
be replaced by contingency measures. These measures are primarily established to ensure the 
safety of study participants during the course of the study and to maintain the study participants 
treatment schedule, if the Investigator considers it appropriate. These measures include but are 
not limited to virtual visits or home-nursing visits replacing site visits, eg, telemedicine contacts 
or home-nursing visits when treatment and/or blood sampling is scheduled. The contingency 
measures are described in a contingency plan and will be implemented as required. 
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8.1 
Efficacy assessments 
Planned timepoints for all efficacy assessments are provided in the Schedule of Activities 
(Section 1.3). 
8.1.1 
MGFA Classification  
The Investigator will classify the study participant’s MG using the MGFA Clinical Classification 
(Jaretzki et al, 2000). This is a 5-stage classification (I to V), with a higher class indicating more 
severe disease. To be eligible for this study, a participant with a gap period must be graded 
MGFA CLASS II to IVa at Visit 1, as per inclusion criteria (see Appendix 12 [Section 10.12]). 
8.1.2 
Quantitative Myasthenia Gravis scale 
For assessment of the QMG scale, Investigators or qualified designee will follow the MGFA’s 
QMG Manual instructions. Clinical personnel must complete mandatory training to assess study 
participants’ QMG score (details are provided in the Study Procedures Manual). If not medically 
appropriate, then the treatment can be continued but the testing should be performed as best as 
possible at the same timeframe post last acetylcholinesterase AChE inhibitor dosing for each 
evaluation during the study. Study participants should not take pyridostigmine (or other AChE 
inhibitor medication) from midnight before testing when medically safe to do so to standardize 
testing (ie, if AChE inhibitors cannot be stopped). The scale tests 13 items, including ocular and 
facial involvement, swallowing, speech, limb strength, and forced vital capacity (FVC). For the 
assessment of FVC, the same spirometer should be used each time a study participant is tested, 
and if possible, the same person should carry out the assessment. The QMG is a validated 
assessment (Barnett et al, 2012), with a higher score indicating more severe disease. Scoring for 
each item ranges from no weakness (0) to severe weakness (3), with an overall score range from 
0 to 39. A 3-point change in the total score is considered clinically relevant. Where possible, the 
same person should carry out the assessment at each visit. 
8.1.3 
MG-Composite scale 
For assessment of the MG-C scale, the Investigator or qualified designee will examine the study 
participant to score all items, except for talking, chewing, and swallowing for which the study 
participant will self-assess. Study participants should not take pyridostigmine (or other AChE 
inhibitor medication) from midnight before testing when medically safe to do so to standardize 
testing. The MG-C scale is a validated assessment (Burns et al, 2010), with a higher score 
indicating more severe disease and a 3-point change being of clinical relevance (Muppidi et al, 
2011). The scale tests 10 items, with individual items being weighted differently. The overall 
score ranges from 0 to 50. Clinical personnel must complete mandatory training to assess study 
participants’ MG-C score (details are provided in the Study Procedures Manual). Where 
possible, the same person should carry out the assessment at each visit. 
8.1.4 
Patient-reported outcomes 
Patient-repoted outcomes must be completed as per time points mentioned in the Schedule of 
Activities (Section 1.3). The PROs should be completed prior to any intrusive procedures in a 
quiet place. 
The PROs should be completed in the following order: MG-ADL, MG Symptoms PRO, EQ-5D-
5L, and MG-QOL15r. The PROs should only be checked for completeness. On dosing days, the 
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PROs will be completed prior to dosing. Study participants should not take pyridostigmine (or 
other AChE inhibitor medication) from midnight before the days when efficacy assessments are 
performed, when medically safe to do so to standardize testing.  
8.1.4.1 
MG-Activities of Daily Living 
The MG-ADL is an 8-item PRO instrument developed on the basis of the QMG (Wolfe et al, 
1999). The MG-ADL targets symptoms and disability across ocular, bulbar, respiratory, and 
axial symptoms. In a recent study, reliability, validity, and responsiveness of the MG-ADL were 
further assessed. The questionnaire showed strong construct validity when evaluated against the 
MG-C as well as against the MG-QOL15r; high test-retest reliability in a 1-week interval; and it 
was demonstrated that a 2-point improvement indicates clinical improvement (Muppidi, 2012; 
Muppidi et al, 2011). The total MG-ADL score ranges from 0 to 24, with a higher score 
indicating more disability.  
Independently of study visit type (site, home, or virtual), the MG-ADL must be completed by 
study participants in a quiet place by themselves without the help of a partner or caregiver, 
before any clinical examination takes place. Study participants should be informed of the 
importance of this questionnaire and instructed to read the items and instructions carefully. They 
should be informed that there are no correct or incorrect answers. 
Study personnel are not allowed to interpret the items for the participant. If a participant asks for 
guidance, study personnel should instruct him/her to respond according to their best 
understanding of the item. The MG-ADL should only be checked for completeness by study 
personnel. In the event a few questionnaire items have not been completed, study personnel 
should only query this with the study participant, if this results from an omission. Study 
personnel shall neither complete missing data nor suggest changes to participant responses. As 
with other study data, responses to the questionnaire should be treated as confidential 
information. Data privacy considerations apply. 
In the specific context of virtual and home visits, paper copies of MG-ADL should be made 
available to study participants ahead of the visit. Site coordinators or study personnel (or an 
automatic alert mechanism) should remind study participants to complete MG-ADL before visit 
start and to record the date upon completion of the questionnaire. Once they have completed 
MG-ADL, study participants should transfer it electronically to site personnel. In the event study 
personnel finds out that MG-ADL has not been completed before the visit, study participants 
should be allowed some additional time to complete the questionnaire before any study related 
assessment is initiated. 
8.1.4.2 
MG Symptoms PRO 
The MG Symptoms PRO instrument consists of 42 items across 5 scales: ocular symptoms 
(items 1-5); bulbar symptoms (items 6-15); respiratory symptoms (items 16-18); physical fatigue 
(items 19-33) and muscle weakness fatigability (items 34-42). 
The study participant will be asked to choose the response option that best describes the severity 
of ocular, bulbar, and respiratory symptoms over the past 7 days using a 4-point Likert scale 
(“none” to “severe”) and how frequently they experience physical fatigue and muscle weakness 
fatigability over the past 7 days using a 5-point Likert scale (“none of the time” to “all of the 
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time”), respectively. A score can be obtained for each scale. All scores range from 0 to 100, with 
higher scores indicating more severe symptoms. 
8.1.4.3 
EQ-5D-5L 
The 5-level EQ-5D (EQ-5D-5L) is designed to improve the instrument’s sensitivity and to 
reduce ceiling effects.  
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EuroQol 
visual analogue scale (EQ VAS). 
The descriptive system comprises five dimensions: mobility, self-care, usual activities, 
pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight 
problems, moderate problems, severe problems and extreme problems. The patient is asked to 
indicate his/her health state by ticking the box next to the most appropriate statement in each of 
the five dimensions. This decision results in a 1-digit number that expresses the level selected for 
that dimension. The digits for the five dimensions can be combined into a 5-digit number that 
describes the patient’s health state. 
The EQ VAS records the patient’s self-rated health on a vertical visual analogue scale, where the 
endpoints are labelled ‘The best health you can imagine’ and ‘The worst health you can 
imagine’. The VAS can be used as a quantitative measure of health outcome that reflect the 
patient’s own judgement. 
8.1.4.4 
MG-QOL15r 
The MG-QOL15r is a brief survey, completed by the study participant, that is designed to assess 
some aspects of "quality of life" related to MG. The MG-QOL15r was designed to assess the 
"patient perspective" in the everyday clinic setting or in a clinical study. 
When completing the 15-item MG-QOL15r, MG study participant should consider only how 
their MG affects these items. For example, if a study participant has no leg weakness but has a 
painful hip (unrelated to the MG) that causes walking trouble, the study participant should report 
"not at all" to the item of, "I have trouble walking.” This is because any hip-related walking 
trouble is unrelated to the MG. One other note of clarification: if the study participant is retired 
(unrelated to MG), he or she should report “not at all” to the item about whether the MG 
negatively impacts job/occupational status. 
8.2 
Safety assessments 
Planned time points for all safety assessments are provided in the Schedule of Activities 
(Section 1.3). 
8.2.1 
Physical examination 
A complete physical examination will include, at a minimum, general appearance; ear, nose, and 
throat; eyes, hair, and skin; and assessments of the of the cardiovascular, respiratory, GI, 
neurological, and musculoskeletal systems. Height and weight will also be measured and 
recorded. Body weight will be measured with the study participant wearing light clothing and 
without wearing shoes. 
A brief physical examination will include, at a minimum, assessments of the skin, respiratory 
system, cardiovascular system, and abdomen (liver and spleen). 
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A full neurological examination should be performed for any study participant who experiences 
severe and/or serious headache and for any study participant who experiences suspected aseptic 
meningitis (Appendix 14 [Section 10.14]). A full neurological assessment will include: 
(1) General appearance, including posture, motor activity and meningeal signs and, if indicated, 
the following assessments will be performed; (2) Cranial nerves examination; (3) Motor system 
examination, including muscle tone and power and sensory system examination – light touch; 
(4) Reflexes, including deep tendon reflexes; (5) Coordination, gait (if possible); and (6) 
Fundoscopy. 
Investigators should pay special attention to clinical signs related to previous serious illnesses. 
Clinically relevant findings or worsening of previous findings will be recorded as AEs.  
8.2.2 
Vital signs 
Oral, tympanic, temporal or axillary temperature, pulse rate, and blood pressure will be assessed. 
Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the 
participant in a quiet setting without distractions (eg, television, cell phones). All measurements 
will be assessed in a sitting position with a completely automated device. Manual techniques will 
be used only if an automated device is not available. 
All vital signs should be taken before any blood sampling and IMP administration, unless 
otherwise indicated. 
In case of untoward event, additional vitals (unscheduled assessment) should be taken at the 
discretion of the investigator and post observation time can be extended. These recommendations 
are applicable for dosing at site and at home. 
For the initial 2 infusions after switching to manual push, vital signs will be measured prior to 
IMP administration, at the end of the infusion (±15 minutes), and 1 hour after the end of the 
infusion (±15 minutes). For the subsequent infusions, vital signs are not collected after IMP 
administration. 
8.2.3 
Electrocardiograms 
Twelve-lead ECG will be obtained as outlined in the Schedule of Activities (see Section 1.3) 
using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, 
and QTc intervals. Refer to Section 7.1.2 for QTc withdrawal criteria and any additional [QTc] 
readings that may be necessary. 
All ECG recordings should be taken with the study participant resting in the supine position for 
at least 5 minutes before the recording.  
In cases of abnormal ECG reading, triplicate ECG will be required, three individual ECG 
tracings should be obtained as closely as possible in succession. 
8.2.4 
Clinical safety laboratory assessments 
See Appendix 2 (Section 10.2) for the list of clinical laboratory tests to be performed and to the 
Schedule of Activities (Section 1.3) for the timing and frequency.  
The Investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF. The 
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laboratory reports must be filed with the source documents. Clinically significant abnormal 
laboratory findings are those which are not associated with the underlying disease, unless judged 
by the Investigator to be more severe than expected for the participant's condition. 
All laboratory tests with values considered clinically significantly abnormal during the 6-week 
treatment period or within 8 weeks after the last dose of study medication should be repeated 
until the values return to normal or baseline or are no longer considered clinically significant by 
the Investigator or Medical Monitor. 
If such values do not return to normal/baseline within a period of time judged reasonable by the 
Investigator, the etiology should be identified, and the Sponsor notified. 
All protocol-required laboratory assessments, as defined in Appendix 2 (Section 10.2), must be 
conducted in accordance with the laboratory manual and the Schedule of Activities (Section 1.3).  
If laboratory values from non-protocol specified laboratory assessments performed at the 
institution’s local laboratory require a change in participant management or are considered 
clinically significant by the Investigator (eg, SAE or AE or dose modification), then the results 
must be recorded in the eCRF. 
8.2.5 
Suicidal risk monitoring 
Study participants being treated with rozanolixizumab should be monitored appropriately for 
suicidal ideation and behavior or any other unusual changes in behavior. Consideration should be 
given to discontinuing rozanolixizumab in study participants who experience signs of suicidal 
ideation or behavior.  
Families and caregivers of study participants being treated with rozanolixizumab should be 
instructed to monitor participants for the emergence of unusual changes in behavior, as well as 
the emergence of suicidal ideation and behavior, and to report such symptoms immediately to the 
study Investigator. 
Suicidality will be assessed by trained study personnel using the Columbia Suicide Severity 
Rating Scale (C-SSRS) (Columbia Univerity Medical Center, 2008). The C-SSRS will be 
performed at the scheduled timepoints as described in the Schedule of Activities (Section 1.3). 
8.2.6 
Assessment and management of TB and TB risk factors 
Precautions are being taken within this protocol to monitor the risk of TB infection in this study 
(see Section 5.2). Any presumptive diagnosis or diagnosis of a TB infection is a reportable event. 
Assessment and management of TB and TB risk factors should follow local/national guidelines. 
Physical Examination 
The Investigator should consider all potential sites of infection when assessing for TB during the 
physical examination, and other evaluations, and based on the study participant’s medical or 
social history. Sites commonly infected by TB include: the lungs, larynx, lymph glands, pleura, 
GI system, genito urinary tract (including renal), bones and joints, meninges, peritoneum, 
pericardium, and skin. This is not an exhaustive list and unusual presentations and areas of 
involvement should always be considered. 
Some common symptoms that the study participant may present are dependent on the primary 
focus of infection and may include cough, blood in sputum, night sweats, lymphadenitis, joint 
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pain/swelling, spinal deformity, headache/confusion, abdominal pain (mimicking inflammatory 
bowel disease), etc. Unusual presentations should always be considered. 
Note: If available, respiratory or other specimens must also be smear and culture negative for TB 
(Center for Disease Control and Prevention diagnosis of LTB infection 
[http://www.cdc.gov/TB/topic/testing/default.htm]). 
TB signs and symptoms questionnaire 
In addition to a physical examination done intermittently throughout the study, study participants 
will be evaluated both for signs and symptoms of latent or active TB infection and for risk 
factors for exposure to TB using the TB questionnaire as indicated in the schedule of study 
assessments (cross reference to table of schedule of study assessment). 
The TB questionnaire should be completed accurately and filed as a critical source document. 
The questionnaire will assist with the identification of study participants who may require 
therapy for TB.  
A “Yes” response to any of the questions in the TB questionnaire during the study may trigger 
further assessment to determine if the study participant has either LTBI and must receive 
prophylactic LTBI therapy or active TB infection and must be withdrawn from the study. As an 
example, a study participant who answers “Yes” at Screening to the question “Has the subject 
been in close (eg, sleeping in the same room) contact with an individual with active TB, or an 
individual who has recently been treated for TB?” should not be allowed into the study pending 
further assessments (including TB specialist consult) as outlined previously. 
TB assessment by IGRA 
The TB test interferon gamma release assay (IGRA) is performed at Screening in MG0003, and 
the final visit in MG0004 (Visit 52 [PEOT] or Visit 53 [EOS]) will serve as Baseline in 
MG0007. The TB screening is mandatory both before study entry and at study completion 
(EOS). The preferred screening test is interferon-gamma release assay (IGRA) performed at a 
Central Laboratory by QuantiFERON tube test (for Japan-specific regulations, see Appendix 8 
[Section 10.8]). Additional IGRA test will be performed if indicated (eg, presence of signs and 
symptoms suggestive of TB, recent exposure).  
In high TB incidence countries, it is recommended that the IGRA be the first test performed at 
screening to reduce the number of unnecessary screening procedures on any IGRA positive study 
participants that may need to be treated for TB prophylaxis or potentially withdrawn from the 
study.  
The test results will be reported as positive, negative, or indeterminate.  
If an IGRA is positive or indeterminate the study participant must be evaluated by a TB 
specialist. 
• Positive IGRA 
The positive IGRA may represent new LTBI or active TB infection. The positive IGRA result 
may also reflect positivity from a recently diagnosed and adequately treated (in progress or 
completed within the past 12 months) LTBI or from adequately treated past TB infection. In such 
cases, the study participants must be evaluated by a TB specialist. 
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• Indeterminate IGRA 
If the IGRA test result is indeterminate, the IGRA previously performed may be repeated once. 
If the test is positive or indeterminate on retest, the study participant must be evaluated by a TB 
specialist. 
TB assessment by chest X-ray  
A Screening chest X-ray is not required for MG0007. However, a chest X-ray or other imaging 
test should be performed only if indicated (eg, presence of signs and symptoms suggestive of 
TB, close exposure to persons with TB), and interpreted by a qualified specialist (ie, radiologist 
or pulmonologist). 
Test Conversion 
Tuberculosis test conversion is defined as a positive or indeterminate (and confirmed 
indeterminate on repeat) IGRA result for the current test when previous IGRA test results were 
negative. During the study, all study participants with positive or indeterminate IGRA test results 
must immediately stop study drug administration.  
In case of a IGRA test conversion, the study participant must be considered as having either a 
suspected new latent or an active TB infection and be promptly referred to an appropriate 
specialist (eg, pulmonologist, infectious disease specialist) for further evaluation. If test 
conversion indicates LTBI, active TB, or NTMB then, TB test conversion (confirmed) should be 
classified adequately, either as due to LTBI, active TB infection, or NTMB, respectively. 
Additional assessments (eg, blood tests or IGRA, chest X-rays, or other imaging) should be 
performed where medically relevant and documented. Such conversions should be reported as 
AEs as described in the protocol. The AE term would need to be updated with final diagnosis 
once available. 
Latent TB 
Latent TB infection is defined as the absence of signs, symptoms (eg, evidence of organ specific 
involvement), or physical findings suggestive of TB infection with a positive IGRA test (or 2 
indeterminate IGRA test results) and a chest X-ray (or other imaging) without evidence of TB 
infection. 
LTBI must be reported as an AE and graded appropriately as described in the protocol. Follow-
up reports should be completed as per protocol requirement until such time as the LTBI resolves. 
Active TB or non-tuberculosis mycobacterium infection  
Study participants who develop active TB or NTMB infection during the study (conversion 
demonstrated by IGRA) must be withdrawn from the study. The study participant must be 
immediately permanently discontinued from study medication and a PEOT Visit must be 
scheduled as soon as possible, but no later than the next scheduled visit. Treatment for active TB 
or NTMB should be started immediately based on local guidelines. 
Confirmed active TB is always considered Serious Adverse Event. UCB’s process requires that 
these must be captured on an SAE report form and provided to the Sponsor in accordance with 
SAE reporting requirements. Follow-up reports should be completed as per protocol requirement 
until such time as the TB infection resolves. 
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LTBI, active TB or other NTMB identified during study 
During the study, study participants who develop evidence of LTBI, active TB or NTMB 
infection must immediately stop further administration of study medication and will be referred 
to an appropriate TB specialist (pulmonologist or infectious disease specialist) for further 
evaluation. Study participants diagnosed with active TB or LTBI should receive appropriate TB 
or prophylaxis therapy. The study participant should be transferred to the care of their Physician 
and managed according to the standard of care.  
If infection with NTMB is identified during the study, the same procedure as for active TB 
acquired during the study and compliant TB treatment shall be followed.  
Follow-up information of suspected and confirmed TB cases should be provided to UCB at least 
after 3, 9, and 12 months of the start date of anti TB treatment, including hematological and 
biochemical safety parameters, X-ray evolution data, and TB diagnostic procedures used to 
follow-up and confirm recovery of TB. 
8.3 
Adverse events and serious adverse events 
The definitions of an AE or SAE can be found in Appendix 3 (Section 10.3). The definitions of 
device-related safety events, (adverse device effects [ADEs] and serious adverse device effects 
[SADEs]), can be found in Appendix 8 (Section 10.8). Device deficiencies are addressed in 
Appendix 8 (Section 10.8). 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally authorized representative).  
The Investigator and any designees are responsible for detecting, documenting, and recording 
events that meet the definition of an AE or SAE and remain responsible for following up AEs 
that are serious, considered related to the study treatment or study procedures, or that caused the 
participant to discontinue study treatment or MG0007 (see Section 7). 
8.3.1 
Time period and frequency for collecting AE and SAE information 
All SAEs will be collected from the signing of the ICF until the EOS visit at the time points 
specified in the Schedule of Activities (Section 1.3). 
All AEs will be collected from the signing of the ICF until the EOS visit at the time points 
specified in the Schedule of Activities (Section 1.3). 
In order to ensure complete safety data collection, all AEs occurring during the study (ie, after 
the signing of the ICF), including any pretreatment and posttreatment periods required by the 
protocol, must be reported in the eCRF even if no study medication was taken but specific study 
procedures were conducted. This includes all AEs not present prior to the initial visit and all AEs 
that recurred or worsened after the initial visit. 
All SAEs will be recorded and reported to the Sponsor or designee within 24 hours, as indicated 
in Appendix 3. The Investigator will submit any updated SAE data to the Sponsor within 
24 hours of it being available. 
The Investigator is specifically requested to collect and report to UCB (or its representative) any 
SAEs (even if the Investigator is certain that they are in no way associated with the study 
medication), up to 30 days from the end of the study for each participant, and to also inform 
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participants of the need to inform the Investigator of any SAE within this period. Serious AEs 
that the Investigator thinks may be associated with the study medication must be reported to 
UCB regardless of the time between the event and the end of the study. 
The method of recording, evaluating, and assessing causality of AE and SAE and the procedures 
for completing and transmitting SAE reports are provided in Appendix 3 (Section 10.3). 
8.3.2 
Method of detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.  
8.3.3 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the Investigator is required to proactively follow each 
participant at subsequent visits/contacts. All SAEs, and non-serious AEs of special interest 
(AESI) or adverse events of special monitoring (AESM) (as defined in Section 8.3.6 and 
Section 8.3.7, respectively), will be followed until resolution, stabilization, the Investigator 
determines that it is no longer clinically significant, the event is otherwise explained, or the 
participant is lost to follow-up (as defined in Section 7.3). Further information on follow-up 
procedures is given in Appendix 3 (Section 10.3). 
8.3.4 
Regulatory reporting requirements for SAEs 
Prompt notification (24 hours) by the Investigator to the Sponsor of a SAE is essential so that 
legal obligations and ethical responsibilities towards the safety of participants and the safety of a 
study treatment under clinical investigation are met.  
The Sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study treatment under clinical investigation. The 
Sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, Institutional Review Boards (IRB)/Independent Ethics Committees 
(IEC), and investigators. 
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
(SUSAR) according to local regulatory requirements and Sponsor policy and forwarded to 
investigators as necessary. 
An Investigator who receives an investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements. 
8.3.5 
Pregnancy 
Details of all pregnancies in female participants and, if indicated, female partners of male 
participants will be collected after the start of study treatment and until 90 days after the last 
dose. 
If a pregnancy is reported, the Investigator must immediately inform the Sponsor within 24 hours 
of learning of the pregnancy and should follow the procedures outlined in Appendix 4 
(Section 10.4). 
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The participant should be withdrawn from the study as soon as pregnancy is known (by positive 
pregnancy test), and the following should be completed: 
• The participant should return for an early discontinuation (PEOT) visit. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs. 
8.3.6 
Adverse events of special interest 
An AESI is any AE that a regulatory authority has mandated be reported on an expedited basis, 
regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a 
UCB product/compound. For rozanolixizumab, the following events require immediate reporting 
(within 24 hours regardless of seriousness) to UCB: 
• Hy’s Law 
− Potential Hy’s Law, defined as >3xULN ALT or AST with coexisting >2xULN total 
bilirubin in the absence of <2xULN ALP, with no alternative explanation for the 
biochemical abnormality (ie, without waiting for any additional etiologic investigations 
to have been concluded). Follow-up information should be reported if an alternative 
etiology is identified during investigation and monitoring of the participant. 
All AESIs will follow the SAE recording and reporting procedures as indicated in Appendix 3 
(Section 10.3). 
8.3.7 
Adverse events of special monitoring 
An AE of special monitoring (AESM) is a product-specific AE, adverse reaction, or safety topic 
requiring special monitoring by UCB. 
For rozanolixizumab, the following events require immediate reporting (within 24 hours 
regardless of seriousness) to UCB: 
• Severe and/or serious headache 
• Suspected aseptic meningitis 
Procedures for the management of AESM are provided in Appendix 14 (Section 10.14).  
Although infections and infusion-related reactions as well as hypersensitivity reactions or 
anaphylaxis are not classified as AESM, these AEs will be monitored by the Investigator. If such 
an event is suspected it should be managed according to the guidance provided in Appendix 13 
(Section 10.13). In case of suspected anaphylaxis, the Sampson’s Criteria (Sampson et al, 2006) 
in Appendix 15 (Section 10.15) should be completed. 
All AESM will follow the SAE recording and reporting procedures as indicated in Appendix 3 
(Section 10.3). 
8.3.8 
Treatment-emergent adverse events 
Treatment-emergent AEs are defined as AEs starting after the time of first IMP administration up 
to and including 8 weeks after the final dose. 
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8.4 
Safety signal detection 
Selected data from this study will be reviewed periodically to detect as early as possible any 
safety concern(s) related to the study medication so that investigators, clinical study participants, 
regulatory authorities, and IRBs/IECs will be informed appropriately and as early as possible. 
In addition, an IDMC will periodically review and monitor safety data from this study and advise 
UCB. Details are provided in the IDMC Charter. 
The Study Physician or medically qualified designee/equivalent will conduct an ongoing review 
of SAEs and perform ongoing SAE reconciliations in collaboration with the Patient Safety 
representative. 
As appropriate for the stage of development and accumulated experience with the study 
medication, medically qualified personnel at UCB may identify additional safety measures 
(eg, AEs, vital signs, laboratory or ECG results) for which data will be periodically reviewed 
during the course of the study. 
8.5 
Treatment of overdose 
For this study, any dose of increase of 10% greater than the assigned dose for each administered 
dose of IMP will be considered an overdose, irrespective of the weight tier band. Overdose 
events are only considered AEs or SAEs if there are associated clinical signs and symptoms or if 
the act of taking the excess IMP itself is an AE or SAE (eg, suicide attempt). 
UCB does not recommend specific treatment for an overdose. 
In the event of an overdose, the Investigator or treating Physician should: 
1. Contact the Medical Monitor immediately. 
2. Closely monitor the participant for any AE/SAE and laboratory abnormalities for at least 5 
days. 
3. Obtain a plasma sample for PK analysis within 3 days from the date of the last dose of study 
treatment if requested by the Medical Monitor (determined on a case-by-case basis). 
4. Document the quantity of the excess dose as well as the duration of the overdose in the 
eCRF. 
Decisions regarding dose interruptions or modifications will be made by the Investigator in 
consultation with the Medical Monitor based on the clinical evaluation of the participant. 
8.6 
Pharmacokinetics and antidrug antibodies 
Whole blood samples will be collected for measurement of plasma concentrations of 
rozanolixizumab and ADA as specified in the Schedule of Activities (Section 1.3). Blood 
samples may be collected at additional time points during the study if warranted and agreed upon 
between the Investigator and the Sponsor. Instructions for the collection and handling of 
biological samples will be provided in the laboratory manual for this study. The actual date and 
time (24-hour clock time) of each sample will be recorded. 
Samples will be used to evaluate the PK of rozanolixizumab and ADA and may be used for 
establishing assay parameters (eg, ADA cut point setting and PK selectivity assessment). 
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Samples collected for analyses of rozanolixizumab concentration and ADA may also be used to 
evaluate safety or efficacy aspects related to concerns arising during or after the study. 
Participant confidentiality will be maintained. At visits during which only plasma samples for the 
determination of concentration of rozanolixizumab will be taken, 1 sample of sufficient volume 
can be used. 
Any changes in the timing or addition of time points for any planned study assessments must be 
documented and approved by the relevant study team member and then archived in the UCB and 
site study files but will not constitute a protocol amendment. The IRB/IEC will be informed of 
any safety issues that require alteration of the safety monitoring scheme or amendment of the 
ICF. 
8.7 
Genetics 
Genetics are not evaluated in this study. 
8.8 
Pharmacodynamics 
Venous blood samples will be collected at time points specified in the Schedule of Activities 
(Section 1.3) for measurement of: 
• Serum IgG and IgG sub-classes concentrations 
• Serum MG-specific autoantibodies (anti-MuSK/anti-AChR) levels  
For all PD assessments, blood samples will be collected predose. Instructions pertaining to 
sample collection, processing, storage, labeling, and shipping are provided in the laboratory 
manual for this study. 
8.9 
Biomarkers 
Collection of samples for exploratory safety biomarker research is part of this study. Baseline 
values from MG0003 will serve as the Baseline value for MG0007. Safety samples must be 
collected 4 hours after the onset of the event, or otherwise as soon as possible within 72 hours 
after the onset of the event in case of AESM of severe and/or serious headache or suspected 
aseptic meningitis.  
If not used immediately, these samples will be stored at -80°C for up to 20 years for later 
exploratory analyses. Any exploratory biomarker will only ever be related to the exploration of 
cause, progression, and appropriate treatment of MG. They may also be used to develop 
tests/assays including diagnostic tests related to rozanolixizumab and/or FcRn inhibitor and MG. 
The nature and format of these tentative additional analyses will be determined at a later time. 
Details on the collection, storage, preparation, and shipping of samples will be presented in the 
laboratory manual provided separately. Instructions pertaining to sample collection, processing, 
storage, labeling, and shipping are provided in the laboratory manual for this study. Detailed 
information on sample analyses will be provided in a bioanalytical report. 
8.9.1 
Immunological assessments  
Blood samples for immunological testing are required and will be collected from all study 
participants in this study as specified in the Schedule of Activities (Section 1.3) for the 
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measurement of 
 and 
 
. All samples should be collected predose.  
For 
 and 
 Baseline values from 
MG0003 will serve as the Baseline value for MG0007. Additional samples should be collected 2 
hours and 4 hours postevent for study participants who experience infusion reaction or 
hypersensitivity reaction at the site. In case the event happens at home, additional samples should 
be collected as soon as possible, but prior to the next dosing as specified in the Schedule of 
Activities (Section 1.3). 
Instructions pertaining to sample collection, processing, storage, labeling, and shipping are 
provided in the laboratory manual for this study. 
8.10 
Medical resource utilization and health economics 
Medical resource utilization and health economics will be measured for this study. 
9 
STATISTICAL CONSIDERATIONS 
A description of statistical methods follows and will be described in more detail in the Statistical 
Analysis Plan (SAP). 
9.1 
Definition of analysis sets 
The definition of analyses sets are as follows:  
• The Enrolled Set: All study participants who have signed the ICF. 
• Full Analysis Set (FAS): All enrolled study participants who were randomized in this study 
or in MG0004. Study participants enrolling from MG0004 will utilize their last assigned dose 
level from MG0004 as their planned dose in MG0007. 
• Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. 
9.2 
General statistical considerations 
Statistical evaluation will be performed by the Sponsor or designee and supervised by the 
Exploratory Statistics Department of UCB. For safety analyses, data will be summarized by dose 
levels of rozanolixizumab at the time of the event or measurement. For efficacy, data will be 
summarized by the dose first received in the study. Additionally, efficacy data will be 
summarized by dose levels of rozanolixizumab received in each treatment cycle. 
All analyses will be performed using Statistical Analysis System (SAS®) version 9.3 or later 
(SAS Institute, Cary, NC, USA). Continuous variables will be summarized by visit (where 
applicable) with the statistics including the number of study participants (n), mean, standard 
deviation (SD), median, minimum, and maximum. Categorical variables will be summarized by 
visit (where applicable) with frequency counts and percentages. 
If not otherwise stated, Baseline values will be the last available predose value, or in the case of 
analyses done by 6-week treatment cycle, Baseline will be defined as the Baseline (Day 1) value 
for that cycle. This will be clearly defined in the SAP. All relevant data will be listed by 
treatment group and study participant.  
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9.2.1 
Intercurrent event handling rationale and impact on the study 
In MG0007, every study participant, except those coming from MG0004, will start with an initial 
fixed mandatory cycle. Prior to dosing in the initial fixed treatment cycle, the study participant 
will be assessed for MG worsening (eg, an increase of 2.0 points on the MG-ADL or 3.0 points 
on the QMG scale). The study participant will be initially randomized to rozanolixizumab 
equivalent to approximately 7mg/kg or 10mg/kg weekly (QW). After the first treatment cycle, 
dose adjustments may be applied at the start of each treatment cycle based on Investigator's 
discretion. Dose adjustments may not be applied during a treatment cycle. 
For the assessment of safety and tolerability, adverse events (AEs) recorded up to 8 weeks after 
the last sc infusion will be utilized for main analyses, regardless of study participants receiving 
treatment with rescue therapy. 
For the analyses of efficacy endpoints, the intercurrent events to be considered are the use of 
rescue therapy prior to Day 43 and permanent treatment discontinuation (or withdrawal from 
study) due to TEAEs. Efficacy endpoints will be summarized in line with a treatment policy 
approach. With this approach, rozanolixizumab results will be analyzed regardless of study 
participants receiving treatment with rescue therapy. Summaries will also be presented for the 
efficacy endpoints where participants will be censored at the time that they take rescue 
medication. 
Missing values will not be imputed. 
9.3 
Planned safety analyses 
9.3.1 
Analysis of the primary safety endpoint 
The frequency and severity of all TEAEs will be presented for each treatment group separately 
and overall by System Organ Class, high level term, and preferred term (Medical Dictionary for 
Regulatory Activities [MedDRA®]). The data will be displayed as number of participants 
experiencing the TEAE, percentage of participants, and number of TEAEs. All safety analyses 
will be based on the SS (Section 9.1). 
For each cycle, a TEAE is defined as any event that was not present prior to the first 
administration of rozanolixizumab or any unresolved event already present before the first 
administration of rozanolixizumab that worsens in intensity following exposure to treatment up 
to and including 8 weeks after the last dose of each treatment cycle. Adverse events occurring 
after the 8-week TEAE period, prior to the next cycle, will be defined as intermittent period AEs. 
Any AEs that occurred during the study will be defined as “any AE”. 
The occurrence of TEAEs and TEAEs leading to withdrawal of IMP will be summarized for the 
entire study by dose at AE onset. This will include all TEAEs that occurred during and between 
treatment cycles.  
These analyses will display the TEAEs (including any TEAEs occurring up to 1 week after the 
last infusion) and intermittent period AEs separately. For intermittent period AEs, the summaries 
will be displayed as “Off-treatment”. 
Further analyses will be described in the SAP. 
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9.3.2 
Other safety analyses 
The occurrence of serious TEAEs and occurrence of treatment-emergent AESM will be 
summarized using the same approach as for the primary endpoints.  
Laboratory evaluations and vital signs as well as ECG data will be analyzed over time. All safety 
analyses will be listed and summarized for the SS. 
9.4 
Planned efficacy and other analyses 
9.4.1 
Efficacy analyses 
The main efficacy endpoint is the "Change from Baseline (Day 1) to Day 43 in MG-ADL score," 
for each of the first three 6-week treatment cycles where the Baseline of the respective cycle will 
be used as reference. 
The summaries will be provided overall and by randomized treatment in-line with a treatment 
policy approach. Observed results will be presented for the different cycles (1 to n) regardless of 
the first cycle being mandatory or not. Missing values will not be imputed. Further summaries 
will be presented by the treatment received in each cycle. 
The other secondary efficacy endpoints, Change from Baseline (Day 1) to Day 43 in QMG score, 
Change from Baseline (Day 1) to Day 43 in MG-C score, Change from Baseline (Day 1) to Day 
43 in MG Symptoms PRO ‘Muscle Weakness Fatigability’ score, Change from Baseline (Day 1) 
to Day 43 in MG Symptoms PRO ‘Physical Fatigue’ score, and Change from Baseline (Day 1) to 
Day 43 in MG Symptoms PRO ‘Bulbar symptoms’ score, will be analyzed in the same way as 
the main secondary endpoint based on the MG-ADL. 
Time to MG-ADL response (≥2.0-point improvement from Baseline [Day 1]) for each treatment 
cycle will be summarized using time-to-event methodology (Kaplan Meier).  
The time between consecutive treatment cycles will be summarized in order to provide 
information on how long the effect of rozanolixizumab lasts, ie, how long it will take to 
introduce a new cycle. 
The number and percentage of participants achieving Minimal Symptom Expression (MG-ADL 
score of 0 or 1) at any time during the Treatment and Observation Periods will be summarized by 
cycle and by dose administration in that cycle.  
Additionally, the number of treatment cycles will be summarized by treatment group. 
Further summaries will be described in the SAP. 
9.4.2 
Other analyses  
9.4.2.1 
Pharmacokinetic analyses 
Plasma concentration data of rozanolixizumab will be summarized by dose arm for each cycle, 
and time point using the number of available observations, mean, median, SD, minimum, 
maximum, geometric mean (and associated 95% confidence intervals), and geometric coefficient 
of variation (assuming log-normally distributed data) for the SS. Values below the lower limit of 
quantification (LLOQ) will be reported with a clear sign indicating that they were below the 
LLOQ. Descriptive statistics of concentrations will be calculated if at least two thirds of the 
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individual data points are quantifiable (≥LLOQ). Individual and mean concentrations of 
rozanolixizumab may be displayed graphically. 
Plasma concentration data of rozanolixizumab may be subjected to population pharmacokinetic 
analysis to derive population estimates of PK parameters and test the effect of various covariates 
such as anti-drug antibodies, age, weight, gender. Details of the analysis will be described in a 
separate Data Analysis Plan (DAP). This analysis may be performed by combining the data from 
the current study with data from other rozanolixizumab studies if deemed appropriate. The 
results of the population PK analysis will not be reported in the clinical study report (CSR) but in 
a separate modelling report. 
9.4.2.2 
Pharmacodynamic analyses 
For all other endpoints relating to PD endpoints, descriptive statistics for the value, change from 
Baseline, and percentage change from Baseline will be tabulated by dose arm, and time point for 
the SS for each cycle. The PD endpoints will include serum total IgG, IgG subclass levels, and 
anti-MuSK and -AChR autoantibodies. 
For the analysis of the IgG data, in case rescue therapies are taken, only the data up to the start 
date of rescue therapy will be utilized for the summary tables. Listings will contain all IgG data 
and the measurements of study participants, which have been excluded from the summary tables. 
In cases where a study participant drops out, no missing value imputation will be performed for 
the IgG. Absolute and relative IgG reduction for a cycle will be calculated with the cycle 
Baseline value as reference. As for safety, the IgG reduction analyses will be compared between 
cycles. 
Population PD or population PK/PD analyses may be conducted for the PD variables of interest. 
Details of such PD or PK/PD analyses will be described in a separate DAP. The results of the 
analyses will not be reported in the CSR but in a separate report. 
9.4.2.3 
Immunological analyses 
For all endpoints relating to immunological assessments, descriptive statistics for the value, 
change from Baseline, and percentage change from Baseline will be tabulated by dose arm, and 
time point for the SS. The immunological assessments will include 
 
 Baseline values from 
MG0003 will serve as the Baseline value for MG0007. 
For complement where data has been collected post adverse event, individual patient data may 
be correlated with infusion reaction or hypersensitivity reaction.   
9.4.2.4 
Anti-drug antibodies analyses 
Samples will first be evaluated in the screening assay using a false positivity rate of 5% (reported 
as negative screen or positive screen), followed by analysis of screened positive samples in the 
confirmatory assay (which is a drug depletion assay) to confirm the true positivity of the samples 
(reported as negative immunodepletion or positive immunodepletion). Samples that are 
confirmed as positive will be evaluated in a titration assay to quantify the ADA level and will be 
reported as titer (reciprocal dilution factor including minimum required dilution). For ADA-
positive immunodepletion samples (or subset of), further characterization for neutralizing ADA 
potential in vitro will be performed. 
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The ADA sample status will be summarized by time point for each cycle. Changes from Baseline 
in sample status in terms of participant ADA classification will be summarized to inform on the 
incidence and emergency of ADA positivity. Graphical summaries may also be presented. 
Associations between ADA and PK, PD, efficacy and safety endpoints may be explored if 
warranted. Full details will be provided in the SAP. 
9.5 
Handling of protocol deviations 
Important protocol deviations are identified as part of the data cleaning process in the Data 
Cleaning Plan (DCP). Ongoing data cleaning meetings will be held throughout the duration of 
the study. Objectives of these meetings include to review and update (if necessary) the important 
protocol deviations in the DCP. Furthermore, overall trends in protocol deviations will be 
discussed at the Data Evaluation Meeting. Through this ongoing data cleaning and evaluation 
process, all decisions regarding important protocol deviations are made on an ongoing basis. 
9.6 
Handling of dropouts or missing data 
All imputation of missing or partial dates for safety assessments, as well as handling missing 
efficacy data (where applicable), will be detailed in the SAP. 
9.7 
Planned interim analysis and data monitoring 
No formal interim analysis is planned for this study. 
An Independent Data Monitoring Committee (IDMC) will be established. The IDMC will 
oversee the safety of the study by reviewing safety and efficacy data at periodic data reviews to 
assess the benefit-risk of rozanolixizumab. The objectives and procedures for the IDMC will be 
detailed in the IDMC Charter. 
In addition, based on data cutoffs, safety and efficacy data for submission purposes will be 
summarized. 
9.8 
Determination of sample size 
No formal sample size calculation can be performed. All eligible study participants from 
MG0003, and MG0004 will be invited to participate in MG0007. It will be assumed that 
approximately 200 study participants will be enrolled into MG0007.  
The number of 200 study participants is assuming a drop-out rate from the lead-in study of 
approximately 15% (including participants who opt not to continue in MG0007). 
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10 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1 
Appendix 1: Regulatory, ethical, and study oversight 
considerations 
10.1.1 
Regulatory and ethical considerations 
The study will be conducted under the auspices of an IRB/IEC, as defined in local regulations, 
ICH-GCP, and in accordance with the ethical principles that have their origin in the Declaration 
of Helsinki. 
The Investigator/UCB will ensure that an appropriately constituted IRB/IEC that complies with 
the requirements of the current ICH-GCP version or applicable country-specific regulations will 
be responsible for the initial and continuing review and approval of the clinical study. Prior to 
initiation of the study, the Investigator/UCB will forward copies of the protocol, ICF, IB, 
Investigator’s curriculum vitae (if applicable), advertisement (if applicable), and all other 
participant-related documents to be used for the study to the IRB/IEC for its review and 
approval. 
Before initiating a study, the Investigator will have written and dated full approval from the 
responsible IRB/IEC for the protocol. 
The Investigator will also promptly report to the IRB/IEC all changes in the study, all 
unanticipated problems involving risks to participants or others, and any protocol deviations, to 
eliminate immediate hazards to participants. 
The Investigator will not make any changes in the study or study conduct without IRB/IEC 
approval, except where necessary to eliminate apparent immediate hazards to the participants. 
For minor changes to a previously approved protocol during the period covered by the original 
approval, it may be possible for the Investigator to obtain an expedited review by the IRB/IEC as 
allowed. 
As part of the IRB/IEC requirements for continuing review of approved studies, the Investigator 
will be responsible for submitting periodic progress reports to the IRB/IEC (based on IRB/IEC 
requirements), at intervals appropriate to the degree of participant risk involved, but no less than 
once per year. The Investigator should provide a final report to the IRB/IEC following study 
completion. 
UCB (or its representative) will communicate safety information to the appropriate regulatory 
authorities and all active investigators in accordance with applicable regulatory requirements. 
The appropriate IRB/IEC will also be informed by the Investigator or the Sponsor, as specified 
by the applicable regulatory requirements in each concerned country. Where applicable, 
Investigators are to provide the Sponsor (or its representative) with evidence of such IRB/IEC 
notification. 
10.1.2 
Financial disclosure 
Insurance coverage will be handled according to local requirements. 
Finance and insurance are addressed in the Investigator and/or CRO agreements, as applicable. 
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10.1.3 
Informed consent process 
Participant’s informed consent must be obtained and documented in accordance with local 
regulations, ICH-GCP requirements, and the ethical principles that have their origin in the 
principles of the Declaration of Helsinki. 
Prior to obtaining informed consent, information should be given in a language and at a level of 
complexity understandable to the participant in both oral and written form by the Investigator (or 
designee). Each participant will have the opportunity to discuss the study and its alternatives 
with the Investigator. 
Prior to participation in the study, the Informed Consent form should be signed and personally 
dated by the participant, or his/her legal representative, and by the person who conducted the 
informed consent discussion (Investigator or designee). The participant or his/her legal 
representative must receive a copy of the signed and dated Informed Consent form. As part of 
the consent process, each participant must consent to direct access to his/her medical records for 
study-related monitoring, auditing, IRB/IEC review, and regulatory inspection. For local 
regulations, see Appendix 8 (Section 10.8). 
If the Informed Consent form is amended during the study, the Investigator (or the Sponsor, if 
applicable) must follow all applicable regulatory requirements pertaining to the approval of the 
amended Informed Consent form by the IRB/IEC and use of the amended form. 
All studies conducted at centers in the United States must include the use of a Health Insurance 
Portability and Accountability Act Authorization form. 
The participant may withdraw his/her consent to participate in the study at any time. A 
participant is considered as enrolled in the study when he/she has signed the Informed Consent 
form. A CRF must not be started, nor may any study specific procedure be performed for a given 
participant, without having obtained his/her written consent to participate in the study. 
10.1.4 
Data protection 
UCB staff (or designee) will affirm and uphold the participant’s confidentiality. Throughout this 
study, all data forwarded to UCB (or designee) will be identified only by the participant number 
assigned at Screening. 
The Investigator agrees that representatives of UCB, its designee, representatives of the relevant 
IRB/IEC, or representatives of regulatory authorities will be allowed to review that portion of the 
participant’s primary medical records that directly concerns this study (including, but not limited 
to, laboratory test result reports, ECG reports, admission/discharge summaries for hospital 
admissions occurring during a participant’s study participation, and autopsy reports for deaths 
occurring during the study). 
The participant must be informed that his/her personal study-related data will be used by the 
Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.  
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the Sponsor, by 
appropriate IRB/IEC members, and by inspectors from regulatory authorities. 
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10.1.5 
Committees structure 
An IDMC will review the safety and tolerability data in this study in order to make 
recommendations for the Sponsor. 
An IDMC will be set up in line with the FDA regulatory requirements and EMA Guideline on 
IDMCs (EMEA/CHMP/EWP/5872/03 Corr, adopted 27/05/2005). The IDMC will consist of 
external experts who are independent from UCB and the clinical operations contract research 
organization, and have no conflict of interest related to the conduct or the outcomes of the study. 
10.1.6 
Data quality assurance 
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the Sponsor or designee electronically (eg, laboratory data). The Investigator is 
responsible for verifying that data entries are accurate and correct by physically or electronically 
signing the CRF.  
The Investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.  
The Investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source data documents.  
The Sponsor or designee is responsible for the data management of this study including quality 
checking of the data.  
Study monitors will perform ongoing source data verification, encompassing remote source data 
verification and source data review in accordance with applicable regulatory guidance. Source 
data verification is performed to confirm that data entered into the CRF by authorized site 
personnel are accurate, legible, contemporaneous, original, and attributable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements, including national and local 
regulations.  
All essential documents must be retained by the Investigator for the minimum retention period 
mandatory under the applicable local laws and regulations. The Investigator will contact UCB 
for authorization prior to the destruction of any study records or in the event of accidental loss or 
destruction of any study records. The Investigator will also notify UCB should he/she relocate or 
move the study-related files to a location other than that specified in the Sponsor’s trial master 
file. 
Quality tolerance limits will be established for the study using parameters related to patient 
safety reporting and reliability of study results. The parameters will be monitored throughout the 
study to identify systematic issues. Parameters used, parameter values, important deviations from 
the quality tolerance limits, and actions taken will be summarized in the clinical study report. 
10.1.6.1 
Case Report form completion 
The Investigator is responsible for prompt reporting of accurate, complete, and legible data in the 
CRFs and in all required reports.  
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Any change or correction to the CRF should be dated, initialed, and explained (if necessary) and 
should not obscure the original entry. Use of correction fluid is not permitted. 
Corrections made after the Investigator’s review and signature of the completed CRF will be 
resigned and dated by the Investigator. 
The Investigator should maintain a list of personnel authorized to enter data into the CRF.  
Detailed instructions will be provided in the CRF Completion Guidelines. 
The Investigator is responsible for prompt reporting of accurate, complete, and legible data in the 
electronic CRFs and in all required reports. 
Any change or correction to the CRF after saving must be accompanied by a reason for the 
change. 
Corrections made after the Investigator’s review and approval (by means of a 
password/electronic signature) will be reapproved by the Investigator. 
The Investigator should maintain a list of personnel authorized to enter data into the electronic 
CRF. 
Detailed instructions will be provided in the CRF Completion Guidelines. 
10.1.7 
Source documents 
All source documents must be accurate, clear, unambiguous, permanent, and capable of being 
audited. They should be made using some permanent form of recording (ink, typing, printing, 
optical disc). They should not be obscured by correction fluid or have temporary attachments 
(such as removable self-stick notes). Photocopies and/or printouts of eCRFs are not considered 
acceptable source documents.  
Source documents are original records in which raw data are first recorded. These may include 
hospital/clinic/general practitioner records, charts, diaries, x-rays, laboratory results, printouts, 
pharmacy records, care records, ECG or other printouts, completed scales, quality of life 
questionnaires, or video, for example. Source documents should be kept in a secure, limited 
access area. 
Source documents that are computer generated and stored electronically must be printed for 
review by the monitor (eg, ECG reports). Once printed, these copies should be signed and dated 
by the Investigator and become a permanent part of the participant’s source documents. The 
Investigator will facilitate the process for enabling the monitor to compare the content of the 
printout and the data stored in the computer to ensure all data are consistent. 
Electronic data records, such as Holter monitor records or electroencephalogram records, must 
be saved and stored as instructed by UCB (or designee). 
10.1.8 
Study and Site Closure 
The Sponsor designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
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The Investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or Investigator may include but are 
not limited to: 
• Failure of the Investigator to comply with the protocol, the requirements of the IRB/IEC or 
local health authorities, the Sponsor's procedures, or GCP guidelines 
• Inadequate recruitment of participants by the Investigator 
• Discontinuation of further study medication development 
10.1.9 
Publication Policy 
The results of this study may be published or presented at scientific meetings. If this is foreseen, 
the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. 
This allows the Sponsor to protect proprietary information and to provide comments.  
The Sponsor will comply with the requirements for publication of study results. In accordance 
with standard editorial and ethical practice, the Sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data. In this case, a 
coordinating Investigator will be designated by mutual agreement. 
Authorship will be determined by mutual agreement and in line with International Committee of 
Medical Journal Editors authorship requirements. 
 
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10.2 
Appendix 2: Clinical Laboratory Tests 
• The tests detailed in the table below will be performed by the central laboratory. 
• Local laboratory results are only required in the event that the central laboratory results 
are not available in time for either study treatment administration and/or response 
evaluation. If a local sample is required, it is important that the sample for central 
analysis is obtained at the same time. Additionally, if the local laboratory results are used 
to make either a study treatment decision or response evaluation, the results must be 
entered into the eCRF. 
• Protocol-specific requirements for inclusion or exclusion of participants are detailed in 
Section 5.1 and Section 5.2 of the protocol. 
• Additional tests may be performed at any time during the study as determined necessary 
by the Investigator or required by local regulations. 
Table 10-1: Protocol-Required Safety Laboratory Assessments 
Laboratory 
Assessments 
Parameters 
Hematology 
Platelet Count  
RBC Indices: 
MCV 
MCH 
%Reticulocytes 
WBC Count with 
Differential: 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
RBC Count 
Hemoglobin 
Hematocrit 
Clinical 
Chemistrya 
Blood Urea 
Nitrogen 
(BUN) 
Potassium 
Aspartate Aminotransferase 
(AST)/ Serum Glutamic-
Oxaloacetic Transaminase 
(SGOT) 
Total and 
direct bilirubin 
 
Creatinine 
Sodium 
Alanine Aminotransferase 
 (ALT)/ Serum Glutamic-
Pyruvic Transaminase (SGPT) 
Total Protein 
Albumin 
 
Glucose 
(fasting state, 
preferred) 
Calcium 
Alkaline phosphatase 
C-reactive 
protein (CRP) 
Lactate 
dehydrogenase 
(LDH) 
Triglycerides  Low-density lipoprotein 
(LDL) 
High-density lipoprotein 
(HDL) 
Total 
Cholesterol 
Routine 
Urinalysis 
• 
Specific gravity 
• 
pH, glucose, protein, blood, ketones, albumin, bilirubin, urobilinogen, 
nitrite, leukocyte esterase by dipstick, albumin/creatinine ratio, creatinine  
• 
Microscopic examination (if blood or protein is abnormal) 
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Laboratory 
Assessments 
Parameters 
Other Screening 
Tests 
• 
Follicle-stimulating hormone and estradiol (as needed in women of 
non-childbearing potential only) 
• 
Urine drug screen (to include at minimum: amphetamines, barbiturates, 
cocaine, opiates, cannabinoids and benzodiazepines) 
• 
Serum or urine human chorionic gonadotropin pregnancy test (as needed 
for women of childbearing potential)b 
• 
PTT and INR 
• 
Serology testing (for Hepatitis B, Hepatitis C, and HIV) 
• 
All study-required laboratory assessments will be performed by a central 
laboratory.  
The results of each test must be entered into the eCRF. 
NOTES: 
For additional assessments that may be required in case of AESM, see Table 1-6. 
a Details of liver chemistry stopping criteria and required actions and follow-up assessments after liver 
stopping or monitoring event are given in Section 7.1.1 and Appendix 6 (Section 10.6). All events of 
ALT 3 × upper limit of normal (ULN) and bilirubin 2 × ULN (>35% direct bilirubin) or ALT 3 × 
ULN and international normalized ratio (INR) >1.5, if INR measured, may indicate severe liver injury 
(possible Hy’s Law) and must be reported as an SAE (excluding studies of hepatic impairment or 
cirrhosis). 
b Local urine testing will be standard for the protocol unless serum testing is required by local 
regulation or IRB/IEC. 
Investigators must document their review of each laboratory safety report. 
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10.3 
Appendix 3: Adverse Events – Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting 
Definition of AE 
AE Definition 
• 
An AE is any untoward medical occurrence in a patient or clinical study participant, 
temporally associated with the use of study medication, whether or not considered related 
to the study medication. 
• 
NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study medication. 
 
Events Meeting the AE Definition  
• 
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the medical 
and scientific judgment of the Investigator (ie, not related to progression of underlying 
disease). 
• 
Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• 
New conditions detected or diagnosed after study medication administration even though 
it may have been present before the start of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
medication or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming 
intent. Such overdoses should be reported regardless of sequelae. 
• 
"Lack of efficacy" or "failure of expected pharmacological action" per se will not be 
reported as an AE or SAE. Such instances will be captured in the efficacy assessments. 
However, the signs, symptoms, and/or clinical sequelae resulting from lack of efficacy 
will be reported as AE or SAE if they fulfil the definition of an AE or SAE.  
• 
The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will be 
reported as AE or SAE if they fulfil the definition of an AE or SAE. Also, "lack of 
efficacy" or "failure of expected pharmacological action" also constitutes an AE or SAE. 
 
Events NOT Meeting the AE Definition  
• 
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
Investigator to be more severe than expected for the participant’s condition. 
• 
The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the study 
participant’s condition. 
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• 
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to 
the procedure is the AE. 
• 
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• 
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen. 
Definition of SAE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met (eg, hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease). 
A SAE is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant 
was at risk of death at the time of the event. It does not refer to an event, which hypothetically 
might have caused death, if it were more severe. 
c. Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (usually involving at 
least an overnight stay) at the hospital or emergency ward for observation and/or treatment that 
would not have been appropriate in the Physician’s office or outpatient setting. Complications 
that occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfills 
any other serious criteria, the event is serious. When in doubt as to whether “hospitalization” 
occurred or was necessary, the AE should be considered serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen from 
baseline is not considered an AE. 
d. Results in persistent disability/incapacity 
• 
The term disability means a substantial disruption of a person’s ability to conduct normal 
life functions. 
• 
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and 
accidental trauma (eg, sprained ankle) which may interfere with or prevent everyday life 
functions but do not constitute a substantial disruption. 
e. Is a congenital anomaly/birth defect 
f. Important medical events: 
• 
Medical or scientific judgment should be exercised in deciding whether SAE reporting is 
appropriate in other situations such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize the 
participant or may require medical or surgical intervention to prevent one of the other 
outcomes listed in the above definition. These events should usually be considered 
serious. 
• 
Examples of such events include, but are not limited to, potential Hy’s law, invasive or 
malignant cancers, intensive treatment in an emergency room or at home for allergic 
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bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, or 
development of drug dependency or drug abuse. 
Recording and Follow-Up of AE and/or SAE 
AE and SAE Recording 
• 
When an AE/SAE occurs, it is the responsibility of the Investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostics reports) 
related to the event. 
• 
The Investigator will then record all relevant AE/SAE information in the CRF. 
• It is not acceptable for the Investigator to send photocopies of the participant’s 
medical records to UCB in lieu of completion of the UCB AE/SAE eCRF page. 
• 
There may be instances when copies of medical records for certain cases are requested by 
UCB. In this case, all participant identifiers, with the exception of the participant number, 
will be redacted on the copies of the medical records before submission to UCB. 
• 
The Investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE/SAE. 
Assessment of Intensity 
The Investigator will make an assessment of intensity for each AE and SAE reported during the 
study and assign it to 1 of the following categories:  
• 
Mild: An event that is easily tolerated by the participant, causing minimal discomfort and 
not interfering with everyday activities. 
• 
Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities. 
• 
Severe: An event that prevents normal everyday activities. An AE that is assessed as 
severe should not be confused with a SAE. Severe is a category utilized for rating the 
intensity of an event; and both AEs and SAEs can be assessed as severe. 
• 
An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe (eg, a severe AE 
may be either serious or not serious, depending on whether these criteria are also met). 
The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 
should be used as a supportive standardization instrument to evaluate AEs and SAEs but the final 
intensity grading by the Investigator must be mild, moderate, or severe.  
 
Assessment of Causality 
• 
The Investigator is obligated to assess the relationship between study medication and 
each occurrence of each AE/SAE. 
• 
A "reasonable possibility" of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
• 
The Investigator will use clinical judgment to determine the relationship. 
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• 
Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study medication 
administration will be considered and investigated. 
• 
The Investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment. 
• 
For each AE/SAE, the Investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality. 
• 
There may be situations in which an SAE has occurred and the Investigator has minimal 
information to include in the initial report to UCB. However, it is very important that 
the Investigator always make an assessment of causality for every event before the 
initial transmission of the SAE data to UCB. 
• 
The Investigator may change his/her opinion of causality in light of follow-up 
information and send a SAE follow-up report with the updated causality assessment. 
• 
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
 
Follow-up of AEs and SAEs 
• 
The Investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by UCB to 
elucidate the nature and/or causality of the AE or SAE as fully as possible. This may 
include additional laboratory tests or investigations, histopathological examinations, or 
consultation with other health care professionals. 
• 
An AE should be followed until it has resolved, has a stable sequelae, the Investigator 
determines that it is no longer clinically significant, the event is otherwise explained, or 
the participant is lost to follow up. This follow-up requirement applies to AEs, SAEs, and 
AEs of special interest. 
• 
If a participant dies during participation in the study or during a recognized follow-up 
period, the Investigator will provide UCB with a copy of any post-mortem findings 
including histopathology. 
• 
New or updated information will be recorded in the originally completed CRF. 
• 
The Investigator will submit any updated SAE data to the Sponsor within 24 hours of 
receipt of the information. 
Reporting of SAEs 
SAE Reporting to UCB via an Electronic Data Collection Tool 
• 
The primary mechanism for reporting an SAE to UCB will be the electronic data 
collection tool. 
• 
If the electronic system is unavailable for more than 24 hours, then the site will use the 
paper SAE data collection tool (see next section). 
• 
The site will enter the SAE data into the electronic system as soon as it becomes 
available. 
• 
After the study is completed at a given site, the electronic data collection tool will be 
taken off-line to prevent the entry of new data or changes to existing data. 
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• 
If a site receives a report of a new SAE from a study participant or receives updated data 
on a previously reported SAE after the electronic data collection tool has been taken off-
line, then the site can report this information on a paper SAE form (see next section). 
• 
Contacts for SAE reporting can be found in SERIOUS ADVERSE EVENT 
REPORTING. 
 
SAE Reporting to UCB via Paper CRF 
• 
Facsimile transmission of the SAE paper CRF is the preferred method to transmit this 
information to UCB. 
• 
In rare circumstances and in the absence of facsimile equipment, notification by 
telephone is acceptable with a copy of the SAE data collection tool sent by overnight 
mail or courier service. 
• 
Initial notification via telephone does not replace the need for the Investigator to 
complete and sign the SAE CRF pages within the designated reporting time frames. 
• 
Contacts for SAE reporting can be found in SERIOUS ADVERSE EVENT 
REPORTING. 
 
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10.4 
Appendix 4: Contraceptive Guidance and Collection of 
Pregnancy Information 
Definitions 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming post-menopausal unless 
permanently sterile (see below). 
Women in the following categories are not considered WOCBP: 
1. Premenarchal 
2. Premenopausal female with 1 of the following: 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
Note:  Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview. 
3. Postmenopausal female 
− A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal 
range may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormonal replacement therapy (HRT). However, in the absence of 12 
months of amenorrhea, a single FSH measurement is insufficient. 
− Females on HRT and whose menopausal status is in doubt will be required to use one of 
the non-estrogen hormonal highly effective contraception methods if they wish to 
continue their HRT during the study. Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before study enrollment. 
Contraception Guidance 
Female participants 
Female participants of childbearing potential are eligible to participate if they agree to use a 
highly effective method of contraception consistently and correctly as described in the table 
below. 
Highly Effective Contraceptive Methodsa 
Highly Effective Contraceptive Methods That Are User Dependentb 
Failure rate of <1% per year when used consistently and correctly.  
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of 
ovulationc  
• 
Oral  
• 
Intravaginal  
• 
Transdermal  
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Progestogen only hormonal contraception associated with inhibition of ovulation 
• 
Oral  
• 
Injectable  
Highly Effective Methods That Are User Independentc 
Implantable progestogen only hormonal contraception associated with inhibition of ovulation 
• 
Intrauterine device (IUD) 
• 
Intrauterine hormone-releasing system (IUS) 
• 
Bilateral tubal occlusion 
Vasectomized partner  
A vasectomy is a highly effective contraception method provided that the vasectomized partner is the sole 
male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional 
highly effective method of contraception should be used (eg, proper use of condom in combination with 
spermicide) 
Sexual abstinence  
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study medication. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual 
lifestyle of the participant.  
NOTES:  
a) In case of newly started contraception pills/IUDs, the investigator should consider the correct timing of 
starting/applying such methods in relation to the menstrual cycle and the manufacturing instruction as 
when these newly started methods would become effective. 
b) Typical use failure rates may differ from those when used consistently and correctly. Use should be 
consistent with local regulations regarding the use of contraceptive methods for participants participating 
in clinical studies.  
c) Hormonal contraception may be susceptible to interaction with the study medication, which may 
reduce the efficacy of the contraceptive method. In this case, two highly effective methods of 
contraception should be utilized during the treatment period and for at least 90 days after the last dose of 
study medication  
Pregnancy testing 
• WOCBP should only be included after a confirmed menstrual period and a negative highly 
sensitive urine pregnancy test. 
• Additional pregnancy testing should be performed during the Treatment Period (Section 1.3), 
at the EOS visit, corresponding to protocol-defined time frame in Section 10.4 after the last 
dose of study medication and as required locally. 
• Pregnancy testing will be performed whenever a menstrual cycle is missed or when 
pregnancy is otherwise suspected  
• Pregnancy testing, with a sensitivity of ≥25mIU/mL will be performed. Urine pregnancy tests 
will be performed at all other visits. 
Male participants with partners who become pregnant 
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• The Investigator will attempt to collect pregnancy information on any male participant’s 
female partner who becomes pregnant while the male participant is in this study. This applies 
only to male participants who receive study medication. If the study participant is later found 
to be on placebo, then pregnancy data collection can stop. 
• After obtaining the necessary signed informed consent from the pregnant female partner 
directly, the Investigator will record pregnancy information on the appropriate form and 
submit it to the Sponsor within 24 hours of learning of the partner’s pregnancy. The female 
partner will also be followed to determine the outcome of the pregnancy. Information on the 
status of the mother and child will be forwarded to the Sponsor. Generally, the follow-up will 
be at least 12 months after the delivery date. Any termination of the pregnancy will be 
reported regardless of fetal status (presence or absence of anomalies) or indication for the 
procedure. 
Female Participants who become pregnant 
• Any female participant who becomes pregnant while participating in the study will be 
withdrawn from the study.  
• The Investigator will collect pregnancy information on any female participant who becomes 
pregnant while participating in this study. Information will be recorded on the appropriate 
form and submitted to the Sponsor within 24 hours of learning of a participant's pregnancy. 
The participant will be followed to determine the outcome of the pregnancy. The Investigator 
will collect follow-up information on the participant and the neonate and the information will 
be forwarded to the Sponsor. Generally, the follow-up will be at least 12 months after the 
delivery date. Any termination of pregnancy will be reported, regardless of fetal status 
(presence or absence of anomalies) or indication for the procedure. 
• While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or 
elective termination of a pregnancy will be reported as an AE or SAE. A spontaneous 
abortion is always considered to be an SAE and will be reported as such. Any post-study 
pregnancy related SAE considered reasonably related to the study medication by the 
Investigator will be reported to the Sponsor as described in Section 8.3.5. While the 
Investigator is not obligated to actively seek this information in former study participants, he 
or she may learn of an SAE through spontaneous reporting.  
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10.5 
Appendix 5: Genetics 
Not applicable. 
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10.6 
Appendix 6: Liver Safety – Suggested Actions and Follow-up 
Assessments 
Participants with potential drug-induced liver injury must be assessed to determine if study 
medication must be discontinued. In addition, all concomitant medications and herbal 
supplements that are not medically necessary should also be discontinued. 
Investigators should attempt to obtain information on study participants in the case of study 
medication disconintuation to complete the final evaluation.  
Study participants with potential drug-induced liver injury should not be withdrawn from the 
study until investigation and monitoring are complete. All results of these evaluations and 
observations, as well as the reason(s) for study medication discontinuation and/or participant 
withdrawal (if applicable), must be recorded in the source documents. The CRF must document 
the primary reason for discontinuation of study medication.  
A specific monitoring plan must be agreed between the UCB Study Physician and the 
Investigator for study participants who have ALT >5 ULN. The monitoring plan should include 
any necessary follow-up assessments (until resolution of the abnormal lab values).  
Phase 3-4 liver chemistry stopping criteria are designed to assure participant safety and to 
evaluate liver event etiology. 
Phase 3-4 liver Chemistry Stopping Criteria and Follow-Up assessments  
Liver Chemistry Stopping Criteria 
ALT-absolute 
ALT 8xULN 
ALT Increase 
ALT 5xULN but <8xULN persists for 2 weeks 
ALT 3xULN but <5xULN persists for 4 weeks 
Bilirubina,b 
ALT 3xULN and bilirubin 2xULN (>35% direct bilirubin)  
INRb 
ALT 3xULN and INR >1.5, if INR measured 
Cannot 
Monitor 
ALT 5xULN but <8xULN and cannot be monitored weekly for 2 weeks 
ALT 3xULN but <5xULN and cannot be monitored weekly for 4 weeks 
Symptomaticc 
ALT 3xULN associated with symptoms (new or worsening) believed to be related 
to liver injury or hypersensitivity 
Suggested Actions and Follow up Assessments 
Actions 
Follow Up Assessments 
• 
Immediately discontinue study medication. 
• 
Report the event to the UCB within 24 hours. 
• 
Complete the liver event CRF, and complete an 
SAE data collection tool if the event also met 
the criteria for an SAE.b 
• 
Perform liver chemistry follow-up assessments.  
• 
Viral hepatitis serologyd 
• 
Obtain INR and recheck with each liver 
chemistry assessment until the 
transaminases values show downward trend 
• 
Only in those with underlying chronic 
hepatitis B at study entry (identified by 
positive hepatitis B surface antigen), 
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Liver Chemistry Stopping Criteria 
• 
Monitor the participant until liver chemistry 
test abnormalities resolve, stabilize, or return to 
baseline (see MONITORING). 
• 
Do not restart/rechallenge participant with 
study medication unless allowed per protocol 
and UCB approval is granted. 
• 
If restart/rechallenge not allowed per protocol 
or not granted, permanently discontinue study 
medication and continue participant in the 
study for any protocol specified follow up 
assessments.Consider the need for a toxicology 
screening. 
 
MONITORING: 
For bilirubin or INR criteria  
• 
Repeat liver chemistry tests (include ALT, 
AST, alkaline phosphatase, bilirubin) and 
perform liver event follow-up assessments 
within 24 hours. 
• 
Monitor participant twice weekly until liver 
chemistry test abnormalities resolve, stabilize, 
or return to baseline. 
• 
A specialist or hepatology consultation is 
recommended. 
For all other criteria  
• 
Repeat liver chemistry tests (include ALT, 
AST, alkaline phosphatase, bilirubin) and 
perform liver chemistry follow-up assessments 
within 24 to 72 hours. 
• 
Monitor participants weekly until liver 
chemistry abnormalities resolve, stabilize, or 
return to baseline. 
quantitative hepatitis B DNA and hepatitis 
delta antibodye 
• 
Obtain blood sample for pharmacokinetic 
(PK) analysis after the most recent dosef 
• 
Serum CPK and LDH 
• 
Fractionate bilirubin, if total bilirubin 
 2xULN 
• 
Obtain complete blood count with 
differential to assess eosinophilia 
• 
Record the appearance or worsening of 
clinical symptoms of liver injury (eg, 
fatigue, nausea, vomiting, right upper 
quadrant pain), or hypersensitivity, on the 
AE report form 
• 
Record use of concomitant medications 
(including acetaminophen, herbal remedies, 
and other over-the-counter medications) on 
the concomitant medications CRF. 
• 
Record alcohol use on the liver event 
alcohol intake CRF 
• 
Exclude pregnancy 
For bilirubin or INR criteria: 
• 
Antinuclear antibody, antismooth muscle 
antibody, Type 1 anti-liver kidney 
microsomal antibodies, and quantitative 
total IgG or gamma globulins. 
• 
 A serum acetaminophen adduct assay for 
assessing the potential acetaminophen 
contribution to liver injury in participants 
with definite or likely acetaminophen use in 
the preceding week. 
• 
Liver imaging (ultrasound, magnetic 
resonance, or computerizsed tomography) 
andor liver biopsy to evaluate liver disease; 
complete Liver Imaging and/or Liver 
Biopsy CRFs. 
AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CPK=creatine 
phosphokinase; CRF=case report form; DNA= deoxyribonucleic acid; HBcAb=hepatitis B core antibody; 
HBsAg= hepatitis B core antigen; Ig=immunoglobulin; INR=international normalized ratio; LDH=lactate 
dehydrogenase; PK=pharmacokinetic; SAE=serious adverse event; ULN=upper limit of normal 
a Serum bilirubin fractionation should be performed if testing is available. If serum bilirubin fractionation is not 
immediately available, discontinue study medication if ALT ≥3xULN and bilirubin ≥2xULN. Additionally, if 
serum bilirubin fractionation testing is unavailable, record the absence/presence of detectable urinary bilirubin 
on dipstick which is indicative of direct bilirubin elevations suggesting liver injury.  
b All events of ALT ≥3xULN and bilirubin ≥2xULN (>35% direct bilirubin) or ALT ≥3xULN and INR >1.5 may 
indicate severe liver injury (possible ‘Hy’s Law’) and must be reported as an SAE (excluding studies of 
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hepatic impairment or cirrhosis). The INR measurement is not required and the stated threshold value will not 
apply to participants receiving anticoagulants.  
c New or worsening symptoms believed to be related to liver injury (such as fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, or jaundice) or hypersensitivity (such as fever, rash, or eosinophilia). 
d Includes: Hepatitis A 
 antibody; HBsAg and HBcAb; hepatitis C RNA; cytomegalovirus 
 antibody; 
Epstein-Barr viral capsid antigen 
 antibody (or if unavailable, heterophile antibody, or monospot testing); and 
hepatitis E 
 antibody. 
e If hepatitis delta antibody assay cannot be performed,, it can be replaced with a PCR of hepatitis D RNA virus 
(where needed) (Le Gal, 2005). 
f Pharmacokinetic sample may not be required for participants known to be receiving placebo or non-comparator 
interventions. Record the date/time of the PK blood sample draw and the date/time of the last dose of study 
medication prior to the PK blood sample draw on the CRF. If the date or time of the last dose is unclear, provide 
the participant’s best approximation. If the date/time of the last dose cannot be approximated OR a PK sample 
cannot be collected in the time period indicated above, do not obtain a PK sample. Instructions for sample 
handling and shipping are in the Study Reference Manual. 
Phase 3-4 Liver Chemistry Increased Monitoring Criteria with Continued Study 
medication 
Liver Chemistry Increased Monitoring Criteria 
Criteria 
Actions 
ALT 5xULN and <8xULN and bilirubin 
<2xULN without symptoms believed to 
be related to liver injury or 
hypersensitivity, and who can be 
monitored weekly for 2 weeks. 
OR 
ALT 3xULN and <5xULN and bilirubin 
<2xULN without symptoms believed to 
be related to liver injury or 
hypersensitivity, and who can be 
monitored weekly for 4 weeks. 
 
• 
Notify the Sponsor Medical Monitor medical monitor 
within 24 hours of learning of the abnormality to 
discuss participant safety.  
• 
Participant can continue study medication 
• 
Participant must return weekly for repeat liver 
chemistry tests (ALT, AST, alkaline phosphatase, 
bilirubin) until the abnormalities resolve, stabilize, or 
return to baseline.  
• 
If at any time, the participant meets liver chemistry 
stopping criteria, proceed as described in 
Section 7.1.1. 
• 
If ALT decreases from ALT 5xULN and <8xULN to 
≥3xULN but <5xULN, continue to monitor liver 
chemistries weekly.  
• 
If, after 4 weeks of monitoring, ALT <3xULN and 
bilirubin <2xULN, monitor participants twice 
monthly until liver chemistry tests resolve, stabilize, 
or return to baseline. 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal 
 
 
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10.7 
Appendix 7: Rapid Alert Procedures 
Not applicable. 
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10.8 
Appendix 8: Country-specific Requirements 
Japan 
Specific requirements for study participants in Japan include: 
• In reference to Section 5.1, for study participants <20 years of age, written informed consent 
will be obtained from both the participant and the legal representative. 
• In reference to Section 5.3, the use of medicinal cannabidiols and medicinal marijuana are 
prohibited by law. 
• In reference to Section 8.2.6, TB assessment by IGRA; the preferred screening test is IGRA 
performed at a Central Laboratory by QuantiFERON tube test, or using a T-SPOT.TB test 
at each site. 
• The country-specific requirements for Japan aligned with Japan GCP will be provided 
separately in Protocol Exhibit. 
For medical devices used, locally approved devices are to be used during the study. If a pump 
and infusion set are used that are regarded in Japan as investigational devices, then additional 
adherence to specific reporting obligations will be required. All adverse device effects (ADEs), 
serious adverse device effects (SADEs), and medical device deficiency (including malfunction 
use error, and inadequate labeling) of these investigational devices shall be documented and 
reported by the Investigator throughout the study and appropriately managed by the Sponsor. 
This reporting requirement is not applicable for locally approved devices for the purpose of sc 
infusions or other purposes in the course of this study, regardless if provided by the sponsor or 
not. 
Furthermore, specific rules for repetition of an ADE and device deficiency should be followed 
by all study sites in Japan; this requirement is not applicable for locally approved devices, 
regardless if provided by the sponsor or not.  
For ADEs and/or device deficiencies that are not related to the natural course of the disease 
under study, an increase in the intensity of the original ADE, and/or device deficiency should 
lead to the repetition of the original ADE and/or device deficiency with the following guidelines: 
• The outcome date of the original ADE and/or device deficiency must be the same as the start 
date of the repeated ADE and/or device deficiency. 
• The outcome of the original ADE and/or device deficiency must be recorded as “worsening.” 
• The verbatim term for the repeated ADE and/or device deficiency must be the same as the 
verbatim term for the original ADE and/or device deficiency so that the repeated ADE and/or 
device deficiency is obviously a worsening of the original. 
As per local requirements in Japan, SAEs associated to an investigational device, and device 
deficiencies (eg, infusion pump product provided from Sponsor) should be reported in 
accordance with the following:  
This reporting requirement is not applicable for locally approved devices for the purpose of sc 
infusions or other purposes in the course of this study, regardless if provided by the Sponsor or 
not. 
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Medical Device – AEs, adverse device effects (ADEs), serious adverse events 
(SAEs) and device deficiencies  
Medical devices are being provided for use in this study subcutaneous infusions. In order to 
fulfill regulatory reporting obligations worldwide, the Investigator is responsible for the 
detection and documentation of events meeting the definitions of incident or malfunction that 
occur during the study with such devices.  
Adverse events will be reported according to the ISO 14155:2011, while recognizing and 
following requirements including reporting timelines specified in other specific laws, 
regulations, directives, standards and/or guidelines as appropriate and as required by the 
countries in which the clinical investigation is conducted.  
NOTE: Events fulfilling the definition of an AE/SAE will also follow the processes outlined in 
Section 8.3.3 and Appendix 3 (Section 10.3) of the protocol. 
Time period for detecting medical device deficiencies 
Medical device deficiency or malfunctions of the device that result a reportable event will be 
detected, documented, and reported during all periods of the study in which the medical device is 
used.  
If the Investigator learns of any deficiency at any time after a participant has been discharged 
from the study, and such event(s) is considered reasonably related to a medical device provided 
for the study, the Investigator will promptly notify the Sponsor. 
Follow-up of medical device deficiencies 
Follow-up applies to all study participants, including those who discontinue study medication 
and/or the study. 
The Investigator is responsible for ensuring that follow-up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the deficiency. 
New or updated information will be recorded on the originally completed form with all changes 
signed and dated by the Investigator. 
Prompt reporting of medical device deficiencies to Sponsor 
Device deficiencies will be reported to the Sponsor within 24 hours after the Investigator 
determines that the event meets the protocol definition of a medical device deficiency. 
The Adverse Event and Device Deficiency Report Form will be sent to the Sponsor by email. If 
email is unavailable, then fax should be utilized. 
The Sponsor will be the contact for the receipt of device deficiency reports. 
Regulatory reporting requirements for medical device deficiencies 
The Investigator will promptly report all device deficiencies occurring with any medical device 
provided for use in the study in order for the Sponsor to fulfill the legal responsibility to notify 
appropriate regulatory authorities and other entities about certain safety information relating to 
medical devices being used in clinical studies. 
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The Investigator, or responsible person according to local requirements (eg, the head of the 
medical institution), will comply with the applicable local regulatory requirements relating to the 
reporting of device deficiencies to the IRB/IEC. 
Medical Device AEs (ADEs, UADEs, SAEs, SADEs, and USADEs) and device 
deficiencies: Definition and procedures for recording, evaluating, follow-up, and 
reporting 
This reporting requirement is not applicable for approved devices for the purpose of sc infusions 
or other purposes in the course of this study, regardless if provided by the Sponsor or not. 
The definitions and procedures detailed in this appendix are in accordance with ISO 14155.  
Both the Investigator and the Sponsor will comply with all local medical device reporting 
requirements. 
The detection and documentation procedures described in this protocol apply to all Sponsor 
medical devices provided for use in the study.  
Definition of AE and ADE 
AE and ADE Definition  
• 
An AE is defined as any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory finding) in study participants, users, or 
other persons, whether or not related to the investigational medical device. This definition 
includes events related to the investigational medical device or comparator and events related 
to the procedures involved except for events in users or other persons, which only include 
events related to investigational devices. 
• 
An adverse device effect (ADE) is defined as an adverse event related to the use of an 
investigational medical device. This definition includes any adverse events resulting from 
insufficient or inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device as well as any event 
resulting from use error or from intentional misuse of the investigational medical device. 
Definition of SAE, SADE and USADE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease). 
An SAE is an AE that: 
a. Led to death  
b. Led to serious deterioration in the health of the participant, that either resulted in: 
1. A life-threatening illness or injury. The term ‘life-threatening' in the definition of serious' refers to 
an event in which the participant was at risk of death at the time of the event. It does not refer to an 
event, which hypothetically might have caused death, if it were more severe 
2. A permanent impairment of a body structure or a body function, 
3. Inpatient or prolonged hospitalization, Planned hospitalization for a pre-existing condition, or a 
procedure required by the protocol, without serious deterioration in health, is not considered an 
SAE 
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4. Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function 
c. Led to fetal distress, fetal death or a congenital abnormality or birth defect 
SADE definition 
• 
A SADE is defined as an adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
USADE definition 
• 
A USADE is a serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the risk analysis report (see 
Section 8.3.8). 
Definition of Device Deficiency 
Device Deficiency definition 
• 
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. Device deficiencies include malfunctions, use 
errors, and inadequate labeling. 
Recording and Follow-Up of AE and/or SAE and Device Deficiencies 
AE, SAE and Device Deficiency Recording 
• 
When an AE/SAE/device deficiency occurs, it is the responsibility of the Investigator to review 
all documentation (e.g., hospital progress notes, laboratory reports, and diagnostics reports) 
related to the event. 
• 
The Investigator will then record all relevant AE/SAE/device deficiency information in the 
participant’s medical records, in accordance with the Investigator’s normal clinical practice 
and on the appropriate form of the CRF. 
• 
It is not acceptable for the Investigator to send photocopies of the participant’s medical records 
to UCB in lieu of completion of the AE/SAE/device deficiency CRF page. 
• 
There may be instances when copies of medical records for certain cases are requested by 
UCB. In this case, all participant identifiers, with the exception of the participant number, will 
be redacted on the copies of the medical records before submission to UCB. 
• 
The Investigator will attempt to establish a diagnosis of the event based on signs, symptoms, 
and/or other clinical information. Whenever possible, the diagnosis (not the individual 
signs/symptoms) will be documented as the AE/SAE. 
• 
For device deficiencies, it is very important that the Investigator describes any corrective or 
remedial actions taken to prevent recurrence of the deficiency 
o A remedial action is any action other than routine maintenance or servicing of a 
medical device where such action is necessary to prevent recurrence of a device 
deficiency. This includes any amendment to the device design to prevent recurrence. 
The Investigator should complete a Product Complaint Form for all reported device 
deficiencies.  
Assessment of Intensity 
The Investigator will make an assessment of intensity for each AE/SAE/device deficiency reported 
during the study and assign it to one of the following categories:  
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• 
Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not 
interfering with everyday activities. 
• 
Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities. 
• 
Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with a SAE. Severe is a category utilized for rating the intensity of an 
event; and both AEs and SAEs can be assessed as severe. 
• 
An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe. 
 
Assessment of Causality 
• 
The Investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE/SAE/device deficiency 
• 
A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
• 
The Investigator will use clinical judgment to determine the relationship. 
• 
Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, 
as well as the temporal relationship of the event to study intervention administration will be 
considered and investigated. 
• 
The Investigator will also consult the IB in his/her assessment. 
• 
For each AE/SAE/device deficiency, the Investigator must document in the medical notes that 
he/she has reviewed the AE/SAE/device deficiency and has provided an assessment of 
causality. 
• 
There may be situations in which an SAE has occurred and the Investigator has minimal 
information to include in the initial report to UCB. However, it is very important that the 
Investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to UCB. 
• 
The Investigator may change his/her opinion of causality in light of follow-up information and 
send a SAE follow-up report with the updated causality assessment. 
• 
The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
 
Follow-up of AE/SAE/device deficiency 
• 
The Investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by UCB to elucidate 
the nature and/or causality of the AE/SAE/device deficiency as fully as possible. This may 
include additional laboratory tests or investigations, histopathological examinations, or 
consultation with other health care professionals. 
• 
If a participant dies during participation in the study or during a recognized follow-up period, 
the Investigator will provide UCB with a copy of any post-mortem findings including 
histopathology.  
• 
New or updated information will be recorded in the originally completed CRF. 
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• 
The Investigator will submit any updated SAE data to UCB within 24 hours of receipt of the 
information. 
Reporting of SAEs 
SAE Reporting to UCB via an Electronic Data Collection Tool 
• 
The primary mechanism for reporting an SAE to UCB will be the electronic data collection 
tool. 
• 
If the electronic system is unavailable, then the site will use the paper SAE data collection tool 
(see next section) in order to report the event within 24 hours. 
• 
The site will enter the SAE data into the electronic system as soon as it becomes available. 
• 
After the study is completed at a given site, the electronic data collection tool will be taken off-
line to prevent the entry of new data or changes to existing data. 
• 
If a site receives a report of a new SAE from a study participant or receives updated data on a 
previously reported SAE after the electronic data collection tool has been taken off-line, then 
the site can report this information on a paper SAE form (see next section) or to the Medical 
Monitor/SAE coordinator by telephone. 
• 
Contacts for SAE reporting can be found in this protocol. 
 
SAE Reporting to UCB via Paper CRF 
• 
Facsimile transmission of the SAE paper CRF is the preferred method to transmit this 
information to the UCB. 
• 
In rare circumstances and in the absence of facsimile equipment, notification by telephone is 
acceptable with a copy of the SAE data collection tool sent by overnight mail or courier 
service. 
• 
Initial notification via telephone does not replace the need for the Investigator to complete and 
sign the SAE CRF pages within the designated reporting time frames. 
• 
Contacts for SAE reporting can be found in this protocol. 
Reporting of SADEs 
SADE Reporting to UCB 
NOTE: There are additional reporting obligations for medical device deficiencies that are potentially 
related to SAEs that must fulfil the legal responsibility to notify appropriate regulatory authorities and 
other entities about certain safety information relating to medical devices being used in clinical studies.  
• 
Any device deficiency that is associated with an SAE must be reported to the Sponsor within 
24 hours after the Investigator determines that the event meets the definition of a device 
deficiency. 
• 
The Sponsor shall review all device deficiencies and determine and document in writing 
whether they could have led to an SAE. These shall be reported to the regulatory authorities 
and IRBs/IECs as required by national regulations. 
• 
Contacts for SAE reporting can be found in this protocol. 
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AE, ADE, SAE, SADE determination flow chart 
Note: Adverse event reporting for countries other than the USA and EU must follow the 
regulatory and ethical requirements for that country. 
 
 
 
Denmark 
In reference to Section 1.1 and Section 4.1, the managed access program will not be applicable, 
and the study duration for each study participant will be 14 months. 
France 
Specific requirements for study participants in France include 1 additional inclusion criterion and 
2 additional exclusion criterions, as listed below. 
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Inclusion Criteria (Section 5.1): 
6. Study participant must be registered at the Sécurité Sociale (French national health system) 
or be beneficiary of a similar system. 
Note: this criterion will be number 3 in the gap period inclusion criteria (Section 10.12).  
Exclusion Criteria (Section 5.2): 
18. Study participant is deprived of their liberty by a judicial or administrative decision, or is 
receiving psychiatric care under sections L3212-1 and L3213-1 who are not covered by 
section L1121-8, and study participant is admitted to a health or social institution (Article 
L1121-6 of the French Public Health Code). 
19. Study participant who is subject to legal protection or is unable to express consent (Article 
L1121-8 of the French Public Health Code). 
Note: these criterions will be number 42 and 43, respectively, in the gap period exclusion 
criteria (Section 10.12).  
UK 
Specific requirements for study participants in the UK include: 
• In reference to Section 1.1 and Section 4.1, the managed access program will not be 
applicable, and the study duration for each study participant will be 14 months. 
• In reference to Section 1.3, a second pregnancy test is scheduled at Day 29 during the 
treatment periods (Visit 6 in the initial fixed treatment cycle and Visit 5 in the subsequent 
treatment cycles). 
• In reference to Section 5.2, exclusion criterion #14a, if any of the repeated tests (ALT, AST, 
or ALP) are >3.0xULN, the study participant will automatically meet the exclusion criterion 
#12 and will not be eligible for participation in MG0007. 
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10.9 
Appendix 9: Abbreviations and Trademarks 
AChE 
acetylcholinesterase 
AChR 
acetylcholine receptor 
ADA 
anti-drug antibody 
ADE 
adverse device effect 
ADL 
activities of daily living 
ADR 
adverse drug reaction 
AE 
adverse event 
AESM 
adverse events of special monitoring 
AESI 
adverse event of special interest 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
ASADE 
anticipated serious adverse device effect 
AST 
aspartate aminotransferase 
BP 
blood pressure 
BUN 
blood urea nitrogen 
CI 
confidence interval 
CNS 
central nervous system 
COVID-19 
Coronavirus Disease 2019 
CPM 
Clinical Project Manager 
CPMP 
Committee for Proprietary Medicinal Products 
CRF 
Case Report form 
CRO 
contract research organization 
CSF 
cerebrospinal fluid 
C-SSRS 
Columbia Suicide Severity Rating Scale 
CTCAE 
Common Terminology Criteria for Adverse Events 
DAP 
Data Analysis Plan 
DCP 
Data Cleaning Plan 
DIAM 
drug-induced aseptic meningitis 
ECG 
electrocardiogram 
eCRF 
electronic Case Report form 
EMA/EMEA 
European Medicines Agency 
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EQ VAS 
EuroQol visual analogue scale  
FcRn 
neonatal Fc receptor 
FIH 
first in human 
EudraCT 
European Union Drug Regulating Authorities Clinical Trials 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GI 
gastrointestinal 
gMG 
generalized myasthenia gravis 
HBsAg 
Hepatitis B surface antigen 
HIV 
human immunodeficiency virus 
HRT 
hormonal replacement therapy 
IB 
Investigator’s Brochure 
IBD 
inflammatory bowel disease 
ICF 
Informed Consent form 
ICH 
International Council for Harmonisation 
IDMC 
Independent Data Monitoring Committee 
IEC 
Independent Ethics Committee 
Ig 
immunoglobulin 
IGRA 
interferon-gamma release assay 
IMP 
investigational medicinal product 
IND 
Investigational New Drug 
INR 
international normalized ratio 
IRB 
Institutional Review Board 
IRT 
interactive response technology 
 
 
iv 
intravenous 
IVIg 
intravenous immunoglobulin 
LDH 
lactate dehydrogenase 
LLOQ 
lower limit of quantification 
LS 
least squares 
LTBI 
latent tuberculosis infection 
MedDRA 
Medical Dictionary for Regulatory Activities 
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MG 
myasthenia gravis 
MG-ADL 
Myasthenia Gravis-Activities of Daily Living 
MG-C 
Myasthenia Gravis Composite 
MGFA 
Myasthenia Gravis Foundation of America 
MG-QOL15r 
Myasthenia Gravis Quality of Life 
MMRM 
mixed model for repeated measures 
MuSK 
muscle-specific kinase 
NMJ 
neuromuscular junction 
NTMBI 
nontuberculous mycobacterial infection 
OLE 
open-label extension 
PD 
pharmacodynamics(s) 
PDILI 
potential drug-induced liver injury 
PEF 
peak expiratory flow 
PEOT 
premature end of treatment 
PEX 
plasma exchange 
PK 
pharmacokinetic(s) 
PRO 
patient-reported outcome 
QMG 
quantitative myasthenia gravis 
SADE 
serious adverse device effect 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SOP 
Standard Operating Procedure 
SS 
Safety Set 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
UADE 
unanticipated adverse device effect 
ULN 
upper limit of normal 
USADE 
unanticipated serious adverse device effect 
 
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10.10 
Appendix 10: Protocol Amendment History 
Amendment 2 (30 Jun 2022) 
Overall Rationale for the Amendment  
The primary reason for this protocol amendment is to incorporate new wording on the options 
for the route of administration, changes specific to the schedule of activities, updates to the study 
medication permanent discontinuation criteria, as well as providing additional information on the 
benefit-risk for study participants who have received a full COVID-19 vaccination.  
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union. 
Section # and Name 
Description of Change 
Brief Rationale 
Global 
Minor administrative and 
formatting changes have been 
made. 
To provide clarity and remain 
consistent with remainder of 
protocol. 
1.1 Synopsis 
3 Objectives and endpoints 
The following other efficacy 
endpoint on MG-C responder rate 
has been amended; responder rate 
has changed from ≥5.0-point to 
≥3.0-point. 
Corrected. 
1.1 Synopsis 
3 Objectives and endpoints 
9.4.1 Efficacy analyses 
Other efficacy endpoint on 
minimal symptom expression has 
been amended to include the 
Treatment and Observation 
Periods in the time frame. 
Updated to provide clarity and 
remain consistent with the study 
design. 
1.1 Synopsis 
3 Objectives and endpoints 
Cross reference to Section 8.9 has 
been added to footnote b. 
Updated to provide clarity on 
which exploratory safety 
biomarkers may be assessed.   
1.1 Synopsis 
4.1 Overall design 
6.5.4 Rescue medication 
7.1.4 Study medication 
permanent discontinuation 
criteria 
Wording on participants who 
receive rescue therapy has been 
updated. 
Taking into account the efficacy 
and safety results from MG0003 
and MG0004, the permanent 
discontinuation criteria was 
updated to provide more 
flexibility to the investigators 
and adjust this criterion to the 
cyclic treatment regimen. 
1.2 Schema 
Updated to provide defined 
periods for the 22-week (6+16 
weeks) cycle. 
Updated to provide clarity and 
remain consistent with the study 
design. 
1.3 Schedule of activities,  
Table 1-2 
Visit 9 has been added to 
demographic and baseline 
characteristics.  
The following new activity has 
been added for Visits 1 and 9: 
Medical history update. 
Included as demographic and 
baseline data are required to be 
reviewed.  
Included as part of a 
requirement for open-label 
extension studies. 
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Section # and Name 
Description of Change 
Brief Rationale 
Study withdrawal: Visit every 4 
weeks during the no treatment 
with rozanolixizumab period has 
been added. 
Medical history has been 
removed.  
 
Previously missing from 
protocol amendment 1. 
 
 
Removed as any new conditions 
occurring after the screening 
visit of the lead-in study are 
recorded as AEs, not as medical 
history. 
1.3 Schedule of activities,  
Table 1-3 
Scheduled visits have been 
removed from the full physical 
activity, and additional visits have 
been added to brief physical 
activities 
Updated to match the correct 
procedures at sites. 
1.3 Schedule of activities,  
Table 1-2 
Footnote b: Updated to remove 
"minus (-)" from the visit 
window, and to include wording 
on the requirement to complete 
missing activities from the lead-in 
study. 
Footnote c: Updated to include 
“MG0003” in relation to study 
participants and “initial” in 
reference to the baseline 
timepoint. 
Footnote j: Updated to remove 
"until the study participants has 
been evaluated by a TB specialist" 
 
New footnote (l): Only applicable 
if study participant requires PEOT 
added to Visit 8. Subsequent 
footnotes have been reordered. 
New footnote (m): Required for 
study withdrawal or study 
completion visit (Section 4.4). 
Footnote q and s (previously o 
and q, respectively): timings of 
collecting additional samples have 
been updated. 
Updated to provide clarity and 
remain consistent with the study 
design. 
 
 
 
Updated for additional clarity 
and align with updates to the 
participant eCRF.  
 
 
Not applicable. Study participant 
would need to be positive, and 
therefore treatment would be 
terminated. 
Updated to remain consistent 
with the study design. 
 
 
Updated to remain consistent 
with the study design. 
 
Updated to remain consistent 
with the study design. 
1.3 Schedule of activities,  
Table 1-3(subsequent cycles) 
General medical history has been 
updated to medical history update. 
Updated to record conditions 
that were not captured during 
the course of the lead-in study, 
and not new conditions that 
initially occurred after the 
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Section # and Name 
Description of Change 
Brief Rationale 
screening visit of the lead-in 
study. 
1.3 Schedule of activities,  
Table 1-3(subsequent cycles) 
For call or enter IRT to register 
the visit, Visit 2 has been added 
and Visit 8 has been removed. 
An IRT call or entry must be 
registered at Visit 2 but is not 
required at Visit 8. 
1.3 Schedule of activities,  
Table 1-3(subsequent cycles) 
Body weight and associated 
footnote (g) have been added to 
the schedule of activities.  
Study withdrawal: Visit every 4 
weeks during the no treatment 
with rozanolixizumab period has 
been added. 
Study drug discontinuation 
criteria removed at Visit 1. 
Weight-based dose adjustments 
are limited to a maximum of 
every 6 months during the study.  
Previously missing from 
protocol amendment 1 
1.3 Schedule of activities,  
Table 1-3(subsequent cycles) 
For QMG scale, visits specific to 
treatment with no 
rozanolixizumab (every 12 
weeks) was updated to replace 
footnote "i" with "m". 
Updated to correct an error in 
protocol amendment 1. 
1.3 Schedule of activities,  
Table 1-3(subsequent cycles) 
Footnote b: Updated to remove 
"minus (-)" from the visit window  
Footnote f: Updated to remove 
"until the study participants has 
been evaluated by a TB specialist" 
To provide clarity and remain 
consistent with the study design. 
Not applicable. Study participant 
would need to be positive, and 
therefore treatment would be 
terminated. 
1.3 Schedule of activities,  
Table 1-3(subsequent cycles) 
New footnote (g): Weight-based 
dose adjustments are limited to a 
maximum of every 6 months has 
been added. Subsequent footnotes 
have been reordered. 
New footnote (h): In case of 
switching to manual push 
administration, for the first 2 
infusions vital signs will be 
measured prior to IMP 
administration, at the end of the 
infusion (±15 minutes), and 1 
hour after the end of the infusion 
(±15 minutes). For the subsequent 
infusions all assessments will be 
performed prior to any blood 
sampling and IMP administration.  
New footnote (i): Only applicable 
if study participant requires PEOT 
added to Visit 7.  
To provide clarity and remain 
consistent with the study design. 
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Section # and Name 
Description of Change 
Brief Rationale 
Footnote i and j, now l and m, 
respectively: timings of collecting 
additional samples has been 
updated.  
1.3 Schedule of activities,  
Table 1-4 (initial fixed cycle 
- study participants who 
receive full COVID-19 
vaccination before or during 
the study) 
Table title was updated to include 
"full". 
Footnote a: New footnote specific 
to define a full COVID-19 
vaccination. 
 
Footnote c: Update to the timing 
for collecting biomarker samples. 
Updated to provide clarity. 
 
Added to provide some guidance 
on a full COVID-19 vaccination 
is defined differently per country 
or region 
To remain consistent with the 
study design 
1.3 Schedule of activities,  
Table 1-5 (subsequent cycles 
- study participants who 
receive full COVID-19 
vaccination before or during 
the study) 
A new schedule of activities table 
has been included specific for 
study participants treated with 
subsequent cycles who receive 
full COVID-19 vaccination before 
or during the study. 
Included as part of the objective 
on 
 
 
 
 
2.3 Benefit/Risk assessment 
Additional wording specific to 
COVID-19 vaccine has been 
included. 
To provide information on the 
benefit-risk on participant who 
have received the COVID-19 
vaccination and remain 
consistent with the Phase 3 
rozanolixizumab clinical 
program. 
4.1 Overall design 
Wording on withheld IMP for low 
IgG in MG0004 and missed doses 
has been removed.  
Updated to remove duplicate 
wording. 
4.4 End of study definition 
Additional wording for the timing 
of completing an EOS visit at the 
time of product approval or the 
availability of a MAP has been 
added.  
Updated to provide clarity and 
remain consistent with the study 
design. 
6.1 Treatments administered 
Table 6-1: "via syringe driver or 
manual push method" has been 
added to the route of 
administration row. 
Additional wording on the options 
for route of administration have 
been added. 
To clarify the methods of IMP 
administration allowed in the 
study. 
6.8 Treatment after the End 
of the Study 
The following wording in 
reference to participants 
considered for additional 
treatment with prophylactic 
Updated to provide clarity and 
remain consistent with the study 
design. 
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Section # and Name 
Description of Change 
Brief Rationale 
antimicrobial therapy has been 
removed. 
7.1.3 Temporary IMP 
discontinuation 
An additional criterion (#3) on the 
decision to start a new treatment 
cycle after moderate to severe 
infection that may or may not 
result in hospitalization has been 
added. 
Taking into account the safety 
results related to infections from 
the studies MG0003 and 
MG0004, the permanent 
discontinuation criteria was 
updated to allow more flexibility 
to the investigators, adjust this 
criterion to a cycling regimen 
with an observation period, and 
better reflect clinical practice. 
7.1.4 Study medication 
permanent discontinuation 
criteria 
Criteria #3 has been updated to 
state the following:  
"Study participant experiences a 
significant infective episode 
including but not limited to 
bacteremia/sepsis, infectious 
meningitis, septic arthritis, 
osteomyelitis, complicated 
pneumonia, or visceral abscess 
which may or may not result in 
hospitalization during a treatment 
period. 
However, if a significant infective 
episode is reported during the 
observation period, decision to 
start a new treatment cycle should 
be based on careful evaluation by 
the Principal Investigator of the 
Benefit-Risk for the individual 
study participant and provided a 
full recovery from infection, an 
acceptable level of total IgG (≥ 2 
g/L) and no other discontinuation 
criteria were met" 
Criteria #9 has been updated to 
include wording on participants 
who receive rescue therapy. 
Taking into account the safety 
results related to infections from 
the studies MG0003 and 
MG0004, the permanent 
discontinuation criteria was 
updated to allow more flexibility 
to the investigators, adjust this 
criterion to a cycling regimen 
with an observation period, and 
better reflect clinical practice. 
8.2.2 Vital signs 
Wording on the requirement to 
collect vital signs for participants 
switching to manual push and the 
option to collect additional vital 
signs in the case of an untoward 
event have been included. 
Updated to provide clarity to 
manual push administration 
recommendations and provide 
the option to collect data in case 
of untoward event. 
 
Touchless forehead temperature 
assessment is an option for 
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Section # and Name 
Description of Change 
Brief Rationale 
Temporal (touchless forehead 
temperature assessment) has been 
added. 
measuring participants’ 
temperature to adapt to the 
current clinical practice. 
8.2.3 Electrocardiograms 
Wording was updated to remove 
references to triplicate.  
No identification of 
cardiotoxicity from nonclinical 
data, supported by lack of signal 
cardiac events in the 
rozanolixizumab program. 
Updated in order to decrease 
burden to the sites and study 
participants. 
8.2.6 Assessment and 
management of TB and TB 
risk factors   
The text was updated to remove 
“appropriate rigorous” and to add 
that assessment and management 
of TB and TB risk factors should 
follow local or national 
guidelines. 
Patients with known 
tuberculosis (TB) infection, at 
high risk of acquiring TB 
infection, or latent tuberculosis 
infection (LTBI), or 
current/history of 
nontuberculous mycobacterial 
infection (NTMBI) are already 
excluded from MG0003, 
therefore the sites are expected 
to follow national/local 
guidelines for the management 
of TB, in case needed. 
In addition, the mechanism of 
action of rozanolixizumab is 
expected to have little or no 
impact on the immune response 
against intracellular organisms 
which is involved in controlling 
the infection with 
mycobacterium tuberculosis. 
8.2.6 Assessment and 
management of TB and TB 
risk factors   
Under Latent TB, text regarding 2 
indeterminate IGRA test results as 
suggestive of TB infection was 
removed 
Updated for consistency with 
study design. 
8.3.6 Adverse events of 
special interest 
The definition of Hy’s Law has 
been updated. 
Updated for consistency with 
study design. 
8.9.1 Immunological 
assessments 
Updated to reference "full" 
COVID-19 vaccine. 
Updated to provide clarity and 
remain consistent with the study 
design. 
10.2, Appendix 2: Clinical 
Laboratory Tests 
Table 10-1:  
Urine drug screen has been added.  
The addition of urine drug 
screen will further aide in proper 
workup and diagnosis of the 
etiology of elevated liver 
enzymes. 
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Section # and Name 
Description of Change 
Brief Rationale 
For routine urinalysis, 
albumin/creatinine ratio, 
creatinine has been added.   
Urine creatinine has already 
been measured in the urine 
collected for the urinalysis (for 
other protocol-specified 
assessments) but by error was 
not included in the wording in 
the protocol.  
10.8, Appendix 8: Country-
specific Requirements 
The numbering for exclusion 
criterions specific to France have 
been corrected.  
Updated to correct an error in 
protocol amendment 1. 
10.10 Appendix 10: Protocol 
Amendment History 
Details of the previous 
amendment (protocol amendment 
1) have been added.  
General update. 
10.13.1 Management of 
headaches 
The following wording has been 
added: "The questionnaire should 
be administered by a health care 
professional via an interview with 
the study participant" 
To add further clarity. 
10.13.3 Management of 
infections and 
hypogammaglobulinemia  
The following wording has been 
added:  
"Study participant experiences a 
significant infective episode 
including but not limited to 
bacteremia/sepsis, infectious 
meningitis, septic arthritis, 
osteomyelitis, complicated 
pneumonia, or visceral abscess 
which may or may not result in 
hospitalization during a treatment 
period. 
If a significant infective episode is 
reported during observation 
period, decision to start a new 
treatment cycle should be based 
on careful evaluation by the 
Principal Investigator of the 
Benefit-Risk for the individual 
study participant and provided a 
full recovery from infection, an 
acceptable level of total IgG (≥ 2 
g/L) and no other discontinuation 
criteria were met" 
Taking into account the safety 
results related to infections from 
the studies MG0003 and 
MG0004, the permanent 
discontinuation criteria was 
updated to allow more flexibility 
to the investigators, adjust this 
criterion to a cycling regimen 
with an observation period, and 
better reflect clinical practice. 
 
10.13.4 Management of 
infusion reactions or 
hypersensitivity reactions 
Table 10-3: Alert crash team has 
been replaced with "emergency 
care services". 
Updated to provide clarity 
 
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Amendment 1 (03 Mar 2021) 
Overall Rationale for the Amendment  
The primary reason for this protocol amendment is to incorporate an additional study objective 
and endpoint on 
. Other required changes include aligning this protocol with the updates for the 
rozanolixizumab myasthenia gravis clinical program, and to incorporate specific local ethics 
committees and/or agency requirements into this global protocol. 
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union. 
Section # and Name 
Description of Change 
Brief Rationale 
Global 
Minor administrative, formatting, 
and typographical changes have 
been made. 
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
Global 
All references to MGC003 within 
body text, tables and figures have 
been removed. 
The China MGC003 study will 
no longer be conducted. 
1.1 Synopsis  
3 Objectives and Endpoints 
An additional efficacy endpoint 
specific to symptom expression 
has been added.  
Updated to be consistent with 
the SAP. 
1.1 Synopsis  
3 Objectives and Endpoints 
Other endpoints specific to 
Change from Baseline (Day 1) in 
 
 
 and in 
serum cytokines have been 
updated to remove gastrointestinal 
disturbances.  
Gastrointestinal disturbance in 
relation these endpoints will not 
be analyzed.  
1.1 Synopsis  
3 Objectives and Endpoints 
An additional objective and 
associated endpoint specific to the 
effect of rozanolixizumab on 
COVID-19 biomarkers has been 
included. 
New objective and endpoint is 
needed for the collection of 
information on 
 
 
 
  
1.1 Synopsis  
4.1 Overall design 
The following wording in 
reference to participants opting to 
receive rescue medication has 
been updated to remove: "after the 
end of rescue therapy" 
Updated to provide clarity and 
remain consistent with the study 
design. 
1.1 Synopsis  
4.1 Overall design 
Cross-reference to Appendix 8 
has been included.  
Updated to provide clarity and 
additional information for 
country-specific requirements. 
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Section # and Name 
Description of Change 
Brief Rationale 
1.1 Synopsis  
4.1.1 Study population 
9.8 Determination of sample 
size 
The approximate number of study 
participants has decreased from 
230 to 200. 
The China MGC003 study will 
no longer be conducted resulting 
in a decreased number of study 
participants for MG0007.    
1.3 Schedule of activities,  
Table 1-2  
A new column has been added to 
include the scheduled procedures 
required for a gap period 
Screening Visit.  
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
1.3 Schedule of activities,  
Table 1-2 and Table 1-3 
Visit windows have been added 
for the no treatment with 
rozanolixizumab period and the 
EOS visit.  
Updated to factor in visit 
windows during Treatment and 
Observation Period.   
1.3 Schedule of activities,  
Table 1-2 
Written informed consent and 
Verification of 
inclusion/exclusion criteria have 
been added to Visit 9. A new 
footnote has been added:  
f: Only applicable to study 
participants enrolling from 
MG0004. 
Updated to provide clarification 
for study participants enrolling 
from MG0004. 
1.3 Schedule of activities,  
Table 1-2 
Vital signs have been added to 
Visit 9 (Day 71). 
Updated to be consistent with 
remainder of protocol. 
1.3 Schedule of activities,  
Table 1-2 
Visits 2, 9, 10, 11, and 12 as well 
as no treatment visits have been 
removed for Call or enter IRT to 
register the visit. 
All visits will be tracked 
(electronic data capture); this 
update will reduce site burden 
and potential backlogged visit 
entries. 
1.3 Schedule of activities,  
Table 1-2 
PTT and INR have been added to 
the abbreviation list. 
Updated to be consistent with 
remainder of protocol. 
1.3 Schedule of activities,  
Table 1-2 
The following footnotes have 
been added:  
a: Only applicable to study 
participants with a gap period, 
defined as any study participant 
who does not enroll in MG0007 
within 4 weeks (or ≤32 days) of 
the screening visit from the lead-
in study (see gap period screening 
assessments, Appendix 11, 
Section 10.11). 
g: Only applicable to study 
participants with a gap period (see 
gap period eligibility criteria, 
Appendix 12, Section 10.12). 
 
 
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
 
 
 
 
 
 
 
 
 
 
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Section # and Name 
Description of Change 
Brief Rationale 
h: For criteria pertaining to 
laboratory measures, the last 
values from MG0003 or MG0004 
will be used for evaluation of 
study participant eligibility, as 
long as the measurement was 
taken within the last 4 weeks prior 
to MG0007 Baseline (Day 1). 
k: For UK-specific requirements 
on additional pregnancy test, see 
Appendix 8, Section 10.8. 
As a result, the order of footnotes 
has been updated. 
 
 
 
 
 
 
 
 
Updated to align with the 
MHRA recommendations. 
1.3 Schedule of activities,  
Table 1-2 
The following footnotes have 
been updated:  
a (updated to b): Updated to 
amend specific for participants 
enrolling from MG0004, and to 
include the following additional 
text: "all activities should be 
completed at Visit 1 (±1 week)" 
and a cross reference to footnote 
a.  
f (updated to j): Updated to 
remove the following text: 
"Additional IGRA TB testing will 
be done at least 12 months since 
last test" and include the correct 
visit numbers applicable to 
MG0004. New wording on 
Wording on requirements positive 
or two indeterminate IGRA tests 
result has been updated. 
i (updated to n): Updated to 
include "Day 1, Visit 2" in 
reference to Baseline, and to 
remove the following text: "2 
hours" in reference to collection 
of additional samples and 
"serious" in relation to severity of 
headaches. 
m (updated to r): Reduced 
observation time from 2 hours to 
1 hour. 
 
 
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
 
 
 
 
 
Updated to be consistent with 
the study design as the IGRA 
TB test will be performed at the 
Screening Visit, not the Baseline 
Visit. 
 
 
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
Updated to be consistent with 
the Phase 3 rozanolixizumab 
clinical program for an OLE 
study. 
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Section # and Name 
Description of Change 
Brief Rationale 
1.3 Schedule of activities,  
Table 1-2 and Table 1-3 
All footnotes with reference to 
MGC003 have been updated to 
remove this reference. 
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
1.3 Schedule of activities,  
Table 1-3 
Visits 2, 9, 10, 11, and 12 as well 
as no treatment visits have been 
removed for Call or enter IRT to 
register the visit. 
All visits will be tracked 
(electronic data capture); this 
update will reduce site burden 
and potential backlogged visit 
entries. 
1.3 Schedule of activities,  
Table 1-3 
The following footnotes have 
been added:  
b: For any study participant 
enrolling from MG0004, the final 
visit in MG0004 (Visit 52 [PEOT] 
or Visit 53 [EOS]) will serve as 
the Baseline Visit in MG0007. All 
activities should be completed at 
Visit 1 (±1 week). For study 
participants with a gap period (>4 
weeks), see Section 4.1. 
g: For UK-specific requirements 
on additional pregnancy test, see 
Appendix 8, Section 10.8. 
As a result, the order of footnotes 
has been updated. 
 
 
Include to ensure consistency 
with the overall study design. 
 
 
 
 
 
 
 
Updated to align with the 
MHRA recommendations. 
1.3 Schedule of activities,  
Table 1-3 
The following footnotes have 
been updated:  
e (now f): Updated to include new 
wording on positive or two 
indeterminate IGRA tests result 
has been updated 
g (updated to i): Updated to 
remove wording relating to 
Baseline measures from MG0003 
and "safety exploratory 
biomarkers" and "2 hours" in 
reference to collection of 
additional samples. 
h (updated to j): Updated to 
remove wording relating to 
Baseline measures from MG0003 
and "GI disturbances." 
j (updated to l): Reduced 
observation times for first and 
subsequent infusions. 
 
 
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
 
 
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
 
 
 
 
Updated to be consistent with 
the Phase 3 rozanolixizumab 
clinical program for an OLE 
study. 
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Section # and Name 
Description of Change 
Brief Rationale 
1.3 Schedule of activities,  
Table 1-4 
A new schedule of activities table 
has been included specific for 
study participants who receive 
COVID-19 vaccination before or 
during the study. 
Included as part of the objective 
on 
 
 
 
 
2.2 Background 
"Ongoing" has been removed 
from the study status for UP0060. 
The study is complete. 
2.3 Benefit/Risk assessment 
Text on potential risks associated 
with administration of 
rozanolixizumab has been 
updated. 
Updated to remove events that 
are no longer considered a 
potential risk across the Phase 3 
rozanolixizumab clinical 
program. 
4.1 Overall design 
 
Wording relating to the start of 
follow up for study participants 
receiving rescue therapy has been 
updated. 
"Steroids" has been replaced with 
corticosteroids. 
Updated to provide clarity and 
remain consistent with the study 
design. 
 
Added to correct an error from 
the original protocol. 
4.1.1 Study population 
The total number of study sites 
has increased from 120 to 130. 
China has been removed from the 
list of sites. 
Updated due to the increased 
number of study sites in the 
lead-in study, MG0003. This 
study will no longer be 
conducted in China.  
4.2 Scientific rationale for 
study design 
Wording related to choice of 
doses and regimen has been 
removed. 
Deleted to remove repetitive 
wording. 
5.1 Inclusion criteria 
Criterion #1 (now 1a) has been 
updated to remove MGC003. 
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
5.1 Inclusion criteria 
Criterion #3 (now 3a) has been 
updated to include "a negative 
urine pregnancy test prior to the 
first dose of study medication at 
Baseline Visit of the initial and 
subsequent treatment cycles" 
Updated to provide clarity 
regarding the timings of a 
negative pregnancy test for each 
treatment cycle.  
5.1 Inclusion criteria 
New wording on France-specific 
requirements has been included. 
Updated to align with French 
Ethics Committee query on 
French Social Security cover for 
study participants. 
5.2 Exclusion criteria 
Criterion #3 (now 3a) has been 
updated to include "or other anti-
FcRn medications." 
Updated to be consistent and 
aligned with eligibility language 
used in Phase 3 rozanolixizumab 
clinical program. 
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Section # and Name 
Description of Change 
Brief Rationale 
Criterion #4 (now 4a) has been 
updated with new ineligibility 
details relating to tuberculosis.  
Criterion #15 (now 15a) has been 
updated to include use of 
Fredericia’s formula.  
5.2 Exclusion criteria 
Criterion #5 (now 5a) has been 
updated to remove MGC003. 
Criterion #14 (now 14a) has been 
updated to remove "rescreening" 
and include a reference to UK-
specific requirements. 
Updated to provide be consistent 
with remainder of protocol. 
Updated to incorporate feedback 
received from the MHRA. 
5.2 Exclusion criteria 
Criterion (#17) specific to history 
of suicide attempt has been added. 
Added to correct an error from 
the original protocol. 
5.2 Exclusion criteria 
New wording on France-specific 
requirements has been included. 
Updated to align with French 
Ethics Committee query on 
exclusion criteria pertaining the 
French Public Health Code. 
5.4 Screening failure 
New text has been added to 
clarify this section is applicable to 
study participants with a gap 
period only. 
Updated to provide clarity and 
to correct an error from the 
original protocol. 
6.1 Treatments administered 
Table 6-1: Updated to replace 
infusion with "injection" for the 
dose formulation and to remove 
the following details: "
" and 
"no less than 
 extractable 
volume of." 
New table (6-2) presenting dose 
levels and body weight tiers has 
been included.  
Updated to reflect the 
foreseeable changes in vial size. 
 
 
 
 
Updated to provide further 
clarity. 
6.1.1 Medical devices 
This section has been deleted and 
all text has been moved to Section 
10.8 Appendix 8: Country-
Specific Requirements. 
Updated to provide clarity and 
be consistent with remainder of 
protocol. 
6.2 Preparation, handling, 
storage, and accountability 
requirements 
The following text has been 
removed:  
The Investigator (or designee) 
will instruct the participant to 
store the study medication 
following the instructions on the 
label. 
There is no requirement for the 
study participant to store study 
medication in this study.  
6.2.1 Drug accountability 
In relation to recording study 
medication dispensing, "drug 
Updated to provide further 
clarity. 
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Section # and Name 
Description of Change 
Brief Rationale 
accountability" has replaced case 
report. 
In reference to SOPs used, 
"and/or site" has been included. 
6.3 Measures to minimize 
bias: randomization and 
blinding 
The following text has been 
added:  
"Randomization in MG0007 is to 
a ratio of 1:1." 
Updated to provide further 
clarity. 
6.5.1 Permitted concomitant 
treatments (medications and 
therapies) 
The following text has been 
removed "and dose adjustments 
are allowed between treatment 
cycles". Additionally, "steroids" 
has been replaced with 
corticosteroids. 
New text has been added in 
specific to the requirement to 
collect information on COVID-19 
vaccinations in the eCRF. 
Updated to remove conflict with 
the requirement for maintaining 
a stable dose of permitted 
concomitant medications.  
Information on COVID-19 
vaccination will be required. 
6.5.2 Prohibited concomitant 
treatments (medications and 
therapies) 
The following prohibited 
concomitant treatment "vinca 
alkaloids (vincristine, 
vinblastine)" has been added. 
Additionally, wording specific to 
treatment-free periods prior to 
initiating a 6-week treatment 
cycle has been removed. 
Updated to correct an error from 
the original protocol.  
6.5.3 Treatments specific to 
NMJ interference 
A new section on treatments that 
may interfere with the function of 
the NMJ has been added.  
Updated to correct an 
inadvertent omission from the 
original protocol. 
7.1.1 Liver chemistry 
stopping criteria 
New text specific to continued 
treatment with increased 
monitoring has been added.  
Updated to provide further 
clarity. 
7.3 Lost to follow up 
The following text has been 
removed:  
Investigators should contact the 
Medical Monitor, whenever 
possible, to discuss the 
withdrawal of a study participant 
in advance. Study participants 
who are withdrawn will not be 
replaced. 
Updated to remove duplication 
in previous section. 
8.2.2 Vital signs 
Wording on blood pressure and 
pulse measurements has been 
removed.  
Updated to remove repetitive 
wording. 
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Section # and Name 
Description of Change 
Brief Rationale 
8.2.5 Suicidal risk 
monitoring 
Wording on the use of C-SSRS at 
specific timepoints has been 
removed.  
Updated to be consistent with 
the study design and schedule of 
activities. 
8.2.6 Assessment and 
management of TB and TB 
risk factors 
TB assessment by IGRA; the 
following updates have been 
made:  
-  Baseline has been replaced with 
Screening. 
- Visit numbers in reference to 
MG0004 have been updated.  
- Added a cross reference to the 
schedule of activities. 
Wording on indeterminate IGRA 
tests result has been updated.  
Test conversion: the following has 
been deleted, "The IGRA result 
must be negative for study 
participants to enroll in this study" 
Updated to be consistent with 
the study designs for MG0004, 
and MG0003 for the IGRA TB 
test to be performed at the 
Screening Visit, not the Baseline 
Visit. 
8.3.3 Follow-up of AEs and 
SAEs 
AESM and the associated cross 
reference have been added. 
Updated to be consistent with 
remainder of protocol. 
8.9 Biomarkers  
This section has been updated to 
remove "2 hours" in reference to 
collection of additional samples 
and to update the severity of 
AESMs, as well as new examples 
of GI disorders.  
Updated to be consistent with 
remainder of protocol. 
8.9.1 Immunological 
assessments 
New text has been added in 
specific to blood sampling for the 
measurement of COVID-19 
antibodies. 
COVID-19 antibodies will be 
collected in this study for all 
participants who have received a 
COVID-19 vaccine. 
8.10 Medical resource 
utilization and health 
economics  
This section has updated to 
remove "not". 
Updated as medical resource 
utilization and health economics 
will be measured in this study. 
8.11 Participant exit 
interview 
This section has been removed. 
The optional participant exit 
interview will no longer be 
conducted. 
9.1 Definition of analysis 
sets 
The randomization analysis set 
has been replaced with full 
analysis set and consequently 
amends the definition of the 
safety set. 
Updated to be consistent with 
the SAP. 
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Section # and Name 
Description of Change 
Brief Rationale 
9.2 General statistical 
considerations 
The approach to summarizing 
data for safety and efficacy 
analyses have been amended. 
Updated to be consistent with 
the SAP. 
9.2.1 Intercurrent event 
handling rationale and 
impact on the study 
Adverse events will be recorded 
up to 8 weeks after last sc 
infusion rather than the 
completion of each 6-week 
treatment cycle. 
Updated to be consistent with 
remainder of protocol. 
9.3.1 Analysis of the primary 
safety endpoint 
Summarizing TEAEs and TEAEs 
leading to withdrawal of IMP will 
be summarized by dose at AE 
onset, and not randomized 
treatment. Additionally, the 
following wording was removed, 
"The primary endpoints will also 
be summarized by treatment cycle 
by the rozanolixizumab dose 
given during that cycle". 
Updated to be consistent with 
the SAP. 
9.4.1 Efficacy analyses  
The following new wording has 
been added: "The number and 
percentage of participants 
achieving Minimal Symptom 
Expression (MG-ADL score of 0 
or 1) at Day 43 will be 
summarized by treatment group." 
Updated to be consistent with 
the SAP. 
10.1.6 Data quality assurance 
In reference to ongoing source 
data verification, new wording 
pertaining to encompassing 
remote source data verification 
and source data review, and 
national and local regulations 
have been included.  
Updated to provide clarity on 
allowing remote data 
verification as per applicable 
regulatory guidance. 
10.2 Appendix 2: Clinical 
Laboratory Tests, Table 10-1 
The following parameter, glucose, 
has been updated to include 
"fasting state, preferred". 
The following have been added: 
"Low-density lipoprotein (LDL), 
High-density lipoprotein (HDL), 
triglycerides, total cholesterol"  
Updated to clarify the specifics 
for fasting glucose testing. 
Lipid profile will be assessed in 
the study. 
10.3 Appendix 3: Adverse 
Events – Definitions and 
Procedures for Recording, 
Evaluating, Follow-up, and 
Reporting  
Additional wording for the 
requirements of follow-up of AEs 
and SAEs has been included. 
Updated to be consistent with 
the procedures for follow-up 
across the Phase 3 
rozanolixizumab clinical 
program. 
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Section # and Name 
Description of Change 
Brief Rationale 
10.4 Appendix 4: 
Contraceptive Guidance and 
Collection of Pregnancy 
Information 
Contraception guidance for male 
participants has been updated to 
include "for the duration of the 
study" and to remove "agree to 
use a male condom plus partner 
use of a contraceptive method 
with a failure rate of <1% per year 
as described in the table below 
when having penile-vaginal 
intercourse with a woman of 
childbearing potential who is not 
currently pregnant." 
Updated to provide further 
clarity on the use of 
contraception during the study.  
10.4 Appendix 4: 
Contraceptive Guidance and 
Collection of Pregnancy 
Information 
Contraception guidance for 
female participants and 
vasectomized partner has been 
updated. 
Updated to be consistent with 
the Phase 3 rozanolixizumab 
clinical program. 
10.6 Appendix 6: Liver 
Safety: Suggested Actions 
and Follow-Up Assessments  
New tables describing Phase 3-4 
liver chemistry stopping criteria. 
and follow up assessments have 
been included.  
Updated as information was 
missing from the original 
protocol. 
10.8 Appendix 8: Country-
specific Requirements  
New requirements specific to 
Denmark, France, Japan, and UK 
have been included. 
Updated in accordance with 
local requirements 
10.11 Appendix 11: Gap 
Period Screening 
Assessments 
PTT and INR have been added as 
a Screening assessment. 
Updated as information was 
missing from the original 
protocol. 
10.12 Gap Period Eligibility 
Criteria 
Appendix title has been updated. 
Gap period inclusion criteria has 
been included to cover eligibility 
in reference to pregnancy and 
contraception use, as well as 
moving the following criterion 
from the exclusion criteria to 
inclusion criteria:  
1. Study participant has MGFA 
Class II to IVa at Visit 1. 
Updated for further clarity and 
to correct errors from the 
original protocol. 
10.12 Gap Period Eligibility 
Criteria 
The following updates for 
exclusion criterion relating to 
scheduled visits include: 
Criterions #2, #11, #27, and #31: 
Screening replaces Visit 1. 
Criterions #7, #9, and #10: 
Baseline replaces Visit 2. 
Updated for further clarity and 
to correct errors with scheduled 
visits. 
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Section # and Name 
Description of Change 
Brief Rationale 
Criterion #16: Updated to replace 
Visit 1 and Visit 2 with Screening 
and Baseline, respectively. 
Consequently, eligibility criteria 
have been renumbered. 
10.12 Gap Period Eligibility 
Criteria, Table 10-2 
The following updates for 
exclusion criterions include: 
Criterion #12 was updated to 
remove "history thereof in past 6 
months prior to Visit 1" 
Criterion #32: The timeframe was 
amended to cover duration of 
study participation.  
Two new exclusion criterions on 
human immunodeficiency virus 
(#35) and primary 
immunodeficiency (#36) have 
been added. 
Updated to be consistent with 
the Phase 3 rozanolixizumab 
clinical program. 
10.12 Gap Period Eligibility 
Criteria, Table 10-2 
Table title: Visit 2 has been 
replaced with Visit 1. 
A new biologic (inebulizumab) as 
well associated the treatment-free 
period were added. 
Updated to be consistent with 
exclusion criterion #9. 
Updated to be consistent across 
the Phase 3 rozanolixizumab 
clinical program. 
 
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10.11 
Appendix 11: Gap Period Screening Assessments 
Gap criteria 
Study participants who do not enroll in MG0007 within 4 weeks (or ≤32 days) of the EOS or 
PEOT visit from the lead-in study will need to complete a specific Screening visit undergoing 
the following assessments:  
• Written informed consent 
• Demographic and Baseline characteristics 
• Verification of inclusion/exclusion criteria  
• Prior and concomitant medications and medical procedures  
• General medical history 
• Body weight 
• Columbia Suicide Severity Rating Scale (CSSRS) 
• Psychiatric history/Query for suicidality 
• IGRA TB test 
• TB Signs and Symptoms questionnaire 
• 12-lead ECG  
• Full physical examination 
• Pregnancy test (serum) 
• PTT and INR  
• Hematology, serum chemistry and urinalysis  
• Serology testing for HIV, Hepatitis B, and Hepatitis C 
• Vital signs 
• Call or enter IRT to register the visit  
• Recording of AEs  
• Blood sampling for total IgG and IgG subclasses  
• MGFA classification  
• MG-ADL  
• QMG scale  
• MG-C scale  
• MG Symptoms PRO  
• Study withdrawal criteria 
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10.12 Appendix 12: Gap Period Eligibility Criteria 
Gap Period Inclusion Criteria 
Study participants eligible to be included in the study only if all of the following criteria apply:  
1. Study participant has MGFA Class II to IVa at Screening. 
2a. Study participants may be male or female: 
a) Removed. 
b) A female participant is eligible to participate if she is not pregnant (see Appendix 4), not 
breastfeeding, and at least one of the following conditions applies: 
i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 
OR 
ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the 
treatment period and for at least for at least 90 days after the last dose of study 
treatment. The study participant must have a negative urine pregnancy test prior to the 
first dose of study medication at Baseline (Day 1) of the initial and subsequent 
treatment cycles. 
For France-specific inclusion criteria, see Appendix 8 (Section 10.8). 
Gap Period Exclusion Criteria 
Study participants who do not enroll within the 4 weeks (or ≤32 days) prior to MG0007 Baseline 
(Visit 1) will be excluded from the study if any of the following criteria apply:  
Medical conditions 
1. Study participant has any medical or psychiatric condition that, in the opinion of the 
Investigator, could jeopardize or would compromise the study participant’s ability to 
participate in this study. 
2. Study participant has a history of alcohol use disorder or other substance use disorder (as per 
Diagnostic and Statistical Manual of Mental Disorders-5 [American Psychiatric Association, 
2013]) within 12 months prior to Screening. 
3. Study participant has a known hypersensitivity to any components of the study medication or 
other anti-FcRn medications. 
4. Study participant has a known history of 
, since 
 is a constituent of 
the rozanolixizumab formulation. 
5. Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) 
in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or 
requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of IMP. 
6. Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB 
infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous 
mycobacterial infection (NTMBI). 
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7. Study participant has received a live vaccination within 8 weeks prior to Baseline; or intends 
to have a live vaccination during the course of the study or within 8 weeks following the final 
dose of rozanolixizumab. 
8. Study participant has been treated with prohibited immunosuppressants, biologics, and other 
therapies within timeframe shorter than no-treatment period detailed in Table 10-2. 
9. Study participant has been treated with any biological agent other than those listed in 
Table 10-2 in the past 3 months or within 5 half-lives prior to Baseline, whichever was 
longer. 
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Table 10-2: Treatment-free Period for Exclusionary Immunosuppressants, 
Biologics, and Other Therapies Prior to Baseline (Visit 1) 
Generic name (commercial/trade names) 
Period relative to Baseline Visit 
(regardless of route) 
Immunosuppressants 
 
Cyclophosphamide (Cytoxan®) 
6 months 
Pimecrolimus (Elidel®) 
4 weeks 
Vinca alkaloids (vincristine, vinblastine) 
12 weeks 
Biologics (Mabs and fusion proteins) 
 
Abatacept (CTLA 4-Ig) (Orencia®) 
6 months 
Eculizumab (Soliris®) 
3 months 
Belimumab (Benlysta®) 
6 months 
Golimumab (Simponi®) 
6 months 
Natalizumab (Tysabri®) 
6 months 
Ofatumumab (Arzerra) 
6 months 
Rituximab (Rituxan®) 
6 months or 12 months if B-cells did 
not return to normal range 
Ocrelizumab (Ocrevus®) 
6 months or 12 months if B-cells did 
not return to normal range 
TACI-Ig (Atacicept) 
10 months 
Veltuzumab 
6 months 
Other biologics 
3 months, or within 5 half-lives 
(whichever was longer) prior to the 
Baseline Visit 
Inebulizumab 
6 months (prior to Baseline Visit) and 
B-cells are within normal range 
Others 
 
Intravenous or subcutaneous immunoglobulin 
4 weeks 
IPP-201101 (Lupuzor™) 
3 months 
PEX 
4 weeks 
Immunoadsorption 
4 weeks 
Mabs=monoclonal antibodies; PEX=plasma exchange 
10. Study participant has prior treatment with rituximab in the 6 months prior to Baseline or 
study participant has prior treatment with rituximab in the 12 months prior to Baseline and B 
cells monitoring have shown they did not return to normal range. 
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11. Study participant had a thymectomy in the past 6 months or a thymoma at any time that 
required chemotherapy and/or radiotherapy prior to Screening. 
12. Study participant has any of the following active GI disorders: inflammatory bowel disease 
(IBD), GI ulceration or diverticulitis. 
Prior/Concurrent clinical study experience 
13. Study participant has participated in another study of an IMP (and/or an investigational 
device) within the previous 3 months or is currently participating in another study of an IMP 
and/or an investigational device. 
14. Study participant has been previously randomized in this study (re-screening for screen-
failed participants is allowed with prior consultation and permission of the medical monitor). 
15. Study participant has experienced hypersensitivity reaction after exposure to other anti-FcRn 
drugs.  
Diagnostic assessments 
16. Study participant with severe (defined as Grade 3 on the MG-ADL scale) weakness affecting 
oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis at 
Screening or Baseline. 
17. Study participant has a serum total IgG level ≤5.5g/L. 
18. Study participant has absolute neutrophil count <1500 cells/mm3. 
19. Study participant has any laboratory abnormality that, in the opinion of the Investigator, is 
clinically significant, has not resolved at randomization, and could jeopardize or compromise 
the study participant's ability to participate in this study. 
20. Study participant has 12-lead ECG with findings considered to be clinically significant upon 
medical review. The clinical significance of the findings needs to be assessed by the 
Investigator to determine eligibility, and any queries regarding continuation of the study 
participants will have to be addressed with the Medical Monitor. 
21. Study participant has renal impairment, defined as GFR less than 45ml/min/1.73m2 at Visit 1. 
22. Alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase 
(ALP) are >3x upper limit of normal (ULN), or bilirubin >1.5xULN (isolated bilirubin 
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). 
23. Study participant has elevations only in total bilirubin that were >ULN and <1.5xULN, 
fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin 
<35%). 
24. For randomized study participants with a Baseline result >ULN for ALT, AST, ALP, or total 
bilirubin but <1.5xULN, a Baseline diagnosis and/or the cause of any clinically meaningful 
elevation will have to be understood and recorded in the electronic Case Report form 
(eCRF). 
25. If study participant has >ULN, ALT, AST, or ALP that does not meet the exclusion limit at 
Visit 1, the tests should be repeated, if possible, prior to dosing to ensure there was no further 
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ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the 
study participants will have to be discussed with the Medical Monitor. 
26. Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit (>3xULN) will 
have to be repeated once for confirmation. This includes rescreening. 
27. Presence of Hepatitis B surface antigen (HBsAg) at Screening.  
28. Positive Hepatitis C antibody test result at Visit 1 or within 3 months prior to starting study 
treatment. NOTE: Study participant with a positive Hepatitis C antibody due to prior 
resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is 
obtained.  
29. Positive Hepatitis C RNA test result at Visit 1 or within 3 months prior to first dose of study 
treatment. NOTE: Test is optional and a study participant with negative Hepatitis C antibody 
test is not required to also undergo Hepatitis C RNA testing. 
30. Current unstable liver or biliary disease per Investigator assessment defined by the presence 
of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, 
persistent jaundice, or cirrhosis. NOTE: with exception of stable hepatobiliary conditions 
(including Gilbert’s syndrome, asymptomatic gallstones). 
31. Study participant has active neoplastic disease or history of neoplastic disease within 5 years 
of study entry prior to Screening (except for basal or squamous cell carcinoma of the skin or 
carcinoma in situ of the uterine cervix that have been definitively treated with standard of 
care approaches). 
32. Study participant has a planned major elective surgical procedure for the duration of their 
participation in the study. 
33. Study participant has a history of a solid organ transplant or hematopoietic stem cell/marrow 
transplant. 
34. Study participant has corrected QT interval (QTcF) >450 msec (for male participants) or 
QTc >470 msec (for female participants) or QTc >480 msec in participants with bundle 
branch block. 
35. Study participant tests positive for HIV. 
36. Study participant has a current or medical history of primary immunodeficiency. 
Other exclusions 
37. The study participant is not considered capable of adhering to the protocol visit schedule, or 
medication intake according to the judgment of the Investigator. 
38. A female study participant, who tests positive for pregnancy, plans to get pregnant during the 
participation in the study, or who is breastfeeding. 
39. Study participant has a lifetime history of suicide attempt (including an 
 
, or had suicidal ideation in the past 6 months as 
indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia 
Suicide Severity Rating Scale (C-SSRS). 
40. Participant with current or medical history of 
deficiency. 
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41. Participant with a medical history of splenectomy. 
For France-specific exclusion criteria, see Appendix 8 (Section 10.8). 
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10.13 
Appendix 13: Management of infections and 
hypogammaglobulinemia and infusion reactions or 
hypersensitivity reactions 
10.13.1 
Management of infections and hypogammaglobulinemia 
Study participants who have signs or symptoms of any infection should be monitored closely and 
managed according to local guidelines. This may include tests for specific organisms if clinically 
indicated. 
Study participants MUST discontinue IMP AND move into the SFU Period if he/she develop 
a significant infective episode including but not limited to bacteremia/sepsis, infectious 
meningitis, or septic arthritis, osteomyelitis, complicated pneumonia, or visceral abscess which 
may or may not result in hospitalization during a treatment period.  
If a significant infective episode is reported during observation period, the decision to start a new 
treatment cycle should be based on careful evaluation by the Principal Investigator of the 
Benefit-Risk for the individual study participant and provided a full recovery from infection, an 
acceptable level of total IgG (≥2g/L) and no other discontinuation criteria were met. 
To maintain the study integrity, IgG level will remain blinded to the study sites and the UCB 
study team for the first 4 weeks of the study. To ensure patient safety, serum IgG level will be 
monitored by an independent Medical Monitor external to UCB including signs and symptoms 
of infection and associated laboratory parameters. The IMP may be temporarily discontinued as 
requested by the independent Medical Monitor when deemed appropriate. 
In the event of a non-serious infection, the Benefit-Risk of continuing treatment with IMP must 
be carefully evaluated by the Investigator in collaboration with the Medical Monitor. Treatment 
may be temporarily discontinued for the study participant who develops a non-serious persisting 
or recurrent infection with a serum total IgG level between ≥1g/L and <2g/L. Upon resolution of 
infection and the IgGs returning to the level of ≥2g/L, the study participant may be allowed to 
resume treatment with the IMP. Ad hoc assessment can be performed to monitor the recovery of 
IgG levels. 
Treatment must be temporarily discontinued for the study participant who develops an event of 
hypogammaglobulinemia with a serum total IgG of <1g/L irrespective of infection. When the 
IgG level reaches ≥2g/L, the study participant may be allowed to continue treatment with IMP. 
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10.13.2 
Management of infusion reactions or hypersensitivity reactions 
Study participants must be closely monitored for reactions during and after the study treatment 
administration period. Standard precautions must be taken for the study participants with regard 
to sc infusion complications. Suggested management guidelines for infusion-related reactions 
and anaphylaxis at the study site are provided in Table 10-3. Definitions of mild, moderate, and 
severe events will be consistent with CTCAE version 5.0 (Section 10.3).  
Nurses administering the IMP at home should follow their own management guidelines, which 
should be reviewed and endorsed by the Investigator prior to first home administration.  
Table 10-3: Suggested management guidelines for infusion reactions or 
anaphylaxis 
Type of reaction 
Suggested action 
Acute – Mild 
Grade 1 
Monitor vital signs every 10 min. 
If the reaction worsens to Grade 2, follow the instruction below.   
Acute – Moderate 
Grade 2 
Interrupt/hold infusion temporarily to further assess and initiate 
treatment if necessary.  
Consider the use of iv fluid and antihistamine iv/im. 
Consider administering paracetamol or NSAIDs. 
Monitor vital signs initially every 5 min. 
If the reaction improves and upon further assessment it is clear that the 
event is not an anaphylaxis, restart the infusion cautiously.  Continue 
monitor vital signs every 5 minutes. 
If reaction recurs or worsens to Grade 3, discontinue infusion. 
Acute – Severe 
Grade 3 or 
anaphylaxis 
Discontinue IMP infusion permanently. 
Emergency care services. 
Maintain airway; ensure oxygen is available. 
Administer: 
− Antihistamine iv/im, corticosteroids iv, epinephrine im, and iv 
fluids as appropriate. 
− Monitor vital signs every 2 min. 
− Hospitalize, if condition not improving or worsens  
− Monitor patient until symptoms resolve. 
CTCAE=Common Terminology Criteria for Adverse Events; im=intramuscular; IMP=investigational medicinal 
product; iv=intravenous(ly); NSAID=nonsteroidal anti-inflammatory drug 
Note: Management criteria were adapted from the CTCAE v5.0 (National Cancer Institute, 2017). 
Conditions in which anaphylaxis is likely should be diagnosed using Sampson’s Criteria 
(Sampson et al, 2006. The infusion must be discontinued immediately, and emergency 
resuscitation measures implemented. 
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If an infusion-related reaction or anaphylaxis occurs, a blood sample will be collected from the 
study participant as soon as possible, while the event is ongoing, to investigate the nature of the 
reaction as per Schedule of Activities (Section 1.3). 
Samples for 
 should be collected as 
specified in the Schedule of Activities (Section 1.3). Additional tests such as 
 levels, 
 
may be performed at the discretion of the investigator, when there is a suspicion of Type I or III 
hypersensitivity reaction. The results of all monitoring, including laboratory testing, should be 
made available to the study site and Sponsor. 
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10.14 
Appendix 14: Management of adverse event of special 
monitoring 
Adverse events of special monitoring are defined as product-specific AEs, adverse reactions, or 
safety topics requiring special monitoring by one or more regulatory authorities or by UCB. 
For rozanolixizumab, AESMs (defined by UCB) are: 
• Severe and/or serious headache 
• Suspected aseptic meningitis  
Occurrence of AESM require immediate reporting (within 24 hours regardless of seriousness) to 
UCB. Upon reception of AESM by UCB a standard medical follow-up query (SMFQ) will be 
sent to the site to gather extensive medical information about the AESM. See Table 1-6 for 
additional assessments that may be required in case of AESM.  
Aseptic meningitis (suspected) 
Drug-induced aseptic meningitis is a diagnosis of exclusion after ruling out infectious causes 
(Jolles et al, 2000). A few cases of aseptic meningitis (drug-induced) have been reported in the 
rozanolixizumab program. Consequently, aseptic meningitis (suspected) is being managed as an 
AESM (see Section 8.3.7).  
Participants should be monitored for signs and symptoms suggestive of central nervous system 
(CNS) involvement and evaluated immediately if meningitis is suspected. A full neurological 
workup should be strongly considered including, but not limited to imaging, eg, computed 
tomography (CT) scan, or preferably gadolinium-enhanced magnetic resonance imaging (MRI), 
a lumbar puncture with cerebrospinal fluid (CSF) analysis inclusive of glucose, protein, 
differential complete blood count (CBC), cultures, gram stain, and/or viral polymerase chain 
reactions (PCRs) as appropriate. Whenever possible, CSF should be stored for assessment of 
rozanolixizumab PK, PD, specific antibody titers, or other biomarkers. A concurrent blood 
sample should be collected as per local practice. The ultimate investigative procedures are at the 
discretion of the Investigator or the treating physician. For studies where a neurologist is not the 
Investigator, a neurological consultation is also recommended to aid in decision making and 
patient management. In addition, blood samples for exploratory safety biomarkers 
(see Section 8.9) should be collected for participants with a diagnosis of DIAM preferably within 
72 hours after onset of symptoms. These investigations will be performed to further understand 
the potential mechanisms of DIAM in the participants. 
All procedures related to the diagnosis, treatment, and investigation of meningitis should be 
recorded in the eCRF, and preliminary data should be included on the SAE form used for 
reporting the event as an AESM within 24 hours (ie, preliminary data reported on the first 
reporting may not have CSF results yet, but the reporting should occur as soon as there is a 
suspected diagnosis. Full results should be communicated in subsequent exchanges with the 
sponsor).  
Treatment must be temporarily held if a participant has a diagnosis of suspected meningitis of 
any cause until the diagnostic workup is complete. Based on CSF findings, negative cultures, 
absence of other disease causes, and relationship with IMP, a diagnosis of DIAM can be made. If 
deemed appropriate by the Investigator and agreed upon by the participant and the Sponsor, the 
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study treatment can resume upon the complete resolution of symptoms. The benefit and risk of 
the treatment should be carefully considered prior to reinitiating the IMP. If a participant 
experiences a second episode of similar symptoms suggestive of DIAM, then the participant 
must permanently discontinue the IMP. 
Participants experiencing an event of DIAM should be strongly encouraged to remain in the 
study regardless of IMP discontinuation. This will allow for monitoring and follow-up of the 
participant including a complete neurological exam on subsequent physical examinations. 
Longer term follow-up on any AEs related to DIAM that are ongoing may be warranted until 
resolution. 
Associated symptoms with aseptic meningitis should be managed at the Investigator’s discretion.  
Severe and/or serious headache 
Based on current available clinical data, headache is the most commonly reported ADR in study 
participants treated with rozanolixizumab. Study participants should be well informed of this 
potential ADR and should be instructed on how to manage it. 
Determination of the severity of headache will be consistent with National Cancer Institute 
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Severe headache is 
defined as severe pain limiting self-care activities of daily living (ADL). Self-care ADL refers to 
bathing, dressing and undressing, feeding self, using the toilet, and taking medications. 
In the event of a headache, the Investigators should take the medical history of previous 
headaches, concomitant medication, and co-morbidities (eg, asthma) in consideration. 
If the severe and/or serious headache is initially reported at a home visit or during a telephone 
call, the study participant should be evaluated by a healthcare professional as soon as possible for 
further investigations. Study participants should be monitored for signs and symptoms suggestive 
of CNS involvement and evaluated immediately if other causes (eg, meningitis, intracranial 
bleeding) are suspected (please see Section 1.3.1 [Table 1-6]). In addition, samples for 
exploratory safety biomarkers should be collected for study participants experiencing severe or 
serious headache when possible. These investigations will be performed to further understand the 
mechanism of headaches in the study participants. 
If deemed appropriate by the Investigator and agreed upon by the study participant and the 
Sponsor, the study treatment can resume upon the resolution of the severe and/or serious 
headache event. The benefit and risk of the treatment should be carefully considered prior to 
reinitiating the IMP. 
Headaches will be treated as clinically indicated according to national guidelines. It is 
recommended that the study participants have an analgesic available in case of headache with the 
instruction for frequency and dosage provided by a healthcare professional. The analgesic can be 
started at the early onset of headache. Study participants experiencing any treatment-related 
headache will be followed until resolution of the event. 
Prophylactic treatment of headaches may be permitted for study participants who have 
experienced previous episodes of treatment-related headache after discussion with the Medical 
Monitor. The benefit risk of continuing treatment with IMP and chronic prophylactic with 
analgesics must be carefully evaluated by the Investigator. 
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10.15 
Appendix 15: Sampson Criteria Questionnaire  
Anaphylaxis is highly likely when any of the following 3 criteria is fulfilled (Sampson et al, 
2006): 
1. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal 
tissue, or both (eg, generalized hives, pruritus or flushing, swollen lips-tongue-uvula) 
AND AT LEAST ONE OF THE FOLLOWING 
a. Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced peak 
expiratory flow [PEF], hypoxemia) 
b. Reduced blood pressure [BP] or associated symptoms of end-organ dysfunction (eg, 
hypotonia [collapse], syncope, incontinence) 
2. Two or more of the following that occur rapidly after exposure to a likely allergen for that 
patient (minutes to several hours): 
a. Involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen lips 
tongue-uvula) 
b. Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, 
hypoxemia) 
c. Reduced BP or associated symptoms (eg, hypotonia [collapse], syncope, incontinence) 
d. Persistent GI symptoms (eg, crampy abdominal pain, vomiting) 
Reduced blood pressure after exposure to known allergen for that subject (minutes to several 
hours): Systolic BP of less than 90mmHg or greater than 30% decrease from the subject’s 
Baseline systolic BP value. 
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UCB 
 
03 Oct 2022 
Clinical Study Protocol Amendment 3 
Rozanolixizumab 
MG0007 
 
 
 
Confidential 
Page 139 of 140 
11 
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Barnett C, Katzberg H, Nabavi M, Bril V. The quantitative myasthenia gravis score: comparison 
with clinical, electrophysiological, and laboratory markers. J Clin Neuromuscul Dis. 
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Burns TM, Conaway M, Sanders DB; MG Composite and MG-QOL15 Study Group. The MG 
Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology. 
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CPMP/ICH/135/95 Note for guidance on Good Clinical Practice (EMEA) Jul 2002. 
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of Virological Response to Interferon Therapy in Chronically Infected Patients. J Clin Microbiol. 
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Muppidi S. The myasthenia gravis-specific activities of daily living profile. Ann N Y Acad Sci, 
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Muppidi S, Wolfe GI, Conaway M, Burns TM, MG composite and MG-QOL15 study group. 
MG-ADL: still a relevant outcome measure. Muscle Nerve. 2011;44(5):727-31. 
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Second symposium on the definition and management of anaphylaxis: summary report – Second 
National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network 
symposium. J Allergy Clin Immunol. 2006;117(2):391-7. 
Roopenian DC, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol. 
2007;7(9):715-25. 
Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis 
activities of daily living profile. Neurology. 1999;52(7):1487-9. 
 
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03 Oct 2022 
Clinical Study Protocol Amendment 3 
Rozanolixizumab 
MG0007 
 
 
 
Confidential 
Page 140 of 140 
SPONSOR DECLARATION 
I confirm that I have carefully read and understand this protocol and agree to conduct this 
clinical study as outlined in this protocol and according to current Good Clinical Practice. 
 
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application and any extensions or variations thereof.

Approval Signatures
Name:
mg0007-protocol-amendment-3
Version:
1. 0
Document Number:
CLIN-000204620
Title:
mg0007 Protocol Amendment 3
Approved Date:
04 Oct 2022
Document Approvals
Approval
Verdict: Approved
Name: 
Capacity: Clinical
Date of Signature: 04-Oct-2022 07:13:52 GMT+0000
Approval
Verdict: Approved
Name: 
Capacity: Regulatory Affairs
Date of Signature: 04-Oct-2022 14:10:52 GMT+0000
Approval
Verdict: Approved
Name:
Capacity: Clinical
Date of Signature: 04-Oct-2022 15:20:38 GMT+0000
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application and any extensions or variations thereof.