Conditions: Granulomatosis With Polyangiitis (GPA) Microscopic Polyangiitis (MPA)
Keywords: granulomatosis polyangiitis corticosteroid replacement glucocorticoid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 57
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Detailed description:
Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a group of potentially life-threatening autoimmune diseases. Preclinical data demonstrate that primed neutrophils are activated by anti-neutrophil cytoplasmic antibody (ANCA) and generate C5a that engages C5a receptors on neutrophils. Patients with ANCA-related disease have elevated plasma and urine levels of C5a in active disease but not in remission. IFX-1 is as a monoclonal antibody specifically binding to the soluble human complement split product C5a, which results in nearly complete blockade of C5a induced biological effects. Therefore, IFX-1 may be effective in the treatment of subjects with AAV.

In this Phase II study of 20 to 55 subjects with granulomatosis with GPA and MPA, IFX-1 will be administered in combination with reduced dose glucocorticoids or a placebo glucocorticoid compared with standard dose glucocorticoids.

Arms:
arm 1: IFX-1 + reduced dose GC arm 2: Placebo-IFX-1 + standard dose GC arm 3: IFX-1 + Placebo-GC

Interventions: intervention 1: IFX-1 intervention 2: Placebo-IFX-1 intervention 3: Glucocorticoid (GC) intervention 4: Placebo-Glucocorticoid (Placebo-GC)
Intervention descriptions: intervention 1: intravenously administered intervention 2: intravenously administered intervention 3: orally administered intervention 4: orally administered

Protocol document:
Prot_SAP_000.pdf: 
 
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CLINICAL STUDY PROTOCOL 
A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, 
MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN 
ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC 
POLYANGIITIS (MPA) 
 
 
Study Number: IFX-1-P2.5 
Study Product: IFX-1 
EudraCT Number: 2018-000768-27 
Sponsor: 
 
InflaRx GmbH 
Winzerlaer Strasse 2 
07745 Jena 
Germany  
Sponsor’s Responsible Medical Officer: 
, MD, MSc 
 
 InflaRx GmbH 
Coordinating Investigator: 
 MD, MPH 
 
 
 
 
Version and Date of Protocol: Version 5.0, Final, 07 October 2020 


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TABLE OF CONTENTS 
 
LIST OF ABBREVIATIONS .............................................................................................................. 9 
DEFINITION OF TERMS ................................................................................................................ 12 
STUDY SYNOPSIS ......................................................................................................................... 16 
SPONSOR SIGNATURE PAGE ..................................................................................................... 23 
COORDINATING INVESTIGATOR SIGNATURE PAGE .............................................................. 24 
INVESTIGATOR SIGNATURE PAGE(S) ....................................................................................... 25 
1 
SCHEDULE OF ASSESSMENTS .................................................................................... 26 
2 
INTRODUCTION ............................................................................................................... 30 
2.1 
Background Information on the Indication ..................................................................30 
2.2 
Background Information on IFX-1 .................................................................................31 
2.3 
Rationale for the Study ...................................................................................................32 
2.3.1 
Study Population ...............................................................................................................32 
2.3.2 
Dosing Regimen ................................................................................................................32 
2.3.3 
Study Design .....................................................................................................................33 
2.3.4 
Expected Benefits .............................................................................................................33 
2.4 
Risk-Benefit Assessment ...............................................................................................34 
2.4.1 
Potential Risks ...................................................................................................................34 
2.4.2 
Risk Associated with Lack of Efficacy ...............................................................................34 
2.4.3 
Conclusion .........................................................................................................................35 
3 
OBJECTIVES .................................................................................................................... 37 
3.1 
Primary Objective ............................................................................................................37 
3.2 
Secondary Objectives .....................................................................................................37 
4 
STUDY DESIGN ............................................................................................................... 38 
4.1 
Overall Study Design and Plan ......................................................................................38 
4.2 
Number of Subjects and Study Sites ............................................................................40 
4.3 
Study Duration .................................................................................................................40 
4.4 
Premature Termination of the Study .............................................................................41 
5 
STUDY POPULATION ..................................................................................................... 42 
5.1 
Screen Failures ................................................................................................................42 
5.2 
Inclusion Criteria .............................................................................................................42 


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5.3 
Exclusion Criteria ............................................................................................................43 
5.4 
Discontinuation of Individual Subject Participation ...................................................45 
5.4.1 
Lack of Efficacy .................................................................................................................45 
5.4.2 
Withdrawal of Informed Consent.......................................................................................46 
5.4.3 
Discontinuation of the Investigational Medicinal Products ...............................................46 
6 
STUDY TREATMENTS .................................................................................................... 48 
6.1 
Details of the Investigational Medicinal Products.......................................................48 
6.1.1 
Description of IFX-1 and Placebo-IFX-1 (IFX-IMP) ..........................................................48 
6.1.1.1 Packaging and Labelling of IFX-IMP ................................................................................ 48 
6.1.1.2 Shipment of IFX-IMP ......................................................................................................... 48 
6.1.1.3 Storage of IFX-IMP............................................................................................................ 49 
6.1.1.4 Drug Accountability of IFX-IMP ......................................................................................... 49 
6.1.1.5 Reconstitution of IFX-IMP ................................................................................................. 50 
6.1.1.6 Administration of IFX-IMP ................................................................................................. 50 
6.1.2 
Description of Glucocorticoids and Placebo-Glucocorticoids (GC-IMP) ..........................51 
6.1.2.1 Packaging and Labeling of GC-IMP ................................................................................. 52 
6.1.2.2 Shipment of GC-IMP ......................................................................................................... 52 
6.1.2.3 Storage of GC-IMP ............................................................................................................ 52 
6.1.2.4 Drug Accountability of GC-IMP ......................................................................................... 53 
6.1.2.5 Administration of GC-IMP ................................................................................................. 53 
6.2 
Details of the Auxiliary Medicinal Products .................................................................54 
6.2.1 
Immunosuppressive Therapy During Remission-Induction Phase ..................................55 
6.2.1.1 Rituximab ........................................................................................................................... 55 
6.2.1.2 Cyclophosphamide ............................................................................................................ 55 
6.2.2 
Immunosuppressive Therapy During Remission-Maintenance Phase ............................55 
6.2.2.1 Azathioprine....................................................................................................................... 55 
6.2.2.2 Methotrexate...................................................................................................................... 56 
6.2.2.3 Mycophenolate Mofetil and Mycophenolate Sodium ........................................................ 56 
6.3 
Randomization and Blinding .........................................................................................56 
7 
PRIOR AND CONCOMITANT THERAPY ....................................................................... 58 
7.1 
Prior Therapy ...................................................................................................................58 
7.2 
Concomitant Therapy .....................................................................................................58 
7.3 
Recommended concomitant Therapy...........................................................................58 
7.3.1 
Pneumocystis Carinii Pneumonia (PCP) Prophylaxis ......................................................58 
7.3.2 
Osteoporosis Prophylaxis .................................................................................................58 
7.4 
Permitted Glucocorticoid Therapy ................................................................................58 
7.5 
Rescue Therapy ...............................................................................................................59 
7.6 
Prohibited Therapy during the study ............................................................................61 
7.7 
Contraception in Women of Childbearing Potential ...................................................62 


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7.8 
Contraception for males with female partners of childbearing potential.................63 
8 
STUDY PROCEDURES AND VISIT SCHEDULE ........................................................... 64 
8.1 
Screening .........................................................................................................................64 
8.2 
Treatment Period .............................................................................................................65 
8.3 
Follow-up Period .............................................................................................................67 
8.4 
Safety Follow-Up Visit ....................................................................................................68 
8.5 
Unscheduled Visit ...........................................................................................................69 
9 
STUDY VARIABLES AND ASSESSMENT METHODS .................................................. 71 
9.1 
Study Subjects ................................................................................................................71 
9.1.1 
Demographics and Baseline Characteristics ....................................................................71 
9.1.2 
GPA/MPA Medical History ................................................................................................71 
9.1.3 
Medical History ..................................................................................................................71 
9.1.4 
Prior and Concomitant Therapy ........................................................................................71 
9.2 
Efficacy .............................................................................................................................72 
9.2.1 
Efficacy Variables ..............................................................................................................72 
9.2.2 
Methods of Assessing Efficacy Variables .........................................................................72 
9.2.2.1 Birmingham Vasculitis Activity Score Version 3.0 ............................................................ 72 
9.2.2.2 Vasculitis Damage Index ................................................................................................... 73 
9.2.2.3 Physician Global Assessment ........................................................................................... 73 
9.2.2.4 36-Item Short Form Survey Version 2 .............................................................................. 73 
9.2.2.5 EuroQol-5L Dimensions Survey ........................................................................................ 74 
9.2.2.6 Urinalysis and Renal Variables ......................................................................................... 75 
9.2.2.7 Anti-neutrophil Cytoplasmic Antibody Titer ....................................................................... 75 
9.3 
Safety ................................................................................................................................76 
9.3.1 
Safety Variables ................................................................................................................76 
9.3.2 
Methods of Assessing Safety Variables ...........................................................................76 
9.3.2.1 Adverse Events ................................................................................................................. 76 
9.3.2.2 Glucocorticoid Toxicity Index ............................................................................................ 76 
9.3.2.3 Physical Examinations ...................................................................................................... 77 
9.3.2.4 Vital Signs .......................................................................................................................... 77 
9.3.2.5 Electrocardiogram ............................................................................................................. 77 
9.3.2.6 Safety Laboratory .............................................................................................................. 77 
9.3.2.7 Pregnancy Test ................................................................................................................. 78 
9.3.2.8 Human Immunodeficiency Virus and Hepatitis Virus Testing .......................................... 79 
9.3.2.9 Anti-Glomerular Basement Membrane Disease Assessment .......................................... 79 
9.3.2.10 Anti-Drug Antibodies ......................................................................................................... 79 
9.4 
Pharmacokinetics, Pharmacodynamics, and Biomarkers .........................................80 
9.4.1 
Variables ............................................................................................................................80 
9.4.2 
Methods of Assessing Variables .......................................................................................80 
9.4.2.1 Pharmacokinetics .............................................................................................................. 80 


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9.4.2.2 Pharmacodynamics ........................................................................................................... 80 
9.4.2.3 Biomarkers ........................................................................................................................ 80 
9.4.2.4 Samples for Future Research ........................................................................................... 81 
10 
ADVERSE EVENT REPORTING ..................................................................................... 82 
10.1 
Adverse Events ...............................................................................................................82 
10.1.1 
Definition ............................................................................................................................82 
10.1.2 
Documentation and Reporting ..........................................................................................83 
10.2 
Serious Adverse Events .................................................................................................86 
10.2.1 
Definition ............................................................................................................................86 
10.2.2 
Documentation and Reporting ..........................................................................................87 
10.3 
Adverse Events of Special Interest ...............................................................................88 
10.4 
Suspected Unexpected Serious Adverse Reactions ..................................................89 
10.4.1 
Definition ............................................................................................................................89 
10.4.2 
Documentation and Reporting ..........................................................................................89 
10.5 
Pregnancy ........................................................................................................................89 
10.6 
Overdose ..........................................................................................................................90 
11 
STATISTICS...................................................................................................................... 91 
11.1 
General Considerations ..................................................................................................91 
11.2 
Determination of Sample Size .......................................................................................91 
11.3 
Analysis Sets ...................................................................................................................92 
11.4 
Endpoints .........................................................................................................................92 
11.4.1 
Efficacy ..............................................................................................................................92 
11.4.1.1 Primary .............................................................................................................................. 92 
11.4.1.2 Secondary ......................................................................................................................... 93 
3 
11.4.2 
Safety.................................................................................................................................94 
11.4.3 
Quality of Life.....................................................................................................................95 
11.4.4 
Pharmacokinetics ..............................................................................................................95 
11.4.5 
Pharmacodynamics ...........................................................................................................95 
11.4.6 
Biomarkers ........................................................................................................................95 
11.5 
Analyses of Endpoints ...................................................................................................95 
11.5.1 
Efficacy ..............................................................................................................................95 
11.5.2 
Safety.................................................................................................................................96 
11.5.3 
Pharmacokinetics ..............................................................................................................96 
11.5.4 
Pharmacodynamics ...........................................................................................................97 
11.5.5 
Quality of Life.....................................................................................................................97 
11.5.6 
Biomarkers ........................................................................................................................97 
11.6 
Demographics and Baseline Characteristics ..............................................................97 


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11.7 
Prior and Concomitant Therapy ....................................................................................97 
11.8 
Subject Disposition .........................................................................................................98 
11.9 
Treatment Exposure .......................................................................................................98 
11.10 
Handling of Missing Data ...............................................................................................98 
11.11 
Interim Analysis ...............................................................................................................99 
12 
ETHICAL, LEGAL, AND ADMINISTRATIVE ASPECTS .............................................. 100 
12.1 
Good Clinical Practice ................................................................................................. 100 
12.2 
Ethics Committee and Responsible Regulatory Authority ..................................... 100 
12.3 
Subjects Information and Informed Consent............................................................ 100 
12.4 
Protocol Amendments ................................................................................................. 101 
13 
DOCUMENTATION ........................................................................................................ 102 
13.1 
Electronic Case Report Forms ................................................................................... 102 
13.2 
Archiving ....................................................................................................................... 103 
14 
SUPERVISION OF THE CLINICAL STUDY .................................................................. 104 
14.1 
Access to Source Data ................................................................................................ 104 
14.2 
Monitoring ..................................................................................................................... 104 
14.3 
Adjudication Committee .............................................................................................. 105 
14.4 
Independent Data Monitoring Committee ................................................................. 105 
14.5 
Audits............................................................................................................................. 106 
14.6 
Inspections.................................................................................................................... 106 
15 
DATA PROTECTION AND CONFIDENTIALITY ........................................................... 107 
15.1 
Declaration Regarding Data Protection ..................................................................... 107 
15.2 
Declaration Regarding the pseudonymized Transfer of Personal Data ................ 107 
16 
ADMINISTRATIVE AGREEMENTS ............................................................................... 108 
16.1 
Adherence to the Protocol/Protocol Deviations ....................................................... 108 
16.2 
Financing and Insurance ............................................................................................. 108 
16.3 
Notification of the Local Authorities .......................................................................... 108 
16.4 
Publication Policy and Registration .......................................................................... 108 
16.4.1 
Publication Policy ........................................................................................................... 108 
16.4.2 
Registration .................................................................................................................... 109 
17 
REFERENCES ................................................................................................................ 110 
18 
APPENDICES ................................................................................................................. 114 
18.1 
Chapel Hill Consensus Conference ........................................................................... 114 
18.2 
Birmingham Vasculitis Activity Score Version 3.0 .................................................. 115 


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18.3 
Glossary and Scoring for BVAS Version 3.0 ............................................................ 116 
18.4 
Other Multi-System Autoimmune Diseases .............................................................. 118 
18.5 
Vasculitis Damage Index ............................................................................................. 119 
18.6 
Glucocorticoid Toxicity Index ..................................................................................... 120 
18.7 
Physician Global Assessment .................................................................................... 122 
18.8 
36-Item Short Form Survey ......................................................................................... 123 
18.9 
The EuroQol-5 Dimensions Survey ............................................................................ 129 


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LIST OF TABLES  
Table 1 
Dosing Schedule for IFX-1 and Placebo-IFX-1 ............................................................. 50 
Table 2 
Dosing Schedule for Glucocorticoid Tapering (Daily Dose per Week) .......................... 54 
Table 3 
Renal Variables ............................................................................................................ 75 
Table 4 
Pharmacodynamic Variables ........................................................................................ 80 
Table 5 
Biomarker Variables ..................................................................................................... 81 
Table 6 
Maximum Sample Size in Study Parts .......................................................................... 92 
 


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LIST OF ABBREVIATIONS 
AAV 
anti-neutrophil cytoplasmic antibody-associated vasculitis 
AC 
Adjudication Committee 
ADA 
anti-drug antibody 
AE 
adverse event 
AESI 
adverse event of special interest 
ANCA 
anti-neutrophil cytoplasmic antibody 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
AxMP 
Auxiliary Medicinal Product 
AZA 
azathioprine 
BVASv3 
Birmingham Vasculitis Activity Score (Version 3) 
CH50 
50% hemolytic complement 
CHCC 
Chapel Hill Consensus Conference 
CMO 
Contract Manufacturing Organization 
CRO 
Contract Research Organization 
CRP 
C-reactive protein 
CYC 
cyclophosphamide 
DNA 
deoxyribonucleic acid 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDTA 
ethylenediaminetetraacetic acid 
eGFR 
estimated glomerular filtration rate 
EGPA 
eosinophilic granulomatosis with polyangiitis 
EOS 
end of study 
EQ-5D-5L 
EuroQol-5 Dimensions 5-Levels survey 
EU 
European Union 
FAS 
full analysis set 
GBM 
glomerular basement membrane 
GC 
glucocorticoid 
GCP 
Good Clinical Practice 


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GDPR 
General Data Protection Regulation 
GPA 
granulomatosis with polyangiitis 
GTI 
glucocorticoid toxicity index 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HS 
hidradenitis suppurativa 
ICH 
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use 
IDMC 
Independent Data Monitoring Committee 
Ig 
immunoglobulin 
IMP 
investigational medicinal product 
IWRS 
Interactive Web Response System 
MAC 
membrane attack complex 
MCP 
monocyte chemoattractant protein 
MMF 
mycophenolate mofetil 
MPA 
microscopic polyangiitis 
MPO 
myeloperoxidase 
MPS 
mycophenolate sodium 
MTX 
methotrexate 
NGC 
No glucocorticoids 
PCP 
Pneumocystis carinii pneumonia 
PD 
pharmacodynamic(s) 
PGA 
Physician Global Assessment 
PK 
pharmacokinetic(s) 
PPS 
per protocol set 
PR3 
proteinase 3 
PRO 
patient-reported outcome 
RDGC 
reduced-dose glucocorticoids 
RTX 
rituximab 
SAE 
serious adverse event 
SAF 
safety analysis set 
SDGC 
Standard-dose glucocorticoids 


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SF-36v2 
36-item Short Form survey version 2 
SFU 
safety follow-up 
SmPC 
Summary of Product Characteristics 
SUSAR 
suspected unexpected serious adverse reaction 
TEAE 
treatment-emergent adverse event 
UACR  
urinary albumin:creatinine ratio 
ULN 
upper limit of normal range 
USV 
unscheduled visit 
V 
visit 
VDI 
Vasculitis Damage Index 
W 
week 


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DEFINITION OF TERMS 
Auxiliary Medicinal Product (AxMP) 
Medicinal product used as rescue 
medication, challenge agent, to 
assess endpoints in the clinical 
study, or background treatment. The 
AxMP should be related to and be 
relevant for the design of the 
clinical study. 
Baseline 
A value or quantity that serves as a 
reference for comparisons over 
time. 
Central laboratory 
A laboratory where subject-derived 
samples (e.g., serum, plasma) are 
centrally analyzed and if necessary, 
distributed for analysis to 
specialized laboratories. 
Clinical remission 
Birmingham Vasculitis Activity 
Score (Version 3 [BVASv3]) = 0. 
Clinical response 
Reduction in BVASv3 of ≥ 50% 
from baseline (=screening 
assessment) and no worsening in 
any body system. 
Compliance 
Adherence to all the study-related, 
Good Clinical Practice (GCP), and 
the applicable regulatory 
requirements. 
Consent 
The act of obtaining informed 
consent for participation in a 
clinical study from subjects deemed 
eligible or potentially eligible to 
participate in the clinical study.  
Electronic case report form (eCRF) 
An electronic form for recording 
subject’s data during the study, as 
required by the protocol. 


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End of Study  
Overall study completion: the day 
of the last visit of the last subject in 
the study. 
Individual subject: the time point 
after which no further study-related 
procedures are performed. 
Endpoint 
Key measurement or observation 
used to measure the effect of 
experimental variables in a study. 
Enrolment 
The time point at which a subject 
formally starts to participate in the 
study by signing an informed 
consent form.  
Follow-up Period 
After IFX-Investigational Medicinal 
Product (IMP) administration in 
Week 16 to Week 24, during which 
no IFX-IMP is given.  
IFX-IMP 
IFX-1 or Placebo-IFX-1. 
Immunosuppressive therapy 
Either Rituximab (RTX) or 
cyclophosphamide (CYC) 
administration in the Remission-
Induction Phase. 
CYC, RTX, azathioprine (AZA), 
methotrexate (MTX), 
mycophenolate mofetil (MMF), or 
mycophenolate sodium (MPS) 
administration in the Remission-
Maintenance Phase. 


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Investigational medicinal product (IMP) 
A pharmaceutical form of an active 
substance or placebo being tested or 
used as a reference in the current 
study, including products already 
with a marketing authorization but 
used or assembled (formulated or 
packaged) in a way different from 
the authorized form. 
Major relapse 
Either BVASv3 > 3 minor items or 
1 major BVASv3 item (listed in 
Appendix 18.2) after clinical 
remission (BVASv3 = 0).  
Minor relapse 
Any new occurrence of 1, 2 or 3 
minor BVASv3 items listed in 
Appendix 18.2 (BVASv3 = 1, 2, 3) 
after clinical remission 
(BVASv3 = 0). 
Pharmacy Manual 
Manual provided to the study sites 
with detailed information on the 
composition of active and inactive 
ingredients of the IMP as well as 
details on shipment to site, site 
receipt, handling, storage, and 
administration. 
Remission-Induction Phase 
The time from the start of 
remission-induction therapy until 
clinical remission (BVASv3 = 0).  
Remission-Maintenance Phase 
The time from clinical remission 
until Week 24.  
Safety follow-up (SFU) visit 
To be performed for any subject 
who discontinues from the study 
during the Treatment Period (i.e., up 
to and including Week 16) at 
1 month (±3 days) after the last IMP 
administration. 


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Screening 
The predetermined series of 
procedures with which each 
investigator selects an appropriate 
and representative sample of 
subjects for randomization into the 
study. 
Study Drug Instructions for the Patient 
Manual provided to subjects with 
details on the active and inactive 
ingredients of the glucocorticoid 
(GC)-IMPs including instructions 
on storage, handling, and intake. 
Study start 
The time point at which the first 
subject gives written informed 
consent; equivalent to first subject’s 
first visit at the first study site that 
has enrolled a subject into the study. 
Treatment Period 
Week 0 to Week 16, during which 
IFX-IMP is given. 
 


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STUDY SYNOPSIS 
Title of Study:  
A randomized, double-blind, double-dummy, active-controlled, multicenter, 2-part 
Phase II study on replacement of steroids by IFX-1 in active granulomatosis with 
polyangiitis (GPA) and microscopic polyangiitis (MPA) 
Protocol/Study Number: IFX-1-P2.5 
EudraCT Number: 2018-000768-27 
Type of Study: 
Proof of Concept Study 
Indication: 
Induction of remission in adult subjects 
with active granulomatosis with GPA and 
MPA indicated for therapy with 
cyclophosphamide (CYC) or rituximab 
(RTX) 
Sponsor: InflaRx GmbH, Winzerlaer Strasse 2, 07745 Jena, Germany 
Coordinating Investigator: 
 MD, MPH 
Study Site(s): 
Approximately 87 sites in approximately 13 countries 
Phase of Development: II 
Objectives: 
Primary Objective: 
The primary objective is to evaluate the efficacy of IFX-1 treatment as replacement for 
glucocorticoid (GC) therapy in subjects with GPA and MPA. 
Secondary Objectives: 
• 
To assess the safety and tolerability of IFX-1 
• 
To compare GC-induced toxicity of standard-dose GC and reduced-dose GC with 
IFX-1 treatment  
• 
To generate data for pharmacokinetic (PK) and pharmacodynamic (PD) modelling 
of IFX-1 treatment. 
Methodology:  
This is a prospective, randomized, double-blind, double-dummy, active-controlled, 
multicenter, 2-part Phase II study. A total of 3 treatment groups will be investigated: 
Group A: 
IFX-1 + reduced-dose GC (RDGC)  
= IFX-1 + RDGC 
Group B: 
Placebo-IFX-1 + standard-dose GC (SDGC) = Placebo-IFX-1 + SDGC 
Group C: 
IFX-1 + no GC (NGC) 
 
 
= IFX-1 + Placebo-GC 


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In Study Part 1 subjects will be randomized in a 1:1 ratio to either Group A or 
Group B. The response to treatment will be evaluated under blinded conditions by an 
Adjudication Committee (AC). An unblinded Independent Data Monitoring Committee 
(IDMC) will then evaluate whether the data show efficacy signals in Group A and give 
a recommendation to continue with Study Part 2. In case more data are needed to give 
a recommendation, the IDMC can propose to prolong the Study Period 1 by recruiting 
additional subjects. 
There will be a recruitment stop for IDMC evaluation after a maximum of 30 subjects 
have been enrolled in Study Part 1. In Study Part 2 subjects will be randomized to 
either Group B or Group C. Study Part 2 aims to investigate the efficacy of IFX-1 
(Group C) compared to SDGC (Group B). 
All subjects may receive RTX or CYC from up to 2 weeks prior to screening up to 
clinical remission (Remission-Induction Phase). Following clinical remission and up to 
Week 24 (Remission-Maintenance Phase), subjects can switch to another 
immunosuppressive therapy (azathioprine [AZA], methotrexate [MTX], 
mycophenolate mofetil [MMF], or mycophenolate sodium [MPS]), to use throughout 
the remainder of the study at the discretion of the investigator, or can stay on RTX or 
CYC.  
Number of Subjects: 
In Study Part 1, 20 subjects will be randomized to either Group A or Group B in a ratio 
of 1:1.  
 
In Study Part 2, approximately 25 additional subjects will be randomized to Group B 
and Group C in an unchanged ratio compared to the previous protocol version. It will 
result in an unbalanced distribution of patients in Group B and C for the final analysis, 
i.e. about 24 treated in Group B (15 from Part 1 and 9 from Part 2) and about 16 in 
Group C (all enrolled in Part 2). 
 
It is planned to not exceed 55 subjects in total. 
Study Population: 
Subjects must meet all the following criteria at screening and at inclusion to be 
randomized into the study: 
1. Male or female, ≥ 18 years of age. 
2. Written informed consent obtained from subject. 


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3. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill 
Consensus Conference (CHCC). 
4. History of positive antigen-specific anti-neutrophil cytoplasmic antibody (ANCA) 
testing since the time of diagnosis or at screening, or documented evidence of 
either anti-proteinase 3 (anti-PR3) or anti--myeloperoxidase (anti-MPO) (for newly 
diagnosed subjects a recent positive antigen-specific ANCA testing or documented 
positive anti-PR3 or anti-MPO is mandatory for inclusion). 
5. Have ≥ 1 major item, or ≥ 3 minor items, or ≥ 2 renal items on the Birmingham 
Vasculitis Activity Score Version 3 (BVASv3). 
6. Newly diagnosed or relapsed GPA or MPA that requires treatment with CYC or 
RTX plus GCs. 
7. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m². 
 
Subjects who fulfil any of the following criteria at screening are not eligible to 
participate in the study: 
1. Any other multi-system autoimmune disease as listed in Appendix 18.4. 
2. Require mechanical ventilation because of alveolar hemorrhage at screening. 
3. Known hypersensitivity to any investigational medicinal product (IMP) (i.e. GC, 
IFX-1) and/or any excipients. 
4. Subject with rare hereditary problems of galactose intolerance, total lactase 
deficiency or glucose-galactose malabsorption. 
5. Have required management of infections, as follows:  
a. Chronic infection requiring anti-infective therapy (such as latent 
tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, herpes 
simplex virus, herpes zoster and atypical mycobacteria) within  
3 months before screening. 
b. Use of intravenous antibacterials, antivirals, anti-fungals, or 
anti-parasitic agents within 30 days of screening. 
6. Current and/or history (within the previous 5 years) of drug and/or alcohol abuse 
and/or dependence. 
7. Evidence of Hepatitis B virus (HBV), Hepatitis C virus (HCV) and/ or human 
immunodeficiency virus (HIV) infection. Only subjects with documented negative 
historical results (within 4 weeks before Screening) for HBV, HCV and HIV or a 
negative test by Screening can be included into the study. 
8. Any of the following abnormal laboratory findings at screening: 
a. White blood cells < 3,500/mm3 
b. Platelet count < 100,000/mm3 


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c. Transaminase values (aspartate aminotransferase [AST] and/or alanine 
aminotransferase [ALT]) ≥ 2.5 times the upper limit of normal range (ULN) 
d. Total bilirubin ≥ 1.5 times ULN 
e. Alkaline Phosphatase (ALP) > 3 times ULN 
9. Current or history of malignancy, lymphoproliferative, or myeloproliferative 
disorder except squamous cell or basal cell carcinomas of the skin and cervical 
carcinoma in situ with curative surgical treatment. 
10. Received CYC or RTX within 12 weeks before screening or within 12 weeks 
before CYC or RTX is started for remission induction within 2 weeks before 
screening. 
If subject is on AZA, MMF or MPS or MTX, these drugs must be discontinued 
prior to receiving the first dose of CYC or RTX. 
11. Received > 3 g cumulative intravenous GCs within 4 weeks before screening (RTX 
intravenous GC premedication is separate and does not count to the 3 g). 
12. a) Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more 
than 6 weeks continuously prior to screening. 
b) Received an oral daily dose of a GC of > 80 mg prednisone-equivalent within 
2 weeks before screening. 
13. Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, 
alemtuzumab, any other experimental or biological therapy, intravenous 
immunoglobulin or plasma exchange, antithymocyte globulin, or required renal 
dialysis within 12 weeks before screening. 
14. Received a live vaccination within 4 weeks before screening or planned between 
screening and Week 24. 
15. Either active or latent tuberculosis treatment is ongoing. 
16. Pregnant or lactating. 
17. Clinically significant abnormal electrocardiogram (ECG) during screening. 
18. Female subjects of childbearing potential unwilling or unable to use a highly 
effective method of contraception (pearl index < 1) during treatment and for at least 
3 months after last administration of IFX-1/Placebo-IFX-1 (or up to 12 months, the 
timeframes for Standard of Care agents have to be considered as described in the 
respective Prescribing Information/Summary of Product Characteristics [SmPC]). 
Contraception methods regarded as highly effective methods and the duration of 
contraception are further described in Section 7.7. 
19. Evidence or suspicion that the subject might not comply with the requirements of 
the study protocol. 
20. The subject is an employee or direct relative of an employee of the sponsor 
(InflaRx GmbH). 
21. The subject is imprisoned or lawfully kept in an institution. 


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22. The subject has participated in an investigational clinical study during the 12 weeks 
(or 5 times the half-life of the previous IMP, whichever is longer) before screening, 
or plans to participate in another investigational clinical study during their 
participation in this study. 
23. Male subjects with female partners of childbearing potential unwilling to use 
contraception (condoms) during treatment and for at least 3 months after last 
administration of IFX-1/Placebo-IFX-1. 
Test Product, Dose, and Mode of Administration:  
IFX-1 is provided in 10 mL vials containing 100 mg IFX-1 and will be infused over a 
period of 30 to 60 min via an intravenous line. 
Placebo-GC are capsules for oral administration filled with an excipient only, they will 
have the same appearance as the GC capsules. 
Reference Therapy, Dose, and Mode of Administration: 
GC are provided in capsules for oral administration. Different numbers and strengths 
of tablets per capsule will be combined in order to have several GC doses available per 
dosing. 
Placebo-IFX-1 is provided in 10 mL vials. The placebo vials and content have the 
same appearance as the IFX-1 vials and will be administered in the same manner as 
IFX-1. 
Study Duration: 
The study duration for an individual subject will be up to 26 weeks: a 2-week 
Screening Period, a 16-week Treatment Period, and an 8-week Follow-up Period. 
Criteria for Evaluation 
Primary Endpoint: 
• 
The proportion of subjects achieving clinical response defined as reduction in 
BVASv3 ≥ 50% at Week 16 compared to baseline (=screening assessment) and no 
worsening in any body system. Subjects who receive rescue therapy up to Week 
16 will be considered as not having achieved clinical response.  
Secondary Endpoints: 
 
Efficacy 
• 
Proportion of subjects with a clinical response, defined as a reduction in BVASv3 
≥ 50% and no worsening in any body system at each measurement time point 
except Week 16 
• 
Proportion of subjects with a clinical remission defined as having a BVASv3 = 0 
at Week 16 
• 
Change from baseline (=screening assessment) in BVASv3 total score at Week 16 
• 
Absolute values and absolute and relative change from Day 1 in the Vasculitis 
Damage Index (VDI) at Week 16 


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• 
Absolute values and absolute and relative change from Day 1 in the Physician 
Global Assessment (PGA) at Week 16 
• 
Absolute values and absolute and relative change from Day 1 in eGFR in 
mL/min/1.73 m² at Week 16 
 
Pharmacokinetic/Pharmacodynamic 
• 
Plasma concentration of IFX-1 at each sample time point 
• 
Absolute values and absolute and relative changes from Day 1 in the PD 
parameters at each sample time point. 
 
Safety 
• Number and percentages of subjects with treatment-emergent adverse events 
(TEAEs), serious adverse events (SAEs), and adverse events of special interest 
(AESIs) 
• Absolute values of the glucocorticoid toxicity index (GTI) at each time point 
• Absolute values and changes from Day 1 (baseline) by visit for safety laboratory 
and vital sign parameters. 
• Immunogenicity will be assessed by determining the number and percentage of 
subjects with detection of anti-drug antibodies (ADAs). 
Statistical Methods: 
Efficacy: 
For Study Part 1 only a descriptive efficacy analysis is planned.  
The primary efficacy variable is the percentage of subjects with a clinical response 
defined as a reduction in BVASv3 ≥ 50% at Week 16 compared to baseline, and no 
worsening in any body system, and not having received rescue therapy. Missing 
primary endpoint data will be imputed. 
The experimental arm (Group C) and the Standard of Care arm (Group B) will be 
compared using the risk difference and its 90% confidence interval based on the 
Farrington-Manning score. 
As a secondary efficacy analysis, a logistic regression model will be fit for the binary 
response at Week 16 including relevant baseline characteristics (such as the baseline 
BVASv3) as covariates to further investigate the effect of subjects’ baseline 
characteristics. 
Further secondary and exploratory efficacy endpoints will be evaluated with 
appropriate statistical methods and will be described in detail in the statistical analysis 
plan. 
Model based analyses (e.g., analysis of covariance, Poisson, and logistic regression 
models) for continuous, count, and binary endpoints will be defined in the statistical 
analysis plan as deemed necessary and possible. 
Safety: 


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TEAEs will be analyzed according to the number and percentage of subjects who had a 
TEAE, as well as the number of TEAEs with the respective Medical Dictionary for 
Regulatory Activities System Organ Class and Preferred Term. Additionally, the 
number and percentage of subjects with TEAEs will be grouped by severity and causal 
relationship. The number and percentage of subjects with SAEs and AESIs and the 
number of SAEs and AESIs will be analyzed. Where AEs are grouped by severity or 
relationship, the maximum severity/relationship per subject and class of adverse event 
(AE) will be considered. If the number of subjects discontinuing treatment or 
discontinuing the study is substantial, further analyses taking into account the time of 
AE onset and cumulative dose may be considered. 
Summary statistics will be presented for the absolute values of the GTI at each time 
point. 
Safety laboratory and vital signs parameters will be analyzed by summary statistics 
(e.g., number of observations, mean, standard deviation, minimum, median, maximum, 
lower quartile, upper quartile) for absolute values and changes from Day 1 by visit. 
Categorical safety parameters like ECG findings will be summarized by absolute and 
relative frequencies by time point. 
Pharmacokinetics and pharmacodynamics: 
Actual PK sampling times will be determined, and the plasma concentration of IFX-1 
will be assessed by time point. 
Where applicable, the absolute values and changes from baseline of PD endpoints will 
be summarized using descriptive statistics (e.g., number of observations, mean, 
standard deviation, minimum, median, maximum, lower quartile, upper quartile, 
geometric mean) by time point. 


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SPONSOR SIGNATURE PAGE 
 
Protocol/Study Number: 
IFX-1-P2.5 
 
Study Title: A randomized, double-blind, double-dummy, active-controlled, 
multicenter, 2-part Phase II study on replacement of steroids by IFX-1 in 
active granulomatosis with polyangiitis (GPA) and microscopic 
polyangiitis (MPA) 
 
 
 
Sponsor’s Responsible Medical Officer: 
 
 
________________________ 
_________________________________________ 
Date 
 
 
 
 
 MD, MSc 
 
                                                
 
  
 


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COORDINATING INVESTIGATOR SIGNATURE PAGE 
 
Protocol/Study Number: 
IFX-1-P2.5 
 
Study Title: A randomized, double-blind, double-dummy, active-controlled, 
multicenter, 2-part Phase II study on replacement of steroids by IFX-1 in 
active granulomatosis with polyangiitis (GPA) and microscopic 
polyangiitis (MPA) 
 
 
 
Coordinating Investigator:  
 
________________________ 
_________________________________________ 
Date 
  
 
 
 


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INVESTIGATOR SIGNATURE PAGE(S) 
 
Protocol/Study Number: 
IFX-1-P2.5 
 
Study Title: A randomized, double-blind, double-dummy, active-controlled, 
multicenter, 2-part Phase II study on replacement of steroids by IFX-1 in 
active granulomatosis with polyangiitis (GPA) and microscopic 
polyangiitis (MPA) 
I have read this study protocol, including the appendices. By signing this protocol, I agree 
to conduct the clinical study, following approval by an Independent Ethics Committee/ 
Institutional Review Board, in accordance with the protocol, ICH-GCP, the Declaration 
of Helsinki, and applicable national regulatory requirements. As required by applicable 
regulatory requirements, changes to the protocol will only be implemented after written 
approval is received from the sponsor and the Independent Ethics Committee/Institutional 
Review Board, with the exception of medical emergencies. I will ensure that all 
personnel involved in the study under my direction will be informed about the contents of 
this protocol and will receive all necessary instructions for performing the study 
according to the protocol.  
A separate signature page should be created for each principal investigator.  
Names and affiliations to be filled out by the investigators. 
 
Principal Investigator: 
 
Name and affiliation: 
_________________________________________ 
 
_________________________________________ 
 
________________________ 
_________________________________________ 
Date 
Signature 


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1 
SCHEDULE OF ASSESSMENTS 
The Schedule of Assessments is applicable to all subjects in Study Parts 1 and 2. 
 
Screening 
Randomization a 
Treatment Period 
Follow-Up 
Period 
SFU c 
USV n 
Visit 
V1 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
V9 
V10 
V11 
V12 
V13 
V14/ 
EOS b 
Week W -2 to -1 
W0 
W1 
W2 
W4 
W6 
W8 
W10 
W12 
W14 
W16 
W20 
W24 
Day 
-14 to -1 
1 
4 
8 
15 
29 
43 
57 
71 
85 
99 
113 
141 
169 
Accepted Time Window 
(in days) 
 
 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±3 
±3 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy test d 
X i 
X 
 
 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
 
Demographics and 
baseline characteristics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight 
X 
X 
 
 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
X 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SF-36v2, EQ-5D-5L e 
 
X 
 
 
 
X 
 
X 
 
X 
 
X  
X 
X 
X 
 
BVASv3 
X 
X 
 
 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
X 
VDI 
 
X 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
X 
PGA 
 
X 
 
 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
X 
GTI f 
 
X  
 
 
 
 
 
 
 
 
 
X 
 
X 
X 
X 


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Screening 
Randomization a 
Treatment Period 
Follow-Up 
Period 
SFU c 
USV n 
Visit 
V1 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
V9 
V10 
V11 
V12 
V13 
V14/ 
EOS b 
Week W -2 to -1 
W0 
W1 
W2 
W4 
W6 
W8 
W10 
W12 
W14 
W16 
W20 
W24 
Day 
-14 to -1 
1 
4 
8 
15 
29 
43 
57 
71 
85 
99 
113 
141 
169 
Accepted Time Window 
(in days) 
 
 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±3 
±3 
Vital signs g 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Electrocardiogram 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
X 
 
Physical examination 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
X 
X 
IFX-IMP administration: 
IFX-1 or Placebo-IFX-1 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Daily GC-IMP intake: 
RDGC/SDGC/NGC 
 
 
X 
Serum sample total 
protein 
X i 
 
X 
 
X 
X 
X 
 
X 
 
X 
 
X 
X 
X 
X 
X 
Safety laboratory 
measurements 
X i 
X 
 
 
 
X 
 
X 
 
X 
 
X 
X 
X 
X 
X 
Serology: HIV/hepatitis 
B/hepatitis C virus 
X i,l 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Anti-GBM 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis  
X i 
X 
 
X 
X 
X 
 
X 
 
X 
 
X 
X 
X 
X 
X 
IFX-1 level h 
 
X 
X 
Xh* 
X 
Xh* 
X 
X 
X 
X 
X 
Xh* 
X 
X 
 
 


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Screening 
Randomization a 
Treatment Period 
Follow-Up 
Period 
SFU c 
USV n 
Visit 
V1 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
V9 
V10 
V11 
V12 
V13 
V14/ 
EOS b 
Week W -2 to -1 
W0 
W1 
W2 
W4 
W6 
W8 
W10 
W12 
W14 
W16 
W20 
W24 
Day 
-14 to -1 
1 
4 
8 
15 
29 
43 
57 
71 
85 
99 
113 
141 
169 
Accepted Time Window 
(in days) 
 
 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
±3 
±3 
Sampling for: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 C5a  
 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
X 
 
 
 
CH50, CRP 
 
X 
 
X 
X 
X 
 
X 
 
X 
 
X 
X 
X 
 
 
 
IFX-1 blocking 
 
activity 
 
 
 
 
X 
 
 
 
 
 
 
X 
X 
X 
 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
 
Samples for future 
research  
 
X 
 
 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
 
Anti-drug antibodies  
 
X 
 
 
X 
X 
 
X 
 
X 
 
X 
X 
X 
 
 
Adverse events 
X 
 
X 
X 
AxMP administration m 
 
 
X 
Prior and concomitant 
therapy 
X 
 
 
X 
X 


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a 
Randomization can be performed at any time between completion of the screening assessments and the first IMP administration on Day 1. 
b 
These assessments should be performed at: 
• 
Week 24 for subjects who complete the study. 
• 
The time when a subject’s participation in the study is prematurely discontinued from the study (end of study [EOS] visit). 
c 
Safety follow-up visit (SFU): 1 month (±3 days) after the last IMP administration for any subject who discontinues from the study up to and including 
Week 16 (i.e., during the Treatment Period). 
d 
Only in women of childbearing potential: Serum pregnancy test (beta-human chorionic gonadotropin) at screening and Visit 14/EOS. Also at 
discontinuation and safety follow-up. Urine pregnancy test (dipstick) at Visits 2, 6, 8, 10, 12 and 13. 
e 
The questionnaires should be completed at the study site before any other assessments are performed. 
f 
Only baseline laboratory parameters and specific list items will be assessed for the GTI. 
g 
Vital signs include: systolic and diastolic blood pressure, pulse rate (after 5 min in a sitting position), respiratory rate, and body temperature. 
h 
 
i 
Only the screening laboratory testing for serology, safety laboratory (including serum total protein), serum pregnancy test, and urinalysis, including BVAS-
relevant laboratory value assessments, for screening and inclusion into the study can be done either in a capable local laboratory or the central laboratory. 
If screening testing is done in a local laboratory, no respective blood samples are shipped to the central laboratory. 
 
Blood samples for laboratory measurements taken from Visit 2 onwards always have to be sent to and analyzed by the central laboratory. 
k 
  
l 
At screening, serology viral tests for HIV, HBV, and HCV are to be done for evidence of active or chronic viral infection, or a documented history (viral 
test results) done within 4 weeks before screening is available for HIV, HBV, and HCV viral testing. 
m 
RTX (with intravenous GC premedication) or CYC as remission-induction treatments are allowed to be started up to 2 weeks prior to screening and are 
to be continued until clinical remission. Any other immunosuppressive therapy has to be stopped when RTX or CYC starts. After clinical remission, 
subject can stay on RTX or CYC, or can be switched to AZA, MTX, MMF, or MPS as remission-maintenance treatment at the discretion of the 
investigator until Week 24. 
n 
For subjects with suspect of major or minor relapse visiting the center between 2 scheduled visits. If subject with suspect of minor or major relapse will 
visit the study center at a scheduled visit, the assessments and procedures of this respective scheduled visit have to be done.  
 
 


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2 
INTRODUCTION 
2.1 
BACKGROUND INFORMATION ON THE INDICATION 
Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are related 
systemic vasculitides that, along with eosinophilic granulomatosis with polyangiitis 
(EGPA), are grouped under the term anti-neutrophil cytoplasmic antibody (ANCA)-
associated vasculitis (AAV). Both GPA and MPA are associated with ANCA, have 
many identical clinical manifestations, many similar histologic features, and similar 
outcomes. GPA and MPA predominantly affect small vessels and are associated with 
myeloperoxidase-ANCA (MPO-ANCA) or proteinase 3-ANCA (PR3-ANCA). 
Although neither sensitive nor specific, common complaints and signs of GPA and MPA 
include fatigue, fever, weight loss, arthralgia, rhinosinusitis, cough and dyspnea, urinary 
abnormalities (an active urine sediment) with or without renal insufficiency, purpura, 
and neurologic dysfunction. These forms of vasculitis can manifest themselves and 
progress slowly over months or explosively over days. If untreated, GPA and MPA 
progress from a limited disease process (e.g., inflammation centered on the upper 
respiratory tract or lung) to a generalized phase, characterized by multiple complications 
of small-vessel vasculitis (i.e., leukocytoclastic vasculitis of the skin, mononeuritis 
multiplex, alveolar hemorrhage, rapidly progressive glomerulonephritis, and mesenteric 
vasculitis) [Reinhold-Keller et al.,2000]. 
GPA and MPA most commonly occur in older adults, although these diseases have been 
reported at all ages [Jennette et al.,1997, Seo et al.,2004]. Men and women are equally 
affected, and the diseases are far more common among white individuals than those of 
other races/ethnicities [Falk et al.,1990]. 
The incidence of these conditions in the United States of America is approximately 
6,000 new cases per year, and the estimated prevalence is 25,000 to 30,000 cases. The 
overall incidence rates of AAV in Europe are reported to be in the range of 13 to 
approximately 20 per million [Watts et al.,2015]. The prevalence of AAV is estimated to 
be 46 to 184 per million [Ormerod et al.,2008, Reinhold-Keller et al.,2000]. The 
prevalence of AAV has generally increased over the last 20 years, this could reflect 
improved patient survival and case identification, e.g., by using multiple retrieval 
sources [Watts et al.,2015]. 
The Standard of Care as recommended in the guideline for AAV [Yates et al.,2016] 
usually consists of rituximab (RTX) or cyclophosphamide (CYC) administration for 
remission-induction, with glucocorticoid (GC) tapering followed by azathioprine (AZA), 
methotrexate (MTX), mycophenolate mofetil (MMF), or mycophenolate sodium (MPS) 
for remission-maintenance. Alternatively, a second cycle of RTX can be given. 
Although treatment failures and disease relapses decreased due to the improvement of 
remission-induction regimens during recent years, patients with MPA and GPA treated 
with conventional regimens have a 9-fold increased mortality risk in the first year 


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attributed to infection, cardiovascular disease, malignancies, vasculitis activity, and 
renal disease [Luqmani et al.,2011 a, Flossmann et al., 2011]. It is proven that current 
therapies contribute to more than half of this increased risk rather than the underlying 
disease itself [Little et al.,2010]. Most of the side effects are attributed to the high-dose 
of GCs, which are still part of Standard of Care for MPA and GPA. GCs have long-term 
side effects such as osteoporosis, Cushing’s syndrome, increased infection risk and risk 
of diabetes mellitus [Goupil et al.,2013, Moghadam-Kia et al.,2010, Charlier et al.,2009, 
McGregor et al.,2012], and progressive organ damage [Robson et al.,2015]. Therefore, 
the replacement of GCs by IFX-1 may improve the short- and long-term safety of the 
treatment of MPA and GPA for the induction of remission. 
2.2 
BACKGROUND INFORMATION ON IFX-1 
IFX-1 is a monoclonal antibody which specifically binds to the soluble human 
complement split product C5a. Nonclinical studies have demonstrated that IFX-1 binds 
to its target rapidly and is capable of a nearly complete blockade of C5a-induced 
biological effects, while not affecting cleavage of C5 or formation of the complement 
membrane attack complex (MAC). 
Various nonclinical studies have been conducted to assess pharmacological and 
toxicological aspects of IFX-1, none of which revealed any obvious toxicological or 
safety concerns for IFX-1. IFX-1 was well tolerated and did not show any toxicity with 
any of the doses tested. 
IFX-1 is an investigational medicinal product (IMP) and is not approved in any country 
worldwide. To date, IFX-1 has been investigated in 1 Phase I study in healthy subjects 
and in 3 Phase II studies: in subjects with early septic organ dysfunction, in subjects 
undergoing complex cardiac surgery, and in subjects with moderate to severe 
hidradenitis suppurativa (HS). 
 
 Based on the study data available, IFX-1 was safe and well 
tolerated when administered to healthy volunteers and subjects. In addition to GPA and 
MPA, IFX-1 is also in clinical development for moderate to severe HS and pyoderma 
gangrenosum. 
 


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2.3 
RATIONALE FOR THE STUDY 
AAV is a group of potentially life-threatening autoimmune diseases. Experimental data 
from animal models and in vitro experiments demonstrate that primed neutrophils are 
activated by ANCA and generate C5a that engages C5a receptors on neutrophils. As 
expected, patients with ANCA-related disease have elevated plasma and urine levels of 
C5a in active disease and not in remission [Chen et al.,2017]. Given the mode of action 
of IFX-1 as a monoclonal antibody specifically binding to the soluble human 
complement split product C5a and the resulting nearly complete blockade of 
C5a-induced biological effects, it may be effective in the treatment of subjects with 
AAV.  
IFX-1 was safe and well tolerated in other life-threatening indications like sepsis and 
cardiac surgery, and long-term data are available from a clinical study in HS. Even 
though IFX-1 has not yet been investigated in AAV, no unexpected safety issues are 
anticipated. 
The aim of this study is to investigate the efficacy and safety of IFX-1 in the 
replacement of GCs used for remission-induction in addition to immunosuppressive 
therapy. High-dose GCs are an important part of Standard of Care in AAV and are 
associated with several toxicities.  
As demonstrated in a series of studies on Avacopan, a drug which blocks the effects of 
C5a by targeting its receptor C5aR, the reduction of C5a effects can replace high-dose 
GCs [Jayne et al.,2017]. The current study will investigate the efficacy and safety of 
IFX-1 in the replacement of GCs using a stepwise approach to reduce the amount of GC. 
The study will also collect data on patient-reported outcomes (PROs) and clinical 
parameters that could be positively affected by a C5a blocking therapy instead of 
treatment with GC. 
2.3.1 Study Population 
Subjects with newly diagnosed or relapsed GPA or MPA who require treatment with 
RTX or CYC plus SDGCs will be randomized in this study. These subjects are 
considered to have a sufficiently severe disease, whereas subjects with life-threatening 
symptoms will not be enrolled since IFX-1 has not been investigated in this indication 
before.  
The exclusion criteria (Section 5.3) will ensure that the study population is as 
homogenous as possible.  
2.3.2 Dosing Regimen 
The aim of treatment with IFX-1 is to achieve an almost complete blockade of the 
overall available C5a (existing and newly produced) in human whole blood during the 
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 According to available data and derived estimates, 
dosing with 800 mg every 2 weeks will result in mean IFX-1 trough levels in the range 
of 10 to 20 µg/mL, which should result in a situation where C5a is almost completely 
blocked over the entire treatment period. 
The toxicological profile of IFX-1 is considered adequate to support the planned 
Phase II clinical study in subjects who will be treated at doses of 800 mg IFX-1 for a 
period of 16 weeks. There were no relevant findings in the toxicology studies which 
would preclude the continued clinical development of IFX-1. 
2.3.3 Study Design 
This is a prospective, randomized, double-blind, double-dummy, active-controlled, 
multicenter, 2-part Phase II study evaluating the efficacy of IFX-1 treatment in the 
replacement of GCs in subjects with GPA or MPA. The primary objective is to evaluate 
the efficacy of IFX-1 treatment as a replacement for GC therapy in subjects with GPA 
and MPA. A design with 2 study parts was chosen, since the safety and efficacy of IFX-
1 have not been investigated in GPA or MPA subjects to date. In Study Part 1, subjects 
will be randomized to either Placebo-IFX-1 with SDGC or to IFX-1 with a reduced-dose 
glucocorticoid (RDGC) treatment tapering regimen. After a blinded adjudication 
committee (AC) and an unblinded IDMC have concluded that subjects treated with IFX-
1 and RDGC have shown an equivalent treatment response as compared to subjects 
treated with conventional SDGC, Study Part 2 will start with a comparison of Placebo-
IFX-1 with SDGC and IFX-1 with placebo-glucocorticoids (Placebo-GC). This stepwise 
design is deemed appropriate for investigating the efficacy and safety of IFX-1 treatment 
in subjects with GPA or MPA without increasing the harm, since continuous monitoring 
of the subjects is guaranteed, and Study Part 2 can only start after such a 
recommendation by the IDMC.  
The study will be conducted in compliance with this study protocol, International 
Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use (ICH) guidelines for Good Clinical Practice (GCP), and the applicable regulatory 
requirements. 
2.3.4 Expected Benefits 
The subjects who will be treated with IFX-1 or placebo in this study will benefit from an 
improvement in GPA and MPA-related symptoms since all subjects will receive 
background standard immunosuppressive therapy as detailed in Section 6.2. Since more 
than half of the subjects will additionally receive IFX- 1, they may experience a faster 


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response to treatment. Half of the subjects in Study Part 1 will receive reduced dose GC, 
and about 2/3 of the subjects enrolled in Study Part 2 will not be administered GC at all. 
These subjects are expected to have less or will not experience GC adverse effects at all, 
meaning a decreased risk of the above described and well-known high mortality during 
the first year of treatment. 
2.4 
RISK-BENEFIT ASSESSMENT 
Considerations on risk-benefit-related aspects are derived from nonclinical data and 
clinical Phase I data in healthy subjects, as well as from clinical data from 3 other 
Phase II studies conducted in subjects with early, newly developing abdominal or 
pulmonary-derived septic organ dysfunction, in subjects undergoing complex cardiac 
surgery, and in subjects with HS. In addition, the mode of action of IFX-1 is clearly 
supported in subjects with GPA and MPA [Van Timmeren et al.,2012]. 
2.4.1 Potential Risks 
No subject with GPA or MPA has been treated with IFX-1 to date, but IFX-1 was 
generally well tolerated in other studies and no new risks are anticipated. However, 
potential and theoretical risks associated with administration of IFX-1 may include 
infections, meningitis/meningococcal sepsis, and anaphylactic reactions/acute allergic 
hypersensitivity (Section 10.3). 
Since no subject with GPA or MPA has been treated with IFX-1 in combination with 
immunosuppressive therapy, the drug-drug interactions, safety, tolerability, and efficacy 
of IFX-1 have not yet been investigated. 
Subjects in Group A and B will receive GCs which may have adverse effects on many 
organ systems and range from those that are not necessarily serious, but are displeasing 
to patients, to those that are life-threatening. In addition, in several countries RTX and 
CYC are not licensed for all treatment periods. However, there are international 
treatment standards and/or local treatment guidelines that must be adhered to by the 
investigators. 
2.4.2 Risk Associated with Lack of Efficacy 
RTX or CYC will be administered as immunosuppressive therapy until clinical 
remission (i.e., during the Remission-Induction Phase) and can be given after clinical 
remission at the discretion of the investigator. Due to the treatment response rate of up to 
90% for this established remission-induction therapy, the risk of lack of efficacy is 
deemed to be very low in this study. In accordance with the current guidelines for AAV 
[Yates et al.,2016], subjects can receive AZA, MTX, MMF, or MPS after clinical 
remission is reached (i.e., during the Remission-Maintenance Phase) as deemed 
appropriate by the investigator. In case of a lack of efficacy with IMP treatment (no 
effect of IFX-1 or too low dose of GC) or in case of any relapses, subjects can receive 


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rescue therapy with GCs as described in Section 5.4.1 and Section 7.5 to avoid harm to 
the subjects. 
With the administration of IFX-1 or Placebo-IFX-1, no deterioration in health status is 
expected with respect to GPA and MPA 
 
In addition, during the Study Part 1 an AC will continuously evaluate the clinical 
response and remission status of each subject (Section 14.3).  
In case of insufficient treatment response, the Independent Data Monitoring Committee 
(IDMC) can recommend stopping the study at any time. Similarly, the principal 
investigator can stop the study at his/her site at any time. The subject can also choose to 
discontinue the study at any time (Section 5.4). 
2.4.3 Conclusion 
GPA and MPA are the 2 major forms of systemic vasculitis associated with ANCA 
[Hoffman,1998]. If untreated, they progress from limited disease processes (e.g., 
inflammation centered on the upper respiratory tract or lung) to a generalized phase, 
characterized by multiple complications of small-vessel vasculitis (i.e., leukocytoclastic 
vasculitis of the skin, mononeuritis multiplex, alveolar hemorrhage, rapidly progressive 
glomerulonephritis, and mesenteric vasculitis) [Reinhold-Keller 2000]. The outcome of 
untreated severe disease is death. 
Although treatment failures and disease relapses have decreased due to improvement of 
remission-induction regimens during recent years, patients with MPA and GPA treated 
with conventional regimens have a 9-fold increased mortality risk in the first year. This 
is attributed to infection, cardiovascular disease, malignancies, vasculitis activity, and 
renal disease [Flossmann et al.,2011, Luqmani et al.,2011 a]. Current therapies 
contribute to more than half of this increased risk, rather than the underlying disease 
itself [Little et al.,2010]. Most of the side effects are attributed to the high dose of GCs, 
which are still part of Standard of Care for MPA and GPA. GCs have long-term side 
effects such as osteoporosis, Cushing’s syndrome, increased infection risk, risk of 
diabetes [Moghadam-Kia et al.,2010, Charlier et al.,2009, McGregor et al.,2012, Goupil 
et al.,2013], and progressive organ damage [Robson et al.,2015]. 
It was demonstrated that C5a and C5b receptors are involved in the pathogenesis of 
AAV and that C5a levels are increased in patients with AAV [Chen et al.,2017, Furuta et 
al.,2013, Halbwachs et al.,2012, Kettritz,2014]. Since IFX-1 is a monoclonal antibody, 
which specifically binds to the soluble human complement split product C5a, it is 
capable of a nearly complete blockade of C5a-induced biological effects, while not 
affecting cleavage of C5 and formation of the complement MAC. Therefore, IFX-1 
could be effective in the treatment of subjects with GPA and MPA and will be 
administered as add-on to immunosuppressive therapy for GPA and MPA to improve 
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Subjects in Group B will receive Standard of Care and are not at a higher risk. Since in 
Study Part 1 subjects randomized to Group A will receive a lower GC regimen, these 
subjects will be at risk for too low levels of GC therapy if IFX-1 is not effective in this 
condition. Other studies are currently ongoing that are investigating GC tapering with 
lower GC doses in AAV [Furuta et al.,2017, Walsh et al.,2013], and it was recently 
shown that a low-dose tapering was non-inferior to standard high-dose GC [Walsh et 
al.,2018]. Group C will only receive Placebo-GCs if a comparable treatment response of 
Group B to Group A was seen by the IDMC in Study Part 1. 
In case of a lack of efficacy or relapse after IMP treatment, subjects will receive 
adequate rescue medication as described in Section 7.5. Risk-limiting procedures have 
been put in place and therefore the hypothesized benefit of treatment with IFX-1 
outweighs the potential risks for subjects participating in this study. 


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3 
OBJECTIVES 
3.1 
PRIMARY OBJECTIVE 
The primary objective is to evaluate the efficacy of IFX-1 treatment as replacement for 
GC therapy in subjects with GPA and MPA. 
3.2 
SECONDARY OBJECTIVES 
The secondary objectives of the study are: 
• 
To assess safety and tolerability of IFX-1 
• 
To compare GC-induced toxicity of standard-dose GC and reduced-dose GC with 
IFX-1 treatment 
• 
To generate data for pharmacokinetic (PK) and pharmacodynamic (PD) modelling 
of IFX-1 treatment. 
All study endpoints are listed in Section 11.4. 


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4 
STUDY DESIGN 
4.1 
OVERALL STUDY DESIGN AND PLAN 
This is a prospective, randomized, double-blind, double-dummy, active-controlled, 
multicenter, 2-part Phase II study.  
After a Screening Period of up to 14 days, 20 to 55 subjects are planned to be enrolled 
into the study (see Table 6 for further details).  
This is a double-dummy study; Placebo-IFX-1 and Placebo-GC will be administered in 
different treatment groups. To investigate the efficacy of IFX-1 in the replacement of 
GC during the study, 2 different GCdose regimens, standard (SDGC), and reduced 
(RDGC) and a Placebo-GC will be investigated. The treatment groups receiving IFX-1 
will receive RDGC or Placebo-GC, and the group with SDGC will receive Placebo-IFX. 
The 3 treatment groups investigated in this study will receive the following IMP 
combinations: 
Group A: 
IFX-1 + reduced-dose GC (RDGC)   
= IFX-1 + RDGC 
Group B: 
Placebo-IFX-1 + standard-dose GC (SDGC) = Placebo-IFX-1 + SDGC 
Group C: 
IFX-1 + no GC (NGC) 
 
 
= IFX-1 + Placebo-GC 
Subjects in all 3 treatment groups will receive either RTX or CYC (for details, see 
Section 6.2.1). RTX or CYC can be started within 2 weeks prior to the screening or at 
any time during the screening period, independently from the planned date of 
randomization. Treatment with RDGC, SDGC, and Placebo-GC (no glucocorticoids 
[NGC]) will start at Day 1 and the SDGC and RDGC will be tapered down according to 
a predefined schedule within 24 weeks (Section 6.1.2.5, Table 2).  
The study will consist of 2 parts: 
Study Part 1 aims to mitigate subjects’ risk by randomizing subjects to either Group A 
or Group B in a 1:1 distribution. Subjects will take either SDGC (Group B) or RDGC 
with IFX-1 (Group A), because there is no clinical data available regarding the efficacy 
of IFX-1 to replace GC treatment. 
In Study Part 2, subjects will be randomized to either Group B or Group C in a ratio that 
yields about 9 subjects in Group B and about 16 subjects in Group C. Subjects who have 
been randomized into Group B in Study Part 1 will contribute to the set of subjects 
analyzed in Study Part 2 resulting in about 24 subjects in Group B vs about 16 subjects 
in Group C for the primary comparison. 
An overview of the overall study design is shown in Figure 1. 
 


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Figure 1 Overall Study Design 
 
 
Adjudication Committee 
An AC will be set up before study start. The AC will continuously evaluate the 
treatment response of each subject for each study visit under blinded conditions 
throughout Study Part 1. (Sections 11.11 and 14.3). The organization and roles of the 
AC, and the individual efficacy data needed for their analysis will be defined and 
provided in a separate charter (Adjudication Committee Charter). 
Independent Data Monitoring Committee 
An IDMC will be set up and will be responsible for (1) a continuous review of subject 
safety data under unblinded conditions throughout the study, and (2) a recommendation 
to continue the study with Part 2 (Section 14.4). Details on the role and organization of 
the IDMC will be provided in a separate charter (Independent Data Monitoring 
Committee Charter).  
The reports of the AC will be continuously provided to the IDMC. On the basis of the 
AC reports and further unblinded safety data analysis (provided by an unblinded 
statistician) the IDMC will make a recommendation without predefined statistical 
criteria at the latest at the end of Study Part 1, after 20 subjects have reached the 
Week 16 timepoint. The recommendation will be: 
• 
If the study must be prematurely terminated 
• 
If a second evaluation needs to be done after enrolment of 10 further subjects 
• 
If a further evaluation needs to be done after 30 subjects, additional subjects should 
be included 
• 
If the study can continue with an amended protocol 


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• 
If the study can continue with Study Part 2 and open Group C for enrolment.  
There will be a recruitment stop after a maximum of 30 subjects have been enrolled in 
Study Part 1 for IDMC evaluation. 
In both study parts, the study schedule for each participating subject comprises a 
Screening, a Treatment, and a Follow-up Period. 
Screening period 
The screening procedures will be conducted between Day -14 and Day -1 before the first 
administration of IMP. Randomization of eligible subjects will be performed during the 
Screening Period and needs to be done at Day 1 (Visit 2) at the latest and prior to Day 1 
specific assessments. 
Treatment Period 
For each subject, the Treatment Period starts with Visit 2 in Week 0 (Day 1, 
immediately before first administration of IMP) and ends in Week 16 (Visit 12) 
immediately after administration of IFX-IMP. 
Follow-up Period 
After the Treatment Period, subjects will enter the Follow-up Period, which will last 
until Week 24. In this Follow-up Period, no IFX-IMP treatment will be administered but 
the subjects will finalize their GC tapering schedule and can receive standard 
maintenance therapy for GPA/MPA, as described in Section 6.2.2. 
A final visit at the study site for efficacy and safety assessments (end of study visit) will 
occur in Week 24. 
4.2 
NUMBER OF SUBJECTS AND STUDY SITES 
This multicenter study is planned to be conducted at approximately 87 sites in 
approximately 13 countries. 
It is planned to randomize 55 subjects   (Section 11.2). 
4.3 
STUDY DURATION 
The study start is defined as the date of the first screening visit of the first subject who 
signs informed consent, and the end of the study is defined as the date of the last visit of 
the last subject, as recorded in the electronic case report form (eCRF). 
The study duration for an individual subject will be up to 26 weeks.  
The duration of the study periods is as follows: 
• 
Screening Period: up to 14 days before randomization (Week -2 to Week -1 [Day -
14 to Day -1]) 


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• 
Treatment Period: starts in Week 0 (Day 1) and ends in Week 16 (Day 113) 
• 
Follow-up Period: starts after administration of IFX-IMP in Week 16 and ends in 
Week 24 (Day 169). 
Subjects, who discontinue the study during the treatment period up to and including 
Week 16, will have a safety follow-up visit (SFU) 1 month (±3 days) after the last IMP 
administration.  
IFX-1 or Placebo-IFX-1 will be administered starting in Week 0 through Week 16, with 
a total of 11 infusions. 
4.4 
PREMATURE TERMINATION OF THE STUDY 
The entire study can be prematurely discontinued at all sites by the sponsor at any time 
for any reason (e.g., medical, ethical, or if the IDMC recommends not to start Part 2). 
The investigator(s) will be notified in writing, outlining the reasons for discontinuation, 
and the investigator(s) must promptly inform all participating subjects. Detailed 
instructions on further assessments will be provided. 
All study materials, except documents needed for archiving requirements, will be 
returned to the sponsor, including all records regarding the IMP. The clinical monitor 
will ensure that any outstanding data clarification issues and queries are resolved and 
that all study records at the study site are completed. 
In accordance with applicable regulatory requirements, the sponsor will promptly inform 
the competent regulatory authorities of the discontinuation and its reason(s), and the 
investigator or sponsor will promptly inform the Ethics Committee. 
Furthermore, the approval of the study can be rescinded, or the study can be 
discontinued by a competent authority or a responsible Ethics Committee. 


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5 
STUDY POPULATION 
5.1 
SCREEN FAILURES 
Screen failures are defined as study subjects who consent to participate in the study but 
are not subsequently randomized to a treatment group. 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 publishing requirements and to 
respond to queries from regulatory authorities. Screen failure information includes 
demographics, AAV-related and general medical history, AAV-related prior and 
concomitant medication, screen failure details, eligibility criteria, and any (serious) 
adverse event ([S]AE). 
Rescreening of subjects who do not meet the criteria for participation in this study is not 
allowed. 
5.2 
INCLUSION CRITERIA 
Subjects must meet all of the following criteria at screening and at inclusion to be 
randomized into the study: 
Inclusion Criteria 
Rationale 
1. Male or female, ≥ 18 years of age. 
Safety concern 
2. Written informed consent obtained from subject. 
Administrative 
3. Diagnosis of GPA or MPA according to the definitions of the 
Chapel Hill Consensus Conference (CHCC). 
Effectiveness 
4. History of positive antigen-specific ANCA testing since the time 
of diagnosis or at screening, or documented evidence of either 
anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) 
(for newly diagnosed subjects a recent positive antigen-specific 
ANCA testing or documented positive anti-PR3 or anti-MPO is 
mandatory for inclusion). 
Effectiveness 
5. Have ≥ 1 major item, or ≥ 3 minor items, or ≥ 2 renal items on the 
BVASv3. 
Effectiveness 
6. Newly diagnosed or relapsed GPA or MPA that requires treatment 
with CYC or RTX plus GCs. 
Effectiveness 
7. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m². 
Effectiveness / 
Safety concern 


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5.3 
EXCLUSION CRITERIA 
Subjects who fulfil any of the following criteria at screening are not eligible to 
participate in the study: 
Exclusion Criteria 
Rationale 
1. Any other multi-system autoimmune disease as listed in 
Appendix 18.4. 
Safety concern 
2. Requires mechanical ventilation because of alveolar 
hemorrhage at screening. 
Safety concern 
3. Known hypersensitivity to any IMP (i.e. GC, IFX-1) and/or 
any excipients. 
Safety concern 
4. Subject with rare hereditary problems of galactose intolerance, 
total lactase deficiency or glucose-galactose malabsorption. 
Safety concern 
5. Have required management of infections, as follows: 
a. Chronic infection requiring anti-infective therapy (such as 
latent tuberculosis, pneumocystis, aspergillosis, 
cytomegalovirus, herpes simplex virus, herpes zoster and 
atypical mycobacteria) within 3 months before screening. 
b. Use of intravenous antibacterials, antivirals, anti-fungals, 
or anti-parasitic agents within 30 days of screening. 
Safety concern 
6. Current and/or history (within the previous 5 years) of drug 
and/or alcohol abuse and/or dependence. 
Safety concern 
7. Evidence of Hepatitis B virus (HBV), Hepatitis C virus (HCV) 
and/ or human immunodeficiency virus (HIV) infection. Only 
subjects with documented negative historical results (within 4 
weeks before Screening) for HBV, HCV and HIV or a 
negative test by Screening can be included into the study. 
Safety concern 
8. Any of the following abnormal laboratory findings at 
screening: 
• White blood cells < 3,500/mm3 
• Platelet count < 100,000/mm3 
• Transaminase values (AST and/or ALT) ≥ 2.5 times the 
ULN 
• Total bilirubin ≥ 1.5 times ULN 
• ALP > 3 times ULN. 
Safety concern 


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Exclusion Criteria 
Rationale 
9. Current or history of, malignancy, lymphoproliferative or 
myeloproliferative disorder except squamous cell or basal cell 
carcinomas of the skin and cervical carcinoma in situ with 
curative surgical treatment. 
Safety concern 
10. Received CYC or RTX within 12 weeks before screening or 
within 12 weeks before CYC or RTX is started for remission 
induction within 2 weeks before screening. 
If subject is on AZA, MMF or MPS or MTX, these drugs must 
be discontinued prior to receiving the first dose of CYC or 
RTX. 
Safety concern 
11. Received > 3 g cumulative intravenous GCs within 4 weeks 
before screening (RTX intravenous GC premedication is 
separate and does not count to the 3 g). 
Effectiveness 
12. a) Received an oral daily dose of a GC of > 10 mg 
prednisone-equivalent for more than 6 weeks continuously 
prior to screening. 
b) Received an oral daily dose of a GC of > 80 mg 
prednisone-equivalent within 2 weeks before screening. 
Effectiveness 
13. Received a CD20 inhibitor, anti-tumor necrosis factor 
treatment, abatacept, alemtuzumab, any other experimental or 
biological therapy, intravenous immunoglobulin (Ig) or 
plasma exchange, antithymocyte globulin, or required renal 
dialysis within 12 weeks before screening. 
Safety concern 
14. Received a live vaccination within 4 weeks before screening 
or planned between screening and Week 24. 
Safety concern 
15. Either active or latent tuberculosis treatment is ongoing. 
Safety concern 
16. Pregnant or lactating. 
Safety concern 
17. Clinically significant abnormal electrocardiogram (ECG) 
during screening. 
Safety concern 
18. Female subjects of childbearing potential unwilling or unable 
to use a highly effective method of contraception (pearl 
index < 1) during treatment, and for at least 3 months after last 
administration of IFX-1/Placebo-IFX-1 (or up to 12 months, 
the timeframes for Standard of Care agents have to be 
considered as described in the respective Prescribing 
Information/SmPC). Contraception methods regarded as 
highly effective methods and the duration of contraception are 
further described in Section 7.7. 
Safety concern 


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Exclusion Criteria 
Rationale 
19. Evidence or suspicion that the subject might not comply with 
the requirements of the study protocol. 
Safety concern 
20. The subject is an employee or direct relative of an employee 
of the sponsor (InflaRx GmbH). 
Administrative 
21. The subject is imprisoned or lawfully kept in an institution. 
Administrative 
22. The subject has participated in an investigational clinical study 
during the 12 weeks (or 5 times the half-life of the previous 
IMP, whichever is longer) before screening, or plans to 
participate in another investigational clinical study during their 
participation in this study. 
Administrative 
23. Male subjects with female partners of childbearing potential 
unwilling to use contraception (condoms) during treatment 
and for at least 3 months after last administration of IFX-
1/Placebo-IFX-1. 
Safety 
5.4 
DISCONTINUATION OF INDIVIDUAL SUBJECT PARTICIPATION 
Each early discontinuation of individual subject participation, irrespective of the reason 
for discontinuation, must be documented by the investigator. If possible, the date, 
circumstances, and reason for discontinuation should be documented.  
The investigator will complete all procedures usually required at the end of the study 
(EOS, i.e., Week 24) visit at the time when the subject’s participation in the study is 
discontinued. Subjects who discontinue until, and including, Week 16 will have a safety 
follow-up visit at 1 month (±3 days) after the last IMP administration. 
5.4.1 Lack of Efficacy 
In case of lack of efficacy (for example: no improvement or deterioration in the 
BVASv3, lack of efficacy according to the clinical judgement of the investigator), it is at 
the discretion of the investigator to administer rescue medication (see Section 7.5), to 
keep the subject in the study and continue with IMP (IFX-IMP and GC-IMP) 
administrations, AxMP intake and study procedures/ assessments as scheduled, to 
discontinue IMPs (IFX-IMP and GC-IMP), or to withdraw the subject from further 
study participation (refer also to Section 7.5) 
If the investigator unblinds the subject to allow for an appropriate treatment, the subject 
must be discontinued from further study participation (see Section 6.3, Emergency 
Identification of Investigational Medicinal Product). Whenever possible, the investigator 
should contact the medical monitor before breaking the blind.  


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5.4.2 Withdrawal of Informed Consent 
Subjects may discontinue their participation in the study by withdrawing their consent at 
any time without giving reasons. Nevertheless, they should be asked about the reason(s) 
for discontinuation after being informed that they do not need to do so. Information as to 
when they withdrew consent must be documented. 
Subjects are to be informed that when consent is withdrawn, the stored and captured 
data as well as blood samples taken up until the time of termination may be used in the 
future to: 
• 
Assess effects of the IMP being tested 
• 
Guarantee that the subject’s personal interests are not adversely affected 
• 
Comply with the requirement to provide complete documentation when seeking 
marketing authorization. 
5.4.3 Discontinuation of the Investigational Medicinal Products 
Subjects’ treatment with IMPs (IFX-IMP and GC-IMP) must be discontinued under any 
of the following circumstances: 
• 
Unacceptable toxicity or treatment-emergent adverse event (TEAE) related to the 
IMP, as determined by the investigator 
• 
Subjects unblinded for IMP administration due to safety concerns or emergency 
treatments. Subjects must be discontinued from further study participation (see 
Section 6.3, Emergency Identification of Investigational Medicinal Product) 
• 
Anaphylactic or other serious allergic reaction 
• 
Serious infection, including meningitis or sepsis 
• 
If, in the investigator’s or sponsor’s opinion, continued administration of IMP could 
be detrimental to the subject’s well-being 
• 
Use of prohibited treatment that in the investigator’s or sponsor’s opinion 
necessitates the subject being removed 
• 
Biopsy confirmation of any malignancy 
• 
Pregnancy. 
Discontinuation of IMPs does not necessarily discontinue the subject from study 
participation and he/she can continue study procedures/assessments as scheduled. 
Lost to follow-up is defined as an unsuccessful attempt at contacting a subject.  
At least 3 attempts, e.g. letter to the subject, phone calls, etc., at 3 different times should 
be performed. In case all attempts are unsuccessful in contacting the subject, a certified 
letter will be issued to the subject. If the attempts and the letter remain unanswered after 
approximately 1 month, the subject is to be declared as lost to follow-up. All the 
attempts at contacting the subject should be documented in the subject’s records. 


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The date of being lost to follow-up is defined as the last date with any assessment of the 
subject. 


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6 
STUDY TREATMENTS 
6.1 
DETAILS OF THE INVESTIGATIONAL MEDICINAL PRODUCTS 
In this double-blind, double-dummy study, the drugs IFX-1 and Placebo-IFX-1, as well 
as GCs (RDGC, SDGC) and Placebo-GC (NGC) are considered IMP and will be 
supplied by the sponsor’s designated Contract Manufacturing Organization (CMO). All 
IMP must be kept strictly blinded to subjects, investigators, and other site personnel and 
will be labelled, handled, and administered accordingly. 
All IMP supplied for use in this study will be manufactured, tested, and released 
according to the standards of Good Manufacturing Practice. 
6.1.1 Description of IFX-1 and Placebo-IFX-1 (IFX-IMP) 
The active pharmaceutical ingredient of IFX-1 is a monoclonal anti-human C5a Ig. 
IFX-1 will be supplied in 10 mL glass vials at a concentration of 10 mg/mL (i.e., 100 mg 
per vial) for intravenous administration. 
 
Placebo-IFX-1 will be supplied in 10 mL glass vials for intravenous administration. 
.  
The Placebo-IFX-1 vials and content will have the same appearance as the IFX-1 vials. 
6.1.1.1 Packaging and Labelling of IFX-IMP 
IFX-1 and Placebo-IFX-1 will be packaged in cartons and labeled in accordance with all 
legal requirements. 
Each carton will contain 4 vials of IFX-1 or Placebo-IFX-1. 
The cartons will be labeled with a unique number (“medication number”). The glass 
vials containing IFX-1 or Placebo-IFX-1 will be labeled with the same medication 
number as the cartons in which they are packed. 
Each carton and each vial will be labeled with a multilingual booklet label or a country 
specific single panel label.  
6.1.1.2 Shipment of IFX-IMP 
The initial, and all subsequent supplies of IFX-IMP required, will be supplied to study 
sites by the sponsor’s designated CMO.  


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The IFX-IMP must be shipped at a temperature of 2°C to 8°C and should not be frozen. 
Each shipment will be controlled by a temperature logger, of which a read-out must be 
obtained by the site personnel upon receipt of the shipment. 
The initial shipment of IFX-IMP to the sites will be automatically triggered by the 
Interactive Web Response System (IWRS). IFX-IMP shipments will be initiated, 
maintained and controlled by the IWRS. 
The site personnel will be responsible for the correct receipt, storage handling, and 
accountability of the IFX-IMP at the study site. Further details on shipment procedures, 
process for receipt, storage and handling of the IFX-IMP is provided in the Pharmacy 
Manual. 
6.1.1.3 Storage of IFX-IMP 
IFX-IMP must be stored at 2°C to 8°C and must not be frozen. All supplies of IFX-IMP 
must be stored separately from other study supplies and site stock in a dedicated locked 
facility with access limited to authorized personnel. All storage facilities must be 
temperature controlled and monitored and compliant with applicable regulatory 
requirements. 
An established and validated local temperature management system with temperature 
logs should be used to record the storage temperature. If this is not possible, the study 
site will be provided with a temperature record form by the Contract Research 
Organization (CRO) and the site personnel will maintain temperature records for the 
entire duration of the study. At a minimum, the daily (working day) minimum and 
maximum temperatures must be documented. 
Any deviation from the specified temperature range must be documented and reported to 
the CMO as soon as possible. Further instruction on the management and reporting of 
temperature deviations is provided in the Pharmacy Manual. 
6.1.1.4 Drug Accountability of IFX-IMP 
During the study, all vials of IFX-IMP will be reconciled against the current inventory 
and the dispensing records as a component of the monitoring visits.  
Data on the administration of IFX-IMP kept at the site will be monitored throughout the 
study by the study monitor. Used vials of IFX-IMP can be destroyed at the site after 
IFX-IMP accountability has been assessed by the study monitor unless there is a 
different procedure agreed to with the site. 
After completion of the study, copies of all IFX-IMP accountability records will be 
provided to the CRO. Unused vials of IFX-IMP will either be returned to the CMO or 
destroyed at the study site according to institutional policy and in compliance with the 
current applicable regulatory requirements. The destruction of any unused vials of 


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IFX-IMP at the study site must be documented on a form provided by the CRO. Further 
details on the monitoring procedures will be provided in the Clinical Monitoring Plan. 
6.1.1.5 Reconstitution of IFX-IMP 
The IFX-IMP for infusion will be reconstituted (prepared) in a controlled area at the 
study site or at the study site’s pharmacy in accordance with local 
regulations/requirements for reconstitution of products for intravenous administration. 
The reconstituted IFX-IMP should be used within 4 hours after dilution if stored at room 
temperature. Otherwise, the reconstituted IFX-IMP has to be stored at 2°C to 8°C and 
used within 24 hours. Details on reconstituting the IFX-IMP will be provided in the 
Pharmacy Manual. 
The number of unused, partially used, and empty vials will be documented accurately, 
and the vials will be kept, in general, at the site until the drug accountability 
documentation has been checked by the study monitor (see Section 6.1.1.4). 
6.1.1.6 Administration of IFX-IMP 
After screening, in Study Part 1, subjects will be randomized into Group A 
(IFX-1 + RDGC) or Group B (Placebo-IFX-1 + SDGC) in a ratio of 1:1. 
IFX-1 and Placebo-IFX-1 will be administered during the Treatment Period up to 
Week 16. Group A will receive 800 mg IFX-1 on Days 1, 4, and 8, and then every other 
week from Week 2 (Day 15) to Week 16; Group B will receive Placebo-IFX-1 infusions 
at the same timepoints as the IFX-1 infusions for Group A (Table 1).  
In Study Part 2, the IMP for subjects in Group C (800 mg IFX-1+ Placebo-GC) will be 
administered at the same time points as the IMP for Group B (Table 1). 
Table 1 
Dosing Schedule for IFX-1 and Placebo-IFX-1 
Visit 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
V9 
V10 
V11 
V12 
Week 
0 
0 
1 
2 
4 
6 
8 
10 
12 
14 
16 
Day 
1 
4 
8 
15 
29 
43 
57 
71 
85 
99 
113 
Group A  
(IFX-1 800 mg 
+ RDGC) 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
Group B 
(Placebo-IFX-1 
+ SDGC) 
P 
P 
P 
P 
P 
P 
P 
P 
P 
P 
P 
Group C 
(IFX-1 800 mg 
+ Placebo-GC) 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
800 
mg 
RDGC = reduced-dose glucocorticoids; P = infusion of placebo; SDGC = standard-dose glucocorticoids; 
V = scheduled visit for all subjects. 


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The IFX-IMP will be administered by the responsible personnel at the site as follows:  
• 
The reconstituted IFX-IMP will be infused over a period of 30 to 60 min, as 
described in the Pharmacy Manual 
• 
At the end of the infusion, the intravenous line will be briefly flushed with 10-
15 mL of sterile sodium chloride to ensure that any IFX-IMP remaining in the 
intravenous line is administered. 
Subjects should remain at the study site for at least 30 min after the end of the IFX-IMP 
administration. Appropriate treatment for potential infusion-related reactions must be 
available during this time.  
Each administration of IFX-IMP will be recorded in detail in the source data and in the 
eCRF.  
If the scheduled infusion cannot be administered at the scheduled time of infusion (also 
considering an acceptable time window of ± 1 day at the respective visit), then the 
medical monitor from the CRO should be contacted to decide on a case by case basis 
whether the infusion can be administered later or whether it should be omitted. 
Further details on the IFX-IMP administration will be outlined in the Pharmacy Manual. 
6.1.2 Description of Glucocorticoids and Placebo-Glucocorticoids (GC-IMP) 
The replacement of steroid tapering is an essential part of the study design. For this 
purpose, prednisone, the GC used in this study, is considered as an IMP.  
Prednisone is a synthetic derivative of cortisone with widespread effects on metabolism 
and organ function. Desirable effects in vasculitis relate to the suppression of acute and 
chronic inflammatory processes and immune cell function. 
Commercially available prednisone tablets with a strength of 5 mg or 10 mg sourced 
from either the United States of America or countries in the European Union will be 
used. The exact composition of the active and inactive ingredients in the tablets will be 
provided in the Pharmacy Manual. Details are also provided in the ‘Study Drug 
Instructions for the Patient’ document that is issued to the subjects. 
To maintain blinding, the prednisone tablets will be over-encapsulated in hard gelatin 
capsule shells. Different numbers and strengths of tablets per capsule will be combined 
to provide the different doses required. The capsules will also be filled with an inactive 
filling excipient (lactose). The amount of lactose per capsule will be less than 1 g. The 
appearance of the capsules will be identical for each dose. 
Placebo-GC capsules will be filled only with lactose. Placebo-GC capsules will be 
identical in appearance to the corresponding GC capsules. 


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6.1.2.1 Packaging and Labeling of GC-IMP 
GC and Placebo-GC capsules will be supplied as blister packs in wallets. Each wallet 
will contain 24 capsules to supply the medication required for 1 week, plus reserve 
capsules for 1 additional day. The subjects will take 3 capsules once per day (i.e., 
3 capsules for each of the 7 days per week). An exception is Week 1, when subjects will 
take 6 capsules per day, and therefore 2 wallets will be provided for Week 1. In total, 
8 different GC wallets and 1 Placebo-GC wallet will be provided to account for the 
different dosages needed for the tapering process (see Table 2). 
Each wallet will be labeled in accordance with local legal requirements (a multilingual 
booklet label or a specific single panel label) and will indicate the number of capsules to 
be taken per day. The GC-IMP capsules, blister packs, and wallets will be identical in 
appearance to maintain the blind. 
6.1.2.2 Shipment of GC-IMP 
The GC-IMP will be supplied to study sites by the sponsor’s designated CMO and must 
be shipped protected from light at a temperature of 15°C to 25°C. Each shipment will be 
controlled by a temperature logger, of which a read-out must be obtained by the site 
personnel upon receipt of the shipment. 
The initial shipment of GC-IMP to the sites will be automatically triggered according to 
the settings in the IWRS. All subsequent shipments of GC-IMP will be initiated, 
maintained, and controlled by the IWRS. During all visits to the site, subjects will 
receive a sufficient number of blinded wallets to cover their requirements until the next 
visit. 
The site personnel will be responsible for the correct receipt, storage, handling, and 
accountability of the GC-IMP at the study site. Further details regarding shipment, 
process for receipt, storage, and dispensing of the wallets to the subjects will be 
provided in the Pharmacy Manual. Subjects will receive “Study Drug Instructions for 
the Patient”, providing details on the correct use of the wallets. 
6.1.2.3 Storage of GC-IMP 
The GC-IMP must be stored protected from light at 15°C to 25°C. All GC-IMP supplies 
must be stored separately from other study supplies and site stock, in a dedicated locked 
facility with access limited to authorized personnel. All storage facilities must be 
temperature controlled and monitored and compliant with applicable regulatory 
requirements. 
Detailed information about the storage after handout to the subjects will be provided in 
the “Study Drug Instructions for the Patient” provided to the subjects. 
A validated temperature management system with temperature logs should be used to 
record the storage temperature at site. If this is not possible, the study site will be 


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provided with a temperature record form by the CRO and the site personnel will 
maintain temperature records for the duration of the study. At a minimum, the daily 
(working day) minimum and maximum temperatures must be documented. 
Any deviation from the specified temperature range must be documented and reported to 
the CMO as soon as possible. Further information on the management and reporting of 
temperature deviations is provided in the Pharmacy Manual. 
6.1.2.4 Drug Accountability of GC-IMP 
During the study, all GC-IMP will be reconciled against the current inventory and the 
dispensing records as a component of the monitoring visits. 
To aid completion of drug accountability records, subjects must return all used and 
unused GC-IMP wallets to the site at the next visit. 
The dates for issuing, administering, and returning the GC-IMP to the study site will be 
recorded and kept at the study site, and monitored throughout the study by the study 
monitor.  
All returned used and unused GC-IMP wallets can be destroyed at the study site 
according to institutional policy and in compliance with the current applicable 
regulatory requirements or sent back to the CMO, in either case after the drug 
accountability has been assessed by the study monitor.  
After completion of the study, certified copies of all GC-IMP accountability records will 
be provided to the CRO. Unused GC-IMP will either be returned to the CMO or 
destroyed at the study site according to institutional policy and in compliance with the 
current applicable regulatory requirements. The destruction of any unused GC-IMP at 
the study site must be documented on a form provided by the CRO. Further details on 
the monitoring procedures will be provided in the Clinical Monitoring Plan. 
6.1.2.5 Administration of GC-IMP 
GC-IMP will be administered once per day in the morning during the Treatment Period 
and up to Week 23 in the Follow-up Period. The GC tapering is an important part of the 
study design because it serves as an active control. An overview of the dosing schedule 
for the GC tapering in each treatment group is shown in Table 2. 
Subjects randomized into Group B (Placebo-IFX-1 + SDGC) will start with a 
standard-dose of 60 mg GC daily and be tapered down as described in Table 2. On 
Day 1 of Week 0, subjects in Group A (IFX-1 + RDGC) will receive only half of the 
starting dose received by subjects in Group B (30 mg). In Group C all subjects will 
receive GC-IMP until Week 24. 
The IWRS will ensure subjects are assigned with sufficient GC-IMP wallets containing 
capsules packaged in blister packs. Each wallet contains 24 capsules (GC and Placebo-


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GC) in blister packs to supply the medication required for 1 week plus reserve 
medication for 1 additional day (i.e., 3 capsules x 8 days). An exception is Week 1, 
when subjects will take 6 capsules per day, and therefore 2 wallets will be provided for 
Week 1. Dosing details are provided in the Study Drug Instructions for the Patient 
document that is issued to the subjects. 
Table 2 
Dosing Schedule for Glucocorticoid Tapering (Daily Dose per Week) 
Week 
Number of 
Wallets per 
week 
Group A:  
RDGC 
Group B:  
SDGC 
Group C:  
Placebo-GC 
0 
1 
30 mg 
60 mg 
0 mg 
1 
2 
20 mg 
50 mg 
0 mg 
2, 3 
1 
15 mg 
40 mg 
0 mg 
4, 5, 6, 7 
1 
10 mg 
30 mg 
0 mg 
8, 9, 10, 11 
1 
5 mg 
25 mg 
0 mg 
12, 13 
1 
5 mg 
20 mg 
0 mg 
14, 15 
1 
0 mg 
15 mg 
0 mg 
16, 17, 18, 19 
1 
0 mg 
10 mg 
0 mg 
20, 21, 22, 23 
1 
0 mg 
5 mg 
0 mg 
24 
0 
- 
- 
- 
GC = glucocorticoids; RDGC = reduced-dose glucocorticoids; SDGC = standard-dose glucocorticoids. 
 
To keep the blind and allow for GC tapering, all subjects will need to take GC-IMP 
capsules up to and including Week 23.  
6.2 
DETAILS OF THE AUXILIARY MEDICINAL PRODUCTS 
An Auxiliary Medicinal Product (AxMP) is defined as immunosuppressive therapy 
administered during Remission-Induction Phase (RTX or CYC) or Remission-
Maintenance Phase (RTX, CYC AZA, MTX, MMF, or MPS). AxMPs will not be 
supplied by the sponsor.   
It is at the discretion of the investigator to choose an immunosuppressive therapy for the 
individual subject that theyconsider being most appropriate from a medical point of 
view, and also depending on international treatment guidelines [Merkel et al.,2017, 
Ntatsaki et al.,2014, Yates et al.,2016], the local Standard of Care, and/or guidelines at 
the study site. Furthermore, investigators must follow the current summaries of product 
characteristics and prescribe the administration and standard safety and laboratory 
procedures according to these summaries. 


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Further details and recommendations regarding immunosuppressive therapy 
administration will be provided in the separate “Recommendations for Standard of Care 
(SoC)” document. 
If intravenous AxMP and IFX-IMP are administered on the same day, IFX-IMP is 
recommended to be administered before intravenous AxMP treatment. 
Each administration of AxMP will be recorded in detail in the source data and in the 
eCRF. 
6.2.1 Immunosuppressive Therapy During Remission-Induction Phase 
6.2.1.1 Rituximab 
RTX can be administered up to 2 weeks prior to screening and during the entire study. 
Administration of intravenous GCs as premedication for RTX is recommended (see also 
Section 7.4). Investigators must follow local guidelines and the current summaries of 
product characteristics and prescribe the administration and standard safety laboratory 
procedures accordingly. 
6.2.1.2 Cyclophosphamide 
CYC can be administered up to 2 weeks prior to screening and during the entire study. 
Investigators must follow local guidelines and the current summaries of product 
characteristics and prescribe the administration and standard safety lab procedures 
accordingly. 
6.2.2 Immunosuppressive Therapy During Remission-Maintenance Phase  
In the Remission-Maintenance Phase, all subjects will receive immunosuppressive 
therapy with either RTX or CYC, or subjects may be switched to immunosuppressive 
therapy with AZA, MTX, MMF, or MPS (following clinical remission and until 
Week 24) at the discretion of the investigator. Investigators should follow applicable 
treatment guidelines for AAV. 
RTX has been shown to be effective and safe for use as maintenance therapy in AAV, 
both in recently diagnosed disease and in subjects with frequent relapses [Alba et 
al.,2016] Therefore, it is left to the investigator’s discretion if RTX will be administered 
to subjects in the Remission-Maintenance Phase. 
6.2.2.1 Azathioprine 
Subjects may be switched from RTX or CYC to AZA, at the investigator’s discretion, 
only during the Remission-Maintenance Phase.  


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6.2.2.2 Methotrexate 
Subjects may be switched from RTX or CYC plus GCs to MTX, at the investigator’s 
discretion, only during the Remission-Maintenance Phase. 
6.2.2.3 Mycophenolate Mofetil and Mycophenolate Sodium 
MMF and MPS are uncompetitive and reversible inhibitors of inosine monophosphate 
dehydrogenase. Subjects may be switched from RTX or CYC plus GCs to MMF or MPS 
at the investigator’s discretion, only during the Remission-Maintenance Phase. 
6.3 
RANDOMIZATION AND BLINDING 
Subjects will be assigned into treatment groups by means of a computer-generated 
randomization list implemented in the IWRS. At each study site, each new subject who 
qualifies for enrolment into the study according to the inclusion and exclusion criteria 
will be assigned a number in ascending order, beginning with the lowest number 
available at the study site.  
Eligible subjects will be randomized to the treatment groups in each of the 2 Study Parts 
by means of a central IWRS. The IWRS will assign the appropriate IMPs to each 
subject. The CRO will supply the investigator with a user guide for the IWRS. 
In Study Part 1, subjects will be randomized into Group A or B in a ratio of 1:1 stratified 
by diagnosis of AAV type (GPA or MPA).  
In Study Part 2, subjects will be randomized into Group B or C in a ratio that yields 
about 9 subjects in Group B and about 16 subjects in Group C. Randomization will also 
be stratified by diagnosis of AAV type (GPA or MPA) as in Study Part 1.  
There will be a recruitment stop after a maximum of 30 subjects have been enrolled in 
Study Part 1 for IDMC evaluation.  
It is planned to randomize 55 subjects.  
The double-blind will be maintained throughout the Treatment and Follow-up Period as 
applicable for all IMP administered or provided to the subjects, including the GC 
tapering process. Label, appearance, and handling of IMP will not compromise the 
blind. 
Subject data for the IDMC will be handled and analyzed by an independent, unblinded 
statistician to maintain the blind for all site and sponsor personnel. 
The randomization and blinding procedures are not applicable to the AxMP 
administered during the study. 


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Emergency Identification of Investigational Medicinal Product 
Breaking of the treatment-assigned blind will be performed in the IWRS. Any premature 
breaking of the blind should be confined to emergency cases in which knowledge of the 
IMP received is necessary, e.g., to be able to provide appropriate emergency medical 
treatment. Whenever possible, the investigator should contact the medical monitor of the 
responsible CRO before breaking the blind, unless this would delay the emergency 
treatment. Subject safety must always be the primary consideration when determining 
whether to break the blind.  
Investigators will be provided with the appropriate IWRS access to unblind the 
treatment assignment of an individual subject. Further information regarding 
randomization and assignment of IFX-IMP or GC-IMP to the individual visits will be 
provided in the Pharmacy Manual. 
If a subject’s treatment assignment is unblinded, the medical monitor will receive an 
alert from the IWRS. In addition, the investigator must inform the medical monitor 
within 24 hours of breaking the blind and the subject will be discontinued from further 
participation in the study. The date and reason why the blind was broken must be 
provided by the investigator and recorded in the source documentation and in the eCRF, 
as applicable. 


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7 
PRIOR AND CONCOMITANT THERAPY 
7.1 
PRIOR THERAPY 
All drugs taken by the subject within 3 months before enrolment into the study are 
regarded as prior therapy and must be documented as such in the source documentation 
and eCRF with details on the reason for use, date(s) of administration (with start and end 
dates), and dosing information, including dose, route, and frequency of administration. 
Any AAV therapy that the subjects received 1 year prior to study enrolment will be 
documented in the source and in the eCRF by verbatim name with start and end dates. 
7.2 
CONCOMITANT THERAPY 
All drugs currently being taken by a subject at enrolment into the study or after 
enrolment are regarded as concomitant therapy. All concomitant therapy must be 
documented in the source documentation and in the eCRF with details on the reason for 
use, administration start dates, and dosing information, including dose, route, and 
frequency of administration. 
7.3 
RECOMMENDED CONCOMITANT THERAPY 
7.3.1 Pneumocystis Carinii Pneumonia (PCP) Prophylaxis 
Participants treated with RTX or CYC should receive PCP prophylaxis during RTX or 
CYC and GC administration. For details, refer to the current SmPCs and relevant 
guidance documents (e.g. Park et al., 2018; Yates et al., 2016). 
7.3.2 Osteoporosis Prophylaxis 
Treatment measures to prevent osteoporosis should be administered at the discretion of 
the investigator. 
7.4 
PERMITTED GLUCOCORTICOID THERAPY 
Inhaled and topical GCs can be used for subjects diagnosed with diseases other than 
AAV (for example: eczema, asthma, chronic obstructive pulmonary disease, 
eosinophilic esophagitis), or for subjects with large airway involvement of GPA as 
documented by bronchoscopy. All use of topical or inhaled GCs must be documented 
accurately in the source documentation and in the concomitant medication section of the 
eCRF. 
Up to 80 mg daily dose of oral GCs (prednisone-equivalent) are allowed to be 
administered within two weeks prior to screening (see exclusion criterion 12b) and 
during screening. The dose should be tapered down to 0 mg/day as fast as possible but 


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the 0 mg/day dose must be achieved 4 weeks after start of IMP treatment (Day 1/Visit 2) 
at the latest. 
Up to 3 g of intravenous GCs are allowed to be administered within 4 weeks prior to 
screening (see exclusion criterion 11) and during screening as maximum cumulative 
dose.  
Intravenous GCs as premedication for RTX administration are permitted and are not 
included in the maximum cumulative dose of 3 g intravenous GCs. 
 
If subjects have been on chronic treatment with oral GCs (prednisone-equivalent) at a 
dose of 10 mg/day or less at Screening, and are not given higher doses of non-study 
GCs, this dose should be tapered to 0 mg/day by 4 weeks after start of IMP treatment at 
Day 1/Visit 2. If the investigator feels it is necessary to continue low-dose daily GCs 
beyond this date to avoid adrenal insufficiency, then the investigator should discuss this 
situation with the medical monitor.  
7.5 
RESCUE THERAPY 
The rescue therapy will not be provided by the sponsor. The administration or the 
receipt of rescue therapy for lack of efficacy or major or minor relapses do not 
necessarily discontinue the subject from further IMP administration or from study 
participation.  
If the investigator unblinds the subject to allow for an appropriate treatment (see Section 
6.3, Emergency Identification of Investigational Medicinal Product), the subject must be 
discontinued from further study participation. Whenever possible, the investigator 
should contact the medical monitor before breaking the blind. 
Lack of efficacy 
In case of lack of efficacy (for example: no improvement or deterioration in the 
BVASv3 or lack of efficacy according to the clinical judgement of the investigator), it is 
at the discretion of the investigator to administer rescue medication, to keep the subject 
in the study and continue with IMP (IFX-IMP and GC-IMP) administrations, AxMP 
intake and study procedures/assessments as scheduled, to discontinue IMPs (IFX-IMP 
and GC-IMP), or to withdraw the subject from further study participation (refer also to 
Section 5.4.1). 
Major Relapse 
A major relapse is defined as having a BVASv3 > 3 minor items or experiencing 1 of 
the major BVASv3 items listed in Appendix 18.3 after clinical remission (BVASv3 = 0). 
Up to 1 g/day of intravenous methylprednisolone or the equivalent dose of other 
intravenous GCs can be given. Depending on the severity of a participant’s presenting 


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symptoms, as well as the clinical picture, the investigator will be allowed to prescribe 
intravenous GC to a maximum of 3 g of methylprednisolone, or to an equivalent dose of 
other intravenous GCs, over 3 days. Subjects experiencing a major relapse can also 
receive up to 20 mg/day of oral GCs (prednisone-equivalent) in addition to the study-
defined dose of GC-IMP for a maximum of 14 days at the discretion of the investigator. 
The investigator, at their discretion, can decide if subjects with a major relapse: 
i. 
can remain in the study and continue with further IMP (IFX-IMP and GC-IMP) 
administrations, AxMP intake, and study procedures/assessments as scheduled; 
OR 
ii. 
can remain in the study but should discontinue IMPs (always both, IFX-IMP and 
GC-IMP), and continue with AxMP intake and study procedures/assessments as 
scheduled; 
OR 
iii. 
should be withdrawn from the study (refer also to Sections 5.4 and 5.4.3).  
If the investigator considers that the relapse requires the early discontinuation or 
unblinding of the subject, they should contact the medical advisor of the 
sponsor’s designated CRO or the sponsor to allow for case by case discussions 
before the subject may be withdrawn from the study. 
At the time a major relapse is suspected by the subject, they have to visit the study 
center for an unscheduled visit (USV) (see Sections 8.5 and 1. Schedule of 
Assessments). 
If withdrawal from the study occurs up to and including Week 16 due to a major relapse, 
the EOS visit (Visit 14) assessments and a safety follow-up visit (see Section 8.4) 
1 month (±3 days) after the last IMP administration must be performed.  
Minor Relapse  
A minor relapse is defined as experiencing 1, 2, or 3 minor items as defined for the 
BVASv3 (BVASv3 = 1, 2, 3, see Appendix 18.2) after clinical remission (BVASv3 = 0) 
in the study. Subjects experiencing a minor relapse can receive up to 20 mg/day of oral 
GCs (prednisone-equivalent) in addition to the study-defined dose of GC-IMP for a 
maximum of 14 days at the discretion of the investigator. 
The investigator, at their discretion, can decide if subjects with a minor relapse: 
i. 
can remain in the study and continue with further IMP (IFX-IMP and GC-IMP) 
administrations, AxMP intake, and study procedures/assessments as scheduled; 
OR 


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ii. 
can remain in the study but should discontinue IMPs (always both, IFX-IMP and 
GC-IMP), and continue with AxMP intake and study procedures/assessments as 
scheduled; 
OR 
iii. 
should be withdrawn from the study (refer also to Sections 5.4 and 5.4.3). and  
If the investigator considers that the relapse requires the withdrawal or 
unblinding of the subject, they should contact the medical advisor of the 
sponsor’s designated CRO or the sponsor to allow for case by case discussions 
before the subject may be withdrawn from the study.  
At the time a minor relapse is suspected by the subject, they have to visit the study 
center for an USV (see Sections 8.5 and 1. Schedule of Assessments). 
If withdrawal from the study occurs up to and including Week 16 due to a minor relapse, 
the EOS visit (Visit 14) assessments and a safety follow-up visit (see Section 8.4) 
1 month(±3 days) after the last IMP administration must be performed . 
7.6 
PROHIBITED THERAPY DURING THE STUDY 
The following therapies are prohibited for all subjects during the study: 
• 
Tumor necrosis factor inhibitor treatment (e.g., etanercept) 
• 
Anti-CD20 therapies other than RTX 
• 
Abatacept 
• 
Alemtuzumab 
• 
Any other experimental or biologic therapies 
• 
Intravenous, intramuscular, or sub-cutaneous immunoglobin 
• 
Plasma exchange 
• 
Antithymocyte globulin 
• 
Live vaccines 
• 
Renal dialysis 
• 
Any other oral or intravenous GCs (than defined by the protocol). 
If administration of any prohibited concomitant therapy becomes necessary during the 
study for medical reasons that in the investigator’s or sponsor’s opinion necessitates the 
subject being removed, the subject must be withdrawn from further study participation. 
The investigator should contact the medical advisor of the sponsor’s designated CRO or 
the sponsor if there are any questions regarding prior or concomitant therapy, and case 
by case discussions are recommended. 


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7.7 
CONTRACEPTION IN WOMEN OF CHILDBEARING POTENTIAL 
Women of childbearing potential must use highly effective methods for contraception 
(pearl index < 1), which are the following: 
• “Combined” (that is oestrogen and progesterone containing with oral, 
intravaginal or transdermal administration) 
• Or “progesteron-only” (with oral, injectable, or implantable formulation) 
hormonal contraceptives 
• Complete sexual abstinence 
• Intrauterine device /Intrauterine system 
• Bilateral tubal occlusion 
• Vasectomized partner. 
Contraception methods with a low user dependence (intrauterine device, intrauterine 
system, bilateral tubal occlusion, vasectomized partner, should preferably be used, in 
particular when contraception is introduced as a result of participation in the clinical 
trial. 
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 
treatments: from screening up to the very last pregnancy test (3 months after the last 
IFX-1 /Placebo-IFX-1 administration). 
Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), 
declaration of abstinence for the duration of exposure to IMP, and withdrawal are not 
acceptable methods of contraception. 
Based on the half-life of IFX-1, the duration of contraception in women of childbearing 
potential should last 3 months after the last IFX-1/Placebo-IFX-1 administration. As the 
choice of the standard of care is at the discretion of the investigator, further 
contraception periods should be taken into consideration by following the corresponding 
SmPC. 
As outlined in the Schedule of Assessments and Section 8, pregnancy tests in women of 
childbearing potential will be performed at screening, Week 0, Week 4, Week 8, 
Week 12, Week 16, Week 20, Week 24 and at SFU. 


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7.8 
CONTRACEPTION FOR MALES WITH FEMALE PARTNERS OF 
CHILDBEARING POTENTIAL  
Males subjects with female partners of childbearing potential must use condoms as a 
contraception method during the study. 


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8 
STUDY PROCEDURES AND VISIT SCHEDULE 
The following sections describe all study assessments and procedures that will be 
performed at screening, in the Treatment- and Follow-up Period. 
The visit schedule is applicable to all subjects in Group A, B and C. 
An overview of the visit schedule is available in the Schedule of Assessments. 
8.1 
SCREENING 
Screening is the predetermined series of procedures with which each investigator selects 
an appropriate and representative sample of subjects for enrolment into the study.  
The screening procedures will be conducted between Day -14 and Day -1 before the first 
administration of IMP. However, the screening period should be as short as possible to 
allow for the enrollment of severely ill subjects. 
The investigator may pre-screen subjects for study inclusion and exclusion criteria 
without first obtaining written informed consent for participation in the current study on 
the basis of 1 or both of the following situations: 
• 
Pre-existing data (e.g., for study inclusion and exclusion criteria, as available in 
medical records held by the investigator) 
• 
Initial contact (e.g., routine visit, phone call) where only routine and/or non-
study-specific questions are allowed. 
After subjects have provided written informed consent, potentially eligible subjects will 
be assessed at the screening visit to determine if all inclusion criteria and no exclusion 
criteria are met. All subjects must provide written informed consent before any study-
specific assessments or procedures are performed. The following procedures will be 
conducted and documented at the screening visit: 
• 
Initiate and complete informed consent procedure and document process 
• 
Check all inclusion and exclusion criteria (see Sections 5.2 and 5.3) 
• 
Serum pregnancy test, required for all women of childbearing potential 
• 
Vital signs (systolic and diastolic blood pressure, pulse rate (after 5 minutes in a 
sitting position), respiratory rate, body temperature) 
• 
Serum sample for total protein 
• 
Blood sample for analysis of safety laboratory parameters 
• 
Blood sample for serological testing for HIV, HBV, and HCV, if no test results for 
HIV, HBV, and HCV available from within 4 weeks before screening 
• 
Document medical history prior to screening (Section 9.1.3) 
• 
Record prior medication or therapy (Section 7) 


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• 
Demographics and baseline characteristics (age, gender, race and ethnicity, body 
weight, height) 
• 
GPA/MPA medical history 
• 
 
• 
Blood sample for anti-glomerular basement membrane (GBM) assessment 
• 
12-lead ECG 
• 
Physical examination 
• 
BVASv3 assessment  
• 
Urine samples for analyses of creatinine, total protein, microalbumin, 
 
, and monocyte chemoattractant protein (MCP)-1 
• 
Documentation of AEs. 
Analyses for laboratory assessments at screening relevant for the inclusion of a subject, 
i.e. serum pregnancy test, safety laboratory measurements including serum total protein, 
serology, and urinalysis, can be done either in a local laboratory or the central 
laboratory. If screening testing is done in a local laboratory, no respective blood samples 
are shipped to the central laboratory. 
If the subject fulfils all the inclusion criteria, does not meet any of the exclusion criteria, 
and written informed consent is available, the subject will be randomized into one of the 
treatment groups. Randomization will be performed during the Screening Period, it must 
be done at Day 1 (Visit 2) at the latest, and prior to Day 1 specific assessments.  
All randomized subjects will be issued with a subject card with relevant contact details, 
including emergency contact details. Subjects will be instructed on the completion of the 
PROs by the investigator at screening. If the subject meets an exclusion criterion or 
another reason for non-inclusion in the study is given after obtaining informed consent, 
the subject will not be randomized into any of the treatment groups and will be deemed a 
screen failure. 
8.2 
TREATMENT PERIOD 
The Treatment Period will comprise Visits 2 to 12 (Weeks 0 to 16). All visits will have 
an accepted time window of ±1 day. Subjects will be provided with the GC wallets to 
comply with the GC dosing schedule (Table 2). 
Before administration of IFX-IMP, the following assessments and procedures will be 
performed at the visits to the study site, as indicated:  
• 
Documentation of PROs: 
o 36-item Short Form survey version 2 (SF-36v2) (Weeks 0 [Day 1], 4, 8, 
12, and 16) 


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o EuroQol-5 Dimensions 5-Levels survey (EQ-5D-5L) (Weeks 0 [Day 1], 
4, 8, 12, and 16) 
• 
Urine pregnancy test (dipstick), required for all women of childbearing potential 
(Weeks 0 [Day 1], 4, 8, 12, and 16) 
• 
Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body 
temperature) (Weeks 0 [Days 1 and 4], 1, 2, 4, 6, 8, 10, 12, 14, 16) 
• 
Serum sample for total protein (Weeks 0 [Day 1] 1, 2, 4, 8, 12, 16) 
• 
Blood sample for analysis of safety laboratory parameters (Weeks 0 [Day 1], 4, 8, 
12, 16) 
• 
Documentation of body weight (Weeks 0 [Day 1], 4, 8, 12, 16) 
• 
 (Weeks 2, 4, 8, 12, 16) 
• 
ECG (Week 16) 
• 
Physical examination (Week 16) 
• 
Glucocorticoid toxicity index (GTI) assessment (Weeks 0 [Day 1], 16) 
• 
BVASv3 assessment (Weeks 0 [Day 1], 4, 8, 12, 16) 
• 
Vasculitis Damage Index (VDI) assessment (Weeks 0 [Day 1], 16) 
• 
Physician Global Assessment (PGA) assessment (Weeks 0 [Day 1], 4, 8, 12, 16) 
• 
Urine samples for analyses of creatinine, total protein, microalbumin, 
 and MCP-1 (Weeks 0 [Day 1], 1, 2, 4, 8, 12, 16) 
• 
sample for analysis of: 
o IFX-1 level (Weeks 0 [Days 1 and 4], 1, 2, 4, 6, 8, 10, 12, 14, 16) 
o IFX-1 blocking activity (Weeks 2 and 16) 
o C5a (Weeks 0 [Days 1 and 4], 1, 2, 4, 8, 12, 16) 
• 
 sample for analysis of: 
o 
(Weeks 0 [Days 1 and 4], 1, 2, 4, 8, 12, 16) 
• 
 sample for analysis of: 
o 50% hemolytic complement (CH50) (Weeks 0 [Day 1], 1, 2, 4, 8, 12, 16) 
o C-reactive protein (CRP) (Weeks 0 [Day 1],1, 2, 4, 8, 12, 16) 
o 
(Weeks 0 [Day 1], 4, 8, 12, 16) 
o Anti-drug antibodies (ADAs) (Weeks 0 [Day 1], 2, 4, 8, 12, 16) 
• 
Additional blood samples for further research, 
(Weeks 0 [Day 1], 4, 8, 12, 16) 
• 
Documentation of AEs (Weeks 0 [Days 1 and 4], 1, 2, 4, 6, 8, 10, 12, 14, 16) 
• 
Documentation of concomitant therapy (Weeks 0 [Days 1 and 4], 1, 2, 4, 6, 8, 10, 
12, 14, 16). 


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After the assessments and procedures listed above have been completed: 
• 
Administration of IFX-IMP according to the dosing schedules shown in Table 1 
(Weeks 0 [Days 1 and 4], 1, 2, 4, 6, 8, 10, 12, 14, 16). 
After administration of IFX-IMP: 
• 
 sample for analysis of IFX-1 peak levels, to be taken within 10 min 
after end of IFX-IMP administration ncluding brief flushing)
These samples must be taken from a vein, from a different sampling site to the IFX-
IMP infusion, such as the other arm. 
During the Treatment Period, subjects will take GC-IMP and AxMP as indicated in the 
Schedule of Assessments and Sections 6.1.2and 6.2.  
For subjects who discontinue the study early during the Treatment Period (i.e., up to and 
including Week 16), all assessments scheduled for the EOS visit (Visit 14) should be 
performed. A safety follow-up visit will occur 1 month (±3 days) after the last IMP 
administration. For further details see Section 5.4. 
8.3 
FOLLOW-UP PERIOD 
The Follow-up Period will run from after the IFX-IMP administration at Week 16, to 
Week 24 and it will include Visits 13 and 14 (EOS visit). All visits will have an 
accepted time window of ±3 days. Subjects will be provided with the GC wallets to 
comply with the GC dosing schedule (Table 2). The following assessments and 
procedures will be performed at the visits to the study site, as indicated: 
• 
Continue documentation of PROs:  
o SF-36v2 (Weeks 20 and 24) 
o EQ-5D-5L (Weeks 20 and 24) 
• 
Urine pregnancy test (Week 20) and serum pregnancy test (Week 24), required for 
all women of childbearing potential  
• 
Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body 
temperature) (Weeks 20 and 24) 
• 
Serum sample for total protein (Weeks 20 and 24) 
• 
Blood sample for analysis of safety laboratory parameters (Weeks 20 and 24) 
• 
Documentation of body weight (Weeks 20 and 24) 
• 
(Week 24) 
• 
ECG (Week 24) 
• 
Physical examination (Week 24) 
• 
GTI assessment (Week 24) 
• 
BVASv3 assessment (Weeks 20 and 24) 


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• 
VDI assessment (Week 24)  
• 
PGA assessment (Weeks 20 and 24) 
• 
Urine samples for analyses of creatinine, total protein, microalbumin, 
 and MCP-1, blood sample for analysis of serum protein (Weeks 20 and 
24) 
• 
 sample for analysis of: 
o IFX-1 level (Weeks 20 and 24) 
o IFX-1 blocking activity (Weeks 20 and 24) 
o C5a (Weeks 20 and 24) 
• 
 sample for analysis of: 
o 
 (Weeks 20 and 24) 
• 
 sample for analysis of: 
o CH50 (Weeks 20 and 24) 
o CRP (Weeks 20 and 24) 
o 
 (Weeks 20 and 24) 
o ADAs (Weeks 20 and 24) 
• 
Additional blood samples for further research, 
 (Weeks 20 and 24) 
• 
Documentation of AEs (Weeks 20 and, 24) 
• 
Documentation of concomitant therapy (Weeks 20 and 24). 
During the Follow-up Period, subjects will receive AxMP and GC-IMP as indicated in 
the Schedule of Assessments, Sections 6.2.2 and 6.1.2, and Table 2.  
For subjects who discontinue the study early during the follow-up period (i.e., up to and 
including Week 24), all assessments scheduled for the EOS visit (Visit 14) should be 
performed. 
8.4 
SAFETY FOLLOW-UP VISIT  
For subjects who discontinue the study during the Treatment Period (i.e., up to and 
including Week 16), a safety follow-up visit will occur 1 month (±3 days) after the last 
IMP administration. For further details see Section 5.4. 
The following assessments and procedures will be performed at the study site as 
indicated: 
• 
Documentation of PROs: 
o 36-item Short Form survey version 2 (SF-36v2) (Weeks 0 [Day 1], 4, 8, 
12, and 16) 


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o EuroQol-5 Dimensions 5-Levels survey (EQ-5D-5L) (Weeks 0 [Day 1], 
4, 8, 12, and 16) 
• 
Serum pregnancy test, required for all women of childbearing potential 
• 
Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body 
temperature) 
• 
Serum sample for total protein 
• 
Blood sample for analysis of safety laboratory parameters 
• 
Documentation of body weight 
• 
 
• 
ECG 
• 
Physical examination 
• 
GTI assessment 
• 
Urine samples for analyses of creatinine, total protein, microalbumin, 
 and MCP-1 
• 
Conclude documentation of AEs 
• 
Conclude documentation of concomitant therapy. 
8.5 
UNSCHEDULED VISIT 
An USV will be arranged for subjects with suspect of a major or minor relapse.  
The following assessments and procedures will be performed during the USV to 
evaluate whether there is major or minor relapse:  
• 
Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, body 
temperature) 
• 
Physical examination 
• 
Documentation of body weight 
• 
Serum sample for total protein 
• 
Blood sample for analysis of safety laboratory parameters 
• 
BVASv3 assessment 
• 
VDI assessment 
• 
PGA assessment 
• 
GTI assessment 
• 
Urine samples for analyses of creatinine, total protein, albumin, 
 MCP-1; blood sample for analysis of serum protein 
• 
Documentation of AEs 


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• 
Documentation of concomitant medication. 
If subject with suspect of minor or major relapse will visit the study center at a 
scheduled visit, the assessments and procedures of this respective scheduled visit have to 
be performed. 


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9 
STUDY VARIABLES AND ASSESSMENT METHODS 
9.1 
STUDY SUBJECTS 
9.1.1 Demographics and Baseline Characteristics 
The following demographic data and baseline characteristics will be documented at 
screening: 
• 
Age 
• 
Gender 
• 
Race 
• 
Body weight 
• 
Height. 
9.1.2 GPA/MPA Medical History 
Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, 
have not yet been developed for GPA and MPA. In 1994, the CHCC developed 
definitions for these vasculitides and some of their mimickers with a revision issued in 
2013 [Jennette et al.,2013]. These definitions are useful in formulating the diagnostic 
criteria that will be applied to determine a subject’s eligibility for this study (see 
Appendix 18.1) [Fries et al.,1990]. 
The GPA/MPA medical history will be documented in terms of: 
• 
Date of GPA/MPA diagnosis  
• 
Positive antigen-specific ANCA titer prior to screening (including the type and last 
date of positive ANCA lab test result) or documented evidence for antibodies to 
proteinase 3 or antibodies to myeloperoxidase 
• 
Number of major relapses since diagnosis 
• 
Date of most recent major relapse 
• 
Family history of GPA/MPA (first degree family pedigree). 
9.1.3 Medical History 
Medical history for the 12 months prior to screening will be obtained from each subject 
at screening.  
9.1.4 Prior and Concomitant Therapy 
All prior and concomitant therapy will be documented, as described in Section 7. 


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9.2 
EFFICACY  
9.2.1 Efficacy Variables 
Efficacy will be assessed on the basis of the following variables: 
• 
BVASv3 
• 
VDI 
• 
PGA 
• 
SF-36v2 
• 
EQ-5D-5L 
• 
Renal variables including eGFR and all ratios (urinary MCP-1:creatinine; urinary 
albumin:creatinine ratio) 
• 
 
9.2.2 Methods of Assessing Efficacy Variables 
All assessments will be performed at the time points specified in the Schedule of 
Assessments. 
9.2.2.1 Birmingham Vasculitis Activity Score Version 3.0 
The BVASv3 is a validated instrument for the assessment of disease activity and 
response to treatment in AAV [Mukhtyar et al.,2009].  
The BVASv3 form is a list of 56 items with a numerical weight attached to each item, 
and each organ system has a ceiling score. The form is divided into 9 organ-based 
systems (i.e., general symptoms such as arthralgia, arthritis, and fever, plus involvement 
of 8 major organ systems), with each section including symptoms/signs that are typical 
of that particular organ involvement in systemic vasculitis (Appendix 18.2). The ceiling 
scores reflect the proportional importance of each manifestation and each organ system. 
Completion of the form provides a numerical score by using the Glossary and Scoring 
for the BVASv3 (Appendix 18.3). Scoring ranges are higher when any of the features 
are new or worse. Creatinine levels can be scored at a subject’s first assessment only. 
Higher scores indicate more severe disease.  
To standardize the BVASv3 assessment in this study, the same investigator should score 
the subject at all visits, if possible. 
In order to use and score the form properly, all investigators performing the BVASv3 
assessment must be certified. Training and specific instructions on the use of BVASv3 
for this study will be provided to sites. 


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9.2.2.2 Vasculitis Damage Index 
The VDI will be used to assess damage induced by GPA or MPA and by the treatment 
applied during this study. The VDI is a validated assessment tool divided into 11 organ 
systems. The scoring sheet is divided into 10 systems plus an 11th section for other 
items, mainly related to the effects of drugs. The VDI is used to record any condition 
that has occurred and lasted for at least 3 months since the start of vasculitis and refers 
to chronic damage whether or not it is related to vasculitis. It consists of 64 items 
selected by expert consensus as representative of the forms of damage developed by 
subjects with systemic vasculitis [Exley et al.,1997]. Completion of the form provides a 
numerical score by summation of each damage (Appendix 18.5). Each item scores 
1 point.  
Three scores will be calculated for each subject: 
• 
Total VDI score: 
the total number of items will be counted leading to a 
minimum score of 0 and a maximum score of 64 
• 
System score: 
the extent of disease defined by the number of separate 
systems with at least 1 item score 
• 
Critical damage score: 
the number of items of damage consistent with organ 
failure (as defined in the glossary). 
To standardize the VDI assessment in this study, the same investigator should score the 
subject at all visits, if possible. 
In order to use and score the form properly, all investigators performing the VDI scoring 
must be certified. 
9.2.2.3 Physician Global Assessment 
The PGA scale is an 11-point scale to record the assessment of the overall disease 
activity of GPA or MPA (not including longstanding damage) within the previous 
28 days [Stone et al.,2001]. The rating ranges from 0 (remission) to 10 (maximum 
activity) (Appendix 18.7). 
If possible, the same investigator should score the subject at all visits and when 
completing this assessment, the investigator should not be influenced by the presence of 
any accumulated damage, complication of treatment, social/emotional problems, or 
other issues not related to active GPA or MPA. 
9.2.2.4 36-Item Short Form Survey Version 2 
The SF-36v2 is a subject-reported generic measurement of health status that has proven 
useful in studies of both general and specific populations, comparing the relative burden 
of diseases and the health benefits produced by different treatments [Ware et al.,1998]. 
Inclusion of the SF-36 has become standard practice for almost all clinical studies and 


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observational studies for most rheumatic diseases, including vasculitis [Merkel et 
al.,2011].  
The SF-36v2 consists of 36 questions from the following 8 domains: vitality, physical 
functioning, bodily pain, general health perceptions, physical role functioning, 
emotional role functioning, social role functioning, and mental health (Appendix 18.8).  
Each domain is directly transformed into a scale from 0 to 100 on the assumption that 
each question carries equal weight. A lower score indicates a poorer health status; a 
higher score indicates a better health status (i.e., a score of zero is equal to maximum 
disability and a score of 100 is equal to no disability). The 8 domains are summarized to 
form 2 distinct higher-ordered clusters (physical health and mental health). 
A paper version of the questionnaire will be provided and thoroughly explained to the 
subjects during their visits to the study site. To avoid bias in the subject’s response, the 
subject has to complete the questionnaire at the study site before the study site personnel 
performs any other assessments. 
The study site personnel will be responsible to enter the data from the completed 
SF--36v2 questionnaire into the eCRF in a timely manner; the original paper 
questionnaires will then be filed in the study records. 
9.2.2.5 EuroQol-5L Dimensions Survey 
The EQ-5D-5L is a standardized subject-reported measure of health status in terms of 
quality of life parameters, such as the subject’s mobility, self-care, usual activities, pain 
and discomfort, and anxiety and depression. There are 5 categorical response choices for 
each of the 5 measures. In addition, subjects are asked to indicate “the state of your 
health today” on a visual analog scale of 0 to 100 (0 = worst imaginable health state, 
100 = best imaginable health state) [Rabin et al.,2001]. 
The EQ-5D-5L relates to the respondent’s situation at the time the assessment is 
completed, therefore the subject does not need to recall their health status over the 
preceding days or weeks (Appendix 18.9). 
A paper version of the questionnaire will be provided and thoroughly explained to the 
subjects during their visits at the study site. To avoid biasing the subject’s response, the 
subject has to complete the questionnaire at the study site before study site personnel 
performs any other assessments. 
The study site personnel will be responsible to enter the data from the completed 
EQ-5D-5L questionnaire into the eCRF in a timely manner; the original paper 
questionnaires will then be filed in the study records. 


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9.2.2.6 Urinalysis and Renal Variables 
Renal variables will be analyzed for both safety and efficacy and will be used to adapt 
the different therapies during the course of the study. 
The renal variables to be analyzed in this study are listed in Table 3. 
Table 3 
Renal Variables 
Variable 
Urine 
Serum 
Calculation 
Laboratory* 
Creatinine 
X 
X 
 
Central 
Total protein 
X 
 
 
Central 
Microalbumin 
X 
 
 
Central 
MCP-1 
X 
 
 
Central 
 
 
 
 
 
Urinary MCP-1: creatinine ratio 
 
 
X 
 
UACR 
 
 
X 
 
eGFR 
 
 
X 
 
*For screening assessment only, local or central laboratory can be used. 
eGFR = estimated glomerular filtration rate; MCP-1 = monocyte chemoattractant protein-1; 
UACR = urinary albumin:creatinine ratio 
Instructions regarding the collection, processing, and shipping of samples for analysis of 
laboratory parameters (i.e., urinary and serum creatinine, 
and 
urinary MCP-1) will be available in the Laboratory Manual provided by the responsible 
CRO. All samples will be analyzed in a central laboratory, or a local laboratory for 
screening assessments only, as indicated in Table 3 using validated assays. 
All derived ratios and the eGFR will be calculated at the time points when the respective 
single serum or urinary parameters are planned to be assessed. 
The eGFR will be calculated by the central laboratory according to the Modified Diet in 
Renal Disease equation: 
eGFR = 175 x (serum creatinine, mg/dL)-1.154 x (age, years)-0.203 x (0.742 if 
female) x (1.212 if black) [Levey et al.,1999].  
 


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9.3 
SAFETY 
9.3.1 Safety Variables 
Safety will be assessed based on the following variables: 
• 
AEs 
• 
GTI 
• 
Physical examination 
• 
Vital signs 
• 
ECG 
• 
Laboratory safety parameters 
• 
Pregnancy test 
• 
Serology: HIV-1, HIV-2, hepatitis B, and hepatitis C status at screening 
• 
ADA status. 
9.3.2 Methods of Assessing Safety Variables 
All assessments will be performed at the time points specified in the Schedule of 
Assessments. 
9.3.2.1 Adverse Events 
The incidence, severity, and causality of AEs will be assessed at every visit from 
signature of the informed consent form at screening to the subject’s last evaluation 
according to the procedures described in Section 10. 
9.3.2.2 Glucocorticoid Toxicity Index 
The GTI measures the change in glucocorticoid toxicity over time and has 
2 components: the composite GTI and a specific list. In a first evaluation, excellent 
reliability and validity was shown [Miloslavsky et al.,2017]. The composite GTI serves 
as the primary instrument and is intended to capture common toxicities that are sensitive 
to differing cumulative GC doses over the period of a typical clinical study. Nine 
domains and 31 items are in the composite GTI and 11 domains and 23 items are 
included in the specific list. When a specific list item occurs, the most severe 
corresponding item in the composite GTI should also be scored (see Appendix 18.6). 


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The specific list items will be assessed at Day 1, Weeks 16, and 24. The composite GTI 
should be scored at least 2 times in this study (in Weeks 16 and 24), since it measures 
changes in GC toxicity. For the comparison of composite GTI domains with quantitative 
laboratory values to Day 1 (baseline), those laboratory values must be analysed at Day 1 
as indicated in the Schedule of Assessment. The laboratory assessments required for this 
index are part of the safety laboratory variables. The bone domain is excluded since the 
study is shorter than 1 year in duration. Therefore, the total score can range from 35 to 
410. Higher scores indicate greater GC toxicity, negative scores demonstrate 
improvement in GC toxicity. Further information will be provided in a specific manual.  
9.3.2.3 Physical Examinations 
Physical examination findings that are related to the medical history will be recorded in 
the source documentation and in the eCRF. 
Any abnormality noted after the informed consent had been signed by the subject will be 
evaluated by the investigator for whether it constitutes an AE. 
9.3.2.4 Vital Signs 
Vital sign determinations of systolic and diastolic blood pressure, pulse rate (after 5 min 
in a sitting position), respiratory rate, and body temperature will be obtained at each 
visit. Body weight will be recorded as specified in the Schedule of Assessments. Blood 
pressure and pulse rate should be measured before blood samples are taken.  
9.3.2.5 Electrocardiogram 
12-lead ECGs will be performed. 
An appropriately certified physician will interpret, sign, and date each ECG. Results will 
be recorded in the source documentation and in the eCRF. 
9.3.2.6 Safety Laboratory 
Blood samples for safety laboratory analysis should be obtained after the subjects have 
provided responses to questionnaires and after vital signs assessments have been 
performed, but before administration of IFX-IMP.  
Analyses will be conducted by a certified central laboratory, or a local laboratory for 
screening assessments only.  
Instructions regarding the collection, processing, and shipping of samples for the 
analysis of laboratory safety parameters will be available in the Laboratory Manual 
provided by the responsible CRO. Instructions for urine pregnancy testing are also 
provided in the Laboratory Manual. 


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The following parameters will be assessed using standard validated methods:  
Clinical chemistry: 
serum creatinine, urea, alanine aminotransferase, aspartate 
aminotransferase, gamma-glutamyltransferase, total bilirubin, 
lactate dehydrogenase, alkaline phosphatase, sodium, potassium, 
calcium, total protein, and albumin 
Hematology:  
red blood cells (erythrocytes), platelets, hemoglobin, white blood 
cells (including differential blood count), and complete blood 
count 
Coagulation:   
partial thromboplastin time and international normalized rate 
For GTI only:  
glycosylated hemoglobin and low density lipoprotein 
All abnormal laboratory values will require a comment in the eCRF according to the 
following classification: 
• 
Not clinically significant 
• 
Clinically significant  
• 
Error (e.g., laboratory error, improper sample preparation, hemolysis, or delayed 
transit to laboratory). 
At screening, any laboratory value that deviates from the reference range and is 
considered by the investigator to be clinically significant or considered to be a result of a 
disease noted in the medical history, must be documented on the medical history page of 
the eCRF. Any deviation from the reference range considered by the investigator as 
clinically significant at any later visit must be documented in the eCRF as an AE if not 
previously documented as an ongoing medical condition or as an ongoing AE. 
Follow-up laboratory investigations due to an AE will be performed at a local laboratory 
at the discretion of the investigator.  
9.3.2.7 Pregnancy Test 
Pregnancy testing will be conducted in all women of childbearing potential. A woman is 
considered to be of childbearing potential, i.e., fertile, following menarche and until 
becoming postmenopausal, unless permanently sterile. Permanent sterilization methods 
include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. 
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. A high follicle-stimulating hormone level in the postmenopausal range 
may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormonal replacement therapy. However, in the absence of 12 months 
of amenorrhea, a single follicle-stimulating hormone measurement is insufficient. 
The pregnancy test is to be performed in serum at screening and in urine (using a 
dipstick) at the other visits indicated in the Schedule of Assessments.  


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If any pregnancy test is positive, the subject will not be eligible for participation, 
randomization, or continuation in the study.  
Lactating women will not be eligible for participation or continuation in the study. 
Further detailed instructions will be provided in the Laboratory Manual provided by the 
responsible CRO. 
9.3.2.8 Human Immunodeficiency Virus and Hepatitis Virus Testing 
Analyses for HIV-1 and 2, HBV andHCV will be conducted at screening, if no 
corresponding historical test results from within 4 weeks before screening are available. 
Analyses for HIV-1 and 2 antibodies will be conducted by the central laboratory or a 
local laboratory according to its standard testing. Subjects will not be eligible for 
participation in the study if they test positive for HIV infection.  
Analyses for the presence of a hepatitis B infection will be conducted by the central 
laboratory using a hepatitis B DNA polymerase chain reaction test or a local laboratory 
according to its standard testing. If the result meets or exceeds detection sensitivity, the 
subjects will be excluded from participation in the study. 
Analyses for the presence of anti-hepatitis C antibodies in serum will be conducted by a 
central laboratory via chemiluminescence or a local laboratory according to its standard 
testing. 
Detailed instructions regarding collection, processing and shipment of samples will be 
provided in the Laboratory Manual provided by the responsible CRO. 
9.3.2.9 Anti-Glomerular Basement Membrane Disease Assessment 
Blood samples taken at screening will additionally be measured for anti-GBM using an 
immunoassay to assess the anti-GBM status.  
Detailed instructions regarding the collection, processing, etc., of samples will be given 
in the Laboratory Manual provided by the responsible CRO. 
9.3.2.10 Anti-Drug Antibodies 
ADAs will be measured in serum samples at a specialized laboratory 
 Samples that are confirmed as ADA-positive will be semi-quantified by 
titration. 
 
Detailed instructions regarding the collection, processing, etc., of samples will be 
included in the Laboratory Manual provided by the responsible CRO.  


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At each sampling time point an additional serum retention sample will also be collected 
for possible future analysis. 
9.4 
PHARMACOKINETICS, PHARMACODYNAMICS, AND BIOMARKERS 
9.4.1 Variables 
PK will be assessed by measuring the IFX-1 concentration 
 
PD will be assessed by measuring: C5a and IFX-1 blocking activity (Table 4). 
Biomarkers will be assessed by measuring: 
 CH50, CRP, and 
 (Table 5).  
9.4.2 Methods of Assessing Variables 
All assessments will be performed at the time points specified in the Schedule of 
Assessments. 
9.4.2.1 Pharmacokinetics 
IFX-1 concentrations will be measured for all subjects 
 
Detailed instructions regarding the collection, processing, etc., of samples will be 
provided in the Laboratory Manual provided by the responsible CRO. 
9.4.2.2 Pharmacodynamics 
Instructions regarding the collection, processing, and shipment of samples to the central 
laboratory will be available in the laboratory manual provided by responsible CRO. 
Central laboratory will further transfer samples to specialized laboratory for analysis.  
Table 4 
Pharmacodynamic Variables 
Variable 
Laboratory 
C5a 
 
Specialized 
IFX-1 blocking activity 
 
Specialized 
 
9.4.2.3 Biomarkers 
Instructions regarding the collection, processing, and shipping of samples to the central 
or specialized laboratory will be available in the Laboratory Manual provided by the 
responsible CRO. 


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Table 5 
Biomarker Variables 
Variable 
Matrix 
Laboratory 
 
 
 
CH50 
Serum 
Central 
CRP 
Serum 
Central 
 
 
Central 
 CH50 = 50% hemolytic complement; CRP = C-reactive protein 
9.4.2.4 Samples for Future Research 
Additional blood samples for 
 preparation will 
be taken to allow future research on certain parameters. 
 


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10 
ADVERSE EVENT REPORTING 
10.1 ADVERSE EVENTS 
10.1.1 Definition 
An AE is any untoward medical occurrence in a subject administered an IMP; an AE 
does not necessarily have to have a causal relationship with the treatment. 
AEs encompass any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease that arises or worsens after the inclusion of the subject 
into the study. 
“Lack of efficacy” per se will not be reported as an AE or SAE. However, the signs and 
symptoms and/or sequelae resulting from lack of efficacy will be reported if they fulfil 
the definition of an AE. 
AEs may include: 
• 
The significant worsening of the disease or symptoms of the disease under 
investigation following administration of an IMP 
• 
Illnesses that coincide with an onset after administration of an IMP 
• 
Exacerbation (i.e., increase in frequency or severity) of a pre-existing condition. 
Chronic illnesses present prior to study entry, other than the indication being 
investigated, should be recorded in the medical history page of the eCRF and only 
be reported as AEs if there is an increase in the frequency or severity of the 
condition during the study 
• 
For laboratory safety parameters, any absolute values outside of the reference range 
or changes after initial administration of the IMP that are considered by the 
investigator as clinically significant must be recorded in the eCRF as AEs if not 
previously documented as ongoing medical conditions or as ongoing AEs. 
Examples of laboratory abnormalities that should be considered as AEs include 
those that result in discontinuation of treatment with the IMP, withholding 
treatment with the IMP pending some investigational outcome, reduction of IMP 
dose, or additional concomitant therapy 
• 
Laboratory abnormalities do not need to be listed as separate AEs if they are 
considered to be part of a clinical syndrome that is being reported as an AE. 
Laboratory findings do not need to be reported as AEs in the following cases: 
• 
Laboratory parameters already beyond the reference range at baseline (unless 
considered as clinically significant) 
• 
Abnormal laboratory parameters caused by mechanical or physical influences on 
the blood sample (e.g., hemolysis) and flagged as such by the laboratory in the 
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• 
Abnormal parameters that are obviously biologically implausible (e.g., values that 
are incompatible with life) 
• 
An abnormal laboratory value that cannot be confirmed after repeated analysis, 
preferably in the same laboratory (i.e., the previous result could be marked as not 
valid and should not necessarily be reported as an AE). 
In addition, at the investigator’s discretion, any changes or trends over time in laboratory 
parameters can be recorded in the eCRF as AEs, if such changes or trends are considered 
to be clinically relevant, even if the absolute values are within the reference range. 
AEs do not include: 
• 
Medical or surgical procedures; the condition that leads to the procedure is an AE 
• 
Untoward medical findings that occur before initial administration of the IMP if 
they occur in the scope of investigations that are performed for assessing inclusion 
and exclusion criteria (e.g., results of laboratory tests conducted at screening) 
• 
Situations where an untoward medical occurrence has not occurred, e.g., planned 
hospitalization due to a pre-existing condition that has not worsened, hospitalization 
that occurs for a procedure not associated with an AE (e.g., elective surgery or 
social admission), or hospitalization for a diagnostic procedure that takes less than 
24 hours 
• 
Overdose of an IMP or any concomitant therapy that does not result in any adverse 
signs or symptoms. Details of the dosing (volume, location of infusion, and infusion 
rate) of the IMP will be recorded in the eCRF 
• 
Anticipated day-to day fluctuations of pre-existing disease(s) or condition(s) present 
at the start of the study that do not worsen 
• 
The disease/disorder being studied or expected progression, sign, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
subject’s condition. 
At each visit to the study site, the investigator will determine whether any AEs have 
occurred. If known, the medical diagnosis of an AE should be recorded according to the 
listing of individual signs and symptoms. 
10.1.2 Documentation and Reporting 
The observation and reporting period for AEs will start with a subject signing the 
informed consent form at screening (i.e., at Day -14 to Day -1) and ends at Week 24 
(EOS). 
All AEs will be collected and recorded in the eCRF, irrespective of whether they were 
solicited or reported spontaneously by the subject. 


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For subjects who discontinue the study up to and including Week 16, AEs will be 
observed and reported at a safety follow-up visit that will be performed 1 month 
(±3 days) after last IMP administration. 
 
Investigators are not obligated to actively seek AEs after conclusion of the study 
participation. However, if the investigator learns of any AE at any time after a subject 
has been discontinued from the study, and theyconsider the event to be reasonably 
related to the study intervention or study participation, the investigator must promptly 
notify the sponsor. 
Every attempt should be made to describe AEs in terms of a diagnosis. If appropriate, 
component symptoms should be listed in addition to the diagnosis. If only nonspecific 
signs or symptoms are present, then these should be recorded as separate diagnoses in 
the eCRF. 
All subjects who experience AEs, irrespective of whether  the AEsare considered by the 
investigator to be at least possibly related to treatment with the IMP, must be monitored 
to determine the outcome. The clinical course of each AE will be followed up according 
to accepted standards of medical practice, even after the subject has completed 
participation in the study, until a satisfactory explanation is found or the investigator 
considers it medically justifiable to terminate the follow-up. Should the AE result in 
death, a full pathologist’s report should be provided, if possible. 
AEs will be classified according to their severity, causal relationship to the IMPs, and 
seriousness. 
If the severity of a recurrent AE changes from mild to moderate, from moderate to 
severe, or from mild to severe, this AE recurrence should be reported as a new AE.  
If the AE is serious or of special interest, as defined in Sections 10.2.1 and 10.3, the 
investigator or other authorized medical personnel at the study site must be notified and 
complete the paper “SAE form” at the time the SAE is detected. SAE reporting should 
occur within 24 hours (Section 10.2.2).  
Severity of Adverse Events 
The severity of AEs will be assessed according to the following criteria: 
Mild  
• 
Transient or mild discomfort 
• 
No limitation in activity 
• 
No medical intervention or therapy required. 


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Moderate  
• 
Marked limitation in activity 
• 
Some assistance usually required 
• 
Medical intervention or therapy required  
• 
Hospitalization possible. 
Severe  
• 
Extreme limitation in activity 
• 
Significant assistance required 
• 
Significant medical intervention or therapy required 
• 
Hospitalization or hospice care probable. 
Causal Relationship of Adverse Events 
The investigator must assess whether or not the AE is causally related to administration 
of the IMP. Even if the investigator considers that there is no causal relationship to the 
IMP, the AE must still be reported.  
The causal relationship of AEs to administration of the IMP will be assessed according 
to the following criteria: 
Not related 
• 
Event or laboratory test abnormality with a time to 
administration of the IMP that makes a relationship 
impossible 
• 
Is most likely explained by concurrent disease or other drugs 
or chemicals (either pathophysiologically or clinically) 
• 
Has occurred before administration of the IMP in comparable 
severity and/or frequency. 
Unlikely related 
• 
Event or laboratory test abnormality with a time to 
administration of the IMP that makes a relationship 
improbable (but not impossible) 
• 
Disease or other drugs provide plausible explanations. 
Possibly related 
• 
Event or laboratory test abnormality with reasonable time 
relationship to administration of the IMP  
• 
Could also be explained by disease or other drugs 
• 
Information on IMP withdrawal may be lacking or unclear. 
Probably related 
• 
Event or laboratory test abnormality with reasonable time 
relationship to administration of the IMP  
• 
Unlikely to be attributed to disease or other drugs 
• 
Response to withdrawal clinically reasonable 
• 
Rechallenge not required. 


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Certainly related 
• 
Event or laboratory test abnormality with plausible time 
relationship to administration of the IMP  
• 
Cannot be explained by disease or other drugs 
• 
Response to withdrawal plausible (pharmacologically or 
pathologically) 
• 
Event definitive pharmacologically or phenomenologically 
(i.e., an objective and specific medical disorder or a 
recognized pharmacological phenomenon) 
• 
Rechallenge satisfactory, if necessary. 
All AEs classified as “possibly”, “probably”, or “certainly” related will be considered as 
“at least possibly related to the IMP”. All AEs classified as “not related” or “unlikely 
related” will be considered as “not related” to the IMP. 
The degree of certainty with which an AE is attributed to administration of the IMP, or 
an alternative cause (e.g., natural history of the underlying disease, concomitant therapy, 
AxMP etc.) must be determined on the basis of how well the AE can be understood in 
terms of: 
• 
Known pharmacology of the IMP 
• 
Clinically and/or pathophysiologically plausible context 
• 
Reaction of a similar nature previously observed with similar products, or reported 
in the literature for similar products as being product-related (e.g., headache, facial 
flushing, pallor) 
• 
Plausibility supported by the temporal relationship (e.g., the event being related by 
time to administration or termination of treatment with the IMP, drug withdrawal, 
or reproduced on rechallenge). 
10.2 SERIOUS ADVERSE EVENTS 
10.2.1 Definition 
An AE is defined as serious (i.e., as an SAE) according to the ICH E2A guideline if any 
of the following criteria are fulfilled: 
• 
Results in death 
• 
Is life-threatening 
NOTE: the term “life-threatening” in the definition of “serious” refers to an event in 
which the subject was at risk of death at the time of the event; it does not refer to an 
event which hypothetically might have caused death had it been more severe. 
• 
Requires in-patient hospitalization or prolongation of existing hospitalization 
• 
Results in persistent or significant disability/incapacity 


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• 
Is a congenital anomaly/birth defect 
• 
Is an important medical event that may not be immediately life-threatening or result 
in death or hospitalization, but may jeopardize the subject or may require 
intervention to prevent 1 of the other outcomes listed above. 
Medical and scientific judgement should be exercised in deciding whether expedited 
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 subject or may require intervention to prevent one of the other outcomes 
listed in the definition above. These should also usually be considered serious. 
The following hospitalizations are not considered to be SAEs because there is no 
“adverse event” (i.e., there is no untoward medical occurrence) associated with the 
hospitalization: 
• 
Hospitalization for respite care 
• 
Hospitalization planned prior to informed consent (where the condition requiring 
the hospitalization has not changed after administration of IMP). 
10.2.2 Documentation and Reporting 
The observation and reporting period for SAEs starts with a subject signing the informed 
consent form at screening (i.e., at Day -14 to Day -1) and ends at Week 24 (EOS). 
Investigators are not obligated to actively seek SAEs after conclusion of the study 
participation. However, if the investigator learns of any SAE, including a death, at any 
time after a participant has been discontinued from the study, and theyconsider the event 
to be reasonably related to the study intervention or study participation, the investigator 
must promptly notify the sponsor. 
SAEs have to be documented on “SAE forms” and the investigator must report them 
immediately to the CRO, or no later than 24 hours after becoming aware of the SAE. If 
more information about the SAE becomes available later, this must also be reported 
immediately or no later than 24 hours after becoming aware of the SAE. 
In case of a subject’s death, the investigator will provide the applicable Ethics 
Committee(s) and the applicable responsible authorities with any further information 
requested. 
In all reports, personal data are to be pseudonymized by using the subject identification 
number. It must be possible to relate the initial and all follow-up reports to each other by 
means of the subject identification number, or name and address, or the like. 
 
 


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The investigator must report all SAEs to the following contact details: 
Fax: 
 
 
10.3 ADVERSE EVENTS OF SPECIAL INTEREST 
An adverse event of special interest (AESI) is an AE of scientific and medical concern 
specific to the sponsor’s product or program, for which ongoing monitoring and rapid 
communication by the investigator to the sponsor could be appropriate. Such an event 
might require further investigation in order to characterize and understand it. 
For this study, the following AEs are defined as AESIs: 
• 
Infusion-related reactions/anaphylactic reactions and acute systemic 
hypersensitivity reaction during or shortly after IFX-IMP infusion:  
In case of any severe, acute systemic hypersensitivity reaction during or shortly 
after infusion of IFX-IMP, the infusion should be stopped immediately and the 
subject discontinued from further dosing with IFX-IMP (and GC-IMP) but can stay 
in the study and continue AxMP and study-related procedures/assessments as 
scheduled. It is at the discretion of the investigator to discontinue the subject from 
further study participation (refer also to Sections 5.4.3 and 8.4). 
In case of such a reaction, subjects should be closely monitored for any changes in 
blood pressure, heart rate, metabolic conditions, or organ function, and appropriate 
measures should be taken to stabilize all vital signs. Fluid resuscitation may be 
needed, as well as vasopressor therapy or other measures to treat changes in blood 
pressure, vital signs, or metabolic conditions in general. In cases of emergency with 
immediate life-threatening potential such as cardiac arrest or similar life-threatening 
changes, appropriate cardiopulmonary resuscitation should be started immediately 
according to applicable guidelines, or as established at the study sites through 
existing standard operating procedures or other algorithms for cardiopulmonary 
resuscitation according to current recommended resuscitation guidelines. 
For any potential infusion-related event, the investigator should check for a 
potentially developing or existing anaphylactic reaction. In case an anaphylactic 
reaction is anticipated, appropriate immediate actions should be taken according to 
the severity or stage of the detected anaphylactic reaction as recommended by 
existing guidelines for the treatment of anaphylactic reactions or, if established at 
the study sites, according to available standard operating procedures or other 
algorithms. 
• Meningitis and meningococcal sepsis:  
In case of signs of meningitis at any time during the study, the IMPs should be 
discontinued for the rest of the study, if meningitis is confirmed, but the subject can 
stay in the study and continue AxMP and study-related procedures/assessments as 
scheduled. It is at the discretion of the investigator to discontinue the subject from 
further study participation (refer also to Sections 5.4.3 and 8.4). 


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In case of meningitis, the subject must be closely monitored and the guidelines for 
treatment of meningitis should be followed [Tunkel et al.,2017, Van de Beek et 
al.,2016]. This includes lumbar puncture, blood culture testing, immediate start of 
treatment with dexamethasone and intravenous antibiotics (combination therapy with 
ampicillin and third generation cephalosporin), and a search for the focus of the 
infection (e.g., computed tomography or magnetic resonance tomography).  
• 
Invasive infection:  
In case of signs of invasive infection at any time during the study, IMPs should be 
discontinued for the rest of the study, if invasive infection is confirmed, but the 
subject can stay in the study and continue AxMP and study-related 
procedures/assessments as scheduled. It is at the discretion of the investigator to 
discontinue the subject from further study participation (refer also to Sections 5.4.3 
and 8.4). 
In case of invasive infection, the subject must be closely monitored and the 
guidelines for treatment of invasive infection should be followed. 
10.4 SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS 
10.4.1 Definition 
Suspected unexpected serious adverse reactions (SUSARs) are side effects whose nature 
or severity is inconsistent with the information available about the product in the 
Investigator’s Brochure. 
10.4.2 Documentation and Reporting 
The sponsor or delegate will submit all available information on a SUSAR immediately 
to the applicable Ethics Committee, the applicable regulatory authority, and the 
investigators in this study, at the latest within 15 calendar days after the event becomes 
known. 
For every SUSAR that results in death or a life-threatening condition, the responsible 
Ethics Committee, the applicable regulatory authority, and the investigators in this study 
must be informed by the sponsor within 7 calendar days after the event becomes known. 
Additional information has to be given within 8 further calendar days. 
10.5 PREGNANCY 
Pregnancy, by definition, is not considered as an AE unless it results in a complication 
that meets the definition of an AE or is associated with a congenital anomaly or birth 
defect in the fetus. Any such complication must then be reported accordingly as an SAE. 


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A female subject who becomes pregnant while participating in the study, or up to and 
including 28 days after the last dose of IMP, must notify the investigator immediately 
and must discontinue treatment with the IMPs. The subject may continue other study 
procedures at the discretion of the investigator.  
The sponsor and the designee of the sponsor must be immediately notified by the 
investigator becoming aware of a pregnancy of a participating female subject or a female 
partner of a participating male subject, using the following contact details:  
Fax: 
 
 
Whenever possible, a pregnancy in subjects exposed to IFX-IMP or female partners of 
participating male subjects exposed to IFX-IMP should be followed to term so as to 
assess any potential occurrence of congenital anomalies or birth defects. Any follow-up 
information, including premature termination and the status of the mother and child after 
delivery, should be reported by the investigator. 
Severe side effects and complications during a pregnancy as well as congenital birth 
defects are SAEs per definition and, therefore, have to be reported additionally as SAEs 
according to the reporting procedures described above. 
10.6 OVERDOSE 
The consequences of an overdose with IFX-1 are not known.  
In case of GC-IMP overdose, the investigator should contact the medical monitor to 
discuss further actions to be taken, 
Overdoses accompanied by adverse outcomes must be recorded as AE. 
AEs caused by overdose should be followed to ensure that the information is as 
complete as possible. 


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11 
STATISTICS 
11.1 GENERAL CONSIDERATIONS 
A detailed statistical analysis plan will be developed and finalized prior to unblinding of 
the study database.  
The statistical analysis plan will include the exact definition of endpoints and variables 
to be analyzed, extensive details on the statistical analysis methods to be used together 
with the structure of tables and figures to be included as end-of-text tables and figures as 
well as appended listings for the clinical study report. 
All endpoints and variables will be adequately evaluated. Individual data will be listed. 
Data will be summarized using suitable descriptive statistics; depending on the structure 
of the data, either sample statistics or frequency tables will be used. 
 
11.2 DETERMINATION OF SAMPLE SIZE 
The study is divided into 2 parts: 
Study Part 1: 
A total of 20 subjects will be randomized 1:1 to either Group A (IFX-1 + RDGC) or 
Group B (IFX-1-Placebo + SDGC). 
 
Study Part 2:  
This Study Part only starts if the IDMC recommends randomizing subjects to Group C 
(IFX-1 + Placebo-GC) at the end of Study Part 1. In Study Part 2, the efficacy of 
treatment with IFX-1 in the experimental treatment (Group C) compared to the control 
treatment (Group B) with respect to the primary efficacy endpoint will be investigated. 
Subjects who have been randomized in Study Part 1 into Group B will contribute to the 
set of subjects analyzed for Study Part 2. A total of approximately 25 additional subjects 
will be randomized to Group B and Group C. The randomization ratio was selected to 
yield an equal number of 33 subjects in Group B and Group C for the primary 
comparison. With the reduced number of subjects in Part 2, this randomization ratio 
remains unchanged. It will result in an unbalanced distribution of patients in Group B 
and C for the final analysis, i.e. about 24 treated in Group B (15 from Part 1 and 9 from 
Part 2) and about 16 in Group C (all enrolled in Part 2). 
 


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In summary, the planned number of subjects are planned to be randomized in this study 
are shown in Table 6. 
Table 6 
Planned Sample Size in Study Parts 
 
Group A 
Group B 
Group C 
Part 1 
 
15 
15 
- 
Part 2 
 
- 
9 
16 
Planned number of subjects per group 
15 
24 
16 
 
11.3 ANALYSIS SETS 
Full analysis set (FAS): the FAS will consist of all subjects who receive at least 
1 administration of study medication (1 infusion of IFX-1 or Placebo-IFX-1 and at least 
1 dose of GCs or Placebo-GCs). 
Per protocol set (PPS): the PPS will be a subset of the FAS and will exclude all subjects 
with major protocol violations that affect the evaluation of the primary endpoint of the 
study. 
Safety analysis set (SAF): the SAF will consist of all subjects who receive at least 
1 administration of study medication (1 infusion of IFX-1 or Placebo-IFX-1 and at least 
1 dose of GCs or Placebo-GCs). 
Safety analyses will be based on the SAF. Efficacy analyses will be provided for the 
FAS and the PPS for subjects in Group B and C. Descriptive analysis will be provided 
for Study Part 1. 
More detailed specifications of the analysis sets and analyses will be provided in the 
statistical analysis plan. 
11.4 ENDPOINTS 
11.4.1 Efficacy 
11.4.1.1 Primary 
The primary efficacy endpoint is the proportion of subjects achieving clinical response 
defined as a reduction in BVASv3 ≥ 50% at Week 16 compared to baseline (=screening 
assessment) and no worsening in any body system. Subjects who receive rescue therapy 
up to Week 16 will be considered as not having achieved clinical response. 


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11.4.1.2 Secondary 
Efficacy 
• 
Proportion of subjects with a clinical response, defined as a reduction in 
BVASv3 ≥ 50% and no worsening in any body system at each measurement time 
point except Week 16. Subjects who receive rescue therapy will be considered as 
not having achieved a clinical response at each time point later than the first 
administration of rescue therapy 
• 
Proportion of subjects with a clinical remission, defined as having a BVASv3 = 0 at 
Week 16  
• 
Change from baseline (=screening assessment) in BVASv3 total score at Week 16 
• 
Absolute values and absolute and relative change from Day 1 in the VDI at 
Week 16 
• 
Absolute values and absolute and relative change from Day 1 in the PGA at 
Week 16 
• 
Absolute values and absolute and relative change from Day 1 in eGFR in 
mL/min/1.73 m² at Week 16. 
Pharmacokinetic/Pharmacodynamic 
• 
Actual PK sampling times will be determined and the plasma concentration of IFX-
1 will be assessed by time point (see Section 11.4.4) 
• 
Where applicable, absolute values and absolute and relative changes from Day 1 in 
the PD parameters at each measured time point (see Section 11.4.5). 
 
• 
 
• 
 
• 
 
• 
• 
 
• 
 
• 
t 
• 


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• 
• 
 
• 
 
• 
• 
 
11.4.2 Safety 
The number and percentage of subjects who had a TEAE as well as the number of 
TEAEs will be assessed for all TEAEs and SAEs as secondary endpoint. Another 
secondary endpoint is the GTI per time point. 
Furthermore, the number and percentage of subjects who have a TEAE as well as the 
number of TEAEs will be assessed for all causally related TEAEs, related SAEs, AESIs, 
TEAEs leading to study discontinuation, related TEAEs leading to study 
discontinuation, TEAEs leading to IMP discontinuation, and related TEAEs leading to 
IMP discontinuation. Causal relationship of AEs will be assessed with regard to IFX—1 
and GC. 
For the analysis of severity and causal relationship of AEs, the worst severity and the 
strongest relationship per subject and class of AE will be considered. 
Laboratory safety parameters (blood and urine), especially the change in inflammatory 
markers and differential blood cell counts, will be described by time point and changes 
in routine laboratory parameters from baseline will be determined. Shifts in safety 
laboratory parameters outside of normal ranges compared with baseline will be 
investigated. 
Immunogenicity will be assessed by determining the number and percentage of subjects 
with detection of ADAs (before administration of IFX-IMP). 
Other safety endpoints will be exploratory, as defined in detail in the statistical analysis 
plan. 
Non-treatment-emergent AEs will be listed. 


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11.4.3 Quality of Life 
The SF-36v2 will be analyzed by time point and changes from baseline will be 
determined overall and per domain. The EQ-5D-5L will be analyzed by time point and 
changes from baseline will be determined. 
11.4.4 Pharmacokinetics 
The exposure to IFX-1 in all subjects will be measured as the plasma concentration of 
IFX-1 determined on Day 1 and at all subsequent scheduled visits to the study site 
through Week 24 before administration of IFX-IMP, and in Weeks 1 (Day 4), 4, and 16 
after administration of IFX-IMP using a separate infusion line. Actual PK sampling 
times will be determined and the plasma concentration of IFX-1 will be assessed by time 
point. 
11.4.5 Pharmacodynamics 
The PD of IFX-1 are primarily measured by plasma concentration of C5a, which is 
determined at pre-specified times after administration of IFX-1. Plasma concentrations 
of C5a and IFX-1 blocking activity will be summarized by time point and as absolute 
and relative changes from Day 1. 
11.4.6 Biomarkers 
Serum concentrations of CRP, CH50 
 will be summarized by time point and as absolute and relative changes from 
Day 1.  
11.5 ANALYSES OF ENDPOINTS 
11.5.1 Efficacy 
Study Part 1 
For Study Part 1 only a descriptive efficacy analysis is planned. 
Study Part 2 
The primary efficacy variable is the percentage of subjects with clinical response 
defined as a reduction in BVASv3 ≥ 50% at Week 16 compared to baseline (=screening 
assessment) and no worsening in any body system and not having received rescue 
therapy. Missing primary endpoint data will be imputed, as described in Section 11.10. 
The experimental arm (Group C) and the Standard of Care arm (Group B) will be 
compared regarding the risk difference and its 90% confidence interval 


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As a secondary efficacy analysis, a logistic regression model will be fit for the binary 
response at Week 16 including relevant baseline characteristics (such as the baseline 
BVASv3) as covariates to further investigate the effect of subjects’ baseline 
characteristics. 
Further secondary and exploratory efficacy endpoints will be evaluated with appropriate 
statistical methods and will be described in detail in the statistical analysis plan. 
11.5.2 Safety 
TEAEs will be analyzed according to the number and percentage of subjects who had a 
TEAE, as well as the number of TEAEs with the respective Medical Dictionary for 
Regulatory Activities System Organ Class and Preferred Term. Additionally, the number 
and percentage of subjects with TEAEs will be grouped by severity and causal 
relationship. The number and percentage of subjects with SAEs and AESIs and the 
number of SAEs and AESIs will be analyzed. Where AEs are grouped by severity or 
relationship, the maximum severity/relationship per subject and class of AE will be 
considered. If the number of subjects discontinuing treatment or discontinuing the study 
is substantial, further analyses taking into account the time of AE onset and cumulative 
dose may be considered. 
Summary statistics (e.g., number of observations, mean, standard deviation, minimum, 
median, maximum, lower quartile, upper quartile) will be presented for the absolute 
values of the GTI at each time point. 
Safety laboratory and vital signs parameters will be analyzed by summary statistics (e.g., 
number of observations, mean, standard deviation, minimum, median, maximum, lower 
quartile, upper quartile) for absolute values and changes from baseline by visit. 
Immunogenicity will be assessed by determining the number and percentage of subjects 
with detection of ADAs.  
Categorical safety parameters like ECG findings will be summarized by absolute and 
relative frequencies by time point. 
11.5.3 Pharmacokinetics 
Actual PK sampling times will be determined and the plasma concentration of IFX-1 
will be assessed by time point. 


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11.5.4 Pharmacodynamics 
Where applicable, the absolute values and changes from baseline of PD endpoints will 
be summarized using descriptive statistics (e.g., number of observations, mean, standard 
deviation, minimum, median, maximum, lower quartile, upper quartile, geometric mean) 
by time point. 
All PD parameters will be analyzed based on the FAS with all values and assessments 
available. Some analyses may be repeated for the PPS. 
11.5.5 Quality of Life 
Absolute values and changes from baseline in the overall SF-36v2 and per domain at 
Weeks 16 and 24 will be analyzed by descriptive statistics (i.e., number of observations, 
mean, standard deviation, minimum, median, maximum, lower quartile, upper quartile) 
for absolute values and changes from baseline (absolute and relative) by time point and 
treatment group. 
11.5.6 Biomarkers 
Absolute values will be analyzed by time point and absolute and relative changes from 
baseline at each time point using descriptive statistics (e.g., number of observations, 
mean, standard deviation, minimum, median, maximum, lower quartile, upper quartile, 
and geometric mean) for each treatment group. 
11.6 DEMOGRAPHICS AND BASELINE CHARACTERISTICS 
Baseline characteristics and demographic information (including medical history and 
surgeries) will be summarized by treatment group and overall. If applicable, the baseline 
measurement will be defined as the latest measurement obtained prior to the first 
administration of IMP. 
11.7 PRIOR AND CONCOMITANT THERAPY 
Prior and concomitant therapies will be summarized by absolute and relative frequencies 
by treatment group and overall. Therapies will be defined as concomitant if the start or 
end date is later than the date of first IMP administration, or if no end date is available 
(ongoing therapy).  
In case of incomplete start and/or end dates, a therapy is considered as concomitant if it 
is possible that the therapy was administered after first dose of IMP (e.g., if only end 
year and month are provided and are equal to the month and year of the first IMP 
administration). 


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11.8 SUBJECT DISPOSITION 
The disposition of subjects who were enrolled (i.e., signed the written informed consent 
form) in the study as well as reasons for discontinuation from study and treatment will 
be summarized for each group. 
11.9 TREATMENT EXPOSURE 
The administration of IMP will be summarized by time point and treatment group and 
will include the number and percentage of subjects completing each treatment visit and 
the mean dose per infusion at each visit. The actual received cumulative dose in mg and 
the dose relative to the planned cumulative dose will be calculated per subject and will 
be summarized for each treatment group. 
11.10 HANDLING OF MISSING DATA 
Data imputation rules are defined for missing values for the primary efficacy endpoint of 
achieving clinical response defined as reduction in BVASv3 ≥ 50% at Week 16 
compared to baseline (=screening assessment) and no worsening in any body system. 
Subjects with missing baseline BVASv3 assessments (baseline assessments must be 
obtained at screening) will not be randomized (i.e., there shall be no missing baseline 
values for the primary endpoint). Missing values for assessments of the BVASv3 at 
Week 16 will be replaced by multiple imputation. 
Multiple imputations will only be performed for subjects with a missing BVASv3 at 
Week 16 who did not discontinue before Week 16 because of one of the following 
reasons: 
• 
AE (e.g., major relapse) or death caused by persistent disease activity  
• 
Lack of efficacy. 
Subjects who will discontinue before Week 16 because of 1 of the above-mentioned 
reasons will be treated as not having achieved clinical response at Week 16 
(non-responders). Additionally, subjects receiving GC as rescue therapy will be 
considered as non-responders regardless of their BVASv3 at Week 16.  
All further specifications for multiple imputations are based on the assumption that the 
number of subjects for whom the BVASv3 at Week 16 needs to be imputed, will be 
relatively small. Further, it is assumed that the BVASv3 assessment at Week 16 is 
missing at random, i.e., being missing will not depend on the BVASv3 at Week 16 itself 
but will only depend on the factors in the imputation model. The factors that will be 
used in the multiple imputation model for BVASv3 at Week 16 are BVASv3 at previous 
visits, treatment group, and GPA/MPA disease type. The multiple imputation model will 
be using fully conditional specification predictive mean matching. Twenty imputations 
will be performed using SAS PROC MI and using a random seed of 1,502. 
Subsequently, it will be determined for each subject within each of the imputed datasets 
whether clinical response is achieved (BVASv3 reduction of ≥ 50% compared to 


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baseline). The risk difference and the corresponding confidence interval will be 
calculated based on the binary response variable (clinical response vs. no clinical 
response at Week 16) for each imputed dataset. 
Additionally, sensitivity analyses will be conducted based on the PPS. Further 
sensitivity analyses (e.g., evaluating subjects with missing BVASv3 at Week 16 as 
non-responders) will be defined in the statistical analysis plan if deemed necessary. 
All other missing data will not be replaced. 
11.11 INTERIM ANALYSIS 
No formal interim analysis will be performed. 
There will be an IDMC recommendation point in Study Part 1 after a total of 20 subjects 
in Group A and B have completed the IFX-IMP administration (Week 16) and the 
corresponding assessments (see also Section 14.4 and 11.2 and IDMC charter). 


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12 
ETHICAL, LEGAL, AND ADMINISTRATIVE ASPECTS 
12.1 GOOD CLINICAL PRACTICE 
All persons participating in the conduct of the study (e.g., sponsor, investigators) 
commit themselves to observe the Declaration of Helsinki (64th World Medical 
Association General Assembly, Fortaleza, Brazil, October 2013) as well as all pertinent 
national laws and the ICH guidelines for GCP (June 2017) and CPMP/ICH/135/95 
(September 1997). 
12.2 ETHICS COMMITTEE AND RESPONSIBLE REGULATORY 
AUTHORITY 
The protocol and other associated documents will be submitted to the applicable Ethics 
Committee for approval. The study documents will be submitted to the applicable 
regulatory authority. 
The study can only start after obtaining a positive evaluation by the applicable Ethics 
Committee and approval from the applicable regulatory authority. The written approval 
of the applicable Ethics Committee and the applicable responsible regulatory authority 
must be filed in the trial master file. Additionally, each study site must receive a copy of 
these documents to be filed in the investigator site file. 
12.3 SUBJECTS INFORMATION AND INFORMED CONSENT 
The investigator must explain to each potential study subject the nature of the study, the 
objectives, the procedures involved, the expected duration, the potential risks and 
benefits involved, and any discomfort it may entail. The potential subjects must be 
informed that participation in the study is voluntary, that they may withdraw their 
consent to participate at any time, and that withdrawal of consent will not affect their 
subsequent medical treatment or relationship with the treating physician. 
The informed consent must be given by means of standard written statements, written in 
non-technical language. The subjects should read the informed consent form and 
consider their decision before signing and dating the document. A copy of the signed 
document must be given to the subject. No subject can be involved in the study if he/she 
is related to the investigator, any member of the team at the study site, or the sponsor. 
The informed consent of the subject must also refer specifically to the assessment and 
processing of data on the subject’s health. The subject is to be informed explicitly about 
the purpose and extent of the assessment and the use of their personal data, especially 
the health-related data. Informed consent will also be given for the storage and testing of 
samples for possible futureresearch, if legally allowed. 


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12.4 PROTOCOL AMENDMENTS 
If modifications are made to the protocol, after it has been positively appraised by the 
Ethics Committee and approved by the responsible regulatory authority, these 
modifications must be reappraised and approved by the Ethics Committee and the 
responsible regulatory authority if the changes: 
• 
Are such that they may affect the subjects’ safety 
• 
Are fundamental to the therapeutic procedures 
• 
Result in further data collection that necessitates changes to the subject information 
and/or informed consent form 
• 
Affect the interpretation of the scientific documents upon which the study is based 
or the significance of the results of the study 
• 
Significantly affect the leadership or conduct of the study 
• 
Concern the quality or the innocuousness of the investigational drug. 
Protocol amendments need the authorization of the sponsor, the coordinating 
investigator, and the responsible biostatistician, if applicable. All protocol amendments 
will be: 
• 
Submitted to the Ethics Committee and, where applicable, to the responsible 
regulatory authority 
• 
Provided in written form to the responsible parties 
• 
Filed in the trial master file. 


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13 
DOCUMENTATION 
13.1 ELECTRONIC CASE REPORT FORMS 
All data assessments required by this clinical study protocol will be collected in an 
eCRF and entered into a database validated by the CRO for eCRFs. 
The sponsor or its designee will supply the study site with access to eCRFs. The sponsor 
or its designee will make arrangements to train appropriate study site personnel in the 
use of the eCRF. 
These eCRFs are used to transmit information collected on the performance of this study 
to the sponsor and regulatory authorities. eCRFs must be completed in English. 
Data will be entered directly into the eCRF by the investigator or study site personnel 
via a single data entry process. Study site personnel will be granted access to the eCRF 
system through a personal user identification and password assigned by the system 
administrator. In the eCRF, subjects will be identified by their subject numbers. The 
eCRF is to be dated and signed by the investigator or a qualified person who has been 
delegated by the investigator to do so on his/her behalf, as documented on a signature 
delegation log filed in the investigator site file. Data entered in the eCRF will be stored 
in a centralized database on a remote server. 
After completion of the entry process, computer logic checks will be run to identify 
items, such as inconsistent dates, missing data, and questionable values. Queries may be 
issued by designees of the sponsor and will be answered by the site.  
Corrections to the eCRF database are recorded in an audit trail that captures a complete 
record of all information. The new information, identification of the person making the 
correction, the date the correction was made, and the reason for change are captured in a 
new record.  
The principal investigator must review the eCRFs for completeness and accuracy and 
must sign and date the appropriate eCRFs as indicated. Furthermore, the principal 
investigator must retain full responsibility for the accuracy and authenticity of all data 
entered into the eCRFs. 
The eCRFs will be reviewed for completeness and acceptability at the study site during 
periodic visits by the clinical monitor. The sponsor and/or its designee will be permitted 
to review the subject’s medical and hospital records pertinent to the study to ensure 
accuracy of the eCRFs. The completed eCRFs are the sole property of the sponsor and 
should not be made available in any form to third parties, except for authorized 
representatives of appropriate governmental health or regulatory authorities, without 
written permission of the sponsor. 
Further information on handling of the eCRF data (e.g., data entry, clarification, and 
validation) will be defined in the data management plan. 


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13.2 ARCHIVING 
Because the study is being conducted to obtain marketing authorization, the 
requirements of ICH Guideline E6 sections 5.5.11 and 5.5.12 shall be taken into 
account. 
The investigator is responsible for archiving the investigator site file, the subject’s 
records, and the source data according to applicable regulatory requirements. These 
documents have to be archived for at least 15 years after completion or discontinuation 
of the trial or at least two years after the granting of the last marketing authorisation in 
the European Union (when there are no pending or contemplated marketing applications 
in the EU) or for at least two years after formal discontinuation of clinical development 
of the investigational product, whatever is the longest. 
If the investigator can no longer maintain the archive of study records (e.g., due to 
retirement or relocation), the sponsor must be informed in writing about any change in 
responsibility for record retention, including the name of the new responsible party, 
contact information, and location of the study records. Records must not be destroyed 
without prior written consent from the sponsor. 


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14 
SUPERVISION OF THE CLINICAL STUDY 
14.1 ACCESS TO SOURCE DATA 
According to ICH guidelines for GCP and the applicable laws, the investigator must 
permit all authorized third parties access to the study site and the medical records of the 
study subjects (source data). These include the clinical monitors, auditors, and other 
authorized employees of the sponsor as well as members of the local or federal 
authorities. All these persons are bound to strict confidentiality. 
14.2 MONITORING 
Monitoring of the study sites will be performed by a CRO designated by the sponsor and 
will be based on the CRO’s monitoring standard operating procedures as well as the 
study-specific Monitoring Manual. 
The clinical monitor, as a representative of the sponsor, has the obligation to follow the 
study closely. The monitor will visit the study site at periodic intervals and, in addition, 
the monitor will be adequately trained and maintain contact with the study site via 
telephone calls as well as in written form, as appropriate. The monitor will be adequately 
trained and maintain a working knowledge of the study through observation, review of 
study records and source documentation, and discussion of the conduct of the study with 
the investigator and study site personnel. Source data review and verification of the most 
important parameters will be performed for all subjects as described in the Monitoring 
Manual. The investigator and institutions involved in the study will permit study-related 
monitoring and provide direct access to all study records and facilities. Adequate time 
and space for monitoring visits should be made by the investigator or other investigator 
site staff. 
The clinical monitor will report via the project manager of the sponsor-designated CRO 
to the sponsor who carefully monitors all aspects of the study for compliance with 
applicable government regulations, with respect to current ICH guidelines for GCP and 
current standard operating procedures. 
Auditors representing the sponsor may also similarly evaluate the study and its monitors. 
For these purposes, the investigator will need to have eCRFs and source documents 
available on request. 
In addition, the study may be evaluated by representatives of the national regulatory 
authorities, who will also be allowed access to study documents. The investigators 
should promptly notify the appointed CRO/clinical monitor of any inspections that will 
be scheduled with any regulatory authority. 
The clinical monitor will discuss the conduct and progress of the study with the 
investigator and other site staff. The investigator must cooperate with the clinical 
monitor to ensure that corrective and preventative action is taken to resolve any 


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problems noted in the course of the monitoring, and that the preventative measures are 
put in place to prevent recurrence of issues. 
As part of the responsibilities assumed by participating in the study, the investigator 
agrees to maintain adequate case histories for the subjects treated under this protocol. 
The investigator agrees to maintain accurate source documentation and eCRFs as part of 
the case histories. 
Study records are comprised of source documents, eCRFs, and all other administrative 
documents (e.g., correspondence, clinical study materials, supply shipping manifests, or 
monitoring logs). An investigator site file will be provided with instructions for the 
maintenance of study records. 
14.3 ADJUDICATION COMMITTEE 
A blinded AC with expertise in vasculitis, will be assembled. The AC will adjudicate the 
response to therapy in a blinded manner in Study Part 1 for all randomized subjects, 
taking all predefined efficacy data into consideration. The responsible CRO will provide 
predefined data for the committee review. Further details on the AC membership, roles, 
timing of the reviews, details of the data and outputs to be provided to the AC, and the 
procedures for ensuring the blinded conditions, with all the operational details, will be 
provided in the AC Charter.  
14.4 INDEPENDENT DATA MONITORING COMMITTEE 
The safety of the subjects will be monitored by an unblinded IDMC. The IDMC will 
receive data for regular safety reviews at pre-specified time points in order to detect and 
report early evidence of unanticipated harm to subjects. To maintain the blind, the data 
for the safety reviews will be delivered by an unblinded CRO biostatistics team different 
from the blinded CRO biostatistics personnel involved in the study. Further details on 
the provided outputs and the time points of the reviews will be specified in the IDMC 
charter. In addition, further ad hoc reviews on safety data may be arranged and 
conducted if deemed necessary. 
Furthermore, 


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If the IDMC recommends enrolling further subjects, the AC will review, under blinded 
conditions, the response to therapy of these additional subjects, up to the last additional 
subject completing Week 16. The outcome of this review will be provided to the IDMC, 
who will also review these new data under unblinded conditions, together with the 
unblinded safety outputs, and make the recommendation about opening Group C or 
stopping the study. 
Further details on the IDMC membership, the responsibilities of the IDMC, the purpose 
and timing of the reviews, details of the data and outputs to be provided to the IDMC 
and the procedures for ensuring confidentiality and proper communication will also be 
provided in the IDMC charter. The charter will also outline the required content of the 
written report to be provided by the IDMC after each safety review, including their 
recommendations for the future conduct of the study. 
14.5 AUDITS 
In order to guarantee that the conduct of the study is in accordance with ICH guidelines 
for GCP and the national laws, audits may be performed at the study sites to be carried 
out by an independent auditor. In addition, for-cause audits may be scheduled. 
The investigator agrees to give the auditor access to all relevant documents for review. 
14.6 INSPECTIONS 
According to the corresponding ICH guidelines for GCP, inspections of the study sites 
may be performed by the local or regulatory authorities at any time during or after 
completion of the study. The investigator will contact the sponsor or designated CRO 
immediately upon knowledge of a planned inspection. 
The investigator agrees to give the inspectors access to all relevant documents for 
review. 


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15 
DATA PROTECTION AND CONFIDENTIALITY 
Within this study, personal data from the study subjects and data regarding the treatment 
and the course of subject’s welfare will be collected. 
The data will be stored and processed in pseudonymized form (i.e., without reference to 
the subject’s name) with the aid of a unique subject identification number. 
Data will be managed by a sponsor-designated CRO (data entry, data cleaning, and data 
exports). The safety concept ensures among other things that data access is limited to 
authorized persons, that measures are taken to prevent loss of data, and that the 
applicable laws pertaining to data protection are observed. The data are protected from 
third party access and only members of the study team are permitted access. These 
members are bound to strict confidentiality. 
Personal data will be stored in an pseudonymous manner after reaching finishing 
completion status of all concomitant scientific projects for at least 15 years, if no other 
or new regulatory requirements come into effect warranting different time periods for 
archiving. 
15.1 DECLARATION REGARDING DATA PROTECTION 
During data entry, processing, and analysis by a sponsor-designated CRO, all 
requirements of the data protection act will be taken into account. Access to data is 
strictly limited to authorized persons. Data are protected against unauthorized access 
according to current federal legislation and regulations.  
The sponsor will ensure that all safeguards are in place to minimize any eventual risk of 
breaches, and complies otherwise with the requirements of European Union General 
Data Protection Regulation (GDPR, Regulation (EU) 2016/679). The sponsor will 
regularly check all procedures relevant to the processing of personal data, as to ensure 
privacy by design and compliance with GDPR. 
15.2 DECLARATION REGARDING THE PSEUDONYMIZED TRANSFER OF 
PERSONAL DATA 
The sponsor certifies herewith that the transfer of pseudonymized personal data will take 
place according to the applicable local laws. Moreover, the sponsor certifies that study 
subjects who do not permit the transfer of data will not be admitted to the study. 


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16 
ADMINISTRATIVE AGREEMENTS 
16.1 ADHERENCE TO THE PROTOCOL/PROTOCOL DEVIATIONS 
The clinical study described here will be conducted and analyzed in accordance with 
local laws and ICH guidelines for GCP. 
After a subject has been enrolled, it is the investigator’s responsibility to avoid protocol 
deviations in order to obtain unbiased data for the analysis of the study. 
All protocol deviations will be documented and discussed with the responsible 
biostatistician before closing the database and carrying out the statistical analyses. 
16.2 FINANCING AND INSURANCE 
The study is financed by the sponsor. 
The subjects are covered by an applicable insurance policy for participation in a clinical 
study. One copy of the insurance certificate and the insurance conditions will be handed 
out to the subject and 1 will be filed in the investigator site file. 
16.3 NOTIFICATION OF THE LOCAL AUTHORITIES 
The sponsor, their contractors, and all investigators and their deputies are responsible for 
notifying the local regulatory authority of their participation in the study prior to 
enrolment of the first subject in the study. Responsibility for notification to the local 
authorities has been delegated to a sponsor-designated CRO. 
This extends also to amendments, discontinuation of study arms or of the entire study, 
and the regular conclusion of the study. 
16.4 PUBLICATION POLICY AND REGISTRATION 
16.4.1 Publication Policy 
The rights and obligations of investigators and the sponsor concerning any formal 
presentation or publication of data collected as a direct or indirect result of this study 
will be addressed specifically in the Clinical Study Agreement for the study.  
The first publication must be based upon all data obtained from all analyses, as 
stipulated in the study protocol. 
The sponsor must receive a copy of any intended communications in advance of the 
proposed submission date. This is to allow the sponsor time to review the 
communication for accuracy (thus avoiding potential discrepancies with submissions to 
regulatory authorities), to verify that confidential and/or proprietary information is not 


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inadvertently divulged, to provide any relevant supplementary information, and to allow 
establishment of co-authorship (as appropriate). The authorship of communications 
arising from pooled data will include investigators from study sites that contributed data 
as well as relevant personnel from the sponsor. Ownership of all data will remain with 
the sponsor. 
Furthermore, the publication policy will follow the recommendations of Good Scientific 
Practice of the Deutsche Forschungsgemeinschaft (www.dfg.de) and will meet the 
criteria of the International Committee of Medical Journal Editors 
(http://www.icmje.org). 
16.4.2 Registration 
The sponsor will provide the relevant study protocol information in a public database 
(e.g., ClinicalTrials.gov, https://clinicaltrials.gov/; EU Clinical Trials Register, 
https://www.clinicaltrialsregister.eu) before or at commencement of the study. The 
sponsor may also provide study information for inclusion in national registries according 
to local regulatory requirements.  
If a potential subject contacts the sponsor regarding participation in the study, the 
investigator agrees that the sponsor may forward the study site and contact details to the 
subject. Based on the inclusion and exclusion criteria for the study, the investigator will 
assess the suitability of the subject for randomization into the study. 
Results of this study will be disclosed according to the relevant regulatory requirements. 
All publications in peer-reviewed medical journals resulting from this study will be 
listed in the original study protocol registration record (e.g., on ClinicalTrials.gov). 


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Flossmann O, Berden A, de Groot K, Hagen C, Harper L, Heijl C, et al. Long-term 
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APPENDICES 
18.1 CHAPEL HILL CONSENSUS CONFERENCE 
DIAGNOSTIC CRITERIA 
Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, 
have not yet been developed for GPA and MPA. In 1994, the CHCC developed 
definitions for these vasculitides and some of their mimickers, that were revised in 2012 
[Jennette 1997, Jennette 2013]. These definitions will be applied to determine a 
participant’s eligibility for this clinical study [Fries 1990].  
Chapel Hill Consensus Conference Definitions for Microscopic Polyangiitis 
• 
Necrotizing vasculitis with few or no immune deposits, predominantly affecting 
small vessels (i.e., capillaries, venules, or arterioles) 
• 
Necrotizing arteritis involving small and medium arteries may be present 
• 
Necrotizing glomerulonephritis is very common 
• 
Pulmonary capillaritis often occurs 
• 
Granulomatous inflammation is absent. 
Chapel Hill Consensus Conference Definitions GPA 
• 
Necrotizing granulomatous inflammation usually involving the upper and lower 
respiratory tract 
• 
Necrotizing vasculitis affecting predominantly small to medium vessels (e.g., 
capillaries, venules, arterioles, arteries and veins) 
• 
Necrotizing glomerulonephritis is common. 


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18.2 BIRMINGHAM VASCULITIS ACTIVITY SCORE VERSION 3.0 


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18.3 GLOSSARY AND SCORING FOR BVAS VERSION 3.0 


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18.4 OTHER MULTI-SYSTEM AUTOIMMUNE DISEASES 
Prohibited Diseases 
Permitted Diseases 
Eosinophilic granulomatosis with 
polyangiitis (Churg-Strauss) according to 
the definitions of the CHCC 
Rheumatoid arthritis without non-
articular manifestations (1) 
Systemic lupus erythematosus 
Ankylosing spondylitis without systemic 
and non-articular manifestations (2) 
IgA vasculitis (Henoch-Schönlein) 
Autoimmune thyroiditis (Hashimoto) 
Rheumatoid vasculitis 
Diabetes mellitus type 1 
Primary and secondary Sjögren’s 
syndrome 
 
Cryoglobulinemic vasculitis 
 
Autoimmune hemolytic anemia 
 
Mixed connective tissue disease 
 
Autoimmune lymphoproliferative 
syndrome 
 
If any other multi-system autoimmune disease is not listed, please contact the 
responsible medical monitor for further decisions. 
(1) Including, but not limited to: gastrointestinal, pulmonary, cardiac, renal, 
neurological, skin and ocular manifestations due to RA.  
(2) Spine and joints may be affected.  
 


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18.5 VASCULITIS DAMAGE INDEX 
 


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18.6 GLUCOCORTICOID TOXICITY INDEX 
 
 


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35-410 


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18.7 PHYSICIAN GLOBAL ASSESSMENT 
The Physician Global Assessment scale is an 11-point scale to record the assessment of 
the overall disease activity of the subject. The investigator should not be influenced by 
the presence of any accumulated damage, complication of treatment, social/emotional 
problems, or other issues not related to GPA or MPA. 
Mark to indicate the amount of GPA or MPA disease activity (not including 
longstanding damage) within the previous 28 days: 
 
 


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18.8 36-ITEM SHORT FORM SURVEY 
 
 


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18.9 THE EUROQOL-5 DIMENSIONS SURVEY 
 
 
 


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