Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients With Severe Eosinophilic Asthma
Phase: PHASE2
Conditions: Eosinophilic Asthma
Sponsor: AnaptysBio, Inc.

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Protocol Number: ANB020-004 
ANB020 
16 Feb 2018 
Confidential 
Clinical Study Protocol 
Protocol Title:  
Placebo-Controlled Proof of Concept Study to Investigate 
ANB020 Activity in Adult Patients with Severe Eosinophilic 
Asthma 
Protocol Number: 
ANB020-004 
Version: 
Amendment 3 
Date of Protocol:  
16 Feb 2018 
Product:  
ANB020 
IND No.:  
126765 
EudraCT No.:  
2017-000647-40 
Study Phase  
IIa 
Sponsor: 
AnaptysBio Inc. 
10421 Pacific Center Court, Suite 200, San Diego, CA 92121, 
United States 
Project Manager: 
AnaptysBio Inc. 
10421 Pacific Center Court, Suite 200, San Diego, CA 92121 
United States 
Email:
Phone
Medical Monitor: 
AnaptysBio Inc. 
10421 Pacific Center Court, Suite 200, San Diego, CA 92121 
United States 
Email: 
Phone:
Chief Investigator: 
Oxford University Hospital and Trust 
NDM Research Building, Nuffield Department of Medicine 
University of Oxford, Old Road Campus, Roosevelt Drive 
Oxford, OX3 7FZ 
Email: 
Phone:
Confidentiality Statement 
This confidential information in this document is provided to you as an Investigator or consultant for review by you, your staff, and the 
applicable Independent Ethics Committee. Your acceptance of this document constitutes agreement that you will not disclose the 
information contained herein to others without written authorization from the Sponsor. 

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Protocol Number: ANB020-004 
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SYNOPSIS 
Name of Sponsor/Company: 
AnaptysBio Inc. 
Name of Finished Product: 
Humanized immunoglobulin subtype G1/kappa (IgG1/kappa) 
monoclonal antibody 
Name of Active Ingredient: 
ANB020 
Title of Study: 
Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult 
Patients with Severe Eosinophilic Asthma 
Protocol No: 
ANB020-004 
Study centers: 
Up to 6 centers in the United Kingdom 
Study duration: 
The expected duration of the study is up to 141 days. Screening period of 
7-14 days and treatment and follow-up period of 127 days. 
Phase: 
IIa 
Objectives: 
Primary: 
• To measure the reduction of eosinophils (blood eosinophil count) from Baseline (Day 1 pre-dose) to 
Day 22 in adult severe eosinophilic asthma patients administered with ANB020. 
• To assess the safety and tolerability of a single, intravenous (IV) dose of ANB020 compared to 
placebo in adult patients with severe eosinophilic asthma. 
Secondary: 
• To measure the reduction of eosinophils (blood eosinophil count) from Baseline (Day 1 pre-dose) to 
the End of Study (EOS) visit (Day 127) in adult severe eosinophilic asthma patients administered 
with ANB020. 
• To assess the change from Baseline in the clinic forced expiratory volume in 1 second (FEV1) from 
Baseline (Day 1 pre-dose) to the EOS visit (Day 127). 
• To assess the change from Baseline in the fractional exhaled nitric oxide (FeNO) in the breath from 
Baseline (Day 1 pre-dose) to the EOS visit (Day 127). 
• To assess the pharmacodynamic (PD) activity of ANB020 on ex vivo induced interferon-gamma 
(IFN-γ) levels. 
• To test for any immunogenicity to ANB020. 
• To describe the limited pharmacokinetics (PK) of ANB020 following a single, IV dose in adult 
patients with severe eosinophilic asthma. 
Exploratory: 
• To assess the effect of ANB020 on circulating serum cytokines. 
• To assess the activity of ANB020 after a single, IV dose on clinical scores such as the Asthma 
Control Questionnaire (ACQ), Patient Global Impression of Change (PGIC), and the Clinical Global 
Impression of Change (CGIC). 
• To assess the effect of ANB020 on asthma symptoms, change in standard of care (SOC) treatment, 
and rescue medication (short-acting beta-agonists [SABA]) usage. 
• To assess the effect of ANB020 on IgE levels. 

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Methodology:  
This is a proof of concept study designed to assess the effects of a single 300 mg/100 mL IV dose of 
ANB020 compared to placebo in adult patients with severe eosinophilic asthma. This study will also assess 
the safety and tolerability of ANB020 in adult patients with severe eosinophilic asthma. 
A written informed consent will be obtained from each patient prior to any study procedures.  At the 
Screening visit (7-14 days before Day 1), inclusion and exclusion criteria will be assessed. Medical history, 
ongoing medications, as well as vital signs will be recorded. Various other study assessments including a 
physical examination, FeNO measurement, spirometry to determine FEV1, and laboratory tests will be 
performed. 
On Day 1, patients will present to the study center, and the inclusion and exclusion criteria will be verified. 
Eligible patients will be randomized to receive one IV dose of either ANB020 (300 mg/100 mL) or placebo 
(0.9% sodium chloride [100 mL]) in a 1:1 ratio. Specific study assessments and safety laboratory tests will be 
performed. Blood samples to determine the eosinophil count, ex vivo induced IFN-γ levels, anti-drug 
antibodies (ADA), serum cytokines, and serial samples for PK analysis will be collected. Patients will remain 
in the study center for approximately 6 to 8 hours to complete the study assessments. Patients with any 
ongoing adverse events (AEs) or serious adverse events (SAEs) at the time of scheduled discharge from the 
study center should remain at the study center until the Investigator has determined that these events have 
been resolved or deemed as not clinically significant. 
After completing the Day 1 assessments, all patients will be followed up for 18 weeks. During the follow-up 
period, patients will return to the study center for study assessments on Day 2, 8, 22, 36, 64, 85, and 106 and 
will be contacted via telephone by study staff on Day 50 and 57. The EOS visit will be on Day 127 
(Week 18) at the study center. 
All patients will undergo the FeNO and FEV1 (spirometry) tests at each study center visit. An ACQ will be 
completed by all patients at each study center visit (except Day 2) and the patient diary must be completed on 
a daily and weekly basis. The Investigator will rate the patient’s response using the CGIC scale and the 
patients will be asked to rate the degree of change in the overall asthma status using the PGIC scale (part of 
the diary card). During the follow-up period, other assessments including vital signs, safety laboratory 
testing, eosinophil count, PK, and biomarker analysis will be performed at specified time points. 
Planned number of patients: 
Approximately 24 
Diagnosis and 
main criteria for inclusion: 
Male or female patients (women of childbearing potential must be 
taking highly effective contraceptive measures) aged ≥18 to ≤65 years 
with a confirmed clinical diagnosis of eosinophilic asthma with 
documented blood eosinophil count ≥300 cells/µL despite receiving 
SOC treatment. 
Test product, dose and mode of 
administration: 
ANB020 is a humanized immunoglobulin subtype G1/kappa 
(IgG1/kappa) monoclonal antibody that specifically neutralizes the 
biological effects of human interleukin-33 (hIL-33). 
A single dose of 300 mg ANB020 will be administered on Day 1 over 
1 hour by IV infusion in polyvinyl chloride or polyolefin bags following 
dilution to a total volume of 100 mL with 0.9% sodium chloride. 
Placebo, dose, and mode of 
administration: 
A total dose of 100 mL of placebo (0.9% sodium chloride) will be 
administered on Day 1 over 1 hour by IV infusion. 
Criteria for evaluation: 
Primary Endpoints: 
Primary Pharmacodynamic Endpoint: 
• 
Reduction of peripheral eosinophil count from Baseline (Day 1) to Day 22. 
Safety and Tolerability Endpoints: 
• 
Assessment of AEs/SAEs (potentially significant and clinically important AEs, SAEs, and AEs 

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leading to withdrawal). 
• 
Physical examinations. 
• 
Vital signs. 
• 
Clinical safety laboratory tests (hematology, biochemistry, immunoglobulins, and urinalysis). 
• 
Electrocardiogram (ECG). 
• 
Number of asthma exacerbations. 
• 
Immunogenicity to ANB020 ADA. 
Secondary Endpoints: 
Secondary Pharmacodynamic Endpoint: 
• 
Reduction of peripheral eosinophil count from Baseline (Day 1) through EOS visit (Day 127). 
• 
Whole blood ex vivo induced IFN-γ levels. 
Secondary Efficacy Endpoints: 
• 
Change in FEV1 from Baseline (Day 1) to the EOS visit (Day 127). 
• 
Change in FeNO from Baseline (Day 1) to the EOS visit (Day 127). 
Secondary Pharmacokinetic Endpoints: 
Where possible, the following limited PK parameters will be determined. 
• 
Maximum observed concentration (Cmax). 
• 
Time to maximum observed concentration (tmax). 
Exploratory Endpoints: 
• 
Circulating cytokines including, but not limited to IL-4, IL-5, IL-9, IL-13, IL-33, and sST2. 
• 
Clinical scores for ACQ, PGIC, and CGIC. 
• 
Patient diary data of asthma symptoms, change in SOC treatment, and rescue medication (SABA) 
usage. 
• 
Reduction of IgE levels from Baseline (Day 1) to the EOS visit (Day 127). 
Statistical methods: 
A total of approximately 24 patients will be randomized in a 1:1 ratio to receive ANB020 or placebo. 
For primary PD endpoint, peripheral eosinophil count on Day 22 will be analyzed by a mixed-model repeated 
measures (MMRM) analysis with terms for treatment, time point of measurement, and treatment by time 
point interaction as fixed effects and Baseline eosinophil count (pre-dose measurement at randomization 
[Day 1]) as covariate. Appropriate correlation matrix will be used. Treatment differences will be presented 
with corresponding p-values for the test of no difference and 95% confidence interval (CI). Observed and 
change from Baseline will be summarized descriptively by nominal time point and treatment.  
For safety and tolerability, AEs, SAEs, vital signs, physical examinations, ECGs, and clinical laboratory 
assessments at specific time points will be evaluated. All safety data will be summarized descriptively. 
Number and percentage of AEs will be presented for each treatment by Preferred Term and System Organ 
Class of the current Medical Dictionary for Regulatory Authorities (MedDRA) dictionary. Individual listings 
of all SAEs and AEs leading to investigational product (IP) discontinuation will be summarized using the 
current MedDRA dictionary. Similar analyses will be performed for potentially significant and clinically 
important AEs. Number of asthma exacerbations will be summarized using frequency count and percentage. 
Observed and change from Baseline for ADA levels will be summarized with descriptive statistics. 
Summaries and listings of vital signs, physical examination, ECG, and laboratory test results will be 
presented. Appropriate descriptive statistics will be summarized for the observed value at each scheduled 
assessment and for the corresponding change from Baseline. Baseline will be the last assessment before IP 

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administration. 
For secondary efficacy endpoint, actual and change in FEV1 from Baseline (Day 1) to the EOS visit 
(Day 127) will be summarized using descriptive statistics. Change from Baseline will be compared between 
ANB020 and placebo using a mixed-effect analysis of covariance (ANCOVA). Treatment differences will be 
presented with corresponding p-values for the test of no difference and 95% CI.  
As a supportive analysis, MMRM analysis will be used to assess the treatment effects. All tests of treatment 
effects will be conducted at a 2-sided alpha level of 0.05 or with 2-sided 95% CIs. Other secondary efficacy 
endpoint and applicable exploratory endpoints analyses will be performed same as FEV1 analyses. 
For the quantitative efficacy variables, descriptive statistics (sample size, mean, minimum, maximum, and 
95% CI) will be presented. 
ANB020 concentrations in serum will be listed and summarized using appropriate descriptive statistics. 
For secondary and exploratory PD endpoints, observed and change from Baseline for ex vivo induced IFN-γ, 
eosinophil count, and serum cytokines will be summarized descriptively by nominal time point and 
treatment. Comparison between ANB020 and placebo will be performed using a similar MMRM analysis as 
described for primary PD endpoint. The relationship between ANB020 concentrations and PD endpoints will 
be explored graphically. 

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TABLE OF CONTENTS 
1.0 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ......................... 13 
2.0 
INTRODUCTION .......................................................................................................... 16 
2.1 
Background Information .................................................................................. 16 
2.2 
Rationale ............................................................................................................. 19 
2.3 
Hypothesis ........................................................................................................... 20 
2.4 
Risk-Benefit Assessment ................................................................................... 20 
3.0 
STUDY OBJECTIVES ................................................................................................. 22 
3.1 
Primary Objectives ............................................................................................ 22 
3.2 
Secondary Objectives ........................................................................................ 22 
3.3 
Exploratory Objectives ..................................................................................... 22 
4.0 
INVESTIGATIONAL PLAN ....................................................................................... 24 
4.1 
Summary of Study Design ................................................................................ 24 
4.2 
Discussion of Study Design ............................................................................... 28 
4.3 
Selection of Study Population .......................................................................... 28 
4.3.1 
Inclusion Criteria............................................................................ 29 
4.3.2 
Exclusion Criteria .......................................................................... 29 
4.3.3 
Disease Diagnostic Criteria ............................................................ 31 
4.3.4 
Patient Restrictions......................................................................... 31 
4.3.5 
Patient Withdrawal ......................................................................... 32 
5.0 
STUDY TREATMENTS ............................................................................................... 34 
5.1 
Treatments Administered ................................................................................. 34 
5.2 
Identity of Investigational Product ................................................................. 34 
5.3 
Packaging and Labelling .................................................................................. 34 
5.4 
Method of Assigning Patients to Treatment Group ..................................... 35 
5.5 
Selection of Doses in the Study ........................................................................ 35 
5.6 
Selection and Timing of Dose for Each Patient ............................................ 35 
5.7 
Blinding/Unblinding .......................................................................................... 35 
5.7.1 
Blinding ......................................................................................... 35 
5.7.2 
Unblinding ..................................................................................... 36 
5.8 
Prior and Concomitant Treatments ............................................................... 36 
5.8.1 
Excluded Medications .................................................................... 36 
5.8.1.1 
Excluded Medications Prior to Lung Function 
Assessments.................................................................. 37 
5.8.2 
Allowed Medications ..................................................................... 37 
5.9 
Medical Care of Patients after End of Study ................................................ 38 

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5.10 
Treatment Compliance ..................................................................................... 38 
5.11 
Investigational Product Accountability.......................................................... 38 
6.0 
STUDY PROCEDURES ............................................................................................... 40 
6.1 
Screening ............................................................................................................. 40 
6.1.1 
Fractional Exhaled Nitric Oxide (FeNO) Test ................................. 40 
6.1.2 
Spirometry (FEV1 Measurement) .................................................... 40 
6.1.3 
Asthma Control Questionnaire ....................................................... 41 
6.1.4 
Patient Diary .................................................................................. 41 
6.2 
Study Day Procedures ....................................................................................... 42 
6.2.1 
Blood volume ................................................................................. 42 
6.2.2 
Day 1 (Randomization) .................................................................. 42 
6.2.3 
Follow-up Period............................................................................ 42 
6.2.3.1 
Patient Global Impression of Change (PGIC) ................ 43 
6.2.3.2 
Investigator’s Assessment-Clinical Global 
Impression of Change (CGIC)....................................... 43 
6.2.4 
End of Study .................................................................................. 43 
6.2.5 
Early Termination .......................................................................... 43 
6.2.6 
Timing of Procedures ..................................................................... 44 
7.0 
SAFETY, PHARMACODYNAMIC, AND PHARMACOKINETIC 
ASSESSMENTS ............................................................................................................. 45 
7.1 
Safety ................................................................................................................... 45 
7.1.1 
Adverse Events .............................................................................. 45 
7.1.1.1 
Reporting of Adverse Events ........................................ 47 
7.1.1.2 
Reporting of Serious Adverse Events to 
Regulatory Authorities and Investigators....................... 48 
7.1.1.3 
Follow-Up of Adverse Events ....................................... 49 
7.1.2 
Clinical Laboratory Evaluations ..................................................... 49 
7.1.3 
Vital Signs, Physical Findings, and Other Safety 
Assessments ................................................................................... 51 
7.1.4 
Safety Monitoring .......................................................................... 51 
7.2 
Pharmacodynamics ........................................................................................... 52 
7.3 
Pharmacokinetics ............................................................................................... 52 
7.4 
Efficacy ................................................................................................................ 53 
7.5 
Health Outcomes ................................................................................................ 53 
7.6 
Pharmacogenetics .............................................................................................. 53 
7.7 
Appropriateness of Measurements ................................................................. 53 
8.0 
QUALITY CONTROL AND QUALITY ASSURANCE ........................................ 54 
8.1 
Monitoring .......................................................................................................... 54 
8.2 
Data Management/Coding ............................................................................... 55 
8.3 
Quality Assurance Audit .................................................................................. 57 

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9.0 
STATISTICS .................................................................................................................. 58 
9.1 
Determination of Sample Size .......................................................................... 58 
9.1.1 
Analysis populations ...................................................................... 58 
9.2 
Patient Disposition ............................................................................................. 59 
9.3 
Patient Characteristics and Concomitant Medications ............................... 59 
9.4 
Safety analyses.................................................................................................... 59 
9.4.1 
Adverse Events .............................................................................. 60 
9.4.2 
Vital Signs Measurements, Physical Findings, and Clinical 
Laboratory Evaluations .................................................................. 60 
9.4.3 
Missing Data .................................................................................. 61 
9.5 
Efficacy analysis ................................................................................................. 61 
9.6 
Pharmacokinetic Analyses ............................................................................... 62 
9.6.1 
Evaluation of Pharmacokinetic Data ............................................... 62 
9.6.2 
Pharmacokinetic Concentration Data Analyses ............................... 62 
9.6.3 
Pharmacokinetic Parameter Data Analyses ..................................... 62 
9.7 
Pharmacodynamic Analyses ............................................................................ 63 
9.8 
Interim Analyses ................................................................................................ 63 
10.0 
ETHICS ........................................................................................................................... 64 
10.1 
Independent Ethics Committee ....................................................................... 64 
10.2 
Ethical Conduct of the Study ........................................................................... 64 
10.3 
Patient Information and Informed Consent .................................................. 65 
10.4 
Patient Data Protection ..................................................................................... 65 
10.5 
Procedures for Premature Termination or Suspension of the 
Study or the Participation of Investigational Site(s) .................................... 65 
11.0 
STUDY ADMINISTRATION ...................................................................................... 66 
11.1 
ADMINISTRATIVE STRUCTURE .............................................................. 66 
11.2 
Data Handling and Record Keeping ............................................................... 66 
11.3 
Direct Access to Source Data/Documents ...................................................... 67 
11.4 
Investigator Information .................................................................................. 67 
11.4.1 
Investigator Obligations ................................................................. 67 
11.4.2 
Protocol Signatures ........................................................................ 67 
11.4.3 
Publication Policy .......................................................................... 68 
11.5 
Financing and Insurance .................................................................................. 68 

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12.0 
REFERENCES ............................................................................................................... 69 
13.0 
APPENDIX I: ASTHMA CONTROL QUESTIONNAIRE.................................... 70 
14.0 
APPENDIX II: PATIENT GLOBAL IMPRESSION OF CHANGE 
(PGIC) SCALE ............................................................................................................... 72 
15.0 
APPENDIX III: CLINICAL GLOBAL IMPRESSION OF CHANGE 
(CGIC) SCALE .............................................................................................................. 73 
16.0 
APPENDIX IV: GLOBAL INITIATIVE FOR ASTHMA (2016) 
ASSESSMENT OF SEVERITY AND STEP THERAPY ....................................... 74 
17.0 
APPENDIX V: SIGNATURE OF INVESTIGATOR .............................................. 76 
18.0 
APPENDIX VI: PHARMACOKINETIC, INTERFERON-GAMMA, 
ANTI-DRUG ANTIBODY, AND BIOMARKER CYTOKINES 
COLLECTION TIME POINTS .................................................................................. 77 
19.0 
APPENDIX 7: SUMMARY OF CHANGES ............................................................. 79 
 
 

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LIST OF TABLES 
Table 4.1 
Schedule of Events ....................................................................................... 26 
Table 5.1 
Dosing Schedule .......................................................................................... 34 
Table 7.1 
Clinical Laboratory Parameters .................................................................... 50 
Table 11.1 
Administrative Structure .............................................................................. 66 
 

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LIST OF FIGURES 
Figure 4.1 
Schematic of Study Design for Protocol ANB020-004 ................................. 25 
 

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1.0 LIST OF ABBREVIATIONS AND DEFINITIONS OF 
TERMS 
Abbreviation 
Definition 
ACQ 
Asthma Control Questionnaire 
ADA 
Anti-drug antibodies 
ADR 
Adverse drug reaction 
AE 
Adverse event 
ANCOVA 
Analysis of covariance 
ATS/ERS 
American Thoracic Society/European Respiratory Society 
BMI 
Body mass index 
BP 
Blood pressure 
CGIC 
Clinical Global Impression of Change 
CI 
Confidence interval 
Cmax 
Maximum observed concentration 
CV 
Coefficient of variation 
DPI 
Dry powder inhaler 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EOS 
End of Study 
ET 
Early Termination 
FeNO 
Fractional exhaled nitric oxide 
FEV1 
Forced expiratory volume in 1 second 
FSH 
Follicle stimulating hormone 
GCP 
Good Clinical Practice 
GINA 
Global Initiative for Asthma Assessment 
GMP 
Good Manufacturing Practice 
HFA 
Hydrofluoroalkane 
hIL-33 
Human interleukin-33 
HR 
Heart rate 
ICF 
Informed Consent Form 

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ICH 
International Council for Harmonisation 
ICS 
Inhaled corticosteroids 
IEC 
Independent Ethics Committee 
IFN-γ 
Interferon-gamma 
Ig 
Immunoglobulin 
IL 
Interleukin 
IP 
Investigational product 
IUD 
Intrauterine devices 
IUS 
Intrauterine system 
IV 
Intravenous(ly) 
LABA 
Long-acting beta-2-agonists 
LAMA 
Long-acting muscarinic antagonist 
LTRA 
Leukotriene receptor antagonists 
mAb 
Monoclonal antibody 
MAD 
Multiple ascending dose 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMRM 
Mixed-model repeated measures 
n 
Sample size or number of observations 
NaCl 
Sodium chloride 
PD 
Pharmacodynamic 
PGIC 
Patient Global Impression of Change 
PK 
Pharmacokinetic 
SABA 
Short-acting beta agonists 
SAD 
Single ascending dose 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SAS 
Statistical analysis system 
SC 
Subcutaneous 
SD 
Standard deviation 
SOC 
Standard of care 
SOP 
Standard operating procedure 
SST 
Serum separator tube 

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ST2 
Surface receptor 2 
t1/2 
Terminal half-life 
TB 
Tuberculosis 
TEAE 
Treatment emergent adverse event 
Th2 
T helper-2 
tmax 
Time to maximum observed concentration 
US 
United States 
WOCBP 
Women of childbearing potential 

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2.0 INTRODUCTION 
ANB020 is a first-in-class, anti-interleukin-33 therapeutic antibody to treat T helper-2 (Th2) cell 
driven inflammatory diseases with underlying interleukin-33 (IL-33) dysregulation. ANB020 is a 
humanized immunoglobulin subtype G1/kappa (IgG1/kappa) monoclonal antibody (mAb) that 
specifically neutralizes the biological effects of human IL-33 (hIL-33). Interleukin-33, a member 
of the IL-1 superfamily,1 is a multifunctional cytokine that plays an important role in 
Th2-mediated cellular immunity and in the pathogenesis of atopic diseases.2,3 ANB020 binds to 
and inhibits the interaction of IL-33 with its specific cell-surface receptor (ST2) thereby blocking 
IL-33-driven downstream signalling and subsequent cellular responses. It is being developed for 
the treatment of atopic diseases such as asthma, food allergies, and atopic dermatitis. 
2.1 
Background Information 
Asthma is a chronic immuno-inflammatory disease associated with significant morbidity and 
mortality and affects people from childhood to old age.4 Asthma is defined by the history of 
respiratory symptoms such as wheeze, shortness of breath, chest tightness, and cough that vary 
over time and in intensity. Asthma is a heterogeneous disease, usually characterized by chronic 
airway inflammation and leads to bronchoconstriction.5 
The more severe forms of asthma are characterized by acute or subacute attacks and 
exacerbations leading to progressively worsening shortness of breath, coughing, wheezing, and 
chest tightness with a combination of systemic symptoms.  
There are different forms (endotypes) of asthma and based on the pathogenic mechanisms 
asthma is generally subdivided into Th2 and non-Th2 asthma. A series of cytokines, associated 
with type 2 immune responses such as IL-5, IL-4, and IL-13 have been observed elevated in Th2 
asthmatic patients.6 These patients also tend to have high levels of circulating immunoglobulin E 
(IgE) and often present co-morbidities such as atopic dermatitis, food allergies, and allergic 
rhinitis. These conditions are considered to be interleaved and to share common pathogenic 
mechanisms and constitute the so called ‘atopic march’.7 8 
Normally patients with type 2 asthma also present with high levels of peripheral and lung 
eosinophils. Regardless of the asthma endotype, respiratory symptoms characterize asthmatic 
patients and worsening of symptoms or need to modify the current treatment indicate 
exacerbation. Exacerbations are also defined by worsening of lung functionality tested via 
spirometry and forced expiratory volume in 1 second (FEV1), the most common parameter used 
to monitor airways obstruction in patients with asthma.  

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Current therapeutic management for asthma takes 2 approaches generally based upon empirical 
evidence rather than on targeting the underlying pathogenesis. Inhaled corticosteroids (ICS) over 
time open swollen airways; oral corticosteroids are required during an acute attack. Long-acting 
beta-2-agonists (LABA) are used to maintain disease control on a day to day basis, by providing 
prolonged bronchodilation. However, a substantial number of patients fail to gain clinical benefit 
from the standard treatments. Poor patient compliance may be a part of the reason for this lack of 
therapeutic benefit. Nonetheless, it is noteworthy that studies assessing asthma control reported 
persistent symptoms in over 20% of the patients, despite full treatment compliance.4 
There are several classes of products available for use in patients with persistent asthma. These 
include, as mentioned above, ICS, inhaled long-acting beta-adrenergic agonists, as well as 
leukotriene modifying drugs and methylxanthines. Biologics (i.e. monoclonal antibodies) are 
also part of the approved medicines used to treat asthma patients. Omalizumab (Xolair) targets 
IgE, a key pathogenic player in asthma, and was approved by the United States (US) Food and 
Drug Administration in 2003 for the treatment of moderate to severe allergic asthma. The 
European Medicines Agency also approved Xolair® in 2005 for use in adults, adolescents, and 
children (6 to <12 years of age) with convincing IgE mediated asthma. Recently, another 
biologic, mepolizumab (Nucala), an anti IL-5 mAb (IgG1 kappa) has been approved as add-on 
maintenance treatment in patients with severe asthma aged 12 years and older and with an 
eosinophilic phenotype. In addition, reslizumab (Cinqair), an anti IL-5 mAb (IgG4 kappa) was 
also approved with a more restricted profile i.e. only for patients aged 18 years and older with 
severe asthma and an eosinophilic phenotype. 
Standard asthma therapies aim to give symptomatic relief for the disease without changing the 
underlying biology, whereas mAbs offer a new class of therapeutic agents, which have the 
potential to alter the course of the disease by interfering with specific aspects of the asthma 
pathogenic cascade. Studies which have focused on patients with severe asthma are ongoing with 
various mAbs targeting Th2 cytokines (i.e. IL-4, IL-5, and IL-13). These studies have shown 
significant clinical benefit. Moreover, approval of the anti IL-5 mAbs mepolizumab (Nucala) 
and reslizumab (Cinqair), stresses the further potential benefit in targeting Th2 cytokines. 
Despite the success of these mAbs targeting Th2 cytokines, patients with severe asthma still 
represent a group of patients with a high medical need. New approaches based on the inhibitions 
of Th2 responses might therefore provide a novel and much needed new strategy. Interleukin-33 
is centrally based on initiating, sustaining, and driving the effector phase of Th2 pathogenic 
responses. Interleukin-33 is known to modulate the function, expansion, and redistribution of 
eosinophils, a type of white cells often increased in the peripheral blood and lungs of asthmatic 
patients. Studies in animal models have demonstrated that inhibition of IL-33 controls this 
eosinophilia. Also in human subjects with a polymorphism of the IL-33 receptor (ST2), which 
confers protection from asthma, low levels of eosinophils have been observed in their periphery. 

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Interleukin-33 also potently activates innate lymphoid cell 2 (ILC2) to release cytokines such as 
IL-4, IL-13, and IL-5 which amplify the pathogenic Th2 response. ANB020 is a powerful and 
efficient inhibitor of IL-33, and thus ANB020 potentially offers an additional and novel 
treatment approach to treat severe patients who fail to respond to the current therapies. 
Non-clinical studies 
ANB020 is being developed by AnaptysBio Inc. as a lead drug candidate and exhibits strong 
inhibitory activity for human as well as cynomolgus monkey IL-33. Non-clinical data obtained 
from studies with ANB020 in primary human and cynomolgus monkey cells and from in vivo 
non-human primate studies demonstrated that: 
• ANB020 shows reactivity with human and cynomolgus monkey IL-33 (dissociation 
constant [KDs] of 1 pM versus 37 pM, respectively), but not with mouse or rat IL-33. 
• In primary human and cynomolgus monkey cell populations, from peripheral blood 
mononuclear cells and human whole blood, ANB020 inhibited IL-33-induced 
interferon-gamma (IFN-γ) production. In human basophils, ANB020 also inhibited 
IL-33-induced IL-5 production. 
• The observed serum half-life (t1/2) of ANB020 in cynomolgus monkeys was 160 hours 
after a single intravenous (IV) dose administration, and 187 hours after a single 
subcutaneous (SC) dose administration at 10 mg/kg, consistent with the anticipated 
pharmacokinetic (PK) characteristics for a human IgG1 scaffold mAb in the monkey. 
• Multiple-dose, Good Laboratory Practice-compliant toxicology and toxicokinetic studies 
(4-week duration with an 8-week recovery phase and 13-week duration with an 8-week 
recovery phase) have been conducted with ANB020 administered by SC and IV injection 
to cynomolgus monkeys. These studies produced no significant test article-related effects 
and established a No Observed Adverse Effect Level of 50 mg/kg. 
These data, together with non-clinical safety data generated, supported a strong scientific 
rationale for advancing ANB020 into clinical development. 
Clinical studies 
A first-in-man, Phase I single ascending dose (SAD) and multiple ascending dose (MAD) study 
(ANB020-001) in healthy subjects is being performed. The SAD part of the study has been 
completed and 64 subjects were enrolled in the SAD part. Dosed cohorts in the SAD part 
included 10, 40, 100, and 300 mg SC and 40, 100, 300, and 750 mg IV (n=32 SC route, n=32 IV 
route). No significant changes in the vital signs (blood pressure [BP], heart rate [HR], or body 
temperature), physical examinations, or electrocardiograms (ECG) were noted. A total of 81% 

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subjects in the placebo group and 79% subjects in the ANB020 group had at least one 
treatment-emergent adverse event (TEAE) during the study. The most commonly reported 
TEAEs were upper respiratory infection (50% versus 48% in placebo and ANB020 group, 
respectively) and headache (31% versus 27% in placebo and ANB020 group, respectively). One 
serious adverse event (SAE) of decreased neutrophils was reported in the ANB020 750 mg dose 
group which resolved without sequelae prior to study completion. This event was also considered 
a serious unexpected adverse reaction and was deemed possibly related to the study treatment. 
No other observations of decreased neutrophils lower than 1.5 × 109/L were observed. One 
subject in the ANB020 40 mg dose group, had an increased troponin level which returned to 
normal prior to study completion. No other significant changes in the laboratory test results were 
noted. 
The PK and pharmacodynamic (PD) data obtained from the Phase I study (ANB020-001, SAD 
part) have been utilized to determine the route and dose of ANB020 to be used in this study. The 
PK data generated indicated that a linear PK profile was observed upon ANB020 administration 
across the dose ranges investigated, regardless of the route, but with less than dose-proportional 
increases in exposure for the SC dosing. The estimated ANB020 mean terminal t1/2 ranged 
approximately 14 to 17 days. Persistent and nearly complete inhibition of ex vivo IL-33 
stimulated INF-γ production in whole blood was observed following a single dose (except 10 mg 
SC) as soon as 24 hours, and lasting through 84 days (latest time point observed for 300 mg and 
750 mg IV).  
There were 32 subjects enrolled in the MAD part of the study (ANB020-001, MAD).  Results 
from data will serve as the basis for the route of administration of ANB020 in future studies. The 
estimated ANB020 mean terminal t1/2 in the MAD was approximately 17 days after SC injection 
and ranged from approximately 16 to 20 days with IV infusion.  
2.2 
Rationale 
This proof of concept study is intended to explore the activity of ANB020 in adult patients with 
severe eosinophilic asthma. ANB020 is a highly efficient inhibitor of IL-33, a cytokine that is 
considered to drive the pathogenic cascade in asthma. Interleukin-33 directly effects eosinophil 
counts and function by acting in the early phases of the atopic immune response which is 
upstream of current asthma treatments with clinically validated targets such as IL-5, IL-4, and 
IL-13. The possibility to influence complementary and synergistic pathways involved in asthma 
pathogenesis, might provide a therapeutic improvement compared to the inhibition of single 
downstream pathways. This study will explore the effects of ANB020 300 mg/100 mL IV 
administration compared to placebo on validated endpoints such as eosinophilia, FEV1, and 
fractional exhaled nitric oxide (FeNO). 

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2.3 
Hypothesis 
The purpose of this study is to explore the effects of ANB020 300 mg/100mL IV administration 
compared to placebo on eosinophilia, FEV1, and FeNO in adult patients with severe eosinophilic 
asthma. 
2.4 
Risk-Benefit Assessment 
A patient with eosinophilic asthma may or may not benefit from participating in this study. 
However, based upon the inhibition of IL-33 by the investigational product (IP) and pre-clinical 
study results, patients with eosinophilic asthma may benefit. Participation in this study may help 
to develop important scientific knowledge that could contribute to the development of a new 
medication and better comprehensive treatment of patients who suffer from asthma, atopic 
dermatitis, or food allergies. 
ANB020 has been extensively tested in animals, and was found to be safe and well tolerated in a 
Phase I SAD study (ANB020-001) conducted in healthy subjects. In animal studies, there were 
no ANB020 related adverse events (AEs) or abnormal ECG findings and the administration of 
ANB020 had no effect on hematology, coagulation, clinical chemistry, or urinalysis test results. 
In the Phase I study (ANB020-001), 64 healthy subjects were enrolled and dosed in the SAD 
part. The doses implemented in the SAD study were 10, 40, 100, and 300 mg SC and 40, 100, 
300, and 750 mg IV. No significant changes in the vital signs (BP, HR, or body temperature), 
physical examinations, or ECGs were noted. The most commonly reported TEAEs were upper 
respiratory tract infection (50% versus 48% in placebo and ANB020 group, respectively) and 
headache (31% versus 27% in placebo and ANB020 group, respectively). A total of 44% 
subjects in the placebo as well as ANB020 group had study drug related TEAEs. One SAE of 
decreased neutrophils was reported in the ANB020 750 mg dose group which resolved without 
sequelae prior to study completion. This event was also considered a serious unexpected adverse 
reaction and was deemed possibly related to the study treatment. No other observations of 
decreased neutrophils lower than 1.5 × 109/L were observed. One subject in the ANB020 40 mg 
dose group, had an increased troponin level which returned to normal prior to study completion. 
No other significant changes in the laboratory test results were noted. 
Although nothing in the testing of ANB020 to date indicates that an allergic reaction is likely; a 
reaction to any drug is possible. Some symptoms of allergic reactions are rash, wheezing or 
difficulty breathing, dizziness or fainting (also a possible outcome of a drop in BP), swelling 
around the mouth, throat or eyes, a fast pulse, or sweating. 

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As ANB020 is a mAb, based on clinical studies with other mAbs, study participants may 
experience symptoms of an apparent allergic reaction to the drug, also known as ‘cytokine 
release syndrome’. The symptoms of this vary dramatically but can include: 
• Mild to moderate fever, chills, headache, nausea, and vomiting. 
• Moderate to severe symptoms such as edema, hypotension, and pulmonary infiltrates 
(e.g. blood and mucus in the lung). 

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3.0 STUDY OBJECTIVES 
3.1 
Primary Objectives 
The primary objectives of the study are as follows: 
• To measure the reduction of eosinophils (blood eosinophil count) from Baseline (Day 1 
pre-dose) to Day 22 in adult severe eosinophilic asthma patients administered with 
ANB020. 
• To assess the safety and tolerability of a single, IV dose of ANB020 compared to placebo 
in adult patients with severe eosinophilic asthma. 
3.2 
Secondary Objectives 
The secondary objectives of the study are as follows: 
• To measure the reduction of eosinophils (blood eosinophil count) from Baseline (Day 1 
pre-dose) to the End of Study (EOS) visit (Day 127) in adult severe eosinophilic asthma 
patients administered with ANB020. 
• To assess the change from Baseline in the clinic FEV1 from Baseline (Day 1 pre-dose) to 
the EOS visit (Day 127). 
• To assess the change from Baseline in FeNO in the breath from Baseline (Day 1 
pre-dose) to the EOS visit (Day 127). 
• To assess the PD activity of ANB020 on ex vivo induced IFN-γ levels. 
• To test for any immunogenicity to ANB020. 
• To describe the limited PK of ANB020 following a single, IV dose in adult patients with 
severe eosinophilic asthma. 
3.3 
Exploratory Objectives 
The exploratory objectives of the study are as follows: 
• To assess the effect of ANB020 on circulating serum cytokines. 
• To assess the activity of ANB020 after a single, IV dose on clinical scores such as the 
Asthma Control Questionnaire (ACQ), Patient Global Impression of Change (PGIC), and 
the Clinical Global Impression of Change (CGIC). 

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• To assess the effect of ANB020 on the asthma symptoms, change in standard of care 
(SOC) treatment, and rescue medication (short-acting beta-agonists [SABA]) usage. 
• To assess the effect of ANB020 on IgE levels. 

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4.0 INVESTIGATIONAL PLAN 
4.1 
Summary of Study Design 
This is a Phase IIa, double-blind, placebo-controlled, proof of concept study designed to assess 
the effects of a single 300 mg/100 mL IV dose of ANB020 compared to placebo in adult patients 
with severe eosinophilic asthma. This study will also assess the safety and tolerability of 
ANB020 in adult patients with severe eosinophilic asthma. 
A written informed consent will be obtained from each patient prior to completing any study 
procedures.  At the Screening visit (7-14 days before Day 1) inclusion and exclusion criteria will 
be assessed. Medical history, ongoing medications, as well as vital signs will be recorded. 
Various other study assessments including a physical examination, FeNO measurement, 
spirometry to determine FEV1, and laboratory tests will be performed (See Table 4.1 for study 
procedures and time points). 
On Day 1, patients will present to the study center, and the inclusion and exclusion criteria will 
be verified. Eligible patients will be randomized to receive one IV dose of either ANB020 
(300 mg/100 mL) or placebo (0.9% sodium chloride [100 mL]) in a 1:1 ratio. Specific study 
assessments (See Section 6.0) and safety laboratory tests (See Table 4.1) will be performed. 
Blood samples to determine eosinophil count (See Table 4.1), ex vivo induced IFN-γ levels, 
anti-drug antibodies (ADA), serum cytokines, and serial samples for PK analysis will be 
collected at specified time points (See Section 18.0). Patients will remain in the study center for 
approximately 6 to 8 hours to complete the study assessments. Patients with any ongoing AEs or 
SAEs at the time of scheduled discharge from the study center should remain at the study center 
until the Investigator has determined that these events have been resolved or deemed as not 
clinically significant. 
After completing the Day 1 assessments, all patients will be followed up period for 18 weeks. 
During the follow-up period, patients will return to the study center for study assessments on 
Day 2, 8, 22, 36, 64, 85, and 106 and will be contacted via telephone by study staff on Day 50 
and 57 (See Table 4.1 for study procedures and time points). The EOS visit will be on Day 127 
(Week 18) at the study center (See Table 4.1). 
All patients will undergo FeNO and FEV1 tests at each study center visit. An ACQ (See 
Section 13.0) will be completed by all patients at each study center visit except (Day 2) and the 
patient diary must be completed on a daily and weekly basis. The Investigator will rate the 
patient’s response using the CGIC scale and the patients will be asked to rate the degree of 
change in the overall asthma status using the PGIC scale (part of the diary card [See Section 6.0 

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for description and Table 4.1 for instructions]). The PGIC and CGIC scales are presented in 
Section 14.0 and Section 15.0, respectively. During the follow-up period, other assessments 
including vital signs, safety laboratory testing, eosinophil count, PK, and biomarker analysis will 
be performed at specified time points (Table 4.1). 
The study design is presented in Figure 4.1 and the Schedule of Events is presented in Table 4.1. 
Figure 4.1 
Schematic of Study Design for Protocol ANB020-004 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: PK = pharmacokinetics; n = sample size 
 
Screening visit (7-14 days prior to Day 1) 
Day 1, ANB020 or Placebo administration (n=24); 
PK and other laboratory assessments 
Follow-up study center visits 
on Day 2, 8, 22, and 36 
Follow-up telephonic contacts on Day 50 and 
Day 57 
Phase IIa study of male and female patients aged 
≥18 to ≤65years diagnosed with eosinophilic asthma 
with peripheral eosinophils count ≥300 cells/µL 
Follow-up study center visits on Day 64, 85, 106 
End of Study visit on Day 127 

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4.2 
Discussion of Study Design 
ANB020 is a first-in-class, anti-IL-33 therapeutic antibody developed by AnaptysBio, to treat 
Th2 cell driven inflammatory diseases with underlying IL-33 dysregulation. Preliminary 
evidence of this compound’s significant PD activity in terms of cytokine modulation has been 
demonstrated in non-clinical and clinical studies, justifying its further development in patients 
with eosinophilic asthma.  
Emergent data of the Phase I study (ANB020-001) in healthy subjects are the basis for the dose 
and IV route of administration of ANB020. The 300 mg IV dose was found to be safe and well 
tolerated in healthy subjects. In the SAD part of the study, 64 subjects were enrolled and dosed. 
The doses implemented in the SAD part were 10, 40, 100, and 300 mg SC and 40, 100, 300, and 
750 mg IV. No significant changes in the vital signs (BP, HR, or body temperature), physical 
examinations, or ECGs were noted. The most commonly reported TEAEs were upper respiratory 
tract infection (50% versus 48% in placebo and ANB020 group, respectively) and headache 
(31% versus 27% in placebo and ANB020 group, respectively). A total of 44% subjects in the 
placebo as well as ANB020 group had study drug related TEAEs. One SAE of decreased 
neutrophils was reported in the ANB020 750 mg dose group which resolved without sequelae 
prior to study completion. No other observations of decreased neutrophils lower than 1.5 × 109/L 
were observed. One subject in the ANB020 40 mg dose group, had an increased troponin level 
which returned to normal prior to study completion. No other significant changes in the 
laboratory test results were noted. 
The dose of ANB020 selected for this study 300 mg/100 mL (IV) has provided complete 
inhibition of IL-33 induced cytokine release (ex vivo) up to 84 days and has been administered 
safely in study ANB020-001. 
Eosinophilic asthma is a Th2 associated atopic disease. Patients with eosinophilic asthma have 
been demonstrated to have improved FEV1 and reduced exacerbations when treated with 
anti-IL5 medications, which reduce eosinophil levels. Interleukin-33 is upstream of IL-5 in the 
Th2 cytokine cascade. Inhibition of IL-33, through the use of ANB020, would be expected to 
reduce IL-5, as well as other Th2 inflammatory mediators (such as IL-4 and IL-13 also 
successfully targeted in Th2 asthma), resulting in reduced asthma symptoms and eosinophil 
levels and improved lung function. 
4.3 
Selection of Study Population 
Eligibility criteria for this study have been carefully considered to ensure the safety of the 
patients included in the study and that the results of the study can be used. It is imperative that 
patients fully meet all of the inclusion criteria and none of the exclusion criteria. 

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4.3.1 
Inclusion Criteria 
Patients will be enrolled in the study only if they meet all of the following criteria: 
• Male and female patients aged ≥18 to ≤65 years and able to give informed consent. 
• Patients with a confirmed clinical diagnosis of eosinophilic asthma with peripheral 
eosinophils count ≥300 cells/µL at screening. 
• Twelve months history of diagnosis of eosinophilic asthma (with asthma exacerbation 
within the last 12 months [before screening] requiring rescue medication). 
• Severe asthma diagnosed according to the Global Initiative for Asthma (GINA) 2016 
requiring GINA treatment steps 3 to 5 (See Section 16.0). 
• Pre-bronchodilator FEV1 of <80% at screening. 
• Body mass index (BMI) of 18 to 38 kg/m2 (inclusive) and total body weight >50 kg 
(110 lb.). BMI = weight (kg)/(height [m2]). 
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test 
at screening and a negative urine pregnancy test on Day 1 and be using highly effective 
methods of contraception (See Section 4.3.4) or be surgically sterile, or  be 
postmenopausal throughout the study and for 18 weeks after the last dose of IP 
administration. Postmenopausal patients defined as (1) aged over 45 years with at least 
1 year of amenorrhea and levels of follicle-stimulating hormone (FSH) over 20 IU/L at 
screening or (2) aged over 50 years with at least 1 year of amenorrhea. 
• Male patients must be willing to use effective methods of contraception during the entire 
study period and for 18 weeks after the last dose of IP administration (See Section 4.3.4). 
• Patient must be on high dose ICS plus LABA (See Section 5.8.2 for high dose 
guidelines). Systemic corticosteroids (intramuscular or oral) up to the equivalent of 
15 mg/day prednisone will be allowed.  
• Willing and able to comply with the study protocol requirements. 
• Have the ability to read and understand the study procedures and can communicate 
meaningfully with the Investigator and staff. 
4.3.2 
Exclusion Criteria 
Patients will not be enrolled in the study if they meet any of the exclusion criteria: 

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• Have concomitant medical condition(s) which may interfere with the Investigator’s 
ability to evaluate the patient’s response to the IP. 
• Have experienced severe life-threatening anaphylactic reactions. 
• Have received any IP within a period of 3 months or 5 half-lives of an IP (whichever is 
longer) before screening (this also includes investigational use of marketed products). 
• Have received high dose systemic corticosteroids (equivalent to >15 mg/day prednisone), 
nonsteroidal, immunosuppressant, or immunomodulating treatments within 8 weeks 
before screening. 
• Have received treatment with biologics such as mepolizumab or omalizumab within 
3 months or 5 half-lives (whichever is longer) before screening. 
• Abnormal ECG assessment at screening (any abnormality that the Investigator believes is 
not safe for study participation). 
• Uncontrolled hypertension, or acute ischemic cardiovascular diseases. 
• Have received antibiotic treatment within 4 weeks before screening. 
• Have a history of hypersensitivity or allergic reactions to polysorbate 80, a component of 
the ANB020 formulation or the inactive ingredients (excipients). 
• If female, is pregnant or lactating, or intend to become pregnant during the study period. 
• History (or suspected history) of alcohol or substance abuse as defined by the Diagnostic 
and Statistical Manual of Mental Disorders (5th edition) Substance Use Disorders 
guidelines within 2 years before screening.  
• Current smokers or former smokers with a smoking history of ≥15 pack years. If a patient 
has less than 15 pack years smoking history, he or she should have quit smoking at least 
6 months before screening to enroll in the study. 
• Positive blood screen for hepatitis C virus antibody, hepatitis B virus surface antigen, 
human immunodeficiency virus 1 and 2 antibodies, or Mycobacterium tuberculosis (TB). 
Patients with an indeterminate QuantiFERON TB Gold result at screening will be 
allowed one retest; if not negative on retesting, the patient will be excluded.  
• Any co-morbidity that the Investigator believes is a contraindication to study 
participation. This includes, but not limited to any respiratory (e.g. pulmonary fibrosis, 
eosinophilic granulomatosis with polyangiitis [EGPA], allergic bronchopulmonary 
aspergillosis [ABPA]), cardiovascular, gastrointestinal, hematological, neurological, 

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immunological, musculoskeletal, renal, infectious, neoplastic, or inflammatory condition 
that may place the safety of the subject at risk during the study, influence the results of 
the study or their interpretation, or prevent the patient from completing the entire duration 
of the study. 
• Have any other physical, mental, or medical conditions which, in the opinion of the 
Investigator, make study participation inadvisable or could confound study assessments. 
• Receipt of a live attenuated vaccine within 4 weeks before screening. 
• Planned surgery during the study or 30 days before screening. 
• History of malignancy within 5 years, except non-melanoma skin cancer which has been 
fully treated with no current active disease. 
4.3.3 
Disease Diagnostic Criteria 
Adult patients (age ≥18 to ≤65 years) with a confirmed clinical diagnosis of eosinophilic asthma 
with a documented blood eosinophil count of ≥300 cells/µL despite receiving SOC treatment.  
4.3.4 
Patient Restrictions 
The following restrictions may affect patient participation in this study: 
• Availability to attend visits according to the protocol. 
• Concomitant medication restrictions as described in Section 5.8. 
• Restricted alcohol intake (<28 units per week). 
• Strenuous exercise should be avoided up to 72 hours before the planned study visits. 
• WOCBP must follow a consistent and correct use of highly effective methods of birth 
control during the study period and for 18 weeks after the last dose of IP administration.  
• Male patients must be willing to use contraception throughout the study and for 18 weeks 
after the last dose of IP administration which includes a total of 5 half-lives of the IP 
(estimated to be approximately 70 days) plus an additional 50 days (which includes the 
duration of sperm turnover) post treatment completion. Additionally, female partners of 
male patients must also use highly effective methods of contraception if she is a 
WOCBP. 
Patients must agree to the use of one method of highly effective contraception as listed 
below: 

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Highly Effective Methods of Contraception 
• Hormonal methods of contraception include oral contraceptive pills, vaginal ring, 
injectables, implants, and intrauterine systems (IUS) such as Mirena. 
• Non-hormonal intrauterine devices (IUDs)  
• Bilateral tubal ligation 
• Vasectomy 
Acceptable alternate methods of highly effective contraception must be discussed with 
the Investigator to ensure highly effective methods of contraception are instituted prior to 
the patient receiving any dose of IP. 
Less effective methods of contraception 
• Diaphragm 
• Cervical cap 
• Vaginal sponge 
• Male condom* 
• Progestin only pills by male patient’s WOCBP partner 
• Female condom* 
*A male and female condom must not be used together. 
Patient Restrictions Prior to Lung Function Assessments 
• Patients should avoid engaging in strenuous exertion for at least 30 minutes prior to all 
lung function assessments. 
• Patients should avoid eating a large meal for at least 2 hours prior to all lung function 
assessments. 
4.3.5 
Patient Withdrawal 
All patients are free to withdraw from participation in the study at any time, for any reason, 
specified or unspecified, and without prejudice to further treatment. The inclusion and exclusion 
criteria are to be followed explicitly. If a patient who does not meet the enrollment criteria is 
inadvertently enrolled, that patient should be withdrawn from the study. AnaptysBio and IQVIA 

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must be contacted, and if the patient has received ANB020 or placebo, the patient must be 
followed up until EOS (Day 127) for any AEs and/or SAEs. 
In addition, the patients will be withdrawn from the study under the following circumstances: 
• 
Prior to IP administration, the Investigator decides that the patient should be withdrawn 
or is at risk. If this decision is made because of an AE or a clinically significant 
laboratory value, the IP should not be administered and appropriate measures are to be 
taken. AnaptysBio and/or IQVIA is to be notified immediately. 
• 
The patient is unwilling to continue in the study. 
• 
Lack of compliance with protocol. 
• 
The Investigator or AnaptysBio, for any reason, stops the study. 
• 
If a female patient becomes pregnant. 
• 
New information suggests taking part in the study may not be in the participant’s best 
interest. 
Patients who discontinue the study early will have early termination (ET) procedures performed 
as shown in Table 4.1 (Schedule of Events).  
Patients who are withdrawn from the study after Day 36 will not be replaced. All patients who 
discontinue the study prior to completing the Day 36 study assessments will be replaced.  The 
study pharmacist should also be notified of any patient who has received IP and discontinues 
prior to Day 36. 

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5.0 STUDY TREATMENTS 
5.1 
Treatments Administered 
ANB020 is a humanized IgG1/kappa mAb and was selected from a panel of mouse mAb 
humanized by complementarity-determining region-grafting, optimized and matured via 
mammalian cell display and somatic hyper mutation using AnaptysBio’s (SHM)-XELTM system 
to achieve a desired functional inhibitory potency. 
ANB020 will be administered to patients by IV infusion in polyvinyl chloride or polyolefin bags 
following dilution to a total volume of 100 mL with sterile normal saline (0.9% sodium chloride 
[NaCl]). Placebo will be administered by IV infusion as 100 mL sterile normal saline (0.9% 
NaCl). Infusions will be administered over 1 hour. 
5.2 
Identity of Investigational Product 
ANB020 is manufactured by Patheon of Greeneville, North Carolina, US under Good 
Manufacturing Practice (GMP) regulations. ANB020 is provided as a sterile clear to slightly 
opalescent solution in a glass vial for IV infusion and contains no preservatives. 
The ANB020 vials must be refrigerated at 2°C to 8°C (36°F to 46°F) until the day of use. 
ANB020 vials may be stored at room temperature (>8°C to 25°C [46°F to 77°F]) in the undiluted 
and/or diluted state for up to 8 hours. The vials should remain in the bulk cartons during storage 
and until use to provide protection from light. Vial contents should not be frozen or shaken. They 
are intended for single-use only; therefore, any remaining solution should be discarded. 
The placebo contains no active drug and will be sterile normal saline (0.9% NaCl) for infusion. 
The placebo will be procured from the pharmacy stock supply. 
Table 5.1 provides an outline of the dosing schedule for the study. 
Table 5.1 
Dosing Schedule 
Investigational product 
Dosage form and strength 
Manufacturer 
ANB020 
IV infusion: 300 mg/100 mL once on Day 1 
Patheon 
Abbreviation: IV = intravenous 
5.3 
Packaging and Labelling 
Labels will be prepared in accordance with GMP and local regulatory guidelines. 

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All IPs should be kept in a secure place under appropriate storage conditions. The IP label on the 
packaging specifies the appropriate storage. 
5.4 
Method of Assigning Patients to Treatment Group 
This is a randomized, double-blind, placebo-controlled study. On Day 1, after verification that all 
inclusion and no exclusion criteria have been met, the patients will be randomized in a 1:1 ratio 
to ANB020 or placebo. As patients become eligible they will be assigned randomization 
numbers which will be used to assign the allocated treatment. The Sponsor, Investigator, and 
patients will be blinded to treatment assignment of ANB020 or placebo. Additional information 
can be found in the study manuals. 
5.5 
Selection of Doses in the Study 
A single IV infusion of 300 mg/100 mL of ANB020 or 100 mL placebo (0.9% NaCl) will be 
administered. 
The dose of ANB020 selected for this study has provided complete inhibition of IL-33 induced 
cytokine release and has been administered safely in study ANB020-001. 
5.6 
Selection and Timing of Dose for Each Patient 
Patients will receive a single dose of ANB020 or placebo administered under supervision at the 
study center. The infusion will be administered at the rate of 100 mL per hour via a Baxter 
infusion solutions set (FNC2110; prime volume 16 mL) or equivalent followed by a 16 mL IV 
saline flush, at the same infusion rate, to ensure that no residual drug remains in the infusion line. 
No in-line filter is to be used. Infusions will be administered over 1 hour. The ANB020 or 
placebo infusion may be slowed or interrupted for patients experiencing infusion-related AEs. 
5.7 
Blinding/Unblinding 
5.7.1 
Blinding 
This is a randomized, double-blind, placebo-controlled study with limited access to the 
randomization code. The IP and placebo will be identical in physical appearance. The Sponsor, 
Investigator, and patients will be blinded to treatment assignment of ANB020 or placebo. The 
unblinded pharmacy staff will be provided the randomization assignments to prepare the 
assigned IP for each patient. 

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5.7.2 
Unblinding 
The investigator is responsible for ensuring treatment-blinding information is maintained for all 
subjects.  Unblinding information is available at the site by the unblinded pharmacist and 
investigator in case of a medical emergency. 
Unblinding of treatment assignment during the study is discouraged and should occur only if it is 
absolutely necessary to know what treatment the subject received.  If the investigator deems 
identification of the study drug is necessary for the purpose of providing urgent subject care, and 
knowledge of the subject’s treatment assignment (ANB020 or placebo) will alter subsequent 
care, the treatment code for the specific subject will be obtained.  Prior to unblinding, the 
investigator or appropriate designee should attempt to contact the Sponsor’s Medical Monitor to 
discuss the need to unblind a subject.  In the event the Medical Monitor cannot be reached, the 
investigator should ensure that the unblinding of the treatment code is performed in a discrete 
manner and the treatment is disclosed only to those persons involved with the direct medical care 
of the subject.  The investigator should contact the Sponsor’s Medical Monitor immediately 
(within 24 hours including weekends) following emergency unblinding. Once the subject’s 
treatment assignment has been obtained in the event of an emergency, the date, time, and reason 
for the unblinding must be recorded in the pharmacy log, on the subject’s CRF and source notes 
and signed by the investigator.   
5.8 
Prior and Concomitant Treatments 
5.8.1 
Excluded Medications 
The following medications will not be permitted during the study. Use of these excluded 
medications is a protocol deviation and should be recorded in the electronic case report form 
(eCRF).  
• Treatment with systemic corticosteroids (intramuscular or oral) equivalent to >15 mg/day 
prednisone, nonsteroidal, immunosuppressant or immunomodulating drugs within 
8 weeks before screening and throughout the study. 
• Any antibiotic treatment within 4 weeks before screening. 
• Use of biologics such as mepolizumab or omalizumab within 3 months or 5 half-lives 
(whichever is longer) before screening and throughout the study. 
• Any live attenuated vaccine within 4 weeks of screening and for the duration of the study 
(Day 127). 

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5.8.1.1 
Excluded Medications Prior to Lung Function Assessments 
Patients should withhold their usual asthma therapies prior to the lung function tests on the 
study visit days. 
• Short-acting bronchodilators (e.g. albuterol [salbutamol] or ipratropium) should be 
withheld for at least 6 hours before spirometry. 
• Twice daily long-acting bronchodilator (LABA or long-acting muscarinic antagonist 
[LAMA] containing therapies) should be withheld for 12 to 24 hours and once daily 
long-acting bronchodilator (LABA or LAMA containing therapies) for >24 hours before 
spirometry. 
• Leukotriene receptor antagonists (LTRA) should be restricted for >24 hours. 
• Twice daily theophyllines should be withheld for at least 12 to 24 hours and once daily 
theophyllines for >24 hours before spirometry.  
• If a patient has taken rescue SABA within 6 hours of the planned spirometry study center 
visit, they should either: 
a. remain at the center until the 6-hour withholding time has been reached or  
b. return on the following day for lung function assessments (If the patient 
completed Day 22 visit, he or she can return within 2 days [allowed window 
period per protocol] for the lung function assessment). 
5.8.2 
Allowed Medications 
Use of high dose ICS plus LABA and systemic corticosteroids (intramuscular or oral) up to the 
equivalent of 15 mg/day prednisone will be allowed in the study. 
High dose guidelines are as follows: 
• Beclomethasone dipropionate (chlorofluorocarbon [CFC]) High: >1000 µg 
• Beclomethasone dipropionate (hydrofluoroalkane [HFA]) High: >400 µg 
• Budesonide (dry powder inhaler [DPI]) High: >800 µg 
• Ciclesonide (HFA) High: >320 µg 
• Fluticasone furoate (DPI) High: 200 µg 
• Fluticasone propionate (DPI or HFA) High: >500 µg 
• Mometasone furoate High: >440 µg 

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• Triamcinolone acetonide: >2000 µg 
Specific treatment for asthma exacerbations will be allowed at the Investigator’s discretion. Oral 
prednisolone and or antibiotics will be allowed at the discretion of the treating physician. 
Administration of the inactivated flu vaccine will be allowed. Females of childbearing potential 
are to continue using their hormonal contraceptives and postmenopausal women are allowed to 
use hormone replacement therapy. 
The Investigator must record the use of all concomitant medications, both prescribed and 
over-the-counter, into the eCRF and patient’s medical records. This includes medications used 
on both a regular and an as needed basis. Patients should be discouraged from starting any new 
medication, both prescribed and over-the-counter, without consulting the Investigator, unless the 
new medication is required for emergency use or has been prescribed for clinical need. 
5.9 
Medical Care of Patients after End of Study 
All patients will return to the study center for the EOS (Day 127) or ET visit for final safety and 
EOS assessments. After this visit, patients should be treated according to the Investigator’s 
clinical judgment. Care after EOS/ET will not be provided by AnaptysBio. Any significant AE 
which in the opinion of the Investigator is related to the IP, SAE, or pregnancy occurring within 
30 days after the EOS visit should be reported to the safety team at IQVIA and followed up until 
final outcome or stabilization. 
5.10 Treatment Compliance 
The prescribed dosage, timing, and mode of administration may not be changed. Any deviations 
from the intended regimen must be recorded in the eCRF. Infusion start date/time and infusion 
end date/time will be documented in the patient’s eCRF. Any infusion interruptions (stop 
date/time and restart date/time) and/or incomplete dose administration will also be documented. 
5.11 Investigational Product Accountability 
The Investigator, a member of the investigational staff, or a hospital pharmacist must maintain an 
adequate record of the receipt and distribution of all the IPs using the Drug Accountability Form. 
These forms must be available for inspection at any time.  
All the IP supplies should be accounted for at the termination of the study and a written 
explanation provided for discrepancies. All unused IP supplies and packaging materials are to be 
inventoried and returned to IQVIA/AnaptysBio by the Investigator or may be destroyed on site 
following institutions standard operating procedures (SOPs) and proper accountability by IQVIA 

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site monitor. The Investigator is not permitted to return or destroy unused IP supplies or 
packaging materials unless authorized by IQVIA. 

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6.0 STUDY PROCEDURES 
Study procedures will be performed as detailed in the Schedule of Events in Table 4.1.  
Assessments scheduled on the day of IP administration must be performed prior to the IP 
infusion unless otherwise noted. All assessments will be performed on the day of the specified 
visit; however, a window period of +/-2 days can be implemented following the Day 22/Week 3 
visit.  
There are visits where the protocol requires more than one procedure to be completed at the same 
time point. When indicated, the procedure must follow specific order of events, refer to 
Section 6.2.6 for instructions.  
Study team must verify that patients withheld their usual asthma therapies prior to the lung 
function tests on each study center visit day. See Section 5.8.1.1 for the details. 
6.1 
Screening 
Each potential patient will provide informed consent at screening before starting any study 
related procedures. The eligibility of patients will be determined during the screening period. 
Vital signs, physical examinations, medical history, and ongoing medications will be recorded. 
Other screening procedures will be carried out in accordance with the Schedule of Events in 
Table 4.1. 
6.1.1 
Fractional Exhaled Nitric Oxide (FeNO) Test 
Measurement of FeNO will be performed at the time points indicated in Table 4.1 and in 
accordance with the guidelines published by American Thoracic Society/European Respiratory 
Society (ATS/ERS).9 The FeNO test must be performed before the spirometry testing. Details 
about the FeNO measurement are provided in the pulmonary function testing manual provided 
by the manufacturer. 
6.1.2 
Spirometry (FEV1 Measurement) 
Spirometry will be performed at the time points indicated in Table 4.1 and according to the 
ATS/ERS guidelines.10 The spirometer should be calibrated per ATS/ERS guidelines prior to the 
start of the lung function assessment on each study center visit day. The spirometer should be set 
to use the Global Lung Function Initiative reference equations.  
Both pre- and post-bronchodilator spirometry should be performed at all clinic visits. Pre-
bronchodilator spirometry will be performed after appropriate bronchodilator withholding period 

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(See Section 5.8.1.1) in the morning and post-bronchodilator spirometry will be performed 
30 minutes following the administration of 400 µg salbutamol via a Volumatic.  
Patients should have spirometry performed at approximately the same time on each study center 
visit day. Forced expiratory maneuvers should be performed with the patient seated in an upright 
position. If this is not comfortable for the patient, standing is permitted; however, the same 
position should be used by the patient for each forced expiratory maneuver from screening 
through EOS visit. Three acceptable maneuvers should be obtained for each test. Additional 
details are provided in the pulmonary function testing manual provided by the manufacturer. 
6.1.3 
Asthma Control Questionnaire 
The ACQ (See Section 13.0) will be used in this study to assess the asthma symptoms 
(night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 
SABA usage) along with the FEV1 measurement.  
Patients will be asked to recall their experiences during the previous week by responding to 5 
symptoms related questions and 1 question related to bronchodilator use. Questions will be 
scored from 0 (totally controlled) to 6 (severely uncontrolled). The questionnaire will be 
completed at each study center visit except Day 2 visit (See Table 4.1) and must be completed 
prior to blood draw/laboratory assessments and other procedures such as FeNO and FEV1. Refer 
to section 6.2.6 and Table 4.1 for timings and instructions. 
6.1.4 
Patient Diary 
The patient diary will be distributed during each study center visit day (except EOS visit) and all 
patients will be trained to record the asthma symptoms and other details in the diary on a daily 
and weekly basis as listed below. All patients will be asked to return the diary cards when they 
come for the next study center visit and the study team will review the patient diary cards (from 
previous weeks) during each study center visit for completeness. (If the patient does not meet 
inclusion/exclusion criteria the diary card will not be collected). 
The following details will be recorded in the patient diary on a daily and weekly basis. 
Daily Recording 
• Number of puffs that the patient needed to use their rescue (SABA) medication during 
the day. 

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Weekly Recording 
• List asthma symptoms experienced during the week: wheezing, cough, shortness of 
breath, chest tightness, or describe other. 
• Change in SOC treatment. 
• Study treatment efficacy (after Day 1). 
• Level of satisfaction with the side effects related to the study treatment (after Day 1). 
• PGIC (after Day 1). 
• Hospitalization due to asthma. 
6.2 
Study Day Procedures 
6.2.1 
Blood volume 
The total blood volume for each patient will be approximately 295.5 mL, and within the National 
Institute of Health allotted amounts of 550 mL in any 8-week period. 
6.2.2 
Day 1 (Randomization) 
On Day 1, study staff will confirm the informed consent and patient’s willingness to participate 
in the study. The patients will be randomized to receive either ANB020 or placebo in a 1:1 ratio 
(12 patients will receive ANB020 and 12 patients will receive placebo). Additional Day 1 
procedures will be carried out in accordance with the Schedule of Events in Table 4.1.  
Patients will be allowed to leave the study center 6 to 8 hours after the ANB020/placebo 
administration and completion of study-specific procedures providing that: 
• No AEs have been reported during the study visit. 
• The patient responds in the affirmative when asked if they are feeling well. 
If any of these conditions are not met, then the patient will only be allowed to leave the study 
center with the authorization of the Investigator or appropriately qualified delegate. 
6.2.3 
Follow-up Period 
After completing the Day 1 assessments, all patients will be in the follow-up period for 
18 weeks. During the 18-week follow-up period, the patients will return to the study center for 
various assessments on Day 2, 8, 22, 36, 64, 85, and 106 and will be contacted via telephone by 

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study staff on Day 50 and 57. The study procedures will be carried out in accordance with the 
Schedule of Events in Table 4.1. 
6.2.3.1 
Patient Global Impression of Change (PGIC) 
The PGIC scale (See Section 14.0) will be used for an overall evaluation of response to 
treatment. The patient will be asked to rate the degree of change in the overall asthma status 
compared to the start of treatment, i.e. Day 1. A 7-point rating scale will be used as listed below: 
1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no changes, 
5 = minimally worse, 6 = much worse, and 7 = very much worse. 
Refer to Table 4.1 for instructions. 
6.2.3.2 
Investigator’s Assessment-Clinical Global Impression of Change (CGIC) 
The CGIC scale (See Section 15.0) will be used for an overall evaluation of response to 
treatment. The Investigator will be asked to rate the degree of change in the overall asthma status 
compared to the start of treatment, i.e. Day 1. A 7-point rating scale will be used as listed below: 
1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no changes, 5 = 
minimally worse, 6 = much worse, and 7 = very much worse. 
The CGIC should be completed prior to blood draw/laboratory assessments and other procedures 
such as FeNO and FEV1. The time points are indicated in the Schedule of Events in Table 4.1. 
Refer to section 6.2.6 and Table 4.1 for timings and instructions. 
It is recommended that the same Investigator/Sub-Investigator completes the scale for all time 
points for a given patient. 
6.2.4 
End of Study 
All patients will return to the study center for the EOS visit on Day 127 (Week 18). The EOS 
procedures will be carried out in accordance with the Schedule of Events in Table 4.1. 
6.2.5 
Early Termination 
Patients who discontinue the study early will be asked to return to the study center for the ET 
procedures as shown in the Schedule of Events (Table 4.1). The ET visit will include all 
procedures to be done at EOS visit as well as any other laboratory assessment (PK or ADA) 
planned at the originally scheduled follow-up visit. 

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6.2.6 
Timing of Procedures 
There are visits where the protocol requires more than one procedure to be completed at the same 
time point. In these instances, the following will apply: 
• All safety assessments will be timed and performed relative to the start of IP 
administration. 
• Blood draw: Lab-flow document should be followed for standardized order of blood draw 
collection.  If entire panel is unable to be collected, hematology panel (eosinophils) will 
take precedence over other tests. 
• Study specific scales and questionnaire forms should be completed prior to blood 
draw/laboratory assessments and other procedures such as FeNO, FEV1. 
• FeNO must be performed before FEV1. 
On Day 1, ACQ, safety laboratory tests, urine pregnancy (confirm negative), ADA, IFN-γ, 
cytokines, FeNO, and FEV1 (both pre- and post-bronchodilator) must be completed prior to IP 
administration. The PK samples will be collected prior to IP administration as well as post-dose 
on Day 1. Refer to Table 4.1 (Schedule of Events) and Section 18.0 (Appendix VI) for additional 
details. 

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7.0 SAFETY, PHARMACODYNAMIC, AND 
PHARMACOKINETIC ASSESSMENTS 
7.1 
Safety 
Safety assessments will be based on medical review of AE reports, the results of physical 
examinations, and clinical laboratory tests. The incidence of observed AEs will be reviewed for 
potential significance and clinical importance. Patients with any ongoing AEs or SAEs at the 
time of scheduled discharge from the study center, should remain at the study center until the 
Investigator has determined that these events have been resolved or deemed as not clinically 
significant. 
7.1.1 
Adverse Events 
The Investigator is responsible for recording all AEs observed during the study period. 
Definition of AE: An AE is any untoward medical occurrence in a patient or clinical 
investigation patient administered a pharmaceutical product and which does not necessarily have 
a causal relationship with this treatment. 
Definition of SAE: An SAE, experience or reaction, is any untoward medical occurrence 
(whether considered to be related to the IP or not) that at any dose: 
• 
Results in death. 
• 
Is life-threatening (the patient is at a risk of death at the time of the event; it does not 
refer to an event which hypothetically might have caused death if it were more severe). 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization: Hospital 
admissions and/or surgical operations planned before or during a study are not considered 
AEs if the illness or disease existed before the patient was enrolled in the study, provided 
that it did not deteriorate in an unexpected way during the study. 
• 
Results in persistent or significant disability/incapacity. 
• 
Is a congenital abnormality/birth defect. 
• 
Other: Medically significant events, which do not meet any of the criteria above, but may 
jeopardize the patient and may require medical or surgical intervention to prevent one of 
the other serious outcomes listed in the definition above. Examples of such events are 

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blood dyscrasias (e.g. neutropenia or anemia requiring blood transfusion, etc.) or 
convulsions that do not result in hospitalization. 
An adverse drug reaction (ADR) is defined as all noxious and unintended responses to a 
medicinal product related to any dose. 
An unexpected ADR is defined as any adverse reaction, the nature of which is not consistent 
with the applicable product information. 
Each AE is to be evaluated for duration, severity, seriousness, and causal relationship to the IP. 
The action taken and the outcome must also be recorded. 
Severity 
The severity of the AE will be characterized as “mild, moderate, or severe” according to the 
following definitions: 
• 
Mild events are usually transient and do not interfere with the patient’s daily activities. 
• 
Moderate events introduce a low level of inconvenience or concern to the patient and 
may interfere with daily activities. 
• 
Severe events interrupt the patient’s usual daily activity. 
Relationship 
The causal relationship between the IP and the AE has to be characterized as unrelated, unlikely, 
possible, probable, or unknown (unable to judge). 
Events can be classified as “unrelated” if there is not a reasonable possibility that the IP caused 
the AE. 
An “unlikely” relationship suggests that only a remote connection exists between the IP and the 
reported AE. Other conditions, including chronic illness, progression or expression of the disease 
state or reaction to concomitant medication, appear to explain the reported AE. 
A “possible” relationship suggests that the association of the AE with the IP is unknown; 
however, the AE is not reasonably supported by other conditions. 
A “probable” relationship suggests that a reasonable temporal sequence of the AE with drug 
administration exists and, in the Investigator’s clinical judgment, it is likely that a causal 
relationship exists between the drug administration and the AE, and other conditions (concurrent 
illness, progression or expression of disease state, or concomitant medication reactions) do not 
appear to explain the AE. 

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All efforts should be made to classify the AE according to the above categories. The category 
“unknown” (unable to judge) may be used only if the causality is not assessable, e.g. because of 
insufficient evidence, conflicting evidence, conflicting data, or poor documentation. 
7.1.1.1 
Reporting of Adverse Events 
All AEs, regardless of severity and whether or not they occurred during the screening (after 
informed consent), treatment, or follow-up period are to be recorded on the appropriate pages in 
the eCRF (either ‘serious’ or ‘non-serious’). The Investigator should complete all the details 
requested including dates of onset, severity, action taken, outcome, and relationship to the IP. 
Each event should be recorded separately. All AEs that occur within 30 days after the patient’s 
last visit (EOS visit) should also be reported. 
The ANB020 or placebo infusion may be slowed or interrupted for patients experiencing 
infusion-related AEs. Following the infusion, all patients will be observed for fever, chills, 
rigors, hypotension, nausea, or other infusion-related AEs. 
All SAEs (as described in Section 7.1.1) that occur after the patient has signed informed consent 
(including the protocol defined follow-up period), regardless of judged relationship to the IP, or 
after the study period, if considered serious and related to IP or to the patient’s participation in 
the study, must be reported to IQVIA within 24 hours of the Investigator’s knowledge of the 
event. The SAE reporting will originate in the electronic data capture (EDC) system and an email 
will be sent to the designated responsible parties defined in the Safety Plan. The paper SAE form 
is in place as a back-up in the rare event that EDC is not accessible to the reporter of the SAE 
and the paper SAE form should be sent to  QLS_Anaptys@quintiles.com. 
The following documents should be submitted to IQVIA Safety: 
• Serious Adverse Event Report Form. 
• The following eCRFs or de-identified source documents: 
o Demographics page(s). 
o Medical history page(s). 
o Adverse event page(s). 
o Concomitant medication page(s). 
o Hospital discharge summary: If the patient is hospitalized because of or during an 
SAE, then a copy of the hospital discharge summary. 
The following are the Investigator’s responsibilities: 

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• Record diagnosis instead of signs and symptoms when available using accepted medical 
terminology. 
• The events recorded on the safety event report form must be consistent with the 
information entered on the respective CRFs. 
• Include any relevant medical history, concurrent illnesses, and concomitant medicines. 
• Include treatment(s) provided. 
• The Investigator must assess causality at the time of the first SAE notification. 
• The Investigator is responsible for obtaining and forwarding or recording the details of 
the outcome of the SAE on the appropriate eCRF, as well as any other details which may 
be requested by AnaptysBio and/or IQVIA in a timely manner: 
o Hospital records. 
o Medical records. 
o Data clarification. 
o Death certificate/autopsy results. 
o Events should be followed until they are resolved or stabilized, “Resolved with 
sequelae” will require specification of the sequelae. 
o For a fatal or life-threatening SAE, please call IQVIA Safety Group (contact 
information is located on the SAE form), in addition to entering the SAE details 
in the eCRF. 
o The SAEs should continue to be reported for at least 5.5 half-lives of IP following 
last dose. Any significant AE which in the opinion of the Investigator is related to 
the IP, SAE, or pregnancy occurring within 30 days after the EOS visit and should 
also be reported to the safety team of IQVIA and followed up until outcome. 
o Queries on SAE reports will be generated when there is missing/discrepant 
information, or when there is a need for additional information to completely 
evaluate the report. All supplemental SAE information and or documentation is to 
be recorded on the appropriate eCRF and must be submitted upon request. 
7.1.1.2 
Reporting of Serious Adverse Events to Regulatory Authorities and Investigators 
All SAEs that are considered unexpected and related to the IP will be reported by IQVIA as a 
15-Day report to the regulatory authorities as applicable and to all participating Investigators. 

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The SAEs that are considered unexpected, related to the study and are life-threatening or result in 
death will be reported by IQVIA to the regulatory authorities as applicable, and to all 
participating Investigators as a 7-Day report. IQVIA will ensure that all SAEs are reported to the 
appropriate regulatory authorities. 
Investigators will be notified by IQVIA of all SAEs that require prompt submission to their 
Independent Ethics Committee (IEC). Each Investigator must notify the IEC responsible for 
reviewing the study at their site of all 15-Day or 7-Day safety reports required by local 
regulations or IEC requirements and should provide written documentation of IEC notification 
for each report to IQVIA. This study will comply with all local regulatory requirements and 
adhere to the full requirements of International Council for Harmonisation (ICH) Guideline for 
Clinical Safety Data Management, Definitions and Standards for Expedited Reporting, Topic E2. 
7.1.1.3 
Follow-Up of Adverse Events 
Any AEs observed from the time of informed consent signed up to the end of the study will be 
followed up to resolution. Resolution means that the patient has returned to a baseline state of 
health or the Investigator does not expect any further improvement or worsening of the AE or the 
patient is deemed lost to follow-up. All AEs that occur within 30 days after the patient’s last visit 
should also be reported to AnaptysBio and/or IQVIA. 
7.1.2 
Clinical Laboratory Evaluations 
Blood samples for the study-specific assessments will be collected at the visits specified in 
Table 4.1 (Schedule of Events) and Section 18.0 (Appendix VI) for the biomarker cytokines, 
ADA, INF-γ, and PK. A list of specific clinical laboratory evaluations is provided in Table 7.1 
below: 

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Table 7.1 
Clinical Laboratory Parameters 
Hematology 
Clinical Chemistry 
Virology 
(Only at 
Screening) 
Urinalysis 
Drugs of Abuse  
(Only at Screening) 
Hematocrit 
Packed Cell Volume 
Hemoglobin 
Mean Cell 
Haemoglobin 
Mean Cell Hemoglobin 
Concentration 
Mean Cell Volume 
Platelet Count 
Red Blood Cell Count 
White Blood Cell Count 
Basophils (Absolute 
and %) 
Eosinophils (Absolute 
and %) 
Monocytes (Absolute 
and %) 
Neutrophils (Absolute 
and %) 
Lymphocytes (Absolute 
and %) 
Immunoglobulins (IgA, 
IgG, IgM, IgE, and IgD) 
ALT 
Albumin 
ALP 
AST 
Bicarbonate 
Bilirubin (Total) 
Bilirubin (Direct) (only if 
Total is elevated) 
Calcium 
Chloride 
C-Reactive Protein 
Creatinine 
GGT 
Glucose 
Potassium 
Phosphate (Inorganic) 
Protein (Total) 
Sodium 
Troponin 
Urea 
WOCBP Only - hCG levels 
 
Postmenopausal woman 
aged over 45 years with at 
least 1 year of amenorrhea 
only - FSH levels (only at 
Screening visit) 
Hepatitis B 
Surface Antigen 
Hepatitis C 
Antibody 
HIV Antibodies  
 
 
TB Screening 
QuantiFERON 
TB Gold test 
Bilirubin 
Blood 
Glucose 
Ketones 
Leukocytes 
Nitrates 
pH 
Protein 
Specific gravity 
Urobilinogen 
 
At discretion 
of Investigator 
based on 
urinalysis 
results 
Microbiology 
Urine 
Microscopy 
 
Urine 
Pregnancy-
dipstick (Day 1 
prior to IP 
administration) 
Amphetamines 
Barbiturates 
Benzodiazepines 
Cocaine 
Marijuana/Cannabis 
Methadone 
Methamphetamine/ 
Ecstasy 
Morphine/Opiates 
Phencyclidine 
Tricyclic 
Antidepressants 
Abbreviations: ALP = alkaline phosphatase; ALT = alanine transaminase; AST = aspartate aminotransferase; 
FSH = follicle stimulating hormone; GGT = gamma glutamyl transferase; hCG = human chorionic gonadotropin 
hormone; HIV = human immunodeficiency virus; IP = investigational product; TB = tuberculosis; 
WOCBP = women of childbearing potential, % = percentage. 
The central laboratory tests will be conducted by Q2 Solutions, at multiple locations such as:  
The Alba Campus Rosebank Livingston West Lothian  
EH54 7EG Scotland, United Kingdom 
Phone:
Fax: + 
Quest House 125-135 
Staines Road, Hounslow TW3 3JB, United Kingdom 
Phone:
Fax: +

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1600 Terrell Mill Road, Suite 100, Marietta 
GA 30067, United States of America 
Phone: 
Fax: + 
27027 Tourney Road, Valencia,  
CA 91355, United States of America 
Phone
Fax: +
The clinical laboratory test results will be reviewed for potential clinical significance, based on 
Investigator’s discretion, at all time points throughout the study. The Investigator will evaluate 
any change in laboratory values. If the Investigator determines a laboratory abnormality to be 
clinically significant, it is considered a laboratory AE; however, if the abnormal laboratory value 
is consistent with a current diagnosis, it may be documented accordingly. 
Serum samples for ADA determination will be collected on Days 1, 8, 36, 85, 106, and 127 
(EOS)/ET according to the schedule presented in Section 18.0 (Appendix VI). The actual date 
and time of the sample collection will be recorded in the patient’s eCRF. The details of blood 
sample collection, sample tube labelling, sample preparation, storage, and shipping procedures 
will be described in a separate laboratory manual. Analytical method to measure the ADA will 
be described in a separate bioanalytical report. 
7.1.3 
Vital Signs, Physical Findings, and Other Safety Assessments 
Vital signs will be measured, and physical examinations and ECGs will be performed at the time 
points indicated in the Schedule of Events (Table 4.1). 
Vital signs include pulse rate, respiratory rate, body temperature, systolic BP, and diastolic BP. 
The physical examination includes evaluation of general appearance, head, eyes, ears, nose, and 
throat, and the pulmonary, cardiovascular, gastrointestinal, renal/genitourological, endocrine 
(including thyroid), musculoskeletal/spinal, lymphatic, and dermatologic systems.  
A standard 12-lead ECG will be performed by a qualified physician or nurse. The following 
parameters will be documented: HR, PR interval, QRS interval, QT interval, and QTc interval. 
The ECG will be reviewed by the Investigator or an authorized representative who is 
experienced in the evaluation of ECGs and assessed for clinical significance.  
7.1.4 
Safety Monitoring 
There is no data monitoring committee for this study. 

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Timely and complete reporting of safety information assists the Sponsor in identifying any 
untoward medical occurrence, thereby allowing: (1) protection of safety of study patients; (2) a 
greater understanding of the overall safety profile of the IP; (3) recognition of dose-related IP 
toxicity; (4) appropriate modification of study protocols; (5) improvements in study design or 
procedures; and (6) adherence to worldwide regulatory requirements. 
7.2 
Pharmacodynamics 
Blood samples to determine the eosinophil count will be obtained as part of the standard 
hematology safety laboratory panel at screening, Day 1, 2, 8, 22, 36, 64, 85, 106, and 127/ET 
(See Table 4.1 and Table 7.1). 
Blood samples will be taken in a serum separator tube (SST) to measure circulating cytokines 
including, but not limited to IL-4, IL-5, IL-9, IL-13, IL-33, and sST2 (See laboratory flowchart 
for detailed collection and processing instructions). Samples will be collected according to the 
schedule presented in Section 18.0 (Appendix VI).  
Blood samples for ex vivo induced IFN-γ assessment will be collected in a sodium heparin tube 
(See laboratory flowchart for detailed collection and processing instructions). Samples will be 
collected according to the schedule presented in Section 18.0 (Appendix VI). The actual date and 
time of the sample collection will be recorded in the patient’s eCRF. The details of blood sample 
collection, sample tube labelling, sample preparation, storage, and shipping procedures will be 
described in a separate laboratory manual. 
The measurement of serum cytokines and ex vivo induced IFN-γ will be performed using 
validated assay methods. The analytical methods used to measure these PD endpoints will be 
described in a separate bioanalytical report. 
7.3 
Pharmacokinetics 
Samples of whole blood will be obtained in a Vacutainer SST for the determination of ANB020 
in human serum. Samples will be collected according to the schedule presented in Section 18.0 
(Appendix VI).  
If a patient refuses blood collection for PK analysis, this will not be considered a protocol 
violation as the PK analysis is a secondary objective. 
The actual date and time of blood sample collection will be recorded in the patient’s eCRF. The 
details of blood sample collection, sample tube labelling, sample preparation, storage, and 
shipping procedures will be described in a separate laboratory manual. 

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Bioanalysis 
The measurement of the concentrations of ANB020 will be performed using a validated assay 
method. The analytical methods used to measure concentrations of ANB020 will be described in 
a separate bioanalytical report. Only the samples within the known stability of ANB020 at the 
time of receipt by the bioanalytical laboratory will be analyzed. 
7.4 
Efficacy 
Efficacy assessments include FEV1 and FeNO test results; clinical scores of ACQ, PGIC, and 
CGIC; patient diary data, and IgE levels. 
Refer to Section 6.0 for more details about efficacy variables. 
7.5 
Health Outcomes 
Not applicable. 
7.6 
Pharmacogenetics 
Not applicable. 
7.7 
Appropriateness of Measurements 
All safety assessments used in this study are standard, i.e. widely used and generally recognized 
as reliable, accurate, and relevant. 

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8.0 QUALITY CONTROL AND QUALITY ASSURANCE 
According to the Guidelines of Good Clinical Practice (GCP) (CPMP/ICH/135/95), Q2 Solutions 
and IQVIA are responsible for implementing and maintaining quality assurance and quality 
control systems with written SOPs. 
Quality control will be applied to each stage of data handling. 
The following steps will be taken to ensure the accuracy, consistency, completeness, and 
reliability of the data: 
• 
Central laboratories for clinical laboratory parameters. 
• 
Center Qualification visit. 
• 
Center Initiation visit. 
• 
Early center visits post-enrollment. 
• 
Routine center monitoring. 
• 
Ongoing center communication and training. 
• 
Data management quality control checks. 
• 
Continuous data acquisition and cleaning. 
• 
Internal review of data. 
• 
Quality control check of the final clinical study report. 
In addition, AnaptysBio and/or IQVIA/Q2 Solutions Clinical Quality Assurance Department may 
conduct periodic audits of the study processes, including, but not limited to study center, center 
visits, central laboratories, vendors, clinical database, and final clinical study report. When audits 
are conducted, access must be authorized for all study related documents including medical 
history and concomitant medication documentation to authorized AnaptysBio’s representatives 
and regulatory authorities. 
8.1 
Monitoring 
AnaptysBio has engaged the services of a contract research organization, IQVIA, to perform all 
monitoring functions within this clinical study. IQVIA’s monitors will work in accordance with 

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IQVIA’s SOPs. The monitor will establish and maintain regular contact between the Investigator 
and AnaptysBio. 
The monitor will evaluate the competence of the study center, informing AnaptysBio about any 
problems relating to facilities, technical equipment, or medical staff. During the study, the 
monitor will check that written informed consent has been obtained from all patients correctly 
and that data are recorded correctly and completely. The monitor is also entitled to compare 
entries in eCRFs with corresponding source data and to inform the Investigator of any errors or 
omissions. The monitor will also assess and control adherence to the protocol and ICH/GCP 
guidelines at the study center. The monitor will arrange for the supply of IP, ensure proper IP 
dispensing/accountability, and appropriate storage conditions are maintained. 
Monitoring visits will be conducted according to all applicable regulatory requirements and 
standards. Regular monitoring visits will be made to each center while patients are enrolled in 
the study.  
During monitoring visits, all entries in the eCRFs will be compared with the original source 
documents (source data verification). For the following and all other items, this check will be 
100%:  
• 
Patient identification number. 
• 
Patient consent obtained. 
• 
Patient eligibility criteria (inclusion and exclusion criteria). 
• 
Efficacy variables. 
• 
Safety variables. 
• 
Medical record of AE. 
8.2 
Data Management/Coding 
Data generated within this clinical study will be handled according to the relevant SOPs of the 
Data Management and Biostatistics departments of IQVIA. 
Electronic data capture will be used for this study, meaning that all eCRF data will be entered in 
electronic forms at the study center. Data collection will be completed by authorized study center 
staff designated by the Investigator. Appropriate training and security measures will be 
completed with the Investigator and all authorized study center staff prior to the study being 
initiated and any data being entered into the system for any study patients. 

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All data must be entered in English. The eCRFs should always reflect the latest observations on 
the patients participating in the study. Therefore, the eCRFs are to be completed as soon as 
possible during or after the patient’s visit. To avoid inter-observer variability, every effort should 
be made to ensure that the same individual who made the initial baseline determinations 
completes all efficacy and safety evaluations. The Investigator must verify that all data entries in 
the eCRFs are accurate and correct. If some assessments are not done, or if certain information is 
not available or not applicable or unknown, the Investigator should indicate this in the eCRF. 
The Investigator will be required to electronically sign off on the clinical data. 
The monitor will review the eCRFs and evaluate them for completeness and consistency. The 
eCRF will be compared with the source documents to ensure that there are no discrepancies 
between critical data. All entries, corrections and alterations are to be made by the responsible 
Investigator or his/her designee. The monitor cannot enter data in the eCRFs. Once clinical data 
of the eCRF have been submitted to the central server, corrections to the data fields will be audit 
trailed, meaning that the reason for change, the name of the person who performed the change, 
together with time and date will be logged. Roles and rights of the center staff responsible for 
entering the clinical data into the eCRF will be determined in advance. If additional corrections 
are needed, the responsible monitor or Data Manager will raise a query in the EDC application. 
The appropriate study center staff will answer queries sent to the Investigator. This will be audit 
trailed by the EDC application meaning that the name of investigational staff, time and date 
stamp are captured. 
The eCRF is essentially considered a data entry form and should not constitute the original (or 
source) medical records unless otherwise specified. Source documents are all documents used by 
the Investigator or hospital that relate to the patient’s medical history, that verify the existence of 
the patient, the inclusion and exclusion criteria and all records covering the patient’s 
participation in the study. They include but are not limited to laboratory notes, ECG results, 
memoranda, pharmacy dispensing records, patient files, etc. 
The Investigator is responsible for maintaining source documents. These will be made available 
for inspection by the study monitor at each monitoring visit. The Investigator must submit a 
completed eCRF for each patient who receives IP, regardless of duration. All supportive 
documentation submitted with the eCRF, such as laboratory or hospital records, should be 
clearly identified with the study and patient number. Any personal information, including patient 
name, should be removed or rendered illegible to preserve individual confidentiality. 
Electronic case report form records will be automatically appended with the identification of the 
creator, by means of their unique User ID. Specified records will be electronically signed by the 
Investigator to document his/her review of the data and acknowledgement that the data are 
accurate. This will be facilitated by means of the Investigator’s unique User ID and password; 

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date and time stamps will be added automatically at time of electronic signature. If an entry on 
an eCRF requires change, the correction should be made in accordance with the relevant 
software procedures. All changes will be fully recorded in a protected audit trail, and a reason for 
the change will be required. 
Adverse events will be coded using current Medical Dictionary for Regulatory Activities 
(MedDRA). Concomitant medications will be coded using World Health Organization Drug 
Dictionary. Concomitant diseases/medical history will be coded using MedDRA. 
8.3 
Quality Assurance Audit 
Study centers, the study database, and study documentation may be subjected to Quality 
Assurance audit during the course of the study by AnaptysBio or IQVIA on behalf of 
AnaptysBio. In addition, inspections may be conducted by regulatory bodies at their discretion. 

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9.0 STATISTICS 
Statistical analyses will be performed by IQVIA using statistical analysis system (SAS), (SAS 
Institute, Cary, North Carolina, US) Version 9.2 or higher. IQVIA’s SOPs and work instructions 
will be used as the default methodology if not otherwise specified. 
Details of statistical analysis methods will be provided in the statistical analysis plan (SAP) that 
will be prepared and signed off prior to database lock. Any change to the data analysis methods 
will be documented in the SAP. Any additional analyses, and the justification for making the 
change, will be described in the clinical study report. Additional exploratory analyses of the data 
will be conducted as deemed appropriate. 
9.1 
Determination of Sample Size 
The number of patients to be enrolled is not based on statistical power considerations. 
A total of approximately 24 patients will be randomized in a 1:1 ratio to receive ANB020 or 
placebo. 
All patients who discontinue the study prior to completing the Day 36 study assessments will be 
replaced. Patients who are withdrawn from the study after Day 36 will not be replaced. 
9.1.1 
Analysis populations 
Randomized Analysis Set 
All patients who have been allocated to a randomized treatment arm, regardless of whether they 
received the planned treatment or not. Patients in this set will be analyzed in the respective 
randomized treatment arm. 
Full Analysis Set 
All patients who have received ANB020 or placebo and have at least one post-baseline blood 
eosinophils count assessment (Day 2). The full analysis set will be used for all efficacy analyses. 
Safety Analysis Set 
All patients who have received ANB020 or placebo. The safety analysis set will be used for all 
safety analyses. Patients in this set will be analyzed in the treatment arm that they actually 
received. 

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Pharmacokinetics Analysis Set 
All patients who have received ANB020 and have at least one post-dose serum concentration 
data available for ANB020 without any events or protocol deviation deemed to affect PK 
assessments. The PK analysis set will be used for all PK analyses. 
Pharmacodynamics Analysis Set 
All patients who have received ANB020 or placebo and provide at least one evaluable post-dose 
PD measurement without any events or protocol deviation deemed to affect PD assessment. The 
PD analysis set will be used for all PD analyses. 
9.2 
Patient Disposition 
A tabular presentation of the patient disposition will be provided. It will include the number of 
patients screened, enrolled, assigned treatment, completed as well as the number of dropouts, 
with reasons for discontinuation, and major protocol deviations or violations. A listing will be 
presented to describe dates of screening, assigned treatment, screen failed with reason, 
completion or early withdrawal, and the reason for early discontinuation, if applicable, for each 
patient. A list of protocol violations will be identified and discussed with the 
Investigator/AnaptysBio to categorize as major or minor and the same will be reported. 
9.3 
Patient Characteristics and Concomitant Medications 
Patient characteristics obtained at screening will be summarized for all patients taking ANB020 
and placebo. Summaries will include descriptive statistics for continuous variables (sample size 
[n], mean, standard deviation [SD], median, minimum, and maximum) and for categorical 
variables (n, frequency, and percent). Patient characteristics may include, but are not limited to 
age, gender, race/ethnicity, height, weight, and BMI. 
Categorical use of concomitant medication will be summarized by treatment period and overall. 
All concomitant medications used will be listed.  
9.4 
Safety analyses 
Following are the safety and tolerability endpoints: 
• Assessment of AEs/SAEs (potentially significant and clinically important AEs, SAEs, 
and AEs leading to withdrawal). 
• Physical examination. 

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• Vital signs. 
• Clinical safety laboratory tests (hematology, biochemistry, immunoglobulins, and 
urinalysis). 
• Electrocardiograms. 
• Number of asthma exacerbations. 
• Assessment of immunogenicity (ADA levels). 
9.4.1 
Adverse Events 
Adverse events will be coded using the current MedDRA. For each treatment, numbers of events 
and percentage will be tabulated by Preferred Term and System Organ Class. The AEs, SAEs, 
AEs leading to treatment discontinuation, and AEs leading to withdrawal of patient will be 
tabulated for each treatment period.  
Summaries over System Organ Class, Preferred Term and listings of AEs, AEs leading to death, 
SAEs, potentially significant AEs, clinically important AEs, and AEs that led to discontinuation 
from the study or of the IP will be presented by treatment. Summaries will also be presented by 
relatedness to IP and the severity of the AE. 
9.4.2 
Vital Signs Measurements, Physical Findings, and Clinical Laboratory 
Evaluations 
Summaries and listings of vital signs, physical examination, ECG, and laboratory test results will 
be presented. Appropriate descriptive statistics will be summarized for the observed value at 
each scheduled assessment and for the corresponding change from Baseline. 
For hematology and clinical chemistry, listings will also flag up any abnormal or out-of-range 
values. Clinically significant changes in the laboratory test parameters will be summarized and 
listed. Hematology and clinical laboratory data will be reported in System International units. 
For ECG variables, the QT correction factor will be based on both the Bazett and Fridericia 
formulae (QTcB and QTcF). Categorical summaries of absolute QT, QTcB, and QTcF values 
and change from (Baseline) values in QT, QTcB, and QTcF values will be presented by 
treatment and visit. 
Descriptive statistics will be used to present the safety outcomes including, physical examination 
results, weight, BMI, vital signs, laboratory test results, and ECG results. Change from Baseline 
will also be summarized for vital signs measurements and clinical laboratory test results. 

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Number of asthma exacerbations will be summarized using frequency count and percentage. 
Time (in days) from randomization to the first asthma exacerbation will be used as a supportive 
variable and will be calculated as follows: 
Start date of first asthma exacerbation − Date of randomization + 1. 
The time to first asthma exacerbation for subjects who do not experience an asthma exacerbation 
during the period till end of study will be censored at the date of their last visit, or at the time 
point after which an exacerbation could not be assessed (for lost to follow-up patients). 
Time to first asthma exacerbation will be analyzed to explore the extent to which treatment 
delays the time to first exacerbation compared with placebo. A cox proportional hazard model 
will be deployed by using treatment group as a class variable and number of exacerbations in the 
study as covariates. Results of the analysis will be summarized as hazard ratios and 95% 
confidence intervals (CIs) comparing ANB020 with placebo. 
Time to first asthma exacerbation will be displayed graphically using a Kaplan-Meier plot. The 
median time to event will be summarized by treatment, if there is sufficient uncensored data 
available to calculate these median values. 
Analyses of ADA will be performed similar to the PD endpoint analysis as describe in Section 
9.7. 
9.4.3 
Missing Data 
No imputation will be performed for the missing data. 
9.5 
Efficacy analysis 
The secondary efficacy variables (change in FEV1 and change in FeNO), and exploratory 
variables (change in clinical scores for ACQ, PGIC, and CGIC, and applicable diary 
assessments) will be analyzed using the full analysis set.  
For secondary efficacy endpoint, actual and change in FEV1 from Baseline (Day 1) to the EOS 
visit (Day 127) will be summarized using descriptive statistics. Change from Baseline will be 
compared between ANB020 and placebo using a mixed-effect analysis of covariance 
(ANCOVA). This model includes, fixed effect as treatment, baseline efficacy variable levels as 
covariates, and patient as a random effect. Appropriate covariance structure will be used. 
Treatment differences will be presented with corresponding p-values for the test of no difference 
and 95% CI. 

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Supportive analyses will be performed using a mixed-model repeated measures (MMRM) 
analysis. The model includes terms for treatment, time point of measurement, and treatment by 
time point interaction as fixed effects and Baseline value (pre-dose measurement at 
randomization [Day 1]) as covariate. At each visit day, ANB020 will be compared with placebo 
and model-based least squares means for the treatment effects, 95% CIs, and p-values will be 
calculated for within and between treatment comparisons.  
Other secondary efficacy endpoint and applicable exploratory endpoints analyses will be 
performed same as FEV1 analyses. 
9.6 
Pharmacokinetic Analyses 
9.6.1 
Evaluation of Pharmacokinetic Data 
The PK parameters will be derived using non-compartmental methods. The actual elapsed 
sampling times will be used in the PK parameter calculations. The PK analyses will follow Q2 
Solutions/IQVIA SOPs, unless otherwise specified. 
Where possible, the following limited PK parameters will be determined for ANB020 after a 
single IV infusion: 
• Maximum observed concentration (Cmax). 
• Time to maximum observed concentration (tmax). 
Additional PK parameters may be determined if deemed appropriate. 
9.6.2 
Pharmacokinetic Concentration Data Analyses 
A patient listing of all concentration-time data for each treatment will be presented. 
Concentration data of ANB020 will be summarized by nominal time point using the number of 
observations (n) and number of observations ≥lower limit of quantification, arithmetic mean, SD, 
coefficient of variation (CV), minimum, median, and maximum. 
Graphs of mean and individual concentration-time data will be generated, as appropriate, and 
will be described in detail in the SAP. 
9.6.3 
Pharmacokinetic Parameter Data Analyses 
Pharmacokinetic parameters will be listed and summarized, as appropriate using n, arithmetic 
mean, SD, CV, minimum, median, maximum, geometric mean, and geometric CV defined as 
 

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where ‘s’ is the SD of the data on a log scale, except that tmax will be reported with n, minimum, 
median, and maximum only. 
Graphs of parameters may be added at the discretion of the PK scientist, as appropriate, and will 
be described in detail in the SAP. 
9.7 
Pharmacodynamic Analyses 
Observed and change from Baseline for the eosinophil count, serum cytokines, and ex vivo 
induced IFN-γ will be listed and summarized descriptively by nominal time point and treatment. 
Baseline will be the last assessment before IP administration.  
Comparison between ANB020 and placebo will be performed using a MMRM analysis with 
terms for treatment, time point of measurement, and treatment by time point interaction as fixed 
effects and Baseline value (pre-dose measurement at randomization [Day 1]) as a covariate. 
Appropriate correlation matrix will be used. Treatment differences will be presented with 
corresponding p-values for the test of no difference and 95% CI. Suitable transformations may 
be applied as appropriate. Graphical summaries will be generated, as appropriate. 
The relationship between ANB020 concentrations and PD endpoints will be explored 
graphically. Further analysis details will be described in the SAP. 
9.8 
Interim Analyses 
No interim analysis is planned for this study. 

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10.0 ETHICS 
10.1 Independent Ethics Committee 
An IEC should approve the final protocol, including the final version of the Informed Consent 
Form (ICF) and any other written information and/or materials to be provided to the patients. 
The Investigator will provide AnaptysBio or IQVIA with documentation of IEC approval of the 
protocol and informed consent before the study may begin at the study center. The Investigator 
should submit the written approval to AnaptysBio or representative before enrolment of any 
patient into the study. 
AnaptysBio or representative should approve any modifications to the ICF that are needed to 
meet local requirements. 
The Investigator will supply documentation to AnaptysBio or IQVIA of required IEC’s annual 
renewal of the protocol, and any approvals of revisions to the informed consent document or 
amendments to the protocol. 
The Investigator will report promptly to the IEC, any new information that may adversely affect 
the safety of patients or the conduct of the study. Similarly, the Investigator will submit written 
summaries of the study status to the IEC as per IEC’s requirements. Upon completion of the 
study, the Investigator will provide the IEC with a brief report of the outcome of the study, if 
required. 
IQVIA or representative will handle the distribution of any of these documents to the national 
regulatory authorities. 
IQVIA’s or a representative will provide Regulatory Authorities, IEC, and Investigators with 
safety updates/reports according to local requirements, including Suspected Unexpected Serious 
Adverse Reactions, where relevant. 
Each Investigator is responsible for providing the IEC with reports of any serious and 
unexpected adverse drug reactions from any other study conducted with the IP. IQVIA or a 
representative will provide this information to the Investigator so that he/she can meet these 
reporting requirements. 
10.2 Ethical Conduct of the Study 
This study will be conducted and the informed consent will be obtained according to the ethical 
principles stated in the Declaration of Helsinki (2008), the applicable guidelines for GCP, or the 

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applicable drug and data protection laws and regulations of the countries where the study will be 
conducted. 
10.3 Patient Information and Informed Consent 
The ICF will be used to explain the risks and benefits of study participation to the patient in 
simple terms before the patient will be entered into the study. The ICF contains a statement that 
the consent is freely given, that the patient is aware of the risks and benefits of entering the 
study, and that the patient is free to withdraw from the study at any time. Written consent must 
be given by the patient and/or legal representative, after the receipt of detailed information on the 
study. 
The Investigator is responsible for ensuring that informed consent is obtained from each patient 
or legal representative and for obtaining the appropriate signatures and dates on the informed 
consent document prior to the performance of any protocol procedures and prior to the 
administration of IP. The Investigator will provide each patient with a copy of the signed and 
dated ICF. 
10.4 Patient Data Protection 
Not applicable, as pharmacogenetic evaluations will not be conducted for this study. 
10.5 Procedures for Premature Termination or Suspension of the Study or 
the Participation of Investigational Site(s) 
In the event that the Sponsor, an IEC, or regulatory authority elects to terminate or suspend the 
study (due to such events as, but not limited to new information becomes available that may 
negatively impact patient safety, IP integrity, withdrawal of IND), a study-specific procedure for 
ET or suspension will be provided by the Sponsor; the procedure will be followed by applicable 
investigational sites during the course of termination or study suspension. 

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11.0 STUDY ADMINISTRATION 
11.1 ADMINISTRATIVE STRUCTURE 
Table 11.1 
Administrative Structure 
Sponsor 
AnaptysBio Inc. 
10421 Pacific Center Ct Suite 200 
San Diego, CA 92121 
United States 
Drug Safety Monitoring 
IQVIA 
Customer Safety Services 
Global Data & Safety Monitoring 
5927 S. Miami Blvd. 
Morrisville, NC 27560 
United States 
Clinical Study Supply Management 
Investigational Product 
AnaptysBio Inc. 
10421 Pacific Center Ct Suite 200 
San Diego, CA 92121 
United States 
Clinical Study Supply Management Other than 
Investigational product 
IQVIA 
10188 Telesis Court, Suite 400 
San Diego, CA 92121 
United States 
Data Management 
IQVIA 
Data Management 
Etamin Block (Building B3) 
Prestige Technology Park II 
Sarjapur-Marathalli Outer Ring Road 
Bangalore - 560103 
India 
Biostatistics 
IQVIA 
12th Floor, G-Corp Tech Park 
Ghodbunder Road, Kasarwadawli, Thane (West) 
Thane - 400 607 
India 
Study Monitoring 
IQVIA 
10188 Telesis Court, Suite 400 
San Diego, CA 92121 
United States 
Medical Writing 
IQVIA 
Global Medical Writing and Document Publishing 
12th Floor, G-Corp Tech Park 
Ghodbunder Road, Kasarwadawli, Thane (West) 
Thane - 400 607 
India 
Medical Monitoring 
AnaptysBio Inc. 
10421 Pacific Center Ct Suite 200 
San Diego, CA 92121 
United States 
Central Laboratory 
Q2 Solutions  
Multiple locations 
11.2 Data Handling and Record Keeping 
The Investigator must maintain essential study documents (protocol and protocol amendments, 
completed eCRFs, signed ICFs, relevant correspondence, and all other supporting 
documentation). The study center should plan on retaining such documents for approximately 

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15 years after study completion. The study center should retain such documents until at least 
2 years after the last approval of a marketing application in an ICH region and until there are no 
pending or contemplated marketing applications in an ICH region or at least 2 years after the 
formal discontinuation of clinical development of the IP. These documents should be retained for 
a longer period if required by the applicable regulatory requirements or the hospital, institution, 
or private practice in which the study is being conducted. Patient identification codes (patient 
names and corresponding study numbers) will be retained for this same period of time. These 
documents may be transferred to another responsible party, acceptable to AnaptysBio, who 
agrees to abide by the retention policies. Written notification of transfer must be submitted to 
AnaptysBio. The Investigator must contact AnaptysBio prior to disposing of any study records. 
11.3 Direct Access to Source Data/Documents 
The Investigator will prepare and maintain adequate and accurate source documents to record all 
observations and other pertinent data for each patient randomized into the study. 
The Investigator will allow AnaptysBio, IQVIA, and authorized regulatory authorities to have 
direct access to all documents pertaining to the study, including individual patient medical 
records, as appropriate. Such information must be kept confidential and must have locked 
facilities that allow for this. Patient identification number and not the patient’s name will be 
recorded on all documents related to the study. 
11.4 Investigator Information 
11.4.1 
Investigator Obligations 
This study will be conducted in accordance with the ICH Harmonized Tripartite Guideline for 
GCP (GCP, 1997), European Legislation; and the ethical principles that have their origin in the 
Declaration of Helsinki. 
The Investigator is responsible for ensuring that all study center personnel, including 
Sub-Investigators, adhere to all applicable regulations and guidelines, including local laws and 
regulations, regarding the study, both during and after study completion. The Investigator is 
responsible for informing the IEC of the progress of the study and for obtaining annual IEC 
renewal. The Investigator is responsible for informing the IEC of completion of the study and 
will provide the IEC with a summary of the results of the study. 
11.4.2 
Protocol Signatures 
After reading the protocol, each Investigator will sign the protocol signature page and send a 
copy of the signed page to AnaptysBio or representative (Section 17.0). By signing the protocol, 

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the Investigator confirms in writing that he/she has read, understands and will strictly adhere to 
the study protocol and will conduct the study in accordance with ICH Guidelines for GCP and 
applicable regulatory requirements. The study will not be able to start at any center where the 
Investigator has not signed the protocol. 
11.4.3 
Publication Policy 
The data generated by this study are confidential information of AnaptysBio. AnaptysBio will 
make the results of the study publicly available. The publication policy with respect to the 
Investigator and study center will be set forth in the Clinical Trial Agreement. 
11.5 Financing and Insurance 
AnaptysBio will provide insurance in accordance with local guidelines and requirements as a 
minimum for the patients participating in this study. The terms of the insurance will be kept in 
the study files. 

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12.0 REFERENCES 
                                               
1 Pastorelli L, Garg RR, Hoang SB, Spina L, Mattioli B, Scarpa M, et al. Epithelial-derived 
IL-33 and its receptor ST2 are dysregulated in ulcerative colitis and in experimental Th1/Th2 
driven enteritis. Proc. Natl. Acad. of Sci USA. 2010 Apr 27;107(17):8017-8022. 
2 Liew Fy. Il-33: A Janus Cytokine. Ann Rheum Dis. 2012 Apr;71(Suppl 2):I101-I104. 
3 Nabe, T. Interleukin (IL)-33: New Therapeutic Target for Atopic Diseases. J. Pharmacol Sci. 
2014;126:85-91. 
4 Nanzer AM, Menzies-Gow A. Defining severe asthma-An approach to find new therapies. 
European clinical Respiratory Journal. 2014;1:1-9. 
5 Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2016. 
Available from: www.ginasthma.org. 
6 Darveaux J, Busse WW. Journal of Allergy and Clinical Immunology. 2015;3(2): 152-160. 
7 Bieber T, Cork M, Reitamo S. Atopic dermatitis: a candidate for disease-modifying strategy. 
Department of Dermatology and Allery 2012;67: 969-975. 
8 Thomson SF. Epidemiology and natural history of atopic diseases. European Clinical 
Respiratory Journal. 2015 Mar 24;2. 
9 American Journal of Respiratory and Critical Care Medicine. ATS/ERS Recommendations for 
Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory 
Nitric Oxide and Nasal Nitric Oxide. 2005;171:912-930. 
10 M.R Miller, J.Hankison, V.Brusasco, F.Burgos, R.Casaburu, A. coates, et al. Series 
“ATS/ERS Task Force: Standardization of Lung Function Testing. 2005;26:319-338. 

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13.0 APPENDIX I: ASTHMA CONTROL QUESTIONNAIRE 
 
Asthma Control Questionnaire 
Patient ID:  
Date:  
Page 1 of 2 
Please answer questions 1-6 
 
Circle the number of the response that best describes how you have been during the past week. 
1. On average, during the past week, how 
often were you woken by your asthma 
during the night?  
0 
Never 
1 
Hardly ever 
2 
A few times 
3 
Several times 
4 
Many times 
5 
A great many times 
6 
Unable to sleep because of asthma 
2. On average, during the past week, how bad 
were your asthma symptoms when you 
woke up in the morning? 
0 
No symptoms 
1 
Very mild symptoms 
2 
Mild symptoms 
3 
Moderate symptoms 
4 
Quite severe symptoms 
5 
Severe symptoms 
6 
Very severe symptoms 
3. In general, during the past week, how 
limited were you in your activities 
because of your asthma? 
0 
Not limited at all 
1 
Very slightly limited 
2 
Slightly limited 
3 
Moderately limited 
4 
Very limited 
5 
Extremely limited 
6 
Totally limited 
4. In general, during the past week, how much 
shortness of breath did you experience 
because of your asthma? 
0 
None 
1 
A very little 
2 
A little 
3 
A moderate amount 
4 
Quite a lot 
5 
A great deal 
6 
A very great deal 

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Asthma Control Questionnaire 
Patient ID:  
Date:  
Page 2 of 2  
5. In general, during the past week, how much 
of the time did you wheeze? 
0 
Not at all 
1 
Hardly any of the time 
2 
A little of the time 
3 
A moderate amount of the time 
4 
A lot of the time 
5 
Most of the time 
6 
All the time 
6. On average, during the past week, how 
many puffs/inhalations of short-acting 
bronchodilator (e.g. Ventolin/Bricanyl) 
have you used each day?  
(If you are not sure how to answer this 
question, please ask for help) 
0 
None 
1 
1-2 puffs/inhalations most days 
2 
3-4 puffs/inhalations most days 
3 
5-8 puffs/inhalations most days 
4 
9-12 puffs/inhalations most days 
5 
13-16 puffs/inhalations most days 
6 
More than 16 puffs/inhalations most days 
 
 
To be completed by a member of the clinic staff 
 
 
 
7. FEV1 pre-bronchodilator:_ _ _ _ _ _ _ _ 
0 
> 95% predicted 
1 
95 - 90% 
2 
89 – 80% 
3 
79 – 70% 
4 
69 – 60% 
5 
59 – 50% 
6 
< 50% predicted 
FEV1 predicted:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
FEV1 % predicted:_ _ _ _ _ _ _ _ _ _ _ _ _ _ 
(Record actual values on the dotted lines and 
score the FEV1 % predicted in the next 
column) 
FEV1 = forced expiratory volume in 1 second 
 
 
© 2001 QOL Technologies LTD. ACQ-United Kingdom/English– Modified on 08 Sep 2010-
Mapi Research Institute. 

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14.0 APPENDIX II: PATIENT GLOBAL IMPRESSION OF 
CHANGE (PGIC) SCALE 
Since beginning of treatment (Day 1) in this study, how would you describe the change (if any) 
in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS and OVERALL QUALITY OF 
LIFE, related to your asthma? (Please tick ONE box). 
 
1 = Very much improved 
  
 
2 = Much improved   
 
 
3 = Minimally improved 
  
 
4 = No changes 
  
 
 
5 = Minimally worse  
 
 
6 = Much worse 
 
 
 
7 = Very much worse  
 
 
 

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15.0 APPENDIX III: CLINICAL GLOBAL IMPRESSION OF 
CHANGE (CGIC) SCALE 
Since this patient has started the study treatment (Day 1) how would you describe the change (if 
any) in this patient’s overall asthma symptoms and control compared to their asthma on Day 1. 
Please tick ONE box. 
1 = Very much improved 
  
 
2 = Much improved   
 
 
3 = Minimally improved 
  
 
4 = No changes 
  
 
 
5 = Minimally worse  
 
 
6 = Much worse 
 
 
 
7 = Very much worse  
 
 

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16.0 APPENDIX IV: GLOBAL INITIATIVE FOR ASTHMA 
(2016) ASSESSMENT OF SEVERITY AND STEP THERAPY 
Assessing Asthma Severity 
Asthma severity is assessed retrospectively from the level of treatment required to control 
symptoms and exacerbations. It can be assessed once the patient has been on controller treatment 
for several months and, if appropriate, treatment step down has been attempted to find the 
patient’s minimum effective level of treatment. Asthma severity is not a static feature and may 
change over months or years. 
Asthma severity can be assessed when the patient has been on regular controller treatment for 
several months: 
Mild asthma is asthma that is well controlled with Step 1 or Step 2 treatment, i.e. with as needed 
reliever medication alone, or with low-intensity controller treatment such as low dose inhaled 
corticosteroids (ICS), leukotriene receptor antagonists, or chromones. 
Moderate asthma is asthma that is well controlled with Step 3 treatment e.g. low dose 
ICS/long-acting beta-2-agonists (LABA). 
Severe asthma is asthma that requires Step 4 or 5 treatment, e.g. high-dose ICS/LABA, to 
prevent it from becoming ‘uncontrolled’, or asthma that remains ‘uncontrolled’ despite this 
treatment. While many patients with uncontrolled asthma may be difficult to treat due to 
inadequate or inappropriate treatment, or persistent problems with adherence or comorbidities 
such as chronic rhinosinusitis or obesity, the European Respiratory Society/American Thoracic 
Society Task Force on Severe Asthma considered that the definition of severe asthma should be 
reserved for patients with refractory asthma and those in whom response to treatment of 
comorbidities is incomplete. 

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17.0 APPENDIX V: SIGNATURE OF INVESTIGATOR 
PROTOCOL TITLE: Placebo-Controlled Proof of Concept Study to Investigate ANB020 
Activity in Adult Patients with Severe Eosinophilic Asthma 
PROTOCOL NO: 
ANB020-004 
This protocol is a confidential communication of AnaptysBio. I confirm that I have read this 
protocol, I understand it, and I will work according to this protocol. I will also work consistently 
with the ethical principles that have their origin in the Declaration of Helsinki and that are 
consistent with good clinical practices and the applicable laws and regulations. Acceptance of 
this document constitutes my agreement that no unpublished information contained herein will 
be published or disclosed without prior written approval from AnaptysBio. 
Instructions to the Investigator: Please SIGN and DATE this signature page. PRINT your name, title, and the 
name of the center in which the study will be conducted. Return the signed copy to IQVIA. 
 
I have read this protocol in its entirety and agree to conduct the study accordingly: 
 
Signature of Investigator:      
___________________________            Date:  ________ 
Printed Name:                                ___________________________ 
Investigator Title:                           ___________________________ 
 
Name/Address of Center:               ___________________________ 
 
___________________________ 
 
___________________________ 
 

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19.0 APPENDIX 7: SUMMARY OF CHANGES 
 
Protocol ANB020-004: Amendment 3, 16 February, 2018 
Replaces: Amendment 2, 04 January, 2018 
 
1. Inclusion Criteria Updated:  
Description of Change: Lowered required blood eosinophil count from ≥400 to 
≥300 cells/µL. 
Purpose for Change: To enable enrollment of severe eosinophilic patients with levels of 
≥300 cells/µL. 
 
2. Section 5.4 (Method of Assigning Patients to Treatment Group):   
Description of Change: Removed specific details on randomization responsibilities. 
Purpose for Change: Instructed site to reference study manuals for complete 
information/instruction. 
 
3. Section 5.7.2 (Unblinding):   
Description of Change: Removed specific details on unblinding language. 
Purpose for Change: Site staff to reference study manuals for detailed processes. 
 
Protocol ANB020-004: Amendment 2, 04 January, 2018 
Replaces: Amendment 1, 08 May 2017 
 
1. Entire Document:  
a. Description of Change: Updated CRO name from QuintilesIMS to IQVIA. 
Purpose for Change: Vendor name change. 
b. Description of Change: General grammatical and typographical corrections. 
Purpose for Change: Correcting errors. 
 
 

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2. Synopsis- Study Center:  
Description of Change: Updated number of study centers. 
Purpose for Change: Increase number of sites participating in protocol. 
 
3. Section 2.1-  (Background Information) and Section 4.2 (Discussion of Study Design): 
Description of Change: Updated background to include MAD information. 
Purpose for Change: Updated to reflect completion of MAD study as reflected in current 
IB. 
4. Section 4.1 (Summary of Study Design):  
Description of Change: Clarification of informed consent window. 
Purpose for Change: Remove “-14-day” window restriction to allow consent prior to 
screening visit. 
5. Section 4.3.1 (Inclusion Criteria):  
a. Description of Change: Increased body mass index. 
Purpose for Change: Increased to reflect BMI of patient population. 
b. Description of Change: Clarified WOCBP language. 
Purpose for Change: Clarified to address Investigator questions. 
c. Description of Change: Inclusion Systemic corticosteroids dosage criteria, 
removal of stable dose requirement. 
Purpose for Change: Removed stable dosage requirement to correspond with SOC 
treatment prior to beginning study treatment. 
 
6. Section 4.3.2 (Exclusion Criteria)  
a. Description of Change:  Removed exclusion: “Participation in any interventional 
study for the treatment of asthma in the 6 months before screening.” 
Purpose for Change: Removed, covered in exclusion criteria “3 months or 5 half-
lives before screening.” 
b. Description of Change: Removed exclusion for use of beta blockers, 
angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or 
calcium channel blockers. 
Purpose for Change: Use of beta blockers, etc. will not affect safety of 
participants and will allow SOC treatment to continue. 
c. Description of Change: Inclusion amended to allow admission of controlled 
cardiovascular disease (controlled ischemic cardiovascular disease). 

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Purpose for Change: Allow inclusion of typical patient population. 
 
7. Section 4.3.4 (Patient Restrictions):  
Description of Change: Clarified language regarding partners of male patients and 
clarified “Highly Effective Methods of Contraception” language to reflect local naming 
conventions. 
Purpose for Change: Clarified requirements for contraception. 
 
8. Section 4.3.5 (Patient Withdrawal):  
Description of Change: Added notification instructions for staff. 
Purpose for Change: Provide instruction to site regarding notification procedures. 
 
9. Section 5.8.1 (Excluded Medications):  
Description of Change: Removed restricted medications per inclusion/exclusion updates. 
Purpose for Change: Updates correspond to revised inclusion/exclusion criteria. 
 
10. Section 6.1.2 (Spirometry):  
Description of Change: Addition of pre-bronchodilator Spirometry readings at each clinic 
visit. 
Purpose for Change: Additional Spirometry reading collected to ensure stable collection 
of data. 
 
11. Section 6.2.6 (Timing of Procedures):  
a. Description of Change: Corrected order of blood draw. 
Purpose for Change: Updated to reflect laboratory instruction guidelines. 
b. Description of Change: Removed repetitive Quality of Life instruction. 
Purpose for Change: Removed repetitive instruction that is covered in bullet point 
#3 (study scales/questionnaire forms). 
 
12. Section18 (Appendix VI - IFN-γ collection time points):  
Description of Change: Removed select IFN-γ blood draws. 
Purpose for Change: Additional blood draws unnecessary per data collected in previous 
trials. 
 
13. Table 4.1 (Schedule of Events):  
Description of Change: Corrected footnotes to reflect Amendment 2 changes. 
Purpose for Change: Updated to reflect necessary changes in procedure requirements. 

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Protocol ANB020-004: Amendment 1, 08 May 2017 
Replaces: Original: 21 Mar 2017 
 
1. Section 4.3.1 (Inclusion Criteria)  
Description of Change: Corrected length of time contraception is required following last 
dose of IP administration from 20 weeks to 18 weeks for both male and female 
participants. 
Purpose for Change: Corrected length of time to 18 weeks to accurately reflect 5 half-
lives of ANB020 300mg IV plus an additional 50 days for sperm turnover. 
 
2. Section 4.3.4 (Patient Restrictions)  
a. Description of Change: Corrected length of time contraception is required 
following last dose from 20 weeks to 18 weeks for both male and female patients. 
Purpose for Change: Typographical error, length of time was decreased based on 
half-life of ANB020. 
b. Description of Change: Corrected five times half-life of drug from 85 days to 70 
days. 
Purpose for Change: To provide accurate ANB020 half-life information based on 
300mg IV dosing of ANB020. 
 
3. Section 5.7 (Blinding) 
Description of Change: Updated headings in section 5.7 to include unblinding 
information and provide details for unblinding procedures. 
Purpose for Change: To provide unblinding information and instruction should 
unblinding be necessary during the study.