Conditions: Eosinophilic Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
This is a proof of concept study designed to assess the effects of a single intravenous dose of etokimab compared to placebo in adult participants with severe eosinophilic asthma. This study will also assess the safety and tolerability of etokimab in adult participants with severe eosinophilic asthma.

Detailed description:

Arms:
arm 1: Participants received a single dose of 300 milligrams (mg) etokimab administered on Day 1 by intravenous (IV) infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. arm 2: Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.

Interventions: intervention 1: Etokimab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered on Day 1 over 1 hour by IV infusion intervention 2: Administered on Day 1 over 1 hour by IV infusion

Protocol document:
Prot_000.pdf: 
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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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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. 
 

SAP_001.pdf: 
 
 
16.1.9 
Documentation of statistical methods 
• Statistical Analysis Plan – Version 1 – 18 December 2018 
• Table Shells – 18 December 2018 
• Listing Shells –18 December 2018 
• Figure Shells – 18 December 2018 
• Biostatistics File Note – Additional Analysis of ACQ5 – 27 April 2020 
 
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Statistical Analysis Plan  
 
Study Number: ANB020-004 
 
Placebo-Controlled Proof of Concept Study to Investigate 
ANB020 Activity in Adult Patients with Severe Eosinophilic 
Asthma 
 
 
 
Author:  
 
 
Version Number:  
1.0 
Date:   
 
18Dec2018 
 
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Table of Contents 
 
 
INTRODUCTION ..................................................................................................................................................10 
 
STUDY OBJECTIVES ...........................................................................................................................................10 
2.1. 
Primary Objectives ...................................................................................................................................10 
2.2. 
Secondary Objectives................................................................................................................................10 
2.3. 
Exploratory Objectives .............................................................................................................................11 
 
STUDY DESIGN` .................................................................................................................................................11 
3.1. 
Schedule of Events ....................................................................................................................................13 
3.2. 
Changes to Analysis from Protocol ..........................................................................................................13 
 
PLANNED ANALYSIS ..........................................................................................................................................13 
4.1. 
Data Monitoring Committee (DMC) ........................................................................................................14 
4.2. 
Interim Analysis ........................................................................................................................................14 
4.3. 
Final Analysis ...........................................................................................................................................14 
 
ANALYSIS SETS .................................................................................................................................................14 
5.1. 
All Patients Screened [SCR] .....................................................................................................................15 
5.2. 
Randomized Analysis Set [RND] ..............................................................................................................15 
5.3. 
Full Analysis Set [FAS] ............................................................................................................................15 
5.4. 
Safety Analysis Set [SAF] .........................................................................................................................15 
5.5. 
Pharmacokinetic Analysis Set [PK] .........................................................................................................15 
5.6. 
Pharmacodynamic Analysis Set [PD] ......................................................................................................15 
 
GENERAL CONSIDERATIONS ..............................................................................................................................16 
6.1. 
Reference Start Date and Study Day ........................................................................................................18 
6.2. 
Baseline ....................................................................................................................................................18 
6.3. 
Retests, Unscheduled Visits and Early Termination Data ........................................................................18 
6.4. 
Windowing Conventions ...........................................................................................................................19 
6.5. 
Statistical Tests .........................................................................................................................................19 
6.6. 
Common Calculations ..............................................................................................................................19 
6.7. 
Software Version .......................................................................................................................................19 
 
STATISTICAL CONSIDERATIONS .........................................................................................................................19 
7.1. 
Adjustments for Covariates and Factors to be Included in Analyses .......................................................19 
7.2. 
Multicenter Studies ...................................................................................................................................19 
7.3. 
Missing data .............................................................................................................................................20 
7.4. 
Multiple Comparisons/ Multiplicity ..........................................................................................................20 
7.5. 
Examination of Subgroups ........................................................................................................................20 
 
OUTPUT PRESENTATIONS ..................................................................................................................................20 
 
DISPOSITION AND WITHDRAWALS .....................................................................................................................20 
 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS ............................................................................21 
 
PROTOCOL DEVIATIONS ................................................................................................................................22 
 
MEDICAL HISTORY ........................................................................................................................................22 
 
CONCOMITANT ILLNESSES .............................................................................................................................23 
 
CONCOMITANT MEDICATIONS .......................................................................................................................23 
 
STUDY TREATMENT EXPOSURE .....................................................................................................................24 
 
STUDY TREATMENT COMPLIANCE.................................................................................................................24 
 
EFFICACY OUTCOMES ...................................................................................................................................24 
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17.1. 
Primary Endpoints ................................................................................................................................24 
17.1.1. 
PRIMARY EFFICACY ENDPOINT .................................................................................................................24 
17.1.2. 
PRIMARY PHARMACODYNAMIC ENDPOINT................................................................................................24 
17.1.2.1. 
ANALYSIS OF PRIMARY PHARMACODYNAMIC ENDPOINT ....................................................................................24 
17.2. 
Secondary Endpoints ............................................................................................................................25 
17.2.1. 
SECONDARY EFFICACY ENDPOINTS ...........................................................................................................25 
17.2.1.1. 
ANALYSIS OF SECONDARY EFFICACY ENDPOINTS ...............................................................................................25 
17.2.2. 
SECONDARY PHARMACOKINETIC ENDPOINTS ...........................................................................................26 
17.2.2.1. 
ANALYSIS OF SECONDARY PHARMACOKINETIC ENDPOINTS .................................................................................26 
17.2.3. 
SECONDARY PHARMACODYNAMIC ENDPOINTS .........................................................................................26 
17.2.3.1. 
ANALYSIS OF SECONDARY PHARMACODYNAMIC ENDPOINTS ..............................................................................27 
17.3. 
Exploratory Endpoints ..........................................................................................................................27 
17.3.1. 
EXPLORATORY EFFICACY ENDPOINTS .......................................................................................................27 
17.3.1.1. 
ANALYSIS OF EXPLORATORY ENDPOINTS .........................................................................................................27 
17.3.2. 
EXPLORATORY PHARMACODYNAMICS ENDPOINTS ...................................................................................28 
17.3.2.1. 
ANALYSIS OF EXPLORATORY PHARMACODYNAMIC ENDPOINTS ............................................................................28 
 
SAFETY OUTCOMES .......................................................................................................................................28 
18.1. 
Adverse Events ......................................................................................................................................28 
18.2. 
Deaths ...................................................................................................................................................30 
18.3. 
Laboratory Evaluations ........................................................................................................................30 
18.4. 
ECG Evaluations ..................................................................................................................................31 
18.4.1. 
ECG SPECIFIC DERIVATION ......................................................................................................................32 
18.4.2. 
ECG MARKEDLY ABNORMAL CRITERIA ...................................................................................................32 
18.5. 
Vital Signs .............................................................................................................................................33 
18.6. 
Physical Examination ...........................................................................................................................33 
18.7. 
Other Safety Assessments (Number of asthma exacerbations) .............................................................33 
18.8. 
Other Safety Assessments (Immunogenicity) ........................................................................................34 
 
PHARMACOKINETIC OUTCOMES ....................................................................................................................34 
 
PHARMACODYNAMIC OUTCOMES ..................................................................................................................37 
 
INTERIM/INTERMEDIATE ANALYSIS ..............................................................................................................38 
 
GENETIC ANALYSIS .......................................................................................................................................39 
 
DATA NOT SUMMARIZED OR PRESENTED ......................................................................................................39 
 
REFERENCES..................................................................................................................................................39 
APPENDIX 1. 
PARTIAL DATE CONVENTIONS.......................................................................................................39 
APPENDIX 2. 
PROGRAMMING CONVENTIONS FOR OUTPUTS ...............................................................................42 
APPENDIX 3. 
SAMPLE SAS CODE ........................................................................................................................45 
 
 
Figure 1: Schematic of Study Design ............................................................................................................................................... 12 
 
 
 
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List of Abbreviations and Definitions of Terms 
 
Abbreviation 
Definition  
ACQ=-7  
Asthma Control Questionnaire 
ADA 
Anti-drug Antibodies 
AE  
Adverse event  
ANCOVA  
Analysis of covariance  
AUC 
Area under the concentration-time curve 
AUC0-inf 
Area under the concentration-time curve from time zero (predose) extrapolated to 
infinite time 
AUC0-last 
area under the concentration-time curve from time zero (predose) to time of last 
quantifiable concentration 
bec 
blood eosinophil count 
BLQ 
Below the lower limit of quantitation 
BMI  
Body mass index  
BP  
Blood pressure  
CGIC 
Clinical Global Impression of Change 
CI  
Confidence interval  
CL  
Systemic clearance following intravenous dosing 
Cmax  
Maximum observed concentration  
CV  
Coefficient of variation  
ECG  
Electrocardiogram  
eCRF  
Electronic case report form  
EOS  
End of Study  
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eos 
eosinophil 
EoT 
End of Treatment 
ET  
Early Termination 
FeNO 
Fractional exhaled nitric oxide 
FEV1 
Forced expiratory volume in 1 second 
FSH 
Follicle stimulating hormone 
gCV  
Geometric coefficient of variation  
Gmean  
Geometric mean 
HR  
Heart rate  
ICH  
International Council for Harmonisation 
IFN-γ 
Interferon-gamma 
IgE  
Immunoglobulin E  
IL 
Interleukin 
IP  
Investigational product  
IV  
Intravenous(ly)  
Oz 
Apparent terminal rate constant 
LLOQ  
Lower limit of quantitation  
MedDRA  
Medical Dictionary for Regulatory Activities  
MMRM 
Mixed-model repeated measures 
n  
Sample size or number of observations  
PD  
Pharmacodynamic(s) 
PGIC 
Patient Global Impression of Change 
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PK  
Pharmacokinetic(s) 
Rsq 
Coefficient of determination  
SABA 
short-acting beta-agonists 
SAE  
Serious adverse event  
SAP  
Statistical analysis plan  
SAS  
Statistical analysis system  
SD  
Standard deviation  
SI 
System International 
TEAE  
Treatment emergent adverse event  
t1/2 
Apparent terminal half-life 
tmax 
Time to maximum observed concentration  
VSS 
Volume of distribution at steady state following intravenous dosing 
VZ 
Volume of distribution during terminal phase 
WBC  
White blood cell 
WHO DD 
World Health Organization Drug Dictionary 
WOCBP 
Women of childbearing potential 
 
 
 
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 INTRODUCTION 
This document describes the statistical analyses to be performed and data presentations to be produced 
for this phase 2a, randomized, double-blind, placebo-controlled, study to assess the effects of a single 
300 mg/100 mL intravenous (IV) dose of ANB020 (etokimab) compared to placebo in adult patients with 
severe eosinophilic asthma. 
The purpose of this statistical analysis plan (SAP) is to ensure the credibility of the study findings by 
specifying the rules and conventions to be used in the presentation and analysis of efficacy, safety, 
pharmacokinetics (PK), and pharmacodynamics (PD) data prior to database lock and unblinding of 
treatment groups at the individual level. It also describes how the data are to be summarized and 
analyzed. 
This SAP has been developed based on the International Council for Harmonization (ICH) E3 and E9 
Guidelines and in reference to the following document: 
Protocol Anaptys ANB020-004 Amendment 4 dated 31 Oct 2018. 
Any changes to the planned analysis, after database lock/ unblinding, will be described in an 
amendment to the SAP. 
 STUDY OBJECTIVES 
2.1. PRIMARY OBJECTIVES 
To measure the reduction of eosinophils (blood eosinophil count [bec or eos])[ 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. 
2.2. SECONDARY OBJECTIVES 
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). 
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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 PD activity of ANB020 on ex vivo induced interferon-gamma (IFN-γ) levels. 
To test for any immunogenicity to ANB020. 
To describe the PK of ANB020 following a single, IV dose in adult patients with severe eosinophilic 
asthma. 
2.3. EXPLORATORY OBJECTIVES 
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-7), Patient Global Impression of Change (PGIC), and the Clinical Global 
Impression of Change (CGIC). 
To assess the effect of ANB020 on the asthma symptoms, change in standard of care treatment, and 
rescue medication (short-acting beta-agonists [SABA]) usage. 
To assess the effect of ANB020 on immunoglobulin E (IgE) levels. 
 STUDY DESIGN` 
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. 
The screening visit will be conducted 7 to 14 days before Day 1. After obtaining the informed consent 
from the patients; medical history, concomitant medications, vital signs, physical examination, FeNO 
measurement, spirometry to determine FEV1, and laboratory tests will be performed at the screening 
visit. 
Eligible patients will be randomized in a 1:1 ratio to receive ANB020 or placebo on Day 1. 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. 
All patients will be followed up for 18 weeks. Patients will return to the study center for study 
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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-7 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, assessments including vital signs, safety laboratory testing, 
eosinophil count, PK, and pharmacodynamic analysis will be performed at specified time points. 
Sample Size: 
The number of patients enrolled is not based on statistical power considerations. 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. A total of approximately 24 patients will 
be randomized in a 1:1 ratio to receive ANB020 or placebo. 
Randomization: 
On Day 1, eligible patients will be assigned sequential randomization numbers, based on a 
randomization schedule, 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.  
Study Treatments: 
Investigational medicinal product is a single IV infusion of ANB020 300 mg/100mL. 
Comparator (placebo) is a single IV infusion of 100 mL sterile normal saline (0.9% NaCl)  
Infusions will be administered over 1 hour. 
Blinding: 
This is a randomized, double-blind, placebo-controlled study with limited access to the randomization 
code. The Sponsor, Investigators, and patients will be blinded to treatment assignment of ANB020 or 
placebo. 
A schematic of the study design is included as Figure 1: 
Figure 1: Schematic of Study Design  
 
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4.1. DATA MONITORING COMMITTEE (DMC) 
No DMC is planned of this study. 
4.2. INTERIM ANALYSIS 
No interim analysis is planned for this study. However, an intermediate analysis has been planned for 
this study after the last subject complete visit Day 36 and Day 64 where a limited number of unblinded 
safety data listings will be generated and the same will be reviewed by a restricted group. The restricted 
group will only include Randomizer/Unblinded Bios and one designated person from AnaptysBio. No 
Statistical analysis or alpha adjustment will be done for this purpose.  
4.3. FINAL ANALYSIS 
The final statistical analysis identified in this SAP will be performed by the IQVIA Biostatistics 
department following sponsor authorization of this SAP, determination of the analysis populations, 
database lock and unblinding of treatment. 
Analysis of the PK of ANB020 will be the responsibility of the clinical pharmacokineticist (PK analyst) at 
IQVIA. The PD analysis, PK/PD summaries, data listings, and PK/PD figures will be the responsibility 
of the ECD biostatistician at IQVIA. 
 ANALYSIS SETS 
Agreement and authorization of patients included/excluded from each analysis set will be obtained prior 
to the database lock of the study. The patients and observations excluded from analysis sets, and the 
reason for the exclusions, will be described in the clinical study report (CSR). 
Pharmacokinetic data will be reviewed in a 2-stage process:   
First stage (before unblinding): no concentrations or PK parameters will be included.  Data are to be 
evaluated on a case-by-case basis whether the subject should be excluded from the PK analysis set 
before the concentration results are disclosed. 
Second stage (after unblinding): data with concentration results will be reviewed.  The PK analysis set 
defined prior to concentration results disclosure will be confirmed or updated. 
The following analysis sets will be used: 
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5.1. ALL PATIENTS SCREENED [SCR] 
Patients who have signed the informed consent form and have been screened. 
5.2. RANDOMIZED ANALYSIS SET [RND] 
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. 
5.3. FULL ANALYSIS SET [FAS] 
 
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. 
Patients will be analyzed according to their randomized treatment. 
5.4. SAFETY ANALYSIS SET [SAF] 
All patients who have received ANB020 or placebo. The safety analysis set will be used for all safety 
analyses. Patients will be analyzed according to the actual treatment received. 
5.5. PHARMACOKINETIC ANALYSIS SET [PK] 
All patients who have received ANB020 and have at least one post-dose serum concentration data 
value 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. 
Allocation of subjects to the PK population and all protocol deviations will be fully documented in the 
BDR report. 
5.6. PHARMACODYNAMIC ANALYSIS SET [PD] 
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. 
Allocation of subjects to the PD population and all protocol deviations will be fully documented in the 
BDR report. 
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 GENERAL CONSIDERATIONS 
All clinical data from the internal database, and immunogenicity, PD and PK data from an external 
database will be provided as raw datasets with validated values. Summaries will be presented by 
treatment and overall as appropriate. 
Listings will be presented for all patients available in the data transfer received from data management. 
Data from patients excluded from an analysis set will be included in the data listings, but not in the 
summaries. 
Coding of adverse events (AEs) and medical history will be done by Medical Dictionary for Regulatory 
Activities (MedDRA) directory version 19.1 (or higher) and medications data by the World Health 
Organization (WHO)-drug dictionary dated Dec2016 (or higher) by IQVIATM. 
The following descriptive statistics will be presented in summary tables for non-PK/PD data: 
Continuous variables: summarized by treatment groups using number of observations (n), mean, 
standard deviation (SD), minimum, median, and maximum. 
Categorical variables: summarized by treatment groups using frequency tables [frequencies (n) and 
percentages (%)]. Percentages will be based on the total category count excluding the missing category, 
if not otherwise mentioned. Missing category with zero count will not be presented. 
In general, for non-PK/PD data, the number of decimal places displayed for each statistic will be 
determined as follows: 
Mean and median: 1 more than the number of decimal places allotted in the raw data received from 
data management. 
SD: 2 more than the number of decimal places allotted in the raw data. 
Minimum and maximum: equal to the number of decimal places allotted in the raw data. 
Percentages: All percentages between 0 and 100 will be rounded to one decimal unless there is a need 
to report more than one decimal for percentages. 
Reference ranges will be reported to the same number of decimal places displayed by the laboratory. 
P-values and confidence intervals (CIs), if any, will be reported to four decimal places. P-values less 
than 0.0001 will be presented as “<0.0001” and p-value greater than 0.9999 will be presented as 
“1.0000”. 
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places as the source data.  The geometric LS mean ratios and bounds of their CIs will be reported with 
2 decimal places, and coefficients of variation (CV and gCV) will be reported to 1 decimal place. 
6.1. REFERENCE START DATE AND STUDY DAY 
The reference start date is defined as the day of the dose administration of study treatment (Day 1), 
and will appear in every listing where an assessment date or event date appears.  
The study day will be calculated from the study treatment start date and will be used to show start/stop 
day of assessments and events. 
If the date of the event is on or after the reference date then:  
Study Day = (date of event – reference date) + 1 
If the date of the event is prior to the reference date then:  
Study Day = (date of event – reference date) 
If the event date is partial or missing, Study Day, and any corresponding durations will appear missing 
for that partial date in the listings. 
Refer to Appendix 1 for more details. 
6.2. BASELINE 
The pre-dose measurement taken prior to ANB020 or placebo administration at randomization [Day 1], 
i.e. reference start date, will be considered as baseline. For all safety variables, baseline will be last 
non-missing measurement taken prior to reference start date (including unscheduled assessments or 
retests). 
If the pre-dose measurement and the reference start date coincide, that measurement will be 
considered baseline.  
6.3. RETESTS, UNSCHEDULED VISITS AND EARLY TERMINATION DATA 
Listings will include scheduled, unscheduled, retest and early termination data.  
For by-visit summaries, data recorded at the nominal visit will be presented. Unscheduled 
measurements will not to be included in by-visit summaries but may contribute to the baseline value.  
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6.4. WINDOWING CONVENTIONS 
Not applicable. 
6.5. STATISTICAL TESTS 
All tests of treatment effects will be conducted at a 2-sided alpha level of 0.05, or with 2-sided 95% CIs. 
6.6. COMMON CALCULATIONS 
For continuous measurements, change from baseline will be calculated as: 
Test Value at scheduled Visit X – Baseline Value 
Ratio to baseline will be calculated for pharmacodynamic endpoints as: 
Test Value (post baseline) / Baseline Value 
6.7. SOFTWARE VERSION 
Non-compartmental analysis of PK data for final or any interim analysis, and descriptive statistics and 
graphics for any interim PK analysis, will be performed using Phoenix WinNonlin 6.4 or higher (Certara, 
L.P., Princeton, New Jersey, USA).  All other analyses, statistics, and graphics (including PK/PD) will
be conducted using Statistical Analysis System (SAS) System® Version 9.4 or higher (SAS-Institute,
Cary, North Carolina, USA).
STATISTICAL CONSIDERATIONS 
7.1. ADJUSTMENTS FOR COVARIATES AND FACTORS TO BE INCLUDED IN ANALYSES 
The change from baseline on Day 22 of peripheral eosinophil count will be compared between ANB020 
and placebo using a mixed-model repeated measures (MMRM) analysis with treatment, visit of 
measurement, and treatment by visit interaction as fixed effects and baseline eosinophil count and 
baseline by visit interaction as a covariate. 
7.2. MULTICENTER STUDIES 
There are a total 7 centers from United Kingdom (3) and USA (4) included in this study. 
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7.3. MISSING DATA 
For non-PK/PD data, no imputations will be performed on missing data. Partial dates will be imputed as 
per Appendix 1. Missing PK or PD data will be handled as described in Section 19 or Section 20. 
7.4. MULTIPLE COMPARISONS/ MULTIPLICITY 
Not applicable. 
7.5. EXAMINATION OF SUBGROUPS 
No subgroups analysis will be performed for this study. 
OUTPUT PRESENTATIONS 
The templates provided with this SAP describe the presentations for this study and the format and 
content of the summary tables, figures and listings to be provided by IQVIA Biostatistics. 
All visit assessments will be presented according to the nominal visit name. 
DISPOSITION AND WITHDRAWALS 
All patients who provide informed consent will be accounted for. 
Data collected in Early Termination (ET) and End of Study (EOS) pages in the electronic Case Report 
Form (eCRF) will be used to present disposition and withdrawal results. Frequency table will be provided 
for: 
Number of patients screened per Informed Consent. 
Number of patients eligible at screening. 
Number of screen failures (from EoS page). 
Number of patients in the Randomized Analysis Set (patients who are assigned treatment). 
Number of patients randomized at day 1. 
Number of patients willing to participate at Day 1. 
Number of patients in the Safety Analysis Set (patients administered the treatment). 
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Number of patients in the Full Analysis Set. 
Number of patients in the Pharmacokinetic Analysis Set. 
Number of patients in the Pharmacodynamic Analysis Set. 
Number of patients who completed the study (from EoS page). 
Number of patients who Completed the Study assessments till Day 36. 
Number of patients who discontinued/withdrew the study (from EoT page). 
Primary reason for discontinuation (from EoT page). 
 
A listing will be presented with the following details. 
screen failure (Yes/No)? 
Willing to Participate at Day 1 
assigned treatment 
completed study (Yes/No)? 
If not completed the study, then reason for end of treatment. 
 DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS 
Demographic data and other baseline characteristics will be presented for the SAF. No statistical testing 
will be carried out for demographic or other baseline characteristics. 
Summary statistics will be provided for: 
Age (years) - calculated relative to date of informed consent 
Weight (kg) as collected on the Vital Signs Screening eCRF 
Height (cm) as collected on the Vital Signs Screening eCRF 
BMI (kg/m2) as collected on the Vital Signs Screening eCRF 
Frequency tables will be provided for: 
Gender  
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Women of child bearing potential 
Race 
Ethnicity 
A listing for patient demographic data and other baseline characteristics will be presented. 
 PROTOCOL DEVIATIONS 
All protocol deviations observed during study conduct will be captured in Clinical Trial Management 
System (CTMS). 
The Investigator and Sponsor will review the protocol violation records from CTMS and provide 
confirmation on the categorization of violations as major/ critical/ minor. 
Major protocol deviations or events include changes to the procedures that may impact the quality of 
the data or any circumstances that can alter the evaluation of the PK or PD data.  Examples include, 
but may not be limited to, sample processing errors that lead to inaccurate bioanalytical results, 
incomplete dose administered, incomplete PK or PD profile collected, and use of disallowed 
concomitant medication thought to affect PK or PD.  In the case of a major protocol deviation or event, 
the corresponding PK or PD data collected will be excluded from the summaries and statistical analyses,  
yet will be reported in the study result listings. 
A list of major protocol deviations that could significantly affect study assessments will be provided. The 
incidence of each protocol violation will be listed.  A frequency table for major protocol violations will be 
provided for Safety Analysis Set. Major protocol deviations or events that impact the quality of the PK 
and/or PD data will be listed only. 
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. 
 MEDICAL HISTORY 
The frequency and percentage will be provided for medical history findings summarized by system 
organ class (SOC), preferred terms (PT) and report term for the SAF. Medical history will be coded 
using version 20.0 (or higher) of MedDRA. 
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Patients experiencing multiple events within the same SOC will only be counted once within that SOC 
and multiple PTs within the same SOC will only be counted once for each unique PT within the SOC. 
Summary tables will be table sorted in descending order of SOC and descending order of PT within 
SOC. 
Percentages will be sorted by decreasing frequency of SOC and PT within SOC for overall.  Events will 
be mentioned as “Uncoded” if they are not coded yet. 
A listing of medical history diagnosis with all details will be presented. 
 CONCOMITANT ILLNESSES 
Medical history that are ongoing at the screening will be coded using version 20.0 (or higher) of MedDRA 
and presented similar to medical history. 
The frequency and percentage will be provided summarized by SOC and PT for the SAF. 
Patients experiencing multiple events within the same SOC will only be counted once within that SOC 
and multiple PTs within the same SOC will only be counted once for each unique PT within the SOC. 
Percentages will be sorted by decreasing frequency of SOC and PT within SOC for overall.  Events will 
be mentioned as “Uncoded” if they are not coded yet. 
A listing of ongoing medical illnesses with all details will be presented along with medical history 
conditions. 
 CONCOMITANT MEDICATIONS 
A frequency table will be provided for prior and concomitant medications and will be summarized by 
SOC and PT for the SAF. Medications will be coded using WHO drug dictionary version Dec 2016. 
Patients with multiple usage of the same medication within the same SOC and PT will only be counted 
once within that level. 
Percentages will be sorted by decreasing frequency of SOC and PT for overall.  Medications will be 
mentioned as “Uncoded” if they are not coded yet. 
See Appendix 1 for handling of partial dates for medications. If it is not possible to define a medication 
as prior or concomitant, the medication will be classified by the worst case; i.e. concomitant.  
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‘Prior’ medications are medications which started and stopped prior to the administration of study drug. 
‘Concomitant’ medications are medications which:  
started prior to, on or after the administration of study drug,  
AND ended on or after the date of administration of study drug or were ongoing at the end of the study. 
A listing for medication with all details will be presented for the SAF. 
 STUDY TREATMENT EXPOSURE 
A listing of study drug exposure will be presented, with details of start date & time and end date & time 
of infusion and total volume administered as well as reason if <100 ml was infused. Data from IP 
Administration eCRF page will be used to generate the summary table and listing. 
 STUDY TREATMENT COMPLIANCE 
Overall compliance is expected as the study treatment is being administered at the clinic, however no 
summary will be provided for compliance. 
 EFFICACY OUTCOMES  
17.1. PRIMARY ENDPOINTS 
17.1.1. PRIMARY EFFICACY ENDPOINT 
Not applicable. 
17.1.2. PRIMARY PHARMACODYNAMIC ENDPOINT 
Reduction of peripheral eosinophil count from Baseline (Day 1) to Day 22 
17.1.2.1. Analysis of Primary Pharmacodynamic Endpoint 
Pharmacodynamic analysis will be carried out for the PD Analysis Set. For analysis of primary PD 
endpoint, refer to Section 20 for details. 
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17.2. SECONDARY ENDPOINTS 
17.2.1. SECONDARY EFFICACY ENDPOINTS 
Change in FEV1 (Litres) from Baseline (Day 1) to the EOS visit (Day 127) 
Change in FeNO (ppb) from Baseline (Day 1) to the EOS visit (Day 127) 
17.2.1.1. Analysis of Secondary Efficacy Endpoints 
The null hypothesis for the secondary efficacy analysis is: 
H0: There is no difference in change from baseline on day 127 (for FEV1 and FeNO) between ANB020 
and placebo. 
Vs the alternative: 
H1: There is a difference in change from baseline on day 127 (for FEV1 and FeNO) between ANB020 
and placebo. 
The analysis of the secondary efficacy endpoints will be carried out for the FAS population. 
Day1 pre-bronchodilator spirometry assessment will be considered as the baseline. 
The actual and change from baseline (Day 1) to the EOS visit (Day 127) for FEV1 and FeNO will be 
summarized using descriptive statistics by treatment groups at all time points where assessment is 
done. Change from baseline will be evaluated where possible. 
Change from baseline for FEV1 and FeNO will be compared between ANB020 and placebo using an 
analysis of covariance (ANCOVA) with treatment as fixed effect and baseline result as covariate and 
patient as a random effect. An unstructured covariance matrix will be used. If the model fails to 
converge, then an appropriate covariance matrix [e.g. compound symmetric (CS), CHS, AR] will be 
selected based on the Akaike Information Criteria (AIC). For AIC, a lower value will imply a better fit. 
The following statistics will be presented:  
Treatment Least Square Mean (LSM) 
Treatment LSM difference  
Standard error of treatment LSM difference 
95% confidence interval (CI) 
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P-value for the difference 
A supportive analyses will be performed using an MMRM analysis. The model includes terms for 
treatment, time point of measurement, and treatment by time point interaction as fixed effects and 
baseline value and baseline*time point as covariate. At each visit day, model-based LSMs for the 
treatment effects, 95% CIs, and p-values will be calculated for within and between treatment 
comparisons. 
Patient-wise data listings will be provided. 
17.2.2. SECONDARY PHARMACOKINETIC ENDPOINTS 
Maximum observed concentration (Cmax) 
Time to maximum observed concentration (tmax) 
Area under the concentration-time curve in serum from time zero (pre-dose) extrapolated to infinite time 
[AUC(0-inf)] 
Area under the serum concentration-time curve from time zero to the time of the last quantifiable 
concentration [AUC(0-last)] 
Systemic clearance (CL) 
Apparent terminal rate constant (Oz) 
Apparent terminal half-life (t1/2) 
Volume of distribution during terminal phase (VZ) 
Volume of distribution at steady state following intravenous dosing (VSS) 
17.2.2.1. Analysis of Secondary Pharmacokinetic Endpoints 
For analysis of secondary PK endpoints, refer to Section 19 for details. 
17.2.3. SECONDARY PHARMACODYNAMIC ENDPOINTS 
Reduction of peripheral eosinophil count from Baseline (Day 1) to EOS visit (Day 127) 
Whole blood ex vivo induced IFN-γ levels 
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17.2.3.1. Analysis of Secondary Pharmacodynamic Endpoints 
For analysis of secondary PD endpoints, refer to Section 20 for details. 
17.3. EXPLORATORY ENDPOINTS 
17.3.1. EXPLORATORY EFFICACY ENDPOINTS 
Clinical scores for ACQ-7 (Screening, Day 1, 8, 22, 36, 64, 85, 106, and EOS), PGIC (throughout the 
study), and CGIC (Day 2, 8, 22, 36, 64, 85, 106, and EOS) 
Patient diary data of asthma symptoms, change in standard of care treatment, and rescue medication 
(SABA) usage (collected throughout the study) 
Reduction of IgE levels from Baseline (Day 1) to the EOS visit (Day 127) 
17.3.1.1. Analysis of Exploratory Endpoints 
The FAS will be used for the exploratory efficacy analysis. 
Total ACQ-7 will be calculated as sum of all individual scores for each patient at each visit.  
Symptoms will be scored on a scale of 0 to 6 with 6 being the worst case. ACQ-7 will be missing if any 
individual score is missing. 
The actual and change from baseline for ACQ, PGIC, CGIC, and IgE levels will be summarized using 
appropriate descriptive statistics by treatment groups at all time points where assessment is done. 
Change from baseline will be evaluated where possible. 
PGIC and CGIC scores will be collected during the study for an overall response to the treatment where 
a score of 1 implies “Very much improved” and a score of 7 implies “Very much worse”. 
Applicable diary assessments, e.g. frequency of asthma symptoms (wheezing, cough, shortness of 
breath, chest tightness, etc.) experienced during the week, number of patients receiving rescue 
medication, and number of patients who have change in SOC treatment will be summarized using 
appropriate descriptive statistics. 
Applicable exploratory endpoints analyses will be performed same as secondary efficacy analyses. 
Clinical Global Impression of Change Scale (CGIC Scores) and Patient Global Impression of Change 
(Summary of PGIC Scores) will be analysed using Cochran–Mantel–Haenszel test at each visit by row-
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mean-score-difference test using ridit scores to compare ANB020 vs placebo. Patient-wise data listings 
will be provided. 
17.3.2. EXPLORATORY PHARMACODYNAMICS ENDPOINTS 
Circulating cytokines including, but not limited to interleukin IL-4, IL-5, , IL-13, IL-33, and sST2 at day 1, 
2, 8, 22, 36, 64, and EOS.  
17.3.2.1. Analysis of Exploratory Pharmacodynamic Endpoints 
For analysis of exploratory PD endpoints, refer to Section 20 for details. 
 SAFETY OUTCOMES   
Safety analyses will be based on the SAF. 
The following are the safety and tolerability endpoints: 
o 
Assessment of Adverse Events (AEs)/ Serious Adverse Events (SAEs) 
o 
Physical examination 
o 
Vital signs 
o 
Clinical safety laboratory tests 
o 
Electrocardiograms 
o 
Number of asthma exacerbations 
o 
Assessment of immunogenicity (ADA status) 
There will be no statistical comparisons between the treatment groups for safety data. 
18.1. ADVERSE EVENTS 
AEs will be coded using MedDRA version 19.1. 
Treatment emergent adverse events (TEAEs) are defined as AEs that started or worsened in severity 
on or after the date and time of the study drug infusion. 
Non-treatment emergent adverse event (Non-TEAE) will be defined as any AE that started on or after 
the date of informed consent and before the administration of study drug. 
AEs with missing start dates will be considered treatment-emergent. AEs with missing stop dates or 
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with stop dates after the end of the study date will be considered to have been ongoing at the end of 
the study. 
The severity of AEs will be characterized as “mild, moderate, 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 
Missing severity will be assumed to be the worst severity case i.e. ‘severe’; however, in the listing, it will 
be displayed as missing. 
The causal relationship between the study drug and the AE will be characterized as “Unrelated, Unlikely, 
Possible, Probable, and Unknown (unable to judge)”. 
The summaries will be presented as “Related” versus “Not Related”. 
Categories “Unrelated” and “Unlikely” will be mapped to “Not Related”, while the categories “Possible”, 
“Probable” and “Unknown” will be mapped to “Related”. 
Missing relationship will be assumed to be the worst severity case i.e. ‘Related; however, in the listing, 
it will be displayed as missing. 
An overview of adverse event along with the number and percentage of patients experiencing TEAEs, 
for each treatment group will be provided. 
If patient has multiple TEAEs by severity and/or multiple relationship with study drug, worst case severity 
and the worst-case relationship to the study drug will used for overview tabulation. 
For TEAE by final outcome, if a patient has multiple TEAEs with different outcomes, worst case will be 
considered, where ‘Fatal’ being the worst. 
For Action Taken with the Drug, patient can be counted in more than one categories. 
The following summary tables will be provided by SOC and PT for each treatment group and overall: 
o 
Number of patients with at least one TEAE 
o 
Number of patients with at least one serious TEAE 
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o
Number of patients with at least one TEAE by severity
o
Number of patients with at least one TEAE by relationship to study drug
o
Number of patients with at least one TEAE leading to permanent discontinuation of study
drug
o
Number of patients with at least one TEAE leading to interruption of study drug
o
Number of patients with at least one TEAE leading to patient withdrawal from study
o
Number of patients with at least one TEAE leading to death
o
Number of patients with non-TEAE
If an AE occurs more than once, the patient will be counted only once per SOC and once per PT within 
each SOC. If a patient reports a TEAE more than once within a SOC/PT, the AE with the worst-case 
severity will be used in the corresponding severity summaries and the worst-case relationship to the 
study drug will be used in the corresponding relationship summaries. 
Percentages will be calculated relative to the total number of patients in the SAF. The summaries will 
be sorted by descending frequencies of SOC and descending frequencies of PT with in SOC. 
Listings will be provided for TEAEs, Serious TEAEs, TEAEs leading to discontinuation from study or 
from IP, and TEAEs leading to death for the SAF. 
18.2. DEATHS 
The number of patients with at least one TEAE leading to death will be summarized as described above. 
18.3. LABORATORY EVALUATIONS 
The following tests will be conducted throughout the study under laboratory evaluations: 
Hematology (Hematocrit, Packed Cell Volume [PCV], Hemoglobin, MCH, MCH concentration, MCV, 
Platelet count, RBC, WBC [absolute], Basophils [absolute and %], Eosinophils [absolute and %], 
Monocytes [absolute and %], Neutrophils [absolute and %], Lymphocytes [absolute and %], 
Immunoglobulins [IgA, IgG, IgM, IgE, IgD]) 
Clinical Chemistry (ALT, Albumin, ALP, AST, Bicarbonate, Bilirubin [Total], Bilirubin [Direct-if total is 
elevated], Calcium, Chloride, C-reactive Protein (CRP), Creatinine, GGT, Glucose, Potassium, 
Phosphate [Inorganic], Protein [Total], Sodium, Troponin, Urea, hCG [WOCBP])   
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Urinalysis (Bilirubin, Blood, Glucose, Ketones, Leukocytes, Nitrates, pH, Protein, Specific gravity, and 
Urobilinogen) 
The following tests were conducted only at screening: 
Virology (Hepatitis B Surface Antigen, Hepatitis C Antibody, HIV Antibodies)  
TB (QuantiFERON TB Gold test) 
Drugs of Abuse 
FSH 
Urine Pregnancy-dipstick (prior to IP administration on Day 1) 
The actual and change from baseline values at scheduled assessment for each laboratory parameter 
will be summarized using appropriate descriptive statistics by treatment groups and all available visits. 
Frequency count and percentages will be provided for categorical variables. 
The following summaries also will be provided for laboratory data: 
Incidence of abnormal values according to normal range criteria 
Normal, Abnormal NCS and Abnormal CS by test 
Shift table for laboratory test parameters from baseline will be summarized at each visit. Percentages 
will be based on the number of patients in the SAF population with data at baseline and the visit of 
interest. 
Hematology and clinical chemistry data will be reported in System International (SI) units. 
18.4. ECG EVALUATIONS 
A standard 12-lead ECG will be performed at screening and EOS visits. The following ECG parameters 
will be summarized: 
Heart Rate (bpm) 
PR Interval (msec) 
QRS Interval (msec) 
QT Interval (msec) 
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QTc Interval (msec) 
QTcF (msec) {based on Fridericia formula} 
The actual and change from baseline values for the above parameters will be summarized using 
descriptive statistics (n, mean, standard deviation, median, and range) by treatment groups and all 
available visits. 
The overall assessment of ECG will be summarized using frequency and percentage of the following 
indications: 
Normal 
Abnormal, Not Clinically Significant (ANCS) 
Abnormal, Clinically Significant (ACS) 
A listing of ECG parameters and of the overall assessment will be provided. 
18.4.1. ECG SPECIFIC DERIVATION 
 
Fridericia’s Correction (msec) 
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18.4.2. ECG MARKEDLY ABNORMAL CRITERIA 
Absolute values of the QT interval will be classified as: 
≥450 msec  
≥480 msec  
≥500 msec 
Since, there are different ranges for QTcF between the males and females, we will summarise the QTcF 
by gender as defined below: 
Absolute values of the QT interval as: Males: 431- 450 msec; Female: 451- 470 msec.  
Abnormal values of the QT interval as: Males: > 450 msec Females: > 470 msec. 
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The change from Baseline of QT interval will be classified as: 
>30 msec increase from baseline 
>60 msec increase from baseline 
18.5. VITAL SIGNS 
The following Vital Signs measurements will be reported for this study: 
Blood Pressure - systolic and diastolic (mmHg) 
Respiratory Rate (resp/min) 
Pulse Rate (breaths/min) 
Temperature (ͼC) 
The actual and change from baseline values for the above parameters will be summarized using 
descriptive statistics (n, mean, standard deviation, median, and range) by treatment groups and all 
available visits. 
A listing of the above parameters will be provided. 
18.6. PHYSICAL EXAMINATION 
The physical examination includes evaluation of general appearance, head, eyes, ears, nose, and 
throat, and the pulmonary, cardiovascular, gastrointestinal, renal/genito-urological, endocrine (including 
thyroid), musculoskeletal/spinal, lymphatic, and dermatologic systems. 
The physical examination will be conducted at screening and EOS. 
The frequency and percentage of patients with normal, abnormal CS, and abnormal NCS assessments 
will be summarized by body system and treatment group at each available visit. 
A listings of physical examination findings will be provided. 
18.7. OTHER SAFETY ASSESSMENTS (NUMBER OF ASTHMA EXACERBATIONS) 
Number of asthma exacerbations will be summarized using frequency count and percentage for the 
SAF. 
Time (in days) from randomization to the first asthma exacerbation will be used as a supportive variable 
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and will be calculated as follows: 
Start date of first asthma exacerbation − Date of randomization + 1 
The time to first asthma exacerbation for patients 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 groups, if there is sufficient uncensored data 
available to calculate these median values. 
18.8. OTHER SAFETY ASSESSMENTS (IMMUNOGENICITY) 
Blood samples will be taken for ADA analysis at day 1, 8, 36, 85, 106, and 127/ET. 
Titer values will be summarized by treatment using appropriate descriptive statistics. The frequency and 
percentage of patients with categorical result assessments will be summarized by treatment groups at 
each available visit and time points. 
 PHARMACOKINETIC OUTCOMES 
The PK parameters will be derived using non-compartmental methods. The actual elapsed sampling 
times will be used in the PK parameter calculations, except any interim analysis will use nominal 
sampling times. 
The PK analysis set will be used for PK analysis. 
Patient listings of PK sampling dates and times and all concentration-time data for each treatment will 
be presented. 
Concentration data of ANB020 will be summarized by treatment and nominal time point, as described 
in Section 6. Concentrations below the lower limit of quantitation 
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(BLQ) will be treated as zero for calculation of descriptive statistics. If the calculated mean concentration 
is BLQ, the mean value will be reported as BLQ and the SD and CV will be reported as not determined 
(ND). Missing data will not be inputted, except any missing pre-dose concentrations will be assigned a 
value of zero for calculation PK parameters. If 1 or more concentrations at a given time point are 
missing, they will be reported as missing and will be omitted from the calculation of descriptive statistics. 
Plots of the mean (±SD) plasma concentration-time profile for ANB020 will be presented by nominal 
sampling time on linear and semi-logarithmic scales.  Individual concentration-time data will be listed 
and plotted by actual sampling times on linear and semi-logarithmic scales.  
For the calculation of PK parameters, concentrations that are BLQ will be assigned a value of zero if 
they precede quantifiable samples prior to tmax.  Any anomalous concentration values observed at pre-
dose will be identified in the study report and will be used for the computation of PK parameters if the 
anomalous value is not greater than 5% of Cmax. If the anomalous value is greater than 5% of Cmax, the 
PK parameters for the given patient will be included in listings but excluded from summary presentations 
and analyses. Following Cmax, BLQ values embedded between 2 quantifiable data points will be treated 
as missing. Trailing BLQ values (BLQ values after the last quantifiable concentration) will be set to zero. 
If consecutive BLQ concentrations are followed by quantifiable concentrations in the terminal portion of 
the concentration curve, these quantified values will be excluded from the PK analysis by setting them 
to missing. 
The following PK parameters will be computed for ANB020, if data permits:     
Cmax 
Maximum concentration in serum (μg/mL), obtained directly from the 
observed concentration versus time data. 
tmax 
Time of maximum concentration (h), obtained directly from the observed 
concentration versus time data. 
AUC(0-inf) 
Area under the concentration-time curve in serum from time zero (pre-dose) 
extrapolated to infinite time (h·μg/mL), calculated by linear up/log down 
trapezoidal summation and extrapolated to infinity by addition of the last 
quantifiable concentration divided by the apparent terminal rate constant:     
AUC(0-last) + Clast/Oz.  
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AUC(0-last)
Area under the serum concentration-time curve from time zero to the time of 
the last quantifiable concentration (h·μg/mL), calculated by linear up/log 
down trapezoidal summation. 
CL 
Systemic clearance (L/h), calculated as dose/ AUC0-inf.  
Oz 
Apparent terminal rate constant (1/h), determined by linear regression of the 
terminal points of the log-linear concentration-time curve.  
t1/2 
Apparent terminal half-life (h), determined as (ln2/Oz). 
Vz 
Volume of distribution (L) during terminal phase, estimated by dividing the 
systemic clearance by Oz. 
VSS 
Volume of distribution at steady state following intravenous dosing (L), 
calculated as [([AUMClast + ([tlast*Clast]/Oz) + Clast/Oz2]/ AUC(0-inf)) − TI/ 
2]*CL, where AUMClast is the area under the moment curve from the time of 
dosing to Clast, tlast is the time of Clast, and TI is infusion duration. 
The following ANB020 PK parameters will be calculated for diagnostic purposes and listed, but will not 
be summarized: 
Oz_lower 
The start time (h) of the interval of the log-linear regression to determine Oz 
and t1/2. 
Oz_upper 
The end time (h) of the interval of the log-linear regression to determine Oz 
and t1/2. 
t1/2, Interval 
The time interval (h) of the log-linear regression to determine Oz and t1/2, 
calculated as Oz_upper − Oz_lower. 
t1/2, N 
Number of data points included in the log-linear regression analysis used to 
calculate Oz and t1/2.  A minimum of 3 data points is required. 
Rsq  
Coefficient of determination for calculation of Oz.  A minimum of 3 data 
points (excluding Cmax) will be used for determination of the terminal linear 
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Effective Date: 01Apr2016 
phase of the concentration-time profile.  If the Rsq is less than 0.800 then λz, 
t1/2, AUC(0-inf), CL, VZ, and VSS will be listed but not included in summary 
presentations or analyses.     
%AUCex 
Percentage of AUC(0-inf) obtained by extrapolation, calculated as [(Clast/Oz)/ 
AUC(0-inf)u100].  If the extrapolated area is greater than 20.0% of AUC(0-inf), 
then AUC(0-inf), CL, VZ, and VSS will be listed but not included in summary 
presentations or analyses.    
The PK parameters will be summarized by treatment as described in Section 6.
 PHARMACODYNAMIC OUTCOMES  
The PD analysis set will be used for PD analysis. The PD endpoints are: 
Eosinophil count 
Cytokines: IL-4, IL-5, IL-13, IL-33, and sST2 
Ex-vivo induced IFN- γ 
Observed, change from baseline, and ratio to baseline for all PD endpoints will be summarized by 
treatment and nominal time point using descriptive statistics as described in Section 6. Values 
that are BLQ will be treated as ½ LLOQ for calculation of descriptive statistics and change 
from baseline. If the calculated mean is BLQ, the mean value will be reported as BLQ and the SD and 
CV will be reported as not determined (ND). Missing data will not be imputed. If 1 or more values 
at a given time point are missing, they will be reported as missing and will be omitted from the 
calculation of descriptive statistics and change from baseline. If the pre-dose value is missing for 
baseline, the screening value, if available, will be used as the baseline. 
For comparison of the primary PD endpoint between the two treatments, change from baseline in 
peripheral eosinophil count for each post-dose time point will be analyzed by an MMRM analysis with 
fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline 
eosinophil count as a covariate, and a repeated time point effect within a subject. An unstructured 
covariance matrix will be used with subject as the experimental unit. If the model fails to converge, then 
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Template No:  CS_TP_BS016 Revision 4 
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appropriate covariance matrix (e.g., compound symmetric) will be selected based on AIC. The same 
model will be used to compare the overall average between the treatment groups. All tests of treatment 
effects will be conducted at a 2-sided alpha level of 0.05 or with 2-sided 95% CIs. The following statistics 
will be presented:  
Treatment LSM 
SE of LS Mean 
95% CI for LS mean 
Treatment LSM difference  
SE of LS Mean Difference 
95% CI for LSM treatment difference 
P-value for comparison of ANB020 versus placebo 
For secondary and exploratory endpoints (ex vivo induced IFN-γ and serum cytokines), comparison 
between ANB020 and placebo will be performed using a similar MMRM analysis as described above 
for primary PD endpoint. 
Ratio to baseline values may be used where change from baseline analysis does not meet analysis 
assumptions. Suitable transformations (e.g., log) may be applied upon such parameters as appropriate 
to meet the analysis assumptions. 
Plots of the mean (±95% CI) observed and change from baseline versus time profiles for PD endpoints 
will be presented by nominal sampling time on a linear scale. 
Plots of observed PD endpoints versus ANB020 concentration will be presented for coinciding nominal 
time points. 
A listing of PD blood sample collection date and times will be provided. 
 INTERIM/INTERMEDIATE ANALYSIS 
No interim analysis is planned for the study. However, there will be two unblinded intermediate analysis 
will be performed once all patients complete the day 36 assessments and again once all patients 
complete the day 64 assessments. The following 2 data cuts will be provided for data review to 
unblinded statistician.  
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Version Date: 
18Dec2018 
 
Template No:  CS_TP_BS016 Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
 
 
D. 36 time point: 
x 
Safety labs (hematology/chem)  
x 
FEV1 
x 
FeNO 
x 
Safety (AE/SAEs) 
  
D.64 time point:  
x 
Safety labs (hematology/chem)  
x 
FEV1 
x 
FeNO 
x 
Safety (AE/SAEs) 
x 
Demographics (Sex/Age) 
 GENETIC ANALYSIS 
Not applicable. 
 DATA NOT SUMMARIZED OR PRESENTED 
The unscheduled visits will not be summarized but listed. 
 REFERENCES 
Protocol amendment 4 dated 31Oct2018 
Annotated study book version 9 dated 22May2018 
APPENDIX 1. 
PARTIAL DATE CONVENTIONS 
Imputed dates will NOT be presented in the listings. 
Algorithm for Treatment Emergence of Adverse Events: 
START DATE 
STOP DATE 
ACTION 
Known 
Known 
If start date < study med start date, then not TEAE 
If start date ≥ study med start date, then TEAE 
Partial 
If start date < study med start date, then not TEAE 
If start date ≥ study med start date, then TEAE 
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Version Date: 
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Template No:  CS_TP_BS016 Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
 
 
All listings will be ordered by the following: 
center-subject ID 
randomized treatment group (or treatment received if it’s a safety output), first by active dose and then 
by placebo 
date (where applicable). 
APPENDIX 3. 
SAMPLE SAS CODE 
SAS CODE FOR ANCOVA 
PROC MIXED DATA=<data_set_name>;  
CLASS trt usubjid;  
MODEL chg = trt base/ ddfm=kr; 
LSMEANS trt / alpha = 0.05;  
ESTIMATE “Test versus placebo” trt -1 1 / cl;  
Random trt / subject=usubjid type=UN;  
RUN; 
Where, 
trt = treatment group (ANB020 and placebo), usubjid=patient 
base=Baseline and chg= change from baseline 
SAS CODE FOR MMRM 
PROC MIXED DATA=<data_set_name> alpha=0.05;  
CLASS trt usubjid avisitn;  
MODEL chg = trt visit trt*visit base base*trt / solution ddfm=kr; 
LSMEANS trt  avisitn  trt*visit / diff cl;  
ESTIMATE “Test versus placebo” trt -1 1 / cl;  
REPEATED avisitn/ subject=usubjid type=UN;  
RUN; 
 
 
Where, 
trt = treatment group (ANB020 and placebo), usubjid=patient, avisitn=visit 
base=Baseline and chg= change from baseline 
SAS CODE FOR CMH TEST 
PROC Freq data=<data_set_name>; 
By visit; 
Where trt in (‘ANB020’ ‘Placebo’); 
Tables trt*score/cmh score=ridit nocol nopercent; 
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Template No:  CS_TP_BS016 Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
 
 
Ods Output cmh=cmh5 (where= (AltHypothesis= “Row Mean Scores Differ”)); 
RUN; 
Where, trt = treatment group (ANB020 and placebo) 
SAS CODE FOR A COX PROPORTIONAL HAZARD MODEL  
PROC PHREG data=<data_set_name>; 
CLASS trt (ref class trt (placebo first); =first); 
MODEL time*censor (0) = number of exacerbations/rl; 
Assess var= (number of exacerbations)/resample; 
hazardratios trt; 
RUN; 
Where, trt = treatment group (ANB020 and placebo) 
SAS CODE FOR KAPLAN-MEIER PLOT 
PROC LIFETEST data=<data_set_name> noprint; 
TIME time*censor (0); 
STRATA trt; 
RUN; 
Where, trt = treatment group (ANB020 and placebo), time=visit.   
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Document Approval Signature(s)
This document has been signed electronically in compliance with Quintiles electronic
signature policies and procedures. This page is a manifestation of the electronic signatures, 
which may be confirmed within the Quintiles source system in accordance with Quintiles 
records retention policies.
Note: the Title field in the signature block has been intentionally left blank.
 
 
UserName: 
Title:  
Date: Wednesday, 19 December 2018, 03:06 PM   Eastern Time
Meaning: I Approve the Document
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)
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Date: Wednesday, 19 December 2018, 11:00 PM   Eastern Time
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   Version Date: 
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TABLE SHELLS  
 
 
Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients with Severe 
Eosinophilic Asthma 
 
 
Study No. ANB020-004 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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   Version Date: 
18Dec2018 
 
Output Templates Signature Page 
Table Shells V1 0 (Dated 18Dec2018) for Protocol ANB020-004 
 
Name 
Signature 
Date  
                    Author: 
 
DDMMMYYYY 
 
  Position: 
 
Company: 
IQVIATM 
 
Upon review of this document, the undersigned approves this version of the Output Templates, 
authorizing that the content is acceptable for the reporting of this study. 
 
Name 
Signature 
Date  
Reviewed and 
Approved By: 
 
DDMMMYYYY 
 
Position: 
 
Company: 
IQVIATM 
 
 
Reviewed and 
Approved By: 
DDMMMYYYY 
 
Position: 
 
Company: 
IQVIATM 
 
 
Reviewed and 
Approved By: 
DDMMMYYYY 
Position: 
Company: 
AnaptysBio, Inc. 
Reviewed and 
Approved By: 
DDMMMYYYY 
 
Position: 
 
Company: 
AnaptysBio, Inc. 
List of Reviewers 
 
Reviewer Name 
Position/ Role 
Company 
IQVIATM 
IQVIATM 
IQVIATM 
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Author: 
Version Number: 
1.0 
 
 
   Version Date: 
18Dec2018 
 
Roland Kloppper 
Senior Biostatistician 
IQVIATM 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
 
 
 
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Author: 
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   Version Date: 
18Dec2018 
 
Modification History 
 
Unique 
Identifier 
for this 
Version 
Date of the 
Document 
Version 
Author 
Significant Changes from  
Previous Authorized Version 
Draft 0.1 
04 Dec 2017 
Not Applicable ‐ First Draft 
Draft 0.2 
07 Dec 2017 
Resolved comments from internal review 
Draft 0.3 
03 Dec 2018 
Resolved comments from Sponsor review 
 
 
 
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   Version Date: 
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Table of Contents 
Output Templates Signature Page ........................................................................................................................ 2 
List of Reviewers .................................................................................................................................................. 2 
Modification History ............................................................................................................................................ 4 
Table 14.1.1.1 Patient Disposition – All Patients Screened ................................................................................ 7 
Table 14.1.2.1 Protocol Deviations – Randomized Analysis Set ........................................................................ 8 
Table 14.1.3.1 Demographic Characteristics – Safety Analysis Set ................................................................... 9 
Table 14.1.3.2 Other Baseline Characteristics – Safety Analysis Set ............................................................... 10 
Table 14.1.4.1 Medical History – Safety Analysis Set ...................................................................................... 12 
Table 14.1.5.1 Prior Medications – Safety Analysis Set ................................................................................... 13 
Table 14.1.5.2  Concomitant Medications – Safety Analysis Set ..................................................................... 14 
Table 14.1.6.1 Study Drug Exposure – Safety Analysis Set ............................................................................. 15 
Table 14.4.2.1.1 Eosinophil Counts (unit) – Pharmacodynamic Analysis Set ................................................. 16 
Table 14.4.2.1.2 Primary Pharmacodynamic Endpoint: Change from Baseline in Peripheral Eosinophil 
Count (cells/μL)  on Day 22 – Pharmacodynamic Analysis Set ....................................................................... 17 
Table 14.4.2.1.3  Whole Blood Ex-vivo induced IFN- γ (pg/mL) – Pharmacodynamic Analysis Set ............ 18 
Table 14.4.2.2.1 Secondary Pharmacodynamic Endpoint: Change from Baseline in Peripheral Eosinophil 
Count (cells/μL)  on Day 127/ET – Pharmacodynamic Analysis Set ............................................................... 19 
Table 14.4.2.2.2 Secondary Pharmacodynamic Endpoint: Change from Baseline in Whole Blood Ex-vivo 
induced IFN-γ (pg/ml) on Day 127/ET – Pharmacodynamic Analysis Set ...................................................... 20 
Table 14.4.2.3.1 Serum Cytokines(pg/mL) – Pharmacodynamic Analysis Set ................................................ 20 
Table 14.4.2.3.2 Exploratory Pharmacodynamic Endpoint: Change from Baseline in Serum 
Cytokines(pg/mL) on Day 127/ET – Pharmacodynamic Analysis Set ............................................................. 22 
Table 14.2.1.1 Spriometry (FEV1) – Full Analysis Set ..................................................................................... 23 
Table 14.2.1.2 Secondary Efficacy Endpoint: Change in FEV1 (Litres) from Baseline to Day 127 – Full 
Analysis Set ........................................................................................................................................................ 24 
Table 14.2.2.1 Fractional Exhaled Nitric Oxide ( FeNO) (in ppb) Test – Full Analysis Set ........................... 24 
Table 14.2.2.2 Secondary Efficacy Endpoint: Change in Fractional Exhaled Nitric Oxide( FeNO) (in ppb) 
from Baseline to Day 127 – Full Analysis Set ................................................................................................... 24 
Table 14.2.1.3 Secondary Efficacy Endpoint: Change in FEV1 (Litres) from Baseline – Supportive Analysis 
–  Full Analysis Set ............................................................................................................................................. 24 
Table 14.2.2.3 Secondary Efficacy Endpoint: Change in FeNO (ppb) from Baseline to Day 127– Supportive 
Analysis –  Full Analysis Set ............................................................................................................................. 25 
Table 14.2.3.1 Asthma Control Questionnaire (Summary of Scores) – Full Analysis Set .............................. 26 
Table 14.2.3.2 Exploratory Efficacy Endpoint: Change in ACQ from Baseline to Day 127 – Full Analysis 
Set ....................................................................................................................................................................... 27 
Table 14.2.4.1 Patient Global Impression of Change ( PGIC Scores) – Full Analysis Set .............................. 28 
Table 14.2.4.2 Asthma Symptoms (Patient Diary) – Full Analysis Set ............................................................ 29 
Table 14.2.5.1 Clinical Global Impression of Change Scale (CGIC Scores) – Full Analysis Set ................... 30 
Table 14.2.6.1 Exploratory Endpoint: Reduction from Baseline in IgE levels(Unit) on Day 127/ET – Full 
Analysis Set ........................................................................................................................................................ 30 
Table 14.4.1.1.1 Serum Concentration(ug/mL) of ANB020 – Pharmacokinetic Analysis Set ........................ 32 
Table 14.4.1.2.1  Pharmacokinetic Parameters of ANB020 – Pharmacokinetic Analysis Set ......................... 33 
Table 14.3.1.1 Overview of Adverse Events – Safety Analysis Set ................................................................. 34 
Table 14.3.1.2 TEAE by System Organ Class and Preferred Term – Safety Analysis Set .............................. 35 
Table 14.3.1.2.1 TEAEs by Preferred Term – Safety Analysis Set .................................................................. 36 
Table 14.3.1.3 TEAEs Leading to Discontinuation of Patient from the Study by 
System Organ Class and Preferred Term – Safety Analysis Set ....................................................................... 36 
Table 14.3.1.4 TEAEs Leading to Interruption of Study Drug by System Organ Class and Preferred Term – 
Safety Analysis Set ............................................................................................................................................. 36 
Table 14.3.1.5 TEAEs by Severity, System Organ Class and Preferred Term – Safety Analysis Set ............. 37 
Table 14.3.1.6 TEAEs by Relationship to Study Drug, System Organ Class and Preferred Term – Safety 
Analysis Set ........................................................................................................................................................ 39 
Table 14.3.1.7 Serious TEAEs by System Organ Class and Preferred Term – Safety Analysis Set ............... 39 
Table 14.3.1.8 TEAEs Leading to Death by System Organ Class and Preferred Term – Safety Analysis Set39 
Table 14.3.1.9 Non TEAEs by System Organ Class and Preferred Term – Safety Analysis Set .................... 39 
Table 14.3.4.1 Potential Clinically Significant Laboratory Assessments (Hematology) – Safety Analysis Set
 ............................................................................................................................................................................. 40 
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Table 14.3.4.2 Potential Clinically Significant Laboratory Assessments (Clinical Chemistry) – Safety 
Analysis Set ........................................................................................................................................................ 40 
Table 14.3.4.3 Potential Clinically Significant Laboratory Assessments (Urinalysis) – Safety Analysis Set . 40 
Table 14.3.4.4 Summary of Potentially Clinically Significant ECG Parameters – Safety Analysis Set ......... 41 
Table 14.3.5.1 Pregnancy Test – Safety Analysis Set ....................................................................................... 42 
Table 14.3.5.2 Laboratory Parameters (Hematology) – Safety Analysis Set ................................................... 43 
Table 14.3.5.3 Laboratory Parameters (Clinical Chemistry) – Safety Analysis Set ......................................... 44 
Table 14.3.5.4 Laboratory Parameters (Urinalysis) – Safety Analysis Set ....................................................... 44 
Table 14.3.5.5 Shifts from Baseline in Clinical Laboratory Results – Safety Analysis Set ............................. 45 
Table 14.3.5.6 12-Lead ECG – Safety Analysis Set .......................................................................................... 46 
Table 14.3.5.7 Summary of QT Changes from Baseline to Last Observation – Safety Analysis Set .............. 47 
Table 14.3.5.8 Vital Signs – Safety Analysis Set .............................................................................................. 48 
Table 14.3.5.9 Physical Examination – Safety Analysis Set ............................................................................. 49 
Table 14.3.5.10 Other Safety Assessments (Number of Exacerbations) – Full Analysis Set .......................... 50 
Table 14.3.5.11 Other Safety Assessments (Immunogenicity - ADA) – Safety Analysis Set ......................... 51 
 
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Table 14.1.1.1 
Patient Disposition – All Patients Screened 
Category 
 ANB020 
 (N=XX) 
 n (%) 
 Placebo 
 (N=XX) 
 n (%) 
 Total 
 (N=xx) 
 n (%) 
 
 Patients Screened[1] 
- 
- 
 xx 
 Patients Eligible at Screening 
- 
- 
 xx 
 Screen Failures 
- 
- 
 xx 
 Patients in Randomized Analysis Set 
 xx 
 xx 
 xx 
 Patients Willing to Participate at Day 1 
 xx 
 xx 
 xx 
 Patients in Safety Analysis Set 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Patients in Full Analysis Set 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Patients in Pharmacokinetic Analysis Set 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Patients in Pharmacodynamic Analysis Set 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 
 
 
 
 Patients who Completed the Study 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Patients who Completed the Study assessments till Day 36 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 
 
 
 
 Patients who Discontinued the Study 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Reason for Discontinuation 
 
 
 
 Adverse Event 
 Screen Failure 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Death 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Lost follow up 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Subject withdrawl consent 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Physical Decision 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
--------------- 
 ----------- 
 
 
  Lack of compliance of protocol 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Other 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 
 
 
 
Source: Listing 16.2.1.1, 16.2.3.1.1 
Note:  
‐ [1] – Patients who provided informed consent 
‐ N is the number of patients within each treatment group in the Randomized Analysis Set. 
‐ Percentages are based on the number of randomized patients in the respective treatment arm (N). 
‐ Percentage for reason for discontinuation is based on number of patients who discontinued the study. 
Programming Note (not part of table):  Add missing row where necessary. 
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Table 14.1.2.1 
Protocol Deviations – Randomized Analysis Set 
Deviations/Violations 
ANB020 
(N=XX) 
n (%) 
Placebo 
(N=XX) 
n (%) 
Total 
(N=XX) 
n (%) 
 
Patients with major protocol deviations 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Patients with category 1 deviation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Patients with category 2 deviation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
------------- 
 
 
 
 
 
 
 
 
Source: Listing 16 2.2.1 
Note:  
‐ N is the number of patients within each treatment group in the Randomized Analysis Set. 
‐ Percentages are based on the number of randomized patients in the respective treatment arm (N). 
‐ Patients with multiple protocol deviations within the same category are counted only once under that category. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14.1.3.1 
Demographic Characteristics – Safety Analysis Set 
Characteristic 
Statistics 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
 
 Age (years) 
n 
xx 
xx 
xx 
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 Gender 
n (%) 
 
 
 
Male 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Female 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 Child Bearing Potential Females 
n (%) 
 
 
 
Yes 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
No 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
If Not Child Bearing Potential, 
n (%) 
 
 
 
<Categories> 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 Race 
n (%) 
 
 
 
<Categories> 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 Ethnicity 
n (%) 
 
 
 
<Categories> 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 Weight (kg) 
 -------- 
 
 
 
 
 
 
 
 
 Height (cm) 
 -------- 
 
 
 
 
 
 
 
 
 BMI (kg/m2) 
 -------- 
 
 
 
 
 
 
 
 
Source: Listing 16 2.4.2 
Note: BMI – Body Mass Index , Age is calculated relative to informed consent date 
‐ N is the number of patients within each treatment group in the Safety Analysis Set Percentages are based on the number of patients in the respective treatment arm (N). 
Programming Note (not part of table):  
‐ Present descriptive statistics similar to age for weight, height and BMI, Present descriptive statistics similar to gender for race and ethnicity. 
 
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Table 14.1.3.2 
Other Baseline Characteristics – Safety Analysis Set 
Characteristic 
Statistics 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
 
 Drugs of Abuse 
 
 
 
 
Sample Collected? 
n (%) 
 
 
 
Yes 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Positive 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Negative 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
No 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 Quantiferon Gold Test [1] 
 
 
 
 
Blood Sample Collected? 
n (%) 
 
 
 
Yes 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Positive 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Negative 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
No 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 Virology 
 
 
 
 
Blood Sample Collected? 
n (%) 
 
 
 
Yes 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
No 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
If Yes, 
 
 
 
 
Hepatitis B Surface Antigen 
n (%) 
 
 
 
Positive 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Negative 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Not Done 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Hepatitis C Antibody 
n (%) 
 
 
 
<Categories> 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
HIV Antibody 
n (%) 
 
 
 
<Categories> 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
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Table 14.1.3.2 
Other Baseline Characteristics – Safety Analysis Set 
Characteristic 
Statistics 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
Source: Listing 16.2.4.5, 16.2.4.6, 16.2.4.7 
Note:  
‐ N is the number of patients within each treatment group in the Safety Analysis Set. Percentages are based on the number of  patients in the respective treatment arm (N). 
‐ [1] – Test for Tuberculosis 
 
Programming Note (not part of table):  Add missing row where applicable. This table can be modified as per the data requirement. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14.1.4.1 
Medical History – Safety Analysis Set 
System Organ Class 
     Preferred Term 
          Report Term 
ANB020 
(N=XX) 
n (%) 
Placebo 
(N=XX) 
n (%) 
Total 
(N=XX) 
n (%) 
 
System Organ Class 1 
 
 
 
 
    Preferred Term1 
xx (xx x) 
xx (xx.x) 
xx (xx.x) 
    Preferred Term2 
xx (xx x) 
xx (xx.x) 
xx (xx.x) 
    ------------ 
xx (xx x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
System Organ Class 2 
 
 
 
 
    Preferred Term1 
xx (xx x) 
xx (xx.x) 
xx (xx.x) 
    Preferred Term2 
xx (xx x) 
xx (xx.x) 
xx (xx.x) 
    ------------ 
xx (xx x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2.4.3 
Note: 
- N is the number of patients within each treatment group in the Safety Analysis Set. 
- Patients experiencing multiple events within the same SOC or PT are counted only once under those categories. 
- Percentages are based on the number of patients in the respective treatment arm (N). 
Programming Note (not part of table): Number and percentage (%) of patients with Medical History, sorted by decreasing frequency of system organ class and preferred 
term in total column. Mention “Uncoded” if there are any terms which are not coded yet. 
 
 
 
 
 
 
 
 
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Version Date: 
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Table 14.1.5.1 
Prior Medications – Safety Analysis Set 
System Organ Class 
     Preferred Term 
 
ANB020 
(N=XX) 
n (%) 
Placebo 
(N=XX) 
n (%) 
Total 
(N=XX) 
n (%) 
 
Number of Patients with at least one Prior Medication 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
System Organ Class 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
----------- 
 
 
 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
System Organ Class 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 2 
 
 
 
----------- 
 
 
 
 
 
 
 
 
 
 
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Source: Listing 16 2.4.4 
Note: 
- N is the number of patients within each treatment group in Safety Analysis Set. 
- Medications are coded using WHO Drug Dictionary Dec 2016. 
- Patients experiencing multiple events within the same SOC or PT are counted only once under those categories. 
- Percentages are based on number of patients within each treatment group under Safety Analysis Set (N). 
- Only the patients with prior medications are summarized. ‘Prior’ medications are medications which started and stopped prior to the administration of study drug. 
Programming Note (not part of table): Number and percentage (%) of patients with prior medications, sorted by descending order of frequency in total column. Add”Uncoded” if any events are not coded yet. 
Programming Note (not part of table): Similar table will be generated as follows: 
 
Table 14.1.5.2  
Concomitant Medications – Safety Analysis Set 
 
Tables 14.1.5.2 will be summarized only for patients having atleast one concomitant medication.  
 
  Source: Listing 16.2.4.4 Programming note: All the above footnotes should be there except the one in yellow. Instead of that the following footnote should be used: 
Only the patients with concomitant medications are summarized. Concomitant’ medications are medications which started prior to, on or after the administration of study drug and ended on or after the date of 
administration of study drug or were ongoing at the end of the study 
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Table 14 1 6 1 
Study Drug Exposure – Safety Analysis Set 
Charateristic 
Statistics 
ANB020 
(N=XX) 
n (%) 
Placebo 
(N=XX) 
n (%) 
Total 
(N=XX) 
n (%) 
 
Total Volume Administered (ml) 
n 
xx 
xx 
xx 
 
Mean (SD) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
 
Median 
xx x 
xx x 
xx x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
Source: Listing 16 2 5 1 
Note: 
- N is the number of patients within each treatment group in Safety Analysis Set  
-  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14 4 2 1 1 
Eosinophil Counts (unit) – Pharmacodynamic Analysis Set 
Visit 
Statistics 
ANB020 
(N=XX) 
Placebo  
(N=XX) 
Observed 
Change from Baseline 
Ratio to baseline 
Observed 
Change from Baseline 
Ratio to baseline 
 
 
 
Screening 
n 
xx 
- 
- 
xx 
- 
- 
 
Mean (SD) 
xx x (xx xx) 
- 
- 
xx x (xx xx) 
- 
- 
 
CV (%) 
xx x 
- 
 
xx x 
- 
- 
 
95% CI 
(xx xxxx, xx xxxx) 
- 
- 
(xx xxxx, xx xxxx) 
- 
- 
 
Median 
xx x 
- 
- 
xx x 
- 
- 
 
Min, Max 
xx, xx 
- 
- 
xx, xx 
- 
- 
 
 
 
 
 
 
 
 
Baseline 
n 
xx 
- 
- 
xx 
- 
- 
 
Mean (SD) 
xx x (xx xx) 
- 
- 
xx x (xx xx) 
- 
- 
 
CV (%) 
xx x 
- 
- 
xx x 
- 
- 
 
95% CI 
(xx xxxx, xx xxxx) 
- 
- 
(xx xxxx, xx xxxx) 
- 
- 
 
Median 
xx x 
- 
- 
xx x 
- 
- 
 
Min, Max 
xx, xx 
- 
- 
xx, xx 
- 
- 
 
 
 
 
 
 
 
 
Day 2 
n 
xx 
xx 
xx 
xx 
xx 
xx 
 
Mean (SD) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
 
CV (%) 
xx x 
- 
xx x 
xx x 
- 
xx x 
 
95% CI 
(xx xxxx, xx xxxx) 
(xx xxxx, xx xxxx) 
(xx xxxx, xx xxxx) 
(xx xxxx, xx xxxx) 
(xx xxxx, xx xxxx) 
(xx xxxx, xx xxxx) 
 
Median 
xx x 
xx x 
xx x 
xx x 
xx x 
xx x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16.2.9.2 
Note: CI = Confidence Interval, CV = coefficient of variation, Max = maximum, Min = minimum, SD = Standard Deviation. 
-  N is the number of patients within each treatment group  inFull Analysis Set  
- Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests)  
 
Programming Note: Continue this table for all available visits and respective change from baseline. 
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Table 14 4 2 1 2 
Primary Pharmacodynamic Endpoint: Change from Baseline in Peripheral Eosinophil Count (cells/μL)  on Day 22 – Pharmacodynamic Analysis Set 
 
Statistic 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
N 
xx 
xx 
LS Mean 
xxx.xx 
xxx.xx 
SE of LS Mean 
xx.xxx 
xx.xxx 
95% CI 
[xxx.xx, xxx.xx] 
[xxx.xx, xxx.xx] 
LS Mean Difference (ANB020 – Placebo) 
xx.xx 
 
SE of LS Mean Difference 
xx.xx 
 
95% CI for LS Mean Difference 
[xx.xx, xx.xx] 
 
P-value 
x.xxxx 
 
 
 
 
 
 
 
Source: Listing 16 2 9 2 
Note: 
- LS: Least Squares; SE: Standard Error; CI: Confidence Interval; MMRM: Mixed Model for Repeated Measures; 
- n is the number of subjects with non-missing values  
- N is the number of subjects within each treatment group under Full Analysis Set  
- P-value is obtained using an MMRM model with treatment, visit, treatment*visit as fixed effects and baseline eosinophil count   
 
Programming Note: Refer SAP for Model  
 
 
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Table 14 4 2 1 3  
Whole Blood Ex-vivo induced IFN- γ (pg/mL) – Pharmacodynamic Analysis Set 
 
Analyte (unit) 
Visit 
Nominal Time Point Statistics 
ANB020 
(N=XX) 
Placebo  
(N=XX) 
Observed 
Change from 
Baseline 
Ratio to baseline 
Observed 
Change from Baseline 
Ratio to baseline 
 
 
 
INF-y (pg/mL) Baseline 
Pre-dose (-0 5 hours) n 
xx 
- 
- 
xx 
- 
- 
 
 
 
Mean (SD) 
xx x (xx xx) 
- 
- 
xx x (xx xx) 
- 
- 
 
 
 
CV (%) 
xx x 
- 
- 
- 
xx x 
- 
 
 
 
95% CI 
(xx xxxx, 
xx xxxx) 
- 
- 
(xx xxxx, xx xxxx) - 
- 
 
 
 
Median 
xx x 
- 
- 
xx x 
- 
- 
 
 
 
Min, Max 
xx, xx 
- 
- 
xx, xx 
- 
- 
 
 
 
 
 
 
 
 
 
 
 
Day 8 
168 hours post SOI 
n 
xx 
xx 
xx 
xx 
xx 
xx 
 
 
 
Mean (SD) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
 
 
 
CV (%) 
xx x 
- 
xx x 
- 
xx x 
xx x 
 
 
 
95% CI 
(xx xxxx, 
xx xxxx) 
(xx xxxx, xx xxxx) (xx xxxx, xx xxxx) (xx xxxx, xx xxxx) (xx xxxx, xx xxxx) 
(xx xxxx, xx xxxx) 
 
 
 
Median 
xx x 
xx x 
xx x 
xx x 
xx x 
xx x 
 
 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
<visits> 
<time points> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2 9 3 
Note: 
- SOI – Start of Infusion, CI = Confidence Interval, SD = Standard deviation CV = coefficient of variation, Max = maximum, Min = minimum,  
- Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests)  
- N is the number of patients within each treatment group  in Full Analysis Set  
Programming Note (not part of table): Continue the table for all ex vivo analytes in whole blood at all available visits and respective time points  
 
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Table 14 4 2 2 1 
Secondary Pharmacodynamic Endpoint: Change from Baseline in Peripheral Eosinophil Count (cells/μL)  on Day 127/ET – Pharmacodynamic Analysis Set 
 
Statistic 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
n 
xx 
xx 
LS Mean 
xxx.xx 
xxx.xx 
SE of LS Mean 
xx.xxx 
xx.xxx 
95% CI 
[xxx.xx, xxx.xx] 
[xxx.xx, xxx.xx] 
LS Mean Difference (ANB020 – Placebo) 
xx.xx 
 
SE of LS Mean Difference 
xx.xx 
 
95% CI for LS Mean Difference 
[xx.xx, xx.xx] 
 
P-value 
x.xxxx 
 
 
 
 
 
 
 
 
Source: Listing 16 2 9 2 
Note: 
- LS: Least Squares; SE: Standard Error; CI: Confidence Interval; MMRM: Mixed Model for Repeated Measures; 
- n is the number of subjects with non-missing values  
- N is the number of subjects within each treatment group under Full Analysis Set  
P-value is obtained using an MMRM model with treatment, visit, treatment*visit as fixed effects and baseline eosinophil count  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14 4 2 2 2 
Secondary Pharmacodynamic Endpoint: Change from Baseline in Whole Blood Ex-vivo induced IFN-γ (pg/ml) on Day 127/ET – Pharmacodynamic Analysis Set 
 
Statistic 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
n 
xx 
xx 
LS Mean 
xxx xx 
xxx xx 
SE of LS Mean 
xx xxx 
xx xxx 
95% CI 
[xxx xx, xxx xx] 
[xxx xx, xxx xx] 
LS Mean Difference (ANB020 – Placebo) 
xx xx 
 
SE of LS Mean Difference 
xx xx 
 
95% CI for LS Mean Difference 
[xx xx, xx xx] 
 
P-value 
x xxxx 
 
 
 
 
 
 
 
 
Source: Listing 16 2 9 3 
Note: 
- LS: Least Squares; SE: Standard Error; CI: Confidence Interval; MMRM: Mixed Model for Repeated Measures; 
- n is the number of subjects with non-missing values  
- N is the number of subjects within each treatment group under Full Analysis Set  
P-value is obtained using an MMRM model with treatment, visit, treatment*visit as fixed effects and baseline eosinophil count  
 
 
 
 
 
Table 14 4 2 3 1 
Serum Cytokines(pg/mL) – Pharmacodynamic Analysis Set 
 
Parameter  
Visit 
Nominal Time Point Statistics 
ANB020 
(N=XX) 
 
Placebo  
(N=XX) 
 
Observed 
Change from 
Baseline 
Ratio to baseline 
Observed 
Change from Baseline 
Ratio to baseline 
 
 
 
IL-4 
Baseline 
Pre-dose (-0 5 hours) n 
xx 
- 
- 
xx 
- 
- 
 
 
 
Mean (SD) 
xx x (xx xx) 
- 
- 
xx x (xx xx) 
- 
- 
 
 
 
95% CI 
(xx xxxx, 
xx xxxx) 
- 
- 
(xx xxxx, xx xxxx) - 
- 
 
 
 
Median 
xx x 
- 
- 
xx x 
- 
- 
 
 
 
Min, Max 
xx, xx 
- 
- 
xx, xx 
- 
- 
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Table 14 4 2 3 1 
Serum Cytokines(pg/mL) – Pharmacodynamic Analysis Set 
 
Parameter  
Visit 
Nominal Time Point Statistics 
ANB020 
(N=XX) 
 
Placebo  
(N=XX) 
 
Observed 
Change from 
Baseline 
Ratio to baseline 
Observed 
Change from Baseline 
Ratio to baseline 
 
 
 
 
 
 
- 
 
 
- 
 
Day 2 
24 hours post SOI 
n 
xx 
xx 
 
xx 
xx 
 
 
 
 
Mean (SD) 
xx x (xx xx) 
xx x (xx xx) 
xx 
xx x (xx xx) 
xx x (xx xx) 
xx 
 
 
 
95% CI 
(xx xxxx, 
xx xxxx) 
(xx xxxx, xx xxxx) xx x (xx xx) 
(xx xxxx, xx xxxx) (xx xxxx, xx xxxx) 
xx x (xx xx) 
 
 
 
Median 
xx x 
xx x 
xx x 
xx x 
xx x 
xx x 
 
 
 
Min, Max 
xx, xx 
xx, xx 
(xx xxxx, xx xxxx) xx, xx 
xx, xx 
(xx xxxx, xx xxxx) 
 
 
 
 
 
 
 
 
 
 
 
<visits> 
<time points> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Parameters>  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2 9 1 
Note: 
- SOI – Start of Infusion 
- Baseline is defined as the the pre-dose measurement taken prior to ANB020 or placebo administration at randomization [Day 1], i e  reference start date  
 
Programming Note (not part of table): Continue the table for all serum cytokines at all available visits and respective time points  
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14 4 2 3 2 
Exploratory Pharmacodynamic Endpoint: Change from Baseline in Serum Cytokines(pg/mL) on Day 127/ET – Pharmacodynamic Analysis Set 
 
Analyte (unit) 
Statistic 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
IL-4 (pg/mL) 
 
 
n 
xx 
xx 
LS Mean 
xxx.xx 
xxx.xx 
SE of LS Mean 
xx.xxx 
xx.xxx 
95% CI 
[xxx.xx, xxx.xx] 
[xxx.xx, xxx.xx] 
LS Mean Difference (ANB020 – Placebo) 
xx.xx 
 
SE of LS Mean Difference 
xx.xx 
 
95% CI for LS Mean Difference 
[xx.xx, xx.xx] 
 
P-value 
x.xxxx 
 
 
 
 
 
 
 
Source: Listing 16 2 9 1 
Note: 
- LS: Least Squares; SE: Standard Error; CI: Confidence Interval;  
- n is the number of subjects with non-missing values  
- N is the number of subjects within each treatment group under Full Analysis Set  
- P-value is obtained using mixed-effect ANCOVA model with treatment as fixed effect and baseline result as covariate and patient as a random effect  
-  
 
Programming Note: Refer SAP for Model  Continue the table for all other parameters of Cytokines  This table can be modified as per the data requirement 
 
 
 
 
 
 
 
 
 
 
 
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Table 14 2 1 1 
Spriometry (FEV1) – Full Analysis Set 
Parameter 
Visit 
Statistics 
ANB020 
(N=XX) 
Placebo  
(N=XX) 
Observed 
Change from Baseline 
Observed 
Change from Baseline 
 
 
Predicted FEV1 (L) 
Screening 
n 
xx 
- 
xx 
- 
 
 
Mean (SD) 
xx x (xx xx) 
- 
xx x (xx xx) 
- 
 
 
95% CI 
(xx xxxx, xx xxxx) 
- 
(xx xxxx, xx xxxx) 
- 
 
 
Median 
xx x 
- 
xx x 
- 
 
 
Min, Max 
xx, xx 
- 
xx, xx 
- 
 
 
 
 
 
 
 
 
Baseline (Pre-
Bronchodilator) 
n 
xx 
- 
xx 
- 
 
 
Mean (SD) 
xx x (xx xx) 
- 
xx x (xx xx) 
- 
 
 
95% CI 
(xx xxxx, xx xxxx) 
- 
(xx xxxx, xx xxxx) 
- 
 
 
Median 
xx x 
- 
xx x 
- 
 
 
Min, Max 
xx, xx 
- 
xx, xx 
- 
 
 
 
 
 
 
 
 
Post-Bronchodilator 
n 
xx 
- 
xx 
- 
 
 
Mean (SD) 
xx x (xx xx) 
- 
xx x (xx xx) 
- 
 
 
95% CI 
(xx xxxx, xx xxxx) 
- 
(xx xxxx, xx xxxx) 
- 
 
 
Median 
xx x 
- 
xx x 
- 
 
 
Min, Max 
xx, xx 
- 
xx, xx 
- 
 
<Visits> 
-------- 
 
 
 
 
 
 
 
 
 
 
 
Actual FEV1(L) 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
 
FEV1 % Predicted 
<Visits> 
-------- 
 
 
 
 
 
Source: Listing 16.2.6.2 
Note: FEV1 = Forced expiratory volume in 1 second, CI = Confidence Interval, SD = Standard deviation. 
- N is the number of patients within each treatment group under Full Analysis Set  
-  
- Day1 pre-bronchodilator spirometry assessment will be considered as the baseline  
 
Programming Note: Continue this table for all available visits and respective change from baseline for FEV1  
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Version Date: 
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Table 14 2 1 2 
Secondary Efficacy Endpoint: Change in FEV1 (Litres) from Baseline to Day 127 – Full Analysis Set 
 
Statistic 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
n 
xx 
xx 
LS Mean 
xxx.xx 
xxx.xx 
SE of LS Mean 
xx.xxx 
xx.xxx 
95% CI 
[xxx.xx, xxx.xx] 
[xxx.xx, xxx.xx] 
LS Mean Difference (ANB020 – Placebo) 
xx.xx 
 
SE of LS Mean Difference 
xx.xx 
 
95% CI for LS Mean Difference 
[xx.xx, xx.xx] 
 
P-value 
x.xxxx 
 
 
 
 
 
 
 
 
Source: Listing 16.2.6.2 
Note: 
- LS: Least Squares; SE: Standard Error; CI: Confidence Interval;  
- n is the number of subjects with non-missing values  
- N is the number of subjects within each treatment group under Full Analysis Set  
- P-value is obtained using mixed-effect ANCOVA model with treatment as fixed effect and baseline result as covariate and patient as a random effect 
 
 
 
- Similar table will be generated for FeNO as following: 
Table 14 2 2 1 
Fractional Exhaled Nitric Oxide ( FeNO) (in ppb) Test – Full Analysis Set 
Source listing for Table 14.2.1 is 16.2.6.1 
Table 14 2 2 2 
Secondary Efficacy Endpoint: Change in Fractional Exhaled Nitric Oxide( FeNO) (in ppb) from Baseline to Day 127 – Full Analysis Set 
 
 
Table 14 2 1 3 
Secondary Efficacy Endpoint: Change in FEV1 (Litres) from Baseline – Supportive Analysis –  Full Analysis Set 
 
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Visit 
Statistic 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
Day 2 
n 
xx 
xx 
 
LS Mean 
xxx.xx 
xxx.xx 
 
SE of LS Mean 
xx.xxx 
xx.xxx 
 
95% CI 
[xxx.xx, xxx.xx] 
[xxx.xx, xxx.xx] 
 
LS Mean Difference (ANB020 – Placebo) 
xx.xx 
 
 
SE of LS Mean Difference 
xx.xx 
 
 
95% CI for LS Mean Difference 
[xx.xx, xx.xx] 
 
 
P-value 
x.xxxx 
 
 
 
 
 
Day 8 
n 
xx 
xx 
 
LS Mean 
xxx.xx 
xxx.xx 
 
SE of LS Mean 
xx.xxx 
xx.xxx 
 
95% CI 
[xxx.xx, xxx.xx] 
[xxx.xx, xxx.xx] 
 
LS Mean Difference (ANB020 – Placebo) 
xx.xx 
 
 
SE of LS Mean Difference 
xx.xx 
 
 
95% CI for LS Mean Difference 
[xx.xx, xx.xx] 
 
 
P-value 
x.xxxx 
 
 
 
 
 
[ETC…] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16.2.6.2 
Note: 
- LS: Least Squares; SE: Standard Error; CI: Confidence Interval; MMRM: Mixed Model for Repeated Measures; 
- n is the number of subjects with non-missing values  
- N is the number of subjects within each treatment group under Full Analysis Set  
- P-value is obtained using MMRM model with treatment, visit, treatment*visit as fixed effects and baseline and baseline*visit as covariates  
 
- Similar table will be generated for FeNO as following: 
Table 14 2 2 3 
Secondary Efficacy Endpoint: Change in FeNO (ppb) from Baseline to Day 127– Supportive Analysis –  Full Analysis Set 
 
 
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Table 14 2 3 1 
Asthma Control Questionnaire (Summary of Scores) – Full Analysis Set 
Visit 
Statistics 
ANB020 
(N=XX) 
Placebo  
(N=XX) 
Observed 
Change from Baseline 
Observed 
Change from Baseline 
 
Screening 
n 
xx 
- 
xx 
- 
 
Mean (SD) 
xx x (xx xx) 
- 
xx x (xx xx) 
- 
 
95% CI 
(xx xxxx, xx xxxx) 
- 
(xx xxxx, xx xxxx) 
- 
 
Median 
xx x 
- 
xx x 
- 
 
Min, Max 
xx, xx 
- 
xx, xx 
- 
 
 
 
 
 
 
Baseline 
n 
xx 
- 
xx 
- 
 
Mean (SD) 
xx x (xx xx) 
- 
xx x (xx xx) 
- 
 
95% CI 
(xx xxxx, xx xxxx) 
- 
(xx xxxx, xx xxxx) 
- 
 
Median 
xx x 
- 
xx x 
- 
 
Min, Max 
xx, xx 
- 
xx, xx 
- 
 
 
 
 
 
 
Day 8 
n 
xx 
xx 
xx 
xx 
 
Mean (SD) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
xx x (xx xx) 
 
95% CI 
(xx xxxx, xx xxxx) 
(xx xxxx, xx xxxx) 
(xx xxxx, xx xxxx) 
(xx xxxx, xx xxxx) 
 
Median 
xx x 
xx x 
xx x 
xx x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16.2.6.3 
Note: 
- N is the number of patients within each treatment group under Full Analysis Set  
- Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests) 
- Total ACQ will be calculated as sum of all individual scores for each patient at each visit  
- If any individual score is missing , the ACQ for that visit will also be missing  
 
Programming Note: Continue this table for all available visits and respective change from baseline  
 
 
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Version Date: 
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Table 14 2 3 2 
Exploratory Efficacy Endpoint: Change in ACQ from Baseline to Day 127 – Full Analysis Set 
 
Statistic 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
n 
xx 
xx 
LS Mean 
xxx.xx 
xxx.xx 
SE of LS Mean 
xx.xxx 
xx.xxx 
95% CI 
[xxx.xx, xxx.xx] 
[xxx.xx, xxx.xx] 
LS Mean Difference (ANB020 – Placebo) 
xx.xx 
 
SE of LS Mean Difference 
xx.xx 
 
95% CI for LS Mean Difference 
[xx.xx, xx.xx] 
 
P-value 
x.xxxx 
 
 
 
 
 
 
 
 
Source: Listing 16.2.6.3 
Note: 
- LS: Least Squares; SE: Standard Error; CI: Confidence Interval;  
- n is the number of subjects with non-missing values  
- N is the number of subjects within each treatment group under Full Analysis Set  
- P-value is obtained using mixed-effect ANCOVA model with treatment as fixed effect and baseline result as covariate and patient as a random effect 
 
 
 
 
 
 
 
 
 
 
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Version Date: 
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Table 14 2 4 1 
Patient Global Impression of Change ( PGIC Scores) – Full Analysis Set 
 
 
Visit 
Category 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Screening 
Very much improved 
xx (xx x) 
xx (xx x) 
 
Much improved 
xx (xx x) 
xx (xx x) 
 
Minimally Improved 
xx (xx x) 
xx (xx x) 
 
No changes 
xx (xx x) 
xx (xx x) 
 
Minimally worse 
xx (xx x) 
xx (xx x) 
 
Much worse 
xx (xx x) 
xx (xx x) 
 
Very much worse 
xx (xx x) 
xx (xx x) 
 
Row mean score differences(a) 
x xxx 
x xxx 
 
 
 
 
Baseline 
Very much improved 
xx (xx x) 
xx (xx x) 
 
Much improved 
xx (xx x) 
xx (xx x) 
 
Minimally Improved 
xx (xx x) 
xx (xx x) 
 
No changes 
xx (xx x) 
xx (xx x) 
 
Minimally worse 
xx (xx x) 
xx (xx x) 
 
Much worse 
xx (xx x) 
xx (xx x) 
 
Very much worse 
xx (xx x) 
xx (xx x) 
 
Row mean score differences(a) 
x xxx 
x xxx 
 
 
 
 
Day 8 
Very much improved 
xx (xx x) 
xx (xx x) 
 
Much improved 
xx (xx x) 
xx (xx x) 
 
Minimally Improved 
xx (xx x) 
xx (xx x) 
 
No changes 
xx (xx x) 
xx (xx x) 
 
Minimally worse 
xx (xx x) 
xx (xx x) 
 
Much worse 
xx (xx x) 
xx (xx x) 
 
Very much worse 
xx (xx x) 
xx (xx x) 
 
Row mean score differences(a) 
x xxx 
x xxx 
 
 
 
 
<Visits>  
 
 
 
 
 
 
 
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Source: Listing 16 2 6 4 
Note: 
- N is the number of patients within each treatment group in Full Analysis Set  
- Percentages are based on number of patients within each treatment group under Full Analysis Set (N)  
CMH- Cochran–Mantel–Haenszel test; 
(a) 
Row mean scores differences obtained from the CMH test comparing ANB020 vs Placebo  
Programming Note (not part of table): Similar table will be generated for CGIC as follows: 
 
 
 
 
Table 14 2 4 2 
Asthma Symptoms (Patient Diary) – Full Analysis Set 
Characteristic 
Visit 
Statistics 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
 
Number of Patients needed to use Rescue Inhaler 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Number of Patients needed to use Rescue Medication 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Number of Patients Experiencing 
 
 
 
 
 
Wheezing 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Cough 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Shortness of Breath 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Chest Tightness 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Others 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Number of Patients who Changed Any of their Prescribed Long Term 
Controller Medicine 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Number of Patients Rating the Study Treatment as 
 
 
 
 
 
<Categories> 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Number of Patients who Rating the Level of Satisfaction With the Side 
Effects Related to the Study Treatment as 
 
 
 
 
 
<Categories> 
<Visits> 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
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Table 14 2 4 2 
Asthma Symptoms (Patient Diary) – Full Analysis Set 
Characteristic 
Visit 
Statistics 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
 
 
 
 
 
 
Source: Listing 16.2.6.4 
Note: 
- N is the number of patients within each treatment group under Full Analysis Set  
- Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests) 
Percentages are based on number of patients within each treatment group under Full Analysis Set (N).Programming Note: Continue this table for all available visits. 
Table 14 2 5 1 
Clinical Global Impression of Change Scale (CGIC Scores) – Full Analysis Set 
Source: Listing 16 2 6 5 
 
 
Table 14 2 6 1 
Exploratory Endpoint: Reduction from Baseline in IgE levels(Unit) on Day 127/ET – Full Analysis Set 
 
Statistic 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
n 
xx 
xx 
LS Mean 
xxx.xx 
xxx.xx 
SE of LS Mean 
xx.xxx 
xx.xxx 
95% CI 
[xxx.xx, xxx.xx] 
[xxx.xx, xxx.xx] 
LS Mean Difference (ANB020 – Placebo) 
xx.xx 
 
SE of LS Mean Difference 
xx.xx 
 
95% CI for LS Mean Difference 
[xx.xx, xx.xx] 
 
P-value 
x.xxxx 
 
 
 
 
 
 
 
 
Source: Listing 16.2.8.5 
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Note: 
- LS: Least Squares; SE: Standard Error; CI: Confidence Interval;  
- n is the number of subjects with non-missing values  
- N is the number of subjects within each treatment group under Full Analysis Set  
- P-value is obtained using mixed-effect ANCOVA model with treatment as fixed effect and baseline result as covariate and patient as a random effect  
 
Programming Note: Refer SAP for Model  This table can be modified as per the data requirement 
 
 
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Table 14 4 1 1 1 
Serum Concentration(ug/mL) of ANB020 – Pharmacokinetic Analysis Set 
Visit 
Nominal Time Point 
Statistics 
ANB020 
(N=XX) 
 
Baseline  
Pre-dose (-0 5 hours) 
n, LLOQ (n) 
xx, xx 
 
 
Mean (SD) 
xx x (xx xx) 
 
 
CV 
xx x  
 
 
Median (Min, Max) 
xx x (xx, xx) 
 
 
 
 
 
0 5 hours post SOI  
n, LLOQ (n) 
xx, xx 
 
 
Mean (SD) 
xx x (xx xx) 
 
 
CV 
xx x  
 
 
Median (Min, Max) 
xx x (xx, xx) 
 
 
 
 
 
EOI  
-------------- 
 
 
 
 
 
 
EOI+3 hours 
-------------- 
 
 
 
 
 
Day 2 
24 hours post SOI 
-------------- 
 
 
 
 
 
Day 8 
168 hours post SOI 
-------------- 
 
 
 
 
 
Day 22 
504 hours post SOI 
-------------- 
 
 
 
 
 
Day 36 
840 hours post SOI 
-------------- 
 
 
 
 
 
Day 64 
1512 houirs post SOI 
-------------- 
 
 
Source: Listing 16 2 5 2 
Note: 
- LLOQ(n)=number of observations ≥lower limit of quantification  
- SOI – Start of Infusion, EOI – End of Infusion  
 
Programming Note (not part of table): Use all relevant visits and time points 
 
 
 
 
 
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Table 14 4 1 2 1  
Pharmacokinetic Parameters of ANB020 – Pharmacokinetic Analysis Set 
Parameter  
Statistics 
ANB020 
(N=XX) 
 
Cmax 
N, LLQ(n) 
xx, xx 
 
Mean (SD) 
xx x (xx xx) 
 
CV 
xx x 
 
Median (Min, Max) 
xx x (xx, xx) 
 
Gmean (gCV) 
xx x (xx xx) 
 
 
 
tmax 
n 
xx 
 
Median 
xx xx 
 
Min, Max 
xx, xx 
 
 
 
------------------- 
 
 
 
 
 
 
Source: Listing 16 2 5 3 
Programming Note (not part of table):  Continue this for all other estimated non-diagnostic parameters, if any   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14 3 1 1 
Overview of Adverse Events – Safety Analysis Set 
Characteristic 
ANB020 
(N=XX) 
n (%) 
Placebo 
(N=XX) 
n (%) 
Total 
(N=XX) 
n (%) 
 
Overall TEAEs 
xx 
xx 
xx 
Overall Non-TEAEs 
xx 
xx 
xx 
 
 
 
 
Patients with at least one 
 
 
 
TEAE 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Serious TEAE  
xx (xx x) 
xx (xx x) 
xx (xx x) 
Severe TEAE 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Related TEAE 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Non-TEAE 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Patients with TEAE by Severity 
 
 
 
< Categories > 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Patients with TEAE by Final Outcome 
 
 
 
< Categories > 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Action Taken with the Study Drug for Patients with TEAE  
 
 
 
< Categories > 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Patients with TEAE with Relationship to Study Drug  
 
 
 
< Categories > 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Patients with TEAE with Seriousness Criteria  
 
 
 
< Categories > 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Patients Discontinued from the Study Due to TEAE 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
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Table 14 3 1 1 
Overview of Adverse Events – Safety Analysis Set 
Characteristic 
ANB020 
(N=XX) 
n (%) 
Placebo 
(N=XX) 
n (%) 
Total 
(N=XX) 
n (%) 
Source: Listing 16 2 7 1, 14 3 2 1, 14 3 2 2, 14 3 2 3 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set, Percentages are based on number of patients within each treatment group under Safety Analysis Set (N)  
- Adverse Event terms are coded using MedDRA version 19 1, Patients experiencing multiple events are counted only once within the treatment group  
- If patient has multiple TEAEs by severity and/or multiple relationship with study drug, worst case severity and the worst case relationship to the study drug will used for overview tabulation  
- AE- Adverse Event, TEAE- Treatment Emergent Adverse Events 
- Treatment emergent adverse events (TEAEs) are defined as AEs that started or worsened in severity on or after the date and time of the study drug infusion  
 
Programming Note (not part of table):  For count of TEAEs, use the coded term (preferred term)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 14 3 1 2 
TEAE by System Organ Class and Preferred Term – Safety Analysis Set 
System Organ Class 
  Preferred Term 
        Verbatim Term 
ANB020 
(N=XX) 
n (%) 
Placebo 
(N=XX) 
n (%) 
Total 
(N=XX) 
n (%) 
 
Number of Patients with at least one TEAE 
xx (xx x) 
xx (xx x) 
xx (xx x) 
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Table 14 3 1 2 
TEAE by System Organ Class and Preferred Term – Safety Analysis Set 
System Organ Class 
  Preferred Term 
        Verbatim Term 
ANB020 
(N=XX) 
n (%) 
Placebo 
(N=XX) 
n (%) 
Total 
(N=XX) 
n (%) 
 
 
 
 
System Organ Class 1 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Preferred Term 1 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Preferred Term 2 
xx (xx x) 
xx (xx x) 
xx (xx x) 
------------ 
 
 
 
System Organ Class 2 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Preferred Term 1 
xx (xx x) 
xx (xx x) 
xx (xx x) 
-------------- 
 
 
 
 
 
 
 
 
Source: Listing 16 2 7 1, 14 3 2 1, 14 3 2 2, 14 3 2 3 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
- Percentages are based on number of patients within each treatment group under Safety Analysis Set (N)  
- Adverse Event terms are coded using System Organ Class and Preferred term using using latest version of MedDRA  
- Patients experiencing multiple events within the same SOC or PT are counted only once under those categories  
 
Programming Note (not part of table): 
- Table will be sorted in decreasing frequency of system organ class and preferred term of total column  Include “Uncoded” if events are not coded  
A subject can have one or more preferred terms reported under a given system organ class  
- Similar tables will be generated for Safety Analysis Set as follows: 
Table 14 3 1 2 1 TEAEs by Preferred Term – Safety Analysis Set 
Table 14 3 1 3 TEAEs Leading to Discontinuation of Patient from the Study by System Organ Class and Preferred Term – Safety Analysis Set 
Table 14 3 1 4 TEAEs Leading to Interruption of Study Drug by System Organ Class and Preferred Term – Safety Analysis Set 
 
 
 
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Version Number: 
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Version Date: 
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Table 14 3 1 5 
TEAEs by Severity, System Organ Class and Preferred Term – Safety Analysis Set 
 System Organ Class 
  Preferred Term 
      Verbatim Term 
ANB020 
(N=XX) 
 
Placebo 
(N=XX) 
Mild 
Moderate 
Severe 
 
Mild 
Moderate 
Severe 
 
Number of Patients with at least one TEAE by Severity 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
System Organ Class 1 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
Preferred Term 1 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
Preferred Term 2 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
System Organ Class 2 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
Preferred Term 1 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
------------ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2 7 1, 14 3 2 1, 14 3 2 2, 14 3 2 3 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
- Percentages are based on number of patients within each treatment group under Safety Analysis Set (N)  
- Adverse Event terms are coded using System Organ Class and Preferred term using using latest version of MedDRA 
- Patients experiencing multiple events within the same SOC or preferred term are counted only once under those categories  
- Patients experiencing the same event with different severity level are counted under the most severe occurrence  
 
Programming Note (not part of table): 
- Table will be sorted in decreasing frequency of system organ class and preferred term of total column  Include “Uncoded” if events are not coded  
- A subject can have one or more preferred terms reported under a given system organ class  
 
 
 
 
 
 
 
 
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Document: 
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Author: 
 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Table 14 3 1 5 
TEAEs by Severity, System Organ Class and Preferred Term – Safety Analysis Set 
 System Organ Class 
  Preferred Term 
          Verbatim Term 
Total 
(N=XX) 
Mild 
Moderate 
Severe 
 
Number of Patients with at least one TEAE by Severity 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
System Organ Class 1 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Preferred Term 1 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Preferred Term 2 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
System Organ Class 2 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
Preferred Term 1 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
------------ 
 
 
 
 
 
 
 
 
Source: Listing 16 2 7 1, 14 3 2 1, 14 3 2 2, 14 3 2 3 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
- Percentages are based on number of patients within each treatment group under Safety Analysis Set (N)  
- Adverse Event terms are coded using System Organ Class and Preferred term using using latest version of MedDRA 
- Patients experiencing multiple events within the same SOC or preferred term are counted only once under those categories  
- Patients experiencing the same event with different severity level are counted under the most severe occurrence  
 
Programming Note (not part of table): 
- Table will be sorted in decreasing frequency of system organ class and preferred term of total column  Include “Uncoded” if events are not coded  
- A subject can have one or more preferred terms reported under a given system organ class  
 
 
 
 
 
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Document: 
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Version Number: 
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Version Date: 
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Table 14 3 1 6 
TEAEs by Relationship to Study Drug, System Organ Class and Preferred Term – Safety Analysis Set 
 System Organ Class 
  Preferred Term 
        Verbatim Term 
ANB020 
(N=XX) 
 
Placebo 
(N=XX) 
 
Total 
(N=XX) 
Related 
Not Related 
 
Related 
Not Related 
 
Related 
Not Related 
 
Number of Patients with at least one TEAE by Relationship 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
System Organ Class 1 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
Preferred Term 1 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
Preferred Term 2 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
System Organ Class 2 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
Preferred Term 1 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
------------ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2 7 1, 14 3 2 1, 14 3 2 2, 14 3 2 3Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
- Percentages are based on number of patients within each treatment group under Safety Analysis Set (N)   
- Adverse Event terms are coded using System Organ Class and Preferred term using using latest version of MedDRA 
- Patients experiencing multiple events within the same SOC or preferred term are counted only once under those categories  
- Patients experiencing the same event with different relationship level are counted under the worst degree of relationship  
- AEs with relationship in (“Possible”, “Probable” and “Unknown”) are mapped to “Related”, else to “Unrelated”  
 
Programming Note (not part of table): 
- Table will be sorted in decreasing frequency of system organ class and preferred term of total column  Include “Uncoded” if events are not coded  
- A subject can have one or more preferred terms reported under a given system organ class  
 
 
Table 14 3 1 7 Serious TEAEs by System Organ Class and Preferred Term – Safety Analysis Set 
Table 14 3 1 8 TEAEs Leading to Death by System Organ Class and Preferred Term – Safety Analysis Set 
Table 14 3 1 9 Non TEAEs by System Organ Class and Preferred Term – Safety Analysis Set 
 
 
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Version Date: 
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Table 14 3 4 1 
Potential Clinically Significant Laboratory Assessments (Hematology) – Safety Analysis Set 
Parameter 
 
Visit 
Potential Clinical Significance Status 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
 
 
 
 
 
 
 
Parameter 1 
<Visits> 
Normal 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Abnormal NCS 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Abnormal CS 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Missing  
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
 
 
 
Parameter 2 
<Visits> 
Normal 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Abnormal NCS 
xx (xx x) 
xx (xx x) 
xx (xx x) 
------------------- 
 
Abnormal CS 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Missing 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
Source: Listing 14 3 4 1 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
- Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests) 
- Percentages are based on number of patients within each treatment group under Safety Analysis Set (N)  
- NCS – Not Clinically Significant, CS – Clinically Significant 
 
Programming Note (not part of table):  
- Use all relevant visits and parameters  
- Similar tables will be generated for Safety Analysis Set as follows: 
Table 14 3 4 2 Potential Clinically Significant Laboratory Assessments (Clinical Chemistry) – Safety Analysis Set 
Table 14 3 4 3 Potential Clinically Significant Laboratory Assessments (Urinalysis) – Safety Analysis Set 
 
 
 
 
 
 
 
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Version Date: 
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Table 14 3 4 4 
Summary of Potentially Clinically Significant ECG Parameters – Safety Analysis Set 
Category 
Visit 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
 
 
Normal 
Screening 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Abnormal, NCS 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Abnormal, CS 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
Normal 
End of study 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Abnormal, NCS 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Abnormal, CS 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2 8 2 
Note: 
CS- Clinically Significant; NCS- Not Clinically Significant 
N is the number of patients under Safety Analysis Set  
Percentages are based on N 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14 3 5 1 
Pregnancy Test – Safety Analysis Set 
 
Visit 
Characteristic 
Result 
Statistics 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
 
 
 
 
 Urine Pregnancy Test 
 Baseline 
 Test Performed 
 Yes 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 No 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
 
 Outcome 
 Positive 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 Negative 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 Serum Pregnancy Test 
 Screening 
 Test Performed 
 Yes 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 No 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
 
 Outcome 
 Positive 
n (%) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 Negative 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
<Visits> 
------------- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2 4 2, 16 2 8 1 
Note:  
‐ N is the number of female patients within each treatment group in the Safety Analysis Set  
‐ Percentages are based on the number of female patients in respective treatment arm (N)  
‐ Above test are conducted only for women of child bearing potential  
 
Programming Note (not part of table):  Add missing row where applicable  This table can be modified as per the data requirement. 
 
 
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Version Date: 
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Table 14 3 5 2 
Laboratory Parameters (Hematology) – Safety Analysis Set 
 
ANB020 
(N=XX) 
 
Placebo  
(N=XX) 
 
Total 
(N = XX) 
Parameter (Unit) 
Visit 
Statistics 
Actual 
Change from Baseline  
Actual 
Change from Baseline  
Actual 
Change from Baseline 
 
 
 
 
 
 
 
 
 
 
 
 
 Parameter 1 
Baseline 
n 
xx 
- 
 
xx 
- 
 
xx 
- 
 
 
Mean (SD) 
xx x (xx xx) 
- 
 
xx x (xx xx) 
- 
 
xx x (xx xx) 
- 
 
 
Median 
xx x 
- 
 
xx x 
- 
 
xx x 
- 
 
 
Min, Max 
xx, xx 
- 
 
xx, xx 
- 
 
xx, xx 
- 
 
 
 
 
 
 
 
 
 
 
 
 
<Visits> 
n 
xx 
xx 
 
xx 
xx 
 
xx 
xx 
 
 
Mean (SD) 
xx x (xx xx) 
xx x (xx xx) 
 
xx x (xx xx) 
xx x (xx xx) 
 
xx x (xx xx) 
xx x (xx xx) 
 
 
Median 
xx x 
xx x 
 
xx x 
xx x 
 
xx x 
xx x 
 
 
Min, Max 
xx, xx 
xx, xx 
 
xx, xx 
xx, xx 
 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
 
 
 
 
---------- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Parameter 2 
----------- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
--------------- 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
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Version Date: 
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Table 14 3 5 2 
Laboratory Parameters (Hematology) – Safety Analysis Set 
 
ANB020 
(N=XX) 
 
Placebo  
(N=XX) 
 
Total 
(N = XX) 
Parameter (Unit) 
Visit 
Statistics 
Actual 
Change from Baseline  
Actual 
Change from Baseline  
Actual 
Change from Baseline 
 
Source: Listing 14 3 4 1 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
-  
- Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests), 
- Unit is SI unit  
 
Programming Note (not part of table): 
- Provide appropriate discreptives for urinalysis  Use all relevant visits  
- Similar tables will be generated for Safety Analysis Set as follows: 
Table 14 3 5 3 
Laboratory Parameters (Clinical Chemistry) – Safety Analysis Set 
Table 14 3 5 4 
Laboratory Parameters (Urinalysis) – Safety Analysis Set 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14 3 5 5 
Shifts from Baseline in Clinical Laboratory Results – Safety Analysis Set 
 
 
 
Post Baseline Assessments 
 
 
 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Laboratory Category 
Parameter (Unit) 
Visit 
Baseline 
Assessment 
Low 
Normal 
High 
Total 
Missing 
Low 
Normal 
High 
Total 
Missing 
 
Hematology 
 
 
 
 
 
 
 
 
 
 
 
 
 Parameter 1 
Day 1 
Low 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Normal 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
High 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Total  
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 Missing 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 2 
 
 
 
 
 
 
 
 
 
 
 
 
---- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Parameter 2 
------ 
 
 
 
 
 
 
 
 
 
 
 
---------- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 14 3 4 1 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
- Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests), Unit is SI unitPercentages are based on the number of patients in the SAF with 
data at Baseline and the visit of interest   
Programming Note (not part of table): Present all the parameters in Hematology, Clinical Chemistry and Urinalysis  Use all relevant visits  
 
 
 
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Table 14 3 5 6 
12-Lead ECG – Safety Analysis Set 
 
 
 
ANB020 
(N=XX) 
 
Placebo  
(N=XX) 
 
Total  
(N=XX) 
Parameter (Unit) 
Visit 
Statistics 
Actual 
Change from 
Baseline 
 Actual 
Change from 
Baseline 
 Actual 
Change from 
Baseline 
 
Heart Rate (bpm) 
Baseline 
n 
xx 
- 
 xx 
- 
 xx 
- 
 
 
Mean (SD) 
xx x (xx xx) 
- 
 xx x (xx xx) 
- 
 xx x (xx xx) 
- 
 
 
Median 
xx x 
- 
 xx x 
- 
 xx x 
- 
 
 
Min, Max 
xx, xx 
- 
 xx, xx 
- 
 xx, xx 
- 
 
 
 
 
 
  
 
  
 
 
End of Study 
n 
xx 
xx 
 xx 
xx 
 xx 
xx 
 
 
Mean (SD) 
xx x (xx xx) 
xx x (xx xx) 
 xx x (xx xx) 
xx x (xx xx) 
 xx x (xx xx) 
xx x (xx xx) 
 
 
Median 
xx x 
xx x 
 xx x 
xx x 
 xx x 
xx x 
 
 
Min, Max 
xx, xx 
xx, xx 
 xx, xx 
xx, xx 
 xx, xx 
xx, xx 
 
 
 
 
 
  
 
  
 
PR Interval (msec) 
------------ 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
QRS Interval (msec) 
----------- 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
QT Interval (msec) 
----------- 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
QTc Interval (msec) 
------------ 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
QTcF (msec) 
------------ 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
 
Source: Listing 16 2 8 2 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
- Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests) 
 
Programming Note (not part of table): Continue the table for all parameters and all available visits  
 
 
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Table 14 3 5 7 
Summary of QT Changes from Baseline to Last Observation – Safety Analysis Set 
Category 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
 
Mean change [a] in QT Interval (msec) from baseline 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Number (%) of patients reaching a value in QT Interval 
      Males: 
     ….. 
      Females: 
     ….. 
      Total 
 
 
 
      >450 (msec) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
      >480 (msec) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
      >500 (msec) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Number (%) of patients experiencing an increase in QT Interval 
xx (xx x) 
xx (xx x) 
xx (xx x) 
      >30  (msec) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
      >60  (msec) 
xx (xx x) 
xx (xx x) 
xx (xx x) 
Number (%) of patients experiencing a decrease in QT Interval 
 
 
 
  >30  (msec) 
 
 
 
      >60  (msec) 
 
 
 
 
 
 
 
Mean change [a] in QTcF Interval (msec) from baseline 
 
 
 
Number (%) of patients reaching a value in QTcF Interval 
 
 
 
      >450 (msec) 
 
 
 
  >480 (msec) 
 
 
 
      >500 (msec) 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2 8 2 
Note: 
QTcF = Fridericia’s correction for QT;  
N is the number of patients under Safety Analysis Set  
Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests) 
[a] Change from baseline to last observation  
 
Programming note: Please refer SAP for the male and female reference ranges  
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Table 14 3 5 8 
Vital Signs – Safety Analysis Set 
 
 
 
ANB020 
(N=XX) 
 
Placebo  
(N=XX) 
 
Total  
(N=XX) 
Parameter (Unit) 
Visit 
Statistics 
Actual 
Change from 
Baseline 
 Actual 
Change from 
Baseline 
 Actual 
Change from 
Baseline 
 
Pulse Rate (bpm) 
<Visits> 
n 
xx 
- 
 xx 
- 
 xx 
- 
 
 
Mean (SD) 
xx x (xx xx) 
- 
 xx x (xx xx) 
- 
 xx x (xx xx) 
- 
 
 
Median 
xx x 
- 
 xx x 
- 
 xx x 
- 
 
 
Min, Max 
xx, xx 
- 
 xx, xx 
- 
 xx, xx 
- 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
Respiratory Rate (resp/min) 
<Visits> 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
Body Temperature (°C) 
<Visits> 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
Systolic Blood Pressure (mmHg) 
<Visits> 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
Diastolic Blood Pressure (mmHg) 
<Visits> 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
  
 
 
Source: Listing 16 2 8 3 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
- Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests)  
 
Programming Note (not part of table): Continue the table for all parameters and all available visits  
 
 
 
 
 
 
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Version Date: 
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Table 14 3 5 9 
Physical Examination – Safety Analysis Set 
Parameter 
Visit 
Category 
ANB020 
(N=XX) 
n (%) 
Placebo 
(N=XX) 
n (%) 
Total 
(N=XX) 
n (%) 
 
General appearance 
Baseline 
Normal 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Abnormal, NCS  
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Abnormal, CS  
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Not Done  
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
EOS 
Normal 
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Abnormal, NCS  
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Abnormal, CS  
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
Not Done  
xx (xx x) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
------------------------ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2 8 4 
Note: 
- N is the number of patients within each treatment group under Safety Analysis Set  
- Percentages are based on number of patients within each treatment group under Safety Analysis Set (N)  
- NCS – Not Clinically Significant, CS – Clinically Significant 
 
Programming Note (not part of table):  Continue the table for all other parameters and all available visits  May need to add “Missing” row if response is not available for some patients  
 
 
 
 
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Version Number: 
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Version Date: 
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Table 14 3 5 10 
Other Safety Assessments (Number of Exacerbations) – Full Analysis Set 
Characteristic 
Statistics 
ANB020 
(N=XX) 
Placebo 
(N=XX) 
Hazard Ratio 
P-value 
 
 
 
 
 
- 
Number of Patients with Exacerbatiuons 
n (%) 
xx (xx x) 
xx (xx x) 
 
 
 
 
 
 
 
 
Total Number of Exacerbations 
E 
xx 
xx 
 
- 
 
 
 
 
 
 
Time to First Asthma Exacerbation[1] (Days) 
n 
xx 
xx 
 
- 
 
Mean (SD) 
xx x (xx xx) 
xx x (xx xx) 
 
 
 
Median 
xx x 
xx x 
 
 
 
Min, Max 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
Number of Censored Patients 
n (%) 
xx (xx x) 
xx (xx x) 
 
 
 
Median (95% CI) 
xx x (xx x, xx x) 
xx x (xx x, xx x) 
 
 
 
1st Quartile (95% CI) 
xx x (xx x, xx x) 
xx x (xx x, xx x) 
 
 
 
3rd Quartile (95% CI) 
xx x (xx x, xx x) 
xx x (xx x, xx x) 
 
0 xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16 2 6 6 
Note: 
- N is the number of patients within each treatment group under Full Analysis Set  
- [1] - Time (in days) from randomization to the first asthma exacerbation = Start date of first asthma exacerbation − Date of randomization + 1 
- The time to first asthma exacerbation for patients who have not experienced an asthma exacerbation during the period till end of study have been 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) 
- The quartiles and confidence intervals are estimated based on the Kaplan-Meier estimation method 
- Hazard ratio and P-value are computed based on cox-proportional hazard model  
 
Programming Note: Continue this table for all available visits and categories  
 
 
 
 
 
 
 
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Author: 
 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Table 14 3 5 11 
Other Safety Assessments (Immunogenicity - ADA) – Safety Analysis Set 
  
Visit 
Result 
(N=xx) 
 n(%) 
Summary of Titre values 
Mean(SD),Median 
  
Day 1 
Positive 
xx (xx x) 
xx xx (xx xxx), xx xx 
 
Negative 
xx (xx x) 
 
  
Day 11 
Positive 
xx (xx x) 
 
 
Negative 
xx (xx x) 
 
  
Day 64 
Positive 
xx (xx x) 
xx xx (xx xxx), xx xx 
 
Negative 
xx (xx x) 
 
  
Day 120 
Positive 
xx (xx x) 
xx xx (xx xxx), xx xx 
 
Negative 
xx (xx x) 
 
  
End of Study 
Positive 
xx (xx x) 
xx xx (xx xxx), xx xx 
 
Negative 
xx (xx x) 
 
  
Source: Listing 16 2 8 5 
N is the number of patients under Safety Analysis Set  
 
Programming Note (not part of table): Continue the table for all other parameters of in whole blood at all available visits and respective time points  
 
 
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Version Date: 
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LISTING SHELLS  
 
 
 
Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients with Severe Eosinophilic Asthma 
 
 
 
Study No. ANB020-004 
 
 
 
 
 
 
 
 
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Version Date: 
18Dec2018 
 
OUTPUT TEMPLATES SIGNATURE PAGE 
Listing Shells V 1.0 (Dated 18Dec2018) for Protocol ANB020-004. 
 
Name 
Signature 
Date  
                    Author: 
 
DDMMMYYYY 
 
  Position: 
 
Company: 
IQVIATM 
 
Upon review of this document, the undersigned approves this version of the Output Templates, authorizing that the content is acceptable for the reporting of this study. 
 
Name 
Signature 
Date  
Reviewed and Approved By: 
 
DDMMMYYYY 
 
Position: 
 
Company: 
IQVIATM 
Reviewed and Approved By:
 
DDMMMYYYY 
 
Position: 
 
Company: 
IQVIATM 
 
 
Reviewed and Approved By: 
 
DDMMMYYYY 
Position: 
Company: 
AnaptysBio, Inc. 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Reviewed and Approved By: 
 
DDMMMYYYY 
 
Position: 
 
Company: 
AnaptysBio, Inc. 
 
 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
List of Reviewers 
 
Reviewer Name 
Position/ Role 
Company 
IQVIATM 
IQVIATM 
IQVIATM 
IQVIATM 
IQVIATM 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
AnaptysBio, Inc 
 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Modification History 
 
Unique 
Identifier for 
this Version 
Date of the 
Document Version 
Author 
Significant Changes from  
Previous Authorized Version 
Draft 0.1 
04 Dec 2017 
Not Applicable - First Draft 
Draft 0.2 
07 Dec 2017 
Resolved comments from internal review 
Draft 0.3 
03 Dec 2018 
Resolved comments from Sponsor review 
 
 
 
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Version Date: 
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Table of Contents 
List of Reviewers ................................................................................................................................................................................................................................................ 4 
Modification History ........................................................................................................................................................................................................................................... 5 
Listing 16.2.1.1 Patient Disposition - All Patients Screened ............................................................................................................................................................................... 8 
Listing 16.2.2.1 Protocol Deviation - All Patients Screened ............................................................................................................................................................................... 9 
Listing 16.2.3.1.1 Analysis Sets - All Patients Screened .................................................................................................................................................................................. 10 
Listing 16.2.4.1.1 Inclusion Criteria - All Patients Screened ............................................................................................................................................................................ 11 
Listing 16.2.4.1.2 Exclusion Criteria - All Patients Screened ........................................................................................................................................................................... 12 
Listing 16.2.4.2  Demography and Other baseline Characteristics - Safety Analysis Set ................................................................................................................................. 13 
Listing 16.2.4.3 Medical History - Safety Analysis Set .................................................................................................................................................................................... 14 
Listing 16.2.4.4 Prior and Concomitant Medication - Safety Analysis Set ....................................................................................................................................................... 15 
Listing 16.2.4.5 Virology at Screening - Safety Analysis Set ........................................................................................................................................................................... 16 
Listing 16.2.4.6 TB Screening - Safety Analysis Set ........................................................................................................................................................................................ 17 
Listing 16.2.4.7 Drugs of Abuse - Safety Analysis Set ..................................................................................................................................................................................... 18 
Listing 16.2.5.1 Study Drug Exposure - Safety Analysis Set ............................................................................................................................................................................ 19 
Listing 16.2.5.2 Individual ANB020 Pharmacokinetic Sampling Times and Concentrations by Time Point - Safety Analysis Set ................................................................ 20 
Listing 16.2.5.3 Individual ANB020 Pharmacokinetic Parameters Following ANB020 Treatment - Safety Analysis Set .............................................................................. 21 
Listing 16.2.5.3 Individual Diagnostic ANB020 Pharmacokinetic Parameters Following ANB020 Treatment - Safety Analysis Set ............................................................ 22 
Listing 16.2.6.1 Fractional Exhaled Nitric Oxide Test - Full Analysis Set ....................................................................................................................................................... 23 
Listing 16.2.6.2 Spirometry - Full Analysis Set ................................................................................................................................................................................................ 24 
Listing 16.2.6.3 Asthma Control Questionnaire - Full Analysis Set ................................................................................................................................................................. 25 
Listing 16.2.6.4 Patient Diary - Full Analysis Set ............................................................................................................................................................................................. 26 
Listing 16.2.6.5 Clinical Global Impression of Change Scale - Full Analysis Set ............................................................................................................................................ 27 
Listing 16.2.6.6 Time to first asthma exacerbation - Full Analysis Set ............................................................................................................................................................ 28 
Listing 16.2.6.7 Rescue Medication - Safety Analysis Set ............................................................................................................................................................................... 29 
Listing 16.2.7.1 Adverse Event - Safety Analysis Set ....................................................................................................................................................................................... 30 
Listing 14.3.2.1 Treatment Emergent Adverse Events Leading to Deaths - Safety Analysis Set ..................................................................................................................... 31 
Listing 14.3.2.2 Serious Treatment Emergent Adverse Event - Safety Analysis Set ........................................................................................................................................ 31 
Listing 14.3.2.3 Treatment Emergent Adverse Events Leading to Discontinuation from Study or of IP - Safety Analysis Set ....................................................................... 31 
Listing 14.3.4.1 Clinically Significant Laboratory Results - Safety Analysis Set ............................................................................................................................................. 31 
Listing 16.2.8.1 Serum Pregnancy Test - Safety Analysis Set .......................................................................................................................................................................... 33 
Listing 16.2.8.2 Electrocardiogram Results - Safety Analysis Set .................................................................................................................................................................... 33 
Listing 16.2.8.3 Vital Signs - Safety Analysis Set ............................................................................................................................................................................................ 35 
Listing 16.2.8.4 Physical Examination - Safety Analysis Set ........................................................................................................................................................................... 36 
Listing 16.2.8.5 Anti-Drug Antibody Assessment - Safety Analysis Set .......................................................................................................................................................... 37 
Listing 16.2.9.1 Cytokines Assessment  - Safety Analysis Set.......................................................................................................................................................................... 38 
Listing 16.2.9.2 Eosinophil Assessment - Safety Analysis Set ......................................................................................................................................................................... 39 
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Version Date: 
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Listing 16.2.9.3 Ex-vivo induced IFN-y assessment - Safety Analysis Set ....................................................................................................................................................... 40 
Listing 16.2.9.4 Patient Screening Summary - All Patients Screened ............................................................................................................................................................... 41 
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Version Date: 
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Listing 16.2.1.1 
Patient Disposition - All Patients Screened 
Patient 
No. 
 
Treatment 
Age/Gender 
Eligible at 
Screening 
Willing to 
Participate at 
Day 1 
Patient 
Discontinued 
Study 
Date of 
Discontinuation 
Date of Last 
Dose 
Primary Reason for 
Discontinuation 
Patient 
Completed the 
Study 
If No, Provide the 
Primary Reason 
Date of 
Completion 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
32/Male 
Yes 
Yes 
Yes  
DDMMMYYYY 
DDMMMYYYY 
xxxxx 
No 
xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
31/Female 
Yes 
Yes 
No 
- 
DDMMMYYYY 
- 
Yes 
- 
DDMMMYYYY 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
28/Female 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number. 
 
 
 
 
 
 
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Version Date: 
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Listing 16 2.2.1 
Protocol Deviation - All Patients Screened 
Patient No. 
 
Treatment 
Age/Gender 
Significance 
Deviation Date 
Deviation Category 
Deviation Description 
Lead to Patient Exclusion 
from PK Population 
Lead to Patient Exclusion 
from PD Population 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
32/Male 
Major 
DDMMMYYYY 
xxxxxxx 
xxxxxxxxxxxxxx 
Yes 
No 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
31/Female 
Major 
DDMMMYYYY 
xxxxxxx 
xxxxxxxxxxxxxx 
xx 
xx 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
28/Female 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
…………… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number. 
 
 
 
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Version Date: 
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Listing 16.2.3.1 1 
Analysis Sets - All Patients Screened 
Patient No. 
 
Treatment 
Age/Gender 
Randomized Analysis Set 
[RND] 
Administered the 
Treatment 
Full Analysis Set 
(FAS) 
Safety Analysis Set 
(SAF) 
Pharmacodynamic 
Analysis Set (PD) 
Pharmacokinetic 
Analysis Set (PK) 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
32/Male 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
31/Female 
Yes 
Yes 
No 
Yes 
No 
No 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
28/Female 
Yes 
No 
No 
No 
No 
No 
 
 
 
 
 
 
 
 
 
……. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number. 
 
 
 
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Version Date: 
18Dec2018 
 
Listing 16.2.4 1.1 
Inclusion Criteria - All Patients Screened 
Patient No. 
 
Treatment 
Age/Gender 
INC1 
INC2 
INC3 
INC4 
……….. 
INC11 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
32/Male 
Yes 
Yes 
Yes 
Yes 
 
Yes 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
31/Female 
Yes 
Yes 
No 
Yes 
 
No 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
28/Female 
Yes 
No 
No 
No 
 
No 
 
 
 
 
 
 
 
 
 
………. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number. If columns do not fit in the one page, move to next page with unique columns patient no., treatment, age and gender. 
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Version Date: 
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Listing 16.2.4.1.2 
Exclusion Criteria - All Patients Screened 
Patient No. 
 
Treatment 
Age/Gender 
EXC1 
EXC2 
EXC3 
EXC4 
……….. 
EXC20 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
32/Male 
Yes 
Yes 
Yes 
Yes 
 
Yes 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
31/Female 
Yes 
Yes 
No 
Yes 
 
No 
 
 
 
 
 
 
 
 
 
XXX 
XXX 
28/Female 
Yes 
No 
No 
No 
 
No 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number. If columns do not fit in the one page, move to next page with unique columns patient no., treatment, age and gender 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Date: 
18Dec2018 
 
 
 
Note: 
- 
WOCBP: Women of Child Bearing Potential. 
- 
[1] – Urine pregnancy test is performed only for WOCBP Patients. 
- 
Age: (Date of Informed Consent - Date of Birth +1)/365 25 
- 
Demographic details such as weight, height and BMI will be based on Screening visit. 
 
 
Programming Note (not part of table): Sort by treatment, patient number. 
 
 
 
Listing 16.2.4.2 
 Demography and Other baseline Characteristics - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Race/ If 
Other, 
Specify 
Ethnicity/ If 
Other, 
Specify 
Weight (kg) 
Height (cm) 
BMI 
(kg/m2) 
If Female, 
then WOCBP 
If Not WOCBP, 
then Specify 
Urine Pregnancy Test 
Performed[1]/ If No, 
Specify 
Date and Time of 
Urine Pregnancy 
Test 
Result 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Asian 
xxxxxx 
xx.xx 
xx.xx 
xx.xx 
- 
- 
- 
- 
- 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
Other: xxxx 
Other: xxxx 
xx.xx 
xx.xx 
xx.xx 
Yes 
- 
Yes 
DDMMMYYYYT 
HH:MM 
Negative 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
28/ 
Female 
xxxxxx 
xxxxxx 
xx.xx 
xx.xx 
xx.xx 
No 
Other: xxxx 
No: xxxx 
- 
- 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Date: 
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Listing 16.2.4.3 
Medical History - Safety Analysis Set 
Patient No./ 
Treatment 
Age/Gender 
Primary System Organ Class 
Preferred Term 
Reported Term 
Start Date/ 
End Date 
Currently taking medication? 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/Male 
Xxxxx 
xxxx 
xxxxx 
DDMMMYYY/  
DDMMMYYY 
No 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/Female 
Xxxxx 
xxxxx 
xxxxx 
DDMMMYYY 
Yes 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
28/Female 
Xxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Medical History Conditions were coded using MedDRA Dictionary, Version 19.1. 
 
 
Programming Note (not part of table): Sort by treatment, patient number. 
 
 
 
 
 
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Version Date: 
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Listing 16.2.4.4 
Prior and Concomitant Medication - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Medication 
Name 
Reported/ 
Preferred 
Term 
Prior or 
Concomitant 
Medication Considered as a 
Standard of Care for the 
Treatment of Asthma 
Start Date/Study 
Day 
End Date/ 
Ongoing/Study Day 
Dose 
(Unit) 
Route/ 
Frequency 
Indication/ 
Specify 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
xxxxx/ xxxx 
Concomitant 
Yes 
DDMMMYYYY/xx 
Ongoing 
xx 
(xxx) 
xxxx 
xxxxxx/ 
xxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
xxxxx/ xxxx 
Prior 
No 
DDMMMYYYY/xx 
DDMMMYYYY/xx 
xx 
(xxx) 
xxxx 
xxxxxx/ 
xxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
28/ 
Female 
xxxxx/ xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
……….. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
 
- 
WHO-DD: World Health Organization-Drug Dictionary. 
- 
Prior medication: Medications which started and stopped prior to the administration of study drug. 
         - 
Concomitant medication: Medications which started prior to, on or after the administration of study drug and ended on or after the date of administration of study drug or were ongoing at the end of the 
study 
         - 
If Date of assessment ≥  Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, else Study Day= Date of assessment – Reference start date. 
         - 
Prior Medications were coded using WHO Drug Dictionary, Version DDMMMYYYY 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number. 
 
 
 
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Version Date: 
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Listing 16.2.4.5 
Virology at Screening - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Blood Sample 
Collected for Virology 
If No, Specify 
Date of Sample 
Collection 
Hepatitis B Surface Antigen/ 
If Not Done, Specify 
Hepatitis C Antibody/ If 
Not Done, Specify 
HIV Antibody/ If Not 
Done, Specify 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Yes 
 
DDMMMYYYY 
Negative 
Negative 
Negative 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Yes 
 
DDMMMYYYY 
Not Done/ xxxxxxxx 
Negative 
Negative 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
No 
xxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming Note (not part of table): Sort by treatment and patient number. 
 
 
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Version Date: 
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Listing 16.2.4.6 
TB Screening - Safety Analysis Set 
Patient No / 
Treatment 
Age/ 
Gender 
Was a blood sample collected for 
quantiferon gold test? 
If No, Specify reason 
Date of sample collection 
Result 
XXX/ 
XXX/ 
XXX/ 
X 
32/ 
Male 
Yes 
 
DDMMMYYYY 
Negative 
XXX/ 
XXX/ 
XXX/ 
X 
31/ 
Female 
No 
xxxx 
 
 
XXX/ 
XXX/ 
XXX/ 
x 
28/ 
Female 
Yes 
 
DDMMMYYYY 
Positvie 
… 
 
 
 
 
 
 
Note: 
           - 
TB: Tuberculosis 
 
Programming Note (not part of table): Sort by treatment and patient number. 
 
 
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Version Date: 
18Dec2018 
 
 
Listing 16.2.4.7 
Drugs of Abuse - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Was a Sample Collected for Drugs of 
Abuse? 
If No, Specify Reason 
Date of Sample Collection 
Result 
If Positive , Specify 
XXX/ 
XXX/ 
XXX/ 
X 
32/ Male 
Yes 
- 
DDMMMYYYY 
Negative 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
XXX/ 
X 
31/ Female 
No 
xxxx 
 
 
 
 
------------ 
 
 
 
 
 
XXX/ 
XXX/ 
XXX/ 
x 
28/ 
Female 
Yes 
- 
DDMMMYYYY 
Positvie 
xxxx 
… 
 
 
 
 
 
 
 
Programming Note (not part of table): Sort by treatment and patient number. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Date: 
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Listing 16 2.5.1 
Study Drug Exposure - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
IP Administered via IV 
Dose Start Date and Time 
Dose End Date and Time 
Total Volume 
Administered (ml) 
Specify Reason if Total Volume 
Administered is <100 ml 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
xxxxx/ xxxx 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
xxx 
xxxxxxx 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
xxxxx/ xxxx 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
xxx 
- 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
28/ 
Female 
xxxxx/ xxxx 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note:  
IP – Investigational Product 
IV – Intravenous 
 
Programming Note (not part of table): Sort by treatment, patient number. 
 
 
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Version Date: 
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Listing 16.2.5.2 
Individual ANB020 Pharmacokinetic Sampling Times and Concentrations by Time Point 
Safety Analysis Set 
 
 
Patient No. 
Visit 
Blood 
sample 
collected 
for PK 
analysis 
If no, 
specify 
reason 
Dose Date/ 
Time 
Nominal Time 
point 
Sample Date/ 
Time  
Collection 
Actual 
Elapsed 
Time (h) 
Deviation 
(h:min) 
(derived) 
Concentration 
(µg/mL) 
Comment 
XXX 
Day 
1 
Yes 
 
DDMMMYYYY/ 
HH:MM 
 Pre-dose (-0.5 
hours) 
DDMMMYYYY/HH:MM 
xx.xx 
HH:MM 
xxxx 
 
 
 
Yes 
 
 
0.5 hours post SOI  
DDMMMYYYY/HH:MM 
xx.xx 
HH:MM 
xxxx 
 
 
 
Yes 
 
 
EOI  
DDMMMYYYY/HH:MM 
xx.xx 
HH:MM 
xxxx 
 
 
 
Yes 
 
 
EOI+3 hours  
DDMMMYYYY/HH:MM 
xx.xx 
HH:MM 
xxxx 
 
XXX 
Day 
2 
No 
xxxxxx 
DDMMMYYYY/ 
HH:MM 
24 hours post SOI  
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
BLQ = below lower limit of quantitation (LLOQ). LLOQ = xxx µg/mL. 
Programming Note (not part of table)  Sort by patient number, visit, nominal time. Present all the visits , including unscheduled/early termination.. 
 
 
 
 
 
 
 
 
 
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Version Date: 
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Listing 16.2.5.3 
Individual ANB020 Pharmacokinetic Parameters Following ANB020 Treatment 
Safety Analysis Set 
 
Patient No. 
Cmax (ug/mL) 
tmax (h) 
AUC(0-inf) 
(h*ug/mL) 
AUC(0-last) 
(h*ug/mL) 
t1/2 (h) 
Lambda_z (1/h) 
CL (L/h) 
Vz (L)  
Vss (L) 
XXX 
xxxx 
xxxx 
 
 
 
 
 
 
 
XXX 
xxxx 
xxxx 
 
 
 
 
 
 
 
XXX 
xxxx 
xxxx 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
Programming Note (not part of table)  Sort by patient number. 
 
 
 
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Version Date: 
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Listing 16.2 5.3 
Individual Diagnostic ANB020 Pharmacokinetic Parameters Following ANB020 Treatment 
Safety Analysis Set 
 
Patient No.  
Lambda-z_lower (h) 
Lambda-z_upper (h) 
t1/2, Interval (h) 
t1/2, N 
Rsq  
%AUCex  
XXX 
 
 
 
 
 
 
XXX 
 
 
 
 
 
 
XXX 
 
 
 
 
 
 
…  
 
 
 
 
 
 
Note(s): Lambda_z_lower = the start time of the interval of the log-linear regression to determine lambda_z and t1/2; Lambda_z_upper = the end time of the interval of the log-linear regression to determine 
lambda_z and t1/2; ND = not determined; Rsq = coefficient of determination for calculation of lambda_z; t1/2, Interval = the time interval in the terminal phase used to determine lambda_z; t1/2, N = number of 
observations included in calculation of lambda_z; %AUCex = percentage of AUC(0-inf) extrapolated.   
 
Programming Note (not part of table)  Sort by patient number. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Date: 
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Listing 16.2.6.1 
Fractional Exhaled Nitric Oxide Test - Full Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Visit 
Fractional Exhaled Nitric Oxide 
Test Performed 
Date and Time of Test/ Study Day 
Measurement of FeNO (in 
ppb) 
Change from Baseline 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Screening 
Yes 
DDMMMYYYYTHH:MM/ xx 
xxx 
- 
 
 
Baseline 
Yes 
DDMMMYYYYTHH:MM/ xx 
xxx 
- 
 
 
Day 2 
Yes 
DDMMMYYYYTHH:MM/ xx 
xxx 
xxx 
 
 
Day 8 
Yes 
DDMMMYYYYTHH:MM/ xx 
xxx 
xxx 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
Screening 
Yes 
DDMMMYYYYTHH:MM/ xx 
xxx 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
……. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
 
- 
FeNO: Fractional Exhaled Nitric Oxide. 
- 
Baseline is defined as the pre-dose measurement taken prior to ANB020 or placebo administration at randomization [Day 1], i.e. reference start date. If the pre-dose measurement and the reference start 
date coincide, that measurement will be considered baseline. 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, 
else Study Day= Date of assessment – Reference start date. 
 
Programming Note (not part of table): Sort by treatment, patient number and visit. 
 
 
 
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Version Date: 
18Dec2018 
 
 
 
Listing 16.2.6.2 
Spirometry - Full Analysis Set 
Patient 
No./ 
Treatment 
Age/ 
Gender 
Visit 
Date of Spirometry or Peak 
Flow/ Study Day 
Predicted 
FEV1 (L) 
Change 
from 
Baseline 
Predicted 
FEV1 (L) 
Actual 
FEV1 
(L) 
Change 
from 
Baseline 
Actual 
FEV1 
(L) 
FEV1 % 
Predicted 
Change from Baseline Predicted FEV1 % 
Bronchodilator 
Administered on 
Day 1/ Time of 
Administration 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Screening 
DDMMMYYYYTHH:MM 
/ xx 
xxx 
 
xxx 
 
xxx 
 
- 
 
 
Baseline Pre 
Bronchodilator 
DDMMMYYYYTHH:MM/ 
xx 
xxx 
 
xxx 
 
xxx 
 
- 
 
 
Post 
Bronchodilator 
DDMMMYYYYTHH:MM/ 
xx 
xxx 
 
xxx 
 
xxx 
 
Yes/ HH:MM 
 
 
Day 2 
DDMMMYYYYTHH:MM 
/ xx 
xxx 
xxx 
xxx 
xxx 
xxx 
xxx 
- 
 
 
Day 8 
DDMMMYYYYTHH:MM 
/ xx 
xxx 
xxx 
xxx 
xxx 
xxx 
xxx 
- 
 
 
………… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
…….. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
- 
FEV1: Forced Expiratory Volume in 1 second. 
- 
Day1 pre-bronchodilator spirometry assessment will be considered as the baseline. 
- 
Post Bronchodilator readingis captured only at Day 1. For all other study center visits, only pre-bronchodilator spirometry has been performed 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, else Study Day= Date of assessment – Reference start date.  
 
 
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Version Date: 
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Listing 16 2.6.3 
Asthma Control Questionnaire - Full Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Visit 
ACQ 
Completed 
Questions  
Result 
Change from 
Baseline 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Screening 
Yes 
On average, during the past week, how often were you woken by your asthma during the night? 
1 
 
 
 
 
 
On average, during the past week, how bad were your asthma symptoms when you woke up in the morning? 
0 
 
 
 
 
 
… 
 
 
 
 
 
 
On average, during the past week, how many puffs/inhalations of short-acting bronchodilator (eg. Ventolin/Bricanyl) 
have you used each day? 
6 
 
 
 
 
 
Total ACQ Score 
xx 
- 
 
 
 
 
FEV1 % predicted 
xx 
 
 
 
Baseline 
Yes 
On average, during the past week, how often were you woken by your asthma during the night? 
1 
 
 
 
 
 
… 
 
 
 
 
 
 
Total Score 
xx 
 
 
 
 
 
FEV1 % predicted 
xx 
 
 
 
Day 8 
Yes 
On average, during the past week, how often were you woken by your asthma during the night? 
1 
 
 
 
 
 
……….. 
 
 
 
 
 
 
Total ACQ Score 
xx 
xx 
 
 
 
 
FEV1 % predicted 
xx 
 
 
 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
…………. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
- 
ACQ: Asthma Control Questionnaire. 
- 
Baseline is defined as the pre-dose measurement taken prior to ANB020 or placebo administration at randomization [Day 1], i.e. reference start date. If the pre-dose measurement and the reference start 
date coincide, that measurement will be considered baseline. 
- 
Total ACQ has been calculated as sum of all individual scores for each patient at each visit. ACQ will be missing if any individual score is missing. 
 
 
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Version Date: 
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Listing 16.2.6.4 
Patient Diary - Full Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Visit 
Date of First Diary 
Entry/ Date of Last 
Diary Entry/ Study 
Days 
Need to Use 
Rescue Inhaler 
If Yes, Total Number of 
Puffs/ Total Number of 
Days the Rescue inhaler 
Used 
Description of 
the Change 
Related to 
Asthma[a] 
Experiencing any 
Symptom/ If 
Others, Specify 
Change in any of 
the Prescribed 
Medicine/ Specify 
Rate of Study 
Treatment 
Level of Satisfaction 
with the Side Effects 
Related to Study 
Treatment 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Screening 
DDMMMYYYY/ 
DDMMMYYYY/ 
xx/xx 
No 
- 
2 
Other/ xxxx 
No 
Good 
Good 
 
 
Baseline 
DDMMMYYYY/ 
DDMMMYYYY/ 
xx/xx 
Yes 
xx/ xx 
2 
Cough 
Yes/ xxxx 
Fair 
Good 
 
 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
………. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
- 
Study day is calculated for both first and last diary entry date. 
 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, else Study Day= Date of assessment – Reference start date. 
- 
[a]: 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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Version Date: 
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Listing 16.2.6.5 
Clinical Global Impression of Change Scale - Full Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Visit 
CGIC Performed/ If No, 
Specify Reason 
Date of Assessment/ 
Study Day 
Description of the Change in 
Patient’s Overall Asthma Symptom 
[a] 
Any Asthma Exacerbations 
Occurred Since the Past Week 
Type of cercerbation 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Day 2 
No/ xxxx 
- 
- 
- 
- 
 
 
Day 8 
Yes 
DDMMMYYYY/ 
xx 
4 
Yes 
Inpatient hospitalization 
due to asthma (>24hrs) 
 
 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
Day 2 
Yes 
DDMMMYYYY/ 
xx 
2 
No 
- 
 
 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
 
 
………… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
 
- 
CGIC: Clinical Global Impression of Change Scale.  
- 
[a]: 1=Very much improved, 2= Much improved, 3=Minimally improved, 4=No changes, 5=Minimally worse, 6=Much worse, 7=Very much worse 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, else Study Day= Date of assessment – Reference start date. 
 
 
Programming Note (not part of table): Sort by treatment, patient number and visit. 
 
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Version Date: 
18Dec2018 
 
 
Listing 16.2.6.6 
Time to first asthma exacerbation - Full Analysis Set 
 
Patient No./ 
Treatment 
Date of Randomization 
Date of first Exacerbation 
Time of first Exacerbation 
Censored 
 
 
 
 
 
XXX/ 
XXX/ 
DDMMMYYYY  
DDMMMYYYY 
xxxx 
Yes 
 
 
 
 
 
XXX/ 
XXX/ 
DDMMMYYYY 
DDMMMYYYY 
xxxx 
No 
 
 
 
 
 
………… 
 
 
 
 
 
 
 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number and visit. 
 
 
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Version Date: 
18Dec2018 
 
Listing 16.2.6.7 
Rescue Medication - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Medication Name 
Start Date/ Study Day 
End Date/ Study Day/ Ongoing 
Dose (Unit)  
Frequency 
Route 
Indication 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
xxxxx 
DDMMMYYYY/ xx 
DDMMMYYYY/ xx 
xx (xx) 
xxxxx 
xxxxx 
xxxxx 
 
 
xxxxx 
DDMMMYYYY/ xx 
Ongoing 
xx (xx) 
xxxxx 
xxxxx 
xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
xxxxx 
DDMMMYYYY/ xx 
DDMMMYYYY/ xx 
xx (xx) 
xxxxx 
xxxxx 
xxxxx 
 
 
………. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
………………….. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, 
else Study Day= Date of assessment – Reference start date. 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number, and start date. 
 
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Version Number: 
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Version Date: 
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Listing 16.2.7.1 
Adverse Event - Safety Analysis Set 
Patient 
No./ 
Treatment 
Age/ 
Gender 
System Organ 
Class/ Preferred 
Term/Verbatim 
Term 
Start Date/ 
Study Day 
End Date/ 
Study Day 
Did AE 
Occur 
Prior to the 
Start of 
IP? 
Severi
ty 
TEAE 
Final 
Outcome 
Action taken  
with the 
Study Drug 
Relationship 
to Study Drug 
Serious/ 
Criteria[a] 
Did the AE 
Cause the 
Patient to 
Discontinue 
from the 
Study? 
Was 
Patient 
Treated 
for AE? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
xx/xx/xx 
DDMMMY
YYY/ xx 
DDMMMY
YYY/ xx 
No 
Severe 
Yes 
Recovered 
Dose 
interrupted 
Unlikely 
Yes/ 
XXX 
Yes 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
xx/xx/xx 
DDMMMY
YYY/ xx 
DDMMMY
YYY/ xx 
Yes 
Mild 
No 
Fatal 
Drug 
permanently 
discontinued 
Possible 
Yes/ 
XXX 
Yes 
Yes 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note:  
- 
[a]: If SAE led to death, then date of death and primary/ secondary cause of death are provided; if required hospitalization, then date  
of admission and date of discharge are provided. 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1,, else Study Day= Date of assessment – Reference start date. 
- 
TEAE: Treatment emergent adverse event is defined as AE that started or worsened in severity on or after the date and time of the study drug infusion. 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number, and start date. 
 
 
 
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Version Number: 
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Version Date: 
18Dec2018 
 
 
 
 
Listing 14.3 2.1 
Treatment Emergent Adverse Events Leading to Deaths - Safety Analysis Set 
 
 
Programming Note:  Repeat the same template of Listing 16.2.7.1. Remove the column “Final Outcome” 
 
 
Listing 14.3 2.2 
Serious Treatment Emergent Adverse Event - Safety Analysis Set 
 
 
Programming Note:  Repeat the same template of Listing 16.2.7.1. Remove the column “Serious/Criteria”. 
 
Listing 14.3 2.3 
Treatment Emergent Adverse Events Leading to Discontinuation from Study or of IP - Safety Analysis Set 
 
 
Programming Note:  Repeat the same template of Listing 16.2.7.1. Remove the column “Did the AE cause the Patient to discontinue from the study and Action taken  with the Study Drug”. 
 
 
 
Listing 14.3.4.1 
Clinically Significant Laboratory Results - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Test 
Blood Sample Collected / 
If No, Specify 
Parameter 
Visit 
Date of Sample 
Collection/ Study Day 
Result[a] 
Unit 
Reference 
Range 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Hematology 
Yes 
Hemoglobin 
Screening 
DDMMMYYYY/ xx 
xxxx 
xx 
(xx-yy) 
- 
 
 
 
 
 
Baseline 
DDMMMYYYY/ xx 
xxxx 
xx 
(xx-yy) 
- 
 
 
 
 
 
Day 2 
DDMMMYYYY/ xx 
xxxx 
xx 
(xx-yy) 
xx 
 
 
 
 
 
Day 8 
DDMMMYYYY/ xx 
xxxx 
xx 
(xx-yy) 
xx 
 
 
 
 
 
…… 
 
 
 
 
 
 
 
 
 
 
EOS 
DDMMMYYYY/ xx 
xxxx 
xx 
(xx-yy) 
xx 
 
 
 
 
 
 
 
 
 
 
 
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Version Date: 
18Dec2018 
 
Listing 14.3.4.1 
Clinically Significant Laboratory Results - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Test 
Blood Sample Collected / 
If No, Specify 
Parameter 
Visit 
Date of Sample 
Collection/ Study Day 
Result[a] 
Unit 
Reference 
Range 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Parameters> 
<Visits> 
……….. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical 
Chemistry 
Yes 
<Parameters> 
<Visits> 
DDMMMYYYY/ xx 
xxxx 
xx 
(xx,xx) 
- 
…………. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
- 
[a]:The high (H) or low (L) values are only flagged. 
- 
Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests). 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, else Study Day= Date of assessment – Reference start date. 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Listing 16.2.8.1 
Serum Pregnancy Test - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Visit 
Test Performed 
If No, Specify 
Date of Pregnancy Test/ 
Study Day 
Result 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Female 
Screening 
Yes 
- 
DDMMMYYYY/ xx 
Negative 
 
 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Female 
Screening 
Yes 
- 
DDMMMYYYY/ xx 
Negative 
 
 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
Screening 
No 
xxxx 
- 
- 
 
 
<Visits> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, 
else Study Day= Date of assessment – Reference start date. 
- 
The listings consists only of female patients in SAF population. 
 
Programming Note (not part of table): Sort by treatment, patient number and visit. 
 
Listing 16.2.8.2 
Electrocardiogram Results - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
ECG Performed 
Test (Unit) 
Visit 
Date of Assessment/ 
(Study Day 
Results  
Change from Baseline 
If Abnormal CS, Details 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Female 
Yes 
Heart Rate (bpm) 
Screening 
DDMMMYYYY/ xx 
xx 
- 
- 
 
 
 
 
EOS 
DDMMMYYYY/ xx 
xx 
xx 
- 
 
 
 
 
 
 
 
 
 
 
 
 
<Parameters> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Overall Result 
Screening 
DDMMMYYYY/ xx 
Normal 
- 
 
 
 
 
 
EOS 
DDMMMYYYY/ xx 
Abnornal CS 
- 
xxxxxxxx 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Listing 16.2.8.2 
Electrocardiogram Results - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
ECG Performed 
Test (Unit) 
Visit 
Date of Assessment/ 
(Study Day 
Results  
Change from Baseline 
If Abnormal CS, Details 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
No 
<Parameters> 
<Visits> 
 
 
 
 
………. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
- 
Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests). 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, else Study Day= Date of assessment – Reference start date. 
- 
CS: Clinically Significant, NCS: Not Clinically Significant 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number and visit. 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
 
Listing 16.2.8.3 
Vital Signs - Safety Analysis Set 
 
Patient No./ 
Treatment 
Age/ 
Gender 
Vital Signs 
Collected 
Parameter 
Unit 
Visit 
Date of Assessment/ 
Study Day 
Result 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Female 
Yes 
Pulse Rate 
xx 
Screening 
DDMMMYYYY/ xx 
xxxx 
- 
 
 
 
 
 
Baseline 
DDMMMYYYY/ xx 
xxxx 
- 
 
 
 
 
 
Day 2 
DDMMMYYYY/ xx 
xxxx 
xx 
 
 
 
 
 
…….. 
 
 
 
 
 
 
 
 
EOS 
DDMMMYYYY/ xx 
xxxx 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
<Parameters> 
xx 
<Visits> 
…………. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
Yes 
<Parameters> 
xx 
<Visits> 
…………. 
 
 
…………… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
 
- 
Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests). 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, else Study Day= Date of assessment – Reference start date. 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number and visit. 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Listing 16.2.8.4 
Physical Examination - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Physical Examination 
Performed 
Body System 
Visit 
Date of Examination/ 
Study Day 
Result 
If Abnormal, clinically 
significant, specify 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Female 
Yes 
General Appearance 
Screening 
DDMMMYYYY/ xx 
Normal 
- 
 
 
 
 
EOS 
DDMMMYYYY/ xx 
Normal 
- 
 
 
 
 
 
 
… 
 
 
 
 
HEENT (head, eyes, ears, nose, throat) 
Screening 
DDMMMYYYY/ xx 
Abnormal CS 
xxxx 
 
 
 
 
EOS 
DDMMMYYYY/ xx 
Normal 
- 
 
 
 
 
 
 
 
 
 
 
 
<Body Systems> 
 
 
 
 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
31/ 
Female 
No 
<Body Systems> 
<Visits> 
…………. 
 
- 
………….. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
- 
Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests). 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, else Study Day= Date of assessment – Reference start date. 
- 
CS: Clinically Significant, NCS: Not Clinically Significant 
 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number and visit. 
 
 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Listing 16 2.8.5 
Anti-Drug Antibody Assessment - Safety Analysis Set 
Patient No./ 
Treatment 
Age/ 
Gender 
Serum Sample Collected/ If 
No, Specify 
 
Visit 
Date and Time of Sample 
Collection/ Study Day 
Result 
Titer 
 
 
 
 
 
 
 
 
XXX/ 
XXX/ 
32/ 
Male 
Yes 
 
Baseline 
DDMMMYYYY/ HH:MM/ xx 
Positive 
- 
 
 
Yes 
 
Day 8 
DDMMMYYYY/ HH:MM/ xx 
Negative 
xx 
 
 
 
 
Day 36 
DDMMMYYYY/ HH:MM/ xx 
Positive 
xx 
 
 
 
 
……… 
 
 
 
 
 
 
 
<Visits> 
DDMMMYYYY/ HH:MM/ xx 
Negative 
- 
…………… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
- 
If Date of assessment ≥ Reference Start Date then Study Day= (Date of assessment – Reference start date) +1, else Study Day= Date of assessment – Reference start date. 
- 
Baseline will be last non-missing measurement taken prior to reference start date (including unscheduled assessments or retests). 
 
 
 
Programming Note (not part of table): Sort by treatment, patient number and visit.Present for all available visits. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Listing 16.2.9.1 
Cytokines Assessment  
Safety Analysis Set 
 
Treatme
nt 
Patien
t No. 
Visi
t 
 
Sample 
Date/Time 
 
IL-4 
(pg/mL) 
IL-5 
(pg/mL) 
IL-13 
(pg/mL) 
IL-33 
(pg/mL) 
sST2 
(pg/mL) 
Obs 
CFB 
RTB 
Obs 
CFB 
RTB 
Obs 
CFB 
RTB 
Obs 
CFB 
RTB 
Obs 
CFB 
RTB 
Placebo 
XXX 
Day 
1 
DDMMMYYY
Y/ HH:MM 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
 
 
Day 
2 
DDMMMYYY
Y/ HH:MM 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
ANB020 
XXX 
Day 
1 
DDMMMYYY
Y/ HH:MM 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
Xxxx 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BLQ = below lower limit of quantitation (LLOQ); CFB = change from baseline; IL = Interleukin; Obs = observed; RTB = ratio to baseline. 
LLOQ: IL-4 = xxx pg/mL; IL-5 = xxx pg/mL; IL-13 = xxx pg/mL; IL-33 = xxx pg/mL; sST2 = xxx pg/mL. 
Note: For summary and analysis purposes BLQ values were considered as 1/2 * LLOQ. 
 
Programming Note (not part of table)  Sort by treatment, patient number, visit. Present all visits. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Listing 16.2.9.2 
Eosinophil Assessment  
Safety Analysis Set 
 
Treatment 
 
Patient No. 
Visit 
 
Blood sample collected for 
eosinophils 
If no, specify 
Sample Date/Time 
 
Eosinophils 
(unit) 
 
Observed 
CFB 
RTB 
Placebo 
XXX 
Day 1 
Yes 
 
DDMMMYYYY/ HH:MM 
Xxxx 
Xxxx 
Xxxx 
 
 
Day 2 
No 
xxxxxx 
 
 
 
 
ANB020 
XXX 
Day 1 
Yes 
 
DDMMMYYYY/ HH:MM 
Xxxx 
Xxxx 
Xxxx 
 
… 
 
 
 
 
 
 
 
BLQ = below lower limit of quantitation (LLOQ); CFB = change from baseline. RTB = ratio to baseline. 
LLOQ: xxx <units>. 
Note: For summary and analysis purposes BLQ values were considered as 1/2 * LLOQ. 
 
Programming Note (not part of table)  Sort by patient number, visit. Present all visits. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Author: 
Version Number: 
1.0 
 
 
Version Date: 
18Dec2018 
 
Listing 16.2.9.3 
Ex-vivo induced IFN-y assessment  
Safety Analysis Set 
 
 
Treatment 
Patient No. 
Visit 
Blood sample 
collected for ex-
vivo induced 
IFN-y analysis  
If no, 
specify 
Date and time of 
sample collection 
Observed 
 (units) 
Change from 
Baseline (units) 
Ratio to baseline 
 
Placebo 
XXX 
Day 1 
Yes 
 
DDMMMYYYY/ 
HH:MM 
xxxx 
xxxx 
xxxx 
 
 
 
Day 127 
Yes 
 
DDMMMYYYY/ 
HH:MM 
xxxx 
xxxx 
xxxx 
 
ANB020 
XXX 
Day 1 
Yes 
 
DDMMMYYYY/ 
HH:MM 
xxxx 
xxxx 
xxxx 
 
 
 
Day 127 
No 
 
DDMMMYYYY/ 
HH:MM 
xxxx 
xxxx 
xxxx 
 
BLQ = below lower limit of quantitation (LLOQ). 
LLOQ = xxx <unit>. 
Note: For summary and analysis purposes BLQ values will be considered as 1/2 * LLOQ. 
Programming Note (not part of table)  Sort by treatment, patient number, visit.  Present all visits. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Author: 
Version Number: 
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Version Date: 
18Dec2018 
 
Listing 16.2.9.4 
Patient Screening Summary - All Patients Screened 
 
 
 
 
Patient No. 
 
Age/Gender 
Date and Time of IC 
Confirmed Informed Consent at 
Day 1/If No, Specify 
Patient Randomized/ 
Date 
Randomization No. 
Assigned Treatment 
Administered the 
Treatment 
 
 
 
 
 
 
 
 
XXX 
32/Male 
DDMMMYYYYTHH:MM 
Yes 
Yes/ DDMMYYYY 
xx 
Yes 
Yes 
 
 
 
 
 
 
 
 
XXX 
31/Female 
DDMMMYYYYTHH:MM 
Yes 
- 
- 
- 
Screen Failure 
 
 
 
 
 
 
 
 
XXX 
28/Female 
DDMMMYYYYTHH:MM 
No: xxxx 
- 
- 
- 
Subject Withdrew 
Consent 
------ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 
- 
IC: Informed Consent. 
 
Programming Note (not part of table): Sort by treatment, patient number. 
 
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FIGURE SHELLS
Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients with Severe 
Eosinophilic Asthma
Study No. ANB020-004
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List of Reviewers
Reviewer Name
Position/ Role
Company
IQVIATM
IQVIATM
IQVIATM
IQVIATM
IQVIATM
AnaptysBio, Inc
AnaptysBio, Inc
AnaptysBio, Inc
AnaptysBio, Inc
AnaptysBio, Inc
AnaptysBio, Inc
AnaptysBio, Inc
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Version Date:
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Modification History
Unique 
Identifier for 
this Version
Date of the Document 
Version
Author
Significant Changes from 
Previous Authorized Version
Draft 0 1
04 Dec 2017
Not Applicable - First Draft
Draft 0 2
07 Dec 2017
Resolved comments from internal review
Draft 0 3
03 Dec 2018
Resolved comments from sponsor review
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Figure 14 4 2 1
Waterfall plot: Change from Baseline in Peripheral Eosinophil Count on Day 22 – Pharmacodynamic Analysis Set
Programming Note: This is graph is only for representation purpose   Y axis should have the % change from baseline, X-axis should have the treatments
Figure 14 4 2 2
Waterfall plot: Change from Baseline in Peripheral Eosinophil Count on Day 127/ET – Pharmacodynamic Analysis Set
Programming note: The abive layout should be followed
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Figure 14 4 2 2
Mean (±95% CI) Change from Baseline Eosinophil Count-time Profiles – Pharmacodynamic Analysis Set
A plot similar to Figure 14 4 2 1 will be presented for change from baseline values
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Figure 14 4 2 4
Mean (±95% CI) Change from Baseline Concentration-time Profiles for Serum Cytokines – Pharmacodynamic Analysis Set
A plot similar to Figure 14 4 2 3 will be presented for change from baseline values
<Programming Note: Present for all cytokines analytes with units Analytes: IL-4, IL-5, IL-13, IL-33, and sST2 >
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Figure 14 4 2 6
Mean (±95% CI) Change from Baseline for Ex-vivo IFN-gamma – Pharmacodynamic Analysis Set
A plot similar to Figure 14 4 2 5 will be presented for change from baseline values
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Figure 14 4 2 7
Scatter Plot of Observed Eosinophil Count versus Serum ANB020 Concentration – Pharmacodynamic Analysis Set
Figure 14 4 2 8
Scatter Plot of Observed Serum Cytokine Levels versus Serum ANB020 Concentration – Pharmacodynamic Analysis Set
Note: All available cytokines will be presented on separate plots
Figure 14 4 2 9
Scatter Plot of Observed Ex-vivo IFN-gamma Levels versus Serum ANB020 Concentration – Pharmacodynamic Analysis Set
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Biostatistics File Note 
Page 1 of 5 
 
Form No.:  CS_FM_BS020 Revision 3 
Reference:  CS_OP_BS001 
Effective Date:  12Nov2017 
 
Copyright © 2010, 2012, 2017 IQVIA. All rights reserved. The contents of this document are confidential and proprietary to IQVIA 
Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
Section A 
 
Customer: 
AnaptysBio, Inc. 
 
 
Project Code: 
CYA74392 
 
 
Protocol Number: 
ANB020-004 
 
 
Title of Note: 
Additional analyses outside the scope of final SAP (Version Date: 
18DEC2018) 
 
Section B 
 
DESCRIPTION: 
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Biostatistics File Note 
Page 2 of 5 
 
Form No.:  CS_FM_BS020 Revision 3 
Reference:  CS_OP_BS001 
Effective Date:  12Nov2017 
 
Copyright © 2010, 2012, 2017 IQVIA. All rights reserved. The contents of this document are confidential and proprietary to IQVIA 
Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
Background 
The note-to-file (NTF) is intended to document the additional analyses that are outside the scope 
of the final SAP dated 18DEC2018. 
 
Objective 
The objective of the additional analysis is to assess the reduction in asthma control questionnaire 
(ACQ) 5 score relative to the scheduled study time points including day 8, 22, 36, 64, 85, 106 
and end of study (EOS) visit. 
 
Endpoint 
The endpoint of the additional analysis is ACQ-5 score and its percent change from baseline 
relative to scheduled study time points. 
 
Analysis Set 
Full analysis set (FAS), as defined in the SAP dated 18DEC2018, will be used for the analysis. 
 
Analysis Method 
The analyses will be performed descriptively using n (number of subjects with non-missing 
values), mean, standard deviation (SD), median, minimum and maximum as summary statistics. 
Additionally, 95% confidence interval (CI) for mean will also be provided.  
 
The above mentioned summary statistics and 95% CI’s for mean using classical method will be 
provided for both observed and percent change from baseline relative to different scheduled 
visits for ACQ-5 score. Summaries for screening and baseline will be provided for the observed 
values only. 
 
Number of subjects within each treatment group under FAS (N) will also be reported along with 
summary statistics for the analysis. 
 
A line plot for mean (± SD) percent change from baseline for ACQ-5 score will be provided for 
each of the treatment groups against the applicable scheduled study visits. 
 
A listing detailing the individual ACQ component scores along with ACQ-5 score will be 
presented for each visit of data collection along with demographic characteristics such as age 
and gender for each subject as applicable. 
 
Derivation 
ACQ-5 score will be derived by summing the 5 individual scores, as described in Table 1, and 
utilizing the average for each subject at each applicable visit. A percentage of change from 
baseline was then assessed.  
 
Symptoms will be scored on a scale of 0 to 6 with 6 being the worst case. ACQ-5 will be missing 
if any individual score is missing. 
 
Table 1: Individual components and corresponding responses for calculating ACQ-5 
score 
 
Individual item 
Response 
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 
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Biostatistics File Note 
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Form No.:  CS_FM_BS020 Revision 3 
Reference:  CS_OP_BS001 
Effective Date:  12Nov2017 
 
Copyright © 2010, 2012, 2017 IQVIA. All rights reserved. The contents of this document are confidential and proprietary to IQVIA 
Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
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 
5. In general, during the past week, how 
much of the time did you wheeze? 
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  
 
 
Further action required: 
CONFIDENTIAL
Clinical Study Report ANB020-004 - Original
29 June 2020
165
AnaptysBio, ANB020
IND 126765, SN 0035


 
 
Biostatistics File Note 
Page 4 of 5 
 
Form No.:  CS_FM_BS020 Revision 3 
Reference:  CS_OP_BS001 
Effective Date:  12Nov2017 
 
Copyright © 2010, 2012, 2017 IQVIA. All rights reserved. The contents of this document are confidential and proprietary to IQVIA 
Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
List of outputs 
 
Below is the list of outputs that will be produced for the proposed analysis on ACQ-5. 
 
Table 1: Asthma Control Questionnaire (Summary of Scores for ACQ-5) - Full Analysis Set 
Listing 1: Asthma Control Questionnaire (ACQ-5) - Full Analysis Set 
Figure 1: Mean (±SD) % change from baseline of ACQ-5 score by visit 
 
Programming Note: 
 
One ADaM dataset “ADQS_AD” will be created by modifying the program of already existing 
dataset “ADQS”. “ADQS_AD” will have all the variables as in “ADQS” with only below mentioned 
additional information under “Programing logic for “ADQS_AD””. 
 
The newly created outputs and dataset mentioned in this NTF and their programs will be stored in 
the respective study folders as in the main analysis for this project. 
 
Programing logic for “ADQS_AD”: 
 
If ACQ-5 individual item are non-missing, then populate  
         PARAM=”ACQ5 Score”;  
         PARAMCD=”ACQ5”;  
         AVAL=5 Average of 5 individual ACQ-5 items if all the individual items are non-missing; else 
set the value of AVAL to missing if at least one individual item score is missing.  
         PARAMN=9; PARCAT2=”Asthma Control Questionnaire”;  
         AVALC=character result of AVAL;  
         ABLFL= “Y” (for baseline value, else populate as blank);  
        BASE=Populate the baseline value;  
        BASEC=Character result of BASE; 
        CHG=Post baseline - Baseline;  
        PCHG= [(Post baseline - Baseline)*100]/Baseline if non-zero baseline (BASE ne 0); else set 
the value of PCHG to missing if BASE = 0; 
 
Section C 
 
AUTHOR: 
 
Signature 
(Print 
Name): 
 
 
Signature 
(Sign): 
 
 
 
 
Job Title: 
 
Date:  
 
Reviewer: 
 
Signature 
(Print 
Name): 
 
 
Signature 
(Sign): 
 
 
 
 
Job Title: 
 
Date:  
 
 
 
 
CONFIDENTIAL
Clinical Study Report ANB020-004 - Original
29 June 2020
166
AnaptysBio, ANB020
IND 126765, SN 0035


 
 
Biostatistics File Note 
Page 5 of 5 
 
Form No.:  CS_FM_BS020 Revision 3 
Reference:  CS_OP_BS001 
Effective Date:  12Nov2017 
 
Copyright © 2010, 2012, 2017 IQVIA. All rights reserved. The contents of this document are confidential and proprietary to IQVIA 
Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
 
 
Approver: 
 
Signature 
(Print 
Name): 
 
 
Signature 
(Sign): 
 
 
 
 
Job Title: 
AnaptysBio, Inc 
Date:  
 
 
 
 
 
 
CONFIDENTIAL
Clinical Study Report ANB020-004 - Original
29 June 2020
167
AnaptysBio, ANB020
IND 126765, SN 0035