Clinical trial NCT04783389
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Sponsor: Connect Biopharm LLC
Start date: 2021-06-16; Completion date: 2022-06-10
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of CBP-201, rademikibart, in adult patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of CBP-201 on a background of mometasone furoate nasal spray (MFNS) in reducing endoscopic nasal polyp score (NPS) and nasal congestion/obstruction score (NCS) severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (INCS) therapy in comparison to placebo. CBP-201 is administered as a subcutaneous (SC) injection. The study is divided into a treatment period of 24 weeks and a follow-up period of 8 weeks.

Arms: arm 1: CBP-201 Dose 1 subcutaneous (SC) injection. arm 2: CBP-201 Dose 2 subcutaneous (SC) injection. arm 3: Placebo subcutaneous (SC) injection.
Interventions: intervention 1: CBP-201 intervention 2: Placebo
Intervention descriptions: intervention 1: CBP-201 subcutaneous (SC) injection. intervention 2: Placebo subcutaneous (SC) injection.

Protocol documents:
SAP_002.pdf: 
Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 1 of 52 
 
Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate CBP-201 in Adult 
Patients with Chronic Rhinosinusitis with Nasal Polyps  
 Statistical Analysis Plan 
Version: 2.0  
Parexel Project Number: 257643 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT04783389
Date: 20Jun2022
Note that the date below is effective date of 
the CRO SAP TEMPLATE document
SAP Signatures applied to last page
in Veeva Vault document management


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 2 of 52 
SPONSOR SIGNATURE PAGE 
 
 
 
Approved by:  
_________________________ 
 
_______________ 
 
Daniel Miconi  
 
 
 
 
Date 
 
Senior Manager, Clinical Operations 
 
 
Suzhou Connect Biopharmaceuticals Ltd. 
 
 
_________________________ 
 
_______________ 
 
Jang Yun, PhD 
 
 
 
 
Date 
 
Senior Director of Biostatistics, Clinical Operations 
 
 
Suzhou Connect Biopharmaceuticals Ltd. 
 
 
 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 3 of 52 
Parexel SIGNATURE PAGE 
Signature(s) below confirm that the Statistical Analysis Plan was developed in accordance with SOP-
GDO-WW-019 and that it is approved for release. 
This document has been approved and signed electronically on the final page by the following:  
 
 
Signatory 
Author 
Amy Kim 
Project Role:  Lead Biostatistician   
Reviewer 
Bazou Kone 
Project Role:  Biostatistician 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 4 of 52 
TABLE OF CONTENTS 
 
1 
INTRODUCTION ............................................................................................................ 10 
2 
STUDY OBJECTIVES .................................................................................................... 10 
2.1 
Primary Objective(s) ...................................................................................................... 10 
2.2 
Secondary Objective(s) .................................................................................................. 10 
2.3 
Exploratory Objective(s) ................................................................................................ 10 
3 
INVESTIGATIONAL PLAN.......................................................................................... 11 
3.1 
Overall Study Design and Plan ....................................................................................... 11 
3.2 
Schedule of Assessments ................................................................................................ 12 
3.3 
Endpoints ........................................................................................................................ 16 
3.3.1 
Efficacy Endpoints ......................................................................................................... 16 
4 
STATISTICAL METHODS ........................................................................................... 17 
4.1 
Data Quality Assurance .................................................................................................. 17 
4.2 
Definitions ...................................................................................................................... 17 
4.3 
General Presentation Considerations .............................................................................. 19 
4.3.1 
Analysis Window ........................................................................................................... 19 
4.3.2 
Handling of Incomplete Dates ........................................................................................ 22 
4.4 
Software .......................................................................................................................... 23 
4.5 
Study Subjects ................................................................................................................ 23 
4.5.1 
Disposition of Subjects ................................................................................................... 23 
4.5.2 
Protocol Deviations ........................................................................................................ 23 
4.6 
Analysis Populations ...................................................................................................... 23 
4.7 
Demographic and Other Baseline Characteristics .......................................................... 24 
4.8 
Medical History .............................................................................................................. 25 
4.9 
Prior and Concomitant Medication ................................................................................ 25 
4.10 
Treatment Compliance ................................................................................................... 25 
4.11 
Efficacy Evaluation ........................................................................................................ 25 
4.11.1 
Statistical Analysis and Data Conventions ..................................................................... 25 
4.11.2 
Co-primary Efficacy Analysis ........................................................................................ 26 
4.11.3 
Sensitivity Analysis ........................................................................................................ 28 
4.11.4 
Secondary Efficacy Analyses ......................................................................................... 30 
4.11.5 
Exploratory Efficacy Analysis ....................................................................................... 32 
4.12 
Safety Evaluation ............................................................................................................ 32 
4.12.1 
Extent of Exposure ......................................................................................................... 32 
4.12.2 
Adverse Events ............................................................................................................... 33 
4.12.3 
Adverse Event of Special Interest .................................................................................. 34 
4.12.4 
Clinical Laboratory Evaluation ...................................................................................... 35 
4.12.5 
Vital Signs ...................................................................................................................... 35 
4.12.6 
Electrocardiograms ......................................................................................................... 35 
4.12.7 
Physical Examinations .................................................................................................... 35 
4.12.8 
Data and Safety Monitoring Board (DSMB) .................................................................. 36 
4.13 
Other Analyses ............................................................................................................... 36 
4.13.1 
Pharmacokinetics ............................................................................................................ 36 
4.13.2 
Pharmacodynamics ......................................................................................................... 37 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 5 of 52 
4.13.3 
Immunogenicity .............................................................................................................. 37 
4.13.4 
Health Economics ........................................................................................................... 37 
4.14 
Determination of Sample Size ........................................................................................ 37 
4.15 
Changes in the Conduct of the Study or Planned Analysis ............................................ 38 
5 
REFERENCES ................................................................................................................. 39 
6 
APPENDICES .................................................................................................................. 40 
6.1 
Appendix A – Visual Analogue Scale for Rhinosinusitis (VAS-RS) ............................ 40 
6.2 
Appendix B – Total Nasal Symptom Score (TNSS) ...................................................... 42 
6.3 
Appendix C – Sino-Nasal Outcome Test-22 QUESTIONNAIRE (SNOT-22) ............. 43 
6.4 
Appendix D – Laboratory SI Units ................................................................................ 44 
6.5 
Appendix E: CTCAE V5.0 Toxicity Grading for Laboratory Parameters ..................... 46 
 
 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 6 of 52 
REVISION HISTORY 
 
Version No. 
Effective Date 
Summary of Change(s) 
0.1 
15-Jun-2021 
New document 
0.2 
14-Jul-2021 
Updated per Connect team review 
1.0 
30-Jul-2021 
Updated per CRM especially adding sensitivity analysis for 
use of rescue medication and statistical analysis for proportion 
of patients with minimal clinically important difference ≥ 8.9 
in SNOT-22 at Week 24. Also subgroup analyses were added 
and minor language was updated in rescue medication per 
client request 
1.1 
18-Jan-2022 
Updated per protocol amendment v3.0 and internal/Connect 
team review 
1.2 
25-Jan-2022 
Updated per Connect team review 
1.3 
19-May-22 
Updated to include change due early termination of the study. 
1.4 
15-Jun-22 
Updated section 4.3.1 and section 4.15 
 
 
 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 7 of 52 
LIST OF ABBREVIATIONS 
Abbreviation / Acronym 
Definition / Expansion 
ADA 
Antidrug antibody 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
ALP 
Alkaline Phosphatase 
ALT 
Alanine Aminotransferase 
AR(1) 
First-order Autoregressive 
AST 
Aspartate Aminotransferase 
BID 
twice daily 
BUN 
Blood Urea Nitrogen 
CI 
Confidence Interval 
CMH 
Cochran-Mantel-Haenszel 
CPK 
Creatine Phosphokinase 
CRP 
C-Reactive Protein 
CRSwNP 
Chronic Rhinosinusitis with Nasal Polyps 
CS 
Compound Symmetry 
DSMB 
Data and Safety Monitoring Board 
ECG 
Electrocardiogram 
ECP 
Eosinophil Cationic Protein 
eCRF 
Electronic Case Report Form 
EOS 
End of Study 
EOT 
End of Treatment 
EQ-5D-5L 
EuroQol Health Status Measure, 5 Dimensions/5 Levels  
FAS 
Full Analysis Set 
FEV1 
Forced Expiratory Volume in the first second of expiration 
GGT 
Gamma-Glutamyltransferase 
HBcAb 
Hepatitis B core Antibody 
HBsAb 
Hepatitis B surface antibody 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 8 of 52 
Abbreviation / Acronym 
Definition / Expansion 
HBsAg 
Hepatitis B surface Antigen 
HCVAb 
Hepatitis C virus antibody 
HEENT 
Head, Eyes, Ears, Nose, and Throat 
HIV 
Human Immunodeficiency Virus 
HRQoL 
Health-Related Quality of Life  
ICH 
International Conference on Harmonisation 
ICS 
Inhaled Corticosteroid(s) 
IgE 
Immunoglobulin E 
IL 
Interleukin (IL-4, IL-13, etc) 
INCS 
Intranasal Corticosteroid 
LABA 
Long-Acting ß-Agonist 
MedDRA 
Medical Dictionary for Regulatory Activities 
MDI 
Metered Dose Inhaler 
MFNS 
Mometasone Furoate Nasal Spray  
MMRM 
Mixed-effect Model for Repeated Measures 
MNAR 
Missing Not at Random 
NAb 
Neutralizing Antibody 
NCS 
Nasal Congestion Score  
NPIF 
Nasal Peak Inspiratory Flow 
NPS 
Nasal Polyp Score  
PK 
Pharmacokinetic(s) 
PKS 
Pharmacokinetic Set 
PD 
Pharmacodynamic(s) 
PMM-MI 
Pattern Mixture Model Multiple Imputation 
PPS 
Per Protocol Set 
PROs 
Patient-Reported Outcomes 
PT 
Preferred Term 
SABA 
Short-Acting ß-agonist 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 9 of 52 
Abbreviation / Acronym 
Definition / Expansion 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SC 
Subcutaneous 
SD 
Standard Deviation 
SE 
Standard Error 
SI 
Standard International 
SOC 
System Organ Class 
SS 
Safety Set 
TARC 
Thymus and Activation-Regulated Chemokine 
TEAE 
Treatment-Emergent Adverse Event 
TNSS 
Total Nasal Symptom Score 
TOEP 
Toeplitz 
ULN 
Upper Limit of Normal 
UN 
Unstructured 
UPSIT 
University of Pennsylvania Smell Identification Test 
VAS-RS 
Visual Analogue Scale for Rhinosinusitis 
VS 
Vital Signs 
WHODrug 
World Health Organization Drug Dictionary 
 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 10 of 52 
1 
INTRODUCTION 
CBP-201 simultaneously targets the inflammatory actions of both IL-4 and IL-13 of patients with 
inflammatory disease.  This study is a standard add-on design for a Phase 2 trial in Chronic 
rhinosinusitis with nasal polyps (CRSwNP) to assess both efficacy and safety of CBP-201. 
The Statistical Analysis Plan (SAP) details the statistical methodology to be used in analyzing study 
data and outlines the statistical programming specifications for the tables, listings, and figures.  It 
describes the variables, analysis populations, anticipated data manipulations and other details of the 
analyses not provided in the protocol. 
The analyses described in this SAP are based upon the following study documents: 
• Study Protocol, Version 3.0 (December 21, 2021) 
• electronic Case Report Form (eCRF), Version 6.0 (September 03, 2021) 
The structure and content of the SAP are based upon the International Conference on Harmonisation 
(ICH) E3 – Guideline for Industry Structure and Content of Clinical Study Reports. 
Pharmacokinetic analyses will be described in a separate document. 
2 
STUDY OBJECTIVES 
2.1 
Primary Objective(s) 
To evaluate the efficacy of CBP-201 on a background of mometasone furoate nasal spray (MFNS) in 
reducing endoscopic NPS and nasal congestion/obstruction score (NCS) severity in patients with 
CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal 
corticosteroid (INCS) therapy in comparison to placebo 
2.2 
Secondary Objective(s) 
To evaluate the effect of CBP-201 on: 
• Symptoms of sinusitis 
• Computed tomography image scores of nasal polyps and sinus inflammation 
• Patient reported outcomes (PROs) and health-related quality of life (HRQoL) 
• Safety and tolerability of CBP-201 in patients with CRSwNP 
2.3 
Exploratory Objective(s) 
To evaluate: 
• To evaluate the effect of CBP-201 in the subgroups of patients with comorbid asthma 
• The PK and PD of CBP-201 in patient with CRSwNP 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 11 of 52 
3 
INVESTIGATIONAL PLAN 
3.1 
Overall Study Design and Plan 
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the effect of 
CBP-201 in patients with CRSwNP whose disease remains inadequately controlled despite daily 
treatment with INCS therapy. 
The study consists of three periods: 
• Screening/Run-In Period: 4 weeks 
• Treatment Period: CBP-201/Placebo for 24 weeks 
• Post-Treatment Follow-Up Period: 8 weeks 
It is anticipated that approximately 147 male and female patients with chronic rhinosinusitis with 
large bilateral nasal polyps that remain uncontrolled despite daily treatment with INCS will be 
recruited into the study.  Approximately 50% of the randomized patients will be targeted to have 
comorbid asthma, defined as ≥12% reversibility (improvement in FEV1) and use of ICS < 1000 
µg/day, and treatment will be stratified on a presence of comorbid asthma.   
CBP-201 will be provided as a single use 2 mL vial containing 1.2 mL clear to slightly yellow sterile 
solution of CBP-201 targeted to be approximately 150 mg/mL.  Placebo will be provided as a single 
use 2 mL vial containing 1.2 mL solution of identical excipients without CBP-201.  Similar volumes 
and number of vials are to be used for placebo doses. 
After screening/run-in has been complete, eligible patients will be stratified by presence of comorbid 
asthma and randomized 1:1:1 to the following treatments: 
• CBP 201 300 mg SC every 2 weeks with a 600 mg loading dose on Day 1 
• CBP 201 300 mg SC every 4 weeks with a 600 mg loading dose on Day 1. This group will 
also receive volume matched placebo every 4 weeks on alternate visits to maintain the blind 
• Placebo volume-matched SC dosing every 2 weeks with a placebo loading dose on Day 1  
Dosing will be volume matched to maintain double-blind with 4 times 1 mL injections on Day 1 and 
2 times 1 mL injections on subsequent dosing days. 
A detailed schedule of assessments for the study is provided in 3.2. 
 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 12 of 52 
3.2 
Schedule of Assessments 
Assessments 
Screen 
Base-
line 
Treatment Period  
Follow-up 
Period  
Unsched-
uled 
Visitst 
Early 
Termina-
tion 
(+7d) 
 
D-31 
to D-1a 
D1 
D8 
W1 
(±3d) 
D15 
W2 
(±3d) 
D29 
W4 
(±3d) 
D43 
W6 
(±3d) 
D57 
W8 
(±3d) 
D71 
W10 
(±3d) 
D85 
W12 
(±3d) 
D99 
W14 
(±3d) 
D113 
W16 
(±3d) 
D127 
W18 
(±3d) 
D141 
W20 
(±3d) 
D155 
W22 
(±3d) 
EOT D169 
W24 (±3d) 
D197 
W28 
(±5d) 
EOS 
D225 
W32 
(±5d) 
 
 
Visit 
V1 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
V9 
V10 
V11 
V12 
V13 
V14 
V15 
V16 
V17 
NA 
NA 
Informed Consent 
and assign patient 
number 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics and 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility Criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior and 
Concomitant 
Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital Signsb 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body Weight 
X 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
X 
 
X 
Complete Physical 
Examinationc 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
Brief Physical 
Examinationd 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
CT scanu 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
X 
NCSe 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
EQ-5D-5L 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
 
X 
 
X 
X 
X 
VAS-RS 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
SNOT-22 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
TNSS 
X 
X 
X 
X  
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
Nasal endoscopy 
NPS 
X 
Xf 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
Spirometryg 
X 
X 
 
 
X 
 
X 
 
X 
 
 
 
 
 
X 
 
X 
X 
X 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 13 of 52 
Assessments 
Screen 
Base-
line 
Treatment Period  
Follow-up 
Period  
Unsched-
uled 
Visitst 
Early 
Termina-
tion 
(+7d) 
 
D-31 
to D-1a 
D1 
D8 
W1 
(±3d) 
D15 
W2 
(±3d) 
D29 
W4 
(±3d) 
D43 
W6 
(±3d) 
D57 
W8 
(±3d) 
D71 
W10 
(±3d) 
D85 
W12 
(±3d) 
D99 
W14 
(±3d) 
D113 
W16 
(±3d) 
D127 
W18 
(±3d) 
D141 
W20 
(±3d) 
D155 
W22 
(±3d) 
EOT D169 
W24 (±3d) 
D197 
W28 
(±5d) 
EOS 
D225 
W32 
(±5d) 
 
 
Visit 
V1 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
V9 
V10 
V11 
V12 
V13 
V14 
V15 
V16 
V17 
NA 
NA 
Smell test (UPSIT) 
 
X 
X 
X 
X 
 
 
 
X 
 
 
 
 
 
X 
 
X 
X 
X 
12-Lead ECG 
X 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
X 
 
X 
Hepatitis & HIV 
Screensh 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Testi 
X 
X 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
X 
Dispense or Review 
Patient Diary/ NPIF 
Meterj 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Health Care Resource 
Utilizationk 
 
X 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Urinalysis 
X 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
X 
 
X 
Serum Chemistryl 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
X 
Hematologym 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
 
X 
PK Blood Samplen 
 
X 
X 
 
X 
 
 
 
X 
 
 
 
 
 
X 
X 
X 
 
X 
PD Blood Sampleo 
 
X 
X 
 
X 
 
 
 
X 
 
 
 
 
 
X 
 
X 
 
X 
Blood Sample for 
ADA, NAbp 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
 
X 
 
X 
 
X 
Study Drug SC 
Administrationq 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Dispense rescue 
medication and 
MFNS as neededr 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Assess Injection 
Site(s)s 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: ADA = antidrug antibodies; AE = adverse event; CT = computed tomography; D = Day, ECG = electrocardiogram; EOS = End-of-Study; EOT = End-of-Treatment; EQ-5D-5L = 
European quality of life questionnaire; FEV1 = forced expiratory volume in the first second of expiration; HBcAb = hepatitis B core antibody; HCVAb = hepatitis C virus antibody; HBsAg = hepatitis 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 14 of 52 
B surface antigen; LABA = long-acting ß-agonist; NAb = neutralizing antibody; NCS = Nasal Congestion Score; NPS = Nasal Polyp Score; NPIF = Nasal peak inspiratory flow; 
PD = pharmacodynamic(s); PK = pharmacokinetic(s); SABA = short-acting ß-agonists; SC = subcutaneous; SNOT-22 = 22-item Sinonasal Outcome Test; TNSS = Total Nasal Symptom Score; UPSIT 
= University of Pennsylvania Smell Identification Test; V = visit; VAS-RS = Visual Analogue Scale for Rhinosinusitis; VS = vital signs; W = Week. 
Footnotes: 
a. The screening period to collect baseline data and determine a patient’s eligibility is 31 days in duration and begins when the ICF is signed.  
b. Vital signs include body temperature, respiratory rate, blood pressure, and heart rate. VS should be recorded predose for all treatment visits. On D1 (V2), W2 (V4), and W4 (V5), VS should be 
recorded hourly during the 2-hour postdose monitoring period. On W6 (V6) and beyond, VS should be recorded at 30 minutes postdose. During the post-treatment Follow-Up Period, VS are to be 
recorded once during each visit. Vital signs may be modified if adapted to telemedicine or home health visits where continuous monitoring may not be possible. 
c. A complete physical examination will be performed, which assesses the following: general appearance, skin, eyes/ears/nose/throat, thyroid, head and neck, cardiovascular system, respiratory system, 
abdomen, fundoscopy (optional), extremities, lymph nodes, musculoskeletal, and nervous system.  
d. A brief physical examination will include an assessment of general appearance, eyes, lungs, and lymph nodes. Physical exams may be modified if adapted to telemedicine or home health visits. 
e. The Nasal Congestion Score should be captured in the patient diary but may be captured by an alternative manner (ie, paper) if the device fails between clinic visits. 
f. If V2 is performed within 7 days of V1, then NPS (central read) from V1 will be used to confirm eligibility, and the endoscopy will not be repeated at V2. For more details see section 7.8.1 
Endoscopic Nasal Polyp Score. 
g. Spirometry, including FEV1, forced vital capacity, and peak expiratory flow, will be performed only for patients with asthma. Due to diurnal variation of lung function it is important that all 
spirometry assessments are performed preferably after 7:00 hours and no later than 11:00 hours. Prior to spirometry assessments, twice-daily LABA therapies, including combination therapies, 
should be withheld 12 hours, once-daily therapies containing LABA or long-acting muscarinic antagonists should be withheld for ≥ 24 hours, and SABAs should be withheld ≥6 hours.  Reversibility 
of lung function will be tested if a medical history record of >12% reversibility (improvement in FEV1) cannot be demonstrated within the previous 12 months. 
h. Hepatitis screen: For more details see section 7.6. 
i. All women of childbearing potential will be tested for pregnancy by a serum pregnancy test at Screening and by urine pregnancy tests at Baseline and thereafter. A negative result must be obtained 
prior to randomization.  
j. A patient diary and NPIF meter will be issued to the patient with training at Screening visit. At all study visits, patients should be assessed for compliance and retrained, if necessary, on the use of the 
patient diary device and NPIF meter.  
k. A questionnaire of Health Care Resource Utilization. For more details see section 7.8.12. 
l. Serum chemistry panel: sodium, potassium, chloride, bicarbonate, creatinine, blood urea nitrogen, glucose, calcium, uric acid, total protein, total bilirubin, albumin, alanine aminotransferase, 
aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, gamma-glutamyltransferase, creatine phosphokinase, total cholesterol, triglycerides, and C-reactive protein. The blood 
sample must be taken with the patient in fasting state which means no intake of any food or drink except for water for at least 8 hours. 
m. Hematology: hemoglobin, hematocrit, platelet count, total white blood cell count with 5-part differential count, differential count, and total red blood cell count. 
n. PK blood samples should be collected prior to dosing; date and clock time for each sample should be recorded. 
o. PD blood samples for biomarkers of inflammation include Eotaxin-3, eosinophil cationic protein, total immunoglobulin E, thymus and activation-regulated chemokine, and periostin. Blood 
eosinophil count will be measured as part of hematology test. C-reactive protein will be determined as part of the serum chemistry. 
p. ADA blood sample: NAb will be tested at all ADA collection time points in samples that are ADA positive. 
q. Patients are to be observed for 2 hours postdose on D1 (V2), W2 (V4), and W4 (V5), and 30 minutes postdose for W6 (V6) and beyond. Assessments and testing should be completed predose except 
as noted otherwise. Rotate injection sites: abdomen (avoid area proximal to umbilicus), outer thigh, and upper arm (lateral or posterolateral). Only 1 mL should be injected per site, and an injection 
site should not be in the same anatomical location used during the previous visit.  
r. Dispense albuterol/salbutamol MDI for reversibility testing and as an optional take-home rescue medication for those patients with asthma. Patients should be offered replacements as needed for 
symptom control throughout the study and should be reminded to document the use in their patient diary. Sites may also provide MFNS for required concomitant use as needed. 


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s. Injection site reactions should be assessed at all visits from the first dosing day until the end of the study. The previous injection site(s) should be assessed prior to dosing. On all dosing days, the new 
injection site should be assessed prior to the patient’s release. The SC injection site may be assessed using a standard instrument provided in Appendix or described as needed by the Investigator in 
the medical notes. Clinically significant findings as determined by the Investigator will be reported as an AE. See section 8.6 for more details. 
t. Unscheduled visits may be conducted as needed, and additional assessments performed at these visits are at the discretion of the Investigator.  
u. CT scan will only be required for subjects that are enrolled at Study Sites that are approved and qualified to perform CT Scans. 
 


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3.3 
Endpoints 
3.3.1 Efficacy Endpoints 
3.3.1.1 Co-primary Efficacy Endpoints 
There will be two co-primary endpoints: 
• Change from baseline at Week 24 in endoscopic NPS 
o Endoscopic NPS score is graded based on polyp size (recorded as the sum of the right 
and left nostril scores with a range of 0 to 8; higher scores indicate worse status) 
• Change from baseline at Week 24 in average daily nasal congestion score (NCS) 
3.3.1.2 Secondary Efficacy Endpoints 
• Change from baseline at Week 24 in: 
o Percentage of maxillary sinus volume occupied by disease on CT and Lund-Mackay 
Computed Tomography scores from patients enrolled at Study Centers that are 
approved and qualified to perform CT scans 
o University of Pennsylvania Smell Identification Test (UPSIT) 
o Visual Analogue Scale for Rhinosinusitis (VAS-RS) 
o Total Nasal Symptom Score (TNSS) 
o 22-item Sinonasal Outcome Test (SNOT-22) 
o Average daily anterior rhinorrhea score (from diary) 
o Average daily posterior rhinorrhea score (from diary) 
o Average daily loss of smell score (from diary) 
o Daily subject-assessed Nasal Peak Inspiratory Flow (NPIF) 
• Requirement of rescue treatment (systemic corticosteroid for > 5 consecutive days) or having 
had surgery for nasal polyps through Week 24 
• Time to rescue treatment (systemic corticosteroid for > 5 consecutive days) or surgery for 
nasal polyps through Week 24 
3.3.1.3 Exploratory Efficacy Endpoints 
• Change from baseline at Week 24 in Forced Expiratory Volume in 1 second (FEV1) for 
patients with asthma 
• Proportion of patients with minimal clinically important difference ≥ 8.9 in SNOT-22 at Week 
24 
• Change from baseline at Week 16 in endoscopic NPS 
• Change from baseline at Week 16 in average daily NCS 
• Change from baseline at Week 24 in European Quality of Life Scale (EQ-5D-5L) 
• Healthcare resource utilization through Week 24 


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3.3.1.4 Pharmacodynamic Endpoints 
• Change from Baseline in blood levels of IgE 
• Change from Baseline in peripheral eosinophil counts 
• Change from Baseline in other markers of atopic inflammation in the blood [eosinophil 
cationic protein (ECP), thymus and activation-regulated chemokine (TARC), Eotaxin-3, and 
periostin.] 
3.3.1.5 Pharmacokinetic Endpoints 
Whole blood for plasma CBP-201 concentrations will be obtained and analyzed. The individual 
steady-state trough PK profile will be calculated for each treatment schedule.  
Additional sampling will be obtained after the last treatment dose as noted above to characterize the 
return to baseline. 
The details of PK analysis will be reported in a separate PK analysis plan. 
3.3.1.6 Safety Endpoints 
• Adverse events (AEs) reported, including serious adverse events (SAEs) and adverse events 
of special interest (AESI) 
• Vital signs (body temperature, respiratory rate, blood pressure, and heart rate) 
• Physical examinations  
o Complete: general appearance, skin, eyes/ears/nose/throat, thyroid, head and neck, 
cardiovascular system, respiratory system, abdomen, fundoscopy (optional), 
extremities, lymph nodes, musculoskeletal, and nervous system 
o Brief: general appearance, eyes, lungs, lymph nodes 
• 12-lead electrocardiogram (ECG) parameters 
• Injection site evaluations 
• Safety laboratory parameters (urinalysis, serum chemistry, and hematology) 
• Antidrug antibodies (ADA) and neutralizing antibodies (NAb) 
4 
STATISTICAL METHODS 
4.1 
Data Quality Assurance 
All tables, listings, and figures to be included in the report will be independently checked by 
biostatistician for consistency, integrity and in accordance with standard Parexel procedures. 
4.2 
Definitions 
Age at Baseline 
Age will be calculated using the date of birth and date of the baseline visit as below: 
Integer part of [(Date of Baseline Visit – Date of Birth) / 365.25] 
 
 
 


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Baseline 
Unless otherwise specified, baseline is defined as the last non-missing value prior to the first dose of 
study drug.  If time is not collected but the assessment is performed on the same day as the first dose 
of study drug, it would be considered as baseline. 
 
Baseline Week 
For weekly average analysis, baseline week is defined as 7 days prior to the baseline visit (Study day 
ranges from -7 to -1). 
 
Change from Baseline 
Change from baseline is defined as post-baseline value minus baseline value. 
 
Study Day 1 
Study day 1 is defined as the date of randomization for untreated randomized subjects or the date of 
first dose for treated subjects. 
 
Study Day 
Study Day will be calculated relative to the date of randomization for untreated randomized subjects 
and relative to the date of first dose for treated subjects. 
If event is prior to the first dose, then study day is calculated as: 
Date of Event – Date of First Dose 
If event is after the first dose, then study day is calculated as: 
Date of Event – Date of First Dose + 1 
 
Duration of Treatment 
Duration of Treatment (days) will be calculated as: 
Last Date of Dose – First Date of Dose + 1 
 
Treatment-Emergent Adverse Events 
Treatment-emergent adverse events are defined as any adverse events occurred or worsen during the 
treatment-period, whether considered related to the treatment. 
Where the AE start date is missing, adverse events will be assumed to be treatment-emergent, unless 
there is clear evidence (through comparison of partial dates) to suggest that the adverse event started 
prior to the first dose of study treatment. 
 
Prior and Concomitant Medication 
Prior and concomitant medication is defined as any medications that started before the first dose of 
study drug and stops on or after the first dose of study drug. 
 
Prior Medication 
Prior medication is defined as any medications that started and stopped before the first dose of study 
drug. 
 
Concomitant Medication 


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Concomitant medication is defined as any medications that started on or after the first dose of study 
drug. 
 
Treatment Compliance 
Treatment compliance (%) will be calculated as: 
Total Amount of Study Drug Administered (mL)
Total Amount of Study Drug Planned (mL)
× 100% 
 
4.3 
General Presentation Considerations 
Continuous data that are assumed to be normally distributed will be summarized in terms of the mean, 
standard deviation (SD), median, minimum, maximum and number of observations. Continuous data 
that are expected to be skewed will be presented in terms of the maximum, upper quartile, median, 
lower quartile, minimum and number of observations.  The minimum and maximum will be reported 
to the same number of decimal places as the raw data recorded in the database.  The mean, median, 
lower quartile and upper quartile will be reported to one more decimal place, and the SD (and the 
standard error [SE], if applicable) will be reported to two more decimal places, than the raw data 
recorded in the database.  In general, the maximum number of decimal places reported shall be four 
for any summary statistic. 
Categorical data will be summarized in terms of the number of subjects providing data at the relevant 
time point (n), frequency counts and percentages.  Any planned collapsing of categories will be 
detailed in the SAP text and the data displays.   
Percentages will be presented to one decimal place except 100%. 100% will be presented as 100% 
instead of 100.0%.  Percentages will not be presented for zero counts.  Percentages will be calculated 
using the number of subjects (n) as the denominator.  If sample sizes are small, the data displays will 
show the percentages, but any textual report will describe frequencies only.  A missing category shall 
be included only for categorical variables where no data is available.  The missing category will be 
omitted if there were no missing values for that variable. 
Changes from baseline in categorical data will be summarized using shift tables where appropriate. 
Laboratory values contain ‘≥ x’ or ‘x ≤’ will be taken as the value of x in the analysis.  If a laboratory 
value contains ‘y <’ then y minus 0.001 will be used for the analysis.  If a laboratory value contains 
‘z >’ then z plus 0.001 will be used for the analysis. 
P-values greater than or equal to 0.001, in general, will be presented to three decimal places.  P-values 
less than 0.001 will be presented as “<0.001”. P-values greater than 0.999 will be presented as 
“>0.999”. 
Confidence intervals will be presented to one more decimal place than the raw data. 
4.3.1 Analysis Window 
For visits that occur on or after the first dose of study treatment, study day is defined as date of event 
– date of first dose of study treatment + 1.  For visits that occur prior to the first dose of study 
treatment, study day is defined as date of event – date of first dose of study treatment.  There is no 
study day 0 defined for this study. 


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Table 1. Analysis Window for Safety Parameters 
Nominal Visit 
Analysis Visit 
Target Study 
Day 
Minimum 
Study Day 
Maximum 
Study Day 
Visit 2 
Baseline 
1 
-30 
1 
Visit 3 
Week 1 
8 
2 
11 
Visit 4 
Week 2 
15 
12 
18 
Visit 5 
Week 4 
29 
26 
32 
Visit 6 
Week 6 
43 
40 
46 
Visit 7 
Week 8 
57 
54 
60 
Visit 8 
Week 10 
71 
68 
74 
Visit 9 
Week 12 
85 
82 
88 
Visit 10 
Week 14 
99 
96 
102 
Visit 11 
Week 16 
113 
110 
116 
Visit 12 
Week 18 
127 
124 
130 
Visit 13 
Week 20 
141 
138 
144 
Visit 14 
Week 22 
155 
152 
158 
Visit 15 
Week 24 (End of 
Treatment) 
169 
166 
172 
Visit 16 
Week 28 
197 
192 
202 
Visit 17 
Week 32 (End of Study) 
225 
220 
230 
 
Table 2. Analysis Window for CT Scan 
Nominal Visit 
Analysis Visit 
Target Study 
Day 
Minimum 
Study Day 
Maximum 
Study Day 
Visit 2 
Baseline 
1 
-30 
1 
Visit 15 
Week 24 (End of 
Treatment) 
169 
166 
172 
 
Table 3. Analysis Window for NPS, VAR-RS, SNOT-22, and TNSS 
Nominal Visit 
Analysis Visit 
Minimum 
Study Day 
Maximum 
Study Day 
Visit 2 
Baseline 
-7 
-1 
Visit 3 
Week 1  
1 
8 
Visit 4 
Week 2 
9 
15 
Visit 5 
Week 4 
23 
29 
Visit 7 
Week 8 
51 
57 
Visit 9 
Week 12 
79 
85 
Visit 11 
Week 16 
107 
113 
Visit 13 
Week 20 
135 
141 


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Visit 15 
Week 24 (End of Treatment) 
163 
169 
Visit 17 
Week 32 (End of Study) 
219 
225 
 
Table 4. Analysis Window for Efficacy Parameters – Weekly average 
Nominal Visit 
Analysis Visit 
Minimum 
Study Day 
Maximum 
Study Day 
Visit 2 
Baseline 
-7 
-1 
Visit 3 
Week 1  
1 
8 
Visit 4 
Week 2 
9 
15 
Visit 5 
Week 4 
23 
29 
Visit 6 
Week 6 
37 
43 
Visit 7 
Week 8 
51 
57 
Visit 8 
Week 10 
65 
71 
Visit 9 
Week 12 
79 
85 
Visit 10 
Week 14 
93 
99 
Visit 11 
Week 16 
107 
113 
Visit 12 
Week 18 
121 
127 
Visit 13 
Week 20 
135 
141 
Visit 14 
Week 22 
149 
155 
Visit 15 
Week 24 (End of Treatment) 
163 
169 
Visit 16 
Week 28 
191 
197 
Visit 17 
Week 32 (End of Study) 
219 
225 
 
Table 5. Analysis Window for Other Efficacy Parameters 
Nominal Visit 
Analysis Visit 
Minimum 
Study Day 
Maximum 
Study Day 
Visit 2 
Baseline 
-7 
-1 
Visit 3 
Week 1  
1 
8 
Visit 4 
Week 2 
9 
15 
Visit 5 
Week 4 
23 
29 
Visit 6 
Week 6 
37 
43 
Visit 7 
Week 8 
51 
57 
Visit 8 
Week 10 
65 
71 
Visit 9 
Week 12 
79 
85 
Visit 10 
Week 14 
93 
99 
Visit 11 
Week 16 
107 
113 
Visit 12 
Week 18 
121 
127 
Visit 13 
Week 20 
135 
141 
Visit 14 
Week 22 
149 
155 


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Visit 15 
Week 24 (End of Treatment) 
163 
169 
Visit 16 
Week 28 
191 
197 
Visit 17 
Week 32 (End of Study) 
219 
225 
 
If more than one assessment is available within the same analysis visit, the assessment with closest 
study day to the target study day will be reported for the analysis window.  If two observations exist 
with the same distance to the target study day, then the first observation will be used. 
Unscheduled visit will not be used in the analysis if scheduled visit is available.  Unscheduled visit 
will be used in the analysis only if scheduled visit is not available. 
4.3.2 Handling of Incomplete Dates 
Every effort will be undertaken to avoid any missing or incomplete data, and missing data will not be 
imputed unless specified.  If variables are imputed, the analysis dataset will contain a new variable 
with imputed value and the original variable will contain the original missing value. 
Inevitable partial dates will be imputed for start/end dates of AEs or concomitant medications.  
Incomplete dates of medical history will not be imputed.  
Partial AE Start Date 
• If only day is missing, then it will be set to: 
o First day of the month that the AE occurred, if month/year of the AE start date is 
different than the month/year of the first dose date. 
o The day of first dose date, if month/year of the AE start date is the same as month/year 
of the first dose date and month/year of the AE end date is different. 
o The day of first dose date or day of AE end date, whichever is earliest, if the 
month/year of the AE start and month/year of the first dose date and month/year of the 
AE end date are the same. 
• If only month is missing, then it will be set to the earliest of the following: 
o January, as long as this date is after the first dose date 
o Month of the first dose date, if this date is the same day and year that the AE occurred 
• If the day and month are both missing, then it will be set to the earliest of the following: 
o January 1 of the year, as long as this date is after the first dose date 
o Month and day of the first dose date, if this date is the same year that the AE occurred 
o The AE end date 
• If dates are completely missing, then no imputation will be made. 
Partial AE End Date 
• If only day is missing, then it will be set to the earliest of the last follow-up date, last day of 
the month, or the date of death. 
• If only month is missing, then it will be set to the earliest of the last follow-up date, December, 
or the date of death. 


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• If year is missing or AE is ongoing, the end date will not be imputed. 
• If dates are completely missing, then no imputation will be made. 
If the imputed AE end date is before the corresponding AE start date, then the AE end date will be 
set to the AE start date. 
The same rule above will be applied to the start and end dates of concomitant medications. 
4.4 
Software 
All report outputs will be produced using SAS® version 9.4 or a later version in a secure and validated 
environment.   
4.5 
Study Subjects 
4.5.1 Disposition of Subjects 
A clear accounting of the disposition of all subjects who enter the study will be provided, from 
screening to study completion. 
Subject disposition will be summarized by treatment and overall for: 
• 
Number of subjects screened 
• 
Number of subjects with screen failure 
• 
Number of subjects randomized 
• 
Number and percentage of subjects received at least one dose of study drug 
• 
Number and percentage of subjects discontinued from study drug and primary reason for 
premature discontinuation 
• 
Number and percentage of subjects discontinued from study and primary reason for premature 
discontinuation 
By-subject listings of disposition details will also be provided. 
4.5.2 Protocol Deviations 
Protocol deviations will be classified as “major” or “minor” on ongoing basis by the clinical study 
team and sponsor. 
Major protocol deviations are defined as those deviations from the protocol likely to have an impact 
on the subject’s right, safety, well-being, and/or the validity of the data for analysis.  Minor protocol 
deviations include all deviations from the protocol excluding the major protocol deviations.   
Major protocol deviations and any action to be taken regarding the exclusion of subjects or affected 
data from specific analyses are defined in the project-specific Protocol Deviation Specification. 
The number and percentage of subjects with a major protocol deviation on Full Analysis Set by 
treatment and overall will be summarized.  By-subject listing of all protocol deviations will also be 
provided. 
4.6 
Analysis Populations 
Randomised Set 


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The Randomised Set consists all subjects who are randomized to treatment. 
Full Analysis Set (FAS) 
The Full Analysis Set (FAS) consists of randomized subjects who received at least 1 dose of study 
treatment and at least one primary endpoint datum collected during the treatment period.  These 
subjects are grouped based on the treatment group to which were randomized.  If a subject is allocated 
the incorrect study treatment as per the study randomization list, subjects will be summarized and 
analyzed ‘as randomized’ i.e. by randomized treatment group.  The efficacy summaries and analyses 
will be based on the Full Analysis Set (FAS), which is based upon the Intention-to-Treat principle.  
Per Protocol Set (PPS) 
The Per Protocol Set (PPS) is defined as a subgroup of patients in FAS without major protocol 
deviations.  A sensitivity analysis will be performed on the Per Protocol Set to assess the robustness 
of the study conclusions to the choice of analysis set for the primary efficacy variable. 
Safety Set (SS) 
The Safety Set (SS) is defined as all randomly assigned patients who received at least 1 dose of study 
treatment.  These patients will be categorized according to the treatment they actually received.  If a 
subject is allocated the incorrect study treatment as per the study randomization list, subjects will be 
summarized and analyzed ‘as treated’ i.e. by allocated treatment group.  The safety summaries and 
analyses will be based on the Safety Set. 
Pharmacokinetic Set (PKS) 
The Pharmacokinetic Set (PKS) consists of all randomly assigned patients from whom at least 1 post-
dose PK blood sample was collected.  Pharmacodynamic (PD) and/or PK relationships will be 
explored in a separate analysis plan and report. 
An analysis population classification meeting will be arranged to discuss the outputs and to decide 
which subjects and/or subject data will be excluded from certain analyses.  Decisions made regarding 
the exclusion of subjects and/or subject data from analyses will be made prior to unblinding and will 
be documented and approved by Suzhou Connect Biopharmaceutical Ltd.   
The number and percentage of subjects in each analysis set by treatment group and overall will be 
summarized on Randomised Set.  By-subject listing of analysis population assignment will also be 
provided. 
4.7 
Demographic and Other Baseline Characteristics 
Age at baseline (years), gender, race, ethnicity, geographic region, height (cm) at Baseline, weight 
(kg) at Baseline, presence of comorbid asthma at Baseline, type 2 inflammation at Baseline marked 
by Baseline blood eosinophil count ≥ 300 cells/µL, endoscopic NPS at Baseline, average daily NCS 
at Baseline week, LMK CT score at Baseline, NPIF at Baseline, and FEV1 at Baseline for asthma 
patients will be summarized on Full Analysis Set by treatment and overall. 
By-subject listing of demographic and other baseline characteristics will also be provided. 


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4.8 
Medical History 
Medical history at screening will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA) Version 24.0 and summarized on Safety Set by treatment and overall using system organ 
class and preferred term.  By-subject listing of medical history will also be provided. 
4.9 
Prior and Concomitant Medication 
Medication start and stop dates will be compared to the date of first dose of study drug to allow 
medications to be classified as either Prior only, both Prior and Concomitant, or Concomitant only as 
defined in 4.2.  Medications starting after the completion/withdrawal date will not be classified or 
summarized. 
Incomplete start and end date of the medications will be imputed as described in Error! Reference 
source not found.. 
Concomitant medications and Prior and Concomitant medications will be coded using the World 
Health Organization Drug (WHODrug) Global March 2021 B3 and summarized on Safety Set by 
treatment and overall.  Subjects with more than one medication in a given ATC level and preferred 
term will be counted only once. 
By-subject listings of prior and concomitant medications will also be provided. 
4.10 
Treatment Compliance 
Treatment compliance (%) is calculated as described in 4.2.  A summary of the treatment compliance 
at each visit and overall treatment period will be provided on Safety Set by treatment and overall.  
By-subject listing of treatment compliance will also be provided. 
4.11 
Efficacy Evaluation 
4.11.1 Statistical Analysis and Data Conventions 
Unless otherwise specified, all statistical tests will be interpreted at a 2-sided significance level of 
0.05 and all CIs at a 2-sided level of 95%.  The overall type I error rate is 0.05 (two-sided) for the 
primary and secondary efficacy hypotheses. 
4.11.1.1 
Adjustments for Covariates 
The primary and secondary efficacy analysis will be adjusted for the following baseline covariates: 
1. Presence of comorbid asthma (stratification factor) 
2. Endoscopic NPS at baseline (baseline measure of the primary efficacy variable) 
For each covariate, a statistical test for the presence of a treatment-by-covariate interaction will be 
performed, by including the interaction term in the primary analysis model.  If any of the treatment-
by-covariate interactions are found to be statistically significant at the 5% level (p<0.05), subgroup 
analyses will be performed to further explore the nature of the interaction. In such cases, conclusions 
based on the primary analysis (no interaction) will be interpreted with caution. 
4.11.1.2 
Handling of Missing Efficacy Data 
For primary analysis, MMRM will be performed to mitigate the impact of missing data.  This 
approach assumes that missing observations are missing-at-random (missingness is related to 


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observed data) during the study and borrows information from patients in the same treatment arm 
taking into account both the missingness of data and the correlation of the repeated measurements.    
All secondary and exploratory efficacy analyses as well as safety analyses will be conducted without 
imputation of missing values. 
To assess the robustness of the study conclusions to the choice of imputation method, the sensitivity 
analyses will be performed for the primary variable (see 4.11.3). 
4.11.1.3 
Multiple Comparisons/Multiplicity 
The primary analysis will compare the CBP-201 Q2W 300 mg group to the placebo group using a 
two-sided test at the alpha=0.05 level of significance.  “Study success” is defined as a statistically 
significant result for both of the co-primary endpoints.  If both of the co-primary endpoints are 
statistically significant (p-value<0.05) then the same model as described 0 will be used for the key 
secondary analysis to compare the CBP-201 Q4W 300 mg group to placebo group using a two-
sided test at the alpha=0.05 level of significance. 
The definition of study success and use of a fixed sequence testing procedure for the primary 
analyses controls the overall level of significance.  Hence there is no formal control for multiplicity 
planned. 
4.11.1.4 
Interim Analyses 
No interim analyses are planned.  
4.11.1.5 
Examination of Subgroups 
Baseline characteristics, all efficacy (including primary, secondary, and exploratory), safety, and 
PK/PD endpoints will be examined for the following subgroups: 
• 
Ethnicity: Asian vs Non-Asian 
• 
Country: Chinese vs Non-Chinese 
Summaries of baseline characteristics, efficacy and safety endpoints by treatment group and subgroup 
will be produced.  No sensitivity analysis will be performed within subgroup.  No formal statistical 
analysis will be performed within subgroup. 
Details of PK subgroup analysis will be provided by a separate PK analysis plan. 
4.11.2 Co-primary Efficacy Analysis 
The co-primary endpoints for the assessment of efficacy are the change from Baseline in endoscopic 
nasal polyp score (NPS) at Week 24 and average daily nasal congestion score (NCS).  Endoscopic 
NPS and average daily NCS at Week 24 will be summarized by treatment group in terms of absolute 
values and changes from baseline. 
4.11.2.1 
Endoscopic Nasal Polyp Score (NPS) 
Nasal Polyps Score (NPS) is assessed by central video recordings of nasal endoscopy. The score 
(NPS) is the sum of left and right nostril scores, as evaluated by means of nasal endoscopy.  NPS is 
graded based on polyp size as described below: 
Polyp Score 
Polyp Size 
0 
No polyps 


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1 
Small polyps in the middle meatus not reaching below the inferior border of the 
middle turbinate 
2 
Polyps reaching below the lower border of the middle turbinate 
3 
Large polyps reaching the lower border of the interior turbinate or polyps medial 
to the middle turbinate 
4 
Large polyps causing complete obstruction of the inferior nasal cavity 
The effect of treatment in terms of the change from Baseline to Week 24 in endoscopic NPS will be 
analyzed using Mixed-effect Model for Repeated Measures (MMRM).   
The model will include treatment, presence of comorbid asthma, visit, treatment-by-visit interaction 
as categorical covariates, and endoscopic NPS at baseline as continuous covariates.  Patient will be 
included as a random effect.  An unstructured (UN) covariance matrix will be used to model the 
within-subject correlation.  If this model fails to converge, then Akaike’s Information Criterion (AIC) 
will be used to select the best covariance matrix among compound symmetry (CS), first-order 
autoregressive (AR(1)), and Toeplitz (TOEP).  The treatment effect will be estimated using the 
difference between the treatments least squares means (adjusted means).  The 95% confidence 
interval for the difference between the treatments least squares means and the p-value from the 
hypothesis test of no difference between the treatment groups will be also presented. 
The sample SAS code for MMRM: 
proc mixed data= data; 
class subjid cmabl trt01pn(ref=’1’) avisitn; 
model chg = trt01pn cmabl trt01pn*avisitn npsbl*avisitn / ddfm=kr; 
repeated avisitn / subject=subjid type=UN; 
lsmeans trt01pn*avisit / pdiff cl alpha=0.05; 
ods output lsmeans=lsmeans diffs=diffs; 
run; 
A plot showing the LS mean of endoscopic NPS ± SE bar over time within each treatment group will 
be provided. 
Sensitivity analyses to investigate the impact of the choice of method for handling missing data and 
the choice of analysis set will be performed as described in 4.11.3.  
By-subject listing of the primary efficacy data will also be provided. 
4.11.2.2 
Average Daily Nasal Congestion Score (NCS) 
Daily Nasal Congestion Score (NCS) will be assessed by the patient through a patient diary from 
Visit 1 throughout the study by using a 0 to 3 categorical scale for severity of symptoms from none 
to severe over the past 24 hours.  
Question: How would you rate nasal congestion over the last 24 hours? 
0 
None 
1 
Minor 
2 
Moderate 
3 
Severe 


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Weekly mean of daily nasal congestion score will be calculated as sum of non-missing daily nasal 
congestion score divided by number of days with non-missing daily nasal congestion score using 
analysis window (Table ).  The effect of treatment in terms of the change from Baseline week (i.e. 
average of 7 days prior to the baseline visit) to Week 24 (i.e. average of 7 days prior to the Week 24 
visit) in average daily NCS will be also analyzed using Mixed-effect Model for Repeated Measures 
(MMRM).   
The model will include treatment, presence of comorbid asthma, visit, treatment-by-visit interaction 
as categorical covariates, and average daily NCS at baseline as continuous covariates.  Patient will be 
included as a random effect.  An unstructured (UN) covariance matrix will be used to model the 
within-subject correlation.  If this model fails to converge, then Akaike’s Information Criterion (AIC) 
will be used to select the best covariance matrix among compound symmetry (CS), first-order 
autoregressive (AR(1)), and Toeplitz (TOEP).  The treatment effect will be estimated using the 
difference between the treatments least squares means (adjusted means).  The 95% confidence 
interval for the difference between the treatments least squares means and the p-value from the 
hypothesis test of no difference between the treatment groups will be also presented. 
The sample SAS code for MMRM: 
proc mixed data= data; 
class subjid cmabl trt01pn(ref=’1’) avisitn; 
model chg = trt01pn cmabl trt01pn*avisitn ncsbl*avisitn / ddfm=kr; 
repeated avisitn / subject=subjid type=UN; 
lsmeans trt01pn*avisit / pdiff cl alpha=0.05; 
ods output lsmeans=lsmeans diffs=diffs; 
run; 
In addition to primary efficacy analysis summary, weekly mean of daily nasal congestion score will 
be summarized using descriptive statistics by treatment and overall. 
A plot showing the LS mean of average daily NCS ± SE bar over time within each treatment group 
will be provided. 
Sensitivity analyses to investigate the impact of the choice of method for handling missing data and 
the choice of analysis set will be performed as described in 4.11.3.  
By-subject listing of the primary efficacy data will also be provided. 
4.11.3 Sensitivity Analysis 
4.11.3.1 
Sensitivity Analysis using PMM-MI 
To assess the robustness of the study conclusions to the choice of imputation method, the sensitivity 
analyses will be performed for the primary variable using control-based Pattern Mixture Model 
Multiple Imputation (PMM-MI) under the missing not at random (MNAR) assumption, which 
assumes the missingness depends on the unobserved study data and cannot be predicted solely based 
on subject’s observed data. 
Control-based PMM-MI under MNAR involves following standard steps. Same procedures will be 
followed for average daily NCS. 
Step 1. Assessing the pattern of missing data 
To investigate the pattern of missing data, ‘ods output misspattern’ will be used in the MI procedure 
of the SAS system (PROC MI).  The imputation method will be based on the observed pattern of 


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missing data and amount of missing data.  The pattern of missing data will be assessed as monotone 
or arbitrary. 
proc mi data=non_mono seed=xxx nimpute=0; 
var trt01pn cmabl y0-y13; *y0=baseline, y13=week24; 
ods output misspattern=pattern; 
run; 
Step 1-a. Turning the arbitrary missing patterns to monotone missing patterns under MAR assumption 
If a mixture of non-monotone and monotone missing patterns exist in the data with majority of 
monotone missing patterns, then the arbitrary missing patterns will be converted to monotone missing 
patterns under MAR assumption. 
proc mi data=non_mono out=mono seed=xxx nimpute=m; 
min=. . x x x x x x x x x x x x x x; *period (.) means no imputation needed; 
max=. . y y y y y y y y y y y y y y; 
var trt01pn cmabl y0 y1 y2 y3 y4 y5 y6 y7 y8 y9 y10 y11 y12 y13; 
mcmc chain=multiple impute=monotone; 
run; 
Step 2. Generation of imputed datasets using control-based pattern imputation 
PROC MI will be used to generate m complete datasets.  The selection of m depends on the required 
computing time but has been recommended varying from 5 to 100. 
proc mi data=mono seed=xxx nimpute=m outs=imputed; 
min=. . x x x x x x x x x x x x x x; 
max=. . y y y y y y y y y y y y y y; 
by _imputation_; 
class trt01pn cmabl; 
var cmabl y0 y1 y2 y3 y4 y5 y6 y7 y8 y9 y10 y11 y12 y13; 
monotone reg(/details); 
mnar model(y1 y2 y3 y4 y5 y6 y7 y8 y9 y10 y11 y12 y13/ modelobs=(trt01pn=’1’)); *only 
control group is used to derive the imputation model; 
run; 
Step 2-a. Convert datasets into long format in which CHG variable represents all change from baseline 
with different values of avisit. 
Step 3. Conducting model-based analysis using each imputed dataset 
The m complete datasets are analyzed using MMRM. 
proc mixed data= imputed; 
by _imputation_; 
class subjid cmabl trt01pn(ref=’1’) avisitn; 
model chg = trt01pn cmabl trt01pn*avisitn ncsbl*avisitn / ddfm=kr; 
repeated avisitn / subject=subjid type=UN; 
lsmeans trt01pn*avisit / pdiff cl alpha=0.05; 
ods output lsmeans=lsmeans diffs=diffs; 
run; 
Step 4. Pooling the results from the imputed m datasets for inference 


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The results from the m complete datasets are combined to produce inferential results. 
proc sort data=lsmeans; 
by trt01pn avisitn _imputation_; 
run; 
 
proc mianalyze parms=lsmeans; 
modeleffects trt01pn*avisitn; 
ods output ParameterEstimates=lsm; 
run; 
 
proc sort data=diffs; 
by avisit _imputation_; 
run; 
 
proc mianalyze parms=diffs; 
modeleffects trt01pn*avisitn; 
ods output ParameterEstimates=dif; 
run; 
The Per Protocol Set analyses will be performed using the same imputation method as for the Full 
Analysis Set analyses. 
4.11.3.2 
Sensitivity Analysis for Use of Rescue Medication 
To assess the robustness of the study conclusions to use of rescue medication, another sensitivity 
analysis will be performed on the primary variable based on FAS. 
Rescue medications are defined as below and will be reviewed by Parexel Medical Monitor: 
• 
Nasal lavage with saline and/or systemic antibiotics (up to 2 weeks in case of acute infection) 
• 
Short course oral CS (prednisone or prednisolone); use of oral/systemic CS for ≤ 5 consecutive 
days  
• 
Treatment with oral/systemic steroids for > 5 consecutive days 
• 
 Sino-nasal surgery for nasal polyps. Based on previous observations, at least 8 weeks of study 
drug treatment is recommended prior to resorting to surgery to allow an onset of the treatment 
effect.  Note: Patients receiving sino-nasal surgery during the study are required to discontinue 
study drug treatment as this is categorized as a treatment failure, although study assessments may 
continue. 
If patients used any rescue medication before Week 24, their assessments after the first use of rescue 
medication will be set to missing, and missing values at week 24 will be imputed using the subject’s 
worst observed value over all previous time points including baseline value. Then the primary 
efficacy analysis using MMRM will be performed. 
4.11.4 Secondary Efficacy Analyses 
The similar analyses to primary analysis will be applied to following secondary endpoints: 
• 
Percentage of maxillary sinus volume occupied by disease on CT and Lund-Mackay 
Computed Tomography scores from patients enrolled at Study Centers that are approved and 
qualified to perform CT scans 


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• 
University of Pennsylvania Smell Identification Test (UPSIT) 
• 
Visual Analogue Scale for Rhinosinusitis (VAS-RS) [Appendix ] 
• 
Total Nasal Symptom Score (TNSS) [Appendix B – Total Nasal Symptom Score (TNSS)] 
• 
22-item Sinonasal Outcome Test (SNOT-22) [Appendix C – Sino-Nasal Outcome Test-22 
QUESTIONNAIRE (SNOT-22)] 
• 
Average daily anterior rhinorrhea score (from diary) * 
• 
Average daily posterior rhinorrhea score (from diary) * 
• 
Average daily loss of smell score (from diary) * 
• 
Daily subject-assessed Nasal Peak Inspiratory Flow (NPIF) * 
*Weekly mean will be calculated as sum of non-missing endpoint divided by number of days with 
non-missing endpoint for daily assessments listed using analysis window (Table ). The effect of 
treatment in terms of the change from Baseline week (i.e. average of 7 days prior to the baseline visit) 
to Week 24 (i.e. average of 7 days prior to the Week 24 visit) will also be analyzed using MMRM. 
Time to first rescue treatment (systemic corticosteroid for > 5 consecutive days) or having had surgery 
for nasal polyps during the 24-week Treatment Period will be analyzed using a Cox proportional 
hazard model.  The model will be adjusted by treatment, presence of comorbid asthma, endoscopic 
NPS at Baseline, and average daily NCS at Baseline.  Subjects who do not experience rescue 
treatment or surgery for nasal polyps during the 24-week Treatment Period will be censored at the 
earliest day among the component censoring times (end of study date, premature study 
discontinuation date, lost to follow-up date, date of death).  Any events after 24-week Treatment 
Period will not be counted. 
Estimated adjusted hazard ratios will be summarized with associated 95% CI and p-values.   
The sample SAS code for the Cox proportional hazards model: 
proc phreg data=datain; 
class subjid cmabl trt01pn(ref=’1’); 
model avisitn*event (1) = trt01pn cmabl / ties=efron rl=wald type3(wald); 
*0 is event, 1 is censored*; 
assess var = (trt01pn cmabl) ph / resample; 
*testing the proportionality assumption. Resample is specified to request the supreme tests 
of the null hypothesis that proportional hazards hold*; 
hazardratio trt01pn / diff=ref cl=wald alpha=0.05; 
ods output hazardratios=hazard; 
run; 
Time to first rescue treatment or having had surgery for nasal polyps during the 24-week Treatment 
Period will be displayed graphically for each treatment group using a Kaplan-Meier curve and 
analyzed using a log-rank test to compare the curved between the treatment groups. 
The sample SAS code for the Kaplan-Meier Curve: 
proc lifetest data=datain atrisk plots=survival (atrisk cb) outs=dataout; 
class subjid cmabl trt01pn(ref=’1’); 
time avisitn*event (1) = trt01pn cmabl; 
run; 


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Proportion of subjects requiring rescue treatment (systemic corticosteroid for > 5 consecutive days) 
or surgery for nasal polyps during the 24-week Treatment Period will be calculated with the 
corresponding 95% CI by treatment group.  Clopper-Pearson interval will used to calculate the exact 
confidence interval for binomial proportion.  The difference between each CBP-201 group and 
placebo group and the corresponding 95% CI will be calculated as well.  Cochran–Mantel–Haenszel 
(CMH) test stratified by presence of comorbid asthma will be performed and odds ratio will be 
provided with 95% confidence interval.  
The sample SAS code for CMH test: 
proc freq data=data order=data; 
table trt01pn*rescuetrt*cmabl / relrisk cmh; 
run; 
4.11.5 Exploratory Efficacy Analysis 
Exploratory analyses will be done using a similar model to the primary endoscopic NPS endpoint 
analysis.  Endpoints will include: 
• 
Change from baseline at Week 24 in FEV1 for subjects with asthma 
• 
Change from baseline at Week 16 in endoscopic NPS 
• 
Change from baseline at Week 16 in Average daily NCS 
• 
Change from baseline at Week 24 in European quality of life scale (EQ 5D-5L) 
Weekly mean of daily nasal congestion score will be calculated as sum of non-missing daily nasal 
congestion score divided by number of days with non-missing daily nasal congestion score using 
analysis window (Table ). 
Proportion of subjects with minimal clinically important difference ≥ 8.9 in SNOT-22 at Week 24 
will be calculated with the corresponding 95% CI by treatment group.  Clopper-Pearson interval will 
used to calculate the exact confidence interval for binomial proportion.  The difference between each 
CBP-201 group and placebo group and the corresponding 95% CI will be calculated as well.    
Cochran–Mantel–Haenszel (CMH) test stratified by presence of comorbid asthma will be performed 
and odds ratio will be provided with 95% confidence interval. 
The sample SAS code for CMH test: 
proc freq data=data order=data; 
table trt01pn*snot*cmabl / relrisk cmh; 
run; 
Healthcare resource utilization at each visit up to Week 24 will be summarized using descriptive 
statistics by treatment and overall, as described in 4.13.4. 
By-subject listings of each exploratory efficacy endpoint will also be provided. 
4.12 
Safety Evaluation 
4.12.1 Extent of Exposure  
Duration of treatment (see 4.2 for definition), cumulative amount of study drug administered during 
treatment period, and number of injection interruption will be summarized on Safety Set by treatment 
and overall.  By-subject listing of extent of exposure will also be provided. 


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4.12.2 Adverse Events 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) 
Version 24.0.  Severity and causality of AE will be evaluated by the investigator.  Severity of AE will 
be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.  
Incomplete start and end date of the AE will be imputed as described in Error! Reference source 
not found.. 
Subjects with multiple incidents of events for a given preferred term (PT) and system organ class 
(SOC) will be counted only once.  Similarly, if a subject experiences multiple incident of events for 
a given PT and SOC, the worst severity will be used in the summaries presenting severity, and the 
worst causality to study drug will be used in the summaries presenting causality, respectively. 
Any missing severity will be queried for completion.  If the severity is still missing in the final data 
and the outcome of AE is death, then it will be deemed as Grade 5, and if the life-threatening is 
marked, then it will be deemed as Grade 4.  Otherwise, the severity still missing in the final data will 
be deemed as Grade 3. 
Any missing causality will also be queried for completion, and any events that still have missing 
causality in the final data will be deemed as ‘Related’. 
The imputed severity and relationship will be used in table summary, but the original value will be 
maintained as missing in the by-subject listing. 
Adverse event summaries will be sorted in terms of decreasing frequency for SOC, and PT within 
SOC, in the overall group, and then alphabetically for SOC, and PT within SOC if there are any ties 
in frequency. 
An overall summary of AEs will include the number and percentage of subjects in the following 
categories: 
• 
Any AEs 
• 
AEs by maximum severity 
• 
Any AEs related to study drug 
• 
Any AEs related to study procedure 
• 
Any AEs occurring more than 5% of subjects in overall 
• 
Any serious AEs 
• 
Any AEs leading to death 
• 
Any AEs leading to study drug discontinuation 
• 
Any AEs leading to study drug interruption 
• 
Any TEAEs 
• 
TEAEs by maximum severity 
• 
Any TEAEs related to study drug 
• 
Any TEAEs related to study procedure 
• 
Any TEAEs occurring more than 5% of subjects in overall 
• 
Any serious TEAEs 


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• 
Any TEAEs leading to death 
• 
Any TEAEs leading to study drug discontinuation 
• 
Any TEAEs leading to study drug interruption 
Summaries of following AEs including the number and percentage of subjects will also be provided: 
• 
AEs by SOC and PT 
• 
Serious AEs by SOC and PT 
• 
TEAEs by SOC and PT 
• 
TEAEs by SOC and PT for Subjects with Rescue Medications 
• 
TEAEs by decreasing frequency of PT 
• 
TEAEs by SOC, PT, and maximum severity 
• 
TEAEs of grade 3 or higher by SOC and PT 
• 
TEAEs related to study drug by SOC and PT 
• 
TEAEs related to study procedure by SOC and PT 
• 
Any TEAEs occurring more than 5% of subjects in overall 
• 
Serious TEAEs by SOC and PT 
• 
TEAEs leading to death by SOC and PT 
• 
TEAEs leading to study drug discontinuation by SOC and PT 
• 
TEAEs leading to study drug interruption by SOC and PT 
By-subject listings of corresponding adverse events summary will also be provided. 
4.12.3 Adverse Event of Special Interest 
The TEAEs of special interests are defined as: 
• 
Conjunctivitis 
• 
Keratitis 
• 
Anaphylaxis 
• 
Parasitic and opportunistic infections 
• 
Pregnancy 
• 
Symptomatic overdose 
• 
Injection site reactions lasting longer than 24 hours 
• 
AST/ALT elevated > 5X ULN 
The TEAEs of special interests will be summarized using frequencies and percentages by SOC and 
PT.  Further analysis on AESI will also be summarized including the risk difference, its 95% 
confidence interval, and p-value using CMH test stratified by presence of comorbid asthma if there 
are at least 4 subjects in any treatment arm.  The risk difference will be computed as each CBP-201 
treatment group versus placebo.    The confidence intervals and p-values will not be adjusted for 


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multiplicity so should be considered accordingly.  By-subject listings will also be provided for all 
AESIs. 
4.12.4 Clinical Laboratory Evaluation 
All laboratory values will be reported and summarized using standard international (SI) units 
(Appendix D – Laboratory SI U).  CTCAE v5.0 will be used for the laboratory toxicity grade 
(Appendix E: CTCAE V5.0 Toxicity Grading for Laboratory Parameters). 
The following central laboratory tests will be summarized: 
• 
Hematology: red blood cell count, hemoglobin level, hematocrit level, white blood cell count 
with differential, and platelet count 
• 
Serum Chemistry: blood urea nitrogen (BUN), creatinine, uric acid, total bilirubin, sodium, 
potassium, calcium, chloride, bicarbonate, alkaline phosphatase (ALP), aspartate 
aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), 
gamma-glutamyltransferase (GGT), creatine phosphokinase (CPK), albumin, total protein, 
total cholesterol, triglycerides, C-reactive protein (CRP), and glucose 
• 
Urinalysis: pH, protein, glucose, ketones, bilirubin, blood (hemoglobin), urobilinogen, 
nitrites, leukocytes, and specific gravity; microscopic analysis if abnormal 
Continuous test results for each parameter and changes from baseline will be summarized at each 
visit by treatment and overall using descriptive statistics.  Categorical test results for each parameter 
will be summarized at each visit by treatment and overall using frequencies and percentages.  Shift 
of laboratory toxicity grade from baseline to each post-baseline visit will be summarized by treatment 
and overall.  By-subject listings of laboratory parameters will also be provided. 
Laboratory values will be listed by subject and study time point including changes from baseline, 
where available.  All values outside the clinical reference ranges will be flagged in the data listings.  
The abnormal values will be flagged with ‘L’ for values below the lower limit of the clinical reference 
range and ‘H’ for values above the upper limit of the clinical reference range and included in the 
listings. 
4.12.5 Vital Signs 
Descriptive summaries of actual values and changes from baseline at each visit will be summarized 
for temperature, systolic blood pressure, diastolic blood pressure, heart rate, and respiratory rate by 
treatment and overall.  Baseline of vital signs is defined as pre-dose at Baseline visit.  By-subject 
listing of vital sign parameters will also be provided.  
4.12.6 Electrocardiograms 
Descriptive summaries of actual values and changes from baseline at each visit will be summarized 
for the electrocardiogram parameters by treatment and overall.  A separate summary of abnormal 
findings will be provided using frequencies and percentages.  By-subject listing of electrocardiogram 
parameters will also be provided.  
4.12.7 Physical Examinations 
A complete or brief physical examinations will be conducted at Screening; Baseline; Weeks 1, 2, 4, 
6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28 during treatment period; Week 28 and End of Study visit during 
follow-up period. 


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A complete physical examination will be conducted at Screening and End of Study visit, and includes: 
• 
General appearance 
• 
Head, eyes, ears, nose, and throat (HEENT) 
• 
Neck 
• 
Thyroid 
• 
Skin 
• 
Cardiovascular system 
• 
Respiratory system 
• 
Lymph nodes 
• 
Musculoskeletal system 
• 
Abdomen 
• 
Fundoscopy (if available) 
• 
Nervous system 
• 
Extremities 
A brief physical examination will be in all other visits and includes: 
• 
General appearance 
• 
Eyeball 
• 
Lungs 
• 
Lymph nodes 
Abnormal findings of physical examinations will be summarized at each visit using frequencies and 
percentages by treatment and overall.  By-subject listing of all physical examination parameters will 
also be provided. 
4.12.8 Data and Safety Monitoring Board (DSMB) 
An independent Data Safety Monitoring Board (DSMB) will be set up periodically to review and 
evaluate all tolerability, descriptive primary efficacy data, and safety data for subject safety, study 
conduct and progress, and to make recommendations to the sponsor concerning the continuation, 
modification, or termination of the trial.  The DSMB will be comprised of relevant clinical experts, 
drug safety and benefit-risk assessment experts, clinical trial methodology experts, and an 
independent DSMB biostatistician.  These members will not be directly involved in the conduct of 
the study.  Each meeting will be consisted of open and closed session.  Unblinded information will 
be only reviewed during the closed session to maintain blinding and to prevent potential bias.  The 
meeting minutes containing unblinded information will be marked as “Confidential” and distributed 
to the members of the DSMB only. 
A separate DSMB Charter document will outline further details about the DSMB responsibilities and 
authorities, schedule of data review, define the board process, communications, meeting format, data 
access, and the lists of the reports. 


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4.13 
Other Analyses 
4.13.1 Pharmacokinetics 
Whole blood for plasma CBP-201 concentrations will be collected, and additional sampling will be 
obtained after the last treatment dose to characterize the return to Baseline, as noted in the schedule 
of assessment.  The individual and treatment group steady-state trough pharmacokinetic (PK) profile 
will be calculated for PK analysis. 
The details of PK analysis will be provided in a separate PK analysis plan. 
4.13.2 Pharmacodynamics 
Pharmacodynamic (PD) blood samples for biomarkers of inflammation include peripheral eosinophil 
counts, Eotaxin-3, eosinophil cationic protein (ECP), total immunoglobulin E (IgE), thymus and 
activation-regulated chemokine (TARC), and periostin.  Blood eosinophil count will be measured as 
part of hematology test and included in hematology summary.  CRP will be determined as part of the 
serum chemistry and included in serum chemistry summary.  Absolute analysis value and change 
from baseline of peripheral eosinophil counts, Eotaxin-3, eosinophil cationic protein (ECP), total 
immunoglobulin E (IgE), thymus and activation-regulated chemokine (TARC), and periostin to each 
visit will be summarized by treatment using descriptive statistics on PK Set.  By-subject listing will 
also be provided. 
4.13.3 Immunogenicity 
The immunogenicity of CBP-201 with prolonged use will be determined with the collection of blood 
samples for measurement of anti CBP-201 antibodies (ADA) throughout the study.  Further, 
neutralizing activity of neutralizing antibodies (NAb) will be measured on samples that test positive 
for anti CBP-201 antibodies.  Absolute analysis value and change from baseline of ADA and NAb 
blood sample will be summarized by treatment using descriptive statistics on PK Set.  By-subject 
listing will also be provided. 
4.13.4 Health Economics  
The following data will be collected during the study in health care utilization eCRF: 
• 
Number of visits (in-person or telehealth) to usual healthcare provider for nasal polyps since 
last visit 
• 
Number of urgent care admissions for nasal polyps since last visit 
• 
Number of emergency room admissions for nasal polyps since last visit 
• 
Number of days on hospitalization for nasal polyps since last visit 
• 
Incident of surgery for nasal polyps since last visit 
Each question at each visit will be summarized by treatment and overall using descriptive statistics.  
By-subject listing of health care utilization will also be provided. 
4.14 
Determination of Sample Size 
The sample size of the study is determined based on the comparison between CBP-201 300 mg every 
2 weeks vs. placebo with regard to the co-primary endpoint change from baseline in NPS at Week 24 
(LIBERTY SINUS studies, Bachert et al 2019).  Assuming a common standard deviation in the NPS 
of 2.1, and based on the use of a two-sided test at the alpha=0.05 level of  significance 41 patients per 


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group will provide 80% power to detect a difference of 1.3 between the CBP-201 group and the 
placebo group in the change of NPS from baseline to Week 24.  To allow for a 15% dropout rate, the 
planned samples size is 49 subjects per group (147 total). 
• 
Roughly, to ensure at least 74 patients have co-morbid asthma: Recruitment of NP patient 
without co-morbid asthma will stop when approximately 70 patients without asthma are 
randomized, and 
• 
Patients with co-morbid asthma will continue to be randomized to complete a total number of 
147 randomized NP patients.  
If greater than 15% of the treated patients do not complete the study, the sample size may be adjusted 
to ensure adequate power. 
4.15 
Changes in the Conduct of the Study or Planned Analysis 
Enrollment of Sponsor’s Phase 2 trial evaluating CBP-201 in chronic rhinosinusitis with nasal polyps, 
which commenced in June 2021, has faced challenges due to the macroenvironment -- namely 
ongoing impact of COVID and the current Russia-Ukraine conflict throughout [Eastern] Europe.  
  
Therefore, the Sponsor has made the decision to terminate this trial early, and the planned analyses 
have been changed to focus on safety assessments.   
 
For the efficacy endpoints, only descriptive summary statistics will be provided for the co-primary 
efficacy assessments. No formal hypotheses will be tested due to the small sample size. No sensitivity 
or subgroup analyses will be performed. All other efficacy assessments will be listed except 
percentage of maxillary sinus volume occupied by disease on CT and Lund-Mackay Computed 
Tomography scores. 
 
 
 


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5 
REFERENCES 
Bachert C, Han JK, Desrosiers M, Hellings P, Amin N, Lee SE, Mullol J, Greos L, Bosso J, 
Laidlaw TM, Cervin A, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, 
Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel 
N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. 
Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps 
(LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, 
randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet 2019; 394: 
1638–50. 
Ratitch, Bohdana, and Michael O’Kelly. “Implementation of Pattern-Mixture Models Using 
Standard SAS/STAT Procedures.” PharmaSUG2011, 2011, 
www.lexjansen.com/pharmasug/2011/SP/PharmaSUG-2011-SP04.pdf. 
SAS® Version 9.4 of the SAS System for Personal Computers. Copyright ©2013. SAS Institute 
Inc. SAS and all other SAS Institute Inc. product or service names are registered trademarks or 
trademarks of SAS Institute Inc., Cary, NC, USA. 
“The MI Procedure”. SAS® 9.4 and SAS® Viya® 3.4 Programming Documentation. SAS Institute 
Inc., 2019, 
https://documentation.sas.com/doc/en/pgmsascdc/9.4_3.4/statug/statug_mi_details61.htm. 
Suzhou Connect Biopharmaceuticals, Ltd., "CLINICAL STUDY PROTOCOL CBP-201-WW003: 
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate CBP-201 in Adult 
Patients with Chronic Rhinosinusitis with Nasal Polyps" 2021. 
 


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6 
APPENDICES 
6.1 
Appendix A – Visual Analogue Scale for Rhinosinusitis (VAS-RS) 
Seriousness of the complaints: Please draw a vertical line to the point that best corresponds to, how 
bothersome were the following symptoms within the last month, as given to the example: 
 
* Example                   None                                                                    More than I can imagine 
 
                                     
* Total sinus symptoms: 
                                    None                                                                    More than I can imagine 
 
   
 
 
 
* Nasal blockage:       None                                                                     More than I can imagine 
 
 
 
 
 
* Headache /pressure on the face:                                                                                   
                                     None                                                                     More than I can imagine 
 
 
* Loss of smell:          None                                                                     More than I can imagine 
 
 
 
 
                                     
* Post-nasal drip (secretions from the nose down to the throat): 
                                    None                                                                     More than I can imagine 
 
 
 
 
                                     
* Runny nose:             None                                                                     More than I can imagine 
 
 
 
 
 
* Itchy eyes:               None                                                                      More than I can imagine 


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* Itchy nose:               None                                                                      More than I can imagine 
 
 
 
 
                                     
* Sneezing:                 None                                                                      More than I can imagine 
 
 
 
 
                                     
* Tearing:                   None                                                                       More than I can imagine        
 
 
 
     
                         
* Cough:                     None                                                                       More than I can imagine 
 
 
 
 
                                     
* Tightness/pressing sensation on the chest: 
None                                                                       More than I can imagine 
 
                                     
* Shortness of breath/difficulty with breathing: 
None                                                                        More than I can imagine 
 
                                     
* Wheezing: 
None                                                                        More than I can imagine 
                                    
 
 
 
 


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6.2 
Appendix B – Total Nasal Symptom Score (TNSS) 
Total Nasal Symptom Scores (TNSS) is the total of 4 related symptoms. Each symptom (sneezing, 
congestion, itching, and rhinorrhea) is graded from 0 to 3 by the patients. 
Score 
Description 
Symptoms 
0 
None 
No symptoms evident 
1 
Mild 
Symptom present but easily tolerated 
2 
Moderate 
Definite awareness of symptom; bothersome but tolerable 
3 
Severe 
Symptom hard to tolerate; interferes with daily activity 
The nasal symptoms are then added together for each symptom to get the total TNSS. 
 
 


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6.3 
Appendix C – Sino-Nasal Outcome Test-22 QUESTIONNAIRE (SNOT-22) 
 
 
 


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6.4 
Appendix D – Laboratory SI Units 
Panel 
Parameter 
SI Unit 
Hematology 
Eosinophil Count 
10^9/L 
 
Hematocrit 
Proportion of 1.0 
 
Hemoglobin 
g/L 
 
Platelet Count 
10^9/L 
 
Red Blood Cell (RBC) Count 
10^12/L 
 
White Blood Cell (WBC) Count with Differential % 
Serum Chemistry 
Alanine Aminotransferase (ALT) 
U/L 
 
Albumin 
g/L 
 
Alkaline Phosphatase (ALP) 
U/L 
 
Aspartate Aminotransferase (AST) 
U/L 
 
Blood Urea Nitrogen (BUN) 
mmol/L 
 
Calcium 
mmol/L 
 
Bicarbonate 
mmol/L 
 
Chloride 
mmol/L 
 
Creatinine 
μmol/L 
 
Creatine Phosphokinase (CPK) 
U/L 
 
C-Reactive Protein (CRP) 
mg/L 
 
Gamma-Glutamyltransferase (GGT) 
U/L 
 
Glucose 
mmol/L 
 
Lactate Dehydrogenase (LDH) 
U/L 
 
Potassium 
mmol/L 
 
Sodium 
mmol/L 
 
Total Bilirubin 
μmol/L 
 
Total Cholesterol 
mmol/L 
 
Total Protein 
g/L 
 
Triglycerides 
mmol/L 
 
Uric Acid 
mmol/L 
Urinalysis 
Bilirubin 
NA 
 
Hemoglobin 
NA 
 
Glucose 
NA 
 
Ketones 
NA 
 
Leukocytes 
NA 
 
Nitrites 
NA 
 
pH 
NA 


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Protein 
NA 
 
Specific Gravity 
NA 
 
Urobilinogen 
NA 
 
Microscopic Analysis if abnormal 
NA 


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6.5 
Appendix E: CTCAE V5.0 Toxicity Grading for Laboratory Parameters 
CTCAE v5.0 
SOC 
CTCAE v5.0 Term 
Laboratory 
Parameter 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Blood and 
lymphatic 
system 
disorders 
Anemia 
Hemoglobin (Hgb) 
Hemoglobin (Hgb) 
<LLN - 10.0 
g/dL; <LLN - 6.2 
mmol/L; <LLN 
- 100 g/L 
Hgb <10.0 - 8.0 
g/dL; <6.2 - 4.9 
mmol/L; <100 - 
80g/L 
Hgb <8.0 g/dL; 
<4.9 mmol/L; 
<80 g/L; 
transfusion 
indicated 
 
 
Eosinophilia 
Eosinophils in the 
blood 
>ULN and 
>Baseline 
- 
 
- 
 
Leukocytosis 
White blood cells in 
the blood 
- 
- 
>100,000/mm3 
 
Investigations 
Activated partial 
thromboplastin time 
prolonged 
Partial 
Thromboplastin 
Time (PTT) 
>ULN - 1.5 x ULN 
>1.5 - 2.5 x ULN 
>2.5 x ULN; 
bleeding 
- 
 
Alanine 
aminotransferase 
increased 
Alanine 
aminotransferase 
(ALT or SGPT) in 
the blood specimen 
>ULN - 3.0 x ULN 
if baseline 
was normal; 1.5 - 
3.0 x 
baseline if baseline 
was 
abnormal 
>3.0 - 5.0 x ULN 
if baseline 
was normal; >3.0 
- 5.0 x 
baseline if 
baseline was 
abnormal 
>5.0 - 20.0 x 
ULN if baseline 
was normal; >5.0 
- 20.0 x 
baseline if 
baseline was 
abnormal 
>20.0 x ULN if 
baseline was 
normal; >20.0 x 
baseline if 
baseline was 
abnormal 
 
Alkaline phosphatase 
increased 
Alkaline 
phosphatase in a 
blood specimen 
>ULN - 2.5 x ULN 
if baseline 
was normal; 2.0 - 
2.5 x 
baseline if baseline 
was 
abnormal 
>2.5 - 5.0 x ULN 
if baseline 
was normal; >2.5 
- 5.0 x 
baseline if 
baseline was 
abnormal 
>5.0 - 20.0 x 
ULN if baseline 
was normal; >5.0 
- 20.0 x 
baseline if 
baseline was 
abnormal 
>20.0 x ULN if 
baseline was 
normal; >20.0 x 
baseline if 
baseline was 
abnormal 


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Aspartate 
aminotransferase 
increased 
Aspartate 
aminotransferase 
(AST or SGOT) in 
a blood specimen 
>ULN - 3.0 x ULN 
if baseline 
was normal; 1.5 - 
3.0 x 
baseline if baseline 
was 
abnormal 
>3.0 - 5.0 x ULN 
if baseline 
was normal; >3.0 
- 5.0 x 
baseline if 
baseline was 
abnormal 
>5.0 - 20.0 x 
ULN if baseline 
was normal; >5.0 
- 20.0 x 
baseline if 
baseline was 
abnormal 
>20.0 x ULN if 
baseline was 
normal; >20.0 x 
baseline if 
baseline was 
abnormal 
 
Blood bicarbonate 
decreased 
Bicarbonate in a 
venous blood 
specimen 
<LLN and no 
intervention 
initiated 
- 
- 
- 
 
Blood bilirubin 
increased 
Bilirubin in a blood 
specimen 
>ULN - 1.5 x ULN 
if baseline 
was normal; > 1.0 - 
1.5 x 
baseline if baseline 
was 
abnormal 
>1.5 - 3.0 x ULN 
if baseline 
was normal; >1.5 
- 3.0 x 
baseline if 
baseline was 
abnormal 
>3.0 - 10.0 x 
ULN if baseline 
was normal; >3.0 
- 10.0 x 
baseline if 
baseline was 
abnormal 
>10.0 x ULN if 
baseline was 
normal; >10.0 x 
baseline if 
baseline was 
abnormal 
 
Blood lactate 
dehydrogenase 
increased 
Lactate 
dehydrogenase in 
the blood specimen 
>ULN 
- 
- 
- 
 
Cholesterol high 
Cholesterol in a 
blood specimen 
>ULN - 300 
mg/dL; >ULN - 
7.75 mmol/L 
>300 - 400 
mg/dL; >7.75 - 
10.34 mmol/L 
>400 - 500 
mg/dL; >10.34 - 
12.92 mmol/L 
>500 mg/dL; 
>12.92 mmol/L 
 
CPK increased 
Creatine 
phosphokinase in a 
blood specimen 
>ULN - 2.5 x ULN 
>2.5 x ULN - 5 x 
ULN 
>5 x ULN - 10 x 
ULN 
>10 x ULN 
 
Creatinine increased 
Creatinine in a 
biological specimen 
>ULN - 1.5 x ULN 
>1.5 - 3.0 x 
baseline; >1.5 - 
3.0 
x ULN 
>3.0 x baseline; 
>3.0 - 6.0 x 
ULN 
>6.0 x ULN 


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GGT increased 
Gamma-
glutamyltransferase 
in the blood 
specimen 
>ULN - 2.5 x ULN 
if baseline 
was normal; 2.0 - 
2.5 x 
baseline if baseline 
was 
abnormal 
>2.5 - 5.0 x ULN 
if baseline 
was normal; >2.5 
- 5.0 x 
baseline if 
baseline was 
abnormal 
>5.0 - 20.0 x 
ULN if baseline 
was normal; >5.0 
- 20.0 x 
baseline if 
baseline was 
abnormal 
>20.0 x ULN if 
baseline was 
normal; >20.0 x 
baseline if 
baseline was 
abnormal 
 
Hemoglobin increased 
Hemoglobin 
Increase in >0 - 2 
g/dL 
Increase in >2 - 4 
g/dL 
Increase in >4 
g/dL 
- 
 
INR increased 
INR 
>1.2 - 1.5; >1 - 1.5 
x baseline if 
on anticoagulation; 
monitoring only 
indicated 
>1.5 - 2.5; >1.5 - 
2.5 x baseline 
if on 
anticoagulation; 
dose 
adjustment 
indicated 
>2.5; >2.5 x 
baseline if on 
anticoagulation; 
bleeding 
- 
 
Lipase increased 
Lipase in a 
biological specimen 
>ULN - 1.5 x ULN 
>1.5 - 2.0 x ULN; 
>2.0 - 5.0 x 
ULN and 
asymptomatic 
>2.0 - 5.0 x ULN 
with signs or 
symptoms; >5.0 x 
ULN and 
asymptomatic 
>5.0 x ULN and 
with signs or 
symptoms 
 
Lymphocyte count 
decreased 
Lymphocytes in a 
blood specimen 
<LLN - 800/mm3; 
<LLN - 0.8 x 
10e9/L 
<800 - 500/mm3; 
<0.8 - 0.5 x 
10e9 /L 
<500 - 200/mm3; 
<0.5 - 0.2 x 
10e9 /L 
<200/mm3; <0.2 
x 10e9 /L 
 
Lymphocyte count 
increased 
Lymphocytes in the 
blood 
- 
>4000/mm3 - 
20,000/mm3 
>20,000/mm3 
- 
 
Neutrophil count 
decreased 
Neutrophils in a 
blood specimen 
<LLN - 1500/mm3; 
<LLN - 1.5 x 
10e9 /L 
<1500 - 
1000/mm3; <1.5 - 
1.0 
x 10e9 /L 
<1000 - 
500/mm3; <1.0 - 
0.5 x 
10e9 /L 
<500/mm3; <0.5 
x 10e9 /L 


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Pancreatic enzymes 
decreased 
Pancreatic enzymes 
in a biological 
specimen 
<LLN and 
asymptomatic 
 
 
 
 
Platelet count decreased 
Platelets in a blood 
specimen 
<LLN - 
75,000/mm3; <LLN 
- 
75.0 x 10e9 /L 
<75,000 - 
50,000/mm3; 
<75.0 
- 50.0 x 10e9 /L 
<50,000 - 
25,000/mm3; 
<50.0 
- 25.0 x 10e9 /L 
<25,000/mm3; 
<25.0 x 10e9 /L 
 
Serum amylase 
increased 
Amylase in a serum 
specimen 
>ULN - 1.5 x ULN 
>1.5 - 2.0 x ULN; 
>2.0 - 5.0 x 
ULN and 
asymptomatic 
>2.0 - 5.0 x ULN 
with signs or 
symptoms; >5.0 x 
ULN and 
asymptomatic 
>5.0 x ULN and 
with signs or 
symptoms 
 
White blood cell 
decreased 
White blood cells in 
a blood specimen 
<LLN - 3000/mm3; 
<LLN - 3.0 x 
10e9 /L 
<3000 - 
2000/mm3; <3.0 - 
2.0 
x 10e9 /L 
<2000 - 
1000/mm3; <2.0 - 
1.0 
x 10e9 /L 
<1000/mm3; 
<1.0 x 10e9 /L 
Metabolism and 
nutrition 
disorders 
Acidosis 
Acidity of the blood pH <normal, but 
>=7.3 
- 
pH <7.3 
 
 
Alkalosis 
Alkalinity of the 
blood 
pH >normal, but 
<=7.5 
- 
pH >7.5 
 
 
Hypercalcemia 
Calcium (corrected 
for albumin) in 
blood 
Corrected serum 
calcium of >ULN - 
11.5 mg/dL; >ULN 
- 2.9 mmol/L; 
Ionized calcium 
>ULN - 1.5 
mmol/L 
Corrected serum 
calcium of >11.5 - 
12.5 mg/dL; >2.9 
- 3.1 mmol/L; 
Ionized calcium 
>1.5 - 1.6 
mmol/L; 
symptomatic 
Corrected serum 
calcium of >12.5 - 
13.5 mg/dL; >3.1 
- 3.4 mmol/L; 
Ionized calcium 
>1.6 - 1.8 
mmol/L; 
hospitalization 
indicated 
Corrected serum 
calcium of >13.5 
mg/dL; >3.4 
mmol/L; Ionized 
calcium >1.8 
mmol/L; life-
threatening 
consequences 


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Hyperkalemia 
Potassium in the 
blood 
>ULN - 5.5 
mmol/L 
>5.5 - 6.0 
mmol/L; 
intervention 
initiated 
>6.0 - 7.0 
mmol/L; 
hospitalization 
indicated 
>7.0 mmol/L; 
life-threatening 
consequences 
 
Hypermagnesemia 
Magnesium in the 
blood 
>ULN - 3.0 mg/dL; 
>ULN - 1.23 
mmol/L 
- 
>3.0 - 8.0 mg/dL; 
>1.23 - 3.30 
mmol/L 
>8.0 mg/dL; 
>3.30 mmol/L; 
life-threatening 
consequences 
 
Hypernatremia 
Sodium in the 
blood 
>ULN - 150 
mmol/L 
>150 - 155 
mmol/L; 
intervention 
initiated 
>155 - 160 
mmol/L; 
hospitalization 
indicated 
>160 mmol/L; 
life-threatening 
consequences 
 
Hypertriglyceridemia 
Triglyceride 
concentration in the 
blood 
150 mg/dL - 300 
mg/dL; 1.71 
mmol/L - 3.42 
mmol/L 
>300 mg/dL - 500 
mg/dL; >3.42 
mmol/L - 5.7 
mmol/L 
>500 mg/dL - 
1000 mg/dL; >5.7 
mmol/L - 11.4 
mmol/L 
>1000 mg/dL; 
>11.4 mmol/L; 
life-threatening 
consequences 
 
Hyperuricemia 
Uric acid 
>ULN without 
physiologic 
consequences 
- 
>ULN with 
physiologic 
consequences 
 
 
Hypoalbuminemia 
Albumin in the 
blood 
<LLN - 3 g/dL; 
<LLN - 30 g/L 
<3 - 2 g/dL; <30 - 
20 g/L 
<2 g/dL; <20 g/L 
 
 
Hypocalcemia 
Calcium (corrected 
for albumin) in the 
blood 
Corrected serum 
calcium of 
<LLN - 8.0 mg/dL; 
<LLN - 2.0 
mmol/L; Ionized 
calcium <LLN 
- 1.0 mmol/L 
Corrected serum 
calcium of 
<8.0 - 7.0 mg/dL; 
<2.0 - 1.75 
mmol/L; Ionized 
calcium <1.0 
- 0.9 mmol/L; 
symptomatic 
Corrected serum 
calcium of 
<7.0 - 6.0 mg/dL; 
<1.75 - 1.5 
mmol/L; Ionized 
calcium <0.9 
- 0.8 mmol/L; 
hospitalization 
indicated 
Corrected serum 
calcium of 
<6.0 mg/dL; 
<1.5 mmol/L; 
Ionized calcium 
<0.8 mmol/L; 
life-threatening 
consequences 


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Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 51 of 52 
 
Hypoglycemia 
Glucose in the 
blood 
<LLN - 55 mg/dL; 
<LLN - 3.0 
mmol/L 
<55 - 40 mg/dL; 
<3.0 - 2.2 
mmol/L 
<40 - 30 mg/dL; 
<2.2 - 1.7 
mmol/L 
<30 mg/dL; <1.7 
mmol/L; 
lifethreatening 
consequences; 
seizures 
 
Hypokalemia 
Potassium in the 
blood 
<LLN - 3.0 mmol/L Symptomatic with 
<LLN - 3.0 
mmol/L; 
intervention 
indicated 
<3.0 - 2.5 
mmol/L; 
hospitalization 
indicated 
<2.5 mmol/L; 
life-threatening 
consequences 
 
Hypomagnesemia 
Magnesium in the 
blood 
<LLN - 1.2 mg/dL; 
<LLN - 0.5 
mmol/L 
<1.2 - 0.9 mg/dL; 
<0.5 - 0.4 
mmol/L 
<0.9 - 0.7 mg/dL; 
<0.4 - 0.3 
mmol/L 
<0.7 mg/dL; 
<0.3 mmol/L; 
lifethreatening 
consequences 
 
Hyponatremia 
Sodium in the 
blood 
<LLN - 130 
mmol/L 
125-129 mmol/L 
and 
asymptomatic 
125-129 mmol/L 
symptomatic; 
120-124 
mmol/L 
regardless of 
symptoms 
<120 mmol/L; 
life-threatening 
consequences 
Renal and 
urinary 
disorders 
Chronic kidney disease 
eGFR or CrCl or 
Urine protein 
eGFR (estimated 
Glomerular 
Filtration Rate) or 
CrCl 
(creatinine 
clearance) <LLN - 
60 ml/min/1.73 m2 
or 
proteinuria 2+ 
present; urine 
eGFR or CrCl 59 
- 30 
ml/min/1.73 m2 
eGFR or CrCl 29 
- 15 
ml/min/1.73 m2 
eGFR or CrCl 
<15 ml/min/1.73 
m2; dialysis or 
renal 
transplant 
indicated 


Parexel International 
Suzhou Connect Biopharmaceuticals Ltd. 
CBP-201-WW003 
Statistical Analysis Plan 
TP-GDO-WW-016-08 
CONFIDENTIAL 
Project Document Version No. 2.0 
Effective Date:  26 Nov 19 
Project Document Effective Date: Date of last signature 
Related to:  SOP-GDO-WW-019 
Page 52 of 52 
protein/creatinine 
>0.5 
 
Proteinuria 
Urine protein 
1+ proteinuria; 
urinary protein 
≥ULN - 
2+ and 3+ 
proteinuria; 
urinary protein 
1.0 - <3.5 g/24 
hrs 
Urinary protein 
>=3.5 
g/24 hrs; 4+ 
proteinuria 
- 
 


Signature Page for VV-TMF-1764580 v1.0
Signature Page for VV-TMF-1764580 v1.0
Reason for signing: Approved
Name: Amy Kim
Role: Biostatistics
Date of signature: 20-Jun-2022 14:12:26
GMT+0000
Reason for signing: Approved
Name: Yun Jang
Role: Biostatistics
Date of signature: 20-Jun-2022 14:16:00
GMT+0000
Reason for signing: Approved
Name: Daniel Miconi
Role: Sponsor
Date of signature: 20-Jun-2022 16:04:14
GMT+0000

Prot_000.pdf: 
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C O N FI D E N TI A L  
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T A B L E O F C O N T E N T S  
SI G N A T U R E P A G E  ..................................................................................................................... 2 
T A B L E O F C O N T E N T S  ............................................................................................................. 5 
P R O T O C O L S Y N O P SI S  ........................................................................................................... 1 2 
LI S T O F A B B R E VI A TI O N S  .................................................................................................... 2 3 
1  
I N T R O D U C TI O N........................................................................................................ 2 6 
1. 1  
Bac k gr o u n d  ................................................................................................................................. 2 6  
1. 2  
I n vesti gati o nal Pr o d uct ............................................................................................................... 2 6  
1. 3  
Effects i n H u ma ns  ...................................................................................................................... 2 6  
1. 4  
C o m plia n ce ................................................................................................................................. 2 7  
2  
S T U D Y O B J E C TI V E S  ................................................................................................ 2 7 
2. 1  
Pri mar y St u d y O bjecti ve  ............................................................................................................ 2 7  
2. 2  
Sec o n dar y O bjecti ves  ................................................................................................................. 2 7  
2. 3  
E x pl orat or y O bjecti ves  ............................................................................................................... 2 7  
3  
I N V ES TI G A TI O N A L S T U D Y P L A N  ....................................................................... 2 8 
3. 1  
O verall Desi g n  ............................................................................................................................ 2 8  
3. 2  
Scree ni n g/ R u n-I n Peri o d: 4 wee ks  ............................................................................................. 2 8  
3. 3  
Treat me nt Peri o d: C B P - 2 0 1/ Place b o f or 2 4 wee ks .................................................................... 2 8  
3. 4  
P ost -treat me nt F oll o w- U p Peri o d: 8 wee ks ................................................................................ 2 9  
3. 5  
Disc o nti n uati o n a n d St u d y St o p pi n g R ules  ................................................................................ 2 9  
3. 6  
Rati o nale f or St u d y Desi g n  ......................................................................................................... 2 9  
3. 7  
St u d y D urati o n  ............................................................................................................................ 3 0  
3. 8  
St u d y P o p ulati o n  ......................................................................................................................... 3 0  
3. 9  
Efficac y Assess me nts  ................................................................................................................. 3 0  
3. 9. 1  
C o - pri mar y Efficac y E n d p oi nts .................................................................................. 3 0  


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C O N FI D E N TI A L  
Pa ge 6  of 9 7  
3. 9. 2  
Sec o n dar y Efficac y E n d p oi nts  ................................................................................... 3 0  
3. 9. 3  
E x pl orat or y Efficac y E n d p oi nts  ................................................................................. 3 1  
3. 9. 4  
P har mac o d y na mic E n d p oi nts  ..................................................................................... 3 2  
3. 9. 5  
P har mac o ki netic E n d p oi nts  ........................................................................................ 3 2  
3. 9. 6  
Safet y E n d p oi nts  ........................................................................................................ 3 2  
4  
S T U D Y T R E A T M E N T S  ............................................................................................. 3 2 
4. 1  
St u d y Dr u g Descri pti o n  .............................................................................................................. 3 2  
4. 2  
St u d y Dr u g A d mi nistrati o n ......................................................................................................... 3 3  
4. 3  
Resc ue Me dicati o ns  .................................................................................................................... 3 3  
4. 4  
Ot her C o nc o mita nt Me dicati o ns  ................................................................................................. 3 4  
4. 5  
Pr o hi bite d Me dicati o ns a n d Restricti o ns  .................................................................................... 3 4  
4. 6  
Restricti o ns  ................................................................................................................................. 3 5  
4. 7  
A v oi da nce of Pre g na nc y  ............................................................................................................. 3 5  
4. 8  
Meas ure me nt of Patie nt C o m plia nce  .......................................................................................... 3 7  
5  
P A TI E N T E N R O L L M E N T  ........................................................................................ 3 7 
5. 1  
I ncl usi o n Criteria ........................................................................................................................ 3 7  
5. 2  
E xcl usi o n Criteria  ....................................................................................................................... 3 8  
5. 3  
Ra n d o misati o n Pr oce d ures  ......................................................................................................... 4 1  
5. 4  
Bli n di n g Pr oce d ures  ................................................................................................................... 4 2  
5. 5  
Reas o ns f or Patie nt Wit h dra wal  ................................................................................................. 4 2  
5. 6  
R hi n osi n usitis or Ast h ma E xacer bati o n as Wit h dra wal Criteri o n  .............................................. 4 3  
5. 7  
Ot her Reas o ns as Wit h dra wal Criteria  ....................................................................................... 4 3  
5. 8  
Ha n dli n g of Wit h dra wals  ............................................................................................................ 4 4  
5. 9  
Re place me nts  .............................................................................................................................. 4 4  
5. 1 0  
S p o ns or’s Ter mi nati o n of St u d y  ................................................................................................. 4 4  


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C O N FI D E N TI A L  
Pa ge 7  of 9 7  
6  
S T U D Y VI SI T S  ............................................................................................................ 4 4 
6. 1  
Scree ni n g ( Visit 1), St u d y Da y - 3 1 t o - 1  .................................................................................... 4 5  
6. 2  
Baseli ne Visit ( Visit 2), St u d y Da y 1  ......................................................................................... 4 6  
6. 3  
Visit 3 ( St u d y Da y 8 ± 3 da ys/ Wee k  1) ...................................................................................... 4 7  
6. 4  
Visit 4 ( St u d y Da y 1 5 ± 3 da ys/ Wee k  2) .................................................................................... 4 7  
6. 5  
Visit 5 ( St u d y Da y 2 9 ± 3 da ys/ Wee k  4) .................................................................................... 4 8  
6. 6  
Visit 6 ( St u d y Da y 4 3 ± 3 da ys/ Wee k  6) .................................................................................... 4 9  
6. 7  
Visit 7 ( St u d y Da y 5 7 ± 3 da ys/ Wee k  8) .................................................................................... 4 9  
6. 8  
Visit 8 ( St u d y Da y 7 1 ± 3 da ys/ Wee k  1 0) .................................................................................. 5 0  
6. 9  
Visit 9 ( St u d y Da y 8 5 ± 3 da ys/ Wee k  1 2) .................................................................................. 5 1  
6. 1 0  
Visit 1 0 ( St u d y Da y 9 9 ± 3 da ys/ Wee k  1 4)  ................................................................................ 5 2  
6. 1 1  
Visit 1 1 ( St u d y Da y 1 1 3 ± 3 da ys/ Wee k  1 6)  .............................................................................. 5 2  
6. 1 2  
Visit 1 2 ( St u d y Da y 1 2 7 ± 3 da ys/ Wee k  1 8)  .............................................................................. 5 3  
6. 1 3  
Visit 1 3 ( St u d y Da y 1 4 1 ± 3 da ys/ Wee k  2 0)  .............................................................................. 5 3  
6. 1 4  
Visit 1 4 ( St u d y Da y 1 5 5 ± 3 da ys/ Wee k 2 2)  ............................................................................... 5 4  
6. 1 5  
Visit 1 5 ( E n d of Treat me nt) ( St u d y Da y 1 6 9 ± 3 da ys/ Wee k 2 4)  .............................................. 5 4  
6. 1 6  
Visit 1 6 ( St u d y Da y 1 9 7 ± 5 da ys/ Wee k  2 8)  .............................................................................. 5 5  
6. 1 7  
Visit 1 7 ( E n d of St u d y) ( St u d y Da y 2 2 5 ± 5 da ys/ Wee k  3 2) ..................................................... 5 6  
6. 1 8  
U nsc he d ule d Visits  ..................................................................................................................... 5 7  
6. 1 9  
Earl y Ter mi nati o n Visit  .............................................................................................................. 5 7  
7  
S T U D Y A S S E S S M E N T S  ............................................................................................ 5 8 
7. 1  
De m o gra p hic Data a n d Me dical Hist or y  .................................................................................... 5 8  
7. 2  
P h ysical E xa mi nati o n  ................................................................................................................. 5 8  
7. 3  
Vital Si g n M eas ure me nts ............................................................................................................ 5 9  
7. 4  
Wei g ht a n d Hei g ht  ...................................................................................................................... 5 9  


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C O N FI D E N TI A L  
Pa ge 8  of 9 7  
7. 5  
Electr ocar di o gra m  ...................................................................................................................... 5 9  
7. 6  
Safet y L a b orat or y Tests .............................................................................................................. 5 9  
7. 7  
Pre g na nc y Test  ........................................................................................................................... 6 0  
7. 8  
Efficac y Assess me nts  ................................................................................................................. 6 0  
7. 8. 1  
E n d osc o pic Nasal P ol y p Sc ore  ................................................................................... 6 0  
7. 8. 2  
Dail y Diar y of Nasal C o n gesti o n / O bstr ucti o n Sc ore  ............................................... 6 3  
7. 8. 3  
Dail y Diar y of Ot her S y m pt o ms  ................................................................................ 6 3  
7. 8. 4  
Dail y Nasal Pea k I ns pirat or y Fl o w (at H o me) ........................................................... 6 6  
7. 8. 5  
C o m p ute d T o m o gra p h y ( C T) Sca n  ............................................................................ 6 6  
7. 8. 6  
I n- Cli nic P ul m o nar y F u ncti o n Tests ( P F T) ................................................................ 6 6  
7. 8. 7  
S mell Test ( U P SI T)  .................................................................................................... 6 6  
7. 8. 8  
Vis ual A nal o g Scale f or R hi n osi n usitis ( V A S- R S)  .................................................... 6 7  
7. 8. 9  
T otal Nasal S y m pt o m Sc ore ( T N S S)  ......................................................................... 6 7  
7. 8. 1 0  
Si n o -Nasal O utc o me Test ( S N O T - 2 2) ....................................................................... 6 7  
7. 8. 1 1  
E ur o Q o L Healt h Stat us Q uesti o n naire ( E Q- 5 D- 5 L)  .................................................. 6 7  
7. 8. 1 2  
Healt hcare Res o urce Utilizati o n Q uesti o n naire  ......................................................... 6 8  
7. 8. 1 3  
P har mac o d y na mic E n d p oi nts  ..................................................................................... 6 8  
7. 8. 1 4  
P har mac o ki netic Assess me nts  .................................................................................... 6 8  
7. 8. 1 5  
Bl o o d V ol u mes  ........................................................................................................... 6 8  
8  
R E P O R TI N G A D V E R S E E V E N T S  .......................................................................... 6 9 
8. 1  
Defi niti o ns  .................................................................................................................................. 6 9  
8. 1. 1  
A d verse E ve nt  ............................................................................................................ 6 9  
8. 1. 2  
Seri o us A d verse E ve nt  ............................................................................................... 6 9  
8. 2  
Eliciti n g A d verse E ve nt I nf or mati o n  .......................................................................................... 7 0  
8. 3  
A d verse E ve nt Re p orti n g  ............................................................................................................ 7 0  
8. 4  
Assess me nt of A d verse E ve nt Ca usalit y  .................................................................................... 7 1  
8. 5  
Assess me nt of A d verse E ve nt Se verit y  ...................................................................................... 7 1  


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8. 6  
A d verse E ve nt of S pecial I nterest  ............................................................................................... 7 2  
8. 7  
Ma n dat or y Earl y Ter mi nati o n  .................................................................................................... 7 4  
8. 8  
Seri o us A d verse E ve nt Re p orti n g  ............................................................................................... 7 4  
8. 8. 1  
S us pecte d U ne x pecte d Seri o us A d verse Reacti o ns  .................................................... 7 5  
8. 9  
Pre g na nc y Re p orti n g  .................................................................................................................. 7 6  
9  
S T A TI S TI C A L M E T H O D S  ....................................................................................... 7 6 
9. 1  
Sa m ple Size  ................................................................................................................................ 7 6  
9. 2  
A nal ysis P o p ulati o ns  .................................................................................................................. 7 7  
9. 3  
I nteri m A nal ysis ......................................................................................................................... 7 8  
9. 4  
Statistical Met h o d ol o g y  .............................................................................................................. 7 8  
9. 5  
Efficac y A nal ysis  ........................................................................................................................ 7 8  
9. 5. 1  
C o - Pri mar y E n d p oi nts a n d Efficac y A nal ysis ............................................................ 7 8  
9. 5. 2  
Sec o n dar y A nal yses  ................................................................................................... 7 8  
9. 5. 3  
E x pl orat or y A nal yses  ................................................................................................. 8 0  
9. 6  
Sa fet y Data A nal ysis .................................................................................................................. 8 0  
9. 7  
Missi n g Data  ............................................................................................................................... 8 1  
9. 8  
Se nsiti vit y A nal ysis  .................................................................................................................... 8 1  
9. 9  
M ulti plicit y C o nsi derati o ns  ........................................................................................................ 8 1  
9. 1 0  
P har mac o ki netic A nal ysis  .......................................................................................................... 8 1  
9. 1 1  
P har mac o d y na mic A nal ysis ........................................................................................................ 8 2  
9. 1 2  
De m o gra p hic a n d Me dical Hist or y  ............................................................................................. 8 2  
9. 1 3  
A nal ysis of C o nc o mita nt Me dicati o n Use  .................................................................................. 8 2  
9. 1 4  
A nal ysis of E x p os ure t o St u d y Dr u g  .......................................................................................... 8 2  
9. 1 5  
Pr ot oc ol Vi olati o ns  ..................................................................................................................... 8 2  
1 0  
D A T A H A N D LI N G A N D Q U A LI T Y A S S U R A N C E  .............................................. 8 2 
1 0. 1  
Case Re p ort F or ms  ..................................................................................................................... 8 2  


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Pa ge 1 0  of 9 7  
1 0. 2  
M o nit ori n g of t he St u d y  ............................................................................................................. 8 3  
1 0. 3  
I ns pecti o n of Rec or ds ................................................................................................................. 8 3  
1 0. 4  
St u d y Rec or d Rete nti o n  .............................................................................................................. 8 4  
1 1  
A D MI NI S T R A TI V E C O N SI D E R A TI O N S  .............................................................. 8 5 
1 1. 1  
C o nfi de ntialit y  ............................................................................................................................ 8 5  
1 1. 2  
Data a n d Safet y M o nit ori n g B oar d  ............................................................................................. 8 5  
1 1. 3  
I nstit uti o nal Re vie w B oar d/ Et hics C o m mittee A p pr o val ........................................................... 8 5  
1 1. 4  
M o dificati o n of t he Pr ot oc ol  ....................................................................................................... 8 6  
1 1. 5  
I nf or me d C o nse nt ....................................................................................................................... 8 6  
1 1. 6  
Pr ot oc ol Vi olati o ns a n d De viati o ns  ............................................................................................ 8 6  
1 1. 7  
St u d y Re p orti n g Re q uire me nts  ................................................................................................... 8 7  
1 1. 8  
Fi na ncial Discl os ure a n d O bli gati o ns  ......................................................................................... 8 7  
1 1. 9  
I n vesti gat or Res p o nsi bilities a n d D oc u me ntati o n ...................................................................... 8 7  
1 1. 1 0  
St u d y C o n d uct  ............................................................................................................................ 8 9  
1 1. 1 1  
Fi na nci n g a n d I ns ura nce  ............................................................................................................. 8 9  
1 1. 1 2  
P u blicati o ns  ................................................................................................................................ 8 9  
1 1. 1 3  
Ris k Miti gati o n a n d Safet y Meas ures d ue t o C O VI D - 1 9 Pa n de mic .......................................... 8 9  
1 2  
I N V E S TI G A T O R’ S S T A T E M E N T ........................................................................... 9 0 
1 3  
R E F E R E N C E S  ............................................................................................................. 9 1 
1 4  
A P P E N DI C E S  .............................................................................................................. 9 3 
 
 
 


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LI S T O F T A B L E S  
T a ble 1:  
Sc he d ule of Assess me nts  ......................................................................................... 1 9  
T a ble 2:  
E n d osc o pic N as al P ol y p Sc ore  ................................................................................ 6 1  
T a ble 3  
Bl o o d V ol u mes  ........................................................................................................ 6 8  
T a ble 4.  
A d verse E ve nt C a us alit y  ......................................................................................... 7 1  
 


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P R O T O C O L S Y N O P SI S  
Pr ot oc ol Title  
A M ultice nter, Ra n d o mize d, D o u ble -bli n d, Place b o -c o ntr olle d St u d y t o E val uate C B P -
2 0 1 i n A d ult Patie nts wit h C hr o nic R hi n osi n usitis wit h Nasal P ol y ps  
I n vesti g ati o n al 
Pr o d uct  
C B P -2 0 1  f or s u bc uta ne o us i njecti o n 
Refere nce Pr o d uct  
Place b o  
I n dic ati o n 
C hr o nic R hi n osi n usitis wit h Nasal P ol y ps  
Pr ot oc ol N u m ber  
C B P -2 0 1 -W W 0 0 3  
St u d y P h ase  
P hase 2  
N u m ber of St u d y 
Sites  
M ulti ple st u d y sites (ap pr o xi matel y 7 0 sites), i n t he U nite d States, C hi na, E ur o pea n 
U ni o n  a n d E urasia n Ec o n o mic U ni o n  
N u m ber of P atie nts 
Pl a n ne d  
1 4 7  
O bjecti ves  
Pri m ar y O bjecti ves:  
T o e val uate t he efficac y of C B P -2 0 1 o n a bac k gr o u n d of m o metas o ne f ur oate nasal 
s pra y ( M F N S) i n re d uci n g e n d osc o pic nasal p ol y p sc ore ( N P S) a n d nasal 
c o n gesti o n/ o bstr ucti o n sc ore ( N C S) se verit y i n patie nts wit h c hr o nic r hi n osi n usitis wit h 
nasal p ol y ps ( C R S w N P) w h os e disease re mai ns i na de q uatel y c o ntr olle d des pite dail y 
treat me nt wit h i ntra nasal c ortic oster oi d (I N C S) t hera p y i n c o m paris o n t o place b o. 
Sec o n d ar y O bjecti ves:  
T o e val uate t he effect of C B P -2 0 1 o n:  
•  
S y m pt o ms of si n usitis  
•  
C o m p ute d t o m o gra p h y i ma ge sc ores of nasal p ol y ps a n d si n us i nfla m mati o n  
•  
P atie nt re p orte d o utc o mes ( P R Os) a n d healt h -relate d q ualit y of life ( H R Q o L) 
•  
S afet y a n d t olera bilit y of C B P-2 0 1 i n patie nts wit h C R S w N P  
E x pl or at or y O bjecti ves:  
•  
T o e val uate t he effect of C B P -2 0 1 i n t he s u b gr o u ps of patie nts wit h c o m or bi d 
ast h ma 
•  
T o e val uate t he p har mac o ki netics  ( P K) a n d p har mac o d y na mics ( P D) of C B P -2 0 1 i n 
patie nts wit h C R S w N P  
St u d y Desi g n  
M ultice nter, ra n d o mize d, d o u ble -bli n d, place b o -c o ntr olle d st u d y e val uati n g t he effect 
of C B P -2 0 1 i n patie nts wit h C R S w N P w h ose disease re mai ns i na de q uatel y c o ntr olle d 
des pite dail y treat me nt wit h I N C S t hera p y.  
T he st u d y c o nsists of 3 peri o ds:  
Scree ni n g/ R u n -i n Peri o d: (U p t o 3 1 d a ys ) 
Be gi n ni n g at t he first scree ni n g visit a n d t hr o u g h o ut t he d urati o n of t he treat me nt 
peri o d , patie nts will be as ke d t o sta n dar dize t heir I NC S t o a re gi me n of m o metas o ne 
f ur oate ( N A S O N E X® ) nasal s pra y ( M F N S) of 2 act uati o ns ( 5 0  mc g /act uati o n) i n eac h 
n ostril t wice dail y ( BI D), t otal dail y d ose of u p t o 4 0 0  mc g , u nless t he y are i nt olera nt t o 
BI D I N C S i n w hic h case, t he y ma y re mai n o n a sta ble d osa ge of m o metas o ne of 2 
act uati o ns ( 5 0 mc g /act uati o n) i n eac h n ostril once dail y, t otal dail y d osa ge of 2 0 0 mc g . 
T he scree ni n g peri o d ca n be u p t o 3 1 da ys t o all o w f or a r u n -i n of at least 2 8 da ys if t he 


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patie nts ha ve n ot bee n o n a d oc u me nte d stea d y d ose of I N C S pri or t o scree ni n g.   If t he 
patie nts are a ble t o d oc u me nt stea d y  use,  t he n t he r u n-i n peri o d ma y be s h orte ne d t o as 
little as 7 da ys ( wit h patie nt diar y e ntr y t o c o nfir m c o m plia nce).  
Tre at m e nt Peri o d: ( C B P -2 0 1/ pl ace b o f or 2 4 wee ks)  
After scree ni n g/r u n -i n has bee n c o m plete d, eli gi ble patie nts will be ra n d o ml y all ocate d 
i n a 1: 1: 1 rati o t o recei ve d o u ble-bli n d treat me nt wit h C B P -2 0 1 or place b o wit h e ver y 
ot her wee k visits t o t he st u d y site f or s u bc uta ne o us ( S C ) i njecti o ns: 
•  
C B P -2 0 1 3 0 0 m g e ver y 2 wee ks  S C a d mi nistrati o n  f or 2 4 wee ks wit h a n i nitial 
l oa di n g d ose of 6 0 0 m g at Da y 1 
•  
C B P -2 0 1 3 0 0 m g e ver y 4 wee ks  S C a d mi nistrati o n f or 2 4 wee ks wit h a n i nitial 
l oa di n g d ose of 6 0 0 m g at Da y 1. These patie nts will als o recei ve v ol u me matc he d 
place b o e ver y 4 wee ks o n alter nati n g visits t o mai ntai n t he st u d y bli n d. 
•  
Place b o e ver y 2 wee ks S C a d mi nistrati o n f or 2 4 wee ks ( Place b o l oa di n g at Da y  1)  
Ra n d o mizati o n will be stratifie d b y c o m or bi d ast h ma.  
A ll patie nts will c o nti n ue sta ble d ose of M F N S ( 2 0 0 mc g ) BI D or o nce dail y  use d 
d uri n g r u n -i n peri o d t hr o u g h o ut t he st u d y. 
P ost -tre at m e nt F oll o w -u p Peri o d: ( 8 wee ks)  
After c o m pleti n g 2 4 wee ks of treat me nt wit h t he i n vesti gati o nal pr o d uct (I P) ( or 
f oll o wi n g earl y disc o nti n uati o n of I P), patie nt s will be f oll o we d f or a d diti o nal 8 wee ks. 
Patie nts  will be as ke d t o c o m plete a st u d y visit  e ver y 4  wee ks f or f oll o w -u p 
assess me nts.  
M ai n Eli gi bilit y 
Criteri a : 
I ncl usi o n Criteri a 
A patie nt m ust meet t he f oll o wi n g criteria t o be eli gi ble t o partici pate i n t his st u d y:  
1.  Fe male a n d male patie nts a ge d > 1 8 a n d < 7 5 years at t he ti me of scree ni n g . 
2.  Patie nts w h o are dia g n ose d wit h chr o nic r hi n osi n usitis wit h bilateral  p ol y ps  
des pite treat me nt wit h s yste mic c ortic oster oi d wit hi n t he past 2 years a n d/ or 
me dical c o ntrai n dicati o n/i nt olera nce t o s yste mic c ortic oster oi d s. T he p ol y ps ha ve  
a mi ni m u m bilateral N P S of 5 o ut of a ma xi m u m sc ore of 8 wit h at least a sc ore of 
2 f or eac h n ostril at scree n i n g (ce ntral rea d) a n d baseli ne (l ocal rea d) e val uate d b y 
e n d osc o p y . N ote: P atie nt i nt oler a nce t o syste mic c ortic oster oi ds i ncl u des p atie nt 
ref us al of tre at me nt wit h syste mic c ortic oster oi ds d ue t o u n desir a ble si de effects.  
3.  Nasal c o n gesti o n/ bl oc ka de/ o bstr ucti o n wit h m o derate or se vere s y m pt o m se verit y 
( Nasal C o n gesti o n Sc ore of > 2) at scree ni n g a n d a wee kl y a vera ge se verit y of >  1 
at ti me of ra n d o mizati o n. 
4.  Patie nts usi n g a d oc u me nte d sta ble d ose of nasal m o metas o ne at least 2 0 0 
mc g/ da y, or a n e q ui vale nt dail y d ose of a n ot her I N C S, f or at least 2 8 da ys bef ore 
ra n d o mizati o n a n d willi n g t o c o nti n ue t he d ose f or t he d urati o n of t he st u d y.  N ote: 
F or p atie nts w h o are usi n g a n I N C S pr o d uct ot her t h a n M F N S pri or t o t he 
scree ni n g visit, t he i nvesti g at or m ust s witc h t he p atie nt t o M F N S at V 1. P atie nts 
m ust use n as al m o met as o ne at le ast 2 0 0 mc g/ d ay, or e q uiv ale nt, f or at le ast 2 8 
d ays bef ore r a n d o miz ati o n, w hic h c a n i ncl u de 2 1 d ays pri or t o scree n i n g wit h 
s u p p ortive d oc u me nt ati o n. R u n-i n c a n be 7-3 1 d ays wit h t he c o m pli a nce 
deter mi ne d i n t he week pri or t o d osi n g . 
5.  Patie nts willi n g t o e nter p atie nt d iar y dail y s y m pt o m assess me nts a n d mai ntai n 
sta ble d osi n g wit h  M F N S wit h a c o m plia nce of at least 7 0 % i n t he 7 da ys  
prece di n g  ra n d o mizati o n.  N ote:  7 0 % c o m pli a nce will be c alc ul ate d as at le ast 5 of 


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7 D A Y S of M F N S use i n t he 7 d ays pri or t o r a n d o miz ati o n A N D at le ast 5 of 7 
D A Y S of N C S c o m pleti o n i n t he p atie nt di ary i n t he 7 d ays pri or t o r a n d o miz ati o n. 
6.  Male patie nts w h o are n o n -sterilize d a n d se x uall y acti ve wit h a fe male part ner of 
c hil d beari n g p ote ntial a gree t o use hi g hl y effecti ve c o ntrace pti o n fr o m 
ra n d o mizati o n u ntil 8 wee ks after last d ose. 
7.  Fe male patie nts of c hil d beari n g p ote ntial w h o are se x uall y acti ve wit h a 
n o nsterilize d male part ner s h o ul d ha ve a c o nfir me d ne gati ve ser u m beta -h u ma n 
c h ori o nic g o na d otr o pi n  test at Visit 1 a n d a grees t o use hi g hl y effecti ve 
c o ntrace pti o n fr o m si g ni n g of i nf or me d c o nse nt t hr o u g h o ut t he d urati o n of t he 
st u d y a n d f or 8 wee ks after last d ose.  
8.  Patie nt is a ble t o u n dersta n d a n d willi n g t o si g n t he i nf or me d c o nse nt f or m (I C F) 
pri or t o a n y st u d y relate d pr oce d ures bei n g perf or me d.  
9.  Willi n g a n d a ble t o c o m pl y wit h all st u d y visits a n d st u d y -relate d pr oce d ures, i n 
t he o pi ni o n of t he I n vesti gat or. 
E xcl usi o n Criteri a  
A patie nt w h o meets a n y of t he f oll o wi n g criteria will be i neli gi ble t o partici pate i n t his 
st u d y: 
1 0.  Patie nts u na ble t o use M F N S . 
1 1.  Patie nts w h o are ta ki n g or ha ve ta ke n t he f oll o wi n g pr o hi bite d t hera pies as  
s pecifie d:  
a. 
S yste mic ster oi ds wit hi n 2 8  da ys  pri or t o scree ni n g,  
b.  Ot her  n o n bi ol o gic  i n vesti gati o nal dr u gs wit hi n 6 0 da ys  ( or 5 half-li ves, 
w hic he ver is l o n ger) of scree ni n g,  
c. 
I ntra nasal c ortic oster oi d dro ps or c ortic oster oi d -a d mi nisteri n g de vices (e g,  
O pti N ose de vice or ste nts) wit hi n 2 8 da ys  pri or t o scree ni n g,  
d.  N o n -ster oi dal i m m u n os u p pressa nts (e g, c ycl os p ori ne, met h otre xate, 
azat hi o pri ne, m yc o p he n olate, sir oli m us, tacr oli m us) wit hi n 6 0 da ys  or 5 half -
li ves, w hic he ver is l o n ger, of scree ni n g, 
e. 
A n y m o n ocl o nal a nti b o d y t hera p y ( e g, be nraliz u ma b, me p oliz u ma b , 
o maliz u ma b, resiliz u ma b, d u pil u ma b ) or i n vesti gati o nal bi ol o gic dr u g f or 
ast h ma or ot her diseases  wit hi n 6 0 da ys  or 5 half -li ves, w hic he ver is l o n ger, 
of scree ni n g,  
f. 
Le u k otrie ne a nta g o nists/ m o difiers  wit hi n 7 da ys pri or t o scree ni n g  f or patie nts 
w h o were n ot o n c o nti n u o us treat me nt f or ≥ 3 0 da ys pri or t o scree ni n g,  
g.  Aller ge n i m m u n ot hera p y f or patie nts w h o were n ot o n mai nte na nce  treat me nt 
f or at least 9 0  da ys pri or t o scree ni n g ,  
h.  A n y mar kete d n o n bi ol o gic dr u g t hat m o d ulates t y pe 2 c yt o ki nes (e g , s u platast 
t osilate) wit hi n 3 0 da ys or 5 half-li ves ( w hic he ver is l o n ger) pri or t o 
scree ni n g. 
i. 
A n y i n vesti gati o nal s mall m olec ule dr u g or treat me nt wit hi n 1 6 wee ks or 5 
half -li ves ( w hic he ver is l o n ger) pri or t o scree ni n g. 
1 2.  Patie nts w h o di d n ot res p o n d fa v ora bl y t o pre vi o us d u pil u ma b treat me nt ( e g, 
t hera p y fail ure or patie nt e x perie nce d a n a d verse reacti o n t o treat me nt).  
1 3.  Patie nts w h o ha ve u n der g o ne a n y nasal s ur ger y (i ncl u di n g p ol y pect o m y) wit hi n 6 
m o nt hs bef ore scree ni n g; or ha ve a hist or y of si n us or nasal s ur ger y m o dif yi n g t he 
str uct ure of t he n ose s uc h t hat assess me nt of N P S is n ot p ossi ble or ha ve ha d 
u nc o ntr olle d e pista xis re q uiri n g s ur gical or pr oce d ural i nter ve nti o n, i ncl u di n g nasal 
pac ki n g.  


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1 4.  Patie nts wit h c o n diti o ns/c o nc o mita nt diseases ma ki n g t he m n o n e val ua ble at 
scree ni n g or f or t he pri mar y efficac y e n d p oi nt s uc h as: a ntr oc h oa nal p ol y ps, nasal 
se ptal de viati o n t hat w o ul d occl u de at least 1 n ostril, ac ute si n usitis, nasal i nfecti o n 
or u p per res pirat or y i nfecti o n at scree ni n g or wit hi n 2 w ee ks bef ore scree ni n g, 
o n g oi n g r hi nitis me dica me nt osa; k n o w n or s us pecte d dia g n osis of c ystic fi br osis; 
c hr o nic gra n ul o mat o us disease a n d gra n ul o mat o us vasc ulitis, gra n ul o mat osis wit h 
p ol ya n giitis ( We ge ner’s Gra n ul o mat osis), e osi n o p hilic gra n ul o mat o us wit h  
p ol ya n giitis ( C h ur g -Stra uss s y n dr o me), Y o u n g’s s y n dr o me, pri mar y d ys ki netic 
ciliar y s y n dr o mes (e g, Karta ge ner’s s y n dr o me) or ot her d ys ki netic ciliar y 
s y n dr o mes. 
1 5.  Si g ns or a C T sca n s u g gesti ve of Aller gic F u n gal R hi n osi n usitis  
1 6.  Patie nts wit h c o -m or bi d ast h ma  are e xcl u de d if: 
a. 
F orce d E x pirat or y V ol u me i n 1 sec o n d ( F E V 1) ≤ 5 0 % of n or mal pre dicte d 
val ue  
O R  
b.  A n e xacer bati o n wit hi n 9 0 da ys  pri or scree ni n g t hat re q uire d h os pitalizati o n 
( > 2 4 ho urs ) 
O R  
c. 
Are o n a dail y d ose  of i n hale d c ortic oster oi ds (I C S)  hi g her t ha n 1 0 0 0 mc g  
fl uticas o ne pr o pi o nate or t he e q ui vale nt . 
1 7.  K n o w n or s us pecte d hist or y of i m m u n os u p pressi o n, i ncl u di n g hist or y of i n vasi ve 
o p p ort u nistic i nfecti o ns, s uc h as as per gill osis, c occi di oi d o m yc osis, hist o plas m o sis, 
h u ma n i m m u n o deficie nc y vir us ( HI V), listeri osis, p ne u m oc yst osis, or t u berc ul osis, 
des pite i nfecti o n res ol uti o n; or u n us uall y fre q ue nt, rec urre nt or pr ol o n ge d 
i nfecti o ns. T u berc ul osis testi n g w o ul d be perf or me d o n a c o u ntr y-b y -c o u ntr y basis 
acc or di n g to l ocal g ui deli nes if re q uire d b y re g ulat or y a ut h orities or et hic s 
c o m mittees.  
1 8.  Patie nts w h o ha ve acti ve He patitis B, He patitis C or HI V i nfecti o ns as deter mi ne d 
b y p ositi ve res ults at Scree ni n g f or he patitis B s urface a nti ge n ( H Bs A g) or he patitis 
B c ore a nti b o d y ( H Bc A b) ; or he patitis C  vir us  a nti b o d y  ( H C V A b); or p ositi ve HI V 
ser ol o g y. N ote: P atie nts w h o test  p ositive f or H Bc A b, ne g ative f or H Bs A g  a n d 
s u bse q ue ntly c o nfir me d p ositive  f or H Bs A b , i n dic ati n g res olve d n at ur al i nfecti o n 
(c o nfir me d by ne g ative H B V -D N A ), m ay p artici p ate . P atie nts wit h p ositive H C V A b 
m ay  p artici p ate  if s u bse q ue nt vir al l o a d is c o nfir me d ne g ative.  
1 9.  A hel mi nt h parasitic i nfecti o n dia g n ose d wit hi n 2 4 wee ks pri or t o t he date of  
i nf or me d c o nse nt t hat has n ot bee n treate d, or has faile d t o res p o n d t o , sta n dar d of 
care t hera p y. 
2 0.  E vi de nce of i nfecti o n re q uiri n g treat me nt wit h s yste mic a nti bacterials, a nti vir als, 
a ntif u n gals, a nti parasitics, or a nti pr ot oz oals wit hi n 7 da ys  bef ore baseli ne , or viral 
i nfecti o ns wit hi n 1 4  da ys  bef ore scree ni n g t hat ma y n ot ha ve recei ve d a nti viral 
treat me nt. 
2 1.  Li ve, atte n uate d vacci nati o ns wit hi n 2 8 da ys pri or t o scree ni n g or pla n ne d li ve, 
atte n uate d vacci nati o ns d uri n g t he st u d y.  
2 2.  Pre g na nt or i nte nt t o bec o me pre g na nt d uri n g t he st u d y, or breast -fee di n g w o me n. 
2 3.  A n y dis or der, i ncl u di n g, b ut n ot li mite d t o, car di o vasc ular, gastr oi ntesti nal, he patic, 
re nal, ne ur ol o gical, m usc ul os keletal, i nfecti o us, e n d ocri ne, meta b olic, 
hae mat ol o gical, ps yc hiatric, or maj or p h ysical i m pair me nt t hat is n ot sta ble i n t he 


S uz h o u C o n nect Bi o p har mace uticals, Lt d 
I n vesti gati o nal Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 Dece m ber  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 1 6  of 9 7  
o pi ni o n of t he i n vesti gat or a n d ma y affect t he safet y of t he patie nt t hr o u g h o ut t he 
st u d y, or i nfl ue nce t he fi n di n gs of t he st u dies or t heir i nter pretati o ns, or i m pe de t he 
patie nt’s a bilit y t o c o m plete t he e ntire d urati o n of st u d y.  
2 4.  A n y cli nicall y si g nifica nt a b n or mal fi n di n gs i n p h ysical e xa mi nati o n, vital si g ns, 
safet y la b tests d uri n g scree ni n g/r u n-i n peri o d, w hic h i n t he o pi ni o n of t he 
i n vesti gat or, ma y p ut t he patie nt at ris k beca use of t heir partici pati o n i n t he st u d y, 
or ma y i nfl ue nce t he res ults of t he st u d y, or t he patie nt’s a bilit y t o c o m plete e ntire 
d urati o n of t he st u d y.  
2 5.  Ha ve a n y of t he f oll o wi n g la b orat or y a b n or malities at Scree ni n g:  
a. 
E osi n o p hils > 1 5 0 0 cells/ m m 3 ( or 1. 5 x 1 0 9/ L) 
b.  Platelets < 1 0 0 0 0 0 cells/ m m 3 ( or 1 0 0 x 1 0 9/ L) 
c. 
Creati ne p h os p h o ki nase ( C P K) > 1 0 u p per li mit of n or mal ( U L N ) 
d.  Ala ni ne a mi n otra nsferase ( A L T) > 2. 5 ti mes t he U L N  
e. 
As partate a mi n otra nsferase ( A S T) ≥ 2. 5  ti mes t he U L N  
f. 
Bilir u bi n  ≥ 2 ti mes t he U L N  
2 6.  Hist or y of alc o h ol or dr u g a b use wit hi n 1 2 m o nt hs pri or t o t he date i nf or me d 
c o nse nt. 
2 7.  A n aller g y t o L -histi di ne, tre hal ose or T wee n ( p ol ys or bate) 8 0 or a hist or y of a 
s yste mic h y perse nsiti vit y reacti o n, ot her t ha n l ocalize d i njecti o n site reacti o n, t o 
a n y bi ol o gic dr u g. 
2 8.  Pla ns t o u n der g o a n y s ur gical pr oce d ure re q uiri n g ge neral a nest hesia d uri n g t he 
st u d y.  
2 9.  Hist or y of ca ncer: Patie nts w h o ha ve ha d basal cell carci n o ma, l ocalize d s q ua m o us 
cell carci n o ma of t he s ki n, or i n sit u carci n o ma of t he cer vi x are eli gi ble pr o vi de d 
t hat t he patie nt  is i n re missi o n a n d c urati ve t hera p y was c o m plete d at least 1 2 
m o nt hs pri or t o t he date i nf or me d c o n se nt. N ote: P atie n ts w h o h ave h a d ot her 
m ali g n a ncies are eli gi ble pr ovi de d t h at t he p atie nt  is i n re missi o n a n d c ur ative 
t her a py w as c o m plete d at le ast 5 ye ars pri or t o t he d ate of i nf or me d c o nse nt. 
St u d y D ur ati o n  
A p pr o xi matel y 3 6 wee ks i ncl u di n g scree ni n g peri o d u p t o 4 wee ks, 2 4 -wee k treat me nt 
peri o d, a n d 8 -wee k peri o d of a d diti o nal f oll o w -u p.  
Test Pr o d ucts a n d 
R o ute of 
A d mi nistr ati o n  
C B P -2 0 1: pr o vi de d as a si n gle -use 2 m L vial c o ntai ni n g 1. 2 m L clear t o sli g htl y yell o w 
sterile s ol uti o n of C B P- 20 1 tar gete d t o be a p pr o xi matel y 1 5 0  m g/ m L.  
Place b o: pr o vi de d as a si n gle -use 2 m L vial c o ntai ni n g 1. 2 m L s ol uti o n c o ntai ni n g 
i de ntical e xci pie nts wit h o ut C B P-2 0 1. Matc he d v ol u mes a n d n u m ber of vials are t o be 
use d f or place b o d oses.  
St u d y dr u g will be a d mi nistere d b y S C i njecti o n.  
D ose Re gi m e n  
Ra n d o mize d 1: 1 : 1 t o t he f oll o wi n g d o u ble bli n de d treat me nt: 
•  C B P -2 0 1 3 0 0 m g S C e ver y 2 wee ks  wit h a 6 0 0 m g l oa di n g d ose o n Da y 1  
•  C B P -2 0 1 3 0 0 m g S C e ver y 4 wee ks  wit h 6 0 0 m g l oa di n g d ose o n Da y 1.  T his gr o u p 
will als o recei ve matc he d place b o e ver y 4 wee ks o n alter nate wee ks t o mai ntai n t he 
bli n d  
•  Place b o S C e ver y 2 wee ks  wit h  matc he d v ol u me  place b o l oa di n g d ose o n Da y 1  
St u d y E n d p oi nts  
Effic ac y  
Pri m ar y Effic ac y E n d p oi nts : 


S uz h o u C o n nect Bi o p har mace uticals, Lt d 
I n vesti gati o nal Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 Dece m ber  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 1 7  of 9 7  
T here will be 2 c o -pri mar y e n d p oi nts:  
•  C ha n ge fr o m baseli ne at W ee k 2 4 i n e n d osc o pic N P S  
E n d osc o pic N P S is gra de d base d o n p ol y p size (rec or de d as t he s u m of t he ri g ht a n d left 
n ostril sc ores wit h a ra n ge of 0  t o 8; hi g her sc ores i n dicate w orse stat us). 
•  C ha n ge fr o m baseli ne at W ee k 2 4 i n a vera ge dail y nasal c o n gesti o n sc ore ( N C S)  
Sec o n d ar y Effic ac y E n d p oi nts:  
•  C ha n ge fr o m baseli ne at W ee k 2 4 i n: 
− 
Perce nta ge of ma xillar y si n us v ol u me occ u pie d b y disease o n C T a n d L u n d -
Mac ka y  C o m p ute d T o m o gra p h y  sc ores fr o m patie nts e nr olle d at St u d y S ites t hat 
are a p pr o ve d a n d q ualifie d t o perf or m C T sca ns  
− 
U ni versit y of Pe n ns yl va nia S mell I de ntificati o n Test ( U P SI T)  
− 
Vis ual a nal o g ue  scale f or r hi n osi n usitis ( V A S-R S)  
− 
T otal nasal  s y m pt o m sc ore ( T N S S) 
− 
2 2 -ite m Si n o nasal O utc o me Test ( S N O T-2 2)  
− 
A vera ge dail y a nteri or r hi n orr hea sc ore  
− 
A vera ge dail y p osteri or r hi n orr hea sc ore  
− 
A vera ge dail y l oss of s mell sc ore  
− 
Dail y s u bject -assesse d nasal pea k i ns pirat or y fl o w ( N PI F)  
•  Re q uire me nt of resc u e treat me nt (s yste mic C S f or > 5 c o nsec uti ve da ys) or ha vi n g 
ha d s ur ger y f or nasal p ol y ps t hr o u g h Wee k 2 4  
•  Ti me t o resc ue treat me nt (s yste mic C S f or > 5 c o nsec uti ve da ys) or s ur ger y f or nasal 
p ol y ps t hr o u g h Wee k 2 4.  
E x pl or at or y e n d p oi nts:  
•  C ha n ge fr o m baseli ne at Wee k 2 4 i n F E V 1 f or s u bjects wit h ast h ma 
•  Pr o p orti o n of patie nts wit h mi ni mal cli nicall y i m p orta nt differe nce > 8. 9 i n S N O T -
2 2 at Wee k 2 4  
•  C ha n ge fr o m baseli ne at Wee k 1 6 i n e n d osc o pic N P S  
•  C ha n ge fr o m baseli ne at Wee k 1 6 i n A vera ge dail y N C S  
•  C ha n ge fr o m baseli ne at Wee k 2 4 i n E ur o pea n q ualit y of life scale ( E Q -5 D -5 L ) 
•  Healt hcare res o urce utilizati o n t hr o u g h Wee k 2 4  
S afet y  
S afet y a n d T oler a bilit y:  
Safet y e n d p oi nts will be s u m marize d b y descri pti ve statistics a n d narrati ves w here 
i n dicate d b y se verit y.  
•  A d verse e ve nts ( A Es) re p orte d, i ncl u di n g S A Es a n d ad verse e ve nts of s pecial 
i nterest ( A E SI)  
•  Vital si g ns   
•  P h ysical e xa mi nati o n  
•  Electr ocar di o gra m ( E C G ) para meters  
•  I njecti o n site e val uati o ns 


S uz h o u C o n nect Bi o p har mace uticals, Lt d 
I n vesti gati o nal Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 Dece m ber  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 1 8  of 9 7  
•  Safet y la b orat or y para meters  
•  A nti dr u g a nti b o dies ( A D A) a n d ne utralizi n g a nti b o dies ( N A b)  
P h ar m ac o ki netics  
W h ole bl o o d f or plas ma C B P -2 0 1 c o nce ntrati o ns will be o btai ne d a n d a nal yse d. T he 
i n di vi d ual a n d mea n stea d y-state tr o u g h P K pr ofile will be calc ulate d a n d a d diti o nal P K 
para meters ma y be esti mate d fr o m a p o p ulati o n P K m o del.  
A d diti o nal sa m pli n g will be o b tai ne d after t he last treat me nt d ose as n ote d a b o ve t o 
c haracterize t he ret ur n t o baseli ne.  
P h ar m ac o d y n a mic s 
C ha n ge fr o m baseli ne i n Bi o mar kers i n t he bl o o d [i ncl u di n g t otal im m u n o gl o b uli n E 
(I g E), e osi n o p hil c o u nt, e osi n o p hil cati o nic pr otei n, t h y m us a n d acti vati o n re g ulate d 
c he m o ki ne ( T A R C), E ota xi n -3, a n d peri osti n ]. 
St atistic al 
C o nsi der ati o ns:  
C o m plete details of t he statisti cal a nal yses a n d met h o ds, i ncl u di n g data c o n ve nti o ns, 
will be c o ntai ne d i n a se parate S tatistical A nal ysis P la n.  
A n al ysis P o p ul ati o n s 
Fi ve p o p ulati o ns will be defi ne d: Ra n d o mise d  Set  ( R S), F ull A nal ys is Set ( F A S), Per 
Pr ot oc ol Set ( P P S ), Safet y Set ( S S) , a n d P K Set ( P K S) .  
T he pri mar y a nal yses of all efficac y e n d p oi nts will be c o n d ucte d i n t he F ull A nal ysis 
Set ( F A S) . S u p p orti ve efficac y a nal yses will be c o n d ucte d i n t he P er P r ot oc ol Set 
( P P S). 
Pri m ar y Effic ac y A n al ysis  
T he c o -pri mar y e n d p oi nts (c ha n ge fr o m baseli ne i n N P S a n d a vera ge dail y N C S at 
Wee k 2 4) will be a nal yse d usi n g S A S pr oc MI X E D pr oce d ure i n t he F ull A nal ysis Set. 
Statistical c o m paris o ns bet wee n eac h treat me nt gr o u p a n d place b o will be perf or me d.  
N P S . T he li near mi xe d m o del will be a p plie d t o c ha n ge fr o m baseli ne t o eac h ti me p oi nt 
t hr o u g h Wee k 2 4 i n en d osc o pic N P S t o e val uate t he treat me nt effect of t he pri mar y 
e n d p oi nts. T he fi xe d effects will be i ncl u de d as f oll o we d: treat me nt gr o u p, e n d osc o pic 
N P S at baseli ne, visit, i nteracti o n bet wee n treat me nt gr o u p a n d visit, a n d t he prese nce 
of c o m or bi d ast h ma i n t he m o del. Patie nt will be i ncl u de d as a ra n d o m effect.  
Base d o n t he m o del, t -test will be perf or me d f or least s q uare mea ns of i nteracti o n 
bet wee n treat me nt gr o u p a n d visit of Wee k 2 4, wit h t w o -si de d si g nifica nce le vel of 
0. 0 5. 9 5 % c o nfi de nce i nter val f or least s q uare mea ns of i nteracti o n bet wee n treat me nt 
gr o u p a n d visit of Wee k 2 4 will be calc ulate d. C o varia nce matri x a p plie d t o t he wit hi n -
s u bject err or will be esti mate d b y Restricte d ma xi m u m li keli h o o d ( R E M L). T he 
Ke n war d -R o ger a p pr o xi mati o n will be use d t o esti mate t he de gree of free d o m. Details 
of ass u m pti o n o n varia nce str uct ure will be descri be d i n t he S A P.  
A ver a ge d ail y N C S . A si milar m o del use d f or N P S will be perf or me d f or t he a vera ge 
dail y c o n gesti o n sc ore ( N C S).  
S a m ple Size Esti m ati o n  
T he sa m ple size esti mati o n is base d o n t he c o m paris o n bet wee n C B P -2 0 1 3 0 0 m g e ver y 
2 wee ks  vs. place b o wit h re gar d t o t he c o -pri mar y e n d p oi nt  of N P S : c ha n ge fr o m 
baseli ne i n N P S at W ee k 2 4.  
Ass u mi n g a c o m m o n sta n dar d de viati o n i n t he N P S of 2. 1, a n d base d o n t he use of a 
t w o-si de d test at t he al p ha = 0. 0 5 le vel , 4 1  patie nts per gr o u p will pr o vi de 8 0 % p o wer t o 
detect a differe nce of 1. 3 bet wee n t he C B P -2 0 1  gr o u p  a n d t he place b o gr o u p i n t he 
c ha n ge of N P S fr o m baseli ne t o Wee k 2 4. T o all o w f or a 1 5 % dr o p o ut rate, t he pla n ne d 
sa m ple size is 4 9 s u bjects per gr o u p ( 1 4 7 t otal). 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I nv esti g ati o n al Dr u g: C B P -2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 1 9  of 9 7  
T a bl e 1: 
Sc h e d ul e of Ass ess m e nts  
Ass ess m e nts  
Scr e e n  
B as e -
li n e 
Tr e at m e nt P eri o d  
F oll o w -u p P eri o d  
U nsc h e d -
ul e d Visits t 
E arl y 
T er mi n a-
ti o n (+ 7 d)  
 
D- 3 1  
t o D- 1a 
D 1  
D 8  
W 1 
(± 3 d)  
D 1 5  
W 2 
(± 3 d)  
D 2 9  
W 4 
(± 3 d)  
D 4 3  
W 6 
(± 3 d)  
D 5 7  
W 8 
(± 3 d)  
D 7 1  
W 1 0 
(± 3 d)  
D 8 5  
W 1 2 
(± 3 d)  
D 9 9  
W 1 4 
(± 3 d)  
D 1 1 3  
W 1 6 
(± 3 d)  
D 1 2 7  
W 1 8 
(± 3 d)  
D 1 4 1  
W 2 0 
(± 3 d)  
D 1 5 5  
W 2 2 
(± 3 d)  
E O T D 1 6 9  
W 2 4 ( ± 3 d)  
D 1 9 7 
W 2 8  
(± 5 d)  
E O S 
D 2 2 5  
W 3 2 
(± 5 d)  
 
 
Visit  
V 1  
V 2  
V 3  
V 4  
V 5  
V 6  
V 7  
V 8  
V 9  
V 1 0  
V 1 1  
V 1 2  
V 1 3  
V 1 4  
V 1 5  
V 1 6  
V 1 7  
N A  
N A  
I nf or m e d C o ns e nt a n d 
assi g n p ati e nt n u m b er  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
D e m o gr a p hics a n d 
M e dic al Hist ory  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eli gi bility  Crit eri a  
X  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pri or a n d 
C o nc o mit a nt 
M e dic ati o ns  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vit al Si g ns b  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
H ei g ht  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
B o d y W ei g ht  
X  
X  
 
 
 
 
 
 
X  
 
 
 
 
 
X  
 
X  
 
X  
C o m pl et e P hysic al 
Ex a mi n ati o n c 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
Bri ef P hysic al 
Ex a mi n ati o n d 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
C T sc a nu  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
X  
N C S e 
X  
X  
X  
X  
X  
 
X  
 
X  
 
X  
 
X  
 
X  
 
X  
X  
X  
E Q -5 D -5L  
 
X  
 
 
X  
 
 
 
X  
 
 
 
 
 
X  
 
X  
X  
X  
V A S -R S  
X  
X  
X  
X  
X  
 
X  
 
X  
 
X  
 
X  
 
X  
 
X  
X  
X  
S N O T -2 2  
X  
X  
X  
X  
X  
 
X  
 
X  
 
X  
 
X  
 
X  
 
X  
X  
X  
T N S S  
X  
X  
X  
X  
X  
 
X  
 
X  
 
X  
 
X  
 
X  
 
X  
X  
X  
N as al e n d osc o py N P S  
X  
X f 
 
X  
 
 
X  
 
 
 
X  
 
 
 
X  
 
X  
 
X  
S pi r o m etryg 
X  
X  
 
 
X  
 
X  
 
X  
 
 
 
 
 
X  
 
X  
X  
X  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I nv esti g ati o n al Dr u g: C B P -2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 0  of 9 7  
Ass ess m e nts  
Scr e e n  
B as e -
li n e 
Tr e at m e nt P eri o d  
F oll o w -u p P eri o d  
U nsc h e d -
ul e d Visits t 
E arl y 
T er mi n a-
ti o n (+ 7 d)  
 
D- 3 1  
t o D- 1a 
D 1  
D 8  
W 1 
(± 3 d)  
D 1 5  
W 2 
(± 3 d)  
D 2 9  
W 4 
(± 3 d)  
D 4 3  
W 6 
(± 3 d)  
D 5 7  
W 8 
(± 3 d)  
D 7 1  
W 1 0 
(± 3 d)  
D 8 5  
W 1 2 
(± 3 d)  
D 9 9  
W 1 4 
(± 3 d)  
D 1 1 3  
W 1 6 
(± 3 d)  
D 1 2 7  
W 1 8 
(± 3 d)  
D 1 4 1  
W 2 0 
(± 3 d)  
D 1 5 5  
W 2 2 
(± 3 d)  
E O T D 1 6 9  
W 2 4 ( ± 3 d)  
D 1 9 7 
W 2 8  
(± 5 d)  
E O S 
D 2 2 5  
W 3 2 
(± 5 d)  
 
 
Visit  
V 1  
V 2  
V 3  
V 4  
V 5  
V 6  
V 7  
V 8  
V 9  
V 1 0  
V 1 1  
V 1 2  
V 1 3  
V 1 4  
V 1 5  
V 1 6  
V 1 7  
N A  
N A  
S m e ll t est ( U P SI T) 
 
X  
X  
X  
X  
 
 
 
X  
 
 
 
 
 
X  
 
X  
X  
X  
1 2 -L e a d E C G 
X  
X  
 
 
 
 
 
 
X  
 
 
 
 
 
X  
 
X  
 
X  
H e p atitis & HI V 
Scr e e ns h  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pr e g n a nc y T est i 
X  
X  
 
 
X  
 
X  
 
X  
 
X  
 
X  
 
X  
X  
X  
 
X  
Dis p e ns e or R evi e w 
P ati e nt Di ary/ N PI F 
M et er
j 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
R a n d o miz ati o n  
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
H e a lt h C ar e R es o urc e 
Utiliz ati o n k 
 
X 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Uri n alysis  
X  
X  
 
 
 
 
 
 
X  
 
 
 
 
 
X  
 
X  
 
X  
S er u m C h e mistry l 
X  
X  
X  
 
X  
 
X  
 
X  
 
X  
 
X  
 
X  
X  
X  
 
X  
H e m at ol o gy m  
X  
X  
X  
 
X  
 
X  
 
X  
 
X  
 
X  
 
X  
X  
X  
 
X  
P K Bl o o d S a m pl e n  
 
X  
X  
 
X  
 
 
 
X  
 
 
 
 
 
X  
X  
X  
 
X  
P D Bl o o d S a m pl e o  
 
X  
X  
 
X  
 
 
 
X  
 
 
 
 
 
X  
 
X  
 
X  
Bl o o d S a m pl e f or 
A D A, N a b p  
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
 
X 
 
X 
 
X 
St u dy Dr u g S C 
A d mi nistr ati o n q  
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Dis p e ns e r esc u e 
m e dic ati o n  a n d M F N S 
as n e e d e d r 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Ass ess I nj ecti o n 
Sit e(s) s 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
A dv ers e E v e nts  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I nv esti g ati o n al Dr u g: C B P -2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 1  of 9 7  
A b br e vi ati o ns:  A D A  = a nti dr u g a nti b o di es; A E  = a dv ers e ev e nt;  C T = c o m p ut e d t o m o gr a p hy; D = D a y,  E C G = el ectr oc ar di o gr a m; E O S  = E n d -of -St u dy; E O T  = E n d -of -Tr e at m e nt; E Q - 5 D- 5L = 
E ur o p e a n q u ality of lif e q u esti o n n air e ; F E V 1 = f orc e d ex pir at or y v ol u m e i n t h e first s ec o n d of ex pir ati o n; H Bc A b = h e p atitis B c or e a nti b o dy; H C V A b = h e p atitis C vir us a nti b o dy; H Bs A g = h e p atitis 
B s urf ac e a nti g e n; L A B A = l o n g-acti n g ß -a g o nist;  N A b = n e utr alizi n g a nti b o dy; N C S = N as al C o n g esti o n Sc or e; N P S = N as al P ol y p Sc or e; N PI F  = N as al p e a k i ns pir at ory fl o w; 
P D  = p h ar m ac o dy n a mic(s); P K  = p h ar m ac o ki n etic(s); S A B A = s h ort-acti n g ß -a g o nists; S C  = s u bc ut a n e o us; S N O T -2 2 = 2 2 -it e m Si n o n as al O utc o m e T est; T N S S = T ot al N as al Sy m pt o m Sc or e; U P SI T = 
U niv er sity of P e n nsylv a ni a S m ell I d e ntific ati o n T est; V = visit; V A S -R S = Vis u al A n al o g u e Sc al e f or R hi n osi n usitis; V S  = vit al si g ns ; W = W e ek. 
F o ot n ot es : 
a.  
T h e scr e e ni n g p eri o d t o c oll ect b as eli n e d at a a n d d et er mi n e a p ati e nt’s eli gi bilit y  is 3 1 d a ys i n d ur ati o n  a n d b e gi ns w h e n t h e I C F is si g n e d .  
b.  
Vit al si g ns  i ncl u d e b o dy t e m p er at ur e, r es pir at or y r at e, bl o o d pr ess ur e, a n d h e art r at e. V S s h o ul d b e r ec or d e d pr e d os e f or all tr e at m e nt visits. O n D 1 ( V 2), W 2 ( V 4), a n d W 4 ( V 5), V S s h o ul d 
b e r ec or d e d  h o urly d uri n g t h e 2 h o ur  p ost d os e m o nit ori n g p eri o d . O n W 6 ( V 6) a n d b ey o n d, V S s h o ul d b e r ec or d e d at 3 0 mi n ut es p ost d os e. D uri n g t h e p ost -tr e at m e nt F oll o w-U p P eri o d, V S 
ar e t o b e r ec or d e d o nc e d uri n g e ac h visit.  Vit al si g ns m a y b e m o d ifi e d if a d a pt e d t o t el e m e dici n e or h o m e h e alt h visits w h er e c o nti n u o us m o nit ori n g m a y n ot b e p ossi bl e. 
c. 
A c o m pl et e p hysic al ex a mi n ati o n will b e p erf or m e d, w hic h ass ess es t h e f oll o wi n g: g e n er al a p p e ar a nc e, s ki n, ey es/ e ars/ n os e/t hr o at, t hyr oi d, h e a d a n d n ec k , c ar di o v asc ul ar syst e m, 
r es pir at ory syst e m, a b d o m e n, f u n d osc o py ( o pti o n al), extr e miti es, l y m p h n o d es , m usc ul os k el et al, a n d n erv o us syst e m.  
d.  
A bri ef p hysic al ex a mi n ati o n  will i ncl u d e a n ass ess m e nt of g e n er al a p p e ar a nc e, ey es, l u n gs, a n d l y m p h n o d es.  P hysic al ex a ms m a y b e m o difi e d if a d a pt e d t o t el e m e dici n e or h o m e h e alt h 
visits.  
e.  
T h e  N as al C o n g esti o n Sc or e s h o ul d b e c a pt ur e d i n t h e p ati e nt di ar y  b ut  m a y b e c a pt ur e d by a n alt er n ativ e m a n n er (i e,  p a p er) if t h e d evic e f ails b et w e e n cli nic visits.  
f. 
If V 2 is p erf or m e d wit hi n 7 d a ys of V 1, t h e N P S (c e ntr al r e a d) fr o m V 1  will b e us e d t o c o nfir m eli gi bilit y, a n d t h e e n d osc o py will n ot b e r e p e at e d at V 2 . F or m or e d et ails s e e s ecti o n 7. 8 . 1 
E n d osc o pic N as al  P oly p Sc or e . 
g.  
S pir o m etry , i ncl u di n g F E V1, f orc e d vit al c a p acit y, a n d p e a k ex pir at or y fl o w, will b e p erf or m e d  o nl y f or p ati e nts wit h ast h m a. D u e t o di ur n al v ari ati o n of l u n g f u ncti o n, it is i m p ort a nt t h at all 
s pir o m etry ass ess m e nts ar e p erf or m e d pr ef er a bl y aft er 7 : 0 0 h o urs a n d n o l at er t h a n 1 1 : 0 0 h o urs . Pri or t o s pir o m etr y ass ess m e nts, t wic e -d aily L A B A t h er a pi es, i ncl u di n g c o m bi n ati o n 
t h er a pi es, s h o ul d b e wit h h el d ≥1 2  h o urs , o nc e -d ail y t h er a pi es c o nt ai ni n g L A B A or l o n g-acti n g m usc ari nic a nt a g o nists  s h o ul d b e wit h h el d f or ≥ 2 4 h o urs , a n d S A B As s h o ul d b e wit h h el d 
≥6 h o urs.   R ev ersi bility of l u n g f u ncti o n will  b e t est e d if a m e dic al hist or y r ec or d of > 1 2 % r ev ersi bilit y (i m pr o v e m e nt i n F E V 1) c a n n ot b e d e m o nstr at e d wit hi n t h e pr evi o us 1 2 m o nt hs.  
h.  
H e p atitis scr e e n: F or m or e d et ails s e e s ecti o n 7 . 6. 
i. 
All w o m e n of c hil d b e ari n g p ot e nti al  will b e t est e d f or pr e g n a nc y b y a s er u m pr e g n a nc y t est at Scr e e ni n g a n d by uri n e pr e g n a nc y t ests at B as eli n e a n d t h er e aft er. A n e g ativ e r es ult m ust b e 
o bt ai n e d pri or t o r a n d o miz ati o n.   
j. 
A p ati e nt d i ary a n d N PI F  m et er will b e iss u e d t o t h e p ati e nt wit h tr ai ni n g at Scr e e ni n g visit. At all st u dy visits, p ati e nts s h o ul d b e ass ess e d f or c o m pli a nc e a n d r e-tr ai n e d, if n ec ess ary, o n t h e 
us e of t h e p ati e nt di ar y d evic e  a n d N PI F m et er .  
k.  
A q u esti o n n air e of H e alt h C ar e R es o urc e Utiliz ati o n will b e a d mi nist er e d.  F or m or e d et ails s e e s ecti o n 7. 8. 1 2 . 
l. 
S er u m c h e mistry p a n el: s o di u m, p ot assi u m, c hl ori d e, bic ar b o n at e , cr e ati ni n e, bl o o d ur e a nitr o g e n, gl uc os e, c alci u m, uric aci d, t ot al pr ot ei n, t ot al bilir u bi n, al b u mi n, al a ni n e 
a mi n otr a nsf er as e, as p art at e a mi n otr a nsf er as e, al k ali n e p h os p h at as e, l act at e d e hy dr o g e n as e, g a m m a -gl ut a m yltr a nsf er as e, cr e ati n e p h os p h o ki n as e, t ot al c h ol est er ol, tri glyc eri d es, a n d C -
r e activ e pr ot ei n. T h e bl o o d s a mpl e m ust b e t a k e n wit h t h e p ati e nt i n f asti n g st at e w hic h m e a ns n o i nt a k e of a ny f o o d or dri nk exc e pt f or w at er f or at l e ast 8 h o urs.  
m.  H e m at ol o gy : h e m o gl o bi n, h e m at ocrit, pl at el et c o u nt, t ot al w hit e bl o o d c ell c o u nt wit h 5- p art diff er e nti al c o u nt, diff er e nti al c o u nt, a n d t ot al r e d bl o o d c ell c o u nt.  
n.  
P K bl o o d s a m pl es s h o ul d b e c oll ect e d pri or t o d osi n g; d at e a n d cl oc k ti m e f or e ac h s a m pl e s h o ul d b e rec or d e d.  
o.  
P D bl o o d s a m pl es  f or bi o m ar k ers of i nfl a m m ati o n i ncl u d e E ot axi n-3, e osi n o p hil c ati o nic pr ot ei n, t ot al  i m m u n o gl o b uli n E, t hy m us a n d activ ati o n -r e g ul at e d c h e m o ki n e, a n d p eri osti n. Bl o o d 
e osi n o p hil c o u nt will b e m e as ur e d as p art of h e m at ol o gy t est. C- r e activ e pr ot ei n will b e d et er mi n e d as p art of t h e s er u m c h e mistry.  
p.  
A D A  bl o o d s a m pl e : N A b will b e t est e d  at all A D A c oll ecti o n ti m e p oi nts i n s a m pl es t h at ar e A D A p ositiv e.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I nv esti g ati o n al Dr u g: C B P -2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 2  of 9 7  
q.  
P ati e nts ar e t o b e o bs erv e d f or 2  h o urs p ost d os e o n D 1  ( V 2), W 2 ( V 4), a n d W 4 ( V 5), a n d 3 0 mi n ut es p ost d os e f or W 6  ( V 6) a n d b ey o n d. Ass ess m e nts a n d t esti n g s h o ul d b e c o m pl et e d 
pr e d os e exc e pt as n ot e d ot h er wis e. R ot at e i nj ecti o n sit es: a b d o m e n ( a v oi d ar e a proxi m al t o u m bilic us), o ut er t hi g h, a n d u p p er ar m (l at er al or p ost er ol at er al). O nly 1  mL s h o ul d b e i nj ect e d 
p er sit e, a n d a n i nj ecti o n sit e s h o ul d n ot b e i n t h e s a m e a n at o mic al l oc ati o n us e d d uri n g  t h e pr evi o us visit.   
r. 
Dis p e ns e al b ut er ol/s al b ut a m ol M DI  f or r ev ersi bilit y t esti n g a n d as a n o pti o n al t a k e -h o m e r esc u e m e dic ati o n f or t h os e p ati e nts wit h ast h m a. P ati e nts s h o ul d b e off er e d r e pl ac e m e nts as 
n e e d e d f or sy m pt o m c o ntr ol t hr o u g h o ut t h e st u dy a n d s h o ul d b e r e mi n d e d t o d oc u m e nt  t h e us e i n t h eir p ati e nt di ar y . Sit es m a y als o pr o vi d e M F N S f or r e q uir e d c o nc o mit a nt us e  as 
n e e d e d.  
s. 
I nj ecti o n sit e r e acti o ns s h o ul d b e ass ess e d at all visits fr o m t h e first d osi n g d a y u ntil t h e e n d of t h e st u dy . Th e pr evi o us i nj ecti o n sit e(s) s h o ul d b e ass ess e d pri or t o d osi n g. O n all d osi n g  
d a ys,  t h e n e w i nj ecti o n sit e s h o ul d b e ass ess e d pri or t o t h e p ati e nt’s r el e as e. T h e S C i nj ecti o n sit e m a y  b e ass ess e d usi n g a st a n d ar d i nstr u m e nt  pr o vi d e d i n A p p e n dix or d escri b e d as 
n e e d e d by t h e I nv esti g at or i n t h e m e dic al n ot es. Cli nic all y si g nific a nt fi n di n gs as d et er mi n e d by t h e I nv esti g at or will b e r e p ort e d as a n A E. S e e s ecti o n 8. 6 f or m or e d et ails.  
t. 
U nsc h e d ul e d  visits m a y b e c o n d uct e d as n e e d e d, a n d a d diti o n al ass ess m e nts p erf or m e d at t h es e visits  ar e  at t h e discr eti o n of t h e I nv esti g at or.  
u.  
C T sc a n will o nly b e r e q uir e d f or s u bj ects t h at ar e e nr oll e d at St u d y Sit es  t h at ar e a p pr o v e d a n d q u alifi e d t o p erf or m C T Sc a ns . 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 3  of 9 7  
LI S T O F A B B R E VI A TI O N S  
A B B R E VI A TI O N  
T E R M  
 
 
A D A  
a nti dr u g a nti b o d y 
A E  
a d verse e ve nt 
A E SI  
a d verse e ve nt of s pecial i nterest  
A L P  
al kali ne p h os p hatase  
A L T  
ala ni ne a mi n otra nsferase  
A S T  
as partate a mi n otra nsferase  
A T S   
A merica n T h oracic S ociet y   
BI D  
t wice dail y 
C F R  
C o de of Fe deral Re g ulati o ns  
C M H  
C oc hra n -Ma ntel -Hae nszel  
C P K  
creati ne p h os p h o ki nase  
C R O  
c o ntract researc h or ga nizati o n  
C R S w N P  
c hr o nic r hi n osi n usitis wit h nasal p ol y ps 
C S  
c ortic oster oi d  
C V  
c urric ul u m vitae 
E C  
Et hics C o m mittee  
E C G  
Electr ocar di o gra m  
e C R F  
electr o nic case re p ort f or m  
E O S  
E n d of St u d y  
E O T  
E n d of Treat me nt  
P R O  
patie nt -re p orte d o utc o mes 
E R S  
E ur o pea n Res pirat or y S ociet y  
E Q -5 D -5 L  
E ur o Q ol Healt h Stat us Meas ure, 5 Di me nsi o ns/ 5 Le vels  
E Q -V A S  
E Q vis ual a nal o g ue scale  
E U  
E ur o pea n U ni o n  
F A S  
F ull A nal ysis Set  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 4  of 9 7  
A B B R E VI A TI O N  
T E R M  
F D A  
F o o d a n d Dr u g A d mi nistrati o n ( U S)  
F E V 1 
f orce d e x pirat or y v ol u me i n t he first sec o n d of e x pirati o n 
G C P  
G o o d Cli nical Practice  
H Bc A b  
he patitis B c ore a nti b o d y  
H Bs A g  
H Bs A b  
he patitis B s urface a nti ge n  
he patitis B s urface a nti b o d y  
H C V A b  
h e patitis C vir us a nti b o d y 
HI P A A  
Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y Act  
HI V  
h u ma n i m m u n o deficie nc y vir us 
H R Q o L  
healt h -relate d q ualit y of life  
I C H 
I nter nati o nal C o nfere nce o n Har m o nisati o n 
I C F 
i nf or me d c o nse nt f or m 
I C S 
i n hale d c ortic oster oi d(s) 
I g E 
i m m u n o gl o b uli n E 
I L 
i nterle u ki n (I L-4, I L -1 3, etc)  
I N C S 
i ntra nasal c ortic oster oi d 
I N D 
in vesti gati o nal ne w dr u g  
I P 
i n vesti gati o nal pr o d uct 
I R B 
I nstit uti o nal Re vie w B oar d 
L A B A  
l o n g-acti n g ß a g o nist  
Me d D R A  
Me dical Dicti o nar y f or Re g ulat or y Acti vities  
M DI  
Metere d D ose I n haler  
M F N S  
m o metas o ne f ur oate nasal s pra y  
N A b  
ne utralizi n g a nti b o d y  
N C S  
nasal c o n gesti o n/ o bstr ucti o n sc ore  
N PI F  
nasal pea k i ns pirat or y fl o w  
N P S  
nasal p ol y p sc ore  
P D  
P K  
p har mac o d y na mic(s)  
p har mac o ki netic(s)  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 5  of 9 7  
A B B R E VI A TI O N  
T E R M  
P K S  
P K set  
P P S  
Per Pr ot oc ol Set  
P R Os  
patie nt re p orte d o utc o mes  
Q Tc F  
Q T i nter val c orrecte d f or heart rate usi n g Fri dericia's f or m ula  
R S  
S A B A  
Ra n d o mise d  Set  
s h ort-acti n g ß a g o nist  
S A E  
seri o us a d verse e ve nt 
S C  
s u bc uta ne o us 
S S  
S U S A R  
safet y set 
s us pecte d u ne x pecte d seri o us a d verse reacti o n 
T A R C  
t h y m us a n d acti vati o n-re g ulate d c he m o ki ne 
T E A E  
treat me nt-e mer ge nt a d verse e ve nt 
T N S S  
t otal nasal s y m pt o m sc ore 
U L N  
u p per li mit(s) of n or mal  
U P SI T  
U ni versit y of Pe n ns yl va nia S mell I de ntificati o n Test  
U S  
U nite d States  
V A S -R S  
vis ual a nal o g ue scale f or r hi n osi n usitis  
V S  
vital si g ns  
W H O Dr u g  
W orl d Healt h Or ga nizati o n Dr u g Dicti o nar y  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 6  of 9 7  
1  
I N T R O D U C TI O N 
1. 1  
B ac k gr o u n d 
C hr o nic r hi n osi n usitis wit h or wit h o ut nasal p ol y ps has a hi g h pre vale nce a n d si g nifica ntl y affects 
healt h -relate d q ualit y of life i n affecte d patie nts (A v dee va 2 0 1 8 ). C hr o nic r hi n osi n usitis, a n 
i nfla m mati o n of t he n ose a n d para nasal si n uses, is deli neate d b y 2 or m ore s y m pt o ms: bl oc ka ge or nasal 
disc har ge a n d/ or facial pai n/ press ure a n d/ or l oss of s mell (F o k ke ns 2 0 2 0). T his c o n diti o n affects 1 1 t o 
1 2 % of t he p o p ulati o n i n vari o us ge o gra p hic l ocati o ns ( Hasta n 2 0 1 1 ; Ki m 2 0 1 6 ; Hirsc h 2 0 1 7 ). 
P he n ot y pes of c hr o nic r hi n osi n usitis i nitiall y are di vi de d b y t he prese nce or a bse nce of p ol y ps base d o n 
e n d osc o pic e xa mi nati o n or ra di ol o gic i ma gi n g ( F o k ke ns 2 0 2 0 ).  
E n d ot y pi n g of patie nts wit h c hr o nic r hi n osi n usitis wit h nasal p ol y ps ( C R S w N P) has i ncrease d a n d has 
s o me be nefit f or treat me nt selecti o n (Car dell 2 0 2 0 ). Ne w treat me nt o pti o ns are n o w bei n g e x pl ore d 
base d o n t he fi n di n g t hat t y pe 2 i m m u ne reacti o ns occ ur i n greater t ha n 8 0 % of nasal p ol y p cases i n 
E ur o pe a n d t he U nite d States ( U S) (Car dell 2 0 2 0 ). C urre nt treat me nt e x pl orati o ns tar get a nti-
i m m u n o gl o b uli n E (I g E) pat h wa ys, a nti -i nterle u ki n (I L- 5) me c ha nis ms, a n d a nti-I L- 4 a n d I L-1 3 rece pt or 
mec ha nis ms ( A v dee va 2 0 1 8 ). A st u d y testi n g s u bc uta ne o us ( S C) d u pil u ma b, a h u ma n m o n ocl o nal 
a nti b o d y t hat bl oc ks t he I L- 4 R α s u b u nit i n t y pe 2 i nfla m mati o n, de m o nstrate d a p ositi ve o ut c o me of t he 
dr u g o n nasal p ol y p sc ore  ( N P S), a Si n o Nasal O utc o me Test, a n d a n i m pr o ve d se nse of s mell i n patie nts 
wit h C R S w N P  w h o were u nres p o nsi ve t o t o pical c ortic oster oi ds ( C S) (Bac hert 2 0 1 6 ).  
1. 2  
I n vesti g ati o n al Pr o d uct 
C B P - 2 0 1 is a n o vel h u ma n m o n ocl o nal a nti b o d y directe d a gai nst t he cell s urface pr otei n I L-4 R α. It is a n 
I n vesti gati o nal Me dici nal Pr o d uct c urre ntl y i n de vel o p me nt as a treat me nt f or aller gic i nfla m mat or y 
diseases b y S uz h o u C o n nect Bi o p har mace uticals, Lt d ( referre d t o here as C O N N E C T). I n vitr o a n d 
i n vi v o n o ncli nical st u dies ha ve bee n c o n d ucte d t o c haracterize t he p har mac ol o gic pr o perties of 
C B P - 2 0 1, c o nfir mi n g t he mec ha nis m of acti o n a n d deter mi ni n g p ote ntial t o xicities of C B P-2 0 1 i n 
h u ma n patie nts. Beca us e C B P- 2 0 1 is a m o n ocl o nal a nti b o d y t hat bi n ds t o t he sa me i m m u ne tar get as a n 
alrea d y mar kete d a nti b o d y a gai nst t he I L - 4 Rα , D u pi xe nt®  ( d u pil u ma b) (D u pi xe nt ®  2 0 1 9), t he C B P- 2 0 1 
cli nical de vel o p me nt  pr o gra m has bee n i nf or me d by cli nical e x perie nce of a pr o d uct i n t his t hera pe utic 
class. 
1. 3  
Effects i n H u m a ns  
C O N N E C T has c o m plete d  3 P hase 1  cli nical st u dies a n d is i n pr o gress wit h 3 P hase 2 cli nical st u dies 
a n d 1 P hase 2/ 3 cli nical st u d y i n h u ma ns t o date t hat are descri be d i n t his d oc u me nt. T he first st u d y was 
a si n gle asce n di n g d ose P hase  1a st u d y t o assess t he safet y, t olera bilit y, p har mac o ki netics ( P K), a n d 
p har mac o d y na mics ( P D) of C B P- 2 0 1 i n healt h y v ol u nteers as t he first -i n- h u ma n st u d y i n A ustralia. A 
sec o n d si milar si n gle asce n di n g d ose st u d y has bee n c o m plete d i n healt h y v ol u nteers i n C hi na. T he t hir d 
st u d y was a m ulti ple asce n di n g d ose P hase 1 b st u d y t o assess safet y, t olera bilit y, P K, a n d P D of 
C B P -2 0 1 i n a d ult patie nts wit h at o pic der matitis. A P hase  2 cli nical st u d y i n patie nts wit h at o pic 
der matitis i n t he U S , A ustralia, Ne w Zeala n d, C hi na, a n d t he E ur o pea n U ni o n ( E U ) has rece ntl y 
c o m plete d d osi n g a n d is i n t he re p orti n g p hase . A P hase 2  st u d y i n patie nts wit h ast h ma is o n- g oi n g i n 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 7  of 9 7  
t he U S wit h a d diti o nal pla n ne d sites i n C hi na a n d t he E U, U krai ne a n d S o ut h K orea. A P hase 2/ 3 st u d y 
i n at o pic der matitis patie nts is als o i n pr o gress i n C hi na. 
T o date t here has bee n o ne u n -relate d deat h  fr o m m y ocar dial i nfarcti o n  a n d 7 a d diti o nal u nrelate d 
seri o us a d verse e ve nts (c hest pai n, ri b fract ure sec o n dar y t o a ut o acci de nt, c h olelit hiasis, hea dac he, 
na usea, v o miti n g a n d p ne u m o nia) occ urri n g i n t he  rece ntl y c o m plete d d o u ble- bli n d P hase 2 trial of C B P -
2 0 1 i n patie nts wit h m o derate-t o-se vere at o pic der matitis. M ost re p orte d treat me nt-e mer ge nt a d verse 
e ve nts ( T EA Es ) t o date ha ve bee n mil d t o m o derate i n se verit y. N o  cli nicall y rele va nt tre n ds i n cli nica l 
safet y la b orat or y data or vital si g n data ha ve bee n o bser ve d acr oss d oses or o ver ti me u p t o 1  t o 4 m o nt h s 
of treat me nt.  
1. 4  
C o m p li a nce 
T his st u d y will be perf or me d i n c o m plia nce wit h t he pr ot oc ol, I nter nati o nal C o nfere nce o n 
Har m o nisati o n ( I C H) G o o d Cli nic al Practices ( G C P ), a n d a p plica ble re g ulat or y re q uire me nts. 
2  
S T U D Y O B J E C TI V E S  
2. 1  
Pri m ar y St u d y O bjecti ve  
T o e val uate t he efficac y of C B P- 2 0 1 o n a bac k gr o u n d of m o metas o ne f ur oate nasal s pra y ( M F N S) i n 
re d uci n g e n d osc o pic N P S a n d nasal c o n gesti o n/ o bstr ucti o n sc ore ( N C S) se verit y i n patie nts wit h 
C R S w N P w h ose disease re mai ns i na de q uatel y c o ntr olle d des pite dail y treat me nt wit h i ntra nasal 
c ortic oster oi d ( I N C S) t hera p y i n c o m paris o n t o place b o. 
2. 2  
Sec o n d ar y O bjecti ves  
T o e val uate t he eff ect of C B P - 2 0 1 o n: 
•  
S y m pt o ms of si n usitis 
•  
C o m p ute d t o m o gra p h y i ma ge sc ores of nasal p ol y ps a n d si n us i nfla m mati o n 
•  
P atie nt re p orte d o utc o mes ( P R Os) a n d healt h -relate d q ualit y of life ( H R Q o L) 
•  
S afet y a n d t olera bilit y of C B P - 2 0 1 i n patie nts wit h C R S w N P 
2. 3  
E x pl or at or y O bjecti ves 
•  T o e val uate t he eff ect of C B P - 2 0 1 i n t he s u b gr o u ps of patie nts wit h c o m or bi d ast h ma 
•  
T o e val uate t he P K  a n d P D  of C B P - 2 0 1 i n patie nts wit h C R S w N P  
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 8  of 9 7  
3  
I N V E S TI G A TI O N A L S T U D Y P L A N 
3. 1  
O ver all Desi g n  
T his is a m ultice nter, ra n d o mize d, d o u ble - bli n d, place b o-c o ntr olle d st u d y e val uati n g t he effect of C B P-
2 0 1 i n patie nts wit h C R S w N P w h ose disease re mai ns i na de q uatel y c o nt r olle d des pite dail y treat me nt 
wit h I NC S t hera p y. 
T he st u d y c o nsists of 3 peri o ds: 
3. 2  
Scree ni n g/ R u n -I n Peri o d: 4 wee ks 
T he Scree ni n g Peri o d is 3 1 da ys.  Patie nts usi n g a d oc u me nte d sta ble d ose of nasal m o metas o ne at least 
2 0 0 mc g/ da y, or a n e q ui vale nt dail y d ose of a n ot her I N C S, f or at least 2 8 da ys bef ore ra n d o mizati o n will 
be as ke d  t o c o nti n ue t he d ose f or t he d urati o n of t he st u d y. F or patie nts w h o are usi n g a n alter nati ve 
I N C S pr o d uct ot her t ha n M F N S pri or t o t he scree ni n g visit, t he i n vesti gat or m ust s witc h t he patie nt t o 
M F N S at V isit 1. Patie nts will be as ke d t o sta n dar dize t heir I NC S t o a re gi me n of m o metas o ne f ur oate 
( N A S O N E X® ) nasal s pra y ( M F N S) of 2 act uati o ns ( 5 0 mc g /act uati o n) i n eac h n ostril BI D, t otal dail y 
d ose of u p t o 4 0 0 mc g , u nless t he y are i nt olera nt t o BI D I N C S, i n w hic h case, t he y ma y re mai n o n a 
sta ble d osa ge of m o metas o ne of 2 act uati o ns ( 5 0 mc g /act uati o n) i n eac h n ostril o nce dail y , t otal dail y 
d osa ge of 2 0 0 mc g . 
Patie nts m ust use nasal m o metas o ne at least 2 0 0 mc g/ da y, or e q ui vale nt, f or at least 2 8 da ys bef ore 
ra n d o mizati o n, w hic h ca n i ncl u de da ys pri or t o scree ni n g wit h s u p p orti ve d oc u me ntati o n.  R u n -i n ca n be 
7- 3 1 da ys wit h c o m plia nce deter mi ne d i n t he wee k pri or t o ra n d o misati o n usi n g patie nt diar y  e ntries.  If 
patie nts fail c o m plia nce  re q uire me nts, t he y ma y u n der g o retrai ni n g wit h t he patie nt diar y  a n d re peat t he 
r u n-i n peri o d of 7 da ys.   
3. 3  
Tre at m e nt Peri o d: C B P - 2 0 1/ Pl ace b o f or 2 4 w ee ks 
After scree ni n g/r u n -i n has bee n c o m plete d, eli gi ble patie nts will be ra n d o ml y all ocate d i n a 1: 1: 1 rati o t o 
recei ve d o u ble- bli n d treat me nt wit h C B P- 2 0 1 Q 2 W or Q 4 W or place b o wit h e ver y ot her wee k visits t o 
t he st ud y site f or S C i njecti o ns:  
•  C B P - 2 0 1 3 0 0 m g e ver y 2 wee ks  S C a d mi nistrati o n f or 2 4 wee ks wit h a n i nitial l oa di n g d ose 
of 6 0 0 m g at Da y 1  
•  C B P - 2 0 1 3 0 0 m g e ver y 4 wee ks  S C a d mi nistrati o n f or 2 4 wee ks wit h a n i nitial l oa di n g d ose 
of 6 0 0 m g at Da y 1. T his gr o u p will als o recei v e matc he d place b o e ver y 4 wee ks o n 
alter nate w ee ks t o mai ntai n t he bli n d.  
•  Place b o e ver y 2 wee ks S C a d mi nistrati o n f or 2 4 wee ks ( Place b o l oa di n g at Da y 1) 
Ra n d o mizati o n will be stratifie d b y c o m or bi d ast h ma .  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 2 9  of 9 7  
D uri n g t he d o u ble -bli n d ra n d o mize d treat me nt, all patie nts will c o nti n ue sta ble d ose of M F N S ( 2 0 0  mc g ) 
BI D or o nce dail y use d d uri n g t he r u n-i n peri o d. 
3. 4  
P ost -tre at m e nt F oll o w-U p Peri o d: 8 wee ks  
Aft er c o m pleti n g 2 4 wee ks of treat me nt wit h t he i n vesti gati o nal pr o d uct (I P) ( or f oll o wi n g earl y 
disc o nti n uati o n of I P), patie nt s will be f oll o we d f or a d diti o nal 8 wee ks. Patie nts  will be as ke d t o 
c o m plete a st u d y visit  e ver y 4 wee ks t o: 
•  E val uate P K, P D, a nti dr u g a nti b o dies ( A D A), p h ysical e xa mi nati o n, Q O L, efficac y, safet y, 
a n d a last e n d osc o p y at t he e n d of st u d y 
•  C o nti n ue t o c o m plete patie nt diar y  f or s y m pt o m e val uati o n 
•  C o nti n ue M F N S sta ble d ose d uri n g p ost- treat me nt peri o d 
•  Re p ort a n y A E 
Patie nts will be e nc o ura ge d t o re mai n i n t he st u d y e ve n if disc o nti n ue d fr o m st u d y dr u g treat me nt. 
Patie nts w h o disc o nti n ue pre mat urel y fr o m st u d y dr u g treat me nt are assesse d as s o o n as p ossi ble usi n g 
t he pr oce d ures n or mall y pla n ne d f or t he E n d of Treat me nt Visit a n d t he 2 p ost-treat me nt F oll o w- u p 
Peri o d Visits.   
3. 5  
Disc o nti n u ati o n a n d St u d y St o p pi n g R ules  
D osi n g f or a n y i n di vi d ual patie nt will be st o p pe d if t he patie nt e x perie nces a dr u g -relate d S A E  or a dr u g -
relate d si g nifica nt n o nseri o us a d verse e ve nt ( A E), w hic h, i n t he o pi ni o n of t he In vesti gat or, p h ysicia n , or 
S p o ns or’s me dical re prese ntati ve, warra nts disc o nti n uati o n of t he st u d y f or t hat patie nt ’s well- bei n g.  
Patie nts s h o ul d be e nc o ura ge d t o re mai n i n t he st u d y e ve n if t he y ha ve disc o nti n ue d st u d y dr u g treat me nt 
d ue t o treat me nt fail ure.  
3. 6  
R ati o n ale f or St u d y Desi g n 
C B P - 2 0 1 si m ulta ne o usl y tar gets t he i nfla m mat or y acti o ns of b ot h I L- 4 a n d I L- 1 3 of patie nts wit h 
i nfla m mat or y disease. T his st u d y is a sta n dar d a d d -o n desi g n f or a P hase 2 trial i n C R S w N P  t o assess 
b ot h efficac y a n d safet y of C B P- 2 0 1. T here will be a s cree ni n g peri o d of 3 1 da ys i n w hic h t he patie nt’s 
C R S w N P  a n d healt h stat us will be assesse d pri or t o d o si n g. At t he Scree ni n g a n d Baseli ne Visits, t he 
patie nt a ns wers t he s y m pt o ms q uesti o n naires a n d will be assesse d b y e n d osc o p y t o meas ure t he nasal 
p ol y p size pri or t o recei vi n g st u d y dr u g. If t he patie nt f ulfils t he eli gi bilit y criteria, t he y will be 
ra n d omize d t o 1  of 3 treat me nts: C B P- 2 0 1 3 0 0 m g  e ver y 2 wee ks, C B P- 2 0 1 3 0 0 m g e ver y 4 wee ks or 
place b o e ver y 2 wee ks  i n a 1: 1: 1 treat me nt rati o. Patie nts will recei ve st u d y dr u g  or place b o  e ver y 2 
wee ks. Patie nts will be all o we d t o c o nti n ue re g ular, pr ot oc ol- per mitte d, c o nc o mita nt me dicati o ns. T he 
patie nt’s s y m pt o ms a n d nasal p ol y p size will be meas ure d t hr o u g h o ut t he st u d y wit h 2 c o-pri mar y 
e n d p oi nts bei n g t he c ha n ge fr o m baseli ne N P S a n d t he N C S at Wee k 2 4 of treat me nt.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 0  of 9 7  
Patie nts will als o be cl osel y m o nit ore d t hr o u g h o ut t he st u d y wit h patie nt diaries t hat will be c o n ve yi n g 
s y m pt o m a n d p h ysi ol o gic data t o site staff f or re vie w. Patie nts will be re g ularl y assesse d b y t he 
p h ysicia n at cli nic , tele-visits , or  h o me healt h care d uri n g t he 2 4 wee ks of treat me nt f oll o we d b y a n 8-
wee k p ost- treat me nt f oll o w- u p peri o d. As i n dicate d i n t he Sc he d ule of Assess me nt (Ta ble 1 ), w here 
p ossi ble, h o me healt h visits or tele me dici ne visits  ma y be utilize d t o c o m plete st u d y visits w he n nee de d 
t o a da pt t o C O VI D- 1 9 pa n de mic restricti o ns a n d/ or patie nt healt h c o ncer ns. H o me healt hcare a n d 
tele me dici ne ma y  re d uce t he ris k of misse d visits d ue t o st u d y site cl os ures a n d re d uce t he nee d f or 
patie nts t o visit t he st u d y site a n d t heref ore mi ni mize t he o v erall b ur de n o n patie nts. 
3. 7  
St u d y D ur ati o n  
T he st u d y d urati o n is a p pr o xi matel y 3 6 wee ks i ncl u di n g a Scree ni n g Peri o d of u p t o 4 wee ks, a 2 4- wee k 
Treat me nt Peri o d, a n d a n 8 -wee k P ost -treat me nt/ F oll o w- u p Peri o d. 
3. 8  
St u d y P o p ul ati o n 
It is a ntici pate d t hat a p pr o xi matel y 1 4 7  male a n d fe male patie nts wit h c hr o nic r hi n osi n usitis wit h lar ge 
bilateral nasal p ol y ps t hat re mai n u nc o ntr olle d des pite dail y treat me nt wit h I NC S will be recr uite d i nt o 
t he st u d y. 
A p pr o xi matel y 5 0 % of t he patie nts will be tar gete d  t o ha ve c o m or bi d ast h ma a n d treat me nt will be 
stratifie d o n c o m or bi d ast h ma.  N ote: T his m ay be de m o nstr ate d wit h a d oc u me nte d me dic al hist ory of 
> 1 2 % reversi bility (i m pr ove me nt i n F E V1) wit hi n t he previ o us 1 2 m o nt hs or m ay be de m o nstr ate d at 
scree ni n g i n t he cli nic.  P atie nts m ay re pe at t he reversi bility o n a differe nt d ay if it is deter mi ne d t h at a 
l o n ger br o nc h o dil at or w as h o ut peri o d is nee de d. 
3. 9  
Effic ac y Assess m e nts  
3. 9. 1  C o -pri m ar y  Effic ac y E n d p oi nts  
T here will be 2 c o - pri mar y e n d p oi nts: 
•  C ha n ge fr o m bas eli ne at Wee k 2 4 i n e n d os c o pic N P S 
− E n d osc o pic N P S is gra de d base d o n p ol y p size (rec or de d as t he s u m of t he ri g ht a n d left n ostril 
sc ores wit h a ra n ge of 0 t o 8; hi g her sc ores i n dicate w orse stat us) 
•  C ha n ge fr o m bas eli ne at Wee k 2 4 i n a v era g e dail y nasal c o n gesti o n sc ore ( N C S)  
3. 9. 2  S ec o n d ar y Effic ac y E n d p oi nts  
•  C ha n ge fr o m bas eli ne at Wee k 2 4 i n:  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 1  of 9 7  
− 
Perce nta ge of ma xillar y si n us v ol u me occ u pie d b y disease o n C T a n d L u n d - Mac ka y C o m p ute d 
T o m o gra p h y sc ores fr o m patie nts e nr olle d at St u d y Sites  t hat are a p pr o ve d a n d q ualifie d t o 
perf or m C T sca ns 
− 
U ni versit y of Pe n ns yl va nia S mell I de ntificati o n Test ( U P SI T ) 
− 
Vis ual a nal o g ue scale f or r hi n osi n usitis ( V A S-R S)  
− 
T otal nasal s y m pt o m sc ore ( T N S S)  
− 
2 2- ite m Si n o nasal O utc o me Test ( S N O T- 2 2) 
− 
A vera ge dail y a nteri or r hi n orr hea sc ore   
− 
A vera ge dail y p osteri or r hi n orr hea sc ore  
− 
A vera ge dail y l oss of s mell sc ore   
− 
D ail y s u bject -assesse d nasal pea k i ns pirat or y fl o w ( N PI F) 
•  Re q uire me nt of r esc ue tr eat me nt (s yste mic C S f or > 5 c o nsec uti ve da ys) or ha vi n g ha d 
s ur ger y f or nasal p ol y ps t hr o u g h Wee k 2 4  
•  Ti me t o resc ue tr eat me nt (s yste mic C S f or > 5 c o nsec uti ve da ys) or s ur ger y f or nasal p ol y ps 
t hr o u g h Wee k 2 4 
3. 9. 3  E x pl or at or y Effic ac y E n d p oi nts  
•  C ha n ge fr o m bas eli ne at Wee k 2 4 i n F orce d E x pirat or y V ol u me i n 1 Sec o n d ( F E V 1) f or 
patie nt s wit h ast h ma 
•  Pr o p orti o n of patie nts wit h mi ni mal cli nicall y i m p orta nt differe nce ≥ 8. 9 i n S N O T 2 2  at 
Wee k 2 4  
•  C ha n ge fr o m bas eli ne at Wee k 1 6 i n e n d os c o pic N P S 
•  C ha n ge fr o m bas eli ne at Wee k 1 6 i n N C S 
•  C ha n ge fr o m bas eli ne at Wee k 2 4 i n E ur o p ea n q u alit y of life scale ( E Q - 5 D- 5 L) 
•  Healt hcare r es o urce utilizati o n t hr o u g h Wee k 2 4 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 2  of 9 7  
3. 9. 4  P h ar m ac o d y n a mic E n d p oi nts  
•  
C ha n ge fr o m Baseli ne i n bl o o d le vels of I g E 
•  
C ha n ge fr o m Baseli ne i n peri p her al e osi n o p hil c o u nts 
•  
C ha n ge fr o m Baseli ne i n ot her mar kers of at o pic i nfla m mati o n i n t he bl o o d [e osi n o p hil 
cati o nic pr otei n ( E C P), t h y m us a n d acti vati o n- re g ulate d c he m o ki ne ( T A R C), E ota xi n- 3, 
a n d peri osti n .] 
3. 9. 5  P h ar m ac o ki n etic E n d p oi nts  
W h ole bl o o d f or plas ma C B P- 2 0 1 c o nce ntrati o ns will be o btai ne d a n d a nal yse d. T he i n di vi d ual stea d y-
state tr o u g h P K pr ofile will be calc ulate d f or eac h treat me nt sc he d ule.  
A d diti o nal sa m pli n g will be o btai ne d after t he last treat me nt d ose as n ote d a b o ve t o c haracterize t he 
ret ur n t o baseli ne. 
3. 9. 6  S af et y E n d p oi nt s 
Safet y e n d p oi nts will be s u m marize d b y descri pti ve statistics a n d narrati ves w here i n dicate d b y 
se verit y. 
•  A Es re p orte d, i n cl u di n g S A Es a n d a d vers e e ve nts of s pecial i nterest ( A E SI)  
•  Vital si g ns  
•  P h ysical e xa mi nati o n  
•  Electr ocar di o gra m ( E C G)  
•  I njecti o n site e val uati o ns  
•  Safet y la b orat or y p ar a meters e val uat e d  
•  A D A a n d ne utralizi n g a nti b o dies ( N A b) 
4  
S T U D Y T R E A T M E N T S  
4. 1  
St u d y Dr u g Descri pti o n  
C B P - 2 0 1: pr o vi de d as a si n gle-use 2 m L vial c o ntai ni n g 1. 2 m L clear t o sli g htl y yell o w sterile s ol uti o n 
of C B P - 2 0 1 tar gete d t o be a p pr o xi matel y 1 5 0 m g/ m L.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 3  of 9 7  
Place b o: pr o vi de d as a si n gle - use 2 m L vial c o ntai ni n g 1. 2 m L s ol uti o n c o ntai ni n g i de ntical e xci pie nts 
wit h o ut C B P - 2 0 1. Si milar v ol u mes a n d n u m ber of vials are t o be use d f or place b o d oses.  
4. 2  
St u d y Dr u g A d mi nistr ati o n  
Eli gi ble patie nts will recei ve st u d y dr u g b y S C i njecti o n a n d will ra n d o mize d 1 : 1: 1 t o t he f oll o wi n g 
treat me nts: 
•  
C B P - 2 0 1 3 0 0 m g  S C e ver y 2 wee ks  wit h a 6 0 0- m g l oa di n g d ose o n Da y  1 
•  
C B P - 2 0 1 3 0 0 m g  S C e ver y 4 wee ks  wit h a 6 0 0 - m g l oa di n g d ose o n Da y 1. T his gr o u p will als o 
recei ve v ol u me matc he d place b o e ver y 4 wee ks o n alter nate visits t o mai ntai n t he bli n d.  
•  
Place b o v ol u me- matc he d S C d osi n g e ver y 2 wee ks wit h a place b o l oa di n g d ose o n Da y  1  
D osi n g will be v ol u me matc he d t o mai ntai n d o u ble- bli n d wit h 4 ti mes 1-m L i njecti o ns o n Da y  1 a n d 
2 ti mes 1- m L i njecti o ns o n s u bse q ue nt d osi n g da ys. 
4. 3  
Resc ue Me dic ati o ns  
As all patie nts will ha ve si g nifica nt r hi n osi n usitis  a n d s o me patie nts will als o ha ve ast h ma , patie nts ma y 
be pr o vi de d wit h resc ue t hera p y o pti o ns. I n t he case of w orse ni n g of e n d osc o pic/ra di ol o gic si g ns a n d/ or 
cli nical s y m pt o ms  re q uiri n g me dical i nter ve nti o n, t he I n vesti gat or ma y c o nsi der sta n dar d of care resc ue 
treat me nt s uc h as: 
•  
Nasal la va ge wit h sali ne a n d/ or s yste mic a nti bi otics ( u p t o 2 wee ks i n  case of ac ute i nfecti o n) 
•  
S h ort c o urse oral/s yste mic c ortic oster oi ds( < 5 c o nsec uti ve da ys ).  
•  
Si n o -nasal s ur ger y f or nasal p ol y ps . Base d o n pre vi o us o bser vati o ns, at least 8 wee ks of st u d y dr u g 
treat me nt is rec o m me n de d pri or t o res orti n g t o s ur ger y t o all o w a n o nset of t he treat me nt effect. 
N ote:   P atie nts receivi n g si n o - n as al s ur gery d uri n g t he st u dy are re q uire d t o disc o nti n ue st u dy dr u g 
tre at me nt as t his is c ate g orize d as a tre at me nt f ail ure, alt h o u g h st u dy assess me nts m ay c o nti n ue. 
Resc ue o pti o ns are base d o n c urre nt sta n dar d of care,  b ut I n vesti gat ors are als o referre d t o Sca d di n g et al 
2 0 0 7 f or i n de pt h g ui da nce f or t he ma na ge me nt of r hi n osi n usitis a n d nasal p ol y p osis.   
I n a d diti o n, i n t he case of w orse ni n g ast h ma s y m pt o ms, patie nts ma y be offere d t he f oll o wi n g resc ue 
t hera pies, or ot hers as dee me d a p pr o priate b y t he i n vesti gat or: 
•  
Al b uter ol ( als o k n o w n as sal b uta m ol, s h ort-acti n g ß a g o nist [ S A B A] i n haler). N ote : P atie nts wit h 
ast h m a are  all o we d t o use al b uter ol/s al b ut a m ol as nee de d a n d use will be d oc u me nte d d aily vi a 
p atie nt di ary . A n i ncre ase of  6 or m ore  reliever occ asi o ns ( 1 p uff  = reliever occ asi o n) i n a 2 4- h o ur 
peri o d f or ≥ 2 c o nsec utive d ays al o n g wit h decre ase d pe ak fl o w will f ulfill t he defi niti o n of “l oss of 
ast h m a c o ntr ol ”.   


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 4  of 9 7  
•  
I ncrease i n d osa ge of i n hale d c ortic oster oi ds. 
Patie nts recei vi n g resc ue me dicati o n d uri n g t he st u d y s h o ul d c o nti n ue o n st u d y dr u g u nless t he 
I n vesti gat or deci des t o wit h dra w t he st u d y treat me nt. Bef ore starti n g treat me nt wit h s yste mic 
c ortic oster oi ds, patie nts s h o ul d c o me t o t he st u d y site f or cli nical assess me nts i ncl u di n g e n d osc o p y a n d 
re vie w of patie nt s y m pt o ms.  
Patie nt sc he d ule d f or si n o -nasal s ur ger y ma y c o nti n ue I M P u p t o t he ti me of s ur ger y or E O T w hic he ver 
date c o mes first a n d at ti me of s ur ger y will be per ma ne ntl y disc o nti n ue d fr o m st u d y treat me nt a n d 
perf or m efficac y a n d safet y assess me nts at t he E O T visit a n d ret ur n t o t he site f or a d diti o nal visits as 
descri be d i n t he Sc he d ule of Assess me nt . 
A patie nt ma y use a differe nt S A B A relie ver ot her t ha n t hat pr o vi de d (e g, a differe nt bra n d of 
al b uter ol/sal b uta m ol). T his i nf or mati o n m ust  be rec or de d i n t he dail y  patie nt diar y. T he use of a n y f or m 
of S A B A d uri n g t he st u d y s h o ul d be fact ore d i nt o t he o verall use of relie ver/resc ue me dicati o n a n d i n 
deter mi ni n g w het her a patie nt meets  t he criteria of e xacer bati o n as defi ne d i n t he pr ot oc ol. 
4. 4  
Ot her C o nc o mit a nt Me dic ati o ns  
Pati e nts will mai ntai n re g ular treat me nt wit h I N C S a n d s h o ul d c o nti n ue o n a sta ble d ose a n d sc he d ule 
t hr o u g h o ut t he st u d y a n d d ose a dj ust me nt is n ot all o we d .  
Patie nts  wit h c o m or bi d ast h ma ma y als o  be c urre ntl y  ta ki n g i n hale d c ortic oster oi d (I C S) a n d s h o ul d 
c o nti n ue o n a re g ular d ose a n d sc he d ule t hr o u g h o ut t he st u d y. I n t he i nterests of t he patie nts’  safet y a n d 
acce pta ble sta n dar ds of me dical care, t he I n vesti gat or will be per mitte d t o prescri be a n y treat me nt(s) at 
t heir discreti o n . All treat me nts, i ncl u di n g prescri pti o n dr u gs, vita mi ns, or her bal me dicati o ns ta ke n 
wit hi n 2 8 da ys pri or t o  Scree ni n g ( Visit 1) a n d t hr o u g h o ut t he trial m ust be rec or de d i n t he s o urce 
d oc u me nts a n d e C R F, i ncl u di n g i n dicati o n, d ose, u nit, r o ute, fre q ue nc y, a n d start a n d st o p dates of 
a d mi nistrati o n . 
4. 5  
Pr o hi bite d Me dic ati o ns a n d Restricti o ns  
•  
I ntra nasal c ortic oster oi d dr o ps or C S -a d mi nisteri n g de vices (e g, or O pti N ose de vice or ste nts) are 
pr o hi bite d. O nl y m o metas o ne f ur oate ( N A S O N E X® ) nasal s pra y ( M F N S) or re gi o nal e q ui valent , if 
a gree d wit h t he me dical m o nit or, will be per mitte d d uri n g t he st u d y as a nasal treat me nt .  
•  
Patie nts ma y n ot use a n y mar kete d bi ol o gic dr u g (e g, o maliz u ma b, be nraliz u ma b, me p oliz u ma b, 
resliz u ma b, d u pil u ma b) wit hi n 6 0 da ys or 5 half-li ves ( w hic he ver is l o n ger) of scree ni n g a n d 
t hr o u g h o ut t he st u d y.  
•  
N o n- ster oi dal i m m u n os u p pressa nts (e g, c ycl os p ori ne, met h otre xate, azat hi o pri ne, m yc o p he n olate, 
sir oli m us, tacr oli m us) are n ot per mitte d d uri n g t he st u d y. 
•  
Le u k otrie ne a nta g o nists/ m o difiers f or patie nts w h o were n ot o n c o nti n u o us treat me nt f or > 3 0 da ys 
pri or t o scree ni n g are pr o hi bite d ta ke n wit hi n 7 da ys pri or t o scree ni n g . If t he patie nts were o n t hese 
me dicati o ns f or > 3 0 da ys pri or t o scree ni n g t he y ma y c o nti n ue o n a sta ble d ose a n d sc he d ule. 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 5  of 9 7  
•  
Patie nts ma y n ot i nitiate treat me nt wit h aller ge n i m m u n ot hera p y fr o m scree ni n g t hr o u g h o ut t he 
d urati o n of t he st u d y; if t he y ha ve bee n o n mai nte na nce aller ge n i m m u n ot hera p y f or at least 9 0 da ys 
pri or t o scree ni n g, t he y ma y sta y o n a sta ble d ose of t his t hera p y d uri n g t he st u d y a n d d ose 
a dj ust me nt is n ot all o we d. 
•  
Patie nts ma y n ot use a n y mar kete d n o n bi ol o gic dr u g t hat m o d ulates t y pe 2 c yt o ki nes (e g. s u platast 
t osilate) wit hi n 3 0 da ys or 5 half-li ves ( w hic he ver is l o n ger) pri or t o scree ni n g a n d t hr ou g h o ut t he 
st u d y. 
•  
Patie nts ma y n ot use a n y i n vesti gati o nal s mall m olec ule dr u g or treat me nt wit hi n 1 6 wee ks or 5 half-
li ves ( w hic he ver is l o n ger) pri or t o scree ni n g a n d t hr o u g h o ut t he st u d y. 
•  
Fr o m V 1 a n d t hr o u g h o ut t he st u d y, p atie nts ma y n ot use l ocall y a d mi nistere d nasal dec o n gesta nts 
e xce pt  f or t he p ur p ose of st u d y re q uire d nasal e n d osc o p y. 
4. 6  
Restricti o ns  
If u n der g oi n g l u n g f u ncti o n testi n g, patie nts s h o ul d be re q ueste d t o: 
•  Refrai n fr o m S A B A f or at least 6 h o urs bef ore Scree ni n g ( Visit  1 a n d visits re q uiri n g l u n g 
f u ncti o n testi n g) 
•  Dela y t he m or ni n g d ose of i n hale d c o m bi nati o n t hera p y or l o n g-acti n g ß a g o nist ( L A B A ) 
u ntil after s pir o metr y  meas ure me nts at Scree ni n g ( Visit  1) a n d visits re q uiri n g l u n g f u ncti o n 
testi n g. T w ice- dail y L A B As or c o m bi nati o n pr o d ucts s h o ul d be dela ye d f or at least 1 2 h o urs 
a n d o nce-d ail y br o nc h o dilat ors or c o m bi nati o n pr o d ucts s h o ul d be dela ye d f or at least 2 4 
h o urs. 
N ote: O n t he m or ni n g of t he Scree ni n g  visit, patie nt s wit h ast h m a  are re q ueste d t o del ay t heir m or ni n g 
d ose of i n h ale d br o nc h o dil at ors ( S A B A, L A B A or ot her) a n d c o m bi n ati o n pr o d ucts , if use d re g ul arly, 
u ntil after p ul m o n ary f u ncti o n testi n g. If t he p atie nt h as t ake n t hese me dic ati o ns bef ore t he scree ni n g 
visit, p atie nts m ay c o nti n ue wit h scree ni n g a n d ret ur n t o c o m plete t he re q uire d p ul m o n ary f u ncti o n test s 
o n a n ot her d ay. P atie nts m ay als o ret ur n f or a re pe at scree ni n g test if t hey f ail t he i niti al atte m pt, 
pr ovi de d t here is re as o n t o believe t h at t he F E V 1 w o ul d i m pr ove d urin g t he ti me bet wee n tests . If 
p atie nts f or get t o del ay t hese me dic ati o ns d uri n g t he d osi n g peri o d, l u n g f u ncti o n me as ure me nt s h o ul d 
be fl a g ge d i n t he e C R F wit h a n ote t o d oc u me nt t h at a p ote nti ally c o nf o u n di n g c o nc o mit a nt me dic ati o n 
w as t ake n pri or t o me as ure me nt.   
4. 7  
A v oi d a nce of Pre g n a nc y  
T o i ncl u de w o me n of c hil d beari n g p ote ntial i n t his cli nical trial, certai n preca uti o ns m ust be ta ke n. T hese 
i ncl u de a ser u m pre g na nc y test at Scree ni n g ( Visit 1), uri ne pre g na nc y testi n g (fe males of c hil d beari n g 
p ote ntial o nl y) t hr o u g h o ut t he st u d y, as well as re q uiri n g t he patie nt t o ta ke e ver y preca uti o n t o e ns ure 
pre g na nc y d oes n ot occ ur fr o m t he first d ose t o t he last visit ( 8 wee ks after t he last d ose).  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 6  of 9 7  
I n or der t o pre ve nt pre g na nc y, all fe male patie nts of c hil d beari n g p ote ntial m ust use hi g hl y effecti ve 
met h o ds of birt h c o ntr ol, defi ne d as t h ose t hat res ult i n a l o w fail ure rate (ie, less t ha n 2 % per year) w he n 
use d c o nsiste ntl y a n d c orrectl y.  
Acce pta ble f or ms of hi g hl y effecti ve c o ntrace pti o n are:  
1.  Esta blis he d use of oral, i njecte d, tra ns d er mal or i m pla nte d h or m o nal met h o ds of 
c o ntrace pti o n. 
2.  Place me nt of a n i ntr a uteri ne de vice or i ntra uteri ne s yste m  
3.  Barrier met h o ds of c o ntr ace pti o n: Male or fe male c o n d o m or occl usi ve ca p ( dia p hra g m or 
cer vical/ va ult ca ps) wit h s per mici dal f oa m/ gel/fil m/crea m/s u p p osit or y. T he use of barrier 
c o ntrace pti ves s h o ul d be s u p ple me nte d wit h t he use of a s per mici de. C o n d o ms t hat are 
pac ka g e d wit h s per mici d e f ulfil t his rec o m me n dati o n. I n c o u ntries w here s per mici de is n ot 
a vaila ble or si n gle b arrier met h o ds are n ot c o nsi d ere d hi g hl y effecti ve, a s ec o n d, p h ysical 
barrier m et h o d m ust be use d . 
4.  Fe male sterilizati o n ( e g, d oc u me nte d bilateral t u bal li gati o n, h ysterect o m y, or bilateral 
o o p h orect o m y) 
5.  Male sterilizati o n ( wit h t he a p pr o pri ate p ost vasect o m y d oc u me ntati o n of t he a bse nce of 
s per m i n t he ejac ul ate). F or fe male p atie nts o n t he st u d y, t he vasect o mize d male part ner 
s h o ul d be t he s ole part ner f or t hat patie nt  
6.  Tr ue a bsti ne nce: W he n t his is i n li ne wit h t he preferre d a n d us ual lifest yle of t he p atie nt (e g, 
si n gle se x m o n o ga m o us relati o ns hi ps, c o m mitte d a bs ol ute a bsti ne nce). N ote:  Peri o dic 
a bsti ne nce ( e g, c ale n d ar, ov ul ati o n, sy m pt ot her m al, p ost ov ul ati o n met h o ds) a n d wit h dr a w al 
are n ot c o nsi dere d tr ue a bsti ne nce a n d are n ot acce pt a ble met h o ds of c o ntr ace pti o n  
I n a d diti o n, t he use of sec o n dar y barrier met h o ds (c o n d o ms, dia p hra g ms) will be str o n gl y e nc o ura ge d 
w hile partici pati n g i n t his st u d y a n d f or 8 wee ks f oll o wi n g last d ose of st u d y dr u g. 
F e male patie nts n ot of c hil d beari n g p ote ntial are t h ose w h o ha ve u n der g o ne bilateral t u bal li gati o n, 
bilateral o o p h orect o m y, h ysterect o m y, or are p ost me n o pa usal a n d ha ve bee n a me n orr h oeic f or greater 
t ha n 1 year wit h a n a p pr o priate cli nical pr ofile (e g, a ge a p pr o priate, hist or y of vas o m ot or s y m pt o ms).  
As a preca uti o n, all male patie nts ra n d o ml y assi g ne d t o t he st u d y s h o ul d use a n a p pr o priate met h o d of 
c o ntrace pti o n (ie, c o n d o m a n d s per mici de) i n a d diti o n t o a d visi n g t heir fe male part ner t o use a n ot her 
f or m of c o ntrace pti o n s uc h as t h ose liste d a b o ve.  
If a fe male patie nt or a male patie nt’s part ner bec o mes pre g na nt d uri n g t his ti me peri o d (fr o m first d ose 
of st u d y dr u g u ntil 8 wee ks after t he last d ose), t he I n vesti gat or will i nf or m t he S p o ns or a n d t he 
I nstituti o nal Re vie w B oar d (I R B) or Et hics C o m mittee ( E C), as a p pr o priate, as well as pr o vi di n g t he 
a p pr o priate me dical f oll o w- u p. Patie nts w h o bec o m e pre g na nt w hile i n t he st u d y m ust be i m me diatel y 
wit h dra w n fr o m st u d y dr u g treat me nt a n d f oll o we d t o res ol uti o n, w hic h i ncl u des birt h or ter mi nati o n of 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 7  of 9 7  
t he pre g na nc y. E ver y atte m pt s h o ul d be ma de t o f oll o w t he pre g na nc y t o c o m pleti o n. If p ossi ble, birt hs 
will be f oll o we d b y t he I n vesti gat or f or 8 wee ks f or o bser vati o n of p ossi ble c o n ge nital a b n or malities. 
Pre g na ncies detecte d pri or t o ra n d o mizati o n at Visit  2 s hall be scree n -faile d a n d d o n ot re q uire f urt her 
f oll o w- u p after t he patie nt has bee n wit h dra w n fr o m t he st u d y. 
4. 8  
Me as ure m e nt of P ati e nt C o m pli a nce  
All d osi n g is s u per vise d i n t he cli nic or b y h o me healt h a d mi nis trati o n. D osi n g c o m plia nce will be 
deter mi ne d fr o m site rec or ds a n d e ntr y i nt o t he e C R F. Patie nt c o m plia nce wit h st u d y pr oce d ures at h o me 
will be esti mate d base d o n re vie w of t he patie nt’s dail y diar y data at eac h visit . If t he patie nt  is less t ha n 
7 0 % c o m plia nt wit h t he re q uire me nts of t he pr ot oc ol base d o n re vie w of t heir diar y data , t he I n vesti gat or 
or desi g nee m ust deter mi ne if t his is a trai ni n g iss ue a n d retrai n t he patie nt  o n use of dail y diar y a n d 
p ul m o nar y f u ncti o n de vice . If the patie nt  c o nti n ues t o de m o nstrate p o or c o m plia nce ( < 7 0%), t heir 
partici pati o n s h o ul d be re vie we d wit h t he c o ntract researc h or ga nizati o n ( C R O) a n d S p o ns or t o 
deter mi ne if t he patie nt s h o ul d be wit h dra w n fr o m t he st u d y f or faili n g t o c o m pl y wit h t he re q u ire me nts 
of t he pr ot oc ol. 
5  
P A TI E N T E N R O L L M E N T  
5. 1  
I ncl usi o n Criteri a 
A patie nt m ust meet t he f oll o wi n g criteria t o be eli gi ble t o partici pate i n t his st u d y:  
1.  Fe male a n d male p atie nts a ge d > 1 8 a n d < 7 5 years at t he ti me of scree ni n g. 
2.  Patie nts w h o are dia g n os e d wit h c hr o nic r hi n osi n usitis wit h bilateral p ol y ps des pite 
treat me nt wit h s yste mic c ortic oster oi d wit hi n t he past 2 years a n d/ or me dical 
c o ntrai n dicati o n/i nt olera nce t o s yste mic c ortic ost er oi ds.  T he p ol y ps ha ve a mi ni m u m 
bilateral N P S of 5 o ut of a ma xi m u m sc ore of 8 wit h at least a sc ore of 2 f or eac h n ostril at 
scree ni n g ( ce ntr al rea d) a n d baseli ne (l ocal rea d) e val uate d b y e n d osc o p y. N ote: P atie nt 
i nt oler a nce t o syste mic c ortic oster oi ds i ncl u des p atie nt ref us al of tre at me nt wit h syste mic 
c ortic oster oi ds d ue t o u n desir a ble si de effects.  
3.  Nasal c o n gesti o n/ bl oc ka de/ o bstr ucti o n wit h m o derate or se v ere s y m pt o m se verit y ( N asal 
C o n gesti o n Sc ore of > 2) at scree ni n g a n d a w ee kl y a vera g e se v erit y of > 1 at ti me of 
ra n d o mizati o n. 
4.  Patie nts usi n g nasal m o metas o ne at least 2 0 0 mc g  per da y, or e q ui vale nt dail y d osi n g of 
a n ot her I NC S, f or at least 2 8 da ys bef ore ra n d o mi zati o n, a n d willi n g t o c o nti n ue f or t he 
d urati o n of t he st u d y. N ote: F or p atie nts w h o are usi n g a n alter n ative I N C S pr o d uct ot her 
t h a n M F N S pri or t o t he scree ni n g visit, t he i nvesti g at or m ust s witc h t he p atie nt t o M F N S at 
V 1.  P atie nts m ust use n as al m o met as o ne at le ast 2 0 0 mc g/ d ay, or e q uiv ale nt, f or at le ast 2 8 
d ays bef ore r a n d o miz ati o n, w hic h c a n i ncl u de 2 1 d ays pri or t o scree ni n g wit h s u p p ortive 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 8  of 9 7  
d oc u me nt ati o n. R u n-i n c a n be 7- 3 1 d ays wit h t he c o m pli a nce det er mi ne d i n t he week pri or 
t o d osi n g 
5.  Patie nts willi n g t o e nter p atie nt d iar y dail y s y m pt o m assess me nts a n d mai ntai n sta ble d osi n g 
wit h M F N S wit h a c o m plia nce of at least 7 0 % i n t he 7 da ys prece di n g ra n d o mizati o n.  N ote: 
7 0 % c o m pli a nce will be c alc ul ate d as at le ast 5 of 7 D A Y S of M F N S use i n t he 7 d ays pri or 
t o r a n d o miz ati o n A N D at le ast 5 of 7 D A Y S of N C S c o m pleti o n i n t he p atie nt di ary i n t he 7 
d ays pri or t o r a n d o miz ati o n.  
6.  Male patie nts w h o ar e n o nsterilize d a n d se x u all y acti ve wit h a fe mal e part n er of 
c hil d beari n g p ote ntial a gree t o use hi g hl y effecti ve c o ntrace pti o n fr o m ra n d o mizati o n u ntil 8 
wee ks after last d ose . 
7.  Fe male p atie nts of c hil d b eari n g p ote ntial w h o are se x uall y acti ve wit h a n o nsterilize d male 
part ner s h o ul d ha v e a c o nfir me d ne gati ve s er u m beta- h u ma n c h ori o nic g o na d otr o pi n test at 
Visit 1 a n d a grees t o use hi g hl y effecti ve c o ntrace pti o n fr o m si g ni n g of i nf or me d c o nse nt 
t hr o u g h o ut t he d urati o n of t he st u d y a n d f or 8 w ee ks after last d ose. 
8.  Patie nt a ble t o rea d a n d u n dersta n d a n d willi n g t o si g n t he i nf or me d c o nse n t f or m (I C F) 
pri or t o a n y st u d y relate d pr oce d ur es bei n g perf or me d. 
9.  Willi n g a n d a ble t o c o m pl y wit h st u d y visits a n d st u d y-relate d pr oce d ures, i n t he o pi ni o n of 
t he I n v esti gat or. 
5. 2  
E xcl usi o n Criteri a  
A patie nt w h o meets a n y of t he f oll o wi n g criteri a will be i neli gi ble t o partici pate i n t his st u d y:  
1 0.  Patie nts u na ble t o use M F N S . 
1 1.  Patie nts w h o are ta ki n g or ha ve ta k e n t he f oll o wi n g pr o hi bite d t hera pies as s pecifie d:  
a. S yste mic ster oi ds wit hi n 2 8 da ys pri or t o scree ni n g 
b.  Ot her  n o n bi ol o gic i n vesti gati o nal dr u gs wit hi n 6 0 da ys ( or 5 half-li ves, w hi c he ver is 
l o n ger) of scree ni n g, 
c. I ntr a nasal c ortic oster oi d dr o ps or C S -a d mi nisteri n g de vices (e g, O pti N ose de vice or 
ste nts) wit hi n 2 8 da ys pri or t o scree ni n g, 
d.  N o n-ster oi dal i m m u n os u p pressa nts ( e g, c ycl os p ori ne, met h otre xate, azat hi o pri ne, 
m yc o p he n olate, sir oli m us, tacr oli m us) wit hi n 6 0 da ys or 5 half-li ves, w hic he ver is 
l o n ger, of scr ee ni n g, 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 3 9  of 9 7  
e. A n y m o n ocl o nal a nti b o d y t hera p y ( e g, be nraliz u ma b, me p oliz u ma b , o maliz u ma b, 
resil uz u ma b, d u pil u ma b) or i n vesti gati o nal bi ol o gic dr u g f or ast h ma or ot her diseases 
wit hi n 6 0 da ys or 5 half-li ves, w hic he ver is l o n ger, of scree ni n g 
f. Le u k otrie ne a nta g o nists/ m o difiers wit hi n 7 da ys pri or t o scree ni n g f or patie nts w h o were 
n ot o n c o nti n u o us treat me nt f or ≥ 3 0 da ys pri or t o scree ni n g 
g.  Aller ge n i m m u n ot hera p y f or patie nts w h o w ere n ot o n  mai nte na nce  treat me nt f or at least 
9 0 da ys pri or t o scr ee ni n g 
h.  A n y mar kete d n o n bi ol o gic dr u g t hat m o d ulates t y pe 2 c yt o ki nes (e g, s u plat ast t osilate) 
wit hi n 3 0 da ys or 5 half-li ves ( w hic he v er is l o n ger) pri or t o scree ni n g 
i. A n y i n vesti gati o nal s mall m olec ule dr u g or treat me nt wit hi n 1 6 wee ks or 5 half- li ves 
( w hic he ver is l o n ger) pri or t o scree ni n g 
1 2.  Patie nts  w h o  di d n ot res p o n d fa v ora bl y t o pre vi o us d u pil u ma b treat me nt (e g, t hera p y 
fail ure or p atie nt e x peri e nce d a n a d vers e reacti o n t o treat me nt). 
1 3.  Patie nts w h o ha ve u n der g o ne a n y nasal s ur ger y (i ncl u di n g p ol y pect o m y) wit hi n 6 
m o nt hs bef ore scree ni n g; or ha ve a hist or y of si n us or nasal s ur ger y m o dif yi n g t he 
str uct ure of t he n os e s uc h t hat assess me nt of N P S is n ot p ossi ble or ha ve ha d 
u nc o ntr olle d e pista xis re q uiri n g s ur gical or pr oce d ural i nter ve nti o n, i ncl u di n g nasal 
pac ki n g. 
1 4.  Patie nts wit h c o n diti o ns/c o nc o mita nt diseases ma ki n g t he m n o n e val ua ble at scree ni n g 
or f or t he pri mar y efficac y e n d p oi nt s uc h as: a ntr o c h oa nal p ol y ps, nasal se ptal de viati o n 
t hat w o ul d occl u de at least 1 n ostril, ac ute si n usitis, nasal i nfecti o n or u p p er res pirat or y 
i nfecti o n at scr ee ni n g or wit hi n 2 wee ks bef ore scree ni n g, o n g oi n g r hi nitis 
me dica me nt osa; k n o w n or s us pecte d dia g n osis of c ystic fi br osis; c hr o nic gra n ul o mat o us 
disease a n d gr a n ul o mat o us vasc ulitis, gra n ul o mat osis wit h p ol ya n giitis ( We ge ner’s 
Gra n ul o mat osis), e osi n o p hilic gra n ul o mat o us wit h p ol ya n giitis ( C h ur g- Stra uss 
s y n dr o me), Y o u n g’s s y n dr o me, pri mar y d ys ki neti c ciliar y s y n dr o mes (e g, Karta ge n er’s 
s y n dr o me) or ot her d ys ki netic ciliar y s y n dr o mes. 
1 5.  Si g ns or a C T sca n s u g gesti ve of Aller gic F u n g al R hi n osi n usitis. 
1 6.  Patie nts wit h c o - m or bi d ast h ma are e xcl u de d if: 
a. F E V 1 ≤ 5 0 % of n or mal pre dicte d val u e . 
O R  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 0  of 9 7  
b.  A n e xacer bati o n wit hi n 9 0 da ys pri or scree ni n g t h at re q uire d h os pitalizati o n ( > 2 4 
h o urs). 
O R  
c. Are o n a d ail y d ose of i n hale d c ortic oster oi ds (I C S) hi g her t ha n 1 0 0 0 mc g 
fl uticas o ne pr o p i o nate or t he e q ui vale nt. 
1 7.  K n o w n or s us pect e d hist or y of i m m u n os u p pressi o n, i ncl u di n g hist or y of i n vasi ve 
o p p ort u nistic i nfecti o ns, s uc h as as per gill osis, c occi di oi d o m yc osis, hist o plas m osis, 
h u ma n i m m u n o deficie nc y vir us ( HI V), listeri osis, p ne u m oc yst osis, or t u berc ul osis, 
des pite i nfecti o n res ol uti o n; or u n us uall y fre q ue nt, rec urre nt or pr ol o n g e d i nfecti o ns. 
T u berc ul osis testi n g w o ul d be perf or m e d o n a c o u ntr y b y c o u ntr y basis acc or di n g t o 
l ocal g ui deli nes if re q uir e d b y re g ulat or y a ut h orities or et hics c o m mittees . 
1 8.  Patie nts w h o ha ve acti ve He patitis B, He patitis C or HI V i nfecti o ns as deter mi ne d b y 
p ositi ve res ults at Scree ni n g f or he patitis B s urface a nti ge n  ( H Bs A g), or he patitis B c ore 
a nti b o d y ( H Bc A b) or h e patitis C vir us a nti b o d y ( H C VA b ); or p ositi ve HI V ser ol o g y. 
N ote: P atie nts w h o test p ositive f or H Bc A b, ne g ati ve f or H Bs A g a n d s u bse q ue ntly 
c o nfir me d p ositive f or H Bs A b, i n dic ati n g res olve d n at ur al i nfecti o n (c o nfir me d by 
ne g ative H B V -D N A) , m a y p artici p ate. P atie nts wit h p ositive H C V A b m ay p artici p ate if 
s u bse q ue nt vir al l o a d is c o nfir me d ne g ative. 
1 9.  A hel mi nt h parasitic i nfecti o n dia g n ose d wit hi n 2 4 wee ks pri or t o t he d ate of i nf or me d 
c o nse nt t hat has n ot bee n treate d wit h, or h as faile d t o res p o n d t o, sta n dar d of care 
t hera p y 
2 0.  E vi de nce of i nf ecti o n r e q uiri n g treat me nt wit h s yste mic a nti bacteri als, a nti virals, 
a ntif u n gals, a nti parasitics, or a nti pr ot oz oals wit hi n 7 da ys bef ore baseli ne , or si g nifica nt 
v iral i nfecti o ns wit hi n 1 4 da ys bef ore scree ni n g t h at ma y n ot ha ve recei v e d a nti viral 
treat me nt. 
2 1.  Li ve, atte n uate d v acci n ati o ns wit hi n 2 8 da ys pri or t o scree ni n g or pla n n e d li ve, 
atte n uate d vacci nati o ns d uri n g t he st u d y. 
2 2.  Pre g na nt or i nte nt t o bec o me pre g na nt d uri n g t he st u d y, or breast- fee di n g w o me n. 
2 3.  A n y dis or der, i ncl u di n g, b ut n ot li mite d t o, car di o vasc ular, g astr oi ntesti nal, he patic, 
re nal, ne ur ol o gical, m usc ul os keletal, i nfecti o us, e n d ocri ne, meta b olic, h ae m at ol o gical, 
ps yc hiatric, or maj or p h ysic al i m pair me nt t hat is n ot sta ble i n t he o pi ni o n of t he 
i n vesti gat or a n d ma y affect t he safet y of t h e patie nt t hr o u g h o ut t he st u d y, or i nfl ue nce 
t he fi n di n gs of t he st u dies or t heir i nter pret ati o ns, or i m pe de t he patie nt’s a bilit y t o 
c o m plete t he e ntire d ur ati o n of st u d y. 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 1  of 9 7  
2 4.  A n y cli nicall y si g nifica nt a b n or mal fi n di n gs i n p h ysical e xa mi nati o n, vital si g ns, safet y 
la b tests d uri n g scree ni n g/r u n-i n peri o d, w hic h i n t he o pi ni o n of t he i n vesti gat or, ma y 
p ut t he patie nt at ris k beca use of t heir p artici pati o n i n t he st u d y, or ma y i nfl ue nce t he 
res ults of t he st u d y, or t he patie nt’s a bilit y t o c o m plete e ntire d urati o n of t he st u d y 
2 5.  Ha ve a n y of t he f oll o wi n g la b orat or y a b n or malities at Scree ni n g:  
a. E osi n o p hils > 1 5 0 0 cells/ m m 3 ( or 1. 5 x 1 0 9/ L) 
b.  Platelets < 1 0 0 0 0 0 cells/ m m 3 ( or 1 0 0 x 1 09/ L) 
c. Creati ne p h os p h o ki nase ( C P K) > 1 0 u p per li mit of n or mal ( U L N ) 
d.  Ala ni ne a mi n otra nsf eras e ( A L T) > 2. 5  ti mes t he U L N  
e. As partate a mi n otra nsferase ( A S T) ≥ 2. 5  ti mes t he U L N  
f. Bilir u bi n ≥ 2 ti mes t he U L N  
2 6.  Hist or y of alc o h ol or dr u g a b use wit hi n 1 2 m o nt hs pri or t o t he date of i nf or me d c o nse nt 
2 7.  A n aller g y t o L- histi di ne, tre hal ose or T wee n ( p ol ys or bate) 8 0 or a hist or y of a s yste mic 
h y perse nsiti vit y reacti o n, ot her t ha n l ocalize d i njecti o n site reacti o n, t o a n y bi ol o gic 
dr u g 
2 8.  Pla ns t o u n der g o a n y s ur gical pr oce d ures re q uiri n g ge neral a nest hesia d uri n g t he st u d y.  
2 9.  Hist or y of ca n cer: Patie nts w h o ha ve ha d b asal cell carci n o ma, l ocalize d s q ua m o us cell 
carci n o ma of t he s ki n, or i n sit u carci n o ma of t he cer vi x are eli gi ble pr o vi de d t hat t he 
patie nt  is i n re missi o n a n d c urati ve t hera p y w as c o m plete d at least 1 2 m o nt hs pri or t o 
t he date i nf or me d c o nse nt. N ote: P atie nts w h o h ave h a d ot her m ali g n a ncies are eli gi ble 
pr ovi de d t h at t he p atie nt is i n re missi o n a n d c ur ative t her a py w as c o m plete d at le ast 5 
ye ars pri or t o t he d ate i nf or me d c o nse nt. 
5. 3  
R a n d o mis ati o n Pr oce d ures  
At Scree ni n g ( Visit 1), p ote ntial st u d y patie nts will be assi g ne d a patie nt n u m ber b y site pers o n nel. T he 
patie nt n u m ber is a 6- di git n u m ber c o nsisti n g of a si n gle di git c o u ntr y c o de, a 2- di git site i de ntifier, a n d 
a se q ue ntial 3- di git patie nt n u m ber  (e g, 3- 0 2-0 0 1 f or t he first scree ne d patie nt i n c o u ntr y 3 at site 0 2, 
3- 0 5- 0 0 2 f or t he sec o n d scree ne d patie nt i n c o u ntr y 3 at site 0 5).  
All patie nt s eli gi ble f or  t he d o u ble- bli n d p hase of t he st u d y will be ra n d o ml y assi g ne d t o recei ve 1 of 
3 treat me nts: C B P - 2 0 1 3 0 0 m g  S C e ver y 2 wee ks , C B P- 2 0 1 3 0 0 m g  S C e ver y 4 wee ks  or v ol u me -
matc he d place b o e ver y 2 wee ks. 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 2  of 9 7  
A p pr o xi matel y 5 0 % of t he ra n d o mise d patie nts will be tar gete d t o ha ve c o m or bi d ast h ma, defi ne d as 
≥1 2 % re versi bilit y a n d use of I C S < 1 0 0 0 u g/ da y. N ote:  T his m ay be de m o nstr ate d wit h a d oc u me nte d 
me dic al hist ory  of > 1 2 % reversi bility  (i m pr ove me nt i n F E V1) wit hi n t he previ o us 1 2 m o nt hs or m ay be 
de m o nstr ate d at scree ni n g i n t he cli nic.  P atie nts m ay re pe at t he reversi bility o n a differe nt d ay if it is 
deter mi ne d t h at a l o n ger br o nc h o dil at or w as h o ut peri o d is nee de d.  
At least 5 0 % of t he ra n d o mize d patie nts wi ll be tar gete d t o  ha ve t y pe 2 i nfla m mati o n mar ke d b y baseli ne 
bl o o d e osi n o p hil c o u nt ≥ 3 0 0  cells/ μ L As t his is o nly a t ar get, t here will be n o h ar d st o p t o recr uit me nt 
b ut w he n t he st u dy be gi ns t o a p pr o ac h 3 5 % p atie nts wit h e osi n o p hils < 2 9 9 cells/ μ L, sites will be 
e nc o ur a ge d t o i de ntify m ore p atie nts wit h > 3 0 0 cells/ μ L.  
As patie nt s q ualif y f or ra n d o mizati o n, t he y will be assi g ne d t o treat me nt b y Interacti ve V oice / We b 
Res p o nse S yste m . T he  ra n d o m treat me nt assi g nme nts will be d o ne i n a 1: 1 : 1 rati o. All ocati o n of eac h 
treat me nt will be bala nce d  b y t he prese nce of c o m or bi d ast h ma.  
•  
Recr uit me nt of N P patie nt s wit h o ut c o - m or bi d ast h ma will st o p w he n a p pr o xi matel y 6 6 patie nts 
wit h o ut ast h ma are ra n d o mize d, a n d  
•  
Patie nts wit h c o - m or bi d ast h ma will c o nti n ue t o be ra n d o mize d t o c o m plete a t otal n u m ber of 1 4 7 
ra n d o mize d N P patie nts. 
N ote: A scree n-f aile d p atie nt m ay be  re-scree ne d at t he I nvesti g at or’s discreti o n,  at le ast 2 8 d ays after 
t he ori gi n al scree ni n g d ate.  If re-scree ne d, t he p atie nt s h o ul d be c o nsi dere d u n der a ne w p atie nt 
n u m ber .    
5. 4  
Bli n di n g P r oce d ures  
T his is a d o u ble - bli n d st u d y; neit her t he patie nts n or t he I n vesti gat or will be a ware of t he treat me nt 
assi g n me nt f or t he patie nts . Bli n di n g will be mai ntai ne d t hr o u g h o ut t he st u d y b y t he use of acti ve a n d 
place b o treat me nt vials of si milar a p peara nce a n d v ol u me -matc he d d osi n g . 
Wit h t h e e xce pti o n of t he  pers o n res p o nsi ble f or  pre pari n g a n d a d mi nisteri n g t he ra n d o mizati o n c o des, 
t he staff of  t he t hir d-part y  ve n d or res p o nsi ble f or  pac ka gi n g st u d y dr u g, t he staff of t hir d part y ve n d ors 
pr ocess i n g t he P K sa m ples a n d data, a n d q ualit y ass ura nce a u dit ors w here necessar y, all cli nical a n d 
n o ncli nical staff will re mai n bli n de d t o t he treat me nt all ocati o n u ntil after t he st u d y data base is l oc ke d  
a n d has c o m plete d u n bli n di n g.  
Bli n di n g, u n bli n di n g, a n d ma na ge me nt of t he ra n d o misati o n c o des will pr ocee d acc or di n g t o a n 
a p pr o priate ma n ual pr o vi de d se paratel y. 
5. 5  
Re as o ns f or P atie nt Wit h dr a w al 
All patie nts ha ve t he ri g ht t o wit h dra w fr o m treat me nt or fr o m t he st u d y at a n y ti me, f or a n y reas o n, 
wit h o ut prej u dice. T he I n vesti gat or ma y, b ut is n ot re q uire d t o,  disc o nti n ue a n y patie nt’s st u d y dr u g 
treat me nt f or reas o ns of n o n-efficac y of t he st u d y dr u g or ot her reas o ns. T he I n vesti gat or will n otif y t he 
C R O a n d S p o ns or of all decisi o ns re gar di n g wit h dra wal of t he patie nt fr o m treat me nt or fr o m t he st u d y . 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 3  of 9 7  
Patie nts will be e nc o ura ge d t o re mai n i n t he st u d y a n d o n treat me nt s o l o n g as t here are n o o verarc hi n g 
safet y c o ncer ns a b o ut t heir c o nti n ue d partici pati o n. 
5. 6  
R hi n osi n usi tis or Ast h m a  E x acer b ati o n as Wit h dr a w al Criteri o n  
If t here are safet y c o ncer ns, t he I n vesti gat or ma y, b ut is n ot re q uire d t o, disc o nti n ue t he patie nt’s st u d y 
dr u g treat me nt f or lac k of efficac y if t he patie nt e x perie nces a r hi n osi n usitis e xacer bati o n t hat  res ults i n 1 
or m ore of t he f oll o wi n g:  
•  
H os pitalizati o n d ue t o r hi n osi n usitis  
O R  
•  
Tr eat me nt wit h s yste mic ster oi ds  f or > 5 da ys  
O R  
•  
Decisi o n t o pr ocee d t o s ur ger y f or re m o val of nasal p ol y ps. 
T he I n vesti gat or ma y, b ut is n ot re q uire d t o, disc o nti n ue t he patie nt’s st u d y dr u g treat me nt f or lac k of 
efficac y if t he patie nt e x perie nces a n ast h ma e xacer bati o n as defi ne d as a deteri orati o n of ast h ma t hat 
res ults i n 1 of t he f oll o wi n g:  
•  
Ast h ma re q uiri n g  pr ol o n ge d treat me nt i ncrease of a p pr o xi matel y 4 ti mes t he baseli ne d ose of I C S or 
t he p h ysicia n- prescri be d a d diti o n of a d diti o nal c o ntr ollers 
O R  
•  
H os pitalizati o n d ue t o ast h ma 
E ve n if t he patie nt’s st u d y dr u g treat me nt is disc o nti n ue d d ue t o treat me nt fail ure, t he patie nt s h o ul d be 
e nc o ura ge d t o re mai n i n t he st u d y a n d all st u d y pr oce d ures s h o ul d be c o m plete d u nless t he patie nt 
wit h dra ws c o nse nt or is l ost t o f oll o w- u p. 
N ote:  P atie nt s m ay ex perie nce sy m pt o ms of decre ase d ast h m a c o ntr ol t h at d o n ot  re ac h t he level of t he 
ex acer b ati o n criteri a b ut w arr a nt c o ncer n fr o m t he cli nic al site.  T hese “l oss of c o ntr ol eve nts ” are 
defi ne d as f oll o ws: A n i ncre ase of 6  or m ore reliever occ asi o ns ( 1 p uff  = reliever occ asi o n) i n a 2 4- h o ur 
peri o d f or ≥ 2 c o nsec utiv e d ays al o n g wit h decre ase d pe ak fl o w will f ulfill t he defi niti o n of “ l oss of 
ast h m a c o ntr ol .” L oss of ast h m a c o ntr ol eve nts s h o ul d be fl a g ge d i n t he e C R F a n d m ay be f urt her 
rec or de d as a n A E ( w orse ni n g of s pecific sy m pt o ms). P atie nts ex perie nci n g a l oss o f ast h m a c o ntr ol m ay 
re m ai n i n t he st u dy b ut t he p atie nt s h o ul d be i nstr ucte d t o c o nt act t he site f or m a n a ge me nt of sy m pt o ms. 
5. 7  
Ot her Re as o ns as Wit h dr a w al Criteri a  
T he I n vesti gat or ma y als o disc o nti n ue a patie nt’s st u d y dr u g treat me nt or st u d y partici pati o n f or reas o ns 
i ncl u di n g, b ut n ot li mite d t o, t he f oll o wi n g: A Es dee me d b y t he I n vesti gat or t o precl u de c o nti n ue d st u d y 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 4  of 9 7  
partici pati o n, pr ot oc ol vi olati o n s, wit h dra wal of c o nse nt, l oss t o f oll o w- u p, deat h of patie nt , or 
ter mi nati o n of t he st u d y b y t he I n vesti gat or or S p o ns or. 
Patie nts w h o de vel o p a n y relate d gra de 2 or hi g her car di o vasc ular, res pirat or y, or o p ht hal mic T E A E or 
a n y relate d gra de 3 or hi g her T E A E i n v ol vi n g ot her or ga n s yste ms m ust be disc o nti n ue d fr o m f urt her 
st u d y dr u g treat me nt a n d m o nit ore d u ntil res ol uti o n or sta bilizati o n. 
5. 8  
H a n dli n g of Wit h dr a w als  
W he n a patie nt is wit h dra w n fr o m st u d y dr u g treat me nt or is wit h dra w n fr o m t he st u d y, t he reas o n(s) f or 
wit h dra wal m ust be rec or de d b y t he I n vesti gat or i n t he patie nt’s me dical rec or d  a n d e C R F.  
W he ne ver p ossi ble, patie nts w h o wit h dra w fr o m t he st u d y pre mat urel y will u n der g o all e n d- of -st u d y 
assess me nts, ie , Earl y Ter mi nati o n Visit pr oce d ures. Pati e nts w h o fail t o ret ur n f or fi nal assess me nts will 
be c o ntacte d b y t he site i n a n atte m pt t o ha ve t he m c o m pl y wit h t he pr ot oc ol. T he o nl y e xce pti o n t o t his  
sc he d ule is if patie nts wit h dra w fr o m t he st u d y pri or t o ra n d o mizati o n at Visit  2. If a patie nt wit h dra ws  
or is wit h dra w n fr o m t he st u d y pri or t o st u d y dr u g  treat me nt, t his will be c o nsi dere d a scree n fail ure a n d 
o nl y t he f oll o wi n g i nf or mati o n nee d be c ollecte d at t heir last visit: A Es , re vie w of c o nc o mita nt 
me dicati o ns , ret ur n of patie nt dia r y, re vie w of diar y data. 
It is vital t o o btai n f oll o w- u p data or c o nti n ue visits f or a n y patie nt wit h dra w n fr o m st u d y dr u g treat me nt 
beca use of a n A E or S A E . Ever y eff ort m ust be ma de t o u n derta ke pr ot oc ol -s pecifie d safet y f oll o w- u p 
pr oce d ures. If a patie nt is disc o nti n ue d fr o m t he st u d y dr u g treat me nt beca use of a n A E, t his e ve nt will 
be f oll o we d u ntil res ol uti o n or sta bilizati o n. 
W he n p ossi ble, last o bser vati o ns of cli nical data will be carrie d f or war d f or a nal ysis fr o m all patie nts 
w h o are wit h dra w n fr o m st u d y dr u g treat me nt pre mat urel y. 
5. 9  
Re pl ace m e nts  
Patie nt s w h o wit h dra w or are wit h dra w n fr o m t he st u d y will n ot be re place d.  
5. 1 0  S p o ns or’s Ter mi n ati o n of St u d y  
Alt h o u g h t he S p o ns or has e ver y i nte nti o n of c o m pleti n g t he st u d y, t he S p o ns or reser ves t he ri g ht t o 
disc o nti n ue t he st u d y at a n y ti me f or cli nical or a d mi nistrati ve reas o ns. 
 
6  
S T U D Y VI SI T S  
Patie nts are re q ueste d t o dela y usi n g br o n c h o dilat ors pri or t o eac h visit w here s pir o metr y is perf or me d 
( S A B A f or at least 6 h o urs, t wice-dail y L A B As or c o m bi nati o n pr o d ucts f or at least 1 2 h o urs, o nce - dail y 
br o nc h o dilat ors, or c o m bi nati o n pr o d ucts f or at least 2 4 h o urs). 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 5  of 9 7  
6. 1  
Sc ree ni n g ( Visit 1), St u d y D a y - 3 1 t o - 1 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  C ollect si g ne d a n d date d I C F, Healt h I ns ura n ce P orta bilit y a n d Acc o u nta bilit y Act (HI P A A ) 
F or m , a n d E x p eri me ntal Researc h S u bject ’s Bill of Ri g hts (if a p pr o priate f or t hat re gi o n). 
•  Recei ve a 6- di git patie nt n u m ber 
•  Re vie w  i ncl usi o n a n d e x cl usi o n criteria 
•  Rec or d me dical h ist or y a n d de m o gra p hics 
•  Vital si g n  meas ure me nt s 
•  Rec or d hei g ht a n d b o d y wei g ht  
•  Re vie w a n d  r ec or d pri or a n d c o nc o mita nt me dicati o ns  
•  C T Sca n  ( o nl y re q uire d f or s u bjects t hat are e nr oll e d at St u d y Sites  t hat are a p pr o ve d a n d 
q ualifie d t o perf or m C T Sca ns) 
•  N C S  assess me nt  
•  V A S -r hi n osi n usitis assess me nt  
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  Nasal e n d osc o p y a n d N P S sc ori n g 
•  S pir o metr y  ( Baseli ne p ul m o nar y f u ncti o n test) a n d re versi bilit y testi n g if d oc u me ntati o n of 
≥1 2 % re versi bilit y is n ot a vaila ble i n t he pri or 1 2 m o nt hs 
•  C o m plete p h ysical e xa mi nati o n   
•  1 2- lea d E C G  
•  He patitis & HI V Scree ns  
•  Pre g na nc y test ( Bl o o d c ollecti o n f or pre g n a nc y test f or fe male p atie nts of c hil d beari n g 
p ote ntial at Visit  1 t he n uri ne pre g n a nc y tests at s u bse q ue nt visits) 
•  Safet y la b orat or y t ests ( h e mat ol o g y, ser u m c he mistr y, uri nal ysis) 
•  Dis pe nse a n d i nstr uct eli gi ble patie nts o n t he pr o p er use of t he h a n d hel d de vice t o ca pt ure 
N PI F , patie nt diar y of s y m pt o ms (r hi n orr hea et c), c o nc o mita nt me dicati o n use. 
•  Sites ma y als o pr o vi de M F N S f or re q uire d c o nc o mita nt use 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns  (al b uter ol/sal b uta m ol) t o ast h ma patie nts , 
if nee de d. I nstr uct patie nts t o d oc u me nt t he use of al b uter ol/sal b uta m ol  i n t heir patie nt diar y. 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 6  of 9 7  
•  A E  re vie w a n d rec or di n g 
Scree n fail ures s h o ul d be rec or de d i n t he e C R F b ut t he y d o n ot nee d t o u n der g o all assess me nts liste d f or 
t he Earl y Ter mi nati o n Visit. T he Earl y Ter mi nati o n Visit assess me nts s h o ul d be perf or me d wit h patie nts 
if t he y wit h dra w fr o m t he st u d y after ra n d o mizati o n.  
 
6. 2  
B aseli ne Visit ( Visit 2 ), St u d y D a y 1  
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble:  
•  Re vie w patie nt diar y a n d N PI F data; retrai n patie nt o n pr o per diar y us e, if n ecessar y 
•  Re vie w a n d r ec or d pri or  a n d c o nc o mita nt me dicati o n 
•  Vital si g n meas ure me nt  
•  Rec or d wei g ht 
•  N C S assess me nt  
•  E Q - 5 D- 5 L q u esti o n naire 
•  V A S -r hi n osi n usitis assess me nt 
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  U P SI T assess me nt of s mell  
•  Nasal e n d osc o p y a n d N P S sc ori n g 
•  P ul m o nar y f u ncti o n tests ( S pir o metr y) f or p atie nts wit h c o m or bi d ast h ma o nl y 
•  Healt hcare Res o ur ce Utilizati o n Q uesti o n naire  
•  Brief p h ysical e x a mi nati o n  
•  1 2- lea d E C G 
•  Uri ne pre g n a nc y test f or fe male patie nt s of c hil d beari n g p ote ntial 
•  Safet y la b orat or y t ests ( h e mat ol o g y, ser u m c he mistr y, uri nal ysis) 
•  P K bl o o d sa m ple ( pre d os e )  
•  A D A  bl o o d sa m ple ( pr e d ose) 
•  P D  bl o o d sa m ple ( pre d os e) 
•  Verif y eli gi bilit y.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 7  of 9 7  
•  Ra n d o mizati o n 
•  A d mi nister st u d y dr u g 
•  Injecti o n site assess me nt   
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts  wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 3  
Visit 3 ( St u d y D a y 8 ± 3 d a ys / Wee k 1) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es t o c o nc o mita nt me dicati o ns  
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  N C S assess me nt  
•  V A S -r hi n osi n usitis assess me nt 
•  S N O T -2 2 assess me nt  
•  T N S S  assess me nt  
•  U P SI T assess me nt of s mell  
•  He mat ol o g y a n d ser u m c he mistr y tests 
•  P K bl o o d sa m ple ( pre d os e) 
•  P D bl o o d sa m ple ( pre d os e) 
•  Re vie w patie nt diar y a n d N PI F  data  
•  I njecti o n site assess me nt fr o m t he pre vi o us i njecti o n 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 4  
Visit 4 ( St u d y D a y 1 5 ± 3 d a ys / Wee k 2) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w, if p ossi ble : 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 8  of 9 7  
•  Re vie w a n d r ec or d c ha n g es t o c o nc o mita nt me dicati o ns  
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  N C S assess me nt  
•  V A S -r hi n osi n usitis assess me nt 
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  U P SI T assess me nt of s mell  
•  Nasal e n d osc o p y a n d N P S sc ori n g 
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 5  
Visit 5 ( St u d y D a y 2 9 ± 3 d a ys / Wee k 4) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es t o c o nc o mita nt me dicati o ns  
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  N C S assess me nt  
•  E Q - 5 D- 5 L Q u esti o n naire 
•  V A S -r hi n osi n usitis assess me nt 
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  P ul m o nar y f u ncti o n tests ( S pir o metr y) f or p atie nts wit h c o m or bi d ast h ma o nl y  
•  H ealt hcare r es o urce utilizati o n q uesti o n naire 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 4 9  of 9 7  
•  U P SI T assess me nt of s mell  
•  Uri ne pre g n a nc y test f or fe male patie nts of c hil d beari n g p ote ntial 
•  He mat ol o g y a n d ser u m c he mistr y tests 
•  P K bl o o d sa m ple ( pre d os e) 
•  P D bl o o d sa m ple ( pr e d os e)  
•  A D A  bl o o d sa m ple ( pr e d ose) 
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts  wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 6  
Visit 6 ( St u d y D a y 4 3 ± 3 d a ys / Wee k 6) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns  
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts  wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 7  
Visit 7 ( St u d y D a y 5 7 ± 3 d a ys / Wee k 8) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w: 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 0  of 9 7  
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  N C S assess me nt  
•  V A S -r hi n osi n usitis assess me nt 
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  P ul m o nar y f u ncti o n tests ( S pir o metr y) f or p atie nts wit h c o m or bi d ast h ma o nl y 
•  Healt hcare r es o urce utilizati o n q uesti o n naire 
•  Nasal e n d osc o p y a n d N P S sc ori n g 
•  Uri ne pre g n a nc y test f or fe male patie nts of c hil d beari n g p ote ntial 
•  He mat ol o g y a n d ser u m c he mistr y tests 
•  Re vie w patie nt  diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts  wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 8  
Visit 8 ( St u d y D a y 7 1 ± 3 d a ys / Wee k 1 0) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w, if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns 
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts  wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 1  of 9 7  
6. 9  
Visit 9 ( St u d y D a y  8 5 ± 3 d a ys/ Wee k 1 2) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns 
•  Vital si g n meas ure me nt s 
•  Rec or d b o d y wei g ht 
•  Brief p h ysical e x a mi nati o n  
•  N C S assess me nt  
•  E Q - 5 D-5 L assess me nt  
•  V A S -r hi n osi n usitis assess me nt  
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  P ul m o nar y f u ncti o n test ( S pir o metr y) f or patie nts wit h c o m or bi d ast h ma o nl y 
•  U P SI T assess me nt of s mell  
•  Healt hcare r es o urce utilizati o n  q uesti o n naire 
•  1 2- lea d E C G 
•  Uri ne pre g n a nc y test f or fe male patie nts of c hil d beari n g p ote ntial 
•  Safet y la b orat or y s a m ples ( he mat ol o g y, ser u m c h e mistr y, uri nal ysis) 
•  P K  bl o o d sa m ple (pre d os e) 
•  P D bl o o d sa m ple ( pre d os e) 
•  A D A bl o o d sa m ple ( pr e d ose) 
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts  wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 2  of 9 7  
6. 1 0  Visit 1 0 ( St u d y D a y 9 9 ± 3 d a ys / Wee k 1 4) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns 
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts  wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 1 1  Visit 1 1 ( St u d y D a y 1 1 3 ± 3 d a ys / Wee k 1 6) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es i n  c o nc o mita nt me dicati o ns 
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  N C S assess me nt  
•  V A S -r hi n osi n usitis assess me nt 
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  Nasal e n d osc o p y a n d N P S sc ori n g 
•  Healt hcare r es o urce utilizati o n  q uesti o n naire 
•  Uri ne pre g n a nc y test f or fe male patie nts of c hil d beari n g p ote ntial 
•  He mat ol o g y a n d ser u m c he mistr y tests 
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 3  of 9 7  
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 1 2  Visit 1 2 ( St u d y D a y 1 2 7 ± 3 d a ys / Wee k 1 8) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or d er gi ve n bel o w, if p ossi ble : 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns 
•  Brief p h ysical e x a mi nati o n  
•  Vital si g n meas ure me nts  
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 1 3  Visit 1 3 ( St u d y D a y 1 4 1 ± 3 d a ys / Wee k 2 0) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w, if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns 
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  N C S assess me nt  
•  V A S -r hi n osi n usitis assess me nt 
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  Healt hcare r es o urce utilizati o n  q uesti o n naire 
•  Uri ne pre g n a nc y test f or fe male patie nts of c hil d beari n g p ote ntial 
•  He mat ol o g y a n d ser u m c he mistr y tests 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 4  of 9 7  
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts  wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 1 4  Visit  1 4 ( St u d y D a y 1 5 5 ± 3 d a ys/ Wee k2 2) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns 
•  Vital si g n meas ure me nts  
•  
Brief p h ysical e xa m  
•  Re vie w patie nt diar y a n d N PI F data  
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt  
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts  wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 1 5  Visit 1 5 ( E n d of Tre at m e nt) ( St u d y D a y 1 6 9 ± 3 d a ys/ Wee k 2 4) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es i n of c o nc o mita nt me dicati o ns  
•  Vital si g n  meas ure me nt s 
•  Brief p h ysical e x a m  
•  Re vie w of patie nt diar y a n d N PI F data  
•  Rec or d b o d y wei g ht 
•  C T sca n ( o nl y re q uir e d f or s u bjects t hat are e nr oll e d at St u d y Sites  t hat are a p pr o ve d a n d 
q ualifie d t o perf or m C T Sca ns) 
•  N C S assess me nt  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 5  of 9 7  
•  E Q - 5 D-5 L assess me nt  
•  V A S -r hi n osi n usitis assess me nt  
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  U P SI T assess me nt of s mell  
•  Nasal e n d osc o p y a n d N P S sc ori n g 
•  P ul m o nar y F u ncti o n Tests ( S pir o metr y ) f or p atie nts wit h c o m or bi d ast h ma o nl y 
•  H ealt hcare r es o urce utilizati o n q uesti o n naire 
•  1 2- lea d E C G 
•  Uri ne pre g n a nc y test  
•  Safet y la b orat or y s a m ples ( he mat ol o g y, ser u m c h e mistr y, uri nal ysis) 
•  P K bl o o d sa m ple (pre d os e) 
•  P D bl o o d sa m ple ( pre d os e) 
•  A D A bl o o d sa m ple ( pr e d ose) 
•  A d mi nister st u d y dr u g 
•  I njecti o n site assess me nt 
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol) t o patie nts wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 1 6  Visit 1 6 ( St u d y D a y 1 9 7 ± 5 d a ys / Wee k 2 8) 
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or d er gi ve n bel o w, if p ossi ble : 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns 
•  Vital si g n meas ure me nts  
•  Brief p h ysical e x a mi nati o n  
•  Re vie w patie nt diar y a n d N PI F data  
•  He mat ol o g y a n d ser u m c he mistr y tests 
•  P K sa m ple  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 6  of 9 7  
•  I njecti o n site assess me nt ( pre vi o us i njecti o n) 
•  Uri ne pre g n a nc y test  
•  Dis pe nse o pti o nal ta ke- h o me resc u e me dicati o ns (al b uter ol/sal b uta m ol ) t o patie nts wit h 
ast h ma, if nee d e d. Re mi n d patie nts t o d oc u me nt t he use i n t heir patie nt diar y . 
•  A E re vie w a n d rec or di n g  
6. 1 7  Visit 1 7 ( E n d of St u d y ) ( St u d y D a y 2 2 5 ± 5 da ys / Wee k 3 2) 
T he E n d of St u d y is defi ne d as t he c o m pleti o n of Visit 1 7 b y t he last patie nt.  
T he f oll o wi n g assess me nts a n d pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w , if p ossi ble: 
•  Re vie w a n d r ec or d c ha n g es i n c o nc o mita nt me dicati o ns 
•  Vital si g n  meas ure me nt s 
•  B o d y wei g ht rec or d e d 
•  N C S assess me nt  
•  E Q - 5 D-5 L assess me nt  
•  V A S -r hi n osi n usitis assess me nt  
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  U P SI T assess me nt of s mell  
•  Nasal e n d osc o p y a n d N P S sc ori n g 
•  P ul m o nar y f u ncti o n tests ( S pi r o metr y) f or p atie nts wit h c o m or bi d ast h ma o nl y 
•  H ealt hcare r es o urce  utilizati o n q uesti o n naire 
•  C o m plete p h ysical e xa mi nati o n  
•  1 2- lea d E C G 
•  Uri ne pre g n a nc y test  
•  
I njecti o n site assess me nt 
•  Safet y la b orat or y s a m ples ( he mat ol o g y, ser u m c h e mistr y, uri nal ysis) 
•  P K bl o o d sa m ple 
•  P D bl o o d sa m ple 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 7  of 9 7  
•  A D A bl o o d sa m ple 
•  C ollect t he dail y patie nt ha n d hel d de vice  
•  A E re vie w a n d rec or di n g  
6. 1 8  U nsc he d ule d Visits  
S h o ul d patie nt s re q uire a n u nsc he d ule d visit, t he visit m ust be rec or de d i n t he patie nt’s me dical rec or d 
a n d t he e C R F , al o n g wit h a n y assess me nts t hat were perf or me d at t he visit.  
6. 1 9  E arl y Ter mi n ati o n Visit   
S h o ul d a patie nt wit h dra w c o nse nt or be wit h dra w n fr o m t he st u d y f or a n y reas o n after ra n d o mizati o n, 
e ver y eff ort s h o ul d be ma de t o sc he d ule a fi nal visit, d uri n g w hic h t he f oll o wi n g assess me nts a n d 
pr oce d ures s h o ul d be c o m plete d i n t he or der gi ve n bel o w, if p ossi ble: 
•  Re vie w a n d r ec or di n g of c ha n ges i n c o n c o mita nt me dicati o ns  
•  Vital si g n  meas ure me nt s 
•  B o d y wei g ht rec or d e d 
•  C T sca n  ( o nl y re q uir e d f or s u bjects t hat are e nr oll e d at St u d y Sites  t hat are a p pr o ve d a n d 
q ualifie d t o perf or m C T Sca ns) 
•  N C S assess me nt  
•  E Q - 5 D- 5 L q u esti o n naire  
•  V A S -r hi n osi n usitis assess me nt  
•  S N O T -2 2 assess me nt  
•  T N S S assess me nt  
•  U P SI T assess me nt of s mell  
•  Nasal e n d osc o p y a n d N P S sc ori n g 
•  P ul m o nar y f u ncti o n tests ( S pir o metr y ) f or p atie nts wit h c o m or bi d ast h ma o nl y 
•  H ealt hcare r es o urce  utilizati o n  q uesti o n naire 
•  C o m plete p h ysical e xa mi nati o n  
•  1 2- lea d E C G 
•  Uri ne pre g n a nc y test  
•  Safet y la b orat or y s a m ples ( he mat ol o g y, ser u m c h e mistr y, uri nal ysis) 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 8  of 9 7  
•  P K  bl o o d sa m ple 
•  P D bl o o d sa m ple 
•  A D A bl o o d sa m ple 
•  C ollect t he dail y patie nt ha n d hel d de vice 
•  A E re vie w a n d rec or di n g  
7  
S T U D Y A S S E S S M E N T S  
All st u d y assess me nts m ust  be perf or me d b y trai ne d cli nical st u d y staff i n cli nic, or w here p ossi ble, via 
tele- visits a n d/ or h o me healt hcare  visits . F or s pecific ti me p oi nts of eac h assess me nt, refer t o  t he 
Sc he d ul e of Assess me nt  (Ta ble 1 ). 
7. 1  
De m o gr a p hic D at a a n d Me dic al Hist or y  
De m o gra p hic data re gar di n g a ge, se x , race a n d et h nicit y will be c ollecte d. 
A c o m plete me dical a n d s ur gical hist or y will i ncl u de e val uati o n f or past or prese nt car di o vasc ular, 
res pirat or y, o p ht hal mic, gastr oi ntesti nal, re nal, he patic, ne ur ol o gical, e n d ocri ne, l y m p hatic, 
he mat ol o gical, i m m u n ol o gic, der mat ol o gic, ps yc hiatric, ge nit o uri nar y, m usc ul os keletal, me dicati o n , a n d 
s ur gical hist or y, or a n y ot her diseases or dis or ders. T he patie nt’s me dical hist or y s h o ul d be e val uate d b y 
t he I n vesti gat or f or cli nical si g nifica nce a n d re-re vie we d at t he Baseli ne visit ( Visit 2). 
7. 2  
P h ysic al E x a mi n ati o n 
All c o m plete p h ysical e xa mi nati o ns will be perf or me d b y a p h ysicia n , p h ysicia n assista nt, or n urse 
practiti o ner a n d will i ncl u de e xa mi nati o n of t he f oll o wi n g:  ge neral a p peara nce, hea d, ears, e yes, n ose, 
t hr oat, nec k, t h yr oi d, s ki n, car di o vasc ular s yste m, res pirat or y s yste m, l y m p h n o des, m usc ul os keletal, 
a b d o me n, f u n d osc o p y ( o pti o nal), e xtre mities, a n d ner v o us s yste m.   
Brief f oc use d p h ysical e xa m i nati o ns will be perf or me d b y a p h ysicia n, p h ysicia n assista nt , or n urse 
practiti o ner a n d will assess t he f oll o wi n g: ge neral a p peara nce, e yes, l u n gs , a n d l y m p h n o des.  
Brief f oc use d p h ysical e xa m i nati o ns will be c o n d ucte d at all visits w here t he c o m plete p h ysical 
e xa mi nati o n is n ot re q uire d.  
P h ysical e xa ms ma y be m o difie d if a da pte d t o tele me dici ne or h o me healt h visits a n d a n y m o dificati o ns 
will be n ote d i n t he e C R F.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 5 9  of 9 7  
7. 3  
Vit al Si g n Me as ure m e nts  
Bl o o d press ure a n d p ulse  rate will be meas ure d i n a se mi-s u pi ne or sitti n g p ositi o n after t he patie nt  has 
reste d f or at least  5 mi n utes . B o d y te m perat ure a n d res pirat or y rate will als o be meas ure d.  
7. 4  
Wei g ht a n d Hei g ht 
Hei g ht a n d b o d y wei g ht will be meas ure d at Scree ni n g ( Visit 1). Wei g ht will be meas ure d a n d rec or de d 
a gai n at Visits 2, 9, 1 5 (E n d of Treat me nt ), a n d 1 7 ( E n d of St u d y) or at t he Earl y Ter mi nati o n  Visit if t he 
patie nt wit h dra ws fr o m t he st u d y. 
7. 5  
Electr oc a r di o gr a m  
Sta n dar d 1 2 -lea d E C G rec or di n gs will be meas ure d at t he ti me p oi nts i n dicate d i n t he Sc he d ule of 
Assess me nts  (Ta ble 1 ). T he f oll o wi n g para meters will be rec or de d: 
•  R h yt h m 
•  Ve ntric ular rate  
•  P R i nter val  
•  Q R S d urati o n 
•  Q T  
•  Q T  i nter val c orrecte d f or heart r ate usi n g Fri d erici a's f or m ula ( Q Tc F) 
T he I n vesti gat or is res p o nsi ble f or re vie wi n g t he E C G t o assess w het her it is wit hi n refere nce li mits a n d 
t o deter mi ne t he cli nical si g nifica nce of t he res ults. T he I n vesti gat or m ust si g n a n d date all E C G 
pri nt o ut s t o i n dicate t heir re vie w of cli nical si g nifica nce . A c o p y of t he E C G assess me nt m ust be ke pt i n 
t he patie nt’s file at t he site. N ote : T he Q Tc F will be  ce ntr ally c alc ul ate d f or st a n d ar diz ati o n of re p orti n g 
acr oss all St u dy Sites . T he I nvesti g at or s h o ul d use t he syste m -c alc ul ate d E C G v al ues  f or deter mi ni n g 
eli gi bility. 
7. 6  
S afet y  L a b or at or y Tests 
Sta n dar d la b orat or y he mat ol o g y, ser u m c he mistr y, uri nal ysis, a n d he patitis B, he patitis C  a n d HI V 
scree ni n g will be pr ocesse d a n d re p orte d b y a ce ntral la b orat or y ( E ur ofi ns) at vari o us ti me p oi nts, per 
Sc he d ule of Assess me nts  (Ta ble 1 ).  
He m at ol o g y:  c o m plete bl o o d c o u nt t o i ncl u de re d cell c o u nt, he m o gl o bi n le vel, he mat ocrit le vel, w hite 
cell c o u nt wit h differe ntial, a n d platelet c o u nt. 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 0  of 9 7  
Ser u m c he mistr y : bl o o d urea nitr o ge n , creati ni ne, uric aci d, t otal bilir u bi n, s o di u m, p otassi u m, calci u m, 
c hl ori de, bicar b o nate, al kali ne p h os p hatase ( A L P ), A S T, A L T, lactate de h y dr o ge nase, ga m ma - gl uta m yl 
tra nsferase, C P K, al b u mi n, t otal pr otei n, t otal c h olester ol, tri gl yceri des, C-reacti ve pr otei n, a n d gl uc ose. 
Uri n al ysis : p H, pr otei n, gl uc ose, ket o nes, bilir u bi n, bl o o d, ur o bili n o ge n, nitrites, le uc oc ytes, a n d 
s pecific gra vit y; micr osc o pic a nal ysis if a b n or mal. 
He p atitis a n d HI V Scree ni n g: He patitis scree n: H Bs A g or H Bc A b a n d he patitis C vir us a nti b o d y 
(H C V A b ). A he patitis C  viral l oa d test is t o be carrie d o ut if H C V A b is p ositi ve. T he patie nt s h o ul d be 
e xcl u de d fr o m t he st u d y i n case of p ositi ve he patitis C  viral l oa d test res ult. If t he he patitis C  viral l oa d 
test res ult is ne gati ve, t he patie nt ca n be e nr olle d i n t he st u dy.  N ote: P atie nts w h o test p ositive f or 
H Bc A b, ne g ative f or H Bs A g a n d s u bse q ue ntly c o nfir me d p ositive f or H Bs A b, i n dic ati n g res olve d n at ur al 
i nfecti o n (c o nfir me d by ne g ative H B V- D N A), m ay p artici p ate. P atie nts wit h p ositive H C V m ay 
p artici p ate if s u bse q ue nt vir al l o a d is c o nfir me d ne g ative.  
A d diti o n al  Testi n g : A d diti o nal  a n d re peat testi n g f or a n y safet y para meter ma y be perf or me d at t he 
discreti o n of t he I n vesti gat or i n t he i nterest of patie nt safet y. If e mer ge nc y testi n g is nee de d or a 
la b orat or y test is n ot a vaila ble i n t he ce ntral la b, a l ocal la b ma y be use d. All la b orat or y test res ults 
s h o ul d be rec or de d i n t he me dical rec or d a n d ca pt ure d i n t he E D C u n der a d verse e ve nt if t he res ults are 
a b n or mal a n d cli nicall y si g n ifica nt. 
As s pecifie d i n t he la b orat or y ma n ual, all la b orat or y safet y tests will be perf or me d b y a ce ntral 
la b orat or y ( E ur ofi ns). Details of all met h o d ol o g y a n d refere nce ra n ges are pr o vi de d i n t he la b orat or y 
ma n ual .  
T he I n vesti gat or is res p o nsi ble f or re vie wi n g a n d si g ni n g all la b re p orts, i n dicati n g t he cli nical 
si g nifica nce of eac h a b n or mal/fla g ge d val ue. I n ge neral, a n d as deter mi ne d b y t he I n vesti gat or, a b n or mal 
cli nicall y si g nifica nt fi n di n gs s h o ul d be ass ociate d  wit h a n ite m rec or de d i n t he me dical hist or y or a n 
A E.  
7. 7  
Pre g n a nc y Test  
A pre g na nc y test  will be perf or me d f or fe male patie nts of c hil d beari n g p ote ntial at t he ti me p oi nts 
s pecifie d i n t he Sc he d ule of Assess me nts (Ta ble 1 ). A ser u m pre g na nc y test will be perf or me d at t he 
Scree ni n g visit a n d a uri ne pre g na nc y test will be perf or me d at all visits t hereafter. A ne gati ve pre g na nc y 
test res ult m ust be o btai ne d pri or t o ra n d o mizati o n. A d diti o nal or m ore fre q ue nt pre g na nc y testi n g ma y 
be perf or me d if re q uire d b y l ocal re g ulati o ns. 
7. 8  
Effic ac y Assess m e nts  
7. 8. 1  E n d osc o pic N as al P ol y p Sc or e  
N P S is assesse d b y ce ntral vi de o rec or di n gs of nasal e n d osc o p y. T he sc ore ( N P S) is t he s u m of left a n d 
ri g ht n ost ril scores, as e val uate d b y mea ns of nasal e n d osc o p y. N P S is gra de d base d o n p ol y p size as 
descri be d i n Ta ble 2  a n d de picte d i n t he N P S fi g ures bel o w. 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 1  of 9 7  
T a ble 2: 
E n d osc o pic N as al P ol y p Sc ore  
P ol y p 
Sc ore  
P ol y p Size  
0 
N o p ol y ps  
1 
S mall p ol y ps i n t he mi d dle meat us n ot reac hi n g bel o w t he i nferi or b or der of t he mi d dle t ur bi nate  
2 
P ol y ps reac hi n g bel o w t he l o wer b or der of t he mi d dle t ur bi nate  
3 
Lar ge p ol y ps reac hi n g t he l o wer b or der of t he i n feri or t ur bi nate or  lar ge p ol y ps me dial t o t he mi d dle 
t ur bi nate (i.e., reac hi n g bel o w t he mi d dle t ur bi nate).  
4 
Lar ge p ol y ps ca usi n g c o m plete o bstr ucti o n of t he i nferi or nasal ca vit y  (i.e., t o uc hi n g t he fl o or of t he 
n ose ). 
 
N as al P ol y p Sc ori n g Fi g ur es  
M T  – mi d dle t ur bi nate; I T – i nferi or t ur bi nate 
 
Fi g ure 1 Nasal P ol y p Sc ore of 0 
Fi g ure 2 Nasal P ol y p Sc ore of 1 
 
 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 2  of 9 7  
Fi g ure 3 Nasal P ol y p Sc ore of 2 
 
        
 
Fi g ure 4 Nasal P ol y p Sc ore of 3 
 
 
Fi g ure 5 Nasal P ol y p Sc ore of 4 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 3  of 9 7  
N ote:  N as al e n d osc o py s h o ul d be c o n d ucte d at t he e n d of t he sc he d ule d visits bef ore t he 
a d mi nistr ati o n of st u dy dr u g a n d prece de d by l oc al a d mi nistr ati o n of a n a est hetic dr u gs c o m bi ne d wit h 
a dec o n gest a nt. C o m plete all assess me nts t h at mi g ht be affecte d by t he pr oce d ure pri or t o a p plic ati o n 
of t he a n aes t hetic (i.e. U P SI T, S N O T - 2 2, N C S, etc). 
Sta n dar d vi de o se q ue nces will be a vaila ble a n d se nt t o ce ntralize d rea der. Ce ntralize d i ma gi n g data 
assess me nts a n d sc ori n g b y i n de pe n de nt p h ysicia n re vie wer(s) f or t he i ma gi n g data will be perf or me d 
f or all e n d osc o pies. At V 1, t he nasal e n d osc o p y vi de o m ust  be se nt f or ce ntral rea di n g a n d t he res ults 
will be pr o vi de d t o t he site. At V isit 2, if nasal e n d osc o p y is perf or me d (i.e. if V 2 is > 7 da ys after V 1), 
t he i n vesti gat or will perf or m t he nasal e n d osc o p y a n d assess N P S t o c o nfir m eli gi bilit y. T h us, t he 
patie nt’s eli gi bilit y will be base d o n V 1 ce ntral rea di n g a n d , if perf or me d, V 2 l ocal rea di n g N P S sc ore of 
≥5 a n d ≥ 2 eac h si de. T he res ults of ce ntral rea di n g fr o m V 2 o n war d will be a vaila ble t o sites after t he 
st u d y.  
Ce ntral rea di n g of V 2 will be use d f or pri mar y e n d p oi nt a nal ysis t o c o m pare wit h t he W ee k 2 4 rea di n gs. 
F urt her details o n nasal  e n d osc o p y will be pr o vi de d t o sites i n a se parate o perati o nal ma n ual.  
If Baseli ne Visit ( V isit 2) is perf or me d wit hi n 7 da ys of Scree ni n g Visit ( V isit 1) t he N P S sc ore (ce ntral 
rea d) fr o m t he scree ni n g visit will be use d t o c o nfir m eli gi bilit y, a n d t he e n d osc o p y will n ot be re peate d 
at Visit 2 u nless t here were tec h nical diffic ulties wit h t he Visit 1 sc ori n g.  
7. 8. 2  D ail y Di ar y of N as al C o n g esti o n / O bstr ucti o n S c or e 
Dail y N C S  will be assesse d b y t he patie nt t hr o u g h a patie nt diar y  fr o m V 1 t hr o u g h o ut t he st u d y b y usi n g 
a 0 t o 3 cate g orical scale f or se verit y of s y m pt o ms fr o m n o ne t o se vere o ver t he past 2 4 h o urs. T his nasal 
c o n gesti o n sc ore is a c o- pri mar y e n d p oi nt a n d is ver y i m p orta nt t o t he o utc o me of t he st u d y a n d it is ver y 
i m p orta nt t hat t he patie nts a ns wer t his q uesti o n dail y i n t he patie nt diar y t hr o u g h o ut t he st u d y i ncl u di n g 
scree ni n g/r u n-i n peri o d.   
H o w w o ul d y o u r ate n as al c o n gesti o n o ver t he l ast 2 4 h o urs ? 
0    N o ne 
1    Mi n or  
2    M o derate  
3    Se vere  
7. 8. 3  D ail y Di ar y of Ot h er S y m pt o ms  
Patie nts will be re q uire d t o kee p a patie nt diar y of r hi n osi n usitis a n d ast h ma  s y m pt o ms BI D . T he 
p ur p ose of t he diar y is t o rec or d t he i m pact of t heir r hi n osi n usitis o n dail y acti vities , se nse of s mell, 
r hi n orr hea, a n d me dicati o n use. T he patie nt s will als o be re q uire d t o perf or m N PI F testi n g at h o me a n d 
t o rec or d t he res ults. T he sc ori n g s yste m is descri be d bel o w. N ote : F or t he p ur p oses of t his st u dy, “ A M 
Q uesti o ns ” are t h ose defi ne d as bei n g a ns were d by t he p atie nt i n t he m or ni n g u p o n w aki n g ( ie, referri n g 
t o t he previ o us ~ 1 2 h o urs, or over ni g ht sy m pt o ms ). “ P M Q uesti o ns ” are defi ne d as t h ose q uesti o ns 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 4  of 9 7  
a ns were d by t he p atie nt i n t he eve ni n g bef ore retiri n g (ie, referri n g t o t he previ o us ~ 1 2 h o urs, or d uri n g 
t he d ay w he n t he p atie nt w as a w ake). T he I nvesti g at or s h o ul d re g ul arly revie w t he p atie nt di ary a n d 
disc uss a ny c o ncer ns o ver sy m pt o m c h a n ges wit h t he p atie nt. Al ar ms will be pr o gr a m me d t o e nc o ur a ge 
p atie nts t o c o nt act t he st u dy st aff if t heir sy m pt o ms w orse n t o i n dic ate a p ossi ble ex acer b ati o n of t heir 
r hi n osi n usitis or ast h m a.  
A M Q U E S TI O N S:  
1.  H o w m a n y ti m es di d y o u a w a k e n d u e t o r hi n osi n usitis s y m pt o ms l ast ni g ht ? 
0 
Di d n ot a w ak e n d u e t o r hi n osi n us itis sy m pt o ms  
1 
A w o k e o nc e d u e t o r hi n osi n usitis s y m pt o ms  
2 
A w o k e t wic e d u e t o r hi n osi n usitis s y m pt o ms  
3 
A w o k e 3 ti m es d u e t o r hi n osi n usitis sy m pt o ms  
4 
W as n ot a bl e t o sl e e p at all d u e t o m y r hi n osi n usitis sy m pt o ms  
2 .  H o w w o ul d y o u r at e y o ur  a bilit y t o s m ell ? 
0 
N ot a bl e t o s m ell a nyt hi n g  
1 
C a n s m ell o nly str o n g o d ors  
2 
C a n  s m ell s o m e, b ut n ot all, o d ors 
3  
 H a v e n o pr o bl e m s m elli n g  
3.   H o w m a n y p uffs of r esc u e  ( al b ut er ol/s al b ut a m ol) i n h al er di d y o u us e l ast ni g ht ? [ F or 
p ati e nts wit h c o m or bi d ast h m a o nl y]  
[ P ati e nt will t y p e i n t h e n u m b er of p uffs, p ati e nts t h at d o n ot h av e c o m or bi d ast h m a (i. e. w er e 
n ot ≥1 2 % r e v ersi bl e at scr e e ni n g or i n t h e y e ar pri or ) will b e i nstr uct e d t o e nt er 0]  
P M Q U E S TI O N S:  
1.  D escri b e y o ur r hi n osi n usitis s y m pt o ms t o d a y. 
0 
N o n otic e a bl e r hi n osi n usitis s y m pt o ms 
1 
Mil d r hi n osi n usitis s y m pt o ms, b ar el y n otic e a bl e 
2 
R h i n osi n usitis sy m pt o ms wit h ex ercis e/ ex erti o n  
3 
R hi n osi n us itis sy m pt o ms wit h mil d ex erti o n 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 5  of 9 7  
4 
Al m ost c o nst a nt diffic ult y d u e t o my r hi n osi n usitis sy m pt o ms 
2.  W er e y o ur d ail y acti viti es aff ect e d b y y o ur r hi n osi n usitis s y m pt o ms t o d a y ? 
0 
N o eff ect of r hi n osi n usitis sy m pt o ms o n m y d ail y acti viti es  
1 
Acti vity w as n or m al a n d o nl y mil dl y aff ect e d by m y r hi n osi n usitis sy m pt o ms 
2 
Acti vity w as n or m al b ut m o d er at el y aff ect e d by m y  r hi n osi n usitis sy m pt o ms 
3 
R hi n osi n us itis sy m pt o ms li mit e d my acti vity t o a si g nific a nt d e gr e e  
4 
R hi n osi n us itis sy m pt o ms s ev er ely r estrict e d m y d ail y acti viti es 
3 .  H o w w o ul d y o u r at e y o ur a nt eri or r hi n orr h e a (t h e disc h ar g e dr ai ni n g fr o m y o ur n os e , 
“r u n n y n os e”) i n t h e p ast 2 4 h o urs ? 
0 
N o n otic e a bl e disc h ar g e fr o m my n os e  
1  
M i n or disc h ar g e fr o m m y n os e, di d n ot r e q uir e tiss u es  
2 
S o m e disc h ar g e fr o m my n os e, r e q uir e d a f e w tiss u es  
3 
Si g nific a nt disc h ar g e fr o m m y n os e  
4 
N e ar c o nst a nt disc h ar g e fr o m my n os e 
4 .  H o w w o ul d y o u r at e y o ur p ost eri or r hi n orr h e a ( p ost n as al p hl e g m d ri p pi n g i nt o y o ur t hr o at)  
i n t h e p ast 2 4 h o urs? 
0 
N o n otic e a bl e p ost n as al dri p  
1 
S o m e mi n or p ost n as al dri p  
2  
M o d er at e p ost n as al dri p  
3 
Si g nific a nt p ost n as al dri p  
4 
N e ar c o nst a nt p ost n as al dri p  
5 .   Di d y o u t a k e y o ur  d ail y  n as al st er oi d ( m o m et as o n e ) t o d a y ? Y es/ N o  
6 .  H o w m a n y p uffs of r esc u e i n h al er di d y o u us e t o d a y ?  [ F or p ati e nts wit h c o m or bi d ast h m a 
o nl y]  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 6  of 9 7  
[ P ati e nt will t y p e i n t h e n u m b er of p uffs, p ati e nts t h at d o n ot h av e c o m or bi d ast h m a will b e 
i nstr uct e d t o e nt er 0] 
7. 8. 4  D ail y N as al P e a k I ns pir at or y Fl o w ( at H o m e) 
All patie nts will be as ke d t o perf or m nasal pea k i ns pirat or y fl o w ( N PI F) testi n g at h o me BI D a n d t o 
rec or d t he res ults usi n g t he patie nt diar y  dis pe nse d at Visit 1.  
7. 8. 5  C o m p ut e d T o m o gr a p h y ( C T) Sc a n  
Si n us C T sca n ni n g is use d t o assess fl ui d -fille d or t hic k-me m bra ne d si n uses, t o assess t he e xte nt of 
i nfla m mati o n, t o assess p ol y ps a n d ot her gr o wt hs i n t he air wa y, a n d t o create a “ ma p” of t he patie nt’s 
si n us ca vities.  A n I ma gi n g Ma n ual will be pr o vi de d se paratel y t o St u d y Sites  t hat are a p pr o ve d a n d 
q ualifie d t o perf or m C T Sca ns. T he I ma gi n g ma n ual will detail t he e q ui p me nt setti n gs a n d re q uire me nts 
f or sca n ni n g.  T he I ma gi n g Ma n ual will als o detail t he ra di ol o gic sc ori n g of C T sca ns.  All sca ns will be 
re vie we d b y bli n de d ce ntral o ver-rea d.  L u n d -Mac ka y C o m p ute d T o m o gra p h y q ualitati ve sc ores a n d 
q ua ntitati ve a nal ysis will be perf or me d fr o m patie nts e nr olle d at St u d y Sites  t hat are a p pr o ve d a n d 
q ualifie d t o perf or m C T sca ns. 
7. 8. 6  I n-Cli nic P ul m o n ar y  F u ncti o n  T ests  (P F T)  
S pir o metr y is re q uire d f or o nl y patie nts wit h c o m or bi d ast h ma (i.e. de m o nstrati n g ≥1 2 % re versi bilit y at 
scree ni n g or i n t he 1 2 m o nt hs pri or).  S pir o metr y ( pea k e x pirat or y fl o w , f orce d vital ca pacit y, a n d F E V1) 
will be perf or me d acc or di n g t o A merica n T h oracic S ociet y a n d t he E ur o pea n Res pirat or y S ociet y 
(A T S /E R S ) Sta n dar dizati o n of S pir o metr y ( 2 0 1 9 ), wit h e q ui p me nt o perate d b y trai ne d cli nical staff.  
P ul m o nar y f u ncti o n will be assesse d i n cli nic or b y h o me healt hcare at t he ti me p oi nts i n dicate d i n t he 
Sc he d ule of Assess me nt  (Ta ble 1 ). 
7. 8. 7  S m ell T est  ( U P SI T) 
T he U P SI T  is a c o m merciall y a vaila ble, vali date d s mell test t hat has 4 0 ite ms, w here eac h ite m has 1 
c orrect a ns wer a n d 3 i nc orrect a ns wers or “ distract ors”. T he test is a f orce d c h oice para di g m, t hat is, if 
a n i n di vi d ual is u ns ure of a n a ns wer, t he y are f orce d t o guess a res p o nse he nce a sc ore of 2 5 % o n 
a vera ge w o ul d reflect ra n d o m g uessi n g. A n U P SI T res ult is sc ore d o ut of 4 0 w here a hi g her sc ore 
i n dicates better olfacti o n. T he test c o nsists of 4 differe nt 1 0- pa ge b o o klets, wit h a t otal of 4 0 q uesti o ns. 
O n eac h pa ge, t here is a differe nt "scratc h a n d s niff" stri p w hic h is e m be d de d wit h a micr oe nca ps ulate d 
o d ora nt. T here is als o a 4- c h oice m ulti ple c h oice q uesti o n o n eac h pa ge. T he sce nts are release d usi n g a 
pe ncil. After eac h sce nt is release d, t he patie nt s mells t he le vel a n d detects t he o d or fr o m t he 4 c h oices. 
T here is a n a ns wer c ol u m n o n t he bac k of t he test b o o klet, a n d t he test is sc ore d o ut of 4 0 ite ms. T he 
sc ore is c o m pare d wit h  sc ores i n a n or mati ve data base fr o m 4 0 0 0 n or mal i n di vi d uals, t his tells t he le vel 
of a bs ol ute s mell f u ncti o n.  T he sc ore als o i n dicates h o w t he patie nt d oes i n acc or da nce t o t heir a ge gr o u p 
a n d se x.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 7  of 9 7  
T he test is occasi o nall y j u d ge d t o ha ve a n A merica n c ult ural bias. T here ha ve bee n Britis h, C hi nese, 
Fre nc h, Ger ma n, Italia n, K orea n a n d S pa nis h U P SI T versi o ns ma de  w hic h ma y be use d de pe n di n g o n 
t he c o u ntries i n w hic h t he st u d y is perf or me d. 
F or t he ti me p oi nts o n w hic h t h e U P SI T is a d mi nistere d, refer t o t he Sc he d ule of Assess me nts  (Ta ble 1 ). 
7. 8. 8  Vis u al A n al o g Sc al e f or R hi n osi n usitis  ( V A S-R S)  
T he Vis ual A nal o g ue Scale f or r hi n osi n usitis ( V A S-R S) is a 1 0 c m scale t hat ra n ges fr o m “ n o 
s y m pt o ms” t o “ w orst s y m pt o ms e ver” f or eac h of t he nasal s y m pt o ms ( A p pe n di x A ). T he V A S will 
direct t he patie nt t o mar k  a vertical li ne at t he p oi nt t hat best c orres p o n ds t o h o w b ot hers o me t heir 
s y m pt o ms ha ve bee n bet wee n visits t he V A S-R S is c ollecte d .  
F or t he ti me p oi nts o n w hic h t he V A S- R S is assesse d, refer t o t he Sc he d ule of Assess me nts  (Ta ble 1 ). 
7. 8. 9  T ot al N as al S y m pt o m Sc or e  ( T N S S) 
T he T otal Nasal S y m pt o m Sc ore ( T N S S) is t he s u m of sc ores f or eac h of nasal o bstr ucti o n , nasal 
itc hi n g/s neezi n g, a n d Secreti o n/ R u n n y n ose (r hi n orr hea), usi n g a 4- p oi nt scale ( 0 , 1, 2, 3), w here 0 
i n dicates n o s y m pt o ms, a sc ore of 1 f or mil d s y m pt o ms t hat are easil y t olerate d, 2 f or a ware ness of 
s y m pt o ms w hic h are b ot hers o me b ut t olera ble a n d 3 is reser ve d f or se vere s y m pt o ms t hat are har d t o 
t olerate a n d i nterfere wit h dail y acti vit y (A p pe n di x B ). T N S S is calc ulate d b y a d di n g t he sc ore f or eac h 
of t he s y m pt o ms t o a t otal sc ore o ut of 9.  
F or t he ti me p oi nts o n w hic h t h e T N S S is assesse d, refer t o t he Sc he d ule of Assess me nts (Ta ble 1 ). 
7. 8. 1 0  Si n o -N as al O utc o m e T est  (S N O T -2 2 ) 
T he  Si n o -Nasal O utc o me Test  ( S N O T- 2 2) is a 2 2-ite m list of s y m pt o ms a n d s ocial/e m oti o nal 
c o nse q ue nces relate d t o t he patie nt ’s r hi n osi n usitis, usi n g a 5- p oi nt scale ( 0, 1, 2, 3, 4, 5), w here sc ore of 0 
i n dicates N o Pr o ble m, 2 f or Ver y Mil d Pr o ble m, 3 f or Mil d or Sli g ht Pr o ble m, 4 f or M o derate Pr o ble m, 
a n d 5 f or Pr o ble m as ba d as it ca n be. Patie nts will als o be as ke d t o mar k t he m ost i m p orta nt ite ms t hat 
affect t heir healt h f or a ma xi m u m of 5 o ut of t he 2 2 ite ms liste d  d uri n g t he re p orti n g peri o d  (A p pe n di x 
C ).  A Mi ni mal Cli nicall y I m p orta nt Differe nce (M CI D ) val ue f or S N O T -2 2 t otal sc ores is defi ne d as 
i m pr o ve me nt of at least 8. 9 p oi nts i n patie nts wit h c hr o nic r hi n osi n usitis  ( H o p ki ns C 2 0 0 9).F or t he 
ti me p oi nts o n w hic h t he S N O T - 2 2 is assesse d, refer t o t he Sc he d ule of Assess me nts (Ta ble 1 ). 
7. 8. 1 1  E ur o Q oL H e alt h St at us Q u esti o n n air e ( E Q -5 D -5L)  
T he E ur o Q o L Healt h Stat us Meas ure, 5 Di me ns i o ns/ 5 Le vels (E Q - 5 D- 5 L) is a well- vali date d, ge neral 
healt h -relate d q ualit y of life assess me nt t o ol p u blis he d b y t he E ur o Q ol Gr o u p. T he E Q- 5 D- 5 L c o nsists 
of 2 pa ges: t he E Q- 5 D descri pti ve s yste m a n d t he E Q vis ual a nal o g ue scale ( E Q - V A S). T he descri pti ve 
syste m c o m prises 5 di me nsi o ns: m o bilit y, self -care, us ual acti vities, pai n/ disc o mf ort a n d 
a n xiet y/ de pressi o n. Eac h di me nsi o n has 5 le vels: n o pr o ble ms, sli g ht pr o ble ms, m o derate pr o ble ms, 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 8  of 9 7  
se vere pr o ble ms a n d e xtre me pr o ble ms. T he patie nt is as ke d t o i n dicate t heir healt h state b y c h o osi n g t he 
m ost a p pr o priate state me nt i n eac h of t he 5 di me nsi o ns. T his decisi o n res ults i n a 1- di git n u m ber t hat 
e x presses t he le vel selecte d f or t hat di me nsi o n . T he di gits f or t he 5 di me nsi o ns ca n be c o m bi ne d i nt o a 5-
di git n u m ber t hat descri bes t he patie nt’s healt h state. T he E Q- V A S rec or ds t he patie nt’s self -rate d healt h 
o n a vertical vis ual a nal o g ue scale, w here t he e n d p oi nts are la belle d ‘ T he best healt h y o u ca n i ma gi ne’ 
a n d ‘ T he w orst healt h y o u ca n i ma gi ne’. F or t he ti me p oi nts o n w hic h t his q uesti o n naire is a d mi nistere d, 
refer t o t he Sc he d ule of Assess me nts (Ta ble 1 ). 
7. 8. 1 2  H e alt h c ar e R es o urc e Utiliz ati o n Q u esti o n n air e  
T he Healt hcare Res o urce Utilizati o n Q uesti o n naire will be use d t o e val uate t he patie nts’ nee d f or 
me dical ser vices relate d t o s y m pt o ms of t heir c hr o nic r hi n osi n usitis wit h nasal p ol y p osis. T his 
q uesti o n naire will be c o m plete d b y patie nts. F or t he ti me p oi nts o n w hic h t his q uesti o n naire is 
a d mi nistere d, refer t o t he Sc he d ule of Assess me nts ( Ta ble 1 ). 
7. 8. 1 3  P h ar m ac o d y n a mic E n d p oi nts  
Bl o o d will be c ollecte d fr o m patie nts t hr o u g h o ut t he st u d y as i n dicate d i n t he Sc he d ule of Assess me nts  
(Ta ble 1 ), f or meas ure me nt of bi o mar kers of i nfla m mati o n ass ociate d wit h c hr o nic r hi n osi n usitis wit h 
nasal p ol y p osis. 
7. 8. 1 4  P h ar m ac o ki n etic Ass ess m e nts  
W h ole bl o o d f or plas ma C B P- 2 0 1 c o nce ntrati o ns will be o btai ne d at t he f oll o wi n g visits t o c haracterize 
t he P K  of t he dr u g at stea d y -state a n d t o c haracterize t he ret ur n t o baseli ne after treat me nt st o ps.  
7. 8. 1 5  Bl o o d V ol u m es  
T he a p pr o xi mate bl o o d v ol u mes t o be c ollecte d f or safet y la borat or y tests , pre g na nc y test, P K, a n d P D 
are gi ve n i n Ta ble 3 . T hese v ol u mes ma y var y sli g htl y base d o n re gi o nal differe nces i n sta n dar d t u be 
sizes. T he t otal sa m ple v ol u mes o ver t he c o urse of t he 3 2 -wee k st u d y  will n ot e xcee d  a safe a n d 
me dicall y a d visa ble a m o u nt i n a n y gi ve n c ollecti o n e ve nt. 
T a ble 3 
Bl o o d V ol u mes  
Assess m e nt  
S a m ple V ol u m e  
( m L) 
N o. of S a m ples  
T ot al V ol u m e  
( m L) 
Safet y  
He mat ol o g y  
3 
1 1  
3 3  
Bi oc he mistr y  
7. 5  
1 1  
8 2. 5  
H u ma n i m m u n o deficie nc y vir us/  
he patitis B s urface a nti ge n test  
4 
1 
4 
Pre g na nc y  
5- 7 
1 
5- 7 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 6 9  of 9 7  
Assess m e nt  
S a m ple V ol u m e  
( m L) 
N o. of S a m ples  
T ot al V ol u m e  
( m L) 
P har mac o ki netics  
5- 7 
7 
3 5 -4 9  
P har mac o d y na mics  
5- 7 
6 
3 0 -4 2  
A nti dr u g a nti b o d y/ ne utralizi n g a nti b o d y  
3- 5 
5 
1 5 -2 5  
 
8  
R E P O R TI N G A D V E R S E E V E N T S  
8. 1  
Defi niti o ns  
8. 1. 1  A d v ers e E v e nt  
A n A E  is defi ne d as a n y u nt o war d me dical occ urre nce i n a patie nt  d uri n g a cli nical st u d y , w het her or n ot 
it is relate d t o t he I P, at a n y ti me after  t he patie nt  si g ns t he I C F u ntil Visit 1 7  (E n d of St u d y ) or a n Earl y 
Ter mi nati o n  Visit, w hic he ver occ urs first. 
8. 1. 2  S eri o us A d v ers e E v e nt  
A n A E  is c o nsi dere d “seri o us” if it: 
•  
Res ults i n deat h  
•  
Is life-t hreate ni n g: w he n t he patie nt  is, i n t he o pi ni o n of t he In vesti gat or,  at i m me diate ris k of deat h 
fr o m t he e ve nt as it occ urs. T his defi niti o n d oes n ot i ncl u de a n e ve nt t hat h y p ot heticall y mi g ht ha ve 
ca use d deat h if it were m ore se vere 
•  
Re q uires h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n  
•  
Res ults i n persiste nt or si g nifica nt disa bilit y or i nca pacit y ( ie, s u bsta ntial disr u pti o n of a pers o n’s 
a bilit y t o c o n d uct n or mal life f u ncti o ns) 
•  
C o nsists of a c o n ge nital a n o mal y or birt h defect i n t he offs pri n g of a patie nt  
•  
Is a me dicall y i m p orta nt e ve nt, base d u p o n t he me dical j u d g me nt  of t he I n vesti gat or , t hat ma y 
je o par dize t he patie nt  a n d ma y re q uire me dical or s ur gical i nter ve nti o n t o pre ve nt o ne of t he 
o utc o mes liste d a b o ve  
H os pitalizati o n is defi ne d as a n y i nitial a d missi o n (e ve n less t ha n 2 4 h o urs) i n a h os pital or e q ui vale nt 
healt hcare facilit y. A n e mer ge nc y r o o m visit d oe s n ot necessaril y c o nstit ute a h os pitalizati o n, h o we ver, 
t he e ve nt lea di n g t o t he e mer ge nc y r o o m visit is assesse d f or me dical i m p orta nce. H os pitalizati o n i n t he 
a bse nce of a preci pitati n g cli nical A E is n ot itself a n S A E. E xa m ples i ncl u de o pti o nal a d missi o n f or 
electi ve s ur ger y, a d mi nistrati ve a d missi o n (f or a yearl y p h ysical or re g ular dia g n ostic pr oce d ure n ot 
ass ociate d wit h a n A E), or a d missi o n f or treat me nt of a pre -e xisti n g c o n diti o n n ot ass ociate d wit h t he 
de vel o p me nt of a ne w A E or t he w orse ni n g of a pre- e xisti n g c o n diti o n. 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 0  of 9 7  
8. 2  
Eliciti n g A d verse E ve nt I nf or m ati o n  
T he peri o d of o bser vati o n f or A Es  a n d S A Es  e xte n ds fr o m t he ti me t he patie nt si g ns t he I C F u ntil e xit 
fr o m t he st u d y. At eac h st u d y visit patie nts will be as ke d a sta n dar d q uesti o n t o elicit a n y me dicall y 
relate d c ha n ges i n t heir well- bei n g. T he y will als o be as ke d if t he y ha ve bee n h os pitalize d, ha d a n y 
acci de nts, use d a n y ne w me dicati o ns, or c ha n ge d c o nc o mita nt me dicati o n re gi me ns ( b ot h prescri pti o n 
a n d o ver-t he-c o u nter me dicati o ns). 
I n a d diti o n t o patie nt o bser vati o ns, A Es will be d oc u me nte d fr o m a n y data c ollecte d o n t he s o urce 
d oc u me nt a n d e C R F ( e g, la b orat or y val ues, p h ysical e xa mi nati o n fi n di n gs, me dical hist or y, E C G 
c ha n ges), or ot her d oc u me nts ( e g, patie nt diaries) t hat are rele va nt t o patie nt safet y. A d verse me dical 
c o n diti o ns prese nt at Baseli ne or si nce last assess me nt w hic h bec ome w orse f oll o wi n g e x p os ure t o st u d y 
dr u g s h o ul d be c o nsi dere d A Es . A n y la b orat or y val ues t hat e mer ge or w orse n si nce t he last la b orat or y 
assess me nt a n d are dee me d cli nicall y si g nifica nt b y t he I n vesti gat or s h o ul d be c o nsi dere d A Es . 
8. 3  
A d verse E ve nt R e p orti n g   
B ot h A Es  a n d S A Es  will be rec or de d fr o m t he ti me t he patie nt si g ns t he I C F u ntil Visit  1 7 or Earl y 
Ter mi nati o n  Visit, w hic he ver occ urs first. All A Es  m ust be f ull y rec or de d  i nt o t he s o urce d oc u me nts 
t hr o u g h o ut t he e ntire st u d y peri o d a n d will be tra nscri be d i nt o t he A E e C R F, w het her or n ot t he y are 
c o nsi dere d t o be dr u g relate d.  
If a dia g n osis c o ul d be esta blis he d, rec or d t he dia g n osis as A E; If i m p ossi ble t o esta blis h a dia g n osis, 
rec or d Si g ns a n d s y m pt o ms as A Es u ntil a dia g n osis c o ul d fi nall y be deter mi ne d, i nf or mati o n i ncl u di n g 
si g ns a n d s y m pt o ms of eac h A E s h o ul d be descri be d i n detail, i ncl u di n g  
•  
O nset ti me a n d date  
•  
O ffset ti me a n d date  
•  
S e verit y ( mil d, m o derate, se vere, life-t hreate ni n g, deat h)  
•  
Relati o ns hi p t o st u d y dr u g (relate d, n ot relate d), 
•  
A cti o n ta ke n wit h st u d y dr u g ( d ose n ot c ha n ge d, st u d y dr u g i nterr u pte d, st u d y dr u g wit h dra w n, n ot 
a p plica ble, u n k n o w n)   
•  
O utc o me  (rec o vere d/res ol ve d, rec o veri n g/res ol vi n g, n ot rec o vere d/ n ot res ol ve d, res ol ve d wit h 
se q uelae, fatal, u n k n o w n) 
A d verse e ve nts s h o ul d be f oll o we d u ntil t he e ve nt is res ol ve d a n d/ or sta bilize d w het her or n ot t he e ve nt 
is c o nsi dere d relate d t o st u d y dr u g. Ad verse e ve nt s res ulti n g fr o m c o nc urre nt ill nesses, reacti o ns t o 
c o nc urre nt ill nesses, reacti o ns t o c o nc urre nt me dicati o ns, or pr o gressi o n of disease states m ust als o be 
re p orte d. All A Es will be f oll o we d t o a de q uate res ol uti o n. Me dical Dicti o nar y f or Re g ul at or y Acti vities 
( Me d D R A) will be use d t o c o de A Es  a n d me dical hist or y . I n a d diti o n, t he W orl d Healt h Or ga nizati o n Dr u g 
Dicti o nar y ( W H O Dr u g ) will be use d t o c o de me dicati o n usa ge.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 1  of 9 7  
A n y me dical c o n diti o n t hat is prese nt at t he ti me t he patie nt is scree ne d b ut d oes n ot deteri orate s h o ul d 
n ot be re p orte d as a n A E. H o we ver, if it deteri orates at a n y ti me d uri n g t he st u d y, it s h o ul d be rec or de d 
as a n A E. 
8. 4  
Assess m e nt of A d verse E ve nt  C a us alit y  
T he i n vesti gat or’s assess me nt of  ca usalit y m ust be pr o vi de d f or all A Es (seri o us a n d n o nseri o us); t he 
i n vesti gat or m ust rec or d t he ca usal relati o ns hi p o n t he e C R F, a n d re p ort s uc h a n assess me nt i n 
acc or da nce wit h t he S A E re p orti n g re q uire me nts, if a p plica ble. A n i n vesti gat or’s ca usalit y assess me nt is 
t he deter mi nati o n of w het her t here e xists a reas o na ble p ossi bilit y t hat t he  I P ca use d or c o ntri b ute d t o a n 
A E; ge nerall y, t he facts (e vi de nce) or ar g u me nts t o s u g gest a ca usal relati o ns hi p s h o ul d be pr o vi de d. T he 
relati o ns hi p of eac h A E t o st u d y me dicati o n will be assesse d usi n g t he cate g ories i n Ta ble 4 . 
T a ble 4. 
A d verse E ve nt C a us alit y  
C a us alit y  C ate g or y  
Descri pti o n  
Relate d   
A n a d verse e ve nt  t hat f oll o ws a reas o na ble te m p oral se q ue nce fr o m a d mi nistrati o n of a 
dr u g (i ncl u di n g t he c o urse after wit h dra wal of t he dr u g), or f or w hic h p ossi ble 
i n v ol ve me nt of t he dr u g ca n n ot be r ule d o ut, alt h o u g h fact ors ot her t ha n t he dr u g, s uc h as 
u n derl yi n g diseases, c o m plicati o ns, c o nc o mita nt dr u gs a n d c o nc urre nt treat me nts, ma y 
als o be res p o nsi ble.   
N ot  relate d  
A n a d verse e ve nt  t hat d oes n ot f oll o w a reas o na ble te m p oral se q ue nce fr o m 
a d mi nistrati o n of a dr u g a n d/ or t hat ca n reas o na bl y be e x plai ne d b y ot her fa ct ors, s uc h as 
u n derl yi n g diseases, c o m plicati o ns, c o nc o mita nt dr u gs a n d c o nc urre nt treat me nts.  
  
If t he i n vesti gat or d oes n ot k n o w w het her or n ot t he I P ca use d t he e ve nt, t he n t he e ve nt will be ha n dle d 
as “relate d t o I P” f or re p orti n g p ur p oses, as defi ne d b y t he s p o ns or. If t he i n vesti gat or ca n n ot deter mi ne 
t he eti ol o g y of t he e ve nt b ut deter mi nes t hat I P di d n ot ca use t he e ve nt, t his s h o ul d be clearl y 
d oc u me nte d o n t he e C R F a n d S A E Re p ort F or m if a p plica ble. 
8. 5  
Assess m e nt of A d verse E ve nt  Se verit y  
T he i n vesti gat or ma y use t he C T C A E Versi o n 5. 0  t o assist i n t he deter mi nati o n of se verit y a n d cli nical 
si g nificance.  T he f oll o wi n g re prese nts C T C A E gra di n g of A E se verit y:   
•  Gr a de 1 /  Mil d : as y m pt o matic or mil d s y m pt o ms  or cli nical or dia g n ostic o bser vati o ns 
o nl y or i nter ve nti o n n ot i n dicate d 
•  Gr a de 2 /  M o der ate : mi ni mal, l ocal or n o n-i n vasi ve i nter ve nti o n i n dicate d or li miti n g a ge-
a p pr o priate i nstr u me nt al acti vities of dail y li vi n g  ( A D Ls). I nstr u me ntal A D Ls refer t o 
pre pari n g meals, s h o p pi n g f or gr oceries or cl ot hes, usi n g t he tele p h o ne, ma na gi n g m o ne y 
etc  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 2  of 9 7  
•  Gr a de 3 /  Se vere  o r Me dic all y Si g nific a nt  B ut  N ot I m me di atel y Life -
t hre ate ni n g: h os pitalizati o n or pr ol o n gati o n of h os pitalizati o n i n dicate d or disa bli n g or 
li miti n g self-care A D Ls.  Self -car e A D Ls refer t o b at hi n g, dressi n g a n d u n dressi n g, fee di n g 
self, usi n g t he t oilet, ta ki n g me dicati o ns a n d n ot be dri d de n  
•  Gr a de 4 / Life T hre ate ni n g  C o nse q ue nces : ur ge nt i nter ve nti o n i n dicate d.  
•  Gr a de 5 / De at h Rel at e d t o A E  
A Es n ot liste d b y t he C T C A E will be gra de d as f oll o ws:  
•  Gr a de 1 /  Mil d : disc o mf ort n otice d b ut n o disr u pti o n of n or mal dail y acti vit y  
•  Gr a de 2 / M o der ate : dis c o mf ort s ufficie nt t o re d uce or affect dail y acti vit y  
•  Gr a de 3 /  Se vere : i na bilit y t o w or k or perf or m n or mal dail y acti vit y 
•  Gr a de 4 /  Life T hre ate ni n g : re prese nts a n i m me diate t hreat t o life 
•  Gr a de 5 / De at h  
8. 6  
A d verse E ve nt  of S peci al I nterest  
A n  A E SI  is a n A E (seri o us or n o nseri o us) of scie ntific a n d me dical c o ncer n s pecific t o t he S p o ns or’s 
pr o d uct or pr o gra m, f or w hic h o n g oi n g m o nit ori n g a n d i m me diate n otificati o n b y t he I n vesti gat or t o t he 
S p o ns or is re q uire d. S uc h e ve nts ma y re q uire f urt her i n vesti gati o n i n or der t o c haracterize a n d 
u n dersta n d t he m. T hese e ve nts s h o ul d be mar ke d “ A E SI” i n t he E D C.  A d verse e ve nts of s pecial i nterest 
ma y be a d de d or re m o ve d d uri n g a st u d y b y pr ot oc ol clarificati o n n ote or a me n d me nt. 
A E SI s f or t his st u d y: 
•  
C o nj u ncti vitis 
•  
Keratitis  
•  
A na p h yla xis ( defi niti o n bel o w) 
•  
A E of i njecti o n site reacti o n lasti n g > 2 4 h o urs ( g ui da nce bel o w) 
•  
A S T/ A L T ele vate d > 5 X U L N  
•  
P arasitic a n d o p p ort u nistic i nfecti o ns  
•  
Pre g na nc y 
•  
S y m pt o matic o ver d ose (i.e. o ver d ose of st u d y dr u g res ulti n g i n a n a d verse e ve nt) 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 3  of 9 7  
C o nj u nctivitis  a n d ker atitis ha ve bee n s u bjects  of i nterest i n t he d u pil u ma b e x perie nce. (A ki nla de 2 0 1 9 ) 
re p orte d t hat i n t he c o m bi ne d d u pil u ma b e x perie nce i n at o pic der matitis patie nts ( n = 1 0 4 7) t here were a 
t otal of 9 0 ( 8. 6 %) patie nts re p orti n g at least 1 A E of “c o nj u ncti vitis” w hile t h ose patie nts i n t he place b o 
gr o u p ( n  = 5 1 7) re p orte d 1 1 ( 2. 1 %) s uc h e ve nts. C o nj u ncti vitis A Es were m ostl y mil d t o m o derate i n 
se verit y wit h se vere e ve nts re p orte d i n ≤ 0. 5 % of t he d u pil u ma b c o m bi ne d gr o u p vs. ≤ 0. 3 % of t he 
place b o gr o u p. T w o patie nts i n t he d u pil u ma b gr o u p per ma ne ntl y disc o nti n ue d st u d y dr u g treat me nt d ue 
t o a c o nj u ncti vitis e ve nt. O nset t y picall y occ urre d d uri n g Wee ks 4 t o 8 a n d e ve nts beca me less c o m m o n 
wit h l o n g -ter m treat me nt. C o nj u ncti vitis was m ore c o m m o n i n t h ose patie nts wit h se vere A D at baseli ne, 
t h ose wit h a pri or hist or y of c o nj u ncti vitis a n d t h ose wit h hi g her baseli ne le vels of T A R C a n d I g E. 
P o ole d d u pil u ma b data s u g geste d t hat c o nj u ncti vitis i nci de nce ma y decrease wit h hi g her tr o u g h 
c o nce ntrati o ns of d u pil u ma b.  
T his patter n was n ot o bser ve d i n d u pil u ma b st u dies i n ot her i n dicati o ns i ncl u di n g as t h ma a n d C R S w N P .  
D ue t o t he d u pil u ma b e x perie nce i n at o pic der matitis, o p ht hal mic a d verse e ve nts of  “c o nj u ncti vitis ” a n d 
“keratitis ” will be c o nsi dere d A Es of Special Interest ( A E SI)  a n d ma y  be e val uate d b y a n 
o p ht hal m ol o gist if dee me d a d visa ble b y t he I n vesti gat or or S p o ns or .  T he a p pr o priate treat me nt s h o ul d 
be re n dere d u ntil res ol uti o n.  
Ot her . I n a d diti o n t o c o nj u ncti vitis a n d keratitis, t he f oll o wi n g A E’s will als o be cate g orize d as A E SI’s: 
a na p h yla xis, i njecti o n site reacti o ns lasti n g l o n ger t ha n 2 4 h o urs, A S T/ A L T ele vate d > 5 X U L N, parasitic 
a n d o p p ort u nistic i nfecti o ns, pre g na nc y, a n d s y m pt o matic o ver d ose.  
A na p h yla xis will be defi ne d b y a c ollecti o n of s y m pt o ms descri be d b y Sa m ps o n et al. 2 0 0 6 a n d pr o vi de d 
bel o w:  
A na p h yla xis is hi g hl y li kel y w he n a n y o ne of t he f oll o wi n g 3 criteria are f ulfille d:  
1. Ac ute o nset of a n ill ness ( mi n utes t o se veral h o urs) wit h i n v ol ve me nt of t he s ki n, m uc osal tiss ue, or 
b ot h (e g, ge neralize d hi ves, pr urit us or fl us hi n g, s w olle n li ps-t o n g ue- u v ula) A N D A T L E A S T O N E O F 
T H E F O L L O WI N G:  
a. Res pirat or y c o m pr o mise (e g, d ys p nea, w heeze -br o nc h os pas m, stri d or, re d uce d Pea k 
E x pirat or y Fl o w ( P E F), h y p o xe mia)  
b. Re d uce d bl o o d press ure ( B P) or ass ociate d s y m pt o ms of e n d- or ga n d ysf u ncti o n (e g, 
h y p ot o nia [c olla pse], s y nc o pe, i nc o nti ne nce)  
2. T w o or m ore of t he f oll o wi n g t hat occ ur ra pi dl y after e x p os ure t o a li kel y aller ge n f or t h at patie nt 
( mi n utes t o se veral h o urs):  
a. I n v ol ve me nt of t he s ki n-m uc osal tiss ue (e g, ge neralize d hi ves, itc h -fl us h, s w olle n li ps-t o n g ue-
u v ula)  
b. Res pirat or y c o m pr o mise (e g, d ys p nea, w heeze- br o nc h os pas m, stri d or, re d uce d P E F, 
h y p o xe mia)  
c. Re d uce d B P o r ass ociate d s y m pt o ms (e g, h y p ot o nia [c olla pse], s y nc o pe, i nc o nti ne nce)  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 4  of 9 7  
d. Persiste nt gastr oi ntesti nal s y m pt o ms (e g, cra m p y a b d o mi nal pai n, v o miti n g)  
3. Re d uce d B P after e x p os ure t o k n o w n aller ge n f or t hat patie nt ( mi n utes t o se veral h o urs); s yst olic B P 
of less t ha n 9 0 m m H g or greater t ha n 3 0 % decrease fr o m t hat pers o n’s baseli ne.  
I njecti o n Site Re acti o n. Assess me nt of t he pre vi o us i njecti o n site will be d o ne pri or t o d osi n g a n d a gai n 
f oll o wi n g t he ne w i njecti o n pri or t o release of t he patie nt fr o m t he cli nic. A n assess me nt t o ol is pr o vi de d 
i n A p pe n di x D as a n ai d i n t he assess me nt of c o m m o n s y m pt o ms of i njecti o n site reacti o n s. T he use of 
t he assess me nt t o ol is e nc o ura ge d b ut t he I n vesti gat or ma y use t heir o w n j u d ge me nt a n d descri pti o n of 
s y m pt o ms i n t he assess me nt of i njecti o n sites f oll o wi n g a d mi nistrati o n of I M P. A n I njecti o n Site 
Reacti o n s h o ul d be re p orte d as a n A d verse E ve nt if t he I n vesti gat or j u d ges t he reacti o n as cli nicall y 
si g nifica nt. As a ge neral g ui da nce, a para meter gra de of less t ha n 2 is ge nerall y c o nsi dere d n ot cli nicall y 
si g nifica nt b ut t he I n vesti gat or s h o ul d use t heir j u d ge me nt i n t he re p orti n g of A Es. If t he A E of I njecti o n 
Site Reacti o n lasts l o n ger t ha n 2 4 h o urs, it will be c o nsi dere d a n A E SI. 
P ar asitic or O p p ort u nistic I nfecti o ns  sh o ul d be c o nsi dere d. Q uesti o ns c o ncer ni n g w het her or n ot a n 
i nfecti o n is c o nsi dere d a n o p p ort u nistic i nfecti o n ma y be disc usse d wit h t he Me dical M o nit or.  T he 
I n vesti gat or ma y als o refer t o Wi nt hr o p et al. 2 0 1 5 f or g ui da nce i n re p orti n g of o p p ort u nistic i nfecti o ns. 
8. 7  
M a n d at or y E arl y Ter mi n ati o n  
Usi n g C T C A E Versi o n 5. 0, patie nts w h o de vel o p a n y relate d gra de 2 or hi g her car di o vasc ular, 
res pirat or y or he mat ol o gic (e xa m ple e osi n o p hilia) T E A E or a n y relate d gra de 3 or hi g her T E A E 
i n v ol vi n g ot her or ga n s yste ms m ust be disc o nti n ue d fr o m f urt her st u d y dr u g treat me nt a n d m o nit ore d 
u ntil res ol uti o n or sta bilizati o n.  
8. 8  
Seri o us A d verse E ve nt Re p orti n g  
Seri o us A Es m ust be re p orte d t o t he S p o ns or or desi g nee wit hi n 2 4 h o urs of k n o wle d ge of t he e ve nt, if 
t he S A E is fatal or life-t hreate ni n g, n otificati o n t o s p o ns or/ C R O m ust be ma de i m me diatel y, irres pecti ve 
of t he e xte nt of a vaila ble e ve nt i nf or mati o n.  
All S A Es m ust be re p orte d i m me di atel y ( wit hi n 2 4 h o urs of disc o ver y) b y e m ail t o P are xel  wit h 
c o p y t o t he S p o ns or:  
S A E Re p orti n g e m ail: N ort h A meric a _ Me dic al @ P are xel.c o m  
C o p y t o S p o ns or: C B P - 2 0 1cli nic al @c o n nect p h ar m.c o m  
P are xel S afet y  S A E Re p orti n g F a x N u m ber:  + 1 7 8 1- 4 3 4- 5 9 5 7  
P are xel S afet y Re p orti n g Hel p Li ne:  + 1 7 8 1- 4 3 4- 5 0 1 0   
2 4/ 7 E mer ge nc y S p o ns or c o nt act: + 1 5 1 0- 5 2 0- 3 3 6 1   
T he i nitial re p ort s h o ul d i ncl u de all i nf or mati o n k n o w n at t he ti me of t he re p ort (a d diti o nal i nf or mati o n 
ca n be re p orte d as disc o vere d). D o n ot dela y t he i nitial re p orti n g i n or der t o o btai n res ol uti o n or f oll o w-
u p i nf or mati o n.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 5  of 9 7  
T he site will re p ort S A E(s ) b y c o m pleti n g a S A E Re p ort F or m, w hic h is pr o vi de d b y s p o ns or/ C R O. I n 
ge neral, t his will i ncl u de a descri pti o n of t he A E  i n s ufficie nt detail t o all o w f or a c o m plete me dical 
assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of p ossi ble ca usalit y. A n y i nf or mati o n rele va nt t o 
t he e ve nt, s uc h as c o nc o mita nt me dicati o ns a n d ill nesses m ust be pr o vi de d. S A E Re p ort F or m will 
i ncl u de t he f oll o wi n g i nf or mati o n, as a vaila ble:  
•  
Patie nt  I D n u m ber 
•  
C o u ntr y w here e ve nt occ urre d  
•  
E ve nt I nf or mati o n  
•  
List of rele va nt te st res ults a n d la b orat or y data  
•  
A n y ot her rele va nt hist or y  
•  
W het her t he st u d y dr u g treat me nt was disc o nti n ue d  
•  
I n vesti gat or’s assess me nt of ca usalit y  
T he C R O Me dical M o nit or or C R O desi g nee / S p o ns or desi g nee ma y c o ntact t he I n vesti gat or t o re q uest 
a d diti o nal i nf or mati o n re gar di n g t he e ve nt or t o c o nfir m i nf or mati o n. All S A Es will be e ntere d o n t he 
A E case re p ort f or m . T he sa me n o me nclat ure s h o ul d be use d o n b ot h t he S A E re p ort f or m a n d t he A E 
case re p ort f or m . T he I n vesti gat or is res p o nsi ble f or t he c o m plete a n d ti mel y re p orti n g of all S A Es t o t he 
S p o ns or ( or desi g nee), re p orti n g perti ne nt f oll o w- u p i nf or mati o n o n t he S A E, a n d n otif yi n g t he 
a p pr o priate I R B/I E C of t he occ urre nce of a n d details s urr o u n di n g t he e ve nt i n acc or da nce wit h l ocal 
re g ulati o ns. I n t he e ve nt t here is a q uesti o n as t o w het her t he A E is seri o us, t he e ve nt s h o ul d be re p orte d.  
A n y S A E br o u g ht t o t he atte nti o n of t he I n vesti gat or at a n y ti me after t he e n d of t he st u d y f or t he patie nt  
a n d c o nsi dere d b y hi m/ her t o be ca use d b y t he st u d y me dicati o n wit h a reas o na ble p ossi bilit y, s h o ul d be 
re p orte d t o t he m o nit ori n g tea m or s p o ns or/ desi g nee wit hi n 2 4 h o urs. 
8. 8. 1  S us p ect e d U n e x p ect e d S eri o us A d v ers e R e acti o ns  
Seri o us A Es a n d s us pecte d u ne x pecte d seri o us a d verse reacti o ns (S U S A Rs ) are n ot treate d differe ntl y 
u ntil a n S A E is deter mi ne d t o be a S U S A R. T he I n vesti gat or will re p ort all S A Es t o  t he S P O N S O R 
wit hi n a gree d ti meli nes .  
A n A E is “ u ne x pecte d” o nl y if its nat ure a n d se verit y are n ot c o nsiste nt wit h t he i nf or mati o n pr o vi de d b y 
t he S p o ns or a b o ut t he me dici nal pr o d uct. I n t he case of a pr o d uct wit h a mar keti n g a ut h orizati o n, t his 
i nf or mati o n is f o u n d i n t he s u m mar y of pr o d uct c haracteristics; i n t he case of a n y ot her i n vesti gati o nal 
me dici nal pr o d uct, it is f o u n d i n t he I n vesti gat or’s Br oc h ure relati n g t o t he trial i n q uesti o n. T here is 
li mite d cli nical e x perie nce wit h C B P- 2 0 1 i n patie nts wit h r hi n osi n usitis  wit h nasal p ol y ps  a n d ast h ma . 
Beca use d u pil u ma b is a mar kete d pr o d uct i n t he sa me class t hat bi n ds t o t he sa me tar get (I L 4 Ral p ha), 
S A Es n ot c urre ntl y reflecti ve of safet y prese nte d i n t he d u pil u ma b pac ka ge i nsert, fr o m t he 
I n vesti gat or’s Br oc h ure, or S A Es n ot c o nsiste nt wit h t he me dical hist or y of t he patie nt  will be 
c o nsi dere d as S U S A Rs.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 6  of 9 7  
A S U S A R  t hat is fatal or life-t hreate nin g m ust be re p orte d t o t he I R B/ E C, t he U S F o o d a n d Dr u g 
A d mi nistrati o n ( F D A) , a n d/ or ot her c o m pete nt a ut h orit ies wit hi n 7 da ys  after t he S p o ns or bec o me s 
a ware of t he e ve nt . T he I n vesti gat or is res p o nsi ble f or n otif yi n g t he I R B/ E C a n d t he S p o ns or is 
res p o nsi ble f or n otif yi n g t he c o m pete nt re g ulat or y a ut h orities. A n y a d diti o nal i nf or mati o n m ust be 
re p orte d wit hi n 8 da ys of se n di n g t he first re p ort.  
A S U S A R  t hat is n ot fatal or life-t hreate ni n g m ust be re p orte d t o I R B/E C, F D A, a n d/ or ot her c o m pete nt 
a ut h orit ies as s o o n as p ossi ble ( wit hi n 1 5 da ys) after t he S p o ns or bec o me s a ware of t he e ve nt . T he 
I n vesti gat or is res p o nsi ble f or re p orti n g t o t he I R B/ E C a n d t he S p o ns or is res p o nsi ble f or n otif yi n g t he 
c o m pete nt re g ulat or y a ut h orities .  
I n a d diti o n, S U S A R s will be re p orte d t o a n y I R Bs/ E Cs a n d Pri nci pal I n vesti gat ors as re q uire d i n t he 
l ocal le gislati o n. Re p orti n g will be t o t he E ur o pea n Me dici nes A ge nc y a n d E U me m ber states via 
E u dra vi gila nce. 
Peri o dic a n d a n n ual re p orti n g will be perf or me d per c o u ntr y- s pecific g ui deli nes. 
8. 9  
Pre g n a nc y Re p orti n g  
F or t he p ur p oses of t his st u d y, pre g na nc y of a n y fe male patie nt will be c o nsi dere d a n A E SI  a n d s h o ul d 
be re p orte d wit hi n 2 4 h o urs t o t he me dical m o nit or a n d S p o ns or o n t he Pre g na nc y F or m. T he patie nt will 
be as ke d t o pr o vi de i nf or mati o n o n t he o utc o me of t he pre g na nc y, i ncl u di n g pre mat ure ter mi nati o n 
(electi ve a b orti o n). S p o nta ne o us miscarria ge a n d c o n ge nital a b n or malities will be re p orte d as a n S A E 
a n d a n S A E f or m s h o ul d be s u b mitte d. Pre g na nc y itself is n ot a n S A E.  Fe male patie nts bec o mi n g 
pre g na nt d uri n g t he st u d y a n d after ra n d o mizati o n m ust be i m me diatel y wit h dra w n fr o m st u d y dr u g 
treat me nt a n d f oll o we d t o res ol uti o n, w hic h i ncl u des birt h or ter mi nati o n of t he pre g na nc y. E ver y 
atte m pt s h o ul d be ma de t o f oll o w t he pre g na nc y t o c o m pleti o n. If p ossi ble, birt hs will be f oll o we d b y t he 
I n vesti gat or f or 8 wee ks f or o bser vati o n of p ossi ble c o n ge nital a b n or malities. Pre g na ncies of a male 
patie nt’s part ner will n ot be c o nsi dere d a n A E a n d t he male patie nt s h o ul d n ot be wit h dra w n fr o m t he 
st u d y. If a male patie nt’s part ner bec o mes pre g na nt d uri n g t his ti me peri o d (fr o m first d ose u ntil 8 wee ks 
after t he last d ose), t he I n vesti gat or will i nf or m t he S p o ns or, a n d t he I R B or E C, as a p pr o priate, as well 
as pr o vi di n g t he a p pr o priate me dical f oll o w - u p if a gree d t o b y t he part ner.  
9  
S T A TI S TI C A L M E T H O D S  
C o m plete details of t he statistical a nal yses a n d met h o ds, i ncl u di n g data c o n ve nti o ns, a n d an y s u bgr o u p 
c o m paris o ns will be c o ntai ne d i n a se parate S tatistical A nal ysis Pla n. 
9. 1  
S a m ple Size  
T he sa m ple size esti mati o n is base d o n t he c o m paris o n bet wee n C B P -2 0 1 3 0 0 m g e ver y 2 wee ks  vs. 
place b o wit h re gar d t o t he c o- pri mar y e n d p oi nt c ha n ge fr o m baseli ne i n N P S at Wee k 2 4 ( LI B E R T Y 
SI N U S st u dies, Bac hert et al 2 0 1 9). 
Ass u mi n g a c o m m o n sta n dar d de viati o n i n t he N P S of 2. 1, a n d base d o n t he use of a t w o- si de d test at t he 
al p ha = 0. 0 5 le vel  of si g nifica nce 4 1 patie nts per gr o u p will pr o vi de 8 0 % p o wer t o detect a differe nce of 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 7  of 9 7  
1. 3 bet wee n t he C B P - 2 0 1 gr o u p a n d t he place b o gr o u p i n t he c ha n ge of N P S fr o m baseli ne t o Wee k 2 4. 
T o all o w f or a 1 5 % dr o p o ut rate, t he pla n ne d sa m ples size is 4 9 s u bjects per gr o u p ( 1 4 7 t otal).   
•  
R o u g hl y, t o e ns ure at least 7 4 patie nts ha ve c o-m or bi d ast h ma:  Recr uit me nt of N P patie nt wit h o ut 
c o- m or bi d ast h ma will st o p w he n a p pr o xi matel y 7 0  patie nts wit h o ut ast h ma are ra n d o mize d, a n d  
•  
Patie nts wit h c o - m or bi d ast h ma will c o nti n ue t o be ra n d o mize d t o c o m plete a t otal n u m ber of 1 4 7 
ra n d o mize d N P patie nts.  
If greater t ha n 1 5 % of t he treate d patie nts d o n ot c o m plete t he st u d y, t he sa m ple size ma y be a dj uste d  t o 
e ns ure a de q uate p o wer. 
9. 2  
A n al ysis P o p ul ati o ns 
Fi ve p o p ulati o ns will be defi ne d: Ra n d o mise d Set ( R S) , F ull A nal ysis Set ( F A S), Per Pr ot oc ol Set ( P PS), 
Safet y Set ( S S) , a n d P K Set ( P K S) . T he efficac y a nal yses will be c o n d ucte d acc or di n g t o t he treat me nt t o 
w hic h t he patie nts are ra n d o mize d.  
R a n d o mise d Set  
T he Ra n d o mise d p o p ulati o n c o nsists of all patie nts w h o are ra n d o mize d i n t he st u d y t o treat me nt.   
F ull A n al ysis Set  
T he pri mar y a nal yses of all efficac y e n d p oi nts will be c o n d ucte d i n t he F ull A nal ysis Set ( F A S), defi ne d 
as all ra n d o mize d patie nts w h o recei ve at least 1 d ose of st u d y treat me nt a n d at least o ne pri mar y 
e n d p oi nt dat u m c ollecte d d uri n g t he treat me nt peri o d .  
Per Pr ot oc ol Set  
T he Per Pr ot oc ol Set , a s u b gr o u p of t he F A S, i ncl u des patie nts wit h o ut maj or pr ot oc ol 
de viati o ns. S u p p orti ve efficac y a nal yses will be c o n d ucte d i n t he P P S p o p ulati o n. 
S afet y Set   
T he a nal ysis p o p ulati o n f or t he safet y e n d p oi nts will be t he Safet y Set . T he Safet y Set  c o nsists of all 
ra n d o ml y assi g ne d patie nts w h o recei ve d at least 1 d ose of st u d y treat me nt. T hese patie nts will be 
cate g orize d acc or di n g t o t he treat me nt t he y act uall y recei ve d. 
P h ar m ac o ki netic Set   
T he P K Set  c o nsists of all ra n d o ml y assi g ne d patie nts fr o m w h o m at least 1 p ost- d ose P K bl o o d sa m ple 
was c ollecte d.  P D/ P K relati o ns hi ps will be e x pl ore d i n a se parate a nal ysis pla n a n d re p ort.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 8  of 9 7  
9. 3  
I nteri m A n al ysis 
T here is n o i nt eri m a nal ysis pla n ne d f or t his st u d y. T he pri mar y a nal ysis is pla n ne d w he n t he last patie nt 
c o m pletes Wee k 3 2 visit. 
9. 4  
St atistic al Met h o d ol o g y 
All statistical tests will be 2 -si de d wit h a si g nifica nce le vel of α  = 0. 0 5, u nless ot her wise state d. 
C o nti n u o us varia bles will be s u m marize d b y descri pti ve statistics , i ncl u di n g t he n u m ber of patie nts, 
mea n, sta n dar d de viati o n ( S D), me dia n, mi ni m u m, ma xi m u m, a n d t he g e o metric mea n, w here 
a p pr o priate. Cate g orical varia bles will be prese nte d wit h t he fre q ue nc y a n d perce nta ge i n eac h cate g or y 
b y treat me nt gr o u p . S pecific statistical met h o d ol o g y will be pr o vi de d i n t he Statistical A nal ysis Pla n t o 
be c o m plete d bef ore t he u n bli n di n g of t he st u d y data.  
9. 5  
Effic ac y A n al ysis 
9. 5. 1  C o -Pri m ar y E n d p oi nts  a n d Effic ac y A n al ysi s 
E n d osc o pic N P S  
A li near mi xe d m o del will be a p plie d t o c ha n ge fr o m baseli ne t o eac h ti me p oi nt t hr o u g h Wee k 2 4 i n 
e n d osc o pic N P S. T he fi xe d effects will i ncl u de treat me nt gr o u p, e n d osc o pic N P S at baseli ne, visit, 
i nteracti o n bet wee n treat me nt gr o u p a n d visit, a n d t he prese nce of c o m or bi d ast h ma i n t he m o del. Patie nt 
will be i ncl u de d as ra n d o m effect. T he c o varia nce matri x a p plie d t o t he wit hi n- s u bject err or will be 
esti mate d b y Restricte d ma xi m u m li keli h o o d ( R E M L). T he Ke n war d- R o ger a p pr o xi mati o n will be use d 
t o esti mate t he de gree of free d o m. Details of ass u m pti o n o n varia nce str uct ure will be descri be d i n t he 
S A P.  
A ver a ge D ail y N C S  
A si milar li near m o del will be use d t o a nal yze a vera ge dail y nas al c o n gesti o n sc ore ( N C S). 
Usi n g t hese t w o m o dels, t he pri mar y a n al ysis f or eac h pri mar y e n d p oi nt will c o m pare t he C B P-
2 0 1 Q 2 W 3 0 0 m g gr o u p t o t he place b o gr o u p usi n g a t w o-si de d test at t he al p ha= 0. 0 5 le vel of 
si g nifica nce.  “ St u d y s uccess” is defi n e d as a statisticall y si g nifica nt res ult f or b ot h of t he c o -
pri mar y e n d p oi nts. 
9. 5. 2  S ec o n d ar y A n al ys es  
Usi n g t he sa me m o dels descri be d i n Secti o n 1 0. 3. 1, t he c o m paris o ns bet wee n t he C B P- 2 0 1 
Q 4 W 3 0 0 m g gr o u p t o t he place b o gr o u p usi n g a t w o-si de d test at t he al p ha = 0. 0 5 le vel of 
si g nifica nce.  “ St u d y s uccess” f or t he Q 4 W gr o u p is defi ne d as a statisticall y sig nifica nt res ult 
f or b ot h of t he c o- pri mar y e n d p oi nts.   


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 7 9  of 9 7  
H o we ver, if t he pri mar y a nal ysis is n ot statisticall y si g nifica nt f or o ne or b ot h of t he t w o c o-
pri mar y e n d p oi nts, t he res ults fr o m t he sec o n dar y a nal ysis will be e x pl orat or y rat her t h a n 
c o nfir mat or y . 
T he si milar a nal yses t o e n d osc o pic N P S will be perf or me d f or eac h s ec o n d ar y c o nti n u o us 
varia ble : 
•  Perce nta g e of ma xillar y si n us v ol u me occ u pie d b y disease o n C T a n d L u n d- Mac ka y 
C o m p ute d T o m o gra p h y sc ores fr o m patie nts e nr olle d at St u d y Sites  t hat are a p pr o ve d 
a n d q ualifie d t o perf or m C T sca ns 
•  U ni versit y of Pe n ns yl va nia S mell I de ntificati o n Test ( U P SI T)  
•  Vis ual a nal o g ue scale  f or r hi n osi n usitis ( V A S-R S)  
•  T otal nasal  s y m pt o m sc ore ( T N S S) 
•  2 2- ite m Si n o nasal O utc o me Test ( S N O T - 2 2) 
•  A vera g e dail y a nteri or r hi n orr hea sc ore  
•  A vera g e dail y p osteri or r hi n orr hea sc ore 
•  A vera g e dail y l oss of s mell sc ore  
•  Dail y s u bject -assess e d nasal pea k i ns pirat or y fl o w ( N PI F) 
Pr o p orti o n of patie nts re q uiri n g resc ue treat me nt (s yste mic C S f or > 5 c o nsec uti ve da ys) or 
ha vi n g ha d s ur ger y f or n asal p ol y ps t hr o u g h Wee k 2 4 will be calc ulate d wit h t he c orres p o n di n g 
9 5 % CI b y tr eat me nt gr o u p. T he differe nce bet w ee n eac h C B P- 2 0 1 gr o u p a n d place b o gr o u p 
a n d t he c orres p o n di n g 9 5 % CI will be calc ulat e d as well. T he C oc hra n -Ma ntel -Hae ns zel 
(C M H ) test a dj uste d b y c o m or bi d ast h ma will be perf or me d t o c o m pare t he pr o p orti o n bet wee n 
eac h C B P - 2 0 1 gr o u p a n d place b o gr o u p. 
T he Ka pla n -Meier pl ot will be prese nte d f or t he ti me t o resc ue treat me nt (s yste mic C S f or > 5 
c o nsec uti ve da ys) or s ur g er y f or n asal p ol y ps t hr o u g h Wee k 2 4. M e dia n of t he ti me a n d t he 
c orres p o n di n g 9 5 % CI will be calc ulate d f or eac h treat me nt gr o u p. T he e ve nt- free rate at Wee k 
2 4 wee k will be pr ese nte d wit h 9 5 % CI. L o g- ra n k test will be perf or me d t o co m pare t he e ve nt 
free distri b uti o n bet wee n eac h C B P- 2 0 1 gr o u p a n d place b o gr o u p. 
All sec o n dar y a nal yses will be c o n d ucte d usi n g t w o-si de d tests at t he al p ha = 0. 0 5 le vel of 
si g nifica nce.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 0  of 9 7  
9. 5. 3  E x pl or at or y A n al ys es  
E x pl orat or y a nal ys es will be d o ne usi n g a si milar m o del t o t he pri mar y e n d osc o pic N P S 
e n d p oi nt a nal ysis.  E n d p oi nts will i ncl u de: 
•  C ha n ge fr o m bas eli ne at Wee k 2 4 i n F E V 1 f or s u bjects wit h ast h ma 
•  Pr o p orti o n of patie nts wit h mi ni mal cli nicall y i m p orta nt differe nce > 8. 9 i n S N O T- 2 2 at 
Wee k 2 4  
•  C ha n ge fr o m bas eli ne at Wee k 1 6 i n e n d os c o pic N P S 
•  C ha n ge fr o m bas eli ne at Wee k 1 6 i n A v era g e dail y N C S  
•  C ha n ge fr o m bas eli ne at Wee k 2 4 i n E ur o p ea n q u alit y of life scale ( E Q 5 D- 5 L)  
•  Healt hcare r es o urce utilizati o n t hr o u g h Wee k 2 4 
9. 6  
S afet y D at a A n al ysis 
A d verse e ve nts will be c o de d usi n g t he Me d D R A. Treat me nt- e mer ge nt a d verse e v e nts ( T E A Es) 
are defi ne d as a n y A Es o cc urr e d or w orse n d uri n g t he treat me nt peri o d fr o m first a d mi nistrati o n 
of st u d y treat me nt t o e n d of t he f oll o w- u p peri o d, w het her or n ot c o nsi dere d relate d t o t he 
treat me nt. T he i nci de n ce of T E A Es will be pres e nte d o verall, b y s yste m or g a n class ( S O C), a n d 
b y preferre d t er m f or eac h treat me nt gr o u p. I n ci de nce of A Es b y s e verit y a n d relati o ns hi p t o 
st u d y dr u g will als o be prese nte d f or eac h treat me nt gr o u p. Deat hs, S A Es, A E SIs a n d a d verse 
e ve nts res ulti n g i n disc o nti n uati o n fr o m t he st u d y will be s u m marize d b y treat me nt gr o u p. 
Safet y la b orat or y p ar a meters, A D A  a n d N A b, vital si g ns, E C G para meters will be s u m marize d 
b y treat me nt gr o u p a n d b y sc he d ule d visit. C ha n ge fr o m Baseli ne i n t hese c o nti n u o us 
para meters will als o be s u m marize d b y treat me nt gr o u p a n d b y sc he d ul e d visit. 
F or A E SI, t he p erce nta ge of s u bjects wit h i nci de nt A E, t he ris k differe nce, its 9 5 % c o nfi de nce 
i nter val, a n d p- v al ue will be pr o vi de d. T he c o nfi d e nce i nter v als a n d p-v al ues are n ot a dj uste d 
f or m ulti plicit y a n d t heref ore m ust be c o nsi dere d acc or di n gl y. T h e re q uire me nt will be at least 4 
s u bjects i n a n y treat me nt ar m. T he c ut-off of at least 4 e ve nts was c h ose n b eca use t h e 9 5 % 
c o nfi de nc e i nter val f or t h e bet wee n -gr o u p differe n ce i n perce nt i nci de n ce will al wa ys i ncl u de 
zer o w h e n treat me nt gr o u ps of e q ual size eac h h a ve less t ha n 4 e ve nts a n d s o a d ds little t o t he 
i nter pretati o n of p ote ntiall y mea ni n gf ul differe nces.  
T w o a p pr oac hes will be use d f or ha n dli n g safet y data occ urri n g aft er t he i nitiati o n of resc ue 
t hera p y. T he first a p pr o ac h will e xcl u de all data f oll o wi n g t he i nitiati o n of resc ue, i n or d er 
t o a v oi d t he c o nf o u n di n g i nfl ue nce of t h e res c ue t hera p y. T h e sec o n d a p pr oac h will i nclu de data 
f oll o wi n g t he i nitiati o n of resc u e t her a p y. F or t he o verall st u d y a nal yses, t h e “i ncl u di n g res c ue” 
a p pr oac h will be c o nsi dere d pri mar y f or all safet y e n d p oi nts.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 1  of 9 7  
 
9. 7  
Missi n g D at a 
Ha n dli n g of missi n g data will be detaile d i n t he S A P.   
F or t he pri mar y  a nal ys es, missi n g val ues at wee k 2 4 will be i m p ute d usi n g met h o ds detaile d  i n 
t he S A P.  I n brief, t he pri mar y a nal ysis w o ul d be M M R M ( mi xe d m o del re peate d meas ures) 
w hic h will be perf or me d t o miti gate t he i m pact of missi n g data. T his a p pr oac h ass u mes t hat  
missi n g o bser vati o ns are missi n g- at-ra n d o m ( missi n g ness is relate d t o o bser ve d data) d uri n g t he 
st u d y a n d b orr o ws i nf or mati o n fr o m patie nts i n t he sa me treat me nt ar m ta ki n g i nt o acc o u nt b ot h 
t he missi n g ness of data a n d t he c orr elati o n of t he re peate d m eas ure me nts. All sec o n dar y a n d 
e x pl orat or y efficac y a n al yses  ma y  be c o n d u cte d usi n g si milar i m p utati o n f or missi n g val ues as 
detaile d  i n t he S A P. 
Safet y a nal yses, will be c o n d ucte d usi n g a vaila ble data wit h n o i m p utati o n f or missi n g val ues.   
 
9. 8  
Se nsiti vit y A n al ysis  
Se nsiti vit y a nal yses will be c o n d ucte d t o c o nfir m t he r o b ust ness of t he res ults f or t he pri mar y  
a nal yses.  T hes e ma y i ncl u de patter n mi xt ure m o d el -m ulti ple i m p utati o n ( P M M - MI), c o ntr ol-
base d P M M -MI wit h a nal ysis of c o varia nce ( A N C O V A) m o del a n d/ or ti p pi n g p oi nt a nal yses, 
as a p pr o priat e. T he d etails will be o utli ne d i n t he S A P. 
9. 9  
M ulti p licit y C o nsi der ati o ns 
T he use of a fi xe d se q u e nce testi n g pr oce d ure f or t he pri mar y  a n al yses c o ntr ols t he o verall 
le vel of si g nifica nce f or t hese c o nfir m at or y a n al yses.  All ot her a nal yses will be c o n d ucte d 
usi n g t w o- si de d tests at t he al p ha =0. 0 5 l e vel of si g nifica nce, wit h n o c o ntr ol f or m ulti plicit y. 
 
9. 1 0  P h a r m ac o ki netic A n al ysis  
W h ole bl o o d f or plas ma C B P- 2 0 1 c o nce ntrati o ns will be o btai ne d a n d a nal yze d. T he i n di vi d ual a n d 
treat me nt gr o u p stea d y-state tr o u g h P K pr ofile will be calc ulate d.  
A d diti o nal sa m pli n g will be o btai ne d after t he last treat me nt d ose, as n ote d i n t he sc he d ule of 
assess me nts  (Ta ble 1 ), t o c haracterize t he ret ur n t o Baseli ne. 
T he details of P K a nal ysis will be re p orte d i n a se parat e a nal ysis pla n a n d  P K a nal ysis re p ort.  


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 2  of 9 7  
9. 1 1  P h ar m ac o d y n a mic A n al ysis 
P har mac o d y na mic e n d p oi nt a nal yses will be c o nsi dere d e x pl orat or y.  P D e n d p oi nts i ncl u di n g I g E, E C P, 
T A R C, e osi n o p hil c o u nt, E ota xi n- 3, a n d peri osti n i n t he bl o o d will be s u m marize d b y treat me nt gr o u p. 
E x pl orat or y P K/ P D a nal yses will be detaile d i n a se parate a nal ysis pla n a n d re p ort.  
9. 1 2  De m o gr a p hic a n d Me dic al Hist or y  
De m o gra p hic c haracteristics (e g, se x, a ge, wei g ht, hei g ht , et h nicit y) a n d me dical hist or y wit h disease -
rele va nt baseli ne c haracteristics (e g, L M K C T sc ore, N P S, N C S, N PI F, p ul m o nar y f u ncti o n, baseli ne 
s y m pt o m sc ores) will be s u m marize d  b y treat me nt gr o u p . All ot her baseli ne c haracteristics will be 
s u m marize d b y treat me nt gr o u p. 
9. 1 3  A n al ysis of C o nc o mit a nt Me dic ati o n Use 
C o nc o mita nt me dicati o ns will be c o de d acc or di n g t o t he W H O Dr u g. C o nc o mita nt me dicati o ns will be 
s u m marize d o verall a n d b y dr u g classificati o n b y treat me nt gr o u p. 
9. 1 4  A n al ysis of E x p os ure t o St u d y Dr u g  
T he d urati o n of e x p os ure will be calc ulate d usi n g t he first a n d last da y of st u d y dr u g d osi n g. A s u m mar y 
of t he d urati o n will be prese nte d  b y treat me nt gr o u p. 
9. 1 5  Pr ot oc ol Vi ol ati o ns 
A list of patie nt s wit h pr ot oc ol vi olati o ns will be c o m plete d base d o n e ntr y criteria a n d vi olati o ns fr o m 
st u d y c o n d uct a n d assess me nts. T he n u m ber of patie nt s wit h maj or  pr ot oc ol vi olati o ns will be 
s u m marize d b y treat me nt gr o u p.  
1 0  D A T A H A N D LI N G A N D Q U A LI T Y A S S U R A N C E  
1 0. 1  C ase Re p ort F or ms  
St u d y data is rec or de d usi n g a n e C R F via t he Me di data R A V E s yste m pr o vi de d b y t he c o ntracte d C R O. 
T he o verall pr oce d ures f or q ualit y ass ura nce of cli nical st u d y data i ncl u di n g data c ollecti o n a n d 
ma na ge me nt, are descri be d i n t he Data Ma na ge me nt Pla n ( D M P).  
St u d y data will be e ntere d i n t he e C R F via Electr o nic Data Ca pt ure ( E D C)  b y cli nical researc h staff at 
eac h cli nical site  fr o m t he s o urce d oc u me nts.  
St u d y data will als o be rec or de d o n s o urce d oc u me nts mai ntai ne d  b y cli nical researc h staff at eac h 
i n vesti gati ve site. S o urce d oc u me nts ma y i ncl u de me dical rec or ds, la b orat or y  re p orts, patie nt diaries, 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 3  of 9 7  
E C G a n d s pir o metr y pri nt o uts, c o ns ult n otes, I n vesti gat or n otes, a n d me dical hist or y data f r o m a pri mar y 
care p h ysicia n, healt h care pr ofessi o nal , or i nstit uti o n. Data rec or de d i n s o urce d oc u me nts will be 
tra nscri be d, w here necessar y a n d a p pr o priate, i nt o e C R Fs b y t he cli nical researc h staff at eac h 
i n vesti gati ve site. All s o urce d oc u me nts will be retai ne d at  t he cli nical site. P h ot oc o pies of c o m plete d 
s o urce d oc u me nts will be pr o vi de d o nl y if esse ntial (ie, f or re g ulat or y p ur p oses or if a pa n de mic -relate d 
q uara nti ne pre ve nts i n- pers o n access) at t he re q uest of t he S p o ns or or its desi g nee a n d o nl y if t here is a n 
a p pr o priate S O P  is i n place t o e ns ure data i nte grit y a n d patie nt pri vac y i n t he case of s uc h a tra nsfer. 
T he e C R Fs m ust be ke pt i n or der a n d u p- t o-date s o t hat t he y al wa ys reflect t he latest o bser vati o ns o n t he 
e nr olle d patie nts. 
Eac h patie nt ’s s o urce d oc u me nts s h o ul d ha ve t he ori gi nal si g ne d I C F attac he d. W he n t he st u d y treat me nt 
is c o m plete d, t he I C F s h o ul d be ke pt wit h a c o p y of t he c o m plete d e C R F i n t he a p pr o priate file met h o d 
pr o vi de d, or wit h a n ote t o i n dicate w here t he rec or ds ca n be l ocate d . All rec or ds s h o ul d be ke pt i n 
c o nf or ma nce t o a p plica ble nati o nal la ws a n d re g ulati o ns. 
All ori gi nal si g ne d la b o rat or y re p orts m ust be a vaila ble f or re vie w.  
T he e C R Fs m ust be re vie we d , a ut h orize d, a n d si g ne d b y t he I n vesti gat or. T he pr oce d ures a n d pr ot oc ol 
f or electr o nic si g nat ure, if a p plica ble, will be pr o vi de d t o a n d disc usse d wit h t he I n vesti gat or a n d 
trai ni n g will be pr o vi de d. 
1 0. 2  M o nit ori n g of t he St u d y  
T he C R O’s Cli nical M o nit or , as a re prese ntati ve of t he S p o ns or, has t he o bli gati o n t o f oll o w t he st u d y 
cl osel y. I n d oi n g s o, t he M o nit or will visit t he Pri nci pal I n vesti gat or or S u b -I n vesti gat or a n d st u d y 
facilit y at peri o dic i nter vals, i n a d diti o n t o mai ntai ni n g necessar y c o ntact t hr o u g h tele p h o ne, e-mail, 
facsi mile, a n d letter . T he M o nit or will mai ntai n c urre nt pers o nal k n o wle d ge of t he st u d y t hr o u g h 
o bser vati o n, re vie w of st u d y rec or ds a n d s o urce d oc u me ntati o n, a n d disc ussi o n of t he c o n d uct of t he 
st u d y wit h t he Pri nci pal I n vesti gat or or S u b -I n vesti gat or a n d staff. 
All as pects of t he st u d y will be caref ull y m o nit ore d, b y t he C R O a n d t he S p o ns or, f or c o m plia nce wit h 
a p plica ble g o ver n me nt re g ulati o n wit h re s pect t o c urre nt G C P a n d sta n dar d o perati n g pr oce d ures. 
1 0. 3  I ns pecti o n of Rec or ds 
T he P ri nci pal In vesti gat ors or S u b -I n vesti gat ors a n d i nstit uti o ns i n v ol ve d i n t he st u d y will per mit trial-
relate d m o nit ori n g, a u dits, I R B/ E C re vie w, a n d re g ulat or y i ns pecti o n(s) b y pr o vi di n g direct access t o all 
st u d y rec or ds. I n t he e ve nt of a n a u dit, t he Pri nci pal I n vesti gat or or S u b -I n vesti gat or a grees t o all o w t he 
S p o ns or , re prese ntati ves of t he S p o ns or, t he C R O, t he F D A , or ot her re g ulat or y a ge ncies access t o al l 
st u d y rec or ds. 
T he Pri nci pal I n vesti gat or or S u b -I n vesti gat or s h o ul d pr o m ptl y n otif y t he S p o ns or, or its desi g nee , of 
a n y a u dits sc he d ule d b y a n y re g ulat or y a ut h orities a n d pr o m ptl y f or war d c o pies of a n y a u dit re p orts 
recei ve d t o S p o ns or or its desi g nee.   


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 4  of 9 7  
1 0. 4  St u d y Rec or d Rete nti o n  
Esse ntial d oc u me nts s h o ul d be retai ne d f or at least 1 5 years after t he e n d of t he trial or 2 years after t he 
last a p pr o val of a mar keti n g a p plicati o n i n a n I nter nati o nal C ou ncil  f or Har m o nisati o n ( I C H) re gi o n a n d 
u ntil t here are n o pe n di n g or c o nte m plate d mar keti n g a p plicati o ns i n a n I C H re gi o n, or at least 5 years 
ha ve ela pse d si nce t he f or mal disc o nti n uati o n of cli nical de vel o p me nt of t he I P. T hese d oc u me nts s h o ul d 
be retai ne d f or a l o n ger peri o d, h o w e ver, if re q uire d b y t he a p plica ble re g ulat or y re q uire me nts or b y a n 
a gree me nt wit h t he S p o ns or. It is t he res p o nsi bilit y of t he S p o ns or t o i nf or m t he Pri nci pal I n vesti gat or or 
S u b -I n vesti gat or or i nstit uti o n as t o w he n t hese d oc u me nts n o l o n ger nee d t o be retai ne d. 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 5  of 9 7  
1 1  A D MI NI S T R A TI V E C O N SI D E R A TI O N S  
T he f oll o wi n g a d mi nistrati ve ite ms are mea nt t o g ui de t he P ri nci pal In vesti gat or or S u b -I n vesti gat or i n 
t he c o n d uct of t he trial b ut ma y be s u bject t o c ha n ge base d o n i n d ustr y a n d g o ver n me nt sta n dar d 
o perati n g pr oce d ures or w or ki n g practice d oc u me nts or g ui deli nes. C ha n ges will be r e p orte d t o t he 
I R B/E C b ut will n ot res ult i n pr ot oc ol a me n d me nts.  
1 1. 1  C o nfi de nti alit y  
All la b orat or y s peci me ns, e val uati o n f or ms, re p orts, a n d ot her rec or ds will be i de ntifie d i n a ma n ner 
desi g ne d t o mai ntai n patie nt  c o nfi de ntialit y. All rec or ds will be ke pt i n a sec ure st ora ge area wit h li mite d 
access . Cli nical i nf or mati o n will n ot be release d wit h o ut t he writte n per missi o n of t he patie nt  (or t he 
patie nt ’s g uar dia n), e xce pt as necessar y f or m o nit ori n g a n d a u diti n g b y t he S p o ns or , its desi g nee, t he 
F D A, or t he I R B/ E C.  
T he Pri nci pal I n vesti gat or or S u b -I n vesti gat or a n d all e m pl o yees a n d c o w or kers i n v ol ve d wit h t his st u d y 
ma y n ot discl ose or use f or a n y p ur p ose ot her t ha n perf or ma nce of t he st u d y, a n y data, rec or d, or ot her 
u n p u blis he d, c o nfi de ntial i nf or mati o n discl ose d t o t h ose i n di vi d uals f or t he p ur p ose of t he st u d y. Pri or 
writte n a gree me nt fr o m S p o ns or or its desi g nee m ust be o btai ne d f or t he discl os ure of a n y sai d 
c o nfi de ntial i nf or mati o n t o ot her parties. 
1 1. 2  D at a a n d S afet y M o nit o ri n g B o ar d  
A n i n de pe n de nt Data Safet y M o nit ori n g B oar d ( D S M B) will be set u p t o peri o dicall y re vie w a n d 
e val uate t he acc u m ulate d st u d y data f or partici pa nt safet y, st u d y c o n d uct a n d pr o gress, a n d t o ma ke 
rec o m me n dati o ns t o t he S p o ns or c o ncer ni n g t he c o nti n uati o n of t he trial. T he D S M B will be c o m prise d 
of i n de pe n de nt e x pert(s) i n t he cli nical as pects of t he disease/ patie nt p o p ulati o n bei n g st u die d, o ne or 
m ore bi ostatisticia ns, a n d o ne or m ore i n vesti gat ors wit h e x pertise i n c urre nt cli nical trials 
c o n d uct.  T hese me m bers ma y n ot be directl y i n v ol ve d i n t he c o n d uct of t he bli n de d st u d y.  
A se parate D S M B  C harter d oc u me nt will o utli ne t he sc he d ule of data re vie w, defi ne t he deli berati ve 
pr ocess, a n y e ve nts t hat w o ul d tri g ger u nsc he d ule d re vie ws, st o p pi n g pr oce d ures t hat are c o nsiste nt wit h 
t he pr ot oc ol, u n mas ki n g a n d v oti n g pr oce d ures, a n d t he c o nte nts of re p orts at t he c o ncl usi o n of eac h 
meeti n g, a n d h o w t he D S M B will v ote as t o w het her t he st u d y s h o ul d c o nti n ue wit h o ut c ha n ge, 
be m o difie d  or be ter mi nate d.  
  
1 1. 3  I nstit uti o n al Re vie w B o ar d/ Et hics C o m mittee A p pr o v al 
Fe deral  a n d nati o nal re g ulati o ns a n d I C H g ui deli nes re q uire a p pr o val be o btai ne d fr o m a n I R B/E C 
bef ore  partici pati o n of h u ma n patie nt s i n researc h st u dies. Bef ore  t he st u d y o nset, t he pr ot oc ol, i nf or me d 
c o nse nt, a d vertise me nts t o be use d f or patie nt recr uit me nt, a n d a n y ot her writte n i nf or mati o n re gar di n g 
t his st u d y t o be pr o vi de d t o t he patie nt  or t he patie nt ’s le gal g uar dia n m ust be a p pr o ve d b y t he I R B/ E C. 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 6  of 9 7  
D oc u me ntati o n of all I R B/ E C a p pr o vals a n d of t he I R B/ E C c o m plia nce wit h I C H G ui deli ne E 6 will be 
mai ntai ne d b y t he site a n d will be a vaila ble f or re vie w b y t he S p o ns or or its desi g nee.  
All I R B/ E C a p pr o vals s h o ul d be si g ne d b y t he I R B/E C C hair ma n or desi g nee a n d m ust i de ntif y t he 
I R B/E C na me a n d a d dress, t he cli nical pr ot oc ol b y title a n d/ or pr ot oc ol n u m ber, a n d t he date a p pr o val 
a n d/ or fa v ora ble o pi ni o n was gra nte d. 
T he Pri nci pal I n vesti gat or or S u b -I n vesti gat or is res p o nsi ble f or o btai ni n g c o nti n ue d re vie w of t he 
cli nical researc h at i nter vals n ot e xcee di n g 1 year or ot her wise s pecifie d b y t he I R B/ E C . T he Pri nci pal 
I n vesti gat or or S u b -I n vesti gat or m ust s u p pl y t he s p o ns or or its desi g nee wit h writte n d oc u me ntati o n of 
c o nti n ue d re vie w of t he cli nical researc h.  
1 1. 4  M o dific ati o n of t he Pr ot oc ol 
A n y c ha n ges i n t his researc h acti vit y, e xce pt t h ose necessar y t o re m o ve a n a p pare nt, i m me diate hazar d 
t o t he patie nt, m ust be re vie we d a n d a p pr o ve d b y t he S p o ns or or its desi g nee . A me n d me nts t o  t he 
pr ot oc ol will be pre pare d b y t he S p o ns or or its desi g nee a n d m ust be s u b mitte d i n writi n g t o t he 
Pri nci pal I n vesti gat or’s or S u b -I n vesti gat or’s I R B/E C f or a p pr o val bef ore patie nt s bei n g e nr olle d i nt o a n 
a me n de d pr ot oc ol or a me n de d pr oce d ures a p plie d t o c urre ntl y e nr olle d patie nts. 
1 1. 5  I nf or m e d C o nse nt 
A writte n I C F i n c o m plia nce wit h Title 2 1 of t he C o de of Fe deral Re g ulati o ns ( C F R) Part 5 0, c urre nt 
versi o n of t he Declarati o n of Helsi n ki ; t he c urre nt re q uire me nts of G C P  ( C P M P/I C H/ 1 3 5/ 9 5); a n d l ocal 
re g ulati o ns, w hic he ver aff or d t he greater patie nt pr otecti o n, s hall be o btai ne d fr o m eac h patie nt  bef ore 
e nteri n g t he st u d y or perf or mi n g a n y u n us ual or n o nr o uti ne pr oce d ure i n v ol vi n g ris k t o t he patie nt. If a n y 
i nstit uti o n-s pecific m o dificati o ns t o st u d y-relate d pr oce d ures are pr o p ose d or ma de b y t he site, t he I C Fs 
s h o ul d be re vie we d b y t he S p o ns or or its desi g nee, if a p pr o priate, bef ore I R B/E C s u b missi o n . O nce 
re vie we d, t he I C Fs will be s u b mitte d b y t he P ri nci pal I n vesti gat or or S u b -I n vesti gat or t o his or her 
I R B/E C f or re vie w a n d a p pr o val bef ore t he start of t he st u d y. If t he I C Fs are re vise d d uri n g t he c o urse of 
t he st u d y, all acti ve partici pati n g patie nts m ust si g n t he re vise d f or m. 
Bef ore recr uit me nt a n d e nr oll me nt, eac h pr os pecti v e patie nt  or t heir le gal g uar dia n will be gi ve n a f ull 
e x pla nati o n of t he st u d y a n d all o we d t o rea d t he a p pr o ve d I C Fs. O nce t he Pri nci pal I n vesti gat or or S u b -
I n vesti gat or is ass ure d t hat t he patie nt /le gal g uar dia n u n dersta n ds t he i m plicati o ns of partici pati n g i n t he 
st u d y, t he patie nt /le gal g uar dia n will be as ke d t o gi ve c o nse nt t o partici pate i n t he st u d y b y si g ni n g t he 
I C F(s). 
T he Pri nci pal I n vesti gat or or S u b -I n vesti gat or s hall pr o vi de an ori gi nal  or a  c o p y of t he si g ne d I C F t o t he 
patie nt  a n d/ or le gal g uar dia n . A n  ori gi nal f or m s hall be mai ntai ne d i n t he patie nt ’s me dical rec or ds at t he 
site. 
1 1. 6  Pr ot oc ol Vi ol ati o ns a n d De vi ati o ns 
T he Pri nci pal I n vesti gat or , S u b -I n vesti gat or, or desi g nee m ust d oc u me nt a n d e x plai n i n t he patie nt’s 
s o urce d oc u me ntati o n a n y de viati o n a n d vi olati o ns fr o m t he a p pr o ve d pr ot oc ol. T he Pri nci pal 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 7  of 9 7  
I n vesti gat or or S u b -I n vesti gat or ma y i m ple me nt a de viati o n fr o m or a c ha n ge of t he pr ot oc ol t o eli mi nate 
a n i m me diate hazar d t o trial patie nt s wit h o ut pri or I R B/ E C a p pr o val. As s o o n as p ossi ble after s uc h a n 
occ urre nce, t he i m ple me nte d de viati o n or c ha n ge, t he reas o ns f or it, a n d a n y pr o p ose d pr ot oc ol 
a me n d me nt(s) s h o ul d be s u b mitte d t o t he I R B/E C f or re vie w a n d  a p pr o val  (if re q uire d), t o t he S p o ns or 
or its desi g nee f or a gree me nt, a n d t o t he re g ulat or y a ut h orities ( if re q uire d). 
A de viati o n fr o m t he pr ot oc ol is a n u ni nte n de d a n d/ or u na ntici pate d de part ure fr o m t he pr oce d ures 
a n d/ or pr ocesses a p pr o ve d b y t he S p o ns or a n d t he I R B/ E C a n d a gree d t o b y t he Pri nci pal I n vesti gat or or 
S u b -I n vesti gat or. De viati o ns us uall y ha ve a n i m pact o n i n di vi d ual patie nt s, or a s mall gr o u p of patie nt s, 
a n d d o n ot i n v ol ve i ncl usi o n/e xcl usi o n or pri mar y e n d p oi nt criteria. A pr ot oc ol vi olati o n occ urs w he n 
t here is n o na d here nce t o t he pr ot oc ol res ulti n g i n a si g nifica nt, a d diti o nal ris k t o t he patie nt , w he n t he 
patie nt  or Pri nci pal I n vesti gat or or S u b -I n vesti gat or has faile d t o a d here t o si g nifica nt pr ot oc ol 
re q uire me nts (i ncl usi o n/e xcl usi o n criteria) a n d/ or  t he patie nt  was e nr olle d wit h o ut pri or S p o ns or 
a p pr o val, or w he n t here is n o na d here nce t o F D A re g ulati o ns a n d/ or I C H G C P g ui deli nes. 
T he cli nical m o nit o r a n d site staff will d oc u me nt pr ot oc ol vi olati o ns a n d de viati o ns t hr o u g h o ut t he 
c o urse of t he cli nical trial. T he m o nit or will n otif y t he Pri nci pal I n vesti gat or or S u b -I n vesti gat ors d uri n g 
a visit a n d d oc u me nt  i n writi n g all vi olati o ns a n d de viati o ns. T he  I R B/E C s h o ul d be n otifie d b y site 
pers o n nel of all pr ot oc ol vi olati o ns a n d a n y a p plica ble pr ot oc ol de viati o ns acc or di n g t o t heir I R B/ E C 
re g ulati o ns i n a ti mel y ma n ner. 
1 1. 7  St u d y Re p orti n g Re q uire m e nts  
B y partici pati n g i n t his st u d y, t he Pri nci pal I n vesti gat or or S u b -I n vesti gat or a grees t o s u b mit re p orts of 
S A Es acc or di n g t o t he ti meli ne a n d met h o d o utli ne d i n t he pr ot oc ol. I n a d diti o n, t he Pri nci pal 
I n vesti gat or or S u b -I n vesti gat or a grees t o s u b mit a n n ual  re p orts t o t heir I R B/E C as a p pr o priate.  
1 1. 8  Fi n a nci al Discl os ure a n d O bli g ati o ns  
T he Pri nci pal I n vesti gat ors or S u b -I n vesti gat ors are re q uire d t o pr o vi de fi na ncial discl os ure i nf or mati o n 
t o all o w t he S p o ns or t o s u b mit t he c o m plete a n d acc urate certificati on or discl os ure state me nts re q uire d 
u n der Part 5 4 of Title  2 1 of t he C F R. I n a d diti o n, t he Pri nci pal I n vesti gat or or S u b -I n vesti gat ors m ust 
pr o vi de t o t he S p o ns or a c o m mit me nt t o u p date t his i nf or mati o n pr o m ptl y if a n y rele va nt c ha n ges occ ur 
d uri n g t he c o u rse of t he i n vesti gati o n a n d f or 1 year f oll o wi n g t he c o m pleti o n of t he st u d y. 
Neit her t he S p o ns or n or C R O is fi na nciall y res p o nsi ble f or f urt her testi n g a n d/ or treat me nt of a n y 
me dical c o n diti o n  w h ic h ma y be detecte d d uri n g t he Scree ni n g ( Visit 1) pr ocess . I n a d diti o n, i n t he 
a bse nce of s pecific arra n ge me nts, neit her t he S p o ns or n or C R O is fi na nciall y res p o nsi ble f or f urt her 
treat me nt of t he patie nt ’s disease. 
1 1. 9  I n vesti g at or Res p o nsi bilities a n d D oc u me nt ati o n  
Bef ore  be gi n ni n g t he st u d y, t he Pri nci pal I n vesti gat or will be as ke d t o c o m pl y wit h I C H E 6  8. 2 a n d 
Title  2 1 of t he C F R b y ass uri n g res p o nsi bilit y f or a n d pr o vi di n g t he f oll o wi n g pr oce d ures a n d esse ntial 
d oc u me nts, i ncl u di n g, b ut n ot li mite d t o: 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 8  of 9 7  
•  
C o n d ucti n g st u d y acc or di n g t o c urre nt pr ot oc ol a p pr o ve d b y a p pr o priate I R B or E C  
•  
Pers o nall y,  c o n d ucti n g st u d y or pers o nall y s u per visi n g S u b -I n vesti gat ors a n d ot her staff i n v ol ve d i n 
st u d y c o n d uct 
•  
E ns uri n g all st u d y staff are i nf or me d of t heir o bli gati o ns t o meet t he  I n vesti gat or c o m mit me nts i n 
F or m F D A  1 5 7 2 ( U S) or I C H E 6 . 4 
•  
Rea d i n g a n d u n dersta n di n g t he C B P - 2 0 1 I n vesti gat or’s Br oc h ure versi o n 5 
•  
O btai n i n g I R B/E C re vie w a n d a p pr o val f or st u d y ( per 2 1 C F R  5 6 [ U S] a n d I C H E 6. 4). 
•  
E ns uri n g I R B/E C pr o vi des i nitial a n d c o nti n ui n g re vie w, a n d t he a p pr o val of t he st u d y c o m plies 
wit h rele va nt re g ulati o ns ( per 2 1 C F R  5 6 [ U S] a n d I C H E 6. 4); pr o m ptl y i nf or mi n g I R B/ E C of 
c ha n ges i n researc h acti vit y or a n y u na ntici pate d pr o ble ms i n v ol vi n g ris k t o patie nts 
•  
Ma k i n g n o c ha n ges t o st u d y wit h o ut a p pr o val b y S p o ns or a n d I R B/ E C re vie w a n d a p pr o val (e xce pt 
w he n nee de d i m me diatel y t o pr otect safet y, ri g hts, or welfare of st u d y patie nt s) 
•  
N otif y i n g st u d y patie nt s t hat C B P - 2 0 1 is i n vesti gati o nal; o btai ni n g i nf or me d c o nse nt fr o m eac h 
patie nt  per rele va nt re g ulati o ns (per 2 1  C F R  5 0 [ U S] a n d I C H E 6. 4) 
•  
I nf or mi n g S p o ns or or desi g nee of A Es  d uri n g st u d y ( per 2 1 C F R 3 1 2. 6 4 [ U S] a n d I C H E 6. 4); S A Es  
t o be re p orte d wit hi n 2 4 h o urs  
•  
Mai ntai n i n g a de q uate a n d acc urate rec or ds ( per 2 1 C F R 3 1 2. 6 2 [ U S] a n d I C H E 6. 4 ); ma ke rec or ds 
a vaila ble f or i ns pecti o n ( per 2 1 C F R 3 1 2. 6 8 [ U S] a n d I C H E 6. 4) 
•  
C o m pl yi n g wit h all ot her perti ne nt re q uire me nts of 2 1 C F R 3 1 2 ( U S) a n d I C H E 6. 4 
•  
A n ori gi nal I n vesti gat or-si g ne d I n vesti gat or A gree me nt pa ge of t he pr ot oc ol  
•  
Pr o vi di n g a n  I R B/E C -a p pr o ve d I C F, sa m ples of site a d vertise me nts f or recr uit me nt, a n d a n y ot her 
writte n i nf or mati o n re gar di n g t his st u d y t hat is t o be pr o vi de d t o t he patie nt  or le gal g uar dia ns  
•  
F or m F D A 1 5 7 2, f ull y e xec ute d, a n d all u p dates o n a ne wl y e xec ute d F or m F D A  1 5 7 2 
•  
C urric ul u m vitae ( C V) f or t he Pri nci pal I n vesti gat or a n d eac h S u b -I n vesti gat or will be liste d o n 
F or m F D A  1 5 7 2 ( U S) or I C H  E 6. 4. C urre nt lice ns ure m ust be n ote d o n t he C V . T he se will be 
si g ne d a n d date d b y t he Pri nci pal I n vesti gat ors a n d S u b -I n vesti gat ors at st u d y start - u p, i n dicati n g 
t he y are acc urate a n d c urre nt 
•  
Pr o vi d i n g fi na ncial discl os ure i nf or mati o n t o all o w t he S p o ns or t o s u b mit c o m plete a n d acc urate 
certificati o n or discl os ure state me nts re q uire d u n der 2 1 C F R 5 4   
•  
Pr o vi di n g l a b orat or y certificati o ns a n d refere nce ra n ges f or a n y l ocal la b orat ories use d b y t he site,  
i n acc or da nce wit h 4 2 C F R 4 9 3 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 8 9  of 9 7  
1 1. 1 0  St u d y C o n d uct  
T he Pri nci pal I n vesti gat or a grees t he st u d y will be c o n d ucte d acc or di n g t o t he pri nci ples of t he I C H E 6 
G ui deli ne f or G C P  a n d t he pri nci ples of t he W orl d Me dical Ass ociati o n Declarati o n of Helsi n ki . T he 
Pri nci pal I n vesti gat or will c o n d uct all as pects of t his st u d y i n acc or da nce wit h all nati o nal, state, a n d 
l ocal la ws or re g ulati o ns. 
1 1. 1 1  Fi n a nci n g a n d I ns ur a nce  
T his st u d y is f u n de d b y S uz h o u C o n nect Bi o p har mace uticals, Lt d. I ns ura nce p olicies will be arra n ge d at 
t he ti me of st u d y start, as re q uire d i n eac h c o u ntr y i n w hic h t he st u d y is c o n d ucte d. 
1 1. 1 2  P u blic ati o ns  
F oll o wi n g c o m pleti o n of t he st u d y, t he data ma y be c o nsi dere d f or re p or ti n g at a scie ntific meeti n g or f or 
p u blicati o n i n a scie ntific j o ur nal. I n t hese cases, t he S p o ns or will be res p o nsi ble f or t hese acti vities a n d 
will w or k wit h t he I n vesti gat ors t o deter mi ne h o w t he ma n uscri pt is writte n a n d e dite d, t he n u m ber a n d 
or der of a ut h ors, t he p u blicati o n t o w hic h it will be s u b mitte d, a n d ot her relate d iss ues. T he S p o ns or has 
fi nal a p pr o val a ut h orit y o ver all s uc h iss ues. Data are t he pr o pert y of t he S p o ns or a n d ca n n ot be 
p u blis he d wit h o ut pri or a ut h orizati o n fr o m C O N N E C T , b ut data a n d p u blicati o n t here of will n ot be 
u n d ul y wit h hel d. 
1 1. 1 3  Ris k Miti g ati o n a n d S afet y Me as ures d ue t o C O VI D- 1 9 P a n de mic 
D ue t o t he C O VI D - 1 9 pa n de mic, o perati o nal meas ures ma y be i m ple me nte d t o e ns ure a c o nti n ue d 
s u p pl y of me dicati o n, t o perf or m efficac y assess me nts, a n d f or a de q uate safet y m o nit ori n g of patie nts. 
T hese meas ures ma y i ncl u de re m ote st u d y visits, h o me healt hcare, ha n dli n g of pr ot oc ol de viati o ns, a n d 
re m ote site m o nit ori n g. 
A n y pr ot oc ol de viati o ns d ue t o C O VI D- 1 9 restricti o ns will be  d oc u me nte d i n t he electr o nic data ca pt ure  
s yste m. 
A n y pr ot oc ol de viati o ns t hat c o ul d p ote ntiall y i m pact data a nal ysis will be fla g ge d a n d t he ha n dli n g of 
s uc h de viati o ns will be descri be d i n t he Statistical A nal ysis Pla n. 
 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 9 0  of 9 7  
1 2  I N V E S TI G A T O R’ S S T A T E M E N T  
I a gree t o c o n d uct t he st u d y as o utli ne d i n t he pr ot oc ol e ntitle d “ A M ultice nter, Ra n d o mize d, D o u ble-
bli n d, Place b o-c o ntr olle d St u d y t o E val uate C B P- 2 0 1 i n A d ult Patie nts wit h C hr o nic R hi n osi n usitis wit h 
Nasal P ol y ps” i n acc or da nce wit h t he g ui deli nes a n d all a p plica ble g o ver n me nt re g ulati o ns i ncl u di n g U S 
Part  5 4 of Title 2 1 of t he C F R . I ha ve rea d a n d u n dersta n d all secti o ns of t he Pr ot oc ol , i ncl u di n g 
Secti o n  1 1 A D MI NI S T R A TI V E C O N SI D E R A TI O N S . 
Pr ot oc ol Versi o n 3. 0  
D ate: 2 1 Dece m ber 2 0 2 1  
 
 
Pri nci pal I n vesti gat or’s Si g nat ure  
 
 
Date  
 
Pri nci pal I n vesti gat or’s Na me  
 
 
Site I D  
 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 9 1  of 9 7  
1 3  R E F E R E N C E S  
A ki nla de B, G utt ma n- Yass k y E, de Br ui n - Weller M, Si m ps o n E L, Bla u velt A, C or k MJ, Pre ns E, As bell 
P, A k pe k E, C orre n J, Bac hert C, Hira n o I, We y ne J, K or otzer A, C he n Z, H ultsc h T, Z h u X, Da vis J D, 
Ma n ne nt L, Ha milt o n J D, Te per A, Sta u di n ger H, Riz o va E, Pir ozzi G, Gra ha m N M H, S h u mel B, 
A r delea n u M, W olle n ber g A. C o nj u ncti vitis i n d u pil u ma b cli nical trials. Br J Der mat ol. 2 0 1 9 
Se p; 1 8 1( 3): 4 5 9- 4 7 3. 
Gra ha m  B L , Stee n br u g ge n I, Miller M R , Barja ktare vic I Z, C o o per B G , Hall G L, Hallstra n d T S, 
Ka mi ns k y D A, Mc Cart h y K, Mc C or mac k M C, Or o pez C E, R ose nfel d M, Sta n oje vic S, S wa n ne y M S, 
T h o m ps o n B R; o n be half of t he A merica n T h oracic S ociet y a n d t he E ur o pea n Res pirat or y S ociet y. 
Sta n dar dizati o n of S pir o metr y 2 0 1 9 U p date A n Official  A merica n T h oracic  S ociet y a n d E ur o pea n 
Res pirat or y S ociet y  Tec h nical State me nt . A m J Res pir Crit Care Me d V ol 2 0 0, Iss 8, p p e 7 0 –e 8 8, Oct 
1 5, 2 0 1 9 
A v dee va K, F o k ke ns W. Precisi o n me dici ne i n c hr o nic r hi n osi n usitis wit h nasal p ol y ps. C urr Aller g y 
Ast h ma Re p. 2 0 1 8; 1 8( 4): 2 5. d oi: 1 0. 1 0 0 7/s 1 1 8 8 2 - 0 1 8- 0 7 7 6- 8. 
Bac hert C, Ma n ne nt L, Nacleri o R M, et al. Effect of s u bc uta ne o us d u pil u ma b o n nasal p ol y p b ur de n i n 
patie nts wit h c hr o nic si n usitis a n d nasal p ol y p osis: a ra n d o mize d cli nical trial. J A M A. 2 0 1 6; 3 1 5: 4 6 9-
4 7 9.  
Bac hert C, Ha n J K, Desr osiers M, Helli n gs P, A mi n N, Lee S E, M ull ol J, Gre os L, B oss o J, Lai dla w 
T M, Cer vi n A, Mas per o J F, H o p ki ns C, Olze H, Ca n o nica G W, Pa g giar o P, C h o S H, F o k ke ns WJ, 
F ujie da S, Z ha n g M, L u X, Fa n C, Drai ki wicz S, Ka mat S A, K ha n A, Pir o zzi G, Patel N, Gra ha m N M H, 
R u d d y M, Sta u di n ger H, Wei nreic h D, Sta hl N, Ya nc o p o ul os G D, Ma n ne nt L P . Efficac y a n d safet y of 
d u pil u ma b i n patie nts wit h se vere c hr o nic r hi n osi n usitis wit h nasal p ol y ps ( LI B E R T Y N P SI N U S- 2 4 a n d 
LI B E R T Y N P SI N U S -5 2): res ults fr o m t w o m ultice ntre, ra n d o mise d, d o u ble- bli n d, place b o-c o ntr olle d, 
parallel - gr o u p p hase 3 trials. La ncet 2 0 1 9; 3 9 4: 1 6 3 8 – 5 0. 
Car dell L - O, Stjär ne Pär, J o nsta m K, Bac hert C. E n d ot y pes of c hr o nic r hi n osi n usitis: I m pact o n 
ma na ge me nt. J Aller g y Cli n I m m u n ol. 2 0 2 0; 1 4 5: 7 5 2- 7 5 6.  
D u pi xe nt ( d u pil u ma b) i njecti o n, f or s u bc uta ne o us use; Refere nce I D 4 4 5 4 3 3 7; J u ne 2 0 1 9; a vaila ble at: 
htt ps:// w w w.access data.f da. g o v/scri pts/c der/ daf/ . 
F o k ke ns WJ, L u n d VJ, H o p ki ns C, Helli n gs P W, Ker n R, Reits ma S, T o p pila- Sal mi S, Ber nal -
S pre kelse n M, M ull ol J, Al o bi d I, Terezi n ha A nsel m o- Li ma W, Bac hert C, Bar o o d y F, v o n B uc h wal d C, 
Cer vi n A, C o he n N, C o nsta nti ni dis J, De Ga b or y L, Desr osiers M, Dia ma nt Z, D o u glas R G, Ge vae rt P H, 
Haf ner A, Har ve y RJ, J o os G F, Kal o gjera L, K nill A, K oc ks J H, La n dis B N, Li m pe ns J, Le beer S, 
L o ure nc o O, Mec o C, Matricar di P M, O' Ma h o n y L, P hil p ott C M, R ya n D, Sc hl osser R, Se ni or B, S mit h 
T L, Teeli n g T, T o mazic P V, Wa n g D Y, Wa n g D, Z ha n g L, A gi us A M, A hlstr o m - E ma n uelss o n C, 
Ala bri R, Al b u S, Al ha bas h S, Ale ksic A, Al o ula h M, Al- Q u da h M, Alsale h S, Ba ba n M A, Ba u d oi n T, 
Bal vers T, Batta glia P, Be d o ya J D, Be ule A, B ofares K M, Bra ver ma n I, Br oze k - Ma dr y E, Ric har d B, 
Callejas C, Carrie S, Ca ulle y L, C h ussi D, de C ors o E, C oste A, El Ha di U, Elfar o u k A, El o y P H, 
Farr o k hi S, Felisati G, Ferrari M D, Fis hc h u k R, Gra ys o n W, G o ncal ves P M, Gr di nic B, Gr gic V, 
Ha miza n A W, Hei nic he n J V, H usai n S, Pi n g TI, I vas ka J, Ja ki m o vs ka F, J o va nce vic L, Ka ka n de E, 
Ka mel R,  Kar pisc he n k o S, Kari ya wasa m H H, Ka wa uc hi H, Kjel dse n A, Kli me k L, Krzes ki A, 
K o pac he va Bars o va G, Ki m S W, Lal D, Let ort JJ, L o pati n A, Ma h dj o u bi A, Mes ba hi A, Net k o vs ki J, 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 9 2  of 9 7  
N ye n b ue Ts hi p u ka ne D, O ba n d o- Val ver de A, O ka n o M, O nerci M, O n g Y K, Orla n di R, Ot or i N, 
O ue n n o u g h y K, Oz ka n M, Peric A, Plza k J, Pr o k o pa kis E, Pre pa gera n N, Psaltis A, P u gi n B, Raft o p ul os 
M, R o m ba u x P, Riec hel ma n n H, Sa ht o ut S, Saraf olea n u C C, Sear y o h K, R hee C S, S hi J, S h k o u ka ni M, 
S h u k ur ya n A K, Sica k M, S m yt h D, S ni d v o n gs K, S o klic K osa k T, Stjar ne P, S uti k n o B, Stei ns va g S, 
Ta ntili pi k or n P, T ha na virata na nic h S, Tra n T, Ur ba ncic J, Vali uli us A, Vas q uez de A parici o C, Vic he va 
D, Vir k k ula P M, Vice nte G, V oe gels R, Wa ge n ma n n M M, War da ni R S, Wel ge -L usse n A, Witteric k I, 
Wri g ht E, Za b ol ot ni y D, Zs olt B, Z wetsl o ot C P. E ur o pea n P ositi o n Pa per o n R hi n osi n usitis a n d Nasal 
P ol y ps 2 0 2 0. R hi n ol o g y. 2 0 2 0 Fe b 2 0; 5 8( S u p pl S 2 9): 1- 4 6 4. d oi: 1 0. 4 1 9 3/ R hi n 2 0. 6 0 0. P MI D: 
3 2 0 7 7 4 5 0. 
Hasta n D, F o k ke ns WJ, Bac hert C, et al. C hr o nic r hi n osi n usitis i n S o ut h K orea a cc or di n g t o dia g n ostic 
criteria. R hi n ol o g y. 2 0 1 1; 6 6: 1 2 1 6- 1 2 2 3.  
Hirsc h A G, Ste wart W F, S u n daresa n A S, et al. Nasal a n d si n us s y m pt o ms a n d c hr o nic r hi n osi n usitis i n a 
p o p ulati o n- base d sa m ple. Aller g y. 2 0 1 7; 7 2: 2 7 4- 2 8 1.  
Ki m J H , C h o C, Lee EJ, et al. Pre vale nce a n d ris k fact ors of c hr o nic r hi n osi n usitis i n S o ut h K orea 
acc or di n g t o dia g n ostic criteria. R hi n ol o g y. 2 0 1 6; 5 4: 3 2 9- 3 3 5.  
Sa m ps o n H A, M u n oz- F url o n g A, Ca m p bell R L, et al. Sec o n d s y m p osi u m o n t he defi niti o n a n d 
ma na ge me nt o f a na p h yla xis: S u m mar y Re p ort- Sec o n d Nati o nal I nstit ute of Aller g y a n d I nfecti o us 
Disease/ F o o d Aller g y a n d A na p h yla xis Net w or k S y m p osi u m. J Aller g y Cli n I m m u n ol 2 0 0 6; 1 1 7( 2): 3 9 1-
9 7). 
Sca d di n g G K, D ur ha m S R, Mira kia n R, J o nes N S, Dra ke- Lee A B, R ya n D, Di x o n T A, H u ber P AJ, a n d 
Nasser S M.  B S A CI g ui deli nes f or t he ma na ge me nt of r hi n osi n usitis a n d nasal p ol y p osis. Cli n E x p 
Aller g y 3 8: 2 6 0- 2 7 5. 
Wi nt hr o p K L,  N o v osa d S A,  Ba d dle y J W, Cala brese L, C hiller T, P ol gree n P,  Bartalesi  F, Li p ma n M, 
Mariette  X,  L ort h olar y O,  Wei n blatt  M E, Saa g M, a n d S m ole n J.   O p p ort u nistic i nfecti o ns a n d bi ol o gic 
t hera pies i n i m m u ne-me diate d i nfla m mat or y diseases:   c o nse ns us rec o m me n dati o ns f or i nfecti o n 
re p orti n g d uri n g cli nical trials a n d p ost mar keti n g s ur veilla nce.  A n n R he u m Dis 2 0 1 5 7 4: 2 1 0 7- 2 1 1 6.  
H o p ki ns C, Gillett S, Slac k R, L u n d VJ, Br o w ne J P. Ps yc h o metric vali dit y of t he 2 2- ite m Si n o nasal 
O utc o me Test. Cli n Ot olar y n g ol. 2 0 0 9; 3 4( 5): 4 4 7 – 4 5 4. 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
2 1 D ec e m b er  2 0 2 1  
 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 9 3  of 9 7  
1 4  A P P E N DI C E S


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d.  
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
2 1 D ec e m b er 2 0 2 1 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 9 4  of 9 7  
 
A P P E N DI X A – VI S U A L A N A L O G S C A L E – R HI N O SI N U SI TI S  ( V A S-R S)  
 
 
 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d.  
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
2 1 D ec e m b er 2 0 2 1 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 9 5  of 9 7  
 
 
A P P E N DI X B  – T O T A L N A S A L S Y M P T O M S C O R E ( T N S S)  
 
 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d.  
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
2 1 D ec e m b er 2 0 2 1 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 9 6  of 9 7  
 
A P P E N DI X  C – Si n o -N as al O utc o me Test -2 2 Q U E S TI O N N AI R E ( S N O T - 2 2) 
 
 
 
 


S uz h o u C o n n ect Bi o p h ar m ac e utic als, Lt d.  
Pr ot oc ol C B P -2 0 1 -W W 0 0 3  
I n v esti g ati o n al Dr u g: C B P-2 0 1  
2 1 D ec e m b er 2 0 2 1 
Versi o n 3. 0  
C O N FI D E N TI A L  
Pa ge 9 7  of 9 7  
 
A P P E N DI X D – I njecti o n Site Assess me nt T o ol 
T h e f oll o wi n g I nj ecti o n Sit e Ass ess m e nt T o ol is pr o vi d e d as a n ai d i n t h e ass ess m e nt of c o m m o n 
s y m pt o ms of i nj ecti o n sit e r e acti o n. T h e I nv esti g at or m a y us e t h eir o w n j u d g e m e nt a n d d escri pti o n of 
s y m pt o ms i n t h e ass ess m e nt of i nj ecti o n sit es f oll o wi n g a d mi nistr ati o n of I M P. A n I nj ecti o n Sit e 
R e acti o n s h o ul d b e r e p ort e d as a n A dv ers e E v e nt if t h e I nv esti g at or j u d g es t h e r e acti o n as cli nic al ly 
si g nific a nt. A p ar a m et er gr a d e of l ess t h a n 2 is g e n er all y c o nsi d er e d n ot cli nic all y si g nific a nt b ut t h e 
I nv esti g at or s h o ul d us e t h eir j u d g e m e nt i n t h e r e p orti n g of A Es. S e e s ecti o n 8. 6.