A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps
Phase: PHASE2
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Sponsor: Connect Biopharm LLC

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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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3. 9. 2  
Sec o n dar y Efficac y E n d p oi nts  ................................................................................... 3 0  
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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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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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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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M o nit ori n g of t he St u d y  ............................................................................................................. 8 3  
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I ns pecti o n of Rec or ds ................................................................................................................. 8 3  
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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  
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I nstit uti o nal Re vie w B oar d/ Et hics C o m mittee A p pr o val ........................................................... 8 5  
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M o dificati o n of t he Pr ot oc ol  ....................................................................................................... 8 6  
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I nf or me d C o nse nt ....................................................................................................................... 8 6  
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Pr ot oc ol Vi olati o ns a n d De viati o ns  ............................................................................................ 8 6  
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St u d y Re p orti n g Re q uire me nts  ................................................................................................... 8 7  
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Fi na ncial Discl os ure a n d O bli gati o ns  ......................................................................................... 8 7  
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I n vesti gat or Res p o nsi bilities a n d D oc u me ntati o n ...................................................................... 8 7  
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St u d y C o n d uct  ............................................................................................................................ 8 9  
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Fi na nci n g a n d I ns ura nce  ............................................................................................................. 8 9  
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P u blicati o ns  ................................................................................................................................ 8 9  
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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  
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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 
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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.  

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I n v esti g ati o n al Dr u g: C B P-2 0 1  
 
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2 1 D ec e m b er  2 0 2 1  
 
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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  
 
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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 
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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.