Clinical trial NCT03664960
Conditions: Eosinophilic Gastritis Eosinophilic Gastroenteritis Eosinophilic Duodenitis
Keywords: Eosinophilic Gastritis Eosinophilic Gastroenteritis Eosinophil EG EGE EGID Eosinophilic gastrointestinal disorders Eosinophilic Duodenitis EoD
Sponsor: Allakos Inc.
Start date: 2018-11-14; Completion date: 2021-11-02
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.

Detailed description:

Arms: arm 1: Subjects in this arm will receive 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg
Interventions: intervention 1: AK002
Intervention descriptions: intervention 1: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.

Protocol documents:
Prot_SAP_001.pdf: 
A P hase 2, M ultice nter, O pe n -La bel, E xte nsi o n St u d y t o E val uate t he Safet y  a n d Tolera bilit y of 
A K 0 0 2 i n Patie nts wit h E osi n o p hilic Gastritis a n d/ or  E osi n o p hilic D u o de nitis (f or merl y referre d 
t o as E osi n o p hilic Gastr oe nteritis) 
N C T N u m ber:  N C T 0 3 6 6 4 9 6 0  
D oc u me nt Date:  0 3 Marc h 2 0 2 1  
I R B A p pr o val Date: 1 8 Oct o ber 2 0 2 1  


 
9 7 5 Isl a n d Dri v e, S uit e 2 0 1, R e d w o o d Cit y, C A 9 4 0 6 5  
 
Pa ge 1 of 8 9  
Cli ni c al R es e a rc h P r ot o c ol A K 0 0 2 -0 0 3 X  
A P h ase 2, M ultic e nte r, O pe n- L a bel, E xte nsi o n St u d y t o E v al u ate t he S afet y  
a n d T oler a bilit y of A K 0 0 2 i n P atie nts wit h E osi n o p hilic G astritis a n d/ or 
E osi n o p hilic D u o de nitis (f or m erl y referre d t o as E osi n o p hilic G astr oe nteritis) 
Pr ot oc ol N u m ber 
A K 0 0 2 - 0 0 3 X 
Versi o n a n d D ate 
Ori gi nal:   
1 3 J u ne 2 0 1 8 
A me n d me nt 1:  0 8 Oct o ber 2 0 1 8 
A me n d me nt 2:  1 1 Dece m b er 2 0 1 8 
A me n d me nt 3:  
1 8 Marc h 2 0 1 9  
A me n d me nt 4:  2 3 Ma y 2 0 1 9 
A me n d me nt 5:  2 4 Se pte m ber 2 0 1 9 
A me n d me nt 6:  2 4 N o ve m ber 2 0 2 0 
A m e n d me nt 7:  0 3 M arc h  2 0 2 1  
I n v esti gati o nal Pr o d uct 
A K 0 0 2  (lire nteli ma b) 
St u d y P hase 
2 
S p o ns or 
Alla k os I n c.  
9 7 5 Isla n d Dri ve, S uite 2 0 1, Re d w o o d Cit y, C A 9 4 0 6 5 U S A 
Me dical M o nit or 
Na me:   
, M D, P h D 
Tele p h o ne: 
 
E- mail:  
  
A p pr o v al: 
 
 
 
 
 
 
 
, M D, P h D, 
 
 
Date  
C o nfi de nti ality St ate me nt  
T his c o nfi de ntial i nf or mati o n a b o ut a n i n vesti gati o nal pr o d uct is pr o vi de d f or t he e xcl usi ve use 
of I n vesti gat ors of t his pr o d uct a n d is s u bject t o recall at a n y ti me. T he i nf or mati o n i n t his 
d oc u me nt ma y n ot be discl ose d u nless fe d eral or state la w or re g ulati o ns re q uire s uc h discl os ure. 
S u bject t o t he f ore g oi n g, t his i nf or mati o n ma y be discl ose d o nl y t o t h ose pers o ns i n v ol ve d i n t he 
st u d y w h o ha ve a n ee d t o k n o w, wit h t he o bli gati o n n ot t o f urt her disse mi nate t his i nf or mati o n. 
0 3 - M a r - 2 0 2 1  |  1 1 : 4 3  P S T


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 2 of 8 9  
C o nfi de nti al  
I n v esti g at o r P r ot o c ol A g re e m e nt 
I h a ve r ea d t he pr ot oc ol s pecifie d bel o w. I n m y f or mal ca pacit y as Pri nci pal I n v esti gat or, m y 
d uties i ncl u de e ns uri n g t he safet y of t h e st u d y patie nts e nr olle d u n der m y s u per visi o n a n d 
pr o vi di n g Alla k os, I n c. wit h c o m plete a n d ti mel y i nf or mati o n, as o utli ne d i n t he pr ot oc ol. It is 
u n derst o o d t hat all i nf or mati o n pertai ni n g t o t he st u d y will be hel d strictl y c o nfi de ntial a n d t hat 
t his c o nfi de ntialit y re q uire me nt a p plies t o all st u d y staff at t his site. F urt her m ore, o n be half of 
t he st u d y staff a n d m yself, I a gr ee t o mai ntai n t he pr oce d ures re q uire d t o carr y o ut t he st u d y i n 
acc or d a nce wit h acce pte d G o o d Cli nical Practice ( G C P) pri nci ples a n d t o a bi de b y t he ter ms of 
t his pr ot oc ol. 
Pr ot oc ol N u m ber:  
A K 0 0 2 - 0 0 3 X 
Pr ot oc ol Title:   
A P hase 2, M ultice nter, O pe n- La b el, E xte nsi o n St u d y t o E val uate t he 
Safet y a n d T olera bilit y of A K 0 0 2 i n Patie nts w it h E osi n o p hilic Gastritis 
a n d/ or E osi n o p hilic D u o de nitis (f or merl y referre d t o as E osi n o p hilic 
Gastr oe nteritis)  
Ori gi nal Pr ot oc ol:  
1 3 J u ne 2 0 1 8 
A me n d me nt 1:   
0 8 Oct o ber 2 0 1 8 
A me n d me nt 2:  
1 1 Dece m b er 2 0 1 8 
A me n d me nt 3:  
1 8 Marc h 2 0 1 9 
A me n d me nt 4:   
2 3 Ma y 2 0 1 9 
A me n d me nt 5:  
2 4 Se pte m ber 2 0 1 9 
A me n d me nt 6:  
2 4 N o ve m ber 2 0 2 0 
A m e n d m e nt 7:  
0 3 M arc h  2 0 2 1 
 
 
 
 
I n vesti g at or’s N a m e ( pri nte d):   
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
Si g n at ure:  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
 
D ate:  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 of 8 9  
C o nfi de nti al  
Ta bl e of C o nt e nts  
Cli nic al Rese arc h Pr ot o c ol A K 0 0 2 - 0 0 3 X ..................................................................................... 1 
I n vesti g at or Pr ot o c ol A gree m e nt.................................................................................................. 2 
T a ble of C o nte nts  ........................................................................................................................... 3 
List of Ta bles  .......................................................................................................................... 7 
List of A b bre viati o ns .............................................................................................................. 8 
1.  
Pr ot oc ol S y n o psis ................................................................................................................ 1 1  
2.  
B ac k gr o u n d ......................................................................................................................... 2 0  
2. 1  
Si glec - 8 a n d A K 0 0 2 ................................................................................................... 2 0 
2. 2  
O ver vie w of N o ncli nical St u dies ................................................................................ 2 0  
2. 3  
O ver vie w of Cli nical St u dies  ...................................................................................... 2 1 
2. 4  
E osi n o p hilic Gastr oi ntesti nal Dis or ders  ..................................................................... 2 3 
3.  
R ati o n ale f or St u d y a n d D ose Selecti o n ........................................................................... 2 4  
4.  
St u d y O bjecti ve  .................................................................................................................. 2 4 
5.  
St u d y Desi g n  ....................................................................................................................... 2 5 
5. 1  
St u d y O ver vie w .......................................................................................................... 2 5  
5. 2  
Sc he d ule of E ve nts ..................................................................................................... 2 6  
6.  
Criteri a f or E v al u ati o n ...................................................................................................... 3 1  
6. 1  
Safet y E n d p oi nts ......................................................................................................... 3 1  
6. 2  
P har mac o ki netic E n d p oi nts ........................................................................................ 3 1  
6. 3  
Efficac y E n d p oi nts ...................................................................................................... 3 1  
6. 4  
P har mac o d y na mic E n d p oi nts ..................................................................................... 3 1  
7.  
P atie nt Selecti o n  ................................................................................................................. 3 2 
7. 1  
N u m ber o f Patie nts ..................................................................................................... 3 2 
7. 2  
. St u d y P o p ulati o n ........................................................................................................ 3 2 
7. 3  
I n cl usi o n Criteria ........................................................................................................ 3 2 
7. 4  
E xcl us i o n Criteria ....................................................................................................... 3 3 
8.  
C o nc urre nt Me dic ati o ns  .................................................................................................... 3 3 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 of 8 9  
C o nfi de nti al  
8. 1  
Pr o hi bite d Me dicati o ns ............................................................................................... 3 4  
8. 2  
Al l o we d Me dicati o ns .................................................................................................. 3 4 
9.  
St u d y Tre at m e nt  ................................................................................................................. 3 4 
9. 1  
F or m ulati o n of Test Pr o d uct ....................................................................................... 3 4  
9. 2  
St u d y Dr u g Pac ka gi n g a n d La beli n g .......................................................................... 3 5  
9. 3  
S u p pl y of St u d y Dr u g t o t he I n v esti gati o nal Site ....................................................... 3 5  
9. 4  
St u d y Dr u g D osa ge/ D osa ge Re gi me n ........................................................................ 3 5  
9. 5  
Pre parati o n of St u d y Dr u g .......................................................................................... 3 5  
9. 6  
St u d y Dr u g A d mi nistrati o n......................................................................................... 3 6  
9. 7  
St u d y Dr u g St ora ge ..................................................................................................... 3 7  
9. 8  
St u d y Dr u g Acc o u nta bilit y ......................................................................................... 3 7  
1 0.  
P atie nt N u m beri n g, Str atific ati o n, R a n d o miz ati o n, a n d Bli n di n g ................................ 3 7  
1 0. 1  Patie nt N u m beri n g  ...................................................................................................... 3 7 
1 0. 2  Stratificati o n a n d Ra n d o mizati o n  ............................................................................... 3 7 
1 0. 3  Bli n di n g ...................................................................................................................... 3 7  
1 1.  
St u d y Pr oce d ures a n d G ui deli nes  ..................................................................................... 3 8 
1 1. 1  Dietar y a n d Lif est yle Restricti o ns  .............................................................................. 3 8 
1 1. 2  P har mac o d y na mic/ Efficac y -Relate d Pr oce d ures  ........................................................ 3 8 
1 1. 2. 1  
Efficac y - Relate d: S h ort F or m- 3 6 H ealt h S ur ve y ......................................... 3 8 
1 1. 2. 2  
Efficac y -Relate d: P R O Q uesti o n naire  ......................................................... 3 8 
1 1. 2. 3  
Patie nt Gl o bal I m pressi o n of C ha n ge ( P GI C) .............................................. 3 9  
1 1. 2. 4  
P har mac o d y na mic: C o m plete Bl o o d C o u nt wit h Differe ntial ..................... 3 9  
1 1. 2. 5  
Es o p ha g o- Gastr o - D u o de n osc o p y wit h Bi o ps y ............................................ 3 9 
1 1. 3  Safet y -Relate d Pr o ce d ur es  .......................................................................................... 4 0 
1 1. 3. 1  
C o nc o mita nt Me dicati o ns ............................................................................ 4 0  
1 1. 3. 2  
B o d y Wei g ht ................................................................................................ 4 0  
1 1. 3. 3  
S y m pt o m- Directe d P h ysical E xa mi nati o n  ................................................... 4 0 
1 1. 3. 4  
Vital Si g ns  .................................................................................................... 4 0 
1 1. 4  Cli nical La b orat or y Meas ure me nts............................................................................. 4 1  
1 1. 4. 1  
C o m plete Bl o o d C o u nt wit h Differe ntial ..................................................... 4 2  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 of 8 9  
C o nfi de nti al  
1 1. 4. 2  
Bl o o d C he mistr y Pr ofile ............................................................................... 4 2  
1 1. 4. 3  
Pre g na nc y T est  ............................................................................................. 4 2 
1 1. 4. 4  
Uri nal ysis  ..................................................................................................... 4 2 
1 1. 4. 5  
A nti - Dr u g A nti b o dies ................................................................................... 4 2 
1 1. 4. 6  
Bl o o d f or P har mac o ki netics a n d St ora ge ..................................................... 4 2  
1 1. 4. 7  
C urre nt Safet y E val u ati o ns (if nee de d)  ........................................................ 4 3 
1 1. 4. 8  
C O VI D - 1 9 Testi n g ....................................................................................... 4 3 
1 2.  
E v al u ati o ns a n d Pr oce d ures b y Visit  ................................................................................ 4 3 
1 2. 1  Pri or t o E xte nsi o n Da y 1 ............................................................................................. 4 3  
1 2. 2  E xte nsi o n Da y 1 – First Da y of D osi n g ...................................................................... 4 4  
1 2. 3  E xte nsi o n Da y 2 9 ( ± 3) ................................................................................................ 4 5  
1 2. 4  E xte nsi o n Da y 5 7 ( ± 3) t o E xte nsi o n Da y 1 9 7 ( ± 3) .................................................... 4 6  
1 2. 5  E xte nsi o n Da y 2 1 1 ( ± 3) .............................................................................................. 4 7  
1 2. 6  E xte nsi o n Da y 2 2 5 ( ± 3) t o E xte nsi o n Da y 5 3 3 ( ± 3) .................................................. 4 7  
1 2. 7  E xte nsi o n Da y 5 4 7 ( ± 3) .............................................................................................. 4 9  
1 2. 8  E xte nsi o n Da y 5 6 1 ( ± 3) t o E xte nsi o n Da y 7 0 1 ( ± 3) .................................................. 4 9  
1 2. 9  E xte nsi o n Da y 7 0 1 + 2 8 ( ± 3) da ys O nly  if Pre vi o us D oses were Misse d .................. 5 0 
1 2. 1 0  F oll o w- u p E xte nsi o n Da y 7 2 9 ( ± 3) or 2 8 ( ± 3) Da ys after L ast D ose, if E T or if 
Misse d D oses are b ei n g ma de u p ................................................................................ 5 1 
1 2. 1 1  F oll o w- u p E xte nsi o n Da y 7 3 6 ( ± 3) or 3 5 ( ± 3) Da ys after L ast D ose, if E T or if 
Misse d D oses are b ei n g ma de u p ................................................................................ 5 1 
1 2. 1 2  F oll o w- u p E xte nsi o n Da y 7 5 7 ( ± 3) a n d D a y 7 8 5 ( ± 3) or 5 6 a n d 8 4 ( ± 3) Da ys after 
Last D ose, if E T or if Misse d D oses are bei n g ma de u p ............................................ 5 2  
1 3.  
A d verse E ve nt R e p orti n g a n d D oc u me nt ati o n  ................................................................ 5 2 
1 3. 1  A d verse E v e nts  ........................................................................................................... 5 2 
1 3. 2  Seri o us A d verse E v e nts .............................................................................................. 5 3  
1 3. 3  A d verse E v e nts of S peci al I nt erest  ............................................................................. 5 4 
1 3. 4  I nf usi o n-Relate d Reacti o ns  ......................................................................................... 5 4 
1 3. 5  A na p h yla xis ................................................................................................................ 5 5  
1 3. 6  E val uati n g A d verse E ve nts a n d Seri o us A d verse E ve nts ........................................... 5 5  
1 3. 6. 1  
Esta blis hi n g Dia g n osis ................................................................................. 5 5  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 of 8 9  
C o nfi de nti al  
1 3. 6. 2  
Assess me nt of I nte nsit y  ................................................................................ 5 6 
1 3. 6. 3  
Assess me nt of Ca usalit y t o St u d y Dr u g ....................................................... 5 6  
1 3. 6. 4  
Assess me nt of Ca usalit y t o St u d y Pr oce d ure ............................................... 5 7  
1 3. 6. 5  
Acti o n Ta ke n  ................................................................................................ 5 8 
1 3. 6. 6  
Assess me nt of O utc o me ............................................................................... 5 8  
1 3. 7  A d verse E v e nt Re p orti n g Pr oce d ures ......................................................................... 5 8  
1 3. 7. 1  
All A d verse E v e nts  ....................................................................................... 5 8 
1 3. 7. 2  
Seri o us A d verse E v e nt Re p orti n g ................................................................ 5 8  
1 3. 7. 3  
Pre g na nc y Re p orti n g .................................................................................... 6 0  
1 3. 7. 4  
A d verse E v e nt of S pecial I nterest Re p orti n g ............................................... 6 0  
1 3. 8  Me dical M o nit ori n g .................................................................................................... 6 1  
1 3. 9  St u d y Wit h dra wal Criteri a  .......................................................................................... 6 1 
1 3. 1 0  St u d y St o p pi n g R ules  ................................................................................................. 6 1 
1 4.  
Disc o nti n u ati o n a n d Re pl ace m e nt of P atie nts  ................................................................. 6 2 
1 4. 1  Defi niti o n of St u d y C o m pleti o n ................................................................................. 6 2  
1 4. 2  Earl y Disc o nti n uati o n of St u d y Dr u g ......................................................................... 6 2  
1 5.  
St atistic al Met h o ds a n d Ge ner al C o nsi der ati o ns  ............................................................ 6 3 
1 5. 1  Sa m ple Size  ................................................................................................................ 6 3 
1 5. 2  Data Sets A nal yze d  ..................................................................................................... 6 3 
1 5. 3  De m o gra p hic a n d Baseli ne C haracteristics  ................................................................ 6 3 
1 5. 4  Patie nt Dis p ositi o n  ...................................................................................................... 6 3 
1 5. 5  A nal ysis of Safet y E n d p oi nts ...................................................................................... 6 3  
1 5. 6  P har mac o d y na mic/ Efficac y -Relate d A n al yses  ........................................................... 6 5 
1 5. 7  Patie nt C o nfi de ntialit y  ................................................................................................ 6 5 
1 6.  
D at a C ollecti o n, Rete nti o n, a n d M o nit ori n g .................................................................... 6 5  
1 6. 1  Data C ollecti o n I nstr u me nts  ....................................................................................... 6 5 
1 6. 2  Data Ma na g e me nt Pr oce d ures  .................................................................................... 6 6 
1 6. 3  Data Q ualit y C o ntr ol a n d Re p orti n g ........................................................................... 6 6  
1 6. 4  Data base L oc k  ............................................................................................................ 6 6 
1 6. 5  Arc hi vi n g of Dat a ....................................................................................................... 6 6  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 of 8 9  
C o nfi de nti al  
1 6. 6  A vail a bilit y a n d Rete nti o n of I n vesti gati o nal Rec or ds ............................................... 6 7  
1 6. 7  M o nit ori n g .................................................................................................................. 6 7  
1 7.  
A d mi nistr ati ve, Et hic al, a n d Re g ul at or y C o nsi der ati o ns ............................................... 6 7  
1 7. 1  Pr ot oc ol A me n d me nts ................................................................................................ 6 8  
1 7. 2  I nstit uti o nal Re vie w B oar d ......................................................................................... 6 8 
1 7. 3  I nf or me d C o nse nt F or m .............................................................................................. 6 8 
1 7. 4  P u blicati o ns ................................................................................................................. 6 9  
1 7. 5  Cli nical Trial Re gistrati o n  .......................................................................................... 6 9 
1 7. 6  Pa y me nt t o Patie nts  ..................................................................................................... 6 9 
1 7. 7  I n v esti gat or Res p o nsi bilities ....................................................................................... 6 9 
1 8.  
Refere nces  ........................................................................................................................... 7 1 
1 9.  
A p pe n dices  .......................................................................................................................... 7 3 
1 9. 1  S F - 3 6 Healt h S ur ve y ................................................................................................... 7 4 
1 9. 2  P R O  Q uesti o n naire ..................................................................................................... 8 0 
1 9. 3  C o m m o n Ter mi n ol o g y Criteria f or A d vers e E ve nts Versi o n 5. 0 ............................... 8 3  
1 9. 4  Sa m ps o n’s Criteria of A na p h yla xis ............................................................................ 8 4  
1 9. 5  A d diti o nal Q uesti o ns f or At o pic C o n diti o ns .............................................................. 8 5  
1 9. 6  Patie nt Gl o bal I m pr essi o n of C ha n ge Q uesti o n naire .................................................. 8 6  
1 9. 7  D ys p ha gia S y m pt o m Q uesti o n naire ........................................................................... 8 7  
1 9. 8  E G D Hist ol o g y I nstr u cti o ns ....................................................................................... 8 8  
 
 
 
List of T a bles  
Ta ble  1 
St u d y A K 0 0 2- 0 0 3 X Sc he d ule of Assess me nts ........................................................... 2 7  
Ta ble  2 
A d verse E v e nt Se verit y per t he Nati o nal Ca n cer I nstit ute C o m m o n Ter mi n ol o g y 
Criteria f or A d v erse E v e nts Versi o n 5. 0 ..................................................................... 5 6  
Ta ble  3 
A d verse E v e nt Relati o ns hi p t o St u d y Dr u g ................................................................ 5 7  
Ta ble  4 
A d verse E v e nt Relati o ns hi p t o St u d y Pr oce d ure ........................................................ 5 7  
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 of 8 9  
C o nfi de nti al  
List of A b bre vi ati o ns 
A C  
Aller gic c o nj u ncti vitis  
A D A  
A nti -dr u g a nti b o d y  
A D C C  
A nti b o d y -de pe n de nt cell ular c yt ot o xicit y  
A E  
A d verse E ve nt  
A E C  
A bs ol ute E osi n o p hil C o u nt  
A E SI  
A d verse e ve nt of s pecial i nterest 
A L T  
Ala ni ne a mi n otra nsferase  
A nti -H Bc  
A nti -He patitis B c ore a nti b o d y  
A S T  
As partate a mi n otra nsferase  
A U C  
Area u n der t he c ur ve  
A V  
A del p hi Val ues  
B MI  
B o d y Mass I n de x  
B Q L  
Bel o w q ua ntifia ble li mit  
B U N  
Bl o o d urea nitr o ge n  
C 
Ce nti gra de  
C B C  
C o m plete bl o o d c o u nt  
C F R  
C o de of Fe deral Re g ulati o ns  
c m  
Ce nti meter  
C O VI D -1 9  
C or o na vir us  disease 2 0 1 9  
C S  
Cli nicall y si g nifica nt  
C T C A E  
C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts  
C U  
C hr o nic Urticaria  
D S Q  
D ys p ha gia S y m pt o m Q uesti o n naire  
E C G  
Electr ocar di o gra m  
e C R F  
Electr o nic Case Re p ort F or m  
E D C  
Electr o nic Data Ca pt ure (s yste m)  
E G  
E osi n o p hilic gastritis  
E G D  
Es o p ha g o -Gastr o -D u o de n osc o p y  
E G E  
E osi n o p hilic gastr oe nteritis  
E GI D  
E osi n o p hilic gastr oi ntesti nal dis or ders  
E o D  
E osi n o p hilic d u o de nitis  
E o E  
E osi n o p hilic Es o p ha gitis  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 9 of 8 9  
C o nfi de nti al  
E os  
E osi n o p hil  
E T  
Earl y ter mi nati o n  
E xt  
E xte nsi o n  
F D A  
F o o d a n d Dr u g A d mi nistrati o n  
F S H  
F ollicle sti m ulati n g h or m o ne  
G C P  
G o o d Cli nical Practice  
G G T  
Ga m ma -gl uta m yl tra nsferase  
G L P  
G o o d La b orat or y Practices  
H Bs A g  
He patitis B s urface a nti ge n  
HI V  
H u ma n i m m u n o deficie nc y vir us  
H E S  
H y pere osi n o p hilic S y n dr o me  
HI P A A  
Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y Act  
h pf  
Hi g h p o wer fiel d  
I C F 
I nf or me d c o nse nt f or m 
I C H 
I nter nati o nal C o nfere nce o n Har m o nisati o n 
I g E 
I m m u n o gl o b uli n E 
I g G 1 
I m m u n o gl o b uli n G 1 
I N D 
I n vesti gati o nal Ne w Dr u g 
I R B 
I nstit uti o nal Re vie w B oar d 
I R R 
I nf usi o n relate d reacti o n 
I S M 
I n d ole nt s yste mic mast oc yt osis 
I S R 
I njecti o n Site Reacti o n 
I R T 
I nteracti ve res p o nse tec h n ol o g y (s yste m) 
I V 
I ntra ve n o us 
k g  
Kil o gra m  
L D H  
Lactate de h y dr o ge nase  
L L O Q  
L o wer li mit of q ua ntificati o n  
L y m p h  
L y m p h oc yte  
Me d D R A  
Me dical Dicti o nar y f or Re g ulat or y Acti vities  
m g  
Milli gra m  
mI U  
Milli -i nter nati o nal u nit 
M T D  
Ma xi m u m t olerate d d ose  
Na Cl  
S o di u m c hl ori de  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 0  of 8 9  
C o nfi de nti al  
N CI  
Nati o nal Ca ncer I nstit ute  
N C S  
N ot cli nicall y si g nifica nt  
N O A E L  
N o -o bser ve d -a d verse -effect le vel 
P C P  
Pri mar y Care P h ysicia n  
P D  
P har mac o d y na mic(s)  
P E  
P h ysical E xa mi nati o n  
P GI C  
Patie nt Gl o bal I m pressi o n of C ha n ge  
PI D  
Patie nt i de ntificati o n n u m ber  
P P  
Per pr ot oc ol  
P K  
P har mac o ki netic(s)  
S A E  
Seri o us a d verse e ve nt  
S F -3 6  
S h ort -f or m healt h s ur ve y 
Si glec -8  
Sialic aci d -bi n di n g, i m m u n o gl o b uli n-li ke lecti n-8  
S O C  
Sta n dar d of care  
T E A E  
Treat me nt -e mer ge nt a d verse e ve nt  
T E S A E  
Treat me nt -e mer ge nt seri o us a d verse e ve nt  
T S S  
T otal s y m pt o m sc ore  
T S S 8  
T otal s y m pt o m sc ore o n 8 s y m pt o m i nte nsit y sc ores  
µ L 
Micr oliter  
U L N  
U p per li mit of n or mal 
W H O  
W orl d Healt h Or ga nizati o n  
w/ v  
Wei g ht/ v ol u me  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 1  of 8 9  
C o nfi de nti al  
1.  
Pr ot oc ol S y n o psis 
St u d y Title  
A P hase 2, M ultice nter, O pe n - La bel, E xte nsi o n St u d y t o E val uate t he Safet y 
a n d T olera bilit y of A K 0 0 2 i n Patie nts wit h E osi n o p hilic Gastritis a n d/ or 
E osi n o p hilic D u o de nitis (f or merl y referre d t o as E osi n o p hilic Gastr oe nteritis)  
S p o ns or  
Alla k os I nc., 9 7 5 Isla n d Dri ve, S uite 2 0 1, Re d w o o d Cit y, C A 9 4 0 6 5 U S A  
N u m ber of Sites  
A p pr o xi matel y 2 0 cli nical ce nters i n t he U nite d States  
N o ncli nic al 
B ac k gr o u n d  
A K 0 0 2 is a h u ma nize d n o n -f uc os ylate d i m m u n o gl o b uli n G 1 (I g G 1) 
m o n ocl o nal a nti b o d y directe d a gai nst Si glec- 8, a me m ber of t he C D 3 3- relate d 
fa mil y of sialic aci d- bi n di n g, i m m u n o gl o b uli n-li ke lecti ns ( Si glecs).  
Si glec -8 has a restricte d tiss ue dis tri b uti o n, e x presse d selecti vel y o n t he s urface 
of mat ure e osi n o p hils a n d mast cells, b ut n ot i n earl y prec urs ors of t hese cell 
p o p ulati o ns. Bi n di n g of A K 0 0 2 t o Si glec- 8 i n d uces a si g nal w hic h lea ds t o 
a p o pt osis of e osi n o p hils a n d br oa d i n hi biti o n of mast cells. I n a d diti o n, t here 
is ra pi d a n d mar ke d de pleti o n of e osi n o p hils i n t he bl o o d d ue t o a nti b o d y-
de pe n de nt cell ular c yt ot o xicit y ( A D C C).  
Cli nic al B ac k gr o u n d 
A K 0 0 2, a d mi nistere d as a n i ntra ve n o us i nf usi o n, has bee n pre vi o usl y teste d i n 
healt h y v ol u nteers a n d i n patie nts wit h i n d ole nt s yste mic mast oc yt osis (I S M), 
c hr o nic urticaria ( C U), se vere aller gic c o nj u ncti vitis ( A C) mast cell gastritis, 
a n d e osi n o p hilic gastritis ( E G) a n d/ or e osi n o p hilic d u o de nitis ( E o D), w hic h 
was referre d t o as e osi n o p hilic gastr oe nteritis i n pre vi o us versi o ns of t his 
pr ot oc ol. M ulti ple d oses of 3 m g/ k g ha ve bee n gi ve n t o patie nts wit h I S M, C U, 
se vere A C, a n d E G/ E o D. I n t hese st u dies, patie nts re p orte d i m pr o ve me nts i n 
disease s y m pt o ms wit h A K 0 0 2 p har mac o d y na mic ( P D) acti vit y bei n g o bser ve d 
f or pr ol o n ge d peri o ds of ti me a n d p har mac o ki netic ( P K) para meters 
de m o nstrati n g a half- life a me n da ble t o a d mi nistrati o n e ver y 4 wee ks.  
T o date, o ver 3 0 0 healt h y v ol u nteers a n d patie nts wit h I S M, C U, se vere A C, 
E G/ E o D, E o E, a n d mast cell gastriti s ha ve bee n e nr olle d i n cli nical st u dies. I n 
ge neral, A K 0 0 2 has bee n well t olerate d. T he m ost c o m m o n treat me nt -e mer ge nt 
a d verse e ve nts ( T E A E) o bser ve d were i nf usi o n -relate d reacti o ns (I R R). M ost 
I R R were mil d t o m o derate; 2 I R R were classifie d as seri o us but res ol ve d 
wit hi n 2 4 h o urs. Tra nsie nt l y m p h o pe nia was o bser ve d after i nf usi o n of A K 0 0 2 
b ut was n ot ass ociate d wit h a n y cli nical c o nse q ue nce, a n d l y m p h oc ytes 
rec o vere d wit hi n 2 4 h o urs. A s ustai ne d de pleti o n of e osi n o p hils was o bser ve d 
t hat is c o nsiste nt wit h t he mec ha nis m of acti o n of A K 0 0 2. 
I n t he ra n d o mize d, d o u ble- bli n d, place b o-c o ntr olle d, P hase 2 st u d y of A K 0 0 2 
i n 6 5 patie nts wit h E G a n d/ or E o D, patie nts were ra n d o mize d t o recei ve 
m o nt hl y d oses of place b o, l o w d ose A K 0 0 2 ( 0. 3, 1, 1, a n d 1 m g/ k g), or hi g h 
d ose A K 0 0 2 ( 0. 3, 1, 3, a n d 3 m g/ k g) i n a 1: 1: 1 rati o (Dell o n, 2 0 2 0 ). 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 2  of 8 9  
C o nfi de nti al  
Cli nic al B ac k gr o u n d 
c o nt. 
All pri mar y a n d sec o n dar y e n d p oi nts were met i n t he st u d y. T here was a 9 7 % 
a n d 9 2 % mea n re d ucti o n i n e osi n o p hils i n t he st o mac h/ d u o de n u m o n t he hi g h 
d ose a n d l o w d ose, res pecti vel y, vers us 1 0 % i ncrease o n place b o ( p < 0. 0 0 0 1). 
T he re d ucti o n of e osi n o p hils wa s ass ociate d wit h a statisticall y si g nifica nt 
re d ucti o n i n t otal s y m pt o m sc ore ( T S S) o n 8 s y m pt o m i nte nsit y sc ores ( T S S 8) 
of 5 8 % i n t he hi g h d ose gr o u p a n d 4 9 % i n t he l o w d ose gr o u p vers us 2 4 % 
re d ucti o n i n t he place b o gr o u p ( p = 0. 0 0 1 2 a n d p = 0. 0 1 5, res pecti vel y). 
I m pr o ve me nt i n s y m pt o ms was o bser ve d wit hi n 2 4 h o urs of t he first d ose of 
st u d y dr u g. I n a d diti o n, 7 0 % of hi g h d ose treate d patie nts a n d 6 8 % of l o w d ose 
treate d patie nts were treat me nt res p o n ders ( defi ne d as > 3 0 % i m pr o ve me nt i n 
T S S a n d > 7 5 % re d ucti o n fr o m baseli ne i n tiss ue e osi n o p hils) vers us 5 % f or 
place b o treate d patie nts ( p < 0. 0 0 0 1).  
T ar get Dise ase 
B ac k gr o u n d a n d 
R ati o n ale 
E G a n d/ or E o D re prese nt w hat are belie ve d t o be rare t y pes of e osi n o p hilic 
gastr oi ntesti nal dis or ders ( E GI D) t hat are c haracterize d b y c hr o nic, ofte n se vere 
i nfla m mati o n d ue t o patc h y or diff use i nfiltrati o n of e osi n o p hils i nt o la yers of 
t he st o mac h, s mall i ntesti ne, or b ot h. (Pr ussi n,  2 0 1 4; Ree d, 2 0 1 5 ; Z ha n g, 2 0 1 7 ).  
T he dia g n osis is ma de base d o n cli nical prese ntati o n ( gastr oi ntesti nal 
s y m pt o ms) c o m bi ne d wit h i ncrease d tiss ue e osi n o p hils i n bi o ps y s peci me ns 
fr o m t he st o mac h a n d/ or d u o de n u m wit h o ut a n y ot her ca use f or t he 
e osi n o p hilia. I n v ol ve me nt of t he s mall i ntesti ne is t y picall y assesse d b y 
perf or mi n g d u o de nal bi o psies usi n g a n es o p ha g o- gastr o -d u o de n osc o p y ( E G D) 
a n d has bee n referre d t o as e osi n o p hilic gastr oe nteritis or e osi n o p hilic e nteritis 
t h o u g h e osi n o p hilic d u o de nitis ( E o D) is m ore acc urate. 
T he gastr oi ntesti nal s y m pt o ms are belie ve d t o be d ue t o t he release of 
i nfla m mat or y me diat ors fr o m acti vate d e osi n o p hils, a n d li kel y, mast cells. 
S y m pt o ms t hat are ofte n se vere a n d de bilitati n g c o m m o nl y i ncl u de a b d o mi nal 
pai n, na usea, bl oati n g, earl y satiet y, l oss of a p petite, a b d o mi nal cra m pi n g, 
v o miti n g, diarr hea, a n d wei g ht l oss ( Al h m o u d, 2 0 1 6 ; L o pez- Me di na, 2 0 1 5 ; 
Ma ns o or, 2 0 1 7 ; Ree d,  2 0 1 5). Je nse n (2 0 1 6 ) esti mate d t he pre vale nce of E G 
a n d E o D t o be 6. 3/ 1 0 0, 0 0 0 a n d 8. 4/ 1 0 0, 0 0 0, res pecti vel y (f or patie nts fr o m 
1 t o 6 4 years of a ge). Ma ns o or ( 2 0 1 7) esti mate d t he o verall pre vale nce of E G 
t o be 5. 1/ 1 0 0, 0 0 0 pers o ns.  
Patie nts ma y als o ha ve c o nc o mita nt at o pic diseases li ke f o o d aller g y, ast h ma, 
a n d at o pic der matitis, w hic h f urt her i m pact q ualit y of life a n d c o ntri b ute t o 
healt h care c osts. A d diti o nall y, 8 % t o 1 0 % of patie nts ha ve c o nc o mita nt 
e osi n o p hilic es o p ha gitis ( E o E) (Je nse n, 2 0 1 6).  
T here are n o F D A-a p pr o ve d treat me nts f or E G a n d/ or E o D. C urre nt t hera pies 
a n d disease ma na ge me nt i ncl u des dietar y rest ricti o n/eli mi nati o n, pr ot o n p u m p 
i n hi bit ors ( P PI), a nti hista mi nes, s yste mic or s wall o we d c ortic oster oi ds, a n d 
occasi o nal off -la bel use of i m m u n o m o d ulat or y bi ol o gics ( Pr ussi n, 2 0 1 4; 
Ree d,  2 0 1 5; Z ha n g, 2 0 1 7). 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 3  of 8 9  
C o nfi de nti al  
T ar get Dise ase 
B ac k gr o u n d a n d 
R ati o n ale c o nt.  
Pr ot o n p u m p i n hi bit ors ha ve little t o n o be nefit i n patie nts wit h E G a n d/ or E o D, 
des pite re p orts of pr o vi di n g partial be nefit i n s o me patie nts wit h E o E 
(Katz,  2 0 1 3). Restricte d/ele me ntal diets are n ot effecti ve l o n g -ter m treat me nt as 
t he y re q uire strict c o m plia nce a n d, i n t he case of ele me ntal diets, are e x pe nsi ve 
a n d are ofte n n ot rei m b urse d b y i ns ura nce. I n a d diti o n, c o m plia nce is p o or a n d 
patie nt q ualit y of life is greatl y i m pacte d ( Be dell, 2 0 1 8 ; Peters o n, 2 0 1 3 ; 
Wec hsler, 2 0 1 4 ). 
C ortic oster oi ds, s yste mic or s wall o we d, ha ve bee n s h o w n t o pr o vi de s y m pt o m 
relief b ut are n ot a p pr o priate f or l o n g-ter m treat me nt d ue t o n u mer o us si de 
effects a n d ass ociate d ris ks i ncl u di n g a dre nal i ns ufficie nc y, b o ne 
de mi neralizati o n, i ncrease d c ha nce of i nfecti o n, oste o p or osis, be ha vi oral iss ues, 
a n d wei g ht gai n. 
B y re d uci n g t he n u m ber of bl o o d a n d tiss ue e osi n o p hils a n d i n hi biti n g t he 
acti vati o n of mast cells, A K 0 0 2 ma y be usef ul i n t he treat me nt of patie nts wit h 
E G a n d/ or E o D. T his pre mise is s u p p orte d b y t he P hase 2 data wit h A K 0 0 2 t hat 
s h o ws si g nifica nt i m pr o ve me nts i n hist ol o g y a n d s y m pt o ms i n t hese patie nts.  
Gi ve n t here are n o a p pr o ve d t hera pies f or t hese c hr o nic a n d de bilitati n g 
diseases, better treat me nt o pti o ns are clearl y nee de d t o ma na ge E G a n d E o D.  
R ati o n ale f or D ose 
Selecti o n  
Base d o n e x perie nce wit h A K 0 0 2 i n healt h y v ol u nteers a n d i n patie nts wit h 
I S M, C U, se vere A C, mast cell gastritis, a n d E G/ E o D, t he pr o p ose d A K 0 0 2 
d ose re gi me n is u p t o 2 6 m o nt hl y i ntra ve n o us i nf usi o ns of A K 0 0 2. 
 
 
 
I n t he d o u ble-bli n d, place b o -c o ntr olle d P hase 2 st u d y i n patie nts wit h E G 
a n d/ or E o D, 2 d ose le vels were e val uate d: a l o wer d ose re gi me n ( 4 m o nt hl y 
d oses of A K 0 0 2 at 0. 3, 1, 1, a n d 1 m g/ k g) a n d a hi g her d ose re gi me n 
( 4 m o nt hl y d oses of A K 0 0 2 at 0. 3, 1, 3, a n d 3 m g/ k g). 
 
 
 
A st arti n g d ose of 1 m g/ k g A K 0 0 2 f oll o we d b y a d ose of 3 m g/ k g A K 0 0 2 f or 
s u bse q ue nt i nf usi o ns has bee n c h ose n f or t he P hase 2 e xte nsi o n st u d y wit h 
A K 0 0 2 i n patie nts wit h E G a n d/ or E o D.  
R ati o n ale f or 
N u m ber of P atie nts  
A p pr o xi matel y 6 0 patie nts will be e nr oll e d i n St u d y A K 0 0 2-0 0 3 X, base d o n t he 
e nr oll me nt of St u d y  A K 0 0 2 - 0 0 3.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 4  of 8 9  
C o nfi de nti al  
St u d y Desi g n  
T his is a P hase 2, m ultice nter, o pe n -la bel, e xte nsi o n st u d y t o e val uate t he 
safet y, t olera bilit y, a n d efficac y of A K 0 0 2 i n patie nts wit h E G a n d/ or E o D. 
Patie nts w h o c o m plete  St u d y A K 0 0 2- 0 0 3 will ha ve t he o pti o n t o recei ve 
A K 0 0 2 i n a n o pe n-la bel ma n ner.  
A patie nt will be cate g orize d as ha vi n g c o m plete d St u d y A K 0 0 2- 0 0 3 if 
4 i nf usi o ns of st u d y dr u g are a d mi nistere d a n d t he patie nt is f oll o we d t hr o u g h 
Da y 1 1 3 ( ± 3 da ys). 
Patie nts  w h o were disc o nti n ue d fr o m treat me nt i n St u d y A K 0 0 2-0 0 3 at t he 
rec o m me n dati o n of t he u n bli n de d safet y m o nit or f or hi g h e osi n o p hil c o u nts 
pri or t o i nf usi o ns 2, 3, or 4, will ha ve t he o pti o n t o recei ve A K 0 0 2 i n a n 
o pe n- la bel ma n ner.  
Patie nts w h o e nr oll i n St u d y A K 0 0 2- 0 0 3 X will recei ve m o nt hl y A K 0 0 2 
i nf usi o ns f or a ma xi m u m of 2 6 i ntra ve n o us d oses. D uri n g E xte nsi o n St u d y 
A K 0 0 2 -0 0 3 X, patie nts will mai ntai n t he sa me patie nt n u m ber t hat was assi g ne d 
i n St u d y A K 0 0 2- 0 0 3.  
Safet y will be assesse d b y b o d y wei g ht, vital si g ns, s y m pt o m - directe d p h ysical 
e xa mi nati o n, c o m plete bl o o d c o u nt ( C B C) wit h differe ntial, bl o o d c he mistr y, 
uri nal ysis, a n d assess me nt of a d verse e ve nts  ( A E) (i ncl u di n g a d verse e ve nts of 
s pecial i nterest [ A E SI] a n d seri o us a d verse e ve nts  [ S A E]). I n a d diti o n, bl o o d 
sa m ples will be o btai ne d f or e val uati o n of a nti- dr u g a nti b o dies ( A D A).  
T he st u d y is desi g ne d as f oll o ws: 
•  
Patie nts c o m pleti n g St u d y A K 0 0 2- 0 0 3 a n d wa nti n g t o e nter t he e xte nsi o n 
st u d y will be gi n e xte n de d d osi n g o n Da y 1 1 3 of St u d y A K 0 0 2- 0 0 3 
(f oll o wi n g fi nal assess me nts of St u d y A K 0 0 2- 0 0 3), w hic h will be 
c o nsi dere d Da y 1 of St u d y A K 0 0 2- 0 0 3 X. If patie nts ca n n ot start e xte n de d 
d osi n g wit hi n 4 5 da ys of A K 0 0 2- 0 0 3 Da y 1 1 3, c urre nt baseli ne safet y 
assess me nts m ust be c o m plete d pri or t o Da y 1  of St u d y A K 0 0 2- 0 0 3 X.  
•  
Patie nts disc o nti n ue d fr o m treat me nt i n St u d y A K 0 0 2- 0 0 3 d ue t o hi g h 
e osi n o p hil c o u nts pri or t o i nf usi o ns 2, 3, or 4 ma y be gi n e xte n de d d osi n g 
wit hi n 6 m o nt hs of last d ose i n St u d y A K 0 0 2- 0 0 3. C urre nt baseli ne safet y 
assess me nts m ust b e c o m plete d pri or t o Da y 1 of St u d y A K 0 0 2 - 0 0 3 X. 
•  
Patie nts will recei ve 2 6 m o nt hl y  i ntra ve n o us i nf usi o ns of A K 0 0 2 i n a n 
o pe n-la bel ma n ner. T he first i nf usi o n of A K 0 0 2 will be 1 m g/ k g, a n d 
s u bse q ue nt i nf usi o ns will be 3 m g/ k g.  
•  
If a m o nt hl y i nf usi o n of A K 0 0 2 is misse d, t he patie nt will be per mitte d t o 
ma ke u p t he misse d d ose after t he 2 6t h m o nt h s o t hat all patie nts ha ve t he 
c ha nce t o recei ve a t otal of 2 6 i nf usi o ns.  
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 5  of 8 9  
C o nfi de nti al  
St u d y Desi g n c o nt.  
•  
A n E G D wit h bi o ps y will occ ur o n Da y 2 1 1 ( ± 3), Da y 5 4 7 ( ± 3), a n d 
Da y  7 2 9 ( ± 3) or 2 8 ( ± 3) da ys after last d ose of st u d y dr u g if earl y 
ter mi nati o n ( E T) or if patie nt recei ve d a d diti o nal misse d d oses. 
•  
Patie nts will be f oll o we d f or 8 4 da ys after t he last d ose. F oll o w- u p will 
occ ur o n E xte nsi o n Da y 7 3 6 ( ± 3), Da y 7 5 7 ( ± 3), a n d Da y 7 8 5 ( ± 3) or 3 5, 
5 6, a n d 8 4 ( ± 3) da ys after last d ose of st u d y dr u g if E T or if patie nt 
recei ve d a d diti o nal misse d d oses. 
T he e xte nsi o n st u d y d oes n ot i ncl u de fasti n g re q uire me nts. Patie nts u n der we nt 
a sta n dar dize d baseli ne e val uati o n of eati n g ha bits, f o o d ha bits/restricti o ns, a n d 
f o o d a v oi da nce be ha vi ors d uri n g St u d y A K 0 0 2- 0 0 3 a n d will be as ke d at st u d y 
visits w het her a n y c ha n ges ha ve bee n ma de fr o m t he baseli ne diet.  
T otal d urati o n of St u d y A K 0 0 2- 0 0 3 X will be a p pr o xi matel y 2 8 m o nt hs if d oses 
are a d mi nistere d m o nt hl y a n d n o ne are misse d, or l o n ger, as nee de d f or t he 
patie nt t o recei ve all 2 6 d oses.  
O bjecti ve  
T he o bjecti ve of t he st u d y is t o ge nerate o pe n- la bel, l o n ger-ter m safet y, 
t olera bilit y, a n d efficac y f oll o w- u p data i n patie nts wit h E G a n d/ or E o D w h o 
c o m plete d St u d y A K 0 0 2 - 0 0 3 or were disc o nti n ue d fr o m treat me nt d ue t o hi g h 
e osi n o p hil c o u nts pri or t o i nf usi o ns 2, 3, or 4.  
T he o bjecti ve of t his e xte nsi o n st u d y is als o t o gi ve patie nts t hat recei ve d 
place b o i n St u d y A K 0 0 2- 0 0 3 access t o A K 0 0 2. 
S afet y E n d p oi nts  
T he safet y a n d t olera bilit y of A K 0 0 2 will be assesse d b y deter mi ni n g t he 
i nci de nce, relati o ns hi p t o st u d y dr u g, a n d se verit y of T E A E, wit h dra wals d ue t o 
A E , vital si g ns, la b orat or y tests, c ha n ges i n c o nc o mita nt me dicati o n use d ue t o 
A E , i m m u n o ge nicit y, a n d ot her safet y para meters. 
P h ar m ac o d y n a mic/  
Effic ac y E n d p oi nts  
•  
S h ort- F or m 3 6 Healt h S ur ve y ( S F- 3 6) q uesti o n naire  
•  
Gastr oi ntesti nal s y m pt o mat ol o g y ( P R O q uesti o n naire) 
•  
C ha n ge i n bl o o d e osi n o p hil c o u nt 
•  
C ha n ge i n e osi n o p hil c o u nts i n gastric a n d/ or d u o de nal bi o psies  
St u d y P o p ul ati o n  
Patie nts w h o c o m plete St u d y A K 0 0 2- 0 0 3 or were disc o nti n ue d fr o m treat me nt 
d ue t o hi g h e osi n o p hil c o u nts pri or t o i nf usi o ns 2, 3, or 4 will ha ve t he o pti o n t o 
recei ve A K 0 0 2 i n a n o pe n-la bel ma n ner.  
A patie nt was cate g orize d as ha vi n g c o m plete d St u d y A K 0 0 2- 0 0 3 if 4 i nf usi o ns 
of st u d y dr u g were a d mi nistere d a n d t he patie nt was f oll o we d t hr o u g h Da y 1 1 3 
( ± 3) of St u d y A K 0 0 2- 0 0 3. 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 6  of 8 9  
C o nfi de nti al  
P atie nt Selecti o n 
Criteri a  
I ncl usi o n Criteri a 
P atie nts are eli gi ble f or t he st u d y if all of t he f oll o wi n g criteria are met:  
1) 
Pr o vi de writte n i nf or me d c o nse nt.  
2)  
C o m plete d St u d y A K 0 0 2- 0 0 3, defi ne d as ha vi n g recei ve d 4 i nf usi o ns of 
st u d y dr u g a n d f oll o we d t hr o u g h Da y 1 1 3 ( ± 3) i n St u d y A K 0 0 2- 0 0 3 or 
dis c o nti n ue d fr o m treat me nt d ue t o hi g h e osi n o p hil c o u nts pri or t o 
i nf usi o ns 2, 3, or 4 a n d willi n g t o be gi n e xte n de d d osi n g o n or a b o ut 
Da y  1 1 3 (f or A K 0 0 2- 0 0 3 c o m pleters) or wit hi n 6 m o nt hs of last d osi n g 
f or patie nts disc o nti n ue d fr o m treat me nt.  
3) 
If patie nt is o n pre -e xisti n g dietar y restricti o ns, willi n g ness t o n ote a n y 
c ha n ges t hat occ ur fr o m t he Baseli ne diet, t hr o u g h o ut t he st u d y.  
4)  
A ble a n d willi n g t o c o m pl y wit h all st u d y pr oce d ures. 
5) 
Fe male patie nts m ust be eit her p ost - me n o pa usal f or at least 1 year or 
s ur gicall y sterile (t u bal li gati o n, h ysterect o m y, or bilateral o o p h orect o m y) 
f or at least 3 m o nt hs, or if of c hil d beari n g p ote ntial, ha ve a ne gati ve 
pre g na nc y test a n d a gree t o use d ual met h o ds of c o ntrace pti o n, or a bstai n 
fr o m se x ual acti vit y u ntil t he e n d of t he st u d y, or f or 1 2 0 da ys f oll o wi n g 
t he last d ose of st u d y dr u g, w hic he ver is l o n ger. 
6) 
Male patie nts wit h fe male part ners of c hil d beari n g p ote ntial m ust a gree t o  
use a hi g hl y effecti ve met h o d of c o ntrace pti o n u ntil t he e n d of t he st u d y 
or f or 1 2 0 da ys f oll o wi n g t he last d ose of st u d y dr u g, w hic he ver is l o n ger. 
All  fertile me n wit h fe male part ners of c hil d beari n g p ote ntial s h o ul d be 
i nstr ucte d t o c o ntact t he I n vesti gat or i m me diatel y if t he y s us pect t heir 
part ner mi g ht be pre g na nt at a n y ti me d uri n g st u d y partici pati o n.  
 
E xcl usi o n Criteri a  
Patie nts will be e xcl u de d fr o m t he st u d y if t he y meet a n y of t he f oll o wi n g 
criteria: 
1)  P o or t olera nce t o pre vi o us a d mi nistrati o n of A K 0 0 2 i n t he o pi ni o n of t he 
I n vesti gat or. 
2)  
K n o w n h y perse nsiti vit y t o a n y c o nstit ue nt of t he st u d y dr u g. 
3)  
A n y disease, c o n diti o n ( me dical or s ur gical), or car diac a b n or malit y, 
w hic h, i n t he o pi ni o n of t he I n vesti gat or, w o ul d place t he patie nt at 
i ncrease d ris k. 
4) 
Vacci nati o n wit h li ve atte n uate d vacci n es wit hi n 3 0 da ys pri or t o i nitiati o n 
of treat me nt i n t he st u d y, d uri n g t he treat me nt peri o d, or vacci nati o n 
e x pecte d wit hi n 5 half-li ves ( 4 m o nt hs) of st u d y dr u g a d mi nistrati o n.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 7  of 8 9  
C o nfi de nti al  
P atie nt Selecti o n 
Criteri a c o nt.  
E xcl usi o n Criteri a c o nt.  
4)  c o nt. 
 
All  t y pes a n d f or m ulati o ns of vacci nes (i ncl u di n g li ve atte n uate d vacci nes) 
a ut h orize d b y F D A or ot her re g ulat or y a ut h orit y f or t he pre ve nti o n of 
C O VI D - 1 9 ma y be a d mi nistere d bef ore, d uri n g, or after t his st u d y. T he 
vacci ne s h o ul d n ot be a d mi nistere d wit hi n 7 da ys pri or t o a n d wit hi n 
7 da ys after t he a d mi nistrati o n of A K 0 0 2 s o t hat a n y si de effects ca use d 
b y eit her of t he 2 me dicati o ns ca n be m ore easil y deter mi ne d.  
5)  
W o me n w h o are pre g na nt, breastfee di n g, or pla n ni n g t o bec o me pre g na nt 
w hile partici pati n g i n t he st u d y. 
6)  
A n y ot her reas o n t hat, i n t he o pi ni o n of t he I n vesti gat or or Me dical 
M o nit or, ma kes t he patie nt u ns uita ble f or e nr oll me nt.  
7)  
Dia g n osis of H y pere osi n o p hilic S y n dr o me ( H E S), base d o n sta n dar d 
criteria ( bl o o d e osi n o p hils > 1 5 0 0/ µ L wit h i n v ol ve me nt of eit her t he heart, 
ner v o us s yste m, a n d/ or b o ne marr o w).  
Test Pr o d uct, D ose, 
a n d A d mi nistr ati o n  
A K 0 0 2 Dr u g Pr o d uct:  1 0 m L s u p plie d i n 1 0 R T y pe 1 clear glass vials f or I V 
i nf usi o n wit h 
 
p H 6. 0, i n water f or i njecti o n ( W FI).  
T here is n o place b o i n t his st u d y.  
A K 0 0 2 at a d ose of 1 m g/ k g will be pre pare d acc or di n g t o t he patie nt’s b o d y 
wei g ht a n d a d mi nistere d via i nf usi o n p u m p o n E xte nsi o n Da y 1. Starti n g wit h 
t he sec o n d i nf usi o n ( E xte nsi o n Da y 2 9), t he d ose of A K 0 0 2 will be i ncrease d 
t o 3 m g/ k g A K 0 0 2, a n d 3 m g/ k g will be a d mi nistere d f or i nf usio ns 2 t hr o u g h 
2 6. Patie nts will be o bser ve d f or 1 h o ur after t he e n d of d osi n g. 
D osi n g will occ ur e ver y 2 8 ( ± 3) da ys f or a t otal of 2 6 m o nt hl y d oses. D osi n g 
will occ ur o n: Da ys 1, 2 9, 5 7, 8 5, 1 1 3, 1 4 1, 1 6 9, 1 9 7, 2 2 5, 2 5 3, 2 8 1, 3 0 9, 3 3 7, 
3 6 5, 3 9 3, 4 2 1, 4 4 9, 4 7 7, 5 0 5, 5 3 3, 5 6 1, 5 8 9, 6 1 7, 6 4 5, 6 7 3, a n d 7 0 1 ( ± 3 d a ys) . 
If a m o nt hl y i nf usi o n is dela ye d s o t hat it occ urs  cl oser i n t he ti me fra me t o t he 
ne xt u pc o mi n g i nf usi o n, t he late i nf usi o n will be c o nsi dere d s ki p pe d a n d ma y 
be ma de u p after Da y 7 0 1. T heref ore, d osi n g c o ul d p ossi bl y occ ur o n Da y 7 2 9 
(ma ke u p f or 1 s ki p pe d d ose) a n d e ver y 2 8 ( ± 3) da ys after t hat, u ntil 2 6 d oses i n 
t otal ha ve bee n recei ve d.  
Pri or t o t he first i nf usi o n of A K 0 0 2, 6 0 m g oral pre d nis o ne will be gi ve n 
1 2- 2 4 h o urs pri or t o t he i nf usi o n. T he i nitial I V i nf usi o n s h o ul d be gi ve n o ver 
at least a 4- h o ur peri o d, a n d t he sec o n d i nf usi o n s h o ul d be gi ve n o ver at least a 
3- h o ur peri o d. S u bse q ue nt I V i nf usi o ns ( 3– 2 6) ca n be gi ve n o ver a p pr o xi matel y 
1 t o 4 h o urs, de pe n di n g o n t he patie nt’s t olera nce of t he pre vi o us i nf usi o ns a n d 
at t he I n vesti gat or’s discreti o n. I nf usi o n rate sc he d ules are descri be d i n m ore 
detail i n t he P har mac y Ma n ual.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 8  of 8 9  
C o nfi de nti al  
D ur ati o n of P atie nt 
P artici p ati o n  
If n o d oses are c o nsi dere d s ki p pe d or misse d , the t otal st u d y d urati o n f or eac h 
patie nt will be a p pr o xi matel y 2 8 m o nt hs, w hic h i ncl u des: 
•  
A treat me nt peri o d of m o nt hl y A K 0 0 2 i nf usi o ns, a d mi nistere d e ver y 
2 8 ( ± 3) da ys i n a n o pe n- la bel ma n ner f or a ma xi m u m of 2 6 i ntra ve n o us 
d oses.  
•  
A p ost- treat me nt F oll o w-U p Peri o d of 8 4 ( ± 3) da ys f oll o wi n g t he last d ose 
of A K 0 0 2.  
If d oses are c o nsi dere d s ki p pe d or misse d , t he t otal st u d y d urati o n will be 
e xte n de d be y o n d 2 8 m o nt hs.  T he 8 4- da y ( ± 3) p ost-treat me nt F oll o w- U p Peri o d 
still a p plies after t he last d ose of st u d y dr u g . 
S afet y E v al u ati o ns 
Safet y a n d t olera bilit y will be assesse d t hr o u g h o ut t he st u d y b y m o nit ori n g a n d 
e val uati n g A E , i ncl u di n g a n y c o m plicati o ns res ulti n g fr o m t he i ntra ve n o us 
i nf usi o n. All A E  will be c ollecte d fr o m t he start of st u d y dr u g a d mi nistrati o n 
t hr o u g h 8 4 ( ± 3) da ys after last d ose of st u d y dr u g.   
Se verit y of A E  will be assesse d usi n g t he Nati o nal Ca ncer I nstit ute C o m m o n 
Ter mi n ol o g y Criteria f or A d verse E ve nts Versi o n 5. 0 ( or m ost c urre nt versi o n). 
All A E  will be assi g ne d a se verit y gra de a n d will be assesse d t o deter mi ne 
w het her t he y are cli nicall y si g nifica nt a n d relate d t o st u d y dr u g. 
A d diti o nal safet y e val uati o ns i ncl u de vital si g ns, C B C wit h differe ntial, bl o o d  
c he mistr y, uri nal yses, s y m pt o matic p h ysical e xa mi nati o ns, a n d A D A t o 
A K 0 0 2. 
P h ar m ac o d y n a mic/  
Effic ac y E v al u ati o ns 
Patie nts will rate t heir q ualit y of life usi n g t he n o n- disease -s pecific S F-3 6 at 
vari o us st u d y visits. Dail y self -a d mi nistrati o n of a disease-s pecific patie nt 
q uesti o n naire ( P R O Q uesti o n naire) will be use d t o e val uate si g ns a n d 
s y m pt o ms ass ociate d wit h E G a n d/ or E o D.  
Patie nts wit h c o nc o mita nt c o n diti o ns of ast h ma, at o pic der matitis, a n d/ or E o E 
will recei ve a n a d diti o nal q uesti o n a b o ut eac h c o n diti o n, as a p pr o priate. 
Patie nts wit h E o E will als o recei ve t he dail y D ys p ha gia S y m pt o m 
Q uesti o n naire ( D S Q).  
Bl o o d e osi n o p hil c o u nts will be assesse d at eac h st u d y visit.  
P h ar m ac o ki netic 
E v al u ati o ns 
Bl o o d (ser u m) will be c ollecte d f or assess me nt of A K 0 0 2 c o nce ntrati o ns usi n g 
a vali date d e nz y me -li n ke d i m m u n os or be nt assa y met h o d. Bl o o d (ser u m) will be 
c ollecte d f or assess me nt of A K 0 0 2 A D A usi n g a vali date d assa y met h o d.  
P har mac o ki netic bl o o d sa m ples wi ll be o btai ne d pre-d ose o n E xte nsi o n Da y  1 
( o btai ne d fr o m Da y 1 1 3 e val uati o ns of St u d y A K 0 0 2-0 0 3 or re dra w n f or 
patie nts t hat were disc o nti n ue d fr o m treat me nt i n A K 0 0 2 - 0 0 3), o n E xte nsi o n 
Da y  5 6 1 ( ± 3), a n d o n E xte nsi o n Da y 7 3 6 ( ± 3) or 3 5 ( ± 3) da ys after last d ose of 
st u d y dr u g, if E T or if patie nt recei ve d a d diti o nal misse d d oses. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 1 9  of 8 9  
C o nfi de nti al  
P h ar m ac o ki netic 
E v al u ati o ns c o nt.  
A D A sa m ples will be o btai ne d pre d ose o n E xte nsi o n Da y 1, pre d ose o n all 
i nf usi o n da ys t hr o u g h E xte nsi o n Da y 3 6 5, E xte nsi o n Da y 5 3 3 ( ± 3), a n d 
E xte nsi o n Da y 7 3 6 ( ± 3) or 3 5 ( ± 3) da ys after last d ose of st u d y dr u g, if E T or if 
patie nt recei ve d a d diti o nal misse d d oses. I n a d diti o n, A D A bl o o d sa m ples 
s h o ul d be o btai ne d at a n y ti me a n i m m u n o ge nicit y-relate d A E occ urs. 
St atistic al A n al ysis  
S u m mar y statist ics will i ncl u de t he mea n, me dia n, sta n dar d de viati o n, 
mi ni m u m, a n d ma xi m u m f or c o nti n u o us varia bles a n d n u m ber a n d perce nta ge 
of patie nts f or cate g orical varia bles). N o i m p utati o n will be use d f or missi n g 
data. Data will be a nal yze d as lai d o ut i n t he Sta tistical A nal ysis Pla n. 
R ati o n ale f or 
A me n d me nt 7 
T he f oll o wi n g m o dificati o ns were i nc or p orate d i nt o A me n d me nt 7: 
•  
Clarifie d t hat d oses m ore t ha n 1 5 da ys o ut of wi n d o w will be c o nsi dere d 
s ki p pe d i n or der t o sta n dar dize o ut- of-wi n d o w de viati o ns a n d get pati e nts 
bac k o n d osi n g trac k.  
•  
Clarifie d t hat a n y d oses s ki p pe d or misse d d uri n g t he i nitial 7 0 1 da ys ma y 
be ma de u p after D a y 7 0 1 ( 2 6 t h d ose) t o gi ve all patie nts a c ha nce t o 
recei ve a t otal of 2 6 d oses. 
•  
U p date d t otal d urati o n of ti me t o reflect t he p ossi bilit y of s ki p pe d / misse d 
d oses bei n g ma de u p after D a y 7 0 1 a n d t heref ore e xte n di n g t he treat me nt 
peri o d d urati o n. 
•  
C ha n ge d E xcl usi o n C riterio n  4 t o all o w f or C O VI D - 1 9 vacci nati o ns of a n y 
ki n d, i ncl u di n g li ve, atte n uate d vacci nes. 
•  
U p date d t otal n u m ber of patie nts treate d wit h A K 0 0 2. 
•  
Clarifie d t hat male patie nts d o n ot nee d t o disc o nti n ue t he st u d y if t he ir 
part ner bec o me s pre g na nt, b ut t he pre g na nc y m ust be f oll o we d t o ter m.  
•  
C orrecte d Sc he d ule of Assess me nts f or Da y 5 4 7 bei n g a n E G D da y, n ot a n 
i nf usi o n da y.  
•  
Re m o ve d Baseli ne Diet c o m plia nce fr o m hist ol o g y Da ys 2 1 1 a n d 5 4 7. 
•  
U p date d A p pe n di x 1 9. 8  t o reflect t hat bi o ps y sa m ples ma y be use d f or 
f urt her researc h i n t he f ut ure. 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 2 0  of 8 9  
C o nfi de nti al  
2.  
B ac k gr o u n d  
2. 1  
Si glec - 8 a n d A K 0 0 2 
Si glec - 8, a me m ber of t he C D 3 3 -relat e d fa mil y of sialic aci d- bi n di n g, i m m u n o gl o b uli n-li ke 
lecti ns ( Si glecs), is a tra ns me m bra ne cell s urface pr otei n wit h restricte d tiss ue distri b uti o n, 
e x presse d s electi vel y o n t he s urface of mat ure e osi n o p hils a n d mast cells, b ut n ot i n earl y 
pre c urs ors of t hese cell p o p ulati o ns. Si glec- 8 c o ntai ns 3 e xtracell ular i m m u n o gl o b uli n- li ke 
d o mai ns, a tra ns me m bra ne re gi o n, a n d a c yt o plas mic tail c o ntai ni n g 2 t yr osi ne- base d si g nali n g 
m otifs i ncl u di n g a n i m m u n orece pt or t yr osi ne- bas e d i n hi bit or y m otif wit h i n hi bit or y f u ncti o n. 
E n ga ge me nt of Si glec- 8 i n mast cells ca n res ult i n i n hi biti o n of me diat or release, a n d i n 
e osi n o p hils, ca n i n d uce a p o pt osis ( B oc h ner, 2 0 0 9 ). A K 0 0 2 als o s h o ws p ote nt a nti b o d y-
de pe n de nt cell ular c yt ot o xicit y ( A D C C) a gai nst e osi n o p hils i n vi v o a n d i n vitr o.  
2. 2  
O ver vie w of N o ncli nic al St u dies  
A K 0 0 2 is a h u ma nize d n o n-f uc os ylate d i m m u n o gl o b uli n G 1 (I g G 1) m o n o cl o nal a nti b o d y 
directe d a g ai nst t he i n h i bit or y rece pt or Si glec- 8, a me m ber of t he C D 3 3-rel ate d fa mil y of 
Si glecs.  
Si glec - 8 has a r estricte d tiss ue distri b uti o n, e x presse d selecti vel y o n t he s urface of mat ure 
e osi n o p hils a n d mast cells, b ut n ot i n earl y prec urs ors of t hese cell p o p ulati o ns. I n bl o o d, bi n di n g 
of A K 0 0 2 t o Si glec- 8 i n d uces A D C C a gai nst e osi n o p hils, lea di n g t o ra pi d a n d s ustai ne d 
de pleti o n of t hese cells fr o m circ ulati o n. I n t he tiss ue, A K 0 0 2 i n d uces direct a p o pt osis of 
e osi n o p hils a n d i n hi biti o n of mast cells. T his pr ofile of acti v it y ma y pr o vi de cli nical be nefit i n 
diseases i n w hic h t hese cell t y pes pla y a r ole, s uc h as e osi n o p hilic gastritis a n d e osi n o p hilic 
d u o de nitis.  
Si glec - 8 is n ot e x presse d i n s pecies ot her t ha n h u m a ns, a n d t heref ore 2 n o vel m o use m o dels ha ve 
bee n de v el o pe d f or i n vi v o testi n g of A K 0 0 2. A K 0 0 2 has bee n st u die d i n Si glec- 8 h u ma nize d 
a n d tra ns ge nic m o use m o dels a n d wit h h u ma n bl o o d a n d tiss ue cells. T he first m o del uses 
i m m u n o deficie nt mice ca pa ble of ge n erati n g h u ma n i m m u ne cells i ncl u di n g mast cells a n d 
e osi n o p hils w he n e n grafte d wit h h u ma n he mat o p oietic ste m cells. T he a bilit y of a nti- Si glec - 8 
a nti b o dies t o i n hi bit mast cell - me diate d reacti o ns has bee n e v al uate d i n t his m o del. T he sec o n d 
r o de nt m o del is a tra ns ge nic m o use li ne t hat e x presses h u ma n Siglec - 8. T he e x pressi o n of 
Si glec - 8 o n t he cell s urf ace i n t hese mice is restricte d t o e osi n o p hils, mast cells, a n d bas o p hils, a 
patter n of s urf ace e x pr essi o n e q ui vale nt t o t hat i n h u ma ns. A nti- Si glec - 8 a nti b o dies ca n pre v e nt 
i m m u n o gl o b uli n E (I g E)-me diate d  a na p h yl a xis i n t his tra ns ge nic m o use li ne, i n dicati n g t hat 
Si glec - 8 is p har mac ol o gi call y acti ve i n t he m o del. T he a bilit y of A K 0 0 2 t o affect mast cells a n d 
e osi n o p hils has bee n e val uate d i n t his m o del. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 2 1  of 8 9  
C o nfi de nti al  
A K 0 0 2 i n hi bits I g E- me di ate d mast cell de gra n ulati o n a n d releas e of t he n e wl y f or me d me diat or 
pr osta gla n di n D 2 i n vitr o wit h o ut affecti n g mast cell via bilit y. I n peri p heral bl o o d pre parati o ns 
fr o m n or mal h u ma n d o n ors, A K 0 0 2 s h o ws selecti ve de pleti o n of e osi n o p hils. I m p orta ntl y, i n a 
w h ole- bl o o d c yt o ki ne- r el ease ass a y usi n g i m m o bilize d A K 0 0 2 t o e n h a nce t he p ote ntial f or 
a nti b o d y cr ossli n ki n g, A K 0 0 2 di d n ot lea d t o d ose- de pe n d e nt rel ease of pr o -i nfla m mat or y 
c yt o ki nes. 
T o e val uate t he i n vi v o acti vit y of a nti- Si glec - 8 a nti b o dies i n a n i m m u n oc o m pete nt r o de nt 
m o del, a tra ns ge nic m o us e strai n has bee n de vel o p e d t hat selecti vel y e x presses h u ma n Si glec- 8 
o n t he s urface of m o use mast cells, e osi n o p hils, a n d bas o p hils. I n si n gle- a n d re peat - d ose st u dies 
i n Si glec- 8 tra ns ge nic mi ce, A K 0 0 2 d e m o nstrate d selecti ve de pleti o n of p erit o neal mast cells a n d 
circ ulati n g a n d tiss ue (s plee n) e osi n o p hils a n d bas o p hils. 
I n 2 G o o d La b or at or y Pr actice ( G L P) t o xicit y a n d t o xic o ki netic st u dies, A K 0 0 2 was well 
t olerate d at d oses of 5 0 m g/ k g a n d 1 0 0 m g/ k g, 5-f ol d a n d 1 0-f ol d, res pecti vel y, the le vel of t he 
hi g hest d ose pr o p ose d t o be st u die d i n h u ma ns. A K 0 0 2 s h o we d s ustai ne d s yste mic e x p os ure i n 
Si glec - 8 tra ns ge nic mice wit h a n e xte n de d ter mi nal half-life esti mate d as 2 7 2 h o urs or 3 3 7 h o urs 
f oll o wi n g si n gle i ntra ve n o us a d mi nistrati o n of 5 0 m g/ k g or 1 0 0 m g/ k g, res pecti vel y, after 
5 wee kl y d oses at t hes e d ose le vels. T here was n o e vi de nce of a nti - dr u g a nti b o dies ( A D A) i n 
eit her st u d y. Decreas es i n e osi n o p hil c o u nts i n b ot h se xes were o bser v e d, w hic h refl ect t he 
e x pecte d p h ar mac ol o g y of A K 0 0 2. T h e n o - o bser ve d-a d verse-effect-le v el f oll o wi n g i ntra ve n o us 
a d mi nistrati o n of A K 0 0 2 t o tra ns ge nic mice w as 1 0 0 m g/ k g, w hic h s u p p orts t he P hase 1 st u dies 
i n h u ma ns. 
2. 3  
O ver vie w of Cli nic al St u dies  
A K 0 0 2, a d mi nistere d as a n i ntra ve n o us i nf usi o n h as bee n pre vi o usl y teste d i n healt h y v ol u nteers 
a n d i n patie nts wit h i n d ole nt s yste mic mast oc yt osis (I S M), c hr o nic urticaria ( C U), se vere aller gic 
c o nj u ncti vitis ( A C), mast cell gastritis, a n d e osi n o p hilic gastritis ( E G) a n d/ or e osi n o p hilic 
d u o de nitis ( E o D), w hic h was pre vi o usl y referre d t o as e osi n o p hilic gastr oe nteritis ( E G E) i n 
pre vi o us versi o ns of t his pr ot oc ol.  
M ulti ple d oses of 3 m g/ k g A K 0 0 2 ha ve b ee n gi ve n t o patie nts wit h I S M, C U, se vere A C, mast 
cell gastritis, a n d E G a n d/ or E o D. I n t hese st u dies, patie nts re p orte d i m pr o v e me nts i n disease 
s y m pt o ms wit h A K 0 0 2 p har mac o d y n a mic ( P D) acti vit y bei n g o bser ve d f or pr ol o n ge d peri o ds of 
ti me a n d A K 0 0 2 p har mac o ki netic ( P K) para meters de m o nstrati n g 
 
.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 2 2  of 8 9  
C o nfi de nti al  
T o date, o ver 3 0 0 h ealt h y v ol u nteers a n d patie nts wit h I S M, C U, se vere A C, E G/ E o D, E o E, a n d 
mast cell gastritis  ha ve b ee n e nr olle d i n cli nical st u dies. I n t otal, 6 5 E G/ E o D patie nts were 
e nr olle d i n t he d o u ble- bli n d St u d y A K 0 0 2- 0 0 3 f or w hic h t his pr ot oc ol is t he o pe n-la b el 
e xte nsi on.  
I n g e ner al, A K 0 0 2 has b ee n well t oler ate d. T he m ost c o m m o n treat me nt -e mer ge nt a d verse 
e ve nts ( T E A E) o bser v e d were i nf usi o n-relate d reacti o ns (I R R). M ost I R R were mil d t o 
m o derate , a n d 2 I R R w er e classifie d as s eri o us b ut res ol ve d wit hi n 2 4 h o urs. C o m m o n s y m pt o ms 
of I R R were h ea d ac he, n a usea, s w eati n g, fl us hi n g, a n d re d ness. M ost I R R t hat occ urre d  d uri n g 
t he i nf usi o n c o ul d be ma na ge d b y sl o wi n g or te m p orar y i nterr u pti o n of t he i nf usi o n, wit h 
mi ni mal i nter ve nti o n. Tra nsie nt l y m p h o pe nia was o bser ve d after i nf usi o n of A K 0 0 2 b ut was n ot 
ass ociate d wit h a n y cli nical c o nse q u e nce, a n d l y m p h oc ytes rec o v ere d wit hi n 2 4 h o urs. A 
s ustai ne d de pleti o n of e osi n o p hils was o bser ve d t hat is c o nsiste nt wit h t he mec ha nis m of acti o n 
of A K 0 0 2. I n 6 healt h y v ol u nteers w h o recei ve d 2 d oses of 0. 3 m g/ k g, 4 wee ks a part, t he sec o n d 
d ose was better t olerate d t ha n t he first d ose. T his was als o t he case i n patie nts wit h I S M, C U, 
se vere A C, a n d E G/ E o D, wit h fe wer a d vers e e v e nts ( A E) re p orte d d uri n g t he sec o n d a n d 
s u bse q ue nt i nf usi o ns w he n c o m par e d t o t he first i nf usi o n.  
I n t he ra n d o mize d, d o u ble- bli n d, place b o-c o ntr oll e d P hase 2 st u d y of A K 0 0 2 i n 6 5 patie nts 
wit h  E G a n d/ or E o D, patie nts were r a n d o mize d t o recei v e m o nt hl y d oses of place b o, l o w d os e 
A K 0 0 2 ( 0. 3, 1, 1, a n d 1 m g/ k g), or hi g h d ose A K 0 0 2 ( 0. 3, 1, 3, a n d 3 m g/ k g) i n a 1: 1: 1 rati o 
(Dell o n, 2 0 2 0 ). All pri mar y a n d sec o n dar y e n d p oi nts were met i n t he st u d y. T here w as a 9 7 % 
a n d 9 2 % mea n re d ucti o n i n e osi n o p hils i n t he st o mac h/ d u o de n u m at t he hi g h d ose a n d l o w d ose, 
res pecti vel y, v ers us 1 0 % i ncreas e o n place b o ( p < 0. 0 0 0 1). 
T he re d u cti o n of e osi n o p hils was ass ociate d wit h a statisticall y si g nifica nt re d ucti o n i n t otal 
s y m pt o m sc ore ( T S S) o n 8 s y m pt o m i nte nsit y sc ores ( T S S 8) of 5 8 % i n t he hi g h d ose gr o u p a n d 
4 9 % i n t he l o w d ose gr o u p vers us 2 4 % re d ucti o n i n t he place b o gr o u p ( p = 0. 0 0 1 2 a n d p = 0. 0 1 5, 
res pecti vel y). I m pr o ve m e nt i n s y m pt o ms was o bser ve d wit hi n 2 4 h o urs of t he first d ose of st u d y 
dr u g. I n a d diti o n, 7 0 % of hi g h d ose treate d p atie nts a n d 6 8 % of l o w d o se treate d patie nts w ere 
treat me nt res p o n d ers ( d efi ne d as > 3 0 % i m pr o ve m e nt i n T S S a n d > 7 5 % re d ucti o n fr o m baseli ne 
i n tiss ue e osi n o p hils) vers us 5 % f or place b o treate d patie nts ( p < 0. 0 0 0 1). 
W he n patie nts c o m plete St u d y A K 0 0 2- 0 0 3 or are disc o nti n ue d fr o m treat m e nt d ue t o hi g h 
e osi n o p hil c o u nts pri or t o i nf usi o ns 2, 3, or 4, t he y are eli gi ble t o e nter t his o pe n-la bel e xt e nsi o n 
st u d y, A K 0 0 2- 0 0 3 X. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 2 3  of 8 9  
C o nfi de nti al  
2. 4  
E osi n o p hilic G astr oi ntesti n al Dis or ders  
E osi n o p hilic gastr oi ntesti nal dis or ders ( E GI D) are c hr o nic i nfla m mat or y dis or ders c h aracterize d 
b y i nfiltrati o n of e osi n o p hils al o n g differe nt se g m e nts of t he gastr oi ntesti nal tract, i n t he a bs e nce 
of a n y ca us e of t he e osi n o p hilia ( Cal d well, 2 0 1 4 ). 
E osi n o p hilic gastritis a n d/ or e osi n o p hilic d u o de nitis re prese nt w h at are beli e ve d t o be rare t y p es 
of E GI D t hat are c har act erize d b y c hr o nic, oft e n s e vere i nfla m mati o n d ue t o patc h y or diff us e 
i nfiltrati o n of e osi n o p hils i nt o la yers of t he st o mac h, s mall i ntesti ne, or b ot h (Pr ussi n, 2 0 1 4 ; 
Ree d,  2 0 1 5; Z ha n g, 2 0 1 7 ).  
T he dia g n osis is ma de base d o n cli nical pres e ntati o n ( gastr oi ntesti nal s y m pt o ms) c o m bi ne d wit h 
i ncreas e d tiss ue e osi n o p hils i n bi o ps y s peci me ns fr o m t he st o mac h a n d/ or s mall i ntesti ne wit h o ut 
a n y ot her ca use f or t he e osi n o p hilia. I n v ol ve me nt of t he s mall i ntesti ne is t y picall y assesse d b y 
perf or mi n g d u o de n al bi o psies usi n g a n es o p ha g o- gastr o - d u o de n osc o p y ( E G D) a n d h as bee n 
referre d t o as EG E or e osi n o p hilic e nteritis, t h o u g h E o D is m ore a cc urat e.  
T he gastr oi ntesti nal s y m pt o ms are belie ve d t o b e d ue t o t he release of i nfl a m mat or y me diat ors 
fr o m acti vate d e osi n o p hils, a n d li kel y mast cells. S y m pt o ms t hat are ofte n s e vere a n d de bilitati n g 
c o mm o nl y i ncl u de a b d o mi nal pai n, na usea, bl oati n g, earl y satiet y, l oss of a p petite, a b d o mi nal 
cra m pi n g, v o miti n g, diarr hea, a n d wei g ht l oss ( Al h m o u d, 2 0 1 6 ; L o pez- Me di na, 2 0 1 5 ; 
Ma ns o or, 2 0 1 7 ; Ree d, 2 0 1 5). Je nse n ( 2 0 1 6 ) esti mate d t he pre v ale nce of E G a n d E o D t o be 
6. 3/ 1 0 0, 0 0 0 a n d 8. 4/ 1 0 0, 0 0 0, res pecti vel y (f or patie nts fr o m 1 t o 6 4 years of a ge). M a ns o or 
( 2 0 1 7) esti mate d t he o verall pre val e nce of E G t o be 5. 1/ 1 0 0, 0 0 0 pers o ns.  
Patie nts ma y als o ha ve c o nc o mita nt at o pic diseas es li ke f o o d aller g y, ast h ma, a n d at o pic 
der matitis, w hic h f urt her i m pacts q ualif y of life a n d c o ntri b utes t o healt h care c osts. 
A d diti o nall y, 8 % t o 1 0 % of patie nts ha ve c o nc o mita nt E o E (Je nse n, 2 0 1 6).  
T here are n o F D A -a p pr o ve d treat me nts f or E G a n d/ or E o D. C urre nt t hera pies a n d disease 
ma na ge me nt i ncl u des dietar y restricti o n/eli mi nati o n, pr ot o n p u m p i n hi bit ors ( P PI), 
a nti hista mi nes, s yste mic or s wall o we d c ortic oster oi ds, a n d occasi o nal off- l a bel use of 
i m m u n o m o d ulat or y bi ol o gics ( Pr ussi n, 2 0 1 4; Ree d, 2 0 1 5; Z ha n g, 2 0 1 7 ).  
Pr ot o n p u m p i n hi bit ors ha ve little t o n o be nefit i n patie nts wit h E G or E o D, des pite re p orts of 
pr o vi di n g partial be nefit i n s o me patie nts wit h E o E ( Katz, 2 0 1 3 ). Restricte d/ele me ntal diets are 
n ot effecti ve l o n g- ter m tr eat me nt as t he y re q uire strict c o m plia nce a n d, i n t he case of ele m e ntal 
diets, are e x p e nsi ve a n d ofte n n ot rei m b urse d b y i ns ura nce. I n a d diti o n, c o m plia nce is ver y p o or 
a n d patie nt q ualit y of life is greatl y i m pacte d ( Be d ell, 2 0 1 8 ; Peters o n, 2 0 1 3 ; Wec hsler, 2 0 1 4 ).  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 2 4  of 8 9  
C o nfi de nti al  
C ortic oster oi ds, s yste mic or s wall o we d , ha v e bee n s h o w n t o pr o vi de s y m pt o m relief b ut are n ot 
a p pr o priate f or l o n g-ter m treat me nt d ue t o n u mer o us si de effects a n d ass o ciate d ris ks i ncl u di n g 
a dre nal i ns ufficie nc y, b o ne de mi neralizati o n, i ncrease d c h a nce of i nfecti o n, oste o p or osis, 
be ha vi oral iss ues, a n d wei g ht gai n.  
B y re d uci n g t he n u m ber of bl o o d a n d tiss ue e osi n o p hils a n d i n hi biti n g t he acti vati o n of mast 
cells, A K 0 0 2 ma y be us ef ul i n t he treat me nt of patie nts wit h E G a n d/ or E o D. T his pre mise is 
s u p p orte d b y t he P hase 2 data wit h A K 0 0 2 t hat s h o ws si g nifica nt i m pr o ve me nts i n hist ol o g y a n d 
s y m pt o ms i n t hese patie nts.  
Gi ve n t here are n o a p pr o ve d t hera pies f or t hese c hr o nic a n d de bilitati n g diseases, better 
treat me nt o pti o ns are clearl y nee d e d t o ma na ge E G a n d E o D.  
3.  
R ati o n ale f or St u d y a n d D ose Se lecti o n 
Base d o n e x perie nce wit h A K 0 0 2 i n healt h y v ol u nteers a n d i n patie nts wit h I S M, C U, se vere 
A C, mast cell gastritis, a n d E G/ E o D, t he pr o p ose d A K 0 0 2 d ose re gi me n is u p t o 2 6 m o nt hl y 
i ntra ve n o us i nf usi o ns of A K 0 0 2.   
I n t he ra n d o mize d, d o u ble- bli n d, place b o-c o ntr oll e d P hase 2 st u d y of A K 0 0 2 i n 6 5 patie nts wit h 
E G a n d/ or E o D, 2 d ose l e vels wer e e v al uate d : a l o wer d ose re gi me n ( 4  m o nt hl y d oses of A K 0 0 2 
at 0. 3, 1, 1, a n d 1 m g/ k g) a n d a hi g h er d os e re gi m e n ( 4 m o nt hl y d oses of A K 0 0 2 at 0. 3, 1, 3, a n d 
3 m g/ k g). 
 
 
  
A starti n g d ose of 1 m g/ k g A K 0 0 2 f oll o we d b y a d ose of 3 m g/ k g A K 0 0 2 f or t he s u bse q ue nt 
i nf usi o ns has bee n c h os e n f or t he P hase 2 e xte nsi o n st u d y wit h A K 0 0 2 i n patie nts wit h E G 
a n d/ or E o D. 
4.  
St u d y O bjecti ve  
T he o bjecti ve of t h e st u d y is t o ge nerate o p e n- la b el, l o n ger-ter m s afet y, t ol era bilit y, a n d efficac y 
f oll o w- u p data i n patie nts wit h E G a n d/ or E o D w h o c o m plete d St u d y A K 0 0 2 - 0 0 3 or were 
disc o nti n ue d fr o m treat m e nt d ue t o hi g h e osi n o p hil c o u nts pri or t o i nf usi o ns 2, 3, or 4. 
T he o bjecti ve of t his e xte nsi o n st u d y is als o t o gi ve patie nts t hat recei ve d pl ace b o i n St u d y 
A K 0 0 2 - 0 0 3 access t o A K 0 0 2 . 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 2 5  of 8 9  
C o nfi de nti al  
5.  
St u d y Desi g n  
5. 1  
St u d y O ver vie w  
T his is a P hase 2, m ultice nter, o pe n-la b el, e xte nsi o n st u d y t o e val uate t he safet y, t olera bilit y, a n d 
efficac y of A K 0 0 2 i n patie nts wit h E G a n d/ or E o D. Patie nts w h o c o m plete St u d y A K 0 0 2- 0 0 3 
will ha ve t he o pti o n t o recei ve A K 0 0 2 i n a n o pe n- la bel ma n ner. A p atie nt will be cate g orize d as 
ha vi n g c o m plete d St u d y A K 0 0 2- 0 0 3 if 4 i nf usi o ns of st u d y dr u g are a d mi nistere d a n d t he p atie nt 
is f oll o we d t hr o u g h Da y 1 1 3 ( ± 3 da ys).  
Patie nts w h o were disc o nti n ue d fr o m treat me nt i n St u d y A K 0 0 2- 0 0 3 at t he rec o m me n dati o n of 
t he u n bli n de d safet y m o nit or f or hi g h e osi n o p hil c o u nts pri or t o i nf usi o ns 2, 3, or 4, will ha ve t he 
o pti o n t o recei ve A K 0 0 2 i n a n o pe n- la bel ma n n er.  
Patie nts w h o e nr oll i n St u d y A K 0 0 2- 0 0 3 X will recei ve m o nt hl y A K 0 0 2 i nf usi o ns f or a 
ma xi m u m of 2 6 i ntra ve n o us d oses. D uri n g E xte nsi o n St u d y A K 0 0 2- 0 0 3 X, patie nts will mai ntai n 
t he sa me patie nt n u m ber t hat was assi g ne d i n St u d y A K 0 0 2- 0 0 3. 
Safet y wil l be assesse d b y b o d y wei g ht, vital si g ns, s y m pt o m- directe d p h ysical e xa mi nati o n, 
c o m plete bl o o d c o u nt ( C B C) wit h differe ntial, bl o o d c he mistr y, uri nal ysis, a n d assess me nt of A E  
(i ncl u di n g a d verse e ve nts of s pecial i nterest [ A E SI] a n d seri o us a d v erse e ve nts  [ S A E]). I n 
a d diti o n, bl o o d sa m ples will be o btai ne d f or e v al uati o n of a nti- dr u g a nti b o dies ( A D A).  
T his e xte nsi o n st u d y d oes n ot i ncl u de fasti n g re q uire me nts. Patie nts u n der we nt a sta n dar dize d 
baseli ne e val u ati o n of eati n g ha bits, f o o d ha bits/restricti o ns, a n d f o o d a v oi d a nce b e ha vi ors 
d uri n g St u d y A K 0 0 2- 0 0 3 a n d will be as ke d at st u d y visits w het her a n y c ha n ges ha ve bee n ma de 
fr o m t he baseli ne diet.  
Patie nts c o m pleti n g St u d y A K 0 0 2- 0 0 3 a n d w a nti n g t o e nter t he e xte nsi o n st u d y will be gi n 
e xte n de d d osi n g o n or a b o ut Da y 1 1 3 of St u d y A K 0 0 2- 0 0 3 (f oll o wi n g fi n al assess me nts of St u d y 
A K 0 0 2 - 0 0 3), w hic h will be c o nsi der e d Da y 1 of St u d y A K 0 0 2- 0 0 3 X. If p atie nts ca n n ot start 
e xte n de d d osi n g wit hi n 4 5 da ys of A K 0 0 2- 0 0 3 Da y 1 1 3, c urre nt b aseli ne safet y ass ess me nts 
m ust be c o m plete d pri or t o Da y 1 of St u d y A K 0 0 2- 0 0 3 X. Patie nts disc o nti n ue d fr o m treat me nt 
i n St u d y A K 0 0 2- 0 0 3 d ue t o hi g h e osi n o p hil c o u nts pri or t o i nf usi o ns 2, 3, or 4 ma y be gi n 
e xte n de d d osi n g wit hi n 6 m o nt hs of t he last d ose i n St u d y A K 0 0 2- 0 0 3.  
Patie nts disc o nti n ue d fr o m t he A K 0 0 2- 0 0 3 st u d y f or hi g h e osi n o p hil c o u nts a n d patie nts t hat 
c o m plete d A K 0 0 2- 0 0 3 b ut were n ot e nr olle d i nt o A K 0 0 2- 0 0 3 X wit hi n 4 5 da ys of Da y 1 1 3 will 
re q uire c urr e nt safet y e val uati o ns.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 2 6  of 8 9  
C o nfi de nti al  
Patie nts w ill recei ve u p t o 2 6 m o nt hl y i ntra ve n o us i nf usi o ns of A K 0 0 2 i n a n o pe n- la b el ma n ner. 
T he first inf usi o n of A K 0 0 2 will be 1 m g/ k g, a n d s u bse q ue nt inf usi o ns w ill be 3 m g/ k g.  
If a m o nt hl y i nf usi o n of  AK 0 0 2  is misse d t he patie nt will be per mitte d t o make  u p t he misse d 
d os e after th e 2 6t h  m o nt h s o t hat all pa tie nts ha ve the cha n ce to recei ve a total of 2 6 i nf usi o ns. 
A n E G D w it h bi o ps y will oc c ur o n Da y 2 1 1 ( ± 3) , Da y 5 4 7 ( ± 3) , a n d Da y 7 2 9 ( ± 3) or 
2 8 ( ± 3)  da ys after the last d os e of st u d y dr u g, if earl y ter mi nati o n (E T)  or if patie nt recei ve d 
a d diti o nal m isse d d oses. 
Patie nts w ill be foll o we d f or 8 4 ( ± 3) d a ys after the last d os e of st u d y dru g. F oll o w- u p  visits w ill 
occ ur o n E xte nsi o n Da y 7 3 6 ( ± 3), Da y 7 5 7 ( ± 3), a n d Da y 7 8 5 ( ± 3) or 3 5 ( ± 3), 5 6 ( ± 3), a n d 
8 4 ( ± 3)  d a ys after last dose of st u d y dr u g, if E T  or if patie nt recei ve d a d diti o nal misse d  d oses.  
T ot al d ur ati o n of S t u d y A K 0 0 2- 0 0 3 X w ill be ap pr o xi matel y 2 8 m o nt hs if d os es are a d mi nistere d 
m o nt hl y a n d n o ne are m isse d, or lo n ger, as n ee d e d f or the pa tie nt to recei v e all 2 6 d oses. 
A p pr o xi matel y 6 0 pa tie nts will be enr olle d  in St u d y A K 0 0 2- 0 0 3 X, bas e d o n e nr oll me nt of S t u d y 
A K 0 0 2- 0 0 3. 
5. 2  
Sc he d ule  of Eve nts  
T he o ver all  sc he d ul e of  pr oce d ur es a n d ass ess me nts is sh o w n i n Ta ble  1. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Al la k os I nc. 
Pa ge 2 7  of 8 9  
C o nfi de nti al  
T a ble 1  
St u d y A K 0 0 2- 0 0 3 X Sc he d ule of Assess me nts  
Assess me nt Descri pti o n  
Pri or 
t o 
D ose 1  
Tre at me nt Peri o d  
( 2 5 m o nt hs or l o n ger if a n y m o nt hl y d oses ha ve bee n misse d /s ki p pe d)3 0 
F oll o w -U p Peri o d  
( 1 2 wee ks) 
D ose #  1 
D a y 1  
 
D ose #  2 
D a y 2 9  
( ± 3) 
D oses  # 3 – 8 
D a y 5 7 – 1 9 7 2 6 
( ± 3) 
 
D a y 2 1 1  
( ± 3) 
D oses # 9 – 2 0  
D a y 2 2 5 – 5 3 3 2 7 
( ± 3) 
 
D a y 5 4 7  
( ± 3) 
D oses # 2 1 – 2 6  
D a y 5 6 1 – 7 0 1 2 8  
( ± 3) 
A d diti o n al 
I nf usi o n D a y(s) 
o nly  if pre vi o us 
i nf usi o ns h a ve 
bee n miss e d 2 9 
D a y 7 2 9 1 
( ± 3) 
or 2 8  da ys 
after last d os e 
D a y 7 3 6 1 
( ± 3) 
or 3 5  da ys 
after last d os e 
D a y 7 5 7 1 
( ± 3) 
or 5 6  da ys 
after last d os e 
D a y 7 8 5 1 
( ± 3) 
or 8 4  da ys 
after last d os e 
I nf or me d c o nse nt 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pri or/ C o n c o mita nt Me dicati o ns 2 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
B o d y wei g ht 3 
 
X 4  ( pre d ose) X ( pre d ose)  
X ( pre d ose) 
 
X ( pre d ose) 
 
X ( pre d ose)  
X ( pre d ose)  
 
X  
X  
X  
Vital Si g ns 5 
 
X 4 
X  
X  
 
X  
 
X  
X  
 
X  
X  
X  
S F -3 6 Healt h S ur v e y  
 
X 4 
X  
X  
 
X  
 
X  
X  
 
X  
X  
X  
e P R O Acti v ati o n a n d Trai ni n g 6 
X  
 
 
 
 
 
 
 
 
 
 
 
 
e P R O Q u esti o n n aire ( ma y i ncl u de 
A d diti o n al Q u esti o ns) 7 
 
< -------------------------------------------------------------------------------- C o m plete electr o nicall y o ne ti me dail y  --------------------------------------------------------------------------------> 
P GI C Q u esti o n naire 1 3 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
Baseli n e Diet C ha n ges  
 
X 4 
X  
X  
 
X  
 
X  
X  
 
X  
X  
X  
Uri n e Di pstic k Pre g na nc y Test 8 
 
X 4 
X  
X  
 
X  
 
X  
X  
 
X  
 
 
Eli gi bilit y Assess me nt  
X  
 
 
 
 
 
 
 
 
 
 
 
 
C urre nt Safet y E v al uati o ns, as 
n ee de d 9 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Access I R T t o e nter PI D a n d 
c urre nt b o d y wei g ht 1 0 
 
X 
X 
X 
 
X 
 
X 
X 
 
 
 
 
Pre me dicati o n: Pre d nis o n e 1 1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
St u d y Dr u g A d mi nistrati o n 1 2 
 
X 
X 
X 
 
X 
 
X 
X 
 
 
 
 
S y m pt o m directe d P h ysical 
E x a m 1 4 
 
X 4 
X 
X 
 
X 
 
X 
X 
 
X 
X 
X 
Bl o o d f or He mat ol o g y wit h 
differe ntial 1 5, 1 6 
 
X 4 
X 
X 
 
X 
 
X 
X 
 
X 
X 
X 
Bl o o d f or C he mistr y 1 5, 1 7  
 
X 4 
X  
X  
 
X  
 
X  
X  
 
X  
X  
X  
Uri n al ysis 1 5, 1 8 
 
X 4 
 
 
 
 
 
 
 
 
X  
 
 
Bl o o d f or P K 1 5, 1 9 
 
X 4 
 
 
 
 
 
 
 
 
X  
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Al la k os I nc. 
Pa ge 2 8  of 8 9  
C o nfi de nti al  
T a ble 1  
St u d y A K 0 0 2- 0 0 3 X Sc he d ule of Assess me nts  
Assess me nt Descri pti o n  
Pri or 
t o 
D ose 1  
Tre at me nt Peri o d  
( 2 5 m o nt hs or l o n ger if a n y m o nt hl y d oses ha ve bee n misse d/s ki p pe d) 3 0 
F oll o w -U p Peri o d  
( 1 2 wee ks) 
D ose # 1  
D a y 1  
 
D ose # 2  
D a y 2 9  
( ± 3) 
D oses # 3 – 8 
D a y 5 7 – 1 9 7 2 6 
( ± 3) 
 
D a y 2 1 1  
( ± 3) 
D oses # 9 – 2 0  
D a y 2 2 5 – 5 3 3 2 7 
( ± 3) 
 
D a y 5 4 7  
( ± 3) 
D oses # 2 1 – 2 6  
D a y 5 6 1 – 7 0 1 2 8  
( ± 3) 
A d diti o n al 
I nf usi o n D a y(s) 
o nly  if pre vi o us 
i nf usi o ns h a ve 
bee n miss e d 2 9 
D a y 7 2 9 1 
( ± 3) 
or 2 8  da ys 
after last d os e 
D a y 7 3 6 1 
( ± 3) 
or 3 5  da ys 
after last d os e 
D a y 7 5 7 1 
( ± 3) 
or 5 6  da ys 
after last d os e 
D a y 7 8 5 1 
( ± 3) 
or 8 4  da ys 
after last d os e 
Bl o o d f or A D A 1 5, 2 0 
 
X 
X 
X 
 
X 2 0 
 
 
 
 
X 
 
 
E G D wit h Bi o ps y 2 1, 2 2 
 
 
 
 
X 
 
X 
 
 
X 
 
 
 
N o n -seri o us a d verse e ve nts 2 3 
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
A d verse e ve nts of s p ecial 
i nterest2 4 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Seri o us a d v erse e ve nts 2 5 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
T a ble 1 N otes  
A D A:  A nti -Dr u g -A nti b o d y  
E xt:  
E xte nsi o n  
PI D:  
Patie nt i de ntificati o n n u m ber  
E G D:  Es o p ha g o -Gastr o -D u o d e n osc o p y  
I R T: 
I nteracti v e res p o nse tec h n ol o g y  
P K:  
P har mac o ki netic  
E os:  
E osi n o p hil  
I V: 
I ntra v e n o us 
P R O:  Electr o nic Patie nt Re p orte d O utc o me ( q uesti o n naire)  
E T:   
Earl y ter mi nati o n 
P GI C: 
Patie nt Gl o b al I m pressi o n of C h a n g e  
 
1)  
T he E T visits s h o ul d b e c o n d u cte d 2 8 ( ± 3), 3 5 ( ± 3), 5 6 ( ± 3) a n d 8 4 ( ± 3) d a ys after t h e last d ose of st u d y dr u g or pri or t o t h is, if necess ar y, t o e ns ure c o m plia nce wit h t he visit. If o nl y o ne ET visit 
is p ossi ble, E G D a n d e n d-of -st u d y pr o ce d ures ( Da y 3 5 after last d ose of st u d y dr u g) ma y o cc ur o n t he sa me d a y. If t h e e n d-of -st u d y visit occ urs m ore t ha n 3 5 da ys after t he last d ose of st u d y dr u g, 
t he n perf or m t he visit as s o o n as p ossi ble. I n t his case, t h e pr o ce d ures liste d u n d er t h e 2 8 -d a y p ost a n d 3 5 -d a y p ost st u d y dr u g visit will be c o n d ucte d u nless ot her wise directe d b y t he Me dical 
M o nit or.  
2)  
All c o nc o mita nt me dicati o ns ta k e n wit hi n 3 0 d a ys of e nr olli n g i nt o A K 0 0 2 -0 0 3 X will b e ca pt ure d. All me dicati o ns use d d uri n g t he st u d y f or t he treat me nt of i nf usi o n relate d reacti o ns, a d verse 
e ve nts, or f or t he c o n d u ct of E G D will b e ca pt ure d.  
3)  
B o d y wei g ht (i n k g) will b e rec or d e d o n all i nf usi o n d a ys a n d o n f oll o w -u p Da ys 7 3 6, 7 5 7, a n d Da y 7 8 5 or 3 5, 5 6, a n d 8 4 d a ys after last d ose, if E T  or if pre vi o us misse d i nf usi o ns were ma de u p . 
C urre nt b o d y wei g ht, or b o d y wei g ht fr o m 1  d a y pri or will b e use d t o calc ulate t h e a m o u nt of A K 0 0 2 t o b e mi x e d wit h Na Cl f or t he a p pr o priate d ose t o be a d mi nistere d o n eac h i nf usi o n da y.  
4)  
D o n ot c ollect if pr oce d ure was perf or me d ≤4 5 d a ys pri or t o E xte nsi o n Da y 1 (as p art of t h e Da y 1 1 3 assess me nt f or St u d y A K 0 0 2 -0 0 3). Dif fere ntial cell c o u nts c ollecte d o n Da y 1 1 3 f or St u d y 
A K 0 0 2 -0 0 3 will n ot b e u n bli n d e d.  
5)  
Vital si g ns i ncl u di n g s yst olic a n d diast olic bl o o d press ure, p ulse, b o d y te m p erat ure, a n d res pirat or y rate will b e ta k e n afte r t h e patie nt has bee n at rest f or ≥5 mi n u tes a n d bef ore a n y bl o o d dra w. 
Vital si g ns will be meas ure d o n all d osi n g d a ys pre -d ose, 1 5 mi n utes ( ± 5 mi n utes) after t h e start of i nf usi o n, a n d i m me diatel y f oll o wi n g t he e n d of i nf usi o n ( 1 5 ± 5 mi n utes) . 
6)  
Acti vate P R O q uesti o n n aire a n d pr o vi d e p atie nt wit h u ni q u e user na me a n d p ass w or d. P R O q u esti o n n aire s h o ul d b e acti v ate d f or a ll patie nts o n E xte nsi o n Da y 1. Patie nts wit h c o nc o mita nt hist or y 
of ast h ma, at o pic der matitis, or E o E will recei v e a n e xtra q u esti o n, a b o ut eac h, as a p pr o priate.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Al la k os I nc. 
Pa ge 2 9  of 8 9  
C o nfi de nti al  
T a ble 1 N otes c o nt.  
7)  
T he E G/ E o D P R O s h o ul d b e c o m plete d ar o u n d t h e sa me ti me of t he d a y. All p atie nts recei v e t h e 1 0 -q u esti o n E G/ E o D q u esti o n naire. O nl y patie nts wit h c o nc o mita nt c o n diti o ns of ast h ma, at o pic 
der matitis, a n d/ or E o E will recei ve a n a d diti o n al q u esti o n f or eac h c o n diti o n, as a p pr o priate. Patie nts wit h c o n c o mita nt E o E will als o recei ve t he o nce -dail y D S Q.  
8)  
Uri ne f or Di pstic k Pre g n a n c y test will b e c ollecte d pre d ose f or  p atie nts of c hil d b eari n g p ote ntial o n a ll i nf usi o n d a ys a n d o n Da y 7 3 6 ( or Da y 3 5 after last d ose of st u d y dr u g, if E T or if pre vi o us 
misse d i nf usi o ns were ma d e u p ). Test kits will b e s u p plie d b y t h e ce ntral la b orat or y. Tests will b e c o m plete d o n site a n d e v al u ate d pri or t o i nf usi o n(s). 
9)   
Bl o od f or Safet y E val u ati o ns (c h e mistr y, h e mat ol o g y wit h differe ntial, a n d uri n al ysis) t o b e c ollecte d if E xte nsi o n Da y 1 is > 4 5 da ys fr o m A K 0 0 2 -0 0 3 Da y 1 1 3 or if patie nt was wit h dra w n fr o m 
A K 0 0 2 -0 0 3 d ue t o hi g h e osi n o p hil c o u nts. He mat ol o g y a n d c h e mistr y res u lts m ust b e a v aila ble pri or t o ra n d o mizati o n. If p atie nt is s us pecte d of e x p os ure t o hel mi nt hic parasites, st o ol sa m ple 
s h o ul d als o be c ollecte d.  
1 0)  Ce n d uit I R T t o be use d f or i n v esti g ati o n al pr o d u ct dis p e nsati o n o n all i nf usi o n d a ys.  
1 1)  All patie nts w ill ta ke 6 0 m g oral pre d nis o n e 1 2– 2 4 h o urs pri or t o t h e first i nf usi o n. A n a p pr o v e d alter n ati v e(s) ma y b e use d wit h t he a p pr o val of t he Me dical M o nit or. Pre me d icati o n ma y be 
a d mi nistere d pri or t o s u bse q u e nt i nf usi o ns at t h e I n v esti g at or’s discreti o n, b ut o nl y wit h writte n a p pr o v al fr o m t h e Me dical M o nit or. If a patie nt is si g nifica ntl y o utsi de t heir 2 8 -da y treat me nt 
wi n d o w, a he mat ol o g y test will be c ollecte d a n d t h e e osi n o p hils e val u ate d. If t h e e osi n o p hils are n o l o n g er s u p presse d, t h e p atie nt will be gi v e n pre me dicati o n of 6 0 m g pre d nis o ne, a n d t he 
i nf usi o n ma y be c o m plete d usi n g a sl o wer i nf usi o n rate.  
1 2)  St u d y dr u g will be a d mi nistere d as a si n gle p eri p h eral i ntra v e n o us i nf usi o n o v er at least 4 h o urs o n E xte nsi o n Da y  1, o v er at least 3 h o urs o n E xte nsi o n Da y 2 9, a n d o ver 1  t o 4 h o urs t hereafter, 
de pe n di n g o n pri or t olera n ce t o st u d y dr u g i nf usi o n. Please refer t o t h e P h ar mac y Ma n u al f or d etaile d i nstr u cti o ns o n st u d y dr u g pre parati o n, a d mi nistrati o n, a n d i nf usi o n rates. I nf usi o n m ust be 
c o m plete d wit hi n 8  h o urs of pre parati o n of st u d y dr u g.  
1 3)  Patie nt Gl o bal I m pressi o n of C h a n g e ( P GI C) q u esti o n n aire ( A p p e n di x 1 9. 6 ) will b e c o m plete d b y t he p atie nt o n E xte nsi o n Da y 2 9 ( ± 3), Da y 5 7 ( ± 3), a n d Da y 8 5 ( ± 3).  
1 4)  A s y m pt o m -directe d p h ysical e x a mi n ati o n (i n cl u di n g assess me nt of p ossi ble i nf usi o n site reacti o ns) will b e p erf or me d b y t h e I n vesti gat or or desi g nee, as nee de d, if a n y s y m pt o ms are re p orte d.  
1 5)  S peci me n pr ocesse d b y ce ntral la b orat or y. See ce ntral la b orat or y ma n u al f or c olle cti o n a n d pr o cessi n g d etails.  
1 6)  Bl o o d f or C B C wit h differe ntial, i n cl u di n g a bs ol ute bl o o d e osi n o p hil a n d b as o p hil c o u nts, will b e o btai n e d j ust pri or t o eac h  i nf usi o n a n d 1 h o ur after t he e n d of eac h i nf usi o n, as well as o n 
E xte nsi o n Da ys 7 3 6, 7 5 7, a n d 7 8 5 ( ± 3 d a ys) or 3 5, 5 6, a n d 8 4 ( ± 3 d a ys) after last d ose of st u d y dr u g , if E T or if pre vi o us misse d i nf usi o ns were ma de u p . 
1 7)  Bl o o d f or C he mistr y will b e o btai n e d j ust pri or t o eac h i nf usi o n, as well as o n E xte nsi o n Da ys 7 3 6, 7 5 7, a n d 7 8 5 ( ± 3 d a ys) or  3 5 , 5 6, a n d 8 4 ( ± 3 da ys) after last d ose of st u d y dr u g, if E T or if 
pre vi o us misse d i nf usi o ns were ma d e u p .  
1 8)  Uri ne f or Uri nal ysis will b e c ollecte d o n E xte nsi o n Da y 1 a n d E xte nsi o n Da y 7 3 6 ( ± 3) or 3 5 ( ± 3 d a ys) after last d ose of st u d y  dr u g, if E T  or if p re vi o us misse d i nf usi o ns were ma de u p. 
1 9)  Bl o o d f or P K will be c ollecte d o n E xte nsi o n Da y 1 a n d E xte nsi o n Da y 7 3 6 ( ± 3) or 3 5 ( ± 3 d a ys) after last d ose of st u d y dr u g, i f E T or if pre vi o us misse d i nf usi o ns were ma de u p . 
2 0)  Bl o o d sa m ples f or A D A will b e c ollecte d pre d ose o n all d osi n g d a ys t hr o u g h E xte nsi o n Da y 3 6 5, o n E xte nsi o n Da y 5 3 3 ( ± 3), a n d E xte nsi o n Da y 7 3 6 ( ± 3) or 3 5 ( ± 3) da ys after last d ose of st u d y 
dr u g, if E T  or if pre vi o us misse d i nf usi o ns were ma d e u p . A D A will als o b e c ollecte d w h e n a n i m m un o g e nicit y -relate d a d v erse e ve nt occ urs.  
2 1)  S peci me n pr ocesse d b y S ur gical Pat h ol o gist of Dallas, via t h e Ce ntral La b. See Hist ol o g y Ma n u al f or pr o cessi n g directi o ns.  
2 2)  See A p pe n di x 1 9. 8  f or bi o ps y assess me nts. E G D s h o ul d o cc ur o n Da y 2 1 1 ( ± 3), Da y 5 4 7 ( ± 3) a n d Da y 7 2 9 ( ± 3) or 2 8 ( ± 3) d a ys after t he last d ose of st u d y dr u g if t he patie nt disc o nti n ues t he st u d y 
earl y  or if pre vi o us misse d i nf usi o ns were ma d e u p,  a n d p atie nt a grees t o h a v e a n earl y -ter mi n ati o n bi o ps y.  
2 3)  N o n -seri o us a d verse e v e nts will be ca pt ure d fr o m Da y 1 (first d ose of st u d y dr u g) t hr o u g h Da y 7 8 5 or 8 4 d a ys after last d ose of st ud y dr u g, if E T  or if pre vi o us misse d i nf usi o ns were ma de u p . 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Al la k os I nc. 
Pa ge 3 0  of 8 9  
C o nfi de nti al  
T a ble 1 N otes c o nt.  
2 4)   Ad verse e ve nt s of s pecial i nterest will b e ca p t ure d fr o m Da y 1 (first d ose of st u d y dr u g) t hr o u g h Da y 7 8 5 or 8 4 d a ys after last d ose of st u d y dr u g, if E T or if pre vi o us misse d i nf usi o ns were 
ma de  u p . 
2 5)   Seri o us a d verse e ve nts  of s p ecial i nterest will b e ca pt ure d fr o m Da y 1 (first d ose of st u d y dr u g) t hr o u g h Da y 7 8 5 or 8 4 d a ys after last d ose of st u d y dr u g, if E T  or if pre vi o us misse d i nf usi o ns were 
ma de u p.  
2 6)  M o nt hl y d oses #  3 –8 will o cc ur o n Da ys 5 7, 8 5, 1 1 3, 1 4 1, 1 6 9, a n d 1 9 7 ( ± 3 d a ys).  
2 7)  M o nt hl y d oses # 9 – 2 0 will o cc ur o n Da ys 2 2 5, 2 5 3, 2 8 1, 3 0 9, 3 3 7, 3 6 5, 3 9 3, 4 2 1, 4 4 9, 4 7 7, 5 0 5, a n d 5 3 3 ( ± 3 d a ys).  
2 8)  M o nt hl y d oses # 2 1 – 2 6 will o cc ur o n Da ys 5 6 1, 5 8 9, 6 1 7, 6 4 5, 6 7 3, a n d 7 0 1 ( ± 3 d a ys).  
2 9)  O nly  if previ o us i nf usi o ns h a ve bee n misse d, ma k e -u p d osi n g ma y o cc ur o n Da y 7 0 1 + 2 8 d a ys ( ± 3), u ntil 2 6 t otal d oses h a v e bee n a d mi nistere d.  
3 0)  D oses will be c o nsi dere d misse d if t h e y o cc ur m ore t h a n 1 5 d a ys o utsi d e t h e pr ot o c ol -s p ecifie d wi n d o w. 
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 1  of 8 9  
C o nfi de nti al  
6.  
Criteri a f or E v al u ati o n 
6. 1  
S afet y E n d p oi nts  
T he safet y a n d t olera bilit y of A K 0 0 2 will be assesse d b y deter mi ni n g t he f oll o wi n g:  
•  
S y m pt o m- directe d p h ysical e xa mi nati o n ( Secti o n 1 1. 3. 3 ) 
•  
C ha n ges i n b o d y wei g ht ( Secti o n 1 1. 3. 2 ) a n d vital si g ns ( Secti o n 1 1. 3. 4 )  
•  
He mat ol o g y ( Secti o n 1 1. 2. 4 ) 
•  
C ha n ges i n c o nc o mita nt me dicati o n use d ue t o A E  ( Secti o n 1 1. 3. 1 ) 
•  
Bl o o d c he mistr y ( Secti o n 1 1. 4. 2 ) 
•  
Uri nal ysis ( Secti o n 1 1. 4. 4 ) 
•  
A D A ( Secti o n 1 1. 4. 5 ) 
•  
A d verse e ve nts ( Secti o n 1 3 .) 
6. 2  
P h ar m ac o ki netic E n d p oi nts  
Bl o o d (ser u m) will be c ollecte d f or assess me nt of A K 0 0 2 c o nce ntrati o ns usi n g a vali date d 
e nz y me-li n ke d i m m u n os or be nt assa y met h o d. Bl o o d (ser u m) will be c ollecte d f or assess me nt of 
A D A t o A K 0 0 2 usi n g a vali date d assa y met h o d. 
P har mac o ki netic  bl o o d s a m ples will be o btai ne d pre d ose o n E xte nsi o n D a y 1 ( o btai ne d fr o m 
Da y 1 1 3 e val u ati o ns of St u d y A K 0 0 2- 0 0 3 or re dra w n f or patie nts t hat were disc o nti n ue d fr o m 
treat me nt i n A K 0 0 2- 0 0 3) a n d o n E xte nsi o n Da y  5 6 1 ( ± 3) a n d E xte nsi o n D a y 7 3 6 ( ± 3) or 3 5 ( ± 3) 
da ys after l ast d ose  of st u d y dr u g, if E T or if patie nt recei ve d a d diti o nal misse d d oses.  
A D A sa m ples will be o bt ai ne d pre d os e o n E xte nsi o n Da y 1, pre d os e o n all i nf usi o n da ys t hr o u g h 
E xte nsi o n Da y 3 6 5, o n E xte nsi o n Da y 5 3 3 ( ± 3), a n d o n E xte nsi o n Da y 7 3 6 ( ± 3) or 3 5 ( ± 3) d a ys 
after last d ose of st u d y dr u g, if E T or if patie nt recei ve d a d diti o nal misse d d oses.  
6. 3  
Effic ac y E n d p oi nts  
Dail y self -a d mi nistrati o n of a disease -s pecific pati e nt q uesti o n naire ( P R O Q uesti o n naire) will be 
use d t o e val uate si g ns a n d s y m pt o ms ass ociate d wit h E G a n d/ or E o D. C ha n ges i n q ualit y of life 
will be meas ure d b y t he S h ort- F or m 3 6 Healt h S ur ve y ( S F- 3 6) q uesti o n naire. C ha n ges i n t he 
n u m ber of e osi n o p hils i n gastric a n d/ or d u o de n al m uc osa fr o m bas eli ne will als o be e val uate d.  
6. 4  
P h ar m ac o d y n a mic E n d p oi nts 
C ha n ge i n bl o o d e osi n o p hils will be assesse d at st u d y visits.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 2  of 8 9  
C o nfi de nti al  
7.  
P atie nt Selecti o n  
7. 1  
N u m ber of P atie nts  
A p pr o xi matel y 6 0 patie nts will be e nr olle d i n St u d y A K 0 0 2- 0 0 3 X. 
7. 2  
. St u d y P o p ul ati o n 
Patie nts w h o c o m plete St u d y A K 0 0 2- 0 0 3 or w ere disc o nti n ue d fr o m treat m e nt i n St u d y 
A K 0 0 2 - 0 0 3 st u d y f or hi g h e osi n o p hil c o u nts pri or t o i nf usi o ns 2, 3, or 4 a n d meet t he i ncl usi o n 
criteria i n Secti o n  7. 3  a n d e xcl usi o n criteria i n Secti o n  7. 4  will ha ve t he o pti o n t o recei ve A K 0 0 2 
i n a n o pe n-la bel ma n n er. A patie nt is cate g ori ze d as ha vi n g c o m plete d St u d y A K 0 0 2- 0 0 3 if 
4 i nf usi o ns of st u d y dr u g were a d mi nistere d a n d t he patie nt was f oll o w e d t hr o u g h Da y 1 1 3 ( ± 3) 
of St u d y A K 0 0 2- 0 0 3.  
7. 3  
I ncl usi o n Criteri a 
Patie nts are eli gi ble f or t he st u d y if all of t he f oll o wi n g criteria are met:  
1)  
Pr o vi de writte n i nf or me d c o nse nt. 
2)  
C o m plete d St u d y A K 0 0 2- 0 0 3, defi ne d as ha vi n g recei ve d 4 i nf usi o ns of st u d y dr u g a n d 
f oll o we d t hr o u g h Da y 1 1 3 ( ± 3) i n St u d y A K 0 0 2- 0 0 3 or disc o nti n ue d fr o m treat me nt d ue t o 
hi g h e osi n o p hil c o u nts pri or t o i nf usi o ns 2, 3, or 4, a n d willi n g t o be gi n e xte n de d d osi n g o n 
or a b o ut Da y 1 1 3 (f or A K 0 0 2- 0 0 3 c o m pleters) or wit hi n 6 m o nt hs of last d osi n g f or 
patie nts disc o nti n ue d fr o m treat me nt.  
3)  If patie nt is o n pre- e xisti n g dietar y restri cti o ns, willi n g ness t o n ote a n y c ha n ges t hat occ ur 
fr o m t he Baseli ne diet, t hr o u g h o ut t he st u d y.   
4)  
A ble a n d willi n g t o c o m pl y wit h all st u d y pr oce d ures. 
5) 
Fe male p atie nts m ust be eit her p ost -me n o pa us al f or at least 1 year or s ur gi call y sterile 
(t u bal li gati o n, h ysterect o m y, or bilateral o o p h orect o m y) f or at least 3 m o nt hs, or if of 
c hild beari n g p ote ntial, ha ve a ne g ati ve pre g n a nc y t est a n d a gree t o use d ual met h o ds of 
c o ntrace pti o n, or a bstai n fr o m se x ual acti vit y u ntil t he e n d of t he st u d y, or f or 1 2 0 da ys 
f oll o wi n g t he last d ose of st u d y dr u g, w hic he ver is l o n ger.  
6)  
M ale patie nts wit h fe mal e part ners of c hil d beari n g p ote ntial m ust a gree t o use a hi g hl y 
effecti ve met h o d of c o ntr ace pti o n u ntil t he e n d of t he st u d y or f or 1 2 0 da ys f oll o wi n g t he 
last d ose of st u d y dr u g, w hic he ver is l o n ger. All fertile me n wit h fe m ale p art ners of 
c hil d beari n g p ote ntial s h o ul d be i nstr ucte d t o c o nt act t he I n vesti gat or i m me diatel y if t he y 
s us pect t heir part n er mi g ht be pre g na nt at a n y ti me d uri n g st u d y partici pati o n. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 3  of 8 9  
C o nfi de nti al  
7. 4  
E xcl usi o n Criteri a  
Patie nts will be e xcl u de d fr o m t he st u d y if t he y meet a n y of t he f oll o wi n g criteria:  
1)  
P o or t olera nce t o pr e vi o us a d mi nistrati o n of A K 0 0 2 i n t he o pi ni o n of t he I n vesti gat or. 
2)  
K n o w n h y perse nsiti vit y t o a n y c o nstit ue nt of t he st u d y dr u g. 
3)  
A n y disease, c o n diti o n ( me dical or s ur gical), or car diac a b n or malit y, w hic h, i n t he o pi ni o n 
of t he I n vesti gat or, w o ul d place t he p atie nt at i ncrease d ris k. 
4) 
Vacci n ati o n wit h li ve atte n uate d vacci nes wit hi n 3 0 da ys pri or t o i nitiati o n of treat me nt 
i n t he st u d y, d uri n g t he treat me nt peri o d, or v acci nati o n e x pecte d wit hi n 5 half-li ves 
( 4 m o nt hs) of st u d y dr u g a d mi nistrati o n. All t y pes a n d f or m ulati o ns of vacci nes (i ncl u di n g 
li ve atte n uate d vacci nes) a ut h orize d b y F D A or ot her re g ul at or y a ut h orit y f or t he pre v e nti o n 
of C O VI D - 1 9 ma y b e a d mi nistere d bef ore, d uri n g, or after t his st u d y. T he vacci ne s h o ul d 
n ot be a d mi nistere d wit hi n 7 da ys pri or t o a n d wit hi n 7 da ys after t he a d mi nistrati o n of 
A K 0 0 2 s o t hat a n y si de effects ca use d b y eit her of t he 2 me dicati o ns ca n b e m ore easil y 
deter mi ne d . 
5)  
W o me n w h o are pr e g na nt, breastfee di n g, or pla n ni n g t o bec o me pre g n a nt w hile 
partici pati n g i n t he st u d y. 
6)  
A n y ot her reas o n t hat, i n t he o pi ni o n of t he I n vesti gat or or Me dical M o nit or, ma kes t he 
patie nt u ns uita ble f or e nr oll me nt.  
7)  
Dia g n osis of H y per e osi n o p hilic S y n dr o me ( H E S) base d o n sta n dar d criteri a ( bl o o d 
e osi n o p hils > 1 5 0 0/ µ L wit h i n v ol ve me nt of eit her t he heart, n er v o us s yste m, a n d/ or b o ne 
marr o w).  
8.  
C o nc urre nt Me dic ati o ns  
C o nc o mita nt me dicati o ns i ncl u de b ot h prescri b e d a n d o ver- t h e-c o u nter me dicati o ns a n d will be 
rec or d e d i n t he electr o nic Case Re p ort F or ms (e C R F).  
A n y me dicati o n m ust ha ve bee n st o p pe d as re q uire d i n A K 0 0 2- 0 0 3 e x cl usi o n criteria. Patie nts 
s h o ul d be a d vise d a gai nst ta ki n g a n y ne w me dicati o n, b ot h prescri be d a n d o ver-t he-c o u nter, 
wit h o ut c o ns ulti n g t he I n vesti gat or, u nless t he ne w me dicati o n is re q uire d f or e mer g e nc y us e. 
I m me diat el y pri or t o t he first i nf usi o n, t he st u d y site pers o n nel s h o ul d e ns ure t hat t he patie nt 
c o nti n ues t o meet t he i ncl usi o n criteria a n d n o ne of t he e xcl usi o n criteria (i ncl u di n g n o recei pt or 
use of pr o hi bite d me dicati o ns). 
All me dicati o ns ta ke n d uri n g partici pati o n i n t his st u d y m ust be d oc u me nte d o n t he e C R F. All 
me dicati o ns use d t o treat I R R or A E  m ust als o be d oc u me nte d. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 4  of 8 9  
C o nfi de nti al  
8. 1  
Pr o hi bite d Me dic ati o ns  
A n y me dicati o ns t hat ma y i nterfer e wit h t he st u d y s uc h as i m m u n os u p pressi ve or 
i m m u n o m o d ulat or y dr u gs (i ncl u di n g azat hi o pri ne, 6- merca pt o p uri ne, met h otre xate, 
c ycl os p ori ne, tacr oli m us, a nti-t u m or necr osis fact or, a nti- i nterle u ki n-5, a nti -i nterle u ki n- 5 
recept or, d u pil u ma b, a nti-I g E a nti b o dies, o maliz u ma b) or s yste mic or t o pical c ortic oster oi ds 
wit h a d ose > 1 0 m g/ da y of pre d nis o ne or e q ui vale nt.  
T here ma y b e s peci al cir c u msta nces w h ere t he us e of s o me of t hes e me dicati o ns ma y be 
acce pta ble. I n t hes e cas es, a p pr o val m ust be o btai n e d fr o m t he Alla k os Me dical M o nit or . 
Vacci n ati o n wit h li ve atte n uate d vacci nes wit hi n 3 0 da ys pri or t o i nitiati o n of treat me nt i n t he 
pr ot oc ol, d uri n g t he treat me nt peri o d, or vacci nati o n e x pecte d wit hi n 5 half-li ves ( 4 m o nt hs) of 
A K 0 0 2 a d mi nistrati o n is pr o hi bite d.  
All t y pes a n d f or m ulati o ns of vacci n es (i ncl u di n g li ve atte n uate d vacci nes) a ut h orize d b y F D A 
or ot her re g ul at or y a ut h orit y f or t he pre v e nti o n of C O VI D- 1 9 ma y b e a d mi nistere d bef ore, 
d uri n g or after t his st u d y. T he vacci ne s h o ul d n ot be a d mi nistere d wit h 7 d a ys pri or t o a n d wit hi n 
7 da ys after t h e a d mi nistrati o n of A K 0 0 2 s o t hat a n y si de effects ca us e d b y eit her of t he 
2 me dicati o ns ca n be m ore easil y det er mi ne d.  
8. 2  
All o we d Me dic ati o ns  
Me dicati o ns, ot her t ha n t h ose t hat are pr o hi bite d ( Secti o n 8. 1 ), s uc h as a nti hista mi nes, 
le u k otrie ne a nta g o nist, c ortic oster oi ds wit h a dail y d ose ≤1 0 m g/ da y of pre d nis o ne a n d mast cell 
sta bilizers ar e all o we d d uri n g t he st u d y a n d, u nless re q uire d d u e t o u nf ores ee n me dical necessit y, 
d oses are t o r e mai n sta bl e.  
All me dicati o n use will be d oc u me nte d i n t he e C R F.   
9.  
St u d y Tre at m e nt  
9. 1  
F or m ul ati o n of Test Pr o d uct 
A K 0 0 2 is a h u ma nize d n o n-f uc os ylate d I g G 1 m o n ocl o nal a nti b o d y directe d a gai nst Si glec- 8. 
A K 0 0 2 dr u g pr o d uct is s u p plie d as a sterile li q ui d i n a si n gle- use 1 0 R glass vial wit h a fill 
v ol u me of n ot less t ha n 1 0 m L. T he pr o d uct is st ore d at 2° – 8° C. T he A K 0 0 2 f or m ulati o n is 
 
 p H 6. 0, i n steril e water f or i njecti o n.  
N ote :  A K 0 0 2 will be ref err e d t o as “st u d y dr u g.” T h ere is n o place b o i n t he e xte nsi o n st u d y.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 5  of 8 9  
C o nfi de nti al  
9. 2  
St u d y Dr u g P ac k a g i n g a n d L a beli n g 
A K 0 0 2 dr u g pr o d uct is s u p plie d as a sterile li q ui d i n a si n gle- use 1 0 R glass vial wit h a fill 
v ol u me of a p pr o xi matel y 1 0. 6 m L. Eac h vial will be la bele d wit h t he re q uire d i n vesti gati o nal use 
state me nt, l ot n u m ber, S p o ns or na me, a n d directi o ns f or st ora ge. E ac h vial will als o c o ntai n a 
tear-off la bel wit h l ot a n d/ or kit n u m ber a n d s pace t o d oc u me nt patie nt i de ntificati o n ( PI D) 
n u m ber a n d pr e par ati o n date. T his tear- off la b el s h o ul d be a p plie d t o t he I n vesti gati o nal Pr o d uct 
D ose Calc ulati o n a n d Pre parati o n W or ks h eet a n d mai ntai ne d wit h t he s o urce d oc u me nts.  
Glass vials are pl u g ge d wit h Tefl o n-c oat e d r u b ber st o p pers a n d seale d wit h al u mi n u m seals.  
9. 3  
S u p pl y of St u d y Dr u g t o t he I n vesti g ati o n al Site  
T he S p o ns or ( or desi g nee) will s hi p st u d y dr u g t o t he i n vesti gati o nal sites. T he i nitial st u d y dr u g 
s hi p me nt will be s hi p pe d after all re q uire d re g ulat or y d oc u me ntati o n a n d a p pr o vals ha ve b ee n 
recei v e d b y t he S p o ns or, a n d c o ntract has bee n e x ec ute d. S u bse q ue nt st u d y dr u g s hi p me nts will 
be tri g gere d a ut o maticall y base d o n pre d eter mi ne d s u p pl y le vels a n d e nr oll me nt acti v it y at t he 
site.  
9. 4  
St u d y Dr u g D os a ge/ D os a ge Re gi me n 
T he first i nf usi o n of A K 0 0 2 will be 1 m g/ k g. Starti n g wit h t he sec o n d i nf usi o n ( E xte nsi o n 
Da y  2 9), t he d ose of A K 0 0 2 will be i ncreas e d t o 3 m g/ k g, a n d 3 m g/ k g will be a d mi nistere d f or 
all s u bse q ue nt i nf usi o ns.  
D osi n g will occ ur o n E xte nsi o n Da ys 1, 2 9, 5 7, 8 5, 1 1 3, 1 4 1, 1 6 9, 1 9 7, 2 2 5, 2 5 3, 2 8 1, 3 0 9, 3 3 7, 
3 6 5, 3 9 3, 4 2 1, 4 4 9, 4 7 7, 5 0 5, 5 3 3, 5 6 1, 5 8 9, 6 1 7, 6 4 5, 6 7 3, a n d 7 0 1 ( ± 3 da ys).  
If a m o nt hl y i nf usi o n is dela ye d s o t hat it occ urs cl oser i n t he ti me fra me t o t he ne xt u pc o mi n g 
i nf usi o n, t he late i nf usi o n will be c o nsi dere d s ki p p e d a n d ma y be m a de u p after Da y 7 0 1. 
T heref ore, d osi n g c o ul d p ossi bl y occ ur o n Da y 7 2 9 ( ma ke u p f or 1 s ki p pe d d ose) a n d e v er y 
2 8 ( ± 3) da ys after t hat, u ntil 2 6 d oses i n t otal ha ve be e n recei ve d.  
T he e xact d ose will be calc ulate d pri or t o eac h i nf usi o n a n d base d o n c urre nt patie nt b o d y 
wei g ht. St u d y dr u g will be a d mi nistere d as a si n gle peri p heral i ntra ve n o us i nf usi o n usi n g a n 
i nf usi o n p u m p as i n dicate d i n t he st u d y P har mac y Ma n ual at t he st u d y visits s pecifie d i n Ta ble  1. 
9. 5  
Pre p ar ati o n of St u d y Dr u g  
A st u d y p har macist or desi g nee will pre pare t he st u d y dr u g f or eac h i nf usi o n. Base d o n patie nt 
b o d y wei g ht o btai ne d t he da y of or t he d a y pri or t o d osi n g, t he desi g nate d st u d y p har macist will 
pre par e t he a p pr o priate dil uti o n of A K 0 0 2 f or i ntra ve n o us a d mi nistrati o n.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 6  of 8 9  
C o nfi de nti al  
A p pr o priate ase ptic tec h ni q ue will be use d, a n d t he dr u g will be pre p are d acc or di n g t o t he 
p har mac y ma n u al f or A K 0 0 2. Please refer t o t he P har mac y Ma n u al f or a d diti o nal details a n d 
ste p- b y-ste p i nstr ucti o ns re gar di n g st u d y dr u g pre parati o n. 
T he i nf usi o n m ust be c o m plete d wit hi n 8 h o urs of pre parati o n. Pre parati o n is w he n t he A K 0 0 2 is 
first mi xe d wit h t he Na Cl. 
Base d o n c urr e nt U S P 2 0 1 9 g ui deli nes, A K 0 0 2 is n ot c o nsi dere d t o be a hazar d o us dr u g, a n d 
t heref or e, s pecial preca uti o ns d o n ot nee d t o be ta ke n w he n ha n dli n g or pre pari n g t he st u d y dr u g.  
9. 6  
St u d y Dr u g A d mi nistr ati o n  
S pecific i nstr ucti o ns o n a d mi nistrati o n a n d s u p plies re q uire d f or a d mi nistrati o n are detaile d i n 
t he P har mac y Ma n u al. I n ge neral, st u d y dr u g will be i nf use d t hr o u g h a p eri p heral vei n 
i ntra ve n o us set. T he i ntra ve n o us li ne ma y  be ke pt o pe n bef ore a n d after t h e i nf usi o n wit h 
s ufficie nt q ua ntities of 0. 9 % Na Cl t o ass ure p ate n c y, as nee d e d.  
A v ol u me of 1 0 0 m L *  of t he calc ulate d d os e of st u d y dr u g will be i nf use d o ver at least 4 h o urs 
o n E xte nsi o n Da y 1, o ver at least 3 h o urs o n E xte nsi o n Da y 2 9, a n d o ver 1 t o 4 h o urs t hereafter, 
de pe n di n g o n t he patie nt’s t olera nce of t he pre vi o us i nf usi o ns a n d at t he I n v esti gat or’s discreti o n.  
If t he i nf usi o n is sl o we d or i nterr u pte d, t he ti me ma y be e xte n d e d l o n ger t ha n 4 h o urs, as l o n g as 
it d oes n ot e xcee d 8 h o urs.  
*   
D ue t o t he r o u n di n g of t h e t otal i nf usi o n v ol u me b y s o me pr o gra m ma ble i nf usi o n p u m ps, 
a n i nf usi o n of 9 9 t o 1 0 1 m L will be c o nsi dere d a c o m plete i nf usi o n a n d will n ot be 
rec or d e d as a d e viati o n of t he st u d y. 
Pri or t o first i nf usi o n of A K 0 0 2, patie nts will be pre me dicat e d wit h 6 0 m g oral pre d nis o ne ( or 
a p pr o ve d e q ui v ale nt) 1 2 – 2 4 h o urs pri or t o t he start of t he st u d y dr u g i nf usi o n. F or s u bse q u e nt 
i nf usi o ns, pre me dicati o n ma y be use d at t he discreti o n of t he I n v esti gat or, f or patie nt t olera bilit y, 
a n d wit h a p pr o val fr o m t he Me dical M o nit or. A n alter nate pre me dicati o n re gi me n ma y be use d 
wit h t he a p pr o val of t he Me dical M o nit or. 
T he i ntra ve n o us i nf usi o n ma y be i nterr u pte d a n d/ or t he rate m a y be re d uce d if a patie nt has a n 
I R R. T he ti me t hat t he i nf usi o n is i nitiated/c o ncl u de d (i ncl u di n g a n y i nterr u pti o ns) will be 
d oc u me nte d i n t he e C R F. If t he i nf usi o n is restart e d after a n i nterr u pti o n, t h e i nf usi o n m ust be 
c o m plete d wit hi n 8 h o urs of pre parati o n. A d mi nistrati o n will be disc o nti n ue d if, i n t he o pi ni o n of 
t he I n v esti gat or, a n i nterr u pte d i nf usi o n ca n n ot be restarte d f or safet y reas o ns or if t he i nf usi o n 
ca n n ot be c o m plet e d wit hi n 8 h o urs of pre parati o n. A d mi nistrati o n will als o be disc o nti n ue d i n 
a n y patie nt e x perie nci n g a seri o us a d verse e ve nt d uri n g t he c o urse of t he i nf usi o n.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 7  of 8 9  
C o nfi de nti al  
T he patie nt will be o bser ve d f or 4 h o urs after t h e e n d of t he first i nf usi o n a n d if n o iss ues are 
n ote d, will be o bser ve d f or at least 1 h o ur f or s u bs e q ue nt i nf usi o ns, as per I n vesti gat or discreti o n 
a n d de pe n di n g o n t oler a n ce t o pri or i nf usi o ns. 
9. 7  
St u d y Dr u g St or a ge 
A K 0 0 2 will be st ore d b y t he st u d y sites at 2º – 8º C u n der l oc k at t he d esi g nate d p har mac y. Access 
will be restricte d t o desi g nate d p har mac y staff. T h e 0. 9 % Na Cl  will be st ore d at a m bie nt 
te m perat ur e, per ma n ufact urer’s re q uire me nts. All st u d y dr u g will be st ore d i n a n area t hat is 
te m perat ur e c o ntr olle d a n d m o nit ore d. If t he te m perat ure of st u d y dr u g st ora ge i n t he 
cli nic/ p har mac y e xcee ds or falls bel o w t his ra n ge, t his will be re p orte d t o t he S p o ns or or 
desi g nee a n d ca pt ur e d as a de via ti o n. T he S p o ns or will n otif y t he site if t he st u d y dr u g is t o be 
q uara nti ne d or ca n b e use d. 
9. 8  
St u d y Dr u g Acc o u nt a bilit y  
T he site’s st u d y p har macist/ desi g nee is res p o nsi ble f or mai ntai ni n g acc urate a n d c urre nt rec or ds 
acc o u nti n g f or t h e recei pt, dis pe nsi n g, pre parati o n, use, ret ur n ( or destr u cti o n), a n d fi nal 
dis p ositi o n of all i n vesti gati o nal pr o d uct. All d osa ge calc ul ati o ns will be d oc u me nte d o n t he 
s o urce d oc u m e nts. T he Master I n vesti gati o nal Pr o d uct Acc o u nta bilit y L o g, or si milar s h o ul d be 
use d t o ca pt ure recei pt, dis pe nsi n g, a n d ret ur n ( or destr ucti o n). Electr o ni c i n vesti gati o nal pr o d uct 
acc o u nta bilit y s yste ms ma y be use d, de pe n di n g o n site prefere nce, as l o n g as t he sa me 
i nf or mati o n is ca pt ure d. T he st u d y m o nit or will verif y e ntries o n t h ese d oc u me nts t hr o u g h o ut t he 
c o urse of t he st u d y.  
St u d y dr u g ma y or ma y n ot be la bele d wit h kit n u m bers.  
1 0.  
P atie nt N u m beri n g, Str atific ati o n, R a n d o miz ati o n, a n d Bli n di n g 
1 0. 1  
P atie nt N u m beri n g  
Eac h patie nt w h o pr o vi des i nf or me d c o ns e nt will be i de ntifie d b y t he PI D assi g ne d i n 
St u d y A K 0 0 2 - 0 0 3. T he p atie nt will mai ntai n t he sa me PI D t hr o u g h o ut t he e ntire st u d y. Patie nts 
will mai ntai n t he sa me PI D w he n e nteri n g A K 0 0 2- 0 0 3 X. 
A patie nt is c o nsi dere d e nr olle d i n t he A K 0 0 2- 0 0 3 X st u d y w he n t he s u bject recei ves t he first 
d ose of o pe n-l a bel A K 0 0 2.  
1 0. 2  
Str atific ati o n a n d R a n d o miz ati o n 
T here will be n o r a n d o mizati o n as all patie nts will recei v e A K 0 0 2.  
1 0. 3  
Bli n di n g  
T here will be n o bli n di n g as all patie nts will recei v e A K 0 0 2.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 8  of 8 9  
C o nfi de nti al  
1 1.  
St u d y Pr oce d ures a n d G ui deli nes  
Ta ble  1 pr o vi des t he s c he d ule of assess me nts t o be perf or me d f or t he d urati o n of t he st u d y. 
W he n m ulti ple e val uati o ns are sc h e d ule d at t he s a me ti me p oi nt, t he pri orit y f or eac h will be as 
f oll o ws:  
•  
S F - 3 6 (self-a d mi nistere d f or mat) s h o ul d be c o m pl ete d at t he be gi n ni n g of t he st u d y visit 
bef ore a n y ot her asses s m e nts or pr oce d ures. 
•  
P R O Q uesti o n naire s h o ul d be c o m plete d b y eac h st u d y s u bject dail y (at a p pr o xi matel y t he 
sa me ti me eac h d a y) d uri n g t he treat me nt a n d f oll o w- u p peri o ds.  
•  
Vital si g ns will be o btai ne d after t he patie nt has b ee n at rest f or ≥5 mi n utes.  
•  
S y m pt o m- directe d p h ysical e xa mi nati o ns ca n be perf or me d, a n d uri ne s a m ples ca n be 
c ollecte d eit her bef ore or after ot her e val u ati o ns.  
1 1. 1  
Diet ar y a n d Lifest yle R estricti o ns  
T his e xte nsi o n st u d y d oes n ot i ncl u de fasti n g re q uire me nts. Patie nts u n der we nt a sta n da r dize d 
baseli ne e val u ati o n of eati n g ha bits, f o o d ha bits/restricti o ns, a n d f o o d a v oi d a nce b e ha vi ors 
d uri n g St u d y A K 0 0 2- 0 0 3 a n d will be as ke d at A K 0 0 2- 0 0 3 X st u d y visits if a n y c ha n g es ha ve 
bee n ma de t o t he b aseli n e diet si nce t he pre vi o us st u d y visit.  
1 1. 2  
P h ar m ac o d y n a mic/ Effic ac y -R el ate d Pr o ce d ures  
1 1. 2. 1  Effic ac y -R el ate d: S h ort F or m - 3 6 He alt h S ur ve y 
A pa per v ersi o n of t he S F- 3 6 ( A p p e n di x 1 9. 1 ) will be c o m plete d b y t he patie nt as part of t he 
Da y  1 1 3 visit of St u d y A K 0 0 2- 0 0 3 a n d will ser v e as t he baseli ne assess me nt. Starti n g o n 
E xte nsi o n Da y 2 9, a n el ectr o nic versi o n of t h e S F- 3 6 will be c o m plete d at s elect st u d y visits 
d uri n g t he E xte nsi o n St u d y. A pa per v ersi o n of t h e S F- 3 6 is a vaila bl e t o patie nts i n case t he y are 
n ot a ble t o c o m plete t he e lectr o nic v ersi o n. 
1 1. 2. 2  Effic ac y -R el ate d: P R O Q uesti o n n aire  
A n electr o nic v ersi o n of t he P R O q uesti o n naire ( A p pe n di x 1 9. 2 ) will be c o m plete d dail y at 
a p pr o xi matel y t he sa me ti me b y t he patie nt t hr o u g h o ut t he st u d y.  
T he recall peri o d f or eac h P R O e ntr y is a p pr o xi matel y 2 4 h o urs. Patie nts will n ot be a ble t o 
c o m plete a q uesti o n nair e m ore t ha n 2 4 h o urs after it is d ue a n d will n ot be a ble t o g o bac k a n d 
ma ke a n y c orrecti o ns or c ha n ges t o t he dat a ori gi nall y e ntere d. T his i nf or mati o n will be 
a ut o maticall y ca pt ur e d a n d mai ntai ne d i n t he e P R O s yste m of t he E D C.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 3 9  of 8 9  
C o nfi de nti al  
A pa per v ersi o n of t he P R O q uesti o n naire is a vail a ble t o s u bjects i n case t h e y are n ot a ble t o 
c o m plete t he electr o nic v ersi o n. O nl y o ne P R O s h o ul d be c o m plete d per d a y, a n d t he recall 
peri o d s h o ul d n ot be a n y m ore t ha n a p pr o xi mat el y 2 4 h o urs l o n g.  
If patie nts ha ve a hist or y of c o nc o mita nt at o pic der matitis, at o pic ast h ma, or E o E, a n e xtra 
q uesti o n ( per c o n diti o n) will be p o p ulate d o n t he P R O we bsite f or t he pati e nts t o c o m plete dail y. 
A pa per v ersi o n of t hes e q uesti o ns is a vaila ble, s h o ul d t he we bsite n ot be accessi ble 
(A p pe n di x 1 9. 6 ). A d diti o nall y, f or patie nts wit h a hist or y of E o E, t he D S Q (A p pe n di x 1 9. 7 ) will 
be a d mi nistere d dail y. T h e D S Q c o nsists of 4 q uesti o ns t hat will be p o p ulate d o n t he e P R O 
we bsite.  
1 1. 2. 3  P atie nt Gl o b al I m pressi o n of C h a n ge ( P GI C) 
A pa per P GI C q u esti o n naire ( A p p e n di x 1 9. 6 ) will be c o m plete d at t he ti mes i de ntifie d i n 
Ta ble  1. 
1 1. 2. 4  P h ar m ac o d y n a mic: C o m plete Bl o o d C o u nt wit h Differe nti al 
Bl o o d will be o btai ne d f or C B C wit h differe ntial at visits a n d ti mes i de ntifie d i n Ta ble  1. T he 
differe ntial cell c o u nt o n Da y 1 1 3 of St u d y A K 0 0 2- 0 0 3 will re mai n bli n de d. 
T he bl o o d sa m ple will be pr ocesse d a n d s hi p pe d i n acc or d a nce wit h la b orat or y ma n ual a n d 
la b orat or y kit i nstr ucti o ns. A ce ntral la b orat or y will a nal yze t he bl o o d sa m ple a n d pr o vi de res ults 
f or C B C wit h differe ntial, i ncl u di n g he m o gl o bi n, he mat ocrit, platelet c o u nt, re d bl o o d cell c o u nt, 
w hite bl o o d cell c o u nt, a n d a bs ol ute differe ntial c o u nt ( ne utr o p hils, l y m p h oc ytes, m o n oc ytes, 
e osi n o p hils, a n d bas o p hils).  
1 1. 2. 5  Es o p h a g o- G astr o - D u o de n osc o p y wit h Bi o ps y 
A n E G D wit h bi o ps y will be perf or m e d o n Da y 2 1 1 ( ± 3), Da y 5 4 7 ( ± 3), a n d Da y 7 2 9 ( ± 3) or 
2 8 ( ± 3) da ys after last d ose of st u d y dr u g, if E T. Bi o ps y sa m ples will be c ollecte d acc or di n g t o 
sta n dar dize d i nstr u cti o ns a n d will be se nt t o t he Ce ntral La b desi g nee f or fi xi n g a n d stai ni n g. A 
Ce ntral rea d er will re p ort, a m o n g ot her t hi n gs, ma xi m u m n u m ber of e osi n o p hils per h pf, 
ma xi m u m n u m ber of tr y ptase- p ositi ve mast cells per h pf, a n d g astric bi o psies will be gra de d 
usi n g t he S y d ne y S yste m o n i nfla m mati o n, meta plasia, atr o p h y, a n d reacti ve gastr o pat h y. T he 
Mars h Scale Classificati o n will be use d t o gra de d u o de nal sa m ples. T he b aseli ne E G D fr o m 
St u d y A K 0 0 2- 0 0 3 will be use d f or c o m paris o n.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 0  of 8 9  
C o nfi de nti al  
1 1. 3  
S afet y -R el ate d Pr o ce d ures  
1 1. 3. 1  C o nc o mit a nt Me dic ati o ns 
All c o nc o mita nt me dicati o n a n d c o nc urre nt t hera pies will be d oc u me nte d at eac h st u d y visit, if 
c ha n ges are ma d e. D ose, r o ute, u nit, fre q ue n c y of a d mi nistrati o n, i n dicati o n f or a d mi nistrati o n, 
a n d dates of me di cati o n will be ca pt ure d. Rec or d a n y me dicati o n recei ve d d uri n g t he st u d y 
t hr o u g h E xte nsi o n Da y 7 8 5 or 8 4 da ys aft er last d ose of st u d y dr u g if E T , or if pre vi o us misse d 
i nf usi o ns were ma d e u p.  
1 1. 3. 2  B o d y Wei g ht 
Wei g ht will be meas ur e d pre - d ose a n d use d t o det er mi ne t he a m o u nt of st u d y dr u g t o be mi xe d 
wit h Na Cl f or i nf usi o n. B o d y wei g ht will be e ntere d i nt o t he i nteracti ve res p o nse tec h n ol o g y 
s yste m (I R T) f or eac h d osi n g visit a n d will als o be rec or d e d o n t he I n v esti gati o nal Pr o d uct D ose 
Calc ulati o n a n d Pre par ati o n W or ks heet t hat t he p h ar macist will mai ntai n a n d d oc u me nt f or eac h 
patie nt’s d ose cal c ulati o ns. B o d y wei g ht s h o ul d be c ollecte d o n t he d a y of eac h st u d y dr u g 
i nf usi o n, or t he da y pri or t o eac h i nf usi o n. B o d y w ei g ht will be ca pt ure d t hr o u g h E xte nsi o n 
Da y  7 8 5 or 8 4 da ys after last d ose of st u d y dr u g if E T, or if pre vi o us misse d i nf usi o ns were 
ma de  u p.  
1 1. 3. 3  S y m pt o m -Directe d P h ysic al E x a mi n ati o n  
A s y m pt o m- directe d p h ysical e xa mi nati o n, a n e x a mi nati o n of re p orte d or o bser ve d patie nt 
s y m pt o ms warra nti n g e x a mi nati o n (i n t he o pi ni o n of t he I n vesti gat or) i n cl u di n g assess me nts of 
p ossi ble i nf usi o n site reacti o ns a n d I R R, will be perf or me d b y eit her t he I n vesti gat or or a 
q ualifie d desi g nee at  certai n st u d y visits t hr o u g h E xte nsi o n Da y 7 8 5 or 8 4 d a ys after l ast d ose of 
st u d y dr u g if E T, or if pr e vi o us misse d i nf usi o ns were ma d e u p. Ne w, a b n or mal, a n d cli nicall y 
si g nifica nt p h ysical e xa mi nati o n fi n di n gs m ust be d oc u me nte d a n d will be f oll o we d b y t he st u d y 
d oct or or S u bi n vesti gat or at t he ne xt sc he d ule d visit or s o o ner if cli nicall y i n dicate d or referre d 
t o a n o n-st u d y p h ysicia n.  
1 1. 3. 4  Vit al Si g ns  
Vital si g ns, i ncl u di n g s yst olic a n d diast olic bl o o d press ure, p ulse, b o d y t e m perat ure, a n d 
res pirat or y r ate, will be t a ke n aft er t he p atie nt has bee n at rest f or ≥5 mi n utes a n d bef ore a n y 
bl o o d dra w (e x ce pt p ost-i nf usi o n f or w hic h vital si g ns will be o btai ne d as descri be d b el o w).  
O n d osi n g da ys, vital si g ns will be meas ure d pre- d ose, 1 5 ( ± 5) mi n utes aft er t he start of i nf usi o n, 
a n d i m me diatel y f oll o wi n g t he e n d of i nf usi o n ( + 5 mi n utes). Please refer t o t he sc he d ule of 
assess me nts i n Ta ble  1.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 1  of 8 9  
C o nfi de nti al  
1 1. 4  
Cli nic al L a b or at or y Me as ure me nts  
Bl o o d a n d uri n e sa m ples f or cli nical safet y la b orat or y tests will be c ollecte d at t he ti me p oi nts 
prese nte d i n Ta bl e  1. I n v esti gat ors ma y ha ve a d diti o nal la b orat or y tests perf or me d f or t h e 
p ur p ose of pla n ni n g treat me nt a d mi nistrati o n or f oll o wi n g A E  or a b n or mal la b orat or y val u es. 
T he site will pr ocess a n d s hi p bl o o d a n d uri ne sa m ples per ce ntral la b orat or y i nstr ucti o ns. A 
ce ntral la b orat or y or d esi g nee will a nal yze bl o o d a n d uri ne sa m ples a n d pr o vi de res ults f or t he 
f oll o wi n g cli nical safet y la b orat or y tests: C B C ( Secti o n 1 1. 2. 4 ), bl o o d c he mistr y 
( Secti o n 1 1. 4. 2 ), uri ne pr e g na nc y test ( Secti o n 1 1. 4. 3 ), a n d uri nal ysis ( Secti o n 1 1. 4. 4 ). 
Cli nical la b orat or y testi n g ma y be perf or me d l ocall y d ue t o iss ue s ass ociate d wit h t he C O VI D- 1 9 
pa n de mic, wit h pri or a p pr o val fr o m Alla k os. T he site will stri ve t o use t he ce ntral la b w h e ne v er 
p ossi ble. 
F or a n y l a b orat or y test v al ue o utsi de t he refere nce ra n ge, t h e I n vesti gat or will deter mi ne cli nical 
si g nifica nce ( N ot Cli nicall y Si g nifica nt [ N C S] or Cli nicall y Si g nifica nt [ C S]). A n a b n or mal la b 
val ue s h o ul d be dee m e d C S if a n y of t he f oll o wi n g c o n diti o ns are met: 
•  
T he a b n or malit y s u g gests a disease a n d/ or or ga n t o xicit y t hat is ne w or has w orse ne d fr o m 
baseli ne.  
•  
T he a b n or malit y is of a d e gree t h at re q uires a d diti o nal acti ve ma na g e me nt, e. g., c ha n g e of 
st u d y dr u g d ose, disc o nti n uati o n of t he st u d y dr u g, cl ose o bser v ati o n, m ore fre q ue nt 
f oll o w- u p assess me nts, or f urt her di a g n ostic i n vesti gati o n. 
T heref ore, a cli nicall y si g nifica nt la b val ue is o ne t hat i n dicates a ne w dis ease pr ocess, a n 
e xacer bati o n or w orse ni n g of a n e xisti n g c o n diti o n, or re q uires f urt her acti o n t o be ta ke n.  
F or a n y l a b orat or y test v al ue o utsi de t he refere nce ra n ge t h at t he I n vesti gat or c o nsi ders cli nicall y 
si g nifica nt, t he I n vesti gat or will: 
•  
Re peat t he test t o verif y t he o ut- of- ra n ge v al ue. 
•  
F oll o w t he o ut- of-ra n ge val ue t o a satisfact or y cli nical res ol uti o n. 
•  
Rec or d as a n a d verse e v e nt a n y la b orat or y test val ue after start of st u d y dr u g t hat: 
–  T he I n ve sti gat or c o nsi ders cli nicall y si g nifica nt 
–  Re q uires a patie nt t o be disc o nti n ue d fr o m t he st u d y, or 
–  Re q uires a patie nt t o r ecei ve treat me nt.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 2  of 8 9  
C o nfi de nti al  
1 1. 4. 1  C o m plete Bl o o d C o u nt wit h Differe nti al  
Bl o o d will be o btai ne d f or C B C wit h differe ntial as descri be d i n Secti o n 1 1. 2. 4 . 
1 1. 4. 2  Bl o o d C he mistr y Pr ofile 
Bl o o d f or c he mistr y tests will be pr ocesse d a n d s hi p pe d i n acc or d a nce wit h ce ntral la b orat or y 
ma n ual a n d la b or at or y kit i nstr ucti o ns. A ce ntral l a b orat or y will a n al yze t h e ser u m sa m ple a n d 
pr o vi de res ults f or c he mistr y tests i ncl u di n g s o di u m, p otassi u m, c hl ori de, bicar b o nate, gl u c ose, 
bl o o d urea nitr o ge n, creati ni ne, creati ne ki nas e, calci u m, p h os p h or us, ma g nesi u m, t otal a n d 
direct bilir u bi n, t otal pr otei n, al b u mi n, as partate a mi n otra nsferas e, ala ni ne a mi n otra nsferase, 
al kali ne p h os p hatase, g a m ma- gl uta m yl tra nsferas e, a n d lact ate de h y dr o g e n ase.  
A n ali q u ot of bl o o d c he mistr y will be pr ocesse d a n d s hi p pe d fr o ze n i n acc or da nce wit h t he 
la b orat or y ma n u al a n d la b orat or y kit i nstr ucti o ns.  
1 1. 4. 3  Pre g n a nc y Test  
W o me n of c hil d beari n g a bilit y will pr o vi de a uri ne sa m ple f or o n-site pre g n a nc y ( h u ma n 
c h ori o nic g o na d otr o pi n) t esti n g. T he site will perf or m t he uri ne pre g n a nc y test usi n g a n i n d icat or 
stic k fr o m t he pre g n a nc y test kit s u p plie d b y t he ce ntral la b orat or y. T his test will be assesse d 
pri or t o t he start of eac h st u d y dr u g i nf usi o n. A pre g na nc y test will als o be p erf or me d o n 
E xte nsi o n Da y 7 3 6 or 3 5 ( ± 3) da ys after last d ose, if E T or i f pre vi o us misse d i nf usi o ns were 
ma de u p. 
F or t he p ur p os es of t he st u d y, patie nts wit h F S H le vels ≤3 0 mI U/ m L s h o ul d recei v e pre g n a nc y 
testi n g.  
1 1. 4. 4  Uri n al ysis  
Uri ne sa m ples will be pr ocesse d a n d s hi p p e d i n acc or da n ce wit h t he la b orat or y ma n ual a n d 
la b orat or y kit i nstr ucti o ns. A ce ntral la b orat or y will a nal yze t he uri n e sa m ple f or s pecific gra vit y, 
p H, pr otei n, gl uc ose, ket o nes, bl o o d, a n d le u k oc yte esteras e.  
1 1. 4. 5  A nti -Dr u g A nti b o dies  
Ser u m sa m ples f or A D A deter mi nati o n will be pr o cesse d a n d s hi p p e d fr o ze n i n acc or d a nce wit h 
t he la b orat or y ma n u al a n d la b orat or y kit i nstr ucti o ns. A ce ntral la b orat or y will a nal yze t he 
sa m ple f or A D A usi n g a vali date d assa y met h o d. Bl o o d sa m ples f or A D A will als o be c ollecte d 
a n yti me a n i m m u n o ge nicit y-relate d A E o cc urs.  
1 1. 4. 6  Bl o o d f or P h ar m ac o ki netics a n d St or a ge 
Bl o o d sa m ples f or ser u m p har mac o ki netic assess me nts will be pr ocesse d a n d s hi p pe d fr o ze n i n 
acc or d a nce wit h t he st u d y la b orat or y ma n u al a n d la b orat or y kit i nstr ucti o ns.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 3  of 8 9  
C o nfi de nti al  
A K 0 0 2 c o nce ntrati o ns will be deter mi ne d b y t he ce ntral la b orat or y or desi g nee usi n g a vali date d 
e nz y me-li n ke d i m m u n os or be nt assa y met h o d. S pecific i nf or mati o n o n p har mac o ki netic sa m ple 
c ollecti o n, pr ocessi n g, st ora ge, a n d s hi p me nt will be pr o vi de d i n t he ce ntral la b orat or y ma n u al.  
1 1. 4. 7  C urre nt S afet y E v al u ati o ns (if nee de d)  
C urre nt safet y e val uati o ns are r e q uire d f or patie nts t hat were pre vi o usl y wit h dra w n fr o m 
A K 0 0 2 - 0 0 3 or w h os e Da y 1 1 3 visit i n A K 0 0 2- 0 0 3 is > 4 5 da ys bef ore E xte nsi o n Da y 1 i n 
A K 0 0 2 - 0 0 3 X.  
Ce ntral la b sa m ples ma y be c ollecte d a n d pr oce sse d as per i nstr ucti o ns i n t he Ce ntral La b 
Ma n ual or L ocal La b sa m ples ma y be use d, as l o n g as res ults are a vaila bl e f or re vie w pri or t o 
e nr oll me nt (first d ose i n A K 0 0 2- 0 0 3 X). Bl o o d c h e mistr y, C B C wit h differe ntial (i ncl u di n g 
a bs ol ute e osi n o p hil c o u nt), a n d uri nal ysis m ust be re vie we d.  
T he I n vesti gat or ma y c h o ose t o c o n d uct ot her safet y pr oce d ures pri or t o e nr olli n g t he patie nt i nt o 
t he E xte nsi o n St u d y, as dee me d necessar y per I n v esti gat or a n d a p pr o v e d b y t he Me dical M o nit or 
f or patie nt saf et y.  
1 1. 4. 8  C O VI D - 1 9 Testi n g  
Testi n g f or C O VI D- 1 9 is n ot re q uire d f or t his st u d y b ut ma y be i m ple me nte d b y t he st u d y site at 
a n y ti me d uri n g t he st u d y d ue t o safet y re g ulati o ns or pr oce d ures. Testi n g f or C O VI D- 1 9 ma y b e 
i n di vi d uall y ma n date d b y E G D facilities a n d, if t his is re q uire d, will be c o ns e nte d t hr o u g h t he 
site a n d n ot liste d i n t he A K 0 0 2- 0 0 3 X i nf or m e d c o nse nt f or m.  
1 2.  
E v al u ati o ns a n d Pr oce d ures b y Visit  
Writte n, i nf or me d c o ns e nt will be o btai ne d bef ore a n y st u d y pr oce d ure is perf or me d. E val uati o ns 
a n d pr oce d ures b y visit are s h o w n i n Ta ble  1.  
All rec or d e d cl oc k ti mes s h o ul d utilize a 2 4 - h o ur cl oc k. E xte nsi o n Da y 1 is t he da y of t he first 
i nf usi o n i n t his e xte nsi o n st u d y. 
1 2. 1  
Pri or t o E xte nsi o n D a y 1  
T he f oll o wi n g pr oce d ures will be perf or me d pri or t o E xte nsi o n Da y 1: 
•  
I nf or me d C o nse nt. 
•  
C ollect a n d assess baseli ne safet y e val uati o ns f or patie nts t hat were disc o nti n ue d fr o m 
A K 0 0 2 - 0 0 3 or are > 4 5 d a ys fr o m t he D a y 1 1 3 visit i n A K 0 0 2 - 0 0 3. 
•  
C o nfir m eli gi bilit y f or t he st u d y.  
•  
A d mi nister 6 0 m g oral pr e d nis o ne ( or a p pr o ve d alter nati ve) 1 2 – 2 4 h o urs pri or t o pre dicte d 
i nf usi o n start. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 4  of 8 9  
C o nfi de nti al  
1 2. 2  
E xte nsi o n D a y 1 – First D a y of D osi n g 
T he f oll o wi n g pr oce d ures will be perf or me d pri or t o st u d y dr u g i nf usi o n: 
•  
C o nfir m eli gi bilit y f or t he st u d y.  
•  
O btai n t he S F - 3 6 H ealt h S ur ve y fr o m t he D a y 1 1 3 visit of St u d y A K 0 0 2 - 0 0 3 or ne wl y 
c o m plete d f or p atie nts t hat were dis c o nti n ue d fr o m st u d y treat me nt d ue t o hi g h e osi n o p hil 
c o u nts or are > 4 5 da ys fr o m t heir Da y 1 1 3 visit i n A K 0 0 2- 0 0 3. 
•  
Deter mi ne b o d y w ei g ht: O btai n fr o m t he Da y 1 1 3 visit of St u d y A K 0 0 2- 0 0 3 if Da y 1 1 3 is 
t he sa me da y or d a y pri or t o E xte nsi o n Da y 1. If D a y 1 1 3 of St u d y A K 0 0 2- 0 0 3 is m ore t ha n 
1 da y pri or t o E xte nsi o n Da y 1, a ne w b o d y wei g ht m ust be o btai ne d. 
•  
E nter PI D a n d w ei g ht i nt o I R T. 
•  
D oc u me nt a n y c h a n ges i n baseli ne diet: O btai n fr o m Da y 1 1 3 visit of St u d y A K 0 0 2- 0 0 3 or 
ne wl y c ollecte d f or patie n ts t hat were disc o nti n ue d fr o m st u d y treat me nt d ue t o hi g h 
e osi n o p hil c o u nts or are > 4 5 da ys fr o m t heir Da y 1 1 3 visit i n A K 0 0 2- 0 0 3. 
•  
C ollect vital si g ns: O btai n fr o m Da y 1 1 3 visit of St u d y A K 0 0 2- 0 0 3 or ne wl y c ollecte d f or 
patie nts t hat were disc o nti n ue d fr o m st u d y treat me nt d ue t o hi g h e osi n o p hil c o u nts or are 
> 4 5 da ys fr o m t heir Da y 1 1 3 visit i n A K 0 0 2- 0 0 3. 
•  
Perf or m s y m pt o m- direct e d p h ysical e xa mi nati o n, as nee de d: O bt ai n fr o m Da y 1 1 3 visit of 
St u d y A K 0 0 2- 0 0 3 or ne wl y c ollecte d f or patie nts t hat were disc o nti n ue d fr o m st u d y 
treat me nt d ue t o hi g h e osi n o p hil c o u nts or are > 4 5 da ys fr o m t heir D a y 1 1 3 visit i n 
A K 0 0 2 - 0 0 3. 
•  
C ollect bl o o d sa m ples f or C B C, bl o o d c he mistr y, A D A, a n d P K if n ot c ollecte d at t he D a y 
1 1 3 visit of St u d y A K 0 0 2- 0 0 3 or f or p atie nts t hat were disc o nti n ue d fr o m st u d y treat me nt 
d ue t o hi g h e osi n o p hil c o u nts or are > 4 5 da ys fr o m t heir Da y 1 1 3 visit i n A K 0 0 2- 0 0 3. 
Differ e ntial cell c o u nts fr o m Da y  1 1 3 i n A K 0 0 2- 0 0 3 will re mai n bli n de d. 
•  
C ollect uri ne f or uri nal ysis: O btai n fr o m t he Da y 1 1 3 visit of St u d y A K 0 0 2- 0 0 3 or ne wl y 
c ollecte d f or patie nts t hat were disc o nti n ue d fr o m st u d y treat me nt d ue t o hi g h e osi n o p hil 
c o u nts or are > 4 5 da ys fr o m t heir Da y 1 1 3 visit i n A K 0 0 2- 0 0 3.  
•  
C ollect uri ne a n d perf or m uri ne pre g na n c y test if patie nt is of c hil d beari n g p ote ntial.  
•  
T he st u d y p har macist will pre par e st u d y dr u g at 1 m g/ k g usi n g t he b o d y wei g ht o btai ne d at 
t he visit. T he fi nal c o m bi ne d v ol u me of t he i ntra v e n o us ba g of st u d y dr u g + 0. 9 % Na Cl will 
be 1 2 0  m L.  
 
N ote :  A v ol u me of 1 0 0 m L  of t he calc ul ate d d ose  of st u d y dr u g will be a d mi nistere d t o 
t he patie nt. T he e xtr a 2 0 m L is t o be use d t o pri me t he i ntra ve n o us i nf usi o n li ne 
d uri n g t he pre parati o n of t he i ntra ve n o us li ne at t h e be dsi de. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 5  of 8 9  
C o nfi de nti al  
Pr oce d ures ass ociate d wit h t he i nf usi o n of st u d y dr u g i ncl u de: 
•  
I nf use 1 0 0 m L of st u d y dr u g o ver at least 4 h o urs usi n g a n i nf usi o n p u m p. See P har mac y 
Ma n ual f or I nf usi o n Rates. Rec or d t he start a n d st o p ti mes of t he i nf usi o n i ncl u di n g a n y 
ti mes t he i nf usi o n is i nterr u pte d. 
•  
C ollect vital si g ns 1 5 ( ± 5) mi n utes after t he start of  i nf usi o n. 
•  
A n u nsc he d ule d A D A bl o o d sa m ple ma y be o btai ne d if a n i m m u n o ge nicit y-relate d A E is 
s us pecte d. 
T he f oll o wi n g pr oce d ures will be perf or me d after st u d y dr u g i nf usi o n: 
•  
C ollect vital si g ns i m me diatel y f oll o wi n g ( + 5 mi n utes) t he e n d of i nf usi o n.  
•  
C olle ct C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e e n d of i nf usi o n.  
•  
O bser ve t he p atie nt f or 1 t o 4 h o urs after t he e n d of i nf usi o n. 
C o nc o mita nt me dicati o n use a n d A E  (i n cl u di n g A E SI  a n d S A E ) will be d o c u me nte d t hr o u g h o ut 
t he cli nic visit. 
1 2. 3  
E xte nsi o n D a y 2 9 ( ± 3) 
T he f oll o wi n g pr oce d ures will be perf or me d pri or t o st u d y dr u g i nf usi o n: 
•  
Ha ve patie nt c o m plete t he S F - 3 6 H ealt h S ur ve y. 
•  
Ha ve patie nt c o m plete P GI C Q uesti o n naire.  
•  
Deter mi ne b o d y w ei g ht. 
•  
E nter PI D a n d w ei g ht i nt o I R T. 
•  
D oc u me nt a n y c h a n ges i n diet fr o m last st u d y visit.  
•  
C ollect vital si g ns.  
•  
C ollect uri ne a n d perf or m uri ne pre g na n c y test if patie nt is of c hil d beari n g p ote ntial.  
•  
Perf or m s y m pt o m- direct e d p h ysical e xa mi nati o n, as nee de d. 
•  
C ollect bl o o d sa m ples f or C B C, bl o o d c he mistr y a n d A D A. 
•  
T he st u d y p har macist will pre par e st u d y dr u g at 3 m g/ k g usi n g t he b o d y wei g ht o btai ne d at 
t he visit. T he fi nal c o m bi ne d v ol u me of t he i ntra v e n o us ba g of st u d y dr u g + 0. 9 % Na Cl will 
be 1 2 0 m L.  
Pr oce d ures ass ociate d wit h t he i nf usi o n of st u d y dr u g i ncl u de: 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 6  of 8 9  
C o nfi de nti al  
•  
Pre me dicati o n ma y be a d mi nistere d at t he I n vesti g at or’s discreti o n, i n disc ussi o n wit h t he 
Me dical M o nit or f or t he Da y 2 9 i nf usi o n.  
•  
I nf use 1 0 0 m L of st u d y dr u g usi n g a n i nf usi o n p u m p o ver 3 h o urs o n E xte nsi o n Da y 2 9. 
See P har mac y M a n ual f or I nf usi o n Rates . Rec or d t he start a n d st o p ti mes of t he i nf usi o n 
i ncl u di n g a n y ti mes t he i nf usi o n is i nterr u pte d. 
T he f oll o wi n g pr oce d ures will be perf or me d after st u d y dr u g i nf usi o n: 
•  
C ollect vital si g ns i m me diatel y f oll o wi n g ( + 5 mi n utes) t he e n d of i nf usi o n.  
•  
C ollect C B C  wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e e n d of i nf usi o n.  
•  
O bser ve t he p atie nt f or at least 1 h o ur after t he e n d of i nf usi o n. 
C o nc o mita nt me dicati o n use a n d A E  (i n cl u di n g A E SI  a n d S A E ) will be d o c u me nte d t hr o u g h o ut 
t he cli nic visit. 
1 2. 4  
E xte nsi o n D a y 5 7 ( ± 3) t o E xte nsi o n D a y 1 9 7 ( ± 3) 
T he f oll o wi n g pr oce d ures will be perf or me d o n E xte nsi o n Da ys 5 7, 8 5, 1 1 3, 1 4 1, 1 6 9, a n d 1 9 7 
( ± 3 da ys). 
T he f oll o wi n g pr oce d ures will be perf or me d pri or t o st u d y dr u g i nf usi o n: 
•  
Ha ve patie nt c o m plete t he P GI C q uesti o n naire o n E xte nsi o n Da y 5 7 a n d D a y 8 5 o nl y.  
•  
Ha ve patie nt c o m plete t he S F - 3 6 H ealt h S ur ve y.  
•  
Deter mi ne b o d y w ei g ht. 
•  
E nter PI D a n d w ei g ht i nt o I R T. 
•  
D oc u me nt a n y c h a n ges i n diet. 
•  
C ollect vital si g ns.  
•  
C ollect uri ne a n d perf or m uri ne pre g na n c y test if patie nt is of c h il d beari n g p ote ntial. 
•  
Perf or m s y m pt o m- direct e d p h ysical e xa mi nati o n, as nee de d. 
•  
C ollect bl o o d sa m ples f or C B C, bl o o d c he mistr y a n d A D A. 
•  
T he st u d y p har macist will pre par e st u d y dr u g at 3 m g/ k g usi n g t he wei g ht o btai ne d at t he 
visit.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 7  of 8 9  
C o nfi de nti al  
Pr oce d ures ass ociate d w it h t he i nf usi o n of st u d y dr u g i ncl u de: 
•  
Pre me dicati o n ma y be a d mi nistere d at t he I n vesti g at or’s discreti o n, i n disc ussi o n wit h t he 
Me dical M o nit or f or D a y 5 7 – Da y 1 9 7 i nf usi o ns. 
•  
I nf use 1 0 0 m L of st u d y dr u g usi n g a n i nf usi o n p u m p o ver at least 1 t o 4 h o urs, de pe n di n g 
o n I n v esti gat or’s discr eti o n a n d t olera nce t o pri or i nf usi o ns. See P har mac y Ma n ual f or 
I nf usi o n Rates. Rec or d t h e start a n d st o p ti mes of t he i nf usi o n i ncl u di n g a n y ti mes t he 
i nf usi o n is i nterr u pte d. 
•  
C ollect vital si g ns 1 5 ( ± 5) mi n utes aft er t he start of i nf usi o n. 
•  
A n u nsc he d ule d A D A bl o o d sa m ple ma y be o btai ne d if a n i m m u n o ge nicit y-relate d A E is 
s us pecte d. 
T he f oll o wi n g pr oce d ures will be perf or me d after st u d y dr u g i nf usi o n: 
•  
C ollect vital si g ns i m me diatel y f oll o wi n g ( + 5 mi n utes) t he e n d of i nf usi o n. 
•  
C ollect C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e e n d of i nf usi o n.  
•  
O bser ve t he p atie nt f or at least 1 h o ur after t he e n d of eac h i nf usi o n. 
C o nc o mita nt me dicati o n use a n d A E  (i n cl u di n g A E SI  a n d S A E ) will be d o c u me nte d t hr o u g h o ut 
t he cli nic visit. 
1 2. 5  
E xte nsi o n D a y 2 1 1 ( ± 3)  
All ris ks a n d ass ociate d d etails re gar di n g t he E G D pr oce d ure will be disc uss e d wit h t he patie nt 
b y t he E G D pr o vi der.  
•  
Patie n t s h o ul d arri ve fasti n g f or t he E G D pr o ce d ure, as s pecifie d b y i nstr ucti o ns fr o m t he 
E G D pr o v i der. 
•  
C ollect A E, S A E , a n d c h a n ges i n c o nc o mita nt me dicati o ns . Ca pt ure all c o n c o mita nt 
me dicati o ns  pr o vi de d t o t he patie n t d uri n g t he E G D. 
•  
Perf or m t he E G D wit h bi o ps y f oll o wi n g pr oce d ures pr o vi de d b y Alla k os a n d all E G D 
facilit y S O Ps.  
1 2. 6  
E xte nsi o n D a y 2 2 5 ( ± 3) t o E xte nsi o n D a y 5 3 3 ( ± 3) 
T he f oll o wi n g pr oce d ures will be perf or me d o n E xte nsi o n Da ys 2 2 5, 2 5 3, 2 8 1, 3 0 9, 3 3 7, 3 6 5, 
3 9 3, 4 2 1, 4 4 9, 4 7 7, 5 0 5, a n d 5 3 3 ( ± 3 da ys). 
T he f oll o wi n g pr oce d ures will be perf or me d pri or t o st u d y dr u g i nf usi o n: 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 8  of 8 9  
C o nfi de nti al  
•  
Ha ve patie nt c o m plete t he S F - 3 6 H ealt h S ur ve y.  
•  
Deter mi ne b o d y w ei g ht. 
•  
E nter PI D a n d w ei g ht i nt o I R T. 
•  
D oc u me nt a n y c h a n ges i n diet. 
•  
C ollect vital si g ns.  
•  
Perf or m uri ne pre g na n c y test if patie nt is of c hil d beari n g p ote ntial. 
•  
Perf or m s y m pt o m- direct e d p h ysical e xa mi nati o n, as ne e de d.  
•  
C ollect bl o o d sa m ples f or C B C, bl o o d c he mistr y, a n d A D A. A D A s h o ul d o nl y be c ollecte d 
o n d osi n g da ys t hr o u g h E xte nsi o n Da y 3 6 5 a n d o n E xte nsi o n Da y 5 3 3.  
•  
T he st u d y p har macist will pre par e st u d y dr u g at 3 m g/ k g usi n g t he wei g ht o btai ne d at t he 
visit.  
Pr oce d ures ass ociate d wit h t he i nf usi o n of st u d y dr u g i ncl u de: 
•  
Pre me dicati o n ma y be a d mi nistere d at t he I n vesti g at or’s discreti o n , i n disc ussi o n wit h t he 
Me dical M o nit or. 
•  
I nf use 1 0 0 m L of st u d y dr u g usi n g a n i nf usi o n p u m p o ver at least 1 t o 4 h o urs, de pe n di n g 
o n I n v esti gat or discreti o n a n d t olera nce t o pri or i nf usi o ns. See P har mac y M a n ual f or 
I nf usi o n Rates. Rec or d t h e start a n d st o p ti mes of t he i nf usi o n i ncl u di n g a n y ti mes t he 
i nf usi o n is i nterr u pte d. 
•  
C ollect vital si g ns 1 5 ( ± 5) mi n utes after t he st art of i nf usi o n. 
•  
A n u nsc he d ule d A D A bl o o d sa m ple ma y be o btai ne d if a n i m m u n o ge nicit y-relate d A E is 
s us pecte d. 
T he f oll o wi n g pr oce d ures will be perf or me d after st u d y dr u g i nf usi o n: 
•  
C ollect vital si g ns i m me diatel y f oll o wi n g ( + 5 mi n utes) t he e n d of i nf usi o n.  
•  
C ollect C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e e n d of i nf usi o n.  
•  
O bser ve t he p atie nt f or 1 t o 4 h o urs after t he e n d of i nf usi o n. 
C o nc o mita nt me dicati o n use a n d A E  (i n cl u di n g A E SI  a n d S A E ) will be d o c u me nte d t hr o u g h o ut 
t he cli nic visit. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 4 9  of 8 9  
C o nfi de nti al  
1 2. 7  
E xte n si o n D a y 5 4 7 ( ± 3)  
All ris ks a n d ass ociate d d etails re gar di n g t he E G D pr oce d ure will be disc uss e d wit h t he patie nt 
b y t he E G D pr o vi der.  
•  
Patie nt s h o ul d arri ve fasti n g f or t he E G D pr o ce d ure, as s pecifie d b y i nstr ucti o ns fr o m t he 
E G D pr o vi der. 
•  
C ollect A E, S A E, a n d c h a n ges i n c o nc o mita nt me dicati o ns. Ca pt ure all c o n c o mita nt 
me d icati o ns pr o vi de d t o t he s u bject d uri n g t he E G D. 
•  
Perf or m t he E G D wit h bi o ps y f oll o wi n g pr oce d ures pr o vi de d b y Alla k os a n d all E G D 
facilit y S O Ps.  
1 2. 8  
E xte nsi o n D a y 5 6 1 ( ± 3) t o E xte nsi o n D a y 7 0 1 ( ± 3) 
T he f oll o wi n g pr oce d ures will be perf or me d o n E xte nsi o n Da ys 5 6 1, 5 8 9, 6 1 7, 6 4 5, 6 7 3, a n d 7 0 1 
( ± 3 da ys). 
T he f oll o wi n g pr oce d ures will be perf or me d pri or t o st u d y dr u g i nf usi o n: 
•  
Ha ve patie nt c o m plete t he S F - 3 6 H ealt h S ur ve y.  
•  
Deter mi ne b o d y w ei g ht. 
•  
E nter PI D a n d w ei g ht i nt o I R T. 
•  
D oc u me nt a n y c h a n ges i n diet. 
•  
C ollect vital si g ns.  
•  
Perf or m uri ne pre g na n c y test if patie nt is of c hil d beari n g p ote ntial. 
•  
Perf or m s y m pt o m- direct e d p h ysical e xa mi nati o n, as nee de d. 
•  
C ollect bl o o d sa m ples f or C B C a n d bl o o d c he m istr y. 
•  
T he st u d y p har macist will pre par e st u d y dr u g at 3 m g/ k g usi n g t he wei g ht o btai ne d at t he 
visit.  
Pr oce d ures ass ociate d wit h t he i nf usi o n of st u d y dr u g i ncl u de: 
•  
Pre me dicati o n ma y be a d mi nistere d at t he I n vesti g at or’s discreti o n, i n disc ussi o n  wit h t he 
Me dical M o nit or. 
•  
I nf use 1 0 0 m L of st u d y dr u g usi n g a n i nf usi o n p u m p o ver at least 1 t o 4 h o urs, de pe n di n g 
o n t he I n vesti gat or’s discreti o n a n d t olera n ce t o pri or i nf usi o ns. See P har mac y Ma n ual f or 
I nf usi o n Rates. Rec or d t h e start a n d st o p ti mes of t he i nf usi o n i ncl u di n g a n y ti mes t he 
i nf usi o n is i nterr u pte d. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 0  of 8 9  
C o nfi de nti al  
•  
C ollect vital si g ns 1 5 ( ± 5) mi n utes after t he start of i nf usi o n.  
•  
A n u nsc he d ule d A D A bl o o d sa m ple ma y be o btai ne d if a n i m m u n o ge nicit y- relate d A E  is 
s us pecte d. 
T he f oll o wi n g pr oce d ures will be perf or me d after st u d y dr u g i nf usi o n: 
•  
C ollect vital si g ns i m me diatel y f oll o wi n g ( + 5 mi n utes ) t he e n d of i nf usi o n. 
•  
C ollect C B C wit h  differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e e n d of i nf usi o n.  
•  
O bser ve t he p atie nt f or at least 1 h o ur after t he e n d of i nf usi o n. 
C o nc o mita nt me dicati o n use a n d A E  (i n cl u di n g A E SI  a n d S A E ) will be d o c u me nte d t hr o u g h o ut 
t he cli nic visit. 
1 2. 9  
E xte nsi o n D a y 7 0 1 + 2 8 ( ± 3) d a ys O nly  if Pre vi o us D oses were Misse d  
T he f oll o wi n g pr oce d ures will be perf or me d o n all I nf usi o n D a ys aft er Da y 7 0 1 – o nly  rele va nt if 
pre vi o us d oses were misse d – u ntil a t otal of 2 6 d oses ha ve bee n recei ve d. 
T he f oll o wi n g pr oce d ures will be perf or me d pri or t o st u d y dr u g i nf usi o n: 
•  
Ha ve patie nt c o m plete t he S F - 3 6 H ealt h S ur ve y.  
•  
Deter mi ne b o d y w ei g ht. 
•  
E nter PI D a n d w ei g ht i nt o I R T. 
•  
D oc u me nt a n y c h a n ges i n diet. 
•  
C ollect vital si g ns.  
•  
Perf or m uri ne pre g na n c y test if patie nt is of c hil d beari n g p ote nt ial. 
•  
Perf or m s y m pt o m- direct e d p h ysical e xa mi nati o n, as nee de d. 
•  
C ollect bl o o d sa m ples f or C B C a n d bl o o d c he mistr y. 
•  
T he st u d y p har macist will pre par e st u d y dr u g at 3 m g/ k g usi n g t he wei g ht o btai ne d at t he 
visit.  
•  
Pr oce d ures ass ociate d wit h t he i nf usi o n of st u d y dr u g i ncl u de: 
•  
Pre me dicati o n ma y be a d mi nistere d at t he I n vesti g at or’s discreti o n, i n disc ussi o n wit h t he 
Me dical M o nit or. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 1  of 8 9  
C o nfi de nti al  
•  
I nf use 1 0 0 m L of st u d y dr u g usi n g a n i nf usi o n p u m p o ver at least 1 t o 4 h o urs, de pe n di n g 
o n t he I n vesti gat or’s discreti o n a n d t olera n ce t o pri or i nf usi o ns. See P har mac y Ma n ual f or 
I nf usi o n Rates. Rec or d t h e start a n d st o p ti mes of t he i nf usi o n i ncl u di n g a n y ti mes t he 
i nf usi o n is i nterr u pte d. 
•  
C ollect vital si g ns 1 5 ( ± 5) mi n utes after t he start of i nf usi o n.  
•  
A n u nsc he d ule d A D A bl o o d sa m ple ma y be o btai ne d if a n i m m u n o ge nicit y-relate d A E is 
s us pecte d. 
T he f oll o wi n g pr oce d ures will be perf or me d after st u d y dr u g i nf usi o n: 
•  
C ollect vital si g ns i m me diatel y f oll o wi n g ( + 5 mi n utes ) t he e n d of i nf usi o n. 
•  
C ollect C B C wit h differe n tial 1 h o ur ( ± 1 5 mi n utes) after t h e e n d of i nf usi o n.  
•  
O bser ve t he p atie nt f or at least 1 h o ur after t he e n d of i nf usi o n. 
C o nc o mita nt me dicati o n use a n d A E  (i n cl u di n g A E SI  a n d S A E ) will be d o c u me nte d t hr o u g h o ut 
t he cli nic visit. 
1 2. 1 0  F oll o w- u p E xte nsi o n D a y 7 2 9 ( ± 3) or 2 8 ( ± 3) D a ys after L ast D os e, if E T or if 
M isse d D oses are bei n g m a de u p  
All ris ks a n d ass ociate d d etails re gar di n g t he E G D pr oce d ure will be disc uss e d wit h t he patie nt 
b y t he E G D pr o vi der.  
•  
Patie nt s h o ul d arri ve fasti n g f or t he E G D pr o ce d ure, as s pecifie d b y i nstr ucti o ns fr o m t he 
E G D pr o vi der. 
•  
C ollect A E , S A E,  a n d c h a n ges i n c o nc o mita nt me dicati o ns . Ca pt ure all c o n c o mita nt 
me dicati o ns  pr o vi de d t o t he patie nt d uri n g t he E G D. 
•  
Perf or m t he E G D wit h bi o ps y f oll o wi n g pr oce d ures pr o vi de d b y Alla k os a n d all E G D 
facilit y S O Ps.  
F or E arl y T er mi n ati o n : Perf or m E G D 2 8 ( ± 3) d a ys after t h e last d ose of st u d y dr u g or pri or t o 
t his, if necessar y, t o e ns ure c o m plia nce wit h t he visit. If patie nt disc o nti n ues t he st u d y m ore t ha n 
2 8 da ys after t h e last d ose of st u d y dr u g, perf or m t he E G D as s o o n as p ossi ble. 
1 2. 1 1  F oll o w- u p E xte nsi o n D a y 7 3 6 ( ± 3) or 3 5 ( ± 3) D a ys after L ast D os e, if E T or if 
Misse d D oses are bei n g m a de u p  
Pr oce d ures f or E xte nsi o n Da y 7 3 6 or 3 5 ( ± 3) d a ys after last d ose of st u d y dr u g, i ncl u de: 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 2  of 8 9  
C o nfi de nti al  
•  
Deter mi ne b o d y w ei g ht. 
•  
C ollect vital si g ns.  
•  
Ha ve patie nt c o m plete t he S F - 3 6 H ealt h S ur ve y. 
•  
D oc u me nt a n y c h a n ges i n diet. 
•  
Perf or m s y m pt o m- direct e d p h ysical e xa mi nati o n, as nee de d. 
•  
C ollect bl o o d sa m ples f or C B C, bl o o d c he mistr y, P K , a n d A D A. 
•  
C ollect uri ne f or uri nal ysis a n d perf or m uri ne pre g na nc y test if patie nt is of c hil d beari n g 
p ote ntial.  
•  
I nstr u ct patie nt t o c o nti n ue c o m pleti n g dail y e P R O q uesti o n naire t hr o u g h 8 4 da ys after t h e 
last d ose of st u d y dr u g. 
C o nc o mita nt me dicati o n use, A E SI , a n d S A E will be d oc u me nte d t hr o u g h o ut t he cli nic visit. 
1 2. 1 2  F oll o w- u p E xte nsi o n D a y 7 5 7 ( ± 3) a n d D a y 7 8 5 ( ± 3) or 5 6 a n d 8 4 ( ± 3) D a ys after 
L ast D ose, if E T or if Misse d D oses are bei n g m a de u p  
Pr oce d ures f or E xte nsi o n Da y 7 5 7 a n d D a y 7 8 5 or 5 6 ( ± 3) da ys a n d 8 4 ( ± 3) da ys after t h e last 
d ose of st u d y dr u g, i ncl u de: 
•  
Ha ve patie nt c o m plete t he S F - 3 6 H ealt h S ur ve y. 
•  
D oc u me nt a n y c h a n ges i n diet. 
•  
C ollect bl o o d sa m ple f or C B C. 
•  
I nstr u ct patie nt t o c o nti n ue c o m pleti n g dail y e P R O q uesti o n naire t hr o u g h 8 4 da ys after t h e 
last d ose of st u d y dr u g.  
C o nc o mita nt me dicati o n use, A E SI , a n d S A E, will be d oc u me nte d t hr o u g h o ut t he cli nic visit. 
1 3.  
A d verse E ve nt R e p orti n g a n d D oc u me nt ati o n  
1 3. 1  
A d verse E ve nts  
I n acc or da n ce wit h 2 1 C o de of Fe der al Re g ulati o n ( C F R) 3 1 2. 3 2( b) a n d I nter nati o nal 
C o nfere nce o n Har m o nisati o n (I C H) G ui da n ce E 2 A, a n A E  is a n y u nt o war d me dical occ urre n ce 
i n a cli nical i n vesti gati o n of a patie nt a d mi nistere d a p har mace utical pr o d uct a n d t hat d oes n ot 
necessaril y ha ve a ca us al relati o ns hi p wit h t he treat me nt. A n A E  is t heref ore a n y u nfa v ora ble 
a n d u ni nte n de d si g n (i ncl u di n g a n a b n or mal la b orat or y fi n di n g), s y m pt o m, or disease te m p orall y 
ass ociate d wit h t he a d mi nistrati o n of a n i n vesti gati o nal pr o d uct, w het her or n ot relate d t o t hat 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 3  of 8 9  
C o nfi de nti al  
i n vesti gati o nal pr o d uct. A n u ne x pect e d A E  is a t y pe n ot i de ntifie d i n nat ure, se verit y, or 
fre q ue n c y i n t he c urre nt I n vesti gat or’s Br oc h ure or of great er se v erit y or fre q ue nc y t ha n 
e x pecte d b ase d o n t he i nf or mati o n i n t he I n v esti gat or’s Br oc h ure.  
E xa m ples of a n A E  i n cl u de: 
•  
Si g nifica nt w orse ni n g or e xacer bati o n of u n d erl yi n g me dical c o n diti o n. 
•  
Si g nifica nt a b n or mal fi n di n gs fr o m p h ysical e xa mi nati o ns, vital si g ns or la b orat or y tests. 
T he f oll o wi n g e xa m ples are n ot c o nsi dere d A E : 
•  
Me dical or s u r gical pr oce d ure, alt h o u g h t he c o n diti o n lea di n g t o t he pr oce d ure is us uall y a n 
a d verse e ve nt.  
•  
A ntici pate d da y -t o- d a y fl uct uati o ns of pree xisti n g me dical c o n diti o ns (i ncl u di n g la b orat or y 
val ues) as l o n g as w orse ni n g fr o m baseli ne d oes n ot occ ur. 
•  
Si g ns or s y m pt o ms of t he dis or der bei n g st u die d, u nless t he y bec o me m ore se vere or occ ur 
wit h a greater fr e q ue n c y t ha n occ urri n g at baseli n e.  
All n o n-seri o us A E  t hat are n ot A E SI , w het h er elicite d b y q uesti o ns fr o m st u d y staff, 
v ol u nteere d, or n ot e d o n p h ysical e xa mi nati o n/la b orat or y testi n g, a n d re gar dless of ca usalit y or 
se verit y, will be assesse d a n d rec or de d i n t he e C R F be gi n ni n g after first a d mi nistrati o n of st u d y 
dr u g a n d e n di n g at E xte nsi o n Da y 7 8 5 or 8 4 ( ± 3) da ys after l ast d ose of st u d y dr u g if patie nt is 
earl y ter mi nati n g  or if misse d d oses are bei n g ma d e u p.  
1 3. 2  
Seri o us A d verse E ve nts  
A seri o us a d verse e v e nt is defi ne d as a n a d verse e ve nt t hat meets t hat o ne of t he f oll o wi n g 
criteria:  
•  
Deat h  
•  
A life -t hreate ni n g A E  t hat places t he patie nt at ris k of deat h at t he ti me of t h e e ve nt. It d oes 
n ot refer t o a n e ve nt t hat h y p ot heticall y mi g ht ca use deat h if it were m ore s e vere.  
•  
I n p atie nt h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n. 
•  
A persiste nt or si g nifica nt disa bilit y/i nca pacit y.  
•  
A c o n ge nital a n o mal y/ birt h defect occ urri n g i n t he offs pri n g of a st u d y pati e nt.  
•  
Ot her i m p orta nt me dical e ve nts ma y als o be c o nsi dere d a S A E  w he n, bas e d o n a p pr o priate 
me dical j u d g me nt, t he y je o par dize t he patie nt or re q uire i nter v e nti o n t o pre ve nt o ne of t he 
o utc o mes liste d a b o ve. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 4  of 8 9  
C o nfi de nti al  
Seri o us a d verse e ve nts will be assesse d a n d rec or d e d after t he first a d mi nistrati o n of st u d y dr u g 
a n d e n di n g at E xte nsi o n Da y 7 8 5 ( ± 3) or 8 4 ( ± 3) da ys after t h e last d ose of st u d y dr u g if patie nt 
is earl y ter mi nati n g or if misse d d oses are b ei n g ma de u p. 
1 3. 3  
A d verse E ve nts of S peci al I nterest  
A d verse e ve nts of s pecial i nterest f or t his st u d y i ncl u de:  
•  
Mali g na ncies c o nfir me d b y hist o pat h ol o gical re p ort. ( Mast cells a n d e osi n o p hils are part of 
t he n or mal i m mu ne res p o nse, b y decreasi n g t heir f u ncti o n, A K 0 0 2 c o ul d t he oreticall y 
i ncreas e t he ris k of mali g na nc y). 
•  
Parasitic i nfecti o ns c o nfir me d b y p ositi ve cli nical la b orat or y test. ( E osi n o p hils are 
es peciall y acti ve i n pr otecti n g t he b o d y fr o m parasitic i nfecti o ns a n d decreasi n g t heir 
f u ncti o n c o ul d t he oreticall y i ncrease t he ris k of parasitic a n d o p p ort u nistic i nfecti o ns). 
•  
O p p ort u nistic i nfecti o ns (i nfecti o ns k n o w n t o be m ore se vere or o cc ur m ore fre q ue ntl y i n 
i m m u n os u p presse d p o p ulati o ns) as c o nfir me d b y p ositi ve cli nical la b orat or y test.  
•  
I nf usi o n-relat e d reacti o ns a n d h y perse nsiti vit y reacti o ns, i ncl u di n g a na p h yla xis. 
Be gi n ni n g fr o m t he ti me of first st u d y dr u g i nf usi o n a n d e n di n g at E xte nsi o n Da y 7 8 5 ( ± 3) or 
8 4 ( ± 3) da ys after t he last d ose of st u d y dr u g if t he patie nt is earl y ter mi nati n g  or if misse d d oses 
are bei n g ma d e u p , a n y n e w A E SI  m ust be rec or d e d i n t he A d vers e E ve nt e C R F a n d desi g nate d 
as a n “a d v erse e ve nt of s pecial i nterest.” If ne w i nf or mati o n relate d t o a n y pre vi o usl y re p orte d 
A E SI  is i de ntifie d, the a p pr o priate e C R F s h o ul d b e u p date d. 
1 3. 4  
I nf usi o n-Rel ate d Re acti o ns  
All A E,  c o nsi dere d b y t h e I n vesti gat or t o be relate d t o t he i nf usi o n of t he bi ol o gical s u bsta nce 
a n d occ urri n g wit hi n 2 4 h o urs of t he start of t he st u d y dr u g i nf usi o n, s h o ul d be ca pt ure d as 
1 I R R.  
C o m m o n s y m pt o ms of I R R i ncl u de:  
•  
Fl us hi n g 
•  
C hills  
•  
Bac k or a b d o mi nal pai n 
•  
C hest disc o mf ort or ti g ht ness 
•  
Dizzi ness  
•  
S h ort ness of breat h 
•  
Hea dac he  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 5  of 8 9  
C o nfi de nti al  
•  
H y p ote nsi o n or h y perte nsi o n 
•  
Na usea  
•  
V o miti n g  
•  
S weati n g  
•  
Fe ver  
•  
Urticaria  
•  
Pr urit us  
•  
Br o nc h os pas m 
All s y m pt o ms e x perie nce d b y a patie nt d uri n g a n i nf usi o n- relate d reacti o n will be liste d i n t he 
e C R F u n der 1 i nf usi o n-r elate d reacti o n, u nless t h e I n vesti gat or belie v es a s y m pt o m is n ot part of 
t he i nf usi o n-relate d reacti o n, i n w hic h case it will be rec or de d se p aratel y. T he start ti me of t he 
i nf usi o n-relate d r eacti o n will be ca pt ure d as t he start ti me of t he first s y m pt o m a n d t he e n d ti me 
of t he i nf usi o n- relat e d reacti o n will be ca pt ure d as t he e n d ti me of t he last s y m pt o m.  
1 3. 5  
A n a p h yl a xis 
A s us pici o n of a na p h yla xis will be caref ull y m o nit ore d a n d treate d acc or di n g t o sta n dar d of care. 
E mer ge nc y cras h cart e q ui p me nt a n d me dicati o ns, i ncl u di n g m ulti ple d oses of e pi ne p hri ne, 
vas o press ors, a n d br o nc h o dilat ors, will be a vaila ble at all ti mes d uri n g t he c o n d uct of t he st u d y. 
T o defi ne a n a p h ylactic reacti o ns i n a c o nsiste nt a n d o bjecti ve ma n ner, all A E  of s us pecte d 
a na p h yla xis will be e val u ate d usi n g Sa m ps o n’s Criteria f or A n a p h yla xis ( A p pe n di x 1 9. 4 ). T he 
assess me nt of a n a d vers e e ve nt will b e d o ne p urs u a nt t o defi niti o ns set f ort h b y I C H G o o d 
Cli nical Practice ( G C P) g ui deli nes a n d a p plica ble re g ulat or y re q uire me nts.  
If a patie nt e x perie n ces si g ns or s y m pt o ms of a na p h yla xis, t he patie nt ma y be treate d wit h 
sta n dar d of car e, s uc h as di p he n h y dra mi ne, aceta mi n o p he n, met h yl pre d nis ol o ne, e pi ne p hri ne, 
a n d ot her s u p p orti ve meas ures al o n g wit h cess ati o n of t he i nf usi o n. 
1 3. 6  
E v al u ati n g A d verse E ve nts a n d Seri o us A d verse E ve nts  
1 3. 6. 1  Est a blis hi n g Di a g n osis 
W he ne v er p ossi ble, dia g n oses s h o ul d be gi ve n w he n si g ns a n d s y m pt o ms are d ue t o a c o m m o n 
eti ol o g y (e. g., d ys uria, uri nar y nitrites s h o ul d be re p orte d as a uri n ar y tract i nfecti o n). If t he 
dia g n osis is n ot k n o w n, i n di vi d ual si g ns a n d s y m pt o ms s h o ul d be assesse d a n d rec or de d i n t he 
A d verse E v e nt e C R F as s e parat e A E. T he I n vesti g at or ( or q ualifi e d S u bi n vesti gat or) m ust assi g n 
t he A E  attri b utes liste d i n t he f oll o wi n g secti o ns a n d is res p o nsi ble f or e ns uri n g t heir ca pt ur e i n 
t he s o urce d o c u me ntati o n. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 6  of 8 9  
C o nfi de nti al  
1 3. 6. 2  Assess m e nt of I nte nsit y  
T he I n vesti gat or will use t heir cli nical j u d g me nt as well as t he g ui deli nes lai d o ut i n t he Nati o nal 
Ca ncer I nstit ute C o m m o n Ter mi n ol o g y Criteria f or A d vers e E ve nts ( C T C A E) Versi o n 5. 0 ( or 
m ost c urre nt versi o n) t a bles ( Ta ble  2 a n d A p pe n di x 1 9. 3 ) t o assess t he i nte nsit y of eac h A E  a n d 
S A E . 
T a ble 2 
A d verse E ve nt Se verit y per t he N ati o n al C a ncer I nstit ute C o m m o n 
Ter mi n ol o g y Criteri a f or A d verse E ve nts V ersi o n 5. 0 
Gr a de *  
Descri pti o n  
1  
Mil d; as y m pt o matic or mil d s y m pt o ms; cli nical or dia g n ostic o bser vati o ns o nl y; i nter ve nti o n n ot i n dicate d  
2 
M o derate; mi ni mal, l ocal or n o ni n vasi ve i nter ve nti o n i n dicate d; li miti n g a ge a p pr o priate i nstr u me ntal 
acti vities of dail y li vi n g  
3 
Se vere or me dicall y si g nifica nt b ut n ot i m me diatel y life -t hreate 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; disa bli n g; li miti n g self -care acti vities of dail y li vi n g  
4 
Life -t hreate ni n g c o nse q ue nces, ur ge nt i nter ve nti o n i n dicate d 
5 
Deat h relate d t o a d verse e ve nt  
* Gra de refers t o t he se verit y of t he a d verse e ve nt. T he C T C A E dis pla ys Gr a des 1 t o 5 wit h u ni q ue cli nical 
descri pti o ns of se verit y f or eac h A E  base d o n t his ge neral g ui deli ne.  
T he ter m “se v er e” is a m eas ure of i nte nsit y, a n d a se vere A E  is n ot necess aril y a S A E . W he n t he 
i nte nsit y of a n A E  c ha n g es m ore t ha n o nce a d a y, t he ma xi m u m se verit y f or t he e ve nt s h o ul d be 
e ntere d i nt o t he A d v erse E ve nt e C R F. If t he i nte nsit y c ha n ges o ver a n u m ber of da ys, t hese 
c ha n ges s h o ul d be rec or d e d se par atel y (i.e., as ha vi n g disti nct o nset dates). 
1 3. 6. 3  Assess m e nt of C a us alit y t o St u d y Dr u g 
T he I n vesti g at or s h o ul d use cli nical j u d g me nt, as well as t he g ui deli nes i n  Ta ble  3, t o assess t he 
relati o ns hi p bet wee n st u d y dr u g a n d A E . 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 7  of 8 9  
C o nfi de nti al  
T a ble 3 
A d verse E ve nt R el ati o ns hi p t o St u d y Dr u g  
Rel ati o ns hi p  
t o St u d y Dr u g 
C o m m e nt  
Relate d  
T here is clear e vi de nce t hat t he e ve nt is relate d t o t he use of st u d y dr u g (e. g., c o nfir mati o n b y 
p ositi ve rec halle n ge test, if p ossi ble). A n ot her eti ol o g y is c o nsi dera bl y less li kel y.  
P ossi ble  
T he e ve nt ca n n ot be e x plai ne d b y t he patie nt’s me dical c o n diti o n, c o nc o mita nt t hera p y, or 
ot her ca uses, a n d t here is a pla usi ble te m p oral relati o ns hi p bet wee n t he e ve nt a n d st u d y dr u g 
a d mi n istrati o n.  
U nli kel y/ Re m ote  
A n e ve nt f or w hic h a n alter nati ve e x pla nati o n is m ore li kel y (e. g., c o nc o mita nt me dicati o ns or 
o n g oi n g me dical c o n diti o ns) or t he te m p oral relati o ns hi p t o st u d y dr u g a d mi nistrati o n a n d/ or 
e x p os ure s u g gests t hat a ca usal relati o ns hi p is u nli kel y. ( F or re p orti n g p ur p oses, 
U nli kel y/ Re m ote will be gr o u pe d t o get her wit h N ot Relate d.)  
N ot Relate d  
T he e ve nt ca n be rea dil y e x plai ne d b y t he patie nt’s u n derl yi n g me dical c o n diti o n, c o nc o mita nt 
t hera p y, or ot her ca uses, a n d t heref ore, t he I n vesti gat or belie ves n o relati o ns hi p e xists bet wee n 
t he e ve nt a n d st u d y dr u g.  
1 3. 6. 4  Assess m e nt of C a us alit y t o St u d y Pr oce d ure 
T he I n vesti gat or s h o ul d use cli nical j u d g me nt as well as t he g ui deli nes i n Ta ble  4 t o assess t he 
relati o ns hi p bet wee n st u d y pr oce d ur e a n d A E . Ass ess me nt of ca us alit y t o St u d y Pr oce d ure 
s h o ul d i ncl u de ca usalit y t o s uc h ite ms as E G D wit h bi o ps y or bl o o d dra w (as a p pr o priat e), or 
ot her. I nf usi o n -r elate d r eacti o ns s h o ul d n ot be assesse d i n relati o n t o St u d y Pr oce d ure, o nl y i n 
relati o n t o St u d y Dr u g.  
T a ble 4 
A d verse E ve nt R el ati o ns hi p t o St u d y Pr oce d ure  
Rel ati o ns hi p t o  
St u d y Pr oce d ure  
C o m m e nt  
Relate d  
T here is clear e vi de nce t hat t he e ve nt is relate d t o a st u d y pr oce d ure.  
P ossi ble  
T he e ve nt ca n n ot be e x plai ne d b y t he patie nt’s me dical c o n diti o n, c o nc o mita nt t hera p y, or 
ot her ca uses, a n d t here is a pla usi ble te m p oral relati o ns hi p bet wee n t he e ve nt a n d a st u d y 
pr oce d ure.  
U nli kel y/ Re m ote  
A n e ve nt f or w hic h a n alter nati ve e x pla nati o n is m ore li kel y (e. g., c o nc o mita nt me dicati o ns or 
o n g oi n g me dical c o n diti o ns) or t he te m p oral relati o ns hi p t o a n y st u d y pr oce d ure s u g gests t hat 
a ca usal relati o ns hi p is u nli kel y. ( F or re p orti n g p ur p oses, U nli kel y/ Re m ote will be gr o u pe d 
t o get her wit h N ot Relate d.) 
N ot Relate d  
T he e ve nt ca n be rea dil y e x plai ne d b y t he patie nt’s u n derl yi n g me dical c o n diti o n, c o nc o mita nt 
t hera p y, or ot her ca uses, a n d t heref ore, t he I n vesti gat or belie ves n o relati o ns hi p e xists betwee n 
t he e ve nt a n d a st u d y pr oce d ure.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 8  of 8 9  
C o nfi de nti al  
1 3. 6. 5  Acti o n T a ke n  
Acti o n ta ke n wit h res p ect t o st u d y dr u g will be cate g orize d as n o ne, st u d y dr u g per ma n e ntl y 
disc o nti n ue d (i nf usi o n is i nterr u pte d a n d is n ot rest arte d, a n d n o s u bs e q ue nt i nf usi o ns are gi ve n), 
st u d y dr u g te m p oraril y wit h dra w n (i nf usi o n is i nterr u pte d a n d is restarte d, or t he ne xt i nf usi o n is 
still a d mi nistere d as pla n ne d), or ot her (s pecif y).  
Acti o n ta ke n wit h res p ect t o st u d y partici pati o n will be cate g orize d as n o ne, wit h dra wal fr o m 
st u d y partici pati o n, or ot her (s pecif y).  
Acti o n ta ke n wit h res p ect t o tr eat me nt of a n A E  will be cate g orize d as n o ne, c o nc o mita nt 
me dicati o n, c o nc o mita nt pr oce d ur e, or ot her (s pecif y).  
1 3. 6. 6  Assess m e nt of O utc o m e  
E ve nt o utc o me at r es ol uti o n or ti me of last f oll o w - u p will be rec or de d as: rec o vere d, rec o veri n g, 
n ot rec o vere d, r ec o vere d wit h se q uelae, fatal, or u n k n o w n.  
1 3. 7  
A d verse E ve nt R e p orti n g Pr oce d ures  
1 3. 7. 1  All A d verse E ve nts  
A n y cli nicall y si g nifica nt a d verse e ve nt t hat is o n g oi n g at t he ti me of st u d y c o m pleti o n or earl y 
ter mi nati o n will be f oll o we d b y t he I n v esti gat or u ntil e ve nt resol uti o n, t he a d verse e ve nt is 
ot her wise e x plai n e d, n ot c o nsi dere d cli nicall y si g nifica nt b y t he I n vesti gat or, or t he patie nt is l ost 
t o f oll o w- u p. 
All n o n-seri o us A E  i de ntifie d will be rec or de d i n t he A d vers e E ve nt e C R F be gi n ni n g  fr o m t he 
ti me of first st ud y dr u g i nf usi o n a n d e n di n g at E xte nsi o n Da y 7 8 5 or 8 4 ( ± 3) da ys after last d ose 
of st u d y dr u g if patie nt is earl y ter mi nati n g or if misse d d oses are m a de u p . All S A E  i de ntifie d 
will be rec or d e d i n t he A d verse E ve nt e C R F be gi n ni n g fr o m t he ti me of first st u d y dr u g i nf usi o n 
a n d e n di n g at E xte nsi o n Da y 7 8 5 or 8 4 ( ± 3) d a ys after t he l ast d ose of st u d y dr u g if patie nt is 
earl y ter mi nati n g  or if misse d d oses ar e ma de u p . W he ne v er a p pr o priate, t h e C T C A E ( versi o n 
5. 0 or m ost c urre nt versi o n) s h o ul d be utilize d f or na mi n g c o m m o n A E  (A p pe n di x 1 9. 3 ). 
1 3. 7. 2  Seri o us A d verse E ve nt Re p orti n g  
I n t he e ve nt of a n y S A E  r e p orte d or o bs er ve d d uri n g t he st u d y, w het her or n ot attri b uta ble t o t he 
st u d y dr u g, site pers o n nel will re p ort it i m me diatel y (wit hi n 2 4  h o urs of bec o mi n g a w are of t he 
S A E ) b y tele p h o ne or e m ail t o t he S p o ns or, Alla k os, I n c.  
Seri o us a d verse e ve nt r e p ort f or ms will be pr o vi de d t o t he i n vesti gati o nal site t o assist i n 
c ollecti n g, or ga nizi n g, a n d re p orti n g S A E , a n d f or ms s h o ul d be c o m plete d wit h as m uc h 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 5 9  of 8 9  
C o nfi de nti al  
i nf or mati o n as is a vaila bl e a n d s u b mitte d t o t he S p o ns or wit hi n 2 4 h o urs. Seri o us a d vers e e v e nts 
s h o ul d als o be rec or de d o n t he A d verse E ve nt e C R F a n d desi g n ate d as “s eri o us.”  
E ve n w he n o nl y mi ni mal i nf or mati o n is a vaila ble f or t he i nitial S A E re p ort, t he I n v esti gat or 
s h o ul d tr y t o ma ke a ca us alit y assess me nt, as t he ca usalit y is use d t o deter mi ne t he ti mi n g of 
re g ulat or y r e p orti n g re q uire me nts. If t he I n v esti gat or or desi g nee is n ot a v aila ble t o si g n t he S A E  
re p ort o n i nitial s u b missi o n, t he y s h o ul d be c o ntacte d via tele p h o ne a n d t heir assess me nt 
d oc u me nte d o n t he S A E  f or m ( wit h a n ote stati n g si g nat ure is f ort hc o mi n g).  
T he I n vesti gat or m a y c h a n ge  t heir ca usalit y assess me nt base d o n f oll o w- u p i nf or mati o n a n d 
s u b mit a n a me n de d S A E  re p ort f or m. All eff orts will be ma de t o o btai n acc urate a n d c o m plete 
me dical rec or ds f or t h e S A E . All eff orts t o o btai n i nf or mati o n s h o ul d be d oc u me nte d i n t he 
patie nt s o urce d o c u me nts. 
T he site will n otif y t he I nstit uti o nal Re vie w B oar d (I R B) acc or di n g t o its g ui deli nes.  
T he patie nt’s c o n diti o n will be f oll o we d b y t he I n vesti gat or or desi g nate d S u bi n vesti gat or u ntil 
res ol uti o n of t he c o n diti o n or a ret ur n t o b aseli ne l e vels. If a d diti o nal visits are re q uire d, t he 
patie nt will be as ke d t o r et ur n t o t he st u d y sit e f or f urt her f oll o w ‐u p. If t he c o n diti o n is still 
o n g oi n g at t he ti me t he patie nt e xits t he st u d y, e ver y eff ort will be ma de t o c o nti n ue t o f oll o w u p 
wit h t he patie nt f or a r eas o na ble peri o d of ti me, as deter mi ne d b y t he I n v esti gat or or u ntil t here is 
a ret ur n t o bas eli ne or sta bilizati o n of t he c o n diti o n. As a d diti o nal i nf or mati o n bec o mes 
a vaila ble, s uc h as h os pital disc har ge n otes a n d p atie nt me dical rec or ds, t he I n vesti gat or will be 
n otifie d a n d pr o vi de d wit h all rele va nt i nf or m ati o n.  
All S A E  t hat ha ve n ot res ol ve d b y t he e n d of t he st u d y or t hat ha ve n ot res ol ve d o n 
disc o nti n uati o n of t he patie nt’s partici pati o n i n t he st u d y m ust be f oll o we d u ntil a n y of t he 
f oll o wi n g occ urs:  
•  
T he e ve nt r es ol ves.  
•  
T he e ve nt sta bilizes.  
•  
T he e ve nt r et ur ns t o baseli ne, if a baseli ne v al ue is a vaila ble.  
•  
T he e ve nt ca n be attri b ute d t o a ge nts ot her t ha n t h e i n vesti gati o nal pr o d uct or t o fact ors 
u nrelate d t o st u d y c o n d u ct.  
•  
It bec o mes u nli kel y t hat a n y a d diti o nal i nf or mati o n ca n be o btai n e d ( patie nt or healt h care 
practiti o ne r r ef usal t o pr o vi de a d diti o nal i nf or mati o n, l ost t o f oll o w- u p after de m o nstrati o n 
of d ue dili ge nce wit h f oll o w- u p eff orts).  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 0  of 8 9  
C o nfi de nti al  
Seri o us a d verse e ve nts m ust be re p orte d wit hi n 2 4 h o urs t o:  
 
Seri o us A d verse E ve nt Re p orti n g  
  
P h o ne:  + 1 4 4 3- 6 9 9- 5 2 3 0 
 
Fa x:  
+ 1 8 8 8- 2 3 7- 7 4 7 5 
  
E-mail:  S A E @alla k os.c o m  
1 3. 7. 3  Pre g n a nc y Re p orti n g  
Pre g na ncies are ca pt ur e d if t he y occ ur i n fe male p atie nts or i n t he se x ual part ners of male 
patie nts fr o m t he ti me t he patie nt is first e x p ose d t o t he i n vesti g ati o nal pr o d uct t hr o u g h 
E xte nsi o n Da y 7 8 5 or 8 4 ( ± 3) da ys after last d ose of st u d y dr u g if earl y ter mi nati o n or if misse d 
d oses are b ei n g ma de u p .  
Fe male p atie nts m ust be i nstr ucte d t o disc o nti n ue all st u d y dr u gs a n d i nf or m t he I n v esti gat or 
i m me diatel y if t he y bec o me pre g na nt d uri n g t he st u d y. Male patie nts m ust be i nstr ucte d t o 
i nf or m t he I n vesti gat or i m me diatel y if t heir part n er bec o m es pre g n a nt d uri n g t he st u d y. 
T he I n vesti gat or m ust re p ort a n y pre g n a nc y t o Alla k os wit hi n 2 4 h o urs of bec o mi n g a ware of it, 
usi n g t he pr o vi de d pre g n a nc y re p orti n g f or ms. T h e patie nt m ust be i m me diatel y disc o nti n ue d 
fr o m st u d y dr u g. A n u nc o m plicate d pre g na n c y will n ot be c o nsi dere d a n a d verse e v e nt or seri o us 
a d verse e ve nt, b ut all pre g na ncies will be f oll o we d t hr o u g h ter m.  
A n y c o n ge nital a b n or m alities n ote d at birt h i n t he offs pri n g of a p atie nt w h o recei v e d st u d y dr u g 
will be re p orte d as a seri o us a d verse e ve nt. T he o utc o me of a n y pre g na n c y a n d t he pres e nce or 
a bse nce of a n y c o n ge nital a b n or malit y will be rec or de d i n t he s o urce d oc u me ntati o n a n d 
re p orte d t o t he Me di cal M o nit or a n d S p o ns or.  
1 3. 7. 4  A d verse E ve nt of S peci al I nterest R e p orti n g  
Be gi n ni n g fr o m t he ti me of first st u d y dr u g i nf usi o n a n d e n di n g at E xte nsi o n Da y 7 8 5 or 
8 4 ( ± 3) da ys after last d ose of st u d y dr u g if earl y ter mi nati o n or if misse d d oses are b ei n g ma de 
u p, a n y ne w A E SI  ( or ne w i nf or mati o n relate d t o a pre vi o usl y re p orte d A E SI ) m ust be rec or de d 
i n t he A d verse E v e nt e C R F a n d desi g nate d as a n “a d vers e e v e nt of s peci al i nterest.”  
A n A E SI  t h at als o q ualifi es as a S A E ( p er Secti o n 1 3. 2 ) m ust als o be re p ort e d as a S A E i n 
acc or d a nce wit h Secti o n  1 3. 7. 2 . A d verse e ve nts of s pecial i nterest t hat are als o S A E m ust be 
rec or d e d i n t he A d verse E ve nt e C R F a n d desi g n ate d as b ot h “seri o us” a n d as a n “a d v erse e ve nt 
of s pecial i nter est.” T hes e will be re p ort e d o n t he S p o ns or- pr o vi de d S A E f or ms a n d s h o ul d be 
re p orte d t o t he S p o ns or wit hi n 2 4 h o urs of site a ware n ess. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 1  of 8 9  
C o nfi de nti al  
1 3. 8  
Me dic al M o nit ori n g  
Dr. He nri k Ras m usse n, or a p p oi nte d desi g nee s h o ul d be c o ntacte d directl y usi n g t he p h o ne 
n u m ber a n d/ or e m ail a d dress bel o w t o re p ort me dical c o ncer ns or f or q uesti o ns re gar di n g safet y. 
 
Alla k os Me dical M o nit or 
 
 M D, P h D  
 
P h o ne: 
 
 
E mail:  
 
1 3. 9  
St u d y Wit h dr a w al Criteri a  
Patie nts will be disc o nti n ue d fr o m t he st u d y i n t he e ve nt t hat: 
•  
Occ urre nce of a n e xcl usi o n criteri o n, w hic h is cli nicall y rele va nt a n d affects t he patie nt’s 
safet y, if disc o nti n uati o n is c o nsi dere d necessar y b y t he I n v esti gat or a n d/ or S p o ns or. 
•  
Re b o u n di n g of e osi n o p hil c o u nts t o > 1 5 0 0/ µ L i n patie nts w h o e ntere d t he st u d y wit h 
e osi n o p hil le vels > 1 5 0 0/ µ L, ha d a n I R R d uri n g t he first a n d/ or sec o n d i nf usi o ns, a n d w h ose 
e osi n o p hil c o u nts were i nitiall y s u p presse d after st u d y dr u g will be wit h dra w n fr o m t he 
st u d y. 
•  
Ser u m tra nsa mi nases ( ala ni ne a mi n otra nsferase a n d/ or as partate a mi n otra nsferas e) 
> 3  × u p per li mit of n or mal ( U L N) a n d t otal bilir u bi n > 2 × U L N (c o nfir me d b y s u bse q ue nt 
re peat) wit h o ut a n alter n ati ve e x pla nati o n.  
•  
Ele vati o n of ala ni ne a mi n otra nsferase or as part ate a mi n otra nsferase > 3 × U L N (c o nfir m e d 
b y re peat) wit h t he a p peara nce or w ors e ni n g of s y m pt o ms felt b y t he I n vesti gat or t o be 
p ote ntiall y relate d t o he p atic i nfla m mati o n, s uc h as fati g ue, na usea, v o miti n g, ri g ht u p per 
q ua dra nt pai n or t e n der n ess, fe ver, a n d ras h. 
1 3. 1 0  St u d y St o p pi n g R ules  
T he st u d y ma y be disc o nti n ue d pre mat urel y i n t he e ve nt of a n y of t he f oll o wi n g: 
•  
A life -t hreate ni n g A E  t hat is p ossi bl y or pr o ba bl y relate d t o treat me nt.  
•  
A fatal A E  t hat is p ossi bl y or pr o ba bl y relate d t o treat me nt.  
•  
Ne w i nf or mati o n lea di n g t o u nfa v ora ble ris k- be nefit j u d g me nt of t he st u d y dr u g. 
•  
S p o ns or’s decisi o n t hat c o nti n uati o n of t he st u d y is u nj ustifia ble f or me dical or et hical 
reas o ns.  
•  
Disc o nti n uati o n of de vel o p me nt of t he S p o ns or’s st u d y dr u g.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 2  of 8 9  
C o nfi de nti al  
Healt h A ut h orities a n d I R Bs will be i nf or me d a b o ut t he disc o nti n uati o n of t he st u d y i n 
acc or d a nce wit h a p plica ble re g ulati o ns. T he st u d y ma y be ter mi nate d or s us pe n de d o n re q uest of 
Healt h A ut h orities or S p o ns or. 
1 4.  
Disc o nti n u ati o n a n d Re pl ace m e nt of P atie nts  
1 4. 1  
Defi niti o n of St u d y C o m pleti o n  
A patie nt w h o c o m pletes 2 6 t otal i nf usi o ns of st u d y dr u g a n d f oll o w- u p visits t hr o u g h E xte nsi o n 
Da y 7 8 5 ( ± 3) or 8 4 ( ± 3) da ys after l ast d ose or if s ki p pe d d oses are bei n g ma de u p will be 
rec or d e d as ha vi n g c o m plete d t he st u d y. 
1 4. 2  
E arl y Disc o nti n u ati o n of St u d y Dr u g  
A patie nt ma y be disc o nti n ue d fr o m st u d y treat me n t at a n y ti me if t he patie nt, t he I n v esti gat or, or 
t he S p o ns or feels t hat it is n ot i n t he patie nt’s best i nterest t o c o nti n ue. T he f oll o wi n g is a list of 
p ossi ble reas o ns f or st u d y treat me nt disc o nti n uati o n: 
•  
Patie nt wit h dra ws c o nse nt.  
•  
A d verse e ve nt t hat,  i n t he o pi ni o n of t he I n vesti gat or, res ults i n it bei n g i n t he best i nterest 
of t he patie nt t o disc o nti n ue st u d y treat me nt.  
•  
Pr ot oc ol vi olati o n re q uiri n g disc o nti n uati o n of st u d y treat me nt.  
•  
Partici pati o n i n a n y ot her trial d uri n g t he d urati o n of t his tri al.  
•  
Use of a n o n- per mitte d c o nc o mita nt dr u g, wit h o ut pri or a p pr o val fr o m t he Me dical 
M o nit or. 
•  
L oss of a bilit y t o freel y pr o vi de c o nse nt t hr o u g h i m pris o n me nt or i n v ol u ntar y i ncarcerati o n 
f or treat me nt of eit her a ps yc hiatric or p h ysical (e. g., i nfecti o us disease) ill ness.  
If a patie nt is wit h dra w n fr o m treat me nt d ue t o a n a d verse e ve nt, t he p atie nt will be f oll o we d a n d 
treate d b y t he I n vesti gat or u ntil t he a b n or mal para meter or s y m pt o m has res ol ve d or sta bilize d.  
All patie nts w h o disc o nti n ue st u d y dr u g treat me nt s h o ul d be e nc o ura ge d t o c o nti n ue o n st u d y 
a n d c o m plete ass ess me nts a n d pr oce d ures acc or di n g t o Ta ble  1, if p ossi ble.  
Reas o na ble atte m pts will be ma de b y t he I n v esti gat or t o pr o vi de reas o ns f or patie nt wit h dra w als. 
T he reas o n f or t he p atie nt’s wit h dra wal fr o m t he st u d y will be s pecifie d i n t he s o urce d o c u me nts.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 3  of 8 9  
C o nfi de nti al  
1 5.  
St atistic al Met h o ds a n d Ge ner al C o nsi der ati o ns  
T his secti o n o utli nes t he nat ure a n d rati o nale f or t he statistical met h o ds t o be use d f or t h e 
a nal ysis of t he data fr o m t he st u d y. A se parate Statistical A nal ysis Pla n will descri be d ata 
ha n dli n g a n d statistical tec h ni q ues i n f ull detail. T he Statistical A nal ysis Pla n will c o ntai n a n y 
m o dificati o ns t o t he a nal ysis pla n descri be d bel o w.  
All patie nt data will be liste d. W he n a p pr o priate, s u m mar y statistics of n u m ber of n o n -missi n g 
val ues, mea n, me dia n, st a n dar d de vi ati o n, mi ni m u m, a n d ma xi m u m will be c o m p ute d f or 
c o nti n u o us varia bles a n d s u m mar y statistics of n u m ber a n d perce nt a ge will be c o m p ute d f or 
cate g orical varia bl es. N o f or mal statistical i nfere n ces will be ma de. N o i m p utati o n will be use d 
f or missi n g data.  
1 5. 1  
S a m ple Size  
A p pr o xi matel y 6 0 patie nts will b e e nr olle d.  
1 5. 2  
D at a Sets A n al yze d 
All patie nts w h o ha ve r ecei ve d st u d y me dicati o n will be i ncl u de d i n t he Safet y p o p ulati o n f or 
safet y a n al ysis.  
1 5. 3  
De m o gr a p hic a n d B aseli ne C h ar acteristics  
T he f oll o wi n g de m o gra p hic a n d baseli ne v aria bles will be s u m marize d: 
•  
De m o gra p hics 
•  
E xte nsi o n Da y 1 pre d os e vital si g ns a n d la b orat or y tests 
1 5. 4  
P atie nt Dis p ositi o n  
T he n u m ber a n d p erce nt of patie nts w h o c o m plete or disc o nti n ue fr o m t he st u d y will be 
s u m marize d. T he reas o ns f or st u d y disc o nti n uati o n will be i ncl u de d i n t he s u m mar y. 
1 5. 5  
A n al ysis of S afet y E n d p oi nts  
A d verse E ve nts : All A E  will be c o de d usi n g t he Me dical Dicti o nar y f or R e g ulat or y Acti vities 
( Me d D R A) a n d will be classifie d b y Me d D R A s yste m or ga n class a n d preferre d t er m. Listi n gs 
will i ncl u de all A E  c ollecte d o n st u d y. T he s u m maries of A E  will be bas e d o n T E A E, defi ne d as 
a n A E  re p orte d i n t he cli nical data bas e wit h a dat e of o nset ( or w orse ni n g) o n or after t h e start 
date of t he first i ntra v e n o us i nf usi o n of t he st u d y me dicati o n.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 4  of 8 9  
C o nfi de nti al  
Patie nt i nci de nce ( N a n d %) of T E A Es will be s u m marize d as f oll o ws:  
•  
O ver vie w of T E A E t o i n cl u de 
–  N u m ber ( %) of patie nts w h o re p ort at least 1 T E A E o verall, b y se v erit y a n d 
b y relati o ns hi p 
–  N u m ber ( %) of patie nts w h o re p ort at least 1 seri o us T E A E  
–  N u m ber ( %) of patie nts w h o re p ort at least 1 T E A E l ea di n g t o treat me nt disc o nti n uati o n  
–  N u m ber ( %) of patie nts w h o re p ort at least 1 T E A E of s pecial i nterest  
•  
T E A E b y pref err e d ter m  
•  
T E A E b y s yste m or ga n class a n d preferre d ter m  
•  
T E A E b y ma xi m u m se verit y, s yste m or ga n class, a n d preferre d ter m  
•  
Dr u g -r elate d T E A E b y s yste m or ga n class a n d preferre d ter m  
•  
T E A E lea di n g t o wit h dra wal b y s yste m or ga n class a n d preferre d ter m  
•  
Seri o us T E A E b y s yste m or ga n class a n d preferre d ter m  
•  
T E A E  of s peci al i nterest b y s yste m or ga n class a n d preferre d t er m  
Cli nic al L a b or at or y Assess m e nts:  Sa m ples will be o btai ne d f or t h e cli nical la b orat or y tests 
i de ntifie d i n Secti o n 1 1. 4 , a n d la b orat or y t ests t o be s u m marize d i ncl u d e bl o o d c he mistr y, 
he mat ol o g y, uri nal ysis, a n d A D A.  
Descri pti ve statistics will be use d t o s u m marize la b orat or y res ul ts at bas eli ne, eac h visit, a n d t he 
c ha n ge fr o m baseli ne f or eac h visit. I n a d diti o n, s hift ta bles will s u m marize t he la b orat or y res ults 
relati ve t o n or mal r efere n ce ra n g es at bas eli ne a n d eac h p ost-b aseli ne ti me p oi nt.  
Vit al Si g ns:  Vital si g ns will be s u m marize d at baseli ne, eac h visit, a n d c ha n ge fr o m baseli ne at 
eac h visit.  
P h ysic al E x a mi n ati o n:  Ne w or w orse ni n g s y m pt o ms i n t he s y m pt o m-directe d p h ysical 
e xa mi nati o ns will be i ncl u de d i n t he b y- patie nt dat a listi n gs.  
C o nc o mit a nt Me dic ati o ns:  All me dicat i o ns will be c o de d usi n g t he m ost c urre nt W orl d Healt h 
Or ga nizati o n Dr u g Dicti o nar y. C o nc o mita nt me dicati o ns will be s u m marize d b y A nat o mical 
T hera p e utic C he mical Class a n d preferre d ter m.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 5  of 8 9  
C o nfi de nti al  
1 5. 6  
P h ar m ac o d y n a mic/ Effic ac y -R el ate d A n al yses  
T he c ha n g e fr o m bas eli ne  t o e n d of st u d y i n t he S F- 3 6 t otal a n d d o mai n sc ores will be 
s u m marize d descri pti vel y. C ha n ge a n d perce nt c h a n ge fr o m b aseli ne t o eac h sc he d ule d st u d y 
visit i n bl o o d e osi n o p hil c o u nt will be s u m marize d descri pti vel y. 
Data fr o m t he e P R O a n d S F - 3 6 fr o m E xte nsi o n D a y 5 6 2 t hr o u g h e n d of st u d y ma y be a nal y ze d 
acc or di n g t o a n al ysis pla ns i n de pe n de nt of t he E D C data base a n d Statistical A nal ysis Pla n f or 
A K 0 0 2 - 0 0 3 X. 
1 5. 7  
P atie nt C o nfi de nti alit y  
Patie nt i de ntit y s h o ul d be c o nfir me d b y t he prese nt ati o n of a p h ot o i de ntificati o n t o e ns ure t he 
c orrect i n di vi d ual is c o nse nte d, scr ee ne d, a n d e nr olle d (if eli gi ble).  
O nl y t he PI D, p atie nt i nitials, a n d de m o gra p hics will be rec or d e d i n t he e C R F. If t he p atie nt 
na me a p pears o n a n y s o urce d oc u m e nt c ollecte d (e. g., h os pital disc har ge s u m mar y), it m ust be 
re m o ve d fr o m t he d o c u m e nt if t he d oc u me nt will be vie we d b y t he S p o ns or or a S p o ns or-
c o ntracte d st u d y v e n d or n ot per mitte d access t o patie nt i de ntif yi n g i nf or mati o n. All st u d y 
fi n di n gs will be st ore d i n electr o nic d ata bases. T h e patie nts will gi ve e x plicit writte n per missi o n 
f or re prese ntati ves of t he S p o ns or, re g ulat or y a ut h orities, a n d t he I R B t o i ns pect t heir me dical 
rec or ds t o verif y t he i nf or mati o n c ollecte d. Patie nts will be i nf or me d t hat all pers o nal 
i nf or mati o n ma de a v aila ble f or i ns pecti o n will be ke pt c o nfi de ntial t o t he e xte nt per mitte d b y all 
a p plica ble state, l ocal, a n d fe der al data pr ot ecti o n/ pri vac y la ws a n d/ or re g ul ati o ns a n d will n ot be 
ma de p u blicl y a vaila ble. If t he res ults of t he tri al are p u blis he d, t he patie nt’s i de ntit y will re mai n 
c o nfi de ntial.  
At st u d y c hec k-i n t o t he st u d y site, patie nts will be a d vise d n ot t o s hare t h eir st u d y i nf or mati o n 
wit h ot her patie nts.  
1 6.  
D at a C ollecti o n, Rete nti o n, a n d M o nit ori n g  
1 6. 1  
D at a C ollecti o n I nstr u m e nts  
All staff at partici p ati n g cli nical sites will a d here t o g o o d d oc u me ntati o n practices. D ata will be 
e ntere d i nt o e C R Fs usi n g s o urce d oc u m e nt data. S o urce d oc u m e nts ma y i ncl u de b ut are n ot 
li mite d t o la b orat or y data, rec or d e d data fr o m a ut o mate d i nstr u me nts, me dical pr o gress n otes, 
a n d e mail c orres p o n de n ce.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 6  of 8 9  
C o nfi de nti al  
1 6. 2  
D at a M a n a ge m e nt Pr oce d ures  
T he data will be e nt ere d i nt o a vali date d data b ase. T he data ma n a ge me nt gr o u p will be 
res p o nsi ble f or d ata pr ocessi n g, i n acc or d a nce wit h pr oce d ural d oc u me ntati o n. Data base l oc k 
will occ ur o nce q u alit y ass ura nce pr oce d ures ha v e bee n c o m plete d.  
All pr oce d ures f or t he h a n dli n g a n d a nal ysis of data will be c o n d ucte d usi n g g o o d c o m p uti n g 
practices m eeti n g F D A g ui deli nes f or t he ha n dli n g a n d a nal ysis of data f or cli nical trials.  
1 6. 3  
D at a Q u alit y C o ntr ol a n d Re p orti n g  
After dat a ha ve b ee n e ntere d i nt o t he st u d y data bas e, a s yste m of c o m p uterize d data v ali dati o n 
c hec ks will be i m ple me nte d a n d a p plie d t o t he dat a base o n a re g ular basis. Q ueries are e nt ere d, 
trac ke d, a n d res ol ve d t hr o u g h t he electr o nic d ata ca pt ure s yste m directl y. T he st u d y data base will 
be u p date d i n acc or d a nce wit h t he res ol ve d q ueri es. All c ha n ges t o t he st u d y data base will be 
d oc u me nte d.  
1 6. 4  
D at a b ase L oc k 
T he data bas e will be l oc k e d i n or der t o pr otect write access after t he f oll o wi n g prec o n diti o ns are 
f ulfille d: 
•  
All rec or ds are e ntere d i n  t he data base a n d all data q ueries are res ol ve d. 
•  
All A E  are c o de d t o t he s atisfacti o n of t he C hief Me dical Offi cer.  
•  
All me dicati o ns are c o de d t o t he satisfacti o n of t h e C hief Me dical Officer.  
•  
All decisi o ns are ma d e re gar di n g all pr ot oc ol vi olati o ns. 
•  
Writt e n a ut h orizati o ns t o l oc k t he data bas e are o bt ai ne d fr o m Alla k os Cli nical Data 
Ma na ge me nt a n d t h e C hief Me dical Officer.  
1 6. 5  
Arc hi vi n g of D at a 
T he data bas e is safe g u ar de d a gai nst u na ut h orize d access b y esta blis he d sec urit y pr oce d ures; 
a p pr o priate b ac k u p c o pie s of t he data bas e a n d relate d s oft ware files will be mai ntai ne d. 
Data bases are b ac k e d u p b y t he data base a d mi nistrat or i n c o nj u ncti o n wit h a n y u p dates or 
c ha n ges t o t he dat a base.  
At critical j u nct ures of t he pr ot oc ol (e. g., pr o d ucti o n of i nteri m re p orts a n d fi nal re p orts), d ata f or 
a nal ysis is l oc ke d a n d clea ne d per esta blis he d pr o ce d ures.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 7  of 8 9  
C o nfi de nti al  
1 6. 6  
A v ail a bilit y a n d Rete nti o n of I n vesti g ati o n al Rec or ds 
I n acc or da n ce wit h 2 1 C F R 3 1 2. 6 2(c), G C P, a n d all ot her a p plica ble re g ul at or y re q uire me nts, 
f oll o wi n g c o m pleti o n or ter mi nati o n of t he st u d y, t he S p o ns or or its desi g nee will retai n a c o p y 
of all st u d y rec or ds i n a li mite d -access st ora ge r o o m f or a mi ni m u m of 2 years after n otificati o n 
t hat t he i n vesti gati o ns ha ve bee n disc o nti n ue d a n d t he F D A h as bee n n otifi e d, or f or 2 y ears after 
all mar keti n g a p plicati o ns ha ve bee n a p pr o v e d. T he trial master file will be create d d uri n g t he 
i m ple me ntati o n p hase of a st u d y, mai ntai ne d o n a n o n g oi n g basis t hr o u g h o ut t he d urati o n of t he 
pr oject, a n d c ollat e d at t h e e n d of t he st u d y. T h e files will c o ntai n f ol ders t h at ma y i ncl u de b ut 
are n ot li mite d t o t he f oll o wi n g s u bcate g ories: 
•  
Fi na ncial a gree me nts  
•  
Re g ulat or y d oc u me nts 
•  
I R B D oc u m e nts 
•  
Dr u g Acc o u nta bilit y 
•  
C orres p o n de nce 
•  
Me dical Re p orts  
•  
Patie nt Data  
•  
M o nit ori n g Visit Re p orts 
•  
Sa m ple case r e p ort f or ms a n d Case Re p ort F or m G ui deli nes 
1 6. 7  
M o nit ori n g  
M o nit ori n g visits will be c o n d ucte d b y re pres e ntati ves of t he S p o ns or acc or di n g t o 2 1 C F R Parts 
5 0, 5 6, a n d 3 1 2 a n d I C H G C P G ui deli ne E 6. B y si g ni n g t his pr ot oc ol, t he I n vesti gat or gra nts 
per missi o n t o t he S p o ns or ( or desi g nee), a n d a p pr o priate re g ul at or y a ut h orities t o c o n d uct o n- site 
m o nit ori n g a n d/ or a u diti n g of all a p pr o priat e st u d y d oc u me ntati o n. As necessitate d b y t he 
C O VI D - 1 9 pa n d e mic, m o nit ori n g of all a p pr o priate st u d y d oc u me ntati o n ma y occ ur off-site, 
wit h re m ote access t o st u d y d oc u me nts.  
1 7.  
A d mi ni str ati ve, Et hic al, a n d Re g ul at or y C o nsi der ati o ns 
T he st u d y will be c o n d ucte d i n a ma n ner c o nsiste nt wit h t he Declarati o n of Helsi n ki, Pr otecti o n 
of H u ma n V ol u nteers ( 2 1 C F R 5 0), I R B ( 2 1 C F R 5 6 a n d I C H E 6), a n d O bli gati o ns of Cli nical 
I n v esti gat ors ( 2 1 C F R 3 1 2 a n d I C H E 6). T h e I n vesti gat or m ust als o c o m pl y wit h all a p plica ble 
pri vac y r e g ulati o ns (e. g., t he Healt h I ns ura nce P ort a bilit y a n d Acc o u nta bilit y Act [ HI P A A], 
E ur o pea n U ni o n D ata Pr otecti o n Directi ve 9 5/ 4 6/ E C).  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 8  of 8 9  
C o nfi de nti al  
1 7. 1  
Pr ot oc ol A m e n d m e nts  
A n a me n d me nt m ust be a gree d t o i n writi n g b y Alla k os, I nc. a n d s u b mitte d t o t he healt h 
a ut h orit y as a Cli nical Trial A p plicati o n/I n v esti gati o nal Ne w Dr u g a me n d m e nt. Pr ot oc ol 
a me n d me nts ca n n ot be i m ple me nte d wit h o ut pri or writte n I R B a p pr o val e xce pt as necessar y t o 
eli mi nate i m me diate safet y hazar ds t o patie nts. Writte n a p pr o val of a pr ot o c ol a me n d me nt is n ot 
re q uire d pri or t o i m ple me ntati o n of c ha n g es t o t he pr ot oc ol t hat eli mi nate i m me diate hazar d t o 
t he patie nt; h o we ver, a p pr o val m ust be o btai ne d as s o o n as p ossi ble t hereafter. A n y pr ot oc ol 
a me n d me nts m ust als o be si g ne d b y t he I n vesti gat or.  
1 7. 2  
I nstit uti o n al Re vie w B o ar d  
T he pr ot oc ol a n d i nf or me d c o nse nt f or m (I C F) will be re vie we d a n d a p pr o ve d b y t he I R B of 
eac h p artici pati n g ce nt er pri or t o st u d y i nitiati o n. All S A E , re gar dless of ca usalit y, will be 
re p orte d t o t he I R B i n acc or da nce wit h t he sta n dar d o perati n g pr o ce d ures a n d p olicies of t he 
I R B, a n d t he I n vesti gat or will kee p t he I R B i nf or me d as t o t he pr o gress of t he st u d y. T he 
I n v esti gat or will o btai n ass ura nce of I R B c o m plia nce wit h re g ulati o ns.  
A n y d oc u me nts t hat t he I R B ma y nee d t o f ulfill its res p o nsi bilities (s uc h as pr ot oc ol, pr ot oc ol 
a me n d me nts, I n vesti gat or’s Br oc h ur e, I C F, i nf or mati o n c o ncer ni n g patie nt recr uit me nt, pa y me nt 
or c o m pe nsati o n pr oce d ures, or ot her p er ti ne nt i nf or mati o n) will be s u b mitte d t o t he I R B. T he 
I R B’s writte n u n c o n diti o nal a p pr o val of t h e st u d y pr ot oc ol a n d t he I C F will be i n t he p ossessi o n 
of t he I n vesti gat or b ef or e t he st u d y is i nitiate d. T he I R B’s a p pr o val of t he I n vesti gati o nal site 
m ust be a vaila ble t o Alla k os pri or t o t he s hi p me nt of st u d y s u p plies t o t he site. T his a p pr o val 
m ust refer t o t he st u d y b y e xact pr ot oc ol title a n d n u m ber a n d s h o ul d i de ntif y t he d oc u me nts 
re vie we d a n d t he dat e of re vie w.  
T he I R B m ust be i nf or me d of re visi o ns t o ot her d oc u me nts ori gi nall y s u b mitte d f or re vie w; 
seri o us a n d/ or u ne x p ecte d a d verse e x peri e nces o cc urri n g d uri n g t he st u d y i n acc or d a nce wit h t he 
sta n dar d o per ati n g pr oce d ures a n d p olicies of t h e I R B; ne w i nf or mati o n t hat ma y affect 
a d versel y t he s afet y of t h e patie nts of t he c o n d u ct of t he st u d y; a n a n n ual u p date a n d/ or re q uest 
f or re-a p pr o v al; a n d w he n t he st u d y has bee n c o m plete d.  
1 7. 3  
I nf or m e d C o nse nt F or m 
Pri or t o st u d y e nr oll me nt, all patie nts m ust c o nse nt t o partici pate. T he pr o cess of o btai ni n g t he 
i nf or me d c o nse nt will c o m pl y wit h all fe deral re g ulati o ns, I C H re q uire me nts, a n d l ocal la ws.  
T he I n vesti gat or or d esi g nee will re vie w t h e st u d y a n d t he I C F wit h eac h p ote ntial patie nt. T he 
re vie w will i ncl u de t he n at ure, sc o p e, pr oce d ures, a n d p ossi ble c o nse q ue n ces of partici pati o n i n 
t he st u d y. T he c o nse nt a n d re vie w m ust be i n a f or m u n dersta n da ble t o t he p ote ntial patie nt. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 6 9  of 8 9  
C o nfi de nti al  
T he I n vesti gat or or d esi g nee a n d t he p atie nt m ust b ot h si g n a n d date t he I C F after re vi e w a n d 
bef ore t h e patie nt ca n partici pate i n t he st u d y. T he patie nt will recei ve a c o p y of t he si g ne d a n d 
d ate d f or m, a n d t h e ori gi nal will be retai ne d i n t he site’s st u d y files.  
T he I n vesti gat or or d esi g nee m ust e m p hasize t o t h e patie nt t hat st u d y partici pati o n is e ntirel y 
v ol u ntar y a n d t hat c o nse nt re gar di n g st u d y partici pati o n ma y be wit h dra w n at a n y ti me wit h o ut 
pe nalt y or l oss of be nefits t o w hic h t he patie nt is ot her wise e ntitle d.  
1 7. 4  
P u blic ati o ns  
T he pre p arati o n a n d s u b mittal f or p u blicati o n of ma n uscri pts c o ntai ni n g t he st u d y res ults s hall be 
i n acc or d a nce wit h a pr o cess deter mi ne d b y m ut u al writte n a gree me nt a m o n g t he st u d y S p o ns or 
a n d res pecti ve site. T he p u blicati o n or prese ntati o n of a n y st u d y res ults s hall c o m pl y wit h all 
a p plica ble pri vac y la ws i ncl u di n g b ut n ot li mite d t o t he HI P A A of 1 9 9 6.  
1 7. 5  
Cli nic al Tri al Re gistr ati o n  
T his cli nical trial is re gistere d o n t he Cli nical Trial Re gistr y We bsite, w w w. Cli nical Trials. g o v 
u n der N C T  # 0 3 6 6 4 9 6 0. 
1 7. 6  
P a y m e nt t o P atie nts  
All patie nts ma y be c o m pe nsate d f or p artici pati n g i n t his st u d y, i n acc or da nce wit h t he pa y me nt 
a m o u nts per st u d y da y state d i n t he patie nt’s si g ne d I C F a p pr o v e d b y t he I R B. If t he p atie nt is 
disc o nti n ue d fr o m t he st u d y pri or t o t he last st u d y visit, t he patie nt will be c o m pe nsate d f or eac h 
c o m plete d st u d y visit o n a pr o rat a basis, as state d i n t he patie nt’s I C F. N o c o m pe nsati o n be y o n d 
w hat is state d i n t he I C F is per mitte d.  
1 7. 7  
I n vesti g at or Res p o nsi bilities  
B y si g ni n g t he A gree me nt of I n v esti gat or f or m, t he I n vesti gat or a grees t o:  
1)  
C o n d uct t he st u d y i n acc or da nce wit h t he pr ot oc ol a n d o nl y ma ke c ha n g es after n otif yi n g 
t he S p o ns or ( or desi g nee), e xce pt w h e n t o pr otect t he safet y, ri g hts, or w elfare of p atie nts.  
2)  
Pers o nall y c o n d uct or s u per vise t he st u d y. 
3)  
E ns ure t hat t he r e q uire m e nts relati n g t o o btai ni n g i nf or me d c o nse nt a n d I R B re vie w a n d 
a p pr o val meet fe deral g ui deli nes.  
4)  
Re p ort t o t he S p o ns or or desi g nee a n y A E  t hat occ ur i n t he c o urse of t he st u d y, i n 
acc or d a nce wit h 2 1 C F R Part 3 1 2. 6 4 a n d I C H G ui deli ne E 2 A.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 0  of 8 9  
C o nfi de nti al  
5)  
E ns ure t hat all ass ociat es, c ollea g ues a n d e m pl o yees assisti n g i n t he c o n d uct of t he st u d y 
are i nf or m e d a b o ut t heir o bli gati o ns i n meeti n g t he a b o ve c o m mit me nts.  
6) 
Mai ntai n a de q uate a n d acc urat e rec or ds i n acc or d a nce wit h 2 1 C F R Part  3 1 2. 6 2 a n d I C H 
G ui deli ne E 6 a n d t o ma k e t h ose rec or ds a v aila ble f or i ns pecti o n wit h t he S p o ns or ( or 
desi g nee).  
7)  
E ns ure t hat a n I R B t hat c o m plies wit h t he re q uire me nts of 2 1 C F R Part 5 6 a n d I C H 
G ui deli ne E 6 will be res p o nsi ble f or i nitial a n d c o nti n ui n g re vie w a n d a p pr o val of t he 
cli nical st u d y.  
8)  
Pr o m ptl y re p ort t o t he I R B a n d t he S p o ns or ( or desi g nee) all c h a n ges i n t he researc h 
acti vit y a n d all u na ntici pate d pr o ble ms i n v ol vi n g ris ks t o patie nts or ot hers (t o i ncl u de 
a me n d me nts a n d I n v esti gati o nal Ne w Dr u g safet y re p orts).  
9)  
See k I R B a p pr o val bef or e a n y c h a n ges are ma d e i n t he researc h st u d y, e x ce pt w he n 
necessar y t o eli mi nate hazar ds t o t he patie nts.  
1 0)  C o m pl y wit h all ot her re q uire me nts re gar di n g t he o bli gati o ns of cli nical I n vesti gat ors a n d 
all ot her perti ne nt r e q uire me nts liste d i n 2 1 C F R Part 3 1 2.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 1  of 8 9  
C o nfi de nti al  
1 8.  
Refere nces  
Al h m o u d T, Ha ns o n J A, Paras her G. E osi n o p hilic gastr oe nteritis: a n u n der dia g n ose d c o n diti o n. 
Di g Dis Sci, 2 0 1 6; 6 1( 9): 2 5 8 5 – 9 2. 
Be dell A, Taft T, Cra v e n M, G ua da g n oli L, Hira n o I, G o nsal ves N. I m p act o n healt h -rel ate d 
q ualit y of life i n a d ults wit h e osi n o p hilic gastritis a n d gastr oe nteritis: A q ualitati ve 
assess me nt. Di g Dis Sci, 2 0 1 8; 6 3: 1 1 4 8 – 5 7. 
B oc h ner B. Si glec- 8 o n h u ma n e osi n o p hils a n d mast cells, a n d Si glec- F o n m uri ne e osi n o p hils, 
are f u n cti o nall y relate d i n hi bit or y rece pt ors. Cli n E x p Aller g y, 2 0 0 9; 3 9( 3): 3 1 7- 2 4. 
Cal d well J, C olli ns M, St uc ke E, et al. Hist ol o gic e osi n o p hilic gastritis is a s yste mic dis or der 
ass ociate d wit h bl o o d a n d e xtra gastric e osi n o p hilia, T H 2 i m m u nit y, a n d a u ni q ue gastr ic 
tra nscri pt o me. J Aller g y Cli n I m m u n ol, 2 0 1 4; 1 3 4( 5): 1 1 1 4- 2 4. 
Dell o n E, Peters o n K, M urra y J, Fal k G, G o nsal v es N, C he ha de M, et al. A nti- Si glec - 8 a nti b o d y 
f or e osi n o p hilic gastritis a n d d u o de nitis. N E n gl J Me d, 2 0 2 0; 3 8 3: 1 6 2 4 – 3 4. 
Je nse n E, Marti n C, Ka p pel ma n M, Dell o n E. Pre vale nce of e osi n o p hilic g astritis, gastr oe nteritis, 
a n d c olitis: esti mates fr o m a nati o nal a d mi nistrati ve data bas e. J Pe diatr Gastr oe nter ol 
N utr, 2 0 1 6; 6 2( 1): 3 6- 4 2. 
Katz P, Gers o n L, Vela M F. G ui deli nes f or t h e dia g n osis a n d ma na ge m e nt of gastr oes o p ha g eal 
refl u x diseas e. A m J Gastr oe nter ol, 2 0 1 3; 1 0 8( 3): 3 0 8- 2 8. 
L ó pez- Me di n a G, G all o M, Pra d o A, Vic u ña- H o n orat o I, Castill o Díaz de Le ó n R. E osi n o p hilic 
gastr oe nteritis: case re p ort a n d re vie w i n searc h f or dia g n ostic ke y p oi nts. Case Re p 
Gastr oi ntest Me d, 2 0 1 5; 2 0 1 5: 1 – 5. 
Ma ns o or E, Sale h M, C o o per G. Pre v ale nce of e osi n o p hilic gastr oe nteritis a n d c olitis i n a 
p o p ulati o n- base d st u d y, fr o m 2 0 1 2- 2 0 1 7. Cli n Gastr oe nter ol He p at ol, 
2 0 1 7; 1 5( 1 1): 1 7 3 3- 1 7 4 1. 
Peters o n K, B yr ne K, Vi ns o n L, et al. Ele me ntal diet i n d uces hist ol o gic res p o nse i n e osi n o p hilic 
es o p ha gitis. A m J Gastr o e nter ol, 2 0 1 3; 1 0 8: 7 5 9 – 6 6. 
Pr ussi n C. E osi n o p hilic gastr oe nteritis a n d relate d e osi n o p hilic dis or ders. G astr oe nter ol Cli n 
N ort h A m, 2 0 1 4; 4 3( 2): 3 1 7- 2 7. 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 2  of 8 9  
C o nfi de nti al  
Ree d C, W o osle y J, Dell o n E. Cli nical c haracteristics, treat me nt o utc o mes a n d res o urce 
utilizati o n i n c hil dre n a n d a d ults wit h e osi n o p hilic gastr oe nteritis. Di g Li ver Dis, 
2 0 1 5; 4 7( 3): 1 9 7- 2 0 1. 
Sa m ps o n H, M u ñ oz- F url o n g A, Ca m p bell R, 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 of 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 n a 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- 7. 
Wec hsler J, Sc h wart z S, A ms de n K, Ka g al walla A. Eli mi nati o n diets i n t he ma na ge m e nt of 
e osi n o p hilic es o p ha gitis. J Ast h ma Aller g y, 2 0 1 4; 7: 8 5 – 9 4. 
Z ha n g M, Li Y. E osi n o p hilic gastr oe nteritis: a state- of-t he- art re vie w. J G astr oe nter ol He p at ol, 
2 0 1 7; 3 2( 1): 6 4- 7 2.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 3  of 8 9  
C o nfi de nti al  
1 9.  A p pe n dices  
1 9. 1 
S F - 3 6 Healt h S ur ve y 
1 9. 2  
P R O Q uesti o n naire  
1 9. 3  
C o m m o n Ter mi n ol o g y Criteria f or A d vers e E ve nts Versi o n 5. 0   
1 9. 4  
Sa m ps o n’s Criteria of A na p h yla xis  
1 9. 5  
A d diti o nal  Q uesti o ns f or At o pic C o n diti o ns 
1 9. 6 
Patie nt  Gl o bal I m pr essi o n of C ha n ge Q uesti o n naire 
1 9. 7  
D ys p ha gia S y m pt o m Q uesti o n naire  
1 9. 8  
E G D Hist ol o g y I nstr u cti o ns  
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 4  of 8 9  
C o nfi de nti al  
1 9. 1  
S F - 3 6 He alt h S ur ve y 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 5  of 8 9  
C o nfi de nti al  
1 9. 1 S F - 3 6 He alt h S ur ve y c o nt. 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 6  of 8 9  
C o nfi de nti al  
1 9. 1 S F - 3 6 He alt h S ur ve y c o nt. 
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 7  of 8 9  
C o nfi de nti al  
1 9. 1 S F - 3 6 He alt h S ur ve y c o nt. 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 8  of 8 9  
C o nfi de nti al  
1 9. 1 S F - 3 6 He alt h S ur ve y c o nt. 
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 7 9  of 8 9  
C o nfi de nti al  
1 9. 1 S F - 3 6 He alt h S ur ve y c o nt. 
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 0  of 8 9  
C o nfi de nti al  
1 9. 2  
P R O Q uesti o n n aire  
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 1  of 8 9  
C o nfi de nti al  
1 9. 2 P R O Q uesti o n n aire c o nt.  
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 2  of 8 9  
C o nfi de nti al  
1 9. 2 P R O Q uesti o n n aire c o nt.  
 
© 2 0 0 0, t h e R o m e F o u n d ati o n, I n c.  
F or a n y i nf or m ati o n o n t h e u s e of t h e B S F S, pl e a s e c o nt a ct M a pi R e s e ar c h Tr u st, L y o n, Fr a n c e. I nt er n et: htt p s:// e pr o vi d e. m a pi -tr u st. or g 
 
 




Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 4  of 8 9  
C o nfi de nti al  
1 9. 4  
S a m ps o n’s Criteri a of A n a p h yl a xis 
A N A P H Y L A XI S : Sa m ps o n’s defi niti o n of a na p h yla xis (cli nical defi niti o n) is t he ac ute o nset of 
ill ness ( mi n utes t o se veral h o urs) w hic h i n v ol ves S KI N, M U C O S A L TI S S U E , or B O T 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) wit h 1 O R m ore of t he 
f oll o wi n g (Sa m ps o n, 2 0 0 6 ): 
•  
R E S PI R A T O R Y:  Air w a y c o m pr o mise (e. g., d ys p nea, w heeze, or br o n c h os pas m, stri d or, 
re d uce d P E F, h y p o xe mia) 
•  
CI R C U L A T O R Y:  Re d uce d bl o o d press ure 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, s y nc o pe) 
O R  
2 or M O R E of t he f oll o wi n g t h at occ ur r a pi dly after e x p os ure: 
•  
S KI N, M U C O S A L TI S S U E:  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 
•  
R E S PI R A T O R Y:  Air w a y c o m pr o mise (e. g., d ys p nea, w heeze, or br o n c h os pas m, stri d or 
a n d re d uce d P E F) 
•  
CI R C U L A T O R Y:  Re d uce d bl o o d press ure 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, s y nc o pe) 
•  
G A S T R OI N T E S TI N A L:  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, na usea, diarr hea) 
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 5  of 8 9  
C o nfi de nti al  
1 9. 5  
A d diti o n al Q uesti o ns f or At o pic C o n diti o ns  
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 6  of 8 9  
C o nfi de nti al  
1 9. 6  
P atie nt Gl o b al I m pressi o n of C h a n ge Q uesti o n n aire 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 7  of 8 9  
C o nfi de nti al  
1 9. 7  
D ys p h a gi a S y m pt o m Q uesti o n n aire  
A K 0 0 2 -0 0 3 X  
D ys p h a gi a S y m pt o m Q u esti o n n air e ( v ersi o n 4. 0)  
a n d sc or e f or e ac h r es p o ns e o pti o n  
 
 


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 8  of 8 9  
C o nfi de nti al  
1 9. 8  
E G D Hist ol o g y I nstr ucti o ns 
See Ce ntral Hist ol o g y Ma n ual f or d etails a b o ut c ollecti n g, la beli n g, a n d s hi p pi n g s peci me ns. 
St ai ni n g  
T he perf or ma nce of t he e val uati o ns liste d bel o w will re q uire t he f oll o wi n g stai ns f or eac h bi o ps y 
set: 
•  
Es o p ha g us: 
1) H & E; 2) tr y ptase; 3) tric hr o me  
•  
St o mac h:   
1) H. p yl ori i m m u n ostai n; 2) H & E; 3) tr y ptase; 4) tric hr o me 
•  
D u o de n u m: 
1) H & E; 2) tr y ptase; 3) tric hr o me  
Bi o psies will be o bt ai ne d fr o m t he f oll o wi n g:  
•  
Es o p ha g us ( o nl y if s u bject has c o nc o mita nt E o E)  
–  A set of 2 fr a g me nts fr o m t he distal es o p ha g us. 
–  A set of 2 fr a g me nts fr o m t he mi d - pr o xi mal es o p ha g us.  
–  U p t o 2 e xtra s peci me ns ma y be c ollecte d if t here are a n y a d diti o nal areas of i nterest.  
•  
St o mac h  
–  A set of 4 s peci me ns fr o m se parate areas of t he g astric a ntr u m ( 2 – 5 c m pr o xi mal t o t he 
p yl or us). 
–  A set of 4 s peci me ns fr o m se parate areas of t he g astric c or p us ( 2 fr o m t he pr o xi mal 
lesser c ur v at ure a n d 2 fr o m t he greater c ur v at ure). 
–  U p t o 2 e xtra s peci me ns ma y be c ollecte d if t here are a n y a d diti o nal areas of i nterest.  
 
D u o de n u m  
–  4 fra g me nts of d u o d e nal m uc osa fr o m t he sec o n d a n d t hir d part of t he d u o d e n u m.  
–  U p t o 2 e xtra s peci me ns ma y be c ollecte d if t here are a n y a d diti o nal areas of i nterest.  
N ote:   A n y st ore d tiss ue fr o m bi o psies of t he es o p ha g us, st o mac h, or d u o de n u m m a y be use d f or 
e x pl orat or y a n al ysis. 
T he f oll o wi n g will be re p orte d f or es o p h a ge al bi o psies: 
•  
Ma xi m u m n u m ber of e osi n o p hils per h pf.  
•  
Ma xi m u m n u m ber of tr y ptase- p ositi ve mast cells per h pf.  


Pr ot oc ol A K 0 0 2 -0 0 3 X  
A me n d me nt 7  
Date: 0 3 Mar 2 0 2 1  
Alla k os I nc.  
Pa ge 8 9  of 8 9  
C o nfi de nti al  
I n a d diti o n, t he f oll o wi n g hist o pat h ol o gic para met ers will be gra d e d fr o m 0 (a bse nt) t o 3 
( mar ke d or s e ver e): 
1 9. 8  
E G D Hist ol o g y I nstr ucti o ns c o nt. 
•  
e osi n o p hilic micr oa bscesses  
•  
e osi n o p hilic de gra n ulati o n 
•  
basal z o ne h y p er plasia  
•  
s p o n gi osis 
•  
s u be pit helial tiss ue prese nt ( Y/ N) 
•  
l a mi n a pr o pri a fi br osis ( gra de o nl y if s u be pit helial tiss ue is prese nt)  
T he f oll o wi n g will be re p orte d f or g astric bi o psies:  
•  
C o nfir mati o n of a bse nce of H . pyl ori. A hi g hl y se nsiti ve m o n ocl o nal i m m u n o hist oc he mical 
stai n will be use d. If ne g ati ve, t he n t he patie nt ca n be i ncl u de d i n t he st u d y, a n d t he 
f oll o wi n g hist o pat h ol o gic para m eters will be gra d e d usi n g t he S y d ne y S yste m fr o m 
0 (a bse nt) t o 3 ( mar ke d or se ver e) f or all e xce pt e osi n o p hil c o u nts. 
–  Ma xi m u m n u m ber of e osi n o p hils per h pf  
–  Ma xi m u m n u m ber of tr y ptase- p ositi ve mast cells per h pf  
–  Acti ve i nfla m mati o n  
–  C hr o nic i nfla m mati o n  
–  I ntesti nal met a plasia 
–  Atr o p h y 
–  Reacti ve gastr o p at h y  
T he f oll o wi n g will be re p orte d f or d u o de n al bi o psies:  
•  
Ma xi m u m n u m ber of e osi n o p hils per h pf  
•  
Ma xi m u m n u m ber of tr y ptase- p ositi ve mast cells per h pf  
•  
D u o de nal i ntrae pit helial l y m p h oc yt osis ( wit h c o u nts per 1 0 0 e nter o c ytes w h e n c o u nt 
is > 2 0) 
•  
Vill o us arc hitect ure