A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Lirentelimab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatments
Phase: PHASE2
Conditions: Atopic Dermatitis
Sponsor: Allakos Inc.

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and 
Safety of Subcutaneous Lirentelimab in Adult Subjects with Moderate-to-Severe Atopic 
Dermatitis Inadequately Controlled by Topical Treatments 
NCT Number: NCT05155085 
Document Date: 08 September 2023 
IRB Approval Date: 12 September 2023 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 3 of 1 3 5 
C o nfi d e 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 rea d t h e pr ot oc ol s pecifie d bel o w. I n m y f or mal ca p acit y as Pri nci pal I n v esti g at 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 s u bjects 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 m el y i nf or mati o n, as o utli ne d i n t he pr ot o c 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 gree t o mai ntai n t he pr oce d ures re q uir e 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, t he Declarati o n of H elsi n ki 
i n t h e a p plica ble versi o n, a n d t h e a p plica bl e le gal a n d re g ulat or y re q uir e me nts, as well as t o 
a bi de b y t he t er ms of t his pr ot oc ol. 
Pr ot oc ol N u m b er:
A K 0 0 2- 0 1 8 
I N D N u m ber: 
1 5 7 5 6 6 
N C T N u m ber:   
N C T 0 5 1 5 5 0 8 5
E u d r a C T N u m ber:   
2 0 2 2- 0 0 1 6 2 5- 7 9 
Pr ot oc ol Title:  
A P h ase 2 Ra n d o mize d, D o u ble- Bli n d, Place b o- C o ntr olle d 
St u d y t o E val u ate t he Efficac y a n d Safet y of S u bc uta ne o us 
Lire nteli ma b i n A d ult S u bjects wit h M o derate-t o- Se vere At o pic 
Der m atitis I n a de q u atel y C o ntr olle d b y T o pical Treat m e nts 
Pr ot oc ol A me n d m e nt 6:  
0 8 Se pte m ber 2 0 2 3 
 
 
 
I n v esti g at or Pri nte d N a me: 
 
 
I n v esti g at or Si g n at ure:
D ate: 
 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 4 of 1 3 5 
C o nfi d e nti al  
Ta bl e of C o nt e nts 
Cli ni c al Res e arc h Pr ot o c ol A K 0 0 2- 0 1 8 ........................................................................................ 1
I n v esti g at or Pr ot oc ol A gree me nt.................................................................................................. 3
T a bl e of C o nte nts ........................................................................................................................... 4
List of Ta bles ......................................................................................................................... 1 1
List of Fi g ure ......................................................................................................................... 1 1
List of A b bre vi ati o ns ............................................................................................................. 1 2
1.
Pr ot oc ol S y n o psis ................................................................................................................. 1 6
2.
B a c k g r o u n d .......................................................................................................................... 3 1
2. 1  
Si glec- 8 a n d Lire nteli ma b ........................................................................................... 3 1
2. 2  
O ver vie w of N o ncli nical St u dies ................................................................................ 3 1
2. 3  
O ver vie w of Cli nical St u dies ...................................................................................... 3 3
2. 4  
At o pic Der matitis a n d Rati o nale f or t he St u d y ........................................................... 3 4
3.
R ati o n ale f or D os e Sel ecti o n ............................................................................................... 3 6
4.
St u d y O bjecti v es a n d E n d p oi nts ........................................................................................ 3 7
4. 1  
Pri mar y O bjecti ve a n d E n d p oi nt ................................................................................ 3 7
4. 2
Sec o n dar y O bj ecti v es a n d E n d p oi nts ......................................................................... 3 7
4. 3
E x pl orat or y O bjecti v es a n d E n d p oi nts ....................................................................... 3 7
4. 4  
Safet y O bjecti ves ........................................................................................................ 3 8
5.
St u d y Desi g n ......................................................................................................................... 3 9
5. 1  
St u d y O ver vie w .......................................................................................................... 3 9
5. 2  
Sc he d ule of E ve nts a n d St u d y Dia gra m ..................................................................... 4 1
6.
Esti m a n d C o nsi der ati o ns .................................................................................................... 4 7
7.
Criteri a f or E v al u ati o n ........................................................................................................ 4 8
7. 1  
Safet y E n d p oi nts ......................................................................................................... 4 8

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 of 1 3 5 
C o nfi d e nti al  
7. 2
P h ar mac o ki netic E n d p oi nts ........................................................................................ 4 8
7. 2. 1 
Pri mar y Efficac y E n d p oi nts ......................................................................... 4 8
7. 2. 2 
S ec o n dar y Efficac y E n d p oi nts ..................................................................... 4 9
7. 2. 3 
E x pl orat or y Effi cac y E n d p oi nts ................................................................... 4 9
8.
S u bject Selecti o n .................................................................................................................. 5 0
8. 1  
N u m ber of S u bjects .................................................................................................... 5 0
8. 2  
N u m ber of Sit es .......................................................................................................... 5 0
8. 3  
St u d y P o p ulati o n ......................................................................................................... 5 0
8. 4  
I n cl usi o n Criteria ........................................................................................................ 5 0
8. 5  
E xcl usi o n Criteria ....................................................................................................... 5 2
8. 6  
Safet y E val uati o ns ...................................................................................................... 5 4
9.
Pri or a n d C o nc urre nt Me dic ati o ns .................................................................................... 5 5
9. 1  
Pr o hi bit e d Me dicati o ns ............................................................................................... 5 6
9. 2  
All o we d Me dicati o ns .................................................................................................. 5 6
9. 3  
Resc ue Me dicati o ns .................................................................................................... 5 7
1 0.
St u d y Tre at me nt .................................................................................................................. 5 8
1 0. 1
F or m ulati o n of Test Pr o d uct a n d Place b o .................................................................. 5 8
1 0. 2
St u d y Dr u g Pac ka gi n g a n d La beli n g .......................................................................... 5 9
1 0. 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 ....................................................... 5 9
1 0. 4  St u d y Dr u g D ose a n d D osi n g Re gi me n ...................................................................... 5 9
1 0. 5  Pre parati o n of St u d y Dr u g .......................................................................................... 6 0
1 0. 6  St u d y Dr u g A d mi nistrati o n......................................................................................... 6 0
1 0. 7  St u d y Dr u g St ora g e ..................................................................................................... 6 0
1 0. 8  St u d y Dr u g Acc o u nta bilit y ......................................................................................... 6 1
1 1.
S u bject 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 ................................. 6 1

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 of 1 3 5 
C o nfi d e nti al  
1 1. 1
S u bject N u m beri n g ..................................................................................................... 6 1
1 1. 2  Stratificati o n a n d Ra n d o mizati o n ............................................................................... 6 1
1 1. 3
Bli n di n g ...................................................................................................................... 6 2
1 1. 4  Brea ki n g t he Bli n d ...................................................................................................... 6 3
1 2.
St u d y Pr oce d u res a n d G ui deli nes ...................................................................................... 6 3
1 2. 1  P har mac o d y na mic/ Efficac y- Relate d Pr oce d ures ........................................................ 6 4
1 2. 1. 1
Vali date d I n vesti gat or Gl o bal Assess me nt................................................... 6 4
1 2. 1. 2
Ecze ma Area a n d Se v erit y I n d e x ................................................................. 6 4
1 2. 1. 3
 ............................................................ 6 5
1 2. 1. 4
 ..................................... 6 5
1 2. 1. 5
 ................................................................... 6 5
1 2. 1. 6
 .................................................................. 6 5
1 2. 1. 7
At o pic C o n diti o ns Q uesti o n naire ................................................................. 6 6
1 2. 1. 8
P h ot o gra p hs .................................................................................................. 6 6
1 2. 1. 9
C o m plete Bl o o d C o u nt wit h Differe ntial ..................................................... 6 6
1 2. 1. 1 0
Fres h bi o psies ............................................................................................... 6 7
1 2. 2  Safet y- Relate d Pr o ce d ures .......................................................................................... 6 7
1 2. 2. 1
C o nc o mita nt Me dicati o ns ............................................................................ 6 7
1 2. 2. 2
C o m plete P h ysical E xa mi n ati o n .................................................................. 6 7
1 2. 2. 3
B o d y Wei g ht a n d Hei g ht .............................................................................. 6 8
1 2. 2. 4
S y m pt o m- Directe d P h ysical E xa mi nati o n ................................................... 6 8
1 2. 2. 5
Electr ocar di o gra m ........................................................................................ 6 8
1 2. 2. 6
Pre vi o us A D Dia g n osis a n d Treat me nts Re vie w ......................................... 6 8
1 2. 2. 7
Vital Si g ns .................................................................................................... 6 9
1 2. 3  Cli nical La b orat or y Meas ure me nts............................................................................. 6 9
1 2. 3. 1
Bl o o d C he mistr y Pr ofile ............................................................................... 7 0
1 2. 3. 2
Pre g n a nc y T est a n d F olli cle- Sti m ulati n g H or m o ne ..................................... 7 1

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 of 1 3 5 
C o nfi d e nti al  
1 2. 3. 3
Effecti ve M et h o ds of C o ntrace pti o n f or Alla k os St u dies ............................ 7 1
1 2. 3. 4
Uri nal ysis ..................................................................................................... 7 3
1 2. 3. 5
Ser ol o g y ....................................................................................................... 7 3
1 2. 3. 6
A nti- Lire nteli ma b A nti b o dies ...................................................................... 7 3
1 2. 3. 7
Bl o o d f or P har mac o ki neti cs ......................................................................... 7 4
1 2. 3. 8
Bl o o d f or I g E ................................................................................................ 7 4
1 2. 3. 9
C O VI D- 1 9 Testi n g ....................................................................................... 7 4
1 3.
E v al u ati o ns a n d P r oce d ures b y Visit ................................................................................. 7 5
1 3. 1  Scree ni n g Da y ( ~ D a y - 1 4)/ Scree ni n g Peri o d ............................................................. 7 5
1 3. 2  Da y 1 – Ra n d o mizati o n/ D ose 1/ Baseli ne ................................................................... 7 6
1 3. 3  Da y 8 ( ± 3) ................................................................................................................... 7 7
1 3. 4  Da y 1 5 ( ± 5) – D os e 2 .................................................................................................. 7 8
1 3. 5  Da y 2 9 ( ± 5) – D os e 3 .................................................................................................. 7 8
1 3. 6  Da y 4 3 ( ± 5) – D os e 4 .................................................................................................. 7 9
1 3. 7  Da y 5 7 ( ± 5) – D os e 5 .................................................................................................. 8 0
1 3. 8  Da y 7 1 ( ± 5) – D os e 6 .................................................................................................. 8 1
1 3. 9  Da y 8 5 ( ± 5) – D os e 7 .................................................................................................. 8 2
1 3. 1 0
Da y 9 9 ( ± 5) or 1 4 Da ys P ost- D os e – F oll o w- u p Visit 1 ............................................ 8 3
1 3. 1 1  Da y 1 4 1 ( ± 5) or 5 6 Da ys P ost- D ose – F oll o w- u p Visit 2 .......................................... 8 4
1 3. 1 2  Da y 1 6 9 ( ± 5)/ E n d of St u d y or 8 4 Da ys P ost- D os e – F oll o w- u p Visit 3 .................... 8 4
1 3. 1 3  E n d of St u d y Defi niti o n .............................................................................................. 8 5
1 4.
A d verse E v e nt R e p orti n g a n d D oc u me nt ati o n ................................................................. 8 5
1 4. 1  A d vers e E v e nts ........................................................................................................... 8 5
1 4. 2  Seri o us A d vers e E v e nts .............................................................................................. 8 6
1 4. 3  A d vers e E v e nts of S pecial I nt erest ............................................................................. 8 7

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 of 1 3 5 
C o nfi d e nti al  
1 4. 4
I nje cti o n- Relate d Reacti o ns ........................................................................................ 8 7
1 4. 5  I njecti o n Site Reacti o ns .............................................................................................. 8 8
1 4. 6
A na p h yla xis ................................................................................................................ 8 8
1 4. 7  E val uati n g A d verse E ve nts a n d Seri o us A d verse E ve nts ........................................... 8 9
1 4. 7. 1
Esta blis hi n g Dia g n osis ................................................................................. 8 9
1 4. 7. 2
Assess me nt of I nte nsit y ................................................................................ 8 9
1 4. 7. 3
Assess me nt of Ca usalit y t o St u d y Dr u g ....................................................... 9 0
1 4. 7. 4
Assess me nt of Ca usalit y t o St u d y Pr oce d ure ............................................... 9 0
1 4. 7. 5
Acti o n Ta ke n ................................................................................................ 9 1
1 4. 7. 6
Assess me nt of O utc o m e ............................................................................... 9 1
1 4. 8  A d vers e E v e nt Re p orti n g Pr oce d ures ......................................................................... 9 1
1 4. 8. 1
All A d v erse E v e nts ....................................................................................... 9 1
1 4. 8. 2
Seri o us A d verse E v e nt Re p orti n g ................................................................ 9 2
1 4. 8. 3
Pre g n a nc y Re p orti n g .................................................................................... 9 3
1 4. 8. 4
A E SI R e p orti n g ............................................................................................ 9 4
1 4. 9  Me dical M o nit ori n g .................................................................................................... 9 4
1 4. 1 0  I n d e pe n d e nt Data M o nit ori n g C o m mittee .................................................................. 9 5
1 4. 1 1  St u d y Wit h dra wal Criteria .......................................................................................... 9 5
1 4. 1 2 St u d y St o p pi n g R ules ................................................................................................. 9 5
1 5.
Disc o nti n u ati o n a n d R e pl a ce me nt of S u bjects .................................................................. 9 6
1 5. 1  Defi niti o n of St u d y C o m pleti o n ................................................................................. 9 6
1 5. 2  Earl y Disc o nti n uati o n of St u d y Dr u g ......................................................................... 9 6
1 6.
St atistic al Met h o ds a n d Ge ner al C o nsi der ati o ns ............................................................. 9 7
1 6. 1  Sa m ple Size ................................................................................................................ 9 7
1 6. 2  A nal ysis P o p ulati o ns .................................................................................................. 9 8
1 6. 3  S u bject Dis p ositi o n ..................................................................................................... 9 8

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 of 1 3 5 
C o nfi d e nti al  
1 6. 4
De m o gra p hic a n d Baseli ne C h aracteristics ................................................................ 9 8
1 6. 5  St u d y Dr u g E x p os ure .................................................................................................. 9 9
1 6. 6
Efficac y A nal ysis ........................................................................................................ 9 9
1 6. 6. 1
Pri mar y Efficac y E n d p oi nt A nal ysis ............................................................ 9 9
1 6. 6. 2
Sec o n dar y Efficac y E n d p oi nt A nal ysis ...................................................... 1 0 0
1 6. 6. 3
E x pl orat or y A nal ysis .................................................................................. 1 0 1
1 6. 6. 4
I nteri m A nal ysis ......................................................................................... 1 0 1
1 6. 7  Safet y A nal ysis ......................................................................................................... 1 0 2
1 6. 7. 1
Treat me nt E mer ge nt A d v erse E ve nts ......................................................... 1 0 2
1 6. 7. 2
A nti- Dr u g A nti b o dies ................................................................................. 1 0 2
1 6. 7. 3
Cli nical La b orat or y Assess me nts ............................................................... 1 0 2
1 6. 7. 4
Vital Si g ns .................................................................................................. 1 0 3
1 6. 7. 5
E C G ............................................................................................................ 1 0 3
1 6. 7. 6
P h ysical E xa m ............................................................................................ 1 0 3
1 6. 7. 7
C o nc o mita nt Me dicati o ns .......................................................................... 1 0 3
1 6. 7. 8
S u bject C o nfi d e nti alit y ............................................................................... 1 0 3
1 7.
D at a C ollecti o n, Rete nti o n, a n d M o nit ori n g ................................................................... 1 0 4
1 7. 1
Data C ollecti o n I nstr u me nts ..................................................................................... 1 0 4
1 7. 2  Data Ma na g e me nt Pr oce d ures .................................................................................. 1 0 4
1 7. 3  Data Q ualit y C o ntr ol a n d Re p orti n g ......................................................................... 1 0 4
1 7. 4  Data base L oc k/ Discl os ure of Ra n d o mizati o n C o de ................................................. 1 0 4
1 7. 5  Arc hi vi n g of D ata ..................................................................................................... 1 0 5
1 7. 6  A vail a bilit y a n d Rete nti o n of I n vesti g ati o nal Rec or ds ............................................. 1 0 5
1 7. 7  M o nit ori n g ................................................................................................................ 1 0 6
1 8.
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 .............................................. 1 0 6
1 8. 1  Pr ot oc ol A me n d me nts .............................................................................................. 1 0 6

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 1 0 of 1 3 5 
C o nfi d e nti al  
1 8. 2
I n d e pe n de nt Et hics C o m mittees/I nstit uti o nal Re vie w B oar ds ................................. 1 0 7
1 8. 3  I nf or me d C o nse nt F or m ............................................................................................ 1 0 7
1 8. 4
P u blicati o ns ............................................................................................................... 1 0 8
1 8. 5  Cli nical St u d y Re gistrati o n ....................................................................................... 1 0 8
1 8. 6
Pa y me nt t o S u bjects .................................................................................................. 1 0 8
1 8. 7  I n v esti gat or Res p o nsi bilities ..................................................................................... 1 0 9
1 9.
Refere nces .......................................................................................................................... 1 1 0
2 0.
A p pe n di ces ......................................................................................................................... 1 1 2
2 0. 1  A p pe n di x 1: At o pic Der matitis – A merica n A ca de m y of Der m at ol o g y  
C o nse ns us Criteria .................................................................................................... 1 1 3
2 0. 2  A p pe n di x 2: Vali date d I n vesti gat or Gl o bal Assess me nt .......................................... 1 1 4
2 0. 3  A p pe n di x 3: Ecze m a Area a n d Se verit y I n d e x ......................................................... 1 1 5
2 0. 4  A p pe n di x 4: 
 .................................................... 1 2 2
2 0. 5  A p pe n di x 5: 
 ........ 1 2 3
2 0. 6  A p pe n di x 6: 
 .......................................................... 1 2 4
2 0. 7  A p pe n di x 7: At o pic C o n diti o ns Q uesti o n naire ......................................................... 1 2 5
2 0. 8  A p pe n di x 8: C o m m o n Ter mi n ol o g y Criteria f or A d verse E v e nts v. 5. 0 .................. 1 2 6
2 0. 9  A p pe n di x 9: Sa m ps o n’s Criteria of A na p h yl a xis ..................................................... 1 2 7
2 0. 1 0  A p pe n di x 1 0: He patitis B a n d He p atitis C Ser ol o gic Testi n g Details ...................... 1 2 8
2 0. 1 1  A p pe n di x 1 1: O pe n L a bel E xte nsi o n Peri o d ( O pti o nal) ........................................... 1 2 9
2 0. 1 1. 1
S u m mar y of t h e O pe n- L a bel E xte n de d D osi n g Peri o d .............................. 1 2 9
2 0. 1 1. 2
O L E O bjecti ve ............................................................................................ 1 3 0
2 0. 1 1. 3
O L E Eli gi bilit y Criteria .............................................................................. 1 3 0
2 0. 1 1. 4
O L E I ncl usi o n Criteria ............................................................................... 1 3 0
2 0. 1 1. 5
O L E E xcl usi o n Criteria .............................................................................. 1 3 0

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 1 1 of 1 3 5 
C o nfi d e nti al  
2 0. 1 1. 6
O L E Treat me nt ........................................................................................... 1 3 1
2 0. 1 1. 7
O L E Pr oce d ures a n d G ui deli n es ................................................................ 1 3 1
List of T a bl es
Ta ble 1 
St u d y A K 0 0 2- 0 1 8 Sc he d ule of Assess me nts: D o u ble- Bli n d Peri o d ......................... 4 2
Ta ble 2 
St u d y Dr u g D osa ge .................................................................................................... 6 0
Ta ble 3  
A d verse E v e nt Se verit y per C T C A E ......................................................................... 8 9
Ta ble 4  
A d verse E v e nt Relati o ns hi p t o St u d y Dr u g ............................................................... 9 0
Ta ble 5  
A d verse E v e nt Relati o ns hi p t o St u d y Pr oce d ure ....................................................... 9 1
Ta ble 6  
He patitis B Testi n g .................................................................................................. 1 2 8
Ta ble 7  
He patitis C Testi n g .................................................................................................. 1 2 8
Ta ble 8 
St u d y A K 0 0 2- 0 1 8 Sc he d ule of Assess me nts: O pe n- La bel E xte nsi o n Peri o d ......... 1 3 2
List of Fi g ure 
Fi g ure 1  
St u d y Dia gra m ........................................................................................................... 4 6

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 1 2 of 1 3 5 
C o nfi d e nti al  
List of A b bre vi ati o ns
A C
Aller gic c o nj u ncti vitis
A C S 
Aller gic C o nj u ncti vitis S y m pt o m(s) 
A D 
At o pic d er matitis 
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 p e n d e nt cell ular c yt ot o xicit y
A D L
Acti vities of dail y li vi n g
A E 
A d v erse e ve nt(s) 
A E SI 
A d v erse e ve nt(s) of s p ecial i nterest 
A K C  
At o pic k erat o c o nj u ncti vitis  
A L T 
Ala ni n e a mi n otra nsferase 
A N C O V A 
A nal ysis of c o varia n ce 
a nti- H Bc 
A nti b o d y t o He patitis B c ore a nti g e n 
A nti- H C V 
H e p atitis C vir us a nti b o d y 
A S T
As p artate a mi n otra nsferase
 
 
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 n 
CI 
C o nfi d e n ce i nter v al
c m 
Ce nti m eter 
C O VI D- 1 9 
C or o n a 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 T er mi n ol o g y Criteria f or A d v erse E ve nts  
C T F G
Cli nical Trials Facilitati o n a n d C o or di n ati o n Gr o u p  
C U 
C hr o nic urticaria 
 
 
E A SI 
E cze ma Area a n d Se verit y I n de x 
E C G 
Electr o car di o gra m
e C R F 
Electr o nic Case Re p ort F or m 
E G 
E osi n o p hilic g astritis 
E LI S A 
E nz y me-li n k e d i m m u n os or be nt assa y 
E o D 
E osi n o p hilic d u o d e nitis (f or merl y referre d t o as e osi n o p hilic gastr o e nteritis) 
E O S
E n d of st u d y

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 1 3 of 1 3 5 
C o nfi d e nti al  
E T 
E arl y Ter mi n ati 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 D P R
Ge neral Data Pr otecti o n Re g ulati o n ( E ur o p ea n U ni o n)
G G T 
Ga m m a- gl uta m yl tra nsferase 
G L P 
G o o d L a b orat or y Practice 
H Bs A g 
He p atitis B s urface a nti g e n 
h C G  
h u ma n c h ori o nic g o n a d otr o pi n 
HI P A A 
Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y Act 
HI V 
H u m a n i m m u n o d eficie n c y vir us 
I C F 
I nf or me d c o nse nt f or m 
I C H 
I nter n ati o n al C o u n cil o n Har m o nisati o n 
i D M C 
I n de p e n de nt Data M o nit ori n g C o m mittee 
I E C 
I n d e pe n d e nt Et hics C o m mittee 
I G A 
I n v esti g at or Gl o b al Assess me nt  
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 v esti g ati o n al Ne w Dr u g (a p plicati o n) 
I P 
I n v esti g ati o n al pr o d u ct 
I R B 
I nstit uti o n al Re vie w B o ar d 
I R R 
I nf usi o n-relate d reacti o n (f or i ntra ve n o us i nf usi o n) 
I njecti o n-relate d reacti o n (f or s u b c uta n e o us i njecti o n) 
I R T 
I nteracti v e Res p o nse T ec h n ol o g y (s yste m) 
I S M 
I n d ole nt s yste mic m ast o c yt osis 
I TI M 
I m m u n orece pt or t yr osi n e- b ase d i n hi bit or y m otif
I T T 
I nte nt t o treat 
I U D 
I ntra uteri n e d e vice 
I U S 
I ntra uteri ne h or m o n e-releasi n g s yste m 
I V 
I ntra ve n o us 
J A K 
Ja n us ki nase(s)
k g 
Kil o gra m 
L A R C 
L o n g- Acti n g Re v ersi ble C o ntrace pti v es  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 1 4 of 1 3 5 
C o nfi d e nti al  
L L N 
L o wer li mit of n or m al 
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 T T 
M o difie d I nte nti o n-t o- Treat 
mI U
Milli-i nter nati o nal u nits
m L 
Milliliter 
m M 
Milli m olar 
M M R M 
Mi x e d m o d el f or re peate d meas ures 
m T O R
m a m m alia n T ar get of Ra p a m yci n 
N CI 
Nati o n al 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 
N O E L 
N o- o bser v e d effect le vel
N R S 
N u meric Rati n g Scale 
O S S 
O c ular Si g ns a n d S y m pt o ms 
P D 
P h ar mac o d y na mics  
P D E 4
P h os p h o diesterase- 4
P E F 
Pea k e x pirat or y fl o w 
PI D 
Patie nt i d e ntificati o n n u m b er 
P K 
P h ar mac o ki n etic(s) 
P P 
Per Pr ot o c ol 
 
P R O 
Patie nt re p orte d o utc o m e 
P U V A 
Ps orale n + ultra vi olet A or B ( U V A or U V B) 
Q o L 
Q u alit y of Life 
S A E
Seri o us a d verse e v e nt(s)
S A P 
Statistical A n al ysis Pla n 
S C 
S u b c uta n e o us 
 
 
Si glec 
Sialic aci d- bi n di n g, i m m u n o gl o b uli n-li k e lecti n 
S O C
S yste m or g a n class
T E A E 
Treat me nt-e mer ge nt a d verse e ve nt(s)  
T E A E SI 
Treat me nt-e mer ge nt a d verse e ve nt(s) of s p ecial i nterest  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 1 5 of 1 3 5 
C o nfi d e nti al  
T N F 
T u m or n ecr osis fact or 
µ L 
Micr oliter 
U L N 
U p p er li mit of n or m al 
U S P 
U nite d States P h ar mac o p eia
U V A
Ultra vi olet A
U V B 
Ultra vi olet B 
 
 
vI G A 
Vali d ate d I n vesti g at or Gl o bal Assess me nt  
V K C
Ver nal c o nj u ncti vitis
w/ v 
Wei g ht/ V ol u me 
W O C B P 
W o me n of c hil d beari n g p ote ntial 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 1 6 of 1 3 5 
C o nfi d e nti al  
1.
Pr ot oc ol S y n o psis 
Title:  
A P hase 2 Ra n d o mize d, D o u bl e- Bli n d, Place b o- C o ntr oll e d St u d y t o E val uat e 
t h e Efficac y a n d Safet y of S u bc uta ne o us Lire nteli ma b i n A d ult S u bj ects wit h 
M o derate-t o- Se vere At o pic Der matitis I na de q uat el y C o ntr oll e d b y T o pical 
Treat me nts 
S p o ns or:  
Alla k os I nc. 
N u m ber of Sites:   
U p t o 7 0 sites i n t he U nite d St ates a n d Ger m a n y 
N u m ber of S u bjects:  
A p pr o xi m at el y 1 3 0 
N o ncli nic al B ac k gr o u n d 
Lire nteli ma b 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 direct e 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 distri b uti o n, e x presse d sel ecti 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 lire nteli ma b t o Si glec- 8 i n d uces 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, l ea di n g t o ra pi d a n d s ustai ne d de pl eti o n of t hese cells fr o m t he circ ulati o n. I n t he tiss ue, 
lire nteli m a b 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. 
Lire nteli ma b has bee n pr o d uce d i n 2 f or m ulati o ns: 1 f or i ntra ve n o us i nf usi o n (lire nteli m a b I V) a n d 1 f or 
s u bc uta ne o us i njecti o n (lire nt eli ma b S C) (see Test Pr o d uct, D ose, a n d A d mi nistrati o n). 
Cli nic al B ac k g r o u n d 
Lire nteli ma b I V, a d mi nistere d e v er y 4 wee ks, has bee n pre vi o usl y teste d i n o ver 7 0 0 healt h y v ol u nt eers 
a n d patie nts wit h i n d ole nt s yste mic mast o c yt osis (I S M), c hr o nic urti caria ( C U), se vere aller gi c 
c o nj u ncti vitis ( A C), mast cell g astritis, 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). 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, A C, mast cell gastritis, 
a n d E G a n d/ or E o D.  
I n ge neral, lire nteli ma b I V has bee n well t olerat e 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). T he I R R were m ostl y mil d t o m o derate 
a n d occ urre d m ost ofte n d uri n g t he first i nf usi o n. I R R t hat were dee m e d m ore seri o us t y pi call y res ol v e d 
wit hi n 2 4 h o urs, a n d a d diti o nal c ortic oster oi ds a n d/ or a nti hista mi nes were use d i n cases w he n sl o wi n g 
t h e rate of i nf usi o n a n d a d diti o nal s u p p orti ve care al o ne di d n ot res ol ve t he iss ue. C o m m o n s y m pt o ms 
of I R R were hea dac he, na usea, s weati 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 h e i nf usi o n, wit h mi ni m al 
i nter ve nti o n. T he ris k of I R R has bee n s u bsta ntiall y re d uce d b y a d mi nistrati o n of a si n gl e d ose of 
oral c ortic oster oi d (e. g., pre d nis o ne 6 0 m g) gi ve n orall y 1 2 t o 2 4 h o urs pri or t o t he first d ose of 
lire nteli m a b I V.  
St u d y A K 0 0 2- 0 1 7 e val uat e d t h e p har m ac o ki netics ( P K) a n d p har mac o d y na mics ( P D) of lire nteli m a b I V 
a n d S C i n healt h y v ol u nteers. S u bjects recei v e d 0. 3, 1, 3, or 5 m g/ k g or a fi xe d d ose of 3 0 0 m g or 
4 5 0 m g lire nteli m a b S C, or 1 m g/ k g or 3 m g/ k g lire nteli ma b I V. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 1 7 of 1 3 5 
C o nfi d e nti al  
Cli nic al B ac k g r o u n d c o nt. 
I n eac h of t he S C c o h orts, 8 s u bjects were ra n d o mize d t o lire nteli ma b ( 6 per gr o u p) or place b o ( 2 per 
gr o u p) i n a d o u ble- bli n d ma n ner; 1 2 s u bjects recei ve d lire nteli m a b I V ( 6 s u bjects per gr o u p) i n a n o pe n-
la bel ma n ner.  
T he st u d y s h o we d t hat t he P D effect ( de pleti o n of bl o o d e osi n o p hils) occ urre d wit hi n 1 h o ur of d osi n g 
a n d laste d f or at l east 1 m o nt h at I V a n d S C d oses of 1 m g/ k g a n d f or 3 m o nt hs at all hi g her I V a n d S C 
d oses. T he S C i njecti o ns were well t olerate d, a n d n o i nj ecti o n site reacti o ns or ge neral i njecti o n 
reacti o ns were n ote d at a n y d ose de m o nstrati n g s uita bilit y f or f urt her e val uati o n.  
I n St u d y A K 0 0 2- 0 0 5 i n patie nts wit h se vere A C, lire nteli m a b de m o nstrate d cli nical acti vit y i n relie vi n g 
t h e si g ns a n d s y m pt o ms of se vere A C acr oss all m eas ure d d o mai ns. T he st u d y s h o we d a 6 1 % 
i m pr o ve m e nt i n patie nt-re p orte d oc ular s y m pt o ms (t otal aller gic c o nj u ncti vitis s y m pt o ms [ A C S]) a n d 
7 9 % of s u bjects were dee me d res p o n ders at 2 wee ks f oll o wi n g t he fi nal lire nteli ma b d ose c o m pare d t o 
baseli ne. I n vesti gat or-assesse d oc ul ar si g ns a n d s y m pt o ms (t otal O S S) als o i m pr o ve d b y 5 3 %, a n d 8 3 % 
of s u bjects were dee me d res p o n ders at t he fi nal d ose ti me p oi nt c o m p are d t o baseli ne. A d diti o nall y, 
s y m pt o m b ur de n was assesse d acr oss m ulti ple at o pi c c o m or bi dities, a n d s y m pt o m s e verit y decrease d 
s u bst a nti all y acr oss all c o n diti o ns assesse d, i ncl u di n g i n at o pic der matitis ( A D), ast h ma, a n d r hi nitis. 
T he lac k of treat me nt-relate d a d verse e ve nts ( A E) be y o n d I R R i n t he I V st u dies c o m bi ne d wit h t he 
cli ni cal acti vit y o bser ve d i n treati n g m ulti ple all er gic c o n diti o ns a n d t he ret ur n of si g ns a n d s y m pt o ms 
off treat me nt ma ke lire nteli m a b a p ote nti all y pr o misi n g ca n di date f or m ulti ple e osi n o p hil a n d m ast cell-
dri ve n i nfla m mat or y dis eases, i ncl u di n g A D. 
T a r get Dise ase B ac k gr o u n d a n d R ati o n ale f or t he St u d y 
At o pic der matitis is a c hr o nic pr uritic i nfl a m m at or y der m atitis t hat affects a p pr o xi m atel y 1 6. 5 milli o n 
( 7. 3 %) a d ults i n t he U S, of w hi c h ar o u n d 6. 6 milli o n ( 4 0 %) ha ve m o derate-t o-s e vere disease. T he 
pat h o ge nesis of A D is c o m ple x a n d i n v ol ves a b n or maliti es i n s ki n barrier f u ncti o n, altere d s ki n fl ora, 
a n d i m m u ne d ysre g ul ati o n ( F u xe nc h, 2 0 1 9). T here is i ncrease d e x pressi o n of T h 2 a n d T h 2 2 c yt o ki nes 
li ke I L- 4, I L- 1 3, I L- 3 1, a n d I L- 2 2. Mast cell n u m bers are el e vat e d i n t he s ki n of A D patie nts. T hese 
cells, b y virt ue of pr o d uci n g pr urit o ge nic me diat ors li ke hista mi ne, tr y ptase a n d I L- 3 1, mi g ht c o ntri b ute 
t o A D s y m pt o ms. I n a d diti o n, mast cells ma y c o ntri b ute t o ne ur o ge ni c i nfla m mati o n b y i nteracti n g wit h 
se ns or y ner ves. I n a d diti o n t o mast cells, e osi n o p hils ma y be ele vate d i n pati e nts wit h A D. It has bee n 
de m o nstrate d t hat e osi n o p hils t a ke n fr o m A D bi o psies are acti vate d a n d s h o w dela ye d pr o gra m m e d cell 
deat h. Ta ke n t o get her, t h ese fi n di n gs s u g gest t h at acti vati o n a n d de gra n ulati o n of mast cells a n d 
e osi n o p hils m a y be a maj or c o m p o ne nt i n t he pat h o ge nesis of A D a n d ma y re prese nt s uita ble tar gets f or 
t h era pe utic i nt er ve nti o n. 
At o pic der matitis patie nts t y picall y e x peri e nce dr y s ki n a n d i nte nse pr urit us, w hi c h ca n l ea d t o 
de vel o p me nt of er yt h e m at o us pa p ules wit h e x u dati o n, cr usti n g, a n d e xc oriati o n. A rece nt st u d y of 
a d ults wit h m o derate-t o-se vere A D f o u n d t hat 7 0. 5 % re p orte d se vere, u n beara ble itc h i n t he past 
2 wee ks, 8 5. 8 % re p orte d dail y itc h, a n d 6 2. 8 % re p orte d itc hi n g at least 1 2 h o urs per da y. C hr o nicall y, 
t his ofte n lea ds t o s ki n t hic ke ni n g a n d lic he nificati o n, m ost c o m m o nl y i n s ki n fle x ures.  
 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 1 8 of 1 3 5 
C o nfi d e nti al  
T a r get Dise ase B ac k gr o u n d a n d R ati o n ale f or t he St u d y c o nt.
At o pic der matitis ma y i n v ol v e t he face, nec k, tr u n k, a n d e xtre mities. At o pic der matitis f oll o ws a 
c hr o nic rel a psi n g c o urs e a n d ca n be c o m pli cate d b y de v el o p m e nt of bacterial a n d viral s ki n i nfecti o ns. 
Patie nts wit h A D als o ha ve a n i ncrease d ris k of aller gic r hi nitis, ast h ma, f o o d aller gi es, a n d oc ular 
c o n diti o ns li ke at o pic kerat oc o nj u n cti vitis ( A K C) a n d ver nal c o nj u ncti vitis ( V K C). 
T he mai n g oals of A D treat me nt are t o mai nt ai n a de q uate s ki n h y drati o n, re d uce pr urit us, a n d pre ve nt 
e xacer bati o ns. W hile oral a nti- hista mi nic a ge nts ma y hel p re d uce pr urit us, t o pical a ge nts are t he 
mai nsta y of treat m e nt. T hese i n cl u de m oist urizi n g/e m ollie nt pre parati o ns, w hic h pr otect t h e s ki n barrier 
a n d pre ve nt wat er l oss. Al o n g wit h m oist uri zi n g a ge nts, t o pical a nti-i nfla m m at or y a ge nts s uc h as 
c orti c oster oi ds a n d calci ne uri n i n hi bit ors (e. g., tacr oli m us a n d pi m ecr oli m us) are use d f or mil d-t o-
m o derat e dis ease as sec o n d li ne o pti o ns. Crisa b or ole, a t o pical p h os p h o diesterase 4 ( P D E 4) i n hi bit or, 
was a p pr o ve d b y t he F D A i n Dece m ber 2 0 1 6, a n d is use d f or treat me nt of mil d-t o- m o derate A D.  
W hil e t o pical a ge nts ca n be effecti v e i n mil d-t o- m o derate disease, t here are l o n g ter m safet y c o ncer ns. 
T o pical ster oi ds ca n ca us e s ki n atr o p h y a n d p ossi ble a dre nal s u p pressi o n d ue t o s yste mic a bs or pti o n. 
Tacr oli m us a n d pi mecr oli m us carr y a p ote nti al ris k of s ki n ca ncer, w hic h has res ulte d i n a blac k b o x 
war ni n g b y t he F D A.  
T he ma na ge me nt of m o derate-t o-s e vere dis ease is m ore diffi c ult. Patie nts ca n be treat e d wit h 
p h ot ot hera p y ( 3 ti mes per wee k), w hi c h is c u m bers o me, e x pe nsi ve, a n d ma y i ncrease t he ris k of 
de vel o pi n g s ki n ca ncer. Oral c ortic oster oi ds are occasi o nall y use d b ut are li mite d b y si de effects 
i n cl u di n g i ncrease d ris k of dia bet es, h y perte nsi o n, a dre nal s u p pressi o n, a n d e ye diseases li ke gla uc o ma 
a n d cat aracts. A n oral calci ne uri n i n hi bit or (c ycl os p ori n) ca n be use d b ut re q uires fre q ue nt m o nit ori n g 
of dr u g le vels a n d carries ris ks of h y perte nsi o n, ne p hr ot o xicit y, h y pertric h osis, a n d g u m h y per pl asia. 
Als o, l o n g-t er m us e of st er oi ds a n d c ycl os p ori n lea ds t o i m m u n os u p pressi o n a n d i ncrease d ris k of 
i nfecti o ns.  
I n M arc h 2 0 1 7, t he F D A a p pr o ve d d u pil u ma b f or t he treat me nt of a d ult patie nts wit h m o derate-t o-
se vere A D n ot a de q uatel y c o ntr oll e d wit h t o pi cal prescri pti o n t hera pi es or w he n t h os e t hera pies are n ot 
a d visa ble. D u pil u m a b is a f ull y h u ma n m o n ocl o nal a nti b o d y t hat bi n ds t o t he al p ha s u b u nit of t he I L- 4 
rece pt or a n d i n hi bits si g nali n g of I L- 4 a n d I L- 1 3, alteri n g T-cell me diate d i m m u ne res p o nse, w hic h is 
belie ve d t o pla y a r ol e i n A D. T he l o n g-t er m ( 5 2 wee k) safet y a n d efficac y of d u pil u ma b was e val uate d 
i n a ra n d o mize d, d o u ble- bli n d, place b o-c o ntr olle d st u d y. C o nc o mit a nt use of t o pi cal c ortic oster oi ds 
(a n d t o pi cal cal ci ne uri n i n hi bit ors, if i n dicate d) was all o we d. 
I n t he d u pil u ma b st u d y, at Wee k 5 2, m ore patie nts i n t he d u pil u ma b-treate d gr o u p ac hie ve d t he 
I n vesti gat or Gl o bal Assess m e nt (I G A) a n d Ecze ma Area a n d Se verit y I n de x ( E A SI)- 7 5 e n d p oi nts t h a n 
t h e place b o-treat e d gr o u p (a p pr o xi m atel y 4 0 % vers us 1 3 % a n d 6 5 % vers us 2 2 %, res pecti v el y). 
H o we ver, t h e d u pil u ma b-treate d patie nts ha d a 2-f ol d hi g her i nci de nce of e ye dis or ders i ncl u di n g 
n o n-i nfecti o us c o nj u ncti vitis. T here c o nti n ues t o be a s u bsta ntial nee d f or ne w a n d better treat me nts f or 
m o derat e-t o- se vere A D. B y re d uci n g e osi n o p hil n u m bers a n d bl oc ki n g m ast cell acti vati o n, lire nteli m a b 
ma y be usef ul i n t he treat me nt of patie nts wit h A D. 
 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 2 0 of 1 3 5 
C o nfi d e nti al  
S a m ple Size c o nt.
T o detect a treat me nt differe nce of 2 9 %, t he n u m ber of s u bjects re q uire d f or 9 0 % p o wer is 5 5. 
H o we ver, t o acc o u nt f or a n a ntici pate d 1 0 % dr o p o ut rate, t he s a m ple size will be i ncrease d t o 6 5 per 
treat me nt gr o u p.  
E nr oll me nt will be m o nit ore d t o li mit t h e i m p act of ra n d o mizi n g a dis pr o p orti o natel y lar ge n u m ber of 
s u bj ects wit h a n E A SI sc ore i n t h e l o wer ra n ge, refl ecti n g m ore m o derate diseas e o nl y (i.e., E A SI s c ore 
< 2 2). T his will als o pr o vi de a s u bject p o p ulati o n wit h a f ull ra n ge of E A SI sc ores c o nsiste nt wit h t he 
i nte nt t o st u d y lire nteli m a b i n m o derate-t o-se vere A D dis ease.
St u d y Desi g n
T his P hase 2, pr o of- of-c o nce pt, ra n d o mi ze d, d o u ble- bli n d, place b o-c o ntr oll e d st u d y will i n vesti gate 
t h e efficac y a n d safet y of lire nteli ma b S C i n a d ult s u bjects wit h m o derate-t o-s e vere A D i na de q uatel y 
c o ntr olle d b y t o pical treat me nts. A p pr o xi matel y 1 3 0 s u bjects will be e nr olle d i n u p t o 7 0 sit es i n t he U S 
a n d Ger ma n y a n d will be ra n d o mi ze d 1: 1 t o recei ve eit her 7 S C i njecti o ns of place b o or lire nteli ma b 
a n d t he n f oll o we d f or 1 2 wee ks after t he last d ose. S u bj ects will be gi v e n t he o pti o n t o e nr oll i nt o a n 
o pe n-l a bel e xte nsi o n ( O L E) peri o d of t he st u d y after c o m pleti n g t he Da y 9 9 visit of t he d o u ble- bli n d 
peri o d. S u bjects c h o osi n g n ot t o e nter t he O L E peri o d will c o nti n ue t o be f oll o we d i n t h e d o u ble- bli n d 
peri o d of t he st u d y f or 1 2 wee ks aft er t he last d ose. 
Base d o n t he fee d bac k fr o m at o pic der matitis e x perts a n d c o m pl ete d feasi bilit y assess me nts, it is 
e x pect e d t hat eac h site will be a ble t o scree n t hree s u bjects a n d e nr oll t w o of t he m i n t he d urati o n of t h e 
e nr oll me nt peri o d. E nr oll me nt is c o nsi dere d t o be c o m petiti ve. T o e ns ure t he e nr oll me nt g oal is 
ac hie ve d i n a ti mel y m a n ner, u p t o 7 0 sites (a p pr o xi mat el y 5 5 i n t he U S a n d a p pr o xi matel y 1 5 i n 
Ger ma n y) will be i nitiate d. If st u d y e nr oll me nt rate ca n be ac hie ve d wit h fe wer sites i n or der t o m eet t he 
st u d y ti meli ne, t he n fe wer sit es ma y be nee de d. 
S u bjects will be c o nse nte d a n d scree ne d, a n d t h ose w h o meet eli gi bilit y crit eri a ca n be e nr olle d i n t he 
st u d y. S u bjects w h o d o n ot meet all eli gi bilit y criteria at scree ni n g or w h o q ualif y at scree ni n g b ut are 
n ot e nr oll e d ma y be assi g ne d a ne w pati e nt i de ntificati o n n u m ber a n d rescree ne d o nce. S u bjects 
rescree ne d wit hi n 3 0 da ys of si g ni n g t he i nitial i nf or me d c o nse nt f or m (I C F) will n ot nee d t o si g n a ne w 
I C F if t here h a ve bee n n o c ha n ges t o t h e I C F. 
S u bjects will be scree ne d f or a p pr o xi matel y 2 wee ks (- 1 4 da ys) pri or t o d ose a d mi nistrati o n. D uri n g 
scree ni n g a n d t hr o u g h vari o us ti me p oi nts d uri n g t he st u d y, t he E A SI, I G A, 
 
 
 assess m e nts will be c o m plete d. A d diti o nal q uesti o ns will be as ke d a b o ut 
s y m pt o ms relate d t o ast h ma, aller gic r hi nitis, a n d aller gi c c o nj u ncti vitis t hat s u bjects wit h t h e at o pi c 
c o n diti o n(s) ma y ha ve o n Da y 1, Da y 9 9, a n d O L E Da y 9 9 ( At o pic C o n diti o ns Q uesti o n naire). 
Certai n me dicati o ns are pr o hi bite d d uri n g t he st u d y. Use of s yste mi c a n d/ or t o pical c ortic oster oi ds, 
calci ne uri n i n hi bit ors, J A K i n hi bit ors, t o pical P D E 4 i n hi bit ors (crisa b or ole), d u pil u ma b, or 
tral o ki n u m a b are pr o hi bit e d d uri n g t he st u d y. S u bjects w h o are o n a n y t o pi cal c orti c oster oi ds, t o pical  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 2 1 of 1 3 5 
C o nfi d e nti al  
St u d y Desi g n c o nt.
calci ne uri n i n hi bit ors, t o pical J A K i n hi bit ors, or P D E 4 i n hi bit ors at t he ti me of s cree ni n g m ust 
dis c o nti n ue t hese at t he first scree ni n g visit. 
Bi ol o gi cs or me dicati o ns t hat m a y i nterfere wit h t he st u d y s afet y or efficac y assess m e nts s uc h as 
s yste mi c 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 or bi ol o gics a n d s yste mic c orti c oster oi ds 
m ust be disc o nti n ue d pri or t o t he first scree ni n g visit (see Secti o n  8. 5 E xcl usi o n Criteria) a n d are 
pr o hi bit e d t hr o u g h o ut t he st u d y. 
D uri n g t he last 7 da ys pri or t o Da y 1 (t h e first da y of st u d y dr u g d osi n g), t he s u bj ect m ust ha ve use d, at 
least t wice dail y, o nl y n o n- me dicate d t o pi cal t hera p y (i.e., e m ollie nt) wit h o ut ot her acti ve i n gre die nts 
i n dicate d t o treat A D or ot her a d diti ves, w hic h c o ul d affect A D (e. g., h yal ur o nic aci d, urea, cera mi d e, or 
fila g gri n de gra dati o n pr o d ucts). If a s u bject is n ot usi n g a n y e m olli e nt at t he ti me of scree ni n g, a 
s uit a ble n o n- me dicat e d, n o n- prescri pti o n e m olli e nt will be rec o m m e n de d b y t h e I n vesti gat or. 
Eli gi ble s u bjects w h o meet s electi o n criteria at scree ni n g a n d at baseli ne will recei ve t he first d ose of 
lire nteli m a b S C or place b o S C o n Da y 1. S u bjects will recei ve 6 m ore d oses o n Da ys 1 5, 2 9, 4 3, 5 7, 7 1, 
a n d 8 5. 
S u bjects will be gi ve n t he o pti o n of e nteri n g a n O L E peri o d of t h e st u d y after c o m pleti n g t h e Da y 9 9 
visit of t he d o u ble- bli n d peri o d of t he st u d y, c o nti n ge nt o n m eeti n g defi ne d st u d y selecti o n criteria. 
S u bjects n ot e nteri n g t he O L E p eri o d will be f oll o we d f or 1 2 wee ks aft er t he last d ose i n t he 
d o u ble- bli n d peri o d.  
T he pri mar y e n d p oi nt will be assesse d at Wee k 1 4, i.e., 2 wee ks f oll o wi n g t he last d ose i n t he d o u ble-
bli n d peri o d of t h e st u d y. 
Ra n d o mi zati o n will be stratifie d base d o n I G A 3 vs. 4 a n d o n bi ol o gic stat us, naï ve vs. e x p ose d. 
A p pr o xi m atel y 4 0 % of t he st u d y p o p ul ati o n will be s u bj ects wit h a n I G A of 4. 
Fres h bi o psies of lesi o nal a n d n o n-lesi o nal s ki n ma y be c ollecte d fr o m s u bjects pre d ose a n d p ost- d ose at 
selecte d U S sites. Pr o vi di n g bi o psies is o pti o nal, a n d s u bjects will si g n a se parat e c o nse nt f or m f or 
bi o ps y c oll ecti o n. 
Pri m ar y O bjecti v e a n d E n d p oi nt 
T he pri mar y o bjecti ve of t he st u d y will be t o c haract erize t he effi cac y of lire nteli ma b S C i n a d ult 
s u bj ects wit h A D as assesse d b y t he differe nce i n t he pr o p orti o n of s u bj ects w h o ac hie ve E A SI- 7 5 at 
Wee k 1 4. 
Sec o n d ar y O bjecti ves a n d E n d p oi nts 
T o f urt her c haracteri ze t he effi cac y of lire nteli ma b S C i n a d ult s u bjects wit h A D as meas ure d b y t he 
f oll o wi n g: 
 
% C ha n ge i n E A SI fr o m baseli n e t o Wee k 1 4. 
 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 2 3 of 1 3 5 
C o nfi d e nti al  
S u bject Selecti o n Criteri a – I ncl usi o n Criteri a c o nt.
3) 
C hr o nic A D (as defi ne d b y t h e A meri ca n Aca de m y of Der mat ol o g y C o nse ns us Crit eria) 
( Eic he nfiel d, 2 0 1 4) t h at has bee n prese nt f or at least 3 years b ef ore s cree ni n g visit.  
4) 
D o c u me nt e d rece nt hist or y of i na de q uate res p o nse t o treat me nt wit h t o pical me dicati o ns s uc h as 
t o pical c ortic ost er oi ds, calci ne uri n i n hi bit ors, J A K i n hi bit ors, or P D E 4 i n hi bit ors (crisa b or ole) f or 
at least 4 wee ks i n t he 6 m o nt hs pri or t o scree ni n g, or s u bjects f or w h o m t hese t o pical treat me nts 
are ot her wise me dicall y i na d vis a bl e (e. g., beca use of si de effects or safet y ris ks). 
5) 
S u bject w h o are bi ol o gic- naï v e or bi ol o gic-e x p ose d. Bi ol o gi c-e x p ose d i ncl u des s u bjects w h o ha ve 
de m o nstrate d sec o n dar y l oss of res p o nse, i nt olera nce, or lac k of access t o bi ol o gics d ue t o 
ec o n o mic reas o ns. 
6) 
 
7) 
I n v ol ve m e nt of at least 1 0 % or m ore of B S A at s cree ni n g a n d at baseli ne. 
8) 
A n I G A s c ore of 3 or a b o ve o n a scale fr o m 0 – 4 at scree ni n g a n d at baseli ne. 
9) 
T he s u bj ect s h o ul d ha ve a p plie d a sta ble d ose of n o n- m e dicat e d, n o n- prescri pti o n, t o pical e m olli e nt 
at least t wi ce d ail y f or 7 c o nsec uti ve da ys i m me di atel y bef ore t he baseli ne visit. 
1 0) 
Willi n g t o a p pl y a sta ble d ose of n o n- m e dicate d, n o n- prescri pti o n, t o pical e m ollie nt, as 
rec o m me n de d b y t he I n vesti gat or at least t wice d ail y f or t he d urati o n of t he st u d y, if n ot alrea d y o n 
a n e m ollie nt at t he ti me of scree ni n g.  
1 1) C o m mit me nt t o re mai n o n t he sa me d ose(s) of A D m e dicati o n(s), i ncl u di n g t o pical e m ollie nts, f or 
t h e e ntire d urati o n of st u d y p arti ci pati o n u nless d ose m o dificati o n is d ue t o u nf ores ee n me dical 
necessit y. 
1 2) 
Willi n g a n d a ble t o c o m pl y wit h t h e st u d y pr oce d ures a n d visit sc he d ule i ncl u di n g f oll o w- u p visits. 
1 3) Fe male s u bjects m ust be eit h er p ost me n o pa usal ( defi ne d as n o me nses f or 1 2 m o nt hs wit h o ut a n 
alter nati v e me dical ca use) wit h F S H l e vel > 3 0 mI U/ m L at scree ni n g or s ur gicall y sterile (t u bal 
li gati o n, h ysterect o m y, or bil at eral 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 v e ser u m pre g na nc y test a n d a gree t o use a hi g hl y effecti ve m et h o d of 
c o ntrace pti o n as defi n e d i n t his pr ot oc ol or a bstai n fr o m se x ual acti vit y, if c o m plia nt wit h preferre d 
a n d us ual lifest yl e of t he s u bject, fr o m scree ni n g 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 hi c he ver is l o n ger. 
s u bj ect will be re q uire d t o ha ve a ne gati ve ser u m pre g na nc y test d uri n g t he scree ni n g peri o d a n d 
will als o be re q uire d t o ha ve a ne gati v e uri ne di pstic k pre g na nc y test pri or t o d osi n g a n d at eac h 
st u d y visit. 
1 4) 
M ale s u bjects wit h fe m al e part ners of c hil d beari n g p ote nti al 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 as d efi ne d i n t his pr ot o c ol or a bst ai n fr o m se x ual acti vit y fr o m scree ni n g 
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 h e last d ose of st u d y dr u g, w hic he ver is l o n ger. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 2 4 of 1 3 5 
C o nfi d e nti al  
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 di at el y if t he y s us pect t heir part ner mi g ht be pre g na nt (e. g., misse d or late 
me nstr ual peri o d) at a n y ti m e d uri n g st u d y partici pati o n. 
E x cl usi o n Criteri a:  S u bjects 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) 
C urre nt use of bi ol o gics f or a n y i n dicati o n. 
2) 
De m o nstrate d lac k of pri mar y res p o ns e t o treat me nt wit h a bi ol o gic f or t he treat me nt of A D 
defi ne d as n o res p o nse t o treat me nt des pite c o m plete a d here nce t o t he prescri be d re gi m e n f or at 
least 3 m o nt hs ( pri m ar y n o n-res p o n ders). 
3) 
Us e of a n y of t he f oll o wi n g treat me nts wit hi n 4 wee ks pri or t o t he bas eli n e visit or a n y c o n diti o n 
t h at i n t h e o pi ni o n of t he I n vesti gat or is li k el y t o re q uire s uc h treat me nt(s) d uri n g t he first 4 wee ks 
of st u d y treat me nt: 
–
P h ot ot hera p y f or A D 
–
I m m u n os u p pressi ve or i m m u n o m o d ul at or y dr u gs, i ncl u di n g b ut n ot li mite d t o s yste mic 
calci ne uri n i n hi bit ors (e. g., c ycl os p ori n, tacr oli m us), m T O R i n hi bit ors (e. g., sir oli m us, 
e ver oli m us), a nti- meta b olites (e. g., azat hi o pri ne, met h otre xate, 6- merca pt o p uri ne, lefl u n o mi d e, 
m y c o p he n olate m ofetil), al k ylati n g a ge nts (e. g., c ycl o p h os p ha mi de), e osi n o p hil- de pleti n g 
dr u gs (e. g., pra mi pe x ole), a n d s yste mic c orti c oster oi ds 
–
Oral J A K i n hi bit ors wit hi n 8 wee ks of baseli ne visit (re q uires disc ussi o n wit h Alla k os Me dical 
M o nit or pri or t o s u bject e nr olli n g i n st u d y) 
4) 
Treat me nt wit h bi ol o gics: 
–
A n y cell- de pleti n g a ge nts i ncl u di n g b ut n ot li mite d t o rit u xi ma b wit hi n 6 m o nt hs pri or t o t he 
baseli ne visit or u ntil l y m p h oc yte c o u nt ret ur ns t o n or mal, w hi c he ver is l o n ger 
–
T N F i n hi bit ors (e. g., i nfli xi ma b, a dali m u m a b) a n d ot her bi ol o gics (e. g., d u pil u ma b, 
o maliz u ma b, et c.) wit hi n 5 half-li ves, if k n o w n, or 8 wee ks pri or t o t h e bas eli ne visit, 
w hic he ver is l o n ger 
5) 
A n y use of t o pical c ortic oster oi ds, t o pical cal ci ne uri n i n hi bit ors, t o pical J A K i n hi bit ors (e. g., 
r u x oliti ni b), or t o pical P D E 4 i n hi bit ors (crisa b or ole) f or t he treat me nt of A D wit hi n 1 wee k pri or t o 
t h e baseli ne visit. 
6) 
Re g ular use ( m ore t ha n 2 visits per wee k) of a ta n ni n g b o ot h/ parl or wit hi n 4 wee ks of t he scree ni n g 
visit. 
7) 
Treat me nt wit h c he m ot hera p y or ra di ot hera p y i n t he prece di n g 6 m o nt hs. 
8) 
Prese nce of s ki n c o m or bi diti es/c o nc o mit a nt c o n diti o ns t hat ma y i nterfere wit h st u d y assess m e nts 
or i nt er pretati o n of st u d y res ults. 
9) 
Pla n ne d or a ntici pat e d use of a n y pr o hi bite d me dicati o n. 
1 0) Hist or y of mali g na nc y e xce pt carci n o ma i n sit u i n t he cer vi x, earl y-sta ge pr ostate ca ncer, or 
n o n- mela n o ma s ki n ca ncers.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 2 5 of 1 3 5 
C o nfi d e nti al  
S u bject Selecti o n Criteri a – E xcl usi o n Criteri a c o nt.
1 1) A n y disease, c o n diti o n ( me di cal or s ur gical), or car diac a b n or malit y t hat i n t he o pi ni o n of t h e 
I n vesti gat or w o ul d place t he s u bj ect at i ncrease d ris k. 
1 2) A hel mi nt h parasitic i nfecti o n dia g n ose d wit hi n 6 m o nt hs pri or t o t he dat e i nf or me d c o nse nt is 
o btai ne d t hat has n ot bee n treate d wit h or has faile d t o res p o n d t o sta n dar d- of-care t hera p y. 
1 3) E vi de nce of acti ve he p atitis B or C at scree ni n g b ase d o n ser ol o g y. 
1 4) E vi de nce of acti ve HI V i nfecti o n at scree ni n g base d o n ser ol o g y. 
1 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 h e 
st u d y. 
1 6) Prese n ce of a n a b n or m al scree ni n g l a b orat or y val u e c o nsi dere d t o be cli nicall y si g nifi ca nt b y t he 
I n vesti gat or. 
1 7) K n o w n or s us pecte d hist or y of alc o h ol, dr u g, or ot her s u bsta nce a b use or de pe n de nce t hat i n t he 
o pi ni o n of t he I n vesti gat or ma y i nterfere wit h st u d y parti ci pati o n or ass ess me nts. 
1 8) Pri or e x p os ure t o lire nteli ma b or 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. 
1 9) Partici pati o n i n a c o nc urre nt i nter ve nti o nal st u d y wit h t he last i nter ve nti o n occ urri n g wit hi n 
3 0 da ys pri or t o st u d y dr u g a d mi nistrati o n ( or 9 0 da ys or 5 half-li ves, w hic he ver is l o n ger, f or 
bi ol o gic pr o d ucts). 
2 0) S u bj ects w h o wei g h < 4 0 k g at scree ni n g. 
2 1) A n y ot h er reas o n t hat i n t he o pi ni o n of t he I n vesti gat or or t he Me dical M o nit or ma kes t he s u bj ect 
u ns uit a ble f or e nr oll me nt. 
2 2) Vacci nati 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 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.  
N ote: 
T his e xcl usi o n criteri o n d oes n ot a p pl y t o all t y pes a n d f or m ulati o ns of v acci nes (i ncl u di n g 
li ve atte n uate d vacci nes) c urre ntl y a ut h orize d/a p pr o ve d b y F D A or ot h er 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, w hic h ma y be a d mi nistere d bef ore, d uri n g, or 
after t he st u d y.  
  
T he vacci ne s h o ul d n ot be a d mi nistere d wit hi n 3 da ys bef ore a n d wit hi n 3 da ys after 
t h e a d mi nistrati o n of lire nteli ma b 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. 
2 3)  E m pl o yees or rel ati ves of t he S p o ns or or t he I n vesti gat or, or ot her pers o ns de pe n de nt o n t h e 
S p o ns or or t h e I n vesti gat or. 
2 4)  C o m mit me nt t o a n i nstit uti o n b y or der iss ue d eit her b y t he j u dicial or t he a d mi nistrati ve a ut h orities. 
 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 2 8 of 1 3 5 
C o nfi d e nti al  
S afet y E v al u ati o ns
Safet y a n d t ol era 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 u ati n g A E, 
i n cl u di n g reacti o ns t o t he S C i nj ecti o n. All T E A E will be c oll ecte 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 Da y 1 6 9 ( ± 5 da ys) or Earl y Ter mi nati o n ( E T).  
Se verit y will be assesse d usi n g t he Nati o n al Ca ncer I nstit ute ( N CI) C o m m o n Ter mi n ol o g y Criteria f or 
A d verse E ve nts ( C T C A E) ta bles a n d t o xicit y gra di n g scale ( versi o n 5 or t h e 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 h er 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 cli ni cal la b orat or y t ests c o m prisi n g a nti- dr u g a nti b o d y ( A D A) t o 
lire nteli m a b S C, c o m plete bl o o d c o u nts, c he mistries, a n d uri nal yses; p h ysical e xa ms; a n d vit al si g n 
meas ure me nts. 
T he Me di cal M o nit or will re vie w bli n de d safet y data t hr o u g h o ut t he st u d y.
P h ar m ac o d y n a mic E v al u ati o ns 
A bs ol ut e a n d perce nt e osi n o p hil c o u nts i n peri p heral bl o o d will be c oll ecte d. 
P h ar m ac o ki netic a n d A nti- Dr u g- A nti b o d y E v al u ati o ns 
P har mac o ki netic ( P K) bl o o d sa m ples will be o btai ne d pri or t o t he first d ose o n Da y 1 a n d pre d ose (as 
a p plica ble) o n Da ys 8, 1 5, 2 9, 4 3, 5 7, 7 1, 8 5, 9 9, 1 4 1, a n d 1 6 9 or E T. A d diti o nal P K sa m pl es will be 
c ollecte d i n t he O L E peri o d of t he st u d y. 
Bl o o d (s er u m) will be c ollecte d f or assess me nt of lire nteli m a b A D A usi n g a vali date d assa y met h o d. 
T he A D A bl o o d s a m ples will be o btai ne d pre d ose o n Da ys 1, 4 3, a n d 8 5, as well as o n Da ys 8, 9 9, a n d 
1 6 9, a n d i n t h e e ve nt of a s us p ect e d i m m u n o ge nicit y-relate d A E. 
St atisti c al A n al ysis 
F or all effi cac y vari a bles, t he a nal ysis will be c o m p aris o n of lire nteli ma b S C a n d t he place b o treat me nt 
gr o u ps. T he f oll o wi n g n ull a n d alt er nati ve h y p ot heses f or t he pri mar y e n d p oi nt will be teste d f or 
lire nteli m a b S C gr o u p a n d t he place b o gr o u p: 
H 0: N o treat me nt differe nce bet wee n lire nteli ma b S C a n d pl ace b o 
H 1: T here is a treat m e nt differe nce bet wee n lire nteli m a b S C a n d place b o 
Baseli n e disease se verit y i n d e x [ m o derat e (I G A = 3) a n d se vere (I G A = 4)] a n d pri or bi ol o gic e x perie nce 
( bi ol o gic- naï ve a n d bi ol o gic-e x p ose d) will be t he 2 stratificati o n fact ors f or s u bject ra n d o mizati o n a n d 
will be acc o u nte d f or i n t he st atisti cal m o deli n g f or efficac y. I n a d diti o n, if it is e vi de nt t h at t he pri mar y 
e n d p oi nt is c o nf o u n de d b y st u d y e ntr y c haracteristics [e. g., t he met h o d of I G A a n d/ or E A SI s c ore 
assess m e nt b y A D s pecialist ( defi ne d as t h e PI a n d or S u b-I bei n g eit her a n aller gist, i m m u n ol o gist or 
der m at ol o gist) as c o m pare d t o n o n- A D s pecialist, c ha n ge i n perce nt B S A greater t ha n 2 0 % at t he e n d 
of t he Lea d-i n P hase ( Da y - 1 4 t o Da y - 8) c o m pare d t o t he e n d of t he Baseli n e P h ase ( Da y - 7 t o  
Da y - 1)], t he n t h e pri mar y efficac y a nal ysis will be c o n d ucte d a dj usti n g f or t h e effects of t he 
bac k gr o u n d c haract eristics. 

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St atisti c al A n al ysis c o nt.
T he pri mar y res p o n der e n d p oi nt will be a nal yze d usi n g t he C oc hra n- Ma ntel- Hae nszel test a dj ust e d b y 
baseli ne disease se verit y i n de x [ m o derat e (I G A = 3) a n d se vere (I G A = 4)], pri or bi ol o gi c e x peri e nce 
( bi ol o gic- naï ve a n d bi ol o gic-e x p ose d), a n d c o u ntr y ( U S A a n d Ger m a n y) at Wee k 1 4. T he Ma ntel-
Fleiss ( M F) criteri o n will be perf or me d, a n d if it is n ot m et w hile usi n g t he o pti o n C M H ( M F) i n S A S 
pr oce d ure P R O C F R E Q, a nal yses i n cl u di n g eac h fact or se paratel y i n C M H t est will b e c o n d ucte d. 
S h o ul d ass u m pti o n per t he M F criteri o n n ot be satisfie d, t he c o m paris o n will be base d o n a Fis her’s 
e xact test after c olla psi n g acr oss le vels of t he stratificati o n fact or a n d c o u ntr y. 
F or t he a nal ysis descri be d a b o ve, s u bjects w h o pre m at urel y disc o nti n ue t he ra n d o mize d treat m e nt or 
i nitiate a n y treat me nt a dj ust me nts (e. g., use of pr o hi bite d/resc ue me dicati o n/resc ue treat me nt f or A D 
s y m pt o ms) will be ha n dle d as des cri b e d bel o w: 
 
If a s u bject wit h dra ws fr o m t he st u d y, t his s u bject will be c o u nte d as a n o n-res p o n der f or t h e ti m e 
p oi nts after wit h dra wal. 
 
T o acc o u nt f or t he i m pact of pr o hi bite d/resc ue me dicati o n/resc ue treat me nt f or A D s y m pt o ms o n 
t h e efficac y effect: if resc ue m e dicati o n/resc ue treat me nt f or A D s y m pt o ms is use d, t he s u bject will 
be s pecifie d as a n o n-res p o n der fr o m t he ti m e t he resc ue me dicati o n/resc ue treat me nt is use d. 
 
If t he s u bject has t h e missi n g val ue at Wee k 1 4, it will be c o u nte d as a n o n-res p o n der at Wee k 1 4. 
T he pri mar y efficac y a nal ysis will b e perf or m e d o n t he m o difie d i nte nt-t o-treat ( mI T T) p o p ulati o n, as 
well as per pr ot oc ol ( P P) p o p ulati o n as a s u p p orti n g a nal ysis. I n a d diti o n, f or c o m plete ness p ur p oses, 
res ults i ncl u di n g all s u bjects a n d e xcl u di n g t he s u bjects w h o ha d maj or pr ot o c ol de viati o ns o n t he basis 
of ke y i ncl usi o n a n d e xcl usi o n crit eria defi ni n g t h e p o p ulati o n of i nterest will be prese nte d. T he 
differe nces bet wee n t hese res ults will be n ote d, a n d t he i m pact of s uc h differe nces will be disc usse d i n 
t h e cli nical st u d y re p ort. 
T he bi nar y sec o n dar y efficac y e n d p oi nt will be a n al yze d usi n g t he sa me a p pr oac hes as t h at are use d f or 
t h e a nal ysis of t he pri mar y e n d p oi nt. 
Mi xe d M o del f or Re peate d M eas ures ( M M R M) a nal yses will be perf or me d o n c o nti n u o us e n d p oi nts t o 
miti gate t he i m p act of missi n g data. T his a p pr oac h ass u mes missi n g o bser vati o ns are missi n g at 
ra n d o m a n d b orr o ws i nf or mati o n fr o m s u bjects i n t he s a me treat m e nt gr o u p, ta ki n g i nt o acc o u nt t h e 
missi n g ness of data t hr o u g h t h e c orrel ati o n of t he re peate d meas ure m e nts.  
All c o nti n u o us e n d p oi nts will utilize M M R M after a p pl yi n g t he pri mar y ce ns ori n g r ule, i.e., t he r ul e 
will ce ns or data aft er per ma ne nt st u d y dr u g disc o nti n uati o n or after resc ue t hera p y. T his ce ns ori n g r ule 
is e q ui vale nt t o usi n g all t he data u p t o disc o nti n uati o n or resc ue. 
T he M M R M m o del will i ncl u de fi xe d effects f or baseli ne val ue, diseas e se verit y gr o u p, bi ol o gic- naï ve 
vs bi ol o gic-e x p ose d, c o u ntr y, treat me nt, st u d y wee k, t he treat me nt- b y- wee k i nteracti o n, a n d t he 
baseli ne- b y- wee k i nt eracti o n a n d all o w f or ra n d o m s u bj ect effects. Treat m e nt a n d wee k will eac h be 
fitt e d as cate g orical varia bles. T he m o del will ass u m e u nstr uct ure d c o vari a nce str uct ure. If t he m o del 
wit h u nstr uct ure d c o vari a nce d oes n ot c o n ver ge, t he n ot her c o vari a nce str uct ures will be c o nsi dere d t o 

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m o del t he wit hi n-s u bject err ors. T he Ke n war d- R o gers a p pr oac h f or c o m p uti n g de n o mi nat or de grees of 
free d o m will be use d t o acc o u nt a p pr o priatel y f or p o oli n g of wit hi n-s u bject a n d bet wee n-s u bject 
varia nce esti mates. Efficac y data o n s u bjects w h o pre m at urel y disc o nti n ue t he ra n d o mize d treat me nt or 
i nitiate a n y treat me nt a dj ust me nts (e. g., use of pr o hi bite d/resc ue me dicati o n/resc ue treat me nt f or A D 
s y m pt o ms) will be set t o missi n g at t he desi g nate d ti me p oi nts after wit h dra wal or after t h e start of s uc h 
treat me nt c ha n ges. T he L S M a n d 9 5 % CI f or t he differe nce bet wee n gr o u ps will be esti m at e d usi n g t he 
si m ple c o ntrast at eac h ti me p oi nt. 

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2.
B a c k g r o u n d 
2. 1 
Si glec- 8 a n d Lire nteli m a b  
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 k e 
lecti ns ( Si glecs), is a tra ns me m bra n e cell s urface pr ot ei n wit h restricte d tiss ue distri b uti o n, 
e x press e d s electi vel y o n t h e 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. Si glec- 8 c o ntai ns 3 e xtracell ular i m m u n o gl o b uli n-li k e 
d o mai ns, a tra ns m e 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 (I TI M) 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 rele ase, 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). Lire nteli ma b 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 
Lire nteli ma b is a h u ma ni ze d n o n-f u c 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 g ai nst Si glec- 8, a me m b er of t h e 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 distri b uti o n, e x presse d 
selecti v el y o n t he s urface of m at 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 lire nteli m a b 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 d e pleti o n of t hese cells fr o m t he circ ulati o n. I n t h e 
tiss ue, lire nteli ma b 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.  
Lire nteli ma b has bee n pr o d uce d i n 2 f or m ulati o ns: 1 f or i ntra ve n o us i nf usi o n (lire nteli ma b I V) 
a n d 1 f or s u bc ut a ne o us i njecti o n (lire nteli ma b S C) (see Se cti o n  1 0: St u d y Treat me nt).
Si glec- 8 is n ot e x press e d i n s pecies ot her t h a n h u m a ns a n d hi g h- or d er pri mates, a n d t heref ore, 
2 n o vel m o use m o dels ha ve bee n d e vel o pe d f or i n vi v o testi n g of lire nteli ma b. Lire nteli ma b has 
bee n st u die d i n Si glec- 8 h u m a nize d a n d tra ns ge ni c 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 nerati 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 h e 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 s ec o n d r o de nt m o del is a tra ns g e nic m o use li ne t h at e x presses h u ma n 
Si glec- 8. T he e x pressi o n of Si glec- 8 o n t h e cell s urface 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 urface e x pressi 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 g E- m e diate d a na p h yla xis i n t his tra ns ge ni c m o use li ne, 
i n dicati n g t h at Si glec- 8 is p har mac ol o gicall y acti v e i n t he m o del. T he a bilit y of lire nteli m a b t o 
affect mast cells a n d e osi n o p hils has bee n e val u ate d i n t his m o del. 

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Lire nteli ma b i n hi bits I g E- me diate d mast cell de gra n ulati o n a n d rel ease of t he ne wl y f or me d 
me diat or pr ost a 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, lire nteli ma b s h o ws selecti ve de pl eti o n of e osi n o p hils.
I m p ort a ntl y, i n a w h ole- bl o o d c yt o ki ne-release ass a y usi n g i m m o bilize d lire nteli ma b t o e n ha nc e 
t he p ote ntial f or a nti b o d y cr ossli n ki n g, lire nteli ma b di d n ot lea d t o d ose- de pe n de nt release 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 h at 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- d ose a n d re peat- d os e 
st u dies i n Si glec- 8 tra ns ge nic mice, lire nteli ma b d e m o nstrate d selecti ve de pleti o n of perit o neal 
mast cells a n d circ ul ati 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 t he 1- m o nt h a n d 6- m o nt h G o o d La b orat or y Practice ( G L P) t o xicit y a n d t o xic o ki neti c st u dies, 
lire nteli ma b I V w as w ell 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, t he l e 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. Lire nteli ma b 
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 m ate 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 V 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. T here w as n o e vi de n ce of a nti- dr u g a nti b o dies ( A D A) i n eit h er st u d y. 
Decr eases i n e osi n o p hil c o u nts i n b ot h se xes were o bser ve d, w hic h refl ect t he e x pecte d 
p har mac ol o g y of lire nteli ma b. T he n o- o bser ve d-a d verse-effect-le v el ( N O A E L) f oll o wi n g 
i ntra ve n o us a d mi nistrati o n of lire nteli ma b t o tra ns ge nic mice w as 1 0 0 m g/ k g. 
A G L P t o xic ol o g y st u d y was c o n d ucte d t o c haract erize t he l o cal t olera n ce a n d bi o a vaila bilit y of 
lire nteli ma b S C i n tra ns g e nic mice t o s u p p ort h u m a n cli nical st u dies. T he d ose, 6 0 m g/ k g, was 
selecte d t o re pres e nt a d ose le vel 6-f ol d hi g her t ha n t he hi g hest h u ma n d ose le vel ( 1 0 m g/ k g), 
t o i d e ntif y a N O A E L/ n o o bser v e d effect le vel ( N O E L) a n d w as re prese nt ati ve of t he I V 
lire nteli ma b d oses pre vi o usl y st u die d ( 5 0 m g/ k g a n d 1 0 0 m g/ k g). T here w ere n o 
lire nteli ma b-relat e d cli nical o bser v ati o ns f oll o wi n g S C or I V a d mi nistrati o n, a n d t here w ere 
n o lire nteli ma b-relat e d s ki n reacti o ns n ote d f oll o wi n g S C or I V a d mi nistrati o n. 
A G L P st u d y of lire nteli ma b S C was c o n d ucte d usi n g C 5 7 Bl/ 6 m ale bree d er mice a n d F 0 
ge nerati o n Si glec- 8 tr a ns ge nic fe mal e mice t o e val u ate t he effects of 6 0 m g/ k g lire nteli ma b S C 
o n fertilit y, de vel o p me nt, a n d p eri n atal/ p ost n atal re pr o d ucti o n, i ncl u di n g p ost natal 
be ha vi or/f u ncti o n. O bser vati o ns were c o nti n ue d t hr o u g h s e x ual mat urit y of t he F 1 g e nerati o n 
mice. T here w ere n o lire nteli ma b-relate d effects o n fertilit y, de vel o p me nt, or peri natal/ p ost natal 
re pr o d ucti o n, or o n t he p ost natal be ha vi oral assess me nts. Base d o n t hese res ults, t h e N O A E L of 
lire nteli ma b S C was c o nsi d ere d t o be 6 0 m g/ k g. 

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O ver vie w of Cli ni c al St u dies
Lire nteli ma b I V, a d mi nistere d e v er y 4 w ee ks, h as bee n pre vi o usl y teste d i n o ver 7 0 0 healt h y 
v ol u nteers a n d 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 gi c c o nj u ncti vitis ( A C), mast cell g astritis, 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). M ulti ple d oses of 3 m g/ k g ha ve bee n gi v e n t o patie nts wit h I S M, 
C U, A C, mast cell gastritis, a n d E G a n d/ or E o D. 
I n g e neral, lire nteli ma b I V has bee n w ell t olerate d. T he m ost c o m m o n treat m e nt-e mer g e nt 
a d verse e ve nts ( T E A E) o bser v e d w ere i nf usi o n-relate d reacti o ns (I R R). T he I R R were m ostl y 
mil d t o m o derate, a n d occ urre d m ost ofte n d uri n g t he first i nf usi o n. I R R t h at were d ee me d m ore 
seri o us t y picall y res ol ve d wit hi n 2 4 h o urs, a n d a d diti o nal c ortic oster oi ds a n d/ or a nti hista mi nes 
were us e d i n cases w he n sl o wi n g t he rate of i nf usi o n a n d a d diti o nal s u p p orti v e care al o ne di d n ot 
res ol v e t h e iss ue. C o m m o n s y m pt o ms of I R R were hea d ac he, n a usea, s w eati n g, fl us hi n g, a n d 
re d n ess. M ost I R R t h at occ urre d d uri n g t h e 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 h e i nf usi o n, wit h mi ni mal i nter ve nti o n. I n s u bjects wit h I S M, C U, se vere A C, 
a n d E G/ E o D, fe wer a d verse e ve nts ( A E) i n cl u di n g I R R were re p orte d d uri n g t h e sec o n d a n d 
s u bse q ue nt i nf usi o ns w he n c o m pare d t o t he first i nf usi o n. T he ris k of I R R has bee n s u bsta nti all y 
re d u ce d b y a d mi nistrati o n of a si n gle d ose of oral c ortic oster oi d (e. g., pre d nis o ne 6 0 m g) gi ve n 
orall y 1 2 t o 2 4 h o urs pri or t o t he first d ose of lire nt eli ma b I V.  
St u d y A K 0 0 2- 0 1 7 e val uate d t he P K a n d P D of lire nteli ma b I V a n d S C i n healt h y v ol u nteers. 
S u bjects recei v e d 0. 3, 1, 3, or 5 m g/ k g or a fi xe d d ose of 3 0 0 m g or 4 5 0 m g lire nteli ma b S C, or 
1 m g/ k g or 3 m g/ k g lire nteli ma b I V. 
I n eac h of t h e S C c o h orts, 8 s u bjects w ere ra n d o mize d t o lire nteli m a b ( 6 per gr o u p) or pla ce b o 
( 2 per gr o u p) i n a d o u ble- bli n d ma n ner; 1 2 s u bjects recei v e d lire nteli ma b I V ( 6 s u bjects per 
gr o u p) i n a n o pe n-la bel m a n ner.  
T he st u d y s h o we d t h at t h e P D effect ( de pl eti o n of bl o o d e osi n o p hils) occ urre d wit hi n 1 h o ur of 
d osi n g a n d laste d f or at l east 1 m o nt h at I V a n d S C d oses of 1 m g/ k g a n d f or 3 m o nt hs at all 
hi g her I V a n d S C d oses. T he S C i njecti o ns w ere well t olerate d, a n d n o i nj ecti o n sit e reacti o ns or 
ge neral i nje cti o n reacti o ns were n ote d at a n y d ose de m o nstrati n g s uita bilit y f or f urt her 
e val uati o n. 
I n t he A K 0 0 2- 0 0 5 st u d y i n patie nts wit h se vere A C, lire nteli ma b de m o nstrate d cli nical acti vit y 
i n relie vi n g t he si g ns a n d s y m pt o ms of se vere A C acr oss all m eas ure d d o m ai ns. T he st u d y 
s h o we d a 6 1 % i m pr o v e me nt i n patie nt-re p ort e d oc ular s y m pt o ms (t otal aller gic c o nj u ncti vitis 
s y m pt o ms [ A C S]) a n d 7 9 % of s u bjects were d ee me d res p o n ders at 2 wee ks f oll o wi n g t h e fi nal 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 3 4 of 1 3 5 
C o nfi d e nti al  
lire nteli ma b d ose c o m p are d t o baseli n e. I n v esti g at or-assesse d o c ular si g ns a n d s y m pt o ms (t otal 
O S S) als o i m pr o ve d b y 5 3 %, a n d 8 3 % of s u bjects were d ee me d res p o n ders at t he fi nal d ose ti me 
p oi nt c o m pare d t o baseli ne. A d diti o nall y, s y m pt o m b ur de n w as ass esse d acr oss m ulti ple at o pic 
c o m or bi dities, a n d s y m pt o m s e verit y decrease d s u bsta ntiall y acr oss all c o n diti o ns assesse d, 
i ncl u di n g i n at o pic der matitis ( A D), ast h ma, a n d r hi nitis. 
T he lac k of tr eat m e nt-rel ate d a d verse e ve nts ( A E) be y o n d I R R i n t he I V st u dies c o m bi ne d wit h 
t he cli nical acti vit y o bser ve d i n treati n g m ulti ple aller gic c o n diti o ns a n d t he ret ur n of si g ns a n d 
s y m pt o ms off treat m e nt ma ke lire nteli ma b a p ote ntiall y pr o misi n g ca n di date f or m ulti ple 
e osi n o p hil a n d mast cell- dri v e n i nfla m mat or y diseases, i ncl u di n g A D. 
2. 4  
At o pi c D er m atitis a n d R ati o n ale f or t he St u d y
At o pic der matitis is a c hr o nic pr uritic i nfla m mat or y der matitis t hat affects a p pr o xi m atel y 
1 6. 5 milli o n ( 7. 3 %) a d ults i n t he U S, of w hic h ar o u n d 6. 6 milli o n ( 4 0 %) ha ve m o derate-t o-
se vere disease. T h e pat h o ge nesis of A D is c o m ple x a n d i n v ol ves a b n or malities i n s ki n barrier 
f u ncti o n, altere d s ki n fl ora, a n d i m m u ne d ysre g ulati o n ( F u xe nc h, 2 0 1 9). T h ere is i ncrease d 
e x pressi o n of T h 2 a n d T h 2 2 c yt o ki nes li ke I L- 4, I L- 1 3, I L- 3 1, a n d I L- 2 2. M ast cell n u m bers are 
ele vate d i n t he s ki n of A D patie nts. T hese cells, b y virt u e of pr o d uci n g pr urit o ge nic me diat ors 
li k e hist a mi n e, tr y ptase a n d I L- 3 1, mi g ht c o ntri b ute t o A D s y m pt o ms. I n a d diti o n, mast cells 
ma y c o ntri b ute t o ne ur o g e nic i nfla m mati o n b y i nteracti n g wit h se ns or y n er ves. I n a d diti o n t o 
mast cells, e osi n o p hils ma y be ele v ate d i n patie nts wit h A D. It has bee n d e m o nstrate d t hat 
e osi n o p hils ta ke n fr o m A D bi o psies are acti v ate d a n d s h o w d ela y e d pr o gra m me d cell deat h. 
Ta ke n t o get her, t hese fi n di n gs s u g gest t hat acti vati o n a n d de gra n ulati o n of mast cells a n d 
e osi n o p hils m a y be a maj or c o m p o ne nt i n t h e pat h o ge nesis of A D a n d ma y re pres e nt s uita ble 
tar gets f or t hera pe utic i nt er v e nti o n. 
At o pic der matitis patie nts t y picall y e x perie n ce dr y s ki n a n d i nte nse pr urit us, w hic h ca n le a d t o 
de vel o p me nt of er yt h e mat o us pa p ules wit h e x u dati o n, cr usti n g, a n d e xc oriati o n. A rece nt st u d y 
of a d ults wit h m o derate-t o-se vere A D f o u n d t h at 7 0. 5 % re p orte d se vere, u n beara bl e itc h i n t he 
past 2 wee ks, 8 5. 8 % re p orte d dail y itc h, a n d 6 2. 8 % re p orte d itc hi n g at least 1 2 h o urs per da y. 
C hr o nicall y, t his ofte n lea ds t o s ki n t hic ke ni n g a n d lic he nificati o n, m ost c o m m o nl y i n s ki n 
fle x ures.  
At o pic der matitis ma y i n v ol ve t he face, n ec k, tr u n k, a n d e xtre mities. At o pi c der m atitis f oll o ws 
a c hr o nic rela psi n g c o urse a n d ca n be c o m plicate d b y de vel o p me nt of b acterial a n d viral s ki n 
i nfecti o ns. Patie nts wit h A D als o ha ve a n i ncrease d ris k of aller gic r hi nitis, ast h ma, f o o d 
aller gi es, a n d o c ular c o n diti o ns li ke at o pic kerat o c o nj u ncti vitis ( A K C) a n d v er nal c o nj u ncti vitis 
( V K C). 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 3 5 of 1 3 5 
C o nfi d e nti al  
T he mai n g oals of A D treat me nt are t o mai ntai n a d e q uate s ki n h y drati o n, re d u ce pr urit us a n d 
pre ve nt e x acer bati o ns. W hile oral a nti- hista mi nic a ge nts ma y hel p re d uce pr urit us, t o pical a ge nts 
are t h e m ai nsta y of treat m e nt. T hese i ncl u de m oist urizi n g/ e m ollie nt pre parati o ns, w hic h pr ote ct 
t he s ki n barrier a n d pre v e nt water l oss. Al o n g wit h m oist urizi n g a ge nts, t o pical a nti-
i nfla m mat or y a ge nts s uc h as c ortic oster oi ds a n d calci ne uri n i n hi bit ors (e. g., tacr oli m us a n d 
pi mecr oli m us) are us e d f or mil d-t o- m o derate disease as sec o n d li ne o pti o ns. Crisa b or ole, a 
t o pical p h os p h o diesteras e 4 ( P D E 4) i n hi bit or, was a p pr o ve d b y t he F D A i n Dece m b er 2 0 1 6, 
a n d is use d f or treat me nt of mil d-t o- m o derate A D. W hile t o pical a ge nts ca n be effecti ve i n mil d-
t o- m o derate disease, t here are l o n g ter m safet y c o ncer ns. T o pical ster oi ds ca n ca use s ki n atr o p h y 
a n d p ossi ble a dre n al s u p pressi o n d ue t o s yste mic a bs or pti o n. Tacr oli m us a n d pi mecr oli m us carr y 
a p ote nti al ris k of s ki n ca ncer, w hic h h as res ulte d i n a blac k b o x w ar ni n g b y t he F D A.  
T he ma na ge me nt of m o d erate-t o-se vere disease is m ore diffic ult. Patie nts ca n be treate d wit h 
p h ot ot h era p y ( 3 ti mes per wee k), w hic h is c u m bers o me, e x p e nsi v e, a n d m a y i ncreas e t he ris k of 
de vel o pi n g s ki n ca ncer. Oral c ortic oster oi ds are o ccasi o nall y use d b ut are li mite d b y si de effects 
i ncl u di n g i n crease d ris k of dia betes, h y perte nsi o n, a dre nal s u p pressi o n, a n d e ye diseas es li ke 
gla uc o ma a n d cataracts. A n oral cal ci ne uri n i n hi bit or (c ycl os p ori n) ca n be use d b ut re q uires 
fre q ue nt m o nit ori n g of dr u g le vels a n d carries ris ks of h y perte nsi o n, ne p hr ot o xicit y, 
h y pertric h osis, a n d g u m h y per plasia. Als o, l o n g-t er m use of ster oi ds a n d c ycl os p ori n lea ds t o 
i m m u n os u p pressi o n a n d i ncreas e d ris k of i nfecti o ns.  
I n M arc h 2 0 1 7, t h e F D A a p pr o ve d d u pil u ma b f or t h e treat m e nt of a d ult patie nts wit h m o derate-
t o-se vere A D n ot a de q uatel y c o ntr olle d wit h t o pical prescri pti o n t hera pies or w he n t h ose 
t hera pies are n ot a d visa bl e. D u pil u ma b is a f ull y h u ma n m o n ocl o nal a nti b o d y t h at bi n ds t o t he 
al p ha s u b u nit of t he I L- 4 rece pt or a n d i n hi bits si g nali n g of I L- 4 a n d I L- 1 3, alteri n g T-cell 
me diate d i m m u ne res p o nse, w hic h is belie ve d t o pla y a r ole i n A D. T h e l o n g-ter m ( 5 2 wee k) 
safet y a n d efficac y of d u pil u ma b was e val uate d i n a ra n d o mi ze d, d o u bl e- bli n d, place b o-
c o ntr olle d st u d y. C o nc o mita nt use of t o pical c ortic oster oi ds (a n d t o pical calci ne uri n i n hi bit ors, if 
i n dicate d) was all o we d. 
I n t he d u pil u ma b st u d y at Wee k 5 2, m ore patie nts i n t he d u pil u ma b-treate d gr o u p ac hie ve d t he 
I n v esti gat or Gl o bal Assess me nt (I G A) a n d Ecz e ma Area a n d Se verit y I n de x ( E A SI)- 7 5 
e n d p oi nts t ha n t he place b o-treate d gr o u p (a p pr o xi matel y 4 0 % vers us 1 3 % a n d 6 5 % vers us 2 2 %, 
res pecti vel y). H o we v er, t he d u pil u ma b-treat e d patie nts ha d a 2-f ol d hi g her i nci de nce of e ye 
dis or ders i n cl u di n g n o n-i nfecti o us c o nj u ncti vitis. T here c o nti n ues t o be a s u bsta ntial nee d f or 
ne w a n d better treat me nts f or m o derat e-t o-se v ere A D. B y re d uci n g e osi n o p hil n u m bers a n d 
bl oc ki n g mast cell acti v ati o n, lire nteli ma b ma y be usef ul i n t he treat m e nt of p atie nts wit h A D. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 3 6 of 1 3 5 
C o nfi d e nti al  
T his pr o of- of-c o nce pt st u d y will e val uate t he safet y, t olera bilit y, a n d P D of re peat d os es of 
lire nteli ma b S C i n pati e nts wit h m o derate-t o-se v ere A D a n d pr o vi de e vi de n ce f or effi cac y as 
assess e d b y s y m pt o mat ol o g y a n d s ki n e xa mi n ati o n. I n t his st u d y, s u bjects wit h m o derate-
t o-se vere dis ease, w hic h is defi ne d usi n g t he f oll o wi n g crit eria, will be i n cl u de d: 
C hr o nic A D t h at h as bee n dia g n ose d a n d prese nt f or at least 3 years at t he ti me of 
scree ni n g.  
 
S u bjects w h o ha ve faile d t o res p o n d t o me dicate d t o pical treat me nts (c ortic oster oi ds, 
calci ne uri n i n hi bit ors a n d/ or crisa b or ole) or w h e n t h ese treat me nts are c o ntrai n dicat e d or 
n ot me dicall y a d visa ble f or t h e s u bject.  
 
b o d y s urfa
 
T hese well-esta blis he d meas ures will o bjecti v el y defi ne t h e se v erit y of t h e dis ease at t h e ti m e of 
e ntr y i nt o t he st u d y. 
3.
R ati o n ale f or D os e Sel ecti o n 
A d osi n g re gi me n of 3 0 0 m g lire nteli ma b S C a d mi nistere d e ver y 2 w ee ks f or 7 d oses is 
pr o p ose d. T his re gi m e n is base d o n P K m o deli n g f or St u d y A K 0 0 2- 0 1 7, c o m p ari n g d osi n g 
re gi m e ns f or t he I V i nf usi o n d oses vs. t he S C i njecti o n d oses a d mi nistere d e ver y 2 8 da ys. T hese 
si m ulati o ns s h o we d t h at a d ose of 3 0 0 m g lire nteli ma b S C pr o vi d e d a s u bsta ntiall y l o wer C ma x  
a n d sli g htl y l o wer 1- m o nt h tr o u g h le vel t h a n 3 m g/ k g lire nteli m a b I V.  
Disc ussi o n wit h e x perts p artici pati n g i n der mat ol o gic trials wit h bi ol o gics a n d re p orts of e xter nal 
data fr o m ot her c o m p o u n ds tar geti n g A D s u p p ort t he use of hi g her or m ore fre q u e nt d osi n g t ha n 
i n ot h er aller gic diseases. Se veral st u dies ha ve re p orte d t hat hi g her or m ore fre q ue nt d osi n g is 
re q uire d f or t y pe II i m m u ne c o n diti o ns, f or e xa m pl e ast h ma, c o m p are d wit h A D. D ose-res p o nse 
relati o ns hi ps a n d res ults acr oss m ulti ple e n d p oi nts s h o w tre n ds t o war d i m pr o ve d efficac y wit h 
i ncreasi n g d ose a n d d urati o n a n d s u g gest t h at f urt h er i n creases i n d ose or treat me nt d urati o n 
mi g ht i m pr o ve efficac y ( Castr o, 2 0 1 8; C orre n, 2 0 1 7; Si m ps o n, 2 0 1 8; Si m ps o n, 2 0 1 9; Si m ps o n, 
2 0 2 0; Sil ver ber g, 2 0 2 0; W olle n ber g, 2 0 1 9) . C o ns e q ue ntl y, i ncreasi n g t he d ose fre q u e nc y of t h e 
3 0 0 m g d ose fr o m e ver y 4 wee ks t o e ver y 2 wee ks is pr o p ose d f or t h e A K 0 0 2- 0 1 8 st u d y.  
Si m ulati o ns usi n g A K 0 0 2- 0 1 7 st u d y data i n dicate t h at a fi xe d d ose of lire nteli ma b S C 3 0 0 m g 
e ver y 2 w ee ks is e x p ecte d t o pr o vi de great er e x p os ure t h a n t he 3 0 0 m g d os e a d mi nistere d 
m o nt hl y wit h o ut a n i ncrease d C ma x  c o m pare d wit h t he 3 m g/ k g I V d os e. T his d ose a n d fre q u e nc y 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 3 7 of 1 3 5 
C o nfi d e nti al  
of a d mi nistrati o n will res ult i n hi g her stea d y state le vels a n d is s u p p orte d b y a n e xc elle nt safet y 
a n d t olera bilit y pr ofile of lire nteli ma b i n patie nts wit h ot h er e osi n o p hilic a n d mast cell diseases. 
T he c o nce ntrati o n of lire nteli ma b S C of 1 5 0 m g/ m L is c o nsiste nt wit h a n i njecti o n v ol u me of 
2 m L f or t he 3 0 0 m g d ose, w hic h was well t olerat e d wit h o ut i njecti o n site reacti o ns i n St u d y 
A K 0 0 2- 0 1 7. W h e n pr o of of c o nce pt is esta blis he d, ot h er lire nteli ma b S C d oses a n d sc he d ul es 
ma y be e x pl ore d.
4.
St u d y O bjecti v es a n d E n d p oi nts
4. 1  
Pri m ar y O bjecti ve a n d E n d p oi nt 
T he pri mar y o bje cti v e of t he st u d y will be t o c haracterize t h e efficac y of lire nt eli m a b S C i n a d ult 
s u bjects wit h A D as assesse d b y t he differe nc e i n t h e pr o p orti o n of s u bjects w h o ac hie ve 
E A SI- 7 5 at Wee k 1 4. 
4. 2  
Sec o n d ar y O bjecti ves a n d E n d p oi nts 
T o f urt her c haracterize t h e effi cac y of lire nteli ma b S C i n a d ult s u bjects wit h A D as meas ure d b y 
t he f oll o wi n g: 
 
% C ha n ge i n E A SI fr o m baseli ne t o Wee k 1 4. 
 
Pr o p orti o n of s u bjects wit h I G A of 0 or 1 a n d a 2- p oi nt i m pr o ve me nt at Wee k 1 4 
vs baseli ne. 
4. 3  
E x pl or at or y O bjecti ves a n d E n d p oi nts 
T he e x pl orat or y o bj ecti v es of t he st u d y are t o better c haracteriz e t h e ti mi n g a n d nat ure of t he 
cli nical res p o nse t o lire nt eli m a b S C i n a d ult s u bjects as meas ure b y t h e f oll o wi n g e x pl orat or y 
effic ac y e n d p oi nts: 
 
C ha n ge i n 
 of 
slee p l oss at Wee k 1 4. 
 
Ti me t o o nset of res p o ns e o n t he 
, w here 
res p o nse is defi n e d as i m pr o ve me nt (at least a  
 re d ucti o n fr o m baseli n e) of wee kl y 
a vera g e of d ail y  
 d uri n g t h e 1 4- wee k treat me nt peri o d. T he a n al ysis will be base d o n 
 
C ha n ge fr o m baseli ne t o Wee k 1 4 i n  
 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 3 8 of 1 3 5 
C o nfi d e nti al  
 
P D of lire nteli ma b S C i n s u bjects wit h A D as meas ure d b y c ha n g es fr o m b aseli ne i n 
. 
 
Ot her i n dices of effic ac y of lire nteli ma b S C i n s u bjects wit h A D. C h a n ges i n si g ns a n d 
s y m pt o ms (c o m p are d t o baseli ne) bet w ee n lire nt eli ma b a n d place b o will b e meas ure d b y:
 C ha n ge fr o m baseli ne t o Wee k 1 4 i n 
 
 C ha n ge i n  
 fr o m baseli ne t o Wee k 1 4
 Pr o p orti o n of s u bjects w h o ac hie ve  
 
 Pr o p orti o n of s u bjects w h o ac hie ve  
 
 C ha n ge fr o m baseli ne t o Wee k 1 4 i n 
  
 C ha n ge fr o m baseli ne t o Wee k 1 4 i n 
  
 C ha n ge fr o m baseli ne o v er ti me i n 
 
4. 4  
S afet y O bjecti v es 
T o e val uate t he s afet y a n d t olera bilit y of lire nteli ma b S C i n s u bjects wit h A D b y deter mi ni n g A E 
i nci de nce a n d se verit y, st u d y wit h dra wals d ue t o A E, c ha n ges i n vital si g ns a n d la b orat or y tests 
i ncl u di n g i m m u n o ge nicit y, c ha n ges i n c o n c o mita nt me dicati o n use d ue t o A E, a n d ot her s afet y 
para m eters.
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 reacti o ns t o t h e S C i njecti o n. All T E A E will be c ollecte d fr o m t he st art of st u d y 
dr u g a d mi nistrati o n t hr o u g h Da y 1 6 9 ( ± 5 da ys) or Earl y T er mi n ati o n ( E T) d uri n g t he d o u ble-
bli n d peri o d of t h e st u d y. 
Se verit y will be assesse d usi n g t he Nati o nal Ca ncer I nstit ute ( N CI) C o m m o n Ter mi n ol o g y 
Criteria f or A d v erse E v e nts ( C T C A E) ta bles a n d t o xicit y gra di n g scale ( versi o n 5 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 d eter mi ne w het h er 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 u ati o ns i ncl u de cli nical la b orat or y tests c o m prisi n g a nti- dr u g a nti b o d y 
( A D A) t o lire nt eli ma b S C, c o m plete bl o o d c o u nts, c he mistries, a n d uri nal yses; p h ysical e xa ms; 
a n d vital si g n meas ure m e nts. 
T he Me dical M o nit or will re vie w bli n de d safet y d ata t hr o u g h o ut t he st u d y. Certai n safet y d ata 
( p ost-treat m e nt cell differe nti als) c ollecte d d uri n g t he d o u ble- bli n d peri o d of t he st u d y will n ot 
be pr o vi de d t o st u d y sites or t o t he S p o ns or as it ma y ca use bi as. T he desi g n ate d Safet y M o nit or 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 3 9 of 1 3 5 
C o nfi d e nti al  
will re vie w bli n de d safet y data as well as p ost-treat me nt cell c o u nts a n d will escalate t o t h e 
Me dical M o nit or, as nee de d, i n a ma n ner t h at d oes n ot ca us e bias.  
A n i n de pe n de nt D ata
M o nit ori n g C o m mittee (i D M C) has bee n c o n v e ne d a n d will meet i n 
acc or d a nce wit h t he i D M C c harter.
5.
St u d y Desi g n
5. 1 
St u d y O ver vie w
T his P h ase 2, pr o of- of-c o n ce pt, ra n d o mi ze d, d o u ble- bli n d, place b o-c o ntr oll e d st u d y will 
i n vesti gate t he effi cac y a n d safet y of lire nt eli m a b S C i n a d ult s u bjects wit h m o derate-t o-s e vere 
A D i na de q uatel y c o ntr olle d b y t o pical treat m e nts. A p pr o xi m atel y 1 3 0 s u bje cts will be e nr olle d 
i n u p t o 7 0 sites i n t he U S a n d Ger ma n y a n d will be ra n d o mize d 1: 1 t o recei ve eit her 
7 S C i njecti o ns of place b o or lire nteli ma b a n d t he n f oll o we d f or 1 2 w ee ks after t h e l ast d ose. 
S u bjects will be gi ve n t he o pti o n t o e nr oll i nt o a n o pe n-la bel e xt e nsi o n ( O L E) peri o d of t he 
st u d y, after c o m pleti n g t he Da y 9 9 visit of t he d o u ble- bli n d peri o d. S u bjects c h o osi n g n ot t o 
e nter t h e O L E p eri o d will c o nti n ue t o be f oll o we d i n t he d o u ble- bli n d peri o d of t he st u d y f or 
1 2 wee ks after t he last d ose. 
Base d o n t he fee d bac k fr o m at o pic der matitis e x p erts a n d c o m plete d feasi bilit y assess me nts, it is 
e x pecte d t h at eac h site will be a ble t o scree n t hree s u bjects a n d e nr oll t w o of t he m i n t he d urati o n 
of t he e nr oll m e nt p eri o d. E nr oll me nt is c o nsi dere d t o be c o m petiti ve. T o e ns ure t he e nr oll me nt 
g oal is ac hi e ve d i n a ti mel y ma n ner, u p t o 7 0 sites (a p pr o xi matel y 5 5 i n t he U S a n d
a p pr o xi matel y 1 5 i n Ger ma n y) will be i niti ate d. If st u d y e nr oll m e nt rate ca n be ac hie v e d wit h 
fe wer sit es i n or der t o meet t he st u d y ti meli ne, t he n fe wer sites ma y be nee de d. 
S u bjects will be c o nse nte d a n d scree ne d, a n d t h ose w h o meet eli gi bilit y crit eria ca n b e e nr olle d 
i n t h e st u d y. S u bjects w h o d o n ot meet all eli gi bilit y criteria at scree ni n g or w h o q ualif y at 
scree ni n g b ut are n ot e nr olle d ma y be assi g ne d a ne w patie nt i de ntificati o n n u m ber a n d 
rescree ne d o n ce. S u bjects rescree ne d wit hi n 3 0 da ys of si g ni n g t he i nitial i nf or me d c o ns e nt f or m 
(I C F) will n ot nee d t o si g n a ne w I C F if t here h a ve bee n n o c ha n ges t o t he I C F. 
S u bjects will be scree n e d f or a p pr o xi matel y 2 w ee ks (- 1 4 da ys) pri or t o d ose a d mi nistrati o n. 
D uri n g scre e ni n g a n d t hr o u g h vari o us ti me p oi nts d uri n g t h e st u d y, t he E A SI, I G A,  
 
 assess me nts will b e c o m plete d. A d diti o nal q uesti o ns will be as ke d 
a b o ut s y m pt o ms relate d t o ast h ma, aller gic r hi nitis, a n d aller gic c o nj u ncti vitis t hat s u bjects wit h 
t he at o pic c o n diti o n(s) m a y ha ve o n Da y 1, Da y 9 9, a n d O L E Da y 9 9 ( At o pic C o n diti o ns 
Q uesti o n naire). T o e ns ure t h ere is s uffi cie nt patie nt-re p orte d o utc o m e ( P R O) d ata at b aseli ne, a 

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s u bject s h o ul d c o m plete at least f o ur dail y P R O q u esti o n naires per wee k f or a mi ni m u m peri o d 
of t he se ve n d a ys pri or t o Da y 1. 
Certai n me dicati o ns are pr o hi bite d d uri n g t he st u d y. Use of s yste mic a n d/ or t o pical 
c ortic oster oi ds, calci ne uri n i n hi bit ors, J A K i n hi bit ors, t o pical P D E 4 i n hi bit ors (crisa b or ol e), 
d u pil u ma b, or tral o ki n u ma b are pr o hi bit e d d uri n g t h e st u d y. S u bjects w h o are o n a n y t o pical 
c ortic oster oi ds, t o pical calci ne uri n i n hi bit ors, t o pical J A K i n hi bit ors, or P D E 4 i n hi bit ors at t he 
ti m e of scree ni n g m ust disc o nti n ue t h ese at t he first scree ni n g visit. Bi ol o gics or m e dicati o ns t hat 
ma y i nterfere wit h t he st u d y safet y or effic ac y ass ess me nts s uc h as s yste mic 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 or bi ol o gics a n d s yste mic c ortic oster oi ds m ust b e dis c o nti n ue d 
pri or t o t he first scree ni n g visit (see Secti o n  8. 5 E xcl usi o n Criteria) a n d are pr o hi bite d 
t hr o u g h o ut t he st u d y. 
D uri n g t he last 7 da ys pri or t o Da y 1 (t he first da y of st u d y dr u g d osi n g), t he s u bject m ust ha ve 
use d, at least t wice d ail y, o nl y n o n- me dicate d t o pi cal t h era p y (i.e., e m olli e nt) wit h o ut ot her 
acti v e i n gre die nts i n dicat e d t o treat A D or ot h er a d diti ves w hic h c o ul d affect A D (e. g., 
h yal ur o nic aci d, urea, cera mi de, or fila g gri n de gra dati o n pr o d ucts). If a s u bject is n ot usi n g a n y 
e m ollie nt at t he ti m e of scree ni n g, a s uita ble n o n- me dicate d, n o n- prescri pti o n e m olli e nt will be 
rec o m me n d e d b y t h e I n v esti g at or. 
Eli gi ble s u bjects w h o m eet selecti o n criteria at scree ni n g a n d at b aseli ne will recei ve t he first 
d ose of lire nteli ma b S C or place b o S C o n Da y 1, f oll o we d b y 6 a d diti o nal d oses o n Da ys, 1 5, 2 9, 
4 3, 5 7, 7 1, a n d 8 5. 
S u bjects will be gi ve n t he o pti o n of e nteri n g a n O L E peri o d of t he st u d y after c o m pleti n g t he 
Da y 9 9 visit of t he d o u ble- bli n d peri o d of t h e st u d y, c o nti n ge nt o n meeti n g defi ne d st u d y 
selecti o n criteria. S u bjects n ot e nteri n g t he O L E p eri o d will be f oll o we d f or 1 2 wee ks after t h e 
last d ose i n t he d o u ble- bli n d peri o d.  
T he pri mar y e n d p oi nt will be assesse d at Wee k 1 4, i.e., 2 wee ks f oll o wi n g t he last d ose i n t he 
d o u ble- bli n d peri o d of t h e st u d y. 
Ra n d o mizati o n will b e stratifie d b ase d o n I G A 3 vs. 4 a n d o n bi ol o gic st at us, naï ve vs. e x p ose d. 
A p pr o xi matel y 4 0 % of t he st u d y p o p ulati o n will be s u bjects wit h a n I G A of 4. 
Fres h bi o psies of l esi o nal a n d n o n-lesi o nal s ki n ma y be c ollecte d fr o m p atie nts pre d ose a n d p ost-
d ose at select e d U S sites. Pr o vi di n g bi o psies is o pti o nal, a n d s u bjects will si g n a se parate c o ns e nt 
f or m f or bi o ps y c ollecti o n. 

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T he st u d y is desi g ne d as f oll o ws: 
A scree ni n g peri o d of a p pr o xi matel y 1 4 da ys wit h baseli n e e val u ati o ns f or st u d y eli gi bilit y. 
 
D uri n g t he scree ni n g peri o d, t h e E A SI, 
 will be deter mi n e d, a n d a 
baseli n e will be esta blis h e d.
 
If s u bjects meet eli gi bilit y criteria, t he I nteracti v e Res p o nse T ec h n ol o g y (I R T) s yste m will 
assi g n s u bjects 1: 1 t o recei ve 7 d oses of 3 0 0 m g lire nteli m a b S C or place b o S C. S u bjects 
will b e stratifie d b ase d o n bi ol o gic- naï ve vs bi ol o gic-e x p ose d stat us a n d I G A sc ore at 
baseli n e. 
 
Eli gi ble s u bjects will recei ve t he first d ose of lire nteli ma b S C or i d e nti cal place b o o n 
Da y 1. If t h e st u d y dr u g is w ell t olerate d ( n o st o p pi n g r ules bei n g met), s u bjects will recei v e 
a d diti o nal d oses of lire nt eli ma b S C or place b o S C o n Da ys 1 5 ( D ose 2), 2 9 ( D ose 3), 
4 3 ( D ose 4), 5 7 ( D ose 5), 7 1 ( D ose 6), a n d 8 5 ( D ose 7). 
 
S u bjects will be gi ve n a n o pti o n of e nteri n g t he O L E peri o d t o recei v e 7 a d diti o nal d oses of 
o pe n-la bel st u d y dr u g. 
 
S u bjects will be f oll o we d f or 1 2 a d diti o nal wee ks or 8 4 da ys aft er last d ose if E T, after t h e 
d o u ble peri o d or t he O L E peri o d. 
 
S u bjects will re mai n at t he site f or at least 1 h o ur of o bser v ati o n f oll o wi n g t he e n d of t he 
S C i njecti o n.  
 
S u bjects will c o m plete a n u m ber of assess m e nts a n d q uesti o n naires, i ncl u di n g dail y e P R O, 
t hr o u g h o ut t he d urati o n of t h e st u d y. 
 
T otal st u d y d urati o n is a p pr o xi matel y 7 m o nt hs f or t he d o u ble- bli n d peri o d a n d 9 m o nt hs if 
t he s u bject c h o oses t o e nt er t h e O L E p eri o d. 
5. 2  
Sc he d ul e of E v e nts a n d St u d y Di a gr a m 
T he o verall sc he d ule of ass ess me nts a n d pr oce d ures is descri be d i n  Ta bl e 1. T he st u d y dia gra m 
is prese nte d i n Fi g ure 1. 

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A D A: 
A nti-lire nteli ma b a nti b o d y 
E O S: E n d of St u d y  
I R T: 
I nteracti ve Res p o nse Tec h n ol o g y 
 
  
F S H: F ollicle- Sti m ulati n g H or m o n e  
P K: 
P h ar mac o ki netics 
C B C: 
C o m plete Bl o o d C o u nt  
h C G: H u ma n C h ori o nic G o n a d otr o pi n  
 
  
  
I g E: I m m u n o gl o b uli n E 
  
E A SI: E cze m a Area a n d Se v erit y I n de x 
I P: 
I n v esti gati o n al Pr o d u ct  
vI G A: 
Vali date d I n v esti g at or’s Gl o bal Assess me nt 
E C G: 
Electr ocar di o gra m  
T a ble 1 N otes 
1) 
D ose 1 is t h e d a y of t h e first S C i njecti o n. D ose 1/ Da y 1 ca n o cc ur wit hi n a ± 3 d a y wi n d o w, i.e., t h e scree ni n g p eri o d ca n be a m a xi m u m of 1 7 d a ys a n d a mi ni m u m of 
1 1 da ys. D osi n g visits m ust be c o n d ucte d wit hi n t h e ± wi n d o ws sti p ulate d i n t h e pr ot oc ol.  
2) 
T he E O S visits s h o ul d b e c o n d u cte d 1 4, 5 6, a n d 8 4 ( ± 5) da ys after t h e last d ose of st u d y dr u g or pri or t o t his, if n ecessar y, t o e ns ure c o m plia n ce wit h t he visit. If t h e E O S visit 
o cc urs m ore t h a n 5 6 d a ys after t h e last d ose of st u d y dr u g, t he n p erf or m t he visit as s o o n as p ossi ble. T h e pr oce d ures liste d u n der t h e 1 4- d a y p ost-st u d y dr u g visit will b e 
c o n d ucte d u nless ot h er wise directe d b y t h e Me dical M o nit or. F or s u bjects p artici p ati n g i n t h e O L E peri o d, A E a n d c o n c o mita nt me dicati o ns s h o ul d be c ollecte d a n d rec or de d 
i n t he A K 0 0 2- 0 1 8 d o u ble bli n d treat me nt peri o d d ata base u p u ntil t h e start of t h e first o pe n-la bel S C i njecti o n after t h e Da y 9 9 visit. 
3) 
D oc u me ntati o n of A D dia g n osis a n d pre vi o us treat m e nts s h o ul d b e n ote d i n d etail. T his ca n b e s u bject re p orte d a n d/ or b ase d o n me dical rec or ds (see d etails i n Secti o n  1 2. 2. 6). 
4) 
At scree ni n g, hei g ht (i n c m) a n d wei g ht (i n k g) will b e rec or d e d. B o d y wei g ht will be meas ure d at e v er y visit. 
5) 
Vital si g ns will be m eas ure d at e v er y visit. O n all d osi n g d a ys: wit hi n 3 0 mi n utes pre d ose, 1 5 ( ± 5) mi n utes after a d mi nistrati o n of st u d y dr u g S C i njecti o n, a n d j ust pri or t o 
disc har g e. A d diti o nal vital si g n m eas ure me nts m a y b e c ollecte d at t h e I n v esti gat or’s discreti o n if a n i njecti o n-relate d reacti o n (I R R) o cc urs. 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 m eas ure d after t h e s u bject 
o btai ne d ( u nless c ollecte d f or a n I R R). 
6) 
A 1 0-lea d or 1 2-lea d E C G will be o btai n e d at scree ni n g b ef ore a n y bl o o d is dra w n a n d after t h e s u bject h as b ee n i n t he resti n g 
 
7) 
A c o m plete p h ysical e x a mi nati o n will b e perf or me d b y eit her t he I n vesti g at or or d esi g n ee a n d i ncl u d e t he f oll o wi n g b o d y s yste m or or g a n assess m e nts: s ki n; h ea d, e yes, ears, 
n ose, a n d t hr o at; t h yr oi d; l u n gs; car di o vasc ular; a b d o me n; e xtre mities; l y m p h n o d es; a n d a brief ne ur ol o gical e xa mi n ati o n. A s y m pt o m- directe d p h ysical e x a m (i ncl u di n g 
assess me nt of p ossi ble i njecti o n site reacti o ns) will b e p erf or me d b y t h e I n v esti g at or or desi g n ee, as n ee d e d, if a n y s y m pt o ms are re p orte d. 
8) 
Acti vate P R O q u esti o n n aire a n d pr o vi d e s u bject wit h u ni q ue user na me a n d pass w or d. P R O q u esti o n n aire s h o ul d b e acti vate d f or all s u bjects o n scree ni n g Da y 1. 
9) 
D uri n g scree ni n g, vI G A, E A SI, 
 will b e d eter mi ne d, a n d a b aseli ne will b e esta blis he d. vI G A, E A SI, 
 m ust b e 
c o m plete d pre d ose o n d osi n g d a ys. T o e ns ure t h ere is s ufficie nt P R O d ata at b aseli n e, a s u bject s h o ul d c o m plete at least f o ur d ail y P R O q uesti o n n aires p er wee k f or a 
mi ni m u m peri o d of t he se ve n da ys pri or t o Da y 1. 
1 0) S u bjects will b e pr o m pte d t o a ns wer a d diti o n al q u esti o ns a b o ut s y m pt o ms relate d t o ast h ma, aller gic r hi nitis, a n d aller gic c o nj u ncti vitis ( At o pic C o n diti o ns Q u esti o n n aire). 
1 1) Bl o o d sa m ples f or t otal ser u m I g E will b e c ollecte d d uri n g scree ni n g, pre d ose o n Da ys 5 7 a n d 8 5, o n f oll o w- u p Da ys 9 9, 1 4 1, a n d 1 6 9, or 1 4, 5 6, a n d 8 4 ( ± 5) d a ys after t h e 
last d ose of st u d y dr u g if earl y ter mi nati o n ( E T). 

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T a ble 1 N otes c o nt.  
1 2) Bl o o d f or ser ol o g y testi n g will b e c ollecte d d uri n g scree ni n g a n d will i ncl u d e H Bs A g, h e p atitis C a nti b o d y, a nti- H Bc, a n d HI V. 
1 3) Fe male s u bjects of c hil d b eari n g p ote ntial are re q uire d t o ha ve h C G meas ure d. P ost m e n o pa usal w o me n are re q uire d t o h a v e F S H meas ure d. If 
n e g ati v e ser u m h C G will b e re q uire d d uri n g t h e scree ni n g p eri o d i n or d er f or s u bject t o pr ocee d t o ra n d o mizati o n. Bl o o d f or c h e mistr y will b e o btai n e d pre d ose o n d osi n g 
d a ys a n d f oll o w- u p da ys ( 1 4, 5 6, a n d 8 4 [ ± 5] d a ys after t he last d ose of st u d y dr u g if E T).  
1 4) Bl o o d f or C B C wit h differe ntial, i ncl u di n g a bs ol ute bl o o d e osi n o p hil c o u nt, will b e o btai ne d at scree ni n g, j ust pri or t o eac h S C i njecti o n, 1 h o ur ( ± 1 5 mi n utes) after t h e e n d of 
eac h S C i njecti o n, a n d o n all f oll o w- u p d a ys ( 1 4, 5 6, a n d 8 4 [ ± 5] d a ys after last d ose if E T). All differe ntial bl o o d c o u nts fr o m Da y 1 ( p ost- d ose) t hr o u g h t he e n d of t h e 
s u bject’s partici pati o n i n t h e d o u ble- bli n d p eri o d will be bli n de d t o t he S p o ns or a n d t h e site. A n u nsc he d ule d C B C ma y be c ollecte d at t h e re q uest of t he Safet y M o nit or. 
1 5) Bl o o d f or P K will b e o btai n e d pre d ose o n all d osi n g d a ys as well as o n Da y 8 ( ± 3) a n d o n f oll o w- u p d a ys ( 1 4, 5 6 a n d 8 4 [ ± 5] d a ys after last d ose of st u d y dr u g if E T).
1 6) Bl o o d f or A D A will be c ollecte d pre d ose o n d osi n g Da ys 1, 4 3, a n d 8 5 ( ± 5), as well as o n Da y 8 ( ± 3), a n d o n f oll o w- u p Da ys 9 9 a n d 1 6 9 ( 1 4 a n d 8 4 [ ± 5] d a ys after last d ose 
of st u d y dr u g if E T). T h e A D A sa m ple will als o b e c ollecte d a n y ti m e a n i m m u n o ge nicit y-relate d A E occ urs. 
1 7) Uri ne will b e c ollecte d f or di pstic k pre g n a n c y test o n all d osi n g d a ys, Da y 8, a n d all f oll o w- u p d a ys ( 1 4, 5 6, a n d 8 4 d a ys after last d ose of st u d y dr u g if E T) f or all s u bjects of 
c hil d beari n g p ote ntial. Test kits will b e s u p plie d b y t h e ce ntral la b orat or y. T ests will b e c o m plete d o n site a n d e v al u ate d pri or t o eac h S C i njecti o n. 
1 8) Uri ne f or sta n dar d uri nal ysis will b e o btai n e d at scree ni n g a n d o n f oll o w- u p Da ys 9 9 a n d 1 6 9 ( 1 4 a n d 8 4 d a ys [ ± 5] if E T), a n d s y m pt o m- b ase d, as n ecessar y. 
1 9) Ra n d o mizati o n will be c o n d u cte d t hr o u g h t he I R T s yste m. S u bjects will b e ra n d o mize d 1: 1, lire nteli m a b S C 3 0 0 m g or place b o S C. T h e y will be stratifie d b ase d o n bi ol o gic 
stat us a n d I G A sc ore at b aseli ne. 
2 0) T h e ca pt ure of n o n-seri o us A E a n d a d v erse e ve nts of s pecial i nterest ( A E SI) will be gi n after t h e first d ose of st u d y dr u g h as o cc urre d. 
2 1) T h e re p orti n g of seri o us a d verse e v e nts ( S A E) o cc urri n g after si g ni n g t he I C F  a n d pri or t o t he first S C i njecti o n will be li mite d t o t h ose t h at relate t o scree ni n g pr oce d ures. T h e 
ca pt ure of all S A E a n d A E t h at are n ot relate d t o scree ni n g pr oce d ures will be gi n at t h e ti me of first S C i njecti o n of st u d y dr u g. F or s u bjects p artici p ati n g i n t h e O L E p eri o d, 
A E will b e assesse d a n d rec or d e d i n t h e C R F of t h e A K 0 0 2- 0 1 8 d o u ble- bli n d treat me nt p eri o d d ata b ase u p u ntil t h e start of t he first O L E S C i njecti o n, after t h e Da y 9 9 visit. 
T he A E will be rec or de d i n t he C R F of t h e A K 0 0 2- 0 1 8 O L E peri o d d ata b ase b e gi n ni n g wit h t h e start of t h e first o p e n-la bel S C i njecti o n after Da y 9 9. 
2 2) Lesi o n al a n d n o n-lesi o n al bi o psies will b e c ollecte d at selecte d U S sites a n d o nl y f or s u bjects w h o c o nse nt t o t his o pti o nal pr oce d ure. Bi o psies ma y be c ollecte d at baseli n e 
pre d ose o n Da y 1 a n d a gai n o n Da y 9 9/ Wee k 1 4. See Secti o n  1 2. 1. 1 0. 
2 3) O p e n-la b el e xte nsi o n d osi n g m a y start o n Da y 9 9 after all Da y 9 9 pr o ce d ures are c o n d u cte d or wit hi n 7 da ys after t h e Da y 9 9 visit. S u bjects w h o deci d e t o e nter t he O L E 
p eri o d a n d meet t he selecti o n criteria f or t h e O L E peri o d, will f oll o w t h e sc h e d ule of e v e nts i n  A p p e n di x 1 1 a n d d o n ot nee d t o re p eat Da y 9 9 pr o ce d ures if O L E Da y 1 visit is 
c o m plete d o n t he sa me d a y as Da y 9 9 visit. 

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Fi g ure 1
St u d y Di a gr a m
D B = D o u ble- Bli n d Peri o d; F U- F oll o w U p; S C =s u b c uta n e o us; O L E = O p e n L a bel E xte nsi o n; E O S = E n d of St u d y

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6.
Esti m a n d C o nsi der ati o ns 
T he esti m a n d f or t h e A K 0 0 2- 0 1 8 st u d y esti mates t he effect of tr eat m e nt, w hile c o nsi deri n g 
treat me nt a d here nce a n d res p o nse. T he esti ma n d will pr o vi de a n a ns wer t o t he q uesti o n t hat is 
cr ucial t o i n di vi d ual s u bjects: “If I ta ke t his st u d y me dicati o n as p art of m y treat m e nt re gi m e n, 
wit h o ut a d di n g a n y f urt h er dr u gs or e xit t h e st u d y pre mat urel y, w hat i m pr o v e me nt ca n I e x pect 
after 1 4 w ee ks?”
T ar get of Esti m ati o n 
C o nsiste nt wit h t he I C H E 9 A d de n d u m ( F D A, 2 0 2 1), defi niti o n of t he attri b utes of t h e esti m a n d 
(tar get of esti mati o n) is pr o vi de d i n t his secti o n. 
T he pri mar y esti m a n d of t he st u d y is a c o m p osite esti ma n d, w hic h esti mates t he effect of 
ra n d o mize d tr eat m e nt a n d acc o u nts f or n o n-res p o n ders b ase d u p o n i nterc urre nt e v e nts as 
defi ne d. 
P o p ul ati o n T ar gete d b y t he Scie ntific Q uesti o n 
T he p o p ulati o n tar gete d b y t he scie ntific q uesti o n is defi n e d via t he i n cl usi o n a n d e xcl usi o n 
criteria as part of t he st u d y pr ot oc ol. S u bjects ma y be male or fe male a n d m ust ha ve a cli nical 
dia g n osis of m o derate-t o-se vere A D i na d e q uat el y c o ntr olle d b y t o pical treat me nts as defi ne d b y 
t he st u d y i ncl usi o n crit eria. 
V ari a ble ( or E n d p oi nt) t o be O bt ai ne d f or E a c h S u bject t h at is Re q ui re d t o A d dress t he 
Scie ntific Q uesti o n
T he pri mar y e n d p oi nt t o be o btai n e d f or eac h s u bject i n t his st u d y t o a d dress t he scie ntific 
q uesti o n is t h e pr o p orti o n of s u bjects w h o ac hie v e E A SI- 7 5 at Wee k 1 4. F or partici pa nts w h o 
dr o p o ut or i nitiate resc u e or pr o hi bite d me dicati o n d uri n g t he st u d y, t he o utc o me will be defi ne d 
as “ n o n-res p o n der” aft er t he date of s uc h e ve nts. 
S pecific ati o n of H o w t o Acc o u nt f or I nterc ur re nt E ve nts t o Reflect t he Scie ntific Q uesti o n
of I nterest
T he f oll o wi n g i nterc urre nt e ve nts will be a ntici pate d a n d a d dresse d: 
Pre mat ure disc o nti n uati o n fr o m t he st u d y  
 
Use of pr o hi bite d me dicati o ns or resc ue t h era p y d uri n g t h e st u d y 
F or t he a nal ysis of t h e esti m a n d, s u bjects w h o pre mat urel y dis c o nti n ue t h e ra n d o mize d tr eat m e nt 
or i nitiate a n y resc ue or pr o hi bite d me dicati o n will be c o nsi dere d treat me nt n o n-res p o n ders at t h e 
desi g nate d ti me p oi nts after t he st art of s uc h treat m e nts .  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 4 8 of 1 3 5 
C o nfi d e nti al  
7.
Criteri a f or E v al u ati o n 
7. 1 
S afet y E n d p oi nts
T he safet y a n d t olera bilit y of lire nt eli m a b S C will be assesse d b y d eter mi ni n g t h e i n ci 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, a n d c ha n g es i n vital 
si g ns, la b orat or y tests, c h a n g es 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 p ara meters. T hese e n d p oi nts will b e base d o n t he f oll o wi n g:  
A d vers e e ve nts ( Secti o n 1 4. 1)  i ncl u di n g se verit y, wit h dra wals d ue t o A E, a n d ot her safet y 
para m eters. 
 
A d vers e e ve nts of s p ecial i nterest ( A E SI), i njecti o n-relate d reacti o ns (I R R), mali g na nc y, 
parasitic i nfecti o ns, a n d o p p ort u nistic i nfecti o ns ( Secti o n  1 4. 3) 
 
A nti- dr u g a nti b o dies ( Secti o n  1 2. 3. 6): Bl o o d (ser u m) will be c ollecte d f or assess me nt of 
A D A usi n g a vali date d assa y met h o d.  
 
Bl o o d c he mistr y ( Secti o n  1 2. 3. 1) 
 
He mat ol o g y ( Secti o n  1 2. 3. 1) 
 
Uri nal ysis ( Secti o n  1 2. 3. 4) 
 
P h ysi cal e xa mi n ati o n ( Secti o n  1 2. 2. 2 a n d Secti o n  1 2. 2. 4) 
 
C ha n ges i n vital si g ns ( Secti o n  1 2. 2. 7) 
 
C ha n ges i n c o nc o mit a nt me dicati o n use d ue t o A E ( Secti o n  1 2. 2. 1)
7. 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 lire nt eli m a b S C 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 ( E LI S A) m et h o d.  
T he P K bl o o d sa m ples will be o btai ne d pre d ose o n Da y 1 ( ± 3), D a y 8 ( ± 3), Da ys 1 5, 2 9, 4 3, 5 7, 
7 1, a n d 8 5 ( ± 5), a n d f oll o w- u p Da ys 9 9, 1 4 1, a n d 1 6 9 ( 1 4, 5 6, a n d 8 4 da ys [ ± 5] after t he last 
d ose if E T). A d diti o nal P K sa m ples will be c oll ect e d i n t he O L E peri o d of t h e st u d y pre d ose o n 
all d osi n g da ys.  
7. 2. 1  
Pri m ar y Effic ac y E n d p oi nts 
T he pri mar y efficac y e n d p oi nt i n t he st u d y will be pr o p orti o n of s u bjects w h o ac hie ve E A SI- 7 5 
at Wee k 1 4. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 4 9 of 1 3 5 
C o nfi d e nti al  
7. 2. 2 
S ec o n d ar y Effic ac y E n d p oi nts 
T he sec o n d ar y efficac y e n d p oi nts will be t h e f oll o wi n g: 
% C ha n ge i n E A SI fr o m baseli ne t o Wee k 1 4.
Pr o p orti o n of s u bjects wit h I G A of 0 or 1 a n d a 2- p oi nt i m pr o ve me nt at Wee k 1 4 c o m pare d
t o place b o.
7. 2. 3  
E x pl or at or y Effic ac y E n d p oi nts 
T he f oll o wi n g e x pl orat or y e n d p oi nts will be meas ure d: 
C ha n ge i n 
 at Wee k 1 4.
Ti me t o o nset of res p o ns e o n t he 
, w here
res p o nse is defi n e d as i m pr o ve me nt (at least a  
 re d ucti o n fr o m baseli n e) of wee kl y
a vera g e of d ail y  
 d uri n g t h e 1 4- wee k treat me nt peri o d. T he a n al ysis will be base d o n
s u bjects wit h a baseli ne  
.
C ha n ge fr o m baseli ne t o Wee k 1 4 i n 
P D of lire nteli ma b S C i n s u bjects wit h A D as meas ure d b y c ha n g es fr o m b aseli ne i n
.
Ot her i n dices of effic ac y of lire nteli ma b S C i n s u bjects wit h A D. C h a n ges i n si g ns a n d
s y m pt o ms (c o m p are d t o baseli ne) bet w ee n lire nt eli ma b a n d place b o will b e meas ure d b y:
C ha n ge fr o m baseli ne t o Wee k 1 4 i n 
C ha n ge i n  
 fr o m baseli ne t o Wee k 1 4
Pr o p orti o n of s u bjects w h o ac hie ve 
Pr o p orti o n of s u bjects w h o ac hie ve 
C ha n ge fr o m baseli ne t o Wee k 1 4 i n 
C ha n ge fr o m baseli ne t o Wee k 1 4 i n 
C ha n ge fr o m baseli ne o v er ti me i n 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 0 of 1 3 5 
C o nfi d e nti al  
8.
S u bject Selecti o n
8. 1  
N u m ber of S u bjects 
A t otal of a p pr o xi m atel y 1 3 0 s u bjects wit h m o derate-t o-se v ere A D will be e nr olle d a n d 
ra n d o mize d i n a d o u ble- bli n d ma n ner, 1: 1, t o recei ve 1 of t he f oll o wi n g tr eat m e nts: 
 
Place b o S C a d mi nistere d e ver y 2 w ee ks  
 
Lire nteli ma b S C at 3 0 0 m g a d mi nistere d e ver y 2 wee ks  
E nr oll me nt will be m o nit ore d t o li mit t he i m pact of ra n d o mi zi n g a dis pr o p orti o natel y lar ge 
n u m ber of s u bjects wit h a n E A SI s c ore i n t he l o w er ra n g e, reflecti n g m ore m o derate disease o nl y 
(i.e., E A SI sc ore < 2 2). T his will als o pr o vi de a s u bject p o p ulati o n wit h a f ull ra n g e of E A SI 
sc ores c o nsiste nt wit h t he i nte nt t o st u d y lire nt eli m a b i n m o derate-t o-s e vere A D dis ease.
8. 2  
N u m ber of Sites 
U p t o 7 0 sites i n t he U nite d States a n d Ger ma n y will partici pate i n t his st u d y. 
Base d o n t he fee d bac k fr o m at o pic der matitis e x p erts a n d c o m plete d feasi bilit y assess me nts, it is 
e x pecte d t h at eac h site will be a ble t o scree n t hree s u bjects a n d e nr oll t w o of t he m i n t he d urati o n 
of t he e nr oll m e nt p eri o d. E nr oll me nt is c o nsi dere d t o be c o m petiti ve. T o e ns ure t he e nr oll me nt 
g oal is ac hi e ve d i n a ti mel y ma n ner, u p t o 7 0 sites (a p pr o xi matel y 5 5 i n t h e U S a n d 
a p pr o xi matel y 1 5 i n Ger ma n y) will be i niti ate d. If st u d y e nr oll m e nt rate ca n be ac hie v e d wit h 
fe wer sit es i n or der t o meet t he st u d y ti meli ne, t he n fe wer sites ma y be nee de d. 
8. 3  
St u d y P o p ul ati o n 
A p pr o xi matel y 1 3 0 male a n d fe male a d ult s u bjects wit h m o derate-t o-se v ere A D i na de q u atel y 
c o ntr olle d b y t o pical treat me nts will be e nr olle d i n t he st u d y. S u bjects will be eit her bi ol o gic-
naï ve or bi ol o gic-e x p os e d. Bi ol o gic-e x p ose d s u bjects i ncl u de t h ose w h o h a ve de m o nstrate d 
sec o n dar y l oss of res p o nse, i nt olera nce, or lac k of access t o bi ol o gics d ue t o ec o n o mic reas o ns. 
8. 4  
I ncl usi o n Criteri a 
S u bjects are eli gi ble f or t he st u d y if all of t he f oll o wi n g crit eria are met: 
1) 
S u bject is a ble t o u n dersta n d t he i nf or mati o n o n t h e st u d y, has t h e ca p acit y t o c o nse nt, a n d 
has pr o vi de d writt e n i nf or me d c o nse nt. 
2) 
 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 1 of 1 3 5 
C o nfi d e nti al  
3) 
C hr o nic A D (as d efi ne d b y t he A merica n A ca d e m y of D er mat ol o g y C o nse ns us Criteria) 
( Eic he nfiel d, 2 0 1 4); t h at has bee n prese nt f or at least 3 years bef ore s cree ni n g visit.  
4) 
D oc u m e nte d rece nt hist or y of i n a de q u ate res p o ns e t o treat m e nt wit h t o pical me dicati o ns 
s uc h as t o pical c ortic ost er oi ds, cal ci ne uri n i n hi bit ors, J A K i n hi bit ors, or P D E 4 i n hi bit ors 
(cris a b or ol e) f or at least 4 wee ks i n t he 6 m o nt hs pri or t o scree ni n g, or s u bjects f or w h o m 
t hese t o pical treat m e nts are ot her wis e m e dicall y i n a d vis a ble (e. g., b eca use of si de effects or 
safet y ris ks). 
5) 
S u bjects w h o are bi ol o gi c- naï ve or bi ol o gic-e x p os e d. Bi ol o gic-e x p ose d i ncl u des s u bjects 
w h o ha ve de m o nstr ate d s ec o n dar y l oss of res p o ns e, i nt olera n ce, or lac k of access t o 
bi ol o gics d ue t o ec o n o mic reas o ns. 
6) 
7) 
I n v ol ve m e nt of at least 1 0 % or m ore of B S A at scree ni n g a n d at baseli n e. 
8) 
A n I G A s c ore of 3 or a b o ve o n a scale fr o m 0 – 4 at scree ni n g a n d at baseli n e. 
9) 
T he s u bject s h o ul d ha ve a p plie d a st a ble d ose of n o n- me dicate d, n o n- pres cri pti o n, t o pical 
e m ollie nt at l east t wice d ail y f or 7 c o nsec uti ve da ys i m me diatel y bef ore t h e baseli ne visit.
1 0) 
Willi n g t o a p pl y a sta ble d ose of n o n- me dicate d, n o n- prescri pti o n, t o pical e m ollie nt, as
rec o m me n d e d b y t h e I n v esti g at or at least t wice d ail y f or t he d urati o n of t h e st u d y, if n ot 
alrea d y o n a n e m ollie nt at t he ti me of scree ni n g.  
1 1) 
C o m mit me nt t o re mai n o n t he s a me d ose(s) of A D me dicati o n(s), i n cl u di n g t o pical 
e m ollie nts, f or t h e e ntire d urati o n of st u d y partici p ati o n u nless d ose m o dificati o n is d ue t o 
u nf ores ee n me dical n ecessit y.
1 2) 
Willi n g a n d a ble t o c o m pl y wit h t he st u d y pr oce d ures a n d visit sc he d ule i n cl u di n g 
f oll o w- u p visits. 
1 3) Fe male s u bjects m ust be eit her p ost me n o pa usal ( d efi ne d as n o me ns es f or 1 2 m o nt hs 
wit h o ut a n alter nati v e m e dical ca use) wit h F S H le vel > 3 0 mI U/ m L at scree ni n g or 
s ur gicall y sterile (t u bal li g ati o n, h yst erect 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 nti al, ha ve a ne gati v e ser u m pre g n a nc y t est a n d a gree t o 
use a hi g hl y effecti ve met h o d of c o ntrace pti o n as defi ne d i n t his pr ot oc ol or a bstai n fr o m 
se x ual acti vit y, if c o m pli a nt wit h preferre d a n d us ual lifest yle of t h e s u bject, fr o m scree ni n g 
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. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 2 of 1 3 5 
C o nfi d e nti al  
t he s u bject will be re q uir e d t o ha ve a n e gati ve ser u m pre g na nc y test d uri n g t he scree ni n g 
peri o d a n d will als o be re q uire d t o ha ve a n e gati ve uri ne di pstic k pre g na n c y test pri or t o 
d osi n g a n d at eac h st u d y visit.
1 4) 
Male s u bjects 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 ntrace pti o n as defi ne d i n t his pr ot oc ol or a bstai n fr o m se x ual acti vit y 
fr o m scree ni n g u ntil t h e 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 v er is l o n ger. All fertil e me n wit h fe m ale part ners of c hil d beari n g p ote nti al 
s h o ul d be i nstr ucte d t o c o ntact t h e I n vesti g at or i m me diatel y if t he y s us pect t h eir part n er 
mi g ht be pre g na nt (e. g., misse d or late me nstr ual peri o d) at a n y ti me d uri n g st u d y 
partici pati o n. 
8. 5  
E xcl usi o n Criteri a 
S u bjects 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 crit eria: 
1) 
C urre nt use of bi ol o gics f or a n y i n dicati o n. 
2) 
De m o nstrate d lac k of pri m ar y res p o nse t o treat me nt wit h a bi ol o gic f or t h e treat m e nt of A D 
defi ne d as n o res p o nse t o treat me nt des pite c o m pl ete a d here n ce t o t he pres cri be d re gi me n 
f or at least 3 m o nt hs ( pri mar y n o n-res p o n d ers).  
3) 
Use of a n y of t he f oll o wi n g treat m e nts wit hi n 4 wee ks pri or t o t he bas eli n e visit or a n y 
c o n diti o n t h at i n t he o pi ni o n of t he I n vesti gat or is li kel y t o re q uire s uc h treat me nt(s) d uri n g 
t he first 4 wee ks of st u d y treat me nt: 
 P h ot ot hera p y f or A D 
 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 b ut n ot li mite d t o s yste mic 
calci ne uri n i n hi bit ors (e. g., c ycl os p ori n, tacr oli m us), m T O R i n hi bit ors (e. g., sir oli m us, 
e ver oli m us), a nti- meta b olites (e. g., azat hi o pri ne, m et h otre xate, 6- m erca pt o p uri ne, 
lefl u n o mi de, m yc o p he n olate m ofetil), al k ylati n g a ge nts (e. g., c ycl o p h os p ha mi d e), 
e osi n o p hil- de pleti n g dr u gs (e. g., pra mi pe x ole), a n d s yste mic c ortic oster oi ds 
 Oral J A K i n hi bit ors wit hi n 8 wee ks of t he b aseli n e visit (re q uires disc ussi o n wit h 
Alla k os Me dical M o nit or pri or t o s u bject e nr olli n g i n st u d y) 
4) 
Treat m e nt wit h bi ol o gics: 
 A n y cell- de pleti n g a ge nts i ncl u di n g b ut n ot li mite d t o rit u xi ma b; wit hi n 6 m o nt hs pri or 
t o t h e baseli ne visit, or u ntil l y m p h oc yte c o u nt ret ur ns t o n or mal, w hic he ver is l o n ger

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 3 of 1 3 5 
C o nfi d e nti al  
 T N F i n hi bit ors (e. g., i nfli xi ma b, a dali m u ma b) a n d ot her bi ol o gics (e. g., d u pil u ma b, 
o maliz u ma b, etc.) wit hi n 5 half-li ves if k n o w n or 8 wee ks pri or t o t he b aseli ne visit, 
w hic he ver is l o n ger 
5) 
A n y use of t o pical c ortic oster oi ds, t o pical calci ne uri n i n hi bit ors, t o pical J A K i n hi bit ors 
(e. g., r u x oliti ni b), or t o pical P D E 4 i n hi bit ors (cris a b or ole) f or t he treat m e nt of A D wit hi n 
1 wee k pri or t o t he b aseli n e visit.
6) 
Re g ular use ( m ore t ha n 2 visits per wee k) of a ta n ni n g b o ot h/ parl or wit hi n 4 wee ks of t he 
scree ni n g visit.
7)
Treat me nt wit h c h e m ot hera p y or ra di ot h era p y i n t he prec e di n g 6 m o nt hs.
8)
Prese nce of s ki n c o m or bi dities/c o nc o mita nt c o n diti o ns t hat ma y i nterfere wit h st u d y 
assess me nts or i nter pretati o n of st u d y res ults.
9)
Pl a n n e d or a ntici pate d us e of a n y pr o hi bite d me di cati o n.
1 0)
Hist or y of mali g na nc y e xce pt carci n o ma i n sit u i n t he cer vi x, earl y sta ge pr ostate ca ncer, or 
n o n- mela n o ma s ki n ca n cers.
1 1)
A n y disease, c o n diti o n ( me dical or s ur gic al), or car diac a b n or malit y t h at i n t he o pi ni o n of 
t he I n v esti gat or w o ul d pl ace t he s u bject at i ncreas e d ris k.
1 2)
A hel mi nt h parasitic i nfecti o n dia g n ose d wit hi n 6 m o nt hs pri or t o t he date i nf or me d c o ns e nt 
is o btai ne d t hat has n ot bee n treate d wit h or h as faile d t o res p o n d t o sta n dar d- of-care 
t hera p y.
1 3)
E vi de nce of acti v e he p atitis B or C at scree ni n g base d o n ser ol o g y.
1 4)
E vi de nce of acti v e HI V i nfecti o n at scree ni n g base d o n ser ol o g y.
1 5)
W o m e 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 n a nt w hil e 
partici pati n g i n t he st u d y.
1 6)
Prese nce of a n a b n or mal scree ni n g la b orat or y v al ue c o nsi dere d t o be cli nicall y si g nifica nt 
b y t he I n vesti gat or.
1 7)
K n o w n or s us pect e d hist or y of alc o h ol, dr u g, or ot her s u bsta nce a b use or d e pe n de nce t hat 
i n t h e o pi ni o n of t he I n v esti gat or ma y i nterfere wit h st u d y partici pati o n or assess me nts.
1 8)
Pri or e x p os ure t o lire nteli ma b or 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.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 4 of 1 3 5 
C o nfi d e nti al  
1 9)
Partici pati o n i n a c o nc urre nt i nter ve nti o nal st u d y wit h t h e last i nter ve nti o n occ urri n g wit hi n 
3 0 da ys pri or t o st u d y dr u g a d mi nistrati o n ( or 9 0 da ys or 5 half-li ves, w hic he ver is l o n ger, 
f or bi ol o gic pr o d ucts).
2 0)
S u bjects w h o wei g h < 4 0 k g at scree ni n g.
2 1) 
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 t he Me dical M o nit or ma kes t he 
s u bject u ns uita ble f or e nr oll m e nt.
2 2) 
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 m e nt i n 
t he st u d y, d uri n g t he treat me nt peri o d, or v acci n ati o n e x p ecte 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.  
N ote:  T his e xcl usi o n crit eri o n d oes n ot a p pl y t o 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 n es) c urre ntl y a ut h orize d/a p pr o v e 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, w hic h ma y be a d mi nist ere d 
bef ore, d uri n g, or after t h e st u d y.  
  
T he vacci ne s h o ul d n ot be a d mi nistere d wit hi n 3 d a ys bef ore a n d wit hi n 3 d a ys after 
t he a d mi nistrati o n of lire nteli ma b s o t hat a n y si d e 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. 
2 3) 
E m pl o yees or rel ati v es of t he S p o ns or or t he I n v esti gat or, or ot her pers o ns d e pe n de nt o n t he 
S p o ns or or t he I n vesti gat or. 
2 4) 
C o m mit me nt t o a n i nstit uti o n b y or der iss ue d eit h er b y t he j u dicial or t h e a d mi nistrati v e 
a ut h orities. 
2 5) Prese nce of a S A R S- C o V- 2 i nfecti o n a n d/ or h a v e n ot c o m plete d a n a ut h orize d/a p pr o v e d 
C O VI D- 1 9 pri mar y i m m u nizati o n series as p er nati o nal rec o m me n d ati o ns at t h e ti me of 
scree ni n g. ( Ger m a n y o nl y) 
Acce pt a ble a n d re q uire d d oc u me ntati o n t o c o nfir m i ncl usi o n a n d e xcl usi o n crit eria is f urt h er 
e x plai n e d i n t he St u d y Refere nc e Ma n ual a n d list e d i n t he e C R F. 
8. 6  
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 reacti o ns t o t he S C i njecti o n. All T E A E will be c oll ecte d fr o m t h e start of st u d y 
dr u g a d mi nistrati o n i n t h e d o u ble- bli n d peri o d of t he st u d y t hr o u g h t he st art of t he dr u g 
a d mi nistrati o n i n t he O L E peri o d, or t hr o u g h D a y 1 6 9 ( ± 5 da ys) or E T if s u bject is n ot e nr olli n g 
i n t h e O L E peri o d of t h e st u d y. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 5 of 1 3 5 
C o nfi d e nti al  
Se verit y will be assesse d usi n g t he N CI C T C A E, v ersi o n 5. 0, or m ost c urre nt versi o n. All A E 
will b e assi g ne d a s e verit y gra de a n d will be assesse d t o deter mi n e w h et her t he y are cli nicall y 
si g nifica nt a n d relat e d t o st u d y dr u g. 
A d diti o nal safet y e val u ati o ns i ncl u de cli nical la b orat or y tests c o m prisi n g A D A t o lire nteli ma b, 
c o m plete bl o o d c o u nts, c he mistries, a n d uri nal yses; p h ysical e xa ms; a n d vital si g n 
meas ure me nts. 
T he Me dical M o nit or will re vie w bli n de d safet y d ata t hr o u g h o ut t he st u d y. Certai n safet y d ata 
( p ost-treat m e nt cell differe nti als as well as tiss ue e osi n o p hil a n d mast cell c o u nts) will n ot be 
pr o vi de d t o st u d y sites or t o t he S p o ns or as it ma y ca use bias. T h e S afet y M o nit or will re vie w 
bli n de d safet y data as well as u n bli n de d cell c o u nts a n d will escalate t o t h e Me dical M o nit or as 
nee de d i n a m a n ner t h at d oes n ot ca us e bias.  
9.
Pri or a n d C o nc urre nt Me dic ati o ns 
Pri or a n d c o nc o mita nt m e 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 
ta ke n 3 0 da ys pri or t o t h e scree ni n g visit a n d will be rec or de d i n t he electr o nic Case Re p ort 
F or ms (e C R F). Pri or me dicati o ns a n d t h era pi es ta ke n f or t h e treat me nt of A D, e ve n if ta ke n
> 3 0 da ys bef ore t h e s cree ni n g visit, will be d oc u me nte d i n t he e C R F.  
F or s u bjects p arti ci pati n g i n t he O L E peri o d, c o n c o mita nt me dicati o ns s h o ul d be rec or de d i n t h e 
A K 0 0 2- 0 1 8 d o u ble- bli n d treat m e nt peri o d d ata bas e be gi n ni n g after t he first a d mi nistrati o n of 
st u d y dr u g i n t h e d o u ble- bli n d peri o d of t h e st u d y u p u ntil t h e first O L E d ose is a d mi nistere d 
after t he Da y 9 9 visit. 
A n y me dicati o ns t h at are e xcl usi o nar y s h o ul d be dis c o nti n ue d or ha n dle d as o utli ne d i n 
Secti o n  9. 1 of t he pr ot o c ol. 
S u bjects 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 ns, b ot h prescri be d a n d 
o ver-t h e-c o u nter, wit h o ut c o ns ulti n g t h e I n v esti gat or, u nless it is re q uire d f or e mer ge nc y use, or 
it is a C O VI D- 1 9 vacci n e. 
I m me diatel y pri or t o t he first S C i njecti o n, st u d y sit e pers o n nel s h o ul d e ns ure t h at t h e s u bject 
c o nti n ues t o meet all of t he i ncl usi o n criteria a n d n o ne of t he e x cl usi o n crit eria (i ncl u di n g use of 
pr o hi bite d me dicati o ns). 
All me dicati o ns ta ke n f or t he treat me nt of A D a n d a n y ot h er me dicati o ns ta ke n d uri n g t h e 
3 0 da ys pri or t o scree ni n g a n d d uri n g t h e st u d y m ust be d oc u m e 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 d uri n g t h e st u d y m ust be d oc u me nte d.  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 6 of 1 3 5 
C o nfi d e nti al  
All A E, w het her elicite d b y q uesti o ns fr o m st u d y staff, v ol u nteer e d, or n ot e d o n p h ysical 
e xa mi n ati o n/la b orat or y t esti n g, a n d re gar dless of ca usalit y or se verit y, will be ass esse d a n d 
rec or d e d i n t he e C R F b e gi n ni n g after t he first a d mi nistrati o n of st u d y dr u g i n t he d o u ble- bli n d 
peri o d of t he st u d y a n d e n di n g at t he ti me of st u d y c o m pleti o n or E T of t h e d o u ble- bli n d peri o d 
or t he O L E peri o d, w hic he ver is later. 
9. 1 
P r o hi bite d Me dic ati o ns 
T he i ntr o d ucti o n of m e di cati o ns or t hera pi es f or ot her m e dical c o n diti o ns k n o w n t o affect A D
(e. g., s yste mic c ortic oster oi ds, m y c o p he n olate- m ofetil, I F N- , J A K i n hi bit ors, t o pical 
c ortic oster oi ds [e xce pt w he n gi ve n f or resc u e t h era p y], t o pical calci ne uri n i n hi bit ors, 
c ycl os p ori ne, azat hi o pri n e, met h otre xate, p h ot ot hera p y, or p h ot oc he m ot hera p y) are n ot p er mitte d 
d uri n g t he st u d y a n d d uri n g t he i nter val pri or t o e ntr y i nt o t he st u d y as defi ne d i n t he e xcl usi o n 
criteria. 
Prescri pti o n e m ollie nts or e m ollie nts c o ntai ni n g a d diti ves s uc h as cera mi de, h yal ur o nic aci d, 
urea, or fila g gri n are n ot all o we d.  
I n a d diti o n, t h e use of ultra vi olet A or B ( U V A or U V B), ps orale n + U V A ( P U V A), ot her 
p h ot ot h era p y, or ta n ni n g be ds is n ot per mitte d d uri n g t he st u d y. 
T he use of 3 or m ore ble ac h bat hs per wee k is pr o hi bite d. 
Pla n ne d or a ntici pate d m aj or me dicati o n pr oce d ures or s ur geries s h o ul d be a v oi de d d uri n g t h e 
st u d y. 
S u bject will be re mi n de d t o n ot ta ke pr o hi bite d me dicati o ns a n d t o n otif y t he site i m me diatel y if 
a pr o hi bite d me dicati o n is prescri be d b y a n ot h er h ealt h care pr o vi d er. If a pr o hi bite d me dicati o n 
is starte d d uri n g t h e c o urse of t h e st u d y, t he s u bject ma y be wit h dra w n fr o m st u d y treat me nt a n d 
f oll o we d f or t he 1 2- wee k f oll o w- u p peri o d. 
9. 2  
All o we d Me dic ati o ns
Me dicati o ns ta ke n f or t he treat me nt of A D, s uc h as a nti hista mi nes, le u k otrie ne a nta g o nists, a n d 
s o di u m cr o m ol y n, are all o we d d uri n g t h e st u d y, u nless pr o hi bite d ( Secti o n  9. 1), a n d d oses are t o 
re mai n sta ble u nless c ha n ge is re q uire d f or a n u nf oresee n m e dical necessit y.
D uri n g t he 7 da ys pri or t o St u d y Da y 1, t he s u bject m ust ha ve use d, at least t wice dail y, n o n-
me dicate d t o pical t hera p y (i.e., e m ollie nt) wit h o ut ot h er acti ve i n gre die nts i n dicate d t o treat A D, 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 7 of 1 3 5 
C o nfi d e nti al  
or ot her a d diti v es w hic h c o ul d aff ect A D ( e. g., h y al ur o nic aci d, urea, cera mi d e or fila g gri n 
de gra dati o n pr o d u cts).
If t h e s u bject w as alrea d y usi n g a n o n- me dicate d t o pical t hera p y (i.e., e m ollie nt) at t h e ti me of 
scree ni n g, t he d os e, fre q ue nc y, a n d t y pe of m e dic ati o n s h o ul d be mai ntai ne d t hr o u g h o ut t he 
st u d y. If t h e s u bject is n ot usi n g t o pical e m olli e nts at t h e ti me of scree ni n g, t he I n v esti gat or will 
rec o m me n d a s uit a bl e n o n- me dicate d, n o n- pres cri pti o n t o pical e m olli e nt/ m oist urizer t h at s h o ul d 
be mai ntai n e d t hr o u g h o ut t he st u d y,
Me dicate d t o pical t hera p y is defi n e d as a t o pical pr o d uct t h at c o ntai ns a n acti ve p har mace uti cal 
i n gre die nt i n dicate d f or t h e treat m e nt of A D (re gar dless of w het her it is a n o ver-t he-c o u nter or 
prescri be d pr o d uct).  
All A D me dicati o ns use d d uri n g t he scree ni n g peri o d a n d t hr o u g h o ut t he st u d y will be 
d oc u me nte d i n t he C R F. A n y all o we d m e dic ati o ns t hat are ta k e n m ust re mai n sta ble t hr o u g h o ut 
t he st u d y. 
T he use of c o nc o mita nt me dicati o ns f or ot h er m e dical c o n diti o ns (e. g., h y perte nsi o n, dia betes, 
ac ute i nfecti o ns) is per mitte d d uri n g t his st u d y. Nasal ster oi ds a n d i n hale d c ortic oster oi ds t o 
c o ntr ol ast h ma are per mitte 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 v acci n es) c urre ntl y 
a ut h orize d/a p pr o ve d b y F D A or ot h er 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 he st u d y.  
T he vacci n e s h o ul d n ot be a d mi nistere d wit hi n 3 d a ys bef ore a n d wit hi n 3 d a ys after t h e 
a d mi nistrati o n of lire nteli m a b s o t hat a n y si d e effects ca use d b y eit her of t h e 2 me dicati o ns ca n 
be m ore easil y deter mi ne d. 
9. 3  
Resc ue Me dic ati o ns 
T he use or i niti ati o n of a n y t o pical or s yste mic t hera p y f or t he p ur p os e of treati n g A D at a n y 
p oi nt i n t he st u d y will be c o nsi dere d resc u e t h era p y. Resc ue me dicati o ns are n ot all o we d d uri n g 
t he st u d y u nless me dicall y necessar y at t he discreti o n of t h e I n vesti gat or (i. e., t o treat flare- u ps of 
A D s y m pt o ms). Resc ue treat m e nt f or A D s y m pt o ms wit h ot her wise pr o hi bite d me dicati o ns ma y 
be pr o vi de d t o st u d y s u bjects at t he discreti o n of t he I n vesti gat or.
St u d y s u bjects re q uiri n g t o pical res c ue t hera p y wit hi n t h e first 4 wee ks of D ose 1 of t h e d o u ble-
bli n d peri o d will be dis c o nti n ue d fr o m t he st u d y b ut will be f oll o we d f or 1 2 wee ks. S u bjects 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 8 of 1 3 5 
C o nfi d e nti al  
re q uiri n g t o pical res c ue t hera p y after t he first 4 w ee ks f oll o wi n g D ose 1 will c o nti n ue wit h t he 
d ose re gi me n a n d b e f oll o we d t hr o u g h t he e n d of st u d y. 
St u d y s u bjects re q uiri n g s yste mic resc ue t h era p y d uri n g a n y p oi nt i n t he d o u ble- bli n d peri o d of 
t he st u d y will be dis c o nti n ue d fr o m t he st u d y b ut will be f oll o we d f or t he 1 2- wee k f oll o w- u p 
peri o d.  
1 0.
St u d y Tre at me nt
1 0. 1
F or m ul ati o n of Test P r o d u ct a n d Pl ace b o
Lire nteli m a b S C Dr u g Pr o d uct: T he lire nt eli ma b dr u g pr o d uct is i nte n de d f or s u bc uta n e o us 
i njecti o n. E ac h dr u g pr o d uct vial c o ntai ns a n o mi n al v ol u me of 1 m L. It is a steril e, preser vati ve-
free s ol uti o n t h at c o ntai ns
lire nteli ma b i n 
 
, p H 6. 0 i n 
Water f or I njecti o n ( W FI). T he s ol uti o n is vis uall y c haracteri ze d as clear t o sli g htl y o palesce nt, 
a p peari n g c ol orless t o sli g htl y yell o w.
Pl ace b o S C Pr o d u ct: T he place b o is i nte n de d f or s u bc uta ne o us i njecti o n. Eac h place b o vial 
c o ntai ns a n o mi nal v ol u me of 1 m L. It is a sterile, preser vati ve-free s ol uti o n t hat c o ntai ns 
 
 
, p H 6. 0 i n W FI. T h e s ol uti o n is vis uall y c haracterize d as clear t o sli g htl y 
o palesce nt, a p p eari n g c ol orless t o sli g htl y yell o w.
N ote : Lire nteli ma b S C a n d place b o S C will be referre d t o as “st u d y dr u g.”
Eac h d osi n g (lire nteli ma b S C or place b o S C) will c o m prise 1 S C i njecti o n of 2 m L of st u d y dr u g 
a d mi nistere d i n t he fr o nt of t h e t hi g h wit h a 2 7- ga u ge S C nee dle. M a xi m u m v ol u me 
a d mi nistere d per S C i njecti o n site will be 2 m L.
Lire nteli ma b S C or place b o S C ( base d o n ra n d o mi zati o n assi g n me nt) will be a d mi nistere d o n 
Da y 1 ( ± 3), D os e 1; Da y 1 5 ( ± 5), D ose 2; Da y 2 9 ( ± 5), D ose 3; Da y 4 3 ( ± 5), D ose 4; Da y 5 7 
( ± 5), D ose 5; Da y 7 1 ( ± 5), D ose 6; a n d D a y 8 5 ( ± 5), D ose 7.
S u bjects will ha ve t he o pti o n t o e nr oll i n a n O L E peri o d t o recei ve a n a d diti o nal 7 d oses of st u d y 
dr u g. S u bjects will be o bser ve d f or at least 1 h o ur after eac h i njecti o n.
D osi n g visits m ust be c o n d ucte d wit hi n t h e ± wi n d o ws sti p ulate d i n t he pr ot oc ol wit h t he 
f oll o wi n g re q uire me nts:

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 5 9 of 1 3 5 
C o nfi d e nti al  
 
T he i nter val bet w ee n d osi n g visits m ust be at least 7 da ys a n d n o m ore t h a n 2 1 da ys fr o m 
t he pre vi o us d osi n g visit u nless directe d ot her wise b y Alla k os. T he i nter val c o u nt starts t he 
da y after t h e visit a n d i ncl u des t he da y of t h e n e xt visit. 
 
T he i nter val bet w ee n t he fi nal d osi n g visit a n d t he efficac y visit ( Da y 9 9) m ust be at least 
1 1 da ys a n d n o m ore t ha n 1 7 da ys fr o m t he fi nal d osi n g visit u nless directe d ot her wis e b y 
Alla k os. T he i nter v al c o u nt starts t h e da y after t he visit a n d i n cl u des t he da y of t he ne xt 
visit. 
1 0. 2  
St u d y Dr u g P ac k a gi n g a n d L a beli n g
St u d y dr u g is s u p plie d i n 2 R T y pe I clear glass vials, sec urel y seale d wit h a fl u or o p ol y mer-
c oate d br o m o b ut yl st o p per a n d al u mi n u m fli p- off ca p. It is i nte n de d f or S C i njecti o n. T he vials 
are pac ke d i n cart o ns, a n d eac h cart o n c o nt ai ns 1 vial.
Eac h vial a n d eac h cart o n will be la bele d wit h all re q uire d d etails as per t h e a p plica ble l o cal 
re g ulati o ns. T he la bels will i n cl u de, a m o n g ot her details, a n i n vesti gati o nal use state me nt, l ot 
n u m ber, kit n u m ber, S p o ns or na me, a n d dir ecti 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 kit n u m ber a n d s pace t o d o c u me nt Patie nt I D a n d dis pe nsi n g/ a d mi nistrati o n date. 
T his tear- off la bel s h o ul d be a p plie d t o t he I P I nje cti o n Dis p e nsi n g W or ks h eet a n d m ai ntai ne d 
wit h t h e s o urce d oc u m e nts.  
1 0. 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 sit es. T he i nitial st u d y dr u g 
s hi p me nt will be s hi p pe d aft er 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, t he c o ntract h as bee n e xec ute d, a n d t he first scree ne d s u bject is e ntere d 
i nt o t he I R T s yste m. 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 mati call y base d o n 
pre deter mi n e d s u p pl y le vels a n d e nr oll me nt acti vit y at t he site.  
1 0. 4  
St u d y Dr u g D os e a n d D osi n g Re gi me n 
S u bjects will be ra n d o ml y assi g ne d t hr o u g h t he I R T s yste m t o a n acti ve d ose gr o u p of 7 d oses of 
lire nteli ma b S C or place b o S C ( Ta ble 2). T he d os e will be assi g ne d at t he ti me of ra n d o mizati o n.  
St u d y dr u g will c o m prise 1 S C i njecti o n of 2 m L a d mi nistere d i n t h e fr o nt of t he t hi g h wit h a 
2 7- ga u g e nee dle. Ma xi m u m v ol u me a d mi nistere d per S C i njecti o n will be 2 m L as i n dicate d i n 
t he st u d y P h ar mac y Ma n ual o n Da y 1 ( ± 3), D ose 1; Da y 1 5 ( ± 5), D ose 2; Da y 2 9 ( ± 5), D os e 3; 
Da y 4 3 ( ± 5), D os e 4; Da y 5 7 ( ± 5), D ose 5; Da y 7 1 ( ± 5), D ose 6; a n d D a y 8 5 ( ± 5), D ose 7. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 0 of 1 3 5 
C o nfi d e nti al  
S u bjects will ha ve t he o pti o n of g oi n g i nt o a n O L E peri o d t o recei ve a n a d diti o nal 7 d oses of 
acti v e st u d y dr u g. 
T a bl e 2 
St u d y Dr u g D os a ge
R o ute 
D ose 
( 7 D oses Bi wee kl y O v er 1 2 W ee ks) 
I njecti o n V ol u me/ D ose 
S u bc uta n e o us
3 0 0 m g Lire nteli ma b S C or Place b o S C
2 m L
1 0. 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 p are t he st u d y dr u g f or eac h S C i njecti o n base d o n t he 
assi g ne d d ose at ra n d o mizati o n. O n t he da y of d osi n g, t h e desi g nate d st u d y p har macist will 
pre pare lire nteli m a b or pl ace b o f or S C i njecti o n. 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 dis pe nse d acc or di n g t o t he P har mac y Ma n ual f or A K 0 0 2- 0 1 8. Refer t o t h e 
P har mac y Ma n u al f or a d diti o nal details.  
Lire nteli ma b d oes n ot meet t h e defi niti o n of a “ hazar d o us dr u g ” a n d t h eref ore is n ot re q uire d t o 
be classifie d acc or di n g t o t h e U S P Hazar d o us Dr u g Gr o u pi n g. A dr u g is c o nsi d ere d t o be 
hazar d o us if it e x hi bits o ne or m ore of t h e f oll o wi n g c haracteristics i n h u m a ns or a ni mals: 
carci n o g e nicit y, terat o ge nicit y or de vel o p me ntal t o xicit y, re pr o d ucti ve t o xi cit y, or ga n t o xicit y at 
l o w d oses, ge n ot o xicit y, or str uct ure a n d t o xicit y pr ofiles of ne w dr u gs t hat mi mic e xisti n g 
hazar d o us dr u gs ( U S P, 2 0 1 9). Si n ce lire nteli ma b is n ot c o nsi d ere d t o be a h azar d o us dr u g, 
s pecial preca uti o ns d o n ot nee d t o be ta ke n w he n h a n dli n g or pre pari n g t he st u d y dr u g.  
1 0. 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 c o m prise 1 S C i njecti o n a d mi nistere d i n t he 
fr o nt of t he t hi g h wit h a 2 7- ga u ge nee dle. S u bjects will be o bser ve d f or at least 1 h o ur aft er t h e 
S C i njecti o n a n d per t he I n v esti gat or’s discreti o n.  
1 0. 7  
St u d y Dr u g St or a ge 
St u d y dr u g will be st ore d b y t he st u d y sit es at 2° C t o 8º C u n der l oc k at t he d esi g nate d 
cli nic/ p har mac y l o cati o n. Access will be restricte d t o desi g nate d cli nic/ p har mac y staff. If t h e 
te m perat ure of st u d y dr u g st ora ge i n t he cli nic/ p h ar mac y e xcee ds or falls bel o w t his ra n ge, t he 
st u d y dr u g will b e q uara nti n e d a n d t he te m perat ure e xc ursi o n will be re p orte d t o t he S p o ns or or 
desi g nee. T he S p o ns or will n otif y t he site if t he st u d y dr u g ca n b e release d fr o m q uara nti ne. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 1 of 1 3 5 
C o nfi d e nti al  
1 0. 8
St u d y Dr u g Acc o u nt a bilit y
T he 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 (I P). All d osa ge assi g n me nts a n d dis pe nsati o ns will be 
d oc u me nte d o n t he s o urce d oc u me nts. T he Mast er I P A cc o u nta bilit y L o g 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 u cti o n). Electr o nic I P acc o u nta bilit y s yste ms ma y 
be use d, d e pe n di n g o n site prefere n ce, 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 hese d oc u me nts t hr o u g h o ut t h e c o urse of t he st u d y. St u d y dr u g 
will b e la bele d wit h kit n u m bers b ut will n ot re veal w het her t h e kit c o ntai ns acti ve dr u g or 
place b o. 
1 1.
S u bject 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 1. 1  
S u bject N u m beri n g  
Eac h s u bject w h o pr o vi des i nf or me d c o ns e nt will be assi g ne d a p atie nt i de ntificati o n n u m ber 
( PI D) t hat u ni q uel y i de ntifies t he m as a s u bject i n t he st u d y. T he PI D will c o nsist of a 9- di git 
n u m ber: 
 
T he first 3 di gits desi g nate t he st u d y n u m ber. F or t his st u d y, t h e n u m ber is 2 1 8. 
 
T he sec o n d 3 di gits desi g nate t he site n u m ber. 
 
T he last 3 di gits d esi g nate t he or der of c o ns e nt at t h e sit e (t he first s u bject w h o pr o vi d es 
c o nse nt is 0 0 1, t he sec o n d s u bject is 0 0 2, etc.). 
T he s u bject will mai ntai n t he s a me PI D t hr o u g h o ut t he st u d y. If a s u bject si g ns t h e I C F b ut d oes 
n ot meet t he i ncl usi o n/e xcl usi o n crit eria or q u alifies f or t h e st u d y b ut d oes n ot e nr oll, t he s u bject
ma y be assi g ne d a n e w PI D a n d rescree ne d o n ce. S u bjects rescree ne d wit hi n 3 0 da ys of si g ni n g 
t he i niti al c o nse nt will n ot nee d t o si g n a ne w I C F pr o vi di n g n o c ha n ges ha ve bee n ma de t o t h e 
I C F. 
1 1. 2
Str atific ati o n a n d R a n d o miz ati o n 
T o be ra n d o mi ze d i nt o t he st u d y, t he s u bject m ust ha ve c hr o ni c A D (acc or di n g t o t he A merica n 
Aca d e m y of Der mat ol o g y C o nse ns us Criteria,  A p pe n di x 1) t hat has bee n prese nt f or at least 
3 years bef ore t h e scree ni n g visit. T he s u bject m ust ha ve a n E A SI s c ore of 
1 6, t he s u bject’s A D 
m ust i n v ol ve at least 1 0 % or m ore of t h e B S A, al o n g wit h a n I G A sc ore of 3 or a b o ve o n a scale 
of 0 – 4. T he s u bject m ust als o meet all ot her a p plic a ble i ncl usi o n criteria a n d n o ne of t he 
e xcl usi o n crit eria. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 2 of 1 3 5 
C o nfi d e nti al  
If t h e s u bject q ualifi es f or t he st u d y after c o m pleti n g all of t he scree ni n g pr oce d ures, o n t h e da y 
of t he first S C i njecti o n ( D osi n g Da y 1), t he site will access t he I R T s yste m i n or der t o stratif y 
a n d ra n d o mize t h e s u bject i n t h e st u d y. T he I R T s yste m will t he n ra n d o ml y assi g n t he s u bject at 
a n all o cati o n rati o t o lire nteli m a b S C 3 0 0 m g, or place b o S C f or 7 d oses i n a d o u ble- bli n d 
ma n ner a n d will se n d a n e mail t o t he p har macist a n d/ or desi g nee det aili n g t h e kit n u m ber(s) t o 
use t o pre pare t he S C i njecti o n. 
T he s u bject will be stratifie d base d o n: 
1) 
Bi ol o gic- naï ve stat us vs. bi ol o gic-e x p ose d stat us 
2) 
I G A sc ore at bas eli ne: I G A sc ore of 3 vs I G A s c ore of 4
A p pr o xi matel y 1 3 0 s u bjects ( 6 5 per ar m) will be ra n d o mize d t o treat m e nt wit h lire nteli m a b S C 
or place b o S C. A s u bject is c o nsi d ere d e nr oll e d i n t he st u d y w he n t h e s u bje ct recei v es t h e first 
d ose of st u d y dr u g. F or s u bse q ue nt S C i njecti o ns t he c o or di nat or will access t he I R T s yste m o n 
t he da y of S C i njecti o n a n d e nter t h e PI D; t he s yst e m will assi g n t he s u bject t he d ose acc or di n g 
t o t h e s u bject’s ra n d o mizati o n n u m ber. T he p har macist a n d/ or desi g nee will t he n recei v e a n 
e mail detaili n g t he kit n u m ber(s) t o pre pare. 
Pri or t o eac h S C i njecti o n, t he I n v esti gat or or d esi g nee will c o nfir m t he PI D rec or de d o n t h e S C 
s yri n ge pr o vi de d b y t he p har macist matc hes t h e s u bject. T he patie nt i de ntifi cati o n s h o ul d be 
c o nfir me d a n d d o c u me nt e d b y a sec o n d part y pri or t o a d mi nisteri n g t h e S C i njecti o n(s), 
w he ne ver p ossi ble. T here will n ot be a n y u n bli n di n g i nf or mati o n o n t he I R T n otificati o n t o t he 
p har macist or o n t h e vials pr o vi d e d t o t he site.  
T he assi g n me nt of treat me nt t o lire nteli ma b S C or place b o S C will be sec urel y retai ne d i n t h e 
I R T s yste m u ntil s uc h ti me as desi g nate d b y t he Statisti cal A nal ysis Pla n ( S A P).  
1 1. 3  
Bli n di n g 
T he i de ntit y of test a n d c o ntr ol treat m e nts will n ot be k n o w n t o I n vesti gat ors, S p o ns or, researc h 
staff, s u bjects, or t h e st u d y m o nit or. T he f oll o wi n g st u d y pr oce d ures will be i n place t o e ns ure 
d o u ble- bli n d a d mi nistrati o n of st u d y treat m e nts: 
 
Access t o t he ra n d o mi zati o n c o des will b e strictl y c o ntr olle d b y t he I R T s yste m. 
 
T hr o u g h o ut t he d o u ble- bli n d st u d y, t he bli n d s h o ul d re mai n u n br o ke n e xce pt f or a n 
e mer ge n c y w he n k n o wle d ge of t he s u bject’s st u d y me dicati o n is necessar y f or f urt her 
ma na ge me nt or if re q uire d f or re g ulat or y re p orti n g. T he Alla k os Me dical M o nit or a p pr o ves 
a n y e mer g e nc y bli n d brea k, if at all p ossi ble, pri or t o t he u n bli n di n g. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 3 of 1 3 5 
C o nfi d e nti al  
 
T he lire nteli ma b a n d place b o f or S C i njecti o n will be i de ntical i n a p peara nce. 
 
Res ults fr o m t he a nal ysis of bl o o d sa m ples f or P K a n d A D A will n ot be pr o vi de d t o t he 
I n v esti gat or a n d S p o ns or u ntil after fi nal data b ase l oc k of t he d o u ble- bli n d st u d y.  
 
Res ults fr o m t he a nal ysis of bl o o d sa m ples f or hista mi ne/tr y ptase tests (c oll ecte d i n case of 
p ossi ble a na p h yla xis) will n ot be pr o vi de d t o t he I n vesti g at or a n d S p o ns or u ntil after fi nal 
data base l oc k of t h e d o u bl e- bli n d st u d y, u nless re q uire d f or i m me diate s afet y reas o ns.  
Res ults of t h e assess me nts n ote d bel o w will n ot be pr o vi d e d t o t he I n vesti gat or a n d S p o ns or 
u ntil after fi nal data b ase l oc k of t h e d o u ble- bli n d st u d y, s o as t o n ot i ntr o d uce bias. T he 
res ults will be re vie w e d o n a n o n g oi n g basis b y t he Safet y M o nit or a n d escalate d as 
a p pr o priate.  
 Differ e nti al cell c o u nts i ncl u di n g ne utr o p hils, e osi n o p hils, bas o p hils, m o n oc ytes, a n d 
l y m p h oc ytes.  
Ot her t h a n u n der t he c o n diti o ns descri be d a b o ve, t he st u d y bli n d will be re veale d o n c o m pleti o n 
of t he st u d y as n ote d i n Secti o n  1 7. 4.
1 1. 4  
Bre a ki n g t he Bli n d 
Brea ki n g t he bli n d i n a cli nical st u d y o n a n e mer ge nc y basis b y t he site s h o ul d o nl y occ ur w he n 
k n o wle d ge of t he treat m e nt t o w hic h a s u bject w as all ocate d w o ul d ha ve i m plicati o ns f or t he 
e mer ge n c y me di cal ma na g e me nt of t he s u bject, if re q uire d f or re g ul at or y re p orti n g, or if t here is 
a pre g na n c y d uri n g t he pre g na nc y re p orti n g peri o d. 
If n ecess ar y, e mer g e nc y brea ki n g of t h e bli n d ca n be c o n d ucte d t hr o u g h t h e I R T b y t he 
I n v esti gat or or ot her re gistere d site users a n d/ or t h e Me dical M o nit or. W h e ne ver p ossi ble, t he 
I n v esti gat or s h o ul d c o ntact t he Me di cal M o nit or b ef ore a n e mer ge nc y brea ki n g of t h e bli n d. 
Reas o n f or u n bli n di n g, pers o n c o n d ucti n g t he u n bli n di n g, pers o n nel w h o k n o w t he u n bli n de d 
treat me nt, a n d dat e/ti m e of u n bli n di n g will be rec or de d. 
1 2.  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 de pi cti n g t he re q uire d t esti n g pr oce d ures t o be 
perf or me d f or t h e d urati o n of t h e st u d y. W he n m ulti ple e val uati o ns are s c he d ule d at t he sa me 
ti m e p oi nt, t he pri orit y f or eac h will be as f oll o ws:  
 
At h o me: F or t he dail y q uesti o n naires t hat t he s u bject c o m pletes at h o me, t he s u bject 
s h o ul d c o m plete t he  
 e xce pt o n da ys of st u d y visits w he n t he  
 will be 
c o m plete d w hil e t h e s u bj ect is at t he st u d y sit e. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 4 of 1 3 5 
C o nfi d e nti al  
 
At t he cli nic:  
1)  
 I G A, E A SI, 
, a n d At o pic C o n diti o ns Q uesti o n naire. 
2) 
Vital si g ns will be o btai ne d after t he s u bject
 
3) P h ysical e xa mi nati o ns ca n be p erf or me d a n d uri ne sa m ples ca n be c ollecte d eit her 
bef ore or aft er ot her e val uati o ns, u nless ot her wise s pecifie d.  
1 2. 1
P h a r m ac o d y n a mic/ Effic ac y- R el ate d Pr oce d ures
T o e ns ure c o nsiste n c y i n gra di n g, t he s a me I n v esti gat or s h o ul d ma ke all ass ess m e nts f or a 
s u bject starti n g fr o m scree ni n g a n d c o nti n ui n g t hr o u g h o ut t he d o u ble- bli n d peri o d a n d O L E 
peri o d of t he st u d y w he n e ver p ossi ble. It will n ot be c o nsi dere d a pr ot oc ol de viati o n if a differe nt 
I n v esti gat or ma kes a n assess me nt f or a s u bject d uri n g t he st u d y, b ut t his s h o ul d be a v oi d e d as 
m uc h as p ossi ble. 
1 2. 1. 1  
V ali d ate d I n vesti g at or Gl o b al Ass ess me nt  
T he vali d ate d I n v esti gat or Gl o bal Assess me nt ( vI G A) is a 5- p oi nt scale t hat pr o vi des a gl o bal 
cli nical assess me nt of A D s e verit y ra n gi n g fr o m 0 t o 4 a n d assesses disease se verit y a n d cli nical 
res p o nse usi n g a 5- p oi nt scale: 0 = cl ear; 1 = al m ost clear; 2 = mil d; 3 = m o derate; a n d 
4 = se vere ( A p p e n di x 2) . T he sc ore is d eter mi n e d b y ra n ki n g t he e xte nt of er yt h e ma a n d 
pa p ulati o n/i nfiltrati o n. A decrease i n sc ore relates t o a n i m pr o ve me nt i n si g ns a n d s y m pt o ms. 
T he vI G A is a p h ysici a n-c o n d ucte d ass ess m e nt.  
T he vI G A will be d eter mi ne d d uri n g scree ni n g, a n d a baseli n e will be est a blis he d. A vI G A sc ore 
of 3 is re q uire d t o e nr oll i n t he st u d y. T he vI G A will be meas ure d b y I n v esti g at ors d uri n g 
scree ni n g, pre d ose o n all d osi n g da ys, a n d d uri n g eac h f oll o w- u p da y or E T.
1 2. 1. 2  
Ecze m a Are a a n d Se verit y I n de x
D uri n g scre e ni n g, t he E A SI will be deter mi ne d, a n d a baseli ne will be est a blis he d. T he E A SI 
sc ore is a t o ol use d t o meas ure t he e xte nt (area) a n d se verit y of at o pic ecze ma wit h res p ect t o 
er yt h e ma, e xc oriati o n, i nfiltrati o n, a n d lic he nificati o n at 4 a nat o mic sites of t he b o d y: l o wer a n d 
u p per e xtre miti es, tr u n k, a n d hea d ( A p pe n di x 3) . T he t otal E A SI s c ore will be i n a ra n g e fr o m 
0 t o 7 2 p oi nts (fr o m n o disease t o ma xi m u m disease se verit y) a n d is c o n d u cte d b y t he 
I n v esti gat or. A n E A SI s c ore of > 1 6 d uri n g scree ni n g is re q uire d t o e nr oll i n t h e st u d y. T he E A SI 
will b e deter mi ne d b y I n v esti gat ors d uri n g scree ni n g, pre d ose o n all d osi n g da ys, a n d d uri n g all
f oll o w- u p o n Da ys 9 9, 1 4 1, a n d 1 6 9 or E T.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 6 of 1 3 5 
C o nfi d e nti al  
o verall sc ori n g s yste m of  
; a hi g h sc ore is i n dicati v e of a 
is a 
self-a d mi nistere d q u esti o n naire. S u bjects will c o m plete t his d uri n g scree ni n g, pre d ose o n all 
d osi n g da ys, a n d d uri n g f oll o w- u p o n Da ys 9 9, 1 4 1, a n d 1 6 9 or E T. 
1 2. 1. 7
At o pic C o n diti o ns Q uesti o n n aire
O n Da y 1, Da y 9 9 a n d O L E Da y 9 9, s u bjects will be pr o m pte d t o a ns wer a d diti o nal q uesti o ns 
a b o ut se verit y of s y m pt o ms relate d t o ast h ma, aller gic r hi nitis a n d aller gic c o nj u ncti vitis 
( A p pe n di x 7).
1 2. 1. 8
P h ot o g r a p hs 
T he site staff ma y ta k e p h ot o gra p hs of s u bjects’ A D dis ease t o trac k st u d y dr u g res p o nse a n d 
disease pr o gressi o n. T his will de pe n d o n t he sites’ sta n dar d o perati n g pr oce d ures re g ar di n g 
p h ot o gra p h y. S u bjects will be c o nse nte d bef ore t h e S p o ns or will ha ve access t o a n y i ma ges. 
1 2. 1. 9  
C o m plete Bl o o d C o u nt wit h Differe nti al 
Bl o o d f or c o m plete bl o o d c o u nt ( C B C) wit h differe ntial, i ncl u di n g a bs ol ute bl o o d e osi n o p hil 
c o u nt, will be o btai ne d at scree ni n g, j ust pri or t o eac h S C i njecti o n, 1 h o ur ( ± 1 5 mi n utes) after 
t he e n d of eac h S C i njecti o n, a n d o n D a ys 9 9, 1 4 1, a n d 1 6 9 ( ± 5) or 1 4, 5 6, a n d 8 4 ( ± 5) d a ys after 
last d ose if E T. T he bl o o d sa m ple will be pr ocess e d a n d s hi p pe d i n acc or da nce wit h t h e 
La b orat or y M a n ual a n d l a b kit i nstr ucti o ns. A ce ntral la b orat or y will a n al 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).  
D uri n g t he d o u ble- bli n d peri o d, all differe nti al bl o o d c o u nts fr o m Da y 1 ( p ost- d ose) t hr o u g h t he 
e n d of t h e s u bject’s p arti ci pati o n will be bli n de d t o t he S p o ns or a n d t h e sit e. A n u nsc he d ule d 
C B C ma y be c ollecte d at t he re q uest of t he Safet y M o nit or. T he bl o o d differe nti al test res ults 
( ne utr o p hils, e osi n o p hils, bas o p hils, m o n oc ytes, a n d l y m p h oc ytes) will be bli n de d fr o m t he 
I n v esti gat or a n d S p o ns or fr o m p ost- d ose Da y 1 t hr o u g h Da y 1 6 9 or E T a n d u ntil data base l o c k 
has occ urre d. If a s u bject c o nti n ues t o t he O L E p eri o d of t he st u d y, all differe ntial bl o o d c o u nts 
will b e bli n de d f or t he first ( O L E Da y 1) pre d ose assess me nts a n d will be u n bli n de d after t h e 
s u bject has recei ve d t h e first d ose of t h e st u d y dr u g. 
As descri b e d i n t he I n vesti gat or’s Br oc h ure, c ha n g es i n certai n la b res ults are a part of t he 
e x pecte d effects of lire nt eli m a b a n d c o ul d p ote ntiall y i ntr o d uce bias i n bli n de d me m bers of t he 
st u d y. T he Safet y M o nit or will ha ve real-ti m e access t o t hese la b orat or y res ults a n d will re vie w 
a n d escal ate a n y c o ncer ns/iss u es t o t he M e dical M o nit or a n d/ or t he site as a p pr o priate. A n 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 7 of 1 3 5 
C o nfi d e nti al  
u nsc he d ule d C B C wit h differe ntial ma y b e c olle cte d if re q u este d b y t he S afet y M o nit or. All 
pa nic alerts f or bli n de d v al ues will be se nt t o t he Safet y M o nit or a n d e v al uate d i n real ti me.
1 2. 1. 1 0
Fres h bi o psies
O pti o nal lesi o nal a n d n o n-lesi o nal bi o ps y sa m ples will be c ollecte d at sele cte d U S sites f or 
e x pl orat or y a n al ysis at baseli ne/ pre d ose o n Da y 1 a n d o n D a y 9 9/ W ee k 1 4 d uri n g t h e d o u ble-
bli n d peri o d. T hese fres h bi o psies will be s hi p pe d o ver ni g ht t o Alla k os f or a d diti o nal cell 
p he n ot y pi n g a n d ot her e x pl orat or y a nal ysis. O nce Alla k os recei v es t h e bi o psies, t he y will be 
diss ociate d i nt o si n gle cells a n d i m m u n o p he n ot y pe d f or i m m u ne cell p o p ulati o ns (l y m p h oc ytes, 
e osi n o p hils, b as o p hils, mast cells, ne utr o p hils, a n d macr o p ha g es) a n d ot her e x pl orat or y a nal ysis. 
Detaile d i nstr ucti o ns o n c oll ecti o n, pac ka gi n g a n d s hi p pi n g will be i n cl u de d i n t h e la b ma n ual. 
All materials re q uire d f or s hi p me nt of t he a d diti o nal sa m ples will be pr o vi de d t o t he site b y t he 
Ce ntral La b orat or y. S u bjects w h o c h o ose t o p artici pate will nee d t o si g n a s e parate I nf or mati o n 
a n d C o nse nt F or m. 
1 2. 2  
S afet y- R el ate d Pr o ce d u res 
1 2. 2. 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 scree ni n g a n d at 
st u d y visits if c ha n ges are m a de. 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. A n y pri or me dicati o n recei ve d wit hi n 
3 0 da ys bef ore scree ni n g a n d d uri n g t h e st u d y t hr o u g h Da y 1 6 9 ( 5 6 or 8 4 [ ± 5] da ys after last 
d ose of st u d y dr u g if E T) will be rec or d e d, or t hr o u g h t h e first d ose of st u d y dr u g if s u bject 
e nters t h e O L E p eri o d of t he st u d y.  
F or s u bjects p arti ci pati n g i n t he O L E peri o d, c o n c o mita nt me dicati o ns s h o ul d be rec or de d i n t he 
A K 0 0 2- 0 1 8 d o u ble- bli n d treat m e nt peri o d d ata bas e u p u ntil t he first O L E d ose is a d mi nistere d 
after t he Da y 9 9 visit. R esc ue m e dicati o ns a n d pr oce d ures m ust be d o c u me nte d as resc u e 
treat me nt i n t he s o urce d oc u me nts a n d o n t he Pri or a n d C o nc o mita nt Me dicati o ns e C R F.
A n y me dicati o ns ta ke n f or A D or A D-relate d s y m pt o ms at a n y ti me (e ve n if l o n ger t h a n 3 0 da ys 
bef ore s cre e ni n g) s h o ul d be liste d as c o nc o mita nt me dicati o ns, e ve n if t he me dicati o n was 
disc o nti n ue d pri or t o st u d y parti ci pati o n.
1 2. 2. 2
C o m pl ete P h ysic al E x a mi n ati o n
A c o m plete p h ysical e x a m will be perf or me d b y eit h er t h e I n vesti g at or or a q ualifie d desi g nee 
d uri n g t he scree ni n g visit. A c o m plete p h ysical e x a m will i ncl u de t he f oll o wi n g b o d y s yste m or 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 8 of 1 3 5 
C o nfi d e nti al  
or ga n assess me nts: s ki n; hea d, e y es, ears, n ose, a n d t hr oat; t h yr oi d; l u n gs; car di o vasc ular; 
a b d o me n; e xtre mities; l y m p h n o des; a n d a brief n e ur ol o gical e x a mi n ati o n.  
1 2. 2. 3
B o d y Wei g ht a n d Hei g ht
At scree ni n g, h ei g ht (i n c m) a n d wei g ht (i n k g) will be m eas ure d b y t he site a n d rec or de d. T h e 
site ca n n ot use val ues state d b y t he s u bject. B o d y wei g ht will als o be meas ure d o n all d osi n g a n d 
f oll o w- u p da ys or 1 4, 5 6, a n d 8 4 da ys aft er last d ose if E T.
1 2. 2. 4
S y m pt o m- Directe d P h ysi c al E x a mi n ati o n
A s y m pt o m- directe d p h ysical e xa m of re p orte d or o bser ve d s u bje ct s y m pt o ms warra nti n g 
e xa mi n ati 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 njecti o n site 
reacti o ns a n d I R R, will b e perf or me d b y eit h er t h e I n v esti gat or or a q u alifie d desi g nee at all 
st u d y visits d uri n g t he treat me nt peri o d a n d f oll o w- u p peri o d. Ne w, a b n or mal p h ysical e xa m 
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 I n vesti gat or or S u bi n vesti g at 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 2. 2. 5  
Electr oc a r di o gr a m 
A n E C G will be o btai ne d d uri n g scree ni n g after t h e s u bject has bee n i n t he resti n g p ositi o n f or 
 mi n utes a n d bef ore a n y bl o o d dra w. T he I n v esti g at or or S u bi n vesti gat ors will re vie w a n d 
assess a n y a b n or malities o n t he E C G i n ter ms of cli nical si g nifica nce. T h e E C G ( wit h o ut 
i nte nsi ve Q T a nal ysis) will be use d t o i de ntif y diseases or c o n diti o ns t h at w o ul d p ut t h e s u bject 
at i ncreas e d ris k if partici pati n g i n a cli nical st u d y, s o t his s h o ul d be t a ke n i nt o c o nsi derati o n 
w he n e val u ati n g eli gi bilit y f or e ntr y i nt o t he st u d y. 
1 2. 2. 6
Pre vi o us A D Di a g n osis a n d Tre at me nts Re vie w
D uri n g t he scree ni n g visit t h e I n v esti gat or or desi g nee will c oll ect d oc u me ntati o n s u p p orti n g t h e 
c hr o nic A D di a g n osis a n d as k t he s u bject a b o ut t h e vari o us treat me nts or met h o ds of s y m pt o m 
c o ntr ol t hat t he y ha ve tri e d i n relati o n t o t h eir A D s y m pt o ms. T he treat me nts m a y i n cl u de 
me dicati o ns ( pres cri pti o n or o ver-t he-c o u nter), t h era pies (i.e., p h ot ot h era p y) or a da pti ve 
be ha vi ors, as w ell as alter nati ve me dici ne (i. e., ac u p u nct ure or h y p n otic t h era p y). A n y pre vi o us 
t hera pies a n d m e dicati o ns as relate d t o s u bjects’ A D disease will be rec or de d i n t h e st u d y C R F.
Re q uire d s pecifi c s o urce d oc u me ntati o n s u p p orti n g t he ass ess me nt of i ncl usi o n a n d e xcl usi o n 
criteria re gar di n g hist or y of A D dia g n osis a n d treat me nts will be t h e f oll o wi n g:
A c hr o nic A D dia g n osis f or at least 3 years (I ncl usi o n Criteria # 3) s h o ul d be c o nfir me d b y 
hist orical me dical rec or ds fr o m a der m at ol o gist, aller gist, or i m m u n ol o gist, or via c urre nt 
d oc u me ntati o n fr o m a st u d y der mat ol o gist, aller gist, or i m m u n ol o gist.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 6 9 of 1 3 5 
C o nfi d e nti al  
 
Me dical rec or ds d oc u m e nti n g t he t o pical A D treat m e nts a n d reas o n f or disc o nti n uati o n are 
re q uire d f or I ncl usi o n Criteria # 4. N otes fr o m p atie nt i nter vie w al o ne f or pre vi o us treat m e nt 
are n ot s ufficie nt. 
 
Der m at ol o gist or st u d y d oct or’s n otes re gar di n g A D treat me nt hist or y are n ee de d f or 
assessi n g I ncl usi o n criteria # 9 a n d E xcl usi o n Criteria # 2. 
M ore d etails are pr o vi de d i n t he i nstr ucti o n of t he Eli gi bilit y C R F pa ge. 
1 2. 2. 7  
Vit al Si g ns
Vital si g ns i n cl u di n g s yst olic a n d diast olic bl o o d press ure, p uls e, b o d y t e m perat ure, a n d 
res pirat or y rate will be ta ke n after t he s u bject
bl o o d dra w (e x ce pt f or p ost- S C i njecti o n w he n vital si g ns will be o btai ne d as descri be d b el o w).  
Vital si g ns will be meas ure d at scree ni n g, o n D a y 8 ( ± 3), o n all f oll o w- u p d a ys or 1 4, 5 6, a n d 8 4 
( ± 5) da ys after last d ose if E T, a n d o n all d osi n g d a ys wit hi n 3 0 mi n utes pre d ose, 
1 5 ( ± 5) mi n utes after c o m pleti o n of t he S C i njecti o n, a n d j ust pri or t o disc har g e. 
A d diti o nal vital si g ns meas ure me nts ma y be c ollecte d at t he I n v esti gat or’s discreti o n if a n I R R 
occ urs. Vital si g ns i ncl u di n g s yst oli c a n d diast olic bl o o d press ure, p ulse, b o d y te m perat ure, a n d 
res pirat or y rate will be m eas ure d after t h e s u bject 
bl o o d dra ws ha ve b ee n o btai n e d ( u nless c ollecte d f or a n I R R). 
Please refer t o t he sc he d ule of assess me nts i n  Ta bl e 1.  
1 2. 3
Cli nic al L a b or at or y Me as ure me nts  
Bl o o d a n d uri ne sa m ples f or cli nical safet y la b orat or y tests will be c ollecte d at t h e ti m e p oi nts 
descri b e d b el o w. I n vesti gat ors ma y ha ve a d diti o nal la b orat or y tests perf or me d f or t he p ur p os e 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 ues. 
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 n e sa m ples a n d pr o vi d e res ults f or t he 
cli nical safet y la b orat or y tests.  
Cli nical la b orat or y t esti n g ma y be perf or me d l ocall y, if necessar y, 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 orat or y w he n e ver p ossi ble. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 0 of 1 3 5 
C o nfi d e nti al  
F or a n y l a b orat or y test v al ue o utsi d e t h e refere nce ra n ge, t h e I n vesti g at or will deter mi ne cli nical 
si g nifica n ce: 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 orat or y val u e s h o ul d be d ee me d C S if a n y of t h e 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 h at is ne w or has w ors e ne d fr o m 
baseli n e. 
 
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 vati 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 orat or y v al u e is a la b test val ue t h at i n dicates a ne w disease 
pr ocess, a n e xacer b ati 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 d e t h e refere nce ra n ge t h at t h e I n vesti g at or c o nsi d ers cli nicall y 
si g nifica nt, t he I n vesti gat or will:
 
Re peat t h e 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 E a n y la b orat or y test val ue after st art of st u d y dr u g t h at: 
 T he I n vesti gat or c o nsi ders cli nicall y si g nifica nt. 
 Re q uires a s u bject t o be disc o nti n ue d fr o m t he st u d y. 
 Re q uires a s u bject t o recei ve treat m e nt.
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 2. 1. 9.
1 2. 3. 1
Bl o o d C he mistr y Pr ofile 
Bl o o d f or c he mistr y, i ncl u di n g h C G a n d F S H ( o nl y f or scree ni n g), will be c oll ecte d. O nl y 
s u bjects of c hil d beari n g p ote nti al a n d p ost me n o pa usal w o me n are re q uire d t o ha ve h C G or F S H 
testi n g (as descri be d i n S ecti o n 1 2. 3. 2). P ost me n o pa usal stat us m ust be c o nfir me d b y testi n g of 
F S H pri or t o t h e first d os e of st u d y dr u g re g ar dless of t he s u bject’s a g e. 
Bl o o d f or c he mistr y will be o btai ne d pre d os e o n all d osi n g da ys, as well as d uri n g scree ni n g, a n d 
o n Da ys 9 9, 1 4 1, a n d 1 6 9 or 1 4, 2 8, 5 6, a n d 8 4 ( ± 5) da ys after last d ose if E T. 
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 t he La b orat or y M a 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 y ze t h e ser u m sa m ple a n d pr o vi de 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 1 of 1 3 5 
C o nfi d e nti al  
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 uc ose, bl o o d 
urea nitr o g e n, creati ni ne, creati ne ki n ase, 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 nsferase ( A S T), ala ni ne a mi n otra nsferase 
( A L T), al k ali ne p h os p hat ase, ga m ma- gl uta m yl tra nsferas e ( G G T), a n d lact ate d e h y dr o g e nase.
1 2. 3. 2  
Pre g n a nc y Test a n d F ollicle- Sti m ul ati n g H or m o ne 
A ser u m pre g n a nc y test ( h C G le vel) will be c o m pl ete d f or all fe male s u bjects of c hil d beari n g 
p ote ntial at scree ni n g. W o me n w h o are s ur gicall y sterile (t u bal li g ati o n, partial or t otal 
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 t h ose w h o are p ost m e n o pa us al 
f or at least 1 year wit h F S H le vel > 3 0 mI U/ m L are n ot c o nsi dere d t o b e of c hil d beari n g p ote ntial. 
At scree ni n g, F S H le vels will be teste d o n fe m ale s u bjects t o c o nfir m p ost m e n o pa usal stat us. 
B ot h F S H a n d h C G sa m ples will be pr ocesse d b y t he ce ntr al la b orat or y.
S u bject
mI U/ m L will be c o nsi dere d t o be of c hil d beari n g p ote ntial. Bl o o d 
will b e c ollecte d f or ser u m pre g na nc y test at scree ni n g. Uri ne will be c ollecte d f or di pstic k 
pre g n a nc y t est o n all d osi n g da ys, Da y 8, a n d all f oll o w- u p da ys ( 1 4, 5 6, a n d 8 4 da ys after last 
d ose of st u d y dr u g if E T) f or all s u bjects of c hil d b eari n g p ote ntial. Test kits will be s u p pli e d b y 
t he ce ntral la b orat or y. T ests will be c o m plete d o n site a n d e val uate d pri or t o eac h S C i njecti o n. If
a s u bject has a p ositi ve pre g na nc y t est, d osi n g will i m me diatel y be dis c o nti n ue d. 
T o e ns ure s u bject safet y, eac h pre g na n c y i n a s u bj ect t hat recei v e d st u d y dr u g m ust be re p orte d 
wit hi n 2 4 h o urs of lear ni n g of its occ urre nce. If t h e s u bject recei ve d lire nteli ma b S C, t h e 
pre g n a nc y s h o ul d b e f oll o we d t o deter mi ne o utc o me, i ncl u di n g s p o nta ne o us or v ol u ntar y 
ter mi nati o n, details of t he birt h, a n d t h e prese nce of a bse nc e of a n y birt h defects, c o n ge nit al 
a b n or malities, or mater nal a n d/ or ne w b or n c o m plicati o ns. If t h e s u bject recei ve d 
lire nteli ma b S C, a n y S A E e x p erie n ce d d uri n g pre g na nc y m ust be re p orte d o n t he S A E Re p ort 
F or m.  
1 2. 3. 3  
Effecti v e Met h o ds of C o ntr ace pti o n f or All a k os St u di es 
T his secti o n a p plies t o st u d y s u bjects w h o are w o me n of c hil d beari n g p ote nti al ( W O C B P) a n d 
male st u d y s u bjects w h ose se x ual part ners are W O C B P.
A p plic a ble f or St u d y Sites i n t he U nite d St ates: 
A bsti ne nce is t he o nl y birt h c o ntr ol met h o d t hat is 1 0 0 % effecti v e i n pre ve nti n g pre g n a nc y. F or 
s u bjects w h o d o n ot practice a bsti ne nce, Alla k os re q uires t h at st u d y s u bjects use hi g hl y effecti v e
met h o ds of c o ntrace pti o n, w hic h i ncl u de:
Per ma ne nt Sterilizati o n: T u bal li gati o n, vasect o m y – 9 9 % effecti ve 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 2 of 1 3 5 
C o nfi d e nti al  
 
L o n g- Acti n g Re versi ble C o ntrace pti v es ( L A R C):  
 I U D – 9 9 % effecti v e  
 I m pla nta ble r o d ( matc hstic k size d r o d t hat c o nt ai ns pr o g esti n h or m o ne i m pla nte d u n der 
t he s ki n of t he u p per ar m; pre ve nts o v ulati o n) – 9 9 % effecti ve 
 
C o ntrace pti ve I njecti o n: 
 I ntra m usc ular or s u bc uta ne o us i njecti o n of pr o gesti n h or m o ne e ver y 3 m o nt hs – 
9 6 % effecti v e  
 
S h ort- Acti n g H or m o nal Met h o ds:  
 Oral c o ntrace pti ves or patc h – 9 1 % effecti v e  
 Va gi nal c o ntrace pti v e ri n g (releases 2 h or m o nes, pr o gesti n a n d estr o ge n, t o pre ve nt 
o v ulati o n) – 9 1 % effecti ve  
N ote:  Effecti v e ness rates o btai ne d fr o m t he Birt h C o ntr ol G ui de o n t he F D A we b sit e 
( F D A, 2 0 2 1).  
Barrier a n d ot her m et h o ds n ot liste d a b o ve w he n us e d t o get her as d u al met h o ds s uc h as a 
c o n d o m + dia p hra g m or c o n d o m + s per mici d e are less effecti ve met h o ds, t heref ore t h ese d ual 
met h o ds are n ot rec o m me n de d as t h e y c o ul d i ncrease t he ris k of b ec o mi n g pre g na nt d uri n g t he 
st u d y or f oll o w- u p peri o d. W he n usi n g d ual met h o ds, at least 1 of t h e met h o ds s h o ul d be a 
hi g hl y effecti ve m et h o d of c o ntrace pti o n.  
A p plic a ble f or St u d y Sites i n Ger m a n y: 
Met h o ds t hat ca n ac hie ve a fail ure rate of less t ha n 1 % p er year w h e n use d c o nsiste ntl y a n d 
c orrectl y are c o nsi dere d as hi g hl y effecti ve birt h c o ntr ol met h o ds. Alla k os re q uires t h at st u d y 
s u bjects use hi g hl y effecti ve m et h o ds of c o ntrace pti o n, w hic h i n cl u de: 
 
C o m bi ne d (estr o ge n a n d pr o gest o ge n c o ntai ni n g) h or m o nal c o ntrace pti o n ass ociate d wit h 
i n hi biti o n of o v ulati o n1: Oral, i ntra va gi n al, or tra ns d er mal
 
Pr o gest o ge n- o nl y h or m o nal c o ntrace pti o n ass ociate d wit h i n hi biti o n of o v ulati o n 1: Oral, 
i njecta ble, or i m pla nta ble2  
 
I ntra uteri ne d e vice (I U D)2  
 
I ntra uteri ne h or m o ne-releasi n g s yste m (I U S)2  
 
Bil ateral t u bal occl usi o n 2

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 3 of 1 3 5 
C o nfi d e nti al  
 
Vasect o mis e d p art ner 2, 3
 
Se x ual a bsti ne nce 4
1) 
H or m o nal c o ntrace pti o n ma y be s usce pti ble t o i nteracti o n wit h t he st u d y dr u g, w hic h ma y 
re d u ce t h e efficac y of t h e c o ntrace pti o n met h o d. 
2) 
C o ntrace pti o n met h o ds t hat i n t he c o nte xt of t his g ui da nce are c o nsi d ere d t o ha ve l o w user 
de pe n de n c y.  
3) 
Vasect o mise d part ner is a hi g hl y effecti ve birt h c o ntr ol met h o d pr o vi de d t h at part ner is t he 
s ole se x ual part ner of t h e W O C B P trial parti ci pa nt a n d t hat t he vasect o mise d part ner h as 
recei v e d me dical assess me nt of t he s ur gical s ucc ess.  
4) 
I n t he c o nte xt of t his g ui da nce se x u al a bsti ne nce is c o nsi d ere d a hi g hl y effecti ve met h o d 
o nl y if defi n e d as refrai ni n g fr o m heter os e x ual i nterc o urs e d uri n g t he e ntir e peri o d of ris k 
ass ociate d wit h t he st u d y treat me nts. T he relia bilit y of se x ual a bsti ne nce nee ds t o be 
e val uate d i n relati o n t o t he d urati o n of t h e cli nical trial a n d t h e preferre d a n d us ual lifest yle 
of t he s u bject. 
N ote: 
Rec o m me n dati o ns relate d t o c o ntrace pti o n a n d pre g n a nc y testi n g i n cli nical trials 
( versi o n 1. 1) b y t h e Cli nical Trials Facilit ati o n a n d C o or di nati o n Gr o u p ( C T F G, 2 0 2 0).
1 2. 3. 4  
Uri n al ysis
Uri ne will be o btai ne d f or uri nal ysis at scree ni n g a n d o n f oll o w- u p Da ys 9 9 a n d 1 6 9 ( 1 4 a n d 
8 4 [ ± 5] da ys f oll o wi n g last d ose if E T), a n d s y m pt o m- base d, as n ecess ar y. T he uri ne sa m ple will 
be pr ocess e d a n d s hi p pe d i n acc or da nce wit h t h e L a 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 y ze t h e uri ne sa m ple f or s p ecific 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 2. 3. 5  
Ser ol o g y 
Bl o o d will be o btai ne d at scree ni n g f or ser ol o g y tests i n cl u di n g he patitis B s urface a nti ge n 
( H Bs A G), he patitis C a nti b o d y, he patitis B c ore a nti b o d y (a nti- H B c), a n d h u ma n i m m u n o-
deficie nc y vir us ( HI V). T he bl o o d sa m ple will be pr ocess e d a n d s hi p pe d t o t he ce ntral la b orat or y 
i n acc or d a nce wit h t he L a b orat or y Ma n ual a n d la b kit i nstr ucti o ns. A p ositi ve res ult, if cli nicall y 
si g nifica nt (a n d n ot d ue t o pre vi o us vacci nati o n or res ol ve d disease or e x p os ure) will e xcl u de t h e 
s u bject fr o m e nr oll me nt (A p pe n di x 1 0) .
1 2. 3. 6  
A nti- Lire nteli m a b A nti b o di es
Bl o o d f or deter mi n ati o n of A D A will be c ollecte d pre d ose o n d osi n g Da ys 1, 4 3, a n d 8 5 ( ± 5), o n 
Da y 8 ( ± 3), a n d o n f oll o w- u p Da ys 9 9 a n d 1 6 9 ( 1 4 a n d 8 4 [ ± 5] da ys after l ast d ose of st u d y dr u g 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 4 of 1 3 5 
C o nfi d e nti al  
if E T). T he A D A sa m ple will als o be c ollecte d a n y ti me a n i m m u n o ge nicit y-relate d A E occ urs.
A d diti o nal A D A sa m ples will be c oll ecte d at eac h d osi n g visit d uri n g t h e O L E peri o d. 
A n u nsc he d ule d bl o o d sa m ple f or A D A ma y als o be o btai ne d if a relate d A E s us pecte d of b ei n g 
ass ociate d wit h i m m u n o ge nicit y occ urs. T h e ser u m sa m ple will be c oll ecte d, pr ocesse d, a n d 
s hi p pe d i n acc or da nce wit h t he L a b orat or y M a n u al a n d l a b 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 nti-lire nteli ma b a nti b o dies usi n g a vali date d assa y m et h o d.
A d diti o nall y, t he ser u m sa m ples c ollecte d f or A D A will be retai n e d f or f ut ure testi n g i n t h e e ve nt 
t hat a n y ne w p ote nti al safet y or i m m u n o ge nicit y iss ues are i de ntifie d. 
1 2. 3. 7  
Bl o o d f or P h a r m ac o ki neti cs  
Bl o o d sa m ples f or ser u m P K ass ess me nts will be c ollecte d pre d ose o n d osi n g Da ys 1, 1 5, 2 9, 4 3, 
5 7, 7 1, a n d 8 5 ( ± 5) as w ell as o n Da y 8 ( ± 3) a n d d uri n g f oll o w- u p o n Da ys 9 9, 1 4 1, a n d 1 6 9 ( ± 5) 
or 1 4, 5 6, a n d 8 4 ( ± 5) d a ys after last d ose of st u d y dr u g if E T. T he ser u m sa m ples will be 
c ollecte d pre d ose a n d pr ocess e d a n d s hi p p e d fr oze n i n acc or da nce wit h t he La b orat or y M a n ual 
a n d la b kit i nstr ucti o ns. 
Lire nteli ma b 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 LI S A met h o d.  S pecific i nf or m ati o n o n P K sa m ple c oll ecti 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 la b orat or y ma n u al.  
1 2. 3. 8  
Bl o o d f or I g E 
Bl o o d will be c ollecte d f or deter mi nati o n of ser u m I g E le v els a n d se nt t o t h e ce ntr al la b orat or y 
f or pr ocessi n g. Bl o o d will be c ollecte d d uri n g s cree ni n g, pre d ose o n D a y 5 7 a n d Da y 8 5, a n d o n 
f oll o w- u p Da ys 9 9, 1 4 1, a n d 1 6 9 or 1 4, 5 6, a n d 8 5 ( ± 5) da ys after last d ose of st u d y dr u g if E T.  
1 2. 3. 9  
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 nt e d b y t h e 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 facilities or b y state or c o u ntr y (e. g., Ger ma n y) re g ulati o n, a n d if 
re q uire d, t his will be c o nse 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 1 8 I C F. Testi n g f or 
C O VI D- 1 9 ma y b e perf or me d acc or di n g t o t he tri al site st a n dar d pr oce d ures a n d safet y 
re g ulati o ns.  
T he ris k assess me nt relat e d t o o n g oi n g C o vi d- 1 9 pa n de mic will be re vi e w e d o n a c o nti n u o us 
basis, a n d meas ures re q uire d f or re d uci n g t h e ris k of i nfecti o n wit h t he n o v el c or o na vir us will be 
ta ke n, as a p pr o priate. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 5 of 1 3 5 
C o nfi d e nti al  
1 3.
E v al u ati o ns a n d P r oce d ures b y Visit
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.  
Ge neral I nf or m ati o n: 
 
All rec or d e d cl oc k ti m es s h o ul d utilize a 2 4- h o ur cl o c k. 
 
Pr oce d ures f or scree ni n g ma y be perf or me d o ver t h e c o urse of m ulti ple visits pri or t o t h e 
first S C i njecti o n. 
 
D ose 1 is t he da y of t he first S C i njecti o n. D ose 1/ Da y 1 ca n o cc ur wit hi n a ± 3 da y wi n d o w, 
i.e., t he scre e ni n g peri o d ca n be a ma xi m u m of 1 7 da ys a n d a mi ni m u m of 1 1 da ys. D osi n g 
visits m ust be c o n d ucte d wit hi n t h e ± wi n d o ws sti p ulate d i n t he pr ot oc ol wit h t he f oll o wi n g 
re q uire me nts: 
 T he i nter val bet w ee n d osi n g visits m ust be at least 7 da ys a n d n o m ore t h a n 2 1 da ys 
fr o m t he pre vi o us d osi n g visit u nless directe d ot her wise b y Alla k os. T he i nt er val c o u nt 
starts t he da y aft er t he visit a n d i ncl u des t he da y of t he n e xt visit. 
 T he i nter val bet w ee n t he fi nal d osi n g visit a n d t he efficac y visit ( Da y 9 9) m ust be at 
least 1 1 da ys a n d n o m ore t h a n 1 7 da ys fr o m t he fi nal d osi n g visit u nless directe d 
ot her wise b y Alla k os. T h e i nter val c o u nt starts t he da y after t he visit a n d i n cl u des t he 
da y of t h e ne xt visit. 
 
F or D a y 8, t he visit ca n o cc ur wit hi n a ± 3 da y wi n d o w. 
1 3. 1  
Scree ni n g D a y ( ~ D a y - 1 4)/ Scree ni n g Peri o d 
1) 
O btai n writt e n i nf or me d c o nse nt. 
2) 
Assi g n t he partici pa nt a PI D. 
3) 
C oll ect d e m o gra p hics. 
4) 
O btai n me dical hist or y. 
5) 
Gat her a n d re vie w A D di a g n osis a n d detaile d pre vi o us treat me nt hist or y a n d c o nc o mita nts 
me dicati o ns ( Secti o n  1 2. 2. 6). 
6) 
C oll ect b o d y wei g ht (i n k g) a n d hei g ht (i n c m) al o n g wit h vital si g ns. 
7) 
Perf or m E C G. 
8) 
C o n d uct c o m plete p h ysical e xa mi nati o n. 
9) 
C oll ect vI G A, E A SI, 
.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 6 of 1 3 5 
C o nfi d e nti al  
1 0)
Acti vate dail y P R O a n d h a ve s u bject c o m plet e first P R O ( p p N R S) i n t he cli nic. T o e ns ure 
t here is s ufficie nt P R O d ata at baseli ne, a s u bject s h o ul d c o m plete at least f o ur dail y P R O 
q uesti o n naires per wee k f or a mi ni m u m peri o d of t he se ve n da ys pri or t o D a y 1.
1 1)
Ha ve s u bject c o m plete t h e  
q u esti o n naire a n d a ns wer 2  
 q u esti o ns.
1 2) 
C ollect bl o o d f or ser ol o g y, ser u m I g E, c he mistr y (i ncl u di n g h C G a n d F S H, if a p pli ca ble),
a n d C B C. Fe male s u bjects of c hil d beari n g p ote ntial are re q uire d t o ha ve h C G meas ure d. 
P ost me n o pa usal w o me n are re q uire d t o ha ve F S H meas ure d. If t he p ost me n o pa usal F S H 
. 
1 3) 
C ollect uri ne f or uri nal ysis. 
1 4) 
C o n d uct eli gi bilit y assess m e nt a n d c o nfir m s u bject is eli gi ble t o m o ve f or war d wit h 
scree ni n g. 
1 3. 2  
D a y 1 – R a n d o mi z ati o n/ D ose 1/ B aseli ne 
Pri or t o St u d y Dr u g A d mi nistrati o n: 
1) 
Assess t he s u bject f or S A E relate d t o scree ni n g pr o ce d ures. 
2) 
C o nfir m c o nti n ui n g eli gi bilit y a n d a vaila bilit y of all re q uire d me dical rec or ds a n d s o urce 
d oc u me nts. 
3) 
D oc u m e nt a n y c h a n ges t o healt h stat us. 
4) 
D oc u m e nt a n y c h a n ges t o me dical hist or y a n d c o nc o mita nt me dicati o ns. 
5) 
Assess  
 c o m plia nce. S u bject s h o ul d c o m plete at least f o ur d ail y P R O q uesti o n naires 
d uri n g t he se ve n da ys pri or t o Da y 1. 
6) 
Perf or m uri ne di pstic k pre g n a nc y test if s u bject is of c hil d beari n g p ote ntial. 
7) 
C oll ect b o d y wei g ht (i n k g). 
8) 
Perf or m s y m pt o m- direct e d p h ysical e xa m, if n ee d e d. 
9) 
C o m plete vI G A, E A SI, 
 
1 0) 
Ha ve s u bject c o m plete t h e  
 q u esti o n naire,  
 ( u nless alrea d y c o m plete d), a n d 
At o pic C o n diti o ns Q uesti o n naire. 
1 1) If c o nse nt is o btai ne d, c ollect bi o ps y (a p plica ble f or select e d U S sites o nl y).
1 2) 
Ra n d o mizati o n: 
a) Pri or t o ra n d o mizi n g t he s u bject i n t he I R T s yste m, t he I n v esti gat or will d eter mi ne 
s u bject’s I G A s c ore a n d bi ol o gic- naï ve vs bi ol o gic-e x p ose d stat us i n or d er t o stratif y 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 7 of 1 3 5 
C o nfi d e nti al  
s u bject a n d si g n s o urce Eli gi bilit y F or m. T he st u d y c o or di nat or or d esi g nee will e nter 
I G A sc ore a n d bi ol o gic stat us i nt o t h e I R T o n St u d y Da y 1 t o stratif y t he s u bject.  
b)
T he I R T s yste m will t he n ra n d o ml y assi g n t he s u bject t o lire nteli m a b S C 3 0 0 m g or 
place b o S C i n a d o u ble- bli n d ma n ner a n d will se n d a n e mail t o t h e p har macist a n d/ or 
desi g nee detaili n g t h e kit n u m ber(s) t o use t o pre p are t he i njecti o n. See t h e P h ar m ac y 
Ma n ual f or detaile d S C i njecti o n pre parati o ns.
1 3) 
C ollect vit al si g ns wit hi n 3 0 mi n utes of t h e start of t he S C i njecti o n.
1 4) 
C ollect bl o o d f or C B C, c he mistr y, P K, a n d A D A j ust pri or t o S C i njecti o n. 
1 5) S C I njecti o n of St u d y Dr u g: 
a) S u bc uta ne o us d osi n g (lire nteli ma b S C or place b o S C) c o m prises 1 S C i njecti o n 
a d mi nistere d i n t he fr o nt of t h e t hi g h wit h a 2 7- ga u ge nee dle. M a xi m u m v ol u me 
a d mi nistere d per S C i njecti o n will be 2 m L. See t h e P h ar mac y M a n ual f or S C i njecti o n 
i nstr ucti o ns. 
b) C ollect vit al si g ns 1 5 ( ± 5) mi n utes after st u d y dr u g a d mi nistrati o n. 
1 6) P ost- S C I njecti o n:
a)
C ollect bl o o d f or C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after S C i njecti o n.
b) 
O bser ve t he s u bj ect f or at least 1 h o ur after st u d y dr u g a d mi nistrati o n. 
c) 
C ollect vit al si g ns j ust pri or t o disc har ge. 
If a n a p hyl axis is s us pecte d, a s a m ple of bl o o d s h o ul d be o bt ai ne d f or pl as m a hist a mi ne level a n d 
try pt ase wit hi n 1 – 2 h o urs of t h e o nset of sy m pt o ms. Als o, a n u nsc he d ule d A D A bl o o d s a m ple 
m ay b e o bt ai ne d if a n i m m u n o ge nicity-rel ate d A E is s us pecte d. 
1 3. 3
D a y 8 ( ± 3)  
1) 
Assess t he s u bject f or A E a n d S A E. 
2) 
D oc u m e nt a n y c h a n ges t o c o nc o mita nt me dicati o ns. 
3) 
Assess  
 c o m plia nce. 
4) 
C oll ect vital si g ns a n d b o d y wei g ht (i n k g).
5) 
C oll ect bl o o d f or P K a n d A D A
6) 
Perf or m uri ne di pstic k pre g n a nc y test if s u bject is of c hil d beari n g p ote ntial.
7) 
Perf or m s y m pt o m- direct e d p h ysical e xa m, as nee de d.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 8 of 1 3 5 
C o nfi d e nti al  
1 3. 4
D a y 1 5 ( ± 5) – D ose 2
1) 
Pri or t o S C I njecti o n:
a)
Assess t he s u bject f or A E a n d S A E. 
b)
D oc u me nt a n y c h a n ges t o c o nc o mita nt me dicati o ns. 
c)
Assess 
 c o m plia nce.
d)
C o m plete I G A, E A SI, 
 assess me nts.
e)
Ha ve s u bject c o m plete  
 a n d  
a n d 2 q u esti o ns o n t he  
 
q uesti o n naire.
f) 
C ollect b o d y wei g ht (i n k g). 
g) Perf or m uri ne pre g na n c y test if s u bject is of c hil d beari n g p ote ntial. 
h) Perf or m s y m pt o m- direct e d p h ysical e xa m, as nee de d. 
2) 
S C I njecti o n of St u d y Dr u g: 
a) E nter t h e visit i n t h e I R T a n d pre pare st u d y dr u g usi n g kit n u m ber(s) pr o vi de d b y t he 
I R T. See t h e P h ar mac y Ma n ual f or det aile d S C i njecti o n pre parati o ns. 
b) C ollect vit al si g ns wit hi n 3 0 mi n utes pri or t o t h e start of t he S C i njecti o n. 
c) 
C ollect bl o o d f or C B C, c he mistr y, a n d P K j ust pri or t o t he S C i njecti o n. 
d) 
A d mi nister S C i njecti o n i n t h e fr o nt of t he t hi g h. 
e) 
C ollect vit al si g ns 1 5 ( ± 5) mi n utes after st u d y dr u g a d mi nistrati o n. 
3) 
P ost- S C I njecti o n: 
a) 
C ollect C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e S C i njecti o n. 
b) 
O bser ve t he s u bj ect f or at least 1 h o ur after st u d y dr u g a d mi nistrati o n.  
c) 
C ollect vit al si g ns j ust pri or t o disc har ge. 
If a n a p hyl axis is s us pecte d, a s a m ple of bl o o d s h o ul d be o bt ai ne d f or pl as m a hist a mi ne level a n d 
try pt ase wit hi n 1 – 2 h o urs of t h e o nset of sy m pt o ms. Als o, a n u nsc he d ule d A D A bl o o d s a m ple 
m ay b e o bt ai ne d if a n i m m u n o ge nicity-rel ate d A E is s us pecte d. 
1 3. 5  
D a y 2 9 ( ± 5) – D ose 3 
1) 
Pri or t o S C I njecti o n: 
a) 
Assess t he s u bject f or A E a n d S A E. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 7 9 of 1 3 5 
C o nfi d e nti al  
b)
D oc u me nt a n y c h a n ges t o c o nc o mita nt me dicati o ns.
c) 
Assess  
 c o m plia nce.
d)
Perf or m I G A, E A SI, 
assess me nts.
e)
Ha ve s u bject c o m plete  
 a n d  
a n d 2 q u esti o ns o n t he  
 
q uesti o n naire. 
f)
C ollect b o d y wei g ht (i n k g).
g) Perf or m uri ne pre g na n c y test if s u bject is of c hil d beari n g p ote ntial. 
h) Perf or m s y m pt o m- direct e d p h ysical e xa m, as nee de d. 
2) 
S C I njecti o n of St u d y Dr u g: 
a) E nter t h e visit i n t h e I R T a n d pre pare st u d y dr u g usi n g kit n u m ber(s) pr o vi de d b y t he 
I R T. See t h e P h ar mac y Ma n ual f or det aile d S C i njecti o n pre parati o ns. 
b) C ollect vit al si g ns wit hi n 3 0 mi n utes pri or t o t h e start of t he S C i njecti o n. 
c) 
C ollect bl o o d f or C B C, c he mistr y, a n d P K j ust pri or t o t he S C i njecti o n. 
d) 
A d mi nister S C i njecti o n i n t h e fr o nt of t he t hi g h. 
e) 
C ollect vit al si g ns 1 5 ( ± 5) mi n utes after t h e st u d y dr u g a d mi nistrati o n. 
3) 
P ost- S C I njecti o n:
a)
C ollect C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e S C i njecti o n. 
b) 
O bser ve t he s u bj ect f or at least 1 h o ur after st u d y dr u g a d mi nistrati o n. 
c) 
C ollect vit al si g ns j ust pri or t o disc har ge. 
If a n a p hyl axis is s us pecte d, a s a m ple of bl o o d s h o ul d be o bt ai ne d f or pl as m a hist a mi ne level a n d 
try pt ase wit hi n 1 – 2 h o urs of t h e o nset of sy m pt o ms. Als o, a n u nsc he d ule d A D A bl o o d s a m ple 
m ay b e o bt ai ne d if a n i m m u n o ge nicity-rel ate d A E is s us pecte d. 
1 3. 6  
D a y 4 3 ( ± 5) – D ose 4 
1) 
Pri or t o S C I njecti o n: 
a) 
Assess t he s u bject f or A E a n d S A E. 
b) 
D oc u me nt a n y c h a n ges t o c o nc o mita nt me dicati o ns. 
c) 
Assess  
 c o m plia nce. 
d) Perf or m I G A, E A SI, 
 assess me nts. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 0 of 1 3 5 
C o nfi d e nti al  
e)
Ha ve s u bject c o m plete  
a n d  
 a n d 2 q uesti o ns o n t he  
 
q uesti o n naire.
f)
C ollect b o d y wei g ht (i n k g). 
g) Perf or m uri ne pre g na n c y test if s u bject is of c hil d beari n g p ote ntial. 
h)
Perf or m s y m pt o m- directe d p h ysical e xa m, as nee de d.
2) 
S C I njecti o n of St u d y Dr u g: 
a) E nter t h e visit i n t h e I R T a n d pre pare st u d y dr u g usi n g kit n u m ber(s) pr o vi de d b y t he 
I R T. See t h e P h ar mac y Ma n ual f or det aile d S C i njecti o n pre parati o ns. 
b) C ollect vit al si g ns wit hi n 3 0 mi n utes pri or t o t h e start of t he S C i njecti o n. 
c) 
C ollect bl o o d f or C B C, c he mistr y, P K a n d A D A j ust pri or t o t he S C i njecti o n. 
d) 
A d mi nister S C i njecti o n i n t h e fr o nt of t he t hi g h. 
e) 
C ollect vit al si g ns 1 5 ( ± 5) mi n utes after st u d y dr u g a d mi nistrati o n. 
3) 
P ost- S C I njecti o n: 
a) 
C ollect C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e S C i njecti o n. 
b) 
O bser ve t he s u bj ect f or at least 1 h o ur after st u d y dr u g a d mi nistrati o n.  
c)
C ollect vit al si g ns j ust pri or t o disc har ge.
If a n a p hyl axis is s us pecte d, a s a m ple of bl o o d s h o ul d be o bt ai ne d f or pl as m a hist a mi n e level a n d 
try pt ase wit hi n 1 – 2 h o urs of t h e o nset of sy m pt o ms. Als o, a n u nsc he d ule d A D A bl o o d s a m ple 
m ay b e o bt ai ne d if a n i m m u n o ge nicity-rel ate d A E is s us pecte d.
1 3. 7
D a y 5 7 ( ± 5) – D ose 5
1)
Pri or t o S C I njecti o n:
a)
Assess t he s u bject f or A E a n d S A E.
b)
D oc u me nt a n y c h a n ges t o c o nc o mita nt me dicati o ns.
c)
Assess  
 c o m plia nce.
d)
C o m plete I G A, E A SI, 
assess m e nts.
e)
Ha ve s u bject c o m plete  
a n d  
 a n d 2 q uesti o ns o n t he  
 
q uesti o n naire.
f)
C ollect b o d y wei g ht (i n k g).

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 1 of 1 3 5 
C o nfi d e nti al  
g)
Perf or m uri ne pre g na n c y test if s u bject is of c hil d beari n g p ote ntial.
h) Perf or m s y m pt o m- direct e d p h ysical e xa m, as nee de d. 
2)
S C I njecti o n of St u d y Dr u g:
a)
E nter t h e visit i n t h e I R T a n d pre pare st u d y dr u g usi n g t he kit n u m ber(s) pr o vi de d b y 
t he I R T. Se e t h e P h ar m ac y Ma n ual f or detaile d S C i njecti o n pre parati o ns. 
b)
C ollect vit al si g ns wit hi n 3 0 mi n utes pri or t o t he start of t he S C i njecti o n.
c) 
C ollect bl o o d f or C B C, I g E, c he mistr y, a n d P K j ust pri or t o t he S C i njecti o n. 
d) 
A d mi nister S C i njecti o n i n t h e fr o nt of t he t hi g h. 
e) 
C ollect vit al si g ns 1 5 ( ± 5) mi n utes after st u d y dr u g a d mi nistrati o n.  
3) 
P ost- S C I njecti o n: 
a) 
C ollect bl o o d f or C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e S C i njecti o n. 
b) 
O bser ve t he s u bj ect f or at least 1 h o ur after t he e n d of t h e S C i njecti o n. 
c) 
C ollect vit al si g ns j ust pri or t o disc har ge. 
If a n a p hyl axis is s us pecte d, a s a m ple of bl o o d s h o ul d be o bt ai ne d f or pl as m a hist a mi ne level a n d 
try pt ase wit hi n 1 – 2 h o urs of t h e o nset of sy m pt o ms. Als o, a n u nsc he d ule d A D A bl o o d s a m ple 
m ay b e o bt ai ne d if a n i m m u n o ge nicity-rel ate d A E is s us pecte d.
1 3. 8  
D a y 7 1 ( ± 5) – D ose 6 
1) 
Pri or t o S C I njecti o n: 
a) 
Assess t he s u bject f or A E a n d S A E. 
b) 
D oc u me nt a n y c h a n ges t o c o nc o mita nt me dicati o ns. 
c) 
Assess  
 c o m plia nce.
d) Perf or m I G A,  
 E A SI, a n d  
 assess m e nts.
e) 
Ha ve s u bject c o m plete  
a n d  
 a n d 2 q uesti o ns o n t he  
 
q uesti o n naire.
f)
C ollect b o d y wei g ht (i n k g). 
g) Perf or m uri ne pre g na n c y test if s u bject is of c hil d beari n g p ote ntial. 
h) Perf or m s y m pt o m- direct e d p h ysical e xa m, as nee de d. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 2 of 1 3 5 
C o nfi d e nti al  
2)
S C I njecti o n of St u d y Dr u g:
a)
E nter t h e visit i n t h e I R T a n d pre pare st u d y dr u g usi n g t he kit n u m ber(s) pr o vi de d b y 
t he I R T. Se e t h e P h ar m ac y M a n ual f or detaile d S C i njecti o n pre parati o ns.
b)
C ollect vit al si g ns wit hi n 3 0 mi n utes pri or t o t he start of t he S C i njecti o n.
c) 
C ollect bl o o d f or C B C, c he mistr y, a n d P K j ust pri or t o t he S C i njecti o n.
d) 
A d mi nister S C i njecti o n i n t h e fr o nt of t he t hi g h. 
e) 
C ollect vit al si g ns 1 5 ( ± 5) mi n utes after st u d y dr u g a d mi nistrati o n. 
3)
P ost- S C I njecti o n:
a)
C ollect C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e S C i njecti o n.
b) 
O bser ve t he s u bj ect f or at least 1 h o ur after t he S C i njecti o n. 
c) 
C ollect vit al si g ns j ust pri or t o disc har ge. 
If a n a p hyl axis is s us pecte d, a s a m ple of bl o o d s h o ul d be o bt ai ne d f or pl as m a hist a mi ne level a n d 
try pt ase wit hi n 1 – 2 h o urs of t h e o nset of sy m pt o ms. Als o, a n u nsc he d ule d A D A bl o o d s a m ple 
m ay b e o bt ai ne d if a n i m m u n o ge nicity-rel ate d A E is s us pecte d.
1 3. 9  
D a y 8 5 ( ± 5) – D ose 7 
1) 
Pri or t o S C I njecti o n: 
a) 
Assess t he s u bject f or A E a n d S A E. 
b) 
D oc u me nt a n y c h a n ges t o c o nc o mita nt me dicati o ns. 
c) 
Assess  
 c o m plia nce. 
d) Perf or m I G A, E A SI, 
 assess me nts.
e) 
Ha ve s u bject c o m plete  
a n d  
 a n d 2 q uesti o ns o n t he  
 
q uesti o n naire.
f)
C ollect b o d y wei g ht (i n k g). 
g) Perf or m uri ne pre g na n c y test if s u bject is of c hil d beari n g p ote ntial. 
h) Perf or m s y m pt o m- direct e d p h ysical e xa m, as nee de d. 
2) 
S C I njecti o n of St u d y Dr u g: 
a) E nter t h e visit i n t h e I R T a n d pre pare st u d y dr u g usi n g t he kit n u m ber(s) pr o vi de d b y 
t he I R T. Se e t h e P h ar m ac y Ma n ual f or detaile d S C i njecti o n pre parati o ns. 
b) C ollect vit al si g ns wit hi n 3 0 mi n utes pri or t o t h e start of t he S C i njecti o n.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 3 of 1 3 5 
C o nfi d e nti al  
c)
C ollect bl o o d f or C B C, I g E, c he mistr y, P K, a n d A D A j ust pri or t o t he S C i njecti o n.
d) 
A d mi nister S C i njecti o n i n t h e fr o nt of t he t hi g h. 
e)
C ollect vit al si g ns 1 5 ( ± 5) mi n utes after st u d y dr u g a d mi nistrati o n.
3)
P ost- S C I njecti o n:
a) 
C ollect C B C wit h differe ntial 1 h o ur ( ± 1 5 mi n utes) after t h e S C i njecti o n.
b)
O bser ve t he s u bj ect f or at least 1 h o ur after st u d y dr u g a d mi nistrati o n. 
c) 
C ollect vit al si g ns j ust pri or t o disc har ge. 
If a n a p hyl axis is s us pecte d, a s a m ple of bl o o d s h o ul d be o bt ai ne d f or pl as m a hist a mi ne level a n d 
try pt ase wit hi n 1 – 2 h o urs of t h e o nset of sy m pt o ms. Als o, a n u nsc he d ule d A D A bl o o d s a m ple 
m ay b e o bt ai ne d if a n i m m u n o ge nicity-rel ate d A E is s us pecte d.
1 3. 1 0  D a y 9 9 ( ± 5) or 1 4 D a ys P ost- D ose – F oll o w- u p Visit 1 
1) 
Assess t he s u bject f or A E a n d S A E. 
2) 
D oc u m e nt a n y c h a n ges t o c o nc o mita nt me dicati o ns. 
3) 
Assess  
 c o m plia nce. 
4) 
Perf or m I G A, E A SI, 
 assess m e nts. 
5) 
Ha ve s u bject c o m plete  
 a n d  
 t w o q u esti o ns o n t he  
 q uesti o n naire, 
a n d t he At o pic C o n diti o ns Q uesti o n naire. 
6) 
C oll ect b o d y wei g ht (i n k g). 
7) 
C oll ect uri ne f or uri nal ysis. 
8) 
Perf or m uri ne pre g na n c y test if s u bject is of c hil d beari n g p ote nti al. 
9) 
C oll ect vital si g ns. 
1 0) Perf or m s y m pt o m- direct e d p h ysical e xa m, as nee de d. 
1 1) 
C ollect bl o o d f or C B C, c he mistr y, P K, a n d A D A.
1 2) 
C ollect bl o o d f or t otal ser u m I g E. 
1 3) If c o nse nt is o btai ne d, c ollect bi o ps y (a p plica ble f or select e d U S sites o nl y).
If t h e s u bject el ects t o recei v e O L E d osi n g, t h e O L E peri o d of t h e st u d y m a y be gi n after all 
Da y 9 9 assess me nts of t h e d o u ble- bli n d peri o d ha ve b ee n c o m plete d. T he st art of O L E d osi n g 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 4 of 1 3 5 
C o nfi d e nti al  
ma y be d ela y e d f or u p t o 7 da ys after c o m pleti o n of t he D a y 9 9 visit. T he s u bject is i n t he 
d o u ble- bli n d peri o d of t h e st u d y u ntil t he first O L E d ose of lire nteli m a b is a d mi nistere d.
1 3. 1 1
D a y 1 4 1 ( ± 5) or 5 6 D a ys P ost- D os e – F oll o w- u p Visit 2
1) 
Assess t he s u bject f or A E a n d S A E. 
2)
D oc u me nt a n y c ha n ges t o c o nc o mita nt me dicati o ns.
3)
Assess  
 c o m plia nce.
4)
Perf or m I G A, E A SI, 
assess m e nts.
5)
Ha ve s u bject c o m plete  
a n d  
 a n d 2 q uesti o ns o n t he  
 q uesti o n naire.
6) 
C oll ect b o d y wei g ht (i n k g). 
7) 
Perf or m uri ne pre g na n c y test if s u bject is of c hil d beari n g p ote nti al. 
8) 
C oll ect vital si g ns. 
9) 
Perf or m s y m pt o m- direct e d p h ysical e xa m, as nee de d. 
1 0) 
C ollect bl o o d f or C B C, I g E, c he mistr y, a n d P K. 
1 3. 1 2  D a y 1 6 9 ( ± 5)/ E n d of St u d y or 8 4 D a ys P ost- D ose – F oll o w- u p Visit 3 
1) 
Assess t he s u bject f or A E a n d S A E. 
2) 
D oc u m e nt a n y c h a n ges t o c o nc o mita nt me dicati o ns. 
3) 
Assess  
 c o m plia nce. 
4)
Perf or m I G A, E A SI, 
 assess me nts.
5)
Ha ve s u bject c o m plete  
a n d  
 a n d 2 q uesti o ns o n t he  
 q uesti o n naire.
6)
C ollect b o d y wei g ht (i n k g).
7)
C ollect uri ne f or uri nal ysis.
8)
Perf or m uri ne pre g na n c y test if s u bject is of c hil d beari n g p ote ntial.
9)
Perf or m s y m pt o m- direct e d p h ysical e xa m, as nee de d.
1 0)
C ollect bl o o d f or C B C, c he mistr y, P K, a n d A D A.
1 1)
C ollect bl o o d f or t otal ser u m I g E.
1 2)
C ollect vit al si g ns.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 5 of 1 3 5 
C o nfi d e nti al  
F or E arl y Ter mi n ati o n ( E T): Perf or m t he visit 1 4, 5 6, or 8 4 ( ± 5) da ys aft er t h e last d ose of 
st u d y dr u g or pri or t o t his, if necess ar y, t o e ns ure c o m plia nce wit h t he visit. 
1 3. 1 3
E n d of St u d y Defi niti o n
T he e n d of t he d o u bl e- bli n d, place b o-c o ntr olle d peri o d of t h e st u d y is defi ne d as t he c o m pleti o n 
of t he last f oll o w- u p visit of t he last e nr olle d s u bject w h o elects n ot t o parti ci p ate i n t he O L E 
peri o d of t he st u d y. 
F or s u bjects electi n g t o e nter t h e O L E peri o d of t h e st u d y, t he e n d of t he O L E peri o d of t he st u d y 
is defi ne d as t he c o m pleti o n of t h e last f oll o w- u p visit f or t he l ast s u bject. 
T he e nr oll m e nt of t h e last s u bject i n t he d o u ble- bli n d peri o d of t he st u d y is a nti ci pate d t o occ ur
i n t h e first half of 2 0 2 3. T he last s u bject’s last f oll o w u p visit will be a p pr o xi matel y 2 4 wee ks 
after t he d ate of e nr oll m e nt if O L E is n ot electe d, or u p t o 3 8 wee ks after t h e date of e nr oll m e nt 
if t he O L E is elect e d. 
Please refer t o Secti o n 1 4. 1 2 f or t h e st u d y e n di n g pre m at urel y.  
1 4.
A d verse E v e nt R e p orti n g a n d D oc u me nt ati o n
1 4. 1
A d v erse E ve nts 
I n acc or da n ce wit h 2 1 C o de of Fe deral 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 nizati o n (I C H) G ui d a nce E 2 A, a n A E is a n y u nt o war d me dical occ urre nce 
i n a cli nical i n vesti gati o n of a s u bject a d mi nistere d a p har mace uti cal pr o d u ct 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 h e treat me nt. 
A n A E is t heref ore a n y u nfa v ora bl e 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 dis ease te m p orall y ass o ciate d wit h t h e 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 i n vesti gati o nal pr o d uct. A n u ne x p ect e d A E is o ne of a 
t y pe n ot i de ntifie d i n nat ure, se verit y, or fre q ue nc y i n t h e c urre nt I n v esti gat or’s Br oc h ure or of 
greater s e verit y or fre q u e nc y t h a n e x pecte d base 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 ms, vital si g ns, or la b orat or y tests. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 6 of 1 3 5 
C o nfi d e nti al  
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 ur 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 E. 
 
A ntici pate d da y-t o- d a y fl u ct 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 si g nifi ca nt w orse ni n g fr o m baseli n e 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 greater fre q u e nc y t h a n occ urri n g at baseli ne.
All A E, w het her elicite d b y q uesti o ns fr o m st u d y staff, v ol u nteer e d, or n ot e d o n p h ysical 
e xa mi n ati o n/la b orat or y t esti n g, a n d re gar dless of ca usalit y or se verit y, will be ass esse d a n d 
rec or d e d i n t he e C R F b e gi n ni n g after t he first a d mi nistrati o n of st u d y dr u g i n t he d o u ble- bli n d 
peri o d of t he st u d y a n d e n di n g at t he ti me of st u d y c o m pleti o n or E T of t h e d o u ble- bli n d peri o d 
or t he O L E peri o d, w hic he ver is later. 
F or s u bjects p arti ci pati n g i n t he O L E peri o d, A E will be rec or d e d i n t he C R F of t h e A K 0 0 2- 0 1 8 
d o u ble- bli n d treat me nt p eri o d data bas e u p u ntil t h e first a d mi nistrati o n of lire nteli ma b i n t he 
O L E peri o d a n d rec or de d i n t he C R F of t h e A K 0 0 2- 0 1 8 O L E peri o d d ata base be gi n ni n g fr o m 
t he ti me of first a d mi nistrati o n of lire nteli ma b e n di n g at t h e ti me of st u d y c o m pleti o n or E T of 
t he O L E p eri o d.
1 4. 2
Seri o us A d verse E v e nts 
A S A E is defi ne d as a n A E t hat m eets t hat o ne of t h e f oll o wi n g criteria: 
 
Deat h 
 
A life-t hreate ni n g A E t hat places t h e s u bject at ris k of deat h at t h e ti me of t he e ve nt. It d oes 
n ot refer t o a n e ve nt t h at 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 nit al 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 s u bj ect. 
 
Ot her i m p orta nt me dical e ve nts ma y als o be c o nsi d ere 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 p ar diz e t he s u bject or re q uire i nter v e nti o n t o pre ve nt a n y of t h e 
o utc o mes liste d a b o ve. 
Seri o us a d verse e ve nts will b e assesse d a n d rec or de d be gi n ni n g after t he first a d mi nistrati o n of 
st u d y dr u g i n t h e d o u ble- bli n d peri o d a n d e n di n g at t he ti me of st u d y c o m pleti o n or E T of t h e 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 7 of 1 3 5 
C o nfi d e nti al  
d o u ble- bli n d peri o d or t h e O L E peri o d, w hic he ver is later. If t he S A E is relate d t o a scree ni n g 
pr oce d ure, it will b e ca pt ure d fr o m t he d ate of t he scree ni n g pr o ce d ure.  
1 4. 3
A d v erse E ve nts of S peci al I nterest 
A d vers e E v e nts of S pecial I nt erest ( A E SI) f or t his st u d y i n cl 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 m u ne res p o nse. B y decreasi n g t heir f u ncti o n, lire nteli m a b c o ul d t h e oreticall y 
i ncreas e t he ris k of m ali 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 beli e ve d 
t o be i n v ol ve d i n pr otecti n g t he b o d y fr o m parasitic i nfecti o ns. D ecreasi n g t h eir f u ncti o n 
c o ul d t he oreti call 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 v e cli nical la b orat or y test. 
 
I njecti o n-rel ate 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. 
A d vers e E v e nts of S pecial I nt erest will be ass esse d be gi n ni n g after t he ti m e of first 
a d mi nistrati o n of st u d y dr u g a n d e n di n g at t h e ti m e of st u d y c o m pleti o n or E T of t he d o u ble-
bli n d peri o d or t h e O L E peri o d, w hic he v er is later. 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 b e rec or de d i n t h e A E e C R F a n d desi g nate d as a n “ A E of 
s pecial i nterest.” 
1 4. 4
I njecti o n- Rel ate d Re acti o ns
All A E c o nsi dere d b y t h e I n v esti gat or t o be rel ate d t o t h e bi ol o gical s u bsta nce a n d o cc urri n g
wit hi n 2 4 h o urs of t he start of t h e S C i njecti o n of st u d y dr u g 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 ma y i ncl u de b ut are n ot e xcl usi ve t o: 
Fl us hi n g
Na us ea
C hills
V o miti n g
 
Bac k or a b d o mi nal pai n 
 
S w eati n g 
 
C hest dis c o mf ort or ti g ht ness 
 
Fe ver 
 
Dizzi ness 
 
Urticaria 
 
S h ort ness of breat h 
 
Pr urit us 
 
Hea d ac he 
 
Br o nc h os pas m 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 8 of 1 3 5 
C o nfi d e nti al  
 
H y p ote nsi o n or h y perte nsi o n 
All s y m pt o ms e x perie nce d b y a s u bject d uri n g a n I R R will be liste d i n t he e C R F u n der 1 I R R, 
u nless t he I n vesti gat or belie ves a s y m pt o m is n ot part of t he I R R, i n w hic h c ase it will be 
rec or d e d se paratel y. T h e start ti me of t he I R R 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 h e I R R will be ca pt ure d as t h e e n d ti me of t h e last s y m pt o m.  
1 4. 5
I njecti o n Site R e acti o ns
All A E c o nsi dere d b y t h e I n v esti gat or t o be rel ate d t o t he S C a d mi nistr ati o n of t he bi ol o gical 
s u bsta nce at t h e i njecti o n site  a n d occ urri n g wit hi n 2 4 h o urs of t he start of t he i njecti o n s h o ul d 
be ca pt ure d as o ne i njecti o n sit e reacti o n (I S R). 
C o m m o n s y m pt o ms of I S R i ncl u de, b ut are n ot e xcl usi v e t o: 
 
Re d ness at t h e i njecti o n sit e 
 
Itc hi n g at t he i njecti o n site 
 
Pai n at t he i njecti o n site 
 
S w elli n g at t h e i njecti o n site ( be y o n d t he b u m p ca use d b y t he v ol u me of dr u g i njecte d 
u n der t h e s ki n) 
 
Br uisi n g at t h e i njecti o n site 
 
B ur ni n g at t he i njecti o n site 
All s y m pt o ms e x perie nce d b y t he s u bject d uri n g a n I S R will be liste d i n t he e C R F u n der 1 I S R, 
u nless t he I n vesti gat or belie ves a s y m pt o m is n ot part of t he I S R, i n w hic h c ase it will be 
rec or d e d se paratel y. T h e start ti me of t he I S R will be ca pt ure d as t he start ti me of t h e first 
s y m pt o m, a n d t he e n d ti me of t h e I S R will be ca pt ure d as t h e e n d ti me of t h e last s y m pt o m. 
1 4. 6  
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 tr eate 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 m e 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 m es d uri n g t h e 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 9) . T he 
assess me nt of a n A E will be d o ne p urs ua nt t o defi niti o ns set f ort h b y I C H G o o d Cli nical Practi ce 
( G C P) g ui deli nes a n d a p plica ble re g ulat or y re q uire me nts.  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 8 9 of 1 3 5 
C o nfi d e nti al  
If a s u bject e x peri e nces si g ns or s y m pt o ms of a na p h yla xis, t he y s h o ul d be treate d wit h sta n dar d 
of care, s uc h as di p h e 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 h er 
s u p p orti ve meas ures al o n g wit h cess ati o n of t h e S C i njecti o n. A sa m ple of bl o o d s h o ul d be 
o btai ne d f or plas m a hista mi ne le vel a n d tr y ptase wit hi n 1 – 2 h o urs of t he o nset of s y m pt o ms. 
Als o, a n u nsc he d ule d A D A bl o o d sa m ple ma y be o btai n e d if a n i m m u n o ge nicit y-relate d A E is 
s us pecte d.
1 4. 7
E v al u ati n g A d verse E ve nts a n d Seri o us A d verse E v e nts 
1 4. 7. 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 E e C R F as se p arat e A E. T he I n vesti gat or ( or q ualifie d S u bi n vesti gat or) m ust assi g n t he 
f oll o wi n g A E attri b utes liste d bel o w ( Ta ble 3, T a ble 4, a n d Ta ble 5) a n d is res p o nsi ble f or 
e ns uri n g t his i nf or mati o n is rec or de d i n t he s o urce d oc u m e ntati o n. 
1 4. 7. 2  
Assess me nt of I nte nsit y 
I n v esti gat ors will use t heir cli nical j u d g me nt as w ell as t he g ui deli n es l ai d o ut i n t he N CI 
C T C A E ( versi o n 5. 0 or m ost c urre nt versi o n) t a bles ( Ta ble 3 a n d  A p pe n di x 8) t o assess t he 
i nte nsit y of eac h A E a n d S A E. 
T a bl e 3  
A d verse E ve nt Se verit y per C T C A E 
Gr a de 
C T C A E  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 v ati o ns o nl y; i nter ve nti o n 
n ot i n dicate d. 
2  
M o d erate; mi ni mal, l o cal, or n o ni n vasi v e 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 d ail y li vi n g ( A D L). 
3  
Se v ere 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 A D L. 
4  
Life-t hreate ni n g c o nse q ue nces, ur g e nt i nter ve nti o n i n dicate d. 
5  
D eat h relate d t o A E. 
* C T C A E v. 5. 0: Gra de refers t o t h e se v erit y of t h e A E. T h e C T C A E dis pla ys Gra des 1 – 5 wit h u ni q u e cli nical 
d escri pti o ns of se verit y f or eac h A E b ase d o n t his g e neral g ui d eli ne. 
T he ter m “se v ere” 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 wit hi n t he sa me da y, t he ma xi m u m se verit y f or t he e ve nt s h o ul d be 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 0 of 1 3 5 
C o nfi d e nti al  
e ntere d i nt o t he A E e C R F. If t he i nte nsit y c h a n ges o ver a n u m ber of da ys, t hese c ha n g es s h o ul d 
be rec or de d s e paratel y (i. e., as ha vi n g disti nct o nset dates). 
1 4. 7. 3
Assess me nt of C a us alit y t o St u d y Dr u g 
T he I n vesti gat or s h o ul d use t heir cli nical j u d g me nt as well as t he g ui deli n es i n Ta ble 4 t o ass ess 
t he relati o ns hi p bet wee n st u d y dr u g a n d A E. 
T a bl e 4  
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 me nt 
Relate d
T h ere is clear e vi de nce t h at t he e ve nt is relate d t o t h e use of st u d y dr u g (e. g., c o nfir mati o n 
b y p ositi v e re-c halle n ge test, if p ossi ble). A n ot h er eti ol o g y is c o nsi d era bl y less li k el y. 
P ossi ble  
T h e e v e nt ca n n ot b e e x plai n e d b y t h e s u bject’s m e dical c o n diti o n, c o nc o mita nt t h era p y, or 
ot h er ca uses, a n d t h ere is a pla usi ble te m p oral relati o ns hi p bet wee n t he e v e nt a n d st u d y dr u g 
a d mi nistrati o n.  
U nli k el y/ Re m ote 
A n e ve nt f or w hic h a n alter nati v e e x pla nati o n is m ore li k el y (e. g., c o n c o mita nt me dicati o ns 
or o n g oi n g m e dical c o n diti o ns) or t h e 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 g ests t h at a ca usal relati o ns hi p is u nli k el y. ( F or re p orti n g p ur p oses, 
U nli k el y/ Re m ote will be gr o u pe d t o get h er wit h N ot Relate d.)  
N ot Relate d  
T he e v e nt ca n b e rea dil y e x plai n e d b y t h e s u bject’s u n derl yi n g m e dical c o n diti o n, 
c o n c o mita nt t h era p y, or ot h er ca uses, a n d t h eref ore, t h e I n vesti gat or b elie v es n o relati o ns hi p 
e xists bet wee n t he e v e nt a n d st u d y dr u g.  
1 4. 7. 4  
Assess me 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 t heir cli nical j u d g me nt as well as t he g ui deli n es i n  Ta ble 5 t o assess 
t he relati o ns hi p bet wee n st u d y pr oce d ure a n d A E. Assess m e nt of ca us alit y t o st u d y pr oce d ure 
s h o ul d i n cl u de ca usalit y t o s uc h ite ms as bl o o d dra w (as a p pr o priate), or ot h er.  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 1 of 1 3 5 
C o nfi d e nti al  
T a bl e 5  
A d verse E ve nt R el ati o ns hi p t o St u d y P r oce d ure
Rel ati o ns hi p t o 
St u d y P r oce d ure
C o m me nt 
Relate d  
T h ere is clear e vi de nce t h at t he e ve nt is relate d t o a st u d y pr o ce d ure. 
P ossi ble  
T h e e v e nt ca n n ot b e e x plai n e d b y t h e s u bject’s m e dical c o n diti o n, c o nc o mita nt t h era p y, or 
ot h er ca uses, a n d t h ere is a pla usi ble te m p oral relati o ns hi p bet wee n t he e v e nt a n d a st u d y 
pr o ce d ure.  
U nli k el y/ Re m ote
A n e v e nt f or w hic h a n alter n ati v e e x pla nati o n is m ore li k el y (e. g., c o n c o mita nt m e dicati o ns 
or o n g oi n g m e dical c o n diti o ns) or t h e 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 g ests 
t h at a ca usal relati o ns hi p is u nli k el y ( F or re p orti n g p ur p oses, U nli kel y/ Re m ote will be 
gr o u p e d t o get h er wit h N ot Relate d).  
N ot Relate d  
T he e v e nt ca n b e rea dil y e x plai n e d b y t h e s u bject’s u n derl yi n g m e dical c o n diti o n, 
c o n c o mita nt t h era p y, or ot h er ca uses, a n d t h eref ore, t h e I n vesti gat or b elie v es n o relati o ns hi p 
e xists bet wee n t he e v e nt a n d a st u d y pr oce d ure.  
1 4. 7. 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, st u d y dr u g te m p oraril y wit h dra w n, or ot her (s pecif y).
Acti o n ta ke n wit h res p ect t o st u d y parti ci 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 treat m e nt of a n A E will b e cate g orize d as n o ne, c o nc o mit a nt 
me dicati o n, c o nc o mita nt pr oce d ure, or ot h er (s pecif y).  
1 4. 7. 6  
Assess me nt of O utc o me 
E ve nt o utc o me at res 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, rec o vere d wit h se q u elae, f atal, or u n k n o w n.  
1 4. 8  
A d verse E ve nt R e p o rti n g Pr oce d ures  
1 4. 8. 1  
All A d verse E v e nts 
A n y cli nicall y si g nifica nt A E t h at is o n g oi n g at t he ti me of st u d y c o m pleti o n or E T will be 
f oll o we d b y t he I n vesti g at or u ntil e ve nt res ol uti o n, t he A E is ot her wise e x pl ai ne 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 h e s u bject is l ost t o f oll o w- u p. 
All A E i de ntifie d, w het h er seri o us or n o n-seri o us, will be rec or d e d i n t he A E e C R F be gi n ni n g 
fr o m t he first a d mi nistrati o n of st u d y dr u g i n t he d o u ble- bli n d peri o d of t he st u d y a n d e n di n g at 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 2 of 1 3 5 
C o nfi d e nti al  
t he ti me of st u d y c o m pleti o n or E T of t he d o u ble- bli n d peri o d or t h e O L E p eri o d, w hic he v er is 
later. S eri o us a d verse e ve nts c o nsi dere d relate d t o scree ni n g pr o ce d ures will be rec or de d i n t h e 
A E e C R F starti n g o n t he date of i nf or m e d c o nse nt. W he ne ver a p pr o priate, t he 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 8).
1 4. 8. 2  
Seri o us A d v erse E ve nt Re p orti n g  
I n t he e ve nt of a n y S A E re p orte d or o bs er v e d d uri n g t h e 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 m ust re p ort it i m me diatel y ( wit hi n 2 4 h o urs of b ec o mi n g a w are of 
t he S A E) b y fa x or e mail t o t h e S p o ns or, All a k os I nc.  
T he S A E re p ort f or ms will be pr o vi de d t o t he i n vesti gati o nal sit e 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 m ust be c o m plete d wit h as m u c h i nf or mati o n as is 
a vaila ble a n d s h o ul d be s u b mitte d t o t h e S p o ns or wit hi n 2 4 h o urs of b ec o mi n g a ware of t he 
S A E. Seri o us a d verse e v e nts m ust als o be rec or de d o n t h e A E e C R F a n d d esi g nate 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 h e 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 h e ca usalit y is use d t o deter mi ne t h e ti mi n g of 
re g ulat or y re 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 h e 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 b y tele p h o ne a n d t h eir 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 
ma y c ha n ge t h eir ca us alit y ass ess 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 he 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 s u bject’s s o urce 
d oc u me nts. 
T he site will n otif y t he I n de pe n de nt Et hics C o m mittee (I E C)/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 s u bject’s c o n diti o n will be f oll o we d b y t he I n vesti gat or or d esi 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 h e 
s u bject will be as k e d t o ret ur n t o t h e st u d y site 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 s u bject 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 h e s u bject f or a reas o na bl e 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 h ere 
is a ret ur n t o baseli 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 g e n otes a n d s u bj ect me dical rec or ds, t he I n v esti gat or will be 
n otifie d a n d pr o vi d e d wit h all rele va nt i nf or mati o n.  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 3 of 1 3 5 
C o nfi d e nti al  
All S A E t hat ha ve n ot res ol ve d b y t he e n d of t h e st u d y or t h at h a ve n ot res ol v e d o n 
disc o nti n uati o n of t he s u bject’s p artici pati o n i n t h e st u d y m ust be f oll o we d u ntil a n y of t h e 
f oll o wi n g occ urs: 
 
T he e ve nt res ol ves.  
 
T he e ve nt sta bilizes. 
T he e ve nt ret 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 h a n t h e i n vesti g ati 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 (s u bject or healt h care 
practiti o ner 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). 
Seri o us A E m ust be re p orte d wit hi n 2 4 h o urs t o:  
  
Fa x: 
+ 1- 8 8 8- 2 3 7- 7 4 7 5 
  
E mail: 
S A E @all a k os.c o m 
1 4. 8. 3  
Pre g n a nc y Re p orti n g 
Pre g na ncies are ca pt ure d if t he y occ ur i n fe male s u bjects or i n t he se x ual p art ners of m ale 
s u bjects fr o m t he ti me t he s u bject is first e x p ose d t o t he i n vesti gati o nal pr o d uct a n d e n di n g at t he 
ti m e of st u d y c o m pleti o n or E T of t he d o u ble- bli n d peri o d or t h e O L E p eri o d, w hi c he ver is later.  
Fe male s u bjects 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 m e diatel y if t he y b ec o me pre g na nt d uri n g t he st u d y. Male s u bjects m ust i nf or m t he 
I n v esti gat or i m me diatel y if t heir part ner bec o m es pre g n a nt d uri n g t h e 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 All a k os wit hi n 2 4 h o urs of bec o mi n g a ware of it 
usi n g t h e pr o vi de d pre g n a nc y re p orti n g f or ms. Fe male s u bjects 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 nc y will n ot be c o nsi d ere d a n A E or 
S A E, b ut all pre g na ncies i n s u bjects w h o rec ei ve d lire nteli ma b will be f oll o we d t hr o u g h t er m. 
F or male s u bjects wit h fe male p art n ers w h o bec o m e pre g na nt, t h e site will as k t he fat h er (t he 
st u d y s u bject) t o pr o vi de i nf or mati o n a b o ut t he o utc o m e of t he pre g na n c y a n d i nf or mati o n a b o ut 
t he ba b y. If d etaile d healt h i nf or mati o n a b o ut t he m ot h er is re q ueste d b y Alla k os, a Pre g n a nt 
Part ner I nf or mati o n Release F or m will be pr o vi de d t o t he site f or t h e m ot her t o si g n.
A n y c o n ge nit al a b n or m alities n ote d at birt h i n t he offs pri n g of a s u bject w h o recei v e d 
lire nteli ma b will be re p orte d as a S A E. If t h e s u bject recei v e d lire nteli ma b, t he o utc o me of a n y 
pre g n a nc y a n d t he prese nce or a bs e nce of a n y c o n ge nit al a b n or malit y will be rec or de d i n t he 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 4 of 1 3 5 
C o nfi d e nti al  
s o urce d oc u m e 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 via t he pre g na n c y 
re p orti n g f or m.  
1 4. 8. 4
A E SI Re p orti n g
Be gi n ni n g fr o m t he ti me of first S C i njecti o n of st u d y dr u g a n d e n di n g at t he ti me of st u d y 
c o m pleti o n or E T of t h e d o u ble- bli n d peri o d or t h e O L E peri o d, w hic he ver is later, a n y ne w 
A E SI ( or ne w i nf or mati o n rel ate 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 E 
e C R F a n d desi g nate d as a n “ A E of s p ecial i nterest.” 
F or s u bjects p arti ci pati n g i n t he O L E peri o d, A E SI will be assesse d a n d rec or de d i n t he C R F of 
t he A K 0 0 2- 0 1 8 d o u ble- bli n d treat m e nt peri o d data base u p u ntil t he st art of t he first O L E 
i njecti o n after t h e Da y 9 9 visit a n d rec or de d i n t he C R F of t he A K 0 0 2- 0 1 8 O L E peri o d data b ase 
be gi n ni n g fr o m t he start of t h e first O L E i njecti o n after t h e D a y 9 9 visit.
A n A E SI t h at als o q ualifi es as a S A E ( p er Secti o n 1 4. 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 4. 8. 2.  A d vers e e ve nts of s peci al i nterest t hat are als o S A E m ust be 
rec or d e d i n t he A E e C R F a n d desi g nate d as b ot h “seri o us” a n d as a n “ A E of s pecial i nterest.” 
T hese will be re p orte 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 ness. 
1 4. 9
Me dic al M o nit ori n g
Dr. 
 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 mail 
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 g ar di n g safet y. 
All a k os Me dic al M o nit or
All a k os B ac k u p Me dic al M o nit or
 
, M D 
, M D 
  
P h o ne: 
 
P h o ne: 
 
E mail: 
E mail: 
 
Me dic al M o nit or f o r Ger m a n y
, M D, P h D 
  
P h o ne: 
 
E mail:
 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 5 of 1 3 5 
C o nfi d e nti al  
1 4. 1 0
I n d e pe n de nt D at a M o nit ori n g C o m mittee
A n i n de pe n de nt D ata M o nit ori n g C o m mittee (i D M C) has bee n c o n v e ne d f or t his st u d y. T he 
i D M C will meet at esta blis he d i nter vals (as per t he i D M C c harter) t hr o u g h o ut t he st u d y a n d will 
als o c o n ve ne as necessitate d b y data a n d/ or s afet y re vie ws.  
1 4. 1 1
St u d y Wit h dr a w al Criteri a
A s u bject’s partici p ati o n i n t h e st u d y will be disc o nti n ue d i n t he e ve nt t h at:
Occ urre n ce of a n e xcl usi o n criteri o n, w hic h is cli nicall y rel e va nt a n d affects t h e s u bject’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/
L i n s u bjects w h o e ntere d t h e st u d y wit h 
e osi n o p hil le vels > 1 5 0 0/ L a n d w h os e 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, as assesse d b y t he S afet y M o nit or, m a y be wit h dra w n fr o m t he st u d y at t h e 
i nstr ucti o n of t h e Me dical M o nit or. 
 
Ser u m tra nsa mi n ases ( A L T a n d/ or A S T) > 3 × U L N a n d t otal bilir u bi n > 2 × U L N 
(c o nfir me d b y re peat) wit h o ut a n alter nati ve e x pl a nati o n.  
 
Ele vati o n of A L T or A S T > 3 × U L N (c o nfir me d b y re peat) wit h t he a p peara nce or 
w orse ni n g of s y m pt o ms felt b y t he I n v esti gat or t o be p ote ntiall y rel ate d t o h e patic 
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 te n der n ess, 
fe ver, a n d ras h. 
1 4. 1 2  St u d y St o p pi n g R ules 
T he st u d y ma y be dis c o nti n ue d pre mat urel y i n t h e 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 m e nt.  
 
Ne w i nf or mati o n le a 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 d ecisi 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.  
 
A p pr o val of t he n ati o nal c o m pete nt a ut h orit y (i.e. Pa ul- E hrlic h-I nstit ut or P EI) or t he 
Fa v ora bl e O pi ni o n/ A p pr o val of I E C/I R B f or t h e c o n d uct of t he cli nical trial is wit h dra w n. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 6 of 1 3 5 
C o nfi d e nti al  
 
T he re q uir e d m o dificati o n of t he m a xi m u m i ns ure d s u m is n ot p ossi ble f oll o wi n g a
ne gati v e c h a n ge i n t he assess m e nt of t h e be nefit-ris k rati o, if a p pli ca ble (i.e., f or Ger ma n y) 
Healt h A ut h orities a n d I E C/I R B 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. 
St u d y st o p pi n g f or a n i n di vi d ual site or i n vesti gat or ma y occ ur i n t he e ve nt of n o nc o m plia nce 
wit h t h e pr ot oc ol or la pse of g o o d cli nical practice. 
1 5.
Disc o nti n u ati o n a n d R e pl a ce me nt of S u bjects
1 5. 1  
Defi niti o n of St u d y C o m pleti o n 
A s u bject w h o c o m pletes visits t hr o u g h t he Da y 1 6 9 visit will be cate g orize d as ha vi n g 
c o m plete d t he d o u ble- bli n d peri o d of t h e st u d y. 
A s u bject w h o c o m pletes visits t hr o u g h t he Da y 9 9 visit a n d e nters t he O L E peri o d of t h e st u d y 
will b e cate g orize d as h a vi n g c o m plete d t he d o u ble- bli n d peri o d of t he st u d y. 
A s u bject w h o c o m pletes visits t hr o u g h t he O L E Da y 1 6 9 visit will be cate g orize d as ha vi n g 
c o m plete d t he O L E p eri o d of t h e st u d y. 
T he st u d y is c o nsi dere d c o m plete d w he n t he last s u bject c o m pletes t he l ast st u d y visit. 
1 5. 2  
E arl y Disc o nti n u ati o n of St u d y Dr u g  
A s u bject m a y be disc o nti n ue d fr o m st u d y treat me nt at a n y ti me if t he s u bject, t he I n vesti g at or, 
or t he S p o ns or feels t hat it is n ot i n t he s u bject’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 m e nt disc o nti n uati o n: 
 
S u bject wit h dra ws c o nse nt.  
 
A n A E 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 
s u bject t o disc o nti n ue st u d y treat m e nt.  
Pr ot oc ol de viati o n re q uiri n g disc o nti n uati o n of st u d y treat m e nt.  
 
Partici pati o n i n a n y ot her st u d y d uri n g t he d urati o n of t his st u d y.  
 
Use of a n o n- per mitte d c o nc o mita nt dr u g, w hic h ma y a d vers el y affect data i nter pretati o n i n 
t he o pi ni o n of t he Me dical M o nit or. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 7 of 1 3 5 
C o nfi d e nti al  
 
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 
or treat m e nt of eit her a ps yc hiatric or p h ysical (e. g., i nfecti o us disease) ill ness.  
If a s u bject is wit h dra w n fr o m treat me nt d ue t o a n A E, t he s u bject will be f oll o we d a n d treat e d 
b y t he I n vesti gat or u ntil t h e a b n or mal para m eter or s y m pt o m has res ol ve d or sta bilize d.  
All s u bjects w h o disc o nti n ue st u d y dr u g treat m e 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 t he 1 2- wee k f oll o w- u p peri o d i n Ta ble 1,
if p ossi ble.  
Reas o na ble atte m pts will be ma de b y t h e I n v esti g at or t o pr o vi de reas o ns f or s u bject wit h dra wals. 
T he reas o n f or t he s u bject’s wit h dra wal fr o m t he st u d y or all atte m pts t o ac q uire s uc h will be 
s pecifie d i n t he s o urce d o c u me nts.  
1 6.
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 n es t h e st atistical met h o ds t o be use d f or t he a nal ysis of t he data fr o m t he st u d y. 
A se parate S A P, w hic h m ust be d oc u me nte d as c o m plete d pri or t o u n bli n di n g t he st u d y, will 
descri b e d ata h a n dli n g a n d statisti cal t ec h ni q ues i n f ull detail.  
U nless s pecifie d ot her wise, baseli ne will be defi ne d as t h e last wee k of scree ni n g bef ore t he first 
S C i njecti o n of st u d y dr u g. All s u bject data will be liste d. W he n a p pr o priat e, s u m m ar y st atistics 
of n u m ber of n o n- missi n g val ues, mea n, me di a n, sta n dar d de viati o n, mi ni m u m, a n d ma xi m u m 
will b e 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 pr o p orti o n will 
be c o m p ute d f or cate g orical varia bl es. T w o-si de d 9 5 % c o nfi de n ce i nter v als ( CI) will be pr o vi d e d 
f or t h e m ea n a n d pr o p orti o n. N o f or mal statisti cal i nfere n ces will be ma d e f or safet y para meters.  
1 6. 1
S a m ple Size
A p pr o xi matel y 1 3 0 e val u a ble s u bjects wit h m o derate-t o-se v ere A D will be e nr olle d. It is 
h y p ot hesize d t hat t h e per ce nta ge of s u bjects w h o ac hie ve E A SI- 7 5 at Wee k 1 4 are 4 4 % f or 
lire nteli ma b a n d 1 5 % f or place b o. T o det ect t he treat m e nt differe nce of 2 9 %, t he n u m ber of 
s u bjects re q uire d f or 9 0 % p o wer is 5 5. H o w e ver, t o acc o u nt f or 1 0 % dr o p o ut rate, t he sa m ple 
size will be i n crease d t o 6 5 per treat me nt gr o u p. 
E nr oll me nt will be m o nit ore d t o li mit t he i m pact of ra n d o mi zi n g a dis pr o p orti o natel y lar ge 
n u m ber of s u bjects wit h a n E A SI s c ore i n t he l o w er ra n g e, reflecti n g m ore m o derate disease o nl y 
(i.e., E A SI sc ore < 2 2). T his will als o pr o vi de a s u bject p o p ulati o n wit h a f ull ra n g e of E A SI 
sc ores c o nsiste nt wit h t he i nte nt t o st u d y lire nt eli m a b i n m o derate-t o-s e vere A D dis ease.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 8 of 1 3 5 
C o nfi d e nti al  
1 6. 2
A n al ysis P o p ul ati o ns
T he S afet y p o p ul ati o n  is defi ne d as all s u bje cts w h o are ra n d o mi ze d a n d ha ve recei ve d at least 
1 S C i njecti o n of t h e st u d y dr u g. 
T he pri mar y efficac y a nal ysis p o p ulati o n is t he m o difie d I nte nt-t o- Tre at ( mI T T) p o p ul ati o n , 
defi ne d as all ra n d o mize d s u bjects w h o ha ve recei ve d at least 1 S C i njecti o n of st u d y dr u g a n d
ha d n o maj or pr ot oc ol vi olati o ns base d o n ke y i ncl usi o n a n d e xcl usi o n criteria defi ni n g t he 
p o p ulati o n of i nterest (i.e., defi ne d as n ot meeti n g a n y of t he k e y i n cl usi o n crit eria n u m ber 3, 4, 
6, 7, 8 or meeti n g e xcl usi o n criteria n u m ber 8 i n t his st u d y).
T he sec o n d ar y efficac y a nal ysis p o p ulati o n is t h e Per Pr ot oc ol ( P P) p o p ul ati o n , defi ne d as 
mI T T s u bjects w h o ha ve recei v e d all 7 i njecti o ns of st u d y dr u g a n d di d n ot ha ve maj or pr ot o c ol 
vi olati o ns p ossi bl y i nterferi n g wit h i nter pretati o n of efficac y a n d safet y fi n di n gs.  
T he mI T T p o p ulati o n will be use d f or all effic ac y a nal ysis. T he P P p o p ulati o n will be use d f or 
t he pri mar y e n d p oi nt a n d select sec o n d ar y e n d p oi nt a nal yses t o e val u ate t he r o b ust ness of t h e 
effic ac y fi n di n gs. T he Safet y p o p ulati o n will be use d f or all safet y a nal ysis. 
T he st u d y statisti cia n al o n g wit h t he st u d y tea m will re vie w pr ot o c ol de viati o ns t o i de ntif y 
s u bjects t o be e xcl u de d fr o m t he P P p o p ulati o n a nal ysis.  
1 6. 3  
S u bject Dis p ositi o n 
S u bject dis p ositi o n a n d reas o n f or earl y disc o nti n uati o n will be ta b ulate d. S u bject de m o gra p hics, 
baseli n e c haracteristi cs, a n d treat m e nt e x p os ure will be s u m marize d. 
1 6. 4  
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 m arize d: 
 
De m o gra p hics 
 
Me dical hist or y 
 
C o m plete p h ysical e xa m 
 
E C G at scree ni n g 
Scree ni n g vital si g ns a n d la b orat or y tests
Neit her t he s u bject’s i nitials n or t h e f ull date of birt h will b e d oc u me nte d i n t he C R F or i n t he 
q uesti o n naires.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa g e 9 9 of 1 3 5 
C o nfi d e nti al  
1 6. 5
St u d y Dr u g E x p os ure
N u m ber a n d p erce nt ( n a n d %) of s u bjects w h o h a ve recei ve d 1, 2, 3, 4, 5, 6, or 7 S C i njecti o ns
will b e prese nte d. 
1 6. 6  
Effic ac y A n al ysis 
1 6. 6. 1  
Pri m ar y Effic ac y E n d p oi nt A n al ysis 
F or all efficac y v ari a bles, t he a nal ysis will b e c o m paris o n of lire nteli ma b S C a n d t h e place b o 
treat me nt gr o u ps. T he f oll o wi n g n ull a n d alter nati ve h y p ot heses f or t h e pri m ar y e n d p oi nt will be 
teste d f or lire nteli ma b S C gr o u p a n d t he place b o gr o u p:
H 0: N o treat me nt differe nce bet w ee n lire nt eli m a b S C a n d place b o.
H 1: T here is a treat m e nt differe n ce b et wee n lire nt eli m a b S C a n d place b o. 
Baseli ne disease se v erit y i n de x [ m o derate (I G A = 3) a n d se vere (I G A = 4)] a n d pri or bi ol o gic 
e x perie n ce ( bi ol o gic- naï ve a n d bi ol o gic-e x p os e d) will b e t he 2 stratificati o n fact ors f or s u bject 
ra n d o mizati o n a n d will b e acc o u nte d f or i n t he statisti cal m o deli n g f or effic ac y. I n a d diti o n, if it 
is e vi de nt t hat t he pri mar y e n d p oi nt is c o nf o u n de d b y st u d y e ntr y c haracteristi cs [e. g., t he 
met h o d of I G A a n d/ or E A SI sc ore assess me nt b y A D s pecialist ( defi ne d as t he PI a n d or S u b-I 
bei n g eit her a n aller gist, i m m u n ol o gist or der mat ol o gist) as c o m p are d t o n o n- A D s peci alist, 
c ha n ge i n perce nt B S A great er t h a n 2 0 % at t h e e n d of t he L ea d-i n P h ase ( Da y - 1 4 t o Da y - 8) 
c o m pare d t o t he e n d of t he B aseli ne P hase ( Da y - 7 t o Da y - 1)), t h e n t he pri m ar y efficac y 
a nal ysis will be c o n d ucte d a dj usti n g f or t he effects of t h e bac k gr o u n d c haracteristi cs.  
T he pri mar y res p o n der e n d p oi nt will be a nal yze d usi n g t he C oc hra n- Ma ntel- Hae nszel test 
a dj uste d b y baseli ne disease se verit y i n de x [ m o derate (I G A = 3) a n d se vere (I G A = 4)], pri or 
bi ol o gic e x perie nce ( bi ol o gic- n aï ve a n d bi ol o gic-e x p ose d), a n d c o u ntr y ( U S A a n d Ger ma n y) at 
Wee k 1 4. T h e Ma ntel- Fl eiss ( M F) criteri o n will be perf or me d, a n d if it is n ot met w hile usi n g t he 
o pti o n C M H ( M F) i n S A S pr oce d ure P R O C F R E Q, a nal yses i ncl u di n g eac h fact or se paratel y i n 
C M H test will be c o n d ucte d. S h o ul d ass u m pti o n per t he M F criteri o n n ot b e satisfie d, t he 
c o m paris o n will be base d o n a Fis her’s e xa ct test after c olla psi n g acr oss le v els of t h e 
stratificati o n fact or a n d c o u ntr y. 
F or t he a nal ysis descri be d a b o ve, s u bjects w h o pre mat urel y dis c o nti n ue t h e ra n d o mize d 
treat me nt or i niti ate a n y treat me nt a dj ust me nts (e. g., use of pr o hi bite d/resc ue me dicati o n/resc ue 
treat me nt f or A D s y m pt o ms) will be ha n dle d as des cri b e d bel o w: 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 0 of 1 3 5 
C o nfi d e nti al  
 
If a s u bject wit h dra ws fr o m t h e st u d y, t his s u bject will be c o u nte d as a n o n-res p o n der f or 
t he ti me p oi nts after wit h dra w al. 
 
T o acc o u nt f or t h e i m pact of pr o hi bite d/resc ue m e dicati o n/resc ue treat me nt f or A D 
s y m pt o ms o n t he efficac y effect: if resc u e me dicati o n/resc ue treat m e nt f or A D s y m pt o ms is 
use d, t he s u bject will be s pecifie d as a n o n-res p o n d er fr o m t he ti me t he resc ue 
me dicati o n/resc ue treat m e nt is use d. 
 
If t h e s u bject has t h e missi n g val ue at Wee k 1 4, it will be c o u nte d as a n o n-res p o n der at 
Wee k 1 4.
T he pri mar y efficac y a nal ysis will b e perf or me d o n mI T T p o p ulati o n, as w ell as P P p o p ulati o n 
as a s u p p orti n g a nal ysis. I n a d diti o n, f or c o m plete ness p ur p oses, res ults i ncl u di n g all s u bjects 
a n d e xcl u di n g t h e s u bjects w h o ha d maj or pr ot o c ol de viati o ns o n t h e basis of ke y i ncl usi o n a n d 
e xcl usi o n crit eria d efi ni n g t he p o p ulati o n of i nterest will be prese nte d. T he differe n ces b et wee n 
t hese res ults will be n ote d, a n d t he i m pact of s uc h differe nces will be disc usse d i n t he cli nical 
st u d y re p ort.
1 6. 6. 2  
Sec o n d ar y Effic ac y E n d p oi nt A n al ysis
T he bi nar y sec o n dar y efficac y e n d p oi nt will be a n al yze d usi n g t he sa me a p pr oac hes as t hat are 
use d f or t he a nal ysis of t h e pri mar y e n d p oi nt. 
Mi xe d M o del f or Re peate d Meas ures ( M M R M) a n al yses will b e perf or me d o n c o nti n u o us 
e n d p oi nts t o miti gate t he i m pact of missi n g data. T his a p pr oac h ass u mes missi n g o bser vati o ns 
are missi n g at ra n d o m a n d b orr o ws i nf or m ati o n fr o m s u bjects i n t he sa me treat m e nt gr o u p ta ki n g 
i nt o acc o u nt t he missi n g ness of data t hr o u g h t he c orrel ati o n of t h e re p eate d meas ure me nts.  
All c o nti n u o us e n d p oi nts will utilize M M R M after a p pl yi n g t he pri m ar y ce ns ori n g r ule, i.e., t he 
r ule will ce ns or dat a aft er per ma ne nt st u d y dr u g disc o nti n uati o n or aft er res c ue t hera p y. T his 
ce ns ori n g r ule is e q ui v ale nt t o usi n g all t h e data u p t o disc o nti n uati o n or resc ue. 
T he M M R M m o del will i ncl u de fi xe d effects f or b aseli ne val ue, disease se v erit y gr o u p, bi ol o gic-
naï ve vs bi ol o gic-e x p ose d, c o u ntr y, treat me nt, st u d y wee k, t h e tr eat m e nt- b y- wee k i nteracti o n, 
a n d t he b aseli ne- b y- wee k i nteracti o n a n d all o w f or ra n d o m s u bject effects. Treat me nt a n d wee k 
will eac h be fitte d as cate g orical vari a bles. T he m o del will ass u me u nstr uct ure d c o varia nce 
str uct ure. If t h e m o del wit h u nstr uct ure d c o varia nce d oes n ot c o n ver ge, t h e n ot her c o varia nc e 
str uct ures will be c o nsi dere d t o m o del t he wit hi n-s u bject err ors. T he K e n war d- R o gers a p pr oac h 
f or c o m p uti n g de n o mi nat or de grees of free d o m will b e use d t o acc o u nt a p pr o priatel y f or p o oli n g 
of wit hi n-s u bject a n d bet wee n-s u bject varia n ce esti m ates. Efficac y data o n s u bjects w h o 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 1 of 1 3 5 
C o nfi d e nti al  
pre mat urel y disc o nti n ue t he ra n d o mize d treat m e nt or i nitiate a n y treat m e nt a dj ust me nts (e. g., use 
of pr o hi bite d/resc u e me dicati o n/resc ue tr eat m e nt f or A D s y m pt o ms) will b e set t o missi n g at t he 
desi g nate d ti me p oi nts after wit h dra w al or after t h e start of s uc h treat me nt c ha n ges. T h e L S M 
a n d 9 5 % CI f or t h e differe nce b et wee n gr o u ps will be esti m ate d usi n g t he si m ple c o ntrast at eac h 
ti m e p oi nt.
1 6. 6. 3
E x pl or at or y A n al ysis
T he f oll o wi n g e x pl orat or y efficac y e n d p oi nts will b e a nal y ze d:
C ha n ge i n 
 at Wee k 1 4.
Ti me t o o nset of res p o ns e o n t he 
, w here 
res p o nse is defi n e d as i m pr o ve me nt (at least a  
 re d ucti o n fr o m baseli n e) of wee kl y 
a vera g e of d ail y  
 d uri n g t h e 1 4- wee k treat me nt peri o d. T he a n al ysis will be base d o n 
s u bjects w
 
C ha n ge fr o m baseli ne t o Wee k 1 4 i n  
 
 
Safet y a n d t olera bilit y of u p t o 7 d oses of lire nteli ma b S C or place b o S C i n s u bjects wit h 
m o derate-t o-s e vere A D. 
 
P D of lire nteli ma b S C i n s u bjects wit h A D as meas ure d b y c ha n g es fr o m b aseli ne i n 
. 
 
Ot her i n dices of effic ac y of lire nteli ma b S C i n s u bjects wit h A D. C h a n ges i n si g ns a n d 
s y m pt o ms (c o m p are d t o baseli ne) bet w ee n lire nt eli ma b a n d place b o will b e meas ure d b y:  
 C ha n ge fr o m baseli ne t o Wee k 1 4 i n 
 
C ha n ge i n  
 fr o m baseli ne t o Wee k 1 4
 Pr o p orti o n of s u bjects w h o ac hie ve  
 
 Pr o p orti o n of s u bjects w h o ac hie ve  
 
 C ha n ge fr o m baseli ne t o Wee k 1 4 i n 
  
 C ha n ge fr o m baseli ne t o Wee k 1 4 i n  
  
 C ha n ge fr o m baseli ne o v er ti me i n 
 
Ha n dli n g of missi n g P R O data f or l ess t ha n f o ur data e ntries p er w ee k, ot her t h a n d uri n g 
Scree ni n g, will be a d dresse d i n t he S A P. 
1 6. 6. 4  
I nteri m A n al ysis 
A n i nteri m a nal ysis will n ot be c o n d ucte d f or t his st u d y. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 2 of 1 3 5 
C o nfi d e nti al  
1 6. 7
S afet y A n al ysis 
A d verse E ve nts:  All A E will be c o de d usi n g t he Me di cal Dicti o nar y f or R e g ulat or y Acti viti es 
( 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 ( S O C) a n d preferre d t er m. 
Listi n gs will i n cl u de all A E c oll ecte d o n st u d y. T he s u m maries of A E will be base 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 base wit h a date of o nset ( or w orse ni n g) o n or after 
t he start date of t he first S C i njecti o n of st u d y dr u g.  
1 6. 7. 1
Tre at me nt E mer ge nt A d v erse E ve nts 
S u bject i n ci de nce ( N a n d %) of T E A E 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 s u bjects w h o re p ort e d 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 s u bjects w h o re p ort e d at least 1 seri o us T E A E  
 N u m ber ( %) of s u bjects w h o re p ort e d at least 1 T E A E lea di n g t o treat m e nt 
disc o nti n uati o n  
 N u m ber ( %) of s u bjects w h o re p ort e d at least 1 T E A E of s p eci al i nterest ( T E A E SI) 
 
T E A E b y preferre d ter m 
 
T E A E b y S O C a n d preferre d ter m 
 
T E A E b y ma xi m u m se verit y, S O C, a n d preferre d t er m  
 
T E A E b y S O C a n d preferre d ter m a n d rel ati o ns hi p t o st u d y dr u g 
 
T E A E lea di n g t o wit h dra wal b y S O C a n d preferre d ter m  
 
Seri o us T E A E b y S O C a n d preferre d t er m  
 
T E A E SI b y S O C a n d preferre d ter m 
1 6. 7. 2  
A nti- Dr u g A nti b o di es
Sa m ples will be o btai ne d f or testi n g of A D A at ti m es i de ntifie d i n Secti o n  1 2. 3. 6.  
1 6. 7. 3  
Cli ni c al L a b or at or y Assess me nts 
Sa m ples will be o btai ne d f or t he cli nical la b orat or y tests i de ntifie d i n Secti o n  1 2. 3, a n d 
la b orat or y tests t o be s u m marize d i ncl u de c he mistr y, he mat ol o g y, uri nal ysis, a n d lire nteli ma b 
A D A. D escri pti ve statisti cs will be use d t o s u m marize la b orat or y res ults at baseli ne, eac h visit, 
a n d t he c ha n g e fr o m b aseli ne f or eac h visit. I n a d diti o n, s hift ta bles will s u m marize t he 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 3 of 1 3 5 
C o nfi d e nti al  
la b orat or y res ults relati v e t o n or mal refere n ce ra n g es at b aseli ne a n d eac h p ost- baseli ne 
ti m e p oi nt. 
1 6. 7. 4
Vit al Si g ns
Vital si g ns will be s u m marize d at baseli n e, eac h visit, a n d c ha n ge fr o m b aseli ne at eac h visit.  
1 6. 7. 5
E C G
S u bject i n ci de nce of t h e I n vesti gat or’s o verall assess me nt ( n or mal, a b n or mal – n ot cli nicall y 
si g nifica nt, a n d a b n or mal – cli nicall y si g nifica nt) will be s u m marize d.
1 6. 7. 6
P h ysic al E x a m
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 x a ms will be i ncl u de d i n t he 
b y-s u bject data listi n g.  
1 6. 7. 7  
C o nc o mit a nt Me dic ati o ns
All me dicati o ns ( pri or a n d c o nc o mita nt) 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 cl ass a n d preferre d t er m. 
1 6. 7. 8  
S u bject C o nfi de nti alit y 
O nl y t he PI D, a n d de m o gra p hics will be rec or d e d i n t he e C R F c o nsiste nt wit h c o u ntr y 
re g ulati o ns. If t he s u bject’s na me or ot her i de ntifiers (e. g., me dic al rec or d n u m ber or a d dress) 
a p pear o n a n y s o urce d oc u me nt c ollecte d ( e. g., h os pit al dis c har ge s u m m ar y), it m ust be re m o ve d 
fr o m t he d oc u me nt if t he d oc u me nt will b e 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 
ve n d or n ot per mitte d access t o s u bject-i d e 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 dat a bases. T he s u bjects 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 oriti es, a n d t he I E C/I R B t o i ns pect t h eir me dical rec or ds t o verif y t he 
i nf or mati o n c oll ecte d. S u bjects will be i nf or me d t h at all pers o nal i nf or m ati o n ma de a vaila ble f or 
i ns pecti o n will be ke pt c o nfi de ntial t o t he e xt e nt per mitte d b y all a p plica ble state, l ocal, a n d 
fe deral data pr ot ecti o n/ pri v ac y la ws a n d/ or re g ulati o ns a n d will n ot be ma de p u blicl y a vaila ble. 
If t h e res ults of t he st u d y are p u blis he d, t h e s u bject’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 h e st u d y site, s u bjects will be a d vise d n ot t o s h are t h eir st u d y i nf or mati o n 
wit h ot h er s u bjects or o n s ocial me dia.  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 4 of 1 3 5 
C o nfi d e nti al  
1 7.
D at a C ollecti o n, Rete nti o n, a n d M o nit ori n g 
1 7. 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 practi ces. D ata will be 
e ntere d i nt o t he e C R F usi n g s o urce d oc u m e nt data. S o urce d oc u me 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 nce. 
1 7. 2
D at a M a n a ge me nt Pr oc e d ures 
T he data will be e nt ere d i nt o a vali d ate d data b ase. T he d ata 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 o c k will 
occ ur o nce q ualit y ass ura nce pr oce d ures ha ve b ee n c o m plete d. 
All pr oce d ures f or 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 
practi ces m eeti n g F D A g ui deli nes f or ha n dli n g a n d a nal ysis of data f or cli nical st u dies. 
1 7. 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 d ati o n 
c hec ks will be i m ple me nte d a n d a p plie d t o t he data base o n a re g ular basis. Q ueries are e nt ere d, 
trac ke d, a n d res ol v e 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 h e 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 7. 4  
D at a b ase L oc k/ Discl os ure of R a n d o miz ati o n C o de
T here will be 2 d ata base l oc ks f or t he d o u ble- bli n d treat me nt peri o d of t h e st u d y:
 
A pr o visi o nal data base l o c k aft er all s u bjects c o m plete t he Da y 9 9 visit t o all o w f or t he 
a nal ysis of safet y a n d efficac y t hr o u g h D a y 9 9.
 
A fi nal data bas e l oc k after all s u bjects c o m plete t h e st u d y t o all o w f or t h e a n al ysis of a n y 
safet y data c ollecte d after Da y 9 9. 
F or eac h dat a base l o c k, a p plica ble E D C data will be l oc ke d i n or der t o pr ot ect write access after 
t he f oll o wi n g prec o n diti o ns are f ulfill e d:
 
All rec or ds are e ntere d i n t h e data base. 
 
All A E are c o de d t o t he s atisfacti o n of t he C hief M e dical Officer or desi g nee. 
 
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 Offic er or desi g nee. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 5 of 1 3 5 
C o nfi d e nti al  
 
All data q ueries h a ve bee n res ol ve d. 
 
All decisi o ns ha ve bee n ma de re g ar di n g all pr ot o c ol vi olati o ns a n d I T T p o p ulati o n 
e xcl usi o ns. 
 
Writte n a ut h orizati o ns t o l oc k t h e data base 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 M e dic al Officer. 
T he ra n d o mi zati o n c o de f or t his st u d y will n ot be re veal e d u ntil t he pre vi o us prec o n diti o ns are 
f ulfille d, a n d d oc u me ntati o n of t h e pr o visi o nal data base l oc k f or efficac y assess me nt is c o m plete.
After t h e d ata base l o c k, t h e ra n d o mizati o n c o d e will be ma de a vaila ble t o i n di vi d uals at Alla k os 
w h o are i n v ol ve d i n t he d ata a nal ysis. Data a nal ysis will c o m me nce aft er t h e data l oc k. I n 
a d diti o n, t h e P K a n d A D A data m a y be l o c ke d a n d assesse d se p aratel y. 
1 7. 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 pies of t he data base a n d relate d s oft ware files will be m ai ntai ne d. 
Data bases are b ac ke 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 h e dat a base. At critical j u nct ures of t he pr ot o c ol (e. g., pr o d ucti o n of i nteri m re p orts 
a n d fi nal re p orts), data f or a nal ysis is l oc ke d a n d clea ne d per est a blis he d pr oce d ures.  
1 7. 6
A v ail a bilit y a n d Rete nti o n of I n v esti 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- V § 1 3 ( 1 0), I C H G C P E 6 ( R 2), a n d all ot her 
a p plica ble re g ulat or y re q uire me nts, all esse ntial d oc u me nts at t h e st u d y site, t he S p o ns or’s 
or ga nizati o n or t h e S p o ns or’s desi g nee s h o ul d be retai n e d u ntil at least 2 y ears after t h e l ast 
a p pr o v al of a n a p pli cati o n f or a mar keti n g a ut h ori zati o n i n a n I C H re gi o n, u ntil t here are n o 
pe n di n g or c o nte m plate d a p plicati o ns f or mar k eti n g a ut h orizati o n i n a n I C H re gi o n, a n d u ntil at 
least 2 years h a ve el a pse d si nce t he f or mal dis c o nti n uati o n of cli nical de vel o p me nt of t he teste d 
I M P a n d at least 1 0 years after t h e e n d of t he cli nical st u d y, w hic he ver peri o d is l o n ger. 
F urt her m ore, t h e ess e ntial d oc u me nts s h o ul d be retai ne d f or a l o n g er peri o d if re q uire d b y t h e 
a p plica ble re g ulat or y re q uire me nts or b y a n a gree me nt wit h t he S p o ns or. T he trial master file 
will b e creat e d d uri n g t he i m ple me ntati o n peri o d 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 h e pr oject, a n d c oll ate d at t he e n d of t he st u d y. T he files will c o ntai n 
f ol ders t h at ma y i ncl u de b ut are n ot li mit e 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 m e nts 
 
I E C/I R B d oc u me nts

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 6 of 1 3 5 
C o nfi d e nti al  
 
Dr u g Acc o u nta bilit y d oc u me nts 
 
C orres p o n de nce 
 
Me dical Re p orts 
 
S u bject Data 
 
M o nit ori n g Visit Re p orts 
 
Sa m ple C R F a n d C R F G ui deli nes 
1 7. 7  
M o nit ori n g 
M o nit ori n g visits will b e 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/ or I C H G C P G ui d eli n e E 6. B y si g ni n g t his pr ot oc ol, t he I n vesti g at or 
gra nts per missi o n t o t h e S p o ns or ( or desi g nee) a n d a p pr o priate re g ulat 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, I E C/I R B re vie w a n d re g ulat or y i ns pecti o ns of all a p pr o priat e 
st u d y d oc u me ntati o n, pr o vi di n g direct access t o s o urce dat a a n d d oc u m e nts. M o nit ori n g of all 
a p pr o priate st u d y d oc u m e nt ati o n ma y o cc ur off-site, wit h re m ote access t o st u d y d oc u me nts if 
all o we d b y l ocal re g ulati o n, as per mitte d b y i n di vi d ual st u d y site re q uire m e nts.  
1 8.
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 
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 his pr ot o c ol, t he Declarati o n of 
Helsi n ki ( 1 9 9 6 versi o n), I R B/I E C ( 2 1 C F R 5 6 a n d/ or 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/ or I C H E 6), Directi v e 2 0 0 1/ 2 0/ E C ( A pril 4, 2 0 0 1) as well as 
ot her a p pli ca ble l o cal re g ulati o ns i ncl u di n g Ger ma n y’s Me dici nal Pr o d ucts Act ( A M G), 
Ger m a n y’s G C P Or di n a nce ( G C P- V), etc. T h e S p o ns or, t he I n vesti g at ors, a n d all s u bc o ntracte d 
or ga nizati o ns i n v ol ve d i n t he st u d y c o n d uct m ust als o c o m pl y wit h all a p plica ble pri vac y 
re g ulati o ns (e. g., HI P A A, G D P R). T he st u d y ca n be i nitiate d o nl y after o bt ai ni n g c o m p ete nt 
a ut h orit y a p pr o val a n d I R B a n d/ or I E C fa v ora bl e o pi ni o n. If t he c o m p ete nt a ut h orit y wit h dra ws 
t he C T A a p pr o val or if t h e I R B wit h dra ws t he fa v ora ble o pi ni o n o n t he C T A, t he c o n d uct of t he 
st u d y will be ter mi n ate d i m m e diatel y. 
1 8. 1  
Pr ot oc ol A me 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 n I n vesti gati o nal N e w Dr u g (I N D) a me n d me nt. A n a me n d me nt w hic h is c o nsi dere d 
s u bsta ntial acc or di n g t o t he E C C T- 1 g ui deli nes, m ust be s u b mitt e d f or re vie w t o t he c o m p ete nt 
a ut h orit y a n d t he res p o nsi ble I E C/I R B a n d ca n n ot be i m ple me nte d wit h o ut pri or writt e n 
c o m pete nt a ut h orit y a p pr o val a n d t he I E C/I R B fa v ora ble o pi ni o n. Writte n a p pr o val of a pr ot o c ol 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 7 of 1 3 5 
C o nfi d e nti al  
a me n d me nt is n ot re q uire d pri or t o i m ple me nt ati o n of c ha n ges t o t he pr ot oc ol t hat eli mi nate 
i m m e diate h azar d t o t h e s u bject; h o we ver, a p pr o v al m ust be o btai ne d as s o o n as p ossi ble 
t hereafter. E ac h pr ot oc ol a me n d me nt m ust als o be si g ne d b y t he I n vesti gat or. 
1 8. 2
I n de pe n de nt Et hics C o m mittees/I nstit uti o n al Re vie w B o ar ds
T he pr ot o c ol a n d I C F will be re vie w e d a n d a p pr o v e d b y t he I E C/I R B of eac h partici pati n g st u d y 
site pri or t o st u d y i nitiati o n. A ce ntral I R B ma y b e use d if per mitte d b y t he partici pati n g st u d y 
site. All S A E, re gar dless of ca usalit y, will be re p orte d t o t he I E C/I R B i n acc or da nce wit h t he 
sta n dar d o perati n g pr oce d ures a n d p olicies of t h e I E C/I R B, a n d t h e I n v esti g at or will k ee p t h e 
I E C/I R B i nf or me d as t o t h e pr o gress of t h e st u d y. T he I n vesti g at or or a desi g nee will o btai n 
ass ura nce of I E C/I R B c o m plia nce wit h re g ulati o ns.  
A n y d oc u m e nts t hat t he I E C/I R B m a y nee d t o f ulfill its res p o nsi biliti es (s uc h as pr ot o c ol, 
pr ot oc ol a me n d me nts, I n vesti gat or’s Br oc h ure, I C F, i nf or mati o n c o n cer ni n g s u bject recr uit me nt, 
pa y me nt or c o m pe ns ati o n pr oce d ures, or ot her perti ne nt i nf or mati o n) will be s u b mitte d t o t he 
I E C/I R B. T he I E C/I R B’s writte n u nc o n diti o nal a p pr o val of t he st u d y pr ot o c 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 g at or bef ore t h e st u d y is i niti ate d. T he I E C/I R B’s a p pr o v al of 
t he i n vesti gati o nal site m ust be a vaila bl e t o Alla k os pri or t o s hi p me nt of st u d y s u p plies t o t h e 
site. T his a p pr o val m ust refer t o t he st u d y b y e x act 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 date of re vie w.  
T he I E C/I R B m ust be i nf or me d of re visi o ns t o ot h er 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 perie nces o cc urri n g d uri n g t h e st u d y i n acc or d a nce wit h t he 
sta n dar d o perati n g pr oce d ures a n d p olicies of t h e I E C/I R B; ne w i nf or m ati o n t hat ma y a d vers el y 
affect t he safet y of s u bjects or t he c o n d uct of t h e st u d y; a n a n n ual u p date a n d/ or re q uest f or 
rea p pr o v al; a n d w he n t h e st u d y has bee n c o m plete d.  
1 8. 3  
I nf or me d C o nse nt F or m 
Pri or t o st u d y e nr oll m e nt, all s u bjects m ust c o nse nt t o partici pate i n writi n g. T he pr ocess of 
o btai ni n g t h e i nf or me d c o nse nt will c o m pl y wit h all fe d eral re g ulati o ns, I C H re q uire me nts, a n d 
l ocal la ws.  
I n acc or da n ce wit h I C H G C P G ui deli ne E 6 Secti o n 4. 3. 3, s u bjects s h o ul d be as ke d w h et her t h e y 
w o ul d li k e t h eir pri mar y care p h ysi cia n n otifie d of t heir st u d y partici pati o n. If yes, t h e pri mar y 
care p h ysi cia n s h o ul d be n otifie d i n writi n g. Ot her wise, t he s u bject s h o ul d si g n a f or m stati n g 
t hat he/s he d oes n ot wis h t o discl ose s uc h i nf or mati o n.  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 8 of 1 3 5 
C o nfi d e nti al  
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 h e I C F wit h eac h p ote ntial s u bject. T he 
re vie w will i ncl u de t h e 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 parti ci 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 s u bject. T he 
I n v esti gat or or desi g nee a n d t he s u bject 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 b ef ore 
t he s u bject ca n p artici pat e i n t he st u d y, i.e., bef ore a n y st u d y-s p ecific pr oce d ures are c o n d uct e d. 
T he s u bject will rec ei 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 v esti gat or or d esi g nee m ust e m p hasize t o t he s u bject t hat st u d y 
partici pati o n is e ntirel y v ol u ntar y a n d t h at c o nse nt re g ar 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 s u bject is ot her wise 
e ntitle d.  
1 8. 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 bli cati o n of ma n uscri pts c o ntai ni n g t he st u d y res ults will be 
i n acc or d a nce wit h a pr o cess deter mi ne d b y m ut u al writt e 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 p ecti v e sit e(s). T h e p u blicati o n or pres e ntati o n of a n y st u d y res ults will c o m pl y wit h all 
a p plica ble pri v ac y la ws i ncl u di n g b ut n ot li mite d t o t he Healt h I ns ura nce P orta bilit y a n d 
Acc o u nta bilit y Act of 1 9 9 6 a n d t he E U G e neral D ata Pr otecti o n Re g ulati o n ( G D P R).  
1 8. 5
Cli nic al St u d y Re gistr ati o n
T his cli nical st u d y will be re gistere d o n t he Cli nical Trial Re gistr y We bsites, 
w w w. Cli nical Trials. g o v a n d w w w.cli nic altrialsre gister.e u.
1 8. 6
P a y me nt t o S u bjects 
All s u bjects m a 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 s u bject’s si g n e d I C F a p pr o ve d b y t he I E C/I R B. I n 
acc or d a nce wit h Secti o n 4. 8. 3 I C H E 6 ( R 2), fi na n cial c o m pe nsati o n fr o m t he s p o ns or t o 
partici pati n g s u bjects s hall be li mite d t o t he rei m b urse me nt of a n y tra vel e x pe nses i nc urre d 
( Ger ma n y o nl y). If t he s u bject 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 
s u bject 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 rata basis, as state d i n t he 
s u bject’s I C F. Be gi n ni n g wit h d osi n g Da y 1, s u bjects will be c o m pe nsate d f or eac h c o m plete d 
wee k of d ail y q uesti o n naires as l o n g as at le ast 4 q uesti o n naires per wee k are c o m plete d. 
S u bjects m a y be rei m b urse d f or e x p e nses ass o ciat e d wit h atte n di n g st u d y visits. N o a d diti o nal 
c o m pe nsati o n be y o n d w h at is state d i n t he I C F is per mitte d.  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 0 9 of 1 3 5 
C o nfi d e nti al  
1 8. 7
I n vesti g at or R es p o nsi bilities 
B y si g ni n g t he I n vesti gat or Pr ot o c ol A gre e me nt pa ge, t h e I n v esti 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 o c 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 d esi g nee), e xce pt w he n t o pr otect t he safet y, ri g hts, or w elfare of s u bjects.  
2) 
Pers o nall y c o n d uct or s u per vise t h e st u d y. 
3) 
E ns ure t h at t h e re 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 E C/I R B re vie w 
a n d a p pr o val meet c o u ntr y re q uire me nts. 
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/ or I C H G ui deli ne E 2 A.  
5) 
E ns ure t h at 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 u ct 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 m e 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/ or 
I C H G ui d eli ne E 6 a n d t o ma ke 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 d esi g nee).  
7) 
E ns ure t h at a n I E C/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/ or I C H 
G ui deli ne E 6 as a p plica ble will be res p o nsi ble f or i niti al a n d c o nti n ui n g re vie w a n d 
a p pr o v al of t he cli nical st u d y.  
8) 
Pr o m ptl y re p ort t o t he I E C/I R B a n d t h e S p o ns or ( or desi g nee) all c ha n g es i n t he researc h 
acti vit y a n d all u na nti ci pate d pr o ble ms i n v ol vi n g ris ks t o s u bjects or ot h ers (t o i n cl u de 
a me n d me nts a n d I N D s afet y re p orts).  
9) 
See k I E C/I R B a p pr o val bef ore a n y c ha n ges are m a de i n t he res ear c h st u d y, e xce pt w h e n 
necessar y t o eli mi nate h azar ds t o t h e s u bjects. 
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 g ati o ns of cli nical I n vesti gat ors a n d 
all ot her perti ne nt re q uire me nts liste d i n 2 1 C F R Part 3 1 2 a n d/ or I C H G ui d eli ne E 6.  

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 0 of 1 3 5 
C o nfi d e nti al  
1 9.
Refere nces 
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.
Castr o
M, C orre n J, Pa v or d I, Mas per o J, We n zel S, Ra be K, et al. D u pil u ma b efficac y a n d 
safet y i n m o derat e-t o-se v ere u nc o ntr olle d ast h ma. N E n gl J
Me d, 2 0 1 8; 3 7 8: 2 4 8 6 – 9 6.
Cli nical Trials Facilitati o n a n d C o or di nati o n Gr o u p ( C T F G). R ec o m m e n dati o ns relate d t o 
c o ntrace pti o n a n d pre g n a nc y testi n g i n cli nical trials, versi o n 1. 1. 2 1 Se p 2 0 2 0, accesse d 
2 8 J u n 2 0 2 2, htt ps://le ge mi d del ver ket. n o/ D oc u me nts/ G o d kje n ni n g/ Kli nis k % 2 0 ut pr % 
C 3 % B 8 vi n g/ 2 0 1 4 _ 0 9 _ H M A _ C T F G _ C o ntrace pti o n _ g ui da nce % 2 0 Versi o n % 2 0 1. 1. p df.
C orre n J, Par nes J, Wa n g L, M o M, R oseti S, Griffit hs J, va n der Mer we R. Teze p el u ma b i n 
a d ults wit h u nc o ntr olle d ast h ma. N E n gl J Me d, 2 0 1 7; 3 7 7: 9 3 6 – 4 6.
Eic he nfiel d L, T o m W, C ha mli n S, Fel d ma n S, Ha nifi n J, Si m ps o n E, et al. G ui deli nes of care 
f or t h e m a na g e me nt of at o pic der m atitis: Part 1. Dia g n osis a n d assess m e nt of at o pic 
der matitis. J A m Aca d D er m at ol, 2 0 1 4; 7 0: 3 3 8 – 5 1.
F o o d a n d Dr u g A d mi nistrati o n. Birt h C o ntr ol C h art fr o m F D A. g o v/c o ns u mers/free- p u bli cati o ns-
w o me n/ birt h-c o ntr ol. F D A. g o v/c o ns u mers/free- p u blicati o ns- w o me n/ birt h-c o ntr ol, 
2 1 J u n 2 0 2 1, retrie ve d 2 7 Fe b 2 0 2 2, fr o m htt ps:// w w w.f da. g o v/c o ns u mers/free-
p u blicati o ns- w o m e n/ birt h-c o ntr ol.
F o o d a n d Dr u g A d mi nistrati o n. E 9 ( R 1) Statisti cal Pri nci ples f or cli nical trials: a d de n d u m: 
esti ma n ds a n d se nsiti vit y a nal ysis i n cli nical trials. G ui da nce f or i n d ustr y, I C H, Ma y 
2 0 2 1.
F u xe nc h Z, Bl oc k J, B o g u nie wicz M, B o yle J, F o nacier L, Gelfa n d J, et al. At o pic der matitis i n 
A merica st u d y: A cr oss-s ecti o nal st u d y e xa mi ni n g t he pre vale n ce a n d disease b ur de n of 
at o pic der matitis i n t he U S a d ult p o p ulati o n. J I n v est Der mat ol, 2 0 1 9; 1 3 9: 5 8 3 – 9 0. 
Sa m ps o n H, M u n oz- F url o n g A, Ca m p bell R, A d ki ns o n Jr N, B oc k S, Bra n u m A, et al. S ec 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 na p h yla xis 
Net w or k s y m p osi u m. J Aller g y Cli n I m m u n ol 2 0 0 6; 1 1 7( 2): 3 9 1 – 7 
Sil ver ber g J, Si m ps o n E, T h ysse n J, G o o der h a m M, C ha n G, Fee ne y C, Bis was P, et al. Efficac y 
a n d safet y of a br ociti ni b i n patie nts wit h m o derate-t o-se vere at o pic d er matitis: Res ults 
fr o m t he P hase 3 J A D E M O N O- 2 St u d y. A bstract 1 4 8 p oster, R A D 2 0 2 0. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 1 of 1 3 5 
C o nfi d e nti al  
Si m ps o n E, Fl o hr C, Eic he nfiel d L, Bie ber T, S ofe n H, Taïe b A, et al. Efficac y a n d safet y of 
le bri kiz u ma b (a n a nti-I L- 1 3 m o n ocl o nal a nti b o d y) i n a d ults wit h m o derate-t o-se vere 
at o pic der matitis i na de q u atel y c o ntr olle d b y t o pical c orti c oster oi ds: A ra n d o mi ze d, 
place b o-c o ntr olle d p hase II trial ( T R E B L E). J A m Aca d D er m at ol, 2 0 1 8; 7 8: 8 6 3 – 7 1. 
Si m ps o n E, Paller A, Si e gfrie d E, B o g u nie wicz M, S her L, G o o der h a m M, et al. Efficac y a n d 
safet y of d u pil u ma b i n a d olesce nts wit h u nc o ntr olle d m o derate t o s e vere at o pic 
der matitis: A p hase 3 ra n d o mize d cli nical trial. J A M A Der mat ol, 2 0 2 0; 1 5 6: 4 4 – 5 6. 
Si m ps o n E, Par nes J, S h e D, Cr o uc h S, Rees W, M o M, va n der Mer we R. Teze pel u ma b, a n 
a nti-t h y mic str o mal l y m p h o p oieti n m o n ocl o nal a nti b o d y, i n t he treat m e nt of m o derate t o 
se vere at o pic der m atitis: A ra n d o mize d p h ase 2a cli nical trial. J A m Aca d D er mat ol, 
2 0 1 9; 8 0: 1 0 1 3 – 2 1.
W olle n ber g A, H o well M, G utt ma n- Yass k y E, Sil ver ber g J, K ell C, Ra na de K, et al. Treat me nt 
of at o pic der m atitis wit h tral o ki n u ma b, a n a nti-I L- 1 3 m A b. J Aller g y Cli n I m m u n ol, 
2 0 1 9: 1 4 3: 1 3 5 – 4 1.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 2 of 1 3 5 
C o nfi d e nti al  
2 0.
A p pe n di ces 
2 0. 1 
A p pe n di x 1: 
At o pic Der matitis: A merica n Aca de m y of D er mat ol o g y C o nse ns us Criteria 
2 0. 2 
A p pe n di x 2: 
Vali date d I n vesti gat or Gl o bal Assess me nt
2 0. 3 
A p pe n di x 3: 
Ecze m a Area a n d Se v erit y I n d e x  
2 0. 4 
A p pe n di x 4: 
2 0. 5 
A p pe n di x 5: 
2 0. 6 
A p pe n di x 6: 
2 0. 7 
A p pe n di x 7: 
At o pic C o n diti o ns Q uesti o n naire 
2 0. 8 
A p pe n di x 8: 
C o m m o n Ter mi n ol o g y Criteria f or A d vers e E ve nts v. 5. 0 
2 0. 9 
A p pe n di x 9: 
Sa m ps o n’s Criteria of A n a p h yla xis 
2 0. 1 0 
A p pe n di x 1 0: He patitis B a n d He p atitis C Ser ol o gic Testi n g Details
2 0. 1 1 
A p pe n di x 1 1: O pe n La b el E xt e nsi o n Peri o d ( O pti o nal) 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 3 of 1 3 5 
C o nfi d e nti al  
2 0. 1
A p p e n di x 1:
At o pic Der m atitis – A meric a n Ac a de m y of Der m at ol o g y 
 
C o ns e ns us Criteri a
A da pt e d fr o m G ui d eli nes of C are f or t h e M a na ge me nt of At o pic D er m atitis: Part 1. Dia g n osis 
a n d Ass ess me nt Of At o pic Der matitis, , J o ur nal of t h e A merica n Aca d e m y of Der mat ol o g y 
( Eic he nfiel d, 2 0 1 4).

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 4 of 1 3 5 
C o nfi d e nti al  
2 0. 2
A p p e n di x 2:
V ali d ate d I n v esti g at or Gl o b al Assess me nt 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 5 of 1 3 5 
C o nfi d e nti al  
2 0. 3
A p p e n di x 3:
Ecze m a Are a a n d Se verit y I n de x 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 6 of 1 3 5 
C o nfi d e nti al  
2 0. 3
A p p e n di x 3:
Ecze m a Are a a n d Se verit y I n de x c o nt.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 7 of 1 3 5 
C o nfi d e nti al  
2 0. 3
A p p e n di x 3:
Ecze m a Are a a n d Se verit y I n de x c o nt.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 8 of 1 3 5 
C o nfi d e nti al  
2 0. 3
A p p e n di x 3:
Ecze m a Are a a n d Se verit y I n de x c o nt.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 1 9 of 1 3 5 
C o nfi d e nti al  
2 0. 3
A p p e n di x 3:
Ecze m a Are a a n d Se verit y I n de x c o nt.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 2 0 of 1 3 5 
C o nfi d e nti al  
2 0. 3
A p p e n di x 3:
Ecze m a Are a a n d Se verit y I n de x c o nt.

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 2 1 of 1 3 5 
C o nfi d e nti al  
2 0. 3
A p p e n di x 3:
Ecze m a Are a a n d Se verit y I n de x c o nt.

Pr ot o c ol A K 0 0 2- 0 1 8
A me n d m e nt 6
Date: 0 8 Se pte m b er 2 0 2 3
Alla k os I nc.
Pa ge 1 2 5 of 1 3 5
C o nfi d e nti al
2 0. 7
A p p e n di x 7:
At o pic C o n diti o ns Q u esti o n n aire

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 2 7 of 1 3 5 
C o nfi d e nti al  
2 0. 9
A p p e n di x 9: 
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 n ess ( 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 wa 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 u ce d P E F, h y p o xe mia) 
 
CI R C U L A T O R Y : Re d u ce 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 h e 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 wa 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 u ce 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 o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 2 8 of 1 3 5 
C o nfi d e nti al  
2 0. 1 0
A p p e n di x 1 0:
He p atitis B a n d He p atitis C Ser ol o gic T esti n g Det ails 
He p atitis B T esti n g Det ails 
H Bs A g p ositi ve s u bjects are e x cl u de d. H o we ver, i n cas e of p ast i nfecti o ns/ vacci n ati o ns i n or der 
t o q ualif y, t he s u bject’s t esti n g stat us nee ds t o ali g n wit h t he i nf or mati o n i n Ta ble 6. 
T a bl e 6  
He p atitis B Testi n g
P ast I nfecti o n ( Res ol v e d) 
Or 
V a cci n ate d 
H Bs A g 
Ne g ati v e 
H Bs A g 
Ne gati v e 
A nti- H Bc
P ositi v e
A nti- H Bc
N e g ati v e
A nti- H Bs
P ositi v e
A nti- H Bs
P ositi v e
He p atitis C Testi n g Det ails 
A nti- H C V p ositi v e a n d H C V- R N A p ositi ve are e xcl u de d. I n or der t o q ualif y f or e nr oll m e nt, t he 
s u bject’s testi n g stat us nee ds t o ali g n wit h t he i nf or mati o n i n Ta ble 7. 
T a bl e 7  
He p atitis C Testi n g 
N o n- R e acti ve 
Or 
P ast I nfecti o n ( Res ol v e d)
A nti- H C V 
N e gati v e 
A nti- H C V 
P ositi v e 
H C V R N A 
N e g ati v e 
 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 2 9 of 1 3 5 
C o nfi d e nti al  
2 0. 1 1
A p p e n di x 1 1: 
O pe n L a bel E xte nsi o n Peri o d ( O pti o n al)
2 0. 1 1. 1  S u m m ar y of t he O pe n- L a bel E xte n de d D osi n g Peri o d 
S u bjects w h o c o m plete t he d o u ble- bli n d, place b o-c o ntr olle d treat me nt peri o d (i ncl u di n g t he 
Da y 9 9 st u d y visit) a n d meet t h e o pe n-la b el e xte n de d d osi n g eli gi bilit y criteria will be gi v e n t h e 
o pti o n t o recei ve 7 d oses of 3 0 0 m g lire nteli ma b S C t hr o u g h t he o pe n-la bel e xte n de d ( O L E) 
d osi n g peri o d. 
O n Da y 9 9 ( ± 5 da ys) of t he d o u ble- bli n d peri o d, eli gi ble s u bjects partici pati n g i n t he O L E peri o d 
will b e gi n f oll o wi n g t he O L E S c he d ule of E v e nts ( Ta ble 8) a n d will n o l o n ger f oll o w t h e d o u ble-
bli n d peri o d Sc he d ule of E ve nts ( Ta ble 1). If O L E Da y 1 is c o m plete d o n t he sa me da y as 
Da y 9 9, alrea d y c o m plet e d assess me nts (f or Da y 9 9) d o n ot nee d t o be re p eate d (f or O L E 
Da y 1), as l o n g as t h e y are perf or me d wit hi n ti m e fra mes n ote d i n t he  T a ble 8 n otes. 
T he O L E d osi n g peri o d is s u m marize d as f oll o ws: 
 
T he I n vesti gat or will e v al u ate w het her t h e s u bject is eli gi ble f or O L E. If eli gi ble, t he 
s u bject will be gi ve n t he o pti o n t o partici pate i n t h e O L E peri o d a n d recei v e 7 d oses of 
o pe n-la bel 3 0 0 m g lire nt eli ma b S C a d mi nistere d e ver y 2 w ee ks starti n g o n Da y 9 9 of t h e 
d o u ble- bli n d peri o d, w hi c h will be c o nsi dere d Da y 1 of t h e O L E peri o d. O L E d osi n g ma y 
be dela ye d f or u p t o 7 da ys after c o m pleti o n of t h e Da y 9 9 visit. 
 
O n Da y 9 9, after c o m pleti n g all Da y 9 9 assess me nts, eli gi ble s u bjects w h o c h o ose t o 
partici pate i n t he O L E p eri o d will be gi n f oll o wi n g t he O L E Sc he d ule of E v e nts ( Ta ble 8). 
 
Da y 1 of t h e O L E ca n o c c ur u p t o 7 da ys f oll o wi n g Da y 9 9 of t h e d o u ble- bli n d peri o d. I n 
case D a y 1 of t h e O L E is n ot t he sa me as Da y 9 9 of t h e d o u ble- bli n d peri o d, a p pli ca ble 
s u bjects ( w o m e n of c hil d beari n g p ote ntial) will ha ve a uri ne di pstic k pre g n a nc y test. 
After O L E Da y 1, s u bse q ue nt d oses will be gi ve n o n O L E Da ys 1 5, 2 9, 4 3, 5 7, 7 1, a n d 8 5 
( ± 5 da ys).  
All differe ntial bl o o d c o u nts will be bli n de d t o t he S p o ns or a n d t h e sit e u ntil aft er O L E Da y 
1 d osi n g. 
S u bjects will re mai n at t he site f or at least 1 h o ur of o bser v ati o n after e ac h d ose. I n t he 
e ve nt of a n I R R, t he s u bj ect ma y re q uire pr ol o n ge d o bser vati o n ( > 1 h o ur or u ntil t he 
s y m pt o ms res ol v e), as per I n vesti gat or discreti o n.  
S u bjects will be f oll o we d f or a p pr o xi matel y 1 2 w ee ks after t h e last d ose. F oll o w- u p visits 
will o cc ur o n O L E D a ys 9 9, 1 4 1, a n d 1 6 9 ( 1 4, 5 6, a n d 8 4 [ ± 5] da ys) f oll o wi n g t he last d ose 
of o pe n-la b el st u d y dr u g. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 3 0 of 1 3 5 
C o nfi d e nti al  
 
If a bs ol ute l y m p h oc yte a n d/ or e osi n o p hil c o u nts ha ve n ot rec o vere d b y t he O L E D a y 1 6 9 
visit (last f oll o w- u p visit), s u bjects will ret ur n a p pr o xi m atel y e ver y 2 8 da ys f or e xte n d e d 
f oll o w- u p u ntil c o u nts ha ve rec o v ere d.
2 0. 1 1. 2  O L E O bjecti v e 
T he o bjecti ve of t h e O L E peri o d is t o e val uate l o n g-ter m safet y a n d t olera bilit y of u p t o 7 d oses 
of o pe n-la b el A K 0 0 2 i n s u bjects wit h A D. T he Me dical M o nit or will re vie w data fr o m t he O L E 
peri o d relati n g t o safet y a n d t olera bilit y t hr o u g h o ut t he c o urse of O L E d osi n g. 
2 0. 1 1. 3  O L E Eli gi bilit y Criteri a 
F oll o wi n g c o m pleti o n of t h e ra n d o mize d, d o u ble- bli n d, place b o-c o ntr olle d treat m e nt peri o d 
(i ncl u di n g t he Da y 9 9 visit), eli gi ble s u bjects will ha ve t he o pti o n t o recei v e 7 d oses of 
o pe n-la bel 3 0 0 m g lire nt eli ma b S C t hr o u g h partici pati o n i n t h e O L E peri o d. 
S u bjects w h o are n ot eli gi ble or w h o c h o ose n ot t o partici pate i n t he O L E p eri o d, will re m ai n i n 
t he d o u ble- bli n d st u d y a n d c o nti n ue t o f oll o w t he d o u ble- bli n d peri o d Sc he d ule of E ve nts 
( Ta ble 1). 
2 0. 1 1. 4  O L E I ncl usi o n Criteri a 
S u bjects are eli gi ble t o p artici p ate i n t he O L E p eri o d if all t he f oll o wi n g criteria are met: 
1) 
S u bject c o m plete d t he ra n d o mize d, d o u ble- bli n d, place b o-c o ntr olle d treat m e nt peri o d, 
defi ne d as h a vi n g recei ve d all 7 S C i njecti o ns of st u d y dr u g (lire nteli ma b or place b o), a n d 
c o m plete d t he D a y 9 9 visit pr oce d ures. 
2) 
S u bject is willi n g a n d a ble t o c o m pl y wit h t he O L E peri o d Sc he d ule of E ve nts ( Ta ble 8),
i ncl u di n g recei vi n g t he first o pe n-la bel 3 0 0 m g lire nteli m a b S C at t he Da y 9 9 visit w hic h is 
1 4 da ys f oll o wi n g t he last d ose of st u d y dr u g i n t h e d o u ble- bli n d peri o d or u p t o 7 da ys 
after t he c o m pleti o n of t h e Da y 9 9 visit. 
3) 
S u bject de m o nstrates c o nti n ue d eli gi bilit y per a p plica ble i n cl usi o n criteria ( Secti o n  8. 4) a n d 
e xcl usi o n crit eria ( Secti o n  8. 5) of t he pr ot o c ol. “ Scree ni n g ” i n Secti o n 1 3. 1. refers o nl y t o 
t he scree ni n g peri o d c o m plete d pri or t o e nr oll me nt i n t he d o u ble- bli n d treat m e nt peri o d of 
t he st u d y a n d is n ot a p plica ble t o t he O L E p eri o d. 
2 0. 1 1. 5  O L E E xcl usi o n Criteri a 
S u bjects are n ot per mitte d t o partici pate i n t he O L E p eri o d if a n y of t h e f oll o wi n g criteria are
met:

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3  
Alla k os I nc. 
Pa ge 1 3 1 of 1 3 5 
C o nfi d e nti al  
1) 
Pre vi o us a d mi nistrati o n of t h e st u d y dr u g (lire nteli ma b or place b o) w as p o orl y t olerate d b y 
t he s u bject, i n t he o pi ni o n of t he I n vesti gat or. 
2) 
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 m a kes t he 
s u bject u ns uita ble f or partici pati o n i n t h e O L E peri o d. 
Acce pt a ble d oc u me ntati o n re q uire d t o c o nfir m i ncl usi o n a n d e xcl usi o n crit eria will be f urt h er 
e x plai n e d i n t he St u d y Refere nc e Ma n ual.
2 0. 1 1. 6  O L E Tre at me nt 
F or m ulati o n, st ora g e, pre parati o n, a n d a d mi nistrati o n of t h e o pe n-la b el lire nteli ma b S C f or O L E 
will b e c o nsiste nt wit h Secti o n  1 0. of t he pr ot o c ol a n d t he A K 0 0 2- 0 1 8 P har mac y Ma n u al. 
T he first O L E st u d y dr u g a d mi nistrati o n of o pe n-l a bel 3 0 0 m g lire nteli ma b S C will be d o ne o n 
Da y 9 9 of t h e d o u ble- bli n d peri o d. T his will be c o nsi dere d Da y 1 of t he O L E peri o d. O L E 
d osi n g ma y be dela ye d f or u p t o 7 da ys after t he c o m pleti o n of t he Da y 9 9 visit. T he s u bse q ue nt 
i njecti o ns will occ ur o n Da ys 1 5, 2 9, 4 3, 5 7, 7 1, a n d 8 5 ( ± 5 da ys). 
T he s u bject will be o bser ve d f or at least 1 h o ur ( or l o n ger as per I n vesti gat or discreti o n) after t h e 
e n d of t h e i njecti o n. I n t h e e ve nt of a n I R R, t h e s u bject ma y re q uir e pr ol o n ge d o bser vati o n 
( > 1 h o ur or u ntil s y m pt o ms res ol ve), as p er I n v esti gat or discreti o n. S u bjects will als o be 
i nstr ucte d t o i m m e diatel y c o ntact t he st u d y d oct or if a n y reacti o ns occ ur aft er dis c har g e. 
2 0. 1 1. 7  O L E Pr oce d ures a n d G ui deli nes 
T he O L E peri o d will be c o n d ucte d i n acc or d a nce wit h  Ta ble 8 ( Sc he d ule of Assess me nts: 
O pe n- La bel E xte nsi o n Peri o d) a n d t h e pr ot oc ol. T his i n cl u des pr o hi bite d me dicati o ns, st u d y 
dr u g pre p arati o n a n d a d mi nistrati o n, st u d y assess me nt a n d pr oce d ure g ui d eli n es, A E re p orti n g, 
wit h dra wal crit eria a n d st o p pi n g r ul es, data c oll ecti o n a n d ma na ge me nt, a n d et hical a n d 
re g ulat or y re q uire me nts. 
T he I n vesti gat or will e v al u ate w het her t h e s u bject is eli gi ble f or t h e O L E p eri o d. O n Da y 9 9, 
eli gi ble s u bjects t h at c h o ose t o parti ci pate i n t he O L E peri o d will be gi n f oll o wi n g t he O L E
Sc he d ule of E ve nts ( T a bl e 8)  a n d will recei v e t h e first o pe n-la bel d ose of lire nteli ma b. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3 
Alla k os I n c.
Pa g e 1 3 4 of 1 3 5
C o nfi d e nti al
T a ble 8 N otes c o nt. 
3) 
E O S visits s h o ul d be c o n d ucte d 1 4 ( ± 5) d a ys after t he last d ose of O L E or pri or t o t his, if necessar y, t o e ns ure c o m plia n ce wit h t h e visit. If a s u bject disc o nti n u es t he st u d y 
> 1 4 d a ys after last d ose of st u d y dr u g, t h e E O S visit s h o ul d b e c o n d u cte d as s o o n as p ossi ble. 
4) 
B o d y wei g ht (i n k g) will b e meas ure d o n all d osi n g a n d f oll o w- u p da ys ( 1 4, 5 6, a n d 8 4 d a ys after t he last d ose of st u d y dr u g if E T). 
5) 
Vital si g ns will b e meas ure d o n all d osi n g a n d f oll o w- u p d a ys ( 1 4, 5 6, a n d 8 4 da ys after t he last d ose of st u d y dr u g if E T). O n all d osi n g d a ys: wit hi n 3 0 mi n utes pre d ose, 
1 5 ( ± 5) mi n utes after a d mi nistrati o n of st u d y dr u g S C i njecti o n, a n d j ust pri or t o disc h ar g e. A d diti o n al vital si g n meas ure me nts ma y be c ollecte d at t h e I n v esti g at or’s 
discreti o n if a n I R R o cc urs. Vital si g ns i n cl 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 meas ure d after t h e s u bject h as 
a n d b ef ore a n y bl o o d dra ws h a ve b ee n o btai n e d ( u nless c ollecte d f or a n I R R). 
6) 
A s y m pt o m- directe d p h ysical e xa m (i n cl u di n g assess me nt of p ossi ble i njecti o n site reacti o ns) will b e perf or me d b y t h e I n v esti gat or or d esi g nee, as n ee d e d, if a n y s y m pt o ms 
are re p orte d. 
7) 
T h e vI G A, E A SI, 
 will be ca pt ure d t hr o u g h o ut t h e O L E peri o d. S u bjects e nteri n g i nt o t h e O L E peri o d of t h e st u d y s h o ul d c o nti n u e c o m pleti n g 
t he P R O d ail y. T h e 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 eac h d a y.  
8) 
S u bjects will b e pr o m pte d t o a ns wer a d diti o n al q u esti o ns a b o ut s y m pt o ms relate d t o ast h ma, aller gic r hi nitis, a n d aller gic c o nj u n cti vitis ( At o pic C o n diti o ns Q u esti o n n aire). 
9) 
Bl o o d sa m ples f or t otal ser u m I g E will b e c ollecte d d uri n g pre d ose o n O L E Da ys 1, 5 7, a n d 8 5 a n d o n f oll o w- u p Da ys 9 9, 1 4 1, a n d 1 6 9 or 1 4, 5 6, a n d 8 4 ( ± 5) d a ys after last 
d ose of st u d y dr u g if E T. 
1 0) 
Bl o o d f or c h e mistr y will b e o btai n e d pre d ose o n d osi n g d a ys a n d f oll o w- u p d a ys ( 1 4, 5 6, a n d 8 4 [ ± 5] d a ys after t he last d ose of st u d y dr u g if E T).  
1 1) 
Bl o o d f or C B C wit h differe ntial will b e o btai n e d j ust pri or t o eac h S C i njecti o n, 1 h o ur ( ± 1 5 mi n utes) after t h e e n d of eac h S C i njecti o n as well as o n all f oll o w- u p da ys 
( 1 4, 5 6, a n d 8 4 [ ± 5] d a ys after last d ose if E T).  
1 2) 
Bl o o d f or P K will b e o btai n e d pre d ose o n d osi n g d a ys a n d o n f oll o w- u p d a ys ( 1 4, 5 6, a n d 8 4 d a ys after t h e last d ose of st u d y dr u g if E T). 
1 3) 
Bl o o d f or A D A will b e c ollecte d pre d ose o n O L E d osi n g Da ys 1, 4 3, a n d 8 5 ( ± 5), o n f oll o w- u p O L E Da ys 9 9 a n d 1 6 9 ( 1 4 a n d 8 4 [ ± 5] d a ys after t he last d ose of st u d y dr u g if 
E T. T h e A D A sa m ple will als o b e c ollecte d a n y ti m e a n i m m u n o ge nicit y-relate d A E occ urs. 
1 4) 
Uri n e will b e c ollecte d f or di pstic k pre g na n c y test o n all d osi n g d a ys a n d f oll o w- u p d a ys ( 1 4, 2 8, 5 6, a n d 8 4 da ys after t h e last d ose of st u d y dr u g if E T) f or all s u bjects of 
c hil d beari n g p ote ntial. Test kits will b e s u p plie d b y t h e ce ntral la b orat or y. T ests will b e c o m plete d o n site a n d e v al u ate d pri or t o eac h S C i njecti o n. If t h e Da y 1 O L E visit 
d oes n ot occ ur o n Da y 9 9 of t he d o u ble- bli n d p eri o d, t h e n a di pstic k uri ne pre g n a n c y test will ha v e t o be d o n e. Da y 1 ca n occ ur u p t o 7 da ys after t h e Da y 9 9 visit of t h e 
d o u ble- bli n d peri o d. 
1 5) 
Uri n e f or sta n d ar d uri n al ysis will be o btai n e d o n O L E Da y 1 a n d f oll o w- u p Da ys 9 9 a n d 1 6 9 ( 1 4 a n d 8 4 d a ys [ ± 5] if E T) a n d s y m pt o m- b ase d, as n ecessar y. 
1 6) 
S u bjects will re mai n u n d er o bser v ati o n at t he site f or at least 1 h o ur after t h e e n d of eac h S C i njecti o n. I n t he e v e nt of a n I R R, t h e s u bject m a y re q uire pr ol o n ge d o bser v ati o n 
( > 1 h o ur or u ntil t h e s y m pt o ms res ol v e), as per t h e I n v esti gat or’s discreti o n. S u bjects will als o be i nstr u cte d t o i m me diatel y c o ntact t h e st u d y d o ct or if a n y reacti o ns o cc ur 
after disc har g e. 

Pr ot o c ol A K 0 0 2- 0 1 8 
A me n d m e nt 6 
Date: 0 8 Se pte m b er 2 0 2 3 
Alla k os I n c.
Pa g e 1 3 5 of 1 3 5
C o nfi d e nti al
T a ble 8 N otes c o nt. 
1 7) 
T h e ca pt ure of S A E, n o n-seri o us A E, a n d A E SI will b e ca pt ure d t hr o u g h t h e O L E p eri o d u ntil O L E Da y 1 6 9 or E T. A d v erse e v e nts will b e assesse d a n d rec or d e d i n t h e C R F 
of t he A K 0 0 2- 0 1 8 O L E p eri o d d ata b ase b e gi n ni n g fr o m t h e start of t h e first o p e n-la bel S C i njecti o n d uri n g t h e O L E Da y 1 visit.