A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics and Safety of Nemolizumab (CD14152) in Adolescent Subjects (12-17 Years) With Moderate-to-Severe Atopic Dermatitis
Phase: PHASE2
Conditions: Atopic Dermatitis
Sponsor: Galderma R&D

 
 
C LI NI C A L S T U D Y P R O T O C O L  
A M ultice nter, O pe n -L a bel, S i n gle-G r o u p C li nic al T ri al t o A ssess t he 
P h ar m ac o ki netics a n d S afety of N e m oliz u m a b ( C D 1 4 1 5 2) i n A d olesce nt S u bjects 
( 1 2-1 7 ye ars) wit h M o der ate -t o-S evere A t o pic D er m atitis a n d A ss oci ate d P r urit us 
 
G al der m a Pr ot oc ol  N u m ber:  
R D. 0 6. S P R. 1 1 6 9 1 2  
E u dr a C T  N u m ber:  
N ot A p plica ble  
 
 
I n vesti g ati o n al Pr o d uct: 
Ne m oliz u ma b ( C D 1 4 1 5 2)  
I N D N u m ber: 
 
P h ase:  
2  
S p o ns or:  
Gal der ma R esearc h &  D e vel o p me nt, L L C 
1 4 5 0 1 N ort h Free wa y  
F ort W ort h, T X 7 6 1 7 7  
U nite d States  
C o ntr act Rese arc h Or g a niz ati o n:  
 
 
 
U nite d States  
Pr ot oc ol  D ate : 
2 1 J U L2 0 2 0  
Pr ot oc ol  Versi o n : 
Versi o n 6 . 0 
 
C O N FI D E N TI A L  
T his d oc u me nt c o nt ai ns c o nfi de nti al, pr o priet ar y i nf or m ati o n, a n d  m a y n ot be re pr o d uce d or 
c o m m u nic ate d t o a t hir d p art y wit h o ut t he writte n per missi o n of G al der m a R ese arc h &  
D e vel o p me nt, L L C . 
 
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0
C CI
C CI
C CI
C CI

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 2  of 9 9  
T A B L E O F C O N T E N T S  
T A B L E O F C O N T E N T S  .............................................................................................................................. 2  
LI S T O F T A B L E S  ........................................................................................................................................ 7  
LI S T O F FI G U R E S  ....................................................................................................................................... 7  
1   
Pr ot oc ol A p pr o val Si g nat ures  ............................................................................................................. 8  
2   
St u d y Pers o n nel  ................................................................................................................................... 9  
3   
S y n o psis  ............................................................................................................................................ 1 0  
4   
List of A b bre viati o ns  ......................................................................................................................... 2 1  
5   
I ntr o d ucti o n ....................................................................................................................................... 2 3  
5. 1   
Bac k gr o u n d & R ati o nale .............................................................................................................. 2 3  
5. 2   
Cli nical St u dies  ............................................................................................................................ 2 5  
5. 2. 1   
P hase 1 Si n gle -D ose Safet y St u d y  .......................................................................................... 2 6  
5. 2. 2   
P hase 2a M ulti -D ose Safet y a n d Efficac y St u d y  .................................................................... 2 6  
5. 2. 3   
P hase 2 b D ose -Ra n gi n g St u d y  ................................................................................................ 2 7  
5. 3   
Ris k/ Be nefit Assess me nt  .............................................................................................................. 2 8  
5. 4   
Dr u g Pr ofile  ................................................................................................................................. 3 0  
5. 5   
D ose Selecti o n Rati o nale  ............................................................................................................. 3 0  
6   
St u d y O bjecti ves & E n d p oi nts  .......................................................................................................... 3 1  
6. 1   
Pri mar y O bjecti ve  ........................................................................................................................ 3 1  
6. 2   
Pri mar y E n d p oi nts ........................................................................................................................ 3 1  
6. 2. 1   
P har mac o ki netics  .................................................................................................................... 3 1  
6. 2. 2   
I m m u n o ge nicit y ...................................................................................................................... 3 1  
6. 2. 3   
Safet y  ...................................................................................................................................... 3 1  
6. 3   
Sec o n dar y O bject i ve .................................................................................................................... 3 1  
6. 4   
Sec o n dar y E n d p oi nts .................................................................................................................... 3 2  
6. 4. 1   
P har mac o ki netics  .................................................................................................................... 3 2  
6. 4. 2   
P har mac o d y na mics  ................................................................................................................. 3 2  
6. 4. 3   
Efficac y  ................................................................................................................................... 3 2  
6. 4. 4   
Q ualit y of Life Assess me nt  ..................................................................................................... 3 2  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 3  of 9 9  
7   
I n vesti gati o nal Pla n ........................................................................................................................... 3 3  
7. 1   
O verall St u d y Desi g n a n d Pla n: Descri pti o n  ............................................................................... 3 3  
7. 2   
Sc he d ule of Assess me nts  ............................................................................................................. 3 5  
7. 3   
Disc ussi o n of St u d y Desi g n  ......................................................................................................... 3 9  
7. 3. 1   
St u d y Desi g n  ........................................................................................................................... 3 9  
7. 4   
Selecti o n of St u d y P o p ulati o n  ...................................................................................................... 4 1  
7. 4. 1   
N u m ber of Pla n ne d S u bjects  ................................................................................................... 4 1  
7. 4. 2   
I ncl usi o n Criteria .................................................................................................................... 4 1  
7. 4. 3   
E x cl usi o n Criteria  ................................................................................................................... 4 3  
7. 4. 4   
Re m o val of S u bjects Fr o m T hera p y or Assess me nts  .............................................................. 4 5  
7. 4. 4. 1   
Pre g na nc y  .......................................................................................................................... 4 6  
7. 5   
I n vesti gati o nal Pr o d uct: Ne m oliz u ma b ........................................................................................ 4 7  
7. 5. 1   
I n vesti gati o nal Pr o d uct A d mi nistere d ..................................................................................... 4 7  
7. 5. 2   
I de ntit y of I n vesti gati o nal Pr o d uct .......................................................................................... 4 8  
7. 5. 3   
Pac ka gi n g a n d La beli n g  .......................................................................................................... 4 8  
7. 5. 4   
St u d y Dr u g Ma na ge me nt  ........................................................................................................ 4 8  
7. 5. 4. 1   
St ora ge of St u d y Dr u g  ....................................................................................................... 4 8  
7. 5. 4. 2   
St u d y Dr u g Acc o u nta bilit y  ................................................................................................ 4 8  
7. 5. 4. 3   
Dis pe nsi n g a n d Ret ur n of St u d y Dr u g  ............................................................................... 4 9  
7. 5. 4. 4   
Treat me nt C o m plia nce  ....................................................................................................... 4 9  
7. 5. 5   
Met h o d of Assi g ni n g S u bjects t o Treat me nt  ........................................................................... 4 9  
7. 5. 6   
Selecti o n of D oses i n t he St u d y  .............................................................................................. 4 9  
7. 5. 7   
D ose M o dificati o n  .................................................................................................................. 4 9  
7. 5. 8   
Pri or a n d C o nc o mita nt T hera p y  .............................................................................................. 5 0  
7. 5. 8. 1   
Per mitte d C o nc o mita nt T hera p y  ........................................................................................ 5 0  
7. 5. 8. 2   
Pr o hi bite d Me dicati o n/ T hera p y  ......................................................................................... 5 2  
7. 6   
D urati o n of S u bject Partici pati o n  ................................................................................................. 5 3  
7. 6. 1   
Earl y Ter mi nati o n Visit  .......................................................................................................... 5 3  
7. 6. 2   
U nsc he d ule d Visit  ................................................................................................................... 5 4  
8   
St u d y As sess me nts ............................................................................................................................ 5 5  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 4  of 9 9  
8. 1   
Efficac y Assess me nts  ................................................................................................................... 5 5  
8. 1. 1   
Ecze ma Area a n d Se verit y I n de x  ............................................................................................ 5 5  
8. 1. 2   
I n vesti gat or Gl o bal Assess me nt .............................................................................................. 5 5  
8. 1. 3   
B o d y S urface Area  .................................................................................................................. 5 6  
8. 1. 4   
S C O Ri n g At o pic Der matitis  ................................................................................................... 5 6  
8. 1. 5   
Pr urit us N u meric Rati n g Scale  ................................................................................................ 5 6  
8. 1. 6   
Slee p Dist ur ba nce N u meric Rati n g Scale  ............................................................................... 5 7  
8. 1. 7   
A p plicati o n of T o pical Me dicati o n f or A D: Diar y  ................................................................. 5 7  
8. 1. 8   
Der mat ol o g y Life Q ualit y I n de x ( D L QI)/ C hil dre n’s D L QI (c D L QI)  .................................... 5 7  
8. 2   
P har mac o ki netics  ......................................................................................................................... 5 7  
8. 2. 1   
Bl o o d Sa m pli n g  ...................................................................................................................... 5 7  
8. 2. 2   
P K Para meters  ......................................................................................................................... 5 8  
8. 3   
I m m u n o ge nicit y ........................................................................................................................... 5 9  
8. 4   
P har mac o d y na mics  ...................................................................................................................... 5 9  
8. 5   
C D 1 4 1 5 2 Q ua ntificati o n i n Bi ol o gical Sa m pli n g  ........................................................................ 6 0  
8. 6   
Safet y Assess me nts  ...................................................................................................................... 6 0  
8. 6. 1   
A d verse E ve nts  ....................................................................................................................... 6 0  
8. 6. 1. 1   
A d ve rse E ve nts of S pecial I nterest .................................................................................... 6 3  
8. 6. 1. 2   
Seri o us A d verse E ve nts  ..................................................................................................... 6 4  
8. 6. 1. 3   
Pr oce d ure f or Re p orti n g a Seri o us A d verse E ve nt  ............................................................ 6 4  
8. 6. 1. 4   
Pr oce d ure f or Re p orti n g a n A d verse E ve nt of S pecial I nterest  ......................................... 6 5  
8. 6. 1. 5   
Pr oce d ure f or Re p orti n g Pre g na ncies  ................................................................................ 6 6  
8. 6. 1. 6   
U ne x pecte d A d verse Reacti o ns  ......................................................................................... 6 7  
8. 6. 2   
Cli nical La b orat or y E val uati o ns  ............................................................................................. 6 7  
8. 6. 2. 1   
He mat ol o g y  ........................................................................................................................ 6 8  
8. 6. 2. 2   
Cli nical C he mistr y  ............................................................................................................. 6 8  
8. 6. 2. 3   
Uri nal ysis  ........................................................................................................................... 6 8  
8. 6. 3   
Pre g na nc y Testi n g  ................................................................................................................... 6 8  
8. 6. 4   
Vir ol o g y  .................................................................................................................................. 6 9  
8. 6. 5   
T u berc ul osis Testi n g  ............................................................................................................... 6 9  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 5  of 9 9  
8. 6. 5. 1   
Defi niti o ns  ......................................................................................................................... 6 9  
8. 6. 5. 2   
T u berc ul osis Scree ni n g  ...................................................................................................... 6 9  
8. 6. 6   
Vital Si g ns  ............................................................................................................................... 6 9  
8. 6. 7   
Hei g ht a n d Wei g ht  .................................................................................................................. 7 0  
8. 6. 8   
P h ysical E xa mi nati o n  .............................................................................................................. 7 0  
8. 6. 9   
Res pirat or y Assess me nts  ........................................................................................................ 7 0  
8. 6. 9. 1   
Ast h ma C o ntr ol Test  .......................................................................................................... 7 0  
8. 6. 9. 2   
Res pirat or y E xa mi nati o n  ................................................................................................... 7 0  
8. 6. 9. 3   
S pir o metr y/ Pea k E x pirat or y Fl o w  ..................................................................................... 7 1  
8. 6. 9. 4   
Res pirat or y Referrals  ......................................................................................................... 7 1  
8. 6. 1 0   
Electr ocar di o gra m  ................................................................................................................... 7 1  
8. 7   
I n de pe n de nt Data M o nit ori n g C o m mittee ................................................................................... 7 2  
9   
Statistical Met h o ds  ............................................................................................................................ 7 3  
9. 1   
Data Tra nsf or mati o ns  ................................................................................................................... 7 3  
9. 2   
A nal ysis P o p ulati o ns  .................................................................................................................... 7 3  
9. 2. 1   
P K  A nal ysis P o p ulati o n  .......................................................................................................... 7 3  
9. 2. 1. 1   
Safet y P o p ulati o n  ............................................................................................................... 7 3  
9. 2. 2   
I nte nt-t o-Treat (I T T) P o p ulati o n  ............................................................................................. 7 3  
9. 3   
I m p utati o n of Missi n g Data ......................................................................................................... 7 4  
9. 4   
Descri pti ve a n d I nfere ntial Statistical A nal yses  .......................................................................... 7 4  
9. 4. 1   
De m o gra p h y a n d Baseli ne C haracteristics  ............................................................................. 7 4  
9. 4. 2   
P K Para meters a n d A D A A nal yses  ......................................................................................... 7 4  
9. 4. 3   
Safet y A nal yses  ....................................................................................................................... 7 5  
9. 4. 3. 1   
E xte nt of E x p os ure  ............................................................................................................ 7 5  
9. 4. 3. 2   
A d verse E ve nts  .................................................................................................................. 7 5  
9. 4. 3. 3   
El ectr ocar di o gra m  .............................................................................................................. 7 5  
9. 4. 3. 4   
Cli nical La b orat or y  ............................................................................................................ 7 5  
9. 4. 3. 5   
Vital Si g ns  ......................................................................................................................... 7 5  
9. 4. 3. 6   
Ast h ma C o ntr ol Test  .......................................................................................................... 7 6  
9. 4. 3. 7   
Pea k E x pirat or y Fl o w  ........................................................................................................ 7 6  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 6  of 9 9  
9. 4. 4   
Efficac y A nal yses  ................................................................................................................... 7 6  
9. 4. 5   
Bi o mar ker A nal yses  ................................................................................................................ 7 6  
9. 4. 6   
Q u alit y of Life A nal yses  ......................................................................................................... 7 6  
9. 5   
Sa m ple Size Ass u m pti o n  ............................................................................................................. 7 6  
9. 6   
Pr ot oc ol De viati o ns  ...................................................................................................................... 7 7  
1 0   
Q ualit y Ass ura nce a n d Q ualit y C o ntr ol  ............................................................................................ 7 8  
1 0. 1   
A u dit a n d I ns pecti o n  .................................................................................................................... 7 8  
1 0. 2   
M o nit ori n g  ................................................................................................................................... 7 8  
1 0. 3   
Pers o n nel Trai ni n g  ....................................................................................................................... 7 8  
1 0. 4   
Data Ma na ge me nt a n d C o di n g  ..................................................................................................... 7 8  
1 0. 5   
Cli nical Trial C o n d uct  .................................................................................................................. 7 9  
1 0. 6   
A me n d me nts  ................................................................................................................................ 7 9  
1 0. 7   
Q ualit y Ma na ge me nt a n d Ris k E val uati o n  .................................................................................. 7 9  
1 1   
Et hics  ................................................................................................................................................. 8 0  
1 1. 1   
I n de pe n de nt Et hics C o m mittee or I nstit uti o nal Re vie w B oar d .................................................... 8 0  
1 1. 2   
Re g ulat or y A ut h orities  ................................................................................................................. 8 0  
1 1. 3   
Et hical C o n d uct of t he St u d y  ....................................................................................................... 8 0  
1 1. 4   
I nf or me d C o nse nt ......................................................................................................................... 8 0  
1 1. 5   
S u bject C o nfi de ntialit y  ................................................................................................................ 8 1  
1 1. 6   
Fi na nci n g a n d I ns ura nce  .............................................................................................................. 8 1  
1 2   
R e p orti n g a n d P u blicati o n, I ncl u di n g Arc hi vi n g  .............................................................................. 8 2  
1 3   
Refere nces  ......................................................................................................................................... 8 3  
1 4   
A P P E N DI C E S  ................................................................................................................................... 8 7  
1 4. 1   
A p pe n di x  1 - A m erica n Aca de m y of Der mat ol o g y C o nse ns us Criteria f or A D 
Dia g n osis  ...................................................................................................................................... 8 7  
1 4. 2   
A p pe n di x  2 - A ut h orize d Bac k gr o u n d T o pical C ortic oster oi ds  ................................................... 8 8  
1 4. 3   
A p pe n di x  3 - Ecze ma Area a n d Se verit y I n de x ( E A SI) ............................................................... 8 9  
1 4. 4   
A p pe n di x  4 - I n vesti gat or’s Gl o bal Assess me nt (I G A) ............................................................... 9 0  
1 4. 5   
A p pe n di x  5 - S C O Ri n g At o pic Der matitis ( S C O R A D)  .............................................................. 9 1  
1 4. 6   
A p pe n di x  6 - Pr urit us N u meric Rati n g Scale ( N R S) ................................................................... 9 2  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 7  of 9 9  
1 4. 7   
A p pe n di x  7 - Slee p Dist ur ba nce N u meric Rati n g Scale ( N R S)  ................................................... 9 3  
1 4. 8   
A p pe n di x  8 - Der mat ol o g y Life Q ualit y I n de x ( D L QI) a n d C hil dre n’s D L QI  ............................ 9 4  
1 4. 9   
A p pe n di x  9 - Ast h ma C o ntr ol Test  .............................................................................................. 9 8  
1 4. 1 0   
I n vesti gat or Si g nat ure Pa ge ......................................................................................................... 9 9  
 
LI S T O F T A B L E S  
Ta ble  1:   
Cli nical Trial Sc he matic  ......................................................................................................... 1 1  
Ta ble  2:   
D osi n g Sc he me  ....................................................................................................................... 1 2  
Ta ble  3:   
Pri or Treat me nts ...................................................................................................................... 1 6  
Ta ble  4:   
Ne m oliz u ma b Pre dicte d A vera ge Ser u m C o nce ntrati o ns ( µ g/ m L) C o m pare d t o Act ual 
C tr o u g h Le vel f or t he 3 0 m g D ose i n A d ults  .............................................................................. 4 0  
Ta ble  5:   
Pri or Treat me nts ...................................................................................................................... 4 3  
Ta ble  6:   
D osi n g Sc he me  ....................................................................................................................... 4 7  
Ta ble  7:   
Descri pti o n of Ne m oliz u ma b  .................................................................................................. 4 8  
Ta ble  8:   
Pr o hi bite d Me dicati o n/ T hera p y  .............................................................................................. 5 2  
 
LI S T O F FI G U R E S  
Fi g ure  1:   
St u d y Desi g n ( S y n o psis)  ......................................................................................................... 1 2  
Fi g ure  2:   
St u d y Desi g n  ........................................................................................................................... 3 4  
 
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 9  of 9 9  
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St u d y Pers o n nel  
G al der m a R ese arc h &  D evel o p me nt, L L C  Pers o n nel  
Na me:  
  
 
Title:  
 
A d dress:  
Gal der ma S. A.  
R ue d’ E ntre -de u x -Villes 1 0  
1 8 1 4 La T o ur -de -Peliz  
S witzerla n d  
 
 
 
Na me:  
  
Title:  
 
A d dress:  
  
  
Tele p h o ne N o.:  
  
M o bile N o.:  
  
E mail:  
  
 
 
Na me:  
 
Title:  
 
A d dress:  
  
  
Tele p h o ne N o.:  
 
M o bile  N o.:  
 
E mail:  
 
 
C o or di n ati n g I nvesti g at or  
Na me:  
 
Title:  
C o or di nati n g I n vesti gat or  
A d dress:  
,  
 
Tele p h o ne N o.:  
 
E mail:  
 
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
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Pa ge 1 0  of 9 9  
3   
S y n o psis  
Pr ot oc ol N u m ber:  
1 1 6 9 1 2  
Title:  
A M ultice nter, O pe n -L a bel, S i n gle-G r o u p C li nical T rial t o A ssess t h e P har mac o ki netics a n d  
S afet y of N e m oliz u ma b ( C D 1 4 1 5 2) i n A d olesce nt S u bjects ( 1 2 -1 7 years) wit h M o derate -t o-
S e vere A t o pic D er matitis a n d Ass ociate d P r urit us 
I n vesti g ati o n al Pr o d uct: 
Ne m oliz u ma b ( C D 1 4 1 5 2)  
I N D N u m ber: 
 
St u d y Ce nters:  
A p pr o xi matel y 1 0 st u d y ce nters acr oss t he U nite d States  
P h ase:  
2  
O bjecti ves:  
Pri mar y o bjecti ve : T o assess t he p har mac o ki netics ( P K) a n d safet y of ne m oliz u ma b i n a d olesce nt 
s u bjects wit h m o derate-t o-se vere at o pic der matitis ( A D ) a n d ass oci ate d pr urit us n ot a de q uatel y 
c o ntr olle d wit h t o pical tr eat me nts, w he n a d mi nistere d c o nc o mita ntl y wit h t o pical c ortic oster oi ds 
(T C S ). 
Sec o n dar y o bj ecti ve : T o e val uate t he efficac y of ne m oliz u ma b a n d t o f urt her c h aracteri ze t he 
relati o ns hi p bet wee n n e m oliz u ma b c o nce ntrati o ns a n d cli nical efficac y e n d p oi nts . 
St u d y Desi g n:  
T his is a n o pe n -la bel, si n gle-gr o u p st u d y t o e val uate t he P K a n d safet y of 3 0 m g of ne m oliz u ma b 
i n a d olesce nt s u bjects ( 1 2 t o 1 7 years of a ge ), wit h m o derate-t o-s e vere A D a n d ass ociate d pr urit us. 
A p pr o xi matel y 2 0 e li gi ble s u bjects will be e nr olle d t o recei ve s u bc uta ne o us i njecti o ns of 
ne m oliz u ma b  ( 3 0 m g) e v er y 4 wee ks  o ver a 1 6 -wee k treat me nt peri o d , wit h a l oa di n g d ose of 6 0 
m g o n Da y 1.  
 
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P P D

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T a ble  1 :  
Cli nic al Tri al Sc he m atic  
Scree ni n g  
 
E nr oll me nt ( ~ 2 0 s u bjects)  
 
Gr o u p 1 ( n = ~ 2 0)  
Tre at m e nt  
Ne m oliz u ma b 3 0  m g (l oa di n g d ose at t he b aseli ne visit: 6 0  m g)  
Tre at m e nt Fre q ue nc y  
E ver y 4 wee ks ( Q 4 W)  
Tre at m e nt D ur ati o n  
1 6  wee ks (last st u d y dr u g i njecti o n at Wee k  1 2 ) 
D ur ati o n of F oll o w -u p Peri o d   
8  wee ks (fr o m Wee k 1 6  t o Wee k 2 4 ) 
A b bre vi ati o ns : n  =  n u m ber of s u bjects; Q 4 W  =  e ver y 4 wee ks.  
Eli gi ble s u bjects m ust als o ha ve a d o c u me nte d hist or y of i na de q uat e res p o nse t o t o pical A D 
me dicati o ns. S u bjects meeti n g t he eli gi bilit y  criteria at t he scree ni n g visit will i nitiate ( or c o nti n ue) 
use of a m oist urizer a n d a ut h orize d bac k gr o u n d T C S  (i ncl u di n g a me di u m p ote nc y T C S f or t he 
b o d y , a n d l o w pote nc y T C S f or T C S -se nsiti ve areas s uc h as t he face, nec k, i ntertri gi n o us areas, 
etc), a n d acc or di n g t o g ui deli nes i n Secti o n  7. 5. 8. 1  f or use t hr o u g h o ut t he st u d y. Use of a ut h orize d 
bac k gr o u n d t hera p y is re q uire d f or at least 1 4 da ys bef ore  b aseli ne/ Da y 1 as s u bjects c o m plet e 
dail y assess me nts of pr urit us , t o c o nfir m eli gi bilit y. S u bjects w h o c o nti n ue t o meet t he eli gi bilit y  
criteria at t he b as eli ne visit will be e nr olle d i n t he st u d y. S u bjects ma y be rescree ne d o n ce u nless 
t he reas o n f or scree n fail ure is relate d t o disease se verit y i ncl usi o n criteria (In vesti gat or’s Gl o bal 
Asses s me nt [I G A], Ecze ma Area a n d Se verit y I n de x  [ E A SI], b o d y s urface area [ B S A] , a n d P ea k 
P r urit us N u meric Rati n g Scale [P P N R S ]). T he latter s u bjects are n ot per mitte d t o rescree n.  
Fi g ure  1  pr o vi des a n  o v er vie w of t h e o pe n -l a bel st u d y desi g n. S u bjects will be scree ne d a n d 
c o m plete a r u n -i n peri o d of at least 1 4 da ys  b ef ore  t he b aseli ne visit . Eli gi ble s u bjects will e nter a 
1 6 -we e k tr eat me nt peri o d wit h ne m oliz u ma b 3 0  m g a d mi nistere d s u bc uta ne o usl y e ver y 4 wee ks, 
wit h a l oa di n g d ose of 6 0  m g at  b aseli ne/ Da y 1. T he fi nal d ose of st u d y dr u g will occ ur at Wee k 
1 2 a n d s u bjects will c o m plete t he treat me nt peri o d at t he Wee k 1 6 visit. A n 8 -wee k  f oll o w-u p 
peri o d is sc he d ule d ( Wee k 2 4 visit) f or s u bjects w h o d o n ot r oll o ver i nt o t he ne m oliz u ma b l o n g-
ter m e xte nsi o n st u d y . S u bjects w h o pre m at urel y disc o nti n ue t he st u d y bef ore  t he Wee k 1 6 visit 
ha ve t o be f oll o we d f or 1 2 wee ks after t heir l ast d ose of st u d y dr u g . 
T he sc he d ule of assess me nts is s u m marize d i n Secti o n  7. 2 . Assess me nts of P K, safet y, a n d efficac y 
will be c o n d ucte d t hr o u g h o ut t he st u d y. Patie nt -re p orte d assess me nts of pr urit us, slee p dist ur ba nce 
a n d t he use of t o pical A D me dicati o n f or t heir ecze ma will be c ollecte d dail y.  
A n i nteri m a nal ysis is pla n ne d after a p pr o xi matel y 1 0 s u bjects c o m plete t he Wee k 8 visit. T he 
st u d y will atte m pt t o e nr oll at least 3 s u bjects wit h a l o w b o d y wei g ht ( ≤ 6 1  k g ) f or t he i nteri m 
a nal ysis a n d a p pr o xi mat el y 6 t otal s u bjects wit h l o w b o d y wei g ht f or t he o v erall st u d y p o p ulati o n, 
w it h i n vesti gat ors atte m pt i n g t o e nr oll s u bjects at t he l o wer a g e ra n ge ( 1 2-1 4 years ol d). T h e 
i nteri m a nal ysis will assess w het her t h e o bser ve d s afet y a n d P K data fr o m a d olesce nts are si milar 
t o t he data o btai ne d i n a d ults, w hic h is t he basis f or all o wi n g recr uit me nt of a d olesce nt s u bjects 
i nt o t he pla n ne d ne m oliz u ma b P hase 3 st u dies f or A D ( pi v otal a n d l o n g-ter m e xte nsi o n  pr ot oc ols ). 
A n I n de p e n de nt Data M o nit ori n g C o m mittee (I D M C) will re vie w a n d m o nit or s u bject  safet y. T he 
I D M C will pr o vi de rec o m me n dati o n s o n t he s afet y of s u bjects.  Details o n t he I D M C, i ncl u di n g 
 
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t he pla n of a nal ysis f or I D M C o ut p uts, t he c o m p ositi o n of t he I D M C, t he pr oce d ures, r oles, 
res p o nsi bilities a n d t heir c o m m u nicati o ns are pr o vi de d i n t he I D MC c harter . 
Fi g ure  1 :  
St u d y Desi g n  ( S y n o psis) 
 
A b bre vi ati o ns : B L = Baseli n e; n = n u m ber of s u bjects; q 4 w = e ver y 4 wee ks; T C S = t o pical c ortic oster oi d; 
W  =  wee k  
N u m ber of Pl a n ne d S u bjects:  
It is a ntici pate d t hat a p pr o xi matel y 3 0 s u bjects will be scree ne d, wit h a p pr o xi matel y 2 0 eli gi ble 
s u bjects e nr olle d. 
I n vesti g ati o n al Pr o d uct Tre at me nt:  
Ne m oliz u ma b ( C D 1 4 1 5 2) will be a d mi nistere d as a s u bc uta ne o us i njecti o n , wit h a l oa di n g d ose 
of 6 0 m g o n Da y 1 , f oll o we d b y i njecti o ns of 3 0 m g e ver y 4 wee ks  f or 1 2 wee ks . 
T a ble  2 :  
D osi n g Sc he me  
Gr o u p  
D ose o n D a y 1  
D ose at Wee k s 4 , 8 a n d  1 2  
1  
6 0 m g  
3 0 m g  
 
B ac k gr o u n d T her a p y:  
Bac k gr o u n d t hera pies are use d t hr o u g h o ut t he st u d y ( scree ni n g t hr o u g h t he foll o w -u p v isit), as 
descri be d b el o w.  
M oist urizer: S u bjects will a p pl y a m oist urizer dail y , a n d li berall y as nee de d , t o dr y s ki n a n d A D 
lesi o ns t hr o u g h o ut t he st u d y. T he s u bject’s c urre nt m oist urizer or a m oist urizer rec o m me n d e d b y 
t he i n vesti gat or ma y be use d. Use s h o ul d n ot occ ur wit hi n 8 h o urs bef ore eac h cli nic visit.  
 
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T C S t hera p y: S u bjects will a p pl y t he a ut h orize d bac k gr o u n d T C S t hera p y t o all A D lesi o ns 
be gi n ni n g wit hi n t he scree ni n g peri o d a n d ≥ 1 4 da ys bef ore  Da y 1 , a n d t hr o u g ho ut t he st u d y as 
directe d b y t he i n vesti gat or . 
S u bjects will a p pl y a me di u m p ote nc y T C S i n areas of t he b o d y w here use of me di u m p ote nc y 
T C S is c o nsi dere d safe  (e g, tr u n k a n d e xtre mities). A l o w p ote nc y T C S will be use d  o n T C S -
se nsiti ve areas (e g, face, nec k, i ntertri gi n o us areas) . 
S u bjects will a p pl y a t hi n la yer of a ut h orize d T C S  o n all A D lesi o ns at a fre q ue nc y t hat is necessar y 
t o e ns ure disease sta bilit y a n d pre ve nt A D flare, b ut w hic h d oes n ot e xcee d t he dail y fre q ue nc y 
rec o m me n de d i n t he pr o d uct la beli n g . It s h o ul d b e n ote d t hat “as nee d e d” ( P R N) use of T C S  is n ot 
per mitte d. Refer t o A p pe n di x  2  f or a ut h orize d T C S a n d per mitte d dail y use. 
T he i n vesti gat or s h o ul d a dj ust b ac k gr o u n d T C S use  d uri n g t he st u d y, acc or di n g t o t he diseas e 
acti vit y a n d t olera bilit y, i ncl u di n g ta peri n g  w he n si g ns a n d s y m pt o ms i m pr o ve , disc o nti n uati o n 
w he n  lesi o ns clear, a n d restarti n g  if si g ns a n d s y m pt o ms rec ur. 
Resc ue T her a p y:  
If dee me d t o be 
me di call y necess ar y b y t he i n vesti gat or (e g, t o c o ntr ol i nt olera ble A D 
si g ns/s y m pt o ms), resc ue t hera pies ca n be pres cri be d t o t he s u bjects at a n y ti me d uri n g t he st u d y 
e xce pt d uri n g t he r u n -i n peri o d. S u bjects recei vi n g resc ue t hera pies d uri n g t he r u n -i n peri o d are 
n ot eli gi ble t o partici pat e i n t he st u d y. As a g e neral g ui deli ne a n d per i n di vi d ual i n vesti gat or 
j u d gm e nt, resc ue t hera p y s h o ul d n ot be prescri be d wit hi n t he first 2 wee ks after b aseli ne (ie, Wee k 
2 visit) t o all o w a mi ni m u m peri o d  f or st u d y dr u g e x p os ure i n t he prese n ce of bac k gr o u n d t hera p y. 
Resc ue treat me nts are o nl y treat me nts t hat directl y treat A D ( m ai nl y t h ose t h at are a p pr o ve d or are 
sta n dar d of care), a n d i ncl u de t o pical a n d s yste mic treat me nts as o utli ne d. S o me r esc u e t hera pies 
i ncl u de:  
•  T o pical calci n e uri n i n hi bit ors ( T CI)  
•  H i g her p ote nc y of T C S (class I-II acc ordi n g t o t he U S classificati o n)  
•  Oral  c ortic oster oi ds  
•  Bi ol o gics (i ncl u di n g t heir bi osi milars)  
•  S yste mic n o nster oi dal i m m u n os u p pressa nts /i m m u n o m o d ulat ors  
•  P h ot ot hera p y  
A nti hista mi nes, slee p ai ds, t o pical a n d s yste mic a nti bi otics, a n d a nti -itc h crea ms are n ot c o nsi dere d 
t o be resc u e t hera p y b eca use t he y d o n ot directl y treat A D.  
W he ne v er p ossi ble, i n vesti gat ors s h o ul d first use t o pical me dicati o n s as resc ue t h era p y b ef ore 
escalati n g t o s yste mic t h era pies. If s u bjects recei ve t o pical treat me nts or p h ot ot hera p y as resc u e 
t hera p y, st u d y dr u g a d mi nistrati o n s h o ul d be c o nti n ue d u nless t here is a safet y c o ncer n acc or di n g 
t o t he i n vesti gat or’s j u d g me nt. If s u bjects recei ve s yste mic resc ue t h era p y, t he st u d y dr u g 
a d mi nistrati o n m ust be per ma ne ntl y disc o nti n ue d.  
St u d y D ur ati o n:  
St u d y partici pati o n ma y i ncl u de a t otal of 2 8 wee ks f or s u bjects t hat c o m plete t he scree ni n g, 
treat me nt a n d f oll o w-u p peri o ds. T his st u d y i ncl u des a 2 t o 4 -wee k r u n -i n peri o d f oll o we d b y a 
1 6 -wee k tr eat me nt peri o d. A f oll o w -u p visit ( Wee k 2 4 ) is sc he d ule d f or s u bjects w h o will n ot 
 
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r oll o ver i nt o t he ne m oliz u ma b l o n g-ter m e xte nsi o n st u d y . S u bjects w h o pre mat urel y disc o nti n ue 
t he st u d y bef ore  t he Wee k 1 6 visit ha ve t o be f oll o we d f or 1 2 wee ks after t heir last d ose of st u d y 
dr u g . 
St u d y P o p ul ati o n:  
In cl usi o n cri teria: 
1.   
S u bjects ≥ 1 2 t o <  1 7  years of a ge at t he scree ni n g visit . 
2.   
C hr o nic A D f or at least 2 years bef ore t h e scree ni n g visit a n d c o nfir me 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 2 (A p pe n di x  1 ) at t he ti me of t he 
scree ni n g visit . 
3.   
E A SI s c ore ≥ 1 6  at b ot h scree ni n g a n d b aseli ne visits . 
4.   
I G A sc ore ≥ 3 ( bas e d o n t he I G A scale ra n gi n g fr o m 0 t o 4, i n w hic h 3 is m o derate a n d 4 is 
se vere) at b ot h scree ni n g a n d b aseli ne visits . 
5.   
A D i n v ol ve me nt ≥ 1 0 % of B S A  at b ot h scree ni n g a n d b aseli ne visits . 
6.   
Pea k ( ma xi m u m) pr urit us  N R S sc ore of at least 4 . 0 at b ot h screeni n g a n d b aseli ne visits:  
•  
 
 
 
 
 
 
 
7.   
D oc u me nte d rece nt h ist or y ( wit hi n 6 m o nt hs bef ore t he scree ni n g visit) of i na de q uate 
res p o nse t o t o pical me dicati o ns ( T C S wit h or wit h o ut T CI). 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
. 
  
 
 
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8.   
A gree t o a p pl y a m oist urizer t hr o u g h o ut t he st u d y fr o m t he scree ni n g visit  dail y, a n d 
li berall y as nee d e d; a gree t o a p pl y a n a ut h orize d T C S fr o m t he scree ni n g visit a n d 
t hr o u g h o ut t he st u d y as deter mi ne d a p pr o priate b y t he i n vesti gat or. 
9.   
W o me n  of c hil d beari n g p ote ntial m ust a gree eit h er t o be strictl y a bsti ne nt t hr o u g h o ut t he 
st u d y a n d f or 1 2 wee ks  after t he last st u d y dr u g i njecti o n or t o use a n effecti ve a n d 
a p pr o ve d met h o d of c o ntrace pti o n t hr o u g h o ut t he st u d y a n d f or 1 2 wee ks  after t he last 
st u d y dr u g i njecti o n. T his criteri o n als o a p plies t o a pre p u bertal fe m ale s u bject w h o be gi ns 
me nses d uri n g t he st u d y.  
  
 Effecti ve a n d a p pr o ve d met h o ds of c o ntrace pti o n a p plica ble f or t he s u bject a n d/ or t heir 
part ner are d efi ne d b el o w:  
•  Pr o gest o ge n -o nl y oral h or m o nal c o ntrace pti o n  
•  Male or fe m ale c o n d o m  
•  Ca p, dia p hra g m , or s p o n ge wit h s per mici de  
•  C o m bi nati o n of male or fe male c o n d o m wit h ca p, dia p hra g m , or s p o n ge wit h s per mici 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 -) oral, i ntra v a gi nal, or tra ns der mal 
h or m o nal c o ntrace pti o n  
•  I njecta ble or i m pla nte d h or m o nal c o ntrace pti o n 
•  I ntr a uteri ne de vices 
1 0.  
S u bject a n d g uar dia n willi n g a n d a ble t o c o m pl y wit h all of t he ti me c o m mit me nts a n d 
pr oce d ural re q uir e me nts of t he cli nical trial pr ot oc ol , i ncl u di n g dail y dia r y rec or di n gs b y 
t he s u bject usi n g a n electr o nic ha n d hel d de vi ce pr o vi de d f or t his st u d y. 
1 1.  
U n dersta n d a n d si g n a n I nf or me d C o nse nt F or m (I C F) a n d Asse nt F or m b ef ore  a n y 
i n vesti gati o nal pr oce d ures bei n g perf or m e d. 
 
E xcl usi o n criteria:  
1.   
B o d y wei g ht <  3 0 k g .  
2.   
S u bjects meeti n g o ne or m ore of t he f oll o wi n g criteria at scree ni n g or b aseli ne: 
2a.  Ha d a n ast h ma e xacer bati o n re q uiri n g h os pitalizati o n i n t he prece di n g  1 2 m o nt hs . 
2 b.  Re p orti n g ast h ma t hat has n ot bee n well -c o ntr olle d (ie, s y m pt o ms > 2 da ys per wee k, 
ni g htti me a wa ke ni n gs > 1 -3 ti mes per wee k, or s o me i nterfere n ce wit h n or mal 
acti vities) d uri n g t he prece di n g  3 m o nt hs.  
2c.  Ast h ma C o ntr ol T est ≤ 1 9 (a p plies o nl y f or s u bjects wit h a hist or y of ast h ma). 
2 d.  Pea k e x pirat or y fl o w ( P E F) < 8 0 % of t he pre dicte d val ue . 
3.   
S u bjects wit h a c urre nt m e dical hist or y of c hr o nic o bstr ucti ve p ul m o nar y disease ( C O P D) 
a n d/ or c hr o nic br o nc hitis.  
 
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4.   
C uta ne o us i nfecti o n wit hi n 1 wee k bef ore  t he scree ni n g visit or a n y i nfecti o n re q uiri n g 
treat me nt wit h oral or p are nteral a nti bi otics, a nti virals, a nti parasitics, or a ntif u n gals wit hi n 
1 wee k bef ore t h e scree ni n g visit. S u bjects ma y be rescree ne d o n ce t he i nfecti o n has 
res ol ve d.  
5.   
Re q uiri n g resc u e t h era p y f or A D d uri n g t he r u n -i n peri o d, or e x p ecte d t o re q uire resc u e 
t hera p y wit hi n 2 wee ks f oll o wi n g t he b aseli ne visit . 
6.   
P ositi ve ser ol o g y res ults f or he patitis B s urface a nti ge n [ H Bs A g] or he p atitis B c ore 
a nti b o d y [ H Bc A b ], he patitis C a nti b o d y, or h u ma n i m m u n o deficie nc y vir us [ HI V] 
a nti b o d y at t he scree ni n g visit; 
N ote : S u bjects wit h a p ositi ve H Bc A b a n d a ne g ati ve H Bs A g ca n b e i ncl u de d i n t his 
cli nical trial if he patitis B s urface a nti b o d y ( H Bs A b ) is p ositi ve (c o nsi dere d i m m u ne after a 
nat ural i nfecti o n).  
7.   
Ha vi n g recei ve d a n y of t he f oll o wi n g treat me nts i n Ta ble  3  wit hi n t he s pecifie d ti mefra me 
bef ore  t h e b aseli ne visi t: 
T a ble  3 :  
Pri or Tre at me nts  
Tre at m e nt(s):  
Ti mefr a m e  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
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Tre at m e nt(s):  
Ti mefr a m e  
 
 
 
 
N ote: T hese treat me nts s h o ul d n ot be disc o nti n ue d f or reas o ns relate d t o t his cli nical st u d y.  
8.   
S u bjects w h o faile d t o res p o n d cli nic all y t o pre vi o us treat me nt wit h a bi ol o gic ( e g, 
d u pil u ma b) or a J A K i n hi bit or .  
9.   
Pre g na nt w o me n ( p ositi ve ser u m pre g n a nc y test res ult at t he scree ni n g visit or p ositi ve 
uri ne pre g n a nc y test at t h e b aseli ne visit), breastfee di n g w o me n, or w o me n pla n ni n g a 
pr e g na nc y d uri n g t he cli nical trial .  
1 0.  
Hist or y of l y m p h o pr oliferati ve disease or hist or y of mali g na nc y of a n y or g a n s yste m 
wit hi n t he last 5 years, e x ce pt f or ( 1) basal cell carci n o ma, acti nic kerat oses or s q ua m o us 
cell carci n o ma i n sit u ( B o we n’s diseas e) t hat ha ve bee n treate d a n d ha ve n o e vi d e nce of 
rec urre nce i n t he last 5 2 wee ks bef ore t he b aseli n e visit, or ( 2) carci n o ma i n sit u of t he 
cer vi x.  
1 1.  
Hist or y of h y perse nsiti vit y (i ncl u di n g a na p h yla xis) t o a n i m m u n o gl o b uli n pr o d uct (plas ma -
deri ve d or rec o m bi na nt , e g, m o n ocl o nal a nti b o d y)  or t o a n y of t he st u d y dr u g e xci pie nts . 
1 2.  
Hist or y of i nt olera nce t o l o w or mi d p ote nc y T C S or f or w h o m T C S is n ot a d visa ble ( e g, 
h y perse nsiti vit y t o T C S, si g nifica nt s ki n atr o p h y , etc). 
1 3.  
K n o w n acti ve or late nt t u berc ul osis ( T B) i nfecti o n. 
1 4.  
K n o w n or s us pect e d i m m u n os u p pressi o n  or u n us uall y fre q ue nt, rec urre nt, se vere, or 
pr ol o n ge d i nfecti o ns as p er i n vesti gat or j u d g me nt . 
1 5.  
Hist o r y of or c urre nt c o nf o u n di n g s ki n c o n diti o n (e g, Net hert o n sy n dr o me, ps oriasis, 
cuta ne o us T -cell ly m p h o ma [ m yc osis fu n g oi des or Sezar y sy n dr o me], c o ntact der matitis, 
c hr o nic acti nic der matitis, der matitis her petif or mis) .  
1 6.  
A n y me dical or ps yc h ol o gical c o n di ti o n or a n y cli nicall y rele va nt la b orat or y a b n or malities, 
s uc h as b ut n ot li mite d t o ele vate d A L T or A S T ( > 3 × u p per li mit of n or mal [ U L N ]) i n 
c o m bi nati o n wit h ele vate d bilir u bi n ( > 2 × U L N), at t he scree ni n g visit t hat ma y p ut t he 
s u bject at si g nifica nt ris k acc or di n g t o t he i n vesti g at or’s j u d g me nt if he/s he partici pates i n 
t he cli nical trial, or ma y i nterfere wit h st u d y assess me nts (e g, p o or ve n o us access or 
nee dle -p h o bia) . 
1 7.  
Pla n ne d or e x pecte d maj or s ur gical pr oce d ure d uri n g t he cli nical trial . 
1 8.  
S u bjects u n willi n g t o refrai n fr o m usi n g pr o hi bite d me dicati o ns d uri n g t he cli nical trial 
(see Secti o n  7. 5. 8. 2 ). 
 
C urre ntl y partici pati n g i n a n y ot h er cli nical trial of a dr u g or de vice, p artici pate d i n a cli nical trial 
wit hi n t he past 3 m o nt hs bef ore  t he scree ni n g visit, or is i n a n e xcl usi o n peri o d (if verifi a ble) fr o m 
a pre vi o us cli nical trial . 
 
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Pri m ar y E n d p oi nt(s):  
▪ P har mac o ki neti cs ( P K): 
•  Ne m oliz u ma b ser u m c o n ce ntrati o ns at b as eli ne, Wee ks 1 -2, 4, 8, 1 2, 1 6 , 24  a n d u nsc he d ule d 
visits f or safet y reas o ns  
•  Ne m oliz u ma b  ser u m P K para met ers at stea d y state e xtra p olat e d wit h a p o p ulati o n P K 
a nal ysis (Cl/ F, V d/ F, Tla g, ka, C ma x , T ma x , Ctr o u g h, A U C0 -4 w , A U C 0 -8 w, A U C 0 -1 2 w, A U C0 -1 6 w, a n d 
t1/ 2) 
▪ I m m u no ge nicit y:  
•  A nti -dr u g a nti b o d y ( A D A) assess me nts ( scree ni n g, c o nfir mat or y, N A b),  at b aseli ne, W ee ks 
4, 8, 1 6 , 2 4 , a n d unsc he d ule d visits f or safet y reas o ns  
▪ Safet y:  
•  I n ci de nce of a d verse e ve nts, i ncl u di n g treat me nt-e mer ge nt a d verse e ve nts ( T E A Es) , a d verse 
e ve nt of s pecial i nterests ( A E SI)  a n d s eri o us a d verse e ve nts ( S A Es) 
•  Ast h ma C o ntr ol Test ( A C T): Scree ni n g, b aseli ne, 
Wee ks 1 -2, 4, 8, 1 2, 1 6, 2 4, a n d 
u nsc he d ule d visit s 
•  P h ysical e xa mi nati o n: C ha n ge fr o m b aseli ne at all visits  
•  Vital si g ns: C ha n ge fr o m b aseli ne at all visits  
•  Cli nical la b orat or y val u es: C ha n ge fr o m b aseli ne at  Wee ks 4, 8, 1 2, 1 6, 2 4 a n d u nsc he d ul e d 
visits f or safet y reas o ns  
•  S pir o metr y ( P E F): C ha n ge fr o m b aseli ne at all visits 
•  Electr ocar di o gra m ( E C G): C ha n ge fr o m scree ni n g at Wee k 1 6 a n d u nsc h e d ule d visits f or 
safet y reas o ns 
Sec o n d ar y E n d p oi nt(s):  
▪ P har mac o ki netics :  
•  Ne m oliz u ma b ser u m P K para meters calc ul ate d wit h a n o n -c o m part me ntal a nal ysis ( N C A ): 
A U C 0 -4 w , A U C0 -8 w, A U C 0 -1 2 w, a n d A U C 0 -1 6 w 
▪ P har mac o d y na mics ( P D):  
•  Bl o o d bi o mar kers (e g, t h y m us a n d acti vati o n-re g ulate d c h e m o ki ne [ T A R C], I L-3 1 a n d/ or 
ot her pr otei ns ) at b aseli ne, Wee k 8, a n d Wee k 1 6    
•  Strat u m c or ne u m bi o mar kers (e g, I L -3 1 a n d/ or ot her pr otei ns ) at b aseli ne a n d Wee k 1 6  
▪ Efficac y : 
•  A bs ol ute a n d perce nt c ha n ge i n E A SI s c ore fr o m b aseli ne t o Wee k 1 6  
•  I G A s uccess rat e fr o m b aseli ne t o W ee k 16  
•  C ha n ge i n B S A i n v ol ve me nt of A D, re p orte d as a perce nta ge of all maj or b o d y secti o ns 
c o m bi ne d  
 
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•  A bs ol ute a n d perce nt c h a n ge i n wee kl y a vera g e of pea k pr urit us N R S sc ore fr o m b aseli ne t o 
W ee k 16   
•  A bs ol ute a n d perce nt c h a n ge i n wee kl y a v era ge of a vera g e pr urit us N R S sc ore fr o m b aseli ne 
t o W ee k 1 6  
•  A bs ol ute a n d perce nt c h a n ge i n  wee kl y  slee p dist ur ba nce N R S sc ore fr o m b aseli ne t o W ee k 
1 6  
•  Perce nt c ha n ge i n S C O Ri n g At o pic Der matitis ( S C O R A D) sc ore fr o m b as eli ne t o W ee k 16  
•  N u m ber  of t o pical A D me dicati o n -free d a ys  
▪ Q ualit y  o f Life ( Q o L) Assess me nt Res ults : 
•  Der mat ol o g y Life Q ualit y I n de x ( D L QI) f or s u bjects >  1 6  years of a ge  or c hil dre n’s D L QI 
f or s u bjects 1 2 -1 6  y ears of a ge  at b aseli ne a n d W ee k 1 6  
St atistic al A n al ysis : 
T he fi nal statistical a nal ysis will i ncl u de all s u bj ects w h o ha ve c o m plete d t he st u d y. A n i nteri m 
a nal ysis f oc use d o n P K a n d safet y will be perf or me d after a p pr o xi mat el y 1 0 s u bjects ha ve 
c o m plete d t he Wee k 8 visit  as t he basis t o all o w recr uit me nt of  a d olesce nt s u bjects i n t he pla n ne d 
P hase 3 pi v otal st u dies.  
P K a nal ysis :  
•  P o p ulati o n para meters at stea d y state ( Cl/ F, V d/ F, Tla g, ka, C ma x , T ma x , Ctr o u g h, A U C0 -4 w , 
A U C 0 -8 w, A U C0 -1 2 w, A U C 0 -1 6 w, a n d t 1/ 2) will be e xtra p olate d wit h a n o n-li near mi xe d effect 
m o deli n g a p pr oac h. T he pre -s pecifie d p o p ulati o n P K m o del base d o n e xisti n g i nf or mati o n 
fr o m pre vi o us st u dies i n a d ults will be use d t o deri ve e m pirical Ba y es esti mates i n t he 
a d olesce nt p o p ulati o n ba se d o n t heir baseli ne c haracteristics, t heir d osi n g hist or y a n d t heir 
meas ure d c o nce ntr ati o ns.  
•  S o me i n di vi d ual P K para meters (A U C 0 -4 w , A U C 0 -8 w , A U C0 -1 2 w , A U C 0 -1 6 w) will als o be 
deri ve d usi n g a n  N C A . 
•  Descri pti ve statistics o n ne m oliz u ma b  ser u m c o nce ntrati o ns will be pr o vi de d per ti me p oi nt.  
•  Descri pti ve statistics o n i n di vi d ual N C A -deri ve d P K para meters will be pr o vi de d . 
•  A c o m paris o n of t he a vera ge tr o u g h ( C tr o u g h) ne m oliz u ma b c o nce ntrati o n bet wee n A D A + 
sa m ples a n d A D A- sa m ples will be pr ovi de d. Det ails will be defi ne d i n t he S A P . 
Safet y a nal ysis : Des cri pti ve s u m maries of t he fre q ue nc y a n d se verit y of T E A Es, A E SIs a n d S A Es.   
E x p os ure -res p o nse ( E/ R) a nal ysis: p har mac o ki netic p har mac o d y n a mics ( P K P D ) a nal ysis will be 
d o ne usi n g t he st ea d y state C tr o u g h n e m oliz u ma b pre dicte d c o nce ntrati o n as t he e x p os ure v aria bl e 
a n d efficac y sec o n dar y e n d p oi nts  as c o nfir m e d b y m o deli n g  (e g, c ha n g e fr o m b aseli ne  i n E A SI, 
I G A, pea k a n d a v era g e pr urit us N R S , etc)  
A d diti o nall y, t he f oll o wi n g data will be s u m marize d descri pti vel y:  
•  De m o gra p hic a n d b aseli n e c haracteristics  
•  P h ysical e xa mi nati o n a n d vital si g ns  
 
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•  La b orat or y p ara m eters  
•  A d verse e ve nts  
•  Efficac y a n d Q o L p ara m eters  
•  P D e n d p oi nts  
Sa m ple size ass u m pti o n : 
Base d o n t he varia bilit y of n e m oliz u ma b ser u m c o nce ntrati o ns ( o bser ve d i n a d ults d uri n g pre vi o us 
st u dies), a sa m ple size of ~ 2 0 was c o nsi der ed s ufficie nt t o calc ulate P K para meters  wit h a de q u ate 
precisi o n  a n d t o e ns ure a de q uate re pres e ntati o n ac r oss t he a d olesce nt a ge ra n g e. N o f or mal 
p o weri n g of t he trial was perf or me d t o d eter mi ne sa m ple size re q ui re me nt. 
T he st u d y will atte m pt t o e nr ol l at least 3 s u bjects wit h l o w b o d y wei g ht ( ≤ 6 1  k g) f or t he i nteri m 
a nal ysis a n d a p pr o xi mat el y 6 t otal s u bjects wit h l o w b o d y wei g ht f o r t he o v erall st u d y p o p ulati o n. 
 
 
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4   
List of A b bre vi ati o ns  
A A D  
A merica n Aca de m y of Der mat ol o g y  
A C T  
ast h ma c o ntr ol test  
A D  
at o pic der matitis  
A D A  
a nti -dr u g a nti b o d y  
A E  
ad verse e ve nt  
A E SI  
a d verse e ve nt of s pecial i nterest  
A L T  
ala ni ne a mi n otra nsferase  
A S T  
as partate a mi n otra nsferase 
A U C  
area u n der t he c ur ve  
B C G  
bacille Cal mette -G u éri n  
B L Q  
b el o w t he li mit of q ua ntificati o n  
B P  
b l o o d press ure 
B S A  
b o d y s urface area  
B U N  
b l o o d urea nitr o ge n 
c D L QI  
C hil dre n’s Der mat ol o g y Life Q ualit y I n de x  
CI  
co nfi de nce i nter val  
C ma x  
ma xi m u m dr u g c o nce ntrati o n  
C O P D  
c hr o nic o bstr ucti ve p ul m o nar y disease  
C P K  
creati ni ne p h os p h o ki nase  
C R F  
case re p ort f or m  
C R O  
co ntract researc h or ga n izati o n 
C tr o u g h 
c o nce ntrati o n bef ore d osi n g  
C Y P 4 5 0   
cyt oc hr o me P 4 5 0  
D L QI  
Der mat ol o g y Life Q ualit y I n de x  
E A SI  
Ecze ma Area a n d Se verit y I n de x  
E C G  
electr ocar di o gra m 
E D C  
electr o nic data ca pt ure 
E LI S A  
e nz y me -li n ke d i m m u n os or be nt assa y 
F D A  
F o o d a n d Dr u g A d mi nistrati o n  
G C P  
G o o d Cli nical Practice  
G G T  
g a m ma gl uta m yltra nsferase  
H Bc A b   
h e patitis B core anti b o d y  
H B sA b   
h e patitis B surface anti b o d y  
H B sA g   
h e patitis B s urface a nti ge n  
H D L  
hi g h -de nsit y li p o pr otei 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 of 1 9 9 6  
HI V  
h u ma n i m m u n o deficie nc y vir us 
I B 
I n vesti gat or’s Br oc h ure 
I C F 
inf or me d c o nse nt f or m  
I C H 
I nter nati o nal C o u ncil f or  Har m o ni sati o n of 
Tec h nical 
Re q uire me nts f or 
P har mace uticals f or H u ma n Use  
I D M C 
I n de pe n de nt Data M o nit ori n g C o m mittee 
I E C 
in de pe n de nt et hics co m mittee  
I G A 
I n vesti gat or’s Gl o bal Assess me nt 
I g G 
i m m u n o gl o b uli n G 
I g E 
i m m u n o gl o b uli n E 
I L 
i nterle u ki n 
I R B 
instit uti o nal re vie w b oar d  
I R R 
injecti o n -relate d reacti o n 
 
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I S R 
injecti o n site reacti o n  
I T T 
inte nt -t o-treat 
J A K 
Ja n us ki nase 
L D H  
lactate de h y dr o ge nase  
L D L  
l o w-de nsit y li p o pr otei n  
L O C F  
last o bser vati o n carrie d for war d  
L T E  
l o n g-ter m e xte nsi o n (st u d y) 
M C V  
mea n cell v ol u me  
Me d D R A   
Me dical Dicti o nar y f or Re g ulat or y Acti vities  
mi R N A   
m icr o ri b o n ucleic aci d 
m R N A  
m esse n ger ri b o n ucleic aci d 
n  
n u m ber of s u bjects wit h a n o bser vati o n  
N  
n u m ber of s u bjects i n t he dataset or p o p ulati o n  
N A b  
n e utralizi n g a nti b o d y  
N C A  
N R S  
n o n -c o m part me ntal  anal ysis  
n u meric rati n g scale 
O C  
o bser ve case 
P D  
p har mac o d y na mic  
P E F  
p ea k ex pirat or y fl o w 
P K  
p har mac o ki netic  
P P N R S   
p ea k p r urit us n u meric rati n g scale 
P R N  
pr o re nata ( w he n necessar y  or  as nee de d) 
Q 4 W  
ever y 4 wee ks  
Q 8 W  
ever y 8 wee ks  
Q o L  
q ualit y of life 
R A  
Rece pt or A  
R B C  
re d bl o o d cell 
R N A  
ri b o n ucleic aci d 
R S E  
relati ve sta n dar d err or 
S A E  
seri o us a d verse e ve nt  
S A P  
Statistical A nal ysis Pla n  
S C O R A D   
S C O Ri n g at o pic d er matitis 
S D  
sta n dar d de viati o n 
SI N  
su bject ide ntificati o n n u m ber  
S O P  
sta n dar d o perati n g pr oce d ure 
S U S A R   
s us pecte d u ne x pecte d seri o us a d verse reacti o n 
t1/ 2 
half -life 
T A R C  
t h y m us a n d acti vati o n-re g ulate d c he m o ki ne 
T B  
tu berc ul osis  
T CI  
to pical calci ne uri n in hi bit or  
T C S  
to pical cortic oster oi d  
T E A E  
treat me nt-e mer ge nt ad verse eve nt  
T h 2  
ty pe 2 hel per T cell  
T ma x  
ti me t o ma xi m u m c o nce ntrati o n 
U L N  
u p per li mit of n or mal  
U P T  
u ri ne p re g na nc y test 
V A S  
v is ual a nal o g ue scale 
W B C  
w hite bl o o d cell  
W H O  
W orl d Healt h Or ga nizati o n  
 
 
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Se veral bi ol o gical a g e nts are c urre ntl y b ei n g use d or de vel o p e d f or t he treat me nt of A D. 
 
 
 
 
Ne m oliz u ma b, a h u ma nize d a nti -h u ma n I L -3 1 rece pt or A ( R A) m o n ocl o nal a nti b o d y, i n hi bits t he 
bi n di n g of I L -3 1 t o I L -3 1 R A a n d s u bse q ue nt si g nal tra ns d ucti o n. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
I n c o ncl usi o n, n e m oliz u ma b ma y prese nt a ne w treat me nt o pti o n f or A D i n pe diatric as well as 
a d ult patie nts.
 
 T he mai n o bjecti ve of t he st u d y is t o assess t he P K 
pr ofile a n d safet y of ne m oliz u ma b , a d mi nistere d c o nc o mita ntl y  wit h bac k gr o u n d T C S, i n 
a d olesce nt s u bjects wit h m o derate -t o-s e vere A D a n d ass ociate d pr urit us w h o are n ot a de q u atel y 
c o ntr olle d wit h t o pical treat me nts . A si milar P K a n d safet y pr ofile c o m pare d t o pre vi o us st u dies 
c o n d ucte d i n a d ults will s u p p ort t he e nroll me nt of a d olesce nt s u bjects i n t he pla n ne d ne m oliz u ma b 
P hase 3 st u dies.  
5. 2   
Cli nic al S t u dies 
T he I n vesti gat or’s Br oc h ure (I B) c o ntai ns det aile d i nf or mati o n o n cli nical a n d n o n -cli nical st u dies. 
  
 
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T he safet y a n d efficac y data ge nerate d i n t he P hase 2 b d ose -fi n di n g st u d y s u p p orte d t he selecti o n 
of t he 3 0-m g d ose as t he treat me nt d ose f or t he P hase 3  st u dies. 
Base d o n t he safet y data fr o m t he 3 c o m plete d st u die s, n o a d diti o nal ris ks f or ne m oliz u ma b ha v e 
bee n i de ntifie d. 
 
  
5. 3   
Ris k/ Be nefit Assess m e nt  
T o pical me dicati o ns are t he mai nsta y of A D t hera p y . Treat me nt o pti o ns are, h o we ver , li mite d f or 
patie nts wit h m o derate -t o-se vere A D w h ose disease ca n n ot be a de q u atel y c o ntr olle d wit h t o pical 
me dicati o ns.   
Res ults of pre vi o us cli nical st u dies i n a d ults de m o nstrate d t hat treat me nt wit h ne m oliz u ma b ha d a 
ma r ke d effect o n A D , pr urit us, a n d pr urit us-relat e d slee p l oss. 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 Resc ue t hera p y, i ncl u di n g t o pical a n d s yste mic 
treat me nts or p h ot ot hera p y, ma y be pr o vi de d i n t he c urre nt st u d y as j u d ge d a p pr o priate b y t he 
i n vesti gat or. 
 
 
 
 
 
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b)  T he e xcl usi o n criteria of t his cli nical trial (ie, restricti n g e ntr y of s u bjects wit h rece nt/c urre nt 
i nfecti o ns or k n o w n/s us p ecte d i m m u n os u p pressi o n  or u n us uall y fre q u e nt, rec urre nt, se vere, 
or pr ol o n ge d i nfecti o ns as per i n vesti gat or j u d g me nt ) will pre ve nt n o n -eli gi ble patie nts fr o m 
recei vi n g ne m oliz u ma b. As n o data are a v aila ble i n pre g na nt or breastf ee di n g w o me n, t hese 
patie n ts are n ot eli gi ble f or t his st u d y. 
 
 
 
 
 
 
 
 
 
 
 
 
 
d)  As  ne m oliz u ma b has n ot  bee n e v al uate d i n pe diatric p o p ulati o ns, i ncl u di n g a d olesce nts, 
safet y will be e v al uate d cl osel y t hr o u g h o ut t he st u d y, 
 
 
.  
 
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e)  A n I D M C will m o nit or t he safet y d ata re g ul arl y t hr o u g h o ut t he st u d y, i ncl u di n g A E SIs, 
w hic h were defi n e d base d o n t he c urre ntl y a vaila ble safet y i nf or m ati o n o n ne m oliz u ma b a n d 
t he ris ks ass ociate d wit h bi ol o gic a ge nts i n ge neral: 
•  I RRs  
− A na p h ylactic reacti o ns  
− Ac ute aller gi c reacti o ns re q uiri n g treat me nt  
− Se vere i njecti o n site reacti o n (I S R)  (ie, lasti n g > 2 4 h o urs) 
•  Ne wl y -dia g n ose d ast h ma or w orse ni n g of ast h ma  
•  I nfecti o ns 
− A n y se vere i nf ecti o n, or a n y i nfecti o n re q uiri n g treat me nt wit h pa re nteral a nti bi otics, or 
wit h oral a nti bi otics /a nti virals/a ntif u n gals f or > 2 wee ks  
•  Peri p heral e d e ma: li m bs, bilateral 
•  Faci al  e de ma  
•  Ele vate d A L T or A S T ( > 3 × U L N) i n c o m bi nati o n wit h ele vate d bilir u bi n ( >  2  ×  U L N)  
I n c o n cl usi o n, w he n ta ki n g i nt o c o nsi derati o n t he c urre ntl y a vaila bl e data of ne m oliz u ma b a n d t he 
ris k-mi ni mizati o n a p pr oac hes t o b e i m ple me nt e d, t he be n efit /ris k rati o of ne m oliz u ma b is 
c o nsi dere d t o be fa v ora bl e i n t his st u d y.  
5. 4   
Dr u g Pr ofile  
Ne m oliz u ma b is  a h u ma nize d 
m o n ocl o nal 
m o difie d i m m u n o gl o b uli n G (I g G) 2 a nti b o d y 
c o m prisi n g a str uct ure of 2  H -c hai ns ( 4 4 5 a mi n o aci d resi d ues) a n d 2  L -c hai ns ( 2 1 4 a mi n o aci d 
resi d ues) c o n necte d b y 1 6 dis ulfi de b o n ds. 
 
 
 
 
 
5. 5   
D ose Selecti o n R ati o n al e  
Base d o n t he o utc o me of t he P hase 2 b d ose -ra n gi n g st u d y, t he 3 0-m g d ose ( wit h 6 0 -m g l oa di n g 
d ose) pr o vi d e d t he best b e nefit /ris k rati o of t h e 3 d ose s e val u ate d, a n d is t heref ore select e d as t h e 
fi nal d ose t o be de v el o pe d f or t he treat me nt of A D . 
 
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6   
St u d y O bjecti ves  & E n d p oi nts  
6. 1   
Pri m ar y O bjecti ve  
T he pri mar y o bjecti ve of t he st u d y is  to assess t he P K a n d safet y of ne m oliz u ma b  i n a d olesce nt 
s u bjects wit h m o derate-t o-se vere A D a n d ass ociate d pr urit us n ot a de q uatel y c o ntr olle d wit h 
t o pical treat me nts, w he n a d mi nistere d c o nc o mita ntl y wit h T C S. 
6. 2   
Pri m ar y E n d p oi nts  
6. 2. 1   
P h ar m ac o ki netics  
•  Ne m oliz u ma b ser u m c o n ce ntrati o ns at b as eli ne, W ee ks 1-2, 4, 8, 1 2, 1 6, 2 4 a n d u nsc he d ule d 
visits f or safet y reas o ns  
•  Ne m oliz u ma b ser u m P K para met ers at stea d y state e xtra p olat e d wit h a p o p ulati o n P K 
a nal ysis (Cl/ F, V d/ F, Tla g, ka, C ma x , T ma x , Ctr o u g h, A U C0 -4 w, A U C0 -8 w, A U C 0 -1 2 w, A U C0 -1 6 w, a n d 
t1/ 2) 
6. 2. 2   
I m m u n o ge nicit y 
•  A D A ass ess me nts ( scree ni n g, c o nfir m at or y, N A b), at b aseli ne, 
Wee ks 4, 8, 1 6 , 2 4  a n d 
u nsc he d ule d visits f or safet y reas o ns  
6. 2. 3   
S afet y  
•  I n ci de nce of ad v erse e ve nts , i ncl u di n g T E A Es, A E SIs a n d S A Es  
•  Ast h ma C o ntr ol Test: Scree ni n g, b aseli ne, Wee ks 1 -2, 4, 8, 1 2, 1 6, 2 4, a n d u nsc h e d ule d 
visit s 
•  P h ysical e xa mi nati o n: C ha n ge fr o m b aseli ne at all visits  
•  Vital si g ns: C ha n ge fr o m b aseli ne at all visits  
•  Cli nical la b orat or y val u es: C ha n ge fr o m b aseli ne at W ee ks 4, 8, 1 2, 1 6, 2 4 a n d u nsc he d ul e d  
visits f or safet y reas o ns  
•  S pir o metr y ( P E F): C ha n ge fr o m b aseli ne at all visits 
•  Electr ocar di o gra m ( E C G): C ha n ge fr o m scree ni n g at W ee k 16  a n d u nsc h e d ule d visits f or 
safet y reas o ns 
6. 3   
Sec o n d ar y O bjecti ve  
T he sec o n d ar y o bjecti ve of t he st u d y is t o e val uate t he efficac y of ne m oliz u ma b a n d t o f urt her 
c haracteri ze t he relati o ns hi p bet wee n n e m oliz u ma b c o nce ntrati o ns a n d cli ni cal efficac y e n d p oi nts.  
 
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6. 4   
Sec o n d ar y E n d p oi nts  
6. 4. 1   
P h ar m ac o ki netics   
•  Ne m oliz u ma b  ser u m P K para meters calc ul ate d wit h an  N C A : A U C0 -4 w, A U C0 -8 w, A U C 0 -1 2 w, 
a n d A U C 0 -1 6 w 
6. 4. 2   
P h ar m ac o d y n a mics  
•  Bl o o d  bi o mar kers ( e g, I L-3 1 , T A R C a n d/ or ot her pr otei ns ) at b aseli ne, Wee k 8, a n d Wee k 
1 6    
•  Strat u m c or ne u m bi o mar kers (e g, I L -3 1 a n d/ or ot her pr otei ns ) at b aseli ne a n d Wee k 1 6  
6. 4. 3   
Effic ac y  
•  A bs ol ute a n d perce nt c ha n ge i n E A SI s c ore fr o m b aseli ne t o Wee k 1 6  
•  I G A s uccess rat e fr o m b aseli ne t o Wee k 1 6  
•  C ha n ge i n B S A i n v ol ve me nt of A D, re p orte d as a perce nta ge of all maj or b o d y secti o ns 
c o m bi ne d  
•  A bs ol ute a n d perce n t c h a n ge i n wee kl y a vera g e of pea k pr urit us N R S sc ore fr o m b aseli ne t o 
Wee k  1 6  
•  A bs ol ute a n d perce nt c h a n ge i n wee kl y a v era ge of a vera g e pr urit us N R S sc ore fr o m b aseli ne 
t o Wee k 1 6 
•  A bs ol ute a n d p erce nt c ha n ge i n wee kl y slee p dist ur ba nce N R S sc ore fr o m b as eli ne t o 
Wee k  1 6  
•  Perce nt c ha n ge i n S C O R A D  sc ore fr o m b as eli ne t o Wee k 1 6  
•  N u m ber  of t o pical A D me dicati o n -free d a ys  
6. 4. 4   
Q u alit y of Life Assess me nt  
•  D er mat ol o g y Life Q ualit y I n de x  f or s u bjects >  1 6 years of a ge or c hil dre n’s D L QI  (c D L QI) 
f or s u bjects 1 2 -1 6 y ears of a ge at b aseli ne a n d Wee k 1 6  
 
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7   
I n vesti g ati o n al Pl a n 
7. 1   
O ver all St u d y Desi g n a n d Pl a n : Descri pti o n 
T his is a n o pe n -la bel, si n gle-gr o u p st u d y t o e val uate t he P K a n d safet y of 3 0 m g of ne m oliz u ma b 
i n a d olesce nt s u bjects ( 1 2 t o 1 7 years of a ge ), wit h m o derate-t o-s e vere A D a n d ass ociate d pr urit us. 
A p pr o xi matel y 2 0 eli gi ble s u bjects will be e nr olle d t o recei ve s u bc uta ne o us i njecti o ns of 
ne m oliz u ma b ( 3 0  m g) e v er y 4 wee ks  o ver a 1 6 -wee k treat me nt peri o d , wit h a l oa di n g d ose of 6 0 
m g o n Da y 1.  
Eli gi ble s u bjects m ust als o ha ve a d o c u me nte d hist or y of i na de q uat e res p o nse t o t o pical A D 
me dicati o ns. S u bjects meeti n g t he eli gi bilit y  criteria at t he scree ni n g visit will i nitiate ( or c o nti n ue) 
use of a m oist urizer a n d a ut h orize d bac k gr o u n d T C S  (i ncl u di n g a me di u m p ote nc y T C S f or t he 
b o d y a n d l o w p ote nc y T C S f or T C S -se nsiti ve areas s uc h as t he face, nec k, i ntertri gi n o us areas, 
etc), a n d acc or di n g t o g ui deli nes i n Secti o n  7. 5. 8. 1  f or use t hr o u g h o ut t he st u d y. Use of a ut h orize d 
bac k gr o u n d t hera p y is re q uire d f or at least 1 4 da ys bef ore  b aseli ne/ Da y 1 as s u bjects c o m plet e 
dail y assess me nts of pr urit u s, t o c o nfir m eli gi bilit y. S u bjects w h o c o nti n ue t o meet t he eli gi bilit y  
criteria at t he b as eli ne visit will be e nr olle d i n t he st u d y. 
 
 
 
Fi g ure  2  pr o vi des a n o v er vie w of t he o p e n -la bel st u d y desi g n. S u bjects will be scree ne d a n d 
c o m plete a r u n -i n peri o d of at least 1 4 da ys b ef ore  t he b aseli ne visit . Eli gi ble s u bjects will e nter a 
1 6 -we e k tr eat me nt peri o d wit h ne m oliz u ma b 3 0 m g a d mi nistere d s u bc uta ne o usl y e ver y 4 wee ks, 
wit h a l oa di n g d ose of 6 0 m g at b aseli ne/ Da y 1. T he fi nal d ose of st u d y dr u g will occ ur at Wee k 
1 2 a n d s u bjects will c o m plete t he treat me nt peri o d at t he Wee k 1 6 visit. 
 
 
 
T he sc he d ule of assess me nts is s u m marize d i n Secti o n  7. 2 . Assess me nts of PK, safet y, a n d efficac y 
will be c o n d ucte d t hr o u g h o ut t he st u d y. Patie nt -re p orte d assess me nts of pr urit us, slee p dist ur ba nce 
a n d t he use of t o pical A D me dicati o n f or t he s u bj ects’  ecze m a will be c ollecte d dail y.  
A n i nteri m a nal ysis is pla n ne d after a p pr o xi matel y 1 0 s u bjects c o m plete t he Wee k 8 visit. T he 
st u d y will atte m pt t o e nr oll at least 3 s u bjects wit h a l o w b o d y wei g ht ( ≤ 6 1  k g ) f or t he i nteri m 
a nal ysis a n d a p pr o xi mat el y 6 t otal s u bjects wit h l o w b o d y wei g ht f or t he o v erall st u d y p o p ulati o n, 
wit h i n v esti gat ors atte m pti n g t o e nr oll  s u bjects at t he l o wer a g e ra n ge ( 1 2-1 4 years ol d).  T h e 
i nteri m a nal ysis  will assess w het her t h e o bser ve d s afet y a n d P K data fr o m a d olesce nts are si milar 
t o t he data o btai ne d i n a d ults, w hic h is t he basis f or all o wi n g recr uit me nt of a d olesce nt s u bjects 
i nt o t he pla n ne d ne m oliz u ma b P hase 3 st u dies f or A D ( pi v otal a n d l o n g-ter m e xte nsi o n  pr ot oc ols ).  
A n I D M C  will re vie w a n d m o nit or s u bject safet y. T he I D M C will pr o vi de rec o m me n datio n s o n 
t he safet y of s u bjects. Details o n t he I D M C, i ncl u di n g t he pla n of a nal ysis f or I D M C o ut p uts, t he 
c o m p ositi o n of t he I D M C, t he pr oce d ures, r oles, res p o nsi bilities a n d t heir c o m m u nicati o ns are 
pr o vi de d i n t he I D M C c harter.  
 
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St u d y Desi g n  
 
A b bre vi ati o ns : B L = Baseli n e; n = n u m ber of s u bjects; q 4 w = e ver y 4 wee ks; T C S = t o pical c ortic oster oi d; 
W  =  wee k . 
 
 
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g Patie nt -re p orte d efficac y meas ure me nts ( A C T a n d D L QI/c D L QI) s h o ul d occ ur bef ore i n vesti gat or (efficac y a n d safet y) assess me nts, bl o o d sa m ple c ollecti o ns, 
a n d st u d y dr u g a d mi nistrati o n.  
h  Pea k a n d a vera ge pr urit us N R S  s h o ul d be rec or de d b y s u bjects o nce dail y i n t he e ve ni n g, be gi n ni n g ≥ 2 wee ks bef ore Da y 1.  
I Slee p dist ur ba nce  N R S s h o ul d be rec or de d b y s u bjects o nce dail y i n t he m or ni n g, be gi n ni n g ≥ 2 wee ks bef ore Da y 1.  
j S u bjects will b e as ke d t o rec or d t he res p o nse ( yes/ n o) t o t he f oll o wi n g q uesti o n eac h e ve ni n g, “ Di d y o u a p pl y t he ecze ma me dicati o n y o ur d oct or ga ve y o u, t o 
y o ur s ki n  t o da y?”, be gi n ni n g ≥ 2 wee ks bef ore Da y 1. See Secti o n  7. 5. 8. 1. 1 . 
k S u bjects wit h a hist or y of ast h ma will c o m plete  t he A C T at eac h st u d y visit bef ore p h ysical e xa mi nati o n a n d ot her i n vesti gat or assess me nts . S u bjects wit h de 
n o v o dia g n ose d ast h ma will c o m plete t he A C T be gi n ni n g at t he  first visit of de n o v o dia g n osis a n d at all f oll o w-u p  st u d y visits. 
l S u bjects a ge d 1 7 years or ol der will c o m plete t he D L QI, w hile s u bjects a ge d 1 2 -1 6 years ol d will c o m plete t he c D L QI.  
m  C o m plete P E s h o ul d be perf or me d at eac h visit. See Secti o n  8. 6. 8  f or P E details. A t all visits, all s u bjects s h o ul d be as ke d a b o ut res pirat or y c ha n ges a n d a 
res pirat or y e xa mi nati o n  s h o ul d als o be d o ne d uri n g t he P E. I n a d diti o n, P E F meas ure me nts will b e perf or me d f or all  s u bjects at scree ni n g a n d baseli ne. For 
s u bjects re p orti n g a me dical hist or y of ast h ma, P E F meas ure me nts  a n d A C T will be perf or me d at all visit s d uri n g t he cli nical trial. S u bjects wit h a me dical 
hist or y of ast h ma will be referre d t o t h e p h ysicia n ma na gi n g t heir ast h ma if A C T ≤ 1 9, P E F < 8 0 % of t he pre dicte d val ue, a n d/ or u ne x pecte d w orse ni n g of 
ast h ma is o bser ve d or re p orte d. F or s u bjects dia g n ose d wit h de n o v o ast h ma, P E F meas ure me nts a n d A C T  will be perf or me d at all visits starti n g wi t h t he visit 
i n w hic h t he dia g n osis  was c o nfir me d . S u bjects wit h o ut a me dical hist or y of ast h ma will be referre d t o a res pirat or y s pecialist if res pirat or y c ha n ges s u g gesti ve 
of ast h ma are o bser ve d or re p orte d. P E F meas ure me nts will be d o ne u n der t he s u per visi o n of q ualifie d st u d y pers o n nel  a n d s h o ul d occ u r at a p pr o xi matel y t he 
sa me ti me of da y f or all visits, w he n p ossi ble. Atte m pts s h o ul d be ma de t o wit h h ol d ast h ma me dicati o n o n st u d y visit da ys u ntil after P E F testi n g is c o m plete, 
t o t he e xte nt it d oes n ot p ose a n u n d ue ris k t o t he s u bject, t o a v oi d i nterfere nce wit h P E F meas ure me nts. See Secti o n  8. 6. 9  f or details o n t he res pirat or y 
e xa mi nati o n assess me nt . 
n  E C Gs s h o ul d be perf or me d bef ore  a n y sc he d ule d vital si g n meas ure me nts a n d bl o o d dra ws. See Secti o n  8. 6. 1 0 . 
o Vital si g ns will i ncl u de p ulse rate, s yst olic a n d diast olic bl o o d press ure (after t he s u bject has bee n sitti n g f or at least 5 mi n utes), a n d b o d y te m perat ure.  
p  At st u d y dr u g i njecti o n visits, l a b orat or y  ( he mat ol o g y, cli nical c he mistr y, a n d uri nal ysis), P K , a n d A D A sa m ples are t o be c ollecte d ≤ 3 0 mi n utes bef ore  st u d y 
dr u g i njecti o n (s). See Secti o ns  8. 6. 2. 1  a n d 8. 6. 2. 2  f or he mat ol o g y a n d cli nical c he mistr y testi n g details, res pecti vel y. 
q  T B scree ni n g: Q ua nti F E R O N -T B G ol d test f or all s u bjects. See Secti o n  8. 6. 5  f or details.  
r O nl y f or W O C B P . Ser u m pre g n a nc y test t o be perf or m e d at t he scree ni n g visit a n d uri ne pre g n a nc y test ( U P T) f or all ot her visits . F or pre p u bertal 
s u bjects, rec o nfir m pre-me nses stat us at e ver y visit a n d, i n case of stat us c ha n ge, c ollect i nf or mati o n o n c o ntrace pti ve meas ures a n d perf or m a U P T a cc or di n g 
t o t he sc he d ule f or W O CB P.  
s See Secti o n  8. 2  f or details o n P K assess me nts. At t he st u d y dr u g i njecti o n visits ( baseli ne, Wee ks 4, 8 a n d 1 2), P K sa m ples will be c ollecte d wit hi n 3 0 mi n utes  
bef ore st u d y dr u g i njecti o n ( pre -d ose sa m ples). At Wee ks 1 -2, 1 6 a n d 2 4, atte m pts s h o ul d be ma de t o c ollect P K sa m ples at a p pr o xi matel y t he sa me ti me of t he 
da y, t o t he e xte nt p ossi ble.  
t See Secti o n  8. 3  a n d Secti o n  8. 4  f or details o n A D A a n d P D/ Bi o mar ker assess me nts, res pe cti vel y. 
u  S u bjects will recei ve a  l oa di n g d ose of 6 0 m g o n Da y 1. 
v  S u bjects are re q uire d t o re mai n at t he st u d y ce nter  f or at least 3 0 mi n utes p ost -i njecti o n, f oll o wi n g t he first 2 i njecti o ns, t o m o nit or f or p ossi ble h y perse nsiti vit y 
reacti o n. 
w  Bac k gr o u n d t hera p y (ie, m oist urizer a n d a ut h orize d T C S) be gi n ni n g ≥ 2 wee ks bef ore Da y 1. M oist urizer s h o ul d N O T be use d f or at le ast 8 h o urs bef ore eac h 
cli nical visit. See Secti o n  7. 5. 8. 1. 1 . T he i n vesti g at or s h o ul d a dj ust b ac k gr o u n d T C S use d uri n g t he st u d y, acc or di n g t o t he dise ase acti vit y a n d 
t oler a bilit y, i ncl u di n g t a peri n g w he n si g ns a n d s y m pt o ms i m pr o ve , disc o nti n u ati o n w he n lesi o ns cle ar, a n d rest arti n g if si g ns a n d s y m pt o ms rec ur. 
 
 
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7. 3   
Disc ussi o n of St u d y Desi g n  
7. 3. 1   
St u d y Desi g n  
T his st u d y will e val uate t he safet y a n d P K i n a d olesce nt A D s u bj ects. T he r ati o nale f or t he ge n eral 
st u d y desi g n is detaile d i n t his secti o n, a n d is base d u p o n t he pri or P hase 2 b desi g n c o n d ucte d i n 
a d ult s u bjects wit h A D. T he r ati o nale f or d ose/ d ose re gi me n are pr o vi d e d i n Secti o n  5. 5 . 
B ase d o n t he res ults of t he pri or P hase 1, 2a , a n d 2 b a n d si m ula ti o n fr o m t he p o p -P K  m o del, t he 
fi xe d d ose of 3 0 m g ( wit h a l oa di n g d ose of 6 0 m g) was c h ose n t o be a d mi nistere d Q 4 W i n t his 
cli nical trial. T he selecte d d ose pr o vi de d t he b est ris k/ be nefits rati o i n a d ults a n d is e x pecte d t o 
pr o vi de si milar efficac y a n d s afet y i n a d ol esc e nt s u bjects. 
Eli gi ble s u bjects f or t his cli nical trial will be a d olesce nts wit h m o derate -t o-se v ere A D a n d 
ass ociate d pr urit us w h o s e disease is n ot a de q uatel y c o ntr olle d b y t o pical treat me nts. T he st u d y 
p o p ulati o n is selecte d base d o n t he c urre nt u n met nee d i n t he ma na ge me nt of A D i n pe diatric 
p o p ulati o ns, t he m o de of acti o n of ne m oliz u ma b, a n d t he nee d t o u n dersta n d t he P K a n d safet y of 
ne m oliz u ma b i n t he a d olesce nt p o p ulati o n f or d ose verificati o n bef ore  i nitiati n g pla n ne d P hase 3 
st u dies, w hic h will als o e nr oll a d olesce nt s u bjects . T he i ncl usi o n criteria f or I G A, B S A a n d E A SI 
are c o nsiste nt wit h t he disease se verit y tar gete d i n t he  P hase 3  st u dies, e nr olli n g a d olesce nts a n d 
a d ults: A n I G A of 3 or 4 c orres p o n ds t o m o derat e or se vere A D , respecti vel y; B S A of at least 1 0 % 
is us uall y o bser ve d i n t hese m ore se vere A D p atie nts; an E A SI t hres h ol d of 1 6  is ge nerall y 
rec o g nize d t o be re prese ntati ve of m o derate -t o-se vere A D, a n d is c o nsiste nt wit h t he p u blis he d 
a nal yses c orrelati n g I G A a n d E A SI assess me nts i n patie nts wit h A D. 3 3 ,3 4 Fi nall y,  s u bjects wit h 
ass ociate d pr urit us are tar gete d beca use of pri or st u dies wit h ne m oliz u ma b  a n d its mar ke d effect 
o n pr urit us.  
T he st u d y i ncl u des a 1 6 -wee k tr eat me nt peri o d a n d a n  8 -wee k f oll o w -u p p eri o d f or s afet y (ie, 1 2  
wee ks after last st u d y dr u g a d mi nis trati o n at W ee k 1 2 ) f or s u bjects w ho will n ot r oll o ver t o t he 
ne m oliz u ma b l o n g-ter m e xte nsi o n st u d y . A 1 6 -wee k treat me nt p eri o d is c o nsi dere d a de q uat e t o 
e val uate t h e safet y a n d efficac y of ne m oliz u ma b base d o n t h e res ults of t he P hase 2 b st u d y 
( 1 1 4 3 2 2). As stea d y state i n a d ults ca n be ac hi eve d i n 4 wee ks, a trial d urati o n of 1 6 wee ks i n 
a d olesce nts w as dee me d s ufficie nt t o assess all st u d y o utc o mes . 
T he d urati o n of t he f oll o w-u p peri o d  (ie, 1 2 wee ks after t he last st u d y dr u g a d mi nistrati o n), 
c orres p o n ds t o 5 h alf-li ves of n e m oliz u ma b: t he dr u g plas ma le vel is e x pect e d t o be l o wer t ha n t he 
Li mit of Q ua ntificati o n at t he e n d of t h e st u d y, a n d t he f oll o w -u p peri o d is t heref ore c o nsi dere d 
a de q uate t o e ns ure t he s afet y of s u bjects.   
Bac k gr o u n d t hera p y i ncl u di n g m oist urizer a n d a ut h orize d T C S will be use d t hr o u g h o ut t his st u d y. 
T his is i n li ne wit h t he c urre nt practice t o use t o pical a ge nts i n c o nj u ncti o n wit h s yste mic treat me nt 
i n m ore se v ere cases.2 Bac k gr o u n d T C S will be st arte d fr o m t he scree ni n g visit, t o e ns ure disease 
sta bilit y a n d a v oi d flares. T he p ote nc y of T C S selecte d f or t his st u d y is cli nicall y j ustifie d . A  
me d i u m p ote nc y T C S will be use d o n t he b o d y w here c o nsi dere d safe (e g, tr u n k a n d e xtre mities) , 
a n d a l o w p ote nc y T C S will be use d i n T C S -se nsiti ve areas (e g, face, n ec k, i ntertri gi n o us areas). 
T he prescri be d bac k gr o u n d T C S use s h o ul d be wit hi n  dail y fre q ue nc y li mits acc or di n g t o t he 
pr o d uct la beli n g. Bac k gr o u n d T C S use i ncl u des g ui deli nes t o a dj ust usa ge t o disease acti vit y a n d 
 
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t olera bilit y of t he s u bject, i ncl u di n g ta peri n g w he n si g ns a n d s y m pt o ms i m pr o ve , disc o nti n uati o n 
w he n  lesi o ns clear, a n d rest arti n g if si g ns a n d s y m pt o ms rec ur. 
Resc ue t hera p y i ncl u di n g t o pical a n d s yste mic treat me nt or p h ot ot hera p y ma y be pr o vi de d if 
j u d ge d t o be necessar y b y t he i n vesti gat or. 
T h is st u d y will assess t he P K a n d safet y pr ofile of n e m oliz u ma b  i n t he a d olesce nt p o pulati o n, i n 
or der t o all o w t heir s u bse q ue nt e nr ol me nt i n pla n ne d P hase 3 st u dies.  
Ne m oliz u ma b ser u m c o n ce ntrati o n will b e  ass esse d at b as eli ne, Wee ks 1 -2, 4, 8, 1 2, 1 6 a n d W ee k 
2 4 a n d at a n y u ns c he d ule d visit f or safet y reas o ns.  Gi ve n t hat t he n e m oliz u ma b  dr u g s u p pl y 
c o nfi g urati o n a n d pre p arati o n are si milar t o t hat use d i n t he P hase 2 b st u d y i n v ol vi n g a d ult A D 
s u bjects, n o c ha n g e is a ntici pate d i n t he a bs or pti o n p hase ( ka). T h us,  li mite d P K assess me nt will 
be d o ne d uri n g t he a bs or pti o n p hase a n d serial pre-d ose  P K sa m ples will be c olle cte d at stea d y 
state. 
P K data fr o m t he P hase 1  a n d P hase 2a  st u dies were use d t o d e vel o p a p o p ulati o n P K m o del t hat 
all o ws a n acc urate si m ulati o n of ne m oliz u ma b ser u m c o nce ntrati o ns wit h differe nt d oses a n d 
d osi n g re gi me ns. T h e p o p ulati o n P K m o del was use d t o si m ulate s yste mic e x p os ure usi n g se veral 
fi xe d d oses f or t he P has e 2 b st u d y . T he P hase 2 b res ults c o nfir m t he pre dicta bilit y of t he p o p -P K  
m o del f or t he 3 0 m g d ose (Ta ble  4 ). 
T a ble  4 :  
Ne m oliz u m a b Pre dicte d A ver a ge Ser u m C o nce ntr ati o ns ( µ g/ m L) C o m p are d 
t o Act u al C tr o u g h Le vel f or t he 3 0 m g D ose  i n A d ults  
C tr o u g h ( µ g/ m L) 
Me a n ± S D  
Pre dicte d ser u m c o nce ntr ati o ns a   
Act u al ser u m c o nce ntr ati o n b  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a N re prese nts t he n u m ber of o bser vati o ns. C o nce ntrati o ns are t he i n di vi d ual pre dicti o ns deri ve d fr o m t he m o del . 
b n  re prese nts t he n u m ber of a d ult s u bjects t hat pr o vi de P K data f or t he i nteri m P K a nal ysis of st u d y 1 1 4 3 2 2 . 
T he P K pr ofile i n a d oles ce nts will be  e xtra p olate d fr o m t h e p o p -P K p o p ulati o n m o del de vel o pe d 
wit h t he data o btai ne d i n a d ults. As t he si m ulati o n i n a d ults was perf or me d o n a b o d y wei g ht ra n ge 
of 3 0 t o 1 5 0 k g, a mi ni m u m b o d y wei g ht of 3 0 k g is re q uire d f or a d o lesce nt partici pati o n i n t he 
prese nt st u d y . B o d y  wei g ht i n patie nts a ge d bet wee n 1 2 a n d 1 7 years is e x pecte d t o be bet w ee n 4 0 
a n d 7 0 k g ( 5 0 t h perce ntile) . 
O n ly a d olesce nts wit h a b o d y wei g ht  3 0  k g will be all o we d t o partici pat e i n t his st u d y, theref ore, 
t he p ossi ble ma xi mal d oses/ k g will be 2. 0  m g/ k g  f or t he 6 0-m g l oa di n g d ose . P har mac o ki netic 
data f or m ulti ple d oses u p t o 2. 0  m g/ k g ha ve alrea d y b ee n c ollecte d i n t he P hase 2a st u d y 
( St u d y CI M 0 0 3J G) i n a d ults , an d u p t o 9 0 m g i n t he P hase 2 b st u d y , a n d ha ve bee n c o nsi dere d as 
 
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safe. T h e  pr o p os e d d ose a p pears t o be b el o w t he hi g hest d oses st u die d pre vi o usl y; t heref ore, t h e  
pr o p ose d d oses are s u p p orte d b y t he a vaila bl e cli nical safet y d ata.  
7. 4   
Selecti o n of St u d y P o p ul ati o n  
7. 4. 1   
N u m ber of P l a n ne d S u bjects  
It is a ntici pate d t hat a p pr o xi matel y 3 0 s u bjects will be scree ne d, wit h a p pr o xi matel y  2 0 eli gi ble  
s u bjects e nr olle d i n a p pr o xi matel y 1 0 st u d y ce nters acr oss t he U nite d States. Refer t o t he statistical 
c o nsi derati o ns o n w hic h t he n u m bers are base d i n Secti o n  9. 5 .  
7. 4. 2   
I ncl usi o n C riteri a 
T o be eli gi ble f or st u d y e ntr y s u bjects m ust satisf y all of t he f oll o wi n g criteria:  
1.   
S u bjects ≥ 1 2 t o <  1 7  years of a ge at t he scree ni n g visit . 
2.   
C hr o nic A D f or at least 2 y ears bef ore t h e scree ni n g visit a n d c o nfir me 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 2 (A p pe n di x  1 ) at t he ti me of t he 
screeni n g visit . 
3.   
E A SI s c ore ≥ 1 6  at b ot h scree ni n g a n d b aseli ne visits . 
4.   
I G A sc ore  3 ( bas e d o n t he I G A scale ra n gi n g fr o m 0 t o 4, i n w hic h 3 is m o derate a n d 4 is 
se vere) at b ot h scree ni n g a n d b aseli ne visits . 
5.   
A D i n v ol ve me nt ≥ 1 0 % of B o d y S urface Area ( B S A) at b ot h scree ni n g a n d b aseli ne visits . 
6.   
Pea k ( ma xi m u m) pr urit us N R S sc ore of at least 4 . 0 at b ot h scree ni n g a n d b aseli ne visit s:  
•  
 
 
 
 
 
 
 
7.   
D oc u me nte d rece nt hist or y ( wit hi n 6 m o nt hs bef ore t he scree ni n g visit) of i na de q uate 
res p o nse t o t o pical me dicati o ns ( T C S wit h or wit h o ut T CI). 
 
 
 
 
 
 
 
 
 
 
  
 
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8.   
A gree t o a p pl y a m oist urizer t hr o u g h o ut t he st u d y fr o m t he scree ni n g visit  dail y, a n d 
li berall y as nee d e d; a gree t o a p pl y a n a ut h orize d T C S fr o m t he scree ni n g visit a n d 
t hr o u g h o ut t he st u d y as deter mi ne d a p pr o priate b y t he i n vesti gat or. 
9.   
W o me n  of c hil d beari n g p ote ntial m ust a gree eit h er t o be strictl y a bsti ne nt t hr o u g h o ut t he 
st u d y a n d f or 1 2 wee ks  after t he last st u d y dr u g i njecti o n or t o use a n effecti ve a n d 
a p pr o ve d met h o d of c o ntrace pti o n t hr o u g h o ut t he st u d y a n d f or 1 2 wee ks  after t he last 
st u d y dr u g i njecti o n. T his criteri o n als o a p plies t o a pre p u bertal  fe m ale s u bject w h o be gi ns 
me nses d uri n g t he st u d y.  
Effecti ve a n d a p pr o ve d met h o ds of c o ntrace pti o n a p plica ble f or t he s u bject a n d/ or t heir 
pa rt ner are d efi ne d b el o w: 
•  Pr o gest o ge n -o nl y oral h or m o nal c o ntrace pti o n  
•  Male or fe m ale c o n d o m  
•  Ca p, dia p hra g m or s p o n g e wit h s per mici de  
•  C o m bi nati o n of male or fe male c o n d o m wit h ca p, dia p hra g m or s p o n ge wit h s per mici de  
•  C o m bi ne d (estr o ge n a n d pr o gest o ge n c o nta i ni n g-) oral, i ntra v a gi nal, or tra ns der mal 
h or m o nal c o ntrace pti o n  
•  I njecta ble or i m pla nte d h or m o nal c o ntrace pti o n 
•  I ntr a uteri ne d e vices  
1 0.  
S u bject a n d g uar dia n willi n g a n d a ble t o c o m pl y wit h all of t he ti me c o m mit me nts a n d 
pr oce d ural re q uir e me nts of t he cli nic al trial pr ot oc ol , i ncl u di n g dail y diar y rec or di n gs b y 
t he s u bject usi n g a n electr o nic ha n d hel d de vi ce pr o vi de d f or t his st u d y. 
1 1.  
U n dersta n d a n d si g n a n I nf or me d C o nse nt F or m (I C F) a n d Asse nt F or m b ef ore  a n y 
i n vesti gati o nal pr oce d ures bei n g perf or m e d. 
 
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7. 4. 3   
E xcl usi o n C riteri a 
S u bjects will be e xcl u de d fr o m t he st u d y if o ne or m ore of t he f oll o wi n g criteri o n  are a p plica ble:  
1.   
B o d y wei g ht <  3 0 k g . 
2.   
S u bjects meeti n g o ne or m ore of t he f oll o wi n g criteria at scree ni n g or b aseli ne: 
2a.  Ha d a n ast h ma e xacer bati o n re q uiri n g h os pitalizati o n i n t he prece di n g  1 2 m o nt hs.  
2 b.  Re p orti n g ast h ma t hat has bee n n ot well -c o ntr olle d (ie, s y m pt o ms > 2 da ys per wee k, 
ni g htti me a wa ke ni n gs > 1 -3 ti mes p er wee k, or s o me i nterfere nce wit h n or mal 
acti vities) d uri n g t he prece di n g  3 m o nt hs.  
2c.  Ast h ma C o ntr ol T est ≤ 1 9 (a p plies o nl y f or s u bjects wit h a hist or y of ast h ma).  
2 d.  Pea k e x pirat or y fl o w < 8 0 % of t he pre dicte d val u e.  
3.   
S u bjects wit h a c urre nt m e dical hist or y of c hr o nic o bstr ucti ve p ul m o nar y disease ( C O P D)  
a n d/ or c hr o nic br o nc hitis.  
4.   
C uta ne o us i nfecti o n wit hi n 1 wee k bef ore t he scree ni n g visit or a n y i nfecti o n re q uiri n g 
treat me nt wit h oral or p are nteral a nti bi otics, a nti virals, a nti parasitics, or a ntif u n gals wit hi n 
1 wee k bef ore t h e scree ni n g visit. S u bject s ma y be rescree ne d o n ce t he i nfecti o n has 
res ol ve d. 
5.   
Re q uiri n g resc ue t h era p y f or A D d uri n g t he r u n -i n peri o d, or e x p ecte d t o re q uire resc u e 
t hera p y wit hi n 2 wee ks f oll o wi n g t he b aseli ne visit . 
6.   
P ositi ve ser ol o g y res ults f or he patitis B s urface a nti ge n [ H Bs A g] or he p atitis B c ore 
a nti b o d y [ H Bc A b], h e patitis C a nti b o d y, or h u ma n i m m u n o deficie nc y vir us [ HI V] 
a nti b o d y at t he scree ni n g visit; 
N ote : S u bjects wit h a p ositi ve H Bc A b a n d a ne g ati ve H Bs A g ca n be i ncl u de d i n t his 
cli nical trial if he patitis B s urface a nti b o d y ( H Bs A b ) is p ositi ve (c o nsi dere d i m m u ne after a 
nat ural i nfecti o n).  
7.   
Ha vi n g recei ve d a n y of t he f oll o wi n g treat me nts i n Ta ble  5  wit hi n t he s pec ifie d ti mefra me 
bef ore  t h e b aseli ne visit:  
T a ble  5 :  
Pri or Tre at me nts  
Tre at m e nt(s):  
Ti mefr a m e  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
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Tre at m e nt(s):  
Ti mefr a m e  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
N ote : T hese treat me nts s h o ul d n ot be disc o nti n ue d f or reas o ns relate d t o t his cli nical st u d y. 
8.   
S u bjects w h o faile d t o res p o n d cli nic all y t o pre vi o us treat me nt wit h a bi ol o gic ( e g, 
d u pil u ma b) or a J A K i n hi bit or . 
9.   
Pre g na nt w o me n ( p ositi ve ser u m pre g n a nc y test res ult at t he scree ni n g visit or p ositi ve 
uri ne pre g n a nc y test at t h e baseli ne visit), breastfee di n g w o me n, or w o me n pla n ni n g a 
pre g na nc y d uri n g t he cli nical trial . 
1 0.  
Hist or y of l y m p h o pr oliferati ve disease or hist or y of mali g na nc y of a n y or g a n s yste m 
wit hi n t he last 5 years, e x ce pt f or ( 1) basal cell carci n o ma, acti nic kerat oses or s q ua m o us 
cell carci n o ma i n sit u ( B o we n’s diseas e) t hat ha v e bee n treate d a n d ha ve n o e vi de nce of 
rec urre nce i n t he last 5 2  wee ks bef ore t he b aseli n e visit, or ( 2) carci n o ma i n sit u of t he 
cer vi x. 
1 1.  
Hist or y of h y perse nsiti vit y (i ncl u di n g a na p h yla xis) t o a n i m m u n o gl o b uli n pr o d uct ( plas ma -
deri ve d or rec o m bi na nt, e g, m o n ocl o nal a nti b o d y)  or t o a n y of t he st u d y dr u g e xci pie nts . 
1 2.  
Hist or y of i nt olera nce t o l o w or mi d p ote nc y T C S or f or w h o m T C S is n ot a d visa ble ( e g, 
h y perse nsiti vit y t o T C S, si g nifica nt s ki n atr o p h y , etc). 
1 3.  
K n o w n acti ve or late nt t u berc ul osis ( T B) i nfecti o n. 
1 4.  
K n o w n or s us pect e d i m m u n os u p pressi o n  or u n us uall y fre q ue nt, rec urre nt, se vere, or 
pr ol o n ge d i nfecti o ns as p er i n vesti gat or j u d g me nt . 
1 5.  
Hist or y of or c urre nt c o nf o u n di n g s ki n c o n diti o n ( e g, Net hert o n S y n dr o me, ps oriasis, 
C uta ne o us T -Cell L y m p h o ma [ M yc osis F u n g oi des or Sezar y S y n dr o m e], c o ntact 
der matitis, c hr o nic acti nic der matitis, der matitis her petif or mis) . 
1 6.  
A n y me dical or ps yc h ol o gical c o n diti o n, or a n y cli nicall y rele va nt la b orat or y 
a b n or malities , s uc h as b ut n ot li mite d t o ele vate d A L T or A S T ( > 3 × U L N) i n c o m bi nati o n 
wit h ele vate d bilir u bi n ( > 2 × U L N), at t he scree ni n g visit t hat ma y p ut t he s u bject at 
si g nifica nt ris k acc or di n g t o t he i n vesti gat or’s j u d g me nt if he/s he partici pat es i n t he cli nical 
trial, or ma y i nterfere wit h st u d y assess me nts (e g, p o or ve n o us access or nee dle -p h o bia) . 
 
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1 7.  
Pla n ne d or e x pect e d maj or s ur gical pr oce d ure d uri n g t he cli nical trial . 
1 8.  
S u bjects u n willi n g t o refrai n fr o m usi n g pr o hi bite d me dicati o ns d uri n g t he cli nical trial 
(see Secti o n  7. 5. 8. 2 ). 
1 9.  
C urre ntl y partici pati n g i n a n y ot her cli nical trial of a dr u g or de vi ce, partici pate d i n a 
cli nical trial wit hi n t he past 3 m o nt hs bef ore  t he s cree ni n g visit, or is i n a n e xcl usi o n peri o d 
(if verifia bl e) fr o m a pre vi o us cli nical trial. 
7. 4. 4   
Re m o v al of S u bjects F r o m T her a p y or A ssess me nts 
Alt h o u g h t he i m p orta nce of c o m pleti n g t he e ntire cli nical trial will be e x plai ne d t o t he s u bjects, 
a n y s u bject is free t o dis c o nti n ue his/ her partici pati o n i n t he st u d y at a n y ti me a n d f or w hate ver 
reas o n, s pecifie d or u ns p ecifie d, a n d wit h o ut a n y prej u dice. N o c o nstrai nts are t o be i m p ose d o n 
t he s u bject, a n d w he n a p pr o priate, a s u bject ma y be treate d wit h ot her c o n ve nti o nal t hera p y w he n 
cli nicall y i n dicate d. I n v esti gat ors or t he sp o ns or ca n als o wit h dra w s u bjects fr o m t he cli ni cal trial 
if dee me d t o be n ecess ar y. 
S u bjects ma y st o p st u d y dr u g f or a n y of t he f oll o wi n g reas o ns: 
•  S u bject c o nse nt wit h dra wal  
•  U se of no n -p er mitte d c o nc urre nt t hera p y  
•  N o n -c o m plia nce wit h t he st u d y dr u g or st u d y sc he d ule  
•  L ost t o f oll o w -u p  
•  O cc urre nce of A Es n ot c o m pati ble wit h t he c o nti n u ati o n of s u bject partici pati o n i n t he st u d y , 
i n t he i n vesti gat or’s o pi ni o n, or u nacce pta ble t o t h e s u bject t o c o nti n ue  
•  Seri o us i m me diate -t y pe aller gic ma nifestati o ns i ncl u di n g a na p h ylactic reacti o n 
•  Pre g na nc y  
•  Use of s yste mic resc u e t hera p y d uri n g t he r u n -i n p eri o d t hr o u g h t he Wee k 1 2 visit (last st u d y 
dr u g i njecti o n) , u nless ot her wise s pecifie d i n Ta bl e  8  of Secti o n  7. 5. 8. 2 . 
•  In v esti gat or re q u est  
•  Interc urre nt ill ness  
•  Dia g n osis of a mali g na nc y (e x ce pt c urati vel y treat e d i n sit u cer vical carci n o ma or b asal cell 
carci n o ma)  
•  A n y o p p ort u nistic i nfecti o n (s uc h as acti ve T B a n d ot her i nfecti o ns w h o se nat ure or c o urse 
s u g gest a n i m m u ne-c o m pr o mise d stat us)  
•  S p o ns or re q uest  
•  T reat me nt f ail ure 
T he reas o n(s) f or wit h dr a wal will be d o c u me nte d i n t he cas e re p ort f or m ( C R F).  S u bjects w h o 
ha ve bee n e nr olle d a n d tr eate d will n ot be re pl ace d b y a n ot her s u bject.   
 
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S u bjects w h o pre mat urel y disc o nti n ue st u d y dr u g  will be e nc o ura ge d t o c o m plete t he sc he d ule d 
st u d y visits. 
W he n a s u bject disc o nti n ues st u d y dr u g, he/s he will be f ull y assesse d w he n e ver p ossi ble. S u bjects 
disc o nti n ui n g st u d y dr u g  bef ore t he W ee k 1 6  visit s h o ul d atte n d a n earl y ter mi nati o n visit a n d a 
foll o w -u p/ fi nal visit 1 2  wee ks after t he last st u d y dr u g i njecti o n f or safet y f oll o w -u p.  
Reas o na ble eff orts will b e ma de t o c o ntact s u bjects w h o are l ost t o f oll o w -u p . T hese eff orts m ust 
be d oc u me nte d i n t he s u bject’s file .  
T he sp o ns or has t he ri g ht t o ter mi nate t he st u d y at a n y ti me i n case of S A Es  or if s pecial 
circ u msta nces c o ncer ni n g t he i n vesti gati o nal pr o d uct or t he c o m pa n y itself occ ur, ma ki n g f urt h er 
treat me nt of s u bjects i m p ossi ble. I n t his e ve nt, t h e i n vesti gat or(s) will be i nf or me d of t he reas o n 
f or st u d y ter mi nati o n. 
7. 4. 4. 1   
Pre g n a ncy  
S u bjects will be i nstr ucte d t hat k n o w n or s us pecte d pre g na nc y  occ urri n g d uri n g t he st u d y , s h o ul d 
be c o nfir me d a n d re p orte d t o t he i n vesti gat or . If a s u bject bec o mes pre g n a nt, t he i n vesti g at or 
m ust wit h dr a w t he  s u bject fr o m t he st u d y wit h o ut del a y. T he s u bject m ust n ot recei ve a n y 
f urt her i njecti o n(s) of t he st u d y dr u g. 
T he i n v esti gat or m ust : 
•  F oll o w t he pr oce d ures f or re p orti n g/f oll o w -u p of a Pre g n a nc y  wit hi n 2 4 h o urs (see 
Secti o n  8. 6. 1. 2 ) of recei pt of t he i nf or mati o n. 
•  C o m plete as f ull y  as p ossi ble t he  a p plica ble Pre g n a nc y F or m (s) (see Secti o n  8. 6. 1. 2 ). 
•  M o nit or a n d rec or d t he pr o gress of t he pre g na n c y u ntil its o utc o me. C o ntact t he s u bject’s 
re g ular p h ysicia n (ge neral practiti o ner or g y n ec ol o gist) or h os pital staff t o o btai n f urt her 
details a n d as k f or re g ular f oll o w -u p i nf or mati o n.  
•  Pr o vi de tri -m o nt hl y u p dates u ntil t he fi nal o utc o me of t he pre g na n c y. If t h e s u bject ca n n o 
l o n ger be reac he d (l ost t o f oll o w-u p), d o c u me ntati o n of t he n o n -res p o nse/c o ntact wit h 2  
p h o ne calls a n d a l etter (certifie d wit h ret ur n recei pt) is re q uire d.  
•  If t he pre g n a nc y l ea ds t o a n a b orti o n ( v ol u ntar y a b orti o n, s p o nta ne o us a b orti o n or 
t hera pe utic a b orti o n), i n uter o  deat h or c o n g e nital a n o mal y, f oll o w t he pr oce d ure f or  
re p orti n g a n S A E (Secti o n  8. 6. 1. 2 ).  
T he i n vesti gat or s h o ul d als o be n otifie d of pre g n a nc y occ urri n g d u ri n g t h e st u d y b ut c o nfir me d 
after c o m pleti o n of t he st u d y . I n t he e ve nt t hat a s u bject is s u bse q ue ntl y f o u n d t o be pre g na nt after 
i ncl usi o n i n t he st u d y, a n y pre g na nc y will be f oll o we d t o ter m, a n d t he stat us of m ot her a n d c hil d 
will be re p orte d t o t he s p o ns or after deli ver y.  
F ull details will b e rec or de d o n t h e wit h dra wal p a g e (t he Exit F or m) of t he C R F, or a n S A E re p ort 
will be c o m plete d if t he s u bject has c o m plete d t he st u d y.  
 
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7. 5   
I n vesti g ati o n al Pr o d uct: Ne m oliz u m a b 
“ St u d y dr u g” or “st u d y me dicati o n” refers t o ne m oliz u ma b ( C D 1 4 1 5 2) dr u g pr o d uct f or p ur p os es 
of t his o pe n -la bel st u d y. T he list of e xci pie nts are detaile d i n t he I B. 
7. 5. 1   
I n vesti g ati o n al Pr o d uct  A d mi nistere d  
Ne m oliz u ma b dr u g s u p pl y c o nfi g urati o n a n d pre parati o n  are si milar t o t hat use d i n t he P hase 2 b 
st u d y i n v ol vi n g a d ult A D s u bjects, t o mi ni mize e x p os ure varia bilit y w he n c o m pari n g a d olesce nt 
res ults t o a d ults.  
Ne m oliz u ma b will be s u p plie d i n si n gle -use vials i n t he f or m of 1 5 3 m g l y o p hilize d p o w der. T he 
dr u g pr o d uct is t o be rec o nstit ute d b y a d di n g 1. 3 m L of sterile water f or i njecti o n. A vial of 
ne m oliz u ma b place b o will be use d f or dil uti o n, t o ac hie ve desir e d d ose le vel. ( S yri n ges, nee dles, 
a n d sterile wat er f or i njecti o n will be pr o vi de d t o t he st u d y ce nters f or use i n t he trial.)  
 
 
 
 
 
 
 
 
 
 
 
All st u d y dr u g d oses will be a d mi nis tere d b y trai ne d a n d q u alifie d pers o n nel  at st u d y ce nters . 
Q ualifie d pers o n nel 
will pre pare t h e d osi n g s ol uti o n b y 
mi xi n g a p pr o priate a m o u nts of 
rec o nstit ute d ne m oliz u m a b, acc or di n g t o t he pr o vi de d “i nstr ucti o n (s) f or use” i n t he p h ar mac y 
ma n ual.  
T a ble  6 :  
D osi n g Sc he me  
Gr o u p  
D ose o n D a y 1  
D ose at Wee ks 4 , 8 , a n d 1 2 
1  
6 0 m g  
3 0 m g  
 
O nce t he d osi n g s ol uti o n is pre pare d, 1. 0 m L of it will be dra w n i nt o a s yri n ge, w hic h will be 
a d mi nistere d s u bc uta ne o usl y i n t he a b d o me n of t he s u bjects. Ot her sites of i njecti o n ma y be 
per mitte d (ie, f or safet y reas o ns) after disc ussi o n wit h t he m e dical m o nit or. T he s ite of i njecti o n 
s h o ul d be rec or de d i n t he s u bject’s treat me nt rec or d at eac h ti me p oi nt.  
 
 
 
 
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7. 5. 2   
I de ntit y of I n vesti g ati o n al Pr o d uct  
T a ble  7 :  
Descri pti o n of Ne m oliz u m a b  
N a me  
Ne m oliz u ma b  
I nter n al c o de   
C D 1 4 1 5 2  
P h ar m ace utic al f or m   
L y o p hilize d p o w der  
F or m ul a n u m ber   
N/ A  
P ac k a gi n g  
Vial  
D os a ge  
3 0 m g ( wit h a l oa di n g d ose of 6 0 m g  at b aseli ne )  
R o ute  
S u bc uta ne o us i njecti o n  
D ose re gi m e n   
E ver y 4 wee ks ( Q 4 W)  
Tre at me nt d ur ati o n   
1 6  wee ks (last i njecti o n at W ee k 1 2 ) 
7. 5. 3   
P ac k a gi n g a n d L a beli n g  
All pac ka gi n g a n d la beli n g o perati o ns will be perf or me d acc or di n g t o G o o d 
Ma n ufact uri n g 
Practice f or Me di ci nal Pr o d ucts  i n t he l ocal la n g ua ge, nati o nal re g ulati o ns/ g ui deli nes, a n d t he 
rele va nt r e g ulat or y re q uir e me nts, s pecif yi n g t hat t he dr u g is f or use i n a cli nical trial . 
7. 5. 4   
St u d y Dr u g M a n a ge me nt  
7. 5. 4. 2   
St u dy Dr u g Acc o u nt a bility  
St u d y dr u g at t he st u d y ce nter will be acc o u nte d f or a n d n o u n a ut h orize d use is per mitte d. T he 
desi g n ate d pers o n nel will ac k n o wl e d ge recei pt of t he st u d y dr u g t o c o nfir m t he s hi p me nt c o n diti o n 
a n d c o nte nt. If a da ma ge d s hi p me nt is recei v e d , he/s he will n otif y t he sp o ns or/ cli nical res earc h 
or ga nizati o n ( C R O ), q uara nti ne t he s hi p me nt i n a s pecific st ora g e area, a n d d oc u me nt t he e ve nt as 
s pecifie d i n t he p har mac y ma n ual.  
T he desi g n ate d pers o n nel will als o mai ntai n acc urate rec or ds of t he st u d y dr u g t hr o u g h o ut t he 
cli nical trial, i ncl u di n g t he i n ve nt or y d eli vere d t o t he st u d y ce nter, t h e use b y eac h s u bj ect, 
 
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t he rec o n ciliati o n of all deli vere d a n d recei ve d vials of  st u d y dr u g, a n d t he ret ur n of us e d a n d 
u n use d st u d y dr u g as s pecifie d i n t he p ha r mac y m a n ual. 
 
 
 
 
 
 
 
7. 5. 4. 3   
Dis pe nsi n g a n d Ret ur n of St u dy Dr u g  
All dr u g pre parati o n m ust be a p pr o priatel y perf or me d a n d d o c u me nte d b y t he desi g nate d 
pers o n nel. 
 
 
 
7. 5. 4. 4   
Tre at me nt C o m pli a nce  
Treat me nt c o m plia nce will be assesse d t hr o u g h t he treat me nt rec or ds a n d dr u g dis pe nsati o n l o gs.  
As st u d y dr u g is a d mi nist ere d i n t h e cli nic, treat me nt c o m plia nce will be o versee n a n d d oc u m e nte d 
b y t he i n vesti gat or a n d st u d y staff (usi n g t he treat me nt rec or ds a n d dr u g acc o u nta bilit y rec or ds). 
 
 
7. 5. 5   
Met h o d of  Assi g ni n g S u bjects t o T re at me nt  
E li gi ble s u bjects will be se q ue ntiall y assi g ne d t o recei ve treat me nt wit h o pe n -la bel ne m oliz u ma b , 
base d o n t he ti me of e nr oll me nt .  
 
  
7. 5. 6   
Selecti o n of D oses i n t he S t u d y 
T he 3 0  m g d os e pr o p ose d f or t his st u d y is s u p p orte d b y t he res ults of t he ne m oliz u ma b P hase 2 b 
st u d y ( 1 1 4 3 2 2). Refer t o Secti o n  5. 5  f or f urt her details.  
7. 5. 7   
D ose M o dific ati o n  
D ose m o di ficati o n of t he st u d y dr u g will n ot be per mitte d d uri n g  t he cli nical trial.  
A n y i na d verte nt d ose m o dificati o n (s) s h o ul d be re p orte d t o t he sp o ns or/ C R O.  
 
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I n t he e v e nt of a misse d d ose (ie, te m p orar y disc o nti n uati o n of t he st u d y dr u g), it will be 
d oc u me nte d i n t he C R F t hat t he dr u g has n ot bee n a d mi nistere d at t he st u d y visit, t o get her wit h 
t he reas o n (e g, f or safet y). S u bjects will be as ke d t o ret ur n t o t he st u d y ce nters f or all re mai ni n g 
v isits a n d c o m plete all st u d y assess me nts a n d pr o ce d ures as descri be d i n Secti o n  7. 2 . 
D osi n g fre q ue n c y is sc he d ule d f or e ver y 4 wee ks, base d o n t he b aseli ne/ Da y 1 v isit date.  
 
 
 
 
 
7. 5. 8   
Pri or a n d C o nc o mit a nt T her a p y  
P ri or t hera pies are defi n e d as t hera pies t hat ha ve bee n st o p pe d wit hi n t he 3 m o nt hs prece di n g  t he 
scree ni n g visit, u nless rele va nt t o t he i ncl usi o n/e xcl usi o n criteria. 
W he ne ver p ossi ble, pri or  
t hera pies f or A D s h o ul d be d oc u me nte d.  
C o nc o mita nt t hera pies are def i ne d as f oll o ws: 
•  a n y e xisti n g t hera pies o n g oi n g at t he ti me of t he scree ni n g visit,  
•  a n y c ha n ges t o e xisti n g t hera pies (s uc h as c h a n ges i n d ose, f or m ulati o n or a p plicati o n 
fre q ue n c y) d uri n g t he c o urse of t he st u d y, or 
•  a n y ne w t hera pies recei v e d b y t he s u bje ct si nce t h e scree ni n g visit . 
T he f oll o wi n g 2 cate g ories are t o b e c o nsi dere d f or pri or a n d c o nc o mita nt t hera pies:  
•  Dr u gs/t hera pies  i ncl u de b ut are n ot li mite d t o prescri pti o n, o ver-t he-c o u nter, birt h c o ntr ol 
pills/ patc hes/ h or m o nal   
de vices,   
vita mi ns,   
m oist u rizers,   
s u nscree ns,   
her bal 
me dici nes/s u p ple me nts, a n d h o me o pat hic pre parati o ns.  
•  Me dical a n d s ur gical pr oce d ures  (e g, p h ot ot hera p y, e x o d o ntia, etc) . Pr oce d ures w h ose s ol e 
p ur p ose is dia g n osis ( n o n -t hera p e utic) are n ot i ncl u de d. 
Pri o r a n d c o nc o mita nt t hera pi es f or dr u gs/t hera pi es or f or me dical/s ur gical pr oce d ures are t o be 
rec or de d i n t he a p pr o pri ate C R F. C o nc o mita nt t hera pies are t o be rec or de d, re vie we d, a n d u p date d 
at eac h visit. At eac h visit , i n vesti gat ors s h o ul d als o c o nfir m c o nc o mita nt t hera pies f or 
co ntrace pti o n. (C o ntrace pti ve c o u nseli n g s h o ul d occ ur at scree ni n g ). A n y ne w c o nc o mita nt 
t hera p y or m o dificati o n of a n e xisti n g t hera p y ma y be li n ke d t o a n A E. A c orres p o n di n g A E f or m 
s h o ul d be c o m plete d t o acc o u nt f or t he c ha n g e i n t hera p y, e xce pt i n s o me cases s uc h as d ose 
m o dificati o n f or a c hr o nic c o n diti o n , i n w hic h case t he me dicati o n will be li n ke d t o a n ite m i n t he 
s u bject’s me dical hist or y.  
7. 5. 8. 1   
Per mitte d C o nc o mit a nt T her a py  
U nless s pecifie d as pr o hi bite d t hera pies (see Secti o n  7. 5. 8. 2 ), all t hera pies are a ut h ori ze d  i ncl u di n g 
basic s ki n care (cl ea nsi n g a n d bat hi n g), e m oll ie nts, bleac h bat hs, t o pical a nest hetics  a n d 
a nti hista mi nes  wit h o ut a se dati ve effect . 
 
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7. 5. 8. 1. 1   
B ack gr o u n d T her a py  
T he pres cri b e d use of b ac k gr o u n d t hera pies s h o ul d be d oc u me nte d i n t he C R F. Bac k gr o u n d 
t hera pies are us e d t hr o u g h o ut t he st u d y (scree ni n g t hr o u g h t he foll o w -u p v isit), as descri b e d bel o w. 
M oist urizer: S u bjects will a p pl y a m oist urizer dail y , a n d li berall y as nee de d, to dr y s ki n a n d A D 
lesi o ns t hr o u g h o ut t he st u d y. T he s u bject’s c urre nt m oist urizer or a m oist urizer rec o m me n d e d b y 
t he i n vesti gat or ma y be use d. 
 
 
T C S t hera p y: S u bjects will a p pl y t he a ut h orize d bac k gr o u n d T C S t hera p y t o all A D lesi o ns 
be gi n ni n g wit hi n t he scree ni n g peri o d a n d ≥ 1 4 da ys bef ore  Da y 1 , a n d t hr o u g h o ut t he st u d y as 
directe d b y t he i n vesti gat or . 
S u bjects will a p pl y a me di u m p ote nc y T C S i n areas of t he b o d y w here use of me di u m p ote nc y 
T C S is c o nsi dere d safe (e g, tr u n k a n d e xtre mities). A l o w p ote nc y T C S will be use d o n T C S -
se nsiti ve areas (e g, face, nec k, i ntertri gi n o us areas).  
 
 
 
 
T he i n vesti gat or s h o ul d a dj ust b ac k gr o u n d T C S use d uri n g t he st u d y, acc or di n g t o t he diseas e 
acti vit y a n d t olera bilit y, i ncl u di n g ta peri n g  w he n si g ns a n d s y m pt o ms i m pr o ve , disc o nti n uati o n 
w he n  lesi o ns clear, a n d restarti n g  if si g ns a n d s y m pt o ms rec ur. 
7. 5. 8. 1. 2   
Resc ue T her a p y  
If dee me d t o be 
me di call y necess ar y b y t he i n vesti gat or (e g, t o c o ntr ol i nt olera ble A D 
si g ns/s y m pt o ms), resc ue t hera pies ca n be pres cri be d t o t he s u bjects at a n y ti me d uri n g t he st u d y 
e xce pt d uri n g t he r u n -i n peri o d. As a ge neral g ui d eli ne a n d per i n di vi d ual i n vesti gat or j u d gme nt , 
resc ue t hera p y s h o ul d n ot be prescri be d wit hi n t he first 2 wee ks fr o m b aseli ne (ie, Wee k 2 visit) 
t o all o w a mi ni m u m peri o d  f or st u d y dr u g e x p os ure i n t he prese n ce of bac k gr o u n d t hera p y. Res c u e 
treat me nts are o nl y treat me nts t hat directl y treat A D ( mai nl y t h ose t hat are a p pr o ve d or are sta n dar d 
of care), a n d i n cl u de t o pical a n d s yste mic treat me nts as o utli ne d . S o me resc ue t hera pies i ncl u de:  
•  T o pical calci n e uri n i n hi bit ors  
•  Hi g her p ote nc y of T C S (class I -II acc or di n g t o t he U S classificati o n) 
•  Oral c ortic os ter oi ds 
•  Bi ol o gics (i ncl u di n g t heir bi osi milars)  
•  S yste mic n o nster oi dal i m m u n os u p pressa nts /i m m u n o m o d ulat ors  
 
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7. 6. 2   
U nsc he d ule d Visit  
T he s u bject s h o ul d be re mi n de d t o a d here t o t he st u d y sc he d ule. U nsc he d ule d visits are defi ne d as 
visits t o re peat testi n g f or a b n or mal la b orat or y res ults or f or f oll o w -u p of A Es. Visits occ urri n g 
o utsi de of t he visit wi n d o w are n ot c o nsi d ere d as u nsc he d ule d visits.  
 
 
bl o o d sa m ple c ollecti o n f or P K a n d A D A a nal ys es are ma n dat or y d uri n g u nsc h e d ule d 
visits f or safet y reas o ns.  
 
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8   
S t u d y Assess m e nts 
A writte n, si g ne d I C F, asse nt f or m a n d HI P A A a ut h orizati o n is re q uire d b ef ore a n y st u d y -relate d 
pr oce d ures are perf or me d.   
U p o n pr o visi o n of t he si g ne d I C F /asse nt f or m, eac h s u bject will be assi g ne d a u ni q ue SI N. F or t he 
d urati o n of t he e ntire cli ni cal trial, t he s u bject will be i de ntifie d usi n g t he SI N i n all d oc u me ntati o ns 
a n d disc ussi o n.  
T he pla n ne d sc he d ul e of assess me nts is d escri be d i n Secti o n  7. 2 . At eac h visit, assess me nts/ 
pr oce d ures s h o ul d be perf or me d i n t he f oll o wi n g or der:  
1.   
Patie nt -re p orte d efficac y meas ure me nts 
2.   
I n v esti gat or assess me nts (i ncl u di n g efficac y a n d s afet y) 
•  E C G s h o ul d be d o n e bef ore vital si g ns 
m eas ure m e nts  (a n d bl o o d dra ws ). See 
Secti o n  8. 6. 1 0 . 
3.   
Bl o o d sa m ple c ollecti o n f or la b orat or y assess me nts  
4.   
A d mi nistrati o n of st u d y dr u g  
8. 1   
Effic ac y  Assess m e nts  
Efficac y meas ure me nts s h o ul d be c o n d ucte d b y t he i n vesti gat ors ( or trai ne d desi g nees) a n d 
s u bjects (f or patie nt-re p orte d effi cac y meas ure m e nts) acc or di n g t o Secti o n  7 . 2 a n d Secti o n  8. 1 . 
W he ne v er p ossi ble, t he s a me e val u at or s h o ul d ma ke t he assess me nt t hr o u g h o ut t he st u d y.  
8. 1. 1   
Ecze m a Are a a n d Se verit y I n de x  
Ecze ma Area a n d Se verit y I n de x  is a vali dat e d meas ure c o m m o nl y use d i n cli nical trials a n d 
cli nical practice t o assess t he se verit y a n d t he e xte nt of A D si g ns. E A SI is a c o m p osite sc ore 
ra n gi n g fr o m 0 t o 7 2 (see A p pe n di x  3 ).3 6 T he se verit y of er yt he ma, i n d urati o n/ pa p ulati o n, 
e xc oriati o n, a n d lic he nifi cati o n will be assesse d b y t he i n vesti gat or or trai n e d desi g nee o n a scal e 
of 0 (a bse nt) t o 3 (se vere) 
 
 
 
T he E A SI sc ore will be calc ulat e d i n t he C R F.  
8. 1. 2   
I n vesti g at or Gl o b al Assess me nt 
T he IG A  is a 5-p oi nt scale ra n gi n g fr o m 0 (clear) t o 4 (se vere)  us e d b y t he i n vesti gat or or trai n e d 
desi g nee t o e val uate t he gl o bal se verit y of A D a n d t he cli nical res p o nse t o a treat me nt. Treat me nt 
s uccess is d efi ne d 0 (clear) or 1 (al m ost clear) a n d a 2 gra d e c h a n g e fr o m b aseli ne (see 
A p pe n di x  4 ).3 7 
 
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8. 1. 3   
B o d y S urf ace Are a  
T he B S A  i n v ol ve me nt of A D will be assesse d b y t he i n vesti gat or or trai ne d desi g nee f or eac h p art 
of t he b o d y 
 
 
 
8. 1. 4   
S C O Ri n g At o pic Der m atitis  
S C O Ri n g  At o pic Der matitis is a vali date d meas ure c o m m o nl y use d i n cli nical trials a n d cli nical 
practice t o ass ess t he se v erit y a n d t h e e xte nt of A D si g ns a n d s y m pt o ms. S C O R A D ra n ges fr o m 0 
t o 1 0 3 a n d has 3  c o m p o ne nts: e xte nt ( B S A, as descri be d i n Secti o n  8. 1. 3 ), si g ns, a n d s y m pt o ms of 
A D a n d s u bject -re p ort e d s y m pt o ms of pr urit us a n d slee p l oss (see A p pe n di x  5 ).3 8  
I n v esti gat or or desi g ne e will assess t he se verit y of 6 si g ns of A D (er yt he ma/ dar ke ni n g, 
e de ma/ pa p ulati o n, o ozi n g/cr usti n g, e xc oriati o n, lic he nificati o n/ pr uri g o a n d dr y ness), eac h o n a 
scale ra n gi n g fr o m 0 ( n o ne) t o 3 (se v ere). I n v esti gat or or desi g nee will als o as k t he s u bjects t o 
e val uate t h eir s y m pt o ms of pr urit us a n d slee p l oss (a vera ge f or t he last 3 da ys/ ni g hts), eac h 
e val uate d o n a V A S fr o m 0 t o 1 0. T he S C O R A D sc ore wil l be calc ulate d i n t he C R F. 
8. 1. 5   
Pr urit us N u m eric R ati n g Sc ale  
Pr urit us  N R S is a scale t o be use d b y t he s u bjects t o re p ort t he i nte nsit y of t heir pr urit us (itc h) 
d uri n g t he last 2 4 h o urs (see A p pe n di x  6 ). Pr urit us N R S has bee n vali date d i n ot her A D cli nical 
trials i n a d ults a n d t he mi ni m u m cli nicall y i m p orta nt differe n ce was s h o w n t o be 3 t o 4.   
T he scree ni n g P P N R S sc ore, meas uri n g ma xi mal pr urit us i nte nsit y, will be deter mi ne d b y a si n gle 
P P N R S assess me nt (sc or e ra n gi n g fr o m 0 t o 1 0) 
 
 
 
 
 
S u bjects will recei ve i nstr ucti o ns o n h o w t o us e a n d rec or d t heir pr urit us N R S sc ores o n a n 
electr o nic d e vice, a n d will c o m plete t he assess m e nt o nce d ail y i n t he e v e ni n g t hr o u g h o ut t he 
cli nical trial (i ncl u di n g t he r u n -i n a n d t he f oll o w-u p peri o d).  
S u bjects will be as ke d t he f oll o wi n g q uesti o ns i n t heir l ocal la n g ua g e:  
•  F or a v era ge itc h i nte nsit y: “ O n a s cale of 0 t o 1 0, wit h 0 bei n g ‘ n o itc h’ a n d 1 0 bei n g ‘ w orst 
itc h i ma gi na ble’, h o w w o ul d y o u rate y o ur itc h 
?”  
•  F or m a xi m u m itc h i nte nsit y: “ O n a scale of 0 t o 1 0, wit h 0 bei n g ‘ n o itc h’ a n d 1 0 bei n g 
‘ w orst itc h i ma gi na ble’, h o w w o ul d yo u rat e y o ur itc h at t he w orst m o me nt   
 
?”  
 
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8. 1. 6   
Slee p D ist ur b a nce N u meric R ati n g Sc ale   
Slee p dist ur ba nce N R S is a scale t o b e use d b y t he s u bjects t o re p ort t he de gree of t heir slee p l oss 
relate d t o A D (see A p pe n di x  7 ). S u bjects will recei ve i nstr ucti o ns o n h o w t o use a n d rec or d t heir 
slee p dist ur ba nce N R S sc ores o n a n electr o ni c de vi ce, a n d will c o m plete t he assess me nt o nce d ail y 
i n t he m or ni n g t hr o u g h o ut t he cli nical trial (i ncl u di n g t he r u n-i n a n d t he f oll o w-u p peri o d).  
S u bjects will be as ke d t he f oll o wi n g q uesti o ns i n t heir l ocal la n g ua g e:  
•  O n a s cale of 0 t o 1 0, wit h 0 bei n g ‘ n o slee p l oss relate d t o si g ns/s y m pt o ms of A D’ a n d 1 0 
bei n g ‘I ca n n ot slee p at all d ue t o t he si g ns/s y m pt o ms of A D’, h o w w o ul d y o u rate y o ur slee p 
last ni g ht?” 
8. 1. 7   
A p pl ic ati o n of T o pic al Me dic ati o n f or A D : Di a r y 
S u bjects will be i nstr ucte d t o use t he a ut h orize d bac k gr o u n d T C S as  prescri be d b y t he i n vesti gat or. 
E ac h e v e ni n g, s u bjects will be as ke d t o rec or d t he res p o nse ( yes/ n o) t o t he f oll o wi n g q uesti o n, 
“ Di d y o u a p pl y t he ecze m a me dicati o n y o ur d oct or ga ve y o u, t o y o ur s ki n t o da y?”, o n a n electr o nic 
de vice  (ie, di ar y), t hr o u g h o ut t he cli nical trial (i ncl u di n g t he r u n-i n a n d t he f oll o w-u p peri o d).  
8. 1. 8   
Der m at ol o g y Life Q u alit y I n de x ( D L QI)/ C hil dre n’s D L QI  (c D L QI) 
Der mat ol o g y Life Q ualit y I n d e x is a vali date d  1 0 -ite m q uesti o n naire f or s u bjects a ge d > 1 6 years, 
c o veri n g d o mai ns i ncl u di n g s y m pt o ms/feeli n gs, dail y acti vities, leis ure, w or k/sc h o ol, pers o nal 
relati o ns hi ps a n d treat me nt (see A p pe n di x  8 ).3 9  
C hil dre n’s D L QI (c D L QI) is a c o m p ara ble vali dat e d  1 0 -ite m q uesti o n naire desi g ne d f or pe diatric 
s u bjects a ge d 1 6 years or less (see A p pe n di x  8 ).4 0  
S u bject will rate eac h q u esti o n ra n gi n g fr o m 0 ( n ot at all) t o 3 ( ver y m u c h). A hi g her t otal sc ore 
i n dicates a p o orer Q o L.T he D L QI/c D L QI will be a d mi nistere d acc or di n g t o t he sc he d ule of 
assess me nts  (Secti o n  7. 2 ). 
8. 2   
P h ar m ac o ki netic s 
8. 2. 1   
B l o o d S a m pli n g  
Bl o o d sa m ple s will be c ollecte d acc or di n g t o Secti o n  7. 2  t o deter mi ne t he P K pr ofile of 
ne m oliz u ma b. T he ser u m c o nce ntrati o n of ne m oli z u ma b will be ass esse d at b aseli ne, W ee ks 1-2, 
4, 8, 1 2, 1 6 , 2 4  a n d at a n y u nsc he d ule d visit f or safet y reas o ns.  
 
 
 
 
 
 T he date a n d t he ti me of eac h s a m ple c ollecti o n will be 
 
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rec or de d i n t h e C R F, t o g et her wit h t h e ti me of st u d y dr u g i njecti o n at t he sa me visit ( or misse d 
i njecti o n if a p plica ble).  
8. 2. 2   
P K P ar a meters  
P K para m eters of n e m oliz u ma b i n t he ser u m will be ca lc ulate d b y t he desi g nate d C R O usi n g 2 
a nal yses: 
P K para meters will be deri ve d usi n g a n o n -li near mi xe d effect m o deli n g a p pr oac h wit h 
N O N M E M. A pre -s pecifie d p o p ulati o n P K m o del base d o n e xisti n g i nf or mati o n fr o m 
pre vi o us st u dies i n a d ults (first-or der a bs or pti o n a n d a 1 -c o m part me nt distri b uti o n m o del) 
will be use d t o deri ve e m pirical Ba yes esti mates i n t he a d olesce nt p o p ulati o n base d o n t heir 
baseli ne c haract eristics, t heir d osi n g hist or y a n d t heir 
meas ure d c o n ce ntrati o ns. T he 
a de q uac y of t he m o del t o pr o perl y d escri be t he a d olesce nt data will be base d o n t he m o del 
dia g n ostic t o ols descri be d i n a i n a de dicate d P K m o deli n g pla n. Esti mates of mai n p o p ulati o n 
P K para meters ( Cl/ F, V d/ F, Tla g, ka), i ncl u di n g i nter-i n di vi d ual varia bilit y, c o variate effects, 
resi d ual err or a n d t heir relati ve sta n dar d err or [R S E ] ), will be o btai ne d usi n g t he p o p P K 
m o del.  
•  Ot her i n di vi d ual ne m oliz u ma b P K para met ers will be deri ve d usi n g t he sa me p o p P K m o del 
(C ma x , T ma x , Ctr o u g h, A U C0 -4 w, A U C0 -8 w, A U C0 -1 2 w, A U C0 -1 6 w, an d t 1/ 2). 
•  I n a d diti o n, a static a n al ysis base d o n pre-d os e ( C tr o u g h) ser u m c o nce ntrati o n will be 
perf or me d usi n g a n  N C A . Data fr o m s u bjects wit h missi n g c o nce ntrati o n val ues ( missi n g 
sa m ples) ma y be use d if P K  para meters ca n b e esti mate d usi n g t he re mai ni n g data p oi nts.  
F or t he N C A a nal ysis, t he f oll o wi n g P K para meters will be deter mi ne d f or eac h s u bject 
base d o n C tr o u g h c o nce ntr ati o n:  
Fr o m b aseli ne t o Wee k 4 : 
▪ A U C 0 -4 w : Area u n der t he c o nce ntrati o n ti me c ur ve fr o m pre-d os e t hr o u g h 4  wee ks p ost d osi n g. 
A U C 0 -8 w  i ncl u des t he ser u m dr u g c o nce ntrati o n u p t o Wee k 4  (ie, t he s er u m c o nce ntrati o n 
c ollecte d at b as eli ne, Wee k 1 -2 , a n d 4).  
Fr o m b aseli ne t o Wee k 8 : 
▪ A U C 0 -8 w : Area u n der t he c o nce ntrati o n ti me c ur ve fr o m pre -d os e t hr o u g h 8 wee ks p ost  d osi n g . 
A U C 0 -8 w  i ncl u des t he ser u m dr u g c o nce ntrati o n u p t o Wee k 8  (ie, t he s er u m c o nce ntrati o n 
c ollecte d at b as eli ne, Wee k 1 -2 , 4  a n d 8). 
Fr o m b aseli ne t o Wee k 1 2:  
▪ A U C 0 -1 2 w: Area u n der t he c o nce ntrati o n ti me c ur ve fr o m pre -d ose t hr o u g h 1 2 wee ks p ost 
d osi n g. A U C 0 -1 2 w i ncl u des t he ser u m dr u g c o nce ntrati o n u p t o 
Wee k 1 2 (ie, t he ser u m 
c o nce ntr ati o n c ollecte d at b aseli ne, Wee k 1 -2, 4, 8 a n d 1 2).  
 
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Fr o m b aseli ne t o Wee k 1 6 : 
▪ A U C 0 -1 6 w: Area u n d er t he c o n ce ntrati o n ti me c ur ve fr o m pre-d ose t hr o u g h 1 6  wee ks p ost 
d osi n g. A U C 0 -1 6 w i ncl u des t he ser u m dr u g c o n ce ntrati o n u p t o 
Wee k 1 6 (ie, t he ser u m 
c o nce ntr ati o n c ollecte d at b aseli ne, Wee k 1 -2, 4, 8 , 1 2  a n d 1 6). 
8. 3   
I m m u n o ge nicit y 
Bl o o d sa m ple s will be c ollecte d acc or di n g t o Secti o n  7. 2  t o assess a nti-dr u g (a nti -ne m oliz u ma b ) 
a nti b o dies ( A D A). Ser u m sa m ples will be assesse d f or A D A at b aseline, W ee ks 4, 8, 1 6 , 2 4  a n d 
at a n y u nsc he d ule d visit f or safet y reas o ns.  A D A will be deter mi ne d at t hese ti me p oi nts b y t he 
desi g nate d C R O  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 ) scree ni n g assa y. 
T he ser u m c o n ce ntr ati o n will be assesse d usi n g a m ulti -tiere d a p pr oac h.  
If ser u m cir c ulati n g A D A is detecte d, pres e nce will be c o nfir me d a n d c haracteri ze d (e g,  f or 
ne utralizi n g p ote ntial) usi n g a vali date d assa y. I nci d e nce of p ositi ve A D A res ults will be 
s u m marize d (a bs ol ute occ urre n ce a n d perce nt of s u bjects).  
 
 
 
 
  
 
 Res ults 
will be 
 i ncl u de d as a n a p pe n di x i n t he fi nal 
C S R . 
8. 4   
P h ar m ac o d y n a mic s 
Bl o o d a n d strat u m c or ne u m  sa m ples will be c ollecte d t o i n vesti gat e t he effect of ne m oliz u ma b o n 
selecte d bi o mar kers. 
 
 
 
 
Bl o o d sa m ples will be c ollecte d f or assess me nt of T A R C  a n d I g E b y t h e ce ntral la b orat or y . 
 
 
 
 
 
 
 
 
 
 
 
 
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8. 5   
C D 1 4 1 5 2 Q u a ntific ati o n i n B i ol o gic al S a m pli n g  
C o nce ntrati o n of ne m oli z u ma b i n t he ser u m will be deter mi ne d b y t he d esi g nate d  C R O usi n g a 
vali date d E LI S A met h o d.  
 
 
Res ults will be 
 
i ncl u de d as a n a p p e n di x i n t he fi nal C S R .  
8. 6   
S afet y Assess me nts  
Safet y assess me nts will be c o n d ucte d f or all s u bjects at t he scree ni n g visit ( u p o n si g n i n g of t he 
I C F) a n d at e ver y s u bse q ue nt visit. 
8. 6. 1   
A d verse E ve nts  
A d verse E ve nt D efi niti o n  
A n A E is de fi ne d as a n y u nt o war d me dical occ urre nce i n a cli nical st u d y s u bject a d mi nistere d a 
me dici nal pr o d uct w hic h d oes n ot necessaril y ha v e a ca us al relati o ns hi p wit h t his treat me nt . A n 
A E ca n t heref ore be a n y u nfa v ora bl e  a n d u ni nt e n de d si g n (i ncl u di n g a n a b n or m al la b orat or y 
fi n di n g), s y m pt o m, or disease te m p orall y ass ociat e d wit h t he use of a me dici nal (i n vesti gati o nal) 
pr o d uct, w het her or n ot it is relate d t o t he me dici nal (i n vesti gati o nal) pr o d uct. T his i ncl u des a n 
e xacer bati o n of pre -e xisti n g c o n diti o ns or e v e nts, i nterc urre nt ill nesses, dr u g i nteracti o n or t h e 
si g nifica nt w orse ni n g of t he i n dicati o n u n der i n vesti gati o n t hat is n ot rec or de d els e w here i n t h e 
case re p ort f or m ( C R F ) u n der s pecifi c efficac y ass ess me nts .  
N otes :  
•  A n y ne w si g n or s y m pt o m re p orte d b y t he s u bject t hat a p pears after acci de ntal or i nte nti o nal 
o ver d ose or mis use s h o ul d be re p orte d as a n A E.  
•  W he ne v er p ossi ble, a dia g n osis s h o ul d be re p orte d o n t he A E f or m, i nstea d of si g ns, 
s y m pt o ms or a b n or mal la b orat or y val ues.  
•  Pre g na nc y is n ot t o b e c o nsi dere d as a n A E; h o we ver, it m ust be m o nit ore d  a n d re p orte d  as 
descri be d i n Secti o n  8. 6. 1. 2 . 
•  Eac h n e w e pis o de o f a c hr o nic diseas e (e g, h a y fe ver, aller g y, etc) fr o m t he scree ni n g visit 
s h o ul d be re p orte d as a n e w A E. 
 
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T he i n vesti gat or or desi g nee will re p ort all A Es t hat occ ur fr o m t he ti me t he I C F is si g ne d u ntil  
t he e n d of t he st u d y. T he sp o ns or/ C R O s h o ul d be i nf or me d if t he i n vesti gat or bec o mes a ware of  
a n y safet y i nf or mati o n t hat a p pears t o be dr u g relate d, e ve n after t he s u bject has c o m plete d t he  
cli nical trial.  
 
 
 
  
 
 
 
 
   
A d verse E ve nts assesse d as relate d t o t he treat me nt or st u d y pr oce d ure will be m o nit ore d u ntil t he y 
ha ve res ol v e d or reac h e d a sta ble c o n diti o n. Ot her A Es will be m o nit ore d u ntil t he last visit if t he y 
ha ve n ot res ol ve d or reac he d a sta ble c o n diti o n.  
T he in vesti gat or will o btai n a n d mai ntai n i n t he s u bject’s files all perti ne nt me dical rec or ds, 
i nf or mati o n a n d medical j u d g me nt fr o m c ollea g ues w h o assiste d i n t he treat me nt a n d f oll o w -u p of 
t he s u bject. If necessar y, t he in vesti gat or will c o nt act t he s u bject’s pers o nal p h ysicia n or h os pital 
staff t o o btai n f urt her det ails. 
Assess m e nt of S e verit y  
Eac h A E will be assi g ne d a cate g or y b y t he i n vesti gat or as f oll o ws:  
Mil d :  
A n A E t hat is easil y t olerate d b y t he s u bject, ca uses mi ni mal disc o mf ort a n d d oes 
n ot i nterfere wit h e ver y da y acti vities.  
M o derate :  
A n A E t hat is s ufficie ntl y disc o mf orti n g t o i nterfere wit h n or mal e ver y da y 
acti vities; i nter ve nti o n ma y be nee de d.  
Se vere :  
A n A E t hat pre ve nts n or mal e ver y da y acti vities; treat me nt or ot her i nter ve nti o n 
us uall y nee de d.  
If t here is a c ha n g e i n se v erit y of a n A E, it m ust be rec or de d as a s e parate e ve nt. 
Assess me nt  of C a us alit y  
T he i n vesti gat or is t o deter mi ne w het her t h ere is a reas o n a ble ca us al relati o ns hi p bet wee n t he  
occ urre nce of t he A E a n d e x p os ure t o t he st u d y dr u g (ie , ne m oliz u ma b) a n d/ or st u d y  pr oce d ure 
(e g, i njecti o n, T C S, bl o o d sa m ple c ollecti o n). 
 
 
 
 
 
 
 
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T he relati o ns hi p assess me nt f or a n A E is t o be c o m plete d usi n g t he f oll o wi n g defi niti o ns as a 
g ui deli ne f or all A Es occ urri n g d uri n g t his cli nical trial.  
Re as o n a ble P ossi bilit y:  
Acc or di n g t o t he re p orti n g i n vesti gat or, t here is a reas o na ble p ossi bilit y (ie , s u g gesti ve e vi de nce 
or ar g u me nts) t hat t here is a ca usal relati o ns hi p irres pecti ve of t he d ose a d mi nistere d: 
•  Bet wee n t he st u d y dr u g ( ne m oliz u ma b) a n d t he A E, a n d/ or  
•  Bet wee n t he cli nical trial pr ot oc ol pr oce d ure (e g , i njecti o n, T C S, bl o o d sa m ple c ollecti o n) 
a n d t he A E  
N o Re as o n a ble P ossi bilit y:  
N o s u g gesti ve e vi de nce or ar g u me nts ca n be i de ntifie d re gar di n g a ca usal relati o ns hi p bet wee n  t he 
st u d y dr u g or t he cli nical trial pr ot oc ol pr oce d ure a n d t he A E. 
Acti o n T a ke n  
T he i n vesti gat or will des cri be t he acti o n ta ke n i n t he a p pr o priate secti o n of t he C R F, as f oll o ws:  
•  N o n e 
•  St u d y dr u g st o p pe d  
•  St u d y dr u g te m p oraril y i nterr u pte d  
•  C o nc o mita nt me dicati o n  
•  O t her, s pecif y. 
F oll o w -u p of A d verse E ve nts  
All i n vesti gat ors s h o ul d f oll o w u p s u bjects wit h A Es u ntil t he e ve nt is res ol ve d or u ntil, i n t he 
o pi ni o n of t he i n vesti gat or, t he e ve nt is sta bilized or det er mi ne d t o b e c hr o nic . Det ails of A E 
res ol uti o n m ust be d oc u me nte d i n t he C R F. 
S u bjects s h o ul d be f oll o we d u p f or 1 2  wee ks ( ± 5 da ys)  after recei vi n g t he last d ose of st u d y dr u g, 
a n d a n y A Es t hat occ ur d uri n g t his  ti me s h o ul d be re p orte d acc or di n g t o t he pr oce d ures o utli ne d 
a b o ve.  
D oc u me nt ati o n a n d R e p orti n g of A d verse E ve nts  
A d verse e v e nt s s h o ul d be re p orte d a n d d o c u me nt e d i n acc or da nce wit h t he pr oce d ures o utli ne d 
bel o w . All A Es occ urri n g d uri n g t he st u d y m ust be  d oc u me nte d o n t he rele va nt C R F pa ges . T he 
f oll o wi n g data s h o ul d be d oc u me nte d f or eac h A E: 
•  D escri pti o n of t he s y m pt o m e ve nt  
•  C lassificati o n of ‘seri o us’ or ‘ not seri o us ’ 
•  Se verit y  
•  D ate of first o cc urre nce a n d dat e of res ol uti o n (if a p plica ble)  
 
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•  Acti o n ta ke n 
•  Ca usal relati o ns hi p  
•  O utc o me of e ve nt ( u n k n o w n, rec o vere d, n ot y et rec o vere d, rec o v ere d wit h se q uelae, deat h 
[ wit h date a n d ca use re p orte d]). 
8. 6. 1. 1   
A dverse Eve nts of S peci al I nterest  
A n A E SI  is a n ote w ort h y e ve nt f or t he st u d y dr u g t hat s h o ul d be m o nit ore d cl osel y a n d re p orte d 
i m me diatel y. See Secti o n  8. 6. 1. 4  f or re p orti n g pr oce d ure. A n A E SI ca n  b e eit her seri o us or n o n -
seri o us. 
Base d o n t he p ote ntial ris ks of ne m oliz u ma b a n d t he ris ks ass ociate d wit h bi ol o gics (a n d t heir 
bi osi milar e q ui vale nts) i n ge neral (ie, class effects), t he f oll o wi n g A Es will be c o nsi dere d A E SIs:  
•  I njecti o n-rel ate d reacti o ns 
− A na p h ylactic reacti o ns  
− Ac ute all er gi c reacti o ns re q uiri n g treat me nt  
− Se vere I S R (ie, lasti n g > 2 4 h o urs) 
•  Ne wl y -dia g n ose d ast h ma or w orse ni n g of ast h ma  
− M ore s pecificall y, s u bjects wit h  a me dical hist or y of ast h ma m ust be referre d t o t he 
p h ysicia n w h o ma na ges t heir ast h ma w he n:  
 A C T sc ore ≤ 1 9; a n A C T sc ore ≤ 1 9 c o n v e ys ast h ma w hic h ma y n ot be a d e q uatel y 
c o ntr olle d. A n A E SI is re p orte d base d o n t he i n vesti gat or’s cli nical j u d g me nt of t he 
ma na gi n g p h ysicia n ’s re p ort. 
 P E F < 8 0 % of t h e pre dict e d val ue; a n A E SI s h o ul d be re p orte d.  
 U ne x pect e d w orse ni n g of ast h ma is o bser ve d or re p orte d . A n A E SI is re p orte d 
base d o n t he i n vesti gat or’s cli nical j u d g me nt.  
− S u bjects wit h o ut  a me dical hist or y of ast h ma m ust be referre d t o a n a p pr o priat e 
res pirat or y p h ysicia n/s p ecialist w he n: 
 Si g ns  a n d/or s y mpt o ms s u g gesti ve of ast h ma h a v e bee n o bser ve d or re p orte d. A n 
A E SI is re p orte d bas e d o n t he i n vesti gat or’s cli nical j u d g me nt of t he s pecialist’s 
re p ort. 
 Res pirat or y assess me nt s u g gests a decli ne i n t he s u bject’s res pirat or y healt h. A n 
A E SI is re p orte d bas e d o n t he i n vesti gat or’s cli nical j u d g me nt of t he s pecialist’s 
re p ort. 
•  I nfecti o ns 
− A n y se vere i nf ecti o n, or a n y i nfecti o n re q uiri n g treat me nt wit h pare nteral a nti bi otics, or 
oral a nti bi otics/a nti virals/a ntif u n gals f or > 2 wee ks  
•  Peri p heral e d e ma: li m bs, bilateral  
•  Faci al e de ma  
 
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•  Ele vate d A L T or A S T ( > 3 × U L N) i n c o m bi nati o n wit h ele vate d bilir u bi n ( > 2 × U L N)  
8. 6. 1. 2   
Seri o us A dverse Eve nts  
A n  S A E is a n y u nt o war d me dical occ urre n ce or effect t hat, at a n y d os e , 
•  Res ults i n deat h.  
•  Is life-t hr eate ni n g (a n A E is life-t hreate ni n g if t h e s u bject was at i m me diate ris k of deat h 
fr o m t he e ve nt as it occ urre d, ie, it d oes n ot i ncl u de a reacti o n t hat mi g ht ha ve ca use d deat h 
if it ha d occ urre d i n a m ore seri o us f or m).  
•  Re q uires 
or 
pr ol o n gs i n patie nt 
h os pitalizati o n . (C o m plicati o ns 
occ u rri n g 
d uri n g 
h os pitalizati o n are A Es a n d S A Es if t he y ca use pr ol o n gati o n of t he c urre nt h os pitalizati o n . 
I n p atie nt h os pitalizati o n is c o nsi dere d t o ha ve occ urre d if t he s u bject has ha d t o sta y f or a 
ni g ht at t he h os pital. T h e criteri o n f or pr ol o n gati o n of h os pitalizati o n is als o defi ne d as a n 
e xtra ni g ht at t he h os pital. H os pitalizati o n ma y n ot c o nstit ute s ufficie nt gr o u n ds t o be 
c o nsi dere d as a n S A E if it is s olel y f or t he p ur p os e of dia g n ostic t ests [e ve n if relat e d t o a n 
A E ], electi ve h os pitalizati o n f or a n i nter ve nti o n t hat was alrea d y pla n ne d bef ore s u bject 
e nr ollme nt i n t he cli nical trial, a d missi o n t o a da y -care facilit y, s ocial a d missi o n [e g, if t h e 
s u bject has n o place t o slee p], or a d mi nistrati ve a d missi o n [e g, f or a y earl y e xa mi nati o n ]. 
T he details of s uc h h os pitalizati o ns m ust be rec or de d o n t he me dical hist or y or p h ysical 
e xa mi nati o n C R F).  
•  R es ults i n persiste nt or si g n ifica nt disa bilit y/i nca pacit y. ( An A E is i nca pacitati n g or 
disa bli n g if it res ults i n a s u bsta ntial a n d/ or per ma ne nt dis r u pti o n of t he s u bject’s a bilit y t o 
carry o ut n or m al life f u ncti o ns).  
•  Res u lts i n a c o n ge nital a n o mal y/ birt h defect.  
•  A n i m p orta nt me dical e ve nt t hat ma y n ot res ult i n deat h, be life-t hreate ni n g, or re q uire 
h os pitalizati o n , ma y be c o nsi dere d a n  S A E w he n, bas e d u p o n a p pr o priate me dical j u d g me nt, 
t he e ve nt ma y j e o par dize t he safet y of t he s u bject, a n d ma y re q uire me dical or s ur gical 
i nter ve nti o n t o pre ve nt o ne of t he o utc o mes liste d a b o ve i n t his defi niti o n. E xa m ples of s uc h 
e ve nts are i nte nsi ve treat me nt i n a n  e mer ge nc y r o o m or at h o me f or aller gic br o nc h os pas m, 
bl o o d d yscrasia, or c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n . 
8. 6. 1. 3   
Pr oce d ure f or Re p orti n g a Seri o us A dverse Eve nt  
F or a n y S A E occ urri n g d uri n g t he cli nical trial, re gar dless of w het her or n ot relate d t o t he st u d y 
dr u g a n d/ or pr o ce d ure, t he i n vesti gat or m ust:  
1.   
Ta ke pr o m pt a n d a p pr o priate me dical acti o n, if necessar y. T he safet y of t he s u bject is t he 
first pri orit y. 
2.   
E ns ure t hat t he e v e nt is e val uate d as a n  S A E. I m m e diatel y n otif y (wit hi n 2 4 h o urs of 
recei pt of t he e v e nt) t he 
 Safet y a n d P har mac o vi gila nce gr o u p of a n S A E 
re p ort, b y e mail or fa x: 
F a x N o.: 
 
S afet y e m ail: 
 
 
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N ote : I m me diate S A E re p orti n g is re q uire d b y t he i n vesti gat or if it occ urs d uri n g t he cli nical 
st u d y or wit hi n 1 2  wee ks ( ±  5 da ys)  of recei vi n g t he last d ose of st u d y dr u g, w het her or n ot 
t he e ve nt is c o nsi dere d t o be relate d t o t he i n v esti gati o nal pr o d uct. 
T he de m o gra p hics, me di cal hist or y, dr u gs /t hera pies, a n d me dical a n d s ur gical pr oce d ures 
f or ms m ust als o be a vaila ble f or re vi e w i n C R F, at t hat ti me. 
3.   
Se n d a n y rele va nt i nf or m ati o n or a n o n y mize d me dical rec or ds (e g , l a b orat or y test res ults) 
t o t he 
 Safet y a n d P har mac o vi gila nce gr o u p (see c o nt act det ails a b o ve), 
wit hi n 2 4 h o urs of recei pt of t his  rele va nt i nf or mati o n. 
4.   
M o nit or a n d rec or d t he pr o gress of t he e ve nt u ntil it res ol ves or reac hes a sta ble c o n diti o n,  
wit h or wit h o ut se q uelae. F or all a d diti o nal f oll o w -u p e val uati o ns, c o m plet e a n u p date d  
S A E f or m wit hi n 2 4 h o urs of recei pt of t he u p d ate d i nf or mati o n.  
5.   
O btai n a n d mai ntai n i n t he s u bject files all perti ne nt me dical rec or ds, i nf or mati o n, a n d 
me dical  j u d g me nts fr o m c ollea g ues w h o partici pat e i n t he treat me nt a n d f oll o w-u p of t he 
s u bject. If necessar y, c o ntact t he s u bject’s pers o nal p h ysicia n or h os pital staff t o o btai n 
f urt her det ails.  
6.   
W he n t he o utc o me of t he e ve nt is k n o w n, c o m plet e a n u p date d S A E f or m, if a p pr o priat e.  
7.   
Pr o m pt n otificati o n  of S A Es b y t he i n vesti g at or is esse ntial s o t hat le gal o bli gati o ns a n d 
et hical res p o nsi bilities t o war d t he safet y of s u bjects are met. T he sp o ns or h as a le gal 
res p o nsi bilit y t o n otif y b ot h t he l ocal re g ulat or y a ut h orit y a n d ot her re g ulat or y a ge nci es 
a b o ut t he safet y of a pr o d uct  u n der cli nical i n vesti gati o n. T he sp o ns or or its dele gate (i e , 
t he C R O) will c o m pl y wit h c o u ntr y-s pecifi c re g ul at or y re q uire me nts relati n g t o safet y 
re p orti n g t o re g ulat or y a ut h orities, I nstit uti o nal Re vie w B oar d (I R B)/I n de p e n de nt Et hics 
C o m mittee (I E C) a n d i n vesti gat ors. I n vesti gat or safet y re p orts are pre pare d f or  S us pecte d 
U ne x pect e d Seri o us A d verse Reacti o ns ( S U S A Rs) acc or di n g t o l ocal re g ul at or y  
re q uire me nts, a n d are f or war de d t o i n vesti gat ors as necessar y. 
A n i n vesti gat or w h o recei ves a n i n vesti gat or  s afet y re p ort d escri bi n g a n S A E(s) or ot her 
s pecific s afet y i nf or mati o n (e g, s u m mar y or listi n g of S A Es) fr o m t he sp o ns or or its  dele gat e 
(ie, t he C R O) will file it wit h t he I B a n d will n otif y t he I R B/I E C, if a p pr o priate acc or di n g t o 
l ocal re q uir e me nts. 
8.   
C o m pl y wit h t he a p plica ble re g ulat or y re q uire m e nt(s) relate d t o t he re p orti n g of S A Es t o  
t he I R B/I E C. 
8. 6. 1. 4   
Pr oce d ure f or Re p orti n g a n A dverse Eve nt of S peci al I nterest  
F or a n y A E SI occ urri n g d uri n g t he cli nical trial, re gar dless of w het her or n ot relate d t o t he 
treat me nt, t he i n vesti gat or m ust: 
1.   
Ta ke pr o m pt a n d a p pr o priate me dical acti o n, if necessar y. T he safet y of s u bjects is t he first  
pri orit y.  
2.   
E ns ure t hat t he e v e nt is e val uate d a n d rec or de d as a n A E SI i n t he C R F wit hi n 2 4 h o urs of 
recei pt of t he e v e nt . T he  
 Safet y a n d P har mac o vi gila nce gr o u p will recei ve 
a ut o mate d n otificati o n of a n A E SI b y e mail.  
 
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N ote : I m me diate A E SI  re p orti n g is re q uire d b y t he i n vesti gat or if it occ urs d uri n g t he cli nical 
st u d y or wit hi n 1 2  wee ks ( ±  5 da ys)  of recei vi n g t he last d ose of st u d y dr u g, w het her or n ot 
t he e ve nt is c o nsi dere d t o be relate d t o t he i n v esti gati o nal pr o d uct. 
T he de m o gra p hics, me di cal hist or y, dr u gs/t hera pies, a n d me dical a n d s ur gical pr oce d ures 
f or ms m ust als o be a vaila ble f or re vi e w i n C R F, at t hat time.  
3.   
Se n d a n y rele va nt i nf or m ati o n or me dical rec or ds (e g , la b orat or y test res ults) t o t he 
 Safet y a n d P har mac o vi gila nce gr o u p wit hi n 2 4 h o urs of recei pt of t his  
rele va nt i nf or m ati o n. 
4.   
M o nit or a n d rec or d t he pr o gress of t he e ve nt u ntil it res ol ves or reac hes a sta ble c o n diti o n, 
wit h or wit h o ut se q uelae. F or all a d diti o nal f oll o w -u p e val uati o ns, u p date t he A E SI  f or m 
wit hi n 2 4 h o urs of recei pt of t he u p date d i nf or mati o n.  
5.   
O btai n a n d mai ntai n i n t he files all perti ne nt me dical rec or ds, i nf or mati o n, a n d me dical 
j u d g me nts fr o m c ollea g u es w h o partici pat e i n t he treat me nt a n d f oll o w-u p of t he s u bject.  If 
necessar y, c o ntact t he s u bject’s pers o nal p h ysicia n or h os pital staff t o o btai n f urt her  details.  
6.   
W he n t he o utc o me of t he e ve nt is k n o w n, u p date t he  A E SI  f or m, if a p pr o priate. 
8. 6. 1. 5   
Pr oce d ure f or Re p orti n g Pre g n a ncies  
A n y pre g na n c y occ urri n g d uri n g cli nical trials, w here t he fet us c o ul d h a ve bee n e x p ose d t o t he  
st u d y dr u g, m ust be m o nit ore d u ntil its o utc o me i n or der t o e ns ure t h e c o m pl ete c ollecti o n of  safet y 
data.  If a s u bject bec o mes pre g na nt, t he i n vesti gat or m ust: 
1.   
Wit h dra w t he s u bject fr o m t he cli nical trial. T he s u bject m ust n ot recei ve a n y f urt her  
i njecti o n of t he st u d y dr u g. 
2.   
C o m plete as f ull y as p ossi ble t he Pre g na nc y S ur veilla nce F or m –  Part I: Hist or y a n d Start  
of Pre g na nc y. Se n d b y e mail or fa x al o n g wit h t h e e xit f or m  wit hi n 2 4 h o urs of recei pt of 
t he i nf or mati o n, t o t he 
 Safet y a n d P har mac o vi gila nce gr o u p. Refer t o 
Secti o n  8. 6. 1. 3 . 
N ote : I m me di ate pre g n a nc y  re p orti n g is re q uire d b y t he i n vesti gat or if it occ urs d uri n g t he 
cli nical st u d y or wit hi n 1 2  wee ks ( ±  5 da ys)  of recei vi n g t he last d ose of st u d y dr u g, w het her 
or n ot t he e ve nt is c o nsid ere d t o be relate d t o t he i n vesti gati o nal pr o d uct . 
3.   
M o nit or a n d rec or d t he pr o gress of t he pre g na n c y u ntil its o utc o me. C o ntact t he s u bject’s  
re g ular p h ysicia n ( ge n eral practiti o ner or g y nec ol o gist) or h os pital staff t o o btai n f urt her 
details a n d as k f or re g ular f oll o w-u p i nf or mati o n.  
4.   
Pr o vi de tri -m o nt hl y u p dates u ntil t he fi nal o utc o me of t he pre g na nc y, b y c o m pleti n g t he  
Pre g na nc y S ur veilla nce F or m –  Part II: C o urse a n d O utc o me of Pre g n a nc y. F or all 
a d diti o nal f oll o w -u p e val uati o ns, se n d t he f or m b y e m ail or fa x t o t he 
 
Safet y a n d P har mac o vi gila nce gr o u p  wit hi n 2 4 h o urs of recei pt of t he i nf or mati o n. If t he 
s u bject ca n n o l o n ger be reac h e d (ie, l ost t o f oll o w-u p), d oc u me nt ati o n of t he 
n o n -res p o nse/c o nt act wit h 2  p h o ne calls a n d a  l etter (certifie d wit h ret ur n recei pt) is 
re q uire d. 
 
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o ut -of -ra n g e la b orat or y val ues after t he scree ni n g visit are t o be re p orte d as a n A E if t his 
a b n or malit y was n ot prese n t at t he scree ni n g visit or is assesse d as ha vi n g w orse ne d si nce t he 
scree ni n g visit (ie, c ha n ge d si g nifica ntl y fr o m t he scree ni n g visit). 
W he ne v er p ossi ble, t he 
i n vesti gat or s h o ul d pr o vi de a dia g n osis of a n A E w he n re p orti n g t he a b n or mal la b orat or y val u e.  
S u bjects s h o ul d be re mi n de d t o be well -h y drate d bef ore  all visits f or p hle b ot o m y p ur p oses.  
S u bjects will be re q uire d t o fast f or at least 8 h o urs bef ore t he visits w he n bl o o d c he mistr y testi n g 
is pla n ne d, e xce pt f or t he scree ni n g visit. T he scree ni n g visit la b orat or y val ues m ust be a vaila ble 
bef ore  t h e baseli ne visit. 
T otal bl o o d v ol u mes t o be dra w n at eac h visit are pr o vi de d i n  t he cli nical la b orat or y ma n ual . 
A d diti o nal sa m ples ma y be re q uire d if me dicall y i n dicate d ( e g, at u nsc he d ule d visits f or safet y 
reas o ns, w h e n a n a b n or mal la b orat or y val ue is o bser ve d a n d re q uires a re -test).  
T he f oll o wi n g la b orat or y safet y tests will be perf or me d  as s pecifie d i n Secti o n  7. 2 : 
8. 6. 2. 1   
He m at ol o gy  
He m o gl o bi n , he m at ocri t, w hite bl o o d cell ( W B C) c o u nt (wit h  differe ntial  i ncl u di n g e osi n o p hils), 
re d bl o o d cell ( R B C) c o u nt, platelet c o u nt, a n d mea n cell v ol u me ( M C V ). 
8. 6. 2. 2   
Cli nic al C he mistry  
Creati ni ne, 
as p artate a mi n otra nsferas e ( A S T), ala ni ne a mi n otra nsferase ( A L T), g a m ma 
gl uta m yltra nsferas e ( G G T), al kali ne p h os p h atase, lactate d e h y dr o ge n ase ( L D H), t otal bilir u bi n, 
direct bilir u bi n, creati ni ne p h os p h o ki nase ([C P K ], C P K is oe nz y me test will be perf or me d o nl y if 
C P K is e le vate d t o > 2. 5  ×  U L N. T he i n vesti gat or s h o ul d als o c o ntact t he m e dical m o nit or i n s uc h 
sit uati o ns.), al b u mi n , t otal pr otei n, uric aci d, s o di u m, p otassi u m, calci u m, c hl ori de, gl uc ose, ur ea, 
t otal c h olester ol, trigl yceri des, l o w-d e nsit y li p o pr otei n ( L D L), a n d hi g h-de nsit y li p o pr otei n 
( H D L). 
8. 6. 2. 3   
Uri n alysis  
p H, gl uc ose, ket o nes, bl o o d, pr otei n , le u k oc ytes, nitrites, bilir u bi n, ur o bili n o ge n, a n d s pecifi c 
gra vit y . 
8. 6. 3   
Pre g n a nc y T esti n g  
All w o me n of c hil d beari n g p ote ntial will ha ve a ser u m pre g na n c y test at t he scree ni n g visit a n d 
uri ne pre g n a nc y tests ( U P Ts)  at s u bse q ue nt visits acc or di n g t o Secti o n  7. 2 .  
U P Ts wit h a se nsiti vit y < 2 5 I U/ L , will be pr o vi de d t o t he st u d y ce nters f or use i n t he trial. 
U P T s will be perf or me d at t he st u d y ce nt ers, a n d all ot her sa m ples will be s e nt t o ce ntral la b orat or y 
f or a nal ysis.  
If t he res ult of a U P T is p ositi ve, it m ust be c o nfir me d wit h a ser u m pre g n a nc y test, a n d n o st u d y 
dr u g s h o ul d be a d mi nistere d pe n di n g t he ser u m pre g na nc y test res ult.  
 
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8. 6. 4   
Vir ol o g y  
Vir ol o g y i ncl u di n g H Bs A g, H Bc A b, he patitis C, HI V-1 a n d -2 a nti b o d y will be assesse d at t he 
scree ni n g visit.  
8. 6. 5   
T u berc ul osis  Testi n g  
I m m u n os u p pressa nt bi ol o gic treat me nts ha ve bee n s h o w n t o i ncrease t he ris k of T B i nfecti o n or 
t o ca use c o n v ersi o n fr o m late nt t o acti ve T B i n s o me circ u msta nces. Beca use of t his, su bjects  will  
be scree ne d f or acti ve or late nt T B bef ore  e ntr y i nt o t his st u d y. 
8. 6. 5. 1   
Defi niti o ns  
Acti ve T B is a disease ca use d b y Myc o b a cteri u m t u berc ul osis  i n a n y part of t he b o d y a n d t hat is 
i n a n acti ve state as det er mi ne d b y eit her a s mear or c ult ure ta ke n fr o m a n y s o urce i n t he pers o n’s 
b o d y w hic h tests p ositi ve f or T B or b y ra di o gra p hic e vi de nce . I n di vi d uals wit h acti ve T B are 
s y m pt o matic, de pe n di n g u p o n t he l ocati o n of t he disease ( m ost c o m m o nl y i n t he l u n gs b ut als o 
p ossi bl y i n t he brai n, ki d ne ys, s pi ne, or else w h ere), a n d ca n s prea d t h e i nfecti o n t o ot hers.  
Late nt T B is sai d t o e xist w he n a n i n di vi d ual is i nfecte d wit h M t u berc ul osis , as e vi de nce d b y a 
p ositi ve I nterfer o n Ga m ma Release Assa y ( or I G R A)3 5, s uc h as Q ua nti F E R O N-T B G ol d, b ut is 
as y m pt o matic a n d has n o e v i de nce of acti ve i nfecti o n o n scree ni n g pat h ol o g y or ra di o gra p hic tests. 
S uc h i n di vi d uals d o n ot pass t he diseas e t o ot hers a n d s h o ul d c o m me nce a c o urse of pr o p h ylactic 
a nti m yc o bacteri al treat me nt t o eli mi nate t h e i nfecti o n a n d c o m mit t o c o m pleti n g t he c o u rse of 
treat me nt. 
8. 6. 5. 2   
T u berc ul osis Scree ni n g  
I d eall y, as part of t he me dical hist or y, t he s u bject s h o ul d be as ke d if t he y ha ve pres e nte d wit h 
acti ve or l ate nt T B i n t h e past a n d w het her t he y ha ve recei ve d a Bacill us Cal mette -G uéri n ( or 
B C G)  vacci nati o n. T he y s h o ul d als o be as ke d if t he y ha ve bee n i n c o ntact wit h a n y i n di vi d uals 
k n o w n t o ha ve acti ve T B, or bee n place d i n a n y circ u msta nces t hat ma y ha ve e x p ose d t he m t o a n 
i ncreas e d ris k of T B i nfecti o n, s uc h as tra vel t o T B-e n de mic re gi o ns, cl ose c o ntact wit h per s o ns 
wit h acti ve T B, or w or k place ris k (e g, pris o n, h os pitals).  
A  s u bject w h o tests p ositi ve f or late nt T B ( wit h a p ositi ve Q ua nti F E R O N test ), s h o ul d be referre d 
t o t he s u bject’s tr eati n g p h ysicia n f or a p pr o priate f oll o w-u p.  If t he res ult is i n deter mi nate, t he test 
ma y be re p eate d  o nce. If c o nfir me d i n d eter mi nate, t he s u bject s h o ul d t he n be ma na g e d as t h o u g h 
t he y ha ve a p ositi ve test res ult. 
8. 6. 6   
Vit al Si g ns  
Vital si g ns will be e val uate d at t he scree ni n g visit a n d at eac h s u bse q ue nt visit acc or di n g t o 
Secti o n  7. 2 . Vital si g ns will i ncl u de p ulse rate, s yst olic a n d diast olic bl o o d press ure (after t h e 
s u bject has bee n sitti n g f or at least 5 min utes), a n d b o d y te m perat ure. All a b n or mal val ues at t he 
 
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scree ni n g visit i de ntifie d as cli nicall y si g nifica nt b y t he i n vesti gat or will be rec or de d. A n y 
cli nicall y si g nifica nt c ha n ges fr o m t he scree ni n g visit will be rec or de d as a n A E.  
8. 6. 7   
Hei g ht a n d Wei g ht  
Hei g ht will be meas ure d at scree ni n g  a n d d esi g nat e d  visit s; wei g ht will be meas ure d at all visits. 
S u bject m ust be at least 3 0  k g  at b ot h scree ni n g a n d baseli ne visits i n or der t o be e nr olle d i nt o t his 
cli nical trial.  
A n y cli nicall y si g nifica nt wei g ht c ha n ges  fr o m t he scree ni n g visit will be rec or de d as a n A E. 
8. 6. 8   
P h ysic al E x a mi n ati o n  
C o m plete p h ysical e x a mi nati o n  ( P E) s h o ul d b e perf or me d at all sc h e d ule d  visits a n d a n y 
u nsc he d ule d visits f or safet y reas o ns, acc or di n g t o Secti o n  7. 2 . A c o m plete  P E  will  i ncl u de 
assess me nts of t he hea d, ears, e yes, n ose, t hr oat, nec k (i ncl u di n g t h yr oi d), s ki n /i nte g u me ntar y 
s yste m, car di o vasc ular s yste m, res pirat or y s yste m ( wit h res pirat or y assess me nt; see Secti o n  8. 6. 9 ), 
gastr oi ntesti nal s yste m, m usc ul os keletal s yste m, l y m p h n o des, a n d ner v o us s yste m.  
I n v esti gat or s h o ul d ass ess all a b n or mal fi n di n gs f or cli nical si g nifica nce. All cli nicall y si g nifica nt 
a b n or mal fi n di n gs at t he scree ni n g visit will be rec or de d i n t he Me di cal Hist or y f or m. A n y 
cli nicall y si g nifica nt c ha n ges fr o m t he scree ni n g visit will be rec or de d as a n A E.  
8. 6. 9   
Res pir at or y Assess m e nt s 
At scree ni n g, t he i n vesti gat or s h o ul d s pecifi call y q uesti o n all s u bjects a b o ut a n y me di cal hist or y 
of ast h ma a n d t heir res pir at or y healt h (e g, w heezi n g, aller gies, i nfecti o ns). S u bjects wit h a hist or y 
of ast h ma will be q uesti o ne d a b o ut t h e seas o nalit y of t heir ast h ma  a n d k n o w n tri g gers, s u c h as 
aller ge ns. Ne wl y -dia g n ose d ast h ma or w orse ni n g of ast h ma d uri n g t he st u d y will be re p orte d as 
a n A E SI.  
8. 6. 9. 1   
Ast h m a C o ntr ol Test  
S u bjects wit h a me dical hist or y of ast h ma will ta ke t he Ast h ma C o ntr ol Test  ( A C T) at eac h st u d y 
visit bef ore q uesti o ni n g a n d p h ysical e xa mi nati o n b y t he i n vesti gat or. S u bjects wit h a ne w ( de 
n o v o) dia g n osis of ast h ma will ta ke t he A C T be gi n ni n g at t he visit t he dia g n osis was first 
c o nfir me d a n d t hereaft er, at all s u bse q ue nt st u d y visit s. S u bjects wit h a n A C T sc ore ≤ 1 9 s h o ul d 
be referre d t o t he p h ysici a n ma na gi n g t heir ast h m a.  
8. 6. 9. 2   
Res pir at ory E x a mi n ati o n  
T he A C T will ai d t he i n vesti gat or’s q uesti o ni n g of s u bjects wit h a me dical hist or y of ast h ma a n d 
s h o ul d be c o m plete d bef ore t h e cli nical q uesti o ni n g . All s u bjects will be as ke d n o n -lea di n g 
q uesti o ns a b o ut a n y res pirat or y c ha n g es. T he i n vesti gat or or desi g nee will t he n perf or m a 
res pirat or y e x a mi nati o n of all s u bjects at all visits. S u bjects wit h a me dical hist or y of ast h ma 
 
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s h o ul d be referred t o t he p h ysicia n ma na gi n g t heir ast h ma if u ne x pecte d w orse ni n g of ast h ma is 
o bser ve d or re p orte d. S u bjects wit h o ut a me di cal hist or y of ast h ma w h o e x perie n ce res pirat or y 
c ha n ges (e x a m fi n di n gs or ne wl y -re p orte d si g ns a n d/ or s y m pt o ms s u g gesti ve of ast h ma) s h o ul d 
be referre d t o a res pirat or y s pecialist .  
8. 6. 9. 3   
S pir o metry/ Pe a k E x pir at ory Fl o w  
All s u bjects will ha ve s pir o met ry ( P E F) perf or me d at scree ni n g a n d b aseli ne. For s u bjects 
re p orti n g a me dical hist or y of ast h ma, s pir o metr y ( P E F) will be perf or me d at eac h visit d uri n g t he 
cli nical trial u n der t he s u per visi o n of q ualifie d st u d y pers o n nel. S u bjects wit h a ne w ( de n o v o) 
dia g n osis of ast h ma will be e val uate d b y s pir o metr y ( P E F) at all vis its after t he dia g n osis is  first 
ma de .   
P ea k e x pir at or y fl o w  meas ure me nts s h o ul d c o nsist of 3 g o o d eff orts , wit h t he b est res ult 
d oc u me nte d. It is prefera ble t hat  t he P E F meas ure me nt be perf or me d bef ore n o o n or at t he sa me 
ti me d uri n g eac h st u d y visit w he ne ver p ossi ble. Atte m pts s h o ul d be ma de t o wit h h ol d ast h ma 
me dicati o n o n st u d y visit da ys u ntil after P E F testi n g is c o m plete, t o t he e xt e nt it d oes n ot p ose a n 
u n d ue ris k t o t h e s u bject, t o a v oi d i nterfere nce wit h P E F meas ure me nts. S u bjects wit h a P E F < 
8 0 % of t he pre dicte d val ue s h o ul d be referre d t o a res pirat or y s p ecialist.  
8. 6. 9. 4   
Re s pir at ory Referr als 
S u bjects wit h a m e dical hist or y of ast h ma m ust b e referre d t o t he p h ysicia n w h o ma na g es t heir 
ast h ma w he n:  
•  P E F < 8 0 % of t h e pre dict e d val ue .  
•  A C T  sc ore ≤ 1 9. As a n A C T sc ore ≤ 1 9 c o n ve ys ast h ma t hat m a y n ot be a de q uatel y 
c o ntr olle d . 
•  U ne x pect e d w orse ni n g of ast h ma  is o bser ve d or re p orte d. 
S u bjects wit h o ut a me dical hist or y of ast h ma m ust be referre d t o a n a p pr o priate s pecialist p h ysicia n 
w he n:  
•  S i g ns a n d/or s y m pt o ms s u g gesti ve of ast h ma are n e wl y -o bser ve d or re p orte d. 
•  Res pirat or y assess me nt s u g gests a decli ne i n t he s u bject’s res pir at or y he alt h. 
8. 6. 1 0   
Electr oc a r di o gr a m  
A 1 2 -lea d Electr o car di o gra m ( E C G) will be perf or me d acc or di n g t o Secti o n  7. 2 . E C Gs f or eac h 
s u bject s h o ul d be o btai ne d usi n g t he sa me electrocar di o gra p h mac hi ne w he ne ver p ossi ble. T o 
mi ni mize varia bilit y, s u bjects m ust re mai n i n a resti n g p ositi o n f or at least 1 0 mi n utes bef ore  eac h 
E C G rec or di n g. E n vir o n me ntal distracti o n s h o ul d be a v oi de d d uri n g t he pre -E C G resti n g peri o d 
a n d d uri n g E C G rec o r di n g. E C Gs s h o ul d be perf or me d bef ore  a n y sc he d ule d vital si g n 
meas ure me nts a n d bl o o d dra ws. F or safet y m o nit ori n g, t he i n vesti gat or or q ualifie d desi g nee m ust 
re vie w, si g n a n d date all E C G traci n gs. Pa per E C G rec or di n gs will be ke pt as part of t he s u bject 
file at t he st u d y ce nter. All a b n or mal E C G fi n di n gs c o nsi dere d t o be cli nicall y si g nifica nt b y t he 
 
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i n vesti gat or at t he scree ni n g visit will be rec or de d. A n y cli nicall y si g nifica nt c ha n ges fr o m t he 
scree ni n g visit will be re p orte d as A Es i n t he C R F. 
8. 7   
I n de pe n de nt D at a M o nit ori n g C o m mittee  
A n I D M C c o nsisti n g of i n de pe n de nt e x p erts will re vie w a n d m o nit or t he acc u m ulati n g safet y dat a 
f or t he st u d y o n a n o n g oi n g basis .  
T he s pecific res p o nsi bilities a n d c o m p ositi o n of t he I D M C are o utli ne d i n a se p arate d oc u me nt, 
t he I D M C C harter . T he details of o ut p uts pr o vi de d f or t he meeti n gs are als o refere nce d i n t his 
se parat e I D M C C harter.  
 
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9   
St atis tic al Met h o ds  
A Statistical A nal ysis Pla n ( S A P) will be de v el o pe d as a s e parate d o c u me nt. T he S A P will c o ntai n 
detaile d a n d tec h ni cal d escri pti o n s of s pecifi c data c o n v e nti o ns, calc ulati o ns a n d of statistical 
pr oce d ures f or e xec uti n g t he a nal yses t hat are s pecifie d i n t he secti o ns of t h e pr ot oc ol bel o w. A n y 
c ha n ges ma de t o t he a n al ysis after fi nalizati o n of t he S A P will be d oc u me nte d i n t he cli nical st u d y 
re p ort. 
T he fi nal statistical a nal ysis will i ncl u de all s u bj ects w h o ha ve c o m plete d t he st u d y. A n i nteri m 
a nal ysis f oc use d o n P K a n d safet y will be perf or me d after a p pr o xi mat el y 1 0 s u bjects ha ve 
c o m plete d t he Wee k 8 visit as t he basis t o all o w recr uit me nt of a d olesce nt s u bjects i n t he pla n ne d 
P hase 3 pi v otal st u dies . 
9. 1   
D at a Tr a nsf or m ati o ns  
Details of a n y dat a tra nsf or mati o n f or e n d p oi nts will be  pr o vi de d i n t he S A P.  
9. 2   
A n al ys is P o p ul ati o ns 
T he f oll o wi n g p o p ul ati o ns a n d e val ua bilit y criteria will be use d t o a nal y ze t he p har mac o ki netic -
p har mac o d y n a mic ( P K/ P D ), safet y, efficac y, a n d Q o L e n d p oi nts. 
9. 2. 1   
P K  A n al ysis P o p ul ati o n  
T he P K a nal ysis p o p ulati o n will i ncl u de all s u bjects i n t he safet y p o p ulati o n w h o pr o vi de at least 
o ne p ost -baseli ne e v al ua ble dr u g c o nce ntrati o n val ue.  All P K a n d P K/ P D e n d p oi nts will be 
a nal yse d usi n g  t he P K p o p ulati o n.  
9. 2. 1. 1   
S afety P o p ul ati o n  
T he safet y p o p ulati o n will c o m prise all s u bjects i n t he I T T p o p ulati o n w h o recei ve at least o ne 
d ose of st u d y dr u g. S u bjects will o nl y be e xcl u de d if t here is clear d oc u m e nte d e vi de nce t hat t he 
s u bject di d n ot recei ve a n y st u d y dr u g i njecti o n. All safet y data will be s u m marize d bas e d o n t he 
safet y p o p ulati o n. 
9. 2. 2   
I nte nt-t o-Tre at (I T T) P o p ul ati o n  
T he I T T p o p ulati o n will c o nsist of all e nr olle d s u bjects. All efficac y e n d p oi nts will be a nal yze d 
base d o n t he I T T p o p ul ati o n.  
 
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9. 3   
I m p ut ati o n of Missi n g D at a 
T he pri mar y met h o d t o i m p ute t he missi n g val ues f or t he efficac y assess m e nts will be as f oll o ws:  
C o nti n u o us E n d p oi nts: T o i m p ute t he missi n g val ues f or efficac y c o nti n u o us e n d p oi nts, Last 
O bser vati o n Carrie d F or war d ( L O C F) a p pr oac h will be use d. I n a d diti o n, O bser ve d Cas e ( O C) 
will be carri e d o ut as se nsiti vit y a nal ysis.  
Bi n ary E n d p oi nts: All missi n g val ues will be treate d as a N o n -Res p o n d er f or t he bi nar y e n d p oi nts. 
L O C F a n d O C will be us e d as se nsiti vit y a nal ysis t o i m p ute t he missi n g val ues.  
Use o f R esc ue T h er a p y: All E fficac y D ata, E xce pt O C, W ill B e S et T o M issi n g A fter R esc ue 
M e dicati o n Is U se d. I n O C A nal ysis, N o O bser ve d D at a A fter S u bject H as R ecei ve d R esc u e 
T reat me nt W ill B e E xcl u de d.  
T here will be n o i m p utati o ns f or P K, missi n g la b orat or y, a n d vital si g n d ata. F urt her det ails o n 
i m p utati o n of missi n g data will be pr o vi de d i n t he S A P. 
9. 4   
Descri pti ve a n d I nfere nti al St atistic al A n al yses  
9. 4. 1   
De m o gr a p h y a n d B aseli ne C h ar acteristics  
S u bject dis p ositi o n, de m o gra p hics, baseli ne c haract eristics, pre vi o us t hera pies, c o nc o mita nt 
t hera pies, a n d p h ysical e xa m i nati o ns will be s u m marize d b y des cri pti ve statistics. Pre - a n d p ost -
treat me nt t hera pi es a n d pr oce d ures will be s u m marize d se p aratel y. 
9. 4. 2   
P K P ar a meters a n d A D A A n al yses  
T he P K para meters o btai ne d usi n g m o del li n g tec h ni q ues will be re gar de d as pri mar y e n d p oi nts f or 
t he P K a n al yses (s ee details i n Secti o n  6. 4. 1 ). Pri mar y i nfere nce f or all t he P K para meters will be 
base d o n t h e p har mac o ki netic a nal ysis p o p ulati o n.  
T he P K P D rel ati o ns hi p bet wee n n e m oliz u ma b plas ma c o nce ntrati o ns a n d t he selecte d cli nical 
o utc o mes  ( E A SI, I G A a n d N R S) will be i n vesti gate d , as a p pr o priate, usi n g a P K P D m o del 
de vel o p me nt base d o n pre vi o us cli nical da ta. 
T he p o p -P K a n d P K P D m o dels will be detaile d i n a se parate M o deli n g A nal ysis Pla n.  
T he c o nce ntr ati o n at eac h ti me p oi nt will be s u m marize d as arit h metic mea n, sta n dar d de viati o n, 
me dia n, mi ni m u m, a n d ma xi m u m, n u m ber of B L Qs ( Bel o w t he Li mit of Q ua ntificati o n).  
Descri pti ve statistics ( n, arit h metic mea n, sta n dar d de viati o n [ S D], mi ni m u m, me dia n, ma xi m u m) 
will be calc ulate d f or all P K para meters o btai ne d usi n g N C A.  
F or A D A anal yses , t he inci de nce of p ositi ve A D A res ults will be s u m marize d (a bs ol ut e 
occ urre nce, perce nt of s u bjects, treat me nt -relate d A D A). A prese nt ati o n of A D A res ults will be 
detaile d i n t he S A P.  
 
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9. 4. 3   
S afet y A n al yses  
All safet y a nal ys es will be base d o n t he s afet y p o p ulati o n. S u m mar y of all safet y e n d p oi nts will 
be prese nt e d.  
9. 4. 3. 1   
E xte nt of E x p os ure  
T he d urati o n of e x p os ure a n d t he n u m ber of s u bjects e x p ose d t o st u d y dr u g  will be s u m marize d 
b y visit. T he n u m ber of s u bjects e x p ose d will be prese nte d b y st u d y peri o ds (treat me nt peri o d a n d 
f oll o w-u p peri o d).  
9. 4. 3. 2   
A dverse Eve nts  
Treat me nt -e mer ge nt ad v erse eve nts ( T E A Es), defi ne d as t h ose A Es occ urri n g after t he first 
a d mi nistrati o n of st u d y treat me nt u ntil t he last st u d y visit, will be ta b ulate d i n fre q ue n c y ta bles b y 
S yste m Or ga n Class a n d Preferre d Ter m base d o n t he Me dical Dicti o nar y f or Re g ulat or y Acti vities 
( Me d D R A) f or eac h st u d y p hase. A d diti o nal s u m mar y ta bles will be pr o vi de d f or S A Es, A Es 
relate d t o t he st u d y dr u g a n d/ or st u d y pr oce d ure, A E SIs, a n d A Es lea di n g t o treat me nt 
disc o nti n uati o n a n d st u d y wit h dra wal. F or a gi v e n A E, a s u bject will be  c o u nte d o nce e v e n if 
he/s he has e x p erie nce d m ulti ple e pis o des of t hat partic ular A E.  
Pre -treat me nt A Es will be liste d se parat el y. 
9. 4. 3. 3   
Electr oc ar di o gr a m  
All E C G c ha n g e s fr o m scree ni n g at Wee k 1 6  a n d u nsc he d ule d visits  will be s u m marize d  f or safet y 
reas o ns. 
9. 4. 3. 4   
Cli nic al L a b or at ory  
La b orat or y d ata (a bs ol ute val ues a n d c ha n g e fr o m b aseli ne) will be s u m marize d. I n a d diti o n, t he 
n u m ber a n d perce nt of s u bjects bel o w, wit hi n, a n d a b o ve t he la b orat or y refere n ce ra n ges will be 
s u m marize d b y visit . S hift ta bles will be ge nerate d usi n g t he refere nce ra n ges.  
A b n or mal la b orat or y v al ues fr o m tests perf or me d o n t he b aseli ne visit will n ot be c o nsi dere d as 
T E A Es, bec au se t he sa m ple c ollecti o n will be c o n d ucte d bef ore  st u d y dr u g a d mi nistrati o n. 
9. 4. 3. 5   
Vit al Si g ns  
All vital si g ns a n d wei g ht data (a bs ol ute val ues a n d c ha n ge fr o m b aseli ne) will be s u m marize d b y 
visit. I n a d diti o n, t he n u m ber a n d p erce nt of s u bj ects wit h cli nicall y si g nifica nt a b n or mal val ues 
of cli nical c o ncer n will b e s u m marize d.  
 
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9. 4. 3. 6   
Ast h m a C o ntr ol Test  
T otal A C T sc ores will be s u m marize d b y visit.  
9. 4. 3. 7   
Pe a k E x pir at ory Fl o w  
Pea k e x pir at or y fl o w  meas ure me nts (a bs ol ute val ues a n d c ha n ge fr o m 
b aseli ne) will be 
s u m marize d b y visit.  
F urt her details o n t he safet y a nal yses will be pr o vi de d i n t he S A P. 
9. 4. 4   
Effic ac y A n al yses  
Pri mar y i nfere nce f or all t he efficac y a n al yses will be b ase d o n t he I T T p o p ulati o n at t he Wee k 1 6  
e n d p oi nt.  
All efficac y varia bl es will be s u m marize d b y visit. T he cate g ori cal varia bles will be s u m marize d 
b y fre q u e nc y a n d perce nta ge f or eac h res p o ns e cat e g or y ( N, %). T he c o nti n u o us varia bles will b e 
s u m marize d usi n g mea n, me dia n, mi ni m u m, ma xi m u m, a n d sta n dar d de viati o ns f or t he data 
c ollecte d at eac h visit. F urt her details o n efficac y a nal yses will be pr o vi de d i n t he S A P.  
9. 4. 5   
Bi o m ar ker A n al yses  
Pri mar y i nfere nce f or all bi o mar ker a nal yses (i ncl u di n g e osi n o p hil, T A R C, I g E, etc) will be bas e d 
o n t he o bser ve d cases. All bi o mar ker v aria bles ( e g, a bs ol ute a n d c h a n ge fr o m b as eli ne) will b e 
s u m marize d d escri pti vel y at eac h ti me p oi nt. If t he varia ble is n ot Ga ussia n distri b ute d t he n it will 
be l o g tra nsf or me d. I n a d diti o n, a b o x -pl ot will be pr o d uce d at eac h ti me p oi nt. Bi o mar ker a n al ysis 
will be c o n d ucte d b y t he desi g nate d C R O base d o n a se parate bi o mar k er a nal ysis pla n.  
9. 4. 6   
Q u alit y of Life A n al yses  
Pri mar y st u d y p o p ulati o n f or all Q o L  a nal yses will be base d o n I T T p o p ulati o n. T he D L QI/c D L QI  
data will be s u m marize d descri pti vel y b y a nal ysis visit. Details of t he a nal yses will be pr o vi de d i n 
t he S A P. 
9. 5   
S a m ple S ize A ss u m pti o n 
Base d o n t he varia bilit y of n e m oliz u ma b ser u m c o nce ntrati o ns ( o bser ve d i n a d ults d uri n g pre vi o us 
st u dies), a sa m ple size of 2 0 was c o nsi dered s uffi cie nt t o calc ulate P K para meters wit h a de q uate 
precisi o n a n d t o e ns ure a de q uate re pres e ntati o n acr oss t he a d olesce nt a ge ra n g e. N o f or mal 
p o weri n g of t he trial was perf or me d t o d eter mi ne sa m ple size re q uire me nt . 
T he st u d y will atte m pt t o e nr oll at least 3 s u bjects wit h l o w b o d y wei g ht ( ≤ 6 1  k g) f or t he i nteri m 
a nal ysis a n d a p pr o xi mat el y 6 t otal s u bjects wit h l o w b o d y wei g ht f or t he o v erall st u d y p o p ulati o n.  
 
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9. 6   
Pr ot oc ol D e vi ati o ns  
All pr ot oc ol de viati o ns relate d t o st u d y i ncl usi o n or e x cl usi o n criteria, c o n d u ct of t he st u d y, s u bject 
ma na ge me nt, or s u bject assess me nt s will be i de ntifie d, e val uate d, a n d res ol ve d (if a p plica ble) 
bef ore  t he res p ecti ve dat a base l oc k (i nteri m or fi nal a nal ysis), a n d will be descri be d i n t he fi nal 
S A P  / cli nical st u d y re p ort. 
 
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1 0  
Q u alit y Ass ur a nce a n d Q u alit y C o ntr ol  
1 0. 1   
A u dit a n d I ns pecti o n  
St u d y ce nters a n d st u d y d oc u me ntati o n ma y be s u bject t o Q ualit y Ass ura nce a u dit d uri n g t he 
c o urse of t he st u d y b y t he s p o ns or or its n o mi nate d re prese ntati ve . I n a d diti o n, i ns pecti ons ma y b e 
co n d ucte d b y re g ulat or y a ut h orities  at t heir discreti o n.  
1 0. 2   
M o nit ori n g  
Data f or eac h s u bject will be rec or de d o n C R F s. Dat a c ollecti o n m ust be c o m plete d f or eac h s u bject 
w h o si g ns a n i nf or me d c o nse nt f or m (I C F) a n d is a d mi nistere d st u d y dr u g. 
I n acc or da n ce wit h curre nt G o o d Cli nical Practice ( G C P ) a n d I C H g ui deli nes, t he st u d y m o nit or 
will carr y o ut s o urce d oc u me nt verificati o n at re g ular i nter vals t o e ns ure t h at t he d ata c ollecte d i n 
t he C R F are acc urate a n d relia ble.  
T he i n vesti gat or m ust per mit t he m o nit or, t he I E C /I R B, t he s p o ns or’s i nter nal a u dit ors, a n d 
re pres e ntati ves fr o m re g ulat or y a ut h orities direct access t o all st u d y-relate d d o c u me nts a n d 
perti ne nt h os pital or me dical rec or ds f or c o nfir mati o n of data  c o ntai ne d wit hi n t he C R Fs . 
1 0. 3   
Pers o n nel Tr ai ni n g  
St u d y m o nit ors a n d all rele va nt p ers o n nel will be trai ne d b ef ore  st u d y i nitiati o n o n t he c o n diti o n 
t o be treate d, t he Sta n dar d O perati n g Pr oce d ures ( S O Ps) t o be use d i n t his cli nical trial, t he 
pr ot oc ol, a n d a ll st u d y-s pecific pr oce d ures. Tea m or ga nizati o n, c o m m u nicati o n, a n d o p erati o nal 
iss ues will als o be disc usse d a n d a gree d u p o n. 
I n v esti gat ors, e v al uat ors, st u d y c o or di nat ors, p h ar macists a n d ot her a p plica ble pers o n nel are 
rec o m me n de d t o atte n d a n i n vesti gator meeti n g. D uri n g t he m eeti n g, partici pa nts will be trai ne d 
o n t he pr ot oc ol, I C H -G C P, st u d y -s pecific pr oce d ures (i ncl u di n g efficac y assess me nt scales a n d 
i nstr ucti o n f or use of t he st u d y dr u g), I R T a n d C R F c o m pleti o n.  
All pers o n nel i n v ol ve d i n t he st u d y c o n d u ct will recei v e trai ni n g bef ore  partici pati n g i n a n y 
pr oce d ure a n d/ or e val uati o n. Eac h st u d y ce nter will ha ve a trai ni n g rec or d as part of t he site file 
a n d Trial Master File.  
1 0. 4   
D at a M a n a ge me nt a n d C o di n g  
T he desi g nat e d C R O  will be res p o nsi ble f or acti v ities ass ociat e d wit h t he data ma na g e me nt of t his 
st u d y. T his will i ncl u de , b ut is n ot li mite d t o, setti n g u p a rele va nt data base a n d data tra nsfer 
mec ha nis ms, al o n g wit h a p pr o priate vali dati o n of data a n d res ol uti o n of q ueries . All data 
ma na ge me nt acti vit ies will be detaile d i n t he data ma na ge me nt pla n ( D M P). 
St u d y ce nters will e nter data directl y i nt o a n electr o nic data ca pt ure ( E D C) s yste m b y c o m pleti n g 
t he C R F via a sec ure i nt er net c o n n ecti o n. Data e ntere d i nt o t he C R F m ust be verifia ble a gai nst 
s o urce d o c u me nts at t he st u d y ce nter. Data t o b e rec or de d directl y o n t he C R F will be i de ntifie d 
 
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Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
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C O N FI D E N TI A L  
Pa ge 7 9  of 9 9  
a n d t he C R F will be c o nsi dere d t he s o urce d oc u me nt  at t he st u d y ce nter. Data t o be rec or de d 
directl y o n t he C R F will be i de ntifie d , a n d t he C R F will be c o nsi dere d t h e  s o urce d oc u me nt. A n y 
c ha n ges t o t he dat a e ntere d i nt o t he E D C s yste m will be rec or de d i n t he a u dit trail .  
1 0. 5   
Cli nic al Tri al C o n d uct  
Wit h t he e xce pti o n of a v oi di n g a n i m me diate ris k t o a s u bject, t he i n vesti gat or s h o ul d n ot de viate 
fr o m t he cli nical trial prot oc ol or i m ple me nt a n y c ha n g es wit h o ut writte n a p pr o val fr o m t he 
sp o ns or a n d pri or re vie w a n d d oc u me nte d a p pr o val/fa v ora bl e o pi ni o n fr o m t he I R B/I E C of a 
pr ot oc ol a me n d me nt.  
C ha n ges t hat i n v ol ve o nl y l o gistical or a d mi nistrati ve c ha n ges t o t he cli nical trial pr ot oc ol are 
a ut h orize d. T he i n vesti g at or s h o ul d d oc u me nt a n d e x plai n a n y de viati o n fr o m t he cli nical trial 
pr ot oc ol.  
1 0. 6   
A me n d me nts  
T he sp o ns or m a y m o dif y t he cli nical trial pr ot oc ol at a n y ti me f or et hical, me dical, or scie ntifi c 
reas o ns. A n y a me n d me nts will be ha n dle d acc or di n g t o a p plica ble l ocal re g ulati o ns.  
T he sp o ns or d o es n ot ha ve t o n otif y n o n -s u bsta ntial a me n d me nts t o t he c o m pete nt a ut h orities or 
I R B/I E C. H o we ver, n o n-s u bsta ntial a me n d me nts will be rec or de d a n d d etaile d i n s u bse q ue nt 
s ub missi o ns (e g, i n t he s u bse q ue nt n otificati o n of a s u bsta ntial a me n d me nt).  
1 0. 7   
Q u alit y M a n a ge me nt a n d Ris k E v al u ati o n  
Details will be pr o vi de d i n a se parate I nte grate d Q ualit y Ris k Ma na ge me nt Pla n. 
 
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I nt er n all y A p pr o v e d
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Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 8 0  of 9 9  
1 1  
Et hics  
1 1. 1   
I n de pe n de nt Et hics C o m mittee or I nstit uti o n al Re vie w B oar d  
Bef ore i nitiati o n of t he st u d y at eac h st u d y ce nter, t he pr ot oc ol, t he I C F, ot her writte n material 
gi ve n t o t he s u bjects, a n d a n y ot her rel e va nt st u d y d oc u me ntati o n will be s u b mitte d t o t he 
a p pr o priate I E C/ I R B. Writte n a p pr o val of t he st u d y a n d all rel e va nt st u d y i nf or mati o n m ust be 
o btai ne d bef ore t he st u d y ca n be i nitiate d or t he st u d y dr u g is release d t o t he i n vesti gat or . A n y 
necessar y e xte nsi o ns or re ne wals of I E C/I R B a p pr o val m ust be o btai ne d f or c ha n ges t o t he st u d y 
s uc h as a m e n d me nts t o  t he pr ot oc ol, t he I C F or ot her st u d y d oc u me ntati o n . T he writte n a p pr o val 
of t he I E C/I R B t o get her wit h t he a p pr o ve d I C F m ust be file d i n t he st u d y files.  
T he i n vesti gat or will re p ort pr o m ptl y t o t he I E C/I R B a n y n e w i nf or mati o n t hat ma y a d versel y 
affect t he safet y of  t he s u bjects or t he c o n d uct of t he st u d y. T he i n vesti gat or will s u b mit writte n 
s u m maries of t he st u d y st at us t o t he I E C/I R B as re q uire d. O n c o m pleti o n of t he st u d y, t he I E C/I R B 
will be n otifie d t hat t he st u d y has e n de d.  
1 1. 2   
Re g ul at or y A ut h orities  
R ele va nt st u d y d oc u me ntati o n will be s u b mitte d t o t he re g ulat or y aut h orities of t he partici p ati n g 
c o u ntries, acc or di n g t o l o cal/ nati o nal re q uire me nts, f or re vie w a n d a p pr o val bef ore t he be gi n ni n g 
of t he st u d y . O n c o m pleti o n of t he st u d y, t he re g ulat or y aut h orities wil l be n otifie d t hat t he st u d y 
has e n de d.  
1 1. 3   
Et hic al C o n d uct of t he St u d y  
T he i n vesti gat or(s) a n d all parties i n v ol ve d i n t his st u d y s h o ul d c o n d uct t he st u d y i n a d here nce t o 
t he et hical pri nci ples b ase d o n t he Declarati o n of Helsi n ki, G C P, I C H g ui deli nes, a n d t he 
a p plica ble nati o nal a n d l ocal la ws a n d re g ulat or y re q uire me nts.  
1 1. 4   
I nf or me d C o nse nt  
T he pr ocess of o btai ni n g i nf or me d c o nse nt m ust be i n acc or da nce wit h a p plica ble re g ulat or y 
re q uire me nt(s) a n d m ust a d here t o G C P. 
T he i n vesti gat or is res p o nsi ble f or e ns uri n g t hat n o s u bject u n der g oes a n y st u d y -relat e d 
e xa mi nati o n or acti vit y bef ore t hat s u bject h as gi v e n writte n i nf or me d c o nse nt t o partici pat e i n t h e 
st u d y. 
All mi n or s u bjects w h o p artici pate i n t his cli nical trial m ust be acc o m pa nie d b y a pare nt/ g uar dia n. 
S u bjects a n d g uar dia ns are re q uire d t o be f ull y i nf or me d a b o ut t he cli nical trial i n acc or da n ce wit h 
G C P g ui deli nes, fe deral re g ulati o ns, (f or t h e U nit e d States, t he Healt h I ns ura nce P orta bilit y a n d 
Acc o u nta bilit y Act [ HI P A A])4 1, a n d g ui deli nes a n d i n acc or da nce wit h l ocal re q uire me nts.   
T he i n vesti gat or or desi g nate d pers o n nel will i nf or m t he s u bject of t h e o bjecti ves, met h o ds, 
a ntici pate d be n efits a n d p ote ntial ris ks a n d i nc o n ve nie nces of t he st u d y . T he s u bject s h o ul d be 
 
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I nt er n all y A p pr o v e d
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Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 8 2  of 9 9  
1 2  
Re p orti n g a n d P u blic ati o n, I ncl u di n g Arc hi vi n g  
Esse ntial d oc u me nts are t h ose d oc u me nts t hat i n di vi d uall y a n d c ollecti vel y per mit e val uati o n of 
t he st u d y a n d q ualit y of t he data pr o duce d . After c o m pleti o n of t he st u d y  (e n d of st u d y defi ne d as 
t he date of t he last visit of t he last s u bject), all d oc u me nts a n d d ata relati n g t o t he st u d y will be 
ke pt i n a n or derl y ma n ner b y t he i n vesti gat or i n a sec ure st u d y file . T his fil e will be a vail a ble f or 
i ns pecti o n b y t he s p o ns or or its re prese ntati ves. Esse ntial d oc u me nts s h o ul d be retai ne d f or 2 y ears 
after t he fi nal mar keti n g a p pr o val i n a n I C H re gi o n or f or at l east 2  years si nce t he disc o nti n uati o n 
of cli nical d e vel o p me nt of t he i n vesti gati o nal pr o d uct . It is t he res p o nsi bilit y of t he s p o ns or t o 
i nf or m t he st u d y ce nter w he n t hese d oc u me nts n o l o n ger n ee d t o be retai ne d . T he i n v esti gat or m ust 
c o ntact t he s p o ns or bef ore destr o yi n g a n y st u d y  relate d d oc u m e ntati o n . I n a d diti o n, all s u bject 
me dical  rec or ds a n d ot her s o urce d oc u me ntati o n will be ke pt f or t he ma xi m u m ti me per mitte d b y 
t he h os pital, i nstit uti o n, or me dical practice.  
T he s p o ns or m ust re vie w a n d a p pr o ve a n y res ults of t he st u d y or a bstracts f or pr ofessi o nal 
meeti n gs pre pare d b y t he i n vesti gat or(s). P u blis he d data m ust n ot c o m pr o mise  t he o bjecti ves of 
t he st u d y. Data fr o m i n di vi d ual st u d y ce nters i n m ulti ce nter st u dies m ust n ot be p u blis he d 
se parat el y. 
 
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Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 8 3  of 9 9  
1 3  
Refere nces  
  
Wei di n ger S, N o va k N. At o pic der matitis. La ncet. 2 0 1 6 Mar 1 2;  3 8 7( 1 0 0 2 3) : 1 1 0 9-1 1 2 2.  
  
Eic he nfiel d L F , T o m W L, Ber ger T G, et al. G ui deli nes of care f or t he ma na ge me nt of at o pi c 
der matitis. Part 2: Ma na ge me nt a n d treat me nt of at o pic der matitis wit h t o pical t hera pies. J 
A m Aca d Der mat ol . 2 0 1 4;  7 1( 1): 1 1 6 -1 3 2.  
  
Li n net J, Je mec G B. A n assess me nt of a n xiet y a n d der mat ol o g y life q ualit y i n patie nts wit h 
at o pic der matitis. Br J Der mat ol . 1 9 9 9;  1 4 0: 2 6 8 -2 7 2.  
  
Willia ms H , Ste wart A, v o n M uti us E, et al. Is ecze ma reall y o n t he i ncrease w orl d wi de? J 
Aller g y Cli n I m m u n ol. 2 0 0 8 A pr;  1 2 1( 4): 9 4 7 -5 4 . e 1 5. 
  
S ha w T E, C urrie G P, K o u del ka C W, Si m ps o n E L. Ecze ma pre val e nce i n t he U nite d States: 
data fr o m t he 2 0 0 3 Nati o nal S ur ve y of C hil dre n's Healt h. J I n vest Der mat ol. 2 0 1 1 Ja n;  
1 3 1( 1): 6 7 -7 3.  
  
Sil ver ber g JI, Si m ps o n E L. Ass ociati o ns of c hil d h o o d ecze ma se v erit y: a U S p o p ulati o n-
base d st u d y. Der m atitis. 2 0 1 4 Ma y -J u n; 2 5( 3): 1 0 7 -1 4.  
  
K u nz B, Ora nje A P, La brèze L, Stal der J F, Ri n g J, Taïe b A. Cli nical vali dati o n a n d 
g ui deli nes f or t he S C O R A D i n de x: c o nse ns us re p ort of t he E ur o pea n Tas k F orce o n At o pic 
Der mati tis. Der mat ol o g y. 1 9 9 7; 1 9 5( 1): 1 0 -9.  
  
E mers o n R M, 
Willia ms H C, Alle n B R. Se verit y distri b uti o n of at o pic der matitis i n t he 
c o m m u nit y a n d its relat i o ns hi p t o sec o n dar y referral. Br J Der mat ol. 1 9 9 8 J ul;  1 3 9( 1): 7 3 -6.  
  
Wasser b a uer N, Ball o w M. At o pic der matiti s. A m J Me d. 2 0 0 9 Fe b; 1 2 2( 2): 1 2 1 -5.  
 R u di k off D, Le b w o hl M. At o pic der matitis. La ncet. 1 9 9 8 J u n 6;  3 5 1( 9 1 1 7): 1 7 1 5 -2 1.   
 R ut k o ws ki K et al. Aller gic diseases: t he price of ci vilizati o nal pr o gress. P os te p y Der mat ol 
Aler g ol 2 0 1 4;  3 1: 7 7 -8 3.  
 St ott B , La ve n dar P, Le h ma n n S, Pe n ni n o D, D ur ha m S, Sc h mi dt-We ber C B . H u ma n I L-3 1 
is i n d uce d b y I L-4 a n d pr o m otes T h 2 -dri ve n i nfla m mati o n. J Aller g y Cli n I m m u n ol 2 0 1 3;  
1 3 2: 4 4 6 -4 5 4.  
 Si n g h B, Je g ga A G, S h a n m u k ha p pa K S, et al. I L -3 1 -dri ve n s ki n re m o deli n g i n v ol ves 
e pi der mal cell pr oliferati o n a n d t hic ke ni n g t hat lea d t o i m paire d s ki n-barri er f u ncti o n. P L o S 
O ne. 2 0 1 6;  1 1:e 0 1 6 1 8 7 7.  
 Gittler J K , S he mer A, S uárez -Fari ñas  M,  et al. Pr o gressi ve acti vati o n of T ( H)2/ T ( H)2 2 
c yt o ki nes a n d s electi ve e pi der mal pr otei ns c haract erizes ac ute a n d c hr o nic at o pic der matitis. 
J Aller g y Cli n I m m u n ol 2 0 1 2; 1 3 0: 1 3 4 4 -1 3 5 4.  
 
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I nt er n all y A p pr o v e d
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Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 8 4  of 9 9  
 S uárez -Fari ñas 
M , Ti ntl e SJ, S he mer A, et al. N o nlesi o nal at o pic der matitis s ki n is 
c haracteri ze d b y br oa d ter mi nal differe ntiati o n defects a n d varia ble i m m u n e a b n or malities. 
J Aller g y Cli n I m m u n ol 2 0 1 1; 1 2 7: 9 5 4 -9 6 4.  
 Wa hl gre n C F. Itc h a n d at o pic der matitis: a n  o ver vie w. J Der mat ol 1 9 9 9; 2 6: 7 7 0 -7 7 9.  
 Sze ge di K , Kre mer A E, Kezic S, et al. I ncrease d fre q u e ncies of I L -3 1 -pr o d uc di n g T cells 
are f o u n d i n c hr o nic at o pic der matitis s ki n. E x p Der mat ol . 2 0 1 2; 2 1: 4 3 1 -4 3 6.  
 Neis M M , Peters B, Dre u w A, et al. E n ha nce d e x pressi o n le vels of I L -3 1 c orrel ate wit h I L -
4 a n d I L -1 3 i n at o pic a n d aller g ic c o nt act der matitis. J Aller g y Cli n I m m u n ol. 2 0 0 6; 1 1 8: 9 3 0 -
9 3 7.  
 S o n k ol y E , M uller A, La uer ma AI, et al. I L-3 1: a ne w li n k bet wee n T -cells a n d pr urit us i n 
at o pic s ki n i nfla m mati o n. J Aller g y Cli n I m m u n ol . 2 0 0 6; 1 1 7: 4 1 1 -4 1 7.  
 Kat o A, F ujii E, Wata na b e T, et  al. Distri b uti o n of I L -3 1 a n d its rece pt or e x pressi n g cells i n 
s ki n of at o pic der matitis. J Der mat ol Sci. 2 0 1 4; 7 4: 2 2 9 -3 5.  
 Sait o S , A o ki A, Arai I, et al. Re g ulati o n of T h 2 res p o nses b y differe nt cell t y pes e x pressi n g 
t he i nterle u ki n-3 1 rece pt or. Aller g y Ast h ma Cli n I m m u n ol. 2 0 1 7 A pr 1 7;  1 3: 2 3.  
 Ha nel K H, Pfaff C M, C or nelisse n C, et al. C o ntr ol of t he p h ysical a n d a nti micr o bial s ki n 
barrier b y a n I L -3 1 -I L-1 si g nali n g net w or k. J I m m u n ol. 2 0 1 6;  1 9 6: 3 2 3 3 -3 2 4 4.  
 E ucrisa ®  [ pac ka ge i ns ert]. Ne w Y or k, N Y: Pfizer I nc; 2 0 1 7. 
 Si d b ur y R , Da vis D M, C o he n D E, et al. G ui deli nes of care f or t he ma na ge me nt of at o pic 
der matitis. Secti o n  3: Ma na ge me nt a n d treat me nt wit h p h ot ot hera p y a n d s yste mic a ge nts. J 
A m Aca d Der mat ol . 2 0 1 4; 7 1( 2): 3 2 7 -3 4 9.  
 Si m ps o n E L , Bie ber T, G utt ma n-Yass k y E,  et al. T w o P hase 3 trials of d u pil u ma b vers us 
place b o i n at o pic der matitis. N E n gl J Me d . 2 0 1 6 ; 3 7 5( 2 4):2 3 3 5 -2 3 4 8 . 
 Dill o n S R , S prec her C, Ha m m o n d A, et al. I nterle u ki n 3 1, a c yt o ki ne pr o d uce d b y acti ve T 
cells, i n d uces der m atitis i n mice. Nat I m m u n ol. 2 0 0 4; 5: 7 5 2 -7 6 0.  
 Gri msta d O , Sa wa n o b ori Y, Vester gaar d C, et al. A nti -i nterle u ki n-3 1 -a nti b o dies a meli orate 
scratc hi n g b e ha vi or i n N C/ N ga mice: a m o del of at o pic der matitis. E x p Der mat o l. 2 0 0 9; 
1 8: 3 5 -4 3 . 
 Mic hels G M , Ra mse y D S, Wals h K F, et al. A bli n de d, ra n d o mize d, place b o -c o ntr olle d, d os e 
deter mi nati o n trial of l o ki vet ma b ( Z T S -0 0 1 0 3 2 8 9), a ca n ni nize d, a nti -ca n ni ne I L -3 1 
m o n ocl o nal a nti b o d y i n clie nt o w ne d d o gs wit h at o pic der matitis. Vet  Der mat ol . 2 0 1 6; 
2 7: 4 7 8 -e 1 2 9.  
 
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I nt er n all y A p pr o v e d
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Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 8 5  of 9 9  
 O ya ma S , Kita m ura H, K ura m oc hi T, et al. C y n o m ol g us m o n ke y m o del of i nterle u ki n -3 1 -
i n d uce d scratc hi n g de picts bl oc ka de of h u ma n i nterle u ki n-3 1 rece pt or A b y a h u ma nize d 
m o n ocl o nal a nti b o d y. E x p Der mat ol . 2 0 1 8 ; 2 7 :1 4 -2 1 . 
 R uzic k a T, Mi hara R. A nti-I nterle u ki n-3 1 Rece pt or A A nti b o d y f or At o pic Der matitis. N 
E n gl J Me d . 2 0 1 7 ; 3 7 6( 2 1): 2 0 9 3.  
 Ne m ot o  O, F ur ue M, Na ka ga wa H, et al. T he first trial of CI M 3 3 1, a h u ma nize d a nti h u ma n 
i nterle u ki n-3 1 rece pt or A a nti b o d y, i n healt h y v ol u nteers a n d patie nts wit h at o pic der matitis 
t o e val uate safet y, t olera bilit y a n d p har mac o ki netics of a si n gle d ose 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. Br J Der mat o l. 2 0 1 6 ; 1 7 4: 2 9 6 -3 0 4.  
 CI M 0 0 3J G Cli nical st u d y re p ort: A p has e  II, ra n d o mize d, d o u ble-bli n d, pl ace b o -c o ntr olle d, 
m ulti ple -d ose st u d y t o e val uate t he safet y, t olera bilit y, a n d efficac y of CI M 3 3 1 i n at o pi c 
der matitis patie nts w h o are i na de q uatel y c o ntr olle d b y or i nt olera nt t o t o pical t hera p y. 2 0 1 7.  
 Les he m Y A , Hajar T, Ha nifi n J M, Si m ps o n E L . W hat t he ecze ma area a n d se verit y in de x 
sc ore t ells us a b o ut t h e se verit y of at o pic d er matitis: a n i nter preta bilit y st u d y. Br J Der mat ol . 
2 0 1 5 ; 1 7 2: 1 3 5 3 -1 3 5 7.  
 Bar bier N , Pa ul C, L u ger T, et al. Vali dati o n of t he ecze ma area a n d se v erit y in de x f or at o pic 
der matitis i n a c o h ort of 1 5 5 0 patie nts fr o m t h e pi mecr oli m us crea m 1 % ra n d o mize d 
c o ntr olle d cli nical trials pr o gra m me. Br J Der mat ol . 2 0 0 4; 1 5 0( 1): 9 6 -1 0 2.  
 Ce nters f or Diseas e C o ntr ol a n d Pre v e nti o n. U p date d g ui deli nes f or  u si n g interfer o n g a m m a 
releas e assa ys t o d etect m yc o bacteri u m t u berc ul osis infecti o n —  U nite d States, 2 0 1 0. 
M M W R 2 0 1 0; 5 9( R R 0 5);  1 -2 5.  
 Ha nifi n J M , T h urst o n M , O m ot o M , C herill R , T ofte SJ , Grae b er M . T he ecze ma area a n d 
se verit y i n de x ( E A SI): assess me nt of relia bilit y i n at o pic der matitis. E A SI E val uat or Gr o u p. 
E x p Der mat ol . 2 0 0 1; 1 0: 1 1 -1 8.  
 Paller A S , T o m W L, Le b w o hl M G, et al. Efficac y a n d safet y of crisa b or ole oi nt me nt, a 
n o vel, n o nster oi dal p h os p h o diesterase 4 ( P D E 4) i n hi bit or f or t he t o pica l treat me nt of at o pic 
der matitis ( A D) i n c hil dr e n a n d a d ults. J A m Aca d Der ma tol . 2 0 1 6 ; 7 5( 3): 4 9 4 -5 0 3 . 
 E ur o pea n tas k f orce o n at o pic der matitis. Se verit y sc ori n g of at o pic der matitis: t he S C O R A D 
i n de x: c o nse ns us re p ort of t he E ur o pea n tas k f orce o n at o pic d er matitis. Der mat ol o g y . 1 9 9 3; 
1 8 6: 2 3 -3 1.  
 Fi nla y A Y, K ha n G K. Der mat ol o g y life q ualit y i n de x ( D L QI) –  a si m ple practical m eas ure 
f or r o uti ne cli nical us e. Cli n E x p Der mat ol. 1 9 9 4; 1 9: 2 1 0 -2 1 6.  
 Le wis -J o nes M S, Fi nla y A Y. T he chil dre n’s d er mat ol o g y life q ualit y in de x ( C D L QI): I nitial 
vali dati o n a n d practical use. B R J Der mat ol. 1 9 9 5; 1 3 2: 9 4 2 -9 4 9.  
 
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Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 8 6  of 9 9  
 
U S De part me nt  of Healt h a n d H u ma n Ser vices. T he h ealt h ins ura n ce p orta bilit y a n d 
acc o u nta bilit y act ( HI P A A) of 1 9 9 6 ( P. L. 1 0 4 -1 9 1) [ HI P A A].  
htt p: //as pe. h hs. g o v/a d m nsi m p/ pl 1 0 4 1 9 1. ht m. Effecti ve A u g ust 2 1, 1 9 9 6. 
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 8 7  of 9 9  
1 4  
A P P E N DI C E S  
1 4. 1   
A p pe n di x  1  - A meric a n A c a de m y of D er m at ol o g y  C o nse ns us  C riteri a  f or A D 
D i a g n osis 
Feat ures t o be c o nsi dere d i n dia g n osis of patie nts wit h at o pic der matitis:  
E S S E N TI A L F E A T U R E S ; m ust be prese nt: 
•  
Pr urit us  
•  
Ecze ma (ac ute, s u bac ute, c hr o nic):  
o  T y pical m or p h ol o g y a n d a ge -s pecific patter ns * 
o  C hr o nic or rela psi n g hist or y  
* P atter ns i ncl u de : 
o  Facial, nec k, a n d e xte ns or i n v ol ve me nt i n i nfa nts a n d c hil dre n;  
o  C urre nt or pri or fle x ural l esi o ns i n a n y a ge gr o u p;  
o  S pari n g of gr oi n a n d a xillar y re gi o ns.  
 
I M P O R T A N T F E A T U R E S; see n i n m ost cases, a d di n g s u p p ort t o t he dia g n osis: 
•  
Earl y a ge of o nset  
•  
At o p y  
o  Pers o nal a n d/ or fa mil y hist or y  
o  I g E reacti vit y  
•  
Xer osis  
 
A S S O CI A T E D F E A T U R E S ; t hese cli nical ass ociati o ns hel p t o s u g gest t he dia g n osis of A D b ut are t o o 
n o n -s pecific t o be use d f or defi ni n g or detecti n g A D f or researc h a n d e pi de mi ol o gic st u dies:  
•  
At y pical vasc ular res p o nses ( e g,, facial pall or, w hite der m o gra p his m, dela ye d bla nc h res p o nse) 
•  
Kerat osis pilaris / pit yriasis al ba / h y perli near pal ms / ic ht h y osis  
•  
Oc ular / peri or bital c ha n ges  
•  
Ot her re gi o nal fi n di n gs ( e g,, peri oral c ha n ges / peria uric ular lesi o ns)  
•  
Perif ollic ular acce nt uati o n / lic he nificati o n / pr uri g o lesi o ns  
 
E X C L U SI O N A R Y C O N DI TI O N S ; it s h o ul d be n ote d t hat a dia g n osis of A D de pe n ds o n e xcl u di n g 
c o n diti o ns s uc h as:  
•  
Sca bies  
•  
Se b orr heic der matitis  
•  
C o ntact der matitis (irrita nt or aller gic)  
•  
Ic ht h y oses 
•  
C uta ne o us T -cell l y m p h o ma  
•  
Ps oriasis  
•  
P h ot ose nsiti vit y der mat oses  
•  
I m m u ne deficie nc y diseases 
•  
Er yt hr o der ma of ot her ca uses  
 
 
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I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 8 9  of 9 9  
1 4. 3   
A p pe n di x  3  - Ecze m a Are a a n d Se verit y I n de x ( E A SI)  
B o d y  re gi o n  
E A SI sc ore  
Hea d/ Nec k ( H)   
( E + I + E x + L) x Area x 0. 1 
U p per li m bs ( U L)   
( E + I + E x + L) x Area x 0. 2 
Tr u n k ( T)  
( E + I + E x + L) x Area x 0. 3 
L o wer li m bs ( L L)   
( E + I + E x + L) x Area x 0. 4 
E A SI =  S u m of t he a b o ve 4 b o d y re gi o n sc ores  
 
T he de gree of se v erit y of eac h si g n ( E =er yt he ma, I =i n d urati o n/ pa p ul ati o n, E x =e xc oriati o n, 
L =lic he nificati o n) i n eac h of t he 4 b o d y re gi o ns is e val uate d base d o n a scale ra n gi n g fr o m 0 t o 3 
( 0: n o ne; 1: mil d; 2: m o derate; 3: se v ere), wit h half p oi nts all o we d. 
A rea (t he affecte d b o d y area) is defi ne d as f oll o ws: 0 = 0 %; 1 = 1-9 %; 2 = 1 0 -2 9 %; 3 = 3 0 -4 9 %; 4 = 5 0 -
6 9 %; 5 = 7 0 -8 9 %; 6 = 9 0 -1 0 0 %. A m o n g t he 4  z o nes, tr u n k i ncl u des t he ge nital area, a n d l o wer li m bs 
i ncl u de t he b utt oc ks (Ha nifi n 2 0 0 1 ).3 6 
 
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I nt er n all y A p pr o v e d
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Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 9 0  of 9 9  
1 4. 4   
A p pe n di x  4  - I n vesti g at or’s Gl o b al Assess me nt (I G A) 
St at us   
Sc ore  Defi niti o n  
Clear   
0   
Mi n or, resi d ual 
h y p o pi g me ntati o n/ h y per pi g me ntati o n, n o er yt he ma or 
i n d urati o n/ pa p ulati o n, n o o ozi n g/cr usti n g. 
Al m ost clear  1   
Trace fai nt pi n k er yt he m a, wit h barel y perce pti ble i n d urati o n/ pa p ulati o n 
a n d n o o ozi n g/cr usti n g.  
Mil d   
2   
Fai nt 
pi n k 
er yt he m a  
wit h  
mil d i n d urati o n/ pa p ulati o n 
a n d 
n o 
o ozi n g/cr usti n g.  
M o derate   
3   
Pi n k -re d er yt he ma wit h m o derate i n d urati o n/ pa p ulati o n wit h or wit h o ut 
o ozi n g/cr usti n g.  
Se vere   
4   
Dee p or bri g ht re d er yt he ma wit h se vere i n d urati o n/ pa p ulati o n wit h 
o ozi n g/cr usti n g.  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 9 1  of 9 9  
1 4. 5   
A p pe n di x  5  - S C O Ri n g  At o pic Der m atitis ( S C O R A D)  
 
E xte nt: T he e xte nt of b o d y area affecte d b y at o pic der matitis  
I nte nsit y: T o deter mi ne t he i nte nsit y, select a re prese ntati ve area a n d assess t he i nte nsit y of eac h 
as 0 (a bse nce), 1 ( mil d), 2 ( m o derate), or 3 (se vere). Dr y ness s h o ul d be assesse d i n a n area wit h o ut 
i nfla m mati o n or a p plicati o n of m oist urizer wit hi n 8 h o urs pri or t o t he assess me nt.  
S u bject s y m pt o ms: S u bject e val u ati o n of pr urit us (itc h) a n d slee p l oss d uri n g t he last 3 da ys pri or 
t o t he visit. 
 
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I nt er n all y A p pr o v e d
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Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 9 4  of 9 9  
1 4. 8   
A p pe n di x  8  - Der m at ol o g y Life Q u alit y I n de x ( D L QI) a n d C hil dre n’s D L QI  
 
  
  
  
D E R M A T O L O G Y LI F E Q U A LI T Y I N D E X  
  
  
  
  
  
  
  
  
  
  
  
  
 D L QI  
H o s pit al N o:    
  
  
  
D at e:    
  
  
  
  
 
N a m e:    
  
  
  
  
  
  
  
  
S c or e:  
A d dr e s s:   
  
  
  
  
Di a g n o si s:   
  
  
  
  
 
 
T h e ai m of t hi s q u e s ti o n n ai r e i s t o m e a s u r e h o w m u c h y o u r s ki n p r o bl e m h a s aff e c t e d y o u r lif e 
O V E R T H E L A S T W E E K.  Pl e a s e ti c k   o n e b o x f o r e a c h q u e s ti o n.  
 
1.   
O v er t h e l a st w e e k, h o w i t c h y, s o r e ,   
  
  
V er y m u c h   
 
  
p ai nf ul  or s ti n gi n g  h a s y o ur s ki n     
  
  
A l ot  
  
 
  
b e e n ?    
  
  
  
  
  
  
A littl e    
 
  
  
  
  
  
  
  
  
  
N ot at all   
 
 
2.   
O v er t h e l a st w e e k, h o w e m b a r r a s s e d   
  
  
V er y m u c h   
 
  
or s elf c o n s ci o u s  h a v e y o u b e e n b e c a u s e   
  
A l ot  
  
 
  
of y o ur s ki n ?    
   
  
  
  
  
A littl e    
 
  
  
  
  
  
  
  
  
  
N ot at all   
 
 
3.   
O v er t h e l a st w e e k, h o w m u c h h a s y o ur    
  
V er y m u c h   
 
  
s ki n i nt erf er e d wit h y o u g oi n g   
  
   
  
A l ot  
  
 
  
s h o p pi n g  or l o o ki n g aft er y o ur h o m e  or    
  
A littl e    
 
  
g a r d e n ?          
  
  
  
  
  
N ot at all   
  
N ot r el e v a nt  
 
4.   
O v er t h e l a st w e e k, h o w m u c h h a s y o ur    
  
V er y m u c h   
 
  
s ki n i nfl u e n c e d t h e cl o t h e s    
  
  
  
A l ot  
  
 
  
y o u w e ar ?   
  
  
  
  
  
  
A littl e    
 
  
  
  
  
  
  
  
  
  
N ot at all   
  
N ot r el e v a nt  
 
5.   
O v er t h e l a st w e e k, h o w m u c h h a s y o ur    
  
V er y m u c h   
 
  
s ki n aff e ct e d a n y s o ci al  or    
  
  
  
A l ot  
  
 
  
l ei s u r e a cti viti e s ?   
  
  
  
  
  
A littl e    
 
  
  
  
  
  
  
  
  
  
N ot at all   
  
N ot r el e v a nt  
 
6.   
O v er t h e l a st w e e k, h o w m u c h h a s y o ur    
  
V er y m u c h   
 
  
s ki n m a d e it diffi c ult f or   
  
  
  
  
A l ot  
  
 
  
y o u t o d o a n y s p o r t ?   
  
  
  
  
A littl e    
 
  
  
  
  
  
  
  
  
  
N ot at all   
  
N ot r el e v a nt  
 
7.   
O v er t h e l a st w e e k, h a s y o ur s ki n pr e v e nt e d   
  
Y e s   
  
 
  
y o u fr o m w o r ki n g  or s t u d yi n g ?   
  
  
  
N o   
  
  
N ot r el e v a nt  
  
 
  
If " N o", o v er t h e l a st w e e k h o w m u c h h a s    
  
A l ot  
  
 
  
y o ur s ki n b e e n a pr o bl e m at   
  
  
  
A littl e    
 
  
w o r k  or s t u d yi n g ?    
  
  
  
  
N ot at all   
 
 
8.   
O v er t h e l a st w e e k, h o w m u c h h a s y o ur    
  
V er y m u c h   
 
  
s ki n cr e at e d pr o bl e m s wit h y o ur    
  
  
A l ot  
  
 
  
p a r t n e r  or a n y of y o ur cl o s e f ri e n d s   
  
  
A littl e    
 
  
or r el a ti v e s ?    
  
  
  
  
  
N ot at all   
  
N ot r el e v a nt  
 
9.   
O v er t h e l a s t w e e k, h o w m u c h h a s y o ur    
  
V er y m u c h   
 
  
s ki n c a u s e d a n y s e x u al    
  
  
  
  
A l ot  
  
 
  
diffi c ul ti e s ?    
  
  
  
  
  
A littl e    
 
  
  
  
  
  
  
  
  
  
N ot at all   
  
N ot r el e v a nt  
 
1 0.   
O v er t h e l a st w e e k, h o w m u c h of a   
  
  
V er y m u c h   
 
  
pr o bl e m h a s t h e t r e a t m e n t  f or y o ur  
  
  
A l ot  
  
 
  
s ki n b e e n, f or e x a m pl e b y m a ki n g    
  
  
A littl e    
 
  
y o ur h o m e m e s s y, or b y t a ki n g u p ti m e ?    
  
N ot at all   
  
N ot r el e v a nt  
Pl e a s e c h e c k y o u h a v e a n s w e r e d E V E R Y q u e s ti o n. T h a n k y o u.   
© A Y Fi nl a y, G K K h a n, A pril 1 9 9 2  w w w. d e r m at ol o g y. or g u k , thi s m u st n ot b e c o pi e d wit h o ut t h e p e r mi s si o n of t h e a ut h or s.  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 9 5  of 9 9  
I nstr ucti o ns f or D L QI sc ori n g: 
‘ Ver y m uc h’ = 3 
‘ A l ot’ = 2 
‘ A little’ = 1 
‘ N ot at all’ = 0 
‘ N ot rele va nt’ = 0 
Q uesti o n 7, ‘ pre v e nte d w or k or st u d yi n g’ = 3  
T he D L QI is calc ulate d b y s u m mi n g t he sc ore of eac h q uesti o n res ulti n g i n a ma xi m u m sc ore of 
3 0 a n d a mi ni m u m of 0. T he hi g her t he sc ore, t he m ore q ualit y of li fe is i m paire d. 
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 9 6  of 9 9  
C HI L D R E N' S D E R M A T O L O G Y LI F E Q U A LI T Y I N D E X  
 
H os pital N o : 
Na me:    
  
  
  
  
  
  
Dia g n osis:   
  
  
  
  
  
  
C D L QI  
 
A ge:    
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
S C O R E:  
A d dress:    
  
  
  
  
  
Date:   
 
T he ai m of t his q uesti o n n air e is t o m e as ure h o w m uc h y o ur s ki n pr o ble m h as  affecte d y o u O V E R T H E L A S T 
W E E K.  Ple ase tic k ✓ o ne b o x f or e ac h q uesti o n.   
 
1.   
O ver t he last wee k, h o w itc h y, "scr atc h y " ,                 
Ver y m uc h  
 
□ 
  
s ore or p ai nf ul  has y o ur s ki n bee n?                                 
Q uite a l ot   
 
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
O nl y a little   
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
N ot at all    
 
□ 
2.   
O ver t he last wee k, h o w e m b arr asse d  
  
  
  
  
  
Ver y m uc h  
 
□ 
  
or self c o nsci o us, u pset  or s a d ha ve y o u   
  
  
  
  
Q uite a l ot   
 
□ 
  
bee n beca use of y o ur s ki n?   
  
  
  
  
  
  
  
  
O nl y a little   
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
N ot at all    
 
□ 
3.   
O ver t he last wee k, h o w m uc h has y o ur    
  
  
  
  
Ver y m uc h  
 
□ 
  
s ki n affecte d y o ur frie n ds hi ps?   
  
  
  
  
  
  
Q uite a l ot   
 
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
O nl y a little   
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
N ot at all    
 
□ 
4.   
O ver t he last wee k, h o w m uc h ha ve y o u c ha n ge d  
  
  
Ver y m uc h  
 
□ 
  
or w or n differe nt  or s peci al cl ot hes/s h oes    
  
  
  
Q uite a l ot   
 
□ 
  
beca use of y o ur s ki n?    
  
  
  
  
  
  
  
  
  
O nl y a little   
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
N ot at all    
 
□ 
5.   
O ver t he last wee k, h o w m uc h has y o ur                    
  
Ver y m uc h  
 
□ 
  
s ki n tr o u ble affecte d g oi n g o ut , pl a yi n g ,   
  
  
  
  
Q uite a l ot   
 
□ 
  
or d oi n g h o b bies ?    
  
  
  
  
  
  
  
  
  
  
O nl y a little   
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
N ot at all    
 
□ 
 
6.   
O ver t he last wee k, h o w m uc h ha ve y o u    
  
  
  
  
Ver y m uc h  
 
□ 
  
a v oi de d s wi m mi n g or ot her s p orts  beca use    
  
  
  
Q uite a l ot  
 
□ 
  
of y o ur s ki n tr o u ble?    
  
  
  
  
  
  
  
  
  
O nl y a little   
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
N ot at all    
 
□ 
 
7.   
Last wee k ,   
  
  
  
If sc h o ol ti me: O ver t he        
Pre ve nte d sc h o ol  □  
  
   
           
  
last wee k, h o w m uc h di d   
  
Ver y m uc h  
 
□ 
  
sc h o ol ti m e ?     
  
  
y o ur s ki n pr o ble m affect y o ur  Q uite a l ot   
 
□ 
  
   
  
  
  
  
  
  
sc h o ol w or k?   
  
  
  
  
O nl y a little   
□ 
  
   O R  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
N ot at all    
 
□ 
 
  
was it  
  
  
  
  
  
If h oli d a y ti me: H o w m uc h   
Ver y m uc h  
 
□ 
  
h oli d a y ti m e ?        
  
o ver t he last wee k, has y o ur    
Q uite a l ot   
 
□ 
  
   
  
  
  
  
  
  
s ki n pr o ble m i nterfere d wit h   
O nl y a little   
□ 
  
   
  
  
  
  
  
  
y o ur e nj o y me nt of t he h oli d a y ? N ot at all    
 
□ 
w as it  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 9 7  of 9 9  
8.   
O ver t he last wee k, h o w m uc h tr o u ble    
  
  
  
  
Ver y m uc h  
 
□ 
  
ha ve y o u ha d beca use of y o ur s ki n wit h    
  
  
  
  
Q uite a l ot   
 
□ 
  
ot her pe o ple c alli n g y o u n a mes , te asi n g,  
  
  
  
  
O nl y a little   
□ 
  
b ull yi n g , as ki n g q uesti o ns  or a v oi di n g y o u ? 
  
  
  
N ot at all    
 
□ 
 
9.   
O ver t he last wee k, h o w m uc h has y o ur slee p    
  
  
Ver y m uc h  
 
□ 
  
bee n affecte d b y y o ur s ki n pr o ble m?    
  
  
  
  
  
Q uite a l ot   
 
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
O nl y a little  
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
N ot at all    
 
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1 0 .  
O ver t he last wee k, h o w m uc h of a    
  
  
  
  
  
Ver y m uc h  
 
□ 
  
pr o ble m has  t he tre at m e nt f or y o ur   
  
  
  
  
  
Q uite a l ot   
 
□ 
  
s ki n bee n?   
  
  
  
  
  
  
  
  
  
  
  
  
O nl y a little   
□ 
  
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
N ot at all    
 
□ 
 
 
Ple ase c hec k t h at y o u h a ve a ns were d E V E R Y q uesti o n. T h a n k y o u.  
 
© M. S. Le wis -J o nes, A. Y. Fi nla y, Ma y 1 9 9 3, T his m ust n ot be c o pie d wit h o ut t he per missi o n of t he a ut h ors.  
 
 
I nstr ucti o ns f or c D L QI sc ori n g: 
‘ Ver y m uc h’ = 3 
‘ A l ot’ = 2 
‘ A little’ = 1 
‘ N ot at all’ = 0 
‘ N ot rele va nt’ = 0 
Q uesti o n 7, ‘ pre v e nte d sc h o ol’ = 3  
T he c D L QI is calc ulate d b y s u m mi n g t he sc ore of eac h q uesti o n res ulti n g i n a ma xi m u m sc ore of 
3 0 a n d a mi ni m u m of 0. T he hi g her t he sc ore, t he m ore q ualit y of life is i m paire d.  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 9 8  of 9 9  
1 4. 9   
A p pe n di x  9 - Ast h m a C o ntr ol Test  
Ast h m a C o ntr ol Test ™ 
 
T his s ur v e y w as d e si g n e d t o h el p y o u d es cri b e y o ur ast h m a a n d h o w y o ur ast h m a aff e cts h o w y o u f e el a n d 
w h at y o u ar e a bl e t o d o.  T o c o m pl et e it, pl e as e m ar k a n  
 i n t h e o n e b o x t h at b est d e s cri b es y o ur a n s w er. 
 
1.  I n t h e p a st 4 w e e k s , h o w m u c h of t h e ti m e di d y o ur a st h m a  k e e p y o u fr o m g etti n g a s 
m u c h d o n e at w or k, s c h o ol or at h o m e ?  
 
All of t h e ti m e   
M ost of t h e ti m e   
S o m e of t h e ti m e  
A littl e of t h e ti m e N o n e of t h e ti m e  
 
 
 
 
 
 
 
1  
 
2  
 
3  
 
4  
 
5 
 
2.  D uri n g t h e p a st 4 w e e k s , h o w oft e n h a v e y o u h a d s h ort n e s s of br e at h ?  
 
M or e t h a n  
o n c e a d a y   
O n c e a d a y  
3 t o 6  
ti m es a w e e k 
O n c e or t wi c e  
a w e e k   
N ot at all  
 
 
 
 
 
 
 
 
1  
 
2  
 
3  
 
4  
 
5 
 
3.  D uri n g t h e p a st 4 w e e k s , h o w oft e n di d y o ur a st h m a  s y m pt o m s ( w h e e zi n g, c o u g hi n g, 
s h ort n e s s of br e at h, c h e st ti g ht n e s s or p ai n ) w a k e y o u u p at ni g ht or e arli er t h a n u s u al 
i n t h e m or ni n g ?  
 
4 or m or e  
ni g hts a w e e k  
2 t o 3  
ni g hts a w e e k   
O n c e a w e e k   
O n c e or T wi c e   
N ot at all  
 
 
 
 
 
 
 
 
1  
 
2  
 
3  
 
4  
 
5 
 
4.  D uri n g t h e p a st 4 w e e k s,  h o w oft e n h a v e y o u u s e d y o ur r e s c u e i n h al er or n e b uli z er 
m e di c ati o n ( s u c h a s Al b ut er ol,  V e nt oli n ® , Pr o v e ntil® , or M a x air® ) ? 
 
3 or m or e  
ti m es p er d a y  
1 or 2  
ti m es p er d a y  
2 or 3  
ti m es p er w e e k 
O n c e a w e e k  
or l es s   
N ot at all  
 
 
 
 
 
 
 
 
1  
 
2  
 
3  
 
4  
 
5 
 
5.  H o w w o ul d y o u r at e y o ur a st h m a  c o ntr ol d uri n g t h e p a st 4 w e e k s ?  
 
N ot C o ntr oll e d  
at all   
P o orl y  
C o ntr oll e d   
S o m e w h at  
C o ntr oll e d  
W ell  
C o ntr oll e d  
C o m pl et el y  
C o ntr oll e d  
 
 
 
 
 
 
 
 
1  
 
2  
 
3  
 
4  
 
5 
 
Ast h m a C o ntr ol T est ™ c o p yri g ht, Q u alit y M etri c I n c or p or at e d 2 0 0 2, 2 0 0 4. All Ri g hts R es er v e d.  
Ast h m a C o ntr ol T est ™ is a tr a d e m ar k of Q u alit y M etri c I n c or p or at e d.  
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0

Gal der ma Researc h & De v el o p me nt, L L C  
2 1 -J U L-2 0 2 0  
Pr o t oc ol N u m ber: R D. 0 6. S P R. 1 1 6 9 1 2  
Versi o n 6. 0  
 
C O N FI D E N TI A L  
Pa ge 9 9  of 9 9  
1 4. 1 0  
I n vesti g at or Si g n at ure P a ge 
Pr ot oc ol Title:   
A 
M ultice nter, 
O pe n -L a bel, Si n gle -G r o u p C li nical T rial t o 
Assess t he 
P har mac o ki netics a n d Safet y of Ne m oliz u ma b ( C D 1 4 1 5 2) i n A d olesce nt 
S u bjects ( 1 2 -1 7 years) wit h 
M o derate -t o-Se vere 
At o pic 
Der matitis a n d 
Ass ociate d Pr urit us  
Pr ot oc ol N u m ber:   
1 1 6 9 1 2  
 
C o nfi d e nti alit y a n d c G C P C o m pli a nce St ate me nt  
I, t h e u n dersi g ne d, ha ve re vie we d t his pr ot oc ol (a n d a me n d me nts), i n cl u di n g a p pe n dices, a n d I 
will c o n d uct t he st u d y as descri be d i n c o m plia nce wit h t his pr ot oc ol (a n d a me n d me nts), G C P, a n d 
rele va nt I C H gui deli nes.  
O nce t he pr ot oc ol has b ee n a p pr o ve d b y t he I E C/I R B, I will n ot m o dif y t his pr ot oc ol wit h o ut 
o btai ni n g pri or a p pr o val of Gal der ma R esearc h &  D e vel o p me nt, L L C  a n d of t he I E C/I R B. I will 
s u b mit t he pr ot oc ol a me n d me nts a n d/ or a n y I C F 
m o dificati o ns t o Gal der ma R es earc h &  
D e vel o p me nt, L L C  a n d I E C/I R B, a n d a p pr o val will be o btai n e d bef ore a n y a me n d me nt s are 
i m ple me nte d. 
I u n dersta n d t hat all i nf or mati o n o btai ne d d uri n g t he c o n d uct of t he st u d y wit h re gar d t o t he 
s u bjects’ state of healt h will be re gar de d as c o nfi de ntial . N o s u bjects’ na m es will  be discl ose d . All 
s u bjects will be i d e ntifie d b y assi g ne d n u m bers o n all C R F s, la b orat or y sa m ples, or s o urc e 
d oc u me nts f or war de d t o t he s p o ns or . Cli nical i nf or mati o n ma y be re vie we d b y t he s p o ns or or its 
a ge nts or re g u lat or y a ge n cies. A gree me nt m ust be o btai ne d fr o m t he s u bject bef ore discl os ure of 
s u bject i nf or mati o n t o a t hir d part y. 
I nf or mati o n de vel o pe d i n t his cli nical st u d y 
ma y be discl ose d b y Gal der ma R esearc h &  
D e vel o p me nt, L L C , t o ot her cli nical i n vesti gat ors, re g ulat or y a ge nci es, or ot her healt h a ut h orit y 
or g o ver n me nt a ge ncies as re q uire d.  
 
 
  
 
I n v esti gat or Si g nat ure 
  
Date  
 
  
 
Pri nte d Na me  
  
Title  
 
  
 
I nstit uti o n 
  
St u d y Ce nter N u m ber  
 
 
C O N FI D E N TI A L   G A L D E R M A                  
I nt er n all y A p pr o v e d
3 0- J ul- 2 0 2 0