Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: M2951 Relapsing Multiple Sclerosis Bruton's Tyrosine Kinase inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 267
Healthy volunteers: no

Brief summary:
The aim of this protocol is to find out about the safety and effectiveness of M2951 in participants with relapsing multiple sclerosis. Participants were placed into 1 of 3 groups to receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the participants on placebo were given M2951.

Detailed description:

Arms:
arm 1: Participants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 milligram (mg) orally, once daily (QD) in blinded extension (BE) period from week 25 to week 48. arm 2: Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 25 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. arm 3: Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. arm 4: Participants received Evobrutinib 75 mg orally, twice daily (BID) up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. arm 5: Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period received Tecfidera 120 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. arm 6: Participants received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1. arm 7: Participants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 mg orally, QD from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.

Interventions: intervention 1: Evobrutinib intervention 2: Evobrutinib intervention 3: Evobrutinib intervention 4: Placebo intervention 5: Tecfidera
Intervention descriptions: intervention 1: Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. intervention 2: Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 25 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. intervention 3: Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. intervention 4: Placebo were administered for 24 weeks in active treatment period. intervention 5: Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period received Tecfidera 120 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.

Protocol document:
Prot_002.pdf: 
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SAP_003.pdf: 
E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 /6 1  
 
 
 
 
Fi n al A n al ysis I nte gr ate d A n al ysis Pl a n   
Cli nic al Tri al Pr ot oc ol 
I de ntific ati o n N o. 
M S 2 0 0 5 2 7 -0 0 8 6  
Title:  
A Ra n d o mize d, D o u ble -Bli n d, Place b o -C o ntr olle d  P hase II 
St u d y of M 2 9 5 1 wit h a Parallel, O pe n -La b el,  Acti ve C o ntr ol 
Gr o u p ( Tecfi dera), i n Patie nts wit h  Rela psi n g M u lti ple Scler osis 
t o E val uate Effi cac y, Safet y, T ole ra bilit y, P har mac o ki netics, 
a n d Bi ol o gical Acti vit y.  
Tri al P h ase  
II 
I n vesti g ati o n al Me dici n al 
Pr o d uct(s)  
E v o br uti ni b  
Cli nic al Tri al Pr ot oc ol 
Versi o n  
0 6 J ul y 2 0 2 3/ Versi o n 8. 0  
I nte gr ate d A n al ysis Pl a n 
A ut h or  
C o or di n ati n g A ut h or  
 
Bi o st ati sti c s, M er c k  
 
F u n cti o n  
A ut h or( s) / D at a A n al y st( s)  
, 
 
 
 
 
I nte gr ate d A n al ysis Pl a n  
D ate a n d Versi o n  
0 3 J u ne  2 0 2 4 / Versi o n 2 .0   
I nte gr ate d A n al ysis Pl a n 
Re vie wers  
 
Merc k/ E M D -Ser o n o Re vie wers:  
F u n cti o n  
 
N a m e  
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: 
P P D
P P D
P P D
P P D
P P D
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 /6 1  
 
 
 
 Re vi e wers:  
F u n cti o n  
 
N a m e  
 
C o nfi de nti al  
T his d oc u me nt is t he pr o pert y of Merc k K Ga A, Dar msta dt, Ger ma n y, or o ne of its affiliate d c o m pa nies.  
It is i nte n de d f or restricte d use o nl y a n d ma y n ot –  i n f ull or part –  be passe d o n, re pr o d uce d, p u blis he d or use d wit h o ut 
e x press per missi o n of Merc k K g a A, Dar msta dt, Ger m a n y or its affiliate.  
C o p yri g ht © 2 0 2 4  b y Merc k K g a A, D ar mst a dt, Ger m a n y or its affili ate. All ri g hts reser ve d.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: 
P P D
P P D
P P D
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 /6 1  
 
 
1  
S i g n at ure P a ge  
I nte gr ate d A n al ysis Pl a n: M S 2 0 0 5 2 7 -0 0 8 6  
A Ra n d o mize d, D o u ble -Bli n d, Place b o -C o ntr olle d P hase II St u d y of M 2 9 5 1 wit h a Parallel, 
O pe n -La b el, Acti ve C o ntr ol Gr o u p ( Tecfi dera), i n Patie nts wit h Rela psi n g M ulti ple Scler osis t o 
E val uate Efficac y, Safet y, T olera bilit y, P har mac o ki netics, a n d Bi ol o gical A cti vit y. 
 
A p pr o val of t he Fi nal A nal ysis  IA P  b y Merc k R es p o nsi ble is d oc u me nte d wit hi n B R E E Z E  via 
e Si g nat ure.  
 
 
, Merc k 
 
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
P P D
P P D


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 /6 1  
 
 
2  
T a ble of C o nte nts   
1  
Si g nat ure Pa ge  ......................................................................................3  
2  
Ta ble of C o nte nts  ..................................................................................4  
3  
List of A b bre viati o ns a n d Defi niti o n of Ter ms  ....................................7  
4  
M o dificati o n Hist or y  ..........................................................................1 0  
5  
P ur p ose of t he I nte grate d A nal ysis Pla n  .............................................1 0  
6  
O bjecti ves/ E n d p oi nts of t he Fi nal A nal ysis  .......................................1 0  
7  
Sa m ple Size/ Ra n d o mizati o n  ...............................................................1 1  
8  
O ver vie w of Pla n ne d A nal yses  ...........................................................1 1  
9  
C ha n ges t o t he Pla n ne d A nal yses i n t he Cli nical Trial Pr ot oc ol  ........1 1  
1 0  
Pr ot oc ol De viati o ns a n d A nal ysis Sets  ...............................................1 2  
1 0. 1  
Defi niti o n of Pr ot oc ol De viati o ns a n d A nal ysis Sets  .........................1 2  
1 0. 2  
Defi niti o n of A nal ysis Sets a n d S u b gr o u ps  ........................................1 2  
1 1  
Ge neral S pecificati o ns f or Statistical A nal yses  ..................................1 4  
1 1. 1  
Treat me nt gr o u ps a n d I n vesti gati o nal Me dical Pr o d uct (I M P)  ..........1 4  
1 1. 2  
Prese ntati o n of Ta bles/ Listi n gs/ Fi g ures  .............................................1 4  
1 1. 3  
Prese ntati o n b y Ti me Peri o d  ...............................................................1 4  
1 1. 4  
Data ha n dli n g aft er c ut -off date  ..........................................................1 5  
1 1. 5  
Prese ntati o n of c o nti n u o us a n d q ualitati ve varia bl es  ..........................1 5  
1 1. 6  
Defi niti o n of baseli ne a n d c ha n ge fr o m baseli ne  ...............................1 5  
1 1. 7  
Defi niti o n of d urati o n  .........................................................................1 6  
1 1. 8  
C o n versi o n fact ors  ..............................................................................1 6  
1 1. 9  
Ha n dli n g of missi n g data  ....................................................................1 6  
1 1. 1 0  
Trial da y / Treat me nt da y  ...................................................................1 7  
1 1. 1 1  
Re peate d a n d u ns c he d ule d meas ure me nts  ..........................................1 7  
1 1. 1 2  
Earl y treat me nt ter mi nati o n assess me nts  ............................................1 8  
1 1. 1 3  
A nal ysis visit wi n d o ws  .......................................................................1 8  
1 1. 1 4  
Ti me si nce M S o nset/ dia g n osis  ..........................................................1 8  
1 1. 1 5  
B o d y Mass I n d e x ( k g/ m²) at st u d y Baseli ne  .......................................1 9  
1 1. 1 6  
S oft ware  ..............................................................................................1 9  
1 2  
Trial S u bjects  ......................................................................................1 9  
1 2. 1  
Dis p ositi o n of S u bjects a n d Disc o nti n uati o ns  ....................................1 9  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 /6 1  
 
 
1 2. 2  
Pr ot oc ol De viati o ns  ............................................................................2 1  
1 2. 2. 1  
I m p ort a nt Pr ot oc ol De viati o ns ............................................................2 1  
1 2. 2. 2  
Reas o ns Lea di n g t o t he E xcl usi o n fr o m a n A nal ysis Set  ...................2 2  
1 3  
De m o gra p hics a n d Ot her Baseli ne C haracteristics  .............................2 2  
1 3. 1  
De m o gra p hics  .....................................................................................2 2  
1 3. 2  
Me dical Hist or y  ..................................................................................2 3  
1 3 . 3 
Ot her Baseli ne C haracteristics  ............................................................2 3  
1 3. 3. 1  
Disease hist or y  ....................................................................................2 3  
1 3. 3. 2  
Ot her  ...................................................................................................2 3  
1 4  
Pre vi o us or C o nc o mita nt Me dicati o ns/ Pr oce d ures  .............................2 4  
1 5  
Treat me nt C o m plia nce a n d E x p os ure  .................................................2 5  
1 6  
Efficac y E val uati o n  ............................................................................2 7  
1 6. 1  
M RI  .....................................................................................................2 7  
1 6. 2  
Rela pses  ..............................................................................................2 7  
1 6. 3  
Ti me t o First Q ualifie d R ela pse a n d esti mates  ...................................2 8  
1 6. 4  
E x pa n de d Disa bilit y Stat us Scale ( E D S S)  ..........................................2 9  
 
2 9  
1 7  
Safet y E val uati o n  ................................................................................2 9  
1 7. 1  
A d verse E v e nts  ...................................................................................3 0  
1 7. 1. 1  
All A d verse E v e nts  .............................................................................3 1  
1 7. 2  
Deat hs, Ot her Seri o us A d verse E ve nts, a n d Ot her Si g nifica nt 
A d verse E v e nts  ...................................................................................3 3  
1 7. 2. 1  
Deat hs  .................................................................................................3 3  
1 7. 2. 2  
Seri o us A d verse E v e nts  ......................................................................3 4  
1 7. 2. 3  
T E A Es of S pecial I nt erest  ..................................................................3 4  
1 7. 3  
Cli nical La b orat or y E val uati o n  ...........................................................3 5  
1 7. 4  
Vital Si g ns  ..........................................................................................3 9  
1 7. 5  
1 2 -Lea d  Electr ocar di o gra m ( E C G)  .....................................................4 0  
1 7. 6  
P h ysical E xa mi nati o n  .........................................................................4 1  
1 7. 7  
Pre g na nc y T est  ....................................................................................4 1  
1 7. 8  
I m m u n o gl o b uli n Le vels, a n d 
 
 
 ..............................................................4 1  
1 7. 9  
Uri nal ysis Micr osc o pic E val uati o n  .....................................................4 2  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI
C CI
C CI
C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
6 /6 1  
 
 
1 7. 1 0  
C ol u m bia - S uici de Se veri t y Rati n g Scale ( C-S S R S)  ..........................4 2  
1 8  
Refere n ces  ...........................................................................................4 3  
1 9  
A p pe n dices  .........................................................................................4 5  
1 9. 1  
A p pe n di x 1: W orst o n treat me nt val ue base d o n n or mal ra n ge of 
la b orat or y e v al uati o ns .........................................................................4 5  
1 9. 2  
A p pe n di x 2: List of para meters f or I m m u n o gl o b uli n Le vels a n d 
I m m u ne cell s u bset c o u nts ..................................................................4 6  
1 9. 3  
A p pe n di x 3: A nal ysis visit wi n d o ws f or Safet y a n d Efficac y 
E n d p oi nts  ............................................................................................4 7  
 
 
.5 4  
1 9. 5  
A p pe n di x 5: A Es of S pecial I nterest  ..................................................6 0  
1 9. 6  
A p pe n di x 6: Data ha n dli n g after c ut -off d ate  .....................................6 1  
1 9. 7  
A p pe n di x 7: List of Pri or D M T  ..........................................................6 1  
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
7 /6 1  
 
 
3  
L ist of A b bre vi ati o ns a n d Defi niti o n of Ter ms  
A L C  
A bs ol ute l y m p h oc yte c o u nt  
A D a M  
A nal ysis Data M o del  
 
A E  
A d verse E v e nt  
A L T  
Ala ni ne A mi n o -Tra nsferase  
A R R  
A n n ualize d Rela ps e Rate  
A S T  
As partate A mi n o -Tra nsferase  
A T C  
A nat o mical T hera pe utic Class  
B E A  
Bli n de d e xte nsi o n a nal ysis  
BI D  
t wice dail y 
B MI  
B o d y Mass I n d e x  
B O A  
Bi ostatistics O ut p uts Asse m bl y  
 
 
 
 
B C P  
B usi ness C o nti n uit y Pla n  
C F B  
C ha n ge fr o m Baseli ne  
CI  
c o nfi de nce i nter val  
C T P  
Cli nical Trial Pr ot oc ol  
D B P  
D o u ble -bli n d peri o d  
D M T  
Disease M o dif yi n g T hera p y  
E AI R  
E x p os ure A dj uste d I n ci de nce Rate  
e C R F 
electr o nic Cas e Re p ort F or m  
E C G  
Electr ocar di o gra m  
E D S S  
E x pa n de d Disa bilit y Stat us Scale  
E E A  
E ur o pea n E c o n o mic Area  
E O T  
E n d of Treat me nt  
F A  
Fi nal A nal ysis  
G d +  
G a d oli ni u m -p ositi ve  
G G T  
Ga m ma -Gl uta m yl Tra nsferase  
GI  
Gastr oi ntesti nal  
 
 
I A 
I nteri m Anal ysis  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI
C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
8 /6 1  
 
 
I A P 
I nte grate d A nal ysis Pla n 
I g 
Im m u n o gl o b uli n  
I M P 
I n v esti gati o nal Me dical Pr o d uct 
I P D 
I m p ort a nt Pr ot oc ol De viati o n 
I V 
I ntr a ve n o us 
I W R S 
I nteracti ve We b Res p o ns e S yste m 
L L N  
L o wer li mit of n or mal  
 
 
Me d D R A  
Me dical Dicti o nar y f or R e g ulat or y Acti vities  
mI T T  
M o difie d I nte nti o n t o Treat  
M M R M  
Mi xe d Effect M o del f or Re peate d Meas ures  
M RI  
Ma g netic R es o na nce Ima gi n g  
M S  
M ulti ple scler osis  
N B  
Ne gati ve bi n o mial  
N CI -C T C A E  
Nati o nal Ca ncer I nstit ute –  C o m m o n Ter mi n ol o g y Criteria f or A d verse 
E ve nts  
O L E  
O pe n -la bel e xte nsi o n 
P A  
Pri mar y A nal ysis  
 
 
 
 
P d e v 
Pr ot oc ol de viati o n  
 
 
P T  
Preferre d Ter m  
Q D  
O nce dail y  
Q 1  
2 5 t h Perce ntile  
Q 3  
7 5 t h Perce ntile  
R M S  
Rela psi n g m ulti ple scler osis  
R o W  
Rest of t he W orl d  
S A F  
Safet y A nal ysis Set  
S A F -O L E  
Safet y O pe n -La bel E xte nsi o n A nal ysis Set  
S A F -S W O L E  
Safet y S witc h O pe n -L a b el E xte nsi o n A nal ysis Set  
S C R  
Scree ni n g A n al ysis Set  
S D  
St a n dar d De viati o n  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI
C CI
C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
9 /6 1  
 
 
S D T M  
St u d y Data Ta b ulati o n M o del  
S E  
Sta n dar d Err or  
 
 
S M C  
Safet y  M o nit ori n g C o m mittee  
S O C  
S yste m Or ga n Class  
S P M S  
Sec o n dar y pr o gressi ve m ulti ple scler osis  
T E A E  
Treat me nt E mer ge nt A d v erse E ve nt  
T BI LI  
T otal Bilir u bi n  
T L F  
Ta ble/ Listi n g /Fi g ure  
U L N  
U p per L i mit of N or mal  
V S  
Vital si g ns  
W H O -D D  
W orl d Healt h Or ga nizati o n Dr u g Dicti o nar y  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 0 /6 1  
 
 
4  
M o dific ati o n Hist or y   
U ni q u e  
I d e ntifi er f or 
IA P V er si o n  
D at e of  
IA P V er si o n  
A ut h or  
C h a n g e s fr o m t h e Pr e vi o u s V er si o n  
1 . 0 
 2 5 A pril 2 0 2 4  
 
N A –  fir st v er si o n 
2. 0  
0 3 J u n e 2 0 2 4  
 
S e cti o n 1 7. 3 : A d d K a pl a n -M ei er pl ot f or ti m e t o fir st 
i n cr e a s e i n A L T ≥ 3 , u p d at e a n al y si s t o i n cl u d e D B P + 
O L E  
S e cti o n 1 6. 3: a d d e d t w o m or e p er c e ntil e s s u m m ar y 
( 3 5t h, 4 0t h) i n t h e K M e sti m at e s of t h e c u m ul ati v e 
pr o b a bilit y of e x p eri e n ci n g q u alifi e d r el a p s e  
 
 
 
 
 
 
 
 
5  
P ur p ose of t he I nte gr ate d A n al ysis Pl a n   
T he p ur p ose of t his I nt e grate d A nal ysis Pla n ( IA P) is t o d oc u me nt tec h nical a n d detaile d 
s pecificati o ns f or t he Fi nal  A nal ysis  (F A ) of data c ollecte d f or pr ot oc ol M S 2 0 0 5 2 7 -0 0 8 6  
c o nsi deri n g t he earl y t er mi nati o n of t h e st u d y; the pri mar y e n d p oi nts  of t he  p hase 3  
M S 2 0 0 5 2 7ˍ 0 0 8 0  a n d M S 2 0 0 5 2 7ˍ 0 0 8 2 st u dies  were  n ot met ). T he IA P is base d u p o n Secti o n 8 
( Statistics) of t he trial pr ot oc ol  date d 0 6 J ul y 2 0 2 3  (Versi o n 8. 0 ) a n d is pre pare d i n c o m plia nce 
wit h I nter nati o nal C o nfere nce o n H ar m o nizati o n E 9.  
T his  F A  data re p ort  will i ncl u de s u m maries of p artici pa nt  dis p ositi o n, de m o gra p hics, baseli ne 
c haracteristics,  me dical hist or y,  pre vi o us a n d  c o nc o mita nt me dicati o ns , treat me nt e x p os ure, 
effic ac y e val u ati o ns,  a d verse e v e nts ( A Es), deat hs, selecte d la b orat or y p ara meters, vital si g ns,  
E C Gs , a n d ot her e n d p oi nts relate d t o safet y m o nit ori n g  u p t o t he e n d of t he st u d y .  
6  
O bjecti ves/ E n d p oi nts of t he Fi n al A n al ysis   
T he o bjecti ve of t he O L E Peri o d of t his st u d y is to e val uate t he l o n g -ter m safet y, efficac y, a n d 
H R Q o L of M 2 9 5 1 f or a n a d diti o nal 8  years, at a n i nitial d ose of 7 5 m g o nce dail y w hic h was  
e ve nt uall y s witc he d t o 7 5 m g t wice dail y.  
E n d p oi nts f or O L E Peri o d:  
•  Efficac y a n d  
 e n d p oi nts at Wee k 4 8, 9 6, 1 4 4, 1 9 2, 2 4 0, 2 8 8, 3 3 6 a n d 3 8 4.  
•  N u m ber of ga d oli ni u m -e n ha nci n g T 1 lesi o ns ; 
•  A R R, base d o n pr ot oc ol -defi ne d q ualifie d rela ps es ; 
•  Q ualifie d rel a pse -free stat us; 
•  C ha n ge fr o m bas eli ne i n disa bilit y sc ore base d o n E D S S sc ore; 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
P P D
P P D
C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 1 /6 1  
 
 
•  Safet y as assesse d b y t he nat ure, se verit y, a n d occ urre nce of A Es; vital si g ns; E C Gs; a bs ol ute 
c o nce ntr ati o ns a n d c ha n ge fr o m Baseli ne i n I g le vels; 
 
; a n d cli nical la b orat or y safet y para meters.  
F or t he Fi nal A nal ysis, s electe d safet y a n d effi cac y e n d p oi nts base d o n d ata fr o m O L E Da y 1  t o 
t he e n d of t he st u d y  will be e val uat e d.  
F or m ore d etails o n t he mai n st u d y o bjecti ves please re vie w secti o n 4 Trial O bjecti ves of t he 
pr ot oc ol.   
7  
S a m ple Size/ R a n d o miz ati o n   
Sa m ple size a n d ra n d o mi zati o n is descri be d i n t he I A P f or t he pri mar y a n al ysis/ bli n de d e xte nsi o n 
a nal ysis perf or m e d after c o m pleti o n of t he  D o u ble -Bli n d Peri o d  ( D B P) of t he st u d y  ( Wee k 
4 8/ Wee k 5 2) .   
8  
O ver vie w of Pl a n ne d A n al yses   
T he pr ot oc ol descri b es a  t otal of 5 a nal yses t hat s h o ul d be perf or me d  f or t his st u d y. 4 of t he m ha ve 
alrea d y b ee n c o n d u cte d acc or di n g t o t he pr ot oc ol.  T hese are:  
•  Pri mar y A nal ysis ( w he n 1 0 0 % of partici pa nts e nr olle d reac he d Wee k 2 4 of treat me nt, or 
pre mat urel y disc o nti n ue d fr o m treat me nt)  
•  Bli n de d E xte nsi o n A nal ysis  (w he n 1 0 0 % of partici pa nt s e nr olle d eit her reac he d Wee k 5 2 ( 4 -
wee k Safet y  F oll o w -u p Visit) a n d c o m plet e d  t he st u d y, e nr olle d i n t h e O L E, or pre mat urel y 
disc o nti n ue d fr o m st u d y) 
•  Safet y O L E W 6 0 I nteri m A nal ysis ( w he n 1 0 0 % of partici pa nts e nr olle d i n t he O L E  reac he d 
O L E Wee k 6 0 or disc o nti n ue d pre mat urel y fr o m t he O L E pri or t o O L E Wee k 6 0)   
•  O L E W 2 4 0 I nt eri m A nal ysis ( ti me d t o occ ur s h ortl y bef ore t he pri mar y a nal ysis of t he P hase 3  
st u dies i n R M S, t o s u p p ort t he res ults of P hase 3  st u dies) 
T he last a nal ysis is :  
•  Fi nal A nal ysis (tri g gere d w he n 1 0 0 % of partici p a nts e nr olle d i n t he O L E will c o m plete t he 
O L E or will disc o nti n ue pre mat urel y fr o m t he O L E)  
T his I A P c o vers t he Fi n al A nal ysis . Statistical a nal yses will be perf or me d usi n g clea ne d electr o nic 
Case Re p ort F or m ( e C R F) data , la b a n d M RI dat a  c ollecte d u p  u ntil e n d of st u d y . All e n d p oi nts 
f or t he O L E p eri o d  will be e val uat e d.    
9  
C h a n ges t o t he Pl a n ne d A n al yses i n t he Cli nic al Tri al Pr ot oc ol   
T here are  n o c ha n g es t o t he pla n ne d a nal yses i n t he Cli nical Trial Pr ot oc ol ( C T P)  f or t he Fi nal 
A nal ysis . 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 2 /6 1  
 
 
1 0  
Pr ot oc ol De vi ati o ns  a n d A n al ysis Sets    
1 0. 1  
Defi niti o n of Pr ot oc ol De vi ati o ns a n d A n al ysis Sets   
I m p ort a nt pr ot oc ol de viati o ns are pr ot o c ol de viati o ns t hat 
mi g ht si g nifica ntl y affect t h e 
c o m plete ness, acc urac y, a n d/ or relia bilit y of t h e st u d y data or t h at mi g ht si g nifica ntl y affect 
partici pa nt s ri g hts, safet y, or well-bei n g.  
T he f oll o wi n g i m p orta nt de viati o ns will be i de ntifie d a n d c o nfir me d pri or t o or at t he Data Re vie w 
Meeti n g at t he latest.  
•  Partici pa nt s w h o  are d os e d o n t he st u d y des pite n ot sa tisf yi n g t he i ncl usi o n criteria 
•  Pa rtici pa nts w h o de vel o p wit h dra wal criteria w hilst o n t he st u d y b ut are n ot wit h dra w n  
•  Partici pa nt s w h o recei ve t he wr o n g treat me nt or a n i nc orrect d ose 
•  Partici pa nt s w h o recei ve a n e xcl u de d c o nc o mita nt me dicati o n 
•  De viati o n fr o m G o o d Cli nical Practice  
•  In cl usi o n a n d e xcl usi o n criteria  vi olati o ns  
•  C o nc o mita nt me dicati o n vi olati o ns  
•  Ot her  
vi olati o ns /e ve nts 
t hat  
ma y  
ha ve  
a  
rel e va nt  
i nfl ue nce  
o n  
t h e 
 a nal ysis (e. g., a d verse e ve nts  ( A Es), v o miti n g, 
sa m ple pr ocessi n g err ors, i naccurate d osi n g,  etc.)  
P r ot oc ol de viati o ns will n ot lea d t o t he e xcl usi o n of a p artici pa nt  fr o m a n a nal ysis set f or t he Fi n al 
A nal ysis . 
All i m p orta nt pr ot oc ol de viati o ns s h o ul d be d oc u me nte d i n Cli nical Data I nterc h a n ge Sta n dar ds 
C o ns orti u m  St u d y Data Ta b ulat i o n M o del ( S D T M) w het her i de ntifie d t hr o u g h sites m o nit ori n g, 
me dical re vie w a n d/or pr o gra m mi n g  base d o n t h e i ncl usi o n/e xcl usi o n criteria pres e nte d i n t he 
pr ot oc ol . I m p orta nt p r ot oc ol d e viati o ns are liste d a n d descri be d i n t he M o nit ori n g Pla n -P D M P -
2 8 N o v 2 0 2 2. p df.  
1 0. 2  
Defi niti o n of A n al ysis Sets a n d S u b gr o u ps   
Scree ni n g A n al ysis Set ( S C R)  
T he Scree ni n g ( S C R) A nal ysis Set i ncl u des all partici pa nt s w h o si g ne d t he i nf or me d c o ns e nt.  
S afet y A n al ysis Set ( S A F)  
T he Safet y A nal ysis Set  ( S A F) c o nsists of all partici pa nt s w h o recei ve at least o ne d ose of trial 
treat me nt. Partici pa nt s will be a nal yz e d acc or di n g t o t he act ual treat me nt t h e y recei ved  d uri n g  t he 
D B P . 
M o di fie d I nte nt-T o -Tre at A n al ysis Set ( mI T T)  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 3 /6 1  
 
 
T he mI T T A n al ysis Set c o nsists of all s u bjects ra n d o ml y all ocate d t o a treat me nt w h o bel o n g t o 
t he Safet y A nal ysis Set, a n d w h o ha ve at least o ne baseli ne a n d o ne p ost -bas eli ne M RI ass ess me nt. 
S u bjects will be a nal yze d acc or di n g t o t he tr eat me nt t he y were ra n d o mize d t o.  
M o difie d I nte nt -T o -Tre at O pe n -L a bel E xte nsi o n A n al ysis Set ( mI T T -O L E)  
T he m o difie d I T T O L E A nal ysis Set  ( mI T T-O L E ) A nal ysis Set c o nsists of all s u bjects ra n d o ml y 
all ocate d t o a treat me nt w h o bel o n g t o t he Safet y  O L E  A nal ysis Set, a n d w h o ha ve at least o ne 
M RI ass ess me nt  o n or after O L E Wee k 0 . S u bjects will be a nal yze d acc or di n g t o t heir pla n ne d 
treat me nt d uri n g t he D B P . 
S afet y O pe n -L a bel E xte nsi o n A n al ysis Set ( S A F -O L E)  
T he Safet y O L E A n al ysis Set c o nsists of all partici pa nt s w h o recei ve at least 1 d ose of E v o br uti ni b 
d uri n g t he O L E. Partici pa nt s will be a nal yze d acc or di n g t o t he act ual treat me nt t he y recei ve d uri n g 
t he D B P . 
S afet y S witc h O pe n -L a bel E xte nsi o n A n al ysis Set ( S A F -S W O L E)  
T he Safet y S witc h O L E A nal ysis Set c o nsists of all partici pa nt s w h o recei ve at least 1 d ose of 
E v o br uti ni b 7 5 m g BI D after a s witc h of d ose  fr o m 7 5 m g QD  d uri n g t he O L E. Partici pa nt s will 
be a nal yz e d acc or di n g t o t he act ual treat me nt t he y recei v e d uri n g D B P . 
T he S A F  a n d mI T T a n al ysis sets were pre -d efi n e d b y t he C T P  a n d mai nl y use d  f or P A/ B E A. 
S pecific safet y O L E a nal ysis sets ( S A F -O L E, S A F -S W O L E) were de fi n e d i n t he I A P f or O L E 
W 6 0 Safet y I A ( versi o n 1. 0, 1 6Ja n 2 0 2 0). T he mI T T -O L E a n al ysis set was defi ne d i n t he O L E 
W 2 4 0 I A  I A P. 
T he use of t he a nal ysis sets i n t he differe nt a nal ys es is s u m marize d i n t he f oll o wi n g ta ble:   
T a ble 1 : A n al ysis set  
A n al y s e s  
S C R 
A n al y si s 
S et  
S A F 
A n al y si s 
S et  
S A F - O L E 
A n al y si s 
S et  
S A F -
S W O L E 
A n al y si s 
S et  
mI T T 
A n al y si s 
S et  
mI T T – O L E 
A n al y si s 
S et  
S u bj e ct Di s p o siti o n  
✓ 
 
✓ 
 
 
 
Pr ot o c ol D e vi ati o n s  
 
 
✓ 
 
 
 
D e m o gr a p hi c a n d Ot h er 
B a s eli n e C h ar a ct eri sti c s  
 
 
✓ 
 
 
 
Pr e vi o u s  a n d 
C o n c o mit a nt 
M e di c ati o n s/ Pr o c e d ur e s  
 
 
✓ 
 
 
 
Tr e at m e nt C o m pli a n c e 
a n d E x p o s ur e  
 
 
✓ 
✓ 
 
 
Effi c a c y  
 
 
 
 
✓ 
✓ 
S af et y  E v al u ati o n   
 
✓ 
✓ 
 
 
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 4 /6 1  
 
 
1 1  
Ge ner al S pecific ati o ns f or St atistic al A n al yses   
All statistical a nal yses will be perf or me d b y 
 I nc. 
1 1. 1  
Tre at me nt gr o u ps a n d I n vesti g ati o n al Me dic al Pr o d uct (I M P)   
Treat me nt gr o u ps are defi ne d acc or di n g t o i nitial act ual treat me nt recei ve d as place b o , E v o br uti ni b  
2 5 m g Q D,  E v o br uti ni b  7 5 m g Q D, E v o br uti ni b  7 5 m g BI D , a n d Tecfidera . All partici pa nt s w h o 
c h o ose t o c o nti n ue t he O L E peri o d e nter e d o n t he 7 5 m g o nce  dail y d ose a n d ha ve  s witc he d t o t he 
7 5 m g t wice dail y d ose foll o wi n g pr ot oc ol a me n d me nt V 5 dat e d  2 1 N o ve m ber 2 0 1 8 . U nless 
ot her wise i n dicate d , all a nal yses will be prese nte d se parat el y f or t he 5 i nitial treat me nt gr o u ps pl us 
c o m bi ne d acr oss tr eat me nt gr o u ps (i.e., “ T otal”) . T he I M P  d uri n g t he O L E p hase is E v o br uti ni b .  
1 1. 2  
Prese nt ati o n of T a bles/ Listi n gs /Fi g ures   
T L F s will b e prese nte d usi n g 
i nitial treat me nt gr o u ps (i.e., tr ue treat me nt gr o u ps as 
“Place b o + E v o br uti ni b 2 5 
m g Q D ”, “E v o br uti ni b 2 5 
m g Q D ”, “E v o br uti ni b 7 5 
m g Q D ”, 
“E v o br uti ni b 7 5 m g BI D” , a n d “Tecfi dera” ) a n d t otal p o p ulati o n . A f o ot n ote  will be a d de d t o 
i n dicate t hat partici pa nt s s witc he d fr o m Place b o t o E v o br uti ni b 2 5 m g Q D f or t he sec o n d 2 4-wee k 
treat me nt peri o d. A sec o n d f o ot n ote will be a d de d t o i n dicate t hat all partici pa nt s s witc he d t o 
E v o br uti ni b 7 5 m g Q D o n O L E 
Wee k 0  a n d foll o wi n g pr ot oc ol a me n d me nt V 5 date d  2 1 
N o ve m ber 2 0 1 8, all partici pa nt s still o n g oi n g i n O L E s witc he d t o E v o br uti ni b 7 5 m g BI D. 
All data rec or de d d uri n g t he trial will be prese nt e d i n i n di vi d ual dat a listi n gs perf or m e d o n t h e 
Safet y  O L E  A n al ysis Set  ( S A F-O L E ), u nless ot her wise s pecifie d. A ll listi n gs will be  s orte d b y 
treat me nt gr o u p, p artici p a nt , a n d sc he d ule d ti me p oi nt ( w here a p plica ble), if n ot ot her wise state d. 
F urt her details are pr o vi d e d i n t he a p pr o pri a te secti o n f or t he a nal ysis of t he s pecific para meter. 
Ta bles a n d fi g ures will be  prese nte d  b y treat me nt gr o u p a n d sc he d ule d ti me p oi nt  d uri n g O L E 
peri o d  ( w h ere a p plica bl e), u nless ot her wise s pecifie d. Ta bles a n d fi g ures will be  s orte d b y 
treat me nt gr o u p an d c hr o n ol o gical sc he d ule d ti me p oi nt ( w here a p plica ble).   
S u m mar y statistics as dis pla ye d i n ta bles a n d fi g ures will i ncl u de data u ntil e n d of st u d y.  
1 1. 3  
Prese nt ati o n b y Ti me Peri o d   
T a bles s u m marizi n g data fr o m t he o verall O L E st u d y peri o d will be pr o vi de d, u nless ot her wise 
s pecifie d.  
B o x pl ots f or la b orat or y p ara meters will be s plit i n se veral p eri o ds t o re mai n rea da bl e.   
S o me o ut p uts will be s plit bet wee n t he O L E peri o d w here t he partici pa nt s are ta ki n g 7 5 m g Q D 
a n d t he peri o d w h ere t h e partici pa nt s are ta ki n g 7 5 m g BI D.  
Listi n gs will be prese nte d f or b ot h D B P  a n d O L E peri o d de pe n di n g o n t he c orres p o n di n g ta ble or 
fi g ure. All listi n gs wit h assess me nts d uri n g O L E p eri o d will ha ve a fla g i n dicati n g  eit her t he first 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
P P D


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 5 /6 1  
 
 
visit w here t he s witc h t o E v o br uti ni b 7 5 m g BI D occ urre d, or all t he e ve nts occ urri n g o n or after 
the date  of t he s witc h.   
1 1. 4  
D at a h a n dli n g after c ut -off d ate   
N ot a p plica ble . 
1 1. 5  
Prese nt ati o n of c o nti n u o us a n d q u alit ati ve v ari a bles   
C o nti n u o us varia bles will be s u m marize d usi n g descri pti ve statistics, i.e.:  
•  n u m ber of partici p a nt s ( N) 
•  n u m ber a n d perce nt a ge of n o n -missi n g val ues  
•  n u m ber a n d perce nt a ge of missi n g val ues .  
•  mea n, sta n dar d de viati o n  ( S D) 
•  me dia n, 2 5 t h Perce ntile - 7 5 t h Perce ntile ( Q 1 -Q 3)  
•  mi ni m u m, a n d ma xi m u m  
T he n u m ber of di gits f or n o n -deri ve d a n d d eri ve d data, prese nt e d i n o ut p uts or a vaila ble i n A Da M 
( A nal ysis Data 
M o del) datasets, is s pecifie d i n t he Bi ostatistics O ut p uts Asse m bl y ( B O A)  
d oc u me nt.  
F or b ot h c o nti n u o us a n d q ualitati ve varia bl es, perce nta ges as 0 % or 1 0 0 % s h o ul d be re p orte d wit h 
t he sa me f or mat use d f or t he c ol u m n a n d t o get her wit h t he c o u nt of val ues. F or e xa m ple, if t he 
c o u nt of val ue is zer o, t h e n dis pla y ‘ 0  (  0. 0)’; if t he perce nta ge is 1 0 0 % t h e n dis pla y ‘ x x ( 1 0 0. 0)’. 
Q ualitati ve varia bles will be s u m marize d b y c o u nts a n d perce nt a ges.  A missi n g cate g or y s h o ul d 
al wa ys be dis pla ye d at baseli ne –  e ve n w he n n o missi n g data.  A missi n g cate g or y, at ot her 
e n d p oi nts t ha n baseli n e, s h o ul d o nl y be dis pla ye d w he n t here are missi n g data . 
U nless ot her wise state d , t he calc ulati o n of pr o p orti o ns will be base d o n t he n u m ber of partici pa nt s 
i n t he a nal ysis set of i nterest. T heref ore, c o u nts of missi n g o bser vati o ns will be i ncl u de d i n t he 
de n o mi nat or a n d prese nt e d as a se p arat e cat e g or y.  
I n case t he a nal ysis refers o nl y t o certai n visits, perce nta ges will be base d o n t he n u m ber of 
partici pa nt s i n t he a n al ysis set of i nterest, u nless ot her wise s p ecifie d. T otal of missi n g a n d n o n -
missi n g o bser vati o ns at eac h ti me -p oi nt will  refl ect t he p o p ulati o n still i n t h e trial at t hat ti me. F or 
e xa m ple, if a partici pa nt  is still i n t he trial at t he ti me-p oi nt b ut wit h missi n g data, it s h o ul d be 
c o u nte d i n t he n u m ber of missi n g o bser vati o ns .  
1 1. 6  
Defi niti o n of b aseli ne  a n d c h a n ge fr o m b aseli ne  
F or t he p ur p ose of statistical a nal ysis, O L E baseli ne is defi ne d as t he last n o n -missi n g 
meas ure me nt (i n cl u di n g t h ose c ollecte d at a n U nsc he d ule d visit) pri or t o t he first d ose of I M P 
d uri n g O L E . St u d y  b aseli ne is defi n e d as t he last n o n -missi n g meas ure me nt (i ncl u di n g t h ose 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 6 /6 1  
 
 
c ollecte d at a n U ns c he d ule d visit) pri or t o t he first d ose of I M P i n t he st u d y. If baseli ne ca n n ot be 
defi ne d , t h e n t he baseli n e val ue will be treate d as missi n g.  O L E bas eli ne will be us e d i n O L E 
ta bles a n d b ot h bas eli nes will be dis pla y e d i n t he listi n gs  base d o n D B P + O L E peri o d , u nless 
ot her wise s pecified .  
Defi niti o n of c h a n ge fr o m b aseli ne ( C F B)   
C F B  a n d perce nt C F B at a gi ve n p ost -baseli ne visit will be c o m p ute d as f oll o ws:  
•  C F B  = visit val ue –  baseli ne val ue  
•  Perce nt C F B  = 1 0 0 * ( visit val ue –  baseli ne val ue ) / baseli ne val ue  
At t he baseli ne visit, t he C F B will be e q ual t o zer o a n d t he perce nt C F B wil l be missi n g.  
1 1. 7  
Defi niti o n of d ur ati o n   
D urati o n will be calc ulat e d as t he differe nce bet w ee n start a n d st o p dates pl us 1 ( e.g ., A E d urati o n 
( da ys) = A E e n d dat e - A E start date + 1).  
T he ti me si nce a n e ve nt will be calc ulate d as:  
•  refere nce d ate mi n us dat e of e ve nt + 1 (e g, d a ys i n st u d y at o nset of A E = A E start d ate - dat e 
of ra n d o mizati o n + 1)  if date of e v e nt is e q ual or greater t ha n refere nce dat e 
•  refere nce date mi n us date of e ve nt (e g, da ys i n st u d y at o nset of A E = A E start date - date of 
ra n d o mizati o n) ot her wise. 
1 1. 8  
C o n versi o n f act ors   
T he f oll o wi n g c o n v ersi o n fact ors will be us e d t o c o n vert d a ys i nt o m o nt hs or years: 1 m o nt h = 
3 0. 4 3 7 5 da ys, 1 year = 3 6 5. 2 5 da ys.  
1 1. 9  
H a n dli n g of missi n g d at a   
U nless ot her wise s pecifie d, missi n g data will n ot be re place d.  
I n all partici pa nt  data listi n g s, i m p ute d val ues will be prese nte d a n d fla g ge d. Partial dates, w hic h 
are n ot t o be i m p ute d acc or di n g t o t his IA P, will be prese nt e d usi n g t he f or mat “ _ _ _ _ _ Y Y Y Y”.  
Missi n g statistics, e g, w he n t he y ca n n ot be calc ulate d, s h o ul d be prese nte d as ‘n d ’, wit h ‘ n d’ 
sta n di n g f or ‘ n ot d o ne’. F or e xa m ple, if n =  1, t he meas ure of varia bilit y ( S D) ca n n ot be c o m p ute d 
a n d s h o ul d be pres e nte d as ‘n d ’. 
I n cas e of zer o rec or ds a vaila ble f or pres e ntati o n i n a gi ve n T L F, t he n a n e m pt y o ut p ut wit h 0  
occ urre nce  or a s e nte nce stati n g t hat t here are n o data  will b e pr o vi de d . F or ta bl es of A d verse 
E ve nts a n d Deat hs ( o ut p uts re q uire d f or E u dra C T a n d/ or cli nicaltrial. g o v), if  t h ere is n o 
o bser vati o n, t he o ut p ut m ust c o ntai n t he first li ne ‘ Partici pa nt  wit h …’ or ‘ Partici pa nt  w h o die d’ 
dis pla ye d wit h 0 occ urre nce.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 7 /6 1  
 
 
If a S yste m Or g a n  Class ( S O C) or A n at o mical T h era pe utic Class ( A T C) ter m is missi n g/ n ot c o de d 
yet, t he n ‘ U nc o de d S O C’ ( or ‘ U nc o d e d A T C’) will be i n dicate d at t he T L F  le vel. W he n a Preferre d 
Ter m ( P T) is missi n g, it will be set t o ‘ U nc o de d P T:’ T E A E ver bati m te xt.  
I n c o m plete A E-relate d d ates will be ha n dle d as f oll o ws: 
•  I n cas e t he o nset d ate is missi n g c o m pletel y or missi n g partiall y b ut t he o nset m o nt h a n d year, 
or t he o nset y ear, are e q ual t o t he start of I M P, t he n t he o nset d ate will be re pl ace d b y t he 
mi ni m u m of t he start of I M P date a n d t he A E res ol uti o n date  (if n ot missi n g).  
•  I n all ot her cases t he missi n g o nset da y or missi n g o nset m o nt h will be re place d b y 1. 
•  I n c o m plete st o p d ates will be re place d b y t he last da y of t he m o nt h (if d a y is missi n g o nl y), if 
n ot res ulti n g i n a date later t ha n t he date of partici pa nt  deat h. I n t he lat ter case, t he date of deat h 
will be use d t o i m p ute t he i nc o m plete st o p date.  
Partici pa nts wit h st u d y ter mi nati o n e -C R F f or m c o m plete d a n d treat me nt ter mi nati o n f or m missi n g 
at t he ti me of t he e n d of st u d y will be ha n dle d as f oll o ws : 
E n d of treat me nt stat us will be set t o “ Disc o nti n ue d” a n d t he f oll o wi n g e n d of treat me nt 
i nf or mati o n will be carrie d o ver fr o m t he st u d y ter mi nati o n e -C R F f or m:  
•  Reas o n f or disc o nti n uati o n of treat me nt will be re pl ace d b y t he reas o n f or st u d y disc o nti n uati o n  
•  Reas o n f or 
disc o nti n uati o n 
of treat me nt 
- pr ot oc ol 
n o n -c o m plia nce/ wit h dr aw al of 
c o nse nt/ Ot her, s pe cif y free-te xt fi el ds will be re pl ace d b y t h e c orres p o n di n g free-te xt fiel ds i n 
t he st u d y ter mi nati o n f or m 
•  E n d of treat me nt date will be re place d b y t he disc o nti n uati o n date fr o m t he st u d y ter mi nati o n 
e-C R F f or m  
1 1. 1 0  
Tri al d a y / Tre at me nt d a y   
Trial da y is d efi ne d relati ve t o t he d ate of ra n d o mi zati o n. Treat me nt da y is defi ne d relati ve t o t h e 
date of start of treat me nt  (i.e. treat me nt da y 1  is t he da y of t he first d ose of I M P). T here wi ll be a 
sec o n d start of tr eat me nt o n t he da y of first a d mi nistrati o n of E v o br uti ni b d uri n g O L E  la bele d O L E 
Treat me nt da y.  
T he da y bef ore t he start date of tr eat me nt is defi n e d as treat me nt da y -1, i. e., t here is n o tr eat me nt 
da y zer o.  
1 1. 1 1  
Re pe ate d a n d u nsc he d ule d me as ure me nts   
Re peate d a n d u nsc h e d ul e d meas ure me nts are i n cl u de d i n t he listi n gs. Data c ollecte d at b ot h 
sc he d ule d a n d u n s c he d ul e d visits will be use d f or s hift a nal yses. 
B y -visit s u m mar y statistics s h o ul d be pr o gra m me d base d o n assess me nts at b ot h sc he d ule d a n d 
u nsc he d ule d visits . Assess me nts at u nsc he d ul e d visits will be i ncl u de d acc or di n g t o t h e visit 
wi n d o wi n g a p pr oac h des cri be d bel o w.  A b y -visit s u m mar y ta ble/fi g ure will i ncl u de a f o ot n ote 
i n dicati n g w het her ass ess me nts fr o m u nsc he d ule d visits are i ncl u de d i n t he a nal ysis. 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 8 /6 1  
 
 
F or b y -visit ta b ulati o ns, i n case of m ulti ple assess me nts (i ncl u di n g u nsc h e d ule d) li n ke d t o t he 
sa me visit, t he first a vaila ble assess me nt (i n c hr o n ol o gical or der) will be i n cl u de d i n t he s u m mar y 
of a visit. T his r ule d oes n’t a p pl y t o baseli ne w here t he latest assess me nt bef ore da y 1 or O L E  da y 
1 is ta ke n.  
Re peate d a n d u ns c he d ule d meas ure me nts will be re p orte d i n t he listi n gs.  
1 1. 1 2  
E arl y tre at me nt ter mi n ati o n  assess me nt s  
B y -visit s u m mar y statistics s h o ul d be pr o gra m me d base d o n  ass ess me nts sl otte d acc or di n g t o t he 
visit wi n d o wi n g a p pr oac h descri be d b el o w. A  b y -visit s u m mar y ta ble/fi g ure will i ncl u de a 
f o ot n ote i n dicati n g w het her assess me nts fr o m earl y treat me nt ter mi nati o n visits are i ncl u de d i n t he 
a nal ysis base d o n sl otti n g t he assess me nt i nt o t he a p pr o priate a nal ysis  visit wi n d o w . T he s u m mar y 
f or t he Early Treat me nt T er mi nati o n visit  (f or assess me nts n ot sl otte d acc or di n g t o a visit wi n d o w 
a p pr oac h) will be disti n g uis he d fr o m t he O L E Wee k 3 8 4  visit, a n d t he Earl y St u d y Ter mi nati o n 
visit fr o m t he s u m mar y f or t he O L E Wee k 3 8 8  visit.  
F or a nal ys es b y ti me peri o d, data fr o m Safet y F oll o w -u p will be i ncl u de d i n t he peri o d i n w hic h 
t he partici pa nt  has disc o nti n ue d. Data fr o m Safet y F oll o w -u p will als o be i ncl u de d i n s hift ta ble t o 
deri ve w orst gr a de or val ue.  
1 1. 1 3  
A n al ysis v isit wi n d o ws   
A ssess me nts ma y be ma de  at ti mes ot her t ha n t he n o mi nal ti mes of pla n ne d visits, d ue t o 
partici pa nt  sc he d uli n g iss ues, u nsc he d ule d visits, or earl y treat me nt ter mi nati o n visits .  
A nal ys is visit wi n d o ws f or efficac y a n d s afet y e n d p oi nts, will be use d t o i nc or p orat e u nsc h e d ule d 
assess me nts i n b y -visit s u m maries. F or partici pa nts disc o nti n ui n g treat me nt d uri n g t he O L E, t he 
pre mat ure E n d of Treat me nt ( E O T ) assess me nt will be wi n d o we d a p pr o pr iatel y, pri or t o t he 
a nal ysis , f or safet y.  
F or t he calc ulati o n of a nal ysis visit usi n g t he ti me wi n d o ws, 1 m o nt h is e x presse d as 3 0 d a ys.  
As t he sc he d ul e of assess me nts is differe nt f or eac h visit, s pecific ti me wi n d o ws m ust be use d f or 
eac h e n d p oi nt. T he y are defi ne d i n A p pe n di x  1 9. 3 . 
F or all bi oc h e mistr y para meters, t he s a me sc he d ule of assess me nt is c o nsi dere d wit h all visits 
p ossi ble per pr ot oc ol.  
If t here are m ulti ple assess me nts wit hi n a sa me visit wi n d o w, t he n t he o ne cl osest t o t he tar get da y 
will be use d. If 2  assess me nts ha ve t he sa me differe n ce wit h tar get da y, t he earlier o ne will be 
use d.  
1 1. 1 4  
Ti me si nce M S o nset/ di a g n osis   
Ti me  i n years si nce M S o nset is calc ulate d fr o m date of i nf or me d c o nse nt –  M S o nset date / 3 6 5. 2 5 
da ys if t he cat e g or y of m e dical hist or y is ’ Hist or y of M S’.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
1 9 /6 1  
 
 
Ti me i n years si nc e M S dia g n osis is calc ulate d fr o m date of i nf or m c o nse nt –  M S Dia g n osis date 
/ 3 6 5. 2 5 da ys. 
1 1. 1 5  
B o d y M ass I n de x ( k g/ m² ) at st u d y B aseli ne   
Is calc ulat e d as:  
B o d y Mass I n d e x ( B MI ) [ k g/ m²] = 
𝑤𝑒𝑖𝑔ℎ𝑡 [𝑘𝑔]𝑎𝑡 𝑏𝑎𝑠𝑒𝑙𝑖𝑛𝑒 
ℎ𝑒𝑖𝑔ℎ𝑡[𝑐𝑚]2  𝑎𝑡 𝑠𝑐𝑟𝑒𝑒𝑛𝑖𝑛𝑔× 1 0 0 0 0  
 
1 1. 1 6  
S oft w are   
All a nal yses will be perf or me d usi n g S A S ® S oft ware v ersi o n 9. 4  or hi g her .  
1 2  
Tri al S u bjects   
T he s u bsecti o ns i n t his secti o n i ncl u de s pecifi cati o ns f or re p orti n g parti ci pa nt  dis p ositi o n a n d 
treat me nt/trial disc o nti n uati o ns. 
1 2. 1  
Dis p ositi o n of S u bjects a n d Disc o nti n u ati o ns   
A ta ble o n scree ne d partici pa nts  descri bi n g t he n u m ber a n d perce nt of partici pa nts  i n eac h of 
f oll o wi n g dis p ositi o n cate g ories will be pr o d uce d b y treat me nt gr o u p: 
•  T otal n u m ber of scree ne d s u bjects, i .e. s u bjects t hat ga ve i nf or me d c o nse nt ( o verall s u m mar y 
o nl y)  
•  N u m ber of s u bjects w h o disc o nti n ue d pri or t o ra n d o mizati o n a n d reas o n ( o ver all s u m mar y 
o nl y)  
•  N u m ber of ra n d o mize d s u bjects  
•  N u m ber of ra n d o mize d s u bjects w h o di d n ot start treat me nt  
•  N u m ber of ra n d o mize d s u bjects w h o c o m plete d t he first 2 4 wee ks of treat me nt  
•  N u m ber of ra n d o mize d s u bjects w h o per ma ne ntl y disc o nti n ue d treat me nt pri or t o Wee k 2 4 a n d 
reas o n 
•  N u m ber of ra n d o mize d s u bjects w h o p er ma ne ntl y disc o nti n ue d treat me nt after Wee k 2 4 a n d 
pri or t o O L E  a n d reas o n  
•  N u m ber of ra n d o mize d s u bjects w h o c o m plete d 4 8 wee ks of tr eat me nt 
•  N u m ber of ra n d o mize d s u bjects  w h o si g ne d t he O L E I nf or me d C o nse nt 
•  N u m ber of ra n d o mize d s u bjects w h o di d n ot si g n it  
•  N u m ber of ra n d o mize d s u bjects w h o e ntere d O L E at d ose 7 5 m g Q D a n d s witc he d t o 7 5 m g 
BI D  d uri n g t he O L E  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 0 /6 1  
 
 
•  N u m ber of s u bjects w h o disc o nti n ue d treat me nt after O L E Wee k 0 a n d pri or t o  O L E Wee k 4 8   
•  N u m ber of s u bjects still o n treat me nt at O L E Wee k 4 8  
•  N u m ber of s u bj ects w h o disc o nti n ue d treat me nt after O L E Wee k 4 8 a n d pri or t o O L E Wee k 9 6  
•  N u m ber of s u bjects w h o c o m plete d t he O L E treat me nt at O L E Wee k 9 6  
•  N u m ber of s u bjects w h o e ntere d a ga p peri o d at O L E Wee k 9 6  
•  N u m ber of s u bjects still o n treat me nt at O L E Wee k 9 6  
•  N u m ber of s u bjects w h o disc o nti n ue d treat me nt after O L E Wee k 9 6  a n d pri or t o O L E Wee k 
1 4 4  
•  N u m ber of s u bjects still o n treat me nt at O L E Wee k 1 4 4  
•  N u m ber of s u bjects  w h o  disc o nti n ue d treat me nt after O L E Wee k 1 4 4  a n d pri or t o O L E Wee k 
1 9 2   
•  N u m ber of s u bjects still o n treat me nt at O L E Wee k 1 9 2  
•  N u m ber of s u bjects  w h o  disc o nti n ue d treat me nt after O L E Wee k 1 9 2 a n d pri or t o O L E Wee k 
2 4 0  
•  N u m ber of s u bjects still o n treat me nt at O L E Wee k 2 4 0  
•  N u m ber of s u bjects  w h o  disc o nti n ue d treat me nt after O L E Wee k 2 4 0 a n d pri or t o O L E Wee k 
2 8 8   
•  N u m ber of s u bjects still o n treat me nt at O L E Wee k 2 8 8  
•  N u m ber of s u bjects  w h o  disc o nti n ue d treat me nt after O L E Wee k 2 8 8 a n d pri or t o O L E Wee k 
3 3 6  
•  N u m ber of  s u bjects still o n treat me nt at O L E Wee k 3 3 6 
•  N u m ber of s u bjects w h o c o m plete d treat me nt d uri n g  O L E . A partici pa nt is c o nsi dere d t o ha ve 
c o m plete d t he O L E if he/s he c o m plete d t he E n d of Treat me nt Visit f or t he O L E Peri o d a n d was 
assi g ne d t he stat us ‘ C o m plete d’, or if t he mai n reas o n f or treat me nt disc o nti n uati o n was “ Ot her, 
s pecif y: St u d y ter mi nate d b y S p o ns or”.  
•  N u m ber of ra n d o mize d s u bjects w h o per ma ne ntl y disc o nti n ue d treat me nt d uri n g O L E a n d 
reas o n. C O VI D-1 9 relat e d reas o n f or disc o nti n uati o n wil l be re p ort e d s e parat el y fr o m t he 
“ Ot her” reas o n.  
•  N u m ber of ra n d o mize d s u bjects i n t he f oll o w-u p p hase w h o h a ve n ot c o m plete d t he trial (ie, 
treat me nt c o m plete d or disc o nti n ue d wit h o ut d oc u me nte d  Safet y F oll o w -u p/ E n d of Trial Visit)   
•  N u m ber of ra n d o mize d su bjects w h o c o m plete d t he trial  
•  N u m ber of ra n d o mize d s u bjects w h o c o m plete d t he trial at Wee k 5 2  
•  N u m ber of ra n d o mize d s u bjects w h o c o m plete d t he trial at O L E Wee k 1 0 0  
•  N u m ber of ra n d o mize d s u bjects w h o c o m plete d t he trial at O L E Wee k 3 4 0  
•  N u m ber of ra n d o mize d s u bjects w h o c o m plete d t he trial at e n d of tri al  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 1 /6 1  
 
 
•  N u m ber of ra n d o mize d s u bjects w h o disc o nti n ue d fr o m trial aft er ra n d o mizati o n  a n d pri or t o 
O L E  a n d reas o n .  
•  N u m ber of ra n d o mize d s u bjects w h o disc o nti n ue d fr o m trial d uri n g O L E  o verall, a n d b y  y ear 
of O L E ( o n or b ef ore O L E W 4 8 , O L E W 4 8 - O L E W 9 6  etc.) a n d reas o n . C O VI D-1 9 relate d 
reas o n f or disc o nti n uati o n will be re p orte d se p aratel y fr o m t he “ Ot h er” reas o n. 
A t a ble bas e d o n scree n e d s u bjects descri bi n g t he n u m ber  a n d p erce nt of s u bjects i n eac h a n al ysis 
set b y treat me nt  gr o u ps  will be pr o d uce d : 
•  N u m ber of scree n e d s u bj ects  
•  N u m ber of s u bjects i ncl u de d i n t he S A F  
•  N u m ber of s u bjects i ncl u de d i n t he S A F -O L E  
•  N u m ber of  s u bjects i ncl u de d i n t he S A F-S W O L E  
•  N u m ber of s u bjects i ncl u de d i n t he mI T T  
•  N u m ber of s u bjects i ncl u de d i n t he mI T T -O L E  
A ta ble descri bi n g t he n u m ber  of partici p a nts  b y re gi o n, c o u ntr y wit hi n re gi o n a n d site  will be 
pr o d uce d b y  a nal ysis set.  A listi n g wit h partici pa nts  b y a nal ysis set will be pr o vi de d.  
St u d y a n d treat me nt disc o nti n uati o n/c o m pleti o n stat us will be liste d f or all p artici pa nts  i n t he S A F -
O L E a nal ysis set . T he details of w h o disc o nti n ue d/c o m plete d treat me nt or st u d y will be pr o vi de d  
wit h t heir reas o n f or disc o nti n uati o n (if a p plica ble)  as well as,  tr eat me nt gr o u p , s u bject I D, First 
Date (rel ati ve da y)/ Last Date (rel ati ve d a y) of d osi n g, first date of d osi n g i n O L E, date o f t h e 
s witc h d uri n g O L E (if s witc h perf or me d), treat me nt a n d st u d y disc o nti n uati o n dates (relati ve da y) . 
Partici pa nts wit h st u d y partici pati o n i m pacte d b y t he U krai ne crisis will als o be liste d wit h a 
descri pti o n of t he differe nt e ve nts a n d i m pacts. T his c o ul d i ncl u de st u d y i nter ve nti o n 
disc o nti n uati o n, st u d y disc o nti n uati o n, pr ot oc ol de viati o ns, misse d d oses a n d misse d visits.  
1 2. 2  
Pr ot oc ol De vi ati o ns   
1 2. 2. 1  
I m p ort a nt Pr ot oc ol De vi ati o ns  
T he  f oll o wi n g s u m mar y ta bles a n d listi n gs of i m p orta nt pr ot oc ol de viati o ns (I P Ds) d uri n g  t he D B P 
a n d t he O L E  peri o d  will be pr o vi de d:  
•  Ta ble pr o vi di n g fre q u e nc y of s u bjects wit h at least o ne I P D a n d fre q u e nc y f or eac h t y pe of I P D; 
U krai ne crisis relate d I P Ds will als o be s u m marize d as a se p arat e cat e g or y wit hi n t he ta ble.  
•  Ta ble pr o vi di n g fre q ue nc y f or eac h t y pe of mi n or U krai ne crisis relate d P De v.  
•  Listi n g of i m p orta nt pr ot oc ol de viati o ns  
•  A s pecific listi n g f or U krai ne crisis rel ate d I P Ds/ P De vs.  
U krai ne crisis relate d P De vs will i ncl u de all P De vs i ncl u di n g t he me nti o n “ B C P 2 2” or “ B C P” 
wit hi n t heir descri pti o n.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 2 /6 1  
 
 
1 2. 2. 2  
Re as o ns Le a di n g t o t he E xcl usi o n fr o m a n A n al ysis Set   
N ot a p plica ble . 
1 3  
De m o gr a p hics a n d Ot her B aseli ne C h ar acteristics   
De m o gra p hics, b aseli ne dise ase c h aracteristics, a n d ot her bas eli ne c h aracteristics  at st u d y baseli ne  
will be s u m marize d base d o n t he S A F -O L E a n al ysis set, prese nte d b y treat me nt gr o u p pl us 
c o m bi ne d acr oss tr eat me nt gr o u ps (i.e. “ T otal”) .  
S u p p orti ve listi n gs will be base d o n t he S A F -O L E a nal ysis set, wit h s u bjects fla g ge d acc or di n g t o 
me m bers hi p i n t he S A F -S W O L E a nal ysis sets.  
1 3. 1  
De m o gr a p hics   
•  De m o gra p hic c haracteristics  
•  Se x : male, fe male  
•  Race : W hite, B lac k or Africa n A merica n,  A sia n, A merica n I n dia n or Alas ka Nati ve , Nati ve 
Ha waiia n or Ot her Pacific Isla n der, O t her 
•  Et h nicit y: His pa nic or Lati n o, N ot His pa nic or Lati n o  
•  A ge ( years)  at i nf or me d c o nse nt : s u m mar y statistics  
•  P o ole d Re gi o n  (U S or Wester n E ur o p e, Easter n E ur o pe, Rest of t he W orl d ) 
•  Ge o gra p hic / Ca p a bilit y Re gi o n  (U S, 
Wester n E ur o pe, Easter n  E ur o pe  a n d 
, 
Easter n E ur o p e a n d n ot 
, Rest of t he W orl d ) 
•  E ur o pea n E c o n o mic Area ( E E A)  
•  A listi n g wit h act ual treat me nt gr o u p , s u bject I D, a nal ysis set, a ge, se x, race, et h nicit y, hei g ht, 
wei g ht, B MI, c o u ntr y a n d re gi o n will als o be pres e nte d.  
S pecificati o ns f or c o m p utati o n:  
•  A ge  ( years):  
•  ( date of gi ve n i nf or me d c o nse nt - date of birt h + 1) / 3 6 5. 2 5  
•  I n case of missi n g da y f or at least o ne d ate, b ut m o nt h a n d year a vaila ble f or b ot h dates, t he 
da y of i nf or m e d c o ns e nt a n d t he da y of birt h will be set t o 1 a n d t he f or m ula a b o ve will be 
use d.  
•  I n case of missi n g m o nt h f or at least o ne date, b ut year a v aila ble f or b ot h d ates, t he m o nt h 
of i nf or me d c o nse nt a n d t he da y a n d m o nt h of birt h will be set t o 1 a n d t h e f or m ula a b o v e 
will be use d.  
•  Site c o des will be use d f or t he deter mi nati o n of t h e partici pa nts  ge o gra p hic re gi o n.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 3 /6 1  
 
 
1 3. 2  
Me dic al Hist or y   
Rele va nt past a n d prese nt me dical c o n diti o ns at  st u d y baseli ne will be s u m ma rize d fr o m t he 
“ Me dical Hist or y Details” e C R F pa g e.  
F or t his a n al ysis, the Me dical Dicti o nar y f or Re g ulat or y Acti vities ( Me d D R A), c urre nt versi o n, 
P T  as e v e nt cate g or y a n d Me d D R A S O C  b o d y ter m as B o d y S yste m cate g or y  will be us e d . T h e 
Me d D R A versi o n use d will be i n dicate d i n  a f o ot n ote. Me dical hist or y will be ta b ulate d b y S O C 
a n d P T. S O C a n d P T will be al p ha beticall y  s orte d. Me dical hist or y will  be als o liste d. 
1 3. 3  
Ot her B aseli ne C h ar acteristics   
1 3. 3. 1  
Dise ase hist or y   
I nf or mati o n o n M S  baseli ne disease c h aracteristics , base d o n data c ollecte d at st u d y baseli ne will 
be s u m marize d i n t otal a n d  b y treat me nt gr o u p f or partici pa nts  e nr olle d i n t he O L E a n d  t he y will 
als o be  liste d. 
Descri pti ve  statistics will be prese nt e d f or:  
•  T y pe of M S, eit her rela psi n g -re mitti n g M S or sec o n dar y pr o gressi ve M S 
•  Ti me ( years ) si nce M S o nset (first s y m pt o m) 
•  Ti me ( years ) si nce M S dia g n osis  
•  Maj or s yste ms affecte d  
•  N u m ber of rela pses i n t h e year pri or t o ra n d o mizati o n  
•  N u m ber of rela pses i n t h e last 2 years  b ef ore scree ni n g  
•  E D S S sc ore  
•  Sc ores f or eac h of t he 7 F u ncti o nal S yste ms ( Vis ual, Brai nste m, P yra mi dal, Cere b ellar, 
Se ns or y, B o wel/ Bla d der, Cere bral) a n d sc ore f or A m b ulati o n use d t o deri ve E D S S sc ore.  
•  Prese nce of at least 1 T 1  G d + lesi o n wit hi n 6 m o nt hs pri or t o ra n d o mizati o n  
•  N u m ber of T 1  G d + lesi o ns 
•  V ol u me of T 1  G d +  lesi o ns  
•  V ol u me of T 2 lesi o ns   
F or ti me si nce M S o nset or M S dia g n osis, a missi n g o nset da y / m o nt h will be re place d b y 1 f or 
d urati o n deri vati o n.  
1 3. 3. 2  
Ot her   
Descri pti ve  statistics will be prese nte d f or  p h ysical e xa mi nati o n as c o nti n u o us varia bles: Hei g ht 
(c m), Wei g ht ( k g) a n d B MI ( k g/ m²). 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 4 /6 1  
 
 
A nal yses of b aseli ne c h aracteristics wit h res pect t o E C Gs a n d cli nical la b orat or y e val u ati o ns are 
disc usse d i n S ecti o n 1 7  Safet y.  
1 4  
P re vi o us  or C o nc o mit a nt Me dic ati o ns/ Pr oce d ures   
Me dicati o ns/ pr oce d ures will be prese nte d o n t he S A F -O L E A nal ysis Set . 
C o nc o mit a nt me dic ati o ns  are me dicati o ns, ot her t ha n I M Ps, w hic h are ta ke n b y partici p a nts  a n y 
ti me o n-trial ( o n or aft er t he first d a y of I M P treat me nt f or eac h partici pa nt ). C o nc o mita nt 
me dicati o ns i ncl u de t h os e starte d pri or t o a n d c o nti n ue d d uri n g a d mi nistrati o n of  I M P, as well as 
t h ose t hat were start e d aft er first a d mi nistrati o n of I M P. If t he date v al ues d o n ot all o w a me dicati o n 
t o be classifie d as a n o n-c o nc o mita nt me dicati o n, t he me dicati o n will be c o nsi dere d as a 
c o nc o mita nt me dicati o n.  
C o nc o mit a nt me dic ati o n s d uri n g O L E treat me nt peri o d are d efi ne d as me dicati o n s starti n g o n 
or after t h e first I M P a d mi nistrati o n d uri n g O L E peri o d or starti n g bef ore first a d mi nistrati o n 
d uri n g O L E b ut e n di n g or o n g oi n g after first a d mi nistrati o n d uri n g O L E peri o d.  
Pre vi o us me d ic ati o ns are me di cati o ns, ot her t h a n trial m e dicati o ns, w hic h starte d bef ore  first 
a d mi nistrati o n of I M P d uri n g t he D B P. Pre vi o us me dicati o ns i ncl u de t h ose t hat were c o nti n ue d 
d uri n g a d mi nistrati o n of I M P  d uri n g t he D B P, as well as t h ose disc o nti n ue d pri or t o first 
a d mi nistrati o n of I M P  d uri n g t he D B P. If t he d ate val ues d o n ot all o w a me dicati o n t o be classifie d 
as c o nc o mita nt  me dicati o n, t he me dicati o n will be c o nsi dere d as a pre vi o us me dicati o n.  
C o nc urre nt  pr oce d ures are pr oce d ures w hic h  were u n derta ke n a n y ti me o n trial . If t he date 
val ues d o n ot all o w a pr oce d ure  t o be classifie d as a n o n-c o nc o mita nt pr oce d ure , t he pr oce d ure 
will be c o nsi dere d as a c o nc o mita nt pr oce d ure . 
C o nc urre nt  pr o ce d ures d uri n g O L E  treat me nt peri o d are defi ne d as pr oce d ures starti n g o n or 
after t h e first I M P a d mi nistrati o n d uri n g O L E peri o d or starti n g b ef ore first a d mi nistrati o n d uri n g 
O L E b ut e n di n g or o n g oi n g after first a d mi nistrati o n d uri n g  t he O L E peri o d.  
C o nc o mita nt me dicati o ns a n d c o nc urre nt pr oce d ures occ urri n g d uri n g  t h e O L E peri o d  will b e 
ta b ulate d. 
F or c o nc o mita nt me dicati o n d uri n g t he O L E t he A T C -sec o n d l e vel a n d preferre d ter m will be 
ta b ulate d as gi ve n fr o m t he 
W orl d Healt h Or ga nizati o n Dr u g Dicti o nar y ( W H O-D D) c urre nt 
versi o n. I n case m ulti ple A T Cs are assi g ne d t o a dr u g, all A T C -2 n d le vel ter ms will be use d f or 
re p orti n g.  
C o nc urre nt  pr oce d ures d uri n g t he O L E peri o d will be classifie d b y me dical re vie w. N u m ber of 
partici pa nts  wit h c o nc o mita nt pr oce d ures ( starti n g pri or t o first d ose of trial treat me nt, o n or after 
t he first da y of I M P a n d pri or t o first d ose d uri n g  t h e O L E p eri o d  a n d starti n g after first d ose d uri n g 
t he O L E p eri o d ) a n d b y t y pe of pr oce d ure (as classifie d b y me dical re vi e w) will be s u m marize d 
b y treat me nt gr o u p a n d liste d.  
L isti n gs of c o nc o mita nt me dicati o ns a n d c o nc o mita nt pr oce d ures  d uri n g t he O L E will be pr o vi de d.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 5 /6 1  
 
 
Dise ase M o dif yi n g T her a p y ( D M T)  is n ot ca pt ur e d  i n t he e C R F b ut is of i nterest f or  t he a nal ysis. 
I n or der t o i de ntif y D M Ts, t he list of all pre vi o us  me dicati o ns was re vie we d b y  t he Merc k me dical 
tea m a n d t he fla g f or D M T was assi g ne d retr os pecti vel y (refer t o A p pe n di x  1 9. 7  f or list of 
i de ntifie d D M Ts). Fla gs were  t he n create d fr o m t his list  i n A Da M:  
•  Pri or D M Ts fr o m Pri or Me dicati o ns e C R F (see defi niti o n f or pre vi o us me dicati o n i n secti o n 
a b o ve), 
•  s u bjects wit h at least o ne pri or D M T,  
•  s u bjects wit h m ore t ha n o ne pri or D M T, 
•  n u m ber of pri or D M Ts p er s u bject.  
Ta ble s f or Pri or D M T will be create d base d o n  t he S A F a n d  S A F -O L E a nal ysis set s wit h selecti o n 
o n t he pre vi o us me dicati o n s a n d prese nti n g n u m ber of s u bjects w it h at least o ne pri or D M T, 
n u m ber of s u bjects wit h m ore t ha n o ne pri or D M T a n d n u m ber of s u bjects per pri or D M T ( W H O -
D D preferre d ter m).  
1 5  
Tre at me nt C o m pli a nce a n d E x p os ure   
E x p os ure a n d c o m plia nce will be prese nt e d o n t he S A F -O L E  a n d S A F -S W O L E  A nal ysis Set s. 
Pl a n ne d a d mi nistr ati o n of E v o br uti ni b d uri n g O L E  
Eac h kit c o nt ai ns 2 4 ta blets of 2 5 m g of E v o br uti ni b w hic h is e n o u g h me dicati o n f or t he 
a d mi nistrati o n of 3 ta blets per da y  (s o 7 5 m g i n t otal) f or 8 da ys. O n  O L E Da y 1, partici pa nts  n ot 
treate d wit h Tecfi dera d uri n g t he D B P recei ved  1 2 kits. Fr o m O L E Wee k 1 2 u ntil  O L E Wee k 8 4, 
t hese partici pa nts  recei ved  b et wee n 1 1 a n d 1 3 kits  de pe n di n g o n t he q ua ntit y of kits carrie d o ver 
fro m last visit. O n O L E Da y 1, partici pa nts  treate d wit h Tecfi dera d uri n g t he D B P recei ved  5 kits. 
Fr o m O L E Wee k 4 u ntil O L E Wee k 8, t he y recei ve d  bet wee n 4 a n d 6 kits de pe n di n g o n t he 
q ua ntit y of kits carrie d o ver fr o m last visit.  At eac h trial visit  fr o m OL E Wee k 1 2 , p artici pa nts  
were  gi ve n treat me nt kits c o ntai ni n g t he n u m ber of ta blets nee de d u p t o t he ne xt pla n ne d trial visit  
de pe n di n g o n t he kits carrie d o ver fr o m last visit . Partici pa nts  recei v ed  7 5 m g of E v o br uti ni b Q D 
( o nce a d a y) u ntil t he y s witc he d t o t he d ose of 7 5 m g of E v o br uti ni b BI D.  
O nce a p artici pa nt  s witc he d t o t he ne w d ose of 7 5 m g BI D a n d n e w kits were  a vaila ble, eac h kit 
c o ntai ne d 4 8 ta blets of 2 5 m g of E v o br uti ni b w hic h was  e n o u g h me dicati o n f or t he a d mi nistrati o n 
of 6 ta blets per da y ( 3 i n t he m or ni n g a n d 3 i n t he e ve ni n g) f or 8 d a ys. At eac h tri al visit, a 
partic ipa nt  w as gi ve n treat me nt kits c o ntai ni n g t he n u m ber of ta blets n ee de d u p t o t he n e xt pla n ne d 
trial visit. N u m be r of kits dis pe nse d was  t he sa m e as bef ore t he s witc h of d ose.  After t he s witc h, 
partici pa nts  recei ved  7 5 m g of E v o br uti ni b BI D (t wice a d a y)  f or t h e re m ai n der of t he O L E.  
E x p os ure  
E x p os ure ti me i n wee ks d uri n g t he O L E will be calc ulate d acc or di n g t o t h e f oll o wi n g f or m ula:  
e x p os ure ( w e e ks) =  
(date of last d ose d uri n g O L E peri o d - date of first d ose d uri n g O L E peri o d + 1 )/ 7  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 6 /6 1  
 
 
If t he e n d date of t he last d ose is missi n g, t he n t he date of last d ose will b e re place d b y t h e last  
visit date. If a partici pa nt  is l ost t o f oll o w u p a n d has n’t perf or me d t he E O T visit, t he n e n d of st u d y 
date will be c o nsi dere d as t he e n d of treat me nt dat e.  
E x p os ure ti me will be prese nte d b y s u m mar y statistics d uri n g t he O L E peri o d a n d acc or di n g t o 
t he cate g ori es ≤ 1 wee k, >  1 t o 1 2  wee ks, >  1 2  t o 2 4  wee ks , > 2 4 t o 3 6 wee ks , > 3 6 t o 4 8  wee ks, 
>  4 8 t o 6 0  wee ks, >  6 0 t o 7 2  wee ks, >  7 2 t o 8 4  wee ks, >  8 4 t o 9 6  we e ks, > 9 6 t o 1 0 8 wee ks, > 1 0 8 
t o 1 2 0 wee ks, > 1 2 0 t o 1 3 2 wee ks,  > 1 3 2 t o 1 4 4 wee ks > 1 4 4  t o 1 5 6 wee ks, > 1 5 6 t o 1 6 8 wee ks, > 
1 6 8 t o 1 8 0 wee ks, > 1 8 0 t o 1 9 2 wee ks, > 1 9 2  t o 2 1 6 wee ks, > 2 1 6 t o 2 4 0 wee ks , > 24 0  t o 26 4  wee ks , 
> 2 6 4 t o 2 8 8 wee ks, > 2 8 8 t o 3 1 2 wee ks , > 3 1 2 wee ks. F or t his a nal ysis t he S A F -O L E a n al ysis set 
will be use d.  T a bles a b o ut e x p os ure ti me bef ore or after t he s witc h  d uri n g t he O L E peri o d  will be 
pr o vi de d , t he da y of s witc h will be c o nsi dere d i n t he peri o d after t he s witc h. F or ta bles a b o ut 
e x p os ure ti me  aft er t he s witc h, t he S A F-S W O L E a nal ysis set  will be use d.   
T he c u m ulati ve act ual d ose ( m g) per partici pa nt  is t he n u m ber of ta blets ta ke n d uri n g t he O L E  
peri o d, m ulti plie d b y 2 5 m g  ( d osa ge of 1  ta blet). T he n u m ber of ta blets i n geste d will be  de d u ce d 
fr o m t he “M 2 9 5 1 B o x N u m ber ( B A T C H 3 )” electr o nic case re p ort f or m (e C R F)  pa g e . Descri pti ve 
statistics f or c u m ulati ve act ual d ose will be pres e nte d d uri n g O L E peri o d usi n g  t he S A F -O L E 
a nal ysis set. Descri pti ve statistics f or c u m ulati ve act ual d ose recei ve d b ef ore a n d aft er t he s witc h 
d uri n g t he O L E peri o d will be als o pr o vi de d. Descr i pti ve statistics after t he s witc h will be restricte d 
t o S A F-S W O L E A n al ysis Set.  
C o m pli a nce  
C o m plia nce wit h treat me nt d uri n g O L E peri o d = 1 0 0 *(
(N 1 b s )
3 ∗N 2 b s
+
(N 1 a s )
6 ∗N 2 a s
) 
w here  
•  N 1 bs = n u m ber of ta blets gi ve n mi n us n u m ber of ta blets ret ur ne d  b ef ore d ose s witc h,    
•  - N 2 bs = n u m ber of da ys bet wee n treat me nt start a n d s witc h visit ( or treat me nt ter mi nati o n visit 
if partici pa nt  disc o nti n ue d bef ore t h e s witc h) ,  
•  - N 1as = n u m ber of ta blets gi ve n mi n us n u m ber of ta blets ret ur ne d  after d ose s witc h,   
•  - N 2as = n u m ber of da ys bet wee n s witc h visit a n d treat me nt ter mi nati o n visit.  F or partici pa nts 
w h o are l ost t o f oll o w -u p t he e n d of st u d y visit date will be use d.  
C o m plia nce 
wit h treat me nt 
bef ore t he 
s witc h 
d uri n g 
O L E 
peri o d is 
defi ne d 
as  
1 0 0 *(
(N 1 b s )
3 ∗N 2 b s
) 
C o m plia nce 
wit h treat me nt 
after t he 
s witc h 
d uri n g 
O L E 
p eri o d is 
defi ne d 
as  
1 0 0 *( (N 1 a s )
6 ∗N 2 a s
) 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 7 /6 1  
 
 
If t he s u bject di d n’t s wit c h t he d ose, 
(N 1 a s )
6 ∗N 2 a s  is set t o 0. If a kit is r ecei v e d b y t h e partici pa nt  b ut n o 
i nf or mati o n a b o ut t he n u m ber of ta blets ret ur n e d is availa ble beca use of l ost t o f oll o w -u p, t he kit 
is n ot c o nsi dere d i n t he calc ulati o n of c o m plia nce.  
C o m plia nce wit h treat me nt will be prese nt e d b y s u m mar y statistics d uri n g t he O L E peri o d a n d 
acc or di n g t o t he cat e g ori es <  6 0 % , ≥ 6 0 %  t o <  8 0 % , ≥ 8 0 %  t o <  9 0 % , ≥ 9 0 %  t o <  1 1 0 % , ≥ 1 0 0 %. 
F or t his a nal ysis t he S A F -O L E a nal ysis set will be use d. Ta bles a b o ut c o m plia nce bef ore or after 
t he s witc h d uri n g O L E p eri o d will be als o pr o vi d e d . Ta bles after t h e s witc h will be restricte d t o 
S A F -S W O L E A n al ysis Set.  
T he f oll o wi n g listi n gs will be pr o vi de d:  
•  listi n g of E v o br uti ni b start/e n d dates of t he si n gle a d mi nistrati o n wit h n u m ber of i n geste d 
ta blets (fr o m E X P O S U R E D T3  eC R F  pa ge ), f or t he st u d y dr u g a d mi nistrati o n  d uri n g  t he O L E 
peri o d.  
•  listi n g wit h e x p os ure ti me, c u m ulati ve d ose, a n d c o m plia nce d uri n g  t he O L E peri o d.  
1 6  
Effic ac y E v al u ati o n   
All effic ac y a nal ys es will be base d o n t he mI T T  a n d mI T T -O L E a nal ysis s et s, as s pecifie d i n b el o w 
secti o ns. All a nal yses are descri pti ve, t here is n o h y p ot hesis testi n g.  
1 6. 1  
M RI   
Descri pti ve statistics f or t he n u m ber of T 1 G d + lesi o ns, ne w/e nlar gi n g T 2 lesi o ns a n d T 2 v ol u me 
at eac h visit (earl y treat me nt disc o nti n uers d uri n g O L E will b e prese nte d at ‘ E O T’ visit) d uri n g  
t he O L E  will be pr o vi de d  b y treat me nt gr o u p a n d  o verall  o n t he mI T T -O L E a nal ysis set.  
Mea n n u m ber of T 1 G d + lesi o ns  a n d ne w/e nlar gi n g T 2 lesi o ns will be prese nte d as a b y -v isit li ne 
pl ot f or eac h treat me nt gr o u p  d uri n g t he O L E o n  t he mI T T -O L E a nal ysis set , wit h a vertical li ne 
se g me nt at eac h visit re prese nti n g ± sta n dar d err or (S E ) (jittere d if nee de d f or le gi bilit y), a n d wit h 
all treat me nt gr o u ps i ncl u de d i n a si n gle fi g ure.  
A listi n g will be pr o vi de d f or t he M RI assess me nt data, b y partici pa nt a n d b y ti me p oi nt f or t he 
O L E  treat me nt peri o d. 
1 6. 2  
Rel a pses   
A n n u alize d Rel a pse R ates ( A R R)  
Descri pti ve statistics o n rela pses  d uri n g t he O L E peri o d will be pr o vi de d b y treat me nt gr o u p a nd  
o verall  o n t he mI T T -O L E a nal ysis s et. I n parti c ular, at t he treat me nt -gr o u p -le vel, n u m b er of 
q ualifie d rela pses, t otal n u m ber of rela pses  ( q ualifie d or n ot), f oll o w-u p  o n treat me nt  (i n 
partici pa nt -years), a n d u na dj uste d A R R base d o n pr ot oc ol -defi ne d q ualifi e d rel a pses  ( n u m b er of 
q ualifie d rela ps es di vi de d b y f oll o w -u p  o n treat me nt ) a n d c o nfi de n ce i nter val s will be re p orte d. I n 
a d diti o n, descri pti ve statistics of partici pa nt -le vel A R R ( n u m ber of q ualifie d rela pses e x perie nce d 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 8 /6 1  
 
 
b y a partici pa nt , di vi de d b y t he f oll o w-u p e x perie nce d b y a partici pa nt ) will be s u m marize d f or 
eac h tr eat me nt gr o u p, i n ter ms of mea n, S D, me d i a n, Q 1, Q 3, mi n, a n d ma x. 
S u bjects disc o nti n ui n g earl y are a nal yz e d acc or di n g t o n u m ber of years of f oll o w -u p  o n treat me nt 
a n d n u m ber of q ualifie d rela pses o bser ve d at t h e ti me of disc o nti n uati o n,  i ncl u di n g data ( b ot h 
f oll o w-u p ti me a n d  n u m ber of  rela pse e ve nts) fr o m t he 4 -wee k Safet y F oll o w -u p  peri o d.  
T he s u m mar y will be prese nte d f or t he o verall O L E peri o d ( O L E Baseli ne  –  last O L E  visit ), f or 
eac h 4 8-wee k p eri o d d uri n g t he O L E , bet wee n  O L E B aseli ne a n d D ose S witc h  d uri n g O L E , a n d 
bet wee n D os e S witc h  d uri n g O L E  t o t he last O L E  vis it. 
A listi n g will be pr o vi de d f or rel a pse data, b y p artici pa nt f or t he  D B P a n d  O L E  treat me nt peri o d 
c o m bi ne d . 
1 6. 3  
Ti me t o First Q u alifie d Rel a pse  a n d esti m ates    
Ti me t o first q ualifie d rela pse will be re prese nte d b y a Ka pla n -Meier ( K M) pl ot  o n t he mI T T  f or 
t he D B P + O L E peri o d wit h orie ntati o n  “i ncreasi n g left t o ri g ht”, a n d wit h la bels “ Ti me fr o m 
ra n d o mizati o n (Wee ks )” vs “ C u m ulati ve pr o ba bilit y of q ualifie d rela ps e”. 1  c ur ve will be pr o vi d e d  
f or eac h of t he 5 treat m e nt gr o u ps. T he c u m ulati ve pr o ba bilit y of a n e ve nt is esti mate d wit h 
P L O T S = S U R VI V A L( F AI L U R E) o pti o n of P R O C LI F E T E S T . 
T he h oriz o ntal a xis s h o ul d e xte n d as far as nee de d t o i ncl u de f oll o w -u p fr o m all partici pa nts , 
re gar dl ess of w het h er t he ti me t o a n e ve nt is o bser ve d or ce ns ore d.  
A q ualifie d rela ps e e ve nt will be c o u nte d e ve n if it occ urs after t he p a rtici pa nt has disc o nti n ue d 
treat me nt. 
Pa rtici pa nts w h o ha v e q ualifie d rel a pse  d uri n g D B P + O L E peri o d , will ha ve t he ti me t o first 
q ualifie d rela ps e ( wee ks) calc ulate d as “ ([ date of first q ualifie d rela ps e] –  [ date of first d ose] + 
1 )/ 7”. 
Pa rtici pa nts w h o d o n ot ha ve q ualifie d rela pse, or are l ost t o f oll o w u p, will be ce ns ore d at t he dat e 
of t he last rela pse assess m e nt f or t his a nal ysis. T he ce ns ori n g ti me  ( wee ks) will be calc ulate d as 
“([ dat e of ce ns ori n g] –  [ date of first d ose] + 1)/ 7”.  
K M  esti mates ( pr o d uct -li mit esti mates) of t he c u m ulati ve pr o ba bilit y of e x perie nci n g q ualifie d 
rela pse o ver ti me will be prese nte d  i n a ta ble b y treat me nt gr o u p,  t o get her wit h a s u m mar y of 
perce ntiles ( 5 t h, 1 0t h, 1 5t h, 2 0t h, 2 5t h, 3 0t h, 3 5 t h, 4 0t h, me dia n) a n d  c orres p o n di n g 2 -si de d 9 5 % CIs , 
as well as n u m ber of partici pa nts at ris k, n u m ber of partici pa nts wit h a n e ve nt, n u m ber of ce ns ore d 
partici pa nts .  
N u m ber a n d p erce nta ge of s u bjects wit h q ualifie d rela pse -free stat us will be pr o vi de d b y treat me nt 
gr o u p a n d o verall.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
2 9 /6 1  
 
 
1 6. 4  
E x p a n de d Dis a bilit y St at us Sc ale ( E D S S)   
Descri pti ve statistics f or t he E D S S sc ore  a n d E D S S C F B  at eac h visit  d uri n g  t he D B P a n d t he O L E 
peri o d c o m bi ne d will  be pr o vi de d b y treat me nt gr o u p a n d o verall  o n t he mI T T a nal ysis set .  
I n a d diti o n, descri pti ve st atistics f or t he E D S S sc ore  a n d E D S S C F B  at eac h visit  d uri n g t he O L E 
peri o d o nl y will be pr o vi de d b y treat me nt gr o u p a n d o verall  o n t h e mI T T -O L E a nal ysis set (earl y 
treat me nt disc o nti n uers d uri n g O L E will be prese nte d at ‘ E O T’ visit).  
Descri pti ve statistics f or cate g oric al E D S S C F B, i. e., n u m ber a n d pr o p orti o n i m pr o vi n g, sta ble, or 
w orse ni n g, will als o b e re p orte d f or eac h ti me p oi nt. Here im pr o ve me nt is defi ne d as a decreas e 
of 1. 0 p oi nt or m ore, sta ble c o n diti o n as a c ha n ge of n o m ore t ha n half a p oi nt  i n eit her directi o n 
a n d w orse ni n g as a n i ncrease of 1. 0 p oi nt or m ore. 
M ea n C F B i n E D S S will be prese nte d  o n mI T T a n al ysis set  as a b y-year  li n e pl ot d uri n g D B P a n d 
O L E peri o d c o m bi ne d. T he pl ot will be  pr o vi de d f or eac h treat me nt gr o u p a n d o verall , wit h a 
vertical li ne s e g me nt at e ac h visit re prese nti n g ± S E (jittere d if nee d e d f or l e gi bilit y), a n d wit h all 
treat me nt gr o u ps i ncl u de d i n a si n gle fi g ure.  
A d diti o nall y, t he pl ot of m ea n C F B i n E D S S will be prese nte d  f or O L E peri o d o nl y (O L E Wee k 
4 8 t o O L E Wee k 3 3 6  a n d E O T ) o n mI T T -O L E a nal ysis set .  
A listi n g will be pr o vi de d f or E D S S data, b y partici pa nt  a n d b y ti me p oi nt f or t he  D B P a n d  O L E 
treat me nt peri o d c o m bi ne d . 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
1 7  
S afet y E v al u ati o n   
T he s u bsecti o ns i n t his secti o n i ncl u de s pecifi cati o ns f or s u m marizi n g safet y e n d p oi nts t hat are 
c o m m o n acr oss cli nical trials s uc h as a d v erse e ve nts, la b orat or y tests a n d vital si g ns.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 0 /6 1  
 
 
All o ut p uts will be pr o vi de d o n t he O L E peri o d  if n ot ot her wise i n dicate d. 
Safet y a n al yses will be base d o n t he S A F f or s u m maries o n t he D B P + O L E peri o d  a n d o n  t he 
S A F -O L E  f or s u m maries o n t he O L E peri o d,  acc or di n g t o t he as -treate d pri nci ple. 
1 7. 1  
A d verse E ve nts   
Tre at me nt -e mer g e nt a d verse e v e nts ( T E A Es)  are defi ne d as t h ose A Es wit h a n  o nset date o n or 
after t he date of first I M P a d mi nistrati o n or  wit h a n o nset date pri or t o first I M P a d mi nistrati o n, 
b ut a n e xacer bati o n date after.  F or t he D B P t he refere nce date is first st u d y I M P a d mi nistrati o n 
date. F or t he O L E peri o d, t he refere n ce date is first a d mi nistrati o n of E v o br uti ni b d uri n g t he O L E 
peri o d.  
T E A Es occ urri n g d uri n g t he 4 wee ks of Safet y F oll o w -u p will be i ncl u de d i n t he ta bles.   
T E A Es occ urri n g d uri n g t he was h -o ut p eri o d f or p artici pa nt  treate d wit h Tecfi dera d uri n g t he D B P 
will be fla g ge d i n t he listi n g of T E A Es fr o m t he o verall st u d y.  
I n cas e a s u bj ect e ntere d t he ga p p eri o d all o we d at OL E  Wee k 9 6, t he A E starti n g d uri n g t his 
peri o d will be c o nsi dere d as starti n g als o d uri n g t h e O L E pe ri o d a n d t he n c o nsi dere d as T E A E i n 
t he a nal yses. T hes e A Es will be fla g ge d i n t he listi n g of all T E A Es. 
Tri al dr u g rel ate d A d verse E ve nts  are t h os e A Es wit h relati o ns hi p t o st u d y treat me nt re p orte d 
b y t he i n vesti gat or as rel ate d or t h ose of u n k n o w n relati o ns hi p.  
Seri o us A d verse E ve nts  are t h ose e ve nts re p orte d o n t he A E e C R F f or m wit h t he seri o us fiel d 
tic ke d “ Yes ” or wit h u n k n o w n seri o us ness. 
A d verse E ve nts l e a di n g t o st u d y wit h dr a w al of I M P  are t h ose A Es wit h acti o n ta ke n re g ar di n g 
st u d y treat me nt as “ Dr u g wit h dra w n” (as rec or de d o n t he A Es e C R F pa g e).  
A d verse E ve nts le a di n g t o  st u d y ter mi n ati o n are t h ose A Es wit h ot her acti o n ta ke n as “ L e d t o 
st u d y ter mi nati o n” (as rec or de d o n t he A Es e C R F pa ge).  
A d verse E ve nts le a di n g t o  de at h  are t h ose A Es wit h o utc o me “ Fatal” (as rec or de d o n t he A Es 
e C R F pa ge).  
A d verse e ve nts will be c o de d acc or di n g t o t he latest Me d D R A versi o n a vaila ble at t he ti me of 
a nal ysis. T he se verit y of A Es will be gra de d usi n g Nati o nal Ca ncer I nstit ute - C o m m o n 
Ter mi n ol o g y Criteria f or A Es ( N CI -C T C A E versi o n 4. 0 3) t o xicit y gra des.  
All A d verse E ve nts rec or de d d uri n g t he c o urse of t he trial ( i.e., assess e d fr o m si g nat ure of 
i nf or me d c o nse nt u ntil t he e n d of t he F oll o w-u p/ E n d of Trial visit) will be c o de d acc or di n g t o t he 
Me d D R A a n d assi g ne d t o a S O C a n d P T.  
Gr o u p/ S O C ter ms will be s orte d al p ha beticall y. Preferre d ter ms wit hi n eac h gr o u p/ S O C will be 
s orte d b y t he T otal c ol u m n  d esce n di n g fre q ue nc y, a n d al p ha beticall y if m ulti ple preferre d ter ms 
ha ve t he sa me fre q u e nc y.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 1 /6 1  
 
 
If a partici pa nt  e x perie n ces m ore t ha n o ne occ urre nce of t he sa me T E A E d uri n g t he trial  f or a 
gi ve n tr ial peri o d of i nterest, t he partici pa nt  will o nl y be c o u nte d  o n ce f or t hat treat me nt (t h e w orst 
se verit y a n d t he w orst rel ati o ns hi p t o trial treat me nt will be ta b ulate d). 
I n case a partici pa nt  ha d e ve nts wit h missi n g a n d n o n -missi n g gra des, t he ma xi m u m of t he 
n o n -missi n g  gra des 
will be dis pla ye d.  A Es 
wit h 
missi n g classificati o n c o ncer ni n g 
st u d y 
i nter ve nti o n relati o ns hi p will be c o nsi dere d relate d t o t he st u d y i nter ve nti o n.  
I n c o m plete A E-relate d d ates will be ha n dle d as d escri be d i n Secti o n 1 1. 9 . 
1 7. 1. 1  
All A d verse E ve nts   
1 7. 1. 1. 1  
O ver vie w of T E A Es   
T he o verall s u m mar y of T E A E s occ urri n g d uri n g t he O L E peri o d  ta ble will i ncl u de t he fre q u e nc y 
( n u m ber a n d p erce nta ge) of partici pa nts wit h eac h of t he f oll o wi n g: 
•  A n y T E A E  
•  I M P-Relat e d T E A E  
•  Seri o us T E A E  
•  I M P-Relat e d seri o us T E A E  
•  T E A E b y i nte nsit y ( N CI-C T C A E gra de 1 t o 4)  
•  I M P-Relat e d T E A E b y i nte nsit y ( N CI -C T C A E gra de 1 t o 4)  
•  T E A E lea di n g t o deat h  
•  Relate d T E A E lea di n g t o deat h  
A d diti o nall y, a T E A E s u m mar y ta ble b y S O C  b y year of O L E will be prese nte d : n u m ber a n d 
perce nt a ge of partici pa nts b y S O C f or eac h peri o d ([ O L E W 0; O L E W 4 8 ], ]O L E W 4 8; O L E W 9 6],  
] O L E W 9 6; O L E W 1 4 4], ]O L E W 1 4 4; O L E W 1 9 2], ] O L E W 1 9 2; O L E W 2 4 0], ] O L E W 2 4 0; 
O L E W 2 8 8] , > O L E W 2 8 8).  
A T E A E s u m mar y ta ble will i ncl u de a r o w f or t h e o verall fre q ue n c y of T E A Es  occ ur ri n g d uri n g 
t he O L E peri o d of t h e f oll o wi n g t y pes:  
•  T E A E lea di n g t o i nterr u pti o n of I M P  
•  I M P-relate d T E A E lea di n g t o i nterr u pti o n of I M P 
•  T E A E lea di n g t o wit h dra wal of I M P  
•  I M P-relate d T E A E lea di n g t o wit h dra wal of I M P  
•  T E A E lea di n g t o c o nc o mita nt me dicati o n  
•  I M P-relate d T E A E lea di n g t o c o nc o mita nt me dicati o n 
•  T E A E lea di n g t o c o nc o mita nt pr oce d ure  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 2 /6 1  
 
 
•  I M P-relate d T E A E lea di n g t o c o nc o mita nt pr oce d ure 
•  T E A E lea di n g t o st u d y ter mi nati o n  
•  I M P-relate d T E A E lea di n g t o st u d y ter mi nati o n 
I n a d diti o n, T E A E ta bles t o be pre pare d are liste d  i n Ta ble 2  bel o w:  
T a ble 2 : T E A E T a bles t o be P r o d uce d   
 
O v er all 
fr e q u e n c y 
B y pri m ar y 
S O C a n d 
P T  
B y P T 
o nl y  
B y pri m ar y S O C, 
P T a n d w or st 
gr a d e  
O L E  
P eri o d  
All T E A E s  
✓ 
✓ 
✓ 
✓ 
✓ 
S eri o u s T E A E s  
✓ 
✓ 
N A  
N A  
✓ 
N o n -s eri o u s 
T E A E s * 
✓ 
✓ 
N A  
N A  
✓ 
T E A E s l e a di n g t o 
st u d y i nt er v e nti o n  
wit h dr a w al  
✓ 
✓ 
N A  
N A  
✓ 
T E A E s l e a di n g t o 
st u d y t er mi n ati o n  
✓ 
✓ 
N A  
N A  
✓ 
T E A E s l e a di n g t o 
d e at h  
✓ 
✓ 
N A  
N A  
✓ 
I M P-r el at e d T E A E s  
✓ 
✓ 
✓ 
✓ 
✓ 
I M P-r el at e d s eri o u s 
T E A E s  
✓ 
✓ 
N A  
N A  
✓ 
I M P-r el at e d T E A E s 
l e a di n g t o tr e at m e nt 
wit h dr a w al  
✓ 
✓ 
N A  
N A  
✓ 
I M P-r el at e d T E A E 
l e a di n g t o st u d y 
t er mi n ati o n 
✓ 
✓ 
N A  
N A  
✓ 
I M P-r el at e d T E A E s 
l e a di n g t o d e at h 
✓ 
✓ 
N A  
N A  
✓ 
* A t a bl e wit h all T E A E s will b e fir st pr o vi d e d a n d t h e n o nl y T E A E s e x c e e di n g a fr e q u e n c y of 5 % i n at l e a st o n e of t h e 
tr e at m e nt gr o u p s ( > 5 %), b y S O C a n d P T will b e pr o vi d e d. 
T E A Es  will be liste d b y  treat me nt gr o u p a n d parti ci pa nt d uri n g O L E .  
I n a d diti o n, a gr o u pe d  c o u nt a n d perce nta ge  of partici pa nts e x p erie n ci n g Ras h (i.e. all P Ts 
c o ntai ni n g Ras h) , a  gr o u pe d c o u nt a n d p erce nta ge of partici pa nts e x perie n ci n g A n ae mia (i.e. all 
P Ts c o ntai ni n g A n ae mia) a n d a gr o u pe d c o u nt a n d perce nta ge of partici pa nts e x perie nci n g 
Le u k oc yt osis (i.e. P Ts ‘ Le u k oc yt osis’ a n d ‘ W hit e bl o o d cell c o u nt i ncrease d’)  will be prese nt e d 
f or O L E peri o d o nl y f or “ T otal”. 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 3 /6 1  
 
 
1 7. 1. 1. 2  
E AI R of T E A Es   
E AI R of T E A Es are calc ulate d as t he n u m ber of partici pa nts  wit h T E A E di vi de d b y t he s u m of 
t he i n di vi d ual ti mes of all partici pa nts  i n t he treat me nt gr o u p  fr o m start of treat me nt t o first o nset 
of T E A E i n t he c orres p o n di n g ti me peri o d. T he i nci de nce rate m ulti plie d wit h 1 0 0 w o ul d gi ve t he 
n u m ber of A Es e x pecte d i n 1 0 0 partici pa nts  wit hi n 1 ti me u nit ( year). E AI R of T E A Es will be 
prese nte d b y S O C a n d P T.  C o n fi de nce i nter val of i nci de nce rate will b e calc ulat e d usi n g t he 
G E N M O D pr oce d ure fr o m S A S ® wit h ls mea ns i nstr ucti o n usi n g a P oiss o n bi n o mial m o del. If a 
partici pa nt  has m ulti ple e ve nts, t he e x p os ure peri o d of t he first e ve nt will be  use d. F or a p artici pa n t 
wit h n o e ve nt, t he e x p os ure peri o d will be  ce ns ore d at t he last f oll o w -u p ti me wit hi n  t he A E 
s u m marizati o n peri o d. 
T he E AI R of T E A E ta bles t o be pre pare d are liste d i n Ta ble 3  bel o w:  
T a ble 3 : E AI R of T E A E T a bles t o be P r o d uce d   
 
O v er all 
fr e q u e n c y 
B y 
pri m ar y 
S O C a n d 
P T  
B y 
pri m ar y 
S O C, 
P T a n d 
w or s e 
gr a d e  
O L E 
P eri o d  
 
O L E 
P eri o d 
b y y e ar  
T E A E s  
X  
X  
X  
X  
X  
I M P-r el at e d T E A E s 
X  
X  
N A  
X  
N A  
S eri o u s T E A E s  
X  
X  
N A  
X  
N A  
I M P-r el at e d S eri o u s T E A E s 
X  
X  
N A  
X  
N A  
T E A E s  of S p e ci al I nt er e st  
X  
N A ( b y 
A E SI 
c at e g or y, 
C M Q/ S M Q 
a n d P T)  
N A  
X  
N A  
1 7. 1. 1. 3  
A d verse E ve nts Le a di n g t o Tre at me nt Disc o nti n u ati o n  or  
Ot her Acti o n T a ke n   
S u m mar y ta bles will be pr o vi de d as detaile d i n  S ecti o n 1 7. 1. 1. 1 . 
A listi n g of T E A Es lea di n g t o wit h dra wal of I M P  a n d a listi n g of T E A Es lea di n g t o st u d y 
termi nati o n  d uri n g t he O L E peri o d , will be pr o vi d e d. 
1 7. 2  
De at hs, Ot her Seri o us A d verse E ve nts, a n d Ot her Si g nific a nt 
A d verse E ve nts   
1 7. 2. 1  
De at hs   
A  s u m mar y of deat hs occ urri n g d uri n g O L E peri o d will  be pr o vi de d i ncl u di n g (cli nicaltrials. go v 
re q uire me nt): 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 4 /6 1  
 
 
•  N u m ber a n d p erce nta ge of (all) deat hs  
•  N u m ber a n d p erce nta ge of t he pri mar y ca us e of deat h (cate g ories: p r o gressi ve disease a n d/ or 
disease rel ate d c o n diti o n , eve nt u nrelat e d t o I M P, eve nt relat e d t o I M P, u n k n o w n)  
T E A Es lea di n g t o deat h a n d I M P -relat e d T E A Es lea di n g t o deat h will be t a b ulate d b y S O C a n d 
P T al o n g wit h o verall fre q ue nc y  as d escri be d  i n Secti o n 1 7. 1. 1. 1 . A listi n g of d eat hs occ u rri n g 
d uri n g  t he D B P  a n d O L E peri o d , if a n y, will be pr o vi de d. I n cas e t here is n o deat h i n t he trial, o nl y 
t he s u m mar y of deat h re q uire d b y cli nicaltrials. g o v will be perf or me d, neit her ta b ulati o n of T E A E 
lea di n g t o deat h will be e dite d, n or t he listi n g of deat h. 
1 7. 2. 2  
Seri o us A d verse E ve nts   
T he ta b ulati o n of seri o us T E A Es is descri be d i n Secti o n 1 7. 1. 1. 1 . A partici pa nt  listi n g of seri o us 
T E A Es  d uri n g t he O L E  p eri o d  will be pr o vi de d.  
1 7. 2. 3  
T E A Es of S peci al I nterest   
T he f oll o wi n g e ve nts are defi ne d as A Es of S pecial I nterest ( A E SI): 
•  Li ver relat e d A Es  
•  I nfecti o ns: 
o  All I nfecti o ns re p orte d as Seri o us A Es or Gra d e ≥ 3  
o  All o p p ort u nistic i nfecti o ns  
•  A m ylase a n d li pase ele vati o ns i ncl u di n g ac ute pa n creatitis 
•  S eiz ures  
A E SI will be i de ntifie d usi n g Sta n dar dize d Me d D R A q uer y ( S M Q) if a v aila ble or s p o ns or -d efi ne d 
list of searc h t er m (refer t o A p pe n di x 1 9. 5 ). A E SI ter ms will b e s u m marize d u n der all cate g ori es 
t he y fall u n der. 
A n o ver vie w o f A E SI will be prese nte d b y treat me nt gr o u p s h o wi n g n u m ber a n d p erce nta ge of 
partici pa nts e x perie n ci n g A E SI  f or t he O L E peri o d. St u d y i nter ve nti o n relate d A E SI will als o be 
prese nte d. A E SIs will be fla g ge d i n t he A E listi n gs.   
A d diti o nal a nal ysis  o n t he i nfecti o ns will be perf or me d.  
T he f oll o wi n g o ut p ut will be pr o vi de d:  
Ka pla n -Mei er fi g ur e f or ti me t o o nset of i nfect i o ns. A n e ve nt is defi ne d as first occ urre n ce of a n y 
P T i n t he S M Q “ Se vere I nfecti o ns” or A E SI  “ O p p ort u nistic i nfecti o ns” fr o m first da y of e x p os ure 
wit h E v o br uti ni b (i.e. f or patie nts i n t he Place b o a n d Tecfi dera gr o u ps t h e ti me peri o d starts aft er 
s witc h t o E v o br uti ni b 2 5 m g Q D ( wee k 2 5) a n d s witc h t o E v o br uti ni b 7 5 m g Q D, res p ecti vel y. 
F or all ot her patie nts t he ti me peri o d starts at st u d y start ( wit h first i nta ke of E v o br uti ni b)). A n 
o verall Ka pla n -Meier c ur ve will be dis pla ye d.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 5 /6 1  
 
 
 
1 7. 3  
Cli nic al L a b or at or y E v al u ati o n   
T he cli nical la b orat or y s afet y para meters meas ure d i n t his trial  a n d re p ort e d as part of t h e safet y 
e val uati o n of he mat ol o g y, bi oc he mistr y, a n d uri nal ysis, are s pecifie d i n t h e pr ot oc ol ( Ta ble 8  of 
t he C li nical T rial P r ot oc ol, Secti o n 7. 4. 3). T he e ntire cli nical la b orat or y s ecti o n will be a nal yze d 
f or O L E peri o d. S o me o ut p uts n ot pr o d uce d at ti me or Pri mar y a nal ysis a n d Bli n de d E xte nsi o n 
a nal ysis will als o be re peate d o n t he D B P f or partici pa nts of t he S A F  a nal ysis set.  
S u m m aries of Cli nic al L a b or at or y D at a  
La b orat or y v al ues (i ncl u di n g c orres p o n di n g n or mal ra n ges) c o n ve rte d i n sta n dar d u nits will be 
use d f or s u m mar y statistics, s h ift ta bles a n d b o x pl ots. Gra da ble la b orat or y res ults  will be classifie d 
acc or di n g t o t he gra des defi ne d i n N CI -C T C A E  Versi o n 4. 0 3 as pr o vi de d b y t he ce ntral la b orat or y. 
If a la b orat or y p ara m eter has bi-directi o nal t o xicities (e .g ., P otassi u m ), b ot h directi o ns will be 
prese nte d f or t he gi ve n p ara meter (i .e., P otassi u m  L o w a n d P otassi u m  Hi g h). O n -tr eat me nt val ues 
are define d as res ults of assess me nts ma de after t h e first I M P a d mi nistrati o n o n Da y 1 . La b orat or y 
res ults c o ntai ni n g a m o difier s uc h as “ <” or “≥” will be ha n dle d cas e b y case f or s u m mar y statistics 
a n d will be re p orte d b ot h as c ollecte d i n t he data base a n d as i m p ute d i n partici pa nt  data listi n gs . 
Data u ntil t he Safet y F oll o w -u p i ncl u de d will be use d t o deri ve t he w orst o n -treat me nt val ues. 
All para met ers  will  als o be pres e nte d acc or di n g t o t he cate g ories b ase d o n n or mal ra n ges : bel o w 
n or mal li mits  ( L o w), wit hi n nor mal li mits ( N or mal) a n d a b o v e n or mal li mits  ( Hi g h). 
S hift ta ble s of baseli ne v al ue (l o w, n or m al, hi g h) vers us w orst o n -tr eat me nt val ue, prese nt e d b y 
treat me nt gr o u p, will be pr o vi de d  f or h e mat ol o g y a n d bi oc he mistr y para meters. 
S hift ta bles of baseli ne gr a de vers us w orst p ost -bas eli ne gra de, prese nt e d b y treat me nt gr o u p, will 
be pr o vi de d f or he mat ol o g y a n d bi oc he mistr y para meters.   
S hift ta bles will be dis pla ye d usi n g t he O L E Bas eli ne a n d w orst o n -treat me nt val ue or w orst p ost-
baseli ne gra d e d uri n g O L E peri o d.  
Directi o nal la b orat or y tests ( he mat ol o g y, bi oc he mistr y) ( A p pe n di x 1 9. 1 ) will be s u m marize d b y 
w orst o n -treat me nt val ue a n d  b y treat me nt  gr o u p.  
P r ot oc ol-s pecifie d cli nic al la b orat or y he mat ol o g y, bi oc he mistr y a n d uri nal ysis para meters will be 
s u m marize d usi n g descri pti ve statistics a p pr o priate t o c o nti n u o us -val ue d ra n d o m varia bles (see 
Secti o n 1 1. 5 ) b y ti me p oi nt a n d b y treat me nt gr o u p  d uri n g t he O L E peri o d . At eac h ti me p oi nt, 
b ot h o bser ve d val ue a n d C F B val ue will be s u m marize d.  
Gr a p hic al Dis pl a y of Cli nic al L a b or at or y D at a  
B o x pl ots of la b orat or y val ues b y tr eat me nt gr o u p a n d ti me p oi nt will be pr o vi d e d f or t he 
he mat ol o g y a n d bi oc he mistr y para meters  dis pla ye d i n Ta ble 4 . 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 6 /6 1  
 
 
T a ble 4 : P ar a meters f o r b o x pl ots   
B o x pl ots will be dis pla ye d fr o m t he O L E Baseli n e u p t o O L E Wee k 4 8  a n d fr o m O L E Wee k 5 2 
t o O L E Wee k 9 6  etc. t o r e mai n rea d a ble.   
C at e g or y  
L a b or at or y  
p ar a m et er  
C o n v e nti o n al 
U nit  
SI U nit s  
He m at ol o g y  
He m o gl o bi n  
g/ d L  
g/ L  
Re d bl o o d cell 
c o u nt 
1 0 6/ µ L 
1 0 1 2/ L 
Retic ul oc yte 
c o u nt 
1 0 3/ µ L 
1 0 9/ L 
W hite bl o o d cell 
c o u nt 
1 0 3/ µ L 
1 0 9/ L 
Ne utr o p hil c o u nt  
1 0 3/ µ L 
1 0 9/ L 
L y m p h oc yte 
c o u nt 
1 0 3/ µ L 
1 0 9/ L 
E osi n o p hils  
1 0 9/ L 
1 0 9/ L 
Bas o p hils  
1 0 9/ L 
1 0 9/ L 
Platelet c o u nt  
1 0 3/ µ L 
1 0 9/ L 
Bi oc h e mistr y  
Ala ni ne 
a mi n otra nsferase 
( A L T) 
U/ L  
U/ L  
Al b u mi n  
g/ d L  
g/ L  
As partate 
a mi n otra nsferase 
( A S T) 
U/ L  
U/ L  
Ga m ma -
gl uta m yl 
tra nsferase 
( G G T) 
U/ L  
U/ L  
Al kali ne 
p h os p hatase  
U/ L  
U/ L  
T otal bilir u bi n  
m g/ d L  
µ m ol/ L  
A m ylase  
U/ L  
U/ L  
Li pase  
U/ L  
U/ L  
e G F R  
m L/ mi n  
m L/ mi n  
Bl o o d urea 
nitr o ge n ( B U N)  
m g/ d L  
m m ol/ L  
Creati ni ne  
m g/ d L  
µ m ol/ L  
Gl uc ose  
m g/ d L  
µ m ol/ L  
S o di u m  
m E q/ L  
m m ol/ L  
P ota ssi u m 
m E q/ L  
m m ol/ L  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 7 /6 1  
 
 
T he U L N a n d L L N will be a d de d t o t he la b p ara meter b o x pl ot, f or a n y la b para meter w here t h e 
n or mal ra n g e is t he sa m e f or all p artici pa nts i n t he a n al ysis set. All gra p hical dis pla ys will be 
s h o w n o n a l o g-scale w h e n nee de d t o ma ke t he pl ot rea da ble . All pl ots of a gi ve n para meter will 
ha ve t he sa me s cale t o all o w c o m paris o n bet w ee n gr o u ps a n d peri o ds.  
Li ver f u ncti o n tests   
A S T , A L T a n d t otal bilir u bi n are use d t o assess p ossi ble dr u g i n d uce d li ver t o xicit y. T he rati os of 
test res ult o ver u p per li mit of n or mal ( U L N) will be calc ulate d a n d classifie d f or t hese 3  para meters 
d uri n g t he O L E  peri o d.  
S u m mar y of li ver f u ncti o n tests will i ncl u de t he f oll o wi n g cate g ories. T he n u m ber a n d perce nta ge 
of partici pa nts wit h eac h of t he f oll o wi n g cate g ories d uri n g t he O L E peri o d  will be s u m marize d 
b y treat me nt gr o u p:  
•  A S T ≥ 3 × U L N, A S T ≥ 5 x U L N, A S T ≥ 1 0 × U L N, A S T ≥ 2 0 × U L N  
•  A L T ≥ 3 × U L N, A L T ≥ 5 × U L N, A L T ≥ 1 0 × U L N, A L T ≥ 2 0 × U L N  
•  ( A L T or A S T) ≥ 3 × U L N, ( A L T or A S T) ≥ 5 × U L N, ( A L T or A S T) ≥ 1 0 × U L N, ( A L T or A S T) 
≥ 2 0 × U L N  
•  T BI LI ≥ 2 × U L N  
•  C o nc urre nt A S T ≥ 3 × U L N a n d T BI LI ≥ 2 × U L N  
•  C o nc urre nt A L T ≥ 3 × U L N a n d T BI LI ≥ 2 × U L N  
•  C o nc urre nt ( A L T or A S T) ≥ 3 × U L N a n d T BI LI ≥ 2 × U L N  
•  C o nc urre nt ( A L T or A S T) ≥ 3 × U L N a n d T BI LI ≥ 2 × U L N a n d A L P > 2 × U L N  
•  C o nc urre nt ( A L T or A S T) ≥ 3 × U L N a n d T BI LI ≥ 2 × U L N a n d A L P ≤ 2 × U L N or missi n g  
C o nc urre nt meas ure me nts are t h ose occ urri n g o n t he sa me date.  
Cate g ories will be c u m ulati ve, i.e., a partici pa nt wit h a n ele vati o n of A S T ≥ 1 0 × U L N will als o 
a p pear i n t he cate g ories ≥ 5 × U L N a n d ≥ 3 × U L N.  
A L T val ues o ver ti me will be prese nte d i n a s pa g h etti pl ot f or partici pa nts wit h o n -treat me nt A L T 
gra de 2 or hi g he r ele v ati o n (i.e. gra de ≥ 2) d uri n g t he O L E peri o d, b y treat me nt gr o u p. T here will 
be 1  pa n el b y treat me nt gr o u p. All pl ots b y para meter will ha ve t he sa me scal es t o all o w 
c o m paris o n bet wee n gr o u ps . 
Ka pla n -Mei er esti mates of pr o p orti o n s ur vi vi n g e ve nt -free as a f u ncti o n of ti me will be prese nte d 
f or t he f oll o wi n g 4  t y pes of e ve nts base d o n t he A L T a n d e G F R para meter s: 
•  Ti me fr o m O L E first d ose t o first o cc urre nce of ≥ g ra de 2 A L T ( da ys)  (f or partici pa nts  wit h  
O L E baseli ne  g ra de < 2) 
•  Ti me fr o m O L E first d os e t o first i ncrease i n A L T ≥ 1 gra de a b o v e O L E b aseli ne  gra de ( da ys)  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 8 /6 1  
 
 
•  Ti me fr o m first E v o br uti ni b d ose t o first i ncrease i n A L T ≥ 2 gra de a b o v e b aseli ne  gra d e ( da ys)  
i n D B P + O L E 
•  Ti me fr o m first E v o br uti ni b  d ose t o first i ncrease i n A L T ≥ 3  gra de a b o v e b aseli ne  gra d e ( da ys)  
i n D B P + O L E.  
•  Ti me fr o m O L E first d ose t o first o cc urre nce of e G F R assess me nt e q ual t o less t ha n ( <) 6 0 
m L/ mi n  f or partici pa nts wit h O L E baseli ne e G F R ≥ 6 0 m L/ mi n b y treat me nt gr o u p ( da ys ) 
F or t he a b o v e fi g ures bas e d o n O L E: ti me-t o-e v e nt fi g ures will be bas e d o n data fr o m O L E wee ks 
0 -e n d of treat me nt; a p artici pa nt  reac hi n g e n d of treat me nt , wit h o ut e x p eri e nci n g t he e ve nt will 
ha ve his/ her e v e nt ti me ri g ht -ce ns ore d at t he ti me of t he last A L T /e G F R assess me nt. A se parate 
K M c ur ve will be esti mate d f or eac h of t he 5 i nitial gr o u ps: Place b o + E v o br uti ni b 2 5 m g Q D, 
E v o br uti ni b (a n y d ose) a n d Tecfi dera.  F or t he fi g ures base d o n D B P + O L E: t he start ti me will be 
t he first E v o br uti ni b d ose irres pective of its occ urre nce d uri n g D B P or O L E p hase.  
T o be i ncl u de d i n a ti me -t o-e ve nt fi g ure, a gr o u p m ust ha ve at least o ne e ve nt.  Bel o w t he h oriz o ntal 
a xis of t he ti me -t o-e v e nt fi g ure , n u m ber  of e ve nts a n d n u m ber  of partici pa nts  at ris k will be 
dis pla ye d e ver y 5 6 da ys ( O L E peri o d) . T he vertical a xis ma y be restricte d t o 0. 5 0 –  1. 0, if n o ne of 
t he c ur ves r eac h 5 0 %. 
e DI S H (E v al uati o n of Dr u g -I n d uce d Seri o us He p at ot o xicit y) fi g ures, as d escri be d i n Merz et al 
( 2 0 1 4), will be pres e nte d f or t he O L E p eri o d. T he fi g ure pr o d uce d will i ncl u de 6 pa n els: 1 f or eac h 
i nitial d ose gr o u p a n d 1  p o ole d  f or all t he partici pa nts  w h o recei v e d E v o br uti ni b d uri n g D B P .  
Listi n gs c o ntai ni n g La b Test, A nal ysis Visit, Visit, Date of Meas ure m e nt ( Da ys u n der Treat me nt/ 
Da ys u n der O L E), Ti me Meas ure me nt, Res ult, C ha n ge fr o m Baseli ne/ O L E Baseli ne, Refere n ce 
Ra n ge L o w –  Hi g h a n d N CI -C T C A E Gra de f or A L T, A S T, T ot al Bilir u bi n a n d A L P f or 
partici pa nts wit h a p ost -b aseli ne L F T ele vati o n will be pr o vi de d f or t he O L E peri o d.  
Listi n gs of Cli nic al L a b or at or y D at a  
B y -partici pa nt  listi n gs of all i n di vi d ual he mat ol o g y, bi oc he mistr y a n d uri nal ysis  val ues prese nt i n  
t he data base will be pr o vide d. O nl y data d uri n g t he O L E peri o d (i ncl u di n g O L E Baseli ne) will be 
dis pla ye d.  A fla g will i n dicate t he first visit of s witc h fr o m E v o br uti ni b 7 5 m g Q D t o E v o br uti ni b 
7 5 m g BI D d uri n g O L E peri o d.  
La b orat or y v al ues t hat are o utsi de t he n or mal ra n g e will b e fla g ge d i n t he data listi n gs, al o n g wit h 
c orres p o n di n g n or m al ra n ges.   
I n t his st u d y, cli nicall y si g nifica nt la b a b n or malities were rec or de d as a d verse e v e nts. I n lie u of a 
listi n g of cli nicall y si g nifica nt la b a b n or malities f or eac h d o m ai n, t he f oll o wi ng b y -partici pa nt  la b 
val ue listi n gs will be pr o vi de d:  
•  Listi n g of Gra de ≥ 3 he m at ol o g y val ues wit h data fr o m D B P a n d O L E peri o d  
•  Listi n g of Gra de ≥ 3 bi oc he mistr y val ues  wit h data fr o m D B P a n d O L E p eri o d  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
3 9 /6 1  
 
 
•  Listi n g of uri nal ysis val ues wit h Gra de ≥ 3, val ue ≥ 2  ti mes U L N (e xcl u di n g  val ues f or S pecific 
Gra vit y or p H p ara met ers), or a n i ncreas e of “ + +” f or n o n -gra d a ble para meters w he n a p plica ble 
wit h data fr o m D B P a n d O L E peri o d  
A d diti o nal a nal ysis  o n t he pa ncreatic a n d li ver e n z y mes ele vati o ns will be perf or me d.  
T he f oll o wi n g o ut p uts will be pr o vi de d:  
1.  Ka pla n -Mei er fi g ure f or ti me t o first occ urre n ce of Li pase i ncrease d > 2 x U L N a n d 
A m ylase i ncrease d > 2 x U L N se paratel y f or D B P a n d O L E.  
2.  A b n or mali ties i n li pase a n d a m ylase (i.e. hi g her t h e U L N). F or t he D B P i nf or mati o n t o be 
dis pla ye d b y ori gi nal treat me nt gr o u ps. F or t he O L E peri o d o nl y “ T otal” is nee de d.  
3.  S u m mar y of p ote ntial DI LI b y R -Val ues a n d Peri o ds f or s u bjects wit h a n y A L T or A S T 
ele vati o n f or D B P + O L E.  
1 7. 4  
Vit al Si g ns   
T he S A F -O L E a nal ysis set will be use d i n prese nti n g t he vital si g ns res ults. Vital si g ns ( hei g ht 
(c m), wei g ht ( k g), B MI ( k g/ m²), b o d y te m perat ure (° C), S yst olic B l o o d P ress ure ( S B P) ( m m H g), 
D iast olic B l o o d P ress ure ( D B P) ( m m H g), res pir at or y rate ( breat hs/ mi n) a n d p ulse rate ( beats/ mi n)) 
will be s u m marize d b y tr eat me nt gr o u p usi n g descri pti ve st atistics (see Secti o n 1 1. 5 ).  
T he descri pti ve statistics will be prese nte d as f oll o ws:  
•  T he O L E bas eli ne will be prese nt e d first   
•  T he n eac h sc h e d ule d ti me p oi nt wil l be prese nte d o n partici pa nt s w h o ha ve reac he d t his ti me 
p oi nt: a bs ol ute val ues  a n d O L E  C F B will be dis pla ye d  (e x ce pt f or hei g ht a n d B MI as t he y are 
o nl y prese nt at scree ni n g visit) .  
B o d y te m perat ure, S B P, D B P, res pirat or y rate a n d p ulse rate will be a n al yze d wit h s hift ta bles of 
ma xi m u m C F B usi n g t he cate g ories d efi ne d i n  T a ble 5 : 
T a ble 5 : Vit al Si g ns C ate g ories  
P ar a m et er  
U nit  
S hift  
B a s eli n e c at e g ori e s  
P o st -b a s eli n e c at e g ori e s 
( a b s ol ut e c h a n g e) 
T e m p er at ur e  
° C 
I n cr e a s e 
< 3 7 / ≥3 7 - < 3 8 / ≥3 8 - 
< 3 9 / ≥3 9 - < 4 0 / ≥ 4 0  
≤0* / > 0 - < 1 / ≥1 - < 2 / ≥2 - < 3 / 
≥3  
P ul s e r at e  
b p m  
I n cr e a s e 
a n d d e cr e a s e  
< 1 0 0 / ≥1 0 0  
≤0* / > 0 - ≤2 0 / > 2 0 - ≤4 0 / > 4 0  
S B P  
m m H g  
I n cr e a s e 
a n d d e cr e a s e  
< 1 4 0 / ≥1 4 0  
≤0* / > 0 - ≤2 0 / > 2 0 - ≤4 0 / > 4 0  
D B P  
m m H g  
I n cr e a s e 
a n d d e cr e a s e  
< 9 0 / ≥9 0  
≤0* / > 0 - ≤ 2 0 / > 2 0 - ≤4 0 / > 4 0  
R e s pir at or y r at e  
br e at h s/ mi n  I n cr e a s e 
a n d d e cr e a s e  
< 2 0 / ≥2 0  
≤0* / > 0 - ≤5 / > 5 - ≤1 0 / > 1 0  
* T hi s c at e g or y will i n cl u d e t h e p arti ci p a nt s wit h n o c h a n g e s or d e cr e a s e/i n cr e a s e i n t h e i n cr e a s e/ d e cr e a s e p art of t h e 
t a bl e r e s p e cti v el y. 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 0 /6 1  
 
 
I n a d diti o n, 2 scatter pl ots o n O L E  peri o d will be pr o vi de d pres e nti n g:  
- 
O L E baseli ne S B P val ue vers us ma xi m u m  ( hi g hest) p ost -baseli ne S B P val ue  
- 
O L E baseli ne D i ast olic B P val ue vers us ma xi m u m ( hi g hest) p ost -baseli ne Diast olic B P 
val ue  
Li ne f or li near re gressi o n will be i ncl u de d. T he fi g ures will be pr o d uce d o verall, i. e., f or all 
partici pa nts p o ole d.  
A listi n g of ma xi m u m C F B  f or O L E peri o d a n d a listi n g of all vital si g n s data f or O L E peri o d will 
be pr o vi de d.  
1 7. 5  
1 2 -Le a d Electr oc ar di o gr a m ( E C G)   
T he 1 2 -lea d E C G data will be liste d a n d s u m marize d f or t he O L E peri o d f or o bser ve d val ues a n d 
c ha n ge fr o m O L E bas eli ne val ues b y treat me nt gr o u p usi n g descri pti ve statistics:  
•  Ve ntric ular rate ( beats/ mi n)  
•  P ulse rate i nter val ( mse c)  
•  Q R S ( msec)  
•  Q T ( msec)  
•  Fri deri cia c orrecte d Q T ( Q Tc F) ( msec).  
T he Q Tc F para meter  will be cate g orize d b y  o bs er ve d  val ue i nt o t he cate g ori es  
•  ≤ 4 3 0  msec , 
•  > 4 3 0 –  4 5 0 msec , 
•  > 4 5 0 –  4 8 0 msec , 
•  > 4 8 0 –  5 0 0 msec ,  
•  > 5 0 0 msec  
a n d b y  C F B val ue  i nt o t he cate g ories 
•  ≤ 3 0 msec , 
•  > 3 0 –  6 0 msec , 
•  > 6 0 msec . 
N u m ber a n d perce nta g e of partici pa nts wit hi n eac h cate g or y liste d a b o v e, base d o n t heir p ost -O L E 
baseli ne Q Tc F dat a, will be prese nt e d  b y treat me nt gr o u p.   
A s hift ta ble of r h yt h m res ults ( Si n us r h yt h m, Atrial fi brillati o n, Ot her, Missi n g) fr o m O L E 
baseli ne t o last o n treat me nt cat e g or y, prese nte d b y treat me nt gr o u p,  wi ll b e pr o vi de d f or t he O L E 
peri o d.  
S hift ta ble s of m or p h ol o gical assess me nts ( N or m al, A b n or mal, Missi n g) fr o m O L E b aseli ne t o 
ma xi m u m o n treat me nt val ue will be pr o vi de d  f or t he O L E peri o d. 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 1 /6 1  
 
 
Listi n gs of E C G q ua ntitati ve val ues, m or p h ol o gical a n d r h yt h m res u lts will be pr o d uce d o n O L E 
peri o d .  
1 7. 6  
P h ysic al E x a mi n ati o n   
N o s u m mar y ta ble will be pr o vi de d si nce p h ysical e xa mi nati o n fi n di n gs d uri n g scree ni n g will be 
rec or de d as me dical hist or y e ve nts a n d fi n di n gs d uri n g t he st u d y as A Es.  
1 7. 7  
Pre g n a nc y Test   
Res ults of pre g na nc y test ( uri ne  or ser u m ) will be liste d f or O L E peri o d b ase d o n S A F-O L E . 
1 7. 8  
I m m u n o gl o b uli n Le vels, a n d  
 
 
  
A nal yses will be perf or m e d f or t he D B P + O L E peri o d  base d o n  t he S A F  a n al ysis set  a n d f or O L E 
peri o d base d o n t he S A F -O L E.  
Data o n  im m u n o gl o b uli n ( I g) le v els, a n d 
 (see list of para meters i n 
A p pe n di x 1 9. 2 ) will be s u m marize d f or t he O L E peri o d f or o bser ve d v al u es, c h a n ge fr o m O L E 
baseli ne val ues , a n d perce nt c ha n g e fr o m O L E baseli ne b y treat me nt gr o u p a n d o verall usi n g 
descri pti ve statistics .  
I n a d diti o n, n u m ber a n d perce nt of s u bjects falli n g a b o ve, b el ow, a n d wit hi n n or mal ra n g e will be 
s u m marize d w here a p plica ble. Assess me nts ma de at t he E n d of Treat me nt  visit f or treat me nt 
disc o nti n uers will be wi n d o we d a p pr o pri atel y . Assess me nts ma de at t he E n d of Trial  visit f or st u d y 
disc o nti n uers will be s u m marize d  se p arat el y fr o m assess me nts ma de at Safet y f oll o w -u p visit at 
O L E Wee k 3 8 8  E n d of Trial visit f or st u d y c o m pleters.  
A d diti o nall y,  descri pti ve  statistics of a bs ol ute val ues of 
 
 
 will be pr o vi de d f or s u bjects falli n g a b o v e, b el o w, 
a n d wit hi n n or mal ra n ge of t he s pecific la b orat or y para meter.  S u m maries will be pr o vi de d o n O L E 
peri o d f or o bs er ve d val u es, c ha n g e fr o m O L E b aseli ne val ues , a n d perce nt c ha n g e fr o m O L E 
baseli ne b y treat me nt gr o u p a n d o verall.  
S hift ta bles fr o m O L E baseli ne val ue (l o w, n or mal, hi g h) t o e n d of O L E  Peri o d  will be pres e nt e d 
b y treat me nt gr o u p a n d o verall, f or eac h I g class  a n d s u bclass, a n d 
 
para meters  w here a p plica ble  (see list of para m eters i n A p pe n di x 1 9. 2 ), usi n g S A F-O L E a n al ysis 
set. 
B o x pl ots f or eac h I g cl ass a n d s u bclass, ( g/ L), a n d 
 (see list of 
para meters i n A p p e n di x  1 9. 2 ) b y tr eat me nt gr o u p a n d ti me p oi nt will be pr o vi de d, f or O L E p eri o d. 
Li ne pl ots of me dia n perce nt c ha n g e fr o m bas eli ne will be pr o vi de d b y ti me p oi nt a n d treat me nt 
gr o u p  o n  D B P a n d  O L E c o m bi ne d peri o d s f or eac h I g cl ass a n d s u bclass, a n d 
  
 (see list of para meters i n A p pe n di x  1 9. 2 ).  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 2 /6 1  
 
 
 (see list of para meters i n A p pe n di x  1 9. 2 ) a n d I g class a n d s u b class 
le vels will be liste d b y treat me nt gr o u p, partici pa nt a n d  ti me p oin t ( w here a p plica ble). I g G val u es 
< 3 g/ L (se v ere h y p o ga m ma gl o b u li ne mia) a n d I g G val ues < 6 g/ L ( h y p o g a m ma gl o b uli ne mia) will 
be fla g ge d i n t he listi n g.  
E AI R of i nfecti o ns  
F or defi niti o n of se vere i nfecti o ns A E SI , see S ecti o n 1 7. 2. 3  a n d A p pe n di x 1 9. 5 . 
E AI R of i nfecti o ns will be pr o vi de d i n s u bjects wit h a n d wit h o ut at least o ne o cc urre nce of 
 l o w er t ha n L L N d uri n g t he D B P a n d O L E p eri o d c o m bi ne d. T his a n al ysis will be 
base d o n S A F. A m o n g s u bjects w h o e x p erie n ce d 
 l o wer t ha n L L N at least o nce 
d uri n g t he D B P a n d O L E peri o d c o m bi ne d  ( o n-treat me nt assess me nts c o nsi dere d o nl y), E AI R will 
be c o m p ute d se paratel y c o nsi deri n g  t he time bet wee n t h e first treat me nt a d mi nistrati o n a n d t he 
first occ urre n ce of 
 l o wer t ha n L L N a n d t he ti me after t he first occ urre nce of 
 l o wer t ha n L L N. 
C o nfi de nce i nter val of i nci de nce rate will be calc ulate d usi n g t he Gar w o o d m et h o d f or P oiss o n 
mea n.  
1 7. 9  
Uri n al ysis Micr osc o pic  E v al u ati o n   
Uri nal ysis Micr osc o pic E val uati o n data will be liste d b y treat me nt gr o u p a n d ti me p oi nt ( w h ere 
a p plica ble) f or t he O L E peri o d. 
1 7. 1 0  
C ol u m bi a - S uici de Se verit y  R ati n g Sc ale ( C -S S R S)   
A nal yses will be perf or m e d o n S A F -O L E.  
T he C ol u m bia -S uici de S e verit y Rati n g Scal e ( C -S S R S) is a n u merical sc ore deri ve d fr o m 1 0 
cate g ories. T h e C -S S R S assesses t he s uici dal be ha vi or a n d s uici dal i deati o n i n partici pa nt s.  
T he C -S S R S o utc o me cate g ories are pr o vi de d b el o w. Eac h cate g or y h as a bi nar y res p o ns e ( yes/ n o) 
a n d are n u m bere d, pr o vi di n g a sc ore. A sc ore of 0 is assi g ne d  if t here is n o s uici dal i deati o n or 
s uici dal be ha vi or prese nt. 
I d eati o n: 
1.  Wis h t o be Dea d  
2.  N o n -s pecific Acti ve S uici dal T h o u g hts 
3.  Acti ve S uici dal I deati o n wit h A n y Met h o ds ( N ot Pla n) wit h o ut I nte nt t o A ct  
4.  Acti ve S uici dal I deati o n wit h S o me I nte nt t o Act, wit h o ut S pecific Pla n  
5.  Acti ve S uici dal I deati o n wit h S pecific Pla n a n d I nte nt  
Be ha vi or:  
6.  Pre parat or y Acts or Be h a vi or  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI
C CI
C CI
C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 3 /6 1  
 
 
7.  A b orte d Atte m pt  
8.  I nterr u pte d Atte m pt 
9.  Act ual Atte m pt ( n o n -fatal) 
1 0.  
C o m plete d S uici de  
Occ urre nce of s uici dal be ha vi or is defi ne d as ha vi n g a ns were d “ yes ” t o a least 1 of t he 4 s uici dal 
be ha vi or s u bcate g ories f or baseli ne/scree ni n g assess me nts a n d t o at least 1 of t he 5 s uici dal 
be ha vi or s u bcate g ories f or p ost -baseli ne “si n ce last visit” assess me nts . N ote t hat n o n -s uici dal self-
i nj uri o us be ha vi or is n ot c o nsi dere d i n t he deri vati o n of s uici d al be h a vi or a n d occ urre n ce will be 
re p orte d se p aratel y. 
Occ urre nce of s uici dal i d eati o n is defi ne d as ha vi n g a ns were d “ yes ” t o at least o ne of t he s uici dal 
i deati o n s u b-cate g ories .  
Occ urre nce of s uici dalit y is defi ne d as ha vi n g at least o ne occ urre nce of s uici dal i deati o n or at 
least o ne occ urre n ce of s uici dal be ha vi or. 
T he  n u m ber a n d perce nta ge of partici pa nt s wit h occ urre n ce of s uici dal be h a vi or at a n y ti me d uri n g 
O L E peri o d , occ urre nce of s uicidal i deati o n  at a n y ti me d uri n g treat me nt, occ urre n ce of s uici dalit y  
at a n y ti me d uri n g treat me nt a n d occ urre nce of s elf-i nj uri o us be ha vi or wit h o ut s uici dal i nte nt at 
a n y ti me d uri n g treat me nt  will be s u m marize d .  
S hifts fr o m  st u d y baseli ne ( ma xi m u m sc ore fr o m " baseli ne/scree ni n g" assess me nt)  a n d fr o m O L E 
baseli ne  t o t he w orst o n treat me nt o utc o m e ( ma xi m u m sc ore fr o m "si nce l ast visit" assess me nts) 
will be prese nte d. T h e f oll o wi n g cate g ories will b e s u m marize d:  
•  N o i deati o n (sc ore 0 ) 
•  N o n -seri o us s uici dal i deati o n (sc ore 1-3)  
•  Seri o us s uici dal i deati o n (sc ore 4 -5)  
•  S uici dal be ha vi or (sc ore 6 -1 0).  
Partici pa nt data listi n gs will be als o pr o vi de d.  
1 8  
R efere nces   
U S D e part me nt of Healt h a n d H u ma n Ser vices. C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts 
Versi o n 4. 0. 2 0 0 9 ( v 4. 0 3: J u ne 1 4, 2 0 1 0).   
 
 
Cr o we BJ, Xia H A, B erli n J A, et al. Rec o m m e n dati o ns f or safet y pla n ni n g, data c ollecti o n, 
e val uati o n a n d re p orti n g d uri n g dr u g, bi ol o gic a n d vacci ne d e vel o p me nt: a re p ort of t he s afet y 
pla n ni n g, e val uati o n, a n d re p orti n g tea m. Cli n Trials. 2 0 0 9; 6( 5): 4 3 0 -4 0.   
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 4 /6 1  
 
 
Mietti ne n O, N ur mi ne n M. C o m parati ve a nal ysis of t w o rates. Stat Me d 1 9 8 5; 4( 2): 2 1 3 -2 6  Ratitc h 
B, O’ Kell y M, T osiell o B. Missi n g data i n cli nical trials: fr o m cl nical ass u m pti o ns t o statistical 
a nal ysis usi n g patter n mi xt ure m o dels. P har m. Stat. 2 0 1 3; 1 2( 6): 3 3 7 -3 4 7 [ D OI : 1 0. 1 0 0 2/ pst. 1 5 4 9].  
 
  
H oe p ner R, Miclea A, P o p o vic J, et al. I m m u n o gl o b uli n le vels ma y ai d i n t he pre dicti o n treat me nt 
res p o nse i n a nti-C D 2 0 treat me nt of m ulti ple scl er osis. Cli nical & Tra nslati o nal Ne ur oscie nce 
2 0 1 8, 1 -6.   
Malli nc kr o dt C, R o ger J, C h ua n g -Stei n C, M ole n ber g hs G, et al.  Rece nt de vel o p me nts i n t he 
pre ve nti o n a n d treat me nt of missi n g data.  T hera pe utic I n n v o vati o n & Re g ulat or y Scie nce, V ol 4 8 
( 1), p p 6 8-8 0.   
 
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 5 /6 1  
 
 
1 9  
A p pe n dices   
1 9. 1  
A p pe n di x 1 : W orst o n tre at me nt v al ue b ase d o n n or m al r a n ge 
of l a b or at or y e v al u ati o ns   
N a m e s of Cli ni c al S af et y L a b or at or y 
E v al u ati o n s i n Pr ot o c ol v er si o n  6 . 0, 0 8  
N o v e m b er 2 0 1 9  
If gr a d a bl e p ar a m et er, 
c orr e s p o n di n g e v al u ati o n n a m e s i n 
N CI -C T C A E 4. 0 3  
W or st o n tr e at m e nt 
v al u e b a s e d o n n or m al 
r a n g e  
Al b u mi n  
H y p o al b u mi n e mi a  
L O W  
A s p art at e a mi n otr a n sf er a s e  
A s p art at e a mi n otr a n sf er a s e i n cr e a s e d  
HI G H  
Al a ni n e a mi n otr a n sf er a s e  
Al a ni n e a mi n otr a n sf er a s e i n cr e a s e d  
HI G H  
Al k ali n e p h o s p h at a s e  
Al k ali n e p h o s p h at a s e i n cr e a s e d  
HI G H  
γ -Gl ut a m yl -tr a n sf er a s e 
G G T i n cr e a s e d  
HI G H  
L a ct at e d e h y dr o g e n a s e  
 
HI G H  
Bilir u bi n (t ot al)  
Bl o o d bilir u bi n i n cr e a s e d  
HI G H  
Pr ot ei n (t ot al)  
 
L O W  
Cr e ati ni n e  
Cr e ati ni n e i n cr e a s e d  
HI G H  
E sti m at e d Gl o m er ul ar Filtr ati o n R at e  
C hr o ni c ki d n e y di s e a s e  
L O W  
A m yl a s e  
S er u m a m yl a s e i n cr e a s e d  
HI G H  
Li p a s e  
Li p a s e i n cr e a s e d 
HI G H  
T ot al c ar b o n di o xi d e  
 
L O W  
Bl o o d ur e a nitr o g e n  
 
HI G H  
Gl u c o s e  
H y p er gl y c e mi a  
HI G H  
Gl u c o s e  
H y p o gl y c e mi a  
L O W  
S o di u m  
H y p er n atr e mi a  
HI G H  
S o di u m  
H y p o n atr e mi a  
L O W  
P ot a s si u m  
H y p er k al e mi a  
HI G H  
P ot a s si u m  
H y p o k al e mi a  
L O W  
C hl ori d e  
 
N A  
C al ci u m  
H y p er c al c e mi a  
HI G H  
C al ci u m  
H y p o c al c e mi a  
L O W  
M a g n e si u m  
H y p er m a g n e s e mi a  
HI G H  
M a g n e si u m  
H y p o m a g n e s e mi a  
L O W  
P h o s p h at e  
H y p o p h o s p h at e mi a  
L O W  
H e m at o crit  
 
L O W/ HI G H  
H e m o gl o bi n  
H e m o gl o bi n i n cr e a s e d  
HI G H  
H e m o gl o bi n  
A n e mi a  
L O W  
R e d bl o o d c ell c o u nt  
 
N A  
M e a n c or p u s c ul ar v ol u m e  
 
N A  
M e a n c or p u s c ul ar h e m o gl o bi n  
 
N A  
M e a n c or p u s c ul ar h e m o gl o bi n c o n c e ntr ati o n  
 
N A  
R eti c ul o c yt e c o u nt  
 
N A  
Pl at el et c o u nt  
Pl at el et c o u nt d e cr e a s e d  
L O W  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 6 /6 1  
 
 
N a m e s of Cli ni c al S af et y L a b or at or y 
E v al u ati o n s i n Pr ot o c ol v er si o n  6 . 0, 0 8  
N o v e m b er 2 0 1 9  
If gr a d a bl e p ar a m et er, 
c orr e s p o n di n g e v al u ati o n n a m e s i n 
N CI -C T C A E 4. 0 3  
W or st o n tr e at m e nt 
v al u e b a s e d o n n or m al 
r a n g e  
W hit e bl o o d c ell c o u nt  
L e u k o c yt o si s  
HI G H  
W hit e bl o o d c ell c o u nt  
W hit e bl o o d c ell d e cr e a s e d  
L O W  
 c ell c o u nt 
 
L O W  
W hit e bl o o d c ell diff er e nti al s a n d a b s ol ut e 
c o u nt s: B a s o p hil s  
 
N A  
W hit e bl o o d c ell diff er e nti al s a n d a b s ol ut e 
c o u nt s: E o si n o p hil s  
 
N A  
W hit e bl o o d c ell diff er e nti al s a n d a b s ol ut e 
c o u nt s: L y m p h o c yt e s  
L y m p h o c yt e c o u nt i n cr e a s e d  
HI G H  
W hit e bl o o d c ell diff er e nti al s a n d a b s ol ut e 
c o u nt s: L y m p h o c yt e s  
L y m p h o c yt e c o u nt d e cr e a s e d  
L O W  
W hit e bl o o d c ell diff er e nti al s a n d a b s ol ut e 
c o u nt s: M o n o c yt e s  
 
N A  
W hit e bl o o d c ell diff er e nti al s a n d a b s ol ut e 
c o u nt s: N e utr o p hil s  
N e utr o p hil c o u nt d e cr e a s e d  
L O W  
1 9. 2  
A p pe n di x 2: List of p ar a meters f or I m m u n o gl o b uli n Le vels 
a n d I m m u ne cell s u bset c o u nts   
I m m u n o gl o b uli n cl asses a n d s u bcl asses 
P ar a m et er  
U nit s  
I m m u n o gl o b uli n A  
g/ L  
I m m u n o gl o b uli n M  
g/ L  
I m m u n o gl o b uli n G  
g/ L  
I m m u n o gl o b uli n G s u b cl a s s 1 
g/ L  
I m m u n o gl o b uli n G s u b cl a s s 2  
g/ L  
I m m u n o gl o b uli n G s u b cl a s s 3  
g/ L  
I m m u n o gl o b uli n G s u b cl a s s 4  
g/ L  
 
  
  
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI
C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 7 /6 1  
 
 
  
  
  
 
1 9. 3  
A p pe n di x 3 : A n al ysis visit wi n d o ws f or S afet y a n d Effic ac y 
E n d p oi nts   
A n al ysis visit wi n d o ws f or bi oc he mistr y p ar a meters t hr o u g h O L E Peri o d  
A n al y si s vi sit  
N o mi n al a n al y si s vi sit 
d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
E v o br uti ni b/ Pl a c e b o  
d uri n g m ai n st u d y  
T e cfi d er a d uri n g  
m ai n st u d y  
O L E W e e k 0  
1  
[ 1, 1] 
[ 1, 1] 
O L E W e e k 1  
7  
 
[ 2, 1 1) 
O L E W e e k 2  
1 4  
[ 2, 2 1) 
[ 1 1, 1 8) 
O L E W e e k 3  
2 1  
 
[ 1 8, 2 5) 
O L E W e e k 4  
2 8  
[ 2 1, 3 5) 
[ 2 5, 3 2) 
O L E W e e k 5  
3 5  
 
[ 3 2, 3 9) 
O L E W e e k 6  
4 2  
[ 3 5, 4 9) 
[ 3 9, 4 6) 
O L E W e e k 7  
4 9  
 
[ 4 6, 5 3) 
O L E W e e k 8  
5 6  
[ 4 9, 6 3) 
[ 5 3, 6 0) 
O L E W e e k 9  
6 3  
 
[ 6 0, 6 7) 
O L E W e e k 1 0  
7 0  
[ 6 3, 7 7) 
[ 6 7, 7 4) 
O L E W e e k 1 1  
7 7  
 
[ 7 4, 8 1) 
O L E W e e k 1 2  
8 4  
[ 7 7, 9 1) 
[ 8 1, 8 8) 
O L E W e e k 1 3  
9 1  
 
[ 8 8, 9 5) 
O L E W e e k 1 4  
9 8  
[ 9 1, 1 0 5) 
[ 9 5, 1 0 2)  
O L E W e e k 1 5  
1 0 5  
 
[ 1 0 2, 1 0 9) 
O L E W e e k 1 6  
1 1 2  
[ 1 0 5, 1 2 6) 
[ 1 0 9, 1 2 6) 
O L E W e e k 2 0  
1 4 0  
[ 1 2 6, 1 5 4) 
O L E W e e k 2 4  
1 6 8  
[ 1 5 4, 1 8 2) 
O L E W e e k 2 8  
1 9 6  
[ 1 8 2, 2 1 0) 
O L E W e e k 3 2  
2 2 4  
[ 2 1 0, 2 3 8) 
O L E W e e k 3 6  
2 5 2  
[ 2 3 8, 2 6 6) 
O L E W e e k 4 0  
2 8 0  
[ 2 6 6, 2 9 4) 
O L E W e e k 4 4  
3 0 8  
[ 2 9 4, 3 2 2) 
O L E W e e k 4 8  
3 3 6  
[ 3 2 2, 3 5 0) 
O L E W e e k 5 2  
3 6 4  
[ 3 5 0, 3 7 8) 
O L E W e e k 5 6  
3 9 2  
[ 3 7 8, 4 0 6) 
O L E W e e k 6 0  
4 2 0  
[ 4 0 6, 4 3 4) 
O L E W e e k 6 4  
4 4 8  
[ 4 3 4, 4 6 2) 
O L E W e e k 6 8  
4 7 6  
[ 4 6 2, 4 9 0) 
O L E W e e k 7 2  
5 0 4  
[ 4 9 0, 5 1 8) 
O L E W e e k 7 6  
5 3 2  
[ 5 1 8, 5 4 6) 
O L E W e e k 8 0  
5 6 0  
[ 5 4 6, 5 7 4) 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 8 /6 1  
 
 
A n al y si s vi sit  
N o mi n al a n al y si s vi sit 
d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
E v o br uti ni b/ Pl a c e b o  
d uri n g m ai n st u d y  
T e cfi d er a d uri n g  
m ai n st u d y  
O L E W e e k 8 4  
5 8 8  
[ 5 7 4, 6 0 2) 
O L E W e e k 8 8  
6 1 6  
[ 6 0 2, 6 3 0) 
O L E W e e k 9 2  
6 4 4  
[ 6 3 0, 6 5 8) 
O L E W e e k 9 6  
6 7 2  
[ 6 5 8, 7 1 4) 
O L E W e e k 1 0 8  
7 5 6  
[ 7 1 4, 7 9 8) 
O L E W e e k 1 2 0  
8 4 0  
[ 7 9 8, 8 8 2) 
O L E W e e k 1 3 2  
9 2 4  
[ 8 8 2, 9 6 6) 
O L E W e e k 1 4 4  
1 0 0 8  
[ 9 6 6, 1 0 5 0) 
O L E W e e k 1 5 6  
1 0 9 2  
[ 1 0 5 0, 1 1 3 4) 
O L E W e e k 1 6 8  
1 1 7 6  
[ 1 1 3 4, 1 2 1 8) 
O L E W e e k 1 8 0  
1 2 6 0  
[ 1 2 1 8, 1 3 0 2) 
O L E W e e k 1 9 2  
1 3 4 4  
[ 1 3 0 2, 1 4 2 8) 
O L E W e e k 2 1 6  
1 5 1 2  
[ 1 4 2 8, 1 5 9 6) 
O L E W e e k 2 4 0  
1 6 8 0  
[ 1 5 9 6, 1 7 6 4) 
O L E W e e k 2 6 4  
1 8 4 8  
[ 1 7 6 4, 1 9 3 2) 
O L E W e e k 2 8 8  
2 0 1 6  
[ 1 9 3 2, 2 1 0 0) 
O L E W e e k 3 1 2  
2 1 8 4  
[ 2 1 0 0, 2 2 6 8) 
O L E W e e k 3 3 6  
2 3 5 2  
[ 2 2 6 8, 2 3 6 6) 
A n al ysis visit wi n d o ws f or bi oc he mistr y p ar a meters t hr o u g h D B P  
A n al y si s vi sit  
N o mi n al a n al y si s vi sit d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
All tr e at m e nt gr o u p s  
D a y 1  
1  
[ 1, 1] 
W e e k 4  
2 8  
[ 2, 4 2)  
W e e k 8  
5 6  
[ 4 2, 6 3) 
W e e k 1 0  
7 0  
[ 6 3, 7 7) 
W e e k 1 2  
8 4  
[ 7 7, 9 1) 
W e e k 1 4  
9 8  
[ 9 1, 1 0 5) 
W e e k 1 6  
1 1 2  
[ 1 0 5, 1 1 9) 
W e e k 1 8  
1 2 6  
[ 1 1 9, 1 3 3) 
W e e k 2 0  
1 4 0  
[ 1 3 3, 1 4 7) 
W e e k 2 2  
1 5 4  
[ 1 4 7, 1 6 1) 
W e e k 2 4  
1 6 8  
[ 1 6 1, X[ 1]] 
W e e k 2 6  
1 8 2  
( X[ 1], X[ 1] + 2 1)  
W e e k 2 8  
1 9 6  
[ X[ 1] + 2 1, X [ 1] + 3 5)  
W e e k 3 0  
2 1 0  
[ X[ 1] + 3 5, X [ 1] + 4 9)  
W e e k 3 2  
2 2 4  
[ X[ 1] + 4 9, X [ 1] + 6 3)  
W e e k 3 4  
2 3 8  
[ X[ 1] + 6 3, X [ 1] + 7 7)  
W e e k 3 6  
2 5 2  
[ X[ 1] + 7 7, X [ 1] + 9 1)  
W e e k 3 8  
2 6 6  
[ X[ 1] + 9 1, X [ 1] + 1 0 5)  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
4 9 /6 1  
 
 
W e e k 4 0  
2 8 0  
[ X[ 1] + 1 0 5, X [ 1] + 1 1 9)  
W e e k 4 2  
2 9 4  
[ X[ 1] + 1 1 9, X [ 1] + 1 3 3)  
W e e k 4 4  
3 0 8  
[ X[ 1] + 1 3 3, X [ 1] + 1 4 7)  
W e e k 4 6  
3 2 2  
[ X[ 1] + 1 4 7, X [ 1] + 1 6 1)  
W e e k 4 8  
3 3 6  
[ X[ 1] + 1 6 1, X [ 1] + 1 7 1)  
X [ 1] c orr e s p o n d s t o t h e ti m e + 3 0 mi n ut e s w h er e s u bj e ct s ar e e x p o s e d f or t h e fir st ti m e t o  
E v o br uti ni b i n t h e s e c o n d 2 4 -w e e k tr e at m e nt p eri o d.  
A n al ysis visit wi n d o ws f or I g le vels, i ncl u di n g b ot h D B P a n d O L E  Peri o d  
A n al y si s 
vi sit  
N o mi n al a n al y si s vi sit 
d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
E v o br uti ni b/ Pl a c e b o d uri n g m ai n 
st u d y  
T e cfi d er a d uri n g m ai n 
st u d y  
D a y 1  
1  
[ 1, 1] 
s a m e  
W e e k 4  
2 8  
[ 2, 7 0) 
s a m e  
W e e k 1 6  
1 1 2  
[ 7 0, 1 4 0) 
s a m e  
W e e k 2 4  
1 6 8  
[ 1 4 0, 1 8 9) 
s a m e  
W e e k 4 8  
3 3 6  
[ 1 8 9, O L E 2 2) 
[ 1 8 9, O L E 1) 
O L E W 0  
O L E 1  
S a m e a s W 4 8 wi n d o w  
[ O L E 1, O L E 1] 
O L E W 2 4  
O L E 1 6 8  
[ O L E 2 2, O L E 2 5 2) 
[ O L E 2, O L E 2 5 2) 
O L E W 4 8  
O L E 3 3 6  
[ O L E 2 5 2, O L E 4 2 0) 
s a m e  
O L E W 7 2  
O L E 5 0 4  
[ O L E 4 2 0, O L E 5 8 8) 
s a m e  
O L E W 9 6  
O L E 6 7 2  
[ O L E 5 8 8, O L E 7 5 6) 
s a m e  
O L E W 1 2 0  
O L E 8 4 0  
[ O L E 7 5 6, O L E 9 2 4 ) 
s a m e  
O L E W 1 4 4  
O L E 1 0 0 8  
[ O L E 9 2 4, O L E 1 0 9 2) 
s a m e  
O L E W 1 6 8  
O L E 1 1 7 6  
[ O L E 1 0 9 2 , O L E 1 2 6 0 ) 
s a m e  
O L E W 1 9 2  
O L E 1 3 4 4  
[ O L E 1 2 6 0 , O L E 1 4 2 8 ) 
s a m e  
O L E W 2 1 6  
O L E 1 5 1 2  
[ O L E 1 4 2 8 , O L E 1 5 9 6 ) 
s a m e  
O L E W 2 4 0  
O L E 1 6 8 0  
[ O L E 1 5 9 6 , O L E 1 7 6 4 ) 
s a m e  
O L E W 2 6 4  
O L E 1 8 4 8  
[O L E 1 7 6 4, O L E 1 9 3 2)  
s a m e  
O L E W 2 8 8  
O L E 2 0 1 6  
[O L E 1 9 3 2 , O L E 2 1 0 0 ) 
s a m e  
O L E W 3 1 2  
O L E 2 1 8 4  
[ O L E 2 1 0 0, O L E 2 2 6 8) 
s a m e  
O L E W 3 3 6  
O L E 2 3 5 2  
[ O L E 2 2 6 8, 2 3 6 6) 
s a m e  
A n al ysis visit wi n d o ws f or i m m u ne cell s u bset c o u nts, i ncl u di n g b ot h D B P a n d O L E  Peri o d  
A n al y si s 
vi sit  
N o mi n al a n al y si s 
vi sit d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
E v o br uti ni b/ Pl a c e b o d uri n g m ai n 
st u d y  
T e cfi d er a d uri n g m ai n st u d y  
S C R [ 1] 
 
 
 
D a y 1  
1  
[ 1, 1] 
s a m e  
W e e k 4  
2 8  
[ 2, 9 8) 
s a m e  
W e e k 2 4  
1 6 8  
[ 9 8, 1 8 9) 
s a m e  
W e e k 4 8  
3 3 6  
 
[ 1 8 9, O L E 2 2) f or p ati e nt s w h o e nt er 
O L E  
[ 1 8 9, O L E 1) f or p ati e nt s w h o 
e nt er O L E  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 0 /6 1  
 
 
 
[ 1 8 9, 3 5 0) f or p ati e nt s w h o d o n ot 
e nt er O L E  
 
[ 1 8 9, 3 5 0) f or p ati e nt s w h o d o n ot 
e nt er O L E  
W e e k 5 2  
3 6 4  
[ 3 5 0, ∞) 
s a m e  
O L E W 0  
O L E 1  
S a m e a s W 4 8 wi n d o w  
[ O L E 1, O L E 1] 
O L E W 4 8  
O L E 3 3 6  
[ O L E 2 2, O L E 5 0 4) 
[ O L E 2, O L E 5 0 4) 
O L E W 9 6  
O L E 6 7 2  
[ O L E 5 0 4, O L E 8 4 0) 
s a m e  
O L E W 1 4 4  
O L E 1 0 0 8  
[ O L E 8 4 0, O L E 1 1 7 6 ) 
s a m e  
O L E W 1 9 2  
O L E 1 3 4 4  
[ O L E 1 1 7 6 , O L E 1 5 1 2 ) 
s a m e  
O L E W 2 4 0  
O L E 1 6 8 0  
[ O L E 1 5 1 2 , O L E 1 8 4 8 ) 
s a m e  
O L E W 2 8 8  
O L E 2 0 1 6  
[O L E 1 8 4 8,  O L E  2 1 8 4 ) 
s a m e  
O L E W 3 3 6  
O L E 2 3 5 2  
[O L E 2 1 8 4 , O L E  2 3 6 6 ) 
s a m e  
[ 1] I g n or e S C R a s s e s s m e nt u nl e s s n e e d e d t o r e pl a c e mi s si n g D 1 a s s e s s m e nt 
A n al ysis visit wi n d o ws f or E C G t h o u g h  O L E Peri o d  
A n al y si s vi sit  
N o mi n al a n al y si s vi sit d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
All tr e at m e nt gr o u p s 
O L E W e e k 0  
1  
[ M ai n p eri o d d a y 1 8 9, O L E 3 0] 
O L E W e e k 4 8  
3 3 6  
[ 3 0, 5 0 4) 
O L E W e e k 9 6  
6 7 2  
[ 5 0 4, 8 4 0) 
O L E W e e k 1 4 4  
1 0 0 8  
[ 8 4 0, 1 1 7 6) 
O L E W e e k 1 9 2  
1 3 4 4  
[ 1 1 7 6, 1 5 1 2) 
O L E W e e k 2 4 0  
1 6 8 0  
[ 1 5 1 2, 1 8 4 8) 
O L E W e e k 2 8 8  
2 0 1 6  
[ 1 8 4 8, 2 1 8 4) 
O L E W e e k 3 3 6  
2 3 5 2  
[ 2 1 8 4, 2 3 8 2) 
A n al ysis visit wi n d o ws f or  he m at ol o g y t hr o u g h O L E Peri o d 
A n al y si s vi sit  
N o mi n al a n al y si s 
vi sit d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
E v o br uti ni b/ Pl a c e b o  
d uri n g m ai n st u d y  
T e cfi d er a d uri n g  
m ai n st u d y  
O L E W e e k 0  
1  
[ 1, 1] 
[ 1, 1] 
O L E W e e k 4  
2 8  
 
[ 2, 3 5) 
O L E W e e k 6  
4 2  
 
[ 3 5, 4 9) 
O L E W e e k 8  
5 6  
 
[ 4 9, 6 3) 
O L E W e e k 1 0  
7 0  
 
[ 6 3, 7 7) 
O L E W e e k 1 2  
8 4  
 
[ 7 7, 9 8) 
O L E W e e k 1 6  
1 1 2  
 
[ 9 8, 1 4 0) 
O L E W e e k 2 4  
1 6 8  
[ 2, 2 1 0) 
[ 1 4 0, 2 1 0] 
O L E W e e k 3 6  
2 5 2  
[ 2 1 0, 2 9 4) 
O L E W e e k 4 8  
3 3 6  
[ 2 9 4, 3 7 8) 
O L E W e e k 6 0  
4 2 0  
[ 3 7 8, 4 6 2) 
O L E W e e k 7 2  
5 0 4  
[ 4 6 2, 5 4 6) 
O L E W e e k 8 4  
5 8 8  
[ 5 4 6, 6 3 0) 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 1 /6 1  
 
 
O L E W e e k 9 6  
6 7 2  
[ 6 3 0, 7 1 4) 
O L E W e e k 1 0 8  
7 5 6  
[ 7 1 4, 7 9 8) 
O L E W e e k 1 2 0  
8 4 0  
[ 7 9 8, 8 8 2) 
O L E W e e k 1 3 2  
9 2 4  
[ 8 8 2, 9 6 6) 
O L E W e e k 1 4 4  
1 0 0 8  
[ 9 6 6, 1 0 5 0) 
O L E W e e k 1 5 6  
1 0 9 2  
[ 1 0 5 0, 1 1 3 4) 
O L E W e e k 1 6 8  
1 1 7 6  
[ 1 1 3 4, 1 2 1 8) 
O L E W e e k 1 8 0  
1 2 6 0  
[ 1 2 1 8, 1 3 0 2) 
O L E W e e k 1 9 2  
1 3 4 4  
[ 1 3 0 2, 1 4 2 8) 
O L E W e e k 2 1 6  
1 5 1 2  
[ 1 4 2 8, 1 5 9 6) 
O L E W e e k 2 4 0  
1 6 8 0  
[ 1 5 9 6, 1 7 6 4) 
O L E W e e k 2 6 4  
1 8 4 8  
[ 1 7 6 4, 1 9 3 2) 
O L E W e e k 2 8 8  
2 0 1 6  
[ 1 9 3 2, 2 1 0 0) 
O L E W e e k 3 1 2  
2 1 8 4  
[ 2 1 0 0, 2 2 6 8) 
O L E W e e k 3 3 6  
2 3 5 2  
[ 2 2 6 8, 2 3 6 6) 
A n al ysis visit wi n d o ws f or he m at ol o g y p ar a meters t hr o u g h D B P  
A n al y si s vi sit  
N o mi n al a n al y si s vi sit d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
All tr e at m e nt gr o u p s  
D a y 1  
1  
[ 1, 1] 
W e e k 4  
2 8  
[ 2, 4 2) 
W e e k 8  
5 6  
[ 4 2, 7 0) 
W e e k 1 2  
8 4  
[ 7 0, 9 8) 
W e e k 1 6  
1 1 2  
[ 9 8, 1 2 6) 
W e e k 2 0  
1 4 0  
[ 1 2 6, 1 5 4) 
W e e k 2 4  
1 6 8  
[ 1 5 4, 2 1 0] 
W e e k 3 6  
2 5 2  
[ 2 1 0, 2 9 4) 
W e e k 4 8  
3 3 6  
[ 2 9 4, 3 3 9) 
A n al ysis visit wi n d o ws f or uri n al ysis p ar a meters t hr o u g h D B P  
A n al y si s vi sit  
N o mi n al a n al y si s vi sit d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
All tr e at m e nt gr o u p s  
W e e k 1 2  
8 4  
[ 2, 1 2 6) 
W e e k 2 4  
1 6 8  
[ 1 2 6, 2 5 2) 
W e e k 4 8  
3 3 6  
[ 2 5 2, 3 5 0) 
A n al ysis visit wi n d o ws f or uri n al ysis p ar a meters t hr o u g h O L E Peri o d  
A n al y si s vi sit  
N o mi n al a n al y si s vi sit 
d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
All tr e at m e nt gr o u p s  
O L E W e e k 0  
1  
[1, 1 ] 
O L E W e e k 2 4  
1 6 8  
[ 2, 2 9 4) 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 2 /6 1  
 
 
O L E W e e k 6 0  
4 2 0  
[ 2 9 4, 5 4 6) 
O L E W e e k 9 6  
6 7 2  
[ 5 4 6, 7 1 4) 
O L E W e e k 1 0 8  
7 5 6  
[ 7 1 4, 7 9 8) 
O L E W e e k 1 2 0  
8 4 0  
[ 7 9 8, 8 8 2) 
O L E W e e k 1 3 2  
9 2 4  
[ 8 8 2, 9 6 6) 
O L E W e e k 1 4 4  
1 0 0 8  
[ 9 6 6, 1 0 5 0) 
O L E W e e k 1 5 6  
1 0 9 2  
[ 1 0 5 0, 1 1 3 4) 
O L E W e e k 1 6 8  
1 1 7 6  
[ 1 1 3 4, 1 2 1 8) 
O L E W e e k 1 8 0  
1 2 6 0  
[ 1 2 1 8, 1 3 0 2) 
O L E W e e k 1 9 2  
1 3 4 4  
[ 1 3 0 2, 1 4 2 8) 
O L E W e e k 2 1 6  
1 5 1 2  
[ 1 4 2 8, 1 5 9 6) 
O L E W e e k 2 4 0  
1 6 8 0  
[ 1 5 9 6, 1 7 6 4) 
O L E W e e k 2 6 4  
1 8 4 8  
[ 1 7 6 4, 1 9 3 2) 
O L E W e e k 2 8 8  
2 0 1 6  
[ 1 9 3 2, 2 1 0 0) 
O L E W e e k 3 1 2  
2 1 8 4  
[ 2 1 0 0, 2 2 6 8) 
O L E W e e k 3 3 6  
2 3 5 2  
[ 2 2 6 8, 2 3 6 6) 
A n al ysis visit wi n d o ws f or  vit al si g ns t hr o u g h O L E Peri o d 
A n al y si s vi sit  
N o mi n al a n al y si s 
vi sit d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
E v o br uti ni b/ Pl a c e b o  
d uri n g m ai n st u d y  
T e cfi d er a d uri n g  
m ai n st u d y  
O L E W e e k 0  
1  
[ 1, 1] 
[ 1, 1] 
O L E W e e k 4  
2 8  
 
[ 2, 4 2) 
O L E W e e k 8  
5 6  
 
[ 4 2, 7 0) 
O L E W e e k 1 2  
8 4  
[ 2, 1 2 6) 
[ 7 0, 12 6 ) 
O L E W e e k 2 4  
1 6 8  
[ 1 2 6, 2 1 0) 
O L E W e e k 3 6  
2 5 2  
[ 2 1 0, 2 9 4) 
O L E W e e k 4 8  
3 3 6  
[ 2 9 4, 3 7 8)  
O L E W e e k 6 0  
4 2 0  
[ 3 7 8, 4 6 2) 
O L E W e e k 7 2  
5 0 4  
[ 4 6 2, 5 4 6) 
O L E W e e k 8 4  
5 8 8  
[ 5 4 6, 6 3 0) 
O L E W e e k 9 6  
6 7 2  
[ 6 3 0, 7 1 4) 
O L E W e e k 1 0 8  
7 5 6  
[ 7 1 4, 7 9 8) 
O L E W e e k 1 2 0  
8 4 0  
[ 7 9 8, 8 8 2) 
O L E W e e k 1 3 2  
9 2 4  
[ 8 8 2, 9 6 6) 
O L E W e e k 1 4 4  
1 0 0 8  
[ 9 6 6, 1 0 5 0) 
O L E W e e k 1 5 6  
1 0 9 2  
[ 1 0 5 0, 1 1 3 4) 
O L E W e e k 1 6 8  
1 1 7 6  
[ 1 1 3 4, 1 2 1 8) 
O L E W e e k 1 8 0  
1 2 6 0  
[ 1 2 1 8, 1 3 0 2) 
O L E W e e k 1 9 2  
1 3 4 4  
[ 1 3 0 2, 1 4 2 8) 
O L E W e e k 2 1 6  
1 5 1 2  
[ 1 4 2 8, 1 5 9 6) 
O L E W e e k 2 4 0  
1 6 8 0  
[ 1 5 9 6, 1 7 6 4) 
O L E W e e k 2 6 4  
1 8 4 8  
[ 1 7 6 4, 1 9 3 2) 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 3 /6 1  
 
 
A n al y si s vi sit  
N o mi n al a n al y si s 
vi sit d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
E v o br uti ni b/ Pl a c e b o  
d uri n g m ai n st u d y  
T e cfi d er a d uri n g  
m ai n st u d y  
O L E W e e k 2 8 8  
2 0 1 6  
[ 1 9 3 2, 2 1 0 0) 
O L E W e e k 3 1 2  
2 1 8 4  
[ 2 1 0 0, 2 2 6 8) 
O L E W e e k 3 3 6  
2 3 5 2  
[ 2 2 6 8, 2 3 6 6) 
A n al ysis visit wi n d o ws f or E D S S t hr o u g h D B P  
A n al y si s vi sit  
N o mi n al a n al y si s vi sit d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
All tr e at m e nt gr o u p s  
D a y 1  
1  
[ 1, 1] 
W e e k 1 2  
8 4  
[ 2, 1 2 6) 
W e e k 2 4  
1 6 8  
[ 1 2 6, 1 8 9)  
W e e k 3 6  
2 5 2  
[ 1 8 9, 2 9 4) 
W e e k 4 8  
3 3 6  
[ 2 9 4, 3 3 9) 
A n al ysis visit wi n d o ws f or E D S S t hr o u g h O L E Peri o d  
A n al y si s vi sit  
N o mi n al a n al y si s vi sit 
d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
All tr e at m e nt gr o u p s  
O L E W e e k 0  
1  
[ M ai n p eri o d d a y 2 9 4, O L E 1 6 9] 
O L E W e e k 4 8  
3 3 6  
[ 1 6 9, 5 0 4) 
O L E W e e k 9 6  
6 7 2  
[ 5 0 4, 8 4 0)  
O L E W e e k 1 4 4  
1 0 0 8  
[ 8 4 0, 1 1 7 6) 
O L E W e e k 1 9 2  
1 3 4 4  
[ 1 1 7 6, 1 5 1 2) 
O L E W e e k 2 4 0  
1 6 8 0  
[ 1 5 1 2, 1 8 4 8) 
O L E W e e k 2 8 8  
2 0 1 6  
[ 1 8 4 8, 2 1 8 4) 
O L E W e e k 3 3 6  
2 3 5 2  
[ 2 1 8 4, 2 3 8 2) 
A n al ysis visit wi n d o ws f or M RI t hr o u g h O L E Peri o d  
A n al y si s vi sit  
N o mi n al a n al y si s vi sit 
d a y  
A n al y si s vi sit wi n d o w ( d a y s)  
All tr e at m e nt gr o u p s  
O L E W e e k 0  
1  
[ M ai n p eri o d d a y 1 8 9, O L E 3 0) 
O L E W e e k 4 8  
3 3 6  
[ 3 0, 5 0 4) 
O L E W e e k 9 6  
6 7 2  
[ 5 0 4, 8 4 0) 
O L E W e e k 1 4 4  
1 0 0 8  
[ 8 4 0, 1 1 7 6) 
O L E W e e k 1 9 2  
1 3 4 4  
[ 1 1 7 6, 1 5 1 2) 
O L E W e e k 2 4 0  
1 6 8 0  
[ 1 5 1 2, 1 8 4 8) 
O L E W e e k 2 8 8  
2 0 1 6  
[ 1 8 4 8, 2 1 8 4) 
O L E W e e k 3 3 6  
2 3 5 2  
[ 2 1 8 4, 2 3 8 2) 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 4 /6 1  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 5 /6 1  
 
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 6 /6 1  
 
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 7 /6 1  
 
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 8 /6 1  
 
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
5 9 /6 1  
 
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
6 0 /6 1  
 
 
1 9. 5  
A p pe n di x 5 : A Es of S peci al I nterest   
A refere nce s prea ds heet c o ntai ni n g t he list of A E ter ms t o pr o gra m maticall y fla g partici pa nts wit h 
A Es of s p ecial i nterest is s hare d b y t he Safet y T ea m a n d re g ularl y u p d ate d acc or di n g t o Me d D R A 
versi o n u p date.  
T he latest versi o n of t he file at ti me of a nal ysis will be use d.  
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
C CI


E v o br uti ni b ( M 2 9 5 1)  
 
 
 
 
P h ase II i n Rel a psi n g M ulti ple Scler osis  
M S 2 0 0 5 2 7 -0 0 8 6   
 
 
 
 
0 3 J u ne 2 0 2 4 / Versi o n 2 . 0 
 
C O N F I D E N T I A L  
I N F O R M A T I O N  
6 1 /6 1  
 
 
1 9. 6  
A p pe n di x 6 : D at a h a n dli n g after c ut -off d ate   
N ot a p plica ble  
1 9. 7  
A p pe n di x 7 : List of Pri or D M T  
U ni q u e_ pr e v_ m e d_ G C
D_ v 2. 1
 
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI


Si g nat ure Pa ge f or V V- C LI N- 3 5 9 9 1 0 v 3. 0
Si g nat ure Pa ge f or V V- C LI N- 3 5 9 9 1 0 v 3. 0
A p pr o val Tas k
Cli nical
1 0-J u n- 2 0 2 4 2 1: 0 0: 5 9 G M T + 0 0 0 0
Gl o bal Versi o n I D: 
Gl o bal Versi o n I D: C CI
P P D