Protocol Number: SA-307JG I Version 2,8

A multicenter, rondomized, oddition to boseline treotment,double-blind, plocebo-controlled, phose 3 study to evcrluotethe efficocy ond sofety of SA237 in potients with neuromyelitisoptico (NMO) ond NMO spectrum disorder (NMOSD)

Potient Nome: Pctient Dote of Birth:

Pleose review the following inclusion ond exclusion criterio with your potient to see if he or she might beeligible to toke port in this cl inicol study,

Inclusion CriteriqPotients who meet the following criterio ore suitoble for screeningrn I. Potients must be diognosed os hoving either:

n o. NMO os defined by 2006 criterior*, or

fl b. NMOSD os defined by either of the following Wingerch uk 2007 criterio with onti-AQP4Ab seropositive stotusof screening.

I i) ldiopothic single or recurrent events of longitudinolly extensive myelitis (>3 vertebrol segment spinol cordMRl les ion)

n iD Optic neuritis: recurrent or simultoneous biloterolt For poiients oged l2 to 17 yeors, onti-AQP4Ab stotus ot screening must be seropositive,

n 2, Clinicol evidence of ot leost 2 documenied relopses (including first ottock) in the lost 2 yeors prior to screening,ot leost one of which hos occurred in the l2 months prior to screening.

n S. f OSS score from 0 to 6.5 inclusive ot screening.

n a. Rge 12Io 74 yeors, inclusive ot the time of informed consent,

I S. One of the following boseline treotments for relopse prevention must be of stoble dose os o monotheropy forB weeks orior to boseline:

n o. Azothioprine.

t] b, Mycophenolote mofetil.

fl c. Orol corticosteroids.

[10, ROitity ond willingness to provide written informed consent ond io comply with the requirements of the protocol,

*According to Wingerchuk et ol, 2006, o diognosis of NMO includes:

L Optic neurit isll. Acute myelitislll. At leosi two of three supportive criterio:

. Contiguous spinol cord lesion identi f ied on o mognetic resononce imoging (VlRl) scon exiending over 3 vertebrol segments

. Broin MRI not meeting diognostic cr i fer io for MS

. NMO-lgG seropositive stotus

,i* 0,,oSky

Protocol Number: $A-307JG I Version 2,0

Exclusion CriterisPotients who meet ony of the following criterio ore NOT suitoble for study entry:

Exclusion criterio relofed to previous or concomifonf theropy:

I L Any previous treotmenl with lL-6 inhibitory theropy (e.g iocilizumob), olemtuzumob, totol body irrodiotion or bonemorrow tronsplontotion of ony time.

[J 2. nny previous treotment with onti-CD20, introvenous immunoglobulin (lVlG), eculizumob, belimumob, interferon,notolizumob, glotiromer ocetote, fingolimod, teriflunomide or dimethylfumorote within 6 months prior io boseline,

n S. S. Any previous treotment with onti-CD4, clodribine or mitoxontrone wilhin 2 yeors prior to boseline,

f| 4. Treotment with ony investigotionol ogent within 3 months prior to boseline.

Exclusions lor generol sofefy:

tr S. Pregnoncy or loctotion,

n 6. For potients of reproductive potentiol, o positive result from o serum pregnoncy test ot screening, or not willing touse relioble meons of controception (physicol borrier Ipotient or portner] in conjunction with o spermicidol product,nnnrrnnanrir,^ ^ill, potch, injectobles, introuterine device or introuterine system) during the treotment period ond forv v , , , , v v v Y , , v v v l

of leost 3 months ofter lhe lost dose of study drug.

n 7. Any surgicol procedure (except for minor surgeries) within 4 weeks prior to boseline,

tr A Evidence of other demyelinoting diseose or progressive multifocol leukoencepholopothy (PML).

tr C. Evidence of serious uncontrolled concomitont diseoses thot moy preclude potient porticipotion, such os:nihar narrrnr rc cr,gtgJ-p1 diseose, cordiovosculor diseose, hemotologiC/hemOtOpOieSiS diSeOSe, respirOtOry diSeOSe,Y v v w v I

musculor diseose, endocrine diseose, renol/urologic diseose, digestive system diseose, congenitol or ocquiredsevere i mmunodefi ciencv,

[ 10, Known octive infection (excluding fungol infections of noil beds or cories dentium) within 4 weeks prior to boseline,

n ll. Evidence of chronic octive hepotitis B or C,

n 12" History of drug or olcohol obuse.

n 13. History of diverticulitis thot, in the Investigotor's opinion, moy preclude potient porticipotion,

[ 14" eviOence of octive tuberculosis (TB; excluding potients receiving chemoprophyloxis for lotent TB infection).

[ 15. tviOence of octive interstitiol lung diseose.

[ 16" Receipt of ony live or live ottenuoted voccine within 6 weeks prior to boseline,

fl 17, History of molignoncy within the lost 5 yeors, including solid tumors, hemotologic molignoncies ond in situ corcinomo(except bosol cell ond squomous cell corcinomos of the skin, or in situ corcinomo of the cervix uteri thot hove beencompletely excised ond cured).

[ 18. History of severe ollergic reoction to o biologic ogent (e g, shock, onophyloctic reoctions),

Loborotory exclusion criterio (ot screening)

n 19. Following loborotory obnormolities of screening*:

I s. White blood cells (WBC) <3.0 xl03/ULI b. Absolute neutrophil count (ANC) <2 0 xl03/ULI c. Absolute lymphocyte count <0.5 xl03/pL

n O. Ptotelet count dOxl04/pLI e. Asportote ominotronsferose (AST) or olonine ominotronferose (ALT) >.l.5 iimes the upper limil of normol (ULN).

- lf retest is conducted, the lost volue of retest before rondomizotion must meet siudv criterio.

Willthe poiient pori icipote in the study? YFS tr NO n

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