Clinical trial NCT04967508
Conditions: Psoriasis Moderate to Severe Plaque Psoriasis
Keywords: Psoriasis Plaque Psoriasis
Sponsor: Samsung Bioepis Co., Ltd.
Start date: 2021-07-06; Completion date: 2022-11-25
Enrollment: 503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.

Detailed description:
Subjects will be randomised in a 1:1 ratio to receive either SB17 or Stelara® via subcutaneous injection. At Week 28, subjects receiving Stelara® will be randomised again in a 1:1 ratio to either continue on Stelara® or be transitioned to SB17. Investigational products (IPs) (SB17 or Stelara®) will be administered at Week 0, 4, and then every 12 weeks up to Week 40, and the last assessment will be done at Week 52.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Stelara® (Ustekinumab) intervention 2: SB17 (Proposed Ustekinumab Biosimilar)
Intervention descriptions: intervention 1: Subjects randomised into Stelara® group will receive Stelara® (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40. intervention 2: Subjects randomised into SB17 group will receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.

Starting at Week 28, subjects transited from Stelara® to SB17 will receive SB17 via subcutaneous injection.

Protocol documents:
Prot_000.pdf: 
SB17 (proposed ustekinumab biosimilar) 
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Clinical Study Protocol 
A Phase III, Randomised, Double-blind, Multicentre Clinical Study to 
Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and 
Immunogenicity of SB17 (proposed ustekinumab biosimilar) Compared to 
Stelara® in Subjects with Moderate to Severe Plaque Psoriasis     
Product 
SB17 (proposed ustekinumab biosimilar) 
EudraCT Number 
2020-006115-19 
US IND Number (if applicable) 
N/A 
Protocol Number 
SB17-3001 
Study Phase 
Phase III 
Version and Effective Date 
Version 2.0 
Version 1.0 
Feb 15, 2021 
Dec 30, 2020 
Sponsor 
Samsung Bioepis Co., Ltd 
76, Songdogyoyuk-ro, Yeonsu-gu, 
Incheon, 21987 
Republic of Korea 
This document contains confidential information belonging to Samsung Bioepis Co., Ltd. Your acceptance or 
review of this document constitutes agreement that you will not copy or disclose the information contained 
herein to others or use it for unauthorised purposes without written authorisation from the Sponsor. 


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SYNOPSIS 
Name of Sponsor/Company: 
Samsung Bioepis Co., Ltd. 
Name of Finished Product: 
SB17 (proposed ustekinumab biosimilar) 
Name of Active Ingredient: 
Ustekinumab 
Title of Study: 
A Phase III, randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, 
pharmacokinetics, and immunogenicity of SB17 (proposed ustekinumab biosimilar) compared to Stelara® in 
subjects with moderate to severe plaque psoriasis 
Protocol No: 
SB17-3001 
Phase: III 
Investigator sites: 
Approximately 70 Investigator sites globally 
Planned Study Period: Approximately 56 weeks 
Screening period will be 4 weeks. SB17 or Stelara® will be administered up to Week 40, and the last assessment 
will be done at Week 52. 
Objectives: 
Primary Objective 
The primary objective is to demonstrate the equivalence of SB17 to Stelara®, in terms of the percent change 
from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 in subjects with moderate to severe 
plaque psoriasis 
Secondary Objective(s) 
The secondary objectives are: 
• 
To evaluate the efficacy of SB17 compared to Stelara® 
₋ 
Percent change from baseline in PASI other than Week 12 
₋ 
Physician’s Global Assessment (PGA) 
₋ 
PASI50, PASI75, and PASI90 response rate 
₋ 
Change from baseline in Dermatology Life Quality Index (DLQI) 
• 
To evaluate safety and tolerability of SB17 compared to Stelara® 
• 
To evaluate the pharmacokinetics (PK) of SB17 compared to Stelara® in subjects participating in PK 
evaluation 
• 
To evaluate the immunogenicity of SB17 compared to Stelara® 
• 
To evaluate safety and immunogenicity in subjects who transitioned to SB17 and who maintained 
Stelara® at Week 28 for the transition period 
Study Design: 
This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, 
and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis. 
Subjects will be randomised in a 1:1 ratio to receive either SB17 or Stelara® via subcutaneous injection. 
Investigational products (IPs) (SB17 or Stelara®) will be administered at Week 0, 4, and then every 12 weeks 
up to Week 40, and the last assessment will be done at Week 52. 


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Name of Sponsor/Company: 
Samsung Bioepis Co., Ltd. 
Name of Finished Product: 
SB17 (proposed ustekinumab biosimilar) 
Name of Active Ingredient: 
Ustekinumab 
At Week 28, subjects who achieved a PASI50 response and are considered eligible will enter the transition 
period. In the transition period, subjects receiving Stelara® will be randomised again in a 1:1 ratio to either 
continue on Stelara® (Stelara®/Stelara®) or be transitioned to SB17 (Stelara®/SB17), up to Week 40. Subjects 
receiving SB17 will continue to receive SB17 up to Week 40 but they will follow the randomisation procedure 
in order to maintain blinding. 
Number of Subjects: 
Sufficient subjects will be screened so that approximately 464 subjects will be randomised in the study. 
Target Population:  
Moderate to severe plaque psoriasis indicated for systemic therapy for psoriasis 
Eligibility Criteria for Main Period: 
Inclusion Criteria 
Subjects must meet all of the following criteria to be eligible for the study: 
1. Aged 18 years or older at Screening (defined as the time of signing the informed consent form 
[ICF]). 
2. Have plaque psoriasis diagnosed at least 6 months prior to Screening, with or without psoriatic 
arthritis. 
3. Have plaque psoriasis at Screening and Randomisation with the involvement and severity defined as 
the following: 
a. 
Total affected body surface area (BSA) ≥ 10%. 
b. 
PASI score of ≥ 12. 
c. 
PGA score of ≥ 3 (moderate). 
4. Considered to be a candidate for phototherapy or systemic therapy for psoriasis at Screening. 
5. Be less than 95 kg of body weight at Screening and at Randomisation. 
6. Adequate haematological function at Screening defined as the following by central lab: 
a. 
White blood cell count ≥ 3.5 × 103 cells/μL (≥ 3.5 × 109 cells/L). 
b. 
Neutrophil count ≥ 1.5 × 103 cells/μL (≥ 1.5 × 109 cells/L). 
c. 
Haemoglobin ≥ 10 g/dL. 
d. 
Platelet count ≥ 125,000/mm3 (≥ 125 × 109/L). 
7. Adequate renal and hepatic function at Screening defined as the following by central lab: 
a. 
Serum creatinine < 1.5 × upper limit of normal (ULN). 
b. 
Serum alanine transaminase (ALT) and aspartate transaminase (AST) < 2 × ULN. 
8. Non-childbearing potential female (e.g., permanently sterilised, postmenopausal [defined as 
amenorrhea of at least 12 months without an alternative medical cause prior to Screening and a 
follicle stimulating hormone (FSH) level of > 40 IU/L at Screening]), OR childbearing potential 


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Name of Sponsor/Company: 
Samsung Bioepis Co., Ltd. 
Name of Finished Product: 
SB17 (proposed ustekinumab biosimilar) 
Name of Active Ingredient: 
Ustekinumab 
female subjects or male subjects with their (respectively male or childbearing female) partners who 
agree to use at least two forms of appropriate contraception method (e.g., established use of oral, 
injected, intravaginal, transdermal, or implanted hormonal contraceptive, placement of an 
intrauterine device or intrauterine hormone-releasing system, physical barrier [Note: female condom 
and male condom should not be used together]) from Screening until 15 weeks after the last dose of 
IP. Vasectomy alone will be allowed for male subjects and female subjects of childbearing potential 
with a sole vasectomised male partner. Vasectomised subjects or partners should be medically 
confirmed for sterilisation. True abstinence alone will be allowed if this is in line with the preferred 
and usual lifestyle of the subject, or for subjects who do not have a partner. 
9. Have provided informed consent and must be able to, in the opinion of the Investigator, understand 
the implications of taking part in the study and be willing to follow the study requirements. 
Exclusion Criteria 
Subjects meeting any of the following criteria are not eligible for the study: 
1. Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced 
psoriasis at Screening. 
2. Have other skin disease than psoriasis that: 
a. 
Requires topical or systemic corticosteroid or other immunosuppressive therapy at Screening. 
b. 
May confound the efficacy evaluation per Investigator discretion at Screening. 
3. Have used biologics (any therapeutic monoclonal antibody or fusion receptor protein) such as; 
a. 
Any tumour necrosis factor (TNF) inhibitors within the previous 6 months prior to 
Randomisation. 
b. 
Any interleukin (IL)-12 or IL-23 inhibitor biologics (including ustekinumab/ustekinumab 
biosimilars, guselkumab, tildrakizumab, or rizankizumab), IL-17 inhibitor (including 
secukinumab, ixekizumab, or brodalumab), rituximab, or integrin inhibitor biologics at any 
time prior to Randomisation. 
c. 
Other biologics within the longer of either 5 half-lives or 3 months prior to Randomisation. 
4. Known allergic reactions or hypersensitivity to ustekinumab or to any ingredients of Stelara® or 
SB17 at Screening. 
5. History of a systemic allergic reaction or hypersensitivity to prior biologic therapies at Screening. 
6. History of asthma that: 
a. 
Required intubation at any time prior to Screening. 
b. 
Required hospitalisation or 14 days or more of oral corticosteroids use (cumulatively) within 
6 months prior to Randomisation. 
c. 
Requires oral corticosteroids or considered to be corticosteroid-dependent in the opinion of 
the Investigator at Randomisation. 
7. History of exfoliative dermatitis, Reversible Posterior Leukoencephalopathy Syndrome (RPLS), 
facial palsy, allergic alveolitis, or non-infectious pneumonia including interstitial pneumonia, 


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Name of Sponsor/Company: 
Samsung Bioepis Co., Ltd. 
Name of Finished Product: 
SB17 (proposed ustekinumab biosimilar) 
Name of Active Ingredient: 
Ustekinumab 
cryptogenic organizing pneumonia, or eosinophilic pneumonia, etc. at Screening. 
8. Have received phototherapy (including ultraviolet B [UVB], psoralen and ultraviolet A [PUVA], or 
sunbaths/tanning beds, etc.) or conventional systemic therapy (including corticosteroids, 
methotrexate [MTX], calcineurin inhibitors, retinoids, vitamin D analogues, fumaric acid esters, 
apremilast, 6-thioguanine, hydroxyurea, etc.) for psoriasis within 4 weeks prior to Randomisation. 
9. Have received topical therapy for psoriasis (including corticosteroids, vitamin D analogues, 
retinoids, calcineurin inhibitors, coal tar, anthralin, urea, alpha-hydroxy acid, or salicylic acid, etc.) 
within 2 weeks prior to Randomisation. 
10. Have received any disease-modifying anti-rheumatic drugs (DMARDs), any systemic 
immunosuppressants (including those mentioned above in systemic psoriasis therapy, antimalarials, 
sulfasalazine, Janus kinase [JAK] inhibitors, gold, minocycline, azathioprine, 6-mercaptopurine, 
mycophenolate mofetil, etc.) or any other injectable or enema corticosteroids, within 4 weeks prior 
to Randomisation (except for leflunomide: within 12 weeks from Randomisation). 
11. Have received non-biologic IP from another study within 5 half-lives of that product prior to 
Randomisation or use of an investigational device at Randomisation. 
12. Women who are pregnant or nursing at Screening, or men and women planning pregnancy during 
the study period and until 15 weeks after the last dose of IP. 
13. Have received a live or live attenuated viral vaccine or a live bacterial vaccine (except Bacille 
Calmette-Guerin [BCG] vaccination) within 4 weeks prior to Randomisation or plan to do so within 
15 weeks after the last dose of IP. For BCG vaccination, subjects who have received BCG within 12 
months prior to Randomisation or plan to do so within 12 months after the last dose of IP. 
14. Have active or latent tuberculosis (TB) at Screening, by known history or any of the following: 
a. 
Positive QuantiFERON®-Gold Plus test. 
b. 
Positive chest X-ray findings (radiographs taken within 3 months prior to Randomisation 
with radiologist confirmation will be accepted) determined by a qualified physician such as 
radiologist or pulmonologist, including active TB, untreated or inadequately treated old, 
inactive or healed TB. 
c. 
By any other positive findings determined by TB specialist, including suggestive signs or 
symptoms of TB or recent close contact with active TB patients. 
15. History of ongoing infection or a positive test of hepatitis B virus (HBV, defined as hepatitis B 
surface antigen [HBsAg] positive or HBsAg negative and hepatitis B core antibody [HBcAb] 
positive), hepatitis C virus (HCV; for subjects who have previously received anti-HCV treatment 
must have a sustained virologic response [SVR] for at least 24 weeks post-treatment and no 
evidence of significant liver fibrosis [i.e., must be METAVIR F0 or F1] in addition to negative 
HCV-ribonucleic acid (RNA) at Screening to be eligible), or human immunodeficiency virus (HIV) 
infection, or any history of primary immunodeficiency at Screening. 
16. History of sepsis (defined as a life-threatening organ dysfunction caused by infection), chronic or 
recurrent infection, conditions that require regular antibiotic prophylaxis (such as rheumatic heart 
disease), opportunistic, granulomatous (for TB, please see above), or invasive fungal infection at 
Screening. 


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Name of Sponsor/Company: 
Samsung Bioepis Co., Ltd. 
Name of Finished Product: 
SB17 (proposed ustekinumab biosimilar) 
Name of Active Ingredient: 
Ustekinumab 
17. History of other bacterial, fungal, viral, parasitic, or helminthic infection requiring oral antimicrobial 
within 2 weeks prior to Randomisation or a serious infection (a bacterial, fungal, viral, parasitic, or 
helminthic infection that requires hospitalisation or treatment with parenteral antimicrobials) within 
8 weeks prior to Randomisation. Other mild infections should be resolved before Randomisation. 
For Coronavirus Disease 2019 (COVID-19), please see below. 
18. History of lymphoproliferative disease or leukaemia at Screening. 
19. History of malignancy (except for squamous or basal cell carcinoma of the skin that has been treated 
and not recurred within 3 months prior to Screening, or surgically treated cervical carcinoma in situ) 
within the last 5 years prior to Screening. 
20. History of myocardial infarction, New York Heart Association (NYHA) III/IV congestive heart 
failure, or stroke within 12 months prior to Randomisation. 
21. Have uncontrolled hypertension (defined as systolic blood pressure [SBP] ≥ 160 mmHg or diastolic 
blood pressure [DBP] ≥ 100 mmHg confirmed after repeat measurement) at Screening. 
22. Have uncontrolled diabetes mellitus (defined as having history of diabetic peripheral neuropathy or 
diabetic foot, or otherwise considered uncontrolled in the opinion of the Investigator) at Screening. 
23. History of organ transplantation at Screening. 
24. Evidence of alcohol or substance abuse within the last 12 months prior to Screening. 
25. History of a major surgery in the opinion of the Investigator within 12 weeks prior to Randomisation 
or have a plan to do so during the study period. 
26. Have psychiatric disease at Screening defined as: 
a. 
Current uncontrolled mental disorder (including depression) in the opinion of the 
Investigator. 
b. 
History of suicidal attempts or ideation. 
c. 
Considered to be at risk of suicide in the opinion of the Investigator. 
27. Have other major organ dysfunction or failure such as liver cirrhosis, dialysis-dependent renal 
failure, any cardiopulmonary disease with functional disability of NYHA III/IV equivalent, aplastic 
anaemia or any other transfusion-dependent/stimulating factor dependent haematological disorders, 
or dementia at Screening. 
28. Considered to be at risk of progressive weight gain or widely fluctuating body weight, in the opinion 
of the Investigator, at Screening. 
29. History of COVID-19 as: 
a. 
History of asymptomatic, mild or moderate COVID-19 within 8 weeks prior to 
Randomisation. 
b. 
Any history of severe or critical COVID-19, or hospitalisation due to COVID-19 at 
Randomisation. 
c. 
Any history of COVID-19 complications or sequalae including lung fibrosis, 
thromboembolism, cardiac, gastrointestinal, neuropsychiatric, ‘long COVID’, or 


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Name of Sponsor/Company: 
Samsung Bioepis Co., Ltd. 
Name of Finished Product: 
SB17 (proposed ustekinumab biosimilar) 
Name of Active Ingredient: 
Ustekinumab 
dermatologic manifestations, etc. at Randomisation. 
Note: COVID-19 severity grade is according to World Health Organization (WHO) COVID-19 
disease severity classification. Subjects who have suggestive signs or symptoms of COVID-19 
must be evaluated and determined to be COVID-19 negative per local regulations before 
Screening. 
30. Have any other disease or disorder, that will put the subject at risk if they are enrolled, in the opinion 
of the Investigator, at Screening. 
31. Have poor venous access or unwillingness to undergo multiple venepuncture and blood sampling at 
Screening. 
Eligibility Criteria for Transition Period: 
Inclusion Criteria 
1. Achieve PASI50 response on Week 28 visit assessment. 
2. Willing to participate in the rest of study and able to follow the study procedure with the opinion of 
the Investigator. 
Exclusion Criteria 
1. Subject is considered to be of increased risk when entered in the Transition Period, in the opinion of 
the Investigator. 
Investigational Products: 
• 
Name: SB17 (proposed ustekinumab biosimilar) or European Union (EU) sourced Stelara® 
• 
Formulation: 0.5 mL of 90 mg/mL solution of ustekinumab in a pre-filled syringe (PFS) 
• 
Route of administration: Subcutaneous injection in abdomen, upper thighs, or upper arm 
• 
Injection volume: 0.5 mL 
• 
Dose regimen: 45 mg at Week 0, 4, and then every 12 weeks up to Week 40. If the subject becomes 
> 100 kg at subsequent dosing visits the subject will receive 90 mg in the form of two doses of 45 
mg. 
Main Criteria for Evaluation 
Primary Endpoint 
• 
Percent change from baseline in PASI at Week 12 
Secondary Endpoints 
The secondary efficacy endpoints are: 
• 
PGA at Week 2, 4, 8, 12, 16, 20, 24, 28, 40, and 52 
• 
PASI50, PASI75, and PASI90 response rate at Week 2, 4, 8, 12, 16, 20, 24, 28, 40, and 52 
• 
Percent change from baseline in PASI at Week 2, 4, 8, 16, 20, 24, 28, 40, and 52 


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Name of Sponsor/Company: 
Samsung Bioepis Co., Ltd. 
Name of Finished Product: 
SB17 (proposed ustekinumab biosimilar) 
Name of Active Ingredient: 
Ustekinumab 
• 
Change from baseline in DLQI at Week 4, 12, 16, 28, 40, and 52 
The safety endpoints are: 
• 
Incidence of adverse events (AEs)  
• 
Incidence of serious AEs (SAEs) 
• 
Changes in vital signs and clinical laboratory parameters 
The PK endpoints are: 
• 
Serum ustekinumab concentration at Week 0, 2, 4, 8, 12, 16, and 28 
The immunogenicity endpoints are: 
• 
Incidence of anti-drug antibodies (ADAs) at Week 0, 4, 8, 12, 16, 28, 40, and 52 
• 
Incidence of neutralising antibodies (NAbs) at Week 0, 4, 8, 12, 16, 28, 40, and 52 
Statistical Methods 
Analysis Sets for Efficacy Analyses 
Full Analysis Set (FAS) consists of all subjects who are randomised. Following the intent-to-treat principle, 
subjects will be analysed according to the treatment group they are assigned to at Randomisation. However, 
subjects who do not have any efficacy assessment result after randomisation or do not receive IP during the 
study period will be excluded from FAS.  
Per-Protocol Set (PPS) consists of all FAS subjects who weight ≤ 100 kg and received 45 mg IP at Week 0 and 
Week 4 and have PASI assessment result at Baseline and Week 12 without any major protocol deviations (PDs) 
that have impact on primary efficacy assessment. Major PDs that will lead to exclusion from this set will be 
pre-defined prior to unblinding the treatment group assignment for analyses. 
Efficacy Analyses 
The primary efficacy analysis will aim to demonstrate equivalence in terms of percent change from baseline in 
PASI at Week 12 between SB17 and EU sourced Stelara®. 
Equivalence between the two treatment groups will be declared if the 95% confidence interval (CI) of the mean 
difference is entirely contained within the pre-defined equivalence margin of [-15%, 15%]. The 95% CI of the 
mean difference between the two treatment groups in relation to the percent change from baseline in PASI will 
be estimated for the both PPS and FAS. 
Additionally, the 90% CI of the mean difference between the two treatment groups will be estimated for both 
FAS and PPS with a narrower pre-defined equivalence margin of [-10%, 10%] as a sensitivity analysis. For 
those subjects who drop out of the study prematurely, a multiple imputation will be used with the assumption 
of monotone missing pattern and regression method for FAS under the missing at random assumption. 
Complete case analysis will also be performed for FAS. 
As the secondary efficacy endpoints, PGA, PASI50, PASI75, PASI90 response rate, percentage change from 
baseline in PASI, and change from baseline in DLQI will be summarised by treatment group and visit for the 
FAS and PPS. 
Safety Analyses 


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Name of Sponsor/Company: 
Samsung Bioepis Co., Ltd. 
Name of Finished Product: 
SB17 (proposed ustekinumab biosimilar) 
Name of Active Ingredient: 
Ustekinumab 
All reported terms for AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). 
All AEs, including SAEs, will be summarised descriptively by treatment group. No statistical test will be 
performed for AEs. 
A treatment-emergent AE (TEAE) will be defined as any AE with an onset date on or after the date of first dose 
of IP. AEs which are conditions or findings already present during the pre-treatment period but increase in 
severity during the treatment period will be considered as treatment-emergent. Pre-existing AEs before the 
treatment period with no increase in severity during the treatment period will not be considered as 
treatment-emergent. 
All AEs, TEAEs, SAEs, AEs of special interest (AESIs), and other AEs will be summarised by the number and 
percentage of subjects experiencing events by system organ class, preferred term, causality, and severity. All 
AEs including those existing during the pre-treatment period will be listed by subject. COVID-19 related AEs 
and SAEs in COVID-19 infected subjects will be summarised by treatment group to determine possible causal 
relationship with the IP, if needed. 
Changes in vital signs and clinical laboratory measurements parameters will be summarised descriptively by 
treatment group and visit. Other safety variables will be summarised descriptively by treatment group and visit 
and listed. 
PK Analyses 
Descriptive statistics will be used to summarise serum drug concentration by treatment group and visit and 
listed for the PK Analysis Set (PKS). 
Immunogenicity Analyses 
The incidence of ADAs and NAbs will be summarised by treatment group and visit and listed. 
Sample Size Calculation 
Approximately 464 subjects will be randomised into the study with a 1:1 ratio. 
A statistical equivalence margin is obtained by fixed-effects meta-analysis of five randomised controlled studies 
of ustekinumab, which estimates a risk difference of 
with a 
 An 
equivalence limit of 
is statistically calculated to preserve 
of the effect of ustekinumab over and above 
placebo, but a clinical equivalence margin of [-15%, 15%] was set for the comparison with the 95% CI of the 
mean difference in the percent change from baseline in PASI at Week 12. 
Based on this equivalence margin, a sample size of 192 subjects per treatment group was calculated with the 
assumptions of common standard deviation (SD) of 31.11, 10% loss from the primary analysis and 
approximately 100 remainders per treatment group after transition at the overall 5% significance level, 
providing over 90% power. Overall 464 subjects (232 per treatment group) will be randomised into the study 
to determine equivalence of percent change from baseline in PASI at Week 12. 
The equivalence margin for the comparison with the 90% CI of the difference in the percent change from 
baseline in PASI at Week 12 will be [-10%, 10%] by the agency recommendation. 
Based on this equivalence margin, a sample size of 169 subjects per treatment group was calculated with the 
assumption of the common SD of 31.11 at the overall 10% significance level, providing 80% power. Overall 
338 subjects (169 per treatment group) will be randomised into the study to determine equivalence of percent 
change from baseline in PASI at Week 12. 
Therefore, the sample size of 464 allows enough power to detect the equivalence in both situations. 
CCI
CCI
CCI
CCI


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GRAPHICAL STUDY DESIGN AND SCHEDULE OF ACTIVITIES 
 
Figure 1. Graphical Study Design 
F/U = Follow-up; ICF = Informed Consent Form; PASI = Psoriasis Area and Severity Index; PGA = Physician’s Global Assessment; ® = Randomisation 
1. Screening will be done within 4 weeks prior to Randomisation. 
2. Informed consent should be obtained prior to any study related procedures. 
3. SB17 or Stelara® 45mg at Week 0, 4, and then every 12 weeks up to Week 40. If the subject becomes > 100 kg at subsequent dosing visits the subject will receive 90 mg in the form of two 
doses of 45 mg. 
4. The primary endpoint (percent change from baseline in PASI) is assessed at Week 12. 
5. At Week 28 subjects who achieved a PASI50 response and are considered eligible will enter the transition period. Subjects receiving Stelara® will be randomised in a 1:1 ratio to either 
continue to receive Stelara® or be transitioned to SB17. Subjects receiving SB17 will continue to receive SB17 up to Week 40, but they will also follow the randomisation procedure in order 
to maintain blinding. 
 




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Investigational product; PASI = Psoriasis Area and Severity Index; PGA = Physician’s Global Assessment; PK = Pharmacokinetic(s); TB = Tuberculosis 
1. Informed consent must be obtained prior to any study related procedures. 
2. Medical history includes menopausal status, clinically significant diseases, surgical procedures, and lifestyle measures (smoking and alcohol). 
3. Complete physical examination at Screening visit; abbreviated physical examination at subsequent visits (the abbreviated physical examination must include general appearance, cardiovascular, 
respiratory systems, and abdomen; other body systems to be examined at the discretion of the Investigator). The result for physical examinations must be confirmed by the Investigator. 
4. Body weight will be measured at Screening and every visit (recommended to be done after overnight fasting state) but height will be measured only at Screening. 
5. Vital signs include blood pressure (BP), pulse rate, and body temperature. 
6. If TB is suspected at any point during the study, a chest X-ray and QuantiFERON®-Gold Plus test should be performed and the Sponsor should be informed. 
7. Previous and concomitant medication or therapy at Screening and concomitant medication or therapy only at visits until Week 52 or ET (visit or safety follow-up phone call, if done). 
Medications before randomisation should be reported as much to ensure eligibility. All ongoing medications at Randomisation should be reported. 
8. AEs will be collected from the time of signing the informed consent (even if this is prior to IP administration) until Week 52 or ET (visit or safety follow-up phone call, if done). 
9. Virology screening will be performed at Screening only. HBV (HBsAg, HBcAb), HCV (HCV antibody [HCV Ab]), and HIV (HIV antibody [HIV Ab]) will be tested. Those who are HCV Ab 
positive will be tested for HCV RNA. Subjects who are HIV Ab positive will do a confirmatory HIV RNA test. 
10. If the QuantiFERON®-Gold Plus test is indeterminate, one retest should be done. If the follow-up test is still indeterminate, the subject will be screen failed. Retests are not allowed for 
positive tests. 
11. Serum pregnancy test should be performed at Screening for women of childbearing potential. For women with amenorrhea of at least 12 months without an alternative medical cause, serum 
FSH test should be performed at Screening. From Randomisation, a urine pregnancy test will be performed and must be negative before each IP administration. Additional pregnancy test(s) 
may be performed besides the schedule after Randomisation at the Investigator’s discretion. 
12. Blood and urine samples for clinical laboratory test will be collected at Screening, Week 12, and 52 (or ET visit), and prior to IP administration at Week 0, 4, 16, 28, and 40. 
 Haematology: Haemoglobin, haematocrit, platelet count, white blood cell count (total and differential); 
 Chemistry: Sodium, potassium, calcium, phosphorus, creatinine, glucose, total bilirubin, albumin, ALT, AST, alkaline phosphatase (ALP), C-reactive protein (CRP); 
 Urinalysis (dipstick): Protein, blood, leucocytes, nitrite, glucose, ketone, pH, specific gravity, bilirubin, urobilinogen 
13. For PK subgroup only (approximately 140 subjects), blood samples for PK analysis will be collected at Week 2, 8, and 12, and prior to IP administration at Week 0, 4, 16, and 28. 
14. Blood samples for immunogenicity will be collected at Week 8, 12, and 52 (or ET visit) and prior to IP administration at Week 0, 4, 16, 28, and 40. 
15. At Week 28, subjects who achieved PASI50 response and are considered eligible will enter the transition period. Subjects who are receiving Stelara® will be re-randomised in a 1:1 ratio to 
either continue to receive Stelara® or be transitioned to SB17. Subjects who are receiving SB17 will continue to receive SB17 up to Week 40 but they will also follow the randomisation 
procedure in order to maintain blinding.  
16. Subjects who prematurely discontinue from the study at any time post 1st IP administration will be required to have an ET visit. ET visit will be performed at 12 weeks from the last IP 
administration. If ET visit happens to occur before 11 weeks, a phone call for safety follow-up will be performed at 12 weeks (± 7 days) from the last IP administration. 


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LIST OF ABBREVIATIONS 
 
ADA 
Anti-drug antibody 
AE 
Adverse event 
AESI 
Adverse event of special interest 
ALP 
Alkaline phosphatase 
ALT 
Alanine transaminase 
AST 
Aspartate transaminase 
BCG 
Bacille Calmette-Guerin 
BP 
Blood pressure 
BSA 
Body surface area 
CHO 
Chinese Hamster Ovary 
CI 
Confidence interval 
COVID-19 
Coronavirus Disease 2019 
CRO 
Contract research organisation 
CRP 
C-reactive protein 
CSR 
Clinical study report 
DBP 
Diastolic blood pressure 
DLQI 
Dermatology Life Quality Index 
DMARD 
Disease-modifying anti-rheumatic drug 
DNA 
Deoxyribonucleic acid 
DSMB 
Data and Safety Monitoring Board 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EMA 
European Medicine Agency 
EOS 
End of the study 
ET 
Early termination 
EU 
European Union 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
FSH 
Follicle stimulating hormone 
 


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GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practice 
HBcAb 
Hepatitis B core antibody 
HBsAg 
Hepatitis B surface antigen 
HBV 
Hepatitis B virus 
HCV 
Hepatitis C virus 
HCV Ab 
Hepatitis C virus antibody 
HIV 
Human immunodeficiency virus  
HIV Ab 
Human immunodeficiency virus antibody 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
ICH 
International Council for Harmonization 
IEC 
Independent Ethics Committee 
IL 
Interleukin 
IP 
Investigational product 
IRB 
Institutional Review Board 
IWRS 
Interactive Web Response System 
JAK 
Janus kinase 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRHD 
Maximum recommended human subcutaneous dose 
MTX 
Methotrexate 
NAb 
Neutralising antibody 
NYHA 
New York Heart Association 
PASI 
Psoriasis Area and Severity Index 
PD 
Protocol deviation 
PFS 
Pre-filled syringe 
PGA 
Physician’s Global Assessment 
PK 
Pharmacokinetic(s) 
PKS 
Pharmacokinetic Analysis Set 
PPS 
Per-Protocol Set 
PUVA 
Psoralen and ultraviolet A 


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QOL 
Quality of life 
RAN 
Randomised Set 
RNA 
Ribonucleic acid 
RPLS 
Reversible Posterior Leukoencephalopathy Syndrome 
SAE 
Serious adverse event 
SAF 
Safety Set 
SAP 
Statistical analysis plan 
SARS-CoV-2 
Severe acute respiratory syndrome coronavirus 2 
SBP 
Systolic blood pressure 
SD 
Standard deviation 
SmPC 
Summary of Product Characteristics 
SOP 
Standard operating procedure 
SVR 
Sustained virologic response 
TB 
Tuberculosis 
TEAE 
Treatment-emergent adverse event 
TNF 
Tumour necrosis factor 
TOST 
Two one-sided equivalence tests 
ULN 
Upper limit of normal 
US 
United States of America 
UV 
Ultraviolet 
UVB 
Ultraviolet B 
WHO 
World Health Organization 
 
 
 


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TABLE OF CONTENTS 
SYNOPSIS ............................................................................................................................................. 2 
GRAPHICAL STUDY DESIGN AND SCHEDULE OF ACTIVITIES ........................................ 10 
LIST OF ABBREVIATIONS .......................................................................................................... 13 
TABLE OF CONTENTS .................................................................................................................. 16 
LIST OF TABLES ............................................................................................................................ 21 
LIST OF FIGURES .......................................................................................................................... 21 
LIST OF STUDY STAFF ................................................................................................................ 22 
1. INTRODUCTION ........................................................................................................................... 23 
1.1. Background ................................................................................................................................ 23 
 Background to Coronavirus Disease-2019 .......................................................................... 23 
1.2. Overview of SB17 ...................................................................................................................... 24 
 Non-Clinical Studies of SB17 ............................................................................................. 24 
1.3. Comparator Investigational Product: Stelara® ............................................................................ 24 
 Non-Clinical Data of Reference Product ............................................................................. 24 
 Clinical Data of Reference Product in Psoriasis .................................................................. 25 
1.4. Study Rationale .......................................................................................................................... 25 
1.5. Risk and Benefit Assessment ..................................................................................................... 26 
 Known Potential Risks ........................................................................................................ 26 
 Known Potential Benefits .................................................................................................... 26 
 Assessment of Potential Risks and Benefits ........................................................................ 26 
2. STUDY OBJECTIVES AND ENDPOINTS ................................................................................. 27 
2.1. Study Objectives......................................................................................................................... 27 
 Primary Objective ................................................................................................................ 27 
 Secondary Objectives .......................................................................................................... 27 
2.2. Study Endpoints ......................................................................................................................... 27 
 Primary Endpoint ................................................................................................................. 27 
 Secondary Endpoints ........................................................................................................... 27 
3. STUDY DESIGN ............................................................................................................................. 28 
3.1. Overview of Study Design ......................................................................................................... 28 
3.2. Rationale for Study Design ........................................................................................................ 28 
 Scientific Rationale for Study Design ................................................................................. 28 


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 Rationale for Dose Selection ............................................................................................... 29 
 Rationale for Pharmacokinetic Assessments ....................................................................... 29 
 Rationale for Immunogenicity Assessments ........................................................................ 29 
3.3. Duration of Study Participation .................................................................................................. 29 
3.4. Number of Subjects .................................................................................................................... 29 
3.5. End of Study Definition ............................................................................................................. 29 
4. STUDY POPULATION .................................................................................................................. 30 
4.1. Overview .................................................................................................................................... 30 
4.2. Inclusion Criteria for Main Period ............................................................................................. 30 
4.3. Exclusion Criteria for Main Period ............................................................................................ 31 
4.4. Eligibility Criteria for Transition Period .................................................................................... 34 
 Inclusion criteria .................................................................................................................. 34 
 Exclusion Criteria for Transition Period .............................................................................. 34 
4.5. Lifestyle Considerations ............................................................................................................. 34 
4.6. Screen Failures, Retesting, and Rescreening .............................................................................. 35 
 Screen Failures..................................................................................................................... 35 
 Retesting .............................................................................................................................. 35 
 Rescreening.......................................................................................................................... 35 
4.7. Replacement ............................................................................................................................... 35 
5. TREATMENT AND INVESTIGATIONAL PRODUCT ............................................................ 35 
5.1. Treatment of the Subjects ........................................................................................................... 35 
 Dosing and Treatment Schedule .......................................................................................... 35 
 Assignment of Subjects to Treatment Group ....................................................................... 36 
 Blinding ............................................................................................................................... 36 
5.2. Investigational Product ............................................................................................................... 36 
 Identity of Investigational Product ...................................................................................... 36 
 Formulation, Packaging, and Labelling ............................................................................... 36 
 Product Storage and Stability .............................................................................................. 37 
 Preparation and Administration of Investigational Products ............................................... 37 
 Treatment Compliance and Investigational Product Accountability.................................... 37 
5.3. Concomitant Medication or Treatment ....................................................................................... 38 


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 Permitted Concomitant Medications or Treatment .............................................................. 38 
 Prohibited Concomitant Medications or Treatment ............................................................. 38 
 Rescue Medications ............................................................................................................. 39 
6. STUDY ASSESSMENT .................................................................................................................. 40 
6.1. Efficacy Assessment ................................................................................................................... 40 
 Psoriasis Area Severity Index .............................................................................................. 40 
 Physician’s Global Assessment ........................................................................................... 41 
 Dermatology Life Quality Index.......................................................................................... 42 
6.2. Safety Assessment ...................................................................................................................... 42 
 Adverse Events .................................................................................................................... 42 
 Clinical Laboratory Evaluations .......................................................................................... 42 
 Physical Examination .......................................................................................................... 43 
 Twelve-lead Electrocardiogram ........................................................................................... 44 
 Vital Signs ............................................................................................................................ 44 
 Chest X-ray .......................................................................................................................... 44 
 Tuberculosis Evaluation ....................................................................................................... 44 
 Pregnancy Test and Follicle Stimulating Hormone Test ...................................................... 45 
6.3. Other Assessments ...................................................................................................................... 45 
 Pharmacokinetic Assessment ............................................................................................... 45 
 Immunogenicity Assessment ............................................................................................... 46 
7. STUDY PROCEDURES ................................................................................................................. 46 
7.1. Study Flow and Visit Schedule ................................................................................................... 46 
 Screening Visit ..................................................................................................................... 46 
 Treatment Period .................................................................................................................. 47 
 Early Termination ................................................................................................................ 53 
 Unscheduled visit................................................................................................................. 53 
7.2. Discontinuation .......................................................................................................................... 54 
 Subject Discontinuation ....................................................................................................... 54 
 Discontinuation of Study Sites ............................................................................................ 55 
 Lost to Follow-up ................................................................................................................ 55 
 Discontinuation of the Study ............................................................................................... 55 


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8. SAFETY MONITORING AND REPORTING ............................................................................ 55 
8.1. Adverse Events ........................................................................................................................... 55 
 Definition of Adverse Event ................................................................................................ 55 
 Period of Observation for Adverse Events .......................................................................... 56 
 Reporting Adverse Events ................................................................................................... 57 
 Severity Assessment ............................................................................................................ 57 
 Causality Assessment ........................................................................................................... 57 
 Expectedness Assessment .................................................................................................... 57 
 Withdrawal due to Adverse Events ...................................................................................... 57 
8.2. Serious Adverse Events .............................................................................................................. 58 
 Definition of Serious Adverse Event ................................................................................... 58 
 Reporting Serious Adverse Events ...................................................................................... 59 
8.3. Adverse Events of Special Interest ............................................................................................. 59 
 Hypersensitivity ................................................................................................................... 60 
 Infections ............................................................................................................................. 60 
 Pulmonary Events ................................................................................................................ 60 
 Injection Site Reaction ......................................................................................................... 60 
8.4. Pregnancy ................................................................................................................................... 60 
8.5. Emergency or Accidental Unblinding of Assigned Treatment ................................................... 61 
8.6. Independent Data and Safety Monitoring Board ........................................................................ 61 
9. STATISTICAL METHODS AND DATA ANALYSIS .................................................................. 61 
9.1. Statistical Hypotheses................................................................................................................. 62 
9.2. Analysis Sets .............................................................................................................................. 62 
9.3. Subject Demographic and Baseline Characteristics ................................................................... 62 
9.4. Analysis of the Primary Objective .............................................................................................. 63 
9.5. Analysis of the Secondary Objectives ........................................................................................ 63 
 Efficacy Variable Analyses .................................................................................................. 63 
 Safety Analyses .................................................................................................................... 63 
 Pharmacokinetic Analyses ................................................................................................... 64 
 Immunogenicity Analyses ................................................................................................... 64 
9.6. Sample Size Calculations ........................................................................................................... 64 


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10. DATA COLLECTION AND MANAGEMENT ......................................................................... 65 
10.1. Data Confidentiality ................................................................................................................. 65 
10.2. Monitoring ................................................................................................................................ 65 
10.3. Data Handling and Record Keeping ......................................................................................... 66 
10.4. Future Use of Stored Specimens and Data ............................................................................... 66 
10.5. Database Management and Coding .......................................................................................... 66 
10.6. Quality Control and Quality Assurance .................................................................................... 67 
10.7. Protocol Deviation .................................................................................................................... 67 
11. ETHICS CONSIDERATIONS AND ADMINISTRATIVE PROCEDURES .......................... 67 
11.1. Institutional Review Boards and Independent Ethics Committees ........................................... 67 
11.2. Ethical Conduct of the Study .................................................................................................... 67 
11.3. Subject Information and Informed Consent ............................................................................. 68 
11.4. Investigator Information ........................................................................................................... 68 
 Investigator Obligations ..................................................................................................... 68 
 Coordinating Investigator .................................................................................................. 68 
 Training of Investigator Site Personnel ............................................................................. 68 
 Protocol Signatures ............................................................................................................ 68 
 Financing and Insurance .................................................................................................... 68 
12. PUBLICATION POLICY ............................................................................................................ 69 
13. REFERENCES .............................................................................................................................. 70 
APPENDIX I. DERMATOLOGY LIFE QUALITY INDEX QUESTIONNAIRE ....................... 72 
PROTOCOL SIGNATURE PAGES.................................................................................................. 73 
CHANGE HISTORY OF PROTOCOL AMENDMENT ................................................................ 75 
Amendment 1: Version 2.0, Feb 15, 2021 ......................................................................................... 75 
 
 


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LIST OF TABLES 
Table 1. Schedule of Activities ............................................................................................................. 11 
Table 2. Investigation Product Description .......................................................................................... 36 
Table 3. Prohibited Medications prior to Randomisation and throughout the Study............................ 38 
Table 4. Prohibited Corticosteroids prior to Randomisation and throughout the Study ....................... 39 
Table 5. Parameters for Clinical Laboratory Tests ............................................................................... 42 
Table 6. Percent Change from Baseline in PASI at Week 12 from Reference Studies ......................... 64 
 
LIST OF FIGURES 
Figure 1. Graphical Study Design ........................................................................................................ 10 
 
 
 


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LIST OF STUDY STAFF 
 
SPONSOR: 
Samsung Bioepis Co., Ltd. 
76, Songdogyoyuk-ro, Yeonsu-gu, 
Incheon, 21987 
Republic of Korea 
 
Clinical Project Manager  
 
 
 
 
Clinical Development Lead 
 
 
 
 
Clinical Research Scientist 
 
 
 
 
Statistician 
 
 
 
 
Safety Physician 
  
 
 
 
Project Safety Lead 
 
 
 
 
 
PPD
PPD
PPD
PPD
PPD
PPD


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1. Introduction 
 Background 
Plaque psoriasis is a chronic immune-mediated inflammatory disease with predominantly skin and joint 
manifestations affecting approximately 2-3% of the population. Psoriasis can occur at any age, and is 
most common in the age group 50-69. The reported prevalence of psoriasis in countries ranges between 
0.09% and 11.4%, making psoriasis a serious global problem [1]. 
The major manifestation of psoriasis is chronic inflammation of the skin. It is characterised by 
disfiguring, thick, scaly, erythematous plaques that may be painful or often severely pruritic and may 
cause significant quality of life (QOL) issues. Psoriasis is a chronic disease that waxes and wanes during 
a patient’s lifetime, and is often modified by treatment initiation and cessation and has few spontaneous 
remissions [2]. Before biologics, psoriasis was treated with topical steroids, or when severe, systemic 
agents such as methotrexate (MTX), cyclosporin, or psoralen and ultraviolet A (PUVA). However, such 
treatments were limited by liver or renal toxicity or risk of skin cancers. Tumour necrosis factor (TNF) 
antagonists changed the landscape of systemic treatment but also have significant toxicities such as 
serious infections and activation of tuberculosis (TB). 
The interleukin (IL)-23 pathway is central to the pathogenesis of psoriasis. Stelara® (ustekinumab) is 
an IL12/23 inhibitor indicated for the treatment of moderate to severe plaque psoriasis in adults who 
failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies 
including cyclosporine, MTX, or PUVA [3]. The recommended doses of Stelara® for psoriasis is 45 mg 
administered via subcutaneous injection at Weeks 0 and 4, then every 12 weeks thereafter. A dose of 90 
mg may be used in patients with a body weight greater than 100 kg [4]. Stelara® has a longer dose 
interval, that may be favourable for patient compliance, and has a better efficacy profile compared with 
TNF inhibitors and is a significant treatment for psoriasis management [5]. A biosimilar is a biological 
medicine highly similar to another already approved biological medicine (the 'reference medicine') [6]. 
Biosimilars have the potential to increase accessibility of biologics to a wider patient population. 
 Background to Coronavirus Disease-2019 
There is currently an outbreak of respiratory disease, Coronavirus Disease 2019 (COVID-19), caused 
by a novel virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that was first 
detected in Wuhan City, Hubei Province, China in 2019. This new virus has rapidly spread across the 
globe, causing the World Health Organization (WHO) to declare a pandemic situation on March 12, 
2020. The countermeasures initiated by national and local governments worldwide and the 
recommendations issued by the health authorities have impacted current and new clinical studies. As 
the threat of pandemic burden, including new outbreaks, locally or globally, will impact the further 
conduct of clinical studies, appropriate risk assessments and mitigation measures will need to be taken 
into consideration in all clinical studies to protect subjects, site staff, and society as a whole. 
Both the European Medicine Agency (EMA) [7] and the United States of America (US) Food and Drug 
Administration (FDA) [8], as well as national health authorities in Europe, have issued new guidelines 
that aim to provide recommendations for actions for conduct of clinical studies of medical products 
during COVID-19 pandemic. Since the pandemic situation is evolving, guidelines, recommendations, 
national laws, and local restrictions may change at a high pace. Given the circumstances of a potentially 
relapsing pandemic or epidemic situation with regard to the spread of COVID-19 in the future, special 
attention will be paid to protect subjects participating in the study and site staff involved in the 
investigations against infection with SARS-CoV-2 in accordance to such guidance. 


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 Overview of SB17 
SB17 has been developed as a similar biological medicinal product to Stelara® having ustekinumab as 
the active substance. Stelara® is currently indicated for plaque psoriasis, paediatric plaque psoriasis, 
psoriatic arthritis, Crohn’s disease, and ulcerative colitis [3, 9]. 
SB17 is produced by recombinant deoxyribonucleic acid (DNA) technology. SB17 is manufactured by 
suspension culture of Chinese Hamster Ovary (CHO) mammalian cells and purified by several steps 
including specific viral inactivation and removal procedures. 
According to the guideline International Council for Harmonization (ICH) Q6B, characterisation of a 
biological therapeutic must involve its physicochemical properties, biological activities, purity, 
impurities, and quantity. The characterisation study will employ the ‘state-of-the-art’ analytical methods 
in order to investigate the primary, secondary, and higher-order structures, as well as the 
post-translational modifications, structural heterogeneity, charge variants, purity, and biological 
activities. 
 Non-Clinical Studies of SB17 
As outlined in the “Guideline on similar biological medicinal products containing biotechnology-
derived proteins as active substance: non-clinical and clinical issues” [10], a risk-based approach was 
taken to the non-clinical evaluation of SB17. A series of in vitro biologic activity studies have been 
performed in order to demonstrate non-clinical similarity between SB17 and Stelara®. As a result, 
observation from above studies has established solid non-clinical evidence of similarity, and therefore 
in vivo studies were thought to be not required in line with the guideline. Also, non-clinical safety 
pharmacology, reproductive and developmental toxicity, and carcinogenicity studies were not 
performed, as they are not required for non-clinical testing of biosimilars as outlined in the guideline 
[10]. 
 Comparator Investigational Product: Stelara® 
 Non-Clinical Data of Reference Product  
Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of Stelara®. 
Published literature showed that administration of murine IL-12 caused an antitumor effect in mice that 
contained transplanted tumours and IL-12/IL-23p40 knockout mice or mice treated with 
anti-IL-12/IL-23p40 antibody had decreased host defence to tumours. Mice genetically manipulated to 
be deficient in both IL-12 and IL-23 or IL-12 alone developed ultraviolet (UV)-induced skin cancers 
earlier and more frequently compared to wild-type mice. The relevance of these experimental findings 
in mouse models for malignancy risk in humans is unknown. 
No effects on fertility were observed in male cynomolgus monkeys that were administered ustekinumab 
at subcutaneous doses up to 45 mg/kg twice weekly (45 times the maximum recommended human 
subcutaneous dose [MRHD] on a mg/kg basis) prior to and during the mating period. However, fertility 
and pregnancy outcomes were not evaluated in mated females. 
No effects on fertility were observed in female mice that were administered an analogous 
IL-12/IL-23p40 antibody by subcutaneous administration at doses up to 50 mg/kg, twice weekly, prior 
to and during early pregnancy. 
In a 26-week toxicology study, one out of 10 monkeys subcutaneously administered 45 mg/kg 
ustekinumab twice weekly for 26 weeks had a bacterial infection [9]. 


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 Clinical Data of Reference Product in Psoriasis 
Two multicentre, randomised, double-blind, placebo-controlled studies (PHOENIX 1 and PHOENIX 2) 
enrolled a total of 1,996 subjects 18 years of age and older with plaque psoriasis who had a minimum 
body surface area (BSA) involvement of 10%, and Psoriasis Area and Severity Index (PASI) score ≥ 12, 
and who were candidates for phototherapy or systemic therapy. Subjects with guttate, erythrodermic, 
or pustular psoriasis were excluded from the studies [3]. 
PHOENIX 1 enrolled 766 subjects and PHOENIX 2 enrolled 1,230 subjects [11, 12]. The studies had 
the same design through Week 28. In both studies, subjects were randomised in equal proportion to 
placebo, 45 mg or 90 mg of Stelara®. Subjects randomized to Stelara® received 45 mg or 90 mg doses, 
regardless of weight, at Weeks 0, 4, and 16. Subjects randomised to receive placebo at Weeks 0 and 4 
crossed over to receive Stelara® (either 45 mg or 90 mg) at Weeks 12 and 16. In both studies, the 
endpoints were the proportion of subjects who achieved at least a 75% reduction in PASI score (PASI75) 
from baseline to Week 12 and treatment success (cleared or minimal) on the Physician’s Global 
Assessment (PGA). The PGA is a 6-category scale ranging from 0 (cleared) to 5 (severe) that indicates 
the physician’s overall assessment of psoriasis focusing on plaque thickness/induration, erythema, and 
scaling. 
In both studies, subjects in all treatment groups had a median baseline PASI score ranging from 
approximately 17 to 18. Baseline PGA score was marked or severe in 44% of subjects in PHOENIX 1 
and 40% of subjects in PHOENIX 2. Approximately two-thirds of all subjects had received prior 
phototherapy, 69% had received either prior conventional systemic or biologic therapy for the treatment 
of psoriasis, with 56% receiving prior conventional systemic therapy and 43% receiving prior biologic 
therapy. A total of 28% of subjects had a history of psoriatic arthritis. 
Examination of age, gender, and race subgroups did not identify differences in response to Stelara® 
among these subgroups. 
In subjects who weighed 100 kg or less, response rates were similar with both the 45 mg and 90 mg 
doses; however, in subjects who weighed greater than 100 kg, higher response rates were seen with 90 
mg dosing compared with 45 mg dosing. 
Subjects in PHOENIX 1 who were PASI75 responders at both Weeks 28 and 40 were re-randomised at 
Week 40 to either continued dosing of Stelara® (Stelara® at Week 40) or to withdrawal of therapy 
(placebo at Week 40). At Week 52, 89% (144/162) of subjects re-randomised to Stelara® treatment 
achieved PASI75 compared with 63% (100/159) of 24 subjects re-randomised to placebo (treatment 
withdrawal after Week 28 dose). The median time to loss of PASI75 response among the subjects 
randomised to treatment withdrawal was 16 weeks [9]. 
The PSOLAR study found no increased risk of malignancy associated with Stelara® use in humans [13]. 
 Study Rationale 
A biosimilar is a biological medicinal product that is highly similar to an already authorised original 
biological medicinal product (reference medicinal product) in terms of quality, tolerability, and efficacy 
based on a comprehensive comparability exercise [10, 14]. The EMA and the US FDA have developed 
specific guidelines for a biologic drug to be approved as a biosimilar [14, 15]. These guidelines 
recommend a stepwise approach in developing a biosimilar starting with extensive physicochemical 
and biological characterisation before initiating clinical studies for the comparison of the efficacy, 
tolerability, pharmacokinetic (PK) properties, and immunogenicity of the biosimilar. The purpose of 
this study is to demonstrate the equivalence in efficacy of SB17 compared to Stelara® and to evaluate 
the safety and immunogenicity in subjects with moderate to severe plaque psoriasis. In addition, 


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systemic exposure of SB17 to Stelara® will also be evaluated in subjects participating in PK evaluation. 
 Risk and Benefit Assessment 
 Known Potential Risks 
According to the European Union (EU) Stelara® Summary of Product Characteristics (SmPC), the most 
common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohn’s 
disease, and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis and headache. 
Most were considered to be mild and did not necessitate discontinuation of study treatment. The most 
serious adverse reaction that has been reported was serious hypersensitivity reactions including 
anaphylaxis. Specific safety precautions include infections, TB, malignancies, systemic and respiratory 
hypersensitivity reactions, and serious skin conditions such as exfoliative dermatitis. The overall safety 
profile was similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. 
In order to ensure the safety of subjects who participate in the study, specific conditions such as TB, 
malignancy, and history of certain pulmonary or cutaneous conditions are excluded from enrolment, 
and the subjects should be instructed to report their symptoms related to adverse events of special 
interest (AESIs) in Section 8.3 without delay and should be managed appropriately. 
Participation in clinical study may require more frequent visits than usual medical practice, thus, 
additional risk under the COVID-19 should be considered, if needed. The Sponsor will consider whether 
to start, continue, temporarily halt, or close the study at some or all clinical study sites based on the risk 
assessment with relevant parties’ input on an ongoing basis. 
This study will take place at multicentre clinical sites with accessible medical facilities which will allow 
immediate treatment of medical emergencies including systemic hypersensitivity. All study related 
procedures will be conducted by medical staffs with appropriate level of training and expertise and an 
understanding of the investigational products (IPs), its target, and mechanism of action. An independent 
Data and Safety Monitoring Board (DSMB) will convene at pre-specified intervals to conduct interim 
monitoring of accumulating safety data. Following each data review, the DSMB will make 
recommendations regarding the conduct of the study, including continuation of the study without 
modifications, modification of the protocol, pausing of subject enrolment until the resolution of an issue, 
or termination of the study for safety reasons. 
 Known Potential Benefits 
Stelara® binds and subsequently inhibits the bioactivity of the human cytokines IL-12 and IL-23. Thus, 
Stelara® prevents abnormal regulation of IL-12 and IL-23 associated with immune mediated diseases, 
such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. 
The efficacy of Stelara® in PASI and PGA scores was statistically significant in plaque psoriasis after 
12 weeks of treatment. The proportion of patients achieving PASI75 response at Week 12 was 72.2% 
and 65% on 45 mg and 90 mg, respectively. Approximately 35 to 50% of subjects achieved a PASI90 
response at Week 12. Similar efficacy was observed when efficacy was assessed using the PGA. 
Although clinical data is currently unavailable, as a proposed ustekinumab biosimilar, SB17 is expected 
to have similar clinical outcome to Stelara® based on the physicochemical and biological similarity. 
Therefore, all subjects who participate in this study would be expected to enjoy similar clinical benefits 
anticipated for Stelara® treatment. 
 Assessment of Potential Risks and Benefits 
The available data demonstrate a high degree of physicochemical and biological similarity of SB17 


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with the reference medicinal product (Stelara®). The suitability of the methodology employed to 
evaluate the similarity of SB17 and Stelara® in a pharmaceutical setting were confirmed by EMA and 
the US FDA. The known and potential risks of receiving SB17 are expected to be similar to those seen 
with Stelara®. As Stelara® is an approved drug for psoriasis, and assuming SB17 having a similar 
risk/benefit profile to that of Stelara®, the risk/benefit balance of this study is expected to be favourable. 
In conclusion, sufficient evidence exists for the justification of the administration of SB17, as a similar 
biological medicinal product of Stelara®, to subjects with psoriasis. 
The study protocol provides adequate instructions for the detection and treatment of adverse events 
(AEs) arising following the administration of the IPs (SB17 or Stelara®). 
Risk assessment for the COVID-19 will be documented on an ongoing basis in relevant documents. The 
risk assessment and associated mitigation measures based on inputs from relevant stakeholders will be 
prioritised to consider the rights, safety, and wellbeing of the study subjects. 
2. Study Objectives and Endpoints 
Study Objectives
 Primary Objective 
The primary objective is to demonstrate the equivalence of SB17 to Stelara®, in terms of the percent 
change of baseline in PASI at Week 12 in subjects with moderate to severe plaque psoriasis. 
 Secondary Objectives 
The secondary objectives are: 

To evaluate the efficacy of SB17 compared to Stelara®
-
Percent change from baseline in PASI other than Week 12
-
PGA
-
PASI50, PASI75, and PASI90 response rate
-
Change from baseline in Dermatology Life Quality Index (DLQI) 

To evaluate safety and tolerability of SB17 compared to Stelara® 

To evaluate the PK of SB17 compared to Stelara® in subjects participating in PK
evaluation

To evaluate the immunogenicity of SB17 compared to Stelara®

To evaluate safety and immunogenicity in subjects who transitioned to SB17 and who
maintained Stelara® at Week 28 for the transition period
 Study Endpoints 
 Primary Endpoint 

Percent change from baseline in PASI at Week 12
 Secondary Endpoints 
Efficacy Endpoints 


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 
PGA at Week 2, 4, 8, 12, 16, 20, 24, 28, 40, and 52 
 
PASI50, PASI75, and PASI90 response rate at Week 2, 4, 8, 12, 16, 20, 24, 28, 40, and 52 
 
Percent change from baseline in PASI at Week 2, 4, 8, 16, 20, 24, 28, 40, and 52 
 
Change from baseline in DLQI at Week 4, 12, 16, 28, 40, and 52 
Safety Endpoints 
 
Incidence of AEs 
 
Incidence of serious AEs (SAEs) 
 
Changes in vital signs and clinical laboratory parameters 
PK Endpoints 
 
Serum ustekinumab concentration at Week 0, 2, 4, 8, 12, 16, and 28 
Immunogenicity Endpoints 
 
Incidence of anti-drug antibodies (ADAs) at Week 0, 4, 8, 12, 16, 28, 40, and 52 
 
Incidence of neutralising antibodies (NAbs) at Week 0, 4, 8, 12, 16, 28, 40, and 52 
3. Study Design 
 Overview of Study Design 
This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, 
PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque 
psoriasis. 
Subjects will be randomised in a 1:1 ratio to receive either SB17 or Stelara® via subcutaneous injection. 
IPs (SB17 or Stelara®) will be administered at Week 0, 4, and then every 12 weeks up to Week 40, and 
the last assessment will be done at Week 52. 
At Week 28, subjects who achieved a PASI50 response and are considered eligible will enter the 
transition period. In the transition period, subjects receiving Stelara® will be randomised again in a 1:1 
ratio to either continue on Stelara® or be transitioned to SB17 up to Week 40. Subjects receiving SB17 
will continue to receive SB17 up to Week 40 but they will follow the randomisation procedure in order 
to maintain blinding. 
Screening period will be 4 weeks. IPs (SB17 or Stelara®) will be administered up to Week 40, and the 
last assessment will be done at Week 52. 
 Rationale for Study Design 
 Scientific Rationale for Study Design 
The purpose of this study is to demonstrate the equivalence in clinical efficacy of SB17 and Stelara® in 
subjects with psoriasis. 
According to EMA and FDA guideline, the study population should generally be representative of 
approved therapeutic indications of the reference product and be sensitive for detecting potential 
differences between the biosimilar and the reference product. For Stelara®, psoriasis is an indication 
approved by both EMA and the US FDA. Also, psoriasis population has the largest effect size which is 


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considered as sensitive, compared to other approved indications such as psoriatic arthritis, Crohn’s 
disease, and ulcerative colitis. Therefore, psoriasis population is selected for this study to assess the 
biosimilarity in efficacy, safety, and immunogenicity between SB17 and Stelara®. 
This study is a randomised, double-blind, and parallel group study for 52 weeks. And transition will be 
performed at Week 28 to investigate the clinical impact (safety and immunogenicity) of switching. 
 Rationale for Dose Selection 
The recommended dose of Stelara® for psoriasis is 45 mg administered via subcutaneous injection 
initially and 4 weeks later, followed by 45 mg every 12 weeks. A dose of 90 mg (in the form of 2 doses 
of 45 mg) may be used in subjects with a body weight being greater than 100 kg during the study. The 
primary analysis will be done with subjects ≤ 100 kg and receiving only 45 mg doses (see Section 9.4). 
Therefore, it is highly recommended to maintain a body weight of ≤ 100 kg. 
 Rationale for Pharmacokinetic Assessments 
A randomised, double-blind, three-arm, parallel group, single-dose Phase I comparative PK study will 
be conducted in healthy subjects to demonstrate similarity in PK profiles of SB17, EU sourced Stelara®, 
and US sourced Stelara®. However, that Phase I study is a single dose study, and to evaluate the PK 
profiles at steady state with repeated dose in a patient population, PK assessment in this Phase III study 
is considered necessary. The evaluation is a descriptive in nature and no hypothesis testing will be done. 
 Rationale for Immunogenicity Assessments 
Biological/biotechnology-derived proteins can induce an unwanted immune response that is triggered 
by more than a single factor and the consequence of immunogenicity may vary considerably, ranging 
from irrelevant to therapy to serious and life-threatening. Immune responses may affect both safety and 
effectiveness such as altering PK, inducing anaphylaxis, or promoting development of NAbs that 
neutralise that as well as its endogenous protein counterpart. 
Approximately 6 to 12.4% of subjects treated with Stelara® in psoriasis and psoriatic arthritis clinical 
studies developed antibodies to ustekinumab, which were generally low-titre. In psoriasis clinical 
studies, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab 
concentrations and reduced efficacy. In psoriasis studies, the majority of patients who were positive for 
antibodies to ustekinumab had NAbs. There is no apparent correlation between the presence of 
anti-ustekinumab antibodies and the occurrence of injection site reactions. 
For subject safety and for demonstrating biosimilarity, immunogenicity will be assessed in this study 
according to the recommended guideline [10, 14]. 
 Duration of Study Participation 
The duration of study participation will be 4 weeks of Screening and up to 52 weeks of study treatment 
period (including 24 weeks transition period) per subject. 
 Number of Subjects 
Approximately 464 subjects are planned to be randomised from approximately 70 sites for study 
duration. 
 End of Study Definition 
A subject is considered to have completed the study if he or she has completed all period of the study 


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including the last scheduled visit shown in Table 1. The end of the study (EOS) is defined as completion 
of the last subject’s Week 52 visit or the last activity (e.g., visit procedure or safety follow-up phone 
call) for early termination (ET) if the last subject prematurely discontinues the IP. 
4. Study Population 
 Overview 
The study population for this study is subjects with moderate to severe plaque psoriasis. Eligibility for 
participation in this study will be based on the inclusion/exclusion criteria. For exclusionary conditions 
to be assessed at Screening, if the subject or Investigator becomes aware of the condition occurring 
during the Screening period before Randomisation, it will be considered exclusionary. 
 Inclusion Criteria for Main Period 
Subjects must meet all of the following criteria to be eligible for the study: 
1. Aged 18 years or older at Screening (defined as the time of signing the informed consent 
form [ICF]). 
2. Have plaque psoriasis diagnosed at least 6 months prior to Screening, with or without 
psoriatic arthritis. 
3. Have plaque psoriasis at Screening and Randomisation with the involvement and severity 
defined as the following: 
a. 
Total affected BSA ≥ 10%. 
b. PASI score of ≥ 12. 
c. 
PGA score of ≥ 3 (moderate). 
4. Considered to be a candidate for phototherapy or systemic therapy for psoriasis at Screening. 
5. Be less than 95 kg of body weight at Screening and at Randomisation. 
6. Adequate haematological function at Screening defined as the following by central lab: 
a. 
White blood cell count ≥ 3.5 × 103 cells/μL (≥ 3.5 × 109 cells/L). 
b. Neutrophil count ≥ 1.5 × 103 cells/μL (≥ 1.5 × 109 cells/L). 
c. 
Haemoglobin ≥ 10 g/dL. 
d. Platelet count ≥ 125,000/mm3 (≥ 125 × 109/L). 
7. Adequate renal and hepatic function at Screening defined as the following by central lab: 
a. 
Serum creatinine < 1.5 × upper limit of normal (ULN). 
b. Serum alanine transaminase (ALT) and aspartate transaminase (AST) < 2 × ULN. 
8. Non-childbearing potential female (e.g., permanently sterilised, postmenopausal [defined as 
amenorrhea of at least 12 months without an alternative medical cause prior to Screening and 
a follicle stimulating hormone (FSH) level of > 40 IU/L at Screening]), OR childbearing 
potential female subjects or male subjects with their (respectively male or childbearing 
female) partners who agree to use at least two forms of appropriate contraception method 
(e.g., established use of oral, injected, intravaginal, transdermal, or implanted hormonal 


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contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, 
physical barrier [Note: female condom and male condom should not be used together]) from 
Screening until 15 weeks after the last dose of IP. Vasectomy alone will be allowed for male 
subjects and female subjects of childbearing potential with a sole vasectomised male partner. 
Vasectomised subjects or partners should be medically confirmed for sterilisation. True 
abstinence alone will be allowed if this is in line with the preferred and usual lifestyle of the 
subject, or for subjects who do not have a partner. 
9. Have provided informed consent and must be able to, in the opinion of the Investigator, 
understand the implications of taking part in the study and be willing to follow the study 
requirements. 
 Exclusion Criteria for Main Period 
Subjects meeting any of the following criteria are not eligible for the study: 
1. Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or 
drug-induced psoriasis at Screening. 
2. Have other skin disease than psoriasis that: 
a. 
Requires topical or systemic corticosteroid or other immunosuppressive therapy at 
Screening. 
b. May confound the efficacy evaluation per Investigator discretion at Screening. 
3. Have used biologics (any therapeutic monoclonal antibody or fusion receptor protein) such 
as; 
a. 
Any TNF inhibitors within the previous 6 months prior to Randomisation. 
b. Any IL-12 or IL-23 inhibitor biologics (including ustekinumab/ustekinumab 
biosimilars, guselkumab, tildrakizumab, or rizankizumab), IL-17 inhibitor (including 
secukinumab, ixekizumab, or brodalumab), rituximab, or integrin inhibitor biologics at 
any time prior to Randomisation. 
c. 
Other biologics within the longer of either 5 half-lives or 3 months prior to 
Randomisation. 
4. Known allergic reactions or hypersensitivity to ustekinumab or to any ingredients of Stelara® 
or SB17 at Screening. 
5. History of a systemic allergic reaction or hypersensitivity to prior biologic therapies at 
Screening. 
6. History of asthma that: 
a. 
Required intubation at any time prior to Screening. 
b. Required hospitalisation or 14 days or more of oral corticosteroids use (cumulatively) 
within 6 months prior to Randomisation. 
c. 
Requires oral corticosteroids or considered to be corticosteroid-dependent in the 
opinion of the Investigator at Randomisation. 


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7. History of exfoliative dermatitis, Reversible Posterior Leukoencephalopathy Syndrome 
(RPLS), facial palsy, allergic alveolitis, or non-infectious pneumonia including interstitial 
pneumonia, cryptogenic organizing pneumonia, or eosinophilic pneumonia, etc. at 
Screening. 
8. Have received phototherapy (including ultraviolet B [UVB], PUVA, or sunbaths/tanning 
beds, etc.) or conventional systemic therapy (including corticosteroids, MTX, calcineurin 
inhibitors, retinoids, vitamin D analogues, fumaric acid esters, apremilast, 6-thioguanine, 
hydroxyurea, etc.) for psoriasis within 4 weeks prior to Randomisation. 
9. Have received topical therapy for psoriasis (including corticosteroids, vitamin D analogues, 
retinoids, calcineurin inhibitors, coal tar, anthralin, urea, alpha-hydroxy acid, or salicylic 
acid, etc.) within 2 weeks prior to Randomisation. 
10. Have received any disease-modifying anti-rheumatic drugs (DMARDs), any systemic 
immunosuppressants (including those mentioned above in systemic psoriasis therapy, 
antimalarials, sulfasalazine, Janus kinase [JAK] inhibitors, gold, minocycline, azathioprine, 
6-mercaptopurine, mycophenolate mofetil, etc.) or any other injectable or enema 
corticosteroids, within 4 weeks prior to Randomisation (except for leflunomide: within 12 
weeks from Randomisation). 
11. Have received non-biologic IP from another study within 5 half-lives of that product prior to 
Randomisation or use of an investigational device at Randomisation. 
12. Women who are pregnant or nursing at Screening, or men and women planning pregnancy 
during the study period and until 15 weeks after the last dose of IP. 
13. Have received a live or live attenuated viral vaccine or a live bacterial vaccine (except 
Bacille Calmette-Guerin [BCG] vaccination) within 4 weeks prior to Randomisation or plan 
to do so within 15 weeks after the last dose of IP. For BCG vaccination, subjects who have 
received BCG within 12 months prior to Randomisation or plan to do so within 12 months 
after the last dose of IP. 
14. Have active or latent TB at Screening, by known history or any of the following: 
a. 
Positive QuantiFERON®-Gold Plus test. 
b. Positive chest X-ray findings (radiographs taken within 3 months prior to 
Randomisation with radiologist confirmation will be accepted) determined by a 
qualified physician such as radiologist or pulmonologist, including active TB, untreated 
or inadequately treated old, inactive or healed TB. 
c. 
By any other positive findings determined by TB specialist, including suggestive signs 
or symptoms of TB or recent close contact with active TB patients. 
15. History of ongoing infection or a positive test of hepatitis B virus (HBV, defined as hepatitis 
B surface antigen [HBsAg] positive or HBsAg negative and hepatitis B core antibody 
[HBcAb] positive), hepatitis C virus (HCV; for subjects who have previously received 
anti-HCV treatment must have a sustained virologic response [SVR] for at least 24 weeks 
post-treatment and no evidence of significant liver fibrosis [i.e., must be METAVIR F0 or 
F1] in addition to negative HCV-ribonucleic acid (RNA) at Screening to be eligible), or 
human immunodeficiency virus (HIV) infection, or any history of primary 
immunodeficiency at Screening. 


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16. History of sepsis (defined as a life-threatening organ dysfunction caused by infection), 
chronic or recurrent infection, conditions that require regular antibiotic prophylaxis (such as 
rheumatic heart disease), opportunistic, granulomatous (for TB, please see above), or 
invasive fungal infection at Screening. 
17. History of other bacterial, fungal, viral, parasitic, or helminthic infection requiring oral 
antimicrobial within 2 weeks prior to Randomisation or a serious infection (a bacterial, 
fungal, viral, parasitic, or helminthic infection that requires hospitalisation or treatment with 
parenteral antimicrobials) within 8 weeks prior to Randomisation. Other mild infections 
should be resolved before Randomisation. For COVID-19, please see below. 
18. History of lymphoproliferative disease or leukaemia at Screening. 
19. History of malignancy (except for squamous or basal cell carcinoma of the skin that has been 
treated and not recurred within 3 months prior to Screening, or surgically treated cervical 
carcinoma in situ) within the last 5 years prior to Screening. 
20. History of myocardial infarction, New York Heart Association (NYHA) III/IV congestive 
heart failure, or stroke within 12 months prior to Randomisation. 
21. Have uncontrolled hypertension (defined as systolic blood pressure [SBP] ≥ 160 mmHg or 
diastolic blood pressure [DBP] ≥ 100 mmHg confirmed after repeat measurement) at 
Screening. 
22. Have uncontrolled diabetes mellitus (defined as having history of diabetic peripheral 
neuropathy or diabetic foot, or otherwise considered uncontrolled in the opinion of the 
Investigator) at Screening. 
23. History of organ transplantation at Screening. 
24. Evidence of alcohol or substance abuse within the last 12 months prior to Screening. 
25. History of a major surgery in the opinion of the Investigator within 12 weeks prior to 
Randomisation or have a plan to do so during the study period. 
26. Have psychiatric disease at Screening defined as: 
a. 
Current uncontrolled mental disorder (including depression) in the opinion of the 
Investigator. 
b. History of suicidal attempts or ideation. 
c. 
Considered to be at risk of suicide in the opinion of the Investigator. 
27. Have other major organ dysfunction or failure such as liver cirrhosis, dialysis-dependent 
renal failure, any cardiopulmonary disease with functional disability of NYHA III/IV 
equivalent, aplastic anaemia or any other transfusion-dependent/stimulating factor dependent 
haematological disorders, or dementia at Screening. 
28. Considered to be at risk of progressive weight gain or widely fluctuating body weight, in the 
opinion of the Investigator, at Screening. 
29. History of COVID-19 as: 
a. 
History of asymptomatic, mild or moderate COVID-19 within 8 weeks prior to 
Randomisation. 


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b. Any history of severe or critical COVID-19, or hospitalisation due to COVID-19 at 
Randomisation. 
c. 
Any history of COVID-19 complications or sequalae including lung fibrosis, 
thromboembolism, cardiac, gastrointestinal, neuropsychiatric, ‘long COVID’, or 
dermatologic manifestations, etc. at Randomisation. 
Note: COVID-19 severity grade is according to WHO COVID-19 disease severity 
classification. Subjects who have suggestive signs or symptoms of COVID-19 must be 
evaluated and determined to be COVID-19 negative per local regulations before Screening. 
30. Have any other disease or disorder, that will put the subject at risk if they are enrolled, in the 
opinion of the Investigator, at Screening. 
31. Have poor venous access or unwillingness to undergo multiple venepuncture and blood 
sampling at Screening. 
 Eligibility Criteria for Transition Period 
 Inclusion criteria 
1. Achieve PASI50 response on Week 28 visit assessment. 
2. Willing to participate in the rest of study and able to follow the study procedure with the 
opinion of the Investigator. 
 Exclusion Criteria for Transition Period 
1. Subject is considered to be of increased risk when entered in the Transition Period, in the 
opinion of the Investigator. 
 Lifestyle Considerations 
During this study, subjects should: 
 
Refrain from exposure to UV rays, including sunbathing and suntanning (see 
Section 5.3.2). 
 
Avoid excessive alcohol consumption. 
 
While subjects who become > 100 kg will receive 90 mg in the form of two 45 mg doses, 
it is highly recommended not to become overweight and maintain a bodyweight of 100 kg 
or below. 
 
Subjects are advised to adhere to local requirements for reduction of the public COVID-19 
exposure while ambulatory. All subjects should self-assess whether they have any signs or 
symptoms consistent with COVID-19, and to check if they have had any contact with 
COVID-19 patients before visiting the clinical study site. If there are suspected signs or 
symptoms of COVID-19 or potential contact with COVID-19 patients, the subjects should 
not visit the site and should contact the site remotely (via phone, email, etc.) first. If 
applicable, subjects will be referred to the local health care system. Physical distancing 
and person-to-person contact restrictions will be applied and explained to subjects while 
staying at the site. Study participants will be asked to use surgical face masks and/or 
gloves if deemed appropriate by the Investigator and site staff and guided by local 
requirements. 


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 Screen Failures, Retesting, and Rescreening 
 Screen Failures 
Screen failures are defined as subjects who consent to participate in the clinical trial but do not meet 
one or more criteria required for participation in the trial during the screening procedures. A minimal 
set of screen failure information is required. If the subject is not randomised within 28 days after signing 
the ICF, the subject will be screen failed. 
 Retesting 
All laboratory-related eligibility criteria (including QuantiFERON®-Gold Plus tests, serum FSH test, 
and serum pregnancy test) will be determined only by central lab measurement. Eligibility related 
laboratory tests are not allowed for retesting unless the laboratory finding was due to technical error 
(e.g., missing value due to sample mishandling, etc.) or retesting is required per protocol (e.g., 
indeterminate QuantiFERON®-Gold Plus test result). 
 Rescreening 
Rescreening is allowed for a technical issue (e.g., repeated laboratory error that makes eligibility 
confirmation difficult within 28 days after signing the ICF, COVID-19 related travel or transport 
restrictions that makes the screening procedure infeasible after signing the ICF, etc.) and not a medical 
issue. Such subjects can be rescreened only once, based on Investigator recommendation and after 
discussion with medical monitor. The rescreened subject will have to undergo the full screening 
procedures (including ICF consent) again. 
 Replacement 
Subjects who are discontinued from IP after randomisation will not be replaced. 
5. Treatment and Investigational Product
Treatment of the Subjects
 Dosing and Treatment Schedule 
Subjects will be administered SB17 or Stelara® 45 mg at Week 0, Week 4, followed by every 12 weeks 
up to Week 40. By eligibility criteria, all subjects will receive 45 mg at Week 0 (Randomisation). If the 
subject gains weight and becomes > 100 kg in subsequent dosing visits the subject will receive two 
doses of 45 mg (total of 90 mg). Each injection should be done in different sites. 
No visit window will be allowed at Week 0 for first IP administration. Visit window for dosing visit 
except for Week 0 will be allowed as follows: 

± 3 days for Week 4

± 5 days for Week 16 and Week 28

± 7 days for Week 40
IP administration delay must be avoided as much as possible. If IP dose delay requiring out-of-window 
administration is necessary due to AE, etc., administer the IP as soon as possible. IP dose delay is 
possible up to 4 weeks from scheduled dosing date. If 4 weeks is exceeded, the IP administration should 
be skipped. Subsequent visit schedules will not be changed due to administration delay or skip. However, 
if the last scheduled IP (Week 40) cannot be given even after a 4-week delay, an ET visit should be 




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and other relevant local laws and/or regulations. 
The temperature will be monitored properly during the study period. The IP should be stored in a secure 
area and clearly labelled and stored away from other IP or medication to prevent confusion (e.g., in a 
clearly marked box on a separate shelf of the refrigerator). 
A detailed guideline for IP preparation, administration, storage, and destruction will be provided in the 
Pharmacy Manual. 
 Product Storage and Stability 
SB17 or Stelara® should be stored at 2°C to 8°C (36°F to 46°F) in the original carton until time of use 
to protect from light. The temperature will be monitored properly during the study period. If continuous 
monitoring is not available then manual temperature logs should be generated and recorded to ensure 
proper storage conditions. If a temperature deviation occurred, responsible person should contact the 
Sponsor to determine if the drug is still appropriate for use.  
Do not freeze SB17 or Stelara® PFS. Do not shake SB17 or Stelara® PFS. The IPs must not be used 
beyond the expiration date. 
 Preparation and Administration of Investigational Products 
IPs should be inspected visually for particulate matter or discoloration prior to administration. SB17 or 
Stelara® is a colourless to light yellow solution and may contain a few small translucent or white 
particles. If it is discoloured or cloudy, or if other particulate matter is present, the IPs must not be used. 
Do not shake SB17 or Stelara® PFS. Strong shaking may damage the IPs. If it has been shaken strongly, 
the IPs must not be used. 
Prior to administration, IPs should be removed from the refrigerator and brought to room temperature. 
Do not remove the syringe’s needle cover while allowing it to reach room temperature. The needle 
cover should not be removed until you are ready to inject the dose. 
IPs will be administered as a single subcutaneous injection in the abdomen (divided by quadrants, 
avoiding the navel), upper thighs, or upper arm. Only the Investigator or trained designee can perform 
and monitor the IP administration. 
Each injection should be administered at a different anatomic location (such as upper arms, upper thighs, 
or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, 
bruised, erythematous, or indurated. 
A detailed guideline for IP preparation, administration, storage, and destruction will be provided in the 
Pharmacy Manual. 
 Treatment Compliance and Investigational Product Accountability 
Compliance will be assessed by the subject’s source documents and electronic case report form (eCRF). 
All dosing information including the exact date and time of IP administration must be recorded in the 
source document and eCRF. 
The Investigator or designee should maintain the documents of IP accountability and record the IP kit 
number administered to subjects. IP accountability and dispensing records must be kept and contain the 
following information: 
 
The identification of the subjects to whom the drug was dispensed. 






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6. Study Assessment 
 Efficacy Assessment 
 Psoriasis Area Severity Index 
PASI incorporates the extent of psoriasis at four anatomic sites with the signs of erythema, scale, and 
elevation. PASI scores range from 0 to 72. The PASI assessment will be performed by the Investigator 
at the time points outlined in Table 1. PASI is highly recommended to be assessed by the same person 
for each subject throughout the study. The severity of the disease is calculated as follows. 
In the PASI system, the body is divided into 4 areas: The head (h), trunk (t), upper extremities (u), and 
lower extremities (l), which account for 10%, 30%, 20%, and 40% of the total BSA, respectively. 
The area of psoriatic involvement of these four areas (Ah, At, Au, and Al) is given a numerical value: 
 
0 = No involvement 
 
1 = 1% to < 10% involvement 
 
2 = 10% to < 30% involvement 
 
3 = 30% to < 50% involvement 
 
4 = 50% to < 70% involvement 
 
5 = 70% to < 90% involvement 
 
6 = 90% to 100% involvement 
Regarding area assessments, please note the following conventions: 
 
The neck is considered part of the head area 
 
The axillae and groin are considered part of the trunk area 
 
The buttocks are considered part of the lower extremities area 
The signs of severity, erythema (E), induration (plaque thickness, I), and scaling (desquamation, S) of 
these four areas are assessed using a numeric scale 0 to 4: 
 
0 = No symptoms 
 
1 = Slight 
 
2 = Moderate 
 
3 = Severe 
 
4 = Very severe 
The PASI score is calculated according to the following formula: 
PASI = 0.1 × (Eh + Ih + Sh) × Ah + 0.3 × (Et + It + St) × At + 0.2 × (Eu + Iu + Su) × Au + 0.4 × (El + Il 
+ Sl) × Al 
A PASI50, PASI75, and PASI90 response is defined as a ≥ 50%, ≥ 75%, and ≥ 90% improvement of 
PASI score from baseline. 


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 Physician’s Global Assessment 
The PGA is used to determine the subject’s psoriasis lesions overall. The PGA assessment will be 
performed by the Investigator at the time points outlined in Table 1. PGA is highly recommended to be 
assessed by the same person for each subject throughout the study. 
Overall lesions will be graded for induration, erythema, and scaling based on scales as below. The sum 
of the 3 scales will be divided by 3 to obtain a final PGA score. 
Induration (I) (averaged over all lesions) 
 
0 = No evidence of plaque elevation 
 
1 = Minimal plaque elevation, = 0.25 mm 
 
2 = Mild plaque elevation, = 0.5 mm 
 
3 = Moderate plaque elevation, = 0.75 mm 
 
4 = Marked plaque elevation, = 1 mm 
 
5 = Severe plaque elevation, = 1.25 mm or more 
Erythema (E) (averaged over all lesions) 
 
0 = No evidence of erythema, hyperpigmentation may be present 
 
1 = Faint erythema 
 
2 = Light red coloration 
 
3 = Moderate red coloration 
 
4 = Bright red coloration 
 
5 = Dusky to deep red coloration 
Scaling (S) (averaged over all lesions) 
 
0 = No evidence of scaling 
 
1 = Minimal; occasional fine scale over less than 5% of the lesion 
 
2 = Mild; fine scale dominates 
 
3 = Moderate; coarse scale predominates 
 
4 = Marked; thick, nontenacious scale dominates 
 
5 = Severe; very thick tenacious scale predominates 
Total Average = (I + E + S)/3 
Physician’s Static Global Assessment based upon above Total Average 
 
0 = Cleared, except for residual discoloration 
 
1 = Minimal - majority of lesions have individual scores for (I + E + S)/3 that averages 1 
 
2 = Mild - majority of lesions have individual scores for (I + E + S)/3 that averages 2 






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Pelvic, breast, and rectal exams are not required unless medically indicated. The abbreviated physical 
examination should include an assessment of the subject’s general appearance, cardiovascular, 
respiratory systems, and the subject’s abdomen. Other body systems may be examined at the discretion 
of the Investigator. 
Abnormal findings will be documented on the source document, and any clinically significant 
abnormality or worsening of a previously noted abnormality should be recorded as an AE. 
Body weight will be measured at Screening and every visit (recommended to be done after overnight 
fasting state) but height will be measured only at Screening. 
 Twelve-lead Electrocardiogram 
Twelve-lead electrocardiogram (ECG) measurements will be performed and reviewed by a cardiologist, 
Investigator, or designee at Screening. 
 Vital Signs 
Vital signs include blood pressure (BP), pulse rate, and body temperature. Vital signs will be assessed 
at the time points outlined in Table 1. 
The Investigator should assess all vital signs and any clinically significant abnormalities should be 
reported as an AE. If SBP is ≥ 160 mmHg or DBP is ≥ 100 mmHg at Screening, it should be confirmed 
after a repeat measure after being seated comfortably without talking for at least 5 minutes apart from 
initial measurement. If repeat test result is still above SBP ≥ 160 mmHg or DBP ≥ 100 mmHg, the 
subject will be screen failed. 
 Chest X-ray 
Posterior-anterior and lateral chest X-rays should be obtained and reviewed by qualified physician such 
as radiologist or pulmonologist at Screening and the results reviewed by the Investigator or designee. 
If chest X-rays were taken within 3 months prior to Randomisation and show no clinically significant 
abnormality, and there are no signs or symptoms suggestive of pulmonary disease, particularly TB or 
malignancy, by qualified physician review, that would exclude the subject from the study, then a chest 
X-ray does not need to be repeated at Screening. 
 Tuberculosis Evaluation 
The Investigator, or designee, will evaluate the subject for signs and symptoms of TB at the time points 
outlined in Table 1. 
This evaluation may be performed in conjunction with the complete or abbreviated physical 
examination. The following series of questions are suggested for use during the evaluation, but not 
limited to: 
 
Please indicate if you are having any of the following problems since last visit. 
- 
New cough of > 14 days duration or a chronic cough of > 3 weeks 
- 
Production of sputum 
- 
Blood-streaked sputum 
- 
Unexplained weight loss 
- 
Fever 


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- 
Fatigue/tiredness 
- 
Night sweats 
- 
Shortness of breath 
 
Have you had close contact with an individual with active TB? 
If TB is suspected at any point during the study, a chest X-ray and QuantiFERON®-Gold Plus test should 
be performed. Any diagnostic uncertainties should be clarified with TB specialist. In addition, 
QuantiFERON®-Gold Plus test will be performed at Screening. Subjects who have indeterminate 
QuantiFERON®-Gold Plus test result at the first time should have the test repeated. If the subject has 
an indeterminate result for the repeat test at Screening, the subject will be screen failed. 
If a subject is diagnosed as having active TB, it should be reported to the Sponsor according to the 
instructions in Section 8.1.3. The subject must immediately discontinue administration of IP and should 
be referred for appropriate treatment.  
If a subject is considered to have latent TB from a positive QuantiFERON®-Gold Plus test result at 
Screening, the subject must be excluded from the study. And subjects who have positive 
QuantiFERON®-Gold Plus test result after Week 0 must discontinue the IP. Positive QuantiFERON®-
Gold Plus test results after Week 0 will be collected as AEs. 
 Pregnancy Test and Follicle Stimulating Hormone Test 
For women of childbearing potential, serum pregnancy test should be performed at Screening. For 
women with amenorrhea of at least 12 months without an alternative medical cause, a serum FSH test 
should be performed at Screening. From Randomisation, a urine pregnancy test will be performed 
locally at the time points outlined in Table 1 and should have a negative result before each IP 
administration. 
Additional pregnancy test(s) may be performed besides the schedule after Randomisation at the 
Investigator’s discretion. 
When a pregnancy test result at Screening would not be available due to technical issues (e.g., handling 
error, sampling error, tube breakage), the test shall be repeated in all circumstances (missing results at 
Screening would be considered as screening failure). 
 Other Assessments 
 Pharmacokinetic Assessment 
Blood samples for PK assessment will be collected at the time points outlined in Table 1. PK assessment 
will be performed in approximately 140 subjects (70 subjects per treatment group in initial 
randomisation at Week 0 [Day 1]) participating in PK evaluation. 
Only subjects who consent to the PK blood sampling will be enrolled in PK sub-study. 
Blood samples for PK assessment will be collected prior to IP administration at the day of IP 
administration (Week 0, 4, 16, and 28). Blood samples for PK assessment at Week 2, 8, and 12 will be 
collected at any time during when subject is staying at investigational sites. Subjects’ samples may be 
used for method development, method validation and/or investigation, only for this study. 
In all cases, the exact date and time of the PK sampling and IP administration must be carefully recorded 
in the source documents and eCRF. Detail instructions of collecting, handling, storage, and shipment 


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for PK samples are described in the Central Laboratory Manual. 
 Immunogenicity Assessment 
Blood samples for immunogenicity assessment will be collected at the time points outlined in Table 1. 
Immunogenicity assessment will be performed in all randomised subjects. 
Blood samples for immunogenicity assessment will be collected prior to IP administration at the day of 
IP administration (Week 0, 4, 16, 28, and 40). Blood samples for immunogenicity assessment at Week 
8, 12, and 52/ET visit will be collected at any time during when subject is staying at investigational 
sites. Subjects’ samples may be used for method development, method validation and/or investigation, 
only for this study. 
In all cases, the exact date and time of the immunogenicity sampling and IP administration must be 
carefully recorded in the source documents and eCRF. Detail instructions of collecting, handling, 
storage, and shipment for immunogenicity samples are described in the Central Laboratory Manual. 
7. Study Procedures 
 Study Flow and Visit Schedule 
During this study, efficacy, safety, PK, immunogenicity assessments will be performed at the time points 
outlined in Table 1. Unless otherwise specified all procedures should be performed pre-dose and highly 
recommended to be done on the same day with IP dosing. Detail instructions of collecting, processing, 
storing, and shipping for blood samples are described in the Central Laboratory Manual. Local SOPs 
will be used for collecting and processing urine samples. All results should be recorded in the source 
documents along with the date and time the procedures were performed. 
 Screening Visit 
Screening should be performed within 28 days before randomisation. The Investigator must discuss the 
study with the subject and obtain written informed consent from the subject prior to any study related 
procedures. Any pre-existing chronic diseases (such as hypertension or diabetes) should be well 
evaluated and controlled to ensure subject’s safety during the study. Any new conditions discovered 
during the Screening process should be adequately assessed and managed. 
The following procedures should be performed: 
 
Written informed consent 
 
Demographic information 
 
Review of medical and surgical history and lifestyle measures (smoking and alcohol 
history) 
 
Physical examination (including height and weight; weight is recommended to be 
measured at overnight fasting state) 
 
Psoriasis BSA involvement 
 
Serum pregnancy test for women of childbearing potential 
 
Serum FSH test for women with amenorrhea of at least 12 months without an alternative 
medical cause 
 
12-lead ECG 


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 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Chest X-ray (radiographs taken within 3 months from Randomisation with radiologist 
confirmation will be accepted) 
 
Blood sampling for QuantiFERON®-Gold Plus test 
 
Blood and urine sampling for clinical laboratory tests (haematology, chemistry, urinalysis, 
and virology) 
 
Eligibility assessment 
 
Efficacy assessment: PASI and PGA 
 
Documentation of AEs 
 
Documentation of all previous and concomitant medications 
If the subject is not randomised within 28 days after signing the ICF, the subject must be screen failed 
(please see Section 4.6). 
Once the subject is confirmed eligible for the study, the subject will be reminded in particular of the 
study restrictions such as contraception, prohibited medications, and other study requirements. The 
Investigator shall pay attention to each subject’s particular needs in order to provide the necessary 
training and advice and foster protocol compliance. 
 Treatment Period 
7.1.2.1. Visit 1 (Week 0/Day 1) 
The following procedures should be performed: 
Prior to randomisation 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Psoriasis BSA involvement 
 
Urine pregnancy test for women of childbearing potential 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood and urine sampling for clinical laboratory tests (haematology, chemistry, and 
urinalysis) 
 
Blood sampling for PK assessment 
 
Blood sampling for immunogenicity assessment 
 
Efficacy assessment: PASI, PGA, and DLQI 
 
Eligibility assessment 
Randomisation and IP administration 


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 
Randomisation 
- 
Randomisation must proceed after all screening procedures including eligibility 
assessment. 
 
IP administration 
- 
The Investigator (or trained designee) must be present at the time of the injection 
and for at least 30 minutes after the injection and all subjects must be observed 
carefully for symptoms of an allergic reaction. 
Any time regardless of IP administration 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
7.1.2.2. Visit 2 (Week 2/Day 15 ± 3 days) 
The following procedures should be performed: 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood sampling for PK assessment 
 
Efficacy assessment: PASI and PGA 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
7.1.2.3. Visit 3 (Week 4/Day 29 ± 3 days) 
The following procedures should be performed: 
Prior to IP administration 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Urine pregnancy test for women of childbearing potential 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood and urine sampling for clinical laboratory tests (haematology, chemistry, and 
urinalysis) 
 
Blood sampling for PK assessment 
 
Blood sampling for immunogenicity assessment 
 
Efficacy assessment: PASI, PGA, and DLQI 


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IP administration 
 
IP administration 
- 
The Investigator (or trained designee) must be present at the time of the injection 
and for at least 30 minutes after the injection and all subjects must be observed 
carefully for symptoms of an allergic reaction. 
Any time regardless of IP administration 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
7.1.2.4. Visit 4 (Week 8/Day 57 ± 3 days) 
The following procedures should be performed: 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood sampling for PK assessment 
 
Blood sampling for immunogenicity assessment 
 
Efficacy assessment: PASI and PGA 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
7.1.2.5. Visit 5 (Week 12/Day 85 ± 3 days) 
The following procedures should be performed: 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood and urine sampling for clinical laboratory tests (haematology, chemistry, and 
urinalysis) 
 
Blood sampling for PK assessment 
 
Blood sampling for immunogenicity assessment 
 
Efficacy assessment: PASI, PGA, and DLQI 
 
Documentation of AEs 
 
Documentation of all concomitant medications 


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7.1.2.6. Visit 6 (Week 16/Day 113 ± 5 days) 
The following procedures should be performed: 
Prior to IP administration 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Urine pregnancy test for women of childbearing potential 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood and urine sampling for clinical laboratory tests (haematology, chemistry, and 
urinalysis) 
 
Blood sampling for PK assessment 
 
Blood sampling for immunogenicity assessment 
 
Efficacy assessment: PASI, PGA, and DLQI 
IP administration 
 
IP administration 
- 
The Investigator (or trained designee) must be present at the time of the injection 
and for at least 30 minutes after the injection and all subjects must be observed 
carefully for symptoms of an allergic reaction. 
Any time regardless of IP administration 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
7.1.2.7. Visit 7 (Week 20/Day 141 ± 5 days) 
The following procedures should be performed: 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Efficacy assessment: PASI and PGA 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
7.1.2.8. Visit 8 (Week 24/Day 169 ± 5 days) 
The following procedures should be performed: 
 
Physical examination (including weight; weight is recommended to be measured at 


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overnight fasting state) 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Efficacy assessment: PASI and PGA 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
7.1.2.9. Visit 9 (Week 28/Day 197 ± 5 days) 
The following procedures should be performed: 
Prior to re-randomisation 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Urine pregnancy test for women of childbearing potential 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood and urine sampling for clinical laboratory tests (haematology, chemistry, and 
urinalysis) 
 
Blood sampling for PK assessment 
 
Blood sampling for immunogenicity assessment 
 
Efficacy assessment: PASI, PGA, and DLQI 
 
Eligibility assessment 
- 
If a subject who does not achieve PASI50 response at Week 28, the subject has to 
discontinue and ET will occur at Week 28 visit. Accordingly, the subject needs to 
complete the ET procedures (Section 7.1.3) 
Re-randomisation and IP administration 
 
Re-randomisation 
- 
Only subjects who achieved at least a PASI50 response at Week 28 assessment will 
be re-randomised and enter the transition period. Subjects receiving Stelara® will be 
randomised in a 1:1 ratio to either continue to receive Stelara® or be transitioned to 
SB17. Subjects receiving SB17 will continue to receive SB17 up to Week 40 but 
they will also follow the randomisation procedure in order to maintain blinding. 
 
IP administration 
- 
The Investigator (or trained designee) must be present at the time of the injection 
and for at least 30 minutes after the injection and all subjects must be observed 
carefully for symptoms of an allergic reaction. 
Any time regardless of IP administration 


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 
Documentation of AEs 
 
Documentation of all concomitant medications 
7.1.2.10. Visit 10 (Week 40/Day 281 ± 7 days) 
The following procedures should be performed: 
Prior to IP administration 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Urine pregnancy test for women of childbearing potential 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood and urine sampling for clinical laboratory tests (haematology, chemistry, and 
urinalysis) 
 
Blood sampling for immunogenicity assessment 
 
Efficacy assessment: PASI, PGA, and DLQI 
IP administration 
 
IP administration 
- 
The Investigator (or trained designee) must be present at the time of the injection 
and for at least 30 minutes after the injection and all subjects must be observed 
carefully for symptoms of an allergic reaction. 
Any time regardless of IP administration 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
7.1.2.11. Visit 11 (Week 52/Day 365 ± 7 days) 
Visit 11 (Week 52) is defined as 12 weeks (± 7 days) after the last scheduled IP administration (i.e., 
Week 40). All subjects who complete the last scheduled IP administration at Week 40 will conduct Visit 
11. 
The following procedures should be performed: 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Urine pregnancy test for women of childbearing potential 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood and urine sampling for clinical laboratory tests (haematology, chemistry, and 
urinalysis) 


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 
Blood sampling for immunogenicity assessment 
 
Efficacy assessment: PASI, PGA, and DLQI 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
After study completion, subjects should discuss with their physician to switch to the most appropriate 
psoriasis treatment after their last study visit. 
 Early Termination 
Subjects who discontinue from the study at any time post 1st IP administration will be required to attend 
an ET visit. 
The ET visit is recommended to be performed at 12 weeks (± 7 days) after the last IP administration. 
When this schedule cannot be done within time (e.g., due to subject not available or other reasons), the 
ET visit should still be performed as soon as possible and no later than the initially scheduled Week 52 
visit date. For subjects who have permanently discontinued the IP between Week 4 and Week 12, it is 
highly recommended to also complete the Week 12 visit before ET. 
The following procedures should be performed: 
 
Physical examination (including weight; weight is recommended to be measured at 
overnight fasting state) 
 
Urine pregnancy test for women of childbearing potential 
 
Vital signs 
 
TB evaluation (refer to Section 6.2.7) 
 
Blood and urine sampling for clinical laboratory tests (haematology, chemistry, and 
urinalysis) 
 
Blood sampling for immunogenicity assessment 
 
Efficacy assessment: PASI, PGA, and DLQI 
 
Documentation of AEs 
 
Documentation of all concomitant medications 
If the ET visit happens to occur before 11 weeks after the last IP administration, a phone call for 
safety follow-up will be performed at 12 weeks (± 7 days) after the last IP administration in order to 
collect AEs and related concomitant medications. If a subject is not available, a phone call for safety 
follow-up will be performed as soon as possible, but no later than Week 52 from the first IP 
administration. If the subject refused ET visit, it should be recorded in the subject’s medical records 
and the eCRF. In all cases, the reason for IP discontinuation must be recorded in the subject’s medical 
records and the eCRF. Subjects should discuss with their physician to switch to the most appropriate 
psoriasis treatment after their last study visit/phone call. 
 Unscheduled visit 
Unscheduled visit is allowed during study period at the discretion of the Investigator, if deemed 
clinically necessary for the patient’s safety. Any tests, procedures, or assessments performed at the 


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unscheduled visits must be recorded in the source documents and eCRF. 
 Discontinuation 
 Subject Discontinuation 
The subject must be permanently discontinued from IPs in the event of any of the following: 
 
Consent withdrawal by subject 
- 
If the subject withdraws his/her consent, the Investigator must inquire the reasons 
for consent withdrawal as to whether it is related to the study (e.g., AE); however, 
the subject could refuse to provide such reason. 
- 
If the main reason for consent withdrawal is considered related to the study, the 
Investigator may select the appropriate reason for withdrawal (other than just 
consent withdrawal) from a pre-defined list as below. 
 
Lost to follow-up 
 
Pregnancy of study subject 
 
Serious toxicity (including serious hypersensitivity such as anaphylaxis, TB, exfoliative 
dermatitis, RPLS, malignancy, pulmonary toxicity such as allergic alveolitis, eosinophilic 
pneumonia, interstitial pneumonia, or cryptogenic organizing pneumonia, etc.) 
 
Failure to achieve PASI50 response on Week 28 visit assessment 
 
Serious lack of IP compliance (Note: if related with toxicity, then toxicity should be 
selected as main reason for IP discontinuation) 
- 
A subject missed any of first two doses (at Week 0 [Day 1] and Week 4 [Day 29]) 
after randomisation. 
- 
A subject missed two or more doses after Week 12. 
 
Using or switching to another psoriasis biologic 
 
Unblinding the study treatment allocation to subject or the Investigator (i.e., breaking the 
double-blind) 
 
Any other reasons per the Investigator or the Sponsor determination 
 
Severe or critical COVID-19, or COVID-19 with sequalae 
In addition, the subject should be considered to be permanently discontinued from IPs in the event of 
any of the following: 
 
Other unacceptable toxicity determined by subject or the Investigator (including recurrent 
or serious infections, etc.) 
 
Lack of efficacy other than Week 28 determined by subject or the Investigator 
 
Other lack of protocol compliance (such as 2 or more dose delays or using other prohibited 
medications/treatment [see Section 5.3.2], etc.) 
Subjects who have active COVID-19 infection (regardless of severity) should have the IP temporarily 
discontinued until the infection resolves. If the condition becomes severe, critical or develops sequalae 


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the subject should permanently discontinue. 
If a subject is prematurely discontinued from IP due to any of the above described reasons, the subject 
needs to complete the ET procedures (Section 7.1.3). 
 Discontinuation of Study Sites 
Investigational site participation may be discontinued if the Sponsor, the Investigator, or the Institutional 
Review Board (IRB)/Independent Ethics Committee (IEC) of the investigational site judge it necessary 
for any reason. Health authorities and IRB/IEC will be informed about the discontinuation of the study 
sites in accordance with applicable regulations. 
 Lost to Follow-up 
A subject will be considered lost to follow-up if he or she fails to return for scheduled visits and is 
unable to be contacted by the study site staff. Determination of subject’s status as lost to follow-up 
should be based on Investigator’s discretion. Some examples when making consideration could be 
 
If a subject fails to visit for 2 consecutive scheduled visits (for Week 40, if Week 52 visit is 
not made) without any notification, loss to follow-up may be considered.  
 
Before a subject is deemed lost to follow-up, the Investigator or designee should make 
every effort to regain contact with the subject (such as 3 telephone calls or any other 
equivalent methods of contact). These contact attempts should be documented in the 
subject’s medical record or study file. 
 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 Discontinuation of the Study 
The Sponsor may terminate this study prematurely for reasonable cause provided that written notice is 
submitted to the Investigator, IRB/IEC, and relevant authorities in advance of the intended termination: 
 
Poor enrolment of subjects making completion of the study within acceptable time frame 
 
Discontinuation of development of the study drug 
 
The decision by the Sponsor to terminate the study based on medical/ethical, business 
decision/strategic, or study conduct-related reasons 
If the study is terminated or discontinued prematurely, the Sponsor will promptly notify to the 
Investigator. The Investigator may be informed of additional procedures to be followed in order to 
assure that adequate consideration is given to the protection of the subject’s welfare and best interests. 
Health authorities and IRB/IEC will be informed about the discontinuation of the study in accordance 
with applicable regulations. 
8. Safety Monitoring and Reporting 
 Adverse Events 
 Definition of Adverse Event 
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered 
the medicinal (investigational) product or other protocol-imposed intervention and which does not 


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necessarily have to have a causal relationship with this treatment or intervention. An AE can therefore 
be an unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or 
disease temporally associated with the use of any dose of a medicinal (investigational) product or other 
protocol-imposed intervention regardless of attribution. 
All AEs during the period of observation (as specified in Section 8.1.2) including the events that 
occurred prior to administration of an IP should be reported as an AE in the AE section of the eCRF. 
Pre-existing conditions which worsen (i.e., increase in severity) that meet the definition of an AE during 
the study are to be reported as AEs. 
Diagnostic and therapeutic non-invasive and invasive procedures, such as surgery, should not be 
reported as AEs. However, the medical condition for which the procedure was performed should be 
reported if it meets the definition of an AE. For example, an acute appendicitis that begins during the 
AE reporting period should be reported as an AE and the resulting appendectomy should be recorded 
as treatment of the AE. 
The AEs that emerge during treatment with an IP (i.e., treatment-emergent AE [TEAE]) will be analysed 
for the purposes of safety analyses. 
8.1.1.1. Clinically Significant Abnormality 
If there are any abnormalities discovered during the laboratory test, physical examination, vital signs, 
and/or other safety assessments and the abnormality is assessed clinically significant by the Investigator, 
it should be reported as an AE. This does not apply to pre-existing conditions which have been 
documented at Screening or if the abnormality is consistent with a current diagnosis (underlying disease 
or other AEs). If it is not specified or defined elsewhere in the protocol, clinically significant 
abnormality may include the events that led to an intervention, including withdrawal of the IP treatment, 
dose reduction, additional concomitant medication, and others evaluated as clinically significant by the 
Investigator. 
If the clinically significant laboratory or other abnormality from safety assessment is not a sign of a 
disease or syndrome, the abnormality itself should be reported as an AE in the eCRF. If the abnormality 
can be characterised by a precise clinical term, the clinical term should be reported as the AE. For 
example, an elevated serum potassium level of 7.0 mEq/L should be reported as ‘hyperkalaemia’. 
Observations of the same clinically significant abnormality from visit to visit should not be repeatedly 
reported as AEs in the eCRF, unless their aetiology changes (e.g., when the AE severity increases, the 
maximum severity for the total duration of the event shall be recorded). However, if the AE started 
before the first IP administration and its severity increases after IP treatment start, a new AE shall be 
reported and the date of severity increase shall correspond to the new AE onset date (while the 
pre-existing AE, with the lower severity, shall be stopped). 
 Period of Observation for Adverse Events 
AEs will be reported from the time the ICF is signed until Week 52 or ET (visit or safety follow-up 
phone call, if done). 
The Investigator should observe the AEs for appropriate medical care of the subject until AE resolution 
or stabilisation. Unresolved AEs during the study period should be followed up until Week 52 or ET 
and recorded in the eCRF. Thus, the Investigator does not need to actively monitor subjects for AEs 
once the clinical study has ended. 
However, if the subject has an ongoing SAE until Week 52 or ET, these cases should be followed up 
until event resolution or stabilisation after clinical study end, and reported through the SAE paper form 


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(see Section 8.2.2). 
In addition, SAEs that occurred after the subject had completed the clinical study and are deemed related 
to the IP in the opinion of the Investigator should be reported to the Sponsor or its designated 
representative if the Investigator becomes aware of the SAEs (see Section 8.2.2). 
 Reporting Adverse Events 
AEs are to be reported in the eCRF and reviewed by the Investigator. When reporting an AE, a diagnosis 
(when possible and appropriate) rather than each individual sign and symptom should be reported. 
Each AE is to be assessed to determine if it meets the criteria of an SAE (see Section 8.2.1 for SAE 
definition). If an AE is classified as an SAE, it must be reported to Sponsor, or its designated 
representative, promptly according to the timeline specified in Section 8.2.2. For an SAE, a diagnosis 
with a description of signs and symptoms as well as other supporting information that led to the 
diagnosis should be described in the SAE form provided by the Sponsor (see Section 8.2.2.). 
 Severity Assessment 
The Investigator is responsible for assessing and reporting the severity of AEs. 
Following classifications should be used to classify AEs: 
 
Mild events are usually transient and do not interfere with the subject’s daily activities, 
 
Moderate events introduce a low level of inconvenience or concern to the subject and may 
interfere with daily activities, 
 
Severe events interrupt the subject’s usual daily activities. 
 Causality Assessment 
The Investigator is responsible for assigning a causal relationship to each AE. The causal relationship 
between the IP and the AE should be defined as not related (no) or related (yes). 
Events should be classified as ‘related’ if there is a reasonable possibility that the IP caused the AE. This 
means that there are facts (evidence) or arguments to suggest a causal relationship. 
Events should be classified as ‘not related’ if there is no reasonable possibility that the IP caused the 
AE. 
 Expectedness Assessment 
Expectedness of AEs will be assessed by referring to the safety information in the Investigator’s 
brochure (IB) of the relevant safety section of IB, as required. More detailed information on 
expectedness assessment will be explained in the IB. 
 Withdrawal due to Adverse Events 
Subject withdrawal from the study due to an AE should be distinguished from withdrawal due to 
personal reasons and recorded on the appropriate eCRF section. Subjects withdrawn due to an AE 
should be followed up until the time point specified in the protocol. When a subject withdraws from the 
study due to an SAE, the SAE must be reported and followed in accordance with the requirements 
outlined in Section 8.2.2. 
Subjects who discontinue the administration of IPs because of serious or significant safety issues should 


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be followed closely until the events are fully and permanently resolved or stabilised. 
 Serious Adverse Events 
 Definition of Serious Adverse Event 
An SAE is any untoward medical occurrence at any dose that: 
 
Results in death, 
 
Is life-threatening, 
 
Requires inpatient hospitalisation or prolongation of existing hospitalisation, 
 
Results in persistent or significant disability/incapacity, 
 
Results in congenital anomaly/birth defects, 
 
Is medically important. 
Medical and scientific judgement should be exercised in deciding whether expedited reporting is 
appropriate in other situations, such as important medical events that may not be immediately 
life-threatening or result in death or hospitalisation. However, if it is determined that the event may 
jeopardise the subject and may require intervention to prevent one of the other outcomes listed in the 
definition above, the important medical event should be reported as serious. Examples of such events 
are intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias, 
or convulsions that do not result in hospitalisation or development of drug dependency or drug abuse. 
The term ‘severe’ is often used to describe the intensity (severity) of a specific event (as in mild, 
moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor 
medical significance (such as severe headache). This is not the same as ‘serious’, which is based on 
subject/event outcome or action criteria usually associated with events that pose a threat to a subject’s 
life or functioning. 
8.2.1.1. Life-threatening 
The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at 
risk of death at the time of the event; it does not refer to an event which hypothetically might have 
caused death if it were more severe. 
8.2.1.2. Hospitalisation 
AEs reported from clinical studies associated with inpatient hospitalisation or prolongations of 
hospitalisation are considered serious. Staying at an observation unit in the emergency room for more 
than 24 hours qualifies for hospitalisation. Any events leading to subsequent emergency room visit 
for less than 24 hours should be in the discretion of Investigator to assess serious as medically 
important. 
Hospitalisation or prolongation of hospitalisation in the absence of a precipitating clinical AE is not 
in itself an SAE. Examples include: 
• 
Admission for treatment of a pre-existing condition not associated with the development 
of a new AE or with a worsening of the pre-existing condition (e.g., for work-up of 
persistent pre-treatment lab abnormality), 
• 
Social admission for convenience (e.g., admission of a subject who does not have a carer), 


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• 
Administrative admission (e.g., for a yearly physical exam), 
• 
Optional admission not associated with a precipitating clinical AE (e.g., for elective 
cosmetic surgery). 
Pre-planned treatments or surgical procedures should be noted in the Screening documentation for 
the individual subject. 
 Reporting Serious Adverse Events 
SAEs must be immediately reported at least within 24 hours of the Investigator becoming aware of the 
event to Sponsor or its designated representative in the eCRF. In any case when the electronic form 
would not be available, a paper SAE form can be used as backup. 
Date and time (wherever possible) of the Investigator becoming aware of the SAE will be recorded in 
the source document and SAE form properly. 
In particular, if the SAE is fatal or life-threatening, Sponsor must be notified immediately, irrespective 
of the extent of available AE information. This timeframe also applies to additional (follow-up) 
information that becomes available on previously forwarded SAE reports. Sponsor will then follow 
expedited safety reporting procedures according to local and international regulations as appropriate. 
The Investigator is obligated to pursue and provide information to Sponsor on all SAEs in accordance 
with the timeframes for reporting specified above. In addition, an Investigator may be requested by 
Sponsor to obtain specific additional follow-up information in an expedited fashion. This information 
may be more detailed than that captured on eCRF. In general, this will include a description of the SAE, 
which should be provided in sufficient detail so as to allow for a complete medical assessment of the 
case and independent determination of possible causality. Information on other possible causes of the 
event, such as concomitant medications and illnesses must be provided. In the case of a subject death, 
a summary of available autopsy findings must be submitted as soon as possible to Sponsor or its 
designated representative. 
All SAEs will be followed until event resolution or stabilisation (for chronic events), if possible, even 
when a subject is withdrawn from treatment. For chronic events that do not fully resolve until years 
later, the outcome should be reported as ‘resolved with sequelae’ as soon as the event has stabilised or 
returned to baseline. Follow-up information for the SAE should be actively sought and submitted as the 
information becomes available. 
When SAE is not resolved or stabilised until Week 52 or ET, SAE should also be followed-up as 
appropriate and the information should be submitted to the Sponsor when the information becomes 
available. If the Investigator detects an SAE in a subject after the Week 52 or ET, and considers the 
event to be related to the IP or study-related procedures, the Investigator should contact the Sponsor to 
determine how the SAE should be documented and reported using the paper SAE form. 
 Adverse Events of Special Interest 
The following AEs will be classified as AESI in this study: 
 
Systemic hypersensitivity 
 
Infections 
 
Pulmonary events 


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 
Injection site reaction 
 Hypersensitivity 
Systemic hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with 
ustekinumab, in some cases several days after treatment. The site must have trained personnel and 
equipment/medications to manage serious hypersensitivity reactions such as anaphylaxis. The 
Investigator (or trained designee) must be present from the time of the injection to at least 30 minutes 
post-injection to detect any immediate hypersensitivity reaction. Mild or moderate hypersensitivity 
reactions may be first treated with paracetamol, nonsteroidal anti-inflammatory drugs or antihistamines. 
If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriated 
therapy and discontinue IPs.  
 Infections 
Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections, 
and serious infections have occurred. Subjects should be instructed to seek medical advice if signs or 
symptoms suggestive of an infection occur. If a subject develops a serious infection, the subject should 
be closely monitored and ustekinumab should not be administered until the infection resolves. 
 Pulmonary Events 
Cases of allergic alveolitis and non-infectious pneumonia including interstitial pneumonia, cryptogenic 
organizing pneumonia, and eosinophilic pneumonia have been reported during post-approval use of 
ustekinumab. Clinical presentations included cough, dyspnoea, and interstitial infiltrates following one 
to three doses. Serious outcomes have included respiratory failure and prolonged hospitalisation. 
Improvement has been reported after discontinuation of ustekinumab and also, in some cases, 
administration of corticosteroids. If infection has been excluded and diagnosis is confirmed, institute 
appropriated therapy and discontinue IPs. 
 Injection Site Reaction 
Injection site reactions have been reported with ustekinumab. There is no apparent correlation between 
the presence of anti-ustekinumab antibodies and the occurrence of injection site reactions. 
 Pregnancy 
Any pregnancy, including those of female partners of male subjects treated with the IP, should be 
reported to the Sponsor. If the female partner of a male subject becomes pregnant, a written consent 
must be obtained from the female partner before collecting any pregnancy-related information. All 
subjects, from the time the subject receives the first dose of IP until Week 52 or ET visit should be 
actively monitored for pregnancy. Subjects who were prescribed birth control methods by the 
Investigator, should be instructed to spontaneously report to the Investigator if a pregnancy occurs up 
to 15 weeks after the last IP administration. Pregnancies shall be reported to Sponsor, and the IP must 
be discontinued. Pregnancy reports should be made within 24 hours of the Investigator becoming aware 
of the pregnancy using the pregnancy report form. 
Although pregnancy is not an AE, all pregnancies must be followed up until 6-8 weeks after the outcome 
of the pregnancy becomes available, unless the subject is lost to follow-up. The pregnancy outcome 
should be notified to Sponsor by submitting a follow-up pregnancy report form. If the outcome of the 
pregnancy meets SAE criteria then the Investigator should report this case according to the SAE 
reporting process (Section 8.2.2). 


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 Emergency or Accidental Unblinding of Assigned Treatment 
Unblinding should be considered only when knowledge of the treatment assignment is deemed essential 
for the subject’s safety by their Investigator or a regulatory body. Emergency unblinding should be 
decided based on the medical judgement by Investigator considering subjects safety. In general, 
unblinding of subjects during the conduct of the clinical study should only be performed where there 
are compelling medical or safety reasons to do so. The responsibility to break the treatment code in 
emergency situations resides solely with the Investigator. 
The IWRS will be used to break the blind and details on how to do this are provided in the IWRS 
manual including back-up method enabling unblinding. The Sponsor must be notified immediately after 
a subject and/or the Investigator is unblinded during the course of the study along with the reason for 
breaking the blind. Pertinent information regarding the circumstances of unblinding of a subject’s 
treatment code must be documented in the subject’s source documents. This includes who performed 
the unblinding, the subject(s) affected, the reason for the unblinding, the date of the unblinding, and the 
relevant IP information. 
Similarly, in case of accidental unblinding (i.e., accidental in that it occurred but it was not deliberated 
by the Investigator), the Investigator should promptly document the accidental unblinding and inform 
the Sponsor and the contract research organisation (CRO) of the unblinding occurrence. 
Important Note: Unblinding (emergency or accidental) is one of the reasons for subject’s 
discontinuation from study treatment (Section 7.2.1). 
 Independent Data and Safety Monitoring Board 
An independent DSMB will be assigned for this study. The DSMB will consist of external experts 
and will review the safety and tolerability data from the study at pre-specified intervals. The details 
of the safety data and time points for review will be described in the DSMB Charter and in the DSMB 
statistical analysis plan (SAP). 
In addition, an ongoing blinded review of AEs, including clinical laboratory data will be continuously 
undertaken by the Sponsor medical monitor and project safety monitor. 
9. Statistical Methods and Data Analysis
Further information on the statistical methods to be used in this study will be provided in the SAP, 
which will be finalised prior to the database lock for reporting the main clinical study report (CSR). 
Statistical analysis and reporting will be performed as follows: 

Interim safety analysis for independent DSMB meeting:
A DSMB SAP, describing the methodology and presentation of results and access to
results will be prepared as a separate document. The safety reports for the DSMB data 
review meetings will be prepared according to the DSMB SAP. 
The statistical analysis will be performed by an independent statistical reporting team 
and the results will be communicated to the DSMB directly by an independent unblinded 
statistician. 

Main CSR:
The main analysis will take place once all subjects complete the procedures at Week 28,
or its corresponding visit. Available efficacy, safety, PK, and immunogenicity data will 


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be analysed and reported. 
At the time of this reporting, a limited number of identified individuals of the Sponsor 
or CRO will be unblinded for reporting purpose. However, subjects, Investigators, and 
other study personnel will remain blinded throughout the entire study period. 
 
Final CSR: 
The final analysis will take place after the last subject completes the procedures at Week 
52 or the corresponding visit. All study data will be analysed and reported for final CSR. 
 Statistical Hypotheses 
This is a study to demonstrate equivalence in percent change from baseline in PASI at Week 12 between 
SB17 and Stelara®. The null hypothesis tested for the primary efficacy analysis is that either (1) SB17 
is inferior to Stelara® or (2) SB17 is superior Stelara® based on a pre-specified equivalence margin. 
 Analysis Sets 
The following sets will be used for the analyses performed in the study: 
 
Randomised Set (RAN) consists of all subjects who receive a randomisation number. 
 
Full Analysis Set (FAS) consists of all subjects who are randomised. Following the 
intent-to-treat principle, subjects will be analysed according to the treatment group they 
are assigned to at Randomisation. However, subjects who do not have any efficacy 
assessment result after randomisation or do not receive IP during the study period will be 
excluded from FAS. 
 
Per-Protocol Set (PPS) consists of all FAS subjects who weight ≤ 100 kg and received 
45 mg IP at Week 0 and Week 4 and have PASI assessment result at Baseline and Week 12 
without any major PDs that have impact on the primary efficacy assessment. Major PDs 
that will lead to exclusion from this set will be pre-defined prior to unblinding the 
treatment group assignment for analyses. 
 
Safety Set 1 (SAF1) consists of all subjects who receive at least one IP during the study 
period. Subjects will be analysed according to the IP received. 
 
Safety Set 2 (SAF2) consists of all subjects in the SAF1 who receive at least one IP after 
re-randomisation at Week 28. Subjects will be analysed according to the IP received. 
 
PK Analysis Set (PKS) consists of all subjects in the SAF1 who have at least one serum 
concentration data. 
 Subject Demographic and Baseline Characteristics 
Subject demographics and baseline characteristics will be summarised by treatment group for the RAN. 
Continuous variables (e.g., age, weight, height) will be summarised with descriptive statistics (n, mean, 
standard deviation [SD], median, minimum, maximum) and categorical variables (e.g., gender, race, 
ethnicity) will be summarised with frequency and percentage. 
Comparison between treatment groups in baseline characteristics will be performed using the chi-square 
test or F-test as appropriate. The results of these tests will be provided including the p-value only for 
descriptive purposes and will not be used as a formal basis to determine the factors to be included in 
primary or secondary efficacy analysis models. If baseline imbalances are detected for any of the factors, 


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additional analyses may be performed to adjust for these baseline differences. 
Relevant medical history will be summarised by treatment group for the RAN. 
 Analysis of the Primary Objective 
The primary efficacy analysis will aim to demonstrate equivalence in terms of percent change from 
baseline in PASI at Week 12 between SB17 and Stelara®. 
The primary efficacy analysis will be performed for the PPS with the percent change from baseline in 
PASI at Week 12 using generalised linear model with the baseline value of PASI as a covariate and site 
(or pooled centres) and treatment group as factors. The equivalence between the two treatment groups 
will be declared if the two-sided 95% confidence interval (CI) of the mean difference of percent change 
from baseline in PASI at Week 12 is entirely contained within the pre-defined equivalence margin of 
[−15%, 15%]. The similar analysis will be performed for the FAS to support the primary analysis. 
Additionally, the two-sided 90% CI of the mean difference between the two treatment groups will be 
estimated for both PPS and FAS with a narrower pre-defined equivalence margin of [-10%, 10%] as a 
sensitivity analysis.  
To conduct the sensitivity analysis for the FAS, missing data will be imputed using multiple imputation 
method with the assumption of monotone missing pattern and regression method for subjects who drop 
out for the study prior to the primary analysis time point. Available case analysis will also be performed 
for the FAS. 
 Analysis of the Secondary Objectives 
 Efficacy Variable Analyses 
As the secondary efficacy endpoints, PGA, PASI50, PASI75, PASI90 response rate, percentage change 
from baseline in PASI, and change from baseline in DLQI will be summarised by treatment group and 
visit for the FAS and PPS. 
 Safety Analyses 
Analysis for AE and concomitant medications will be performed for main period, transition period, and 
overall study period. Analyses for main and transition period will be performed in the SAF1 and SAF2 
respectively and analyses for the overall study period will be performed in the SAF1. 
All reported terms for AEs will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA). For all AE and SAE tables, subjects will be counted once for each preferred term and each 
system organ class. 
A TEAE will be defined as any AE with an onset date on or after the date of the initiation of study drug. 
AEs which are already present before the initiation of study drug and increase in severity after the 
initiation of study drug will be considered as TEAEs. Pre-existing AEs before the initiation of study 
drug with no increase in severity after the initiation of study drug will not be considered as TEAEs. 
Other AE will be defined as all TEAEs excluding SAEs. 
All AEs, TEAEs, SAEs, AESIs, and other AEs with incidence by preferred term > 5% within any 
treatment group will be summarised by the number and percentage of subjects experiencing events by 
system organ class, preferred term, and treatment group. COVID-19 related AEs and SAEs in 
COVID-19 infected subjects will be summarised by treatment group to determine possible causal 
relationship with the IP, if needed. SAEs leading to IP discontinuation and TEAEs by causality and 




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standard mean is above 15 i.e., that the test and standard are not equivalent, in favor of the alternative 
hypothesis that the means of the two groups are equivalent, assuming that the expected difference in 
means is 0, the common standard deviation is 31.33 and that each test is made at the 2.5% level." 
The equivalence margin for the comparison with the 90% CI of the difference in the percent change 
from baseline in PASI at Week 12 will be [-10%, 10%] by the agency recommendation. 
Based on this equivalence margin, a sample size of 169 subjects per treatment group was calculated 
with the assumption of the common SD of 31.11 at the overall 10% significance level, providing 80% 
power. Overall 338 subjects (169 per treatment group) will be randomised into the study to determine 
equivalence of percent change from baseline in PASI at Week 12. 
The nQuery Advisor® option TOST for two-group design gives the following statement to estimate the 
n per group to show the equivalence: "When the sample size in each group is 169, a two group design 
will have 80% power to reject both the null hypothesis that the test mean minus the standard mean is 
below -10 and the null hypothesis that the test mean minus the standard mean is above 10 i.e., that the 
test and standard are not equivalent, in favor of the alternative hypothesis that the means of the two 
groups are equivalent, assuming that the expected difference in means is 0, the common standard 
deviation is 31.33 and that each test is made at the 5% level." 
Therefore, the sample size of 464 allows enough power to detect the equivalence in both situations. 
10. Data Collection and Management 
 Data Confidentiality 
Study information will be labelled with a code number, and will not include the subject’s name, hospital 
number or other information that could identify them. A list linking the code and the subject’s name 
will be kept in the site files as required by ICH E6 (R2) Good Clinical Practice (ICH-GCP). 
The coded information will be sent to the Sponsor (or designee) who will analyse it and report the study 
results both to regulatory and ethical authorities. The Sponsor may also place data on public websites 
or publish journal articles based upon these results. Care will be taken to prevent subjects being 
identified through these publications. In addition, data may be shared with other companies or 
researchers to aid further research. Such data sharing practices will be covered by confidentiality 
agreements. No-one outside the Investigator site will have access to subject-identifiable information. 
 Monitoring 
The Sponsor has engaged the services of CRO to perform all monitoring functions within this clinical 
study. The monitors will work in accordance with the CRO SOPs (and/or Sponsor SOP, if applicable) 
and have the same rights and responsibilities as monitors from the Sponsor organisation. Monitors will 
establish and maintain regular contact between the Investigator and the Sponsor. 
Monitors will evaluate the competence of each Investigator site and inform the Sponsor about any 
problems relating to facilities, technical equipment, or medical staff. During the study, monitors will 
check that written informed consent has been obtained correctly from all subjects and that data are 
recorded correctly and completely. Monitors will also perform source data verification by comparing 
entries in the eCRF with corresponding source data and informing the Investigator of any errors or 
omissions. Monitors will verify adherence to the protocol at the Investigator site. All PDs will be 
reported to the Sponsor. Monitors will arrange for the supply of IP and ensure appropriate storage 
conditions are maintained. 
Monitoring visits will be conducted at regular intervals according to ICH-GCP and monitoring plan. 


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The monitor will provide written reports to the Sponsor on each occasion they contact with the 
Investigator regardless of whether it is by phone or in person. 
Further details on the monitoring processes and the level of source data verification to be performed 
will be outlined in the monitoring plan. 
 Data Handling and Record Keeping 
The Investigator must maintain essential study documents (protocol and protocol amendments, 
completed eCRFs, signed ICFs, relevant correspondence, and all other supporting documentation) until 
at least 2 years after the last approval of a marketing application in an ICH region and until there are no 
pending or contemplated marketing applications in an ICH region or at least 2 years after the formal 
discontinuation of clinical development of the IP. These documents should be retained for a longer 
period if required by the applicable regulatory requirements or the hospital, institution or private 
practice in which the study is being conducted. Subject identification codes (subject names and 
corresponding study numbers) will be retained for the same period of time. These documents may be 
transferred to another responsible party, deemed acceptable by the Sponsor, and who agrees to abide by 
the retention policies. Written notification of transfer must be submitted to the Sponsor. The Investigator 
must contact the Sponsor prior to disposing of any study records and obtain written permission to do 
so. 
 Future Use of Stored Specimens and Data 
The Sponsor or designated representative can store PK and/or immunogenicity samples for maximum 
10 years after the end of the clinical study (refer to Section 3.5). The Sponsor or designated 
representative should operate under the same regulations related to and take the same responsibility to 
save personal data. The sample may be used for additional assay to be performed if considered 
scientifically relevant or requested by regulatory authorities in order to have the possibility to perform 
the assay. 
 Database Management and Coding 
Data generated within this clinical study will be handled according to the relevant SOPs of the data 
management and biostatistics departments of the Sponsor (or an appropriate company designated by 
the Sponsor to perform these activities). Subject data will be captured in an eCRF and reviewed by the 
monitor in order to check adherence to the protocol and to detect any data inconsistency or discrepancy. 
The Investigator must ensure that the clinical data required by the study protocol are carefully reported 
in the eCRF. He/she must also check that the data reported in the eCRF correspond to those in the 
medical records. 
Data must be entered into eCRFs in English by the designated Investigator site personnel in a timely 
manner. Forms should be available during periodic visits by study monitors to enable review for 
completeness and acceptability. Any correction to the data entered into the eCRF must be carried out 
by the Investigator or a designated member of staff. These changes may be made either on the initiative 
of the investigational staff or in response to monitoring or data queries. Any changes or corrections to 
the CRF should not obscure the original entry (i.e., an audit trail should be maintained). Monitors and 
clinical data managers will review the eCRF for accuracy and can generate queries to the investigational 
staff for resolution. Corrections will be recorded in an audit trail that records the old information, the 
new information, and identification of the person making the changes, date of correction made, and 
reason for change. The Investigator must sign and date the eCRF pages as indicated. 
Medical/surgical history and underlying diseases and AEs will be coded using the MedDRA. 


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Concomitant medications will be coded using the World Health Organization-Drug Dictionary. The 
versions of coding dictionaries used will be stated in the clinical study report. 
 Quality Control and Quality Assurance 
During the conduct of the study, the Sponsor or its agent will conduct periodic monitoring visits to 
ensure that the protocol and ICH-GCP are being followed. The monitors may review source documents 
to confirm that the data recorded are accurate. The Investigator and institution will allow the domestic 
and foreign regulatory authorities and the authorised representative of the Sponsor including monitors 
and auditors’ direct or remote access to source documents to perform this verification without violating 
the confidentiality of the subject, to the extent permitted by the applicable laws and regulations. The 
investigational site may be subject to review by the IRB/IEC, to quality assurance audits and/or quality 
control visits performed by the Sponsor, and/or to inspection by appropriate regulatory authorities. It is 
important that the Investigators and their relevant personnel are available during the monitoring visit, 
possible audits, and/or regulatory inspection(s) and that sufficient time is devoted to the process. 
 Protocol Deviation 
PDs will be pre-defined prior to subject enrolment and documented separately named as Protocol 
Deviation Definition List which includes category (e.g., violation of inclusion/exclusion criteria, use of 
prohibited medication, non-compliance with treatment), deviation description, severity (major or 
minor), time point for each PD. Major PDs are defined as those deviations from the protocol likely to 
have an impact on the perceived efficacy and/or safety of study treatments.  
PDs will be reviewed and confirmed prior to database lock to decide which subjects and/or subject data 
will be excluded from certain analyses. Decisions regarding the exclusion of subjects and/or subject 
data from analyses will be documented and approved prior to database lock. 
PDs related to COVID-19 will be listed separately, if needed. 
11. Ethics Considerations and Administrative Procedures 
 Institutional Review Boards and Independent Ethics Committees 
The Investigator and the Sponsor will follow all local laws and regulations relating to contact with and 
approvals from the IRB/IEC. 
The Investigator must provide the Sponsor with documentation of IRB/IEC approval of the protocol 
and informed consent before the study may begin at the Investigator site. The Investigator will supply 
documentation to the Sponsor relating to the annual renewal of the protocol, if applicable, from the 
IRB/IEC and any approvals of revisions to the ICF or amendments to the protocol. 
The Investigator will report promptly to the IRB/IEC any new information that may adversely affect 
the safety of subjects or the conduct of the study. Similarly, the Investigator will submit written 
summaries of the study status to the IRB/IEC on a regular basis and in accordance with the timelines 
required locally. Upon completion of the study, the Investigator will provide the ethics committee with 
a report on the outcome of the study if required by local regulations. 
 Ethical Conduct of the Study 
This study will be conducted and informed consent will be obtained from each subject according to the 
ethical principles stated in the Declaration of Helsinki (2013), the ICH-GCP and the applicable drug 
and data protection laws and regulations of the countries where the study will be conducted. 


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 Subject Information and Informed Consent 
The ICF will be used to explain the risks and benefits of study participation to the subject in simple 
terms before the subject enters into the study. The ICF contains a statement that the consent is freely 
given, that the subject is aware of the risks and benefits of entering the study, and that the subject is free 
to withdraw from the study at any time. Written consent must be given by the subject and/or legal 
representative, after the receipt of detailed information on the study. 
The Investigator is responsible for ensuring that informed consent is obtained from each subject or legal 
representative and for obtaining the appropriate signatures and dates on the ICF prior to the performance 
of any protocol procedures and prior to the administration of IP. The Investigator will provide each 
subject with a copy of the signed and dated ICF and this will be documented in the subject’s source 
notes. 
 Investigator Information 
 Investigator Obligations 
This study will be conducted in accordance with the ICH-GCP (2016), the ethical principles that have 
their origin in the Declaration of Helsinki (2013) and local laws and regulations. 
The Investigator is responsible for ensuring that the study is conducted according to the signed 
Investigator statement, the study protocol and applicable regulations; for protecting the rights, safety 
and welfare of subjects under the Investigator’s care; and for the control of drugs under investigation. 
The Investigator must obtain the informed consent of each subject to whom IP is administered. 
 Coordinating Investigator 
The Sponsor will designate the Coordinating Investigator who will have the responsibility for the 
coordination of the Investigators in a multicentre clinical study. 
 Training of Investigator Site Personnel 
Before the first subject is enrolled into the study, a Sponsor representative will review and discuss the 
requirements of the clinical study protocol and related documents with the investigational staff and will 
also train them in any study-specific procedures. 
The Investigator will ensure that appropriate training relevant to the study is given to all investigational 
staff and that any new information relevant to the performance of this study is forwarded to the 
investigational staff involved. 
The Investigator will maintain a record of all individuals involved in the study (medical, nursing, and 
other investigational staff). 
 Protocol Signatures 
The Investigator must sign the Investigator Signature Page of this protocol prior to starting recruitment 
for the study. By signing the protocol, the Investigator confirms in writing that he/she has read, 
understands and will strictly adhere to the study protocol and will conduct the study in accordance with 
ICH-GCP and applicable regulatory requirements. 
 Financing and Insurance 
Samsung Bioepis is the Sponsor of this study and will be providing the finances to cover the operation 
of the study. Details of financial agreements are provided in the Clinical Study Agreements with the 


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Investigator sites and in contracts with other companies involved in the running of the study. 
The Sponsor has obtained suitable insurance for this study. A copy of the insurance details will be 
provided to each Investigator who will be responsible for providing the IRB/IEC with these details 
according to local requirements. 
12. Publication Policy 
The Sponsor supports the efforts of health authorities to increase the transparency of medical research 
conducted in human subjects. The Sponsor will register and maintain the information of clinical studies 
on a public registry program. The Sponsor is committed to the public disclosure of the results from 
clinical studies through posting on public clinical study data banks. The Sponsor will comply with the 
guidelines of regulatory authorities with regards to public registration and disclosure of clinical study 
data. 
The clinical study data collected during the study are confidential and proprietary to the Sponsor. 
Sponsor shall have the right to delete any confidential or proprietary information contained in any 
proposed abstract or presentation. 
Any publications from this study should be approved by the Sponsor prior to publication or presentation. 
The rights of the Investigator with regard to publication of this study are described in the Clinical Study 
Agreement. 
 
 


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13. References 
1. Global report on Psoriasis. WHO. (2016). Retrieved Feb 18, 2020 from 
https://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189 eng.pdf 
2. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and 
psoriatic arthritis. J Am Acad Dermatol. 2008; 56 (5): 826-850. 
3. Product Information of Stelara®. EMA. (Jan 29, 2021). Retrieved Feb 15, 2021 from 
https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-
information en.pdf 
4. European Public Assessment Report (EPAR) of Stelara®. EMA. (Feb 09, 2009). Retrieved Feb 
18, 2020 from https://www.ema.europa.eu/en/documents/assessment-report/stelara-epar-public-
assessment-report en.pdf 
5. Griffiths CE, Strober BE, van de Kerkhof P, et al. Comparison of ustekinumab and etanercept for 
moderate-to-severe psoriasis. N Engl J Med. 2010; 362 (2): 118-28. 
6. Biosimilar medicines: Overview. EMA. Retrieved Mar 09, 2020 from 
https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview 
7. Guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic. 
EMA. (Mar 2020, Version 4.0 on Feb 04, 2021). Retrieved Feb 15, 2021 from 
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-
10/guidanceclinicaltrials covid19 en.pdf 
8. Guidance on conduct of clinical trials of medical products during COVID-19 public health 
emergency. FDA. (Mar 2020, updated on Jan 27, 2021). Retrieved Feb 15, 2021 from 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-
conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency 
9. Prescribing Information of Stelara®. FDA. (Dec 11, 2020). Retrieved Feb 15, 2021 from 
https://www.accessdata.fda.gov/drugsatfda docs/label/2020/761044s008lbl.pdf 
10. Guideline on similar biological medicinal products containing biotechnology-derived protein as 
active substance: non-clinical and clinical issues. EMA. (Jul 01, 2015). Retrieved Feb 18, 2020 
from https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-
medicinal-products-containing-biotechnology-derived-proteins-active en-2.pdf 
11. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human 
interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a 
randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008; 371 (9625): 
1665-74. 
12. Papp KA, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human 
interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a 
randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008; 371 (96251675-
84. 
13. Fiorentino D, Ho V, Lebwohl MG, et al. Risk of malignancy with systemic psoriasis treatment in 
the Psoriasis Longitudinal Assessment Registry. J Am Acad Dermatol. 2017; 77(5): 845-854.e5 
14. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference 
product. FDA. (Apr 2015). Retrieved Feb 18, 2020 from 


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https://www.fda.gov/media/82647/download 
15. Guideline on similar biological medicinal products containing biotechnology-derived proteins as 
active substance: quality issues (revision 1). EMA. (Dec 01, 2014). Retrieved Feb 18, 2020 
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-
medicinal-products-containing-biotechnology-derived-proteins-active en-0.pdf 
16. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) -- a simple practical measure for 
routine clinical use. Clin Exp Dermatol. 1994; 19 (3), 210-06. 
17. Tsai TF, Ho JC, Song M, et al. Efficacy and safety of ustekinumab for the treatment of moderate-
to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean 
patients (PEARL). J Dermatol Sci. 2011; 63 (3): 154-63. 
18. Zhu X, Zheng M, Song M, et al. Efficacy and safety of ustekinumab in Chinese patients with 
moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS). J Drugs 
Dermatol. 2013; 12 (2): 166-74. 
19. Igarashi A, Kato T, Kato M, et al. Efficacy and safety of ustekinumab in Japanese patients with 
moderate-to-severe plaque-type psoriasis: long-term results from a phase 2/3 clinical trial. J 
Dermatol. 2012; 39 (3): 242-52. 
 
 
 


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APPENDIX I. Dermatology Life Quality Index Questionnaire 
Hospital No: 
Date: 
DLQI 
Name: 
Score: 
Address: 
Diagnosis: 
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER 
THE LAST WEEK. Please tick  one box for each question. 
1.
Over the last week, how itchy, sore, painful or
stinging has your skin been?
Very much 

A lot 

A little 

Not at all 

2.
Over the last week, how embarrassed or self
conscious have you been because of your skin?
Very much 

A lot 

A little 

Not at all 

3.
Over the last week, how much has your skin
interfered with you going shopping or looking after
your home or garden?
Very much 

A lot 

A little 

Not at all 

Not relevant

4.
Over the last week, how much has your skin
influenced the clothes you wear?
Very much 

A lot 

A little 

Not at all 

Not relevant

5.
Over the last week, how much has your skin affected
any social or leisure activities?
Very much 

A lot 

A little 

Not at all 

Not relevant

6.
Over the last week, how much has your skin made it
difficult for you to do any sport?
Very much 

A lot 

A little 

Not at all 

Not relevant

7.
Over the last week, has your skin prevented you from
working or studying?
If "No", over the last week how much has your skin
been a problem at work or studying?
Yes 

No 

Not relevant

A lot 

A little 

Not at all 

8.
Over the last week, how much has your skin created
problems with your partner or any of your close
friends or relatives?
Very much 

A lot 

A little 

Not at all 

Not relevant

9.
Over the last week, how much has your skin caused
any sexual difficulties?
Very much 

A lot 

A little 

Not at all 

Not relevant

10.
Over the last week, how much of a problem has the
treatment for your skin been, for example by making
your home messy, or by taking up time? 
Very much 

A lot 

A little 

Not at all 

Not relevant

Please check you have answered EVERY question. Thank you. 
© AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the permission of the authors. 




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SIGNATURE PAGE 
Declaration of the Principal Investigator 
Protocol Title: A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the 
Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (proposed ustekinumab 
biosimilar) Compared to Stelara® in Subjects with Moderate to Severe Plaque Psoriasis 
This clinical study protocol was subjected to critical review. The information it contains is consistent 
with current knowledge of the risks and benefits of the investigational medicinal product, as well as 
with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration 
of Helsinki, 2013 and the guidelines on Good Clinical Practice applicable to this clinical study. 
Principal Investigator 
Name: 
 
Institution: 
 
Signature: 
 
Date: 
 
 
 
 
(MMM DD, YYYY) 
 
 











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