A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis
Phase: PHASE3
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Sponsor: Biocon Biologics UK Ltd



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INVESTIGATOR SIGNATURE PAGE 
Protocol Title: 
A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 
Study to Compare the Efficacy and Safety of Bmab 1200 and Stelara® in 
Patients with Moderate to Severe Chronic Plaque Psoriasis 
Protocol Number: 
BM12H-PSO-03-G-02
Confidentiality and Current Good Clinical Practice (GCP)/E6(R2)/Compliance Statement 
 I, the undersigned, have reviewed this protocol, including appendices, and I will conduct 
the study as described in compliance with this protocol, GCP, and relevant International 
Council for Harmonisation (ICH) guidelines. 
 I am thoroughly familiar with the appropriate use of the study drug, as described in this 
protocol and any other information provided by Biocon Biologics UK Limited including, 
but not limited to, the current investigator’s brochure. 
 Once the protocol has been approved by the independent ethics committee 
(IEC)/institutional review board (IRB), I will not modify this protocol without obtaining 
prior approval of Biocon Biologics UK Limited and of the IEC/IRB. I will submit the 
protocol amendments and/or any informed consent form modifications to Biocon 
Biologics UK Limited and the IEC/IRB, and approval will be obtained before any 
amendments are implemented. 
 I ensure that all persons or party assisting me with the study are adequately qualified and 
informed about the Biocon Biologics UK Limited study drug and of their delegated 
study-related duties and functions as described in the protocol. 
 I ensure that source documents and trial records that include all pertinent observations on 
each of the site’s trial patients will be attributable, legible, contemporaneous, original, 
accurate, and complete.  
 I understand that all information obtained during the conduct of the study with regard to 
the patients’ state of health will be regarded as confidential. No patients’ names will be 
disclosed. All patients will be identified by assigned numbers on all case report forms, 
laboratory samples, or source documents forwarded to the Sponsor. Clinical information 
may be reviewed by the Sponsor or its agents or regulatory agencies. Agreement must be 
obtained from the patient before disclosure of patient information to a third party.
 Information developed in this clinical study may be disclosed by Biocon Biologics UK 
Limited to other clinical investigators, regulatory agencies, or other health authority or 
government agencies as required. 
<Name> 
<Title> 
Investigator Signature
<Institution>
Date (DD-Mmm-YYYY) 

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2
SYNOPSIS
Title of Study: 
A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 Study to 
Compare the Efficacy and Safety of Bmab 1200 and Stelara® in Patients with 
Moderate to Severe Chronic Plaque Psoriasis 
Protocol Number: 
BM12H-PSO-03-G-02 
Investigators/Study Sites: 
The study is planned to be conducted in Europe and North America across 
approximately 42 sites in 6 countries. 
Phase of Development: 
Phase 3 
Objectives: 
Primary Objective:
• 
To demonstrate equivalent efficacy between Bmab 1200 and Stelara® in 
patients with moderate to severe chronic plaque psoriasis. 
Secondary Objectives: 
• 
To assess the efficacy of Bmab 1200 based on other efficacy parameters and 
timepoints over the study period as compared with Stelara®. 
• 
To assess the safety and tolerability of Bmab 1200 as compared with Stelara®
over the study period. 
• 
To assess the immunogenicity of Bmab 1200 as compared with Stelara® over 
the study period. 
• 
To assess the PK of Bmab 1200 as compared with Stelara®. 
• 
To assess the safety and immunogenicity after switching from Stelara® to 
Bmab 1200. 
Study Endpoints: 
Primary Endpoint: 
• 
Percentage change from baseline in the Psoriasis Area and Severity Index 
(PASI) score at Week 12 (Time Frame: Baseline [Day 1] to Week 12). 
Secondary Endpoints:  
Efficacy Endpoints: 
• 
Percentage change from baseline in the PASI score at Weeks 4, 8, 16, 20, 28, 
40, and 52 (Time Frame: Baseline [Day 1] through Weeks 28 and 52). 
• 
PASI improvement of 50% relative to baseline (PASI 50), PASI 
75% relative to baseline (PASI 75), and PASI improvement 
of 90% relative to baseline (PASI 90) at Weeks 4, 8, 12, 16, 20, 28, 40, and 
52 (Time Frame: Baseline [Day 1] through Weeks 28 and 52). 
• 
Static Physician’s Global Assessment (sPGA) response of cleared or almost 
clear/minimal (PGA of 0 or 1) at Weeks 4, 8, 12, 16, 20, 28, 40, and 52 (Time 
Frame: Baseline [Day 1] through Weeks 28 and 52). 
• 
Area under effect curves (AUECs) of PASI score from baseline to Week 12 
(Time Frame: Baseline [Day 1] through Week 12). 
• 
Raw PASI scores at Weeks 4, 8, 12, 16, 20, 28, 40, and 52 (Time Frame: 
Baseline [Day 1] through Weeks 28 and 52). 
• 
Change from baseline in affected body surface area (BSA) at Weeks 4, 8, 12, 
16, 20, 28, 40, and 52 (Time Frame: Baseline [Day 1] through Weeks 28 and 
52). 
• 
Change from baseline in quality of life (QoL) as measured by Dermatology 
Life Quality Index (DLQI) scores at Weeks 4, 8, 12, 16, 20, 28, 40, and 52 
(Time Frame: Baseline [Day 1] through Weeks 28 and 52). 
Safety Endpoints: 
• 
Treatment-emergent adverse events (TEAEs) including adverse events of 
special interest (AESIs) and adverse reactions (ADRs) during the treatment 
periods (Time Frame: Baseline [Day 1] through Weeks 28 and 52). 

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All continuing patients who receive study treatment at the baseline visit and Week 4 
and achieve at least PASI 50 response by Week 12 will be rerandomized before 
receiving study treatment at Week 16. Before dosing at Week 16, patients in the 
Stelara® arm will be randomly assigned in a 1:1 ratio to receive either Bmab 1200 or 
Stelara® at Week 16. This is done to obtain data after a single switch in patients who 
have been treated with Stelara®. To maintain the study blinding, the patients in the 
original Bmab 1200 group will also go through the rerandomization procedure; 
however, they will be assigned and continue to receive Bmab 1200. The 
rerandomization will take place using the original strata used for the randomization 
at baseline. 
TP3 - From Week 28 dosing to Week 52:  
All continuing patients who complete TP2 (receive study treatment at the baseline 
visit and Weeks 4 and 16) and achieve at least PASI 75 response at Week 28 will be 
offered to enter TP3 of the study to continue the same treatment they were 
rerandomized to receive during TP2 (Bmab 1200 or Stelara®) in a blinded manner.  
For patients not eligible to enter the TP3, the end of study visit will occur at Week 
28. 
 
During the double-blind, active-controlled treatment period, all randomized patients 
will be evaluated for efficacy, safety, tolerability, PK, and immunogenicity at 
scheduled visits per the Schedule of Assessments (Table 1). All assessments except 
for those related to the occurrence of injection site and hypersensitivity reactions 
will take place before the administration of study treatment at the baseline visit and 
Weeks 4, 16, 28, and 40. 
Efficacy assessments will include the clinician’s assessments of PASI, sPGA, BSA, 
and patient’s reported QoL measured by DLQI (see Table 1 for all the scheduled 
visits). Refer to Section 11 for more details on efficacy assessments. 
Safety and tolerability will be assessed by monitoring adverse events (AEs), 
injection site reactions and hypersensitivity, vital signs, physical examination, 
12 -lead ECG, and safety laboratory tests (hematology, chemistry, and urinalysis) at 
scheduled visits (see Table 1 for all the scheduled visits). Complete details on the 
safety and tolerability assessments are provided in Section 12. 
For the PK and immunogenicity assessments, blood samples will be collected at the 
Baseline visit (predose), Week 2, Week 4 (predose), Week 8, Week 12, Week 16 
(predose), Week 20, Week 28 (predose), Week 40 (predose), and Week 52. Serum 
levels of ustekinumab, as well as the presence and titer of ADAs and NAbs, will be 
evaluated for both the Bmab 1200 and Stelara® arms.  
All patients will have an end of study (EOS) visit at Week 52 for efficacy, safety, 
PK, and immunogenicity assessments as per the Schedule of Assessments (Table 1). 
Patients who discontinue study treatment before the end of Week 16 will be 
followed up for efficacy to the Week 16 scheduled assessment. However, the 
primary endpoint analysis will be done at Week 12 only. Patients who discontinue 
study treatment on or after Week 16 dosing and before the Week 28 dosing will be 
followed up for efficacy to the Week 28 scheduled assessment. Any patient that 
discontinues study treatment during TP1 or TP2 will be followed up for safety and 
immunogenicity to Week 28 and will then be discontinued from the study. Patients 
who discontinue study treatment on or after Week 28 dosing (ie, during TP3) will be 
followed up for efficacy, safety and immunogenicity to the EOS at Week 52.  
Every reasonable effort will be made to contact early discontinued patients who are 
lost to follow-up to obtain further safety information. Details regarding follow-up 
efforts are to be documented in the patient’s medical records/source documentation. 
Selection of Patients: 
Inclusion Criteria: 
Individuals must meet all of the following criteria to be included in the study: 

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4. Patient has an underlying condition (including, but not limited to metabolic, 
hematologic, renal, hepatic, pulmonary, neurologic including central 
nervous system demyelinating disease, endocrine, cardiac, infection, or 
gastrointestinal) which, in the opinion of the investigator, significantly 
immune-compromises the patient and/or places the patient at unacceptable 
risk for receiving an immunomodulatory therapy. 
5. Patient had a major surgical intervention within 12 weeks of the baseline or 
planned major surgery during the study period. 
6. Patient who has prior exposure to more than 1 biologic agent for the 
treatment of psoriasis or psoriatic arthritis. 
7. Patient who has received or plans to receive any of the following prohibited 
medications or treatment that could affect psoriasis: 
a) Topical therapies for the treatment of psoriasis (including, but not 
limited to, corticosteroids, vitamin D analogs, calcineurin inhibitors or 
retinoids) within 2 weeks before the baseline visit. However, 
restricted use of rescue topical treatment may be allowed as per 
Section 9.8. 
b) Ultraviolet A phototherapy (with or without oral psoralen) or 
ultraviolet B phototherapy for the treatment of psoriasis within 
4 weeks before the baseline visit. 
c) Systemic steroids within 4 weeks before the baseline visit.   
d) Any nonbiologic systemic therapies for the treatment of psoriasis or 
psoriatic arthritis within 4 weeks before the baseline visit. 
e) Any biologic systemic therapy with a mechanism of action that could 
impact the course of psoriasis/psoriatic arthritis or its evaluations, 
within 5 half-lives or 90 days, whichever is longer, before the baseline 
visit. 
f) 
Any monoclonal antibody (mAb) within 5 half-lives or 90 days, 
whichever is longer, before the baseline visit. 
g) Any drug that directly targets interleukin (IL)-12, IL-17, or IL-23 
including ustekinumab either investigational or approved. 
h) Any investigational drug other than study treatment within 4 weeks or 
5 half-lives (whichever is longer) before the baseline visit. 
i) 
Any other drug that may impact psoriasis (eg, beta-blockers, lithium, 
antimalarials) within 4 weeks before the baseline visit. 
Note: However, patients on stable doses of beta-blockers for 3 months 
before the baseline visit are allowed. 
j) 
Herbal or any nonpharmaceutical medicine to treat psoriasis within 2 
weeks before the baseline visit. 
8. Patient has received a live or live-attenuated vaccine within 4 weeks before 
the baseline visit. Patient must agree not to receive a live or live-attenuated 
vaccine during the study and up to 15 weeks after the last dose of the study 
treatment. 
9. Patient who has had Bacillus Calmette-Guérin (BCG) vaccination within 1 
year before the baseline visit. Patients must agree not to receive a BCG 
vaccination during the study and at least 1 year after the last dose of the 
study treatment. 
10. Patient who had confirmed coronavirus disease 2019 (COVID-19) infection 
and was hospitalized requiring oxygen in the last 8 weeks prior to 
screening. In case of asymptomatic/mildly symptomatic patient with 
confirmed COVID-19 infection during the last 4 weeks prior to screening, 
and who have not recovered from COVID-19 as per site and/ local 
regulatory guidelines at screening, would also be excluded from the study. 

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patients including a dropout rate of 10% patients ensures a power of 85% with a two 
one-sided 5% level of significance.
Statistical Methods and 
Planned Analyses: 
Statistical analysis will be performed using SAS software Version 9.4 or later (SAS 
Institute, Cary, NC). Unless otherwise specified, continuous variables will be 
summarized using the mean, SD, median, minimum value, and maximum value, by 
treatment group. Categorical variables will be summarized using frequency counts 
and percentages by treatment group. Data will be listed in data listings. 
All CIs presented, except for the primary endpoint (percentage change from baseline 
in the PASI score) will be two-sided 95% CIs, unless otherwise specified. For the 
primary efficacy endpoint, a 90% CI will be presented, and equivalence will be 
established if the 90% CI falls entirely within the predefined margin of ±10%; this 
approach is equivalent to two one-sided tests (TOST) at the 5% significance level. 
Unless otherwise specified, analyses for TP1 will be presented by treatment group 
(Bmab 1200, Stelara®) up to predose Week 16. However, the primary endpoint 
analysis will be done at Week 12 only. Analyses for TP2 and TP3 will be presented 
by the treatment regimen (Bmab 1200-Bmab 1200, Stelara®-Bmab 1200, Stelara®-
Stelara®).  
Analysis Sets: 
Full Analysis Set (FAS): The FAS will consist of all patients who sign the ICF and 
are randomized into TP1. The FAS will be used for the primary analyses of efficacy. 
Per-Protocol Set (PPS): The PPS will consist of all patients in the FAS, who receive 
at least 2 study treatment administrations (Baseline and Week 4), and do not 
experience any important protocol deviations affecting primary efficacy at Week 12. 
The PPS will be used for supportive analyses of efficacy.  
Safety Set (SAF): The SAF will consist of all patients who receive at least one study 
treatment administration. The SAF will be used for analyzing safety and 
immunogenicity data during the treatment period. The SAF will be used for all 
analyses of safety and immunogenicity. 
PK Set (PKS): The PKS will consist of all patients who receive at least one full dose 
of study treatment and have at least 1 post-treatment PK result before Week 16, 
excluding observations after relevant intercurrent events (ICEs) that may impact PK 
evaluations (eg, missing a dose, errors or deviations in dosing or receipt of other 
therapies which also contain ustekinumab). The PKS will be used for analyses of 
PK. 
Further analysis sets are proposed for the analyses of TP2 and TP3. See 
Section 15.2. 
Efficacy Analysis: 
The statistical hypothesis associated with the primary efficacy analysis of the 
percentage change from baseline in the PASI score at Week 12 is: 
 
H0: (µBmab 1200 - µStelara 
 -10%) or (µBmab 1200 - µStelara 
 +10%) 
 
H1: -10% < µ Bmab 1200 - µStelara < +10% 
where µBmab 1200 and µStelara denote the true mean percentage change from baseline in 
the PASI score at Week 12 for Bmab 1200 and Stelara®, respectively.   
The estimand framework will be applied for the primary efficacy endpoint, per 
International Council for Harmonisation (ICH) E9 addendum. ICEs are described in 
Section 15.5.1.2. The primary estimand is aligned with a treatment policy approach 
for all ICEs except death. The estimate of the treatment effect in this instance will be 
influenced by any effects of prohibited medication that are used to treat psoriasis, 
missing or early/late treatment, and/or premature discontinuation where a poor 
outcome may not be expected. 

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efficacy. The handling of estimands as detailed above will also only apply up to and 
including Week 16. After this point, data will only be analyzed as observed.
Safety Analysis:  
Safety data reported during TP1, TP2, and TP3 will be separately analyzed by 
treatment group on the SAF or by treatment regimen on the SAF for TP2 and/or 
TP3, respectively.  
AEs will be classified according to the time of onset of the AE into pretreatment 
AEs, TEAEs and post-treatment-emergent AEs. All reported AEs will be coded 
using the most recent version of the Medical Dictionary for Regulatory Activities 
(MedDRA) coding dictionary. An overall summary of incidence will be presented 
for TEAEs, treatment-emergent serious adverse events (SAEs), study treatment-
related TEAEs and treatment-emergent SAEs, TEAEs leading to study 
discontinuation, TEAEs leading to discontinuation of study treatment (Bmab 1200 
or Stelara®), and AESIs by treatment period and treatment/regimen. Additional 
summaries of these AEs will be presented by MedDRA system organ class (SOC) 
and preferred term (PT), by treatment period and treatment/regimen. The clinical 
safety laboratory test values, vital signs, ECG parameter values, and physical 
examinations will be summarized by treatment period and treatment/regimen. For 
laboratory parameters and vital signs, original results and change from baseline will 
be summarized at each visit. Potentially clinically significant values will be flagged 
and summarized. 
PK Analysis:  
Serum concentrations of Bmab 1200 and Stelara® will be listed and descriptively 
summarized by treatment (Bmab 1200, Stelara®) and visit for TP1 and by treatment 
regimen (Bmab 1200-Bmab 1200, Stelara®-Bmab 1200, Stelara®-Stelara®) and visit 
for TP2 and TP3. Descriptive statistics will include arithmetic and geometric mean, 
SD, coefficient of variation and geometric coefficient of variation, minimum, 
maximum, and median, plus percentage of concentration values below the lower 
limit of quantification. Additional subgroup analyses of PK data by treatment and 
ADA status will be presented. 
Immunogenicity Analysis:  
Incidence of ADAs to Bmab 1200 and Stelara® including titer and NAbs will be 
descriptively summarized at each time point and cumulative up to the time point by 
treatment (Bmab 1200, Stelara®) for TP1 and by treatment regimen (Bmab 1200 
Bmab 1200, Stelara®-Bmab 1200, Stelara®-Stelara®) for TP2 and TP3. The titer 
values for positive ADA will be descriptively summarized. 
 

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3
TABLE OF CONTENTS 
1
FINAL CLINICAL STUDY PROTOCOL .............................................................................1
2
SYNOPSIS ..............................................................................................................................4
3
TABLE OF CONTENTS ......................................................................................................15
3.1 
List of In-text Tables ........................................................................................................19
3.2 
List of In-text Figures .......................................................................................................19
4
LIST OF ABBREVIATIONS ...............................................................................................20
5
INTRODUCTION .................................................................................................................22
5.1 
Background on Plaque Psoriasis ......................................................................................22
5.2 
Background on Study Treatments ....................................................................................22
5.2.1 
Background on Bmab 1200 ......................................................................................22
5.2.1.1
Nonclinical Studies ............................................................................................23
5.2.1.2
Clinical Studies ..................................................................................................23
5.2.2 
Background on reference product Stelara® (ustekinumab) ......................................24
5.3 
Clinical Risks/Benefits of Bmab 1200 .............................................................................26
5.4 
Study Rationale ................................................................................................................27
6
STUDY OBJECTIVES AND ENDPOINTS ........................................................................29
6.1 
Study Objectives ...............................................................................................................29
6.1.1 
Primary Objective ....................................................................................................29
6.1.2 
Secondary Objectives ...............................................................................................29
6.2 
Study Endpoints................................................................................................................29
6.2.1 
Primary Endpoint .....................................................................................................29
6.2.2 
Secondary Endpoints ................................................................................................29
6.2.2.1
Efficacy Endpoints .............................................................................................29
6.2.2.2
Safety Endpoints ................................................................................................30
6.2.3 
Immunogenicity Endpoints ......................................................................................30
6.2.4 
Pharmacokinetic Endpoints......................................................................................30
7
INVESTIGATIONAL PLAN ...............................................................................................31
7.1 
Description of Overall Study Design and Plan .................................................................31
7.2 
Discussion of Study Design..............................................................................................33
7.3 
End of Study .....................................................................................................................34
8
SELECTION OF STUDY POPULATION ...........................................................................35
8.1 
Inclusion Criteria ..............................................................................................................35
8.2 
Exclusion Criteria.............................................................................................................36

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8.3 
Rescreening/Retesting ......................................................................................................39
8.4 
Study Withdrawal, Removal, and Replacement of Patients .............................................40
8.4.1 
Pregnancy.................................................................................................................41
8.4.2 
Completion of the Study or Lost to Follow-up ........................................................42
9
TREATMENTS .....................................................................................................................43
9.1 
Details of Study Treatments .............................................................................................43
9.1.1 
Identity of Study Treatments ....................................................................................43
9.1.2 
Packaging and Storage .............................................................................................43
9.1.3 
Study Drug Retention, Return and Destruction .......................................................44
9.2 
Method of Administration of Study Treatments ..............................................................44
9.3 
Measures to Minimize Bias: Study Treatment Assignment and Blinding .......................44
9.3.1 
Method of Study Treatment Assignment .................................................................44
9.3.2 
Blinding....................................................................................................................45
9.4 
Dosage Modification ........................................................................................................46
9.5 
Treatment Accountability and Compliance ......................................................................46
9.6 
Prior and Concomitant Therapy .......................................................................................47
9.7 
Prohibited Therapies .........................................................................................................47
9.8 
Permitted Medications ......................................................................................................48
9.9 
Intervention After the End of the Study ...........................................................................49
10
STUDY PROCEDURES.......................................................................................................50
10.1 Informed Consent.............................................................................................................55
10.2 Study Procedures ..............................................................................................................55
11
EFFICACY ASSESSMENTS ...............................................................................................57
11.1 Psoriasis Area Severity Index ...........................................................................................57
11.2 Static Physician’s Global Assessment..............................................................................57
11.3 Body Surface Area ...........................................................................................................57
11.4 Dermatology Life Quality Index ......................................................................................57
12
SAFETY ASSESSMENTS ...................................................................................................59
12.1 Medical History ................................................................................................................59
12.2 Vital Signs ........................................................................................................................59
12.3 Physical Examination.......................................................................................................59
12.4 Electrocardiograms ...........................................................................................................60
12.5 Laboratory Assessments...................................................................................................60
12.5.1 
Laboratory Assessments at Screening......................................................................61
12.5.2 
Viral Serology Tests .................................................................................................61

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12.5.3 
Interferon-
 ..............................................................................62
12.6 Injection Site Reaction Monitoring ..................................................................................62
12.7 Hypersensitivity Monitoring ............................................................................................62
12.8 Adverse Events .................................................................................................................62
12.8.1 
Adverse Events ........................................................................................................62
12.8.1.1
Eliciting and Documenting Adverse Events ......................................................63
12.8.1.2
Action Taken with Study Treatment ..................................................................65
12.8.1.3
Outcome of Adverse Events ...............................................................................65
12.8.1.4
Adverse Event Reporting ...................................................................................66
12.8.1.5
Follow-Up of Patients Reporting Adverse Events .............................................66
12.8.2 
Adverse Events of Special Interest ..........................................................................66
12.8.3 
Serious Adverse Events ...........................................................................................68
12.8.3.1
Serious Adverse Events Reporting.....................................................................69
12.8.4 
Suspected Unexpected Serious Adverse Reactions .................................................70
12.8.5 
Pregnancy.................................................................................................................70
12.8.6 
Overdose, Underdose, and Medication Error ...........................................................71
12.9 Tuberculosis Assessment..................................................................................................71
12.9.1 
Chest Radiography...................................................................................................72
13
PHARMACOKINETICS ......................................................................................................73
14
IMMUNOGENICITY ASSESSMENTS ..............................................................................74
15
STATISTICAL ANALYSIS .................................................................................................75
15.1 Determination of Sample Size..........................................................................................75
15.2 Analysis Sets ....................................................................................................................76
15.3 Patient Disposition............................................................................................................77
15.4 Demographic and Baseline Characteristics......................................................................77
15.5 Efficacy Analysis..............................................................................................................78
15.5.1 
Analysis of the Primary Efficacy Endpoint .............................................................78
15.5.1.1
Statistical Hypothesis .........................................................................................78
15.5.1.2
Intercurrent Events .............................................................................................78
15.5.1.3
Estimands for the Primary Efficacy Endpoint....................................................79
15.5.1.4
Sensitivity and Supportive Analyses of the Primary Efficacy Endpoint ...........82
15.5.2 
Analysis of Secondary Efficacy Endpoints ..............................................................83
15.6 Safety Analyses ................................................................................................................84
15.6.1 
Adverse Events ........................................................................................................85

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15.6.2 
Analysis of Other Safety Endpoints.........................................................................85
15.7 Pharmacokinetic Analysis ................................................................................................85
15.8 Immunogenicity Analyses ................................................................................................86
15.9 Handling of Missing Data ................................................................................................86
15.10 Interim Analysis ...............................................................................................................87
15.11 Protocol Deviations Leading to Exclusion from the Per-Protocol Set .............................87
15.12 COVID-19 ........................................................................................................................87
16
STUDY MANAGEMENT ....................................................................................................89
16.1 Approval and Consent......................................................................................................89
16.1.1 
Regulatory Guidelines ..............................................................................................89
16.1.2 
Confidentiality .........................................................................................................89
16.1.3 
Data Protection.........................................................................................................89
16.1.4 
Institutional Review Board/Independent Ethics Committee ....................................89
16.1.5 
Patient Information and Informed Consent ..............................................................90
16.2 Data Handling/Management .............................................................................................90
16.3 Source Documents ............................................................................................................91
16.4 Record Retention ..............................................................................................................91
16.5 Monitoring ........................................................................................................................91
16.5.1 
Monitoring of the Study ...........................................................................................91
16.5.2 
Inspection of Records ...............................................................................................92
16.6 Quality Control and Quality Assurance ...........................................................................92
16.7 Protocol Amendment and Protocol Deviation..................................................................92
16.7.1 
Protocol Amendment ...............................................................................................92
16.7.2 
Protocol Deviations..................................................................................................92
16.8 Ethical Considerations ......................................................................................................93
16.9 Financing and Insurance ...................................................................................................93
16.10 Publication Policy/Disclosure of Data and Clinical Study Reporting ..............................93
17
REFERENCES ......................................................................................................................94
18
APPENDICES .......................................................................................................................96
APPENDIX 1.  CONTRACEPTION GUIDELINES ..................................................................97
APPENDIX 2.  PSORIASIS AREA SEVERITY INDEX .........................................................100
APPENDIX 3.  STATIC PHYSICIAN’S GLOBAL ASSESSMENT.......................................101
APPENDIX 4.  DERMATOLOGY LIFE QUALITY INDEX ..................................................102
APPENDIX 5.  BODY SURFACE AREA INVOLVEMENT ..................................................103

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3.1
List of In-text Tables 
Table 1. Schedule of Assessments ..............................................................................................51
Table 2. Laboratory assessment ..................................................................................................60
Table 3.
Eligibility Based on Serologic Markers for Hepatitis B Infection................................61
Table 4. Intercurrent Events ........................................................................................................78
Table 5. Estimands for the Primary Efficacy Endpoint ..............................................................79
Table 6. Sensitivity and Supportive Analyses .............................................................................82
3.2
List of In-text Figures
Figure 1. Study Design Schematic ...............................................................................................33

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4
LIST OF ABBREVIATIONS 
Abbreviation
Definition
ADA
antidrug antibody
ADR 
adverse reaction 
AE
adverse event 
AESI
adverse event of special interest
ANCOVA
analysis of covariance 
AUEC 
area under effect curve 
BCG 
BDRM
Bacillus Calmette-Guérin
Blinded Data Review Meeting 
BSA
body surface area
CI
confidence interval
CMH
Cochran-Mantel-Haenszel 
COVID-19 
coronavirus disease 2019 
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLQI
Dermatology Life Quality Index 
ECG 
electrocardiogram 
eCRF
electronic case report form
EOS
end of study 
EU
European Union 
FAS 
Full Analysis Set 
FAS2
Full Analysis Set for treatment period 2 
FDA 
HBcAb 
Food and Drug Administration 
hepatitis B core antibody
HBsAb
hepatitis B surface antibody
HBsAg
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV
hepatitis C virus
HIV 
human immunodeficiency virus 
HRT 
hormone replacement therapy 
IB 
Investigator’s Brochure 
ICE 
intercurrent event
ICF 
informed consent form
ICH
International Council for Harmonisation 
IEC 
independent ethics committee 
IGRA 
interferon-
 
IL 
interleukin 
IRB
institutional review board 
mAb 
monoclonal antibody 
MAR
missing-at-random 

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Abbreviation
Definition
MedDRA  
Medical Dictionary for Regulatory Activities 
MI 
multiple imputation 
MNAR
missing-not-at-random
NAb
neutralizing antibody  
PASI 
Psoriasis Area and Severity Index 
PASI 
50/75/90/100
Psoriasis Area and Severity Index 
to baseline
PFS
prefilled syringe  
PGA 
Physician’s Global Assessment
PK
pharmacokinetic(s)
PKS 
Pharmacokinetic Set 
PKS2
Pharmacokinetic Set for treatment period 2 
PMDA 
Pharmaceuticals and Medical Devices Agency 
PPS
Per-Protocol Set 
PRES
posterior reversible encephalopathy syndrome  
PT 
preferred term
QoL 
quality of life
RNA 
ribonucleic acid 
RTSM 
Randomization and Trial Supply Management
SAE
serious adverse event
SAF 
Safety Set
SAF2
Safety Set for treatment period 2 
SAP 
statistical analysis plan 
SD
standard deviation
SOC 
system organ class
sPGA
static Physician’s Global Assessment 
SUSAR 
suspected unexpected serious adverse reaction 
TB
tuberculosis
TEAE
treatment-emergent adverse event
TOST 
two one-sided tests 
TP1
treatment period 1
TP2
treatment period 2
TP3
treatment period 3
UK 
United Kingdom 
US
United States 
ULN 
upper limit of normal 
WHO
World Health Organization

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5
 INTRODUCTION
5.1
Background on Plaque Psoriasis
Psoriasis is a chronic, immune-mediated, inflammatory condition that affects more than 8 million 
people in the United States and approximately 125 million people (2% to 3% of the total 
population) worldwide.1 In Europe, the prevalence of psoriasis among adults varies 
geographically. In Southern and North Eastern Europe, 3% to 5% of the population are affected, 
compared to just over 1% of the population in the United Kingdom (UK).2 Psoriasis is 
characterized by scaly, erythematous papules, and plaques that are often pruritic. There are many 
types of psoriasis, including guttate psoriasis, pustular psoriasis, plaque psoriasis, inverse 
psoriasis, and erythrodermic psoriasis. The most common type is plaque psoriasis, affecting 80% 
to 90% of patients. In individuals with lighter skin complexion, plaque psoriasis typically 
appears as raised, red patches covered with a silvery white buildup of dead skin cells or scale. On 
skin of color, the discoloration is darker and thicker, and more of a purple or grayish color or 
darker brown. These patches or plaques most often appear on the scalp, knees, elbows and lower 
back, and their size can range between 1 and >10 cm in diameter.3,4 Psoriasis may reduce 
physical and mental functioning, affects psychosocial functions, and also significantly affects 
health- related quality of life (QoL).5,6,7 
Treatment options for psoriasis include topical treatments for milder disease, and systemic 
treatments for moderate to severe disease that does not respond sufficiently to topical treatments. 
Topical treatments include corticosteroids, anthralin, synthetic vitamin D3, and vitamin A. 
Systemic therapies include phototherapy including psoralen and ultraviolet A, acitretin, 
cyclosporine, methotrexate, apremilast, and various systemic biologic products. Biologic 
products work by interfering with specific components of the autoimmune response, including 
tumor necrosis factor al
) or various interleukin (IL) inhibitors. 
5.2
Background on Study Treatments 
5.2.1
Background on Bmab 1200 
Bmab 1200 is a fully human immunoglobulin G subunit 1 kappa (
) monoclonal antibody 
(mAb) that is being developed as a proposed biosimilar medicinal product to the reference 
product, Stelara® (ustekinumab) marketed by Janssen Biotech Inc. Stelara® was originally 
approved in the European Union (EU) in January 2009 and in the United States in September 
2009. Stelara® is indicated for the following conditions: moderate to severe plaque psoriasis, 
active psoriatic arthritis, and moderately to severely active Crohn’s disease and ulcerative 
colitis.8,9 
Bmab 1200 is of approximate molecular weight of 148 600 Daltons and composed of 
1326 amino acid residues with 2 identical heavy and light chains linked by covalent disulfide 
bonds and noncovalent heavy-heavy and heavy-light chain interactions. All cysteine residues are 
involved in disulphide bonds resulting in a total of 16 disulphide bonds. 

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Physicochemical/analytical comparability evaluations have been done to show that Bmab 1200 is 
of similar quality profile as that of Stelara®. Details are provided in the Investigator’s Brochure 
(IB).10
5.2.1.1
Nonclinical Studies
Nonclinical Pharmacology 
The primary pharmacodynamic studies conducted with Bmab 1200 included multiple assays for 
measuring Fab and Fc functionality such as p40 binding potency, neutralization of IL-12 induced 
Signal Transducer and Activator of Transcription (STAT)-4 activation, IL-12 and IL-23 binding, 
neutralization of IL-23 induced STAT-3 activation, neutralization of IL-
-V158
-
. 
These assays demonstrated that Bmab 1200 had potency comparable to US-Licensed Stelara® 
and EU-Approved Stelara® for the various batches analyzed. 
Toxicology 
No pharmacokinetic (PK), toxicokinetic (TK), antidrug antibody (ADA) evaluation and 
toxicology have been performed yet for Bmab 1200. 
Based on appropriate Food and Drug Administration (FDA) and EMEA guidelines as well as the 
feedback received from FDA type 2 meeting (Reference ID: 4796456) and EMA Scientific 
Advice (EMEA/H/SA/4410/1/2020/III) in vivo studies are deemed not necessary for the 
establishment of biosimilarity, as functional assays performed as a part of primary 
pharmacodynamics are highly sensitive in detecting differences between Bmab 1200, US-
Licensed Stelara® and EU-Approved Stelara®. 
A detailed description of nonclinical studies is provided in the IB.10 
5.2.1.2 Clinical Studies 
To date, 2 clinical studies have been initiated with Bmab 1200. As part of the biosimilar 
development program and in accordance with the applicable biosimilar guidelines, the following 
clinical studies with Bmab 1200 have been initiated: 
 Study BM12H-NHV-01-G-01: A randomized, double-blind, 3-arm, parallel design study 
in healthy volunteers to evaluate the PK, safety, tolerability, and immunogenicity of 
Bmab 1200 after single subcutaneous injection (45 mg) in comparison with EU-approved 
Stelara® and US-licensed Stelara®. 
 Study BM12H-PSO-03-G-02 (present study): A randomized, double-blind, parallel 
group, multicenter, Phase 3 study to compare the efficacy and safety of Bmab 1200 and 
Stelara® in patients with moderate to severe chronic plaque psoriasis. 
Information from clinical studies conducted with Stelara® in psoriasis is summarized in 
Section 5.2.2. 

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5.2.2
Background on reference product Stelara® (ustekinumab)  
Ustekinumab is a recombinant, fully human immunoglobulin G subunit 1 kappa (
) mAb 
that binds with specificity to the shared p40 protein subunit of human cytokines IL-12 and IL-23. 
These are naturally occurring proteins that regulate the immune system and immune-mediated 
inflammatory disorders. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by 
preventing p40 from binding to the IL-
immune cells. Ustekinumab cannot bind to IL-12 or IL-23 that is already bound to IL-
surface receptors. Thus, ustekinumab is not likely to contribute to complement- or 
antibody-mediated cytotoxicity of cells with IL-12 and/or IL-23 receptors. IL-12 and IL-23 are 
heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and 
dendritic cells, and both cytokines participate in immune functions. IL-12 stimulates natural 
killer (NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 cell (Th1) 
phenotype, IL-23 induces the T helper 17 cell (Th17) pathway. However, abnormal regulation of 
IL-12 and IL-23 has been associated with immune-mediated diseases, such as psoriasis and 
psoriatic arthritis. By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert 
its clinical effects in psoriasis and psoriatic arthritis through interruption of the Th1 and Th17 
cytokine pathways, which are central to the pathology of these diseases.8,9 
In adult patients with plaque psoriasis, Stelara® is administered subcutaneously at an initial dose 
of 45 mg, followed by a dose of 45 mg after 4 weeks, and then every 12 weeks thereafter. For 
patients with a body weight of >100 kg, an initial dose of 90 mg is recommended because of 
better efficacy, followed by a dose of 90 mg after 4 weeks, and then every 12 weeks thereafter.
The safety and efficacy of ustekinumab for treatment of moderate to severe plaque psoriasis was 
assessed in 2 multicenter, randomized, double-blind, and placebo-controlled studies in patients 
who were candidates for phototherapy or systemic therapy (PHOENIX 1 and PHOENIX 2). In 
addition, a randomized, assessor-blind, and active-controlled study compared ustekinumab and 
etanercept in patients with moderate to severe plaque psoriasis who had an inadequate response 
to, intolerance to, or contraindication to cyclosporin, methotrexate, or psoralen and ultraviolet A.
Psoriasis Study 1 (PHOENIX 1) evaluated 766 patients. Patients randomized to ustekinumab 
received 45 mg or 90 mg doses at Weeks 0 and 4 followed by the same dose every 12 weeks. 
Patients originally randomized to ustekinumab who achieved Psoriasis Area and Severity Index 
(PASI) 
(PASI 75) at both Weeks 28 and 40 were 
re-randomized to receive ustekinumab every 12 weeks or to receive placebo (ie, withdrawal of 
therapy). 
At Week 12, PASI 75 was achieved by 171 (67.1%) patients who received ustekinumab 45 mg 
and 170 (66.4%) patients who received ustekinumab 90 mg, as compared with 8 (3.1%) patients 
who received placebo (difference in response rate versus placebo 63.9%, 95% confidence 
interval [CI] 57.8-70.1, P <0.0001 for 45 mg and 63.3%, 57.1-69.4, P <0.0001 for 90 mg). At 
Week 40, long-term response had been achieved by 150 patients in the 45 mg group and 
172 patients in the 90 mg group. Of these, 162 patients were randomly assigned to maintenance 

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ustekinumab and 160 to withdrawal. PASI 75 response was better maintained to at least 1 year in 
those receiving maintenance ustekinumab than in those withdrawn from treatment at Week 40 
(P <0.0001 by log-rank test).11
In a long-term study, initial clinical responses were generally maintained through Week 244 
(PASI 75: 63.4% and 72.0%; PASI improvement of 90% relative to baseline [PASI 90]: 39.7% 
and 49.0%; PASI improvement of 100% relative to baseline [PASI 100]: 21.6% and 26.4%) for 
patients receiving 45 mg and 90 mg, respectively. Similarly, PASI 75 responses were generally 
maintained among initial responders (79.1% [45 mg] and 80.8% [90 mg]) and partial responders 
(57.6% [45 mg] and 55.1% [90 mg]).12 
Psoriasis Study 2 (PHOENIX 2) evaluated 1230 patients. Patients randomized to ustekinumab 
received 45 or 90 mg doses at Weeks 0 and 4 followed by an additional dose at Week 12. All 
patients were followed for up to Week 52 after first administration of study treatment. 
At Week 12, PASI 75 was achieved by 273 (66.7%) patients who received ustekinumab 45 mg 
and 311 (75.7%) patients who received ustekinumab 90 mg, as compared with 15 (3.7%) patients 
who received placebo (difference in response rate 63.1%, 95% CI 58.2-68.0, P <0.0001 for the 
45 mg group versus placebo and 72.0%, 67.5-76.5, P <0.0001 for the 90 mg group versus
placebo). More partial responders at Week 28 who received ustekinumab 90 mg every 8 weeks 
achieved PASI 75 at Week 52 than did those who continued to receive the same dose every 
12 weeks (22 [68.8%] versus 11 [33.3%]; difference in response rate 35.4%, 95% CI 12.7-58.1, 
P =0.004).13
Psoriasis Study 3 (ACCEPT) evaluated 903 patients with moderate to severe psoriasis who 
inadequately responded to, were intolerant to, or had a contraindication to other systemic therapy 
and compared the efficacy of ustekinumab to etanercept and evaluated the safety of ustekinumab 
and etanercept. During the 12-week active-controlled portion of the study, patients were 
randomized to receive etanercept (50 mg twice a week), or ustekinumab 45 mg, or ustekinumab 
90 mg (at Weeks 0 and 4). 
At Week 12, PASI 75 was achieved by 67.5% of patients who received 45 mg of ustekinumab 
and 73.8% of patients who received 90 mg, as compared with 56.8% of those who received 
etanercept (P =0.01 and P <0.001, respectively). Similarly, 65.1% of patients who received 
45 mg of ustekinumab and 70.6% of patients who received 90 mg of ustekinumab had cleared or 
minimal disease according to the Physician’s Global Assessment (PGA), as compared with 
49.0% of those who received etanercept (P <0.001 for both comparisons).14
The most common adverse reactions (ADRs) (>5% of patients) of Stelara® reported in clinical 
trials were nasopharyngitis and headache, which were mild in severity and did not necessitate 
treatment discontinuation. The most common serious ADR was hypersensitivity including 
anaphylaxis.8,9 Stelara® may increase the risk of infections and reactivation of latent infections 
including tuberculosis (TB). Approximately 6% to 12.4% of patients treated with Stelara® in 
psoriasis and psoriatic arthritis clinical studies developed antibodies to ustekinumab, which were 

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generally low titer. In psoriasis studies, the majority of patients who were positive for antibodies 
to ustekinumab had neutralizing antibodies (NAbs).15 
5.3
Clinical Risks/Benefits of Bmab 1200
In this study, the therapeutic equivalence of Bmab 1200 versus Stelara® in patients with 
moderate to severe plaque psoriasis will be assessed. The nonclinical characterization of Bmab
1200 that supports its biosimilarity to Stelara® is the basis to also expect clinical comparability in 
terms of safety and efficacy of Bmab 1200 and Stelara®. 
The Bmab 1200 drug product will have the same pharmaceutical form and strength as Stelara® 
(45 mg/0.5 mL). The proposed dosing regimen is in line with the label of Stelara®.8,9
The proposed safety monitoring is deemed to be sufficient to monitor potential risks of 
Bmab 1200 administration. Patients deemed at a higher risk of developing serious ADRs to 
Stelara® or Bmab 1200, such as those with a prior history of cancer, active TB, or anaphylactic 
reactions will not be allowed to participate in the study as per eligibility criteria of current 
protocol and in agreement with the Warnings and Precautions of the reference product label. 
Patients with latent TB can enter the study only if they have completed or are receiving antibiotic 
prophylactic therapy for TB, and all enrolled patients will be closely monitored all along the 
study for potential signs and symptoms of TB. 
Use of topical medication, even if with some restrictions, is allowed in the course of the trial.
This trial does not include a placebo arm, 50% of enrolled patients will receive Stelara® while 
50% will receive Bmab 1200 for which there is an expectation of favorable efficacy and safety, 
even if not yet demonstrated. However, patients not responding to treatment at Week 12 (ie, not 
achieving PASI improvement of 50% relative to baseline [PASI 50] response) will not receive 
any further dosing with study treatment thus avoiding any further exposure to an ineffective drug 
as per psoriasis management guidelines. Based upon the clinical evidence as well as the proven 
safety profile of Stelara® and the above main aspects of the study design, the benefits of the 
conduct of the proposed clinical study outweigh the associated risks. Detailed information about 
the known and expected benefits and risks and reasonably expected adverse events (AEs) of 
Bmab 1200 and Stelara® is provided in the Bmab 1200 IB.10 
Given the current worldwide coronavirus disease 2019 (COVID-19) pandemic and the potential 
risk for COVID-19 viral infection at the time and in the countries of this study, measures are 
implemented in this protocol to enable identification of patients who are likely to be infected to 
exclude them from enrollment or from subsequent study drug administration. Enrolled patients 
are required to comply with recommendation for individual protection from COVID-19 infection 
for the duration of the study. In addition, their condition will be closely monitored so that, in case 
of suspected infection, administration of study drug can be withhold and further examinations 
conducted as deemed appropriate by the Investigator. Such measures may need to be modified or 
implemented in accordance with the pandemic status, availability of a vaccine, relevant national 
guidelines, or recommendations from medical associations at the time of trial execution. 

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A single switch is included in the study through rerandomization as Week 16 for demonstration 
of comparable immunogenicity and safety (descriptive statistics) after switching from original 
biologic to the biosimilar.

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6
STUDY OBJECTIVES AND ENDPOINTS 
6.1 
Study Objectives 
6.1.1 Primary Objective 
 To demonstrate equivalent efficacy between Bmab 1200 and Stelara® in patients with 
moderate to severe chronic plaque psoriasis.
6.1.2 Secondary Objectives
The secondary objectives are as follows:
To assess the efficacy of Bmab 1200 based on other efficacy parameters and timepoints 
over the study period as compared with Stelara®.
 To assess the safety and tolerability of Bmab 1200 as compared with Stelara® over the 
study period.
 To assess the immunogenicity of Bmab 1200 as compared with Stelara® over the study 
period. 
 To assess the PK of Bmab 1200 as compared with Stelara®. 
 To assess the safety and immunogenicity after switching from Stelara® to Bmab 1200. 
6.2
Study Endpoints
6.2.1 Primary Endpoint
 Percentage change from baseline in the PASI score at Week 12 (Time Frame: Baseline 
[Day 1] to Week 12). 
6.2.2 Secondary Endpoints 
6.2.2.1 Efficacy Endpoints 
The secondary efficacy endpoints are as follows: 
 Percentage change from baseline in the PASI score at Weeks 4, 8, 16, 20, 28, 40, and 52 
(Time Frame: Baseline [Day 1] through Weeks 28 and 52). 
 PASI 50, PASI 75, and PASI 90 at Weeks 4, 8, 12, 16, 20, 28, 40, and 52 (Time Frame: 
Baseline [Day 1] through Weeks 28 and 52). 
 Static Physician’s Global Assessment (sPGA) response of cleared or almost 
clear/minimal (PGA score of 0 or 1) at Weeks 4, 8, 12, 16, 20, 28, 40, and 52 (Time 
Frame: Baseline [Day 1] through Weeks 28 and 52). 
 Area under effect curves (AUECs) of PASI score from baseline to Week 12 (Time 
Frame: Baseline [Day 1] through Week 12). 
 Raw PASI scores at Weeks 4, 8, 12, 16, 20, 28, 40, and 52 (Time Frame: Baseline 
[Day 1] through Weeks 28 and 52). 

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 Change from baseline in affected body surface area (BSA) at Weeks 4, 8, 12, 16, 20, 28, 
40, and 52 (Time Frame: Baseline [Day 1] through Weeks 28 and 52).
 Change from baseline in QoL as measured by Dermatology Life Quality Index (DLQI) 
scores at Weeks 4, 8, 12, 16, 20, 28, 40, and 52 (Time Frame: Baseline [Day 1] through 
Weeks 28 and 52).
6.2.2.2 Safety Endpoints 
The safety endpoints of this study are as follows: 
Treatment-emergent adverse events (TEAEs) including adverse events of special interest 
(AESIs) and ADRs during the treatment periods (Time Frame: Baseline [Day 1] through 
Weeks 28 and 52). 
Injection site reactions and hypersensitivity at Day 1, Week 4, Week 16, Week 28, 
Week 40, and throughout the study (Time Frame: Baseline [Day 1] through Weeks 28 and 
52).
Other safety endpoints as follows (Time Frame: Baseline [Day 1] through Weeks 28 
and 52): 
o Absolute values and changes from baseline in  
 Clinical laboratory assessments (hematology, clinical chemistry, and urinalysis) 
 Vital sign parameters (systolic and diastolic blood pressure, pulse rate, respiratory 
rate, and body temperature)  
 12-lead electrocardiogram (ECG) 
o Physical examination 
6.2.3 Immunogenicity Endpoints 
 Proportion of patients developing ADAs and NAbs during treatment period 1 (TP1)
(Time Frame: Baseline [Day 1] through Week 16).
Proportion of patients developing ADAs and NAbs during treatment period 2 (TP2)
(Time Frame: post rerandomization/dosing on Week 16 through Week 28 predosing).
 Proportion of patients developing ADAs and NAbs during treatment period 3 (TP3) 
(Time Frame: postdosing on Week 28 through Week 52). 
6.2.4
Pharmacokinetic Endpoints
 Serum concentrations of ustekinumab during TP1 (Time Frame: Baseline [Day 1] 
through Week 16).
Serum concentrations of ustekinumab during TP2 (Time Frame: post 
rerandomization/dosing on Week 16 through Week 28 predosing). 
 Serum concentrations of ustekinumab during TP3 (Time Frame: postdosing on Week 28 
through Week 52). 

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of the study to continue the same treatment they were rerandomized to receive during TP2 
(Bmab 1200 or Stelara®) in a blinded manner. 
For patients not eligible to enter the TP3, the end of study visit will occur at Week 28. 
During the double-blind, active-controlled treatment period, all randomized patients will be 
evaluated for efficacy, safety, tolerability, PK, and immunogenicity at scheduled visits per the 
Schedule of Assessments (Table 1). All assessments except for those related to occurrence of 
injection site and hypersensitivity reactions will take place before the administration of study 
treatment at the baseline visit and Weeks 4, 16, 28, and 40.  
Efficacy assessments will include the clinician’s assessments of PASI, sPGA, BSA, and patient’s 
reported QoL measured by DLQI (see Table 1 for all the scheduled visits). Refer to Section 11 
for more details on efficacy assessments. 
Safety and tolerability will be assessed by monitoring AEs, injection site reactions and 
hypersensitivity, vital signs, physical examination, 12-lead ECG, and safety laboratory tests 
(hematology, chemistry, and urinalysis) at scheduled visits (see Table 1 for all the scheduled 
visits). Complete details on the safety and tolerability assessments are provided in Section 12. 
For the PK and immunogenicity assessments, blood samples will be collected at the baseline 
visit (predose), Week 2, Week 4 (predose), Week 8, Week 12, Week 16 (predose), Week 20, 
Week 28 (predose), Week 40 (predose), and Week 52. Serum levels of ustekinumab, as well as 
the presence and titer of ADAs and NAbs, will be evaluated for both the Bmab 1200 and 
Stelara® arms. 
All patients will have an end of study (EOS) visit at Week 52 for efficacy, safety, PK, and 
immunogenicity assessments as per the Schedule of Assessments (Table 1). 
Patients who discontinue study treatment before the end of Week 16 will be followed up for 
efficacy to the Week 16 scheduled assessment. However, the primary endpoint analysis will be 
done at Week 12 only. Patients who discontinue study treatment on or after Week 16 dosing and 
before the Week 28 dosing will be followed up for efficacy to the Week 28 scheduled 
assessment. Any patient that discontinues study treatment during TP1 or TP2 will be followed up 
for safety and immunogenicity to Week 28 and will then be discontinued from the study. Patients 
who discontinue study treatment on or after Week 28 dosing (ie, during TP3) will be followed up 
for efficacy to the EOS at Week 52.  
Every reasonable effort will be made to contact early discontinued patients who are lost to 
follow-up to obtain further safety information. Details regarding follow-up efforts are to be 
documented in the patient’s medical records/source documentation. 
An overview of the study design is shown in Figure 1. 
 

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Figure 1.
Study Design Schematic
*US FDA has agreed to 28 Week study while extended study to fulfill PMDA requirement will continue and end at 
Week 52.
Abbreviations: EU, European Union; PASI, Psoriasis Area and Severity Index; R1, randomization-; 
R-2, rerandomization; Wk, Week.
Note: Study treatment will be administered at a dose of 45 mg or 90 mg (based on body weight category) at baseline 
visit, Week 4, Week 16, Week 28, and Week 40. 
To maintain the study blinding, the patients in the original Bmab 1200 group will also go through the 
rerandomization procedure; however, they will be assigned and continue to receive Bmab 1200.
7.2
Discussion of Study Design
This study has been designed in accordance with guidelines for the development of biosimilars, 
that require a double-blind, parallel arm, active-controlled confirmatory clinical study comparing
the clinical efficacy, safety, and immunogenicity of the biosimilar product (Bmab 1200) with 
those of the reference product (Stelara®). The study design accommodates for a single switch 
design, which allows for the assessment of any safety and immunogenicity or efficacy effects of 
a single transition from the reference product Stelara® to Bmab 1200 as required by the FDA in 
therapeutic equivalence trials of biosimilar products.
The doses of 45 mg and 90 mg ustekinumab based on patient’s body weight at enrollment have 
been selected for this study in accordance with the approved dosing recommendations of 
Stelara®. 
The primary efficacy endpoint of the study is the percent improvement from baseline in the PASI 
score at Week 12. PASI score is a tool that has been widely used in the psoriasis clinical trials to 
determine the severity of disease and its improvement or worsening in the course of treatment. 
Although percent change of PASI from baseline was not the primary endpoint of the pivotal 

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studies of Stelara® in psoriasis, it was a key secondary endpoint, and is deemed as a more 
sensitive and adequate endpoint for a therapeutic equivalence study. Percent improvement from 
baseline in PASI score will be assessed throughout the study to adequately monitor and compare 
the time course of the response to study treatment and its effects on the clinical signs and 
symptoms of plaque psoriasis. The additional efficacy end points (sPGA, BSA, DLQI) are those 
more commonly used in psoriasis clinical trials and also represent the main efficacy end points 
of the pivotal Stelara® studies. The physician global assessment chosen for this study is the same 
6-point sPGA that was employed in the Stelara® pivotal trials.
Patients not achieving a minimal clinically significant response (PASI 50) after receiving 2 doses 
of study treatment (baseline visit and Week 4) will be withdrawn from the study treatment to be 
directed to different and more effective therapeutic options and to avoid exposing them to the 
risks of receiving further doses of ustekinumab without clinical benefit.  
Patients not achieving at least PASI 75 response after 3 doses of study treatment (baseline visit, 
Week 4, and Week 16), as measured at Week 28 visit, will not be offered to proceed with TP3 
and will not be dosed further nor continue until Week 52. Their end of study visit will be at 
Week 28. 
The potential immunogenic effects of Bmab 1200 in comparison with Stelara® will be evaluated 
over a 52-week period in parallel with measurement of ustekinumab serum concentration to be 
able to observe any potential relationship between ADA production, ustekinumab plasma drug 
levels, and efficacy measures. 
The study design, evaluations, and duration are considered adequate to support the objectives of 
the study, which is to assess similarity of efficacy, safety, and immunogenicity between 
Bmab 1200 and the reference product. Justification for the equivalence margins for percent PASI 
improvement is provided in Section 15.1. 
7.3 
End of Study  
A patient will have fulfilled the requirements for study completion if/when the patient has 
completed all study periods, including the visit at Week 52, as indicated in the Schedule of 
Assessments (Table 1). For patients not entering the TP3, the end of study visit will occur at 
Week 28.  
The end of the study or study completion will be the last patient’s last visit for any protocol
related activity. 

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8
SELECTION OF STUDY POPULATION 
Section 7.1 provides information regarding number of patients planned to be enrolled.  
8.1 
Inclusion Criteria 
Individuals must meet all of the following criteria to be included in the study: 
1. Patient is willing and able to provide informed consent form (ICF), able to follow study 
instructions, and comply with the protocol requirements as per the investigator’s opinion. 
2. Patient is aged 18 to 80 years, both inclusive, and weighing <130 kg at the time of the 
screening visit. 
3. Patient has a diagnosis of chronic plaque psoriasis for at least 6 months and is a candidate 
for systemic therapy or phototherapy at the time of the screening visit. 
4. Patient with moderate to severe chronic plaque psoriasis as defined by BSA involvement 
the screening and baseline visits. 
5. Patient has stable disease for at least 2 months before the baseline visit (ie, without 
clinically significant changes in the investigator’s opinion).
6. Patient has adequate renal and hepatic function at the screening as defined by the 
following clinical chemistry results: 
a)
b) Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
 × ULN 
c) 
× ULN, unless there is a documented history of Gilbert 
syndrome 
7. Patient has the following hematology laboratory test results at screening:
a) 
 
b) 
1500/
9 cells/L) 
c) 
100 000/
9 cells/L) 
8. Patient has had a previous failure, inadequate response, intolerance, or contraindication to 
at least one antipsoriatic systemic therapy.
9. Women of childbearing potential must have a negative serum pregnancy test during 
screening and a negative urine pregnancy test at baseline. A female patient is considered 
not of childbearing potential when postmenopausal (at least 12 consecutive months 
without menses without an alternative medical cause) or surgically sterilized 
(hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). 

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10. Women of childbearing potential and male patients with a female partner of childbearing 
potential must be willing to use highly effective contraceptive precautions which are 
consistent with local regulations regarding the use of birth control methods for patients
participating in clinical studies throughout the study period and continuing for at least 
15 weeks after the last dose of study drug. See APPENDIX 1 for acceptable highly 
effective contraceptive methods. Abstinence from heterosexual intercourse is accepted 
when this is the usual lifestyle of the patient and must be continued for at least 15 weeks 
after the last dose of study drug. 
8.2
Exclusion Criteria 
Individuals meeting any of the following criteria at the screening or baseline are ineligible to 
participate in this study:
1. Patient has nonplaque psoriasis, such as erythrodermic psoriasis, pustular psoriasis, guttate 
psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), other current 
or chronic systemic autoimmune or inflammatory disease at the time of screening visit 
that would interfere with the evaluation of the effect of the study treatment of psoriasis. 
Patients with concurrent psoriatic arthritis will be allowed to participate. 
2. Patient who has a current or past history of any of the following infections: 
a) Current or past history of congenital or acquired immunodeficiency or patient is 
positive for the human immunodeficiency virus (HIV) antibodies (HIV-1 or HIV-2) at 
screening. 
b) Patient has current infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) 
as per serological tests at screening. 
o For HBV, patients who test positive to hepatitis B surface antigen (HBsAg) will 
be excluded. Patients who test positive to hepatitis B core antibody (HBcAb) only 
(HBsAg negative), may be enrolled if they also test positive to hepatitis B surface 
antibody (HBsAb). 
o For HCV, patient who test positive to HCV antibody will be excluded unless they 
test negative for HCV RNA. 
c) Presence of active infection at screening or history of infection requiring intravenous 
or oral/intramuscular 
4 weeks before baseline visit, or topical 
2 weeks before 
baseline visit. Minor localized fungal infections or topical antibiotics for facial acne 
may be allowed. 
d) Any recurrent bacterial, fungal, opportunistic, or viral infection including 
recurrent/disseminated herpes zoster that, based on the investigator´s clinical 
assessment, causes a safety risk and makes the patient unsuitable for the study. 

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Note: Recurrent infections are defined as 2 or more severe infections in 1 year, 3 or 
more respiratory infections (eg, sinusitis, otitis, bronchitis) in 1 year, or the need for 
antibiotics for 2 months/year.
e) History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular 
mycobacterial infection. 
3. Patient meeting any of the following TB-related conditions: 
a) Patient who has current or history of active TB. 
b) Patient who has signs or symptoms suggestive of active TB upon medical history or 
physical examination including chest radiography at screening. If a chest radiography 
performed within the past 3 months before screening is available, it does not need to 
be repeated at screening. 
c) Patients with current latent TB (defined as a positive result of interferon- release 
assay [IGRA] with a negative examination of chest radiography [posterior-anterior 
and lateral views, or per country regulations where applicable] and absence of 
symptoms).   Patients with positive IGRA may be enrolled if they have documentation 
of completed appropriate country-specific TB prophylaxis within the past 5 years or 
have received at least 1 month of country-specific TB prophylaxis before the baseline 
visit and are willing to complete its entire course, and do not have other risk factors, 
radiologic findings, or physical evidence supporting latent or active TB. It is the 
responsibility of the investigator to verify the adequacy of previous anti-TB treatment 
and provide appropriate documentation. If a patient’s initial IGRA test result is 
indeterminate, the test can be repeated once. If the test result is again indeterminate, 
the patient will be excluded from the study.  
d) Patient who has had exposure to a person with active TB, such as first-degree family 
members or coworkers within 16 weeks before the baseline visit. 
4. Patient has an underlying condition (including, but not limited to metabolic, hematologic, 
renal, hepatic, pulmonary, neurologic including central nervous system demyelinating 
disease, endocrine, cardiac, infection, or gastrointestinal) which, in the opinion of the 
investigator, significantly immune compromises the patient and/or places the patient at 
unacceptable risk for receiving an immunomodulatory therapy. 
5. Patient had a major surgical intervention within 12 weeks of the baseline or planned 
major surgery during the study period. 
6. Patient who has prior exposure to more than 1 biologic agent for the treatment of 
psoriasis or psoriatic arthritis. 

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7. Patient who has received or plans to receive any of the following prohibited medications 
or treatment that could affect psoriasis: 
a) Topical therapies for the treatment of psoriasis (including, but not limited to, 
corticosteroids, vitamin D analogs, calcineurin inhibitors or retinoids) within 2 weeks 
before the baseline visit. However, restricted use of rescue topical treatment may be 
allowed as per Section 9.8. 
b) Ultraviolet A phototherapy (with or without oral psoralen) or ultraviolet B 
phototherapy for the treatment of psoriasis within 4 weeks before the baseline visit.
c) Systemic steroids within 4 weeks before the baseline visit.   
d) Any nonbiologic systemic therapies for the treatment of psoriasis or psoriatic arthritis 
within 4 weeks before the baseline visit. 
e) Any biologic systemic therapy with a mechanism of action that could impact the 
course of psoriasis/psoriatic arthritis or its evaluations, within 5 half-lives or 90 days, 
whichever is longer, before the baseline visit. 
f) Any mAb within 5 half-lives or 90 days, whichever is longer, before the baseline 
visit. 
g) Any drug that directly targets IL-12, IL-17, or IL-23 including ustekinumab either 
investigational or approved. 
h) Any investigational drug other than study treatment within 4 weeks or 5 half-lives 
(whichever is longer) before the baseline visit. 
i) Any other drug that may impact psoriasis (eg, beta-blockers, lithium, antimalarials) 
within 4 weeks before the baseline visit. 
Note: However, patients on stable doses of beta-blockers for 3 months before the 
baseline visit are allowed. 
j) Herbal or any nonpharmaceutical medicine to treat psoriasis within 2 weeks before 
the baseline visit. 
8. Patient has received a live or live-attenuated vaccine within 4 weeks before the baseline 
visit. Patient must agree not to receive a live or live-attenuated vaccine during the study 
and up to 15 weeks after the last dose of the study treatment.
9. Patient who has had Bacillus Calmette-Guérin (BCG) vaccination within 1 year before
the baseline visit. Patients must agree not to receive a BCG vaccination during the study 
and at least 1 year after the last dose of the study treatment. 

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10. Patient who had confirmed COVID-19 infection and was hospitalized requiring oxygen 
in the last 8 weeks prior to screening. In case of asymptomatic/mildly symptomatic 
patient with confirmed COVID-19 infection during the last 4 weeks prior to screening, 
and who have not recovered from COVID-19 as per site and/ local regulatory guidelines 
at screening, would also be excluded from the study. 
11. Patient who has received or is planning to receive COVID-19 vaccination within 2 weeks 
before or after the baseline visit. However, COVID-19 vaccination >2 weeks before or 
after the baseline visit is permitted.
12. Patient has a history of hypersensitivity to any biologic systemic therapy or any of the 
excipients of Stelara®.
13. Patient who is not willing to limit ultraviolet light exposure (eg, excessive sun exposure 
and/or the use of tanning devices) during the study. 
14. Patient is pregnant or breastfeeding (lactating) at the time of screening or baseline visit. 
15. Patient has history of malignancy within 5 years except adequately treated cutaneous 
squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal 
carcinoma.
16. Have a transplanted organ/tissue or stem cell transplantation.
17. Evidence (as assessed by the investigator using good clinical judgment) of alcohol or 
drug abuse or dependency in the last 3 years before screening. 
18. Patient has a severe progressive or uncontrolled, clinically significant disease that in the 
judgment of the investigator renders the patient unsuitable for the study. 
Treatment Period 3 (TP3) specific enrollment criteria: 
 
Patient is willing and able to provide revised informed consent form (ICF), able to follow 
study instructions, and comply with the protocol requirements as per the investigator’s 
opinion. 
 
Patient has not developed any condition/ or met study discontinuation or treatment 
discontinuation criteria which precludes his/her participation in the TP3. 
Note: For patients not meeting TP3 specific enrollment criteria, the end of study visit will occur 
at Week 28. 
8.3 
Rescreening/Retesting 
Individuals who sign the ICF to participate in the study but who do not subsequently meet all the 
requirements as outlined in the inclusion and exclusion criteria and therefore do not enroll 
(screen failures) may be rescreened depending on the criteria that were not met. Such individuals 
may be allowed to rescreen up to 1 time upon discussion and agreement with the medical 
monitor and/or Sponsor. 

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Repeating an exclusionary laboratory test such as alanine aminotransferase (ALT), aspartate 
aminotransferase (AST), or bilirubin within the same screening procedure may be allowed only 
once, upon agreement with the medical monitor, if the abnormal result was not associated with a 
pathology or was considered incidental by the investigator. Retesting should not prolong the 
screening duration beyond the allowed 4 weeks. Serology or TB tests cannot be repeated. 
8.4
Study Withdrawal, Removal, and Replacement of Patients
Patients may withdraw from the study at any time and for any reason without prejudice to their 
future medical care by the investigator or at the study site. The investigator may also discontinue 
the study treatment in the interest of patient safety.  
Study Treatment Discontinuation Reasons: 
1. Patient does not comply with the protocol and has an important protocol deviation(s) in 
the investigator's opinion. 
2. Patient receives prohibited medication(s). 
3. Patient has serious or any other AEs, or any medical, physical, or psychiatric condition(s) 
that, in the investigator's opinion, would pose a significant risk to the patient or interfere 
with interpretation of study data.  
4. Patient does not achieve PASI 50 response at Week 12.  
5. Patient becomes pregnant. 
6. Patient withdraws consent for study treatment, or the investigator or Sponsor decides to 
discontinue study treatment.
Study Discontinuation Reasons: 
1. Patient is lost to follow-up.
2. Patient withdraws consent from study participation. 
3. Death. 
4. Patient withdrawn at investigator’s discretion because of medical (eg, condition as 
assessed by the investigator as requiring therapy/intervention that will interfere with the 
patient’s subsequent study visits) or administrative (eg, persistent noncompliance, 
inability to comply with the study schedule) reasons.
5. Study or site terminated by Sponsor
6. Patient does not achieve at least PASI 75 response at Week 28.  
Additionally, the Sponsor may stop the study at any time for safety, regulatory, legal, or other 
reasons aligned with good clinical practice (GCP). The Sponsor should promptly inform the 
investigators and the regulatory authority of the termination or suspension and the reason(s) for 
the termination or suspension. This study may be terminated at the discretion of the Sponsor or 

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any regulatory agency. An investigator may elect to discontinue or stop the study at his or her 
study site for any reason, including safety or low enrollment. 
Patients who discontinue study treatment before the end of Week 16 will be followed up for 
efficacy to the Week 16 scheduled assessment. Patients who discontinue study treatment on or 
after Week 16 dosing and before Week 28 dosing will be followed up for efficacy to the Week 
28 scheduled assessment. All patients that discontinue study treatment during TP1 and TP2 will 
be required to attend the scheduled visits for safety and immunogenicity to Week 28, at which 
point they will be discontinued from the study. Patients who discontinue study treatment after
entering TP3 at Week 28 will be required to attend the scheduled visits for efficacy, safety, and 
immunogenicity to the EOS at Week 52.  
Every reasonable effort will be made to contact early discontinued patients who are lost to 
follow-up to obtain further safety information. Details regarding follow-up efforts are to be 
documented in the patient’s medical records/source documentation.  
If a patient terminates participation in the study and does not return for the 
completion/termination visit, their last recorded assessments shall remain recorded with their last 
visit. The reason for discontinuation will be recorded. In accordance with applicable regulatory 
guidance, de-identified data that have already been collected and incorporated in study database 
will continue to be used and/analyzed (and any identifiable data will be destroyed).
Patients who receive study treatment and withdraw from the study before its completion will not 
be replaced.  
8.4.1 Pregnancy 
Patients will be instructed that known or suspected pregnancy occurring during the study should 
be confirmed and reported to the investigator. If a patient becomes pregnant, the investigator 
must withdraw the patient from the study without delay. The patient must not receive any further 
doses of the study drug. The investigator should also be notified of pregnancy occurring during 
the study but confirmed after completion of the study. In the event that a female patient or female 
partner of a male patient is subsequently found to be pregnant after inclusion in the study, any 
pregnancy will be followed up to term or as per the applicable local guidelines for follow-up, and 
the status of mother and child will be reported to the Sponsor after delivery. A separate consent 
will be obtained from the pregnant partner before collecting any information pertaining to the 
pregnancy. See Section 12.8.5 for further reporting and monitoring details. 
The investigator should notify the Sponsor on a Pregnancy Reporting form within 24 hours of 
knowledge of the pregnancy. Full details of the pregnancy will be recorded on the withdrawal 
page (exit form) of the electronic case report form (eCRF). Pregnancy is not to be considered an 
AE; however, spontaneous miscarriages, congenital abnormalities, and any premature 
termination of pregnancy will be reported as serious adverse event (SAEs) as described in 
Section 12.8.5. 

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8.4.2
Completion of the Study or Lost to Follow-up 
The study will be completed when all patients have completed their study-related procedures in 
accordance with the protocol including the follow-up period and EOS visit. 
The following actions must be taken if a patient fails to return to the clinic for a required study 
visit:
The site must attempt to contact the patient and reschedule the missed visit as soon as 
possible and counsel the patient on the importance of maintaining the assigned visit 
schedule and ascertain whether the patient wishes to and/or should continue in the study. 
Before a patient is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the patient (where possible, 3 telephone calls and, if 
necessary, a certified letter to the patient’s last known mailing address or local equivalent 
methods). These contact attempts should be documented in the patient’s medical record.
If the patient continues to be unreachable, he/she will be considered to have withdrawn from the 
study because of reason of lost to follow-up. 

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carton to protect from light. Once a syringe has been stored at room temperature (up to 30 °C), it 
should not be returned to the refrigerator. The recommended storage conditions, and expiry date 
where required, are stated on the product label approved by each regulatory authority.
9.1.3
Study Drug Retention, Return and Destruction
Study drug must be retained at sites until completion or termination of the study, and written 
authorization from the Sponsor has been received. All unused and used study drug must be 
destroyed at the site or returned, as specified by Sponsor. It is the investigator’s responsibility to 
ensure that appropriate records of the disposal are documented and maintained. No used or 
unused study drug may be disposed until fully accounted for by the study monitor. Retention 
samples will be stored in compliance with the current applicable regulatory guidance at the 
clinical trial depot or warehouse. 
9.2 
Method of Administration of Study Treatments 
Patients will receive either Bmab 1200 or Stelara® by subcutaneous injection via PFS at the 
baseline visit, Week 4, Week 16, Week 28, and Week 40 based on the patient’s baseline body 
weight as follows: 
 
® 45 mg (1 injection of 45 mg PFS)
 Patients who weigh >100 kg: Bmab 1200 or Stelara® 90 mg (2 injections of 45 mg PFS) 
Injection sites include upper arms, thighs, and abdomen. For patients who receive two 45 mg 
PFSs for a 90-mg dose, the 2 injections will be one right after the other at different injection 
sites. If possible, areas of the skin that show psoriasis lesions should be avoided as injection 
sites. The actual injection site(s) should be documented. 
Detailed administration instructions will be provided in the Pharmacy Manual. 
9.3 
Measures to Minimize Bias: Study Treatment Assignment and Blinding 
9.3.1
Method of Study Treatment Assignment 
At screening RAVE EDC will assign a unique patient identification number to the patient known 
as the patient number. This number will be associated with the patient throughout the study. 
Every patient who signs an ICF must be entered into the RAVE EDC regardless of eligibility to 
obtain a patient number. This 8-digit number will consist of a 3-digit country-specific code, 
followed by a 2-digit site identification and a 3-digit number assigned sequentially within each 
site to each patient, starting at 001. 
At the baseline visit patients will be randomly assigned to receive Bmab 1200 (test product) or 
Stelara® (reference product) in a 1:1 allocation ratio (using a permuted block design), stratified 
by the factors described below. A separate unblinded Biostatistical team will generate the 
randomization schedule using SAS software Version 9.4 or later (SAS Institute Inc, Cary, North 
Carolina) for RAVE EDC, which will link sequential patient randomization numbers to 
treatment codes. Based on the randomization schedule, each patient will be assigned a unique 

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blinding from the primary packaging will not be feasible, but blinding will be maintained at the 
secondary packaging level with similar packaging for both the products. Therefore, 2 different 
teams, ie, blinded and unblinded team will be assigned to maintain the blinding and handle the 
study treatment administration. The designated, unblinded site staff will administer the study 
medication injections in such a manner that the participant remains blinded (eg, by eye coverings 
at the time of the injection). Blinded staff/any other personnel must not be involved in any 
activities pertaining to the receipt, handling, or administration of study medication. All study 
medication documentation (ie, shipping receipts, accountability logs, and RTSM randomization 
materials) must be maintained only by unblinded site staff. Designated, unblinded personnel 
must be appropriately trained and certified (per country guidelines) to administer injections. 
Unblinded site staff should not share any treatment assignment information with others. 
No other study site personnel, patients, Sponsor personnel, or Sponsor designees will be 
unblinded to treatment assignment throughout the duration of the study unless unblinding is 
required. If an investigator becomes unblinded to a given patient’s study treatment, that patient 
will be discontinued from the study unless there are ethical reasons for that patient not to be 
discontinued; approval from the Sponsor’s medical monitor must be obtained in such instances. 
In the event that emergency unblinding is required for a given patient because of AEs or 
concerns for the patient’s safety or wellbeing, the investigator may break the randomization code 
for the patient via RAVE RTSM, by which system the unblinding will be captured. The 
investigator should try every effort to discuss with medical monitor before the code break and 
the investigator is responsible for notifying the medical monitor and/or Sponsor of such an event 
as soon as possible. The unblinding and its cause will also be documented in the eCRF. 
In the event of drug-related, serious, unexpected AE (suspected unexpected serious adverse 
reaction [SUSAR]), Pharmacovigilance Group will be provided with the treatment assignment 
for the patient for the purpose of regulatory reporting. Details of the process are outlined in 
separate Safety Management Plan. 
Two database locks are planned for this study: one at the time of the Week 28 analysis and the 
other at the time of the Week 52 analysis. The study team will continue to remain blinded to the 
study treatments until the final analysis; a separate analysis team and reporting team will conduct 
the unblinded analyses for the Week 28 clinical study report (CSR) which will be described in 
detail in a separate document for the study.
9.4 
Dosage Modification 
No dose adjustment is permitted for this study.
9.5 
Treatment Accountability and Compliance
The unblinded pharmacist or other designated unblinded site staff will maintain records of study 
treatment delivered to the study site, the inventory at the study site, the distribution to each 
patient, and the return of materials to the Sponsor or designee for storage or disposal. These 

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records should include dates, quantities, batch/serial numbers, expiration dates, in-clinic 
temperature log, and unique code numbers assigned to the product and study patients. 
Only patients enrolled in the study may receive the study treatment and only authorized site 
personnel may supply or administer the study treatment. Reasons for departure from the expected 
dispensing regimen must also be recorded. At the completion of the study, to satisfy regulatory 
requirements regarding drug accountability, all study treatments will be reconciled and retained 
or destroyed according to applicable regulations. Further guidance and information for the final 
disposition of unused study treatment are provided in the Study Reference Manual.
Treatment compliance will be evaluated by comparing the number of doses expected with the 
number of doses administered and comparing the amount of the total dose planned with the 
amount of total dose administered. 
A dose visit window of ±3 days is recommended for Week 4 dosing and ±7 days for the 
Week 16 and Week 40 dosing. For Week 28, a dose visit window is recommended to be ±7 days, 
however, a longer visit window may be considered only in cases where needed to ensure that the 
eligible patients are given opportunity to participate in TP3 (but dosing is not to be postponed to 
more than 4 weeks). Data handling for analysis of scheduled assessments performed outside of 
the allotted time window will be discussed and agreed on a by-patient basis in the Blinded Data 
Review Meetings (BDRMs), with the report finalized before each database lock. 
9.6 
Prior and Concomitant Therapy 
Restricted prior therapies are provided in Section 8.2, and a complete list of prohibited 
medications is provided in Section 9.7. 
Patients are recommended to continue maintaining their usual lifestyle during the study and 
refrain from initiating a diet to lose weight unless medically indicated for their safety. 
All medications and other treatments taken by the patient during the study must be recorded on 
the eCRF. The entry must include the dose, regimen, route, indication, and dates of use. This will 
include all prescription drugs, herbal products, vitamins, minerals, and over-the-counter
medications. Any changes in concomitant medications also will be recorded in the patient’s 
eCRF. 
Any concomitant medication deemed necessary for the welfare of the patient during the study 
may be given at the discretion of the investigator. However, it is the responsibility of the 
investigator to ensure that details regarding the medication are recorded in full in the eCRF. 
9.7
Prohibited Therapies 
Medications taken by or administered to the patient for the period before screening will be 
recorded in the eCRF. 
The following therapies are prohibited during the study period. Patients who have received these 
prohibited therapies (see Section 8.2) or plan to receive these prohibited therapies will not be 

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enrolled in the study. Patient who is permanently discontinued from study treatment can be 
treated with alternative therapy at the investigator’s discretion. Inactivated vaccines are 
acceptable during the study.
 Ustekinumab, either approved or investigational (other than study treatment). 
 Any drug that directly targets IL-12, IL-17, IL-23. 
 Any biologic systemic therapy for the treatment of psoriasis/psoriatic arthritis or one that 
could affect its course. 
Any nonbiologic systemic therapy that could affect psoriasis (including, but not limited 
to, methotrexate, cyclosporine, or systemic steroids).
Any mAb.
 Topical therapies for the treatment of psoriasis (including, but not limited to, 
corticosteroids, vitamin D analogs, calcineurin inhibitors, or retinoids) 
Note: restricted use of rescue topical treatment may be allowed as stated in Section 9.8. 
 Ultraviolet A phototherapy (with or without oral psoralen) or ultraviolet B phototherapy 
for the treatment of psoriasis.
 Any investigational drug other than study treatment.
 Initiation of any other drug that may impact psoriasis (eg, beta-blockers, lithium, 
antimalarials). 
 Herbal or any nonpharmaceutical treatment that could affect psoriasis. 
 Live or live-attenuated vaccination until at least 15 weeks after last dose of study 
treatment. 
 BCG vaccination up to 1 year after last dose of study treatment. 
9.8 
Permitted Medications 
Low potency topical corticosteroids, ie, least potent and mild immediately (Class VI to VII of 
USA 7 Group TCS Classification) on scalp, face, axillae, groin, or genitalia are allowed with the 
restriction NOT to use them within 24 hours before the screening and other study visits requiring 
PASI or sPGA measurements.
Bland moisturizers/emollients (without urea or beta or alpha hydroxy acids or any 
pharmaceutically active ingredients) and shampoos with salicylic acids are also allowed for 
treatment of psoriasis, but these should not be used in the mornings of study visits when any 
efficacy assessments are going to be performed. 
COVID-19 vaccination >2 weeks before and after each dosing with study treatment during the 
study is allowed. 

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No other medications (for psoriasis) are permitted in this study.
9.9 
Intervention After the End of the Study 
After the end of the study, study treatments will not be made available to patients and their 
further treatment, if required, will be decided by the investigator. 

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10 STUDY PROCEDURES 
Table 1 outlines the timing of procedures and assessments to be performed throughout the study. 
Section 12.5 specifies laboratory assessment samples to be obtained. See Sections 11, 12, 13, 
and 14 for additional details regarding efficacy, safety, PK, and immunogenicity assessments, 
respectively.

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Table 1. 
Schedule of Assessments 
Study Periods
Screening
Treatment Period 
1
Treatment Period 
2
Treatment Period 3
Visits 
1 
2 
(Baseline) 
3 
4 
5 
6 
7 
8 
9 
10 
11 
(EOS) 
Week 
 -4 
0 
2 
4 
8 
12 
16 
20  
28  
40 
52 
Day 
-28 to -1 
1 
15±3 
29±3 
57±5 
85±5 
113±7 
141±7 
197±7p 
281±7 
365±7 
Informed consent 
X 
 
 
 
 
 
 
 
X 
 
 
Demographic, medical 
history  
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/
Exclusion criteria 
X
Xa
Xo
% BSA involvement 
X 
Xb 
 
X 
X 
X 
X 
X 
X 
X 
X 
Randomization 
 
Xb 
 
 
 
 
 
 
 
 
 
Rerandomization  
 
 
 
 
 
 
Xb 
 
 
 
 
Hepatitis B, Hepatitis C 
and HIV-1 & -2 testc
X 
 
 
 
 
 
 
 
 
 
 
Serum pregnancy testd 
X 
 
 
 
 
 
 
 
 
 
 
Urine pregnancy testd 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Chest radiographye
X
IGRA testf 
X 
 
 
 
 
 
 
 
 
 
 
Study treatment (Bmab 
1200 or Stelara®) 
administration 
 
X 
 
X 
 
 
X 
 
X 
X 
 
Hypersensitivity/injecti
on site reactions 
monitoringg 
 
X 
 
X 
 
 
X 
 
X 
X 
 
PASI assessmentb 
X 
X  
 
X 
X 
X 
X 
X 
X 
X 
X 
sPGA assessmentb
X
X 
X
X
X
X
X
X
X
X
DLQI assessmentb 
 
X  
 
X 
X 
X 
X 
X 
X 
X 
X 
PK sampling 
 
X (predose) 
X 
X (predose) 
X 
X 
X (predose)  
X 
X 
X 
X 

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Study Periods 
Screening 
Treatment Period 
1 
Treatment Period 
2 
Treatment Period 3 
Visits 
1 
2
(Baseline) 
3 
4 
5 
6 
7
8 
9
10
11
(EOS)
Week 
 -4 
0 
2 
4 
8 
12 
16 
20  
28  
40 
52 
Day
-28 to -1
1
15±3
29±3
57±5
85±5
113±7
141±7
197±7p
281±7
365±7
(predose) 
(predose) 
Immunogenicity 
sampling 
X (predose)
X
X (predose)
X
X
X (predose)
X
X
(predose) 
X
(predose) 
X
Blood sample for 
method validations 
Xh
Clinical Laboratory 
Evaluations 
(Hematology, clinical 
chemistry, and 
urinalysis)i 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Physical examinationj 
X 
X  
 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signsk
X
X
X
X
X
X
X
X
X
X
Body weight, heightl
X
X
X
X
X
X
12-lead ECGm 
X 
X  
 
 
 
 
X 
 
X 
X 
X 
Prior and concomitant 
medications 
X
X
X
X
X
X
X
X
X
X
X
TB clinical monitoringn
X
X
X
X
X
X
X
X
X
X
X
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

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Abbreviations: BSA, body surface area; DLQI, Dermatology Life Quality Index; ECG, electrocardiogram; EOS, end of study; HBcAb, hepatitis B core antibody; 
HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; IGRA, interferon-
release assay; PASI, Psoriasis Area and Severity Index; PK, pharmacokinetic; sPGA, static Physician’s Global Assessment; TB, tuberculosis; V, Visit; 
Wk, Week.  
EOS, End of Study visit: for patients not entering the TP3, EOS will occur at Week 28. Otherwise, EOS will occur at Week 52. 
Note: For all patients who discontinue study treatment early, every effort should be made to complete regularly scheduled study visits as recommended in 
Section 7.1. Patients who discontinue study treatment before the end of Week 16 will be followed up for efficacy to the Week 16 scheduled assessment. However, 
the primary endpoint analysis will be done at Week 12 only. Patients who discontinue study treatment on or after Week 16 dosing and before Week 28 dosing 
will be followed up for efficacy to the Week 28 scheduled assessment. Any patient that discontinues study treatment during TP1 or TP2 will be followed up for 
safety and immunogenicity to Week 28 and will then be discontinued from the study. Patients who discontinue study treatment on or after Week 28 dosing (ie, 
during TP3) will be followed up for efficacy to the EOS at Week 52. Every reasonable effort will be made to contact early discontinued patients who are lost to 
follow-up to obtain further safety information. If a patient terminates participation in the study and does not return for the completion/termination visit, their last 
recorded assessments shall remain recorded with their last visit. Details regarding follow-up efforts are to be documented in the patient’s medical records/source 
documentation. 
a. 
Confirmation of eligibility (per applicable inclusion/exclusion criteria). 
b.
For study treatment administration visits, procedures will be performed before the study treatment administration.
c. 
At screening, if the HBsAg test result is positive, the patient will be excluded from the study. If a patient has HBsAg negative and HBcAb positive, the 
patient will be excluded from the study if testing HBsAb negative while may be enrolled if HBsAb positive.  At screening, hepatitis C antibody and HIV will 
be assessed in all patients. If the HCV test results is positive, HCV RNA will be performed at screening. If the HCV RNA test result is negative, the patient 
can be included in the study at the investigator’s discretion. If the HIV test result is positive, the patient must be excluded from the study. See Section 12.5.2 
for details. 
d. 
Pregnancy test is only required for woman of childbearing potential. Urine pregnancy test can be performed more frequently if required by country-specific 
legislation. 
e.
A chest radiography (both posterior-anterior and lateral views) is not required at screening if a chest radiography within 12 weeks before screening is 
available unless it is required by the investigator. 
f.
The IGRA analysis will be performed at the central laboratory. No further IGRA testing is required during the treatment period for patients who have at least 
1 positive IGRA result and have completed the country-specific TB prophylaxis. For patients who discontinued early from the study treatment, IGRA test is 
unnecessary after the discontinuation.
g. 
Additional vital signs including blood pressure, pulse and respiratory rates, and body temperature (prior to the beginning of the study treatment 
administration and at least 1 hour after the end of the study treatment administration) will be monitored for possible hypersensitivity reactions. In addition, 
hypersensitivity will be monitored by routine continuous clinical monitoring, including patient-reported signs and symptoms. In case of hypersensitivity, 
emergency equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational therapy, oxygen, and artificial 
ventilation must be available; in addition, any types of ECG can be performed. Hypersensitivity that may occur after the administration of the study 
treatment will be monitored. If the patient experiences any hypersensitivity signs and symptoms outside study site, the patient can visit the study site for 
further assessment. Injection site reactions will be assessed at least 1 hour after the end of the study treatment administration. After the study visits, all 
patients will be instructed to report hypersensitivity or injection site reactions promptly to the study site; see Section 10.2. 
h. 
Blood sample will be collected from all patients, 5 mL blood will be collected before the first dose administration for PK method validations, additional 
10 mL blood will be collected before the first dose administration for immunogenicity method validations. 

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i.
See Section 12.5 for the list of clinical laboratory tests.
j. 
Full physical examination will be done at screening. Abbreviated, ie, sign/symptom-directed examination will be done at subsequent time points. 
k.
Vital signs include systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate. On the dosing day visits, vital signs will be 
assessed within 2 hours before dosing. Vital sign measurements are to be taken before blood collection for laboratory tests. 
l. 
Height will be measured only at screening. 
m. 
All scheduled 12-lead ECGs must be performed at the study site after the patient has rested quietly for at least 5 minutes in the supine position. Regardless of 
the 12-lead ECG result, further cardiological evaluation can be conducted at the investigator’s discretion. 
n.
Throughout the study, patients will be monitored for the clinical signs and symptoms of TB. An additional IGRA or chest radiography can be performed at 
the investigator’s discretion based on the judgment per the signs and symptoms of TB monitoring. The investigator will confirm the absence of active TB 
prior to the subsequent dose administration. 
o. 
Confirmation of eligibility for TP3 (per applicable inclusion/exclusion criteria). 
p. 
Visit window for Week 28 may be extended only in cases where needed to ensure that the eligible patients are given opportunity to participate in TP3 (but 
dosing is not to be postponed to more than 4 weeks). Prior discussion with the Sponsor and/or delegate is needed. 

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10.1 Informed Consent 
ICFs must be approved for use by the reviewing independent ethics committee 
(IEC)/institutional review board (IRB). Before performing any study-related procedures, the 
investigator (or designee) will obtain written ICF from the patient. 
In the event that rescreening occurs, the individual is required to sign a new ICF and must be 
assigned a new identification number.
All patients who are eligible and are willing to enter the TP3 are required to be re-consented as 
outlined in the Schedule of Assessments (Table 1). 
10.2 Study Procedures 
Assessments and their timing are to be performed as outlined in the Schedule of Assessments 
(Table 1). Section 12.5 specifies laboratory assessment samples to be obtained. 
Assessments and procedures scheduled at a visit where study drug is administered should be 
performed before administration of treatment unless otherwise indicated in the Schedule of 
Assessments (Table 1). 
Efficacy assessments are described in Section 11 and include assessment of PASI score, sPGA, 
BSA, and DLQI. 
Safety assessments are described in Section 12 and include AE monitoring, injection site 
reactions and hypersensitivity, vital signs, physical examinations (complete and/or abbreviated), 
12-lead ECGs, laboratory results (routine hematology, chemistry, and urinalysis).
PK and immunogenicity assessments are described in Sections 13 and 14, respectively.  
DLQI should be administered before any other procedures of the visit. Blood sampling for safety 
laboratory, PK or immunogenicity should be performed after vital signs and ECG measurements. 
Study drug injection and monitoring for hypersensitivity reactions should be the last procedures 
of the visit.
The investigator may, at his/her discretion, arrange for a patient to have an unscheduled 
assessment, especially in the case of AEs that require follow-up or are considered by the 
investigator to be possibly related to the use of study drug. The unscheduled visit page in the 
eCRF must be completed.  
All patients will be required to remain at the study site for at least 1 hour after study treatment 
administration to monitor them for potential hypersensitivity reactions. Injection site will also be 
inspected for potential injection site reactions. Patients will be advised to promptly report to the 
study site any symptoms occurring within 24 hours after the study treatment that may be 
suggestive of hypersensitivity reaction. 

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If social distancing rules are in effect because of the pandemic situations such as COVID-19, 
sites will have the option to perform the scheduled site visits (per Table 1) either at the patient’s 
home or remotely at the investigator’s discretion and according to local regulations even if 
limited study assessments could be performed. During this time, where access to study site is 
restricted, the study drug injections except the first dose, may be administered at the patient’s 
home by qualified unblinded site staff. All patients will be instructed to promptly report any 
hypersensitivity or injection site reactions to the study site. 
If a patient tests positive for COVID-19 during the study, he/she may be quarantined as needed 
and any affected scheduled visits can be arranged or skipped at the discretion of the investigator 
upon discussing with the medical monitor. Compliance with the permitted visit window should 
be applied at the best possibility. If the patient requires hospitalization, an SAE should be 
reported and the patient should be followed up as outlined in Section 12.8.3. 
During the COVID-19 pandemic, any potential measures or changes will be handled according to 
local regulations. If the COVID-19 pandemic wanes off, there is no need to amend the protocol in 
terms of any specific information relating to COVID-19, including whether some tests/procedures 
are no longer required. 

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11 EFFICACY ASSESSMENTS 
The Schedule of Assessments (Table 1) outlines the efficacy assessments to be performed 
throughout the study and their timing.  
11.1 Psoriasis Area Severity Index
The PASI is a quantitative rating score for measuring the severity of psoriatic lesions based on 
area coverage and plaque appearance and their response to therapy.16 For the PASI assessment, 
the body is divided into 4 regions: the head, upper limbs, trunk, and lower limbs (APPENDIX 2). 
Each of these areas is assessed separately for erythema, induration/thickness, and scaling, which 
are each rated on a scale of 0 to 4 based on severity of the lesion. Degree of involvement on each 
of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% 
involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is 
multiplied by the degree of involvement for each body region and then multiplied by a constant. 
The sum of all lesion scores can range from 0 (no disease) to 72 (maximal disease), with the 
higher score indicating more severe disease. PASI scores are treated as a continuous score with 
0.1 increments and if any individual score is missing, the PASI score will not be calculated. 
reduction 
from baseline in the PASI score). 
11.2 Static Physician’s Global Assessment 
The sPGA is a quantitative rating score of the patient’s psoriasis based on physician’s assessment 
at a given time point according to the following categories: induration, erythema, and scaling 
(APPENDIX 3). The sPGA is a 6-point scale and patient’s psoriasis is graded as clear (0), 
minimal (1), mild (2), moderate (3), marked (4), severe (5). The sum of the scores for induration, 
erythema, and scaling will be divided by 3 to obtain a final sPGA score. 
11.3 Body Surface Area
Total % BSA afflicted by psoriasis will be estimated using a handprint of the patient at each visit 
as outlined in the schedule of events (Table 1). The entire palmar surface of the patient’s 
handprint is assumed to correspond to approximately 1% of total BSA.17,18 
11.4 Dermatology Life Quality Index 
The DLQI is a dermatology specific QoL instrument designed to assess the impact of the disease 
on a patient’s QoL (APPENDIX 4).19 It is a 10-item patient-reported outcome questionnaire that, 
in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect 
QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal 
relationships, and treatment. Nine of the 10 questions have response categories including “not 
relevant” (score of 0), “not at all” (score of 0), “a little” (score of 1), “a lot” (score of 2) and 
“very much” (score of 3); Question 7 is a “yes”/ “no” question where “yes” is scored as 3. Eight 
items also have a “Not relevant” option scored “0,” which indicates no problems. Total scores 

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range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered a 
clinically important difference. If the answer to one question in a domain is missing, that domain 
is treated as missing. If 2 or more questions are left unanswered (missing), DLQI total score is 
treated as missing.

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12 SAFETY ASSESSMENTS 
12.1 Medical History 
Medical history will be recorded at screening. Investigators should document the occurrence, 
signs, and symptoms of the patient’s pre-existing conditions, including all prior significant 
illnesses before screening. Additional pre-existing conditions present at the time when ICF is 
given and up to the time of first dosing are to be regarded as concomitant. Medical history will 
include alcohol consumption and smoking history, if applicable. 
Illnesses first occurring or detected during the study and/or worsening of a concomitant illness 
during the study are to be documented as AEs on the eCRF in accordance with Section 12.8. All 
changes not present at baseline or described in the past medical history and identified as 
clinically noteworthy must be recorded as AEs. 
Additionally, demographic data will be collected for all patients and include date of birth or age 
according to applicable regulations, sex, race, and ethnicity. The demographic details will be 
recorded in the eCRF. 
12.2 Vital Signs 
Systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature will be 
assessed. Blood pressure and pulse measurements will be assessed in a semisupine position, 
preferably with a completely automated device. Blood pressure and pulse measurements should 
be preceded by at least 5 minutes of rest for the patient in a quiet setting without distractions (eg, 
television, cell phones). Vital sign measurements are to be taken before blood collection for 
laboratory tests. On the dosing day visits, vital signs will be assessed within 2 hours before 
dosing. 
Vital signs will be measured at scheduled visits as indicated in the schedule of events (Table 1).  
Out-of-range blood pressure, respiratory rate, or heart rate measurements will be repeated at the 
investigator’s discretion. Any confirmed, clinically significant vital sign measurements must be 
recorded as AEs. 
12.3 Physical Examination
A complete physical examination will include, at a minimum, assessments of the cardiovascular, 
respiratory, gastrointestinal, musculoskeletal, and neurological systems. Height and weight will 
also be measured and recorded. The complete physical examination will be performed at 
screening only. Abbreviated, ie, sign/symptom-directed examination including weight will be 
performed at subsequent time points as specified in the schedule of events (Table 1). 
Investigators should pay special attention to clinical signs related to previous serious illnesses.

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12.4 Electrocardiograms
All scheduled 12-lead ECGs will be performed at the study site after the patient has rested 
quietly for at least 5 minutes in a supine position. A 12-lead ECG will be performed at the time 
points specified in the schedule of events (Table 1); additional ECG recordings can be performed 
during study treatment administration or the 1-hour monitoring for hypersensitivity reactions at 
the investigator’s discretion. If following the ECG review by the investigator, there are any ECG 
findings that would indicate any clinically significant cardiac abnormalities, the patient will be 
referred to a cardiologist for further evaluation. The investigator will then report the event in the 
source documents and the eCRF. Regardless of the 12-lead ECG result, further evaluation with a 
cardiologist can be done at the investigator’s discretion.  
12.5 Laboratory Assessments 
Laboratory assessment samples (Table 2) are to be obtained at designated visits as detailed in the 
Schedule of Assessments (Table 1). 
Table 2. 
Laboratory assessment 
Clinical chemistry 
total protein, serum bilirubin (total, direct), alanine aminotransferase, aspartate 
aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, blood urea 
nitrogen, creatinine, albumin, sodium, potassium, calcium, chloride, inorganic 
phosphorus, glucose, lactate dehydrogenase, total cholesterol, triglyceride, 
high-density lipoprotein cholesterol, C-reactive protein (CRP), estimated glomerular 
filtration rate (eGFR), and uric acid 
Hematology 
red blood cells, total and differential white blood cell count, absolute neutrophil count, 
platelet count, hemoglobin, and hematocrit 
Urinalysis 
bilirubin, blood, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, 
and urobilinogen 
Viral serology 
Hepatitis B, hepatitis C and human immunodeficiency virus (HIV) tests (see 
Section 12.5.2 for details) 
Blood and urine samples will be analyzed at a central laboratory facility. Any abnormal 
laboratory test results (hematology, clinical chemistry, or urinalysis) including those that worsen 
from baseline and are clinically significant in the medical and scientific judgment of the 
investigator are to be recorded as AEs or SAEs. For urine sample analysis, if there are any 
clinically significant abnormalities, a microscopic analysis will be performed. 
However, any clinically significant safety assessments that are associated with the underlying 
disease, unless judged by the investigator to be more severe than expected for the patient’s 
condition, are not to be reported as AEs or SAEs. 
The investigator must review the laboratory reports, document this review, and record any 
clinically relevant changes occurring during the study. If the laboratory reports are not 
transferred electronically, the values must be filed with the source information (including 
reference ranges). In most cases, clinically significant abnormal laboratory findings are those that 

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12.5.3 Interferon- Release Assay Test 
A blood IGRA test will be performed at screening on all patients to test for latent TB. Patients 
will be enrolled or excluded from the study as described in Section 8.2. Additional IGRA test can 
be conducted during the study at the investigator’s discretion if there a suspicion of TB infection.
12.6 Injection Site Reaction Monitoring
Patients will be assessed for injection site reactions for at least 1 hour after the end of each 
dosing, as specified in the schedule of events (Table 1). Severity of injection site reactions will 
be based on Common Terminology Criteria for Adverse Events (CTCAE) criteria. 
Details will be recorded in both the source documents and the eCRF. 
12.7 Hypersensitivity Monitoring 
Patients will be assessed for hypersensitivity reactions for at least 1 hour after the end of the 
study treatment administration, as specified in the schedule of events (Table 1) Emergency 
medication and equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory 
support including inhalational therapy, oxygen, and artificial ventilation must be available at the 
study site and any additional procedures like ECG recording as required can be performed. If 
patients have signs and symptoms of hypersensitivity/allergic reactions at home (hives, difficulty 
breathing, or swelling of face, eyes, lips, or mouth or any symptoms of cardiac origin), patients 
or caregivers should be advised to call the study site or get immediate help. 
For patients who experience or develop life-threatening treatment-related anaphylactic reactions, 
study treatment administration must be stopped and permanently discontinued. 
Details will be recorded in both the source documents and the eCRF. 
12.8 Adverse Events
12.8.1 Adverse Events
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to the study treatment or their clinical significance.
An AE is any untoward medical occurrence in a patient or clinical investigation patient 
administered a pharmaceutical product and which does not necessarily have to have a causal 
relationship with this treatment. 
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding, for example), symptom, or disease temporally associated with the use of a medicinal 
product, whether or not considered related to the medicinal product. Patients will be instructed to 
contact the investigator at any time after randomization if any symptoms develop. 
A TEAE is defined as any event absent before exposure to the study treatment that emerges after 
first exposure to study treatment, or any event already present that worsens in either intensity or 
frequency after exposure to the study treatment. 

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An ADR is defined as any noxious and unintended responses to an investigational medicinal 
product related to any dose administered.
Anticipated day-to-day fluctuations of pre-existing diseases or conditions present or detected at 
the start of the study that do not worsen would not be considered AEs. Situations where an 
untoward medical occurrence has not occurred (eg, hospitalization for elective surgery, social 
and/or convenience admissions) would not be considered AEs. Laboratory results of the disease 
being studied, medical/surgical procedures are not an AE but rather the condition/event that leads 
to it are defined as an AE, details please refer to Sections 12.2 and 12.5. 
12.8.1.1 Eliciting and Documenting Adverse Events 
AEs will be assessed from the time the patient signs the ICF until the end of the study. 
If the investigator learns of any SAE, including a death, at any time after the end of the study, 
and he/she considers the event to be reasonably related to the study treatment or study 
participation, the investigator must promptly notify the Sponsor/Sponsor representative.
At every study visit, patients will be asked a standard nonleading question to elicit any medically 
related changes in their wellbeing. 
In addition to patient observations, AEs identified from any study data (eg, laboratory values, 
physical examination findings, ECG changes) or identified from review of other documents that 
are relevant to patient safety will be documented on the AE page in the eCRF. The investigator 
can follow-up AEs by unscheduled clinic visits or telephone calls with the patients at their 
discretion. Either unscheduled visits or follow-up calls need to be documented in the patient’s 
medical records and in the eCRF as appropriate. 
AEs will be recorded in the patient’s medical records in accordance with the investigator’s 
normal clinical practice and on the AE page of the eCRF. SAEs that occur during the study must 
be documented in the patient’s medical record, on the AE/SAE page of the eCRF. 
The investigator should attempt to establish a diagnosis of the event based on the signs, 
symptoms and/or other clinical information. In such cases, the diagnosis should be documented 
as the AE (and SAE if serious) and not the individual signs/symptoms. If a clinically significant 
abnormal laboratory finding or other abnormal assessment meets the definition of an AE (and 
SAE if serious), then the AE/SAE page of the eCRF page must be completed as appropriate. A 
diagnosis, or clinical signs or symptoms if the diagnosis is unknown, rather than the clinically 
significant laboratory finding or abnormal assessment, should be used to complete the AE/SAE 
page. As additional information becomes available and a diagnosis is achieved, the 
signs/symptoms or abnormal finding verbatim should be updated on the eCRF. 
If no diagnosis is known and clinical signs or symptoms are not present, then the abnormal 
finding should be recorded on the AE/SAE page. 

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12.8.1.1.1 Assessment of Severity 
The severity of an AE refers to the extent to which an AE affects the patient’s daily activities. 
The severity of the AE will be graded based on the CTCAE v5.0, based on the following general 
guidelines (a semicolon indicates “or” within each description). Any AEs not covered by the 
CTCAE criteria will be assessed and classified as per the same guidelines below: 
Grade 1: 
Mild: asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention 
not indicated 
Grade 2:
Moderate: minimal, local, or noninvasive intervention indicated; limiting age-appropriate 
instrumental activities of daily living* 
Grade 3: 
Severe or medically significant but not immediately life-threatening: hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily 
living** 
Grade 4: 
Life-threatening consequences: urgent intervention indicated 
Grade 5: 
Death related to AE 
Abbreviation: AE, adverse event. 
* Instrumental activities of daily living refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc. 
** Self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden. 
Changes in the severity of an AE should be documented to allow an assessment of the duration 
of the event at each level of intensity. AEs characterized as intermittent do not require 
documentation of onset and duration of each episode. 
The SAE will not be closed out if it is of changing severity during the course. It will be reported 
with changes in the severity as it upgrades in follow-up reports such that each upgraded sequela 
will not be recorded as a new SAE but continuation of same SAE and the serious and unexpected 
ADRs will be reported to the local regulatory authority/IEC within the stipulated timeline. Only 
the highest grade of severity will be considered for analysis purpose. 
12.8.1.1.2 Assessment of Causality 
The investigator’s assessment of an AE’s relationship to the study treatment is part of the 
documentation process, but it is not a factor in determining what is or is not reported in the study. 
If there is any doubt as to whether a clinical observation is an AE, the event should be reported.
The investigator’s causality assessment should consider the potential etiologies for the observed 
AE. An AE may be related to study treatment, other concomitant medications, the underlying 
disease pathology, intercurrent illness, a procedure performed in the course of the study, or 
another reason. Among the potential etiologies, the investigator should decide based on the most 
likely causal relationship. When a causality assessment is provided for an SAE, it is important to 
include a rationale for the assessment so that a better understanding of the reported event can be 
compiled. The rationale should be accompanied by all available supporting evidence, including 

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relevant laboratory tests, histopathology evaluations, and the results of other diagnostic 
procedures. 
The relationship or association of the study treatment in causing or contributing to the AE will be 
characterized using the following:
UNRELATED: There is no temporal association between the investigational product and 
the reported event and event is clearly due to other causes (eg, concomitant medication, 
underlying disease etc). 
 UNLIKELY: Time to drug intake makes a relationship improbable. Another explanation 
is more likely such as disease, environment, or other medication. 
 POSSIBLY: Treatment with the study drug caused or contributed to the AE, ie, the event 
follows a reasonable temporal sequence from the time of drug administration or follows a 
known response pattern to the study drug, but could also have been produced by other 
factors. 
 PROBABLY: A reasonable temporal sequence of the event with drug administration 
exists and, based upon the known pharmacological action of the drug, known or 
previously reported ADRs to the drug or class of drugs, or judgment based on the 
investigator’s clinical experience, the association of the event with the investigational 
product seems likely. The event disappears or decreases on cessation or reduction of the 
dose of investigational product. 
 DEFINITELY: A definite causal relationship exists between drug administration and the 
AE, and other conditions (concurrent illness, progression/expression of disease state, or 
concurrent medication reaction) do not appear to explain the event. The event reappears 
or worsens if the investigational product is readministered. 
12.8.1.2 Action Taken with Study Treatment 
Action taken for an AE associated with the study treatment: 
Treatment interrupted 
The treatment was temporarily interrupted, with intent to restart 
Treatment withdrawn  
The treatment was permanently discontinued 
Unknown 
Not known, not observed, not recorded, or refused  
No action taken 
The AE did not result in any modification of dose or frequency of dosing  
Not applicable  
The AE occurred before first dose or after last study dose  
Abbreviation: AE, adverse event. 
Note:  Dose increased, or dose reduced action taken can be evaluated on case to case basis as applicable. 
 
12.8.1.3 Outcome of Adverse Events 
The outcome at the time of last observation will be classified as: 
 Recovered/resolved 
 Recovered/resolved with sequelae 
 Recovering/resolving 

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 Not recovered/not resolved 
 Fatal*
 Unknown 
*Only select fatal as an outcome when the AE results in death. If more than one AE is possibly 
related to the patient’s death, the fatal outcome should be indicated for the AE which is the most 
plausible cause of death in the opinion of the investigator. All other ongoing AE/SAEs will be 
recorded as not recovered/not resolved at the time of death. 
Note: Although “fatal” is usually an event outcome, events such as sudden death or unexplained 
death should be reported as SAEs. 
12.8.1.4 Adverse Event Reporting 
All AEs reported or observed during the study will be recorded on the AE page in the eCRF. 
AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent 
medications, or progression of disease states must also be reported. All AEs will be followed to 
adequate resolution. The Medical Dictionary for Regulatory Activities (MedDRA) will be used 
to code all AEs. 
Any medical condition that is present at the time that the patient is screened but does not 
deteriorate should not be reported as an AE. However, if it deteriorates at any time during the 
study, it should be recorded as an AE. 
12.8.1.5 Follow-Up of Patients Reporting Adverse Events 
All AEs must be reported in detail on the appropriate page in the eCRF and followed to 
satisfactory resolution, until the investigator deems the event to be chronic or not clinically 
significant, the event is considered to be stable, or the patient is lost to follow-up. 
The investigator will administer appropriate treatment for the AE/SAE resolution. The 
Investigator is responsible to ensure that follow-up includes any supplemental investigations as 
may be indicated to elucidate as completely as practical the nature and/or causality of the 
AE/SAE. This may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other health care professionals. 
12.8.2 Adverse Events of Special Interest
An AESI (serious or nonserious) is defined as an AE or SAE of scientific and medical concern 
specific to the Sponsor’s product or program, for which ongoing monitoring and rapid 
communication by the investigator to the Sponsor/Sponsor representative could be appropriate 
(International Council for Harmonisation [ICH] E2F; Council for International Organizations of 
Medical Sciences [CIOMS] VI).
The following events will be considered as AESIs: infections, malignancies, hypersensitivity 
reactions, posterior reversible encephalopathy syndrome (PRES), and noninfectious pneumonia. 
All AESIs must be reported to the Sponsor/Sponsor representative immediately (ie, within 

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24 hours) after site personnel first learn of the event. Further details on the reporting and 
management of AESIs are provided in the Safety Management Plan. 
Infections
All AEs related to infection, including TB and sepsis, will be reported.
Malignancies 
AEs related to malignancy including but not limited to cutaneous and non-cutaneous 
malignancies will be reported. 
Hypersensitivity reactions 
All AEs related to hypersensitivity reactions, including anaphylaxis and angioedema, will be 
reported. 
Anaphylactic reactions 
Anaphylaxis will be identified according to Sampson criteria.20 Anaphylaxis is likely when any 
1 of the 3 criteria are fulfilled. 
1. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal 
tissue, or both (eg, generalized hives, pruritus or flushing, swollen lips-tongue-uvula) and 
at least one of the following: 
a) Respiratory compromise (eg, dyspnea, wheeze or bronchospasm, stridor, reduced 
peak expiratory flow, hypoxemia) 
b) Reduced blood pressure or associated symptoms of end-organ dysfunction (eg, 
hypotonia [collapse], syncope, incontinence) 
2. Two or more of the following that occur rapidly after exposure to a likely allergen for that 
patient (minutes to several hours):  
a) Involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen 
lips-tongue-uvula) 
b) Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced peak 
expiratory flow, hypoxemia) 
c) Reduced blood pressure or associated symptoms (eg, hypotonia [collapse], syncope, 
incontinence) 
d) Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting) 
3. Reduced blood pressure after exposure to known allergen for that patient (minutes to 
several hours): 
a) Adults: Systolic blood pressure of less than 90 mm Hg or greater than 30% decrease 
from that person’s baseline. 

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Posterior Reversible Encephalopathy Syndrome 
All AEs of PRES will be reported. Clinical presentation may include headaches, seizures, 
confusion, visual disturbances, and imaging changes consistent with PRES a few days to several 
months after ustekinumab initiation.
Noninfectious Pneumonia 
All AEs of noninfectious pneumonia will be reported. Clinical presentations may include cough, 
dyspnea, and interstitial infiltrates. 
12.8.3 Serious Adverse Events 
An SAE is defined as any event that 
 results in death 
 is immediately life-threatening* 
 requires inpatient hospitalization or prolongation of existing hospitalization** 
 results in persistent or significant disability/incapacity 
 is a congenital anomaly/birth defect 
 important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered SAEs when, based upon appropriate medical 
judgment, they may jeopardize the patient or may require medical or surgical intervention 
to prevent one of the outcomes listed in this definition. Examples of such medical events 
include allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or 
the development of drug dependency or drug abuse.
* The term "life-threatening" in the definition of "serious" refers to an event in which the patient 
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.
**“Inpatient hospitalization” does not imply that the patient must have had an overnight stay in 
the hospital. If the patient was admitted to the hospital for less than a day for the purpose of 
treatment or observation, the definition of “Inpatient hospitalization” is met, provided the patient 
is admitted solely for treatment of the event and not admitted for any other reasons including, 
rehabilitation, hospice care, respite care (eg, caregiver relief), skilled nursing facilities, nursing 
homes, social reasons, ease of compliance, day care procedures, or for medical or hospital 
records (insurance reimbursement) purpose. Although, brief treatment in an outpatient clinic or 
emergency department does not constitute “inpatient hospitalization”, depending on the 
intervention/treatment required for the event, it may satisfy the criteria of inpatient 
hospitalization to be reported as an SAE. 
Events NOT to be reported as SAEs are hospitalizations for the following: 

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Any SAE that is not resolved by the end of the study or upon discontinuation of the patient’s 
participation in the study is to be followed up until it either resolves, stabilizes, returns to 
baseline values (if a baseline value is available), the lost to follow-up, or is shown to not be 
attributable to the study drug or procedures.The investigator (and any designee) is required to 
comply with applicable regulations (including local law and guidance) regarding notification to 
his/her regulatory authority, IRB, IECs, institutional ethics committees, and institutions. 
SUSARs, SAEs or other cases as required by the concerned competent authorities and IECs will 
be reported by the sponsor/representative to all concerned parties within applicable timelines. 
The sponsor/representative will notify the SAEs to other sites/investigators and will also submit 
periodic safety reports (eg, Development Safety Update Reports) as required by local and 
international regulations. 
Additional details for SAE/SUSAR reporting including periodic safety reporting are provided in 
the Safety Management Plan. 
Clarification in Reporting of Deaths 
All patient deaths (regardless of relationship to study treatment) should be reported for patients 
on the study, and recorded in the eCRF. If a patient dies after signing consent but before the first 
dose of the study treatment, this should also be recorded in the eCRF. Death is an outcome of an 
AE and not an AE in itself. All reports of patient death should include an AE term (other than 
“Death”) for the cause of the death. If an AE term is not provided, the investigator will be 
queried to obtain the cause of death. Only in the rare occurrence that no verbatim description of 
an AE can be obtained from the investigative site, will “Death-Unknown cause” be used as the 
event term. 
12.8.4 Suspected Unexpected Serious Adverse Reactions 
SUSARs are SAEs having a reasonable possibility of a causal relationship with the study drug, 
the nature or severity of which is not consistent with the applicable product information (eg, IB 
or approved product labels). 
12.8.5 Pregnancy 
Pregnancy is not regarded as an AE unless there is a suspicion that study treatment may have 
interfered with the effectiveness of a contraceptive medication. Any pregnancy that occurs 
during study participation must be reported by the patient or female partner of the patient to the 
clinical study site where the investigator will collect information related to the pregnancy and its 
outcome. To ensure patient safety, each pregnancy must be reported to the Sponsor/Sponsor 
representative within 24 hours of learning of its occurrence. The pregnancy must be followed to 
determine outcome (including spontaneous miscarriage, elective termination, normal birth, or 
congenital abnormality) and status of mother and child, even if the patient was discontinued from 
the study. Investigator should fill the Pregnancy Reporting Form and send to the 
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should include an assessment of the possible relationship to study drug of any pregnancy 
outcome. Refer Section APPENDIX 1 for details on collection of pregnancy information. 
If the pregnancy is associated with an SAE (eg, if the mother is hospitalized for a medical 
reason), the same should be reported using the same process as for SAEs as detailed under 
Section 12.8.3.1 (in addition to the Pregnancy Reporting Form). Pregnancy complications and 
elective terminations for medical reasons must be reported as an AE or SAE. Spontaneous 
miscarriages must be reported as an SAE. Any SAE occurring in association with a pregnancy, 
brought to the investigator’s attention after the patient has completed the study, and considered 
by the investigator as possibly related to the study treatment, must be promptly reported to the 
Sponsor. 
12.8.6 Overdose, Underdose, and Medication Error
Because study treatments are directly administered by personnel involved in the study in a 
controlled manner, overdose/underdose/medication error is unlikely to occur. However, in case 
of overdose/underdose/medication error, the management will be as per the standard of care. In 
case there is overdose/underdose/ medication error, the same should be informed to the 
Sponsor/Sponsor representative safety team immediately (ie, within 24 hours). If 
overdose/underdose/medication error is associated with an AE/ SAE, AE/SAE reporting 
timelines (as applicable) to be followed. 
In case of overdose, underdose, or medication error, it is recommended that the patient be 
monitored for any signs or symptoms of ADRs and appropriate symptomatic treatment be 
instituted immediately. 
12.9 Tuberculosis Assessment
Patients with current or history of TB at screening will be excluded from the study as well as 
patients with latent TB as per IGRA test result who have not completed or are not receiving 
antibiotic prophylactic therapy as per local guidelines (see Section 8.2). 
Throughout the study, patients will be monitored for the clinical signs and symptoms of TB. An 
additional IGRA or chest radiography may be performed at the investigator’s discretion based on 
the judgment per the signs and symptoms of TB monitoring. Patients with active TB based on 
the chest radiography result and/or the clinical signs and symptoms must be permanently 
discontinued from study treatment. 
If a patient is exposed to a person with active TB or to any condition increasing the risk of TB 
infection during the study period, an IGRA test will be conducted as soon as possible and prior to 
next administration of study treatment for those who had tested negative at screening. If the 
result of the IGRA is positive, patients will be referred to the clinician immediately to investigate 
the presence of active or latent TB based on medical history and any clinical signs and symptoms 
including chest radiography result. Even in the absence of clinical suspicion for active TB, study 
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12.9.1 Chest Radiography 
A chest radiography (posterior-anterior and lateral views, or per country regulations where 
applicable) should be done during screening and read by a qualified radiologist or pulmonary 
physician to specifically look for evidence of current or previous active or latent TB. If a chest 
radiography within 12 weeks prior to screening is available, it is not required at screening, and 
the result will be recorded in both the source documents and the eCRF. 
Radiographic findings suggestive of healed TB or active TB may include but are not limited to 
pulmonary nodules, fibrotic scars, calcified granulomas, upper lobe infiltrates, cavitation, and 
pleural effusions. Any abnormal radiological changes should be discussed with the medical 
monitor before the baseline visit. The chest radiological examination should be available to the 
investigator for review before the baseline visit of the patient. 

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13 PHARMACOKINETICS 
For all patients, PK blood samples for the determination of serum concentration of ustekinumab 
will be collected at the time points specified in the schedule of events (Table 1). On the days of 
study treatment administration, blood samples must be taken before the treatment. Details of 
blood sample collection, processing, storage, and shipping procedures are provided in a separate 
laboratory manual. The PK of ustekinumab will be assessed using a validated bioanalytical 
method for serum concentration at a central laboratory. 
An additional blood sample of 5 mL will be collected from all patients before the first dose 
administration for PK method validation. 

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14 IMMUNOGENICITY ASSESSMENTS 
The immunogenicity of Bmab 1200 and Stelara® will be assessed by ADA and NAb tests using a 
validated immunoassay. It will be specified in a separate method validation report.  
Serum samples for immunogenicity testing will be collected at the time points specified in the 
schedule of events (Table 1). The ADA serum samples will be stored frozen before shipment to a 
central laboratory for evaluation. Details of blood sample collection, processing, storage, and 
shipping procedures are described in the central laboratory manual. In case of positive results in 
the ADA evaluation, the ADA titer will be evaluated, and evaluation of NAb levels will be 
conducted. 
An additional blood sample of 10 mL will be collected from all patients before the first dose 
administration for immunogenicity assay validation.
Additional blood samples for immunogenicity for patients with hypersensitivity reactions
considered as possibly, probably, or definitely related to study treatment will be obtained as soon 
as possible after the onset of the reaction whenever this is feasible. 

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The sample size calculation is based on the primary endpoint, percentage change from baseline 
in the PASI score at Week 12. Equivalence will be established if the 90% CI of the difference 
between the treatments (Bmab 1200, Stelara®) in the percentage change in the PASI score from 
baseline to Week 12 is within the equivalence margin of ±10%. Assuming that the treatments are 
equally effective and that the common SD of the percentage change from baseline in the PASI 
score at Week 12 is 30%, a total sample size of 384 patients including a dropout rate of 10% 
patients ensures a power of 85% with a two one-sided 5% level of significance. 
15.2 Analysis Sets
The following analysis sets will be considered for analysis during TP1 (ie, before 
rerandomization at Week 16 for treatment switch) and throughout the whole study, where 
applicable: 
Full Analysis Set (FAS): The FAS will consist of all patients who sign the ICF and are 
randomized into TP1. Patients in the FAS will be analyzed under the treatment as randomized. 
The FAS will be used for the primary analyses of efficacy. 
Per-Protocol Set (PPS): The PPS will consist of all patients in the FAS, who receive at least 
2 study treatment administrations (Baseline and Week 4), and do not experience any important 
protocol deviations affecting primary efficacy at Week 12  (see Section 15.11 for initial list of 
protocol deviations to be considered). Patients in the PPS will be analyzed under the treatment as 
randomized. The PPS will be used for supportive analyses of efficacy.  
Safety Set (SAF): The SAF will consist of all patients who receive at least one study treatment 
administration. The SAF will be used for analyzing safety and immunogenicity data during the 
treatment period. Patients in the SAF will be analyzed under the treatment as actually received. 
The SAF will be used for all analyses of safety and immunogenicity. 
PK Set (PKS): The PKS will consist of all patients who receive at least one full dose of study 
treatment and have at least 1 post-treatment PK result before Week 16, excluding observations 
after relevant intercurrent events (ICEs) that may impact PK evaluations (eg, missing a dose, 
errors or deviations in dosing or receipt of other therapies which also contain ustekinumab). 
Patients in the PKS will be analyzed under the treatment as actually received. The PKS will be 
used for analyses of PK. 
The following analysis sets will be considered for analysis during TP2 (ie, after rerandomization 
at Week 16 for treatment switch up to Week 28) and TP3 (from Week 28 up to Week 52): 
FAS for TP2 (FAS2): The FAS2 will consist of all patients who are rerandomized into TP2 at 
Week 16. Patients from the FAS2 will be analyzed under the treatment as randomized during 
TP2. The FAS2 will be used for the analyses of efficacy during TP2. 
FAS for TP3 (FAS3): The FAS3 will consist of all patients who are re-consented and continue 
into TP3 at Week 28. Patients from the FAS3 will be analyzed under the treatment as 
randomized during TP2. The FAS3 will be used for the analyses of efficacy during TP3. 

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SAF for TP2 (SAF2): The SAF2 will consist of all patients who receive the rerandomized study 
treatment administration at Week 16 or later. Patients from the SAF2 will be analyzed under the 
treatment as actually received during TP2. The SAF2 will be used for the analyses of safety and 
immunogenicity during TP2.
SAF for TP3 (SAF3): The SAF3 will consist of all patients who continue to receive the study 
treatment administration at Week 28 or later. Patients from the SAF3 will be analyzed under the 
treatment as actually received during TP3. The SAF3 will be used for the analyses of safety and 
immunogenicity during TP3.
PKS for TP2 (PKS2): The PKS2 will consist of all patients who receive a full dose of 
rerandomized study treatment administration at Week 16 and have at least 1 PK result at Week 
20 or Week 28 (predose), excluding observations after relevant events after Week 16 and up to 
Week 28 predose that may impact PK evaluations (eg, missing a dose, errors or deviations in 
dosing or receipt of other therapies which also contain ustekinumab). Patients in the PKS2 will 
be analyzed under the treatment as actually received during TP2. The PKS2 will be used for 
analyses of PK during TP2. 
PKS for TP3 (PKS3): The PKS3 will consist of all patients who receive a full dose of study 
treatment administration at Week 28 or later and have at least 1 PK result at Week 40 or 
Week 52, excluding observations after relevant events after Week 28 that may impact PK 
evaluations (eg, missing a dose, errors or deviations in dosing or receipt of other therapies which 
also contain ustekinumab). Patients in the PKS3 will be analyzed under the treatment as actually 
received during TP3. The PKS3 will be used for analyses of PK during TP3.
Assignment to all analysis sets, including decisions made on inclusion/exclusion for the PPS and 
other data handling issues will be agreed on and documented in BDRM, to occur (with report 
finalized) before each database lock. The assignment of the PPS will be finalized during the 
BDRM at the time of the Week 28 database lock. As such, the PPS will not be further reviewed 
during the BDRM at the time of the Week 52 database lock. 
15.3 Patient Disposition 
Patient disposition will be summarized by treatment period and treatment/regimen and will 
include the number and percentage of patients achieving the following criteria: screened, screen 
failed, included and excluded from each analysis set (including reasons for exclusion), completed 
or prematurely discontinued study treatment for each period, and completed and prematurely 
discontinued the study, including reasons for discontinuation for both study treatment and the 
study. 
15.4 Demographic and Baseline Characteristics 
Demographic and baseline characteristics will be listed. Demographic and baseline 
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For analyses using MI, the analysis will be conducted on the complete dataset, for each 
imputation separately. Modelled results will be combined using Rubin’s rule (PROC 
MIANALYZE) for tabulation.
Additional subgroup analyses based on baseline characteristics will be presented with forest 
plots, as will analyses of primary efficacy based on ADA and NAbs positive/negative status up 
to Week 12. 
All inferential analyses of the primary efficacy endpoint, including MI approaches will be 
conducted during TP1 only (ie, up to and including Week 16). However, primary analysis will be 
done at Week 12 only. During TP2 (Week 16 post rerandomization through Week 28 predosing) 
and TP3 (Week 28 postdosing through Week 52), only descriptive analyses will be performed 
for efficacy. The handling of estimands as detailed above will also only apply up to and 
including Week 16. After this point, data will only be analyzed as observed. 
15.5.2 Analysis of Secondary Efficacy Endpoints 
The secondary objective of the trial with respect to efficacy is “to assess the efficacy of Bmab 
1200 based on other efficacy parameters and time points over the study period as compared to 
Stelara®”. The estimands framework will apply for the following endpoints related to the 
secondary efficacy objective, for all visits up to and including Week 16 (ie, during TP1, or as 
otherwise stated): 
 PASI: 
o Percentage change from baseline in the PASI score at Weeks 4, 8, and 16  
o PASI 50, PASI 75, and PASI 90 relative to baseline at Weeks 4, 8, 12, and 16 
o Raw PASI scores at Weeks 4, 8, 12, and 16 
o AUECs of PASI score from baseline to Week 12
 sPGA response of cleared or almost clear/minimal (PGA score of 0 or 1) at Weeks 4, 8, 
12, and 16. 
 Change from baseline in affected BSA at Weeks 4, 8, 12, and 16. 
 Change from baseline in QoL as measured by DLQI scores at Weeks 4, 8, 12, and 16. 
The same estimands (primary, secondary, and tertiary) as for the primary efficacy endpoint will 
be applied for the secondary efficacy endpoints related to PASI and sPGA. Where ICEs relating 
to deviations in study treatment are assessed, dosing up to Week 4 will be considered. 
For the secondary efficacy endpoints related to BSA and DLQI, a single primary estimand 
handling all ICEs with a treatment policy strategy will be applied. For this estimand, available 
data occurring on or after the ICE will be analyzed as observed (except remote visits, similar to 
the primary efficacy endpoint). Missing PASI assessment will be imputed by an MAR 
application of SAS Proc MI (see Section 15.9). 

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Similar to the primary efficacy analyses, for the main analyses of the secondary efficacy 
endpoints, data obtained from remote visits will not be considered; the handling of such events as 
ICEs under the estimands framework will be discussed in the SAP. Sensitivity analyses, 
considering such data, may be added as appropriate.
No margins of equivalence are applied to secondary efficacy endpoints. 
Continuous secondary efficacy endpoints related to PASI will implement the same analysis 
method as that for the primary efficacy endpoint. Continuous secondary efficacy endpoints 
related to BSA and DLQI will be analyzed using mixed effect model for repeated measures 
(MMRM), similar to the sensitivity analysis of the primary efficacy endpoint. Binary secondary 
efficacy endpoints will be analyzed using a Cochran-Mantel-Haenszel (CMH) test, adjusted for 
the randomization strata (region, body weight at baseline category, baseline psoriatic arthritis 
status, and previous biologic use). The estimate of the risk difference, with corresponding 
CMH-adjusted 2-sided 95% CI, will be presented. The validity of the CMH test, in particular 
with respect to the size of strata combination, will be reviewed. If small strata combinations cast 
doubt on the use of the CMH test, strata may be pooled, or a nonstratified test will be used. For 
analyses using MI, the analysis will be conducted on the complete dataset, for each imputation 
separately. Modelled results will be combined using Rubin’s rule (PROC MIANALYZE) for 
tabulation. 
Additionally, supportive analyses will be conducted for the endpoints related to PASI and sPGA 
for the primary, secondary, and tertiary estimands on the PPS. 
All time points up to Week 16 will also be analyzed descriptively for all efficacy measures on 
the FAS. For the secondary efficacy endpoints relating to TP2 (all scheduled visits after Week 16 
up to Week 28 predosing) and TP3 (all scheduled visits after Week 28 postdosing to Week 52), 
analyses will be purely descriptive, and the estimands framework (including ICEs) will not be 
applied. 
Subgroup analyses of secondary efficacy based on ADA status (positive versus negative up to 
Week 16, Week 28, and Week 52) and selected baseline characteristics may also be explored. 
Subgroup analyses will be conducted at least for the efficacy analyses of PASI. Further details of 
all analyses will be included in the SAP. 
15.6 Safety Analyses 
Safety data reported during TP1, TP2 and TP3 will be separately analyzed by treatment group on 
the SAF or by treatment regimen on the SAF2 and SAF3, respectively. No formal statistical 
comparisons are planned. Subgroup analyses of safety based on ADA status (positive versus 
negative up to Week 16, Week 28, and Week 52, or before start of AE) may also be explored for 
TEAEs and SAEs by MedDRA SOC and PT. Further details of all analyses will be included in 
the SAP. 

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15.6.1  Adverse Events 
AEs will be classified according to the time of onset of the AE into pretreatment AEs, TEAEs 
and post-treatment-emergent AEs. All reported AEs will be coded using the most recent version 
of the MedDRA coding dictionary. An overall summary of incidence will be presented for 
TEAEs, treatment-emergent SAEs, study treatment-related TEAEs and treatment-emergent 
SAEs, TEAEs leading to study discontinuation, TEAEs leading to discontinuation of study 
treatment (Bmab 1200 or Stelara®), and AESIs (see Section 12.8.2) by treatment period and 
treatment/regimen. Additional summaries of these AEs will be presented by MedDRA SOC and 
PT, by treatment period and treatment/regimen. Summaries will include the total number of 
events with number and percentage of patients with the specified AE. 
All AEs will be listed by patient, along with information regarding date of onset, duration, 
severity, relationship to study drug, action taken with study drug, treatment of event, and 
outcome.  
15.6.2  Analysis of Other Safety Endpoints
The clinical safety laboratory test values, vital signs, ECG parameter values, and physical 
examinations will be summarized by treatment period and treatment/regimen. For laboratory 
parameters and vital signs, original results and change from baseline will be summarized at each 
visit. Potentially clinically significant values will be flagged and summarized.  
Exposure in terms of number of study treatment administration and days of study treatment 
administration since baseline will be summarized by treatment period and treatment/regimen. 
The number and percentage of patients with prior and concomitant medications will be tabulated 
using anatomic therapeutic classification (ATC) level of the latest version of World Health 
Organization Drug Dictionary (WHODrug), and PT, by treatment period and treatment/regimen. 
A medication’s usage will be considered concomitant if it was started or continued after first 
administration of the study treatment. If the start date is missing, it will be assumed that the 
medication was used concomitantly. Details on handling partial dates (ie, year or only year and 
month) will be described in the SAP.
15.7 Pharmacokinetic Analysis 
Serum concentrations of Bmab 1200 and Stelara® will be listed and descriptively summarized by 
treatment (Bmab 1200, Stelara®) and visit for TP1 and by treatment regimen (Bmab 1200-Bmab 
1200, Stelara®-Bmab 1200, Stelara®-Stelara®) and visit for TP2 and TP3. Descriptive statistics 
will include arithmetic and geometric mean, SD, coefficient of variation and geometric 
coefficient of variation, minimum, maximum, and median, plus percentage of concentration 
values below the lower limit of quantification. Additional subgroup analyses of PK data by 
treatment and ADA status will be presented. Details of the PK analysis will be provided in the 
SAP. 

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15.8 Immunogenicity Analyses 
Incidence of ADAs to Bmab 1200 and Stelara® including titer and NAbs will be descriptively 
summarized at each time point and cumulative up to the time point by treatment (Bmab 1200, 
Stelara®) for TP1 and by treatment regimen (Bmab 1200-Bmab 1200, Stelara®-Bmab 1200, 
Stelara®-Stelara®) for TP2 and TP3. The titer values for positive ADA will be descriptively 
summarized. A listing will be produced showing all immunogenicity results for patients with any 
confirmed positive result. 
15.9 Handling of Missing Data
Every effort will be made to prevent patients early terminating the study and for patients who 
discontinue study treatment, every effort will be made to continue to collect data after 
discontinuation. 
Where missing data exist for primary and secondary efficacy endpoints, imputation will occur 
where specified. 
For determination of the primary efficacy endpoint analyses of percentage change in PASI score 
from baseline to Week 12, and other PASI related endpoints during TP1, an MI approach for 
missing data will be employed where appropriate. For categorical analyses related to PASI score 
(ie, PASI-50, PASI-75, and PASI-90), imputation of the missing PASI score data will occur, and 
then the category will subsequently be derived. This will also apply prior to percentage 
calculation.  
Imputation of missing data for PASI score will occur as follows: Where a composite strategy is 
applied, a multiple imputed return-to-baseline approach will be implemented. The missing data 
will be imputed considering the stratification factors and only including the baseline PASI score. 
Randomized treatment group will not be considered for this imputation, as baseline response is 
irrespective of treatment group later assigned. 
Where missing data exists that is not affected by an ICE applying either a composite or 
hypothetical strategy, the missing data will be imputed using an MAR approach, taking into 
account the treatment group as randomized, stratification factors, baseline PASI, any available 
PASI assessments and ICE indicators up to the visit to be imputed. 
Where missing data exists that is affected by an ICE applying a hypothetical strategy, the 
missing data will be imputed using a MNAR approach, including available data only from 
patients who do not experience any ICE up to and including the visit to be imputed. Imputation 
under these MNAR conditions will similarly take into account the treatment group as 
randomized, stratification factors, baseline PASI and any available PASI assessments up to the 
visit to be imputed. 
The number of imputations and the seed to be used, plus any further details required, will be 
detailed in the SAP. 

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A similar approach will be implemented for the secondary efficacy endpoints that are not related 
to PASI score, unless otherwise stated. For these analyses, the respective baseline result will be 
included rather than PASI score at baseline as described above.
Further to the above, a nonresponder approach will additionally be implemented for the primary 
estimand of binary secondary efficacy response endpoints (PASI-50, PASI-75, PASI-90, and 
sPGA response) as sensitivity analysis. 
15.10 Interim Analysis 
There is no interim analysis planned. Two database locks are planned for this study: one at the 
time of the Week 28 analysis and the other at the time of the Week 52 analysis. The study team 
will continue to remain blinded to the study treatments until the Week 52 analysis; a separate 
analysis team and reporting team will conduct the unblinded analyses for the Week 28 CSR 
which will be described in detail in a separate document for the study. 
Further details will be provided in the SAP.
15.11 Protocol Deviations Leading to Exclusion from the Per-Protocol Set 
Important protocol deviations leading to exclusion from the PPS may include, but are not limited 
to: 
 Randomization criteria violations 
 Inclusion/exclusion criteria violations
 Inadequate compliance with study drug, including significant deviations from the study 
drug administration schedule 
 Prohibited medications taken
 No valid evaluation of the primary efficacy endpoint 
 Other protocol deviations that could affect patients’ primary efficacy outcomes 
Protocol deviations affecting primary efficacy will be defined and reviewed in a standalone 
document during the BDRMs, to be held (with report finalized) before each database lock. The 
assignment of the PPS will be finalized during the BDRM at the time of the Week 28 database 
lock. As such, the PPS will not be further reviewed during the BDRM at the time of the Week 52 
database lock. 
15.12  COVID-19 
Given the current COVID-19 pandemic, per regulatory guidance, a listing of patients either 
experiencing COVID-19 or possibly affected by COVID-19 related measures will be produced 
where applicable. As discussed above, the main analyses of estimands for the primary and 
secondary efficacy endpoints will be based on attended visits only, and remote assessment will 
not be considered. Details of handling of such events will be discussed in the SAP.  

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Further details relating to additional populations and subgroup analyses, handling of protocol 
deviations, handling of missing data (including use of virtual assessments and/or switches from
local to centralized laboratories), and any other considerations related to COVID-19 and related 
measures will be detailed further in the SAP, which will be finalized and signed-off before 
database lock. 

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16 STUDY MANAGEMENT 
16.1 Approval and Consent 
16.1.1 Regulatory Guidelines
The investigator agrees that the study will be conducted according to the principles of ICH 
E6 (R2). The investigator will conduct all aspects of this study in accordance with EU General 
Data Protection Regulation (GDPR) directive, all national, state, and local laws or regulations. 
Study information from this protocol will be posted on publicly available clinical trial registers 
before enrollment of patients begins. 
16.1.2 Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain patient confidentiality. All records will be kept in a secure storage 
area with limited access. Clinical information will not be released without the written permission 
of the patient (or the patient’s legal guardian), except as necessary for monitoring and auditing 
by the Sponsor, its designee, the IRB/IEC, or other applicable regulatory agencies. 
The investigator and all employees and coworkers involved with this study may not disclose or 
use for any purpose other than performance of the study any data, record, or other unpublished, 
confidential information disclosed to those individuals for the purpose of the study. Prior written 
agreement from the Sponsor or its designee must be obtained for the disclosure of any said 
confidential information to other parties.
16.1.3 Data Protection
All personal data collected related to patients, investigators, or any person involved in the study, 
which may be included in the Sponsor’s databases, shall be treated in accordance with local data 
protection law. 
Data collected must be adequate, relevant, and not excessive, in relation to the purposes for 
which they are collected. Each category of data must be properly justified and in line with the 
study objective. 
16.1.4 Institutional Review Board/Independent Ethics Committee 
Federal regulations and the ICH guidelines require that approval be obtained from an IRB/IEC 
before patients participate in research studies. Before study onset, the protocol, ICF, 
advertisements to be used for the recruitment of patients, and any other written information 
regarding this study to be provided to the patient or the patient’s legal guardian must be approved 
by the IRB/IEC. Documentation of all IRB/IEC approvals and of the IRB/IEC compliance with 
ICH harmonized tripartite guideline E6 (R2): GCP will be maintained by the site and will be 
available for review by the Sponsor or its designee. 
All IRB/IEC approvals should be signed by the IRB/IEC chairman or designee and must identify 
the IRB/IEC name and address, the clinical protocol by title or protocol number or both, and the 
date approval or a favorable opinion was granted. 

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The investigator is responsible for providing written summaries of the progress and status of the 
study at intervals not exceeding 1 year or otherwise specified by the IRB/IEC. The investigator 
must promptly supply the Sponsor or its designee, the IRB/IEC, and, where applicable, the 
institution, with written reports on any changes significantly affecting the conduct of the study or 
increasing the risk to patients. 
16.1.5 Patient Information and Informed Consent 
A written ICF in compliance with all applicable regulatory requirements, ICH GCP, and ethical 
principles that have their origin in Declaration of Helsinki shall be obtained from each patient 
before entering the study or performing any unusual or nonroutine procedure that involves risk to 
the patient. An ICF template may be provided by the Sponsor to investigative sites. If any 
institution-specific modifications to study-related procedures are proposed or made by the site, 
the consent should be reviewed by the Sponsor or its designee or both before IRB/IEC 
submission. Once reviewed, the consent will be submitted by the investigator to his or her 
IRB/IEC for review and approval before the start of the study. If the ICF is revised during the 
course of the study, all active patients must be reconsented by signing the revised form. 
Before recruitment and enrollment, each prospective patient or his or her legal guardian will be 
given a full explanation of the study, be allowed to read the approved ICF, and have any 
questions answered. Once the investigator is assured that the patient/legal guardian understands 
the implications of participating in the study, the patient/legal guardian will be asked to give 
consent to participate in the study by signing the ICF. The authorized person obtaining the ICF 
also signs the ICF. 
The ICF will contain a separate section that addresses the use of remaining mandatory samples 
for optional exploratory research (if applicable) and explain/address the exploratory research 
portion of the study. Patient medical records need to state that written ICF was obtained. 
The investigator shall retain the signed original ICF(s) and give a copy of the signed original 
form to the patient or legal guardian. 
16.2 Data Handling/Management 
As part of the responsibilities assumed by participating in the study, the investigator agrees to 
maintain adequate case histories for the patients treated as part of the research under this 
protocol. The investigator agrees to maintain accurate eCRFs and source documentation as part 
of the case histories. These source documents may include diary cards, laboratory reports, ECG 
strips, etc. 
All eCRF information is to be filled in. If an item is not available or is not applicable, this fact 
should be indicated. Blank spaces should not be present unless otherwise directed. 
Investigative site personnel will enter patient data into eCRF. The analysis data sets will be a 
combination of these data and data from other sources (eg, laboratory data). 

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Clinical data management will be performed in accordance with applicable Sponsor’s standards 
and data cleaning procedures to ensure the integrity of the data, eg, removing errors and 
inconsistencies in the data. AE terms will be coded using MedDRA, an internal validated 
medical dictionary, and concomitant medications will be coded using World Health Organization 
Drug Dictionary (WHODrug). 
16.3 Source Documents 
Source documents are considered to be all information in original records and certified copies of 
original records of clinical findings, observations, data, or other activities in a clinical study 
necessary for the reconstruction and evaluation of the study. The investigator will provide direct 
access to source documents and/or source data in the facilitation of trial-related monitoring, 
audits, review by IECs/IRBs, and regulatory inspections. 
The investigator/institution should maintain adequate and accurate source documents and trial 
records that include all pertinent observations on each of the site’s trial patient. Source data 
should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to 
source data should be traceable, not obscure the original entry, and be explained if necessary.
16.4 Record Retention 
Essential documents should be retained 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 have elapsed since the formal discontinuation of 
clinical development of the study treatment (Bmab 1200). These documents should be retained 
for a longer period; however, if required by the applicable regulatory requirements or by an 
agreement with the Sponsor. It is the responsibility of the Sponsor to inform the 
investigator/institution as to when these documents no longer need to be retained. No records 
may be transferred to another location or party without written notification to the Sponsor.
16.5 Monitoring 
16.5.1 Monitoring of the Study 
This study will be monitored according to an approved monitoring plan based on the objectives, 
purpose, design, and complexity of the study. The investigator will allocate adequate time for all 
monitoring visits and between visits to facilitate the requirements of the study and study 
timelines. The investigator will also ensure that the monitor or other compliance or quality 
assurance reviewer is given direct access to all study-related documents and study-related 
facilities (eg, pharmacy, diagnostic laboratory), phone, fax, and internet and has adequate space 
to conduct the monitoring visit. Site monitoring is conducted to ensure that the rights of patients 
are protected, that the study is implemented in accordance with the protocol and/or other 
operating procedures, and that the study uses high quality data collection processes. The monitor 
will evaluate study processes based on the Sponsor or designee standards, ICH E6, and all 
applicable, regulatory guidelines. 

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16.5.2 Inspection of Records 
Investigators and institutions involved in the study will permit study-related monitoring, audits, 
IRB/IEC review, and regulatory inspections by providing direct access to all study records. In the 
event of an audit, the investigator agrees to allow the Sponsor, representatives of the Sponsor, or 
a regulatory agency access to all study records.
The investigator should promptly notify the Sponsor and contract research organization (CRO) 
of any audits scheduled by any regulatory authorities and promptly forward copies of any audit 
reports received to the Sponsor. 
16.6 Quality Control and Quality Assurance 
The Sponsor or its designee will perform the quality assurance and quality control activities of 
this study; however, responsibility for the accuracy, completeness, security, and reliability of the 
study data presented to the Sponsor lies with the investigator generating the data. 
The Sponsor will arrange audits as part of the implementation of quality assurance to ensure that 
the study is being conducted in compliance with the protocol, standard operating procedures, 
GCP, and all applicable regulatory requirements. Audits will be independent of and separate 
from the routine monitoring and quality control functions. Quality assurance procedures will be 
performed at study sites and during data management to assure that safety and efficacy data are 
adequate and well documented. 
16.7 Protocol Amendment and Protocol Deviation 
16.7.1 Protocol Amendment 
Any changes in the required procedures defined in this protocol, except those necessary to 
remove an apparent, immediate hazard to the patient, must be reviewed and approved by the 
Sponsor or designee. Amendments to the protocol (including emergency changes) must be 
submitted in writing to the investigator’s IRB/IEC, along with any applicable changes to the ICF, 
for approval before patients can be enrolled into an amended protocol.
16.7.2 Protocol Deviations 
A deviation from the protocol is an unintended or unanticipated departure from the procedures or 
processes approved by the Sponsor and the IRB/IEC and agreed to by the investigator. An 
important deviation occurs when there is nonadherence to the protocol or to local regulations or 
ICH GCP guidelines that may result in a significant, additional risk to the patient or impacts the 
integrity of study data. Should a protocol deviation occur, the Sponsor must be informed as soon 
as possible. Protocol deviations and the reasons they occurred will be documented in the 
patient’s source documentation. Reporting of protocol deviations to the IEC/IRB and in 
accordance with applicable regulatory authority mandates is an investigator’s responsibility.
Protocol deviations listing will also be included in the CSR. 
The protocol deviations classification and management will be defined in a standalone document 
and reviewed before each database lock (see also Section 15.11).

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16.8 Ethical Considerations
The study will be performed in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki, ICH GCP, and all applicable regulations.
16.9 Financing and Insurance
Before the study commences, the Sponsor (or its designee) and the investigator (or the 
institution, as applicable) will agree on costs necessary to perform the study. This agreement will 
be documented in a financial agreement that will be signed by the investigator (or the institution 
signatory) and the Sponsor (or its designee). 
The investigator is required to have adequate current insurance to cover claims for negligence 
and/or malpractice. The Sponsor will provide no-exclusion insurance coverage for the clinical 
study as required by national regulations. 
16.10 Publication Policy/Disclosure of Data and Clinical Study Reporting 
After completion of the study, the data may be considered for reporting at a scientific meeting or 
for publication in a scientific journal. Two clinical study reports will be issued: one CSR (Week 
28 CSR for FDA) with the analyses up to Week 28, and another CSR (Week 52 CSR for other 
agencies like PMDA) with the analyses of data up to Week 52, as described in Section 15.10.  In 
these cases, the Sponsor will be responsible for these activities and will work with the 
investigators to determine how the manuscript is written and edited, the number and order of 
authors, the publication to which it will be submitted, and other related issues. The Sponsor has 
final approval authority over all such issues. 
Data are the property of the Sponsor and cannot be published without prior authorization from 
the Sponsor, but data and publication thereof will not be unduly withheld. 
Whether the study is completed or prematurely terminated, the Sponsor will ensure that the final 
data are summarized and provided to the regulatory agency(ies) as required by the applicable 
regulatory requirement(s). The Sponsor will also ensure that the CSRs in marketing applications 
(as applicable) meet the standards of the ICH harmonized tripartite guideline E3: Structure and 
content of CSRs. 

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17 REFERENCES 
1. National Psoriasis Foundation. Psoriasis Statistics. Updated October 8, 2020. Accessed 
December 22, 2021. https://www.psoriasis.org/content/statistics 
2. Parisi R, Symmons DP, Griffiths CE, Ashcroft DM. Identification and Management of 
Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of 
psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 
2013;133(2):377-385. doi:10.1038/jid.2012.339 
3. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis 
and psoriatic arthritis: section 1. overview of psoriasis and guidelines of care for the 
treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826-850. 
doi:10.1016/j.jaad.2008.02.039 
4. National Psoriasis Foundation. Plaque Psoriasis. Updated May 18, 2021. Accessed 
December 22, 2021. https://www.psoriasis.org/about-psoriasis/types/plaque 
5. Rapp SR, Feldman SR, Exum ML, Fleischer AB Jr, Reboussin DM. Psoriasis causes as much 
disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3 Pt 1):401-407.
doi:10.1016/s0190-9622(99)70112-x 
6. Nguyen CM, Beroukhim K, Danesh MJ, Babikian A, Koo J, Leon A. The psychosocial 
impact of acne, vitiligo, and psoriasis: a review. Clin Cosmet Investig Dermatol. 2016; 
9:383-392. doi:10.2147/CCID.S76088 
7. Duvetorp A, Østergaard M, Skov L, et al. Quality of life and contact with healthcare systems 
among patients with psoriasis and psoriatic arthritis: results from the NORdic PAtient survey 
of Psoriasis and Psoriatic arthritis (NORPAPP). Arch Dermatol Res. 2019;311(5):351-360. 
doi:10.1007/s00403-019-01906-z 
8. Stelara®. (ustekinumab) [US prescribing information] (USPI). Janssen Biotech, Inc; 2019. 
Accessed December 22, 2021. https://www.janssenlabels.com/package-insert/product-
monograph/prescribing-information/STELARA-pi.pdf 
9. Stelara® (ustekinumab) [summary of product characteristics] (SmPC). Janssen-Cilag 
Limited; 2021. Accessed December 22, 2021. 
https://www.medicines.org.uk/emc/product/4413/smpc#gref 
10. Biocon Biologics UK Limited. Bmab 1200 - Investigator’s Brochure, version 1.0 from 
28 Dec 2021. 
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):1665-1674. doi:10.1016/S0140-6736(08)60725-4 
12. Kimball AB, Papp KA, Wasfi Y, et al. 
J Eur Acad 
Dermatol Venereol. 2013;27(12):1535-1545. doi:10.1111/jdv.12046 
13. 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 

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randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 
2008;371(9625):1675-1684. doi:10.1016/S0140-6736(08)60726-6 
14. Griffiths CEM, 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):118-128. 
doi:10.1056/NEJMoa0810652 
15. Stelara® (ustekinumab) Prescribing information. Janssen Biotech, Inc; 2016. Accessed 
December 22, 2021. 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdf  
16. Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. 
Dermatologica. 1978;157(4):238-244. doi:10.1159/000250839 
17. Giretzlehner M, Ganitzer I, Haller H. Technical and medical aspects of burn size assessment
and documentation. Medicina (Kaunas). 2021;57(3):242. doi:10.3390/medicina57030242 
18. National Institute for Health and Care Excellence. Mersey Burns for calculating fluid 
resuscitation volume when managing burns. March 15, 2016. Accessed December 22, 2021. 
www.nice.org.uk/guidance/mib58 
19. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure 
for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216. 
doi:10.1111/j.1365-2230.1994.tb01167.x 
20. Sampson HA, Muñoz-Furlong A, Campbell RL, et al. Second symposium on the definition 
and management of anaphylaxis: summary report-second National Institute of Allergy and 
Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin 
Immunol. 2006;117(2):391-397. doi:10.1016/j.jaci.2005.12.1303 

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18 APPENDICES 
APPENDIX 1 describes the contraception guidelines applicable for this study. 
APPENDIX 2 presents an example Psoriasis Area Severity Index worksheet.
APPENDIX 3 describes the Static Physician’s Global Assessment.
APPENDIX 4 presents an example of the Dermatology Life Quality Index.
APPENDIX 5 describes calculation method for total Body Surface Area involvement. 

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APPENDIX 1.  CONTRACEPTION GUIDELINES 
Definitions: 
Woman of Childbearing Potential 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot be 
confirmed before the first dose of study treatment, additional evaluation should be considered. 
Women in the following categories are not considered women of childbearing potential 
(WOCBP): 
1. Premenarchal 
2. Premenopausal female with 1 of the following: 
Documented hysterectomy 
Documented bilateral salpingectomy 
Documented bilateral oophorectomy 
For individuals with permanent infertility due to an alternate medical cause other than the above, 
(eg, Mullerian agenesis, androgen insensitivity), investigator discretion should be applied to 
determine study entry. 
Note: Documentation can come from the site personnel’s review of the patient’s medical records, 
medical examination, or medical history interview. 
3. Postmenopausal woman 
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause.
 Women on HRT and whose menopausal status is in doubt will be required to use one 
of the nonestrogen hormonal highly effective contraception methods if they wish to 
continue their HRT during the study. Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before study enrollment.
Contraception Guidance: 
Fertile men and women of childbearing potential participating in heterosexual relations must be 
willing to use adequate contraception (i.e., 2 effective methods, one of which must be a physical 
barrier method) throughout the study starting from screening and for at least 15 weeks after their 
last dose of study treatment; or must be sexually inactive by abstinence, which is consistent with 
the preferred and usual lifestyle of the patient. 

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Effective forms of contraception are a condom, an established form of hormonal contraception, a 
diaphragm or cervical/vault cap, or an intrauterine device. Periodic abstinence (eg, calendar, 
ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of 
contraception. Sterile men and women, postmenopausal women, and patients who have same-sex 
sexual relations do not have to use contraception. Sterile males and females must be surgically 
sterile for at least 6 months or postmenopausal (for females, amenorrhea duration for at least 
1 year). 
Collection of Pregnancy Information
Male Patients With Partners Who Become Pregnant 
 The investigator will attempt to collect pregnancy information on any male patient’s 
female partner who becomes pregnant while the male patient is in this study. This applies 
only to male patients who receive the study treatment. 
 If the investigator becomes aware of a pregnancy in a female partner of a male patient, 
the investigator should obtain a partner pregnancy informed consent form. Consent of the 
pregnant partner must be obtained before any details of the pregnancy can be shared with 
Sponsor/Sponsor representative. If the pregnant partner provides consent to have the 
pregnancy followed, the investigator will record pregnancy information on the pregnancy 
form and submit it to the Sponsor within 24 hours of learning of the partner’s pregnancy. 
The female partner will also be followed to determine the outcome of the pregnancy. 
Information on the status of the mother and child will be forwarded to the 
Sponsor/Sponsor representative. Follow-up of outcomes will be performed case-by-case 
basis if required, based on the local requirements. Any termination of the pregnancy will 
be reported regardless of fetal status (presence or absence of anomalies) or indication for 
the procedure. 
Female Patients Who Become Pregnant 
 The investigator will collect pregnancy information on any female patient who becomes 
pregnant while participating in this study. The initial information will be recorded on the 
appropriate form and submitted to the Sponsor/Sponsor representative within 24 hours of 
learning of a patient’s pregnancy.
 The patient will be followed to determine the outcome of the pregnancy. The investigator 
will collect follow-up information on the patient and the neonate and the information will 
be forwarded to the Sponsor/Sponsor representative. Follow-up of outcomes will be 
performed case-by-case basis if required, based on the local requirements. Any 
termination of pregnancy will be reported, regardless of fetal status (presence or absence 
of anomalies) or indication for the procedure.

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 While pregnancy itself is not considered to be an adverse event (AE) or serious adverse 
event (SAE), any pregnancy complication or elective termination of a pregnancy for 
medical reasons will be reported as an AE or SAE.
A spontaneous abortion (occurring at <22 weeks gestational age) or still birth (occurring 
at >22 weeks gestational age) is always considered to be an SAE and will be reported as 
such. 
 Any poststudy pregnancy-related SAE considered reasonably related to the study 
treatment by the investigator will be reported to the Sponsor/Sponsor representative as 
described in Section 12.8.3.1. While the investigator is not obligated to actively seek this 
information in former study patients, he or she may learn of an SAE through spontaneous 
reporting. 
 Any female patient who becomes pregnant while participating in the study will 
discontinue the study treatment or may be withdrawn from the study. 

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APPENDIX 2. PSORIASIS AREA SEVERITY INDEX
Reference: British Association of Dermatologists. Accessed at http://www.bad.org.uk/shared/get-
file.ashx?id=1654&itemtype=document. Accessed on 21 December 2021.

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APPENDIX 3.  STATIC PHYSICIAN’S GLOBAL ASSESSMENT 
For the determination of static Physician’s Global Assessment, the degree of overall lesion 
severity will be evaluated using the categories below: 
Induration (I) (averaged over all lesions; use the National Psoriasis Foundation Reference card 
for measurement): 
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 
Add I + E + S = / 3 = (Total Average) 
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 
3 = Moderate - majority of lesions have individual scores for I + E + S / 3 that averages 3 
4 = Marked - majority of lesions have individual scores for I + E + S / 3 that averages 4 
5 = Severe - majority of lesions have individual scores for I + E + S / 3 that averages 5
 1.50, score = 2. 
Reference: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000_StatR.pdf  Accessed 
21 December 2021. 

Biocon Biologics UK Limited
BM12H-PSO-03-G-02
Bmab 1200
Version 3.0/Final
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Page 103 of 103
APPENDIX 5.  BODY SURFACE AREA INVOLVEMENT  
Total % body surface area (BSA) involvement afflicted by psoriasis will be estimated using a 
handprint of the patient at each visit as outlined in the schedule of events (Table 1). The entire 
palmar surface of the patient’s handprint (i.e., the patient’s flat hand, thumb and fingers) is 
assumed to correspond to approximately 1% of total BSA.1,2
The investigator must first evaluate eligibility of the inclusion criterion for the BSA
involvement before evaluating the total psoriatic involvement on the head and neck, upper 
extremities, trunk, and lower extremities.
 
 
References:
1.
Giretzlehner M, Ganitzer I, Haller H. Technical and medical aspects of burn size assessment and 
documentation. Medicina (Kaunas). 2021;57(3):242. doi:10.3390/medicina57030242
2.
National Institute for Health and Care Excellence. Mersey Burns for calculating fluid resuscitation volume 
when managing burns. March 15, 2016. Accessed December 22, 2021. www.nice.org.uk/guidance/mib58