A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy And Safety of SCD-044 in the Treatment of Moderate to Severe Plaque Psoriasis
Phase: PHASE2
Conditions: Moderate to Severe Plaque Psoriasis
Sponsor: Sun Pharmaceutical Industries Limited

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and 
Safety of SCD-044 in the Treatment of Moderate to Severe Plaque Psoriasis   
Document: Study Protocol 
NCT number: NCT04566666 
Document date: 22 December 2023 

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CONTACT LIST 
Study Managing Lead Representative:
 
 
 
 
 
 
  
 
 
Sponsor Medical Expert: 
 
 
 
 
 
 
 
 
Independent Sponsor Medical Monitor: 
 
 
 
 
 
 
 
  
 
Independent Medical Monitor: 
 
 
 
 
 
 
Contract Research Organization (CRO): 
 
  
 
 
 
 
 
 
 
 
Medical Monitor (MM)[America] 
 
 
 
 
 
 
Contract Research Organization [Europe] 
 
 
 
 
  
  
 
 
 
 
Medical Monitor (MM) [Europe] 
 
 
 
 
 
 
Drug Labeling, Packaging and Shipping 
Facility [America] 
 
 
  
 
  
 
 
Statistical Consultant: 
 
 
 
 
 
 
 
 
 
 
Statistics and Data Management (DM): 
 
 
 
 
 
 
 
 
 
Institutional Review Board (IRB) [America] 
 
 
 
 
 
 
 

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PRINCIPAL INVESTIGATOR AGREEMENT 
 
I have carefully read and understand the foregoing protocol SCD-044-19-14 “A RANDOMIZED, DOUBLE-
BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SCD-044 IN 
THE TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS” and agree that it contains all the 
necessary information for conducting this study safely. I will conduct this study in strict accordance with this 
protocol, International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP), the 
Code of Federal Regulations (CFR) and local regulatory guidelines. I will attempt to complete the study 
within the time designated. 
 
I will ensure that the rights, safety, and welfare, of Subjects under my care are protected. I will ensure 
control of the drugs under investigation in this study. 
 
I will provide copies of the protocol and all other study-related information supplied by the Sponsor to all 
personnel responsible to me who participate in the study. I will discuss this information with them to assure 
that they are adequately informed regarding the drug and conduct of the study. 
 
I agree to keep records on all Subject information (case report forms, shipment and drug return forms and 
all other information collected during the study) and drug disposition in accordance with Food and Drug 
Administration (FDA) regulations. 
 
I will not enroll any Subjects into this protocol until IRB approval and Sponsor approval are obtained. 
 
 
 
 
 
 
 
Principal Investigator 
 
Signature, Date 

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TABLE OF CONTENTS 
 
CONTACT LIST .......................................................................................................................................................... 2 
PRINCIPAL INVESTIGATOR AGREEMENT .......................................................................................................... 3 
TABLE OF CONTENTS .............................................................................................................................................. 4 
LIST OF ABBREVIATIONS ....................................................................................................................................... 8 
STUDY SYNOPSIS ................................................................................................................................................... 11 
1. 
INTRODUCTION AND BACKGROUND ........................................................................................................ 20 
2. 
OBJECTIVES ..................................................................................................................................................... 20 
3. 
STUDY OVERVIEW ......................................................................................................................................... 21 
 
 
 
 
4. 
STUDY POPULATION ..................................................................................................................................... 34 
4.1 
Number of Subjects ................................................................................................................................ 34 
4.2 
Inclusion Criteria .................................................................................................................................... 34 
4.3 
Exclusion Criteria ................................................................................................................................... 35 
4.4 
Prohibited Medications, Procedures, and Activities ............................................................................... 38 
4.5 
Permitted Medications ............................................................................................................................ 39 
4.6 
Precautions ............................................................................................................................................. 39 
4.7 
Subject Disposition and Discontinuation ............................................................................................... 40 
4.8 
Criteria to Discontinue Study ................................................................................................................. 41 
4.9 
Meals and Refreshments ........................................................................................................................ 41 
5. 
SAFETY AND TOLERABILITY EVALUATIONS ......................................................................................... 41 
5.1 
Medical History ...................................................................................................................................... 42 
5.2 
Physical Examination ............................................................................................................................. 42 
5.3 
Vital Signs .............................................................................................................................................. 43 
5.4 
Pregnancy Test ....................................................................................................................................... 43 
5.5 
Laboratory assessments .......................................................................................................................... 43 
5.6 
Pulmonary assessments .......................................................................................................................... 45 
5.7 
Ophthalmological assessments ............................................................................................................... 45 
5.8 
Concomitant medications ....................................................................................................................... 45 
5.9 
Adverse Events (AEs) and Adverse Events of Special Interest (AESI) ................................................. 46 
5.10 
Query for Progressive multifocal leukoencephalopathy (PML) ............................................................. 46 
5.11 
Query for Posterior reversible encephalopathy syndrome (PRES) ......................................................... 46 
5.12 
ECG ........................................................................................................................................................ 47 
 
 
 
 
 
 
6 
STUDY EVALUATIONS .................................................................................................................................. 51 
6.1 
Efficacy .................................................................................................................................................. 51 
6.1.1 
Dermatology Life Quality Index (DLQI) 19 ............................................................................................ 52 
6.1.2 
Psoriasis Symptoms and Signs diary (PSSD)  20 ..................................................................................... 52 
6.1.3 
Patient Global Impression of Severity (PGIS)  21 .................................................................................... 52 
6.1.4 
Patient Global Impression of Change (PGIC)  21 .................................................................................... 52 
6.1.5 
Itch Numeric Rating Scale (itch NRS) ................................................................................................... 52 
6.1.6 
Scalp Itch Numeric Rating Scale (scalp itch NRS) – for subjects with Scalp psoriasis ......................... 53 
6.1.7 
Health Assessment Questionnaire of disability (HAQ-DI) – for subjects with PsA ............................... 53 
6.1.8 
Patient Global Assessment of Disease Activity (PtGA) – for subjects with PsA ................................... 53 
6.1.9 
Patient Assessment of Pain (PtA-P) – for subjects with PsA .................................................................. 53 
6.1.10 Investigator’s Global Assessment (IGA) ................................................................................................ 53 
6.1.11 Scalp IGA – for subjects with Scalp psoriasis........................................................................................ 54 
6.1.12 Palmoplantar Physician Global Assessment (PPPGA) – for subjects with Palmoplantar psoriasis ...... 54 
6.1.13 Psoriasis Area and Severity Index (PASI) evaluation ............................................................................ 55 
6.1.14 Body Surface Area (BSA) ...................................................................................................................... 56 
6.1.15 Modified Nail Psoriasis Severity Index (mNAPSI) – for subjects with Nail psoriasis .......................... 56 
6.1.16 CASPAR Classification Criteria for Psoriatic Arthritis ......................................................................... 57 
6.1.17 Tender and Swollen Joint count – for subjects with PsA ........................................................................ 57 

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6.1.18 Physician Global Assessment of Disease Activity (PGA) – for subjects with PsA ................................ 58 
6.1.19 American College of Rheumatology (ACR) response Assessments ...................................................... 58 
6.2 
Pharmacokinetics.................................................................................................................................... 58 
6.3 
Pharmacodynamic (PD) biomarkers ....................................................................................................... 59 
6.4 
Photography (Optional) .......................................................................................................................... 59 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 
INVESTIGATIONAL PRODUCT ................................................................................................................... 100 
8.1 
Description ........................................................................................................................................... 100 
8.2 
Storage Conditions ............................................................................................................................... 101 
8.3 
Packaging and Labeling ....................................................................................................................... 101 
8.4 
Treatment Assignment ......................................................................................................................... 101 
8.4.1 Randomization .......................................................................................................................................... 101 
8.5 
Administration of Investigational Product ........................................................................................... 101 
8.6 
Assessment of Compliance................................................................................................................... 102 
8.7 
Investigational Product Accountability ................................................................................................ 103 
8.8 
Return of Clinical Supplies .................................................................................................................. 103 
9. 
STATISTICAL METHODS ............................................................................................................................. 103 
9.1 
Scientific and Statistical Considerations of the Study Design .............................................................. 103 
9.1.1 
Rationale for the Selected Subject Population...................................................................................... 103 
 
 
 
 

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9.1.4 
Rationale for the Use of Comparator .................................................................................................... 104 
9.1.5 
Rationale for Study Endpoints.............................................................................................................. 105 
9.1.6 
Rationale for the Overall Study Design ................................................................................................ 105 
9.2 
Sample Size Rationale .......................................................................................................................... 106 
 
 
9.4 
Significance Level ................................................................................................................................ 107 
9.5 
Datasets to be analyzed ........................................................................................................................ 108 
9.6 
Demographics and Baseline/Randomization Characteristics ............................................................... 108 
9.7 
Safety Assessment ................................................................................................................................ 108 
9.8 
Efficacy Assessment............................................................................................................................. 108 
9.9 
Concomitant Medication ...................................................................................................................... 111 
9.10 
Summary of Subjects who terminate prematurely ................................................................................ 111 
9.11 
Pharmacokinetic parameters ................................................................................................................. 111 
9.12 
Pharmacodynamic parameters .............................................................................................................. 111 
10. 
ADVERSE EVENTS................................................................................................................................... 111 
10.1 
Reporting of Adverse Events................................................................................................................ 111 
10.2 
Pregnancy ............................................................................................................................................. 112 
10.3 
Serious Adverse Events ........................................................................................................................ 113 
10.4 
Suspected Unexpected Serious Adverse Reactions (SUSARs) ............................................................ 115 
10.5 
Adverse Events of Special Interest ....................................................................................................... 115 
10.6 
Post-study Events ................................................................................................................................. 115 
11. 
ETHICS ....................................................................................................................................................... 115 
11.1 
Informed Consent ................................................................................................................................. 115 
11.2 
Institutional Review Board ................................................................................................................... 116 
11.3 
Subject Confidentiality ......................................................................................................................... 116 
11.4 
Indemnity/Liability and Insurance ....................................................................................................... 117 
12. 
DOCUMENTATION .................................................................................................................................. 117 
12.1 
Site Regulatory Documents Required for Initiation ............................................................................. 117 
12.2 
Maintenance and Retention of Records ................................................................................................ 117 
12.3 
Data Collection and Reporting ............................................................................................................. 117 
12.4 
Primary Source Documents .................................................................................................................. 118 
12.5 
Study Monitoring ................................................................................................................................. 118 
12.6 
Data and Safety Monitoring Board ....................................................................................................... 119 
12.7 
Audits and Inspections ......................................................................................................................... 120 
12.8 
Modifications to the Protocol ............................................................................................................... 120 
12.9 
Completion of Study ............................................................................................................................ 120 
12.10 
Data Protection in the European Economic Area ................................................................................. 121 
13. 
REFERENCES ............................................................................................................................................ 122 
APPENDIX I: Revision History ............................................................................................................................... 124 
APPENDIX II: Body Surface Area (BSA) ............................................................................................................... 129 
APPENDIX III: Psoriasis Area Severity Index  (PASI) source document example ................................................. 130 
APPENDIX IV: Dermatology Life Quality Index (DLQI) Example ........................................................................ 131 
APPENDIX V: Psoriasis Symptom and Sign Diary (PSSD) Example ..................................................................... 132 
APPENDIX VI: Patient Global Impression of Severity (PGIS) Example ................................................................ 133 
APPENDIX VII: Patient Global Impression of Change (PGIC) Example ............................................................... 134 
APPENDIX VIII: Itch Numeric Rating Scale (itch NRS) Example ......................................................................... 135 
APPENDIX IX: Health Assessment Questionnaire of disability (HAQ-DI) Example ............................................. 136 
APPENDIX X: Patient Global Assessment of Disease Activity (PtGA) Example ................................................... 140 
APPENDIX XI: Patient Assessment of Pain (PtA-P) Example ................................................................................ 141 
APPENDIX XII: Tender and Swollen Joint Count Example ................................................................................... 142 
APPENDIX XIII: Physician’s Global Assessment of Disease Activity (PGA) Example ........................................ 144 
APPENDIX XIV: Protocol for Orthostatic (Postural) Vital Sign Measurement Example ....................................... 145 
 
  
 
 

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LIST OF TABLES 
 
Table 1: Investigator’s Global Assessment (IGA)........................................................................................... 54 
Table 2: Scalp Investigator’s Global Assessment (IGA) ............................................................................... 54 
Table 3: Palmoplantar Physician Global Assessment (PPPGA) ................................................................. 54 
Table 4: Psoriasis Area and Severity Index (PASI): Severity ...................................................................... 55 
Table 5: Modified Nail Psoriasis Severity Index (mNAPSI) .......................................................................... 56 
Table 6: CASPAR Classification Criteria for Psoriatic Arthritis .................................................................. 57 
 
 

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LIST OF ABBREVIATIONS 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
ALC 
Absolute Lymphocyte Counts 
ALP 
Alkaline Phosphatase 
ALT 
Alanine aminotransferase 
ANC 
Absolute neutrophil count 
ACR 
American College of Rheumatology 
AST 
Aspartate aminotransferase 
ATWC 
Active Treatment Worst Case 
AUC 
Area under the concentration-time curve 
AV block 
Atrioventricular block 
BL 
Baseline 
BMI 
Body Mass Index 
bpm 
beats per minute 
BP 
Blood Pressure 
BSA 
Body Surface Area 
CASPAR 
Classification Criteria for Psoriatic Arthritis 
CFR 
Code of Federal Regulations 
Cmax 
Maximum Concentration/Maximum Observed Concentration 
CMH 
Cochran-Mantel-Haenszel 
CNS 
Central Nervous System  
COPD 
Chronic obstructive pulmonary disease 
CRA 
Clinical Research Associate 
CT 
Computerized Tomography 
eCRF 
Electronic Case Report Form 
CRO 
Contract Research Organization 
CRP 
C-reactive protein 
Ctrough 
lowest concentration reached by a drug before the next dose 
DLQI 
Dermatology Life Quality Index 
DM 
Data Management 
DMARD 
Disease Modifying Anti-rheumatic drug 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 
ECG 
Electrocardiography 
ED 
Early Discontinuation 
EDC 
Electronic Data Capture 
e.g. 
exempli gratia, “for example”, “such as” 
EoS 
End-of-Study 
EOT 
End of Treatment  
EU 
European Union 
EU Ct No. 
European Union Clinical Trial Register number  
FEV 
Forced expiratory volume 
FDA 
Food and Drug Administration 
FVC 
Forced vital capacity 
GCP 
Good Clinical Practice 
GGT 
Gamma glutamyltransferase 
GLP 
Good Laboratory Practice 
GRAPPA 
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 
HAQ-DI 
Health Assessment Questionnaire of Disability 
HBsAg 
Surface antigen of the hepatitis B virus (HBV) 
hCG 
Human Chorionic Gonadotropin 
HEENT 
Head, Eyes, Ears, Nose and Throat 
HIV 
Human immunodeficiency virus 
hr 
Hour 
HR 
Heart rate 
hrs 
Hours 
HDL 
High-density lipoproteins 
ICF 
Informed Consent Form 

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ICH 
International Conference on Harmonization 
ID 
Identification 
IRB 
Institutional Review Board 
IUD 
Intrauterine Device 
ICH  
International Conference on Harmonization  
IGA 
Investigator’s Global Assessment 
INR 
International Normalized Ratio 
IND 
Investigational New Drug 
IP (IMP) 
Investigational (Medical) Product  
IR 
Infrared  
IRT 
Interactive Response Technology 
ITT 
Intent To Treat 
IV 
Intravenous 
JC 
John Cunningham virus 
Kg 
Kilogram 
LDL 
Low-density lipoprotein  
LLN 
Lower limit of normal 
L/kg 
Liter per kilogram 
LOCF  
Last Observation Carried Forward 
MAD 
Multiple Ascending Dose 
MCV 
Mean Corpuscular Volume 
mg  
Milligram 
mL 
Milliliter 
mm 
millimeter 
MM 
Medical Monitor 
MMRM 
Mixed Model Repeated Measures 
Mm Hg 
millimeter of mercury 
msec 
millisecond 
mNAPSI 
modified Nail Psoriasis Severity Index 
NCE 
New Chemical Entity 
NDA 
New Drug Application 
ng 
Nanogram 
NK cell 
Natural Killer cell 
NOAEL 
No Observed Adverse Effect Level 
NRS 
Numeric Rating Scale 
NSAID 
Non-Steroidal Anti-Inflammatory Drug 
NYHA 
New York Heart Association 
OC 
Observed Cases 
OCT 
Optical Coherence Tomography 
OTC 
Over-The-Counter 
p.o. 
Per Oral 
PASI 
Psoriasis Area and Severity Index 
PD 
Pharmacodynamic 
PFT 
Pulmonary Function Test 
PGIC 
Patient Global Impression of Change 
PGIS 
Patient Global Impression of Severity 
PtGA 
Patient Global Assessment of Disease Activity 
PtA-P 
Patient Assessment of Pain 
PI 
Principal Investigator 
PK 
Pharmacokinetics 
PL 
Placebo 
PML 
Progressive Multifocal Leukoencephalopathy 
PRES 
Posterior Reversible Encephalopathy Syndrome 
PP 
Per Protocol 
PPPGA 
Palmoplantar Physician Global Assessment 
PsA 
Psoriatic Arthritis 
PSSD 
Psoriasis Symptoms and Signs Diary 
PT 
Prothrombin time 
aPTT 
Activated partial thromboplastin time 
PUVA 
psoralen and ultraviolet A 

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RF 
Rheumatoid Factor 
SAP 
Statistical Analysis Plan 
QRS 
A combination of the Q wave, R wave and S wave 
QT 
QT Interval (the time from the start of the Q wave to the end of the T wave) 
QTcF 
QT corrected Fridericia's formulas 
SAE 
Serious Adverse Event 
S1P 
Sphingosine-1-phosphate 
S1PR1 
Sphingosine-1-phosphate Receptor 1 
SPARC 
Sun Pharma Advanced Research Company Limited 
SPIL 
Sun Pharmaceutical Industries Ltd. 
SUSAR 
Suspected Unexpected Serious Adverse Reactions 
t1/2 
Half-Life 
TB 
Tuberculosis 
TBL 
Total Bilirubin 
TEAE 
Treatment Emergent Adverse Event 
TIA 
Transient Ischemic Attack 
Tmax 
Time to Maximum Plasma Concentration 
VAS 
Visual Analogue Scale 
ULN 
Upper Limit of Normal 
UPT 
Urine Pregnancy Test 
UTN 
Universal Trial Number 
UV-B 
type B ultraviolet 
WBC 
White Blood Cell 
ȝJP/ 
Microgram Per Milliliter 
µg•h/mL 
Microgram Times Hour Per Milliliter 
µM 
Micro Molar 
VZV 
Varicella Zoster Virus 

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STUDY SYNOPSIS 
 
Protocol Number: 
SCD-044-19-14 
Title of Study:  
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO 
ASSESS THE EFFICACY AND SAFETY OF SCD-044 IN THE TREATMENT OF 
MODERATE TO SEVERE PLAQUE PSORIASIS 
Study Managing  
Lead: 
Taro Pharmaceuticals U.S.A., Inc. 
Sponsor:  
Sun Pharmaceutical Industries Ltd. 
IND:  
144951 
Start of the study: 
in North and Latin America: 
 [first participant enrolled]  
 
in Europe: 
 
 
End of the study: 
the study is expected to be concluded upon final collection of data for all outcome 
measures and adverse events, including safety follow up (last participant’s last visit). 
Investigational 
Products:  
SCD-044 Tablets
 (low dose)  
 
SCD-044 Tablets 
 (intermediate dose) 
 
SCD-044 Tablets 
 (high dose) 
 
SCD-044 Tablets 
 
 
Control:  
Placebo of SCD-044 product  
Treatment Duration: The study treatment period will last up to 52 weeks  
Dose and Mode  
of Administration:  Once daily according to a randomization scheme and titration schedule.  
Objectives:  
Primary Objective:  
x 
To determine the effect of SCD-044 treatment on moderate to severe plaque 
psoriasis, as measured by proportion of subjects showing at least 75% 
improvement in Psoriasis Area and Severity Index (PASI) at Week 16.  
Secondary Objectives: 
x 
To evaluate the efficacy of SCD-044 as measured by proportion of subjects 
achieving predefined improvement in Investigator’s Global Assessment (IGA) of 
disease severity 
x 
To evaluate the efficacy of SCD-044 as measured by proportion of subjects 
achieving predefined improvement in Psoriasis Area and Severity Index (PASI) 
and change in PASI scores over the treatment period  
x 
To assess the effect of SCD-044 on the subject reported outcome measure of 
Psoriasis Symptoms and Signs Diary (PSSD) 
x 
To assess the effect of SCD-044 on quality of life, as measured by Dermatology 
Life Quality Index (DLQI) 
x 
To evaluate the efficacy of SCD-044 as measured by change in body surface 
area (BSA) involvement over the treatment period   
x 
To assess the effect of SCD-044 on Patient Global Impression of Severity 
(PGIS) 
x 
To assess the effect of SCD-044 on Patient Global Impression of Change (PGIC) 
x 
To evaluate the PASI75 response in non-responders at low dose and 
intermediate dose when switched to high dose of SCD-044 
x 
To assess the safety and tolerability of SCD-044 in subjects with moderate to 
severe plaque psoriasis 
x 
To characterize the pharmacokinetics (PK) of SCD-044 in subjects with 

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moderate to severe plaque psoriasis  
Tertiary Objectives: 
x 
To evaluate the efficacy of SCD-044 in the treatment of Scalp psoriasis as 
measured by Scalp IGA 
x 
To evaluate the efficacy of SCD-044 in the treatment of nail psoriasis as 
measured by modified Nail Psoriasis Severity Index (mNAPSI) scores 
x 
To evaluate the efficacy of SCD-044 in the treatment of psoriatic arthritis as 
measured by American College of Rheumatology (ACR) response 
x 
To evaluate the efficacy of SCD-044 in the treatment of Palmoplantar Psoriasis 
as measured by Palmoplantar Physician Global Assessment (PPPGA) score 
Exploratory Objectives: 
x 
To examine the pharmacodynamic/pharmacokinetic (PK/PD) relationship 
between SCD-044 plasma concentrations and PASI response 
x 
 
 
 
 
 
x 
To evaluate the effect of SCD-044 on subject reported outcome of itching 
associated with Psoriasis 
x 
To evaluate the effect of SCD-044 on Psoriatic Arthritis (PsA)-related Pain 
(Patient Assessment of Pain (PtA-P) 
x 
To evaluate the effect of SCD-044 on blood-based biomarkers.  
Design:  
Subjects in this randomized, double-blind, placebo controlled, parallel-group, 
multiple-center study will be assigned to treatment with the investigational products 
or placebo control according to a randomization scheme and titration schedule: 
x Part I: 16 weeks: Subjects will be randomized to placebo, Low dose 
 
Intermediate dose 
 or High dose 
 of SCD-044 
 
 
 
 
 
 to assess primary and secondary endpoints at 16 weeks 
x Part II: Week 16 to Week 28:  
At Week 16, subjects initially randomized to a treatment group will be re-
randomized or discontinued from the study based on the PASI response as 
follows: 
- Subjects initially randomized to placebo with a response of: 
 will be re-randomized to Intermediate dose, High dose, 
 
  
 will be re-randomized to Intermediate dose or High dose 
 
  
- Subjects originally randomized to Low dose and Intermediate dose arms with a 
response of: 
 will be switched to High dose 
 
 
 
 will remain on their assigned dosing regimen  
- Subjects originally randomized to High dose arm with a response of: 
 
will remain on their assigned dosing regimen 

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Phone or in person contacts may be scheduled 
 
 to collect 
information on concomitant medication, compliance with the study drug use, health 
changes (AEs & AESI), queries for PML and PRES and to provide instructions.  
 
 
 
 
Subjects will be admitted into the study after informed consent has been obtained. 
An Unscheduled Visit is allowed at any time, for any reason, if in the Principal 
Investigator’s opinion it is warranted. If a subject is discontinued from the study 
during an Unscheduled Visit, the Unscheduled Visit will be referred to as an Early 
Discontinuation Visit and all procedures scheduled for Early Discontinuation will be 
performed. If the Unscheduled Visit is not an Early Discontinuation Visit (i.e., the 
subject will continue to take part in the study), then all procedures scheduled for that 
Unscheduled Visit will be performed. Subjects who are discontinued early from the 
study must attend the Follow-up visit 4 weeks after the date of Early Discontinuation. 
Study Population:  
 
Key Inclusion Criteria 
1. Males and non-pregnant non-ODFWDWLQJ IHPDOHV   \HDUV RI DJH SURYLGLQJ
written informed consent prior to any study-related procedures.  
2. Diagnosis of SUHGRPLQDQWO\SODTXHSVRULDVLVIRUPRQWKVDVGHWHUPLQHGE\
subject interview and confirmation of diagnosis through physical examination by 
Investigator 
3. Subject is a candidate for phototherapy or systemic therapy for plaque 
psoriasis.* 
*Note: Subjects are required to be candidates for systemic/phototherapy, 
however no such therapy will be allowed during the study. Please refer to 
exclusion criteria 3 
4. Moderate to severe plaque psoriasis at Screening and Baseline defined as: 
x 
%6$LQYROYHPHQWRI 
x 
3$6,VFRUHRI 
x 
,*$RIDWOHDVWPRGHUDWHGLVHDVH 
Key Exclusion Criteria 
1. Female subjects who are pregnant, nursing or planning to become pregnant 
during the study participation or within 6 months of completing the study.   
2. Predominantly non-plaque forms of psoriasis like erythrodermic psoriasis, 
pustular psoriasis, medication-induced or medication exacerbated psoriasis, or 
new-onset guttate psoriasis. 
3. Anticipated requirement of topical therapy, phototherapy, or systemic therapy 
for psoriasis 
 during 
the study. 

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x 
Any prior treatment with lymphocyte-depleting therapies (e.g., anti-CD4 
antibodies, 
cladribine, 
rituximab, 
ocrelizumab, 
cyclophosphamide, 
mitoxantrone, total body irradiation, bone marrow transplantation, 
alemtuzumab, daclizumab) 
x 
Any prior treatment with lymphocyte trafficking blockers (e.g., natalizumab, 
fingolimod, other S1PR agonists) 
x 
Treatment with ustekinumab within 6 months, secukinumab within 5 months, 
etanercept within 4 weeks and any other biologics within 12 weeks or 5 half-
lives whichever is longer 
x 
Systemic immunosuppressive therapy (e.g., Tacrolimus) within 4 weeks 
x 
Treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) within 4 
weeks 
x 
Oral systemic psoriasis therapy (e.g., cyclosporine, methotrexate, acitretin, 
fumaric acid esters, apremilast) within 4 weeks 
x 
Phototherapy (e.g., UV-B light phototherapy, PUVA (Psoralen and ultraviolet 
A) therapy, tanning salon or home-administered UV-B) within 4 weeks 
x 
Oral or injectable corticosteroids within 4 weeks 
x 
Treatment with a non-biologic investigational agent within 4 weeks (or 5 half-
lives whichever is longer) 
x 
Topical psoriasis treatment within 2 weeks prior to randomization 
x 
Treatment with JAK inhibitors within 4 weeks prior to randomization 
Number of Subjects:   
Approximately 240 subjects will be enrolled in the study in a 1:1:1:1 ratio to the 
following treatment groups:  
x 
Placebo of SCD-044 
x 
SCD-044 Tablets 
 (Low dose) 
x 
SCD-044 Tablets 
 (Intermediate dose) 
x 
SCD-044 Tablets 
High dose 
At the beginning of Part III (Week 28 to Week 52) subjects will be discontinued from 
the study or will continue their existing dosing regimen based on their PASI response. 
A subset of eligible subjects will participate in photographic evaluation 
Randomization and re-randomization will be stratified by gender and prior biologic 
therapy for psoriasis. Approximately the same number of male and female subjects 
will be enrolled between treatment groups. A maximum of 
 of randomized 
subjects may have prior exposure to biologics therapy for psoriasis.  
Approximately the same number of subjects who have prior exposure to biologics 
therapy for psoriasis will be enrolled between treatment groups. 
Criteria for Evaluation:   
Following assessments will be performed by the Investigator according to the 
schedule of assessments: 
Efficacy:  
x 
Psoriasis Area and Severity Index (PASI), Investigator’s Global Assessment 
(IGA), BSA, Scalp IGA (for subjects with Scalp psoriasis), modified Nail 
Psoriasis Severity Index (mNAPSI) (for subjects with nail psoriasis), 
Palmoplantar Physician Global Assessment (PPPGA) (for subjects with 
Palmoplantar Psoriasis).  

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x 
For subjects with PsA: Tender and Swollen Joint Count assessment and 
Physician’s Global Assessment (PGA) of Disease Activity. 
* Note: For subjects with PsA, assessments will be made by an independent 
joint assessor experienced in performing psoriatic arthritis joint assessments. 
Assessments will not be performed at sites where an independent assessor 
experienced in performing psoriatic arthritis joint assessments is not available.  
x 
Subjects will be asked to complete DLQI, PSSD, PGIS, PGIC, and Itch Numeric 
Rating Scale (NRS).  
x 
Subjects with PsA will also be asked to complete Health Assessment 
Questionnaire of Disability (HAQ-DI), Patient Assessment of Pain (PtA-P), 
Patient Global Assessment of Disease Activity (PtGA). 
x 
Laboratory assessment: Serum C - reactive protein (CRP). 
x 
A subset of eligible subjects will participate in photographic evaluation.   
Safety:  
x 
Vital signs  
x 
Physical examination 
x 
Monitoring of all adverse events (AEs)  
x 
Laboratory assessments: Hematology, Clinical chemistry, Lipid Profile, 
Urinalysis, Pregnancy test, Coagulation profile, Serology at screening: anti-VZV 
IgG, HIV antibodies, HBsAg, HCV antibodies, and QuantiFERON Gold.  
x 
ECG 
x 
Pulmonary assessments: Pulmonary function tests (PFTs) will include 
assessment of FEV1 and FVC.  
x 
Ophthalmological assessments: A complete ophthalmologic examination will be 
performed by an ophthalmologist; this will include an ophthalmological history, 
best corrected visual acuity, ophthalmoscopy, and Optical Coherence 
Tomography (OCT) assessment (measurement of central foveal thickness). 
Pharmacokinetics:  
x 
Pre-dose (trough) PK samples will be collected within 1 hour prior to dosing on 
weeks 16, 20, 28, and 52 visits.  
In addition, PK sample will be collected, if possible, approximately 1 hour within 
the onset of an adverse event 
 during on-site visits 
 
  
Under the Protocol version 2.0 approximately 
 have completed PK 
sampling 
 post-dose on 
  
 
  
PK samples collected only from the active treatment groups will be analysed in 
an unblinded manner. 
Pharmacodynamics:  
x 
 
. The exploratory pharmacodynamics biomarkers include cytokines 
in plasma/serum and cell types in blood 
Photography (Optional): 
x 
Photography is an optional procedure in the study and will be performed only at 
selected centres. Photographs will be used for visual evaluation only and will 
not be included in any analyses 
Study Endpoints: 
Primary:  

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x 
Proportion of subjects with at least 75% improvement in PASI (PASI75) at Week 
16 
Key Secondary: 
x 
Proportion of subjects achieving IGA of “clear” (0) or “almost clear” (1) with at 
least two-grade reduction from baseline to Week 16 
Other Secondary: 
x 
Percent change from Baseline in mean PASI score at Weeks 12, 16, 20, 28 and 
52 
x 
PASI75 response rate at Weeks 12, 20, 28, and 52  
x 
PASI50, PASI90, and PASI100 response rate at Weeks 12, 16, 20, 28, and 52 
x 
Change from Baseline in PSSD score at Weeks 16, 20, 28, and 52 
x 
Change from Baseline in DLQI score at Weeks 16, 20, 28, and 52 
x 
Proportion of subjects with IGA score of “clear” or “almost clear” with at least 
two-grade reduction from baseline to Weeks 12, 20, 28, and 52 
x 
Time to achieve PASI75 response  
x 
Time to achieve IGA response of “clear” or “almost clear” with at least two-grade 
reduction from baseline 
x 
Change from baseline in BSA involvement at Weeks 12, 16, 20, 28, and 52 
x 
Change from baseline in PGIS at Weeks 16, 20, 28, and 52 
x 
Proportion of subjects with improvement in PGIC at Weeks 16, 20, 28, and 52 
x 
PASI50 and PASI75 response rate at Week 4 
x 
 
 
  
x 
Steady state Ctrough concentrations of SCD-044 at the dose levels evaluated in 
the study population    
x 
Frequency, type, and severity of adverse events (AEs) 
Tertiary 
x 
Proportion of subjects with Scalp IGA “clear” or “almost clear” with at least two-
grade reduction from baseline at Weeks 16, 20, 28, and 52 among subjects with 
a baseline Scalp ,*$VFRUHRI 
x 
Proportion of subjectVZLWKQDLOSVRULDVLVEDVHOLQHP1$36,VFRUHRIZKR
achieve at least a 75% improvement from baseline in total fingernail mNAPSI 
at Weeks 16, 20, 28, and 52  
x 
Proportion of psoriatic arthritis subjects who achieve ACR20 response at Weeks 
16, 20, 28, and 52.  
x 
Proportion of subjects with PPPGA score of 0 or 1 at Weeks 16, 20, 28, and 52 
among subjectVZLWKDEDVHOLQH333*$VFRUHRI. 
Exploratory   
x 
Relationship between SCD-044 plasma concentrations and PASI response 
x 
 
 
x 
Relationship between SCD-044 plasma concentrations and change in 
lymphocyte counts 
x 
Proportion of subjectVDFKLHYLQJ-point improvement in NRS from baseline 
at Weeks 16, 20, 28, and 52 among subjects with a baseline Itch NRS of  

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x 
Proportion of subjectVDFKLHYLQJ-point improvement in Scalp Itch NRS from 
baseline at Weeks 16, 20, 28 and 52 among subjects with a baseline Scalp Itch 
NRS of 4  
x 
Change from baseline in subject global assessment of PtA-P at Weeks 16, 20, 
28, and 52 among subjects with PsA at baseline 
x 
Level of lymphocyte sub-types and cytokines in blood/plasma/serum. 
Other exploratory analyses may be performed based on available data. The Intent-
to-Treat Population (ITT) will be used for all efficacy analyses. 
Statistical Methods:  
 
The primary and key secondary efficacy variables will be analysed using a Cochran-
Mantel-Haenszel (CMH) test, stratified by gender and prior biologic therapy 
(Yes/No), and using the Intent-to-Treat (ITT) Population.  
 
 
 
 
.  
The Mantel-Haenszel common risk (response rate) difference between each SCD-
044 dose group and placebo, along with 95% Confidence Interval, will be estimated. 
Subjects with missing values will be imputed using non-responder imputation (NRI).  
Summary of Subjects who terminate prematurely 
Reasons for premature termination will be summarized by treatment group. 
Concomitant medication 
The start and stop date of concomitant medication use during the study will be 
provided in the data set in addition to the reason for the medication use.  
Safety Analyses 
Safety analyses will be conducted on the Safety Population. Safety Incidence of all 
adverse events reported during the study will be summarized by treatment group, 
severity, and relationship to study drug. 
Summary of Subjects who Screen Fail 
Reasons for removal of subjects during screening will be summarized. 

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1. INTRODUCTION AND BACKGROUND 
Psoriasis is an immune-mediated inflammatory skin disease that affects approximately 125 million people 
in Europe, the USA and Japan.1 The most common type of psoriasis affecting 90% of patients is plaque 
psoriasis, which is characterized by the presence of raised, thick red lesions covered by silver or white 
scales most commonly affecting the knees and elbows but can appear anywhere on the body.1 The red 
plaques are due to dilation of blood vessels, while the silver or white scales result from the rapid proliferation 
of keratinocytes. Thus, psoriatic patients have lesioned or involved skin as well as areas of uninvolved skin 
with normal appearance. The disease is chronic, cycling between periods of exacerbation and remission.1 
Despite reports implicating a genetic association with the disease, published studies have established 
several psoriatic triggers including stress, medications (e.g., lithium, antimalarials, indomethacin, quinidine, 
beta blockers), injury or infection.1-3 
Many affected individuals with psoriasis can be treated with topical agents including creams, sprays, lotions, 
and foams; however, up to one third of patients with severe psoriasis require other therapies such as 
ultraviolet (UV) light therapy, biologics, or systemic medications (e.g., methotrexate and oral retinoids).1,3,5,6  
The treatment of moderate to severe chronic plaque psoriasis remains challenging due to issues relating 
to efficacy and safety. Biologics are reported having higher efficacy in treatment of chronic plaque psoriasis. 
However, treatment with biologics needs injections and multiple visits to the clinical facility. Hence, there is 
a probability of poor adherence to therapy, which may reduce the actual therapeutic benefit.  
 
 
 
 
 there remains an unmet 
medical need for developing a safer and effective oral therapy for treating subjects with chronic plaque 
psoriasis 
Sun Pharmaceutical Industries Limited. (SPIL) is developing a Sphingosine-1-phosphate receptor 1 
(S1PR1) agonist, SCD-044 (Vibozilimod)i, to treat moderate to severe plaque psoriasis. SCD-044 is a 
potent S1P1R and 
 S1P5R agonist, devoid of any activity on S1P2 or S1P3 receptors and 
is 
 at S1P4 receptor. 
S1PR1 modulation and the resulting lymphocyte sequestration have the potential for treating multiple 
autoimmune and chronic inflammatory diseases, including psoriasis. Ponesimod, another S1PR1 agonist 
has been found to be effective in the treatment of plaque psoriasis.11  
SCD-044 has shown efficacy in preclinical models of psoriasis. SCD-044 demonstrated a clinically 
meaningful reduction in lymphocyte counts with an acceptable safety profile in the Phase I study. The 
reduction in lymphocyte count is anticipated to result in therapeutic benefit in the treatment of psoriasis.  
The current study is a Phase IIb dose ranging study to assess the efficacy and safety of SCD-044 in the 
treatment of moderate to severe plaque psoriasis. 
. 
2. 
OBJECTIVES  
The objectives of this study are as follows: 
Primary Objective:  
x 
To determine the effect of SCD-044 treatment on moderate to severe plaque psoriasis, as measured 
by proportion of subjects showing at least 75% improvement in Psoriasis Area and Severity Index 
(PASI) at week 16.  
Secondary Objectives: 
x 
To evaluate the efficacy of SCD-044 as measured by proportion of subjects achieving predefined 
improvement in Investigator’s Global Assessment (IGA) of disease severity 
x 
To evaluate the efficacy of SCD-044 as measured by proportion of subjects achieving predefined 
improvement in Psoriasis Area and Severity Index (PASI) and change in PASI scores over the 
treatment period  
x 
To assess the effect of SCD-044 on the subject reported outcome measure of Psoriasis Symptoms 

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and Signs Diary (PSSD) 
x 
To assess the effect of SCD-044 on quality of life, as measured by Dermatology Life Quality Index 
(DLQI) 
x 
To evaluate the efficacy of SCD-044 as measured by change in body surface area (BSA) involvement 
over the treatment period   
x 
To assess the effect of SCD-044 on Patient Global Impression of Severity (PGIS) 
x 
To assess the effect of SCD-044 on Patient Global Impression of Change (PGIC) 
x 
To evaluate the PASI75 response in non-responders at low dose and intermediate dose when 
switched to high dose of SCD-044 
x 
To assess the safety and tolerability of SCD-044 in subjects with moderate to severe plaque psoriasis 
x 
To characterize the pharmacokinetics (PK) of SCD-044 in subjects with moderate to severe plaque 
psoriasis 
Tertiary Objectives: 
x 
To evaluate the efficacy of SCD-044 in the treatment of Scalp psoriasis as measured by Scalp IGA 
x 
To evaluate the efficacy of SCD-044 in the treatment of nail psoriasis as measured by modified Nail 
Psoriasis Severity Index (mNAPSI) scores 
x 
To evaluate the efficacy of SCD-044 in the treatment of psoriatic arthritis as measured by American 
College of Rheumatology (ACR) response 
x 
To evaluate the efficacy of SCD-044 in the treatment of Palmoplantar Psoriasis as measured by 
Palmoplantar Physician Global Assessment (PPPGA) score 
Exploratory Objectives: 
x 
To examine the pharmacodynamic/pharmacokinetic (PK/PD) relationship between SCD-044 plasma 
concentrations and PASI response 
x 
To examine the PK/PD relationship between SCD-044 plasma concentrations and 
 parameters 
 
x 
 
 
x 
To evaluate the effect of SCD-044 on subject reported outcome of itching associated with Psoriasis 
x 
To evaluate the effect of SCD-044 on Psoriatic Arthritis (PsA)-related Pain (Patient Assessment of 
Pain (PtA-P) 
x 
To evaluate the effect of SCD-044 on blood-based biomarkers. 
3. 
STUDY OVERVIEW 
Start of the study: in North and Latin America: 
 
 
 
in Europe: 
 
End of the study:  the study is expected to be concluded upon final collection of data for all outcome 
measures and adverse events, including safety follow up (last participant’s last visit). 
Subjects in this randomized, double-blind, placebo controlled, parallel-group, multiple-center study will be 
assigned to treatment with the investigational products or placebo control according to a randomization 
scheme and titration schedule. 
x 
Part I: 16 weeks; Subjects will be randomized to placebo, Low dose 
 Intermediate dose 
 
 or High dose 
 of SCD-044 
 
 
 
 to assess primary and 
secondary endpoints at Week 16 
x 
Part II: Week 16 to Week 28:  
At Week 16, subjects initially randomized to a treatment group will be re-randomized or discontinued 
from the study based on the PASI response as follows: 
- Subjects initially randomized to placebo with a response of: 

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Clinical Evaluations will be performed at: 
 
 
 
On-site 9LVLW6FUHHQLQJ9LVLW:HHN -4 / Day -28 to -1); 
On-site Visit 2: Baseline Visit (Week 0 / Day 1; before 12 noon);  
On-site Visit 7: 
  
On-site Visit 8: 
 
On-site Visit 9: 
 
On-site Visit 10: 
  
On-site Visit 14: (
  
On-site Visit 15: 
  
On-site Visit 16: 
 
On-site Visit 17: 
 
On-site Visit 18: 
 
On-site Visit 19: End of Treatment Visit (Week 52 / Day 365 ± 3 Days);  
On-site Visit 20: Follow-up Visit (Week 56 / Day 393 ± 3 Days); 
 
 
 
 
 
 
  
  
Phone or in person contacts may be scheduled 
 
 to collect information on concomitant medication, compliance 
with the study drug use, health changes (AEs & AESI), queries for PML and PRES and to provide 
instructions.  
 
 
 
Subjects will be admitted into the study after informed consent has been obtained. An Unscheduled Visit is 
allowed at any time, for any reason, if in the Principal Investigator’s opinion it is warranted. If a Subject is 
discontinued from the study during an Unscheduled Visit, the Unscheduled Visit will be referred to as an 
Early Discontinuation Visit and all procedures scheduled for Early Discontinuation will be performed. If the 
Unscheduled Visit is not an Early Discontinuation Visit (i.e., the Subject will continue to take part in the 
study), then all procedures scheduled for that Unscheduled Visit will be performed. Subjects who are 
discontinued early from the study must attend the Follow-up visit 4 weeks after the date of Early 
Discontinuation. 
If necessary due to the COVID-19 pandemic, 
 may have assessments done at home or 
remote visit. Remote visits must be discussed and consulted with the CRO’s and the Sponsor’s medical 
monitor before planning. Scheduled blood collection (for these visits only) may be waived if the individual 
subjects have not had a clinically significant changes or undesired trend in lab or chemistry values prior to 
  Subjects that have remote assessments or delayed visits 
 will be recorded in the source 
documents and noted as a minor protocol deviation.  
COVID-19 related protocol deviations will be analyzed to assess whether a protocol amendment or other 
modifications are needed.  The Sponsor together with investigators plan to assess the COVID-19 situation 
to evaluate the benefit: risk of the study on an ongoing basis. 
Changes in study visit schedules, missed visits, or subject discontinuations may lead to missing information 
(e.g., for protocol-specified procedures). It is important to capture specific information in the subject records 
that explains the basis of the missing data, including the relationship to COVID-19, for missing protocol-
specified information (e.g., from missed study visits or study discontinuations due to COVID-19).  
A subset of eligible subjects will participate in photographic evaluation. 

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Randomization and re-randomization will be stratified by gender and prior biologic therapy for psoriasis. 
Approximately the same number of male and female subjects will be enrolled between treatment groups. 
A maximum of 
of randomized subjects may have prior exposure to biologics therapy for psoriasis. 
Approximately the same number of subjects who have prior exposure to biologics therapy for psoriasis will 
be enrolled between treatment groups. 
The assigned Investigational Product will be administered orally once a day. Subjects will be required to 
use diaries to document the date of study treatments, any missed treatments and the occurrence of all 
adverse events. 
The duration of each subject’s participation in the study will be approximately 56 weeks (393 days).  
If the Principal Investigator determines that the subject’s condition has worsened to the degree that it is 
unsafe for the subject to continue in the study, the subject may be discontinued from the study as a 
treatment failure and the subject may be treated using the standard care.  
Subjects with conditions or treatments that may affect cardiovascular safety (e.g. heart rate less than 
 
, history of uveitis or history of pulmonary conditions such as active severe respiratory disease (e.g. 
COPD, tuberculosis or pulmonary fibrosis, severe asthma or asthma requiring regular treatment with oral 
steroids) will be excluded due to the known mechanism-based AEs within this class which may expose 
such subjects to unwarranted excess risk for a condition with available alternatives. 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4. 
STUDY POPULATION  
4.1 Number of Subjects  
Approximately 240 subjects will be enrolled in the study in a 1:1:1:1 ratio to the following treatment 
groups: 
 
 
   
 
 
 
 
 
The number of subjects contributed by a site will not exceed approximately 
 of total study 
population unless approved by the Sponsor. Enrolment in a country other than USA will be limited to 
approximately 
 unless approved by the Sponsor. 
4.2 Inclusion Criteria  
1. Males and non-pregnant non-ODFWDWLQJ IHPDOHV   \HDUV RI DJH SURYLGLQJ ZULWWHQ LQIRUPHG
consent prior to any study-related procedures.  
2. 'LDJQRVLVRISUHGRPLQDQWO\SODTXHSVRULDVLVIRUPRQWKVDVGHWHUPLQHGE\VXEMHFWLQWHUYLHZ
and confirmation of diagnosis through physical examination by Investigator 
3. Subject is a candidate for phototherapy or systemic therapy for plaque psoriasis.* 
*Note: subjects are required to be candidates for systemic/phototherapy, however no such therapy 
will be allowed during the study. Please refer to exclusion criteria 3 
4. Moderate to severe plaque psoriasis at Screening and Baseline defined as: 
x 
BSA LQYROYHPHQWRI 
x 
3$6,VFRUHRI 
x 
,*$RIDWOHDVWPRGHUDWHGLVHDVH 
5. Negative evaluation for tuberculosis (TB) within 4 weeks prior to initiating IMP, defined as a 
negative QuantiFERON test. Subjects with a positive or 2 successive indeterminate QuantiFERON 
tests are allowed if they have all of the following: 
x 
No history of active TB or symptoms of TB 
x 
A posterior-anterior (PA) chest radiogram or chest computerized tomography (CT) Scan 
(with associated report available at the site) performed within 3 months of Screening with 
no evidence of active TB or of any other pulmonary infectious diseases) 
x 
If prior latent TB infection, must have history of adequate prophylaxis (per local standard of 
care) 
x 
If presence of latent TB is established, then treatment according to local country guidelines 
must have been followed for 4 weeks, prior to inclusion in the study. A maximum of 2 
QuantiFERON tests are allowed. A re-test is only permitted if the first is indeterminate; the 
result of the second test will then be used. 
6. Subjects must be in good health and free from any clinically significant disease, including but not 
limited to, known hypersensitivity to similar products or excipients, conditions that may interfere 
with the evaluation of plaque psoriasis. Such conditions include, but are not limited to atopic or 
contact dermatitis, eczema, tinea corporis, and psoriasis other than stable plaque psoriasis (e.g., 
erythrodermic, exfoliative or pustular psoriasis). 
7. Willing to refrain from using all study prohibited medications during the treatment period.  

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8. Female subjects of childbearing potential, in addition to having a negative pregnancy test (serum 
at Screening Visit, urine at Baseline Visit), must be willing to use  a highly effective form (failure 
rate of less than 1% per year when used consistently and correctly) of birth control during the study 
from the day of the first dose administration to 30 days after the last administration of study drug. 
For the purpose of this study the following are considered highly effective methods of birth control: 
combined (estrogen and progestogen containing) hormonal  contraceptives associated with 
inhibition of ovulation (oral, intra-vaginal or transdermal), progestogen-only hormonal 
contraceptives associated with inhibition of ovulation (oral, injectable or implantable), intrauterine 
device (IUD), intrauterine hormone-releasing system (IUS); bilateral tubal ligation, vasectomized 
male partner and complete sexual  abstinence with a 2nd highly effective method of birth control 
should the subject become sexually active.  
Notes: 
x 
For the purpose of this study, a female is considered of childbearing potential i.e. fertile 
following menarche and until becoming post-menopausal unless permanently sterile. The 
methods of permanent sterilization are hysterectomy, bilateral salpingectomy, and bilateral 
oophorectomy. A post-menopausal state is defined as no menses for 12 months without any 
other medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal 
range may be used to confirm a post-menopausal state in women not using hormonal 
contraception or hormonal replacement therapy. However in the absence of 12 months of 
amenorrhea, a single FSH measurement is in-sufficient [CTFG guidelines (Clinical Trials 
Facilitation and Coordination Group CTFG 21/09/2020 Version 1.1] 
x 
Subjects on hormonal contraception must be stabilized on the same type for at least three 
months prior to enrollment in the study and must not change the method during the study. A 
sterile sexual partner is NOT considered an adequate form of birth control. 
x 
Vasectomized partner is a highly effective birth control method provided that partner is the 
sole sexual partner of the WOCBP trial participant and that the vasectomized partner has 
received medical assessment of the surgical success 
x 
Sexual abstinence is considered a highly effective method only if the subject refrains from 
heterosexual intercourse during the entire period of the contraception requirement i.e., from 
first dose administration to 30 days after the last administration of study drug. The reliability of 
sexual abstinence should be evaluated in relation to the duration of the clinical trial and the 
preferred and usual lifestyle of the subject 
9. All male subjects must agree to use accepted methods of birth control with their partners, from the 
day of the first dose administration to 30 days after the last administration of study drug. Complete 
sexual abstinence is a “highly effective” method of birth control and acceptable for this study.  
Female partners should use an acceptable method of birth control as described in the above Item 
Number 8. 
Notes: For the purpose of this study, a male is considered fertile following puberty unless 
permanently sterile by bilateral orchidectomy [CTFG guidelines (Clinical Trials Facilitation and 
Coordination Group CTFG 21/09/2020 Version 1.1].  
10. Willing and able to understand and comply with the requirements of the protocol, including 
attendance at the required study visits. 
11. Documentation of positive varicella zoster virus (VZV) IgG antibody status. 
 
 
 
12. To participate in whole body photography, the subject must be willing to give written informed 
consent for whole body photography and be able to adhere to the procedures involved. A subject 
unwilling to consent for whole body photography may still be included in the trial. 
4.3 Exclusion Criteria 
1. Female subjects who are pregnant, nursing or planning to become pregnant during the study 
participation or within 6 months of completing the study. 
2. Predominantly non-plaque forms of psoriasis like erythrodermic psoriasis, pustular psoriasis, 
medication-induced or medication exacerbated psoriasis, or new-onset guttate psoriasis. 

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x 
Treatment with ustekinumab within 6 months, secukinumab within 5 months, etanercept within 
4 weeks and any other biologics within 12 weeks or 5 half-lives whichever is longer 
x 
Systemic immunosuppressive therapy (e.g., Tacrolimus) within 4 weeks 
x 
Treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) within 4 weeks 
x 
Oral systemic psoriasis therapy (e.g., cyclosporine, methotrexate, acitretin, fumaric acid 
esters, apremilast) within 4 weeks 
x 
Phototherapy (e.g., UV-B light phototherapy, PUVA (Psoralen and ultraviolet A) therapy, 
tanning salon or home-administered UV-B) within 4 weeks 
x 
Oral or injectable corticosteroids within 4 weeks 
x 
Treatment with a non-biologic investigational agent within 4 weeks (or 5 half-lives whichever 
is longer) 
x 
Topical psoriasis treatment within 2 weeks prior to randomization 
x 
Treatment with JAK inhibitors within 4 weeks prior to randomization 
10. Laboratory abnormalities at screening: 
x 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
x 
Any other laboratory abnormalities, which, in the opinion of the Investigator will expose the 
subject to undue risk, prevent the subject from completing the study or will interfere with the 
interpretation of the study results. Out of range laboratory results at screening not specified 
above should have been assessed as clinically non-significant by the Investigator and 
confirmed by the Medical Monitor (MM) as acceptable for participation in the study 
11. Presence of any infection or history of infection requiring treatment with systemic antibiotics within 
2 weeks prior to Screening, or severe infection (e.g., pneumonia, cellulitis, bone or joint infections) 
requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening. 
12. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface antigen (HBsAg), or 
hepatitis C virus (HCV) test result. Subjects with a positive HCV test are allowed if HCV RNA is 
negative 
13. Prior malignancy, or concurrent malignancy (excluding successfully treated basal cell carcinoma, 
squamous cell carcinoma of the skin in situ, squamous cell carcinoma with no evidence of 
recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated). 
14. Subject who has received live viral or bacterial vaccination within 4 weeks prior to Screening, or 
who intends to receive live viral or bacterial vaccination during the study. 
15. Presence of macular edema at Screening (subjects with a history of macular edema are allowed 
provided they do not have macular edema at Screening Visit) 
16. Consumption of excessive amounts of alcohol (greater than 2 drinks per day) or use drugs of 
abuse (including, but not limited to, cannabinoids, cocaine, and barbiturates). 
17. Presence of autoimmune disorder other than Psoriasis 
18. Documented organ transplantation 
19. History or presence of clinically relevant, hepatic, neurological, pulmonary, ophthalmological, 
endocrine, psychiatric, or other systemic disease making implementation of the protocol or 
interpretation of the study difficult or that would put the subject at risk by participating in the study 
20. History of alcohol abuse  
21. History of substance abuse in the previous year, in the opinion of the Investigator 
22. History of attempted suicide.  
23. History of or currently active primary or secondary immunodeficiency. 

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24. Engagement in activities that involve excessive or prolonged exposure to sunlight or weather 
extremes, such as wind or cold. 
25. Participation in an investigational drug study (i.e., Subjects have been treated with an 
investigational drug) within 30 days prior to screening. Subjects who are participating in non-
treatment studies such as observational studies or registry studies can be considered for inclusion. 
26. Presence of excessive hair, tattoos, pigmentation, extensive scarring, pigmented lesions, or 
sunburn in the treatment area, which could make the affected plaque psoriasis BSA difficult to 
visualize. 
27. Previous enrolment in this study. 
28. The subject or a family member is among the personnel of the investigational site or Sponsor 
designee staff directly involved with this trial. 
29. Subjects who are members of the same household with subjects participating or previously 
enrolled in this study 
4.4 Prohibited Medications, Procedures, and Activities 
Medication necessary for the health and well-being of the subject are permitted provided the subject 
has been at a stable dose for 30 days prior to screening/baseline. The use of any medication that could 
affect the course of psoriasis is prohibited during the entire study period. Subjects will be advised to 
refrain from making any significant change in the use of consumer products during the study (including 
moisturizers, new brands of make-up, creams, ointments, lotions, and powders) applied on or near the 
treatment area. 
 
The following are prohibited during this study: 
1. Use of new or changes in use of hormonal contraceptives 
2. Analgesics, including NSAIDS and Acetaminophen, within 
 before scheduled study visits. 
3. Topical psoriasis treatment.  
 
 
 
 
 
4. Oral systemic psoriasis therapy (e.g., cyclosporine, methotrexate, acitretin, fumaric acid esters, 
apremilast)  
5. Phototherapy (e.g.,  UV-B light phototherapy, PUVA therapy, tanning salon, home-administered 
UVB), or excessive exposure to the sun 
6. Oral or injectable corticosteroids  
7. Biologic agents  
8. Class Ia or III antiarrhythmic drugs (e.g. quinidine, disopyramide, amiodarone, bretylium, sotalol, 
ibutilide, azimilide, dofetilide, ajmaline, procainamide) 
9. Drugs that cause QT prolongation and/or with a known risk of torsades de pointes (e.g., 
citalopram, chlorpromazine, haloperidol, methadone, erythromycin) 
10. Medications that may cause AV block and suppress AV conduction (e.g. Beta blockers, 
carbamazepine, non-dihydropyridine calcium-channel blockers, or cardiac glycosides) 
11. Medications that may decrease heart-rate such as calcium channel blockers (verapamil or 
diltiazem), digoxin, ivabradine, anticholinesteratic agents or pilocarpine 
12. Lymphocyte-depleting therapies (e.g., Campath, anti-CD4, cladribine, rituximab, ocrelizumab, 
cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, 
alemtuzumab, daclizumab) 
13. Lymphocyte trafficking blockers (e.g., natalizumab, fingolimod, other S1PR agonists) 

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14. Disease modifying anti-rheumatic drugs. 
15. Immunosuppressive agents (e.g., Methotrexate, Azathioprine, cyclosporine, 6-thioguanine, 
mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) 
16. Immunosuppressive procedures that deplete lymphocytes (e.g., total body irradiation, bone 
marrow transplantation). 
17. JAK inhibitors 
 
4.5 Permitted Medications  
1. Non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics given to treat psoriatic arthritis 
(PsA) only if the subject was on a stable dose for at least 4 weeks prior to Day 1 and is expected 
to maintain a stable dose for the first 16 weeks of the study. NSAIDs should not be used within 
 
 before scheduled study visits. 
2. Analgesics: Acetaminophen may be used by the subject PRN except within 
 before 
scheduled study visits. 
3. 
 
 
 
 
 
 
4.6 Precautions  
The following precautions are to be taken during this study:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
The therapeutic class of S1P agonists carries following known and/or potential risks: 
x 
Bradyarrhythmia and atrioventricular conduction delays 
x 
Hypotension 
x 
Increased blood pressure 
x 
Increased risk of infections 
x 
Macular edema 
x 
Decline in pulmonary function 
x 
Liver injury 
x 
Progressive multifocal leukoencephalopathy (PML) 
x 
Posterior reversible encephalopathy syndrome (PRES) 
If an adverse reaction suggesting Subject’s condition has worsened to the degree that it is unsafe for 
the Subject to continue in the study, the Principal Investigator should assess the Subject’s condition 
as soon as possible (i.e., during an Unscheduled Visit) and determine whether treatment should be 

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x 
 
 
  
 
 
 
 
 
 
  
Medical Monitor/Sponsor notification is required before removing/discontinuing subjects for any of the 
reasons noted above, as soon as possible.   
The Principal Investigator must strive to follow the Subjects that are discontinued for any of the above 
reasons due to safety until the adverse event has resolved, becomes clinically insignificant, is stabilized 
or the Subject is lost to follow-up. 
A significant protocol violation is defined as any Subject or Investigator activity that could have possibly 
interfered with the therapeutic administration of the treatment or the precise evaluation of treatment 
efficacy. 
The reasons for a Subject discontinuation will be documented. If a Subject is discontinued from the 
study for any reason, the procedures scheduled for Early Discontinuation will be completed and any 
outstanding data and study drug should be collected if possible. Data, in addition to the reason for 
discontinuation and the date of removal, will be documented. 
Before a Subject is considered to be lost to follow-up, the Principal Investigator will document all (at 
least three) attempts to reach the Subject twice by telephone and will send a certified follow-up letter. 
If a Subject discontinues from the study at any time due to an adverse event, the reason for 
discontinuation, the nature of the event and its clinical course must be fully documented. For such a 
Subject, the Principal Investigator must strive to follow the Subject until the adverse event has resolved, 
becomes clinically insignificant, is stabilized or the Subject is lost to follow-up. 
 
 
Subjects who drop out after randomization will not be replaced. 
4.8 Criteria to Discontinue Study 
The entire trial may be discontinued by the sponsor pertaining to lack of efficacy, safety, feasibility or 
unspecified strategic or business reasons. 
The Data Safety Monitoring Board (DSMB) may make a recommendation for discontinuation of the trial 
based on safety assessments of treated subjects when there is no justification for exposing additional 
subjects to additional potential risks by continuing the trial. The DSMB may recommend discontinuation 
of the study if the safety profile of SCD-044 is anticipated to be significantly inferior to other drugs in 
the class.  
 
4.9 Meals and Refreshments 
No consumption of energy drinks, alcohol, or caffeine-containing products, or the start, stop or change 
in dose of any prescription or over-the-counter (OTC) medication will be allowed during the housing at 
dose titration visits. 
No excessive sodium consumption (>2,400 mg/day or >1 teaspoon equivalent/day) in food or beverage, 
and no caffeine containing beverages and foods (e.g., tea, coffee, cola drinks, and chocolate) and 
grapefruit containing beverages may be taken by subjects during the housing at dose titration visits. 
5. 
SAFETY AND TOLERABILITY EVALUATIONS 
Safety monitoring in this study will be performed by: 

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x 
Site PI (blinded). PI will identify a local ophthalmologist and a pulmonologist for screening or 
consultation, as necessary, 
x 
 
 
 
 
 
.  
 
  
 
 
 
x 
Study Medical Monitor (blinded) will be available to consult on enrollment, medical questions, 
discontinuation, safety evaluations, 
x 
 
 
  
x 
 
  
x 
Data Safety Monitoring Board (see Section 12.6). 
 
 
 
 
 
 
 
 
 
  
 
 
  
  
5.1 Medical History 
A complete medical history will be obtained for the Subject’s current and past medical conditions. 
Significant medical history should include, but not be limited to evidence of hypertension, lipid disorders, 
obesity, heart attack, stroke, congestive heart failure, kidney disease, auto immune disease and 
diabetes. Significant surgical history should include, but not be limited to, removal of blockage from an 
artery and gallbladder removal. 
5.2 Physical Examination 
The Investigator, sub-Investigator or appropriately delegated designee, (Physician’s Assistant, 
Advanced Registered Nurse Practitioner, or Registered Nurse as per local regulations) will perform a 
physical examination, prior to the Subject starting study drug and at the end of treatment.   
The physical examination will include, at a minimum, examination of the Subject’s general appearance, 
comprehensive skin examination, HEENT (head, eyes, ears, nose and throat), heart, lungs, 
musculoskeletal system, neurological system, lymph nodes, abdomen and extremities. 
Height and weight will be measured without shoes. 
At the study Visits 1, 10, and 19 (Screening and study Weeks 16, and 52) the Subject’s body weight 
will also be measured while the Subject is lightly clothed (e.g., no coat or shoes).  

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5.3 Vital Signs 
Vital signs, including blood pressure*, pulse rate**, respiratory rate and oral body temperature, will be 
documented at every on-site visit. Vital signs will be measured after the Subject has rested in a seated 
or supine position for at least 5 minutes.
 
 
  
* The same arm should be used if triplicate measurements are required for blood pressure. 
** Pulse rate will be measured once by counting the number of heart beats over 60 seconds (the pulse 
rate should not be extrapolated after counting for part of 60 seconds). 
5.4 Pregnancy Test 
All female Subjects of childbearing potential will undergo serum beta-human chorionic gonadotropin 
(hCG) testing at Screening. 
 
 
 
 
For the purpose of this study, a female is considered of childbearing potential i.e. fertile following 
menarche and until becoming post-menopausal unless permanently sterile. The methods of permanent 
sterilization are hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A post-menopausal 
state is defined as no menses for 12 months without any other medical cause. A high follicle stimulating 
hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in 
women not using hormonal contraception or hormonal replacement therapy. However in the absence 
of 12 months of amenorrhea, a single FSH measurement is in-sufficient. [Per CTFG guidelines (Clinical 
Trials Facilitation and Coordination Group CTFG 21/09/2020 Version 1.1). 
 
Women of childbearing potential, in addition to having a negative pregnancy test, must be willing to use 
a highly effective form (failure rate of less than 1% per year when used consistently and correctly) of 
birth control during the study from the day of the first dose administration to 30 days after the last 
administration of study drug. For the purpose of this study the following are considered highly effective 
methods of birth control: combined (estrogen and progestogen containing) hormonal contraceptives 
associated with inhibition of ovulation (oral, intra-vaginal, or transdermal) progestogen-only hormonal 
contraceptive associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device 
(IUD), intrauterine hormone-releasing system (IUS); bilateral tubal ligation, vasectomized male partner, 
complete sexual abstinence with a 2nd highly effective method of birth control should the subject 
become sexually active.  A sterile sexual partner is NOT considered an adequate form of birth control. 
Subjects on hormonal contraception must be stabilized on the same type for at least three months prior 
to enrollment in the study and must not change the method during the study.  Subjects who had used 
hormonal contraception and stopped must have stopped no less than three months prior to the study. 
5.5 Laboratory assessments 
A central laboratory will be used for all assessments unless noted otherwise. Unscheduled laboratory 
assessments can be performed at discretion of the Investigator in response to AEs. The laboratory 
assessments include: 
Hematology*: at all on-site study visits a blood sample will be collected for total and differential WBC 
count, Absolute Neutrophil count (ANC), Absolute Lymphocyte count (ALC), Platelet count, 
Hemoglobin, Hematocrit, Mean Corpuscular Volume (MCV) testing. 
 
   
 
 
 

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Lipid profile*: at the study Visits 1, 2, 10 and 19 (Screening and study Weeks 0, 16, and 52) a blood 
sample will be collected for LDL, HDL and total cholesterol and Triglycerides testing. 
Clinical chemistry*: at the study Visits 1, 2, 7, 8, 10, 15, 16, and 19 (Screening and study Weeks 0, 
4, 8, 16, 20, 28, and 52) a blood sample will be collected for sodium, potassium, chloride, calcium, 
magnesium, bicarbonate, phosphate, blood urea nitrogen, random glucose, albumin, total protein, 
alkaline phosphatase, creatinine, ALT, AST, gamma glutamyl transferase (GGT), total bilirubin, 
conjugated bilirubin testing. 
 
Coagulation profile*: at the study visits 1, 2, 10, 16, and 19 (Screening and study weeks 0, 16, 28 and 
52) a blood sample will be collected for PT, INR, and aPTT testing. 
Serology: at Screening visit a blood sample will be collected for: anti-VZV IgG, HIV antibodies, HBsAg, 
and HCV antibodies testing. 
QuantiFERON Gold test: at Screening Visit a blood sample will be collected for TB antigens testing. 
 
 
 
.  
Serum pregnancy test: at Screening Visit a blood sample will be collected for serum beta-hCG testing. 
The following tests will be performed at a clinic site: 
Urinalysis dipstick*: at the study Visits 1, 2, 10, and 19 (Screening and study Weeks 0, 16, and 52) a 
urine sample will be collected for pH, specific gravity, protein, glucose, ketones, and blood testing. 
Microscopic exam may be performed at the central laboratory at the discretion of the Investigator if the 
dipstick is positive (i.e. trace or above). 
Urine Pregnancy Test: 
 
 a urine sample will be collected in women of childbearing potential 
for hCG testing (see section 5.4). 
 
The safety team will take confirmation of the result through scheduled phone calls.  
 
 
. 
C-reactive protein test (CRP):  

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Test for CRP will be done for all subjects. 
At the study visits 2, 10, 16, and 19 (study Weeks 0, 16, 28, and 52) a blood sample will be collected 
for CRP testing. 
Rheumatoid Factor (RF):  may be performed at study visit 1 or 2 at the central laboratory at the 
discretion of the Investigator to establish if there is a diagnosis of PsA per the Classification of Psoriatic 
Arthritis (CASPAR) criteria.12 
 
 
For Hematology, Chemistry, and Coagulation profile the labs, which were abnormal and clinically 
significant at EOT, are needed at safety follow-up visit. 
5.6 Pulmonary assessments 
 pulmonary function tests (PFTs) will be 
performed, including assessment of FEV1 and FVC. Spirometry will be performed in accordance with 
American Thoracic Society standards.13  The results will be compared to the predicted values based 
on factors such as age, gender, and ethnicity. The ATS standardized report form will be used as a 
source to record spirometry readings.14,15,16   
Additional pulmonary assessments will be done in case of clinically significant abnormal findings on the 
PFTs or physical examination and at the discretion of the Investigator in subjects with respiratory 
complaints like dyspnea, shortness of breath, chest tightness, wheezing etc. 
5.7 Ophthalmological assessments 
 a complete ophthalmologic 
examination will be performed by an ophthalmologist, including an ophthalmological history, best 
corrected visual acuity (Snellen chart), ophthalmoscopy (preferably slit-lamp) and Optical Coherence 
Tomography (OCT) assessment (measurement of central foveal thickness).  
A comprehensive eye examination by an ophthalmologist must be scheduled immediately for any 
subject who complains of any visual disturbance. Subjects will be instructed to contact the site for any 
problems with vision. The results of this test will be provided to the sites’ Independent Safety Assessor 
(unblinded team). 
If there is a suspicion of macular edema, additional assessments like fluorescein angiogram may be 
performed at the discretion of the ophthalmologist. Subjects who develop blurred or changed vision 
(redness, pain, light sensitivity, blurred vision, and dark floating spots in the field of vision), that may be 
indicative of uveitis (based on Standardization of Uveitis Nomenclature (SUN) Working Group) or 
macular edema will have follow up ophthalmic examinations every month or as per the discretion of the 
ophthalmologist. 
 
 
 
 
 
  
5.8 Concomitant medications 
Concomitant medications, including the use of non-drug treatments/therapies, in addition to the reason 
for the medication use, will be assessed at baseline and at each subsequent study visit. The start and 
stop date of concomitant medication use during the study should be provided in the data set in addition 
to the reason for the medication use. 
A record of concomitant medications taken by the Subject is to be obtained using generic name, if 
known, with the corresponding indication. The medications to be recorded will include prescription and 
over-the-counter (OTC) medications and dietary supplements.  All medications taken on a regular 
basis, including acetaminophen, should be recorded. 

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5.9 Adverse Events (AEs) and Adverse Events of Special Interest (AESI) 
Any AEs occurring after signing Informed Consent should be reported. An adverse event is defined as 
any untoward medical occurrence (sign, symptom or clinically significant abnormal laboratory finding) 
regardless of severity in a subject or clinical-trial subject administered a medicinal product and which 
does not necessarily have to have a causal relationship with this treatment. All adverse events, whether 
observed by an Investigator or Study Coordinator or reported by the subject, whether related to study 
drug or not related to study drug, shall be documented on Subject records, together with details, i.e. 
date of onset, description of the AE, the duration and intensity of each episode, the action taken, the 
relationship to the investigational product and the degree of severity, the seriousness, date of 
resolution, and the outcome.  
After first dose, AEs (including AESIs and cardiac arrhythmias) should only be reported to and assessed 
by the independent safety team. 
Following are Adverse Events of Special Interest (AESI): 
x 
Serious Infections 
x 
New onset malignancy  
x 
  
x 
New Onset Macular edema 
x 
PML and PRES 
5.10 
Query for Progressive multifocal leukoencephalopathy (PML) 
Progressive multifocal leukoencephalopathy (PML) is a rare viral disease of the brain caused by a 
common infection called the John Cunningham (JC) virus. Up to 85% of adults in the general population 
have the JC virus. The virus usually remains dormant in the lymph nodes, bone marrow, or kidneys 
throughout life. If the immune system becomes severely compromised for any reason, the virus can be 
reactivated.  
At each study Visit starting from Screening, the subject will be assessed for initial symptoms of PML: 
x 
clumsiness or loss of coordination 
x 
sensory loss 
x 
difficulty walking 
x 
changes in vision 
x 
facial drooping 
x 
personality changes 
x 
memory problems and mental slowness 
x 
trouble speaking 
x 
weak muscles 
x 
changes in thinking 
x 
confusion 
x 
progressive weakness on one side of the body 
Symptoms can progress rapidly to include complications such as dementia, seizures, or coma. PML 
is a life-threatening medical emergency and usually leads to death or severe disability over weeks 
or months. 
At each study visit, subjects will be instructed to immediately contact their doctor and stop treatment 
with the study drug if they experience any symptoms of PML. Subjects should also be instructed 
that typical symptoms associated with PML are diverse and progress over days to weeks. 
5.11 
Query for Posterior reversible encephalopathy syndrome (PRES) 
Posterior reversible encephalopathy syndrome (PRES) may occur due to a number of causes, 
predominantly malignant hypertension, eclampsia and some medical treatments.  
At each study visit starting from screening the subject will be assessed for symptoms of PRES: 
x 
headache 
x 
confusion or altered mental state 
x 
seizures 

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x 
changes in vision  
The symptoms tend to resolve after a period of time, although visual changes sometimes remain. 
Symptoms of PRES may be sudden and are usually reversible but may evolve into ischemic stroke or 
cerebral hemorrhage. 
At each study visit, subjects will be instructed to immediately contact their doctor and stop treatment with 
the study drug if they experience any symptoms of PRES. Subjects will also be informed that delayed 
treatment could lead to permanent neurological sequelae.  
5.12 
ECG 
 
 
 
 
 
x 
the end of treatment visit 19 (study week 52) before the pre-dose PK sample 
x 
if needed, at the discretion of the independent medical monitor, post-treatment follow up visit.  
 
 
  
All 12-lead ECGs will be recorded after the subject is rested in supine position for at least 5 minutes. 
 
  
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
   
 
  
 
 
 
 
 
  
 
  
 
 
 

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Pre-dose: 
Vital Signs (supine): Vital signs, including blood pressure, pulse rate, respiratory rate and oral body 
temperature will be documented before administration of the study drug. To establish an accurate 
baseline measurement, systolic and diastolic blood pressure will be measured after the Subject is rested 
for at least 5 minutes.  
Pulse rate will be measured once by counting the number of heart beats over 60 seconds (the pulse 
rate should not be extrapolated after counting for part of 60 seconds).  
If needed, at the independent safety assessor’s discretion, pulse rate and BP may be measured in 
triplicate (at 1-2 minute intervals using the same arm for each repeat). The lowest pre-dose value of 
supine pulse rate and BP (based on the systolic BP) will be taken as the visit baseline measure and 
used for comparison to post-dose values.  
Orthostatic (postural) vital signs:  orthostatic (postural) vital signs, including blood pressure and pulse 
rate will be obtained 2-5 minutes after a subject stands (
 If needed, at the independent 
safety assessor’s discretion, pulse rate and BP may be measured in triplicate (at 1-2 minute intervals).18 
 
 
ECG: a predose 12-lead ECG using an appropriate device 
) will be obtained.  
 
 
 
HR/ECG monitoring: 
 ECG recording using an appropriate device 
) will 
be performed 
  
 
 
 
 
 
   
 
 
  
Pulse rate will be measured once by counting the number of heart beats over 60 seconds (the pulse 
rate should not be extrapolated after counting for part of 60 seconds).  
If needed, at the independent safety assessor’s discretion, pulse rate and BP may be measured in 
triplicate (at 1-2 minute intervals using the same arm for each repeat).The lowest post-dose values of 
HR and BP (based on the systolic BP) will be taken as the measures for the corresponding time point.  
Orthostatic (postural) vital signs:  orthostatic (postural) vital signs, including blood pressure and pulse 
rate 2-5 minutes after a subject stands, will be documented 
 
 If needed, at the independent safety assessor’s discretion, pulse rate and BP may be 
measured in triplicate (at 1-2 minute intervals). 

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The treatment period should not be extended beyond 52 weeks due to missed doses or treatment 
interruption periods. Subjects whose condition worsens should be re-evaluated by the Investigator and 
management reconsidered. 
 
 
 
 
 
 
 
 
  

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Pulmonary Function Tests (PFTs): 
Unscheduled PFTs should be performed in subjects with respiratory symptoms such as dyspnea, 
shortness of breath, chest tightness, wheezing after an assessment by the Investigator. The Investigator 
shall decide if additional assessment by a pulmonologist is needed based on results of the PFTs. A 
decision on the study treatment interruption and/or discontinuation shall be taken in consultation with 
the pulmonologist, the Independent Safety Assessor and the independent MM.  
Ophthalmological examination:  
Unscheduled comprehensive eye examination should be performed in subjects with visual disturbances. 
 
 
 
 
 
Infections:  
In the case of suspected or confirmed serious infection, the Investigator should report the event as an 
AESI to the CRO MM and independent MM within 24 hours. Treatment interruption and/or 

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discontinuation can be considered in consultation with the independent safety assessor and the 
independent MM. 
Progressive multifocal leukoencephalopathy (PML):  
If PML is suspected, the study treatment should be withdrawn until PML has been excluded, and 
the subject should immediately receive emergency care for proper diagnosis and/or treatment. 
If PML is diagnosed, the subject should be discontinued from the study and followed up for safety 
according to Section 10. 
Posterior reversible encephalopathy syndrome (PRES): 
If PRES is suspected, the study treatment should be withdrawn until PRES has been excluded. 
If a subject develops any unexpected neurological or psychiatric symptoms/signs (e.g., cognitive 
deficits, behavioral changes, cortical visual disturbances, or any other neurological cortical 
symptoms/signs), any symptom/sign suggestive of an increase of intracranial pressure, or 
accelerated neurological deterioration, the Investigator or the independent safety assessor and the 
independent MM should promptly schedule a complete physical and neurological examination and 
should consider a magnetic resonance imaging (MRI).  
At the discretion of the Investigator, the subject may also be referred to emergency care for proper 
diagnosis and/or treatment. 
If PRES is diagnosed, the subject should be discontinued from the study and followed up for safety 
according to Section 10. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical Monitor/Sponsor notification is required before removing subjects for any of the reasons 
noted above at the earliest.  
The Principal Investigator must strive to follow the subjects who are discontinued for any of the 
above-mentioned reasons due to safety until the adverse event has resolved, becomes clinically 
insignificant, is stabilized or the subject is lost to follow-up. 
 
 
 
 
6 
STUDY EVALUATIONS 
6.1 Efficacy  
Efficacy assessments should be performed by the Investigator or a designee who is appropriately trained 
and experienced in the assessment of psoriasis patients. 
 
 
 

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an 11-point scale anchored at 0, representing ‘No itch’ and 10, representing ‘Worst itch imaginable’. 
(Appendix VIII) 
6.1.6 Scalp Itch Numeric Rating Scale (scalp itch NRS) – for subjects with Scalp psoriasis 
At the study Visits 2, 10, 15, 16, and 19 (study Weeks 0, 16, 20, 28, and 52) subjects will be asked to 
assess severity of itching of the scalp due to psoriasis perceived over past 24 hours at the moment of 
scoring on an 11-point scale anchored at 0, representing ‘No scalp itch’ and 10, representing ‘Worst 
scalp itch imaginable’. (Appendix VIII) 
6.1.7 Health Assessment Questionnaire of disability (HAQ-DI) – for subjects with PsA 
The HAQ-DI is a component of American College of Rheumatology (ACR) response Assessments. 
ACR response assessments will be performed only in subjects who meet the CASPAR Criteria. (see 
6.1.16) The ACR components evaluations will be used to calculate the subject’s ACR response criteria 
(ACR20 / 50 / 70) 
At the study Visits 2, 10, 15, 16, and 19 (study Weeks 0, 16, 20, 28, and 52) the subject will assess 
their general disability using the HAQ-DI questionnaire. The HAQ-DI is designed to assess patients’ 
usual abilities using their usual equipment. The time frame for the disability questions is the past week 
and scoring within each section is from 0 (without any difficulty) to 3 (unable to do). (Appendix IX) A 
higher score indicates greater disability. 
6.1.8 Patient Global Assessment of Disease Activity (PtGA) – for subjects with PsA 
The PtGA is a component of American College of Rheumatology (ACR) response Assessments. ACR 
response assessments will be performed only in subjects who meet the CASPAR Criteria. (see 6.1.16) 
The ACR components evaluations will be used to calculate the subject’s ACR response criteria (ACR20 
/ 50 / 70) 
At the study visits 2, 10, 15, 16, and 19 (study weeks 0, 16, 20, 28, and 52) the subject will assess their 
current (‘today’) global status of PsA using a Visual Analogue Scale (VAS) of 0 to 100. (Appendix X) 
6.1.9 Patient Assessment of Pain (PtA-P) – for subjects with PsA  
The PtA-P is individual measurement and also a component of American College of Rheumatology 
(ACR) response Assessments. PtA-P assessments will be performed only in subjects who meet the 
CASPAR Criteria. (see 6.1.16) 
At the study visits 2, 10, 15, 16, and 19 (study weeks 0, 16, 20, 28, and 52) the subject will assess their 
pain due to PsA using a Visual Analogue Scale (VAS). It is a subjective measure of pain. It is a 
continuous scale, 100 mm in length, anchored by 2 verbal descriptors, one for each symptom extreme 
(“no pain” and “worst pain imaginable”). Subjects are asked to rate their pain by placing a mark on the 
line corresponding to their current level of pain. The distance along the line from the “no pain” marker 
is then measured with a calibrated ruler giving a pain score out of 100. (Appendix XI) 
6.1.10 Investigator’s Global Assessment (IGA)  
At Screening and Baseline, to be eligible for inclusion in the study, subjects must have a definite clinical 
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psoriatic lesions. 
 
 the Investigator will perform an average assessment of all psoriatic lesions based on erythema, 
scale, and induration. The static IGA determines psoriasis severity at a single point in time, without 
taking the baseline disease condition into consideration. The following scale will be used for the IGA: 

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Joint count includes the majority of joints affected in PsA, 68 for tenderness and 66 for swelling. It 
includes the temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist (including 
the carpometacarpal and intercarpal joints as 1 unit), metacarpophalangeal (MCP), proximal 
interphalangeal (PIP), DIP, hip, knee, talotibial, midtarsal (including subtalar), metatarsophalangeal, 
and interphalangeal joints of the toes (proximal and distal joints of each toe is counted as 1 unit) for 
assessment of tenderness. The 66 joints to be examined for swelling are the same as those of 
tenderness, except the hip joints are not included. The assessments will be performed using 
instructions in Appendix XII and tender and swollen joint numbers will be recorded in a Joint Count 
Scoring Sheet.  
6.1.18 Physician Global Assessment of Disease Activity (PGA) – for subjects with PsA 
The PGA is a component of American College of Rheumatology (ACR) response assessments. ACR 
response assessments will be performed only in subjects who meet the CASPAR Criteria. (see 6.1.16) 
The ACR components evaluations will be used to calculate the subject’s ACR response criteria (ACR20 
/ 50 / 70) 
At the study Visits 2, 10, 15, 16, and 19 (study Weeks 0, 16, 20, 28, and 52) the status of the subject’s 
PsA will be assessed by an independent Investigator rheumatologist or qualified trained designee using 
a VAS of 0 to 100. The subject will be assessed according to how their current arthritis is. The VAS will 
be anchored with verbal descriptors of “No Disease Activity” to “Maximum Disease Activity” (Appendix 
XIII) 
6.1.19 American College of Rheumatology (ACR) response Assessments  
ACR response assessments will be performed only in subjects who meet the CASPAR Criteria. (See 
6.1.16) The ACR components evaluations will be used to calculate the subject’s ACR response criteria 
(ACR20 / 50 / 70). ACR20 response indicates a decrease of at least 20% in both the number of tender 
and swollen joint counts, as well as a 20% improvement in at least three of five scores of individual 
components:  
1. Health Assessment Questionnaire of disability (HAQ-DI).  
2. Patient global assessment of disease activity (PtGA) on VAS of 0 to 100. 
3. Patient assessment of pain (PtA-P) on VAS of 0 to 100. 
4. Physician global assessment of disease activity (PGA) on a VAS of 0 to 100. 
5. C-reactive protein (CRP) level, mg/dl. 
ACR50 and ACR70 are the same measurements with improvement levels defined as 50% and 70% 
respectively. 
6.2 Pharmacokinetics 
Blood (approximately 4 ml) will be collected for each PK sample. Pre-dose (trough) PK samples (within 
one hour before dosing) will be collected at study Visits 10, 15, 16, and 19 (study Weeks 16, 20, 28, 
and 52).  
In addition, PK sample will be collected, if possible, approximately 1 hour within the onset of an adverse 
event related to bradycardia during on-site visits with dose titration monitoring.  
PK samples collected only from the active treatment groups will be analysed in an unblinded manner. 
The plasma samples collected at above-mentioned time points may be used for assay of metabolites, 
if required.  
 
 
 
    

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prior to Visit 15.  Remote assessments or delayed Visits 17 or 18 will be recorded in the source documents 
and noted as a minor protocol deviation.   
Changes in study visit schedules, missed visits, or subject discontinuations may lead to missing information 
(e.g., for protocol-specified procedures). It is important to capture specific information in the case report 
form that explains the basis of the missing data, including the relationship to COVID-19, for missing 
protocol-specified information (e.g., from missed study visits or study discontinuations due to COVID-19).  
7.1 FOR ALL SUBJECTS 
 
See Study Visit Schedule 
On-VLWH9LVLW6FUHHQLQJ9LVLW:HHN -4 / Day -28 to -1); 
On-site Visit 2: Baseline Visit (Week 0 / Day 1; before 12 noon);  
On-site Visit 7: 
;  
On-site Visit 8: 
); 
On-site Visit 9: 
 
On-site Visit 10: 
);  
On-site Visit 14: (
  
On-site Visit 15: 
  
On-site Visit 16: 
 
On-site Visit 17: 
 
On-site Visit 18: 
 
On-site Visit 19: End of Treatment Visit (Week 52 / Day 365 ± 3 Days; before 12 noon);  
On-site Visit 20: Follow-up Visit (Week 56 / Day 393 ± 3 Days); 
Phone or in person contacts may be scheduled for
 
 to collect information on concomitant medication, compliance 
with the study drug use, health changes (AEs & AESI), queries for PML and PRES and to provide 
instructions.  
 
 
 
 
For on-site visits conducted in the morning, study drug administration should be done in a clinic to ensure 
dosing before 12:00 (noon).   
7.1.1 On-site Visit 6FUHHQLQJ9LVLW:HHN-4 / Day -28 to -1) 
Potential subjects will be screened during a 4-week period prior to randomization. CRO/Sponsor’s approval 
is required on a case-by-case basis for an extension of the Screening Period to obtain all test results and 
to re-screen a subject. 
 
 The new informed consent/assent is not required, unless an amended or 
revised informed consent/assent is introduced during the study. 
The following procedures will be performed at Screening: 
1. Written informed consent will be obtained. Subjects must have provided IRB approved written 
informed consent. Subjects will be given the approved ICF describing the study and any risks 
associated with participation. The subject will be allowed as much time as needed to read and 
understand the information presented in the consent form. Appropriate study personnel will be 
available to answer any questions the subject might have regarding the study or study-related 
procedures. If the subject chooses to participate in the study, he or she will be asked to sign and date 
the consent form and will be provided with a copy for his or her records. The ICF must be signed by 
the subject before any protocol assessments can be undertaken. 
2. Demographics will be collected, including date of birth, gender, race and ethnicity. 
3. A compliance with applicable inclusion and exclusion criteria will be reviewed. (See Sections 4.2, 4.3)  
4. After confirming the eligibility, the subject will be assigned a screening number. 

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5. A complete medical history will be obtained for the Subject’s current and past medical conditions, 
including a complete list of current and past (within the previous 30 days) medications. Significant 
medical history should include, but not be limited to, evidence of hypertension, lipid disorders, obesity*, 
heart attack, stroke, congestive heart failure, kidney disease, and auto immune disease and diabetes. 
Significant surgical history should include, but not be limited to, removal of blockage from an artery 
and gallbladder removal. (See Section 5.1) 
2EHVLW\ %0,DVGHILQHGE\0HWURSROLWDQ/LIH,QVXUDQFH&RPSDQ\&KDUW 
6. A physical examination will be performed. At a minimum, the physical examination will include the 
following: height, weight, assessment of general appearance, comprehensive skin examination, 
HEENT, heart, lungs, musculoskeletal system, lymph nodes, neurological systems, abdomen, and 
extremities. (See Section 5.2) 
7. A urinalysis dipstick will be performed and evaluated at a site (See Section 5.5) 
8. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be documented. 
Subjects must remain in a seated or supine position for at least 5 minutes before vital signs are 
obtained. (See Section 5.3)    
9. Blood samples will be collected for Hematology, Lipid Profile, Chemistry, Coagulation profile, 
Serology, QuantiFERON Gold test, and Serum pregnancy test for women of childbearing potential 
(See Sections 5.5 and 5.4)   
10. Any AEs occurring after signing Informed Consent should be reported (See Section 5.9) 
11. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10)   
12. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See Section 
5.11)  
13. A 12-lead electrocardiogram (ECG) will be performed (See Section 5.12)   
14. A pulmonary function test will be performed or scheduled with an external expert (See Section 5.6)   
15. An ophthalmologic examination including OCT will be performed or scheduled with an external expert 
(See Section 5.7) 
16. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
17. The overall status of the Subject’s psoriasis will be assessed using the IGA. (See Section 6.1.10). To 
be included in the study, subjects must have plaque psoriasis with moderate (3) score or higher. 
18. Psoriasis Area Severity Index (PASI) will be evaluated. To be included in the study, subjects must 
have plaque psoriasis with PASI score 12 or higher (See Section 6.1.13) 
19. Body Surface Area (BSA) involvement will be assessed. To be included in the study, subjects must 
have plaque psoriasis with BSA involvement 10% or higher (See Section 6.1.14) 
20. Evaluate CASPAR criteria for diagnosis of PsA; may include assessment of rheumatoid factor and/or 
X-ray (See Section 6.1.16). 
21. The following will be dispensed during Screening visit:  
x 
A diary card to record health changes and concomitant medication 
22. On-site Visit 2 (Study Day 1; before 12 noon) will be scheduled and the Subject will be instructed to 
bring the subject diary with him or her to this visit.  
7.1.2 On-site Visit 2: Baseline Visit (Week 0 / Day 1; before 12 noon)  
If the Screening assessment was completed more than 2 weeks prior: 
1. A physical examination will be performed. At a minimum, the physical examination will include the 
following: height, weight, assessment of general appearance, comprehensive skin examination, 

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HEENT, heart, lungs, musculoskeletal system, lymph nodes, neurological systems, abdomen, and 
extremities. (See Section 5.2) 
2. A urinalysis dipstick will be performed and evaluated at a site (See Section 5.5) 
3. A blood sample(s) will be collected for Hematology, Lipid Profile, Chemistry, and Coagulation (See 
Section 5.5)   
4. CASPAR criteria – for subjects with PsA (See Section 6.1.16) 
The following procedures will be performed at Baseline: 
5. Compliance with the inclusion and exclusion criteria, including results of laboratory evaluations, a 
pulmonary function test, and an ophthalmologic examination will be reviewed.  
6. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
7. After confirming the eligibility, the Subject will be assigned a randomization number using Interactive 
Response Technology (IRT). (see Section 8.4.1) 
8. The Subject’s diary provided at the previous visit will be collected and reviewed. 
9. A medical history will be updated with any changes of the Subject’s health since the previous study 
visit. (See Section 5.1) 
10. The use of concomitant medications since the previous study visit will be documented and assessed. 
(See Section 5.8) 
11. A blood sample will be collected for PD biomarkers sample (See Section 6.3) 
12. A blood sample will be collected for C-reactive protein (CRP) – (See Section 5.5) 
13. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
14. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10)   
15. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See Section 
5.11)  
16. Subject Reported Assessments will be collected for: 
x 
Dermatology Life Quality Index (DLQI) (See Section 6.1.1) 
x 
Psoriasis Symptoms and Signs Diary (PSSD) (See Section 6.1.2) 
x 
Patient Global Impression of Severity (PGIS) (See Section 6.1.3) 
x 
Itch Numeric Rating Scale (itch NRS) (See Section 6.1.5) 
x 
Scalp Itch Numeric Rating Scale (scalp itch NRS) – for subjects with Scalp psoriasis (See 
Section 6.1.6) 
x 
Health Assessment Questionnaire of disability (HAQ-DI) – for subjects with PsA (See 
Section 6.1.7) 
x 
Patient Global Assessment of Disease Activity (PtGA) – for subjects with PsA (See Section 
6.1.8) 
x 
Patient Assessment of Pain (PtA-P) – for subjects with PsA (See Section 6.1.9) 
17. Focused Area Assessments will be performed for: 
x 
Investigator’s Global Assessment (IGA) (See Section 6.1.10) 
x 
Scalp Investigator’s Global Assessment (Scalp IGA) – for  subjects with Scalp psoriasis 
(See Section 6.1.11)  
x 
Palmoplantar Physician Global Assessment (PPPGA) – for subjects with Palmoplantar 
Psoriasis (See Section 6.1.12) 
x 
Psoriasis Area Severity Index (PASI) (See Section 6.1.13) 
x 
Body Surface Area (BSA) (See Section 6.1.14) 
x 
modified Nail Psoriasis Severity Index (mNAPSI) – for subjects with Nail psoriasis 
 

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Following will be assessed by an independent assessor (See Section 6.1.15) 
x 
Tender and Swollen Joint Count – for subjects with PsA (See Section 6.1.17) 
x 
Physician Global Assessment of Disease Activity (PGA) – for subjects with PsA (See 
Section 6.1.18) 
18. A whole-body photography – for subjects consenting for photography (See Section 6.4) 
19. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be documented. 
Subjects must remain in a seated or supine position for at least 5 minutes before vital signs are 
obtained. (See Section 5.3) 
20. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
 
 
 
 
x 
As available  
i. Lab results 
ii. Exam results  
21. Study drug administration in a clinic before 12 noon (See Section 8.5)  
  
 
 
 
 
23. A general safety review before discharge 
 
 
 
 
 
  
7.1.3 On-site Visit 7:  Visit (
  
The following procedures will be performed at Visit 7: 
1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
2. Focused Area Assessments will be performed for: 
x 
Investigator’s Global Assessment  (IGA) (See Section 6.1.10) 
x 
Psoriasis Area Severity Index  (PASI) (See Section 6.1.13) 
The following procedures will be performed by an independent safety team: 
3. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
4. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10) 
5. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See Section 
5.11)  
6. The Subject’s diary provided at the previous visit will be collected and reviewed. 
7. The returned study drugs will be counted 
8. The use of concomitant medications since the previous study visit will be documented and assessed. 
(See Section 5.8) 

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9. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be documented. 
Subjects must remain in a seated or supine position for at least 5 minutes before vital signs are 
obtained. (See Section 5.3)    
10. A blood sample(s) will be collected for (See Section 5.5):  
x 
Hematology (total WBC count with differential counts including ALC and ANC)  
x 
Chemistry  
11. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
 
x 
As available 
i. Lab results 
ii. Exam results 
The following procedures will be performed prior a subject discharged from a clinic: 
12. The following will be dispensed during Visit 7:  
x 
The study drug assembled for Visit 7 
x 
A diary card with instructions and to record the study drug use, health changes and 
concomitant medication 
13. A general safety review before discharge 
14. 
 
 
 
7.1.4 On-site Visit 8: Visit (
) 
The following procedures will be performed at Visit 8: 
1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
2. Focused Area Assessments will be performed for: 
x 
Investigator’s Global Assessment (IGA) (See Section 6.1.10) 
x 
Psoriasis Area Severity Index (PASI) (See Section 6.1.13) 
The following procedures will be performed by an independent safety team: 
3. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
4. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 
5.10)   
5. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See 
Section 5.11)  
6. The Subject’s diary provided at the previous visit will be collected and reviewed. 
7. The returned study drugs will be counted 
8. The use of concomitant medications since the previous study visit will be documented and 
assessed. (See Section 5.8) 
9. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be 
documented. Subjects must remain in a seated or supine position for at least 5 minutes before 
vital signs are obtained. (See Section 5.3)    
10. A blood sample(s) will be collected for Hematology and Chemistry (See Section 5.5) 

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11. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
  
x 
As available 
i. Lab results 
ii. Exam results 
The following procedures will be performed prior a subject discharged from a clinic: 
12. The following will be dispensed during Visit 8:  
x 
The study drug assembled for Visit 8 
x 
A diary card with instructions and to record the study drug use, health changes and 
concomitant medication 
13. A general safety review before discharge 
14. 
 
 
 
7.1.5 On-site Visit 9:  Visit 
 
The following procedures will be performed at Visit 9: 
1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
2. Focused Area Assessments will be performed for: 
x 
Investigator’s Global Assessment  (IGA) (See Section 6.1.10) 
x 
Psoriasis Area Severity Index  (PASI) (See Section 6.1.13) 
x 
Body Surface Area (BSA) (See Section 6.1.14) 
The following procedures will be performed by an independent safety team: 
3. An ophthalmologic examination including OCT will be performed or scheduled with an external expert 
(See Section 5.7) 
4. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
5. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10)   
6. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See Section 
5.11)  
7. The Subject’s diary provided at the previous visit will be collected and reviewed. 
8. The returned study drugs will be counted 
9. The use of concomitant medications since the previous study visit will be documented and assessed. 
(See Section 5.8) 
10. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be documented. 
Subjects must remain in a seated or supine position for at least 5 minutes before vital signs are 
obtained. (See Section 5.3)    
11. A blood sample will be collected for Hematology (See Section 5.5) 
12. A blood sample will be collected for PD biomarkers sample (See Section 6.3) 
13. Independent Safety Assessor review:  
x 
Safety Lab Alerts 

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x 
 
x 
As available 
i. Lab results 
ii. Exam results 
The following procedures will be performed prior a subject discharged from a clinic: 
14. The following will be dispensed during Visit 9:  
x 
The study drug assembled for Visit 9 
x 
A diary card with instructions and to record the study drug use, health changes and 
concomitant medication 
15. A general safety review before discharge 
16. 
 
 
. 
7.1.6 On-site Visit 10:  Visit 
 
The visit 10 must be scheduled in a morning to allow the dosing before 12 noon.   
The following procedures will be performed at Visit 10: 
1. Subject Reported Assessments will be collected for: 
x 
Dermatology Life Quality Index (DLQI) (See Section 6.1.1) 
x 
Psoriasis Symptoms and Signs Diary (PSSD) (See Section 6.1.2) 
x 
Patient Global Impression of Severity (PGIS) (See Section 6.1.3) 
x 
Patient Global Impression of Change (PGIC) (See Section 6.1.4) 
x 
Itch Numeric Rating Scale (itch NRS) (See Section 6.1.5) 
x 
Scalp Itch Numeric Rating Scale (scalp itch NRS) – for subjects with Scalp psoriasis (See 
Section 6.1.6) 
x 
Health Assessment Questionnaire  of disability (HAQ-DI) – for subjects with PsA (See 
Section 6.1.7) 
x 
Patient Global Assessment of Disease Activity (PtGA) – for subjects with PsA (See Section 
6.1.8) 
x 
Patient Assessment of Pain (PtA-P) – for subjects with PsA (See Section 6.1.9) 
2. Focused Area Assessments will be performed for: 
x 
Investigator’s Global Assessment  (IGA) (See Section 6.1.10) 
x 
Scalp Investigator’s Global Assessment (Scalp IGA) – for  subjects with Scalp psoriasis 
(See Section 6.1.11) 
x 
Palmoplantar Physician Global Assessment (PPPGA) – for subjects with Palmoplantar 
Psoriasis (See Section 6.1.12) 
x 
Psoriasis Area Severity Index  (PASI) (See Section 6.1.13) 
x 
Body Surface Area (BSA) (See Section 6.1.14) 
x 
modified Nail Psoriasis Severity Index (mNAPSI) – for subjects with Nail psoriasis 
 
Following will be assessed by an independent assessor (See Section 6.1.15) 
x 
Tender and Swollen Joint Count – for subjects with PsA (See Section 6.1.17) 
x 
Physician Global Assessment of Disease Activity (PGA) – for subjects with PsA (See 
Section 6.1.18) 
3. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
4. IRT system consulted for re-randomization and selection of kit  
5. A whole body photography – for subjects consenting for photography (See Section 6.4) 

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The following procedures will be performed by an independent safety team: 
6. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be documented. 
Subjects must remain in a seated or supine position for at least 5 minutes before vital signs are 
obtained. (See Section 5.3) 
7. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
8. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10)   
9. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See Section 
5.11)  
10. The Subject’s body weight will be measured while the Subject is lightly clothed (e.g., no coat or shoes) 
11. The Subject’s diary provided at the previous visit will be collected and reviewed. 
12. The returned study drugs will be counted 
13. The use of concomitant medications since the previous study visit will be documented and assessed. 
(See Section 5.8) 
14. A urinalysis dipstick will be performed and evaluated at a site (See Section 5.5) 
15. A blood sample will be collected for Hematology, Lipid Profile, Chemistry, and Coagulation profile 
(See Section 5.5) 
16. A blood sample will be collected for PD biomarkers sample (See Section 6.3) 
17. A blood sample will be collected within one hour before dosing for PK testing (See Section 6.2) 
18. A blood sample will be collected for C-reactive protein (CRP) – (See Section 5.5) 
19. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
 
 
  
x 
As available 
i. Lab results 
ii. Exam results 
20. Study drug administration in a clinic before 12 noon (See Section 8.5)  
21. 
  
 
  
 
 
 
22. A general safety review before discharge 
23. On-site Visit 14 (Study Day 134 ±1 Day) will be scheduled and the Subject will be instructed to bring 
the Study Product (used, unused, and partially used packs), and Subject diary with him or her to this 
visit. 
24. 
 
 
  
 
 
 

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 
 
 
 
 
 
7.1.7 On-site Visit 14:  Visit 
 
The following procedures will be performed by an independent safety team at Visit 14: 
1. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
2. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 
5.10)   
3. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See 
Section 5.11)  
4. The Subject’s diary provided at the previous visit will be collected and reviewed. 
5. The returned study drugs will be counted 
6. The use of concomitant medications since the previous study visit will be documented and 
assessed. (See Section 5.8) 
7. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be 
documented. Subjects must remain in a seated or supine position for at least 5 minutes before 
vital signs are obtained. (See Section 5.3)    
8. A blood sample will be collected for Hematology (See Section 5.5) 
9. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
  
x 
As available 
i. Lab results 
ii. Exam results 
10. The following will be dispensed during Visit 14:  
x 
The study drug assembled for Visit 14 
x 
A diary card with instructions and to record the study drug use, health changes and 
concomitant medication 
11. A general safety review before discharge 
12. 
 
 
 
7.1.8 On-site Visit 15:  Visit (
)  
The following procedures will be performed at Visit 15: 
1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
2. Subject Reported Assessments will be collected for: 
x 
Dermatology Life Quality Index (DLQI) (See Section 6.1.1) 
x 
Psoriasis Symptoms and Signs Diary (PSSD) (See Section 6.1.2) 
x 
Patient Global Impression of Severity (PGIS) (See Section 6.1.3) 
x 
Patient Global Impression of Change (PGIC) (See Section 6.1.4) 

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x 
Itch Numeric Rating Scale (itch NRS) (See Section 6.1.5) 
x 
Scalp Itch Numeric Rating Scale (scalp itch NRS) – for subjects with Scalp psoriasis (See 
Section 6.1.6) 
x 
Health Assessment Questionnaire  of disability (HAQ-DI) – for subjects with PsA (See 
Section 6.1.7) 
x 
Patient Global Assessment of Disease Activity (PtGA) – for subjects with PsA (See Section 
6.1.8) 
x 
Patient Assessment of Pain (PtA-P) – for subjects with PsA (See Section 6.1.9) 
3. Focused Area Assessments will be performed for: 
x 
Investigator’s Global Assessment  (IGA) (See Section 6.1.10) 
x 
Scalp Investigator’s Global Assessment  (Scalp IGA) – for  subjects with Scalp psoriasis 
(See Section 6.1.11) 
x 
Palmoplantar Physician Global Assessment (PPPGA) – for subjects with Palmoplantar 
Psoriasis (See Section 6.1.12) 
x 
Psoriasis Area Severity Index  (PASI) (See Section 6.1.13) 
x 
Body Surface Area (BSA) (See Section 6.1.14) 
x 
modified Nail Psoriasis Severity Index (mNAPSI) – for subjects with Nail psoriasis 
 
Following will be assessed by an independent assessor (See Section 6.1.15) 
x 
Tender and Swollen Joint Count – for subjects with PsA (See Section 6.1.17) 
x 
Physician Global Assessment of Disease Activity (PGA) – for subjects with PsA (See 
Section 6.1.18) 
The following procedures will be performed by an independent safety team: 
4. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
5. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10)   
6. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See Section 
5.11)  
7. The Subject’s diary provided at the previous visit will be collected and reviewed. 
8. The returned study drugs will be counted 
9. The use of concomitant medications since the previous study visit will be documented and 
assessed. (See Section 5.8) 
10. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be 
documented. Subjects must remain in a seated or supine position for at least 5 minutes before 
vital signs are obtained. (See Section 5.3)    
11. A blood sample(s) will be collected for Hematology and Chemistry (See Section 5.5) 
12. A blood sample will be collected within one hour before dosing for PK testing (See Section 6.2) 
13. Study drug administration in a clinic before 12 noon (See Section 8.5)  
14. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
  
x 
As available 
i. Lab results 
ii. Exam results 
The following procedures will be performed prior a subject discharged from a clinic: 

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15. The following will be dispensed during Visit 15:  
x 
UPT to be performed at home at week 24 – for female Subjects of childbearing 
potential (see section 5.4) 
x 
The study drug assembled for Visit 15 
x 
A diary card with instructions and to record the study drug use, health changes and 
concomitant medication 
16. A general safety review before discharge 
17. 
 
 
 
18. A phone call will be scheduled at the study week 24 to collect information on the study drug use, 
UPT, health changes and concomitant medication. 
7.1.9 On-site Visit 16:  Visit (
) 
The following procedures will be performed at Visit 16: 
1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
2. Subject Reported Assessments will be collected for: 
x 
Dermatology Life Quality Index (DLQI) (See Section 6.1.1) 
x 
Psoriasis Symptoms and Signs Diary (PSSD) (See Section 6.1.2) 
x 
Patient Global Impression of Severity (PGIS) (See Section 6.1.3) 
x 
Patient Global Impression of Change (PGIC) (See Section 6.1.4) 
x 
Itch Numeric Rating Scale (itch NRS) (See Section 6.1.5) 
x 
Scalp Itch Numeric Rating Scale (scalp itch NRS) – for subjects with Scalp psoriasis (See 
Section 6.1.6) 
x 
Health Assessment Questionnaire  of disability (HAQ-DI) – for subjects with PsA (See 
Section 6.1.7) 
x 
Patient Global Assessment of Disease Activity (PtGA) – for subjects with PsA (See Section 
6.1.8) 
x 
Patient Assessment of Pain (PtA-P) – for subjects with PsA (See Section 6.1.9) 
3. Focused Area Assessments will be performed for: 
x 
Investigator’s Global Assessment  (IGA) (See Section 6.1.10) 
x 
Scalp Investigator’s Global Assessment  (Scalp IGA) – for  subjects with Scalp psoriasis 
(See Section 6.1.11) 
x 
Palmoplantar Physician Global Assessment (PPPGA) – for subjects with Palmoplantar 
Psoriasis (See Section 6.1.12) 
x 
Psoriasis Area Severity Index  (PASI) (See Section 6.1.13) 
x 
Body Surface Area (BSA) (See Section 6.1.14) 
x 
modified Nail Psoriasis Severity Index (mNAPSI) – for subjects with Nail psoriasis 
 
Following will be assessed by an independent assessor (See Section 6.1.15) 
x 
Tender and Swollen Joint Count – for subjects with PsA (See Section 6.1.17) 
x 
Physician Global Assessment of Disease Activity (PGA) – for subjects with PsA (See 
Section 6.1.18) 
 
The following procedures will be performed by an independent safety team: 
4. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
5. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10)   

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6. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See Section 
5.11)  
7. The Subject’s diary provided at the previous visit will be collected and reviewed. 
8. The returned study drugs will be counted 
9. The use of concomitant medications since the previous study visit will be documented and 
assessed. (See Section 5.8) 
10. A blood sample(s) will be collected for Hematology, Chemistry, and Coagulation profile (See 
Section 5.5) 
11. A blood sample will be collected for PD biomarkers sample (See Section 6.3) 
12. A blood sample will be collected within one hour before dosing for PK testing (See Section 6.2) 
13. A blood sample will be collected for C-reactive protein (CRP) – (See Section 5.5) 
14. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be documented. 
Subjects must remain in a seated or supine position for at least 5 minutes before vital signs are 
obtained. (See Section 5.3)    
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15. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
  
x 
As available  
i. Lab results 
ii. Exam results 
16. Study drug administration in a clinic before 12 noon (See Section 8.5) 
17. The following will be dispensed during Visit 16: 
x 
The study drug assembled for Visit 16  
x 
A diary card with instructions and to record the study drug use, health changes and 
concomitant medication 
18. A general safety review before discharge 
19. 
 
 
 
If Subject discontinue from the study drug dosing based on PASI response <75 (the visit is to be reported 
as End of Treatment) 
15. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
  
x 
As available  
i. Lab results 
ii. Exam results 
16. The following will be dispensed during Visit 16: 
a. A diary card with instructions and to record health changes and concomitant medication 
17. A general safety review before discharge 

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18. 
 
 
7.1.10 On-site Visit 17:  Visit (
 
The following procedures will be performed at Visit 17: 
1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
 
The following procedures will be performed by an independent safety team: 
2. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
3. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10)   
4. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See 
Section 5.11) 
5. The Subject’s diary provided at the previous visit will be collected and reviewed. 
6. The returned study drugs will be counted 
7. The use of concomitant medications since the previous study visit will be documented and 
assessed. (See Section 5.8) 
8. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be 
documented. Subjects must remain in a seated or supine position for at least 5 minutes before 
vital signs are obtained. (See Section 5.3)    
9. A blood sample will be collected for Hematology (See Section 5.5) 
10. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
  
x 
As available  
i. Lab results 
ii. Exam results 
The following procedures will be performed prior a subject discharged from a clinic: 
11. The following will be dispensed during Visit 17:  
x 
UPT to be performed at home at week 36 – for female Subjects of childbearing 
potential (see section 5.4) 
x 
The study drug assembled for Visit 17 
x 
A diary card with instructions and to record the study drug use, health changes and 
concomitant medication 
12. A general safety review before discharge 
13. 
 
 
 
14. A phone call will be scheduled at the study week 36 to collect information on the study drug use, 
UPT, health changes and concomitant medication. 
7.1.11 On-site Visit 18:  Visit (
) 
The following procedures will be performed at Visit 18: 

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1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
The following procedures will be performed by an independent safety team: 
2. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
3. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10)   
4. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See Section 
5.11) 
5. The Subject’s diary provided at the previous visit will be collected and reviewed. 
6. The returned study drugs will be counted 
7. The use of concomitant medications since the previous study visit will be documented and 
assessed. (See Section 5.8) 
8. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be documented. 
Subjects must remain in a seated or supine position for at least 5 minutes before vital signs are 
obtained. (See Section 5.3)    
9. A blood sample will be collected for Hematology (See Section 5.5) 
10. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
  
x 
As available  
i. Lab results 
ii. Exam results 
The following procedures will be performed prior a subject discharged from a clinic: 
11. The following will be dispensed during Visit 18:  
x 
2 UPT to be performed at home at weeks 44 and 48 – for female Subjects of childbearing 
potential (see section 5.4) 
x 
The study drug assembled for Visit 18 
x 
A diary card with instructions and to record the study drug use, health changes and 
concomitant medication 
12. A general safety review before discharge 
13. Visit 19 (Study Day 365 ± 3 Days; before 12 noon) will be scheduled and the Subject will be 
instructed to bring the Study Product (used, unused, and partially used packs) and Subject diary 
with him or her to this visit. 
14. Phone calls will be scheduled at the study weeks 44 and 48 to collect information on the study drug 
use, UPT, health changes and concomitant medication. 
7.1.12 On-site Visit 19: End of Treatment Visit (Week 52 / Day 365 ± 3 Days; before 12 noon)  
The visit 19 must be scheduled in a morning to allow the dosing before 12 noon.   
The following procedures will be performed at Visit 19: 
1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
2. Subject Reported Assessments will be collected for: 
x 
Dermatology Life Quality Index (DLQI) (See Section 6.1.1) 
x 
Psoriasis Symptoms and Signs Diary (PSSD) (See Section 6.1.2) 

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x 
Patient Global Impression of Severity (PGIS) (See Section 6.1.3) 
x 
Patient Global Impression of Change (PGIC) (See Section 6.1.4) 
x 
Itch Numeric Rating Scale (itch NRS) (See Section 6.1.5) 
x 
Scalp Itch Numeric Rating Scale (scalp itch NRS) – for subjects with Scalp psoriasis (See 
Section 6.1.6) 
x 
Health Assessment Questionnaire  of disability (HAQ-DI) – for subjects with PsA (See 
Section 6.1.7) 
x 
Patient Global Assessment of Disease Activity (PtGA) – for subjects with PsA (See Section 
6.1.8) 
x 
Patient Assessment of Pain (PtA-P) – for subjects with PsA (See Section 6.1.9) 
3. Focused Area Assessments will be performed for: 
x 
Investigator’s Global Assessment  (IGA) (See Section 6.1.10) 
x 
Scalp Investigator’s Global Assessment  (Scalp IGA) – for  subjects with Scalp psoriasis 
(See Section 6.1.11) 
x 
Palmoplantar Physician Global Assessment (PPPGA) – for subjects with Palmoplantar 
Psoriasis (See Section 6.1.12) 
x 
Psoriasis Area Severity Index  (PASI) (See Section 6.1.13) 
x 
Body Surface Area (BSA) (See Section 6.1.14) 
x 
modified Nail Psoriasis Severity Index (mNAPSI) – for subjects with Nail psoriasis 
 
Following will be assessed by an independent assessor (See Section 6.1.15) 
x 
Tender and Swollen Joint Count – for subjects with PsA (See Section 6.1.17) 
x 
Physician Global Assessment of Disease Activity (PGA) – for subjects with PsA (See 
Section 6.1.18) 
4. A whole body photography – for subjects consenting for photography (See Section 6.4) 
The following procedures will be performed by an independent safety team: 
5. A physical examination will be performed. At a minimum, the physical examination will include 
the following: height and weight, assessment of general appearance, comprehensive skin 
examination, HEENT, heart, lungs, musculoskeletal system, lymph nodes, neurological 
systems, abdomen, and extremities. (See Section 5.2) 
6. The Subject’s diary provided at the previous visit will be collected and reviewed. 
7. The returned study drugs will be counted 
8. The use of concomitant medications since the previous study visit will be documented and 
assessed. (See Section 5.8) 
9. A urinalysis dipstick will be performed and evaluated at a site (See Section 5.5) 
10. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be 
documented. Subjects must remain in a seated or supine position for at least 5 minutes before 
vital signs are obtained. (See Section 5.3) 
11. A blood sample(s) will be collected for Hematology, Lipid Profile, Chemistry, and Coagulation profile 
(See Section 5.5) 
12. A blood sample will be collected for PD biomarkers sample (See Section 6.3) 
13. A blood sample will be collected within one hour before dosing for PK testing (See Section 6.2) 
14. A blood sample will be collected for C-reactive protein (CRP) – (See Section 5.5) 
15. A 12-lead electrocardiogram (ECG) will be performed (See Section 5.12)   
16. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 

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17. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 
5.10)   
18. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See 
Section 5.11)  
19. A pulmonary function test will be performed or scheduled with an external expert (See Section 
5.6)   
20. An ophthalmologic examination including OCT will be performed or scheduled with an external 
expert (See Section 5.7) 
21. Study drug administration in a clinic before 12 noon (See Section 8.5)  
22. Independent Safety Assessor review:  
x 
Safety Lab Alerts 
x 
12-lead ECG 
x 
As available  
i. Lab results 
ii. Exam results 
The following procedures will be performed prior a subject discharged from a clinic: 
23. The following will be dispensed during Visit 19:  
x 
A diary card with instructions and to record health changes and concomitant 
medication 
24. A general safety review before discharge 
25. Visit 20 (Study Day 393 ± 3 Days) will be scheduled and the Subject will be instructed to bring 
the Subject diary with him or her to this visit.  
7.1.13 On-site Visit 20: Follow-up Visit (Week 56 / Day 393 ± 3 Days or 4 weeks after End of 
Treatment) 
The following procedures will be performed at Visit 20: 
1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
The following procedures will be performed by an independent safety team: 
2. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
3. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 5.10)   
4. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See Section 
5.11)  
5. The Subject’s diary provided at the previous visit will be collected and reviewed. 
6. The use of concomitant medications since the previous study visit will be documented and 
assessed. (See Section 5.8) 
7. A blood sample(s) will be collected, if needed for Hematology, Chemistry, and Coagulation profile 
that were abnormal and clinically significant at Visit 19 (EOT) (See Section 5.5) 
8. Vital signs (blood pressure, pulse, respiratory rate and oral body temperature) will be documented. 
Subjects must remain in a seated or supine position for at least 5 minutes before vital signs are 
obtained. (See Section 5.3) 
9. A 12-lead electrocardiogram (ECG) will be performed, if needed (See Section 5.12)   
10. Independent Safety Assessor review:  

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x 
If performed, 12-lead ECG   
x 
Safety Lab Alerts 
x 
As available  
i. Lab results 
ii. Exam results 
11. A general safety review before discharge  
  
 
 
 
 
 
 
 
7.1.15 Unscheduled Visits and Early Discontinuation Visit 
An Unscheduled Visit is allowed at any time, for any reason, if in the Principal Investigator’s opinion 
it is warranted. If the Unscheduled Visit is due to an AE, the Principal Investigator will determine 
whether additional visits are needed.  
If a Subject is discontinued from the study during an Unscheduled Visit, the Unscheduled Visit will 
be referred to as an Early Discontinuation Visit and all procedures scheduled for Early 
Discontinuation will be performed (additional procedures may be performed as needed): 
1. A urine pregnancy test will be conducted for all females of childbearing potential (see Section 5.4) 
The following procedures will be performed by an independent safety team: 
2. The use of concomitant medications since the previous study visit will be documented and 
assessed. (See Section 5.8) 
3. The occurrence of all AEs & AESIs will be assessed and documented following the procedures in 
Sections 5.9, 10.1, and 10.3. 
4. A query for PML (progressive multifocal leukoencephalopathy) will be performed (See Section 
5.10)   
5. A query for PRES (Posterior reversible encephalopathy syndrome) will be performed (See 
Section 5.11)  
6. Independent Safety Assessor review:  
x 
As available:  
i. Lab results 
ii. Exam results 
If the Unscheduled Visit is not an Early Discontinuation Visit (i.e., the Subject will continue to take 
part in the study), then all procedures scheduled for that Unscheduled Visit will be performed.   
If the Subject’s condition has worsened to the degree that it is unsafe for the Subject to continue in 
the study, the Subject may be discontinued from the study as treatment failure and a standard of 
care treatment may be advised at the Principal Investigator’s discretion.  
Subjects who are discontinued early from the study must attend the Follow-up visit 4 weeks after 
the date of Early Discontinuation.  

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For subjects requiring cardiac monitoring the Baseline visit must be scheduled in a morning to allow the 
dosing before 12 noon.   
 
 
 
 

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5. 
 
 
 
 
 
 
 
 
 
 
   
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 

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x 
 
  
 
 
  
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
   
 
 
  
 
 
 
 
 
 
 
 
 
 
  

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x 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
   
 
 
   
  
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 

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2. 
 
   
 
 
  
 
 
 
 
 
 
 
 
 
 
    
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 

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x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
  
 
  
 
 
 
 
 
 
 
  
 
 
 
 

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x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
 
  
 
 
 
  
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 

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.  
   
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
  
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
 
 
 
 
 
  
 
 

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. 
8 
INVESTIGATIONAL PRODUCT 
8.1 Description 
All study medications will be dispensed by and returned to a qualified dispenser designated by the 
Principal Investigator. The investigational product will be dispensed only from the institution(s) 
approved by an Institutional Review Board. 
The Investigational Product will be supplied by the Sponsor. The following treatments will be self-
administered or administered by the subject's caregiver during this study. 
Investigational 
Products: 
 
SCD-044 Tablets 
 (low dose)  
SCD-044 Tablets 
 (intermediate dose) 
SCD-044 Tablets 
 (high dose) 
SCD-044 Tablets 
 
 
Control: 
Placebo of SCD-044 product 

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8.2 Storage Conditions  
All study products should be stored in a limited access area, at 20°C to 25°C (68°F to 77°F); excursions 
permitted between 15°C and 30°C (59°F and 86°F). 
8.3 Packaging and Labeling  
In order to maintain the study blind the randomization schedule will be generated by a third party. 
Randomization will be performed according to a computer-generated randomization scheme.  Only one 
Subject number will be assigned to each Subject.  The Subject will maintain the same number 
throughout the study.  The Investigational Product will be identically labeled and packaged such that 
neither the Subject nor any Investigator can identify the treatment.  
 
 
 
 
 
 
Each bottle will be labeled with a two-part, double blind label and will display the following text:  "content 
statement, protocol number, subject number, instructions for use and storage, Sponsor's name, an 
investigational use statement and warnings: "Keep out of reach of children". Part 2 of the label will 
contain a sealed copy of the randomization scheme (as a scratch off portion of the product label).  
This label should be detached from the container prior to dispensing to the Subject and retained at 
the study site, to be opened in case of medical emergency only. Where possible, the Medical Monitor 
should be contacted before breaking the blind for any Subject. The Sponsor must be notified in the 
event the blind is broken. 
Details of the IMP packaging and labelling for the European region will be separately described in the 
IMP manual. 
8.4 Treatment Assignment  
The subject study identification number will correspond to a computer-generated randomization 
schedule assigning that number to one of the study treatment groups in Part I. The randomization 
scheme will be generated so that the placebo, low, intermediate, and high dose products are assigned 
 
. 
  
 
 
 
 
Randomization will be stratified by gender and prior biologic therapy for psoriasis. 
8.4.1 Randomization  
The subject numbers at the site will be assigned by an Interactive Response Technology (IRT) using 
global data across all sites and identification numbers available at a site. IRT randomization will be 
stratified by gender and prior biologic therapy for psoriasis. In Part II the study treatment may be 
reassigned according to the randomization scheme and based on the subject’s PASI score at Week 16 
(visit 10) 
). 
 
 
 
8.5 Administration of Investigational Product  
At study Visits 2 through 18, Investigational Product will be dispensed to randomized subjects along 
with a diary. Each subject will also receive written study instructions, which detail the proper 

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administration method of the Investigational Product and general study instructions.  
The study medication should be taken once daily, preferably at the same time each day before 12 noon 
with or without food. The doses should be taken with approximately 240 mL (8 oz.) of water. 
Investigational Product will be used for 365 consecutive days. 
Subjects will be required to use diaries to document the date and time of doses, any missed doses, 
and the occurrence of all adverse events. 
At each visit during the study, the Investigator or designee should review proper use of the 
Investigational Product. 
Missed doses: 
Subjects should be instructed that if they forget to take a dose, they can take the dose within 4 hours 
of the normal dosing time; otherwise they should take their next dose at the regular time on the following 
day. If the subject vomits the tablet, he/she should be instructed not to take another tablet on the same 
day, but to take the next dose at the regular time on the following day.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
8.6 Assessment of Compliance  
Compliance with scheduled use of Investigational Product will be determined from the subject’s diary. 
Subjects will be instructed to bring their daily diary and used and unused study drug containers at all 

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scheduled visits or Early Discontinuation Visit to allow for tablet count and compliance checks. Subjects 
will also be asked to record in a daily diary the date and time at which they took the study drug. In 
addition, subjects will be instructed to document all AEs on the diary.  
If the subject does not return the Diary, Subject-reported dosing compliance will be recorded in the 
source notes and will be used to derive compliance between those visits. 
For scheduled visits greater than 4 weeks apart, subjects will be called (at w24, w36, w44, w48) and 
asked about compliance with study drug. 
Starting with the first dose at Baseline, only the independent safety team should review compliance 
and dispensing/returning of diary and study drug use. 
8.7 Investigational Product Accountability  
It is the responsibility of the Principal Investigator to ensure that the current disposition of the 
Investigational Product is maintained at each study site where Investigational Product is inventoried 
and dispensed. When a drug shipment is received at a study site, the Principal Investigator or the 
Principal Investigator’s designee must inventory the drug and sign the receipt form provided with the 
shipment. The receipt form should be emailed as per instructions provided on the receipt.  A copy of 
the receipt should remain at the site. 
The Investigator will not supply study test articles to any person not enrolled in this study, or to any 
physician or scientist except those named as sub-Investigators. 
A Drug Accountability Log will assist study site staff in maintaining inventory records of study drug. 
Subjects must return used, partially used or unused Investigational Product so that any remaining drug 
supplies can be accounted for and noted in the Drug Accountability Log.  
A certified copy of the Drug Accountability Log will be collected by the study monitor at the conclusion 
of the study and the original should remain at the study site.  
8.8 Return of Clinical Supplies  
All used and unused containers of Investigational Product may be returned to the Drug Labeling, 
Packaging and Shipping Facility for destruction or be destructed at the site after study close-out and 
final drug accountability is reconciled.  
 
9. 
STATISTICAL METHODS  
9.1 
Scientific and Statistical Considerations of the Study Design 
 
 
  
 
9.1.1 
Rationale for the Selected Subject Population 
Randomization and re-randomization will be stratified by gender and prior biologic therapy for psoriasis. 
Approximately the same number of male and female subjects will be enrolled between treatment groups. 
A maximum of 
of randomized subjects may have prior exposure to biologics therapy for psoriasis. 
Approximately the same number of subjects who have prior exposure to biologics therapy for psoriasis 
will be enrolled between treatment groups.  
Subjects with conditions or treatments that may affect cardiovascular safety (e.g. heart rate less than 
 
, history of uveitis or history of pulmonary conditions such as active severe respiratory disease (e.g. 
COPD, tuberculosis or pulmonary fibrosis, severe asthma or asthma requiring regular treatment with 
oral steroids) will be excluded due to the known mechanism-based AEs within this class which may 
expose such subjects to unwarranted excess risk for a condition with available alternatives. 

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9.1.2 
Rationale for Dose Selection 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
9.1.4 
Rationale for the Use of Comparator 
A placebo control arm is included to demonstrate that the investigational products are active and as a 

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parameter that the study is sufficiently sensitive to detect differences between products.  
9.1.5 
Rationale for Study Endpoints 
The primary end-point will be the proportion of subjects with at least a 75% improvement in Psoriasis 
Area and Severity Index (PASI75) at Week 16. Duration of 16 Weeks is considered adequate to detect 
a clinically meaningful difference between placebo and active treatment and is consistent with previous 
studies in this indication. Proportion of subjects achieving Investigator’s Global Assessment (IGA) of 
“clear” or “almost clear” with at least a two-grade reduction from baseline to Week 16 will be a key 
secondary end-point. It is anticipated that only a limited proportion of randomized patients will meet 
baseline criteria for assessment of efficacy in scalp psoriasis, nail psoriasis, psoriatic arthritis and palmar 
plantar psoriasis. Hence assessments of efficacy in these subsets are designated as tertiary end-points. 
9.1.6 
Rationale for the Overall Study Design 
 
. The primary and key secondary endpoints are based on 
efficacy assessments at Week 16 (end of Part 1). The study involves evaluation of efficacy and safety 
over a longer duration of up to 52 weeks. This long term evaluation comprises Parts 2 and 3 of the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 

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9.3 
Blinding and Unblinding Procedures  
In order to maintain the study blind the randomization schedule will be generated by a third party. 
Randomization will be performed according to a computer-generated randomization scheme.  The 
placebo and tablets for all strengths of SCD-044 look alike which ensures blinding. The Investigational 
Product will be identically labeled and packaged such that neither the Subject nor any Investigator can 
identify the treatment. The Drug Labeling, Packaging and Shipping facility will hold the randomization 
code throughout the conduct of the study to minimize bias.  A sealed copy of the randomization scheme 
(as a scratch off portion of the product label attached to the drug accountability page) will be retained at 
the study site. In the event of an emergency, the Subject-specific treatment may be identified; however, 
every effort should be made to maintain the blind. Where possible, the Medical Monitor should be 

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contacted before breaking the blind for any subject. The Sponsor must be notified in the event the blind 
is broken. 
The treatment assignments will remain blinded until the final database is closed. 
The following safety professionals will be allowed to be unblinded as necessary on a case by case basis: 
 
 
 
 
  
 
 
If SUSAR requires unblinding by a Regulatory Agency, a designated member of the Sponsor’s safety 
team will be un-blinded on case-by-case basis by receiving the randomization directly from the study 
unblinded statistical consultant.  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
9.4 
Significance Level  
Tests for superiority over placebo for the primary and the key secondary endpoint will be conducted 
using a hierarchical closed testing step-down approach to preserve the overall Type I error rate of 
0.05. 
 
 
 

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9.5 
Datasets to be analyzed  
Three analysis populations will be used in the analysis of the clinical data: 
1. A Safety Population subject is any individual who was randomized into the study and dispensed 
study drug. 
2. The ITT Population includes all randomized subjects regardless of whether they received the 
investigational product.  
3. The Per Protocol (PP) Population includes all ITT subjects who meet all inclusion/exclusion criteria 
and have no protocol violations that affect proper administration of the treatment or accurate 
evaluation of its effectiveness. 
Additionally, the Screen Fail subjects will be summarized, including reasons for removal. 
9.6 
Demographics and Baseline/Randomization Characteristics   
Demographic and baseline/randomization characteristics will be summarized descriptively by treatment 
group for the ITT, PP, and Safety Populations.   
9.7 
Safety Assessment  
Safety Assessments will include vital signs, physical examination, adverse events (AEs), laboratory 
tests, ECG monitoring, pulmonary function tests, ophthalmologic exams. 
The safety of SCD-044 will be evaluated by:  
o 
Incidence, seriousness and severity of all adverse events 
o 
Shifts from baseline in hematology and laboratory tests 
o 
Incidence of AEs of special interest (AE-SI) 
o 
 
 
 
 
The extent of exposure will be summarized using descriptive statistics. No inferential analyses are 
planned. 
Incidence of all adverse events reported during the study will be summarized using the MedDRA 
dictionary by System Organ Class and Preferred Term, by treatment group, severity, and relationship to 
study drug.  
An AE is considered treatment emergent if it was not present prior to the first dose of treatment or, if it 
was present, it worsened in severity or treatment attribution. 
Safety analyses will be performed on the Safety Population. All safety data will be listed by treatment 
and subject in data listings. AEs will also be summarized by actual dose at time of onset of the AE to 
account for possible dose reductions over the course of the study. 
9.8 
Efficacy Assessment  
Primary endpoint:  
x 
Proportion of subjects with at least 75% improvement in PASI (PASI75) at Week 16 
Key Secondary endpoint: 
x 
Proportion of subjects achieving IGA of “clear” (0) or “almost clear” (1) with at least two-grade 
reduction from Baseline to Week 16 
Other Secondary endpoints: 
x 
Percent change from Baseline in mean PASI score at Weeks 12, 16, 20, 28 and 52 
x 
PASI75 response rate at Weeks 12, 20, 28, and 52  

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x 
PASI50, PASI90, and PASI100 response rate at Weeks 12, 16, 20, 28, and 52 
x 
Change from Baseline in PSSD score at Weeks 16, 20, 28, and 52 
x 
Change from Baseline in DLQI score at Weeks 16, 20, 28, and 52 
x 
Proportion of subjects with IGA score of “clear” or “almost clear” with at least two-grade reduction 
from baseline to Weeks 12, 20, 28, and 52 
x 
Time to achieve PASI75 response  
x 
Time to achieve IGA response of “clear” or “almost clear” with at least two-grade reduction from 
baseline 
x 
Change from baseline in BSA involvement at Weeks 12, 16, 20, 28, and 52 
x 
Change from baseline in PGIS at Weeks 16, 20, 28, and 52 
x 
Proportion of subjects with improvement in PGIC at Weeks 16, 20, 28, and 52 
x 
 
x 
 
  
x 
Steady state Ctrough concentrations of SCD-044 at the dose levels evaluated in the study population    
x 
Frequency, type, and severity of adverse events (AEs) 
Tertiary endpoints 
x 
Proportion of subjects with Scalp IGA “clear” or “almost clear” with at least two-grade reduction from 
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75% improvement from baseline in total fingernail mNAPSI at Weeks 16, 20, 28, and 52  
x 
Proportion of psoriatic arthritis subjects who achieve ACR20 response at Weeks 16, 28, and 52.  
x 
Proportion of subjects with PPPGA score of 0 or 1 at Weeks 16, 20, 28, and 52 among subjects with 
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Exploratory endpoints   
x 
 
 
 
 
 
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x 
Change from baseline in subject global assessment of PtA-P at Weeks 16, 28, and 52 among 
subjects with PsA at baseline 
x 
Level of lymphocyte sub-types and cytokines in blood/plasma/serum. 
Other exploratory analyses may be performed based on available data. The Intent-to-Treat Population 
(ITT) will be used for all efficacy analyses. 
Efficacy Analysis 
The primary and key secondary efficacy variables will be analyzed using a Cochran-Mantel-Haenszel 
(CMH) test, stratified by gender and prior biologic therapy (Yes/No), and using the Intent-to-Treat (ITT) 
Population. Additional details will be included in the SAP 
Tests for superiority over placebo for the primary and the key secondary endpoint will be conducted 
using a hierarchical closed testing step-down approach to preserve the overall Type I error rate of 0.05. 
 
 
 

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Sensitivity Analyses 
For sensitivity testing, the primary and key secondary endpoints analyses will also be performed using 
the per protocol (PP) population. 
Additional sensitivity analyses will be performed for the primary efficacy variable using the following 
populations: 
x 
The Intent-to-Treat (ITT) Population using Last-Observation-Carried-Forward imputation (LOCF) 
x 
The Per Protocol (PP) Population, using Observed Cases (OC) 
x 
The Intent-to-Treat (ITT) Population, active treatment worst case (ATWC), defined as all missing 
assessments in the placebo group defaulted to responder but missing assessments in active 
treatment arm defaulted to nonresponder. Full tipping point analysis methods will be discussed in 
the SAP. 
Subgroup analysis on the stratification factors gender and prior biologic therapy (yes/no) may be 
performed for the primary and key secondary endpoints.  
Tests for superiority over placebo for the primary and the key secondary endpoint will be conducted 
using a hierarchical closed testing step-down approach to preserve the overall Type I error rate of 0.05. 
 
 
 
 
Continuous secondary efficacy endpoints will be analyzed using a mixed model repeated measures 
procedure (MMRM) based on the ITT Population. The MMRM will include fixed effects for treatment, 
visit, treatment by visit interaction, gender, prior biologic therapy (yes/no), and Baseline value as a 
covariate. This MMRM approach will also be applied at the single time point of Week 16. All such 
analyses are considered supportive. Additional details of the statistical approach will be provided in the 
statistical analysis plan. 
 
 
 
 
 
 
 
 
 
 
 
 
  
Further details will be provided in the Statistical Analysis Plan (SAP). 
 
 
 
 
 
 
 
 
 
 
 
 

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Blood samples collected from subjects treated with SCD-044 will be assayed and the samples collected 
from placebo treated subjects will not be assayed. The bio-analyst will receive the subject IDs of the 
samples that needs to be analyzed.   
 
 
 
  
9.9 
Concomitant Medication 
The start and stop date of concomitant medication use during the study will be provided in the data 
listings in addition to the reason for the medication use.  
9.10 
Summary of Subjects who terminate prematurely 
Reasons for premature termination will be summarized by treatment group. 
9.11 
Pharmacokinetic parameters 
Concentrations of SCD-044 in plasma will be measured by the central laboratory using a fully validated 
analytical method. In addition, remnant plasma PK samples from the study may be used for exploratory 
metabolite profiling or to assess PK of metabolites. The approach to steady-state concentrations will be 
evaluated from the measurable pre-dose concentrations on the study weeks 16, 20, 28, and 52.  
Graphical presentations of mean results will use the scheduled times of sample collections. A complete 
listing of the scheduled and actual times of sample collections for each patient and the concentration 
reported for each collected sample will be provided. The PK data related to metabolites would be 
reported separately. 
Additional details of PK analysis will be included in the SAP.  
Analyses will be performed to evaluate relationship between SCD-044 plasma concentrations and PASI 
response, 
 and change in lymphocyte counts. 
Plasma concentrations from samples collected due to adverse events related to bradycardia will be 
tabulated. Other exploratory analyses may be performed based on available data. 
9.12 
Pharmacodynamic parameters 
Change from baseline and during the course of the study treatment will be evaluated for levels of ALC, 
lymphocyte sub-types and cytokines in blood/plasma. 
10. 
ADVERSE EVENTS  
10.1 
Reporting of Adverse Events  
Any untoward medical occurrence in a subject or clinical-trial subject administered a medicinal product 
and which does not necessarily have to have a causal relationship with this treatment. An AE can 

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therefore be any unfavorable and unintended sign, symptom, clinically significant abnormal laboratory 
finding or disease temporally associated with the use of a medicinal product, whether or not considered 
related to the medicinal product. 
Any AE associated with the use of a drug in humans, whether or not considered product-related, 
including the following: An AE occurring in the course of the use of a drug product in professional 
practice; an adverse event occurring from drug overdose whether accidental or intentional; an AE 
occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of 
expected pharmacological action. Reporting an adverse event does not necessarily reflect a conclusion 
that the product caused or contributed to the adverse event. 
All AEs, whether observed by an Investigator or Study coordinator or reported by the Subject, whether 
related to study drug or not related to study drug, shall be documented in the Subject records, together 
with details, i.e., date of onset, description of the AE, the duration and intensity of each episode, the 
action taken, the relationship to the Investigational Product and the degree of severity, the seriousness, 
date of resolution, and the outcome. 
 
 
.  SCD-044 also resulted in 
gastrointestinal adverse events like diarrhea, abdominal pain, flatulence, constipation and frequent 
bowel movements that did not need any corrective treatment or discontinuation of SCD-044 and 
resolved with continued administration of SCD-044.  
The Principal Investigator must strive to follow the subject until the AE has resolved, becomes clinically 
insignificant, is stabilized or the subject is lost to follow-up. The Principal Investigator must immediately 
report to the Contract Research Organization, by telephone and follow-up in writing, all study drug 
discontinuations due to adverse events.  
Assessment of Severity  
The intensity or severity of an AE is characterized as:  
x 
Mild: an AE that is easily tolerated  
x 
Moderate: an AE sufficiently discomforting to interfere with daily activity  
x 
Severe: an AE that prevents normal daily activities  
Relationship to Study Medication  
The relationship is characterized as:  
x 
Not Related: This applies to any AE that is clearly not related to use of the study drug.  
x 
Possible: This means the association of the AE with the study drug is unknown; however, 
a relationship between drug and event cannot be ruled out.  
x 
Probable: There is a reasonable temporal relationship between the use of the study drug 
and the AE. Based upon the Principal Investigator’s clinical experience, the association of 
the event with the study drug seems likely.  
x 
Definite: The AE occurs following the application of the study drug and it cannot be 
reasonably explained by any known characteristics of the Subject’s clinical state, 
environmental or toxic factors or other modes of therapy administered to the Subject. It 
disappears or decreases upon discontinuation of the study drug and reappears on a re-
challenge of the investigational product.  
10.2 
Pregnancy 
Female Subjects of childbearing potential must have been using and must agree to continue to use 
accepted methods of birth control, throughout the study.  
 

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For the purpose of this study, a female is considered of childbearing potential i.e. fertile following 
menarche and until becoming post-menopausal unless permanently sterile. The methods of permanent 
sterilization are hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A post-menopausal 
state is defined as no menses for 12 months without any other medical cause. A high follicle stimulating 
hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state 
in women not using hormonal contraception or hormonal replacement therapy. However in the absence 
of 12 months of amenorrhea, a single FSH measurement is in-sufficient [Per CTFG guidelines (Clinical 
Trials Facilitation and Coordination Group CTFG 21/09/2020 Version 1.1)] 
Women of childbearing potential, in addition to having a negative pregnancy test, must be willing to use 
a highly effective form (failure rate of less than 1% per year when used consistently and correctly) of 
birth control during the study from the day of the first dose administration to 30 days after the last 
administration of study drug (refer to section 5.4). 
A negative result of a pregnancy test having a minimum sensitivity of at least 50mIU/ml for hCG should 
be obtained from each applicable visit. Pregnancy testing will be performed at applicable study visits 
and the results of all pregnancy tests (positive or negative) will be documented. 
If following initiation of study treatment, it is subsequently discovered that a study Subject is pregnant 
or may have been pregnant at the time of Investigational Product exposure, the Investigational Product 
will be permanently discontinued. The Principal Investigator must immediately notify the CRO of this 
event. 
Protocol-required procedures for study discontinuation and follow-up must be performed on the 
Subject. Other appropriate pregnancy follow-up procedures should be considered if indicated. In 
addition, the Principal Investigator must report to the sponsor follow-up information regarding the 
course of the pregnancy, including perinatal and neonatal outcome. Infants should be followed for a 
minimum of eight weeks after birth.   
10.3 
Serious Adverse Events  
An Adverse Event or Suspected Adverse Reaction is considered ‘‘serious’’ if, in the view of either the 
Investigator or sponsor, it results in any of the following outcomes: 
x 
Death  
x 
A life threatening adverse event; (Note: the term “life-threatening” as used here refers to an 
event in which the Subject was at risk of death at the time of the event; it does not refer to an 
event which hypothetically might have caused death if it were more severe.)  
x 
In-Subject hospitalization or prolongation of existing hospitalization 
(A planned hospitalization for pre-existing condition, or a procedure required by the Clinical 
Investigation Plan, without a serious deterioration in health or if the hospitalization is clearly not 
associated with an AE (e.g., hospitalization due to social / logistic reason) are not to be 
considered as SAEs)  
x 
A persistent or significant disability/incapacity (substantial disruption of the ability to conduct 
normal life functions) 
x 
A congenital anomaly/birth defect 
x 
Any “other” important medical event  
Important medical events that may not result in death, be life-threatening or require hospitalization may 
be considered Serious Adverse Events when, based on appropriate medical judgment, they may 
jeopardize the Subject and may require medical or surgical intervention to prevent one of the outcomes 
listed in this definition.  
Regardless of the above, any additional adverse events, which the Principal Investigator considers 
significant, should be immediately reported to the Contract Research Organization. 
SAE reporting by the Investigator: 

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Any Serious Adverse Event (SAE), whether deemed drug-related or not, must be reported by the 
Investigator to the Contract Research Organization (CRO) within 24 hours after the Principal 
Investigator or Study Coordinator becomes aware of its occurrence.  The Principal Investigator or the 
Principal Investigator’s Designee must complete an SAE Form and email it to the CRO, along with the 
subject’s AEs, Medical History, and Concomitant Medications Log within 24 hours of notification of the 
event.   
The Principal Investigator or the Principal Investigator’s Designee must be prepared to supply the 
following information: 
a.  
Principal Investigator Name and Site Number 
b.  
Subject I.D. Number 
c.  
Subject initials and date of birth 
d.  
Subject Demographics 
e.  
Clinical Event 
1) Diagnoses and Description 
2) Date of onset 
3) Severity 
4) Treatment  
5) Medical records, hospitalization/discharge records 
6) Relationship to study drug 
7) Action taken regarding study drug  
f. 
If the AE was Fatal or Life-threatening  
1) Cause of death (whether or not the death was related to study drug) 
2) Autopsy findings (if available) 
3) Death Certificate 
The Principal Investigator must provide a follow-up written report within 5 calendar days of reporting 
the event to the CRO. The written report must contain a full description of the event and any sequelae. 
Subjects who have had an SAE must be followed clinically until all parameters (including laboratory) 
have either returned to normal or are stabilized. The Investigator must also report follow-up information 
if it becomes known to the Investigator. 
SAE reporting by the CRO: 
The CRO must notify the Taro Pharmaceuticals U.S.A, Inc.’s Study Manager and Sponsor Drug Safety 
Department within 24 hours of the initial notification of the event.  Documentation should be sent to 
Taro’s SAE Coordinator and Sponsor Drug Safety listed below:  
 
 
 
 
  
 
 
 
  
 
 
  
 
 
 
 
 
 
Taro Pharmaceuticals U.S.A, Inc.’s Study Manager and/or Sponsor Drug Safety Department must 
receive any follow-up within 24 hours of receipt by CRO.   

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10.4 
Suspected Unexpected Serious Adverse Reactions (SUSARs)  
An AE or Suspected Adverse Reaction is considered a SUSAR if it is serious, unexpected, and 
suspected. Prior to reporting to the applicable Regulatory Authorities, the Sponsor will evaluate the 
available evidence and to judge the likelihood that the drug actually caused the adverse event. The 
SUSAR must be reported to FDA within 15 days, or if fatal or life threatening, within 7 days, by the 
Sponsor. The Sponsor must report an adverse event as a suspected adverse reaction only if there is 
evidence to suggest a causal relationship between the drug and the adverse event. Additionally, 
potential Hy’s law cases will be reported as SUSARs.  
The Sponsor is responsible for reporting of suspected unexpected serious adverse reactions and 
notifying the relevant regulators (including the authorities in the EEA via EudraVigilance and the 
IRBs/IECs) and the Investigator sites within the specified timeframes of all SUSARs, as applicable per 
local requirements. 
The applicable Regulatory Authorities shall be notified by Sponsor Safety Physician of any SUSAR, as 
per local Regulatory Authorities guidelines and timeframe specified as per local regulation.  
All participating Investigators, EC/IRB and other stakeholders shall be notified of any SUSAR by CRO’s 
Medical Monitor as per local regulatory requirement. 
10.5 
Adverse Events of Special Interest  
Adverse events of special interest (AESI) should be reported by a site to the CRO using an SAE form 
within 24 hours of awareness. The CRO must notify the Taro Pharmaceuticals U.S.A, Inc.’s Study 
Manager and Sponsor Drug Safety within 24 hours of the initial notification of the event. 
10.6 
Post-study Events  
Any AE/SAE that occurs up until the follow-up visit, or if the follow-up visit does not occur within the 
defined time window, then 4 weeks post the end of treatment visit or 4 weeks post the last dose of 
study drug for subjects with early discontinuation, should be reported and included in the safety analysis 
of the study.  
Any AE/SAE which occurs past this date will be reported if it is considered related to study drug by the 
Investigator. 
11. 
ETHICS  
This study will be conducted in accordance with the ethical principles that have their origin in the current 
Declaration of Helsinki and will be consistent with International Conference on Harmonization Good 
Clinical Practice (ICH GCP) and applicable regulatory requirements (including EU CT Regulation 
536/2014). The study will be conducted in compliance with the protocol. 
The rights, safety and well-being of the study Subjects are the most important considerations and 
should prevail over interests of society and science. 
The Sponsor ensures that local regulatory requirements are met before the start of the study. The 
Sponsor (or a nominated designee) is responsible for the preparation, submission, and confirmation of 
receipt of any RA approvals required prior to release of IP for shipment to the site.   
11.1 
Informed Consent 
The Principal Investigator must ensure that subjects are clearly and fully informed about the purpose, 
potential risks and other critical issues regarding clinical studies in which they volunteer to participate. 
The principles of Informed Consent, according to applicable  Regulations and ICH GCP will be followed. 
Whenever applicable   copy of the proposed consent form must be submitted to the IRB, together with 
the protocol, for approval. Before study initiation, and wherever applicable, the Principal Investigator 
must have written and dated approval from the IRB for the protocol, consent form, subject recruitment 
materials and any other written information to be provided to Subjects. 
In the EU region, the Sponsor will submit the required study documents, including the informed consent 

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form, for Member State authorization through the Clinical Trials Information System (CTIS). 
The Principal Investigator will use the informed consent approved under Regulation (EU) No 536/2014 
of the European Parliament. The Principal Investigator must obtain fully informed consent per Chapter 
V (Protection of subjects and informed consent) defined in the European Union Regulation No. 
536/2014 on clinical trials on medicinal products for human use. 
Informed consent will be obtained from all subjects using the following procedure: Subjects must have 
provided IRB/Member State approved written informed consent. Prior to initiating screening for the 
study, Subjects will be given the approved ICF describing the study and any risks associated with 
participation. The subject will be allowed as much time as needed to read and understand the 
information presented in the consent form. Appropriate study personnel will be available to answer any 
questions the subject might have regarding the study or study-related procedures. If the Subject 
chooses to participate in the study, he or she will be asked to sign and date the consent form and will 
be provided with a copy for his or her records. The ICF must be signed by the Subject before any 
protocol assessments can be undertaken. Each Subject’s signed informed consent must be kept on 
file by the Principal Investigator. 
11.2 
Institutional Review Board  
Before study initiation, the Principal Investigator must have written and dated approval from the IRB for 
the protocol, consent form, subject recruitment materials and any other written information to be 
provided to Subjects.  
Any changes to the protocol as well as a change of the Principal Investigator, which is approved by the 
Sponsor, must also be approved by the site’s IRB and documentation of this approval provided to the 
Sponsor/designee. Records of the IRB review and approval of all documents pertaining to this study 
must be kept on file by the Principal Investigator and are subject to inspection during or after completion 
of the study.  All SAEs must also be reported to the IRB. 
Periodic status reports must be submitted to the IRB at least annually, as well as notification of 
completion of the study and a final report within one (1) month  of study completion or discontinuation 
or per the local ethics committee requirements. A copy of all reports submitted to the IRB must be sent 
to the Sponsor/designee. 
The Principal Investigator will ensure that an IRB that complies with the requirements set forth in 21 
CFR Part 56 will be responsible for the initial and continuing review and approval of the proposed 
clinical study. 
11.3 
Subject Confidentiality 
The investigator and the sponsor or its designee must adhere to applicable data protection laws and 
regulations. The investigator and the sponsor or its designee are responsible for ensuring that sensitive 
personal information is handled in accordance with local data protection laws (including, but not limited 
to, HIPAA and GDPR). Appropriate consent for collection, use, and disclosure and/or transfer (if 
applicable) of personal information must be obtained in accordance with local data protection laws. 
Participant names will not be supplied to the sponsor or its designee. Only the participant number will 
be recorded in the study database; if the participant's name appears on any other document (eg 
laboratory report), it must be obliterated on the copy of the document to be supplied to the sponsor or 
its designee. Study findings stored on a computer will be stored in accordance with appropriate 
technical and organizational measures as required by local data protection laws. 
 
The monitor(s), the auditor(s), IRB/IEC, and the regulatory authority (ies), will be granted direct access 
to the Subject’s original medical records for verification of the clinical trial procedures and/or data, 
without violating the confidentiality, to the extent permitted by the applicable laws and regulations and 
that by signing a written informed consent form, the Subject or the Subject’s legally acceptable 
representative is authorizing such access.  

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The identifying the Subject will be kept confidential and, to the extent permitted by the applicable laws 
and regulations, will not be made publicly available. If the results of the trial are published, the Subject’s 
identity will remain confidential. 
11.4 
Indemnity/Liability and Insurance 
The Sponsor ensures that suitable clinical study insurance coverage is in place prior to the start of the 
study. An insurance certificate is supplied to the CRO/Investigator as necessary. 
12. 
DOCUMENTATION  
12.1 
Site Regulatory Documents Required for Initiation  
The following documents will be received by the CRO prior to the initiation of the study:  
1. Completed and signed FDA Form 1572 
2. Current curricula vitae, signed and dated for the Principal Investigator and each Sub-Investigator 
named in the FDA Form 1572 (current within 2 years) 
3. Current medical licenses of the Principal Investigator and Sub-Investigators named in FDA Form 
1572 
4. Documentation of IRB approval of this study protocol, Principal Investigator and informed consent 
form 
5. Current IRB membership list or roster  
6. A copy of the protocol agreement page signed by the Principal Investigator  
7. Non-disclosure Agreements for the Principal Investigator and Sub-Investigators named in FDA 
Form 1572  
8. Financial Disclosure Statement for the Principal Investigator and each Sub-Investigator named in 
FDA Form 1572. 
9. Statement of Non-Debarment 
12.2 
Maintenance and Retention of Records  
It is the responsibility of the Principal Investigator to maintain a comprehensive and centralized filing 
system of all relevant documentation. 
Copies of all pertinent records will be retained by the Principal Investigator for at least two years 
following final approval of the drug and/or notification from the Sponsor. These regulatory documents 
should be retained for a longer period if required by local regulatory authorities. These records include 
documents pertaining to the receipt and return of drug supplies, IRB, informed consent, source 
documents. No documents shall be transferred from the site or destroyed without first notifying the 
Sponsor. If the Principal Investigator withdraws from the study, the records shall be transferred to a 
mutually agreed upon designee. Notice of such transfer will be given in writing to the Sponsor. 
The Principal Investigator is required to prepare and maintain adequate and accurate case histories 
designed to document all observations and other data pertinent to the investigation on each individual 
treated with the Investigational Product or entered as a control in the investigation.   
12.3 
Data Collection and Reporting  
Data for individual Subjects will be collected on source documents. The data management system will 
be Electronic Data Capture (EDC). The Investigator and his/her study site personnel will be responsible 
for transferring data to the electronic Case Report Forms (eCRFs). The Investigator is required to verify 
that all of the requested information is accurately recorded in the eCRFs. All information requested in 
the eCRFs needs to be supplied, including subject identification, date(s), assessment values, etc., and 
any omission or discrepancy will require explanation. All information on eCRFs must be traceable to 
source documents.  

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Source documents such as the clinic chart are to be maintained separately from the eCRF in order to 
allow data verification. Because of the potential for errors, inaccuracies and illegibility in transcribing 
data into eCRFs, originals of laboratory and other test results must be kept on file. Source documents 
and copies of test results must be available at all times for inspection by the study monitor. The following 
should also be available for review:  
1. Subject Screening Log – reflecting the reason any Subject screened for the study was found to be 
ineligible 
2. Delegation of Authority / Study Personnel Signature Log – all site personnel will be listed along with 
their responsibilities and signatures; to be maintained at the site throughout the study 
3. Monitoring Log – the date and purpose of all monitoring visits by the Sponsor/Designee will be 
documented 
4. Enrollment Log – documenting Subject initials and start and end dates for all Subjects enrolled 
5. Drug Inventory/Packing Slip – reflecting the total amount of drug shipped to the site and received 
and signed for by the Principal Investigator 
6. Drug Accountability Log – reflecting the total amount of Investigational Product dispensed to and 
returned by each Subject 
7. Informed Consent Form and Assent Form  – which must be available for each Subject and be 
verified for proper documentation 
The study monitor will be responsible for reviewing and verifying the data recorded in the eCRFs, 
utilizing the original source documentation and will query discrepant findings. The Investigator and 
study site personnel will be responsible for answering all queries. All queries issued by the data 
management personnel will be answered by site personnel and verified by the monitor. 
Electronically generated data like laboratory results, ECG results etc. could be directly integrated with 
or transferred to the clinical database. 
 
 
12.4 
Primary Source Documents  
The Principal Investigator must maintain primary source documents supporting significant data for each 
Subject’s medical notes. These documents, which are considered “source data”, should include 
documentation of:  
x 
Demographic information  
x 
Evidence supporting the diagnosis/condition for which the Subject is being studied  
x 
General information supporting the Subject’s participation in the study  
x 
General history and physical findings  
x 
Hospitalization or Emergency Room records (if applicable)  
x 
Each study visit by date, including any evaluations, relevant  findings/notes by the Principal 
Investigator(s), occurrence (or lack) of adverse events and changes in medication usage, 
including the date the study drug commenced and completed.  
x 
Any additional visits during the study  
x 
Any relevant  telephone conversations with the Subject regarding the study or possible adverse 
events  
x 
An original, signed informed consent form or assent form for study participation  
The Principal Investigator must also retain all Subject specific printouts/reports of tests/procedures 
performed as a requirement of the study.  
12.5 
Study Monitoring  
The study will be monitored by a representative of the Contract Research Organization to assess 
compliance with ICH-GCP and applicable regulations. The Principal Investigator will be visited by a 

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monitor prior to the study and at regular intervals during the course of the study. These visits are for 
the purposes of verifying adherence to the protocol. The investigators and institutions involved in the 
clinical trial are to permit clinical trial-related monitoring, including provision of direct access to source 
data and documents. 
The study monitor will review the informed consent/assent forms and verify eCRF entries by comparing 
them with the source documents (hospital/clinic/office records) that will be made available for this 
purpose. The monitor will review the maintenance of regulatory documentation and drug accountability. 
The monitor will review on a regular basis the progress of the study with the Principal Investigator and 
other site personnel.  
eCRF sections may be monitored during these visits. At the end of the study, a closeout monitoring 
visit will be performed. Monitoring visits will be arranged in advance at a mutually acceptable time with 
site personnel. Sufficient time must be allowed by the site personnel for the monitoring of eCRFs and 
relevant source documents. The Study Coordinator and/or Principal Investigator should be available to 
answer questions or resolve data clarifications. Adequate time and space for these visits should be 
made available by the Principal Investigator. 
12.6 
Data and Safety Monitoring Board  
An independent DSMB has been established for periodic review of safety data for this study. The 
composition and responsibilities of the DSMB are described in the DSMB Charter. The DSMB has 
access to study un-blinded data. In order not to disseminate the data, only the members of the DSMB 
and the un-blinded study statistician have access to these data. The results are sent confidentially to 
the DSMB by the statistician. Based on the accumulating data review the DSMB may recommend to the 
study team to modify or stop the trial early due to safety concerns. . 
Adverse event of special interest will be adjudicated by the DSMB periodically throughout the study. 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 

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12.7 
Audits and Inspections  
During the course of the study and/or after it has been completed, one or more site visits may be 
undertaken by auditors as authorized representatives of the Sponsor. The purpose of the audit is to 
determine whether or not the study is being conducted and monitored in compliance with the protocol, 
recognized GCP guidelines and all applicable regulations. 
Additionally, the study may be inspected by regulatory agencies. These inspections may take place at 
any time during the course of the study and/or after it has been completed. 
The investigators and institutions involved in the clinical trial are to permit clinical trial-related audits 
and regulatory inspections, including provision of direct access to source data and documents. 
THE INVESTIGATOR MUST NOTIFY THE CONTRACT RESEARCH ORGANIZATION and 
SPONSOR PROMPTLY OF ANY INSPECTIONS SCHEDULED BY REGULATORY AUTHORITIES, 
AND PROMPTLY FORWARD COPIES OF INSPECTION REPORTS TO THE SPONSOR. 
12.8 
Modifications to the Protocol  
The procedures defined in the protocol will be carefully reviewed to ensure that all parties involved with 
the study fully understand the protocol. In order to ensure the validity of the data, no violations from the 
protocol, with minimal exceptions, may be made unless the issue is broad enough to warrant revision 
of the protocol. Such revisions must be submitted to and have documented approval from the Sponsor 
and the IRB/regulatory agency, as applicable, prior to implementation.  
The only circumstance in which an amendment may be initiated without prior IRB approval is to 
eliminate apparent immediate hazards to a Subject or Subjects. However, the Principal Investigator 
must notify the Sponsor immediately and the IRB within 5 working days after implementation.  
All protocol violations will be reported on the protocol violation log and included in the study reports. A 
protocol violation is defined as any change, deviation, or departure from the study design or procedures 
of  research project that is NOT approved by the IRB prior to its initiation or implementation, OR 
deviation from standard operating procedures, Good Clinical Practices (GCPs), federal, state or local 
regulations. 
The sponsor will notify the authorities as applicable (in line with country/region requirements) about a 
serious breach of the regulations or of the version of the protocol applicable at the time of the breach. 
A ‘serious breach’ means a breach likely to affect to a significant degree the safety and rights of a 
participant or the reliability and robustness of the data generated in the clinical trial. 
12.9 
Completion of Study  
The Principal Investigator is required to sign the eCRFs and all other relevant data and records to the 
Contract Research Organization.  
The Principal Investigator is expected to submit a final report to the IRB and the Sponsor within one (1) 
month of study completion or discontinuation.   
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
Investigators, the IRBs/IECs, the regulatory authorities, and any Contract Research Organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable regulatory 
requirements. 
Study results reporting: 

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The Sponsor will provide Clinical Study Report (or its summary) to the regulatory agencies, as 
applicable, in timeframe in line with country requirements.  
For the EU countries: irrespective of the outcome of the clinical trial, the Sponsor will submit a summary 
of the intermediate results, as well final results of the clinical study to the relevant EU clinical study 
database (the Clinical Trials Information System [CTIS] database at https://euclinicaltrials.eu/home) in 
a timely manner. As appropriate, the final study results posting this will be accompanied by a summary 
written in a manner that is understandable to laypersons. 
12.10 Data Protection in the European Economic Area 
The Sponsor, as Data Controller, ensures that all processing activities involving personal data 
performed in the scope of this Study are compliant with, but not limited to, the requirements set by EU 
General Data Protection Regulation (GDPR 679/2016), its subsequent amendments and any additional 
national laws on Data Protection, recommendations, and guidelines as applicable 
 
The Sponsor will take adequate measures to comply with the applicable rules on the protection of 
personal data, specifically regarding the implementation of the organizational and technical 
arrangements aiming to avoid unauthorised access, disclosure, dissemination, alteration, or loss of 
information and processed personal data. Similarly, measures will be taken to implement and for 
ensuring confidentiality of records and personal data of subjects. 
 
In case of the occurrence of any data breach, the Sponsor will immediately apply relevant measures to 
mitigate the risks to data of subjects as appropriate in relation to the specific context of the data breach, 
taking into account its source, underlying intentions, possibilities of recovery etc. Any data breach 
presenting risks to the rights and freedoms of data of subjects will be reported to the relevant 
supervisory data protection authority within 72 hours of the Sponsor becoming aware of the data 
breach. 
 
 

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APPENDIX I: REVISION HISTORY 
Version #  
Affected Sections 
Final 1.0 (September 23, 2020) 
N/A (new not implemented) 
 
Final 2.0 (February 9, 2021) 
1. 
 
 
2. “List of Tables” was added after Table of Contents. 
3. Section 2 was updated to include “intermediate dose” in the secondary endpoint to evaluate the 
 response in non-responders at low dose and intermediate dose when switched to high 
dose of SCD-044 
4. Section 3 (Page 20) is revised to describe the scheme for re-randomization at Week 16 (i.e. at 
start of Part II). Briefly, subjects will be re-randomized based on PASI response as following: 
 
  
 
 
  
 
 
 
 
 
 
 
 
  
5. Section 3 (Study Overview Page 21): The flow diagram of study design in Section 3 is updated to 
illustrate the scheme of re-randomization 
6. Section 3 (Study Overview Page 22): In order to manage the challenges regarding study visits 
caused due to COVID-19 pandemic, study visits 15, 17 and 18 may be performed 
 
. 
 
 
 
8. Section 3.1 (Page 24):Schedule of Assessment is edited and updated for consistency and 
concurrence with the edits made in the text 
 
 
 
 
 
 
 
11. In Section 4.4, (Page 31), NSAIDS were added to prohibited medications within 24 hours before 
scheduled study visit. 
12. In Section 4.5 (Page 32), permitted medications #3 is added to provide clarification regarding 
provision for vaccination during participation in the study. 
 
 

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.  
 
 
 
 
 
 
 
   
15. 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
18. In Section 5.7 (Page 38), text is added to explicitly clarify that an ophthalmologist will perform 
comprehensive eye examination when any subject report visual disturbance during participation in 
the study 
19. Section 5.9 (Page 38) is revised and updated to clarify definition of an adverse event also include 
clinically significant abnormal lab values 
 
 
 
 
  
 
 
  
 
 
 
 
. 
24. Sections 6.1.13, 6.1.15, and 6.1.16: Table numbers 4, 5, 6, were added, respectively. 
 
 
. 
26. Sections 7.3, 7.4, 7.5, 7.6, 7.11, 7.12, 7.13, and 7.14 were updated to include the pre-dose 
pharmacokinetic sample and safety events that are to be reviewed 
 
 
27. In Sections 7.2, 7.7, 7.8, 7.9, 7.10, 7.15, 7.16, 7.17, 7.18, 7.19, 7.23 following information is added: 
will review the reports related to lab results and exam results, if 
available 
 
 
 
 

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.  
 
 
 
36. The scales of assessments in Appendices VIII, X, XI, and XIII were updated. 
37. References were rearranged and renumbered in order of appearance, and references #12 and #20 
were added. 
In addition, administrative and editorial changes have been made throughout the version 2 protocol to 
improvise readability and syntax. 
 
Final Version 3.0 (March 10, 2023) 
1. Title page: To enable CTR filing in the EU region EU CT number and UTN number are added on 
title page 
2. Contact list updated to reflect change in the team. 
3. List of abbreviation updated 
4. Details of “Start of the study” and definition of “End-of-study” are added in the synopsis and in 
Section 3. 
 
 
  
 
 
 
 
 
 
 
6. In section 1, added a foot-note to provide update regarding International Non-proprietary Name 
(INN) published in WHO’s INN Recommended list 
7. In Section 1, a brief summary is added to describe the un-met medical need  
 
 
 
  
 
 
 
10. The inclusion criterion #6 is updated to clarify subjects should not be hypersensitive to drug 
product or excipients  
11. In section 4.2, inclusion criteria #8 and section 5.4, are updated to align with the Protocol 
Clarification Letter 
 
12. In section 4.2, inclusion criteria #8 and #9, are updated to clarify the male subjects must use 
acceptable contraceptive methods from the day of 1st dose administration to at least 30 days after 
last administration. 
 
 
 
 
 
 

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21. The section 6.1.15 is updated to correct the typo in Table 5, score and description for pitting 
22. The Section 6.2 is updated to clarify pre-dose (trough) blood samples will be collected only at 
week 16, 20, 28 and 52. 
 
 
24. In Section 8.3 a statement is added to clarify the IMP packaging and labelling for the EU region 
will be described in the IMP manual 
 
 
 
 
 
  
 
 
30. The Section 11.4 is added and Section 10.4, Section 11, Section 11.2, Section 12.8 and Section 
12.9 are updated for compliance with the CTR requirements 
 
 
 
 
 
32. The Section 12.10 is added for compliance with the EU General Data Protection Regulation 
requirements  
 
 
 
 
Final Version 4.0 (April 10, 2023) 
 
 
 
2. Section 3: Covid-19 related information added to address possible deviations  
3. Editorial changes for consistency between Sections 3.1 and 7 
 
 
 
 
5. Other editorial changes through the document to maintain consistency between sections.  
 
 

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Final Version 4.1 (July 28, 2023) 
1. Protocol version 4.1, dated July 28, 2023, for study number SCD-044-19-14, is the region-specific 
version of protocol version 4.0, dated April 10, 2023. 
 
 
2. The title page is updated to include 
 the EU CT number (2023-506477-35-00) is 
corrected on the title page of the protocol to fulfill the requirements of the Clinical Trial Regulation 
(Regulation (EU) No 536/2014) 
3. In the title page, the contact details of the Sponsor and the 
 are updated on 
the title page. 
 
Final Version 4.2 (Dec 20, 2023) 
1. The study overview (Section 3.0) is updated to clarify 
 
  
2. A paragraph is added 
 to clarify the 
definitions of women of childbearing potential (WOCBP), fertile men, and post-menopausal state. 
3. The exclusion criterion #3 in the synopsis and section 4.3 is edited to provide further clarification. 
4. Section 9.1.1. is updated to clarify 
. 
5. Section 11.1 is updated to clarify the process of obtaining approval 
 
 
 
In addition, to maintain internal consistency, a few administrative and editorial changes have been made 
to sections 3.1, 3.2, 7.1 and 7.2 of version 4.2 protocol  
 

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APPENDIX II: BODY SURFACE AREA (BSA) 
To estimate the % BSA Affected, the Investigator should use the method of approximation: the patient’s 
palm surface of the hand (including fingers) represents approximately one percent of his/her BSA. 
Measurement of psoriasis body surface area involvement is estimated using the handprint method with the 
size of a subject’s handprint representing ~1% of body surface area involved. The total BSA = 100% with 
breakdown by body region as follows: head and neck = 10% (10 handprints), upper extremities = 20% (20 
handprints), trunk including axillae and groin = 30% (30 handprints), lower extremities including buttocks = 
40% (40 handprints). BSA assessments should be performed by the Investigator or a designee who is 
appropriately trained and experienced in the assessment of psoriasis patients. 
 
 
 
 

 
 
APPENDIX IV: DERMATOLOGY LIFE QUALITY INDEX (DLQI) EXAMPLE 
The aim of this questionnaire is to measure how much your skin problem has affected your life over the past 
week.  Please check ;one box for each question. 
 
1 
Over the last week, how itchy, sore, painful 
or stinging has your skin been? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
2 
Over the last week, how embarrassed or 
self-conscious have you been because of 
your skin? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
3 
Over the last week, how much has your skin 
interfered with you going shopping or 
looking after your home or garden? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
4 
Over the last week, how much has your skin 
influenced the clothes you wear? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
5 
Over the last week, how much has your skin 
affected any social or leisure activities? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
6 
Over the last week, how much has your skin 
made it difficult for you to do any sport? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
7 
Over the last week, has your skin prevented 
you from working or studying? 
Yes 
No 
 
 
 
Not relevant 
 
 
 
If "No", over the last week how much has 
your skin been a problem at work or 
studying? 
A lot 
A little 
Not at all 
 
 
 
 
 
8 
Over the last week, how much has your skin 
created problems with your partner or any 
of your close friends or relatives? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
9 
Over the last week, how much has your skin 
caused any sexual difficulties? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
10 Over the last week, how much of a problem 
has the treatment for your skin been, for 
example by making your home messy, or by 
taking up time? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 

 
 
APPENDIX V: PSORIASIS SYMPTOM AND SIGN DIARY (PSSD) EXAMPLE 
Please indicate how severe each of the following skin symptoms was in the past week. Please select only 
one number for each item on the 0 to 10 scale (0=Absent and 10= Worst imaginable). 
 
1. Rate the severity of itch in 
the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
2. Rate the severity of dryness 
in the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
3. Rate the severity of cracking 
in the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
4. Rate the severity of skin 
tightness in the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
5. Rate the severity of scaling 
(built-up of skin in the past 7 
days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
6. Rate the severity of shedding 
or flaking in the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
7. Rate the severity of redness 
in the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
8. Rate the severity of bleeding 
in the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
9. Rate the severity of burning 
in the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
10. Rate the severity of stinging 
in the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
11. Rate the severity of pain 
from your psoriasis lesion in 
the past 7 days 
0 
Absent 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
Worst  
imaginable 
 
 
To be completed by the clinic staff: 
 
PSSD Score:  _________ 
 
  
 

 
 
APPENDIX VI: PATIENT GLOBAL IMPRESSION OF SEVERITY (PGIS) EXAMPLE 
 
Please choose the response below that best describes the severity of your Psoriasis SYMPTOM / 
OVERALL STATUS over the 
 
 
 None  
 Mild  
 Moderate  
 Severe  
 
 
 
 

 
 
 
APPENDIX VII: PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC) EXAMPLE 
 
Please choose the response below that best describes the overall change in your psoriasis since 
you started taking the study medication: 
Please check ;one box only 
 
 
Much better 
 
 
A little better 
 
 
No Change 
 
 
A little worse 
 
 
Much Worse 
 
 
 

APPENDIX VIII: ITCH NUMERIC RATING SCALE (ITCH NRS) EXAMPLE
Please rate the itching severity due to your psoriasis by circling the number that best describes your worst 
level of itching in the 
.
For subjects with scalp psoriasis:
Please rate the itching severity of your scalp due to your psoriasis by circling the number that best 
describes your worst level of itching in the 
.

 
 
APPENDIX IX: HEALTH ASSESSMENT QUESTIONNAIRE OF DISABILITY (HAQ-DI) EXAMPLE 
 
Please check ;the box which best describes your abilities over the past week: 
 
 
DRESSING & GROOMING 
Are you able to:  
Without 
ANY 
difficulty 
With SOME 
difficulty 
with MUCH 
difficulty 
UNABLE 
to do 
Dress yourself, including shoelaces and 
buttons?  
Shampoo your hair? 
 
 
 
 
 
 
 
 
Check 
 if you usually need help from another person 
Check 
 if you usually use button hook, zipper pull, shoe horn, etc. 
ARISING 
Are you able to:  
Without 
ANY 
difficulty 
With SOME 
difficulty 
with MUCH 
difficulty 
UNABLE 
to do 
Stand up from a straight chair?  
Get in and out of bed? 
 
 
 
 
 
 
 
 
Check 
 if you usually need help from another person 
Check 
 if you usually use special or built up chair 
EATING 
Are you able to:  
Without 
ANY 
difficulty 
With SOME 
difficulty 
with MUCH 
difficulty 
UNABLE 
to do 
Cut your own meat?  
Lift a full cup or glass to your mouth?  
Open a new milk carton? 
 
 
 
 
 
 
 
 
 
 
 
 
Check 
 if you usually need help from another person 
Check 
 if you usually use built up or special utensils 
WALKING  
Are you able to:  
Without 
ANY 
difficulty 
With SOME 
difficulty 
with MUCH 
difficulty 
UNABLE 
to do 
Walk outdoors on flat ground?  
Climb up five steps? 
 
 
 
 
 
 
 
 

 
 
Check 
 if you usually need help from another person 
Check 
 if you usually use cane, walker, crutches, wheelchair 
HYGIENE  
Are you able to:  
Without 
ANY 
difficulty 
With SOME 
difficulty 
with MUCH 
difficulty 
UNABLE 
to do 
Wash and dry your body?  
Take a tub bath?  
Get on and off the toilet? 
 
 
 
 
 
 
 
 
 
 
 
 
Check 
 if you usually need help from another person 
Check 
 if you usually use bathtub bar, long-handled appliances in bathroom, raised toilet seat 
REACH  
Are you able to: 
Without 
ANY 
difficulty 
With SOME 
difficulty 
with MUCH 
difficulty 
UNABLE 
to do 
Reach and get down a 5 pound object (such as 
a bag of sugar) from above your head?  
Bend down to pick up clothing from the floor? 
 
 
 
 
 
 
 
 
Check 
 if you usually need help from another person 
Check 
 if you usually use long-handled appliances for reach 
GRIP 
Are you able to:  
Without 
ANY 
difficulty 
With SOME 
difficulty 
with MUCH 
difficulty 
UNABLE 
to do 
Open car doors?  
Open previously opened jars?  
Turn faucets on and off? 
 
 
 
 
 
 
 
 
 
 
 
 
Check 
 if you usually need help from another person 
Check 
 if you usually use jar opener for jars previously opened 
ACTIVITIES  
Are you able to:  
Without 
ANY 
difficulty 
With SOME 
difficulty 
with MUCH 
difficulty 
UNABLE 
to do 
Run errands and shop?  
 
 
 
 

 
 
Get in and out of a car?  
Do chores such as vacuuming or yard work? 
 
 
 
 
 
 
 
 
Check 
 if you usually need help from another person to do errands and chores 
 
To be completed by the clinic staff: 
 
HAQ-DI Score:  _________ 
 
 
HAQ-DI Scoring 
There are four possible responses for the Disability Index questions:  
 
If more than 2 of the categories, or 25%, are missing, the scale is not scored. 
There are 3 steps to scoring the HAQ: 
1. For each section the score given to that section is the worst score within the section, i.e. if one 
question is scored 1 and another 2, then the score for the section is 2. 
x Without ANY difficulty = 0 
x With SOME difficulty = 1  
x With MUCH difficulty = 2 
x UNABLE to do =3 
2. In addition, if an aide or device is used or if help is required from another individual, then the 
minimum score for that section is 2. If the section score is already 2 or more then no 
modification is made.  
x No assistance is needed, add ‘0’ 
x A special device is used by the patient in his/her usual activities, minimum score is ‘2’ 
x The patient usually needs help from another person, minimum score is ‘2’ 
x The patient usually needs BOTH a special device AND help from another person, the 
section score is ‘3’ 
3. Divide the final sum by the number of categories answered. The score for the disability index 
is the mean of the 8 category scores rounded to the nearest value. If 1 or 2 of the categories are 
missing, the sum of the categories is divided by the number of answered categories.  
Some patients may question whether their response should reflect a particularly good or bad time, 
which is out of the time frame requested, because they feel that their response may be missing those 
times when their functional ability changes. The study requires repeating the HAQ at specific and 
regular time intervals to examine patterns of function. Inquiring about these activities only when 
patients are feeling particularly good or bad would result in inaccurate and biased data. The score 
is not modified if they have difficulties sometimes or required help only occasionally.  
Addressing some scenarios which occasionally arise:  

 
 
• If an item does not apply to an individual, e.g., they do not shampoo their hair, take tub baths, or 
reach for a heavy object above their heads, then they should leave the item(s) blank since the 
purpose is to obtain data about what they can do. 
•If a patient uses adapted or modified aids or devices (e.g., clothing, faucets, cars), then they should 
answer the questions based on their usual equipment. If they have no difficulty using the adapted 
equipment, then they would mark the “no difficulty” column. The adapted equipment (aids and 
devices) will be taken into account in the assistance variables (see below).  
• If an individual can open their own door but not for others, then they should respond in 
consideration of their own requirements.  
 

 
 
APPENDIX X: PATIENT GLOBAL ASSESSMENT OF DISEASE ACTIVITY (PtGA) EXAMPLE 
 
 
Note: please ensure that the line is 100 mm in length after printing the source document and 
measuring the distance 
 
 
Considering all the ways your arthritis affects you, how are you feeling TODAY?” Please 
answer by placing a mark on the line below: 
 
 
 
                  0 
Very Good 
                               100 
Very Poor  
 
 
 
To be completed by the clinic staff:  
 
VAS Score: ______ / 100  
 
 
 

APPENDIX XI: PATIENT ASSESSMENT OF PAIN (PtA-P) EXAMPLE
Note: please ensure that the line is 100 mm in length after printing the source document and 
measuring the distance
How much pain due to your arthritis are you currently experiencing?
Please rate you pain by placing a mark on the line corresponding to your CURRENT level of pain.
No Pain
Worst pain imaginable
               
      0
                       
                       100
       
To be completed by the clinic staff:  
VAS Pain: ______ / 100

 
 
  
APPENDIX XIII: PHYSICIAN’S GLOBAL ASSESSMENT OF DISEASE ACTIVITY (PGA) EXAMPLE 
 
 
Note: please ensure that the line is 100 mm in length after printing the source document and 
measuring the distance 
 
How do you assess your patient’s current arthritis? 
 
 
 
               0 
                       100 
       No Disease Activity 
 
 
 
 
      Maximum Disease Activity 
  
 
 
To be completed by the clinic staff:  
 
VAS Score: ______ / 100