Conditions: Psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 426
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with moderate-to-severe plaque psoriasis.

Detailed description:
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 in subjects with moderate-to-severe plaque psoriasis. Study subjects will be enrolled at approximately 75 sites in the United States (US).

Approximately 400 subjects who meet the study entry criteria will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms:

1. PPC-06 400 mg once daily (QD)
2. PPC-06 400 mg BID
3. PPC-06 600 mg BID
4. Placebo BID The maximum study duration for each subject will be approximately 29 weeks.

Arms:
arm 1: Tepilamide Fumarate 400 mg once per day arm 2: Tepilamide Fumarate 400 mg twice per day arm 3: Tepilamide Fumarate 600 mg twice per day arm 4: White placebo tablet to mimic Tepilamide Fumarate

Interventions: intervention 1: PPC-06 400 mg QD intervention 2: PPC-06 400 mg BID intervention 3: PPC-06 600 mg intervention 4: Placebo
Intervention descriptions: intervention 1: Tepilamide Fumarate 400 mg tablet once per day intervention 2: Tepilamide Fumarate tablets 400 mg twice per day intervention 3: Tepilamide Fumarate tablets 600 mg twice per day intervention 4: white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets

Protocol document:
Prot_000.pdf: 
Dr. Reddy’s Laboratories, SA 
PPC-06-CD-004 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, 
Multicenter, 24-Week Study to Assess the Efficacy and 
Safety of PPC-06 (Tepilamide Fumarate) Extended 
Release Tablets in Subjects with Moderate-to-Severe 
Plaque Psoriasis (AFFIRM Study) 
Drug Name/Dosage: 
PPC-06/400 mg QD, 400 mg BID, 600 mg BID 
Protocol No: 
PPC-06-CD-004 
IND No: 
120973 
Development Phase: 
2 
Document Status, Date: 
26 October 2018 
Document Version: 
Previous Version: 
V3.0, Amendment 2 
V2.0, Amendment 1, 30 May 2018 
Original Protocol 25 October 2017 
Sponsor: 
Dr Reddy’s Laboratories, SA 
Elisabethenanlage 11 
CH-4051 Basel 
Switzerland 
Sponsor Agent: 
Dr Reddy’s Laboratories, Inc. 
107 College Road East 
Princeton, NJ 08540 
Property of Dr. Reddy’s Laboratories, SA 
Confidential 
The confidential information provided in this document is for use by parties directly involved in this 
investigation. By accepting this document, you agree that the information contained herein will not be 
disclosed to any person not directly involved in this investigation without written authorization from 
Dr. Reddy’s Laboratories, SA  




Dr. Reddy’s Laboratories, SA 
Amendment 2  
Clinical Study Protocol 
PPC-06-CD-004 
26 October 2018 
- 3 - 
SIGNATURE PAGE FOR INVESTIGATOR(S) 
Product: 
PPC-06 (Tepilamide Fumarate) Extended Release Tablets 
Protocol Number: 
PPC-06-CD-004 
Protocol Title: 
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 
24-Week Study to Assess the Efficacy and Safety of PPC-06 
(Tepilamide Fumarate) Extended Release Tablets in Subjects with 
Moderate-to-Severe Plaque Psoriasis 
The signature of the study investigator below constitutes his/her approval of this protocol and 
provides the necessary assurances that this study will be conducted according to all 
stipulations, clinically and administratively, as detailed in the protocol. It is agreed that the 
conduct and results of this study will be kept confidential.  
COMPLIANCE STATEMENT 
The study will be carried out in accordance with Good Clinical Practice (GCP) as required by 
the United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 
(45 CFR Part 46; 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312) and ICH E6; 62 
Federal Register 25691 (1997). 
SIGNATURES 
The signatures below provide the necessary assurances that this trial will be conducted 
according to all stipulations of the protocol, including all statements regarding 
confidentiality, and according to local legal and regulatory requirements and applicable 
US federal regulations and ICH guidelines. 
Principal Investigator’s printed name 
Principal Investigator’s signature 
Date 


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TABLE OF CONTENTS 
TABLE OF CONTENTS ..............................................................................................................4 
LIST OF TABLES .........................................................................................................................7 
LIST OF FIGURES .......................................................................................................................8 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ...............................................9 
1.
SYNOPSIS ..........................................................................................................................12
2.
INTRODUCTION ..............................................................................................................21
2.1 
Plaque Psoriasis ........................................................................................................21 
2.2 
Fumaric Acid Esters .................................................................................................22 
2.3 
Investigational Product .............................................................................................22 
2.4 
Rationale of the Study ..............................................................................................23 
3.
TRIAL OBJECTIVES AND PURPOSE ..........................................................................24
4.
STUDY DESIGN ................................................................................................................24
4.1 
Overall Study Design ...............................................................................................24 
4.2 
Study Endpoints .......................................................................................................26 
4.2.1 
Efficacy Endpoints .......................................................................................26 
4.2.2 
Health Outcome/Quality of Life Endpoints .................................................27 
4.2.3 
Safety Endpoints ..........................................................................................27 
5.
SELECTION OF STUDY POPULATION ......................................................................27
5.1 
Subject Population ....................................................................................................27 
5.2 
Inclusion Criteria ......................................................................................................28 
5.3 
Exclusion Criteria .....................................................................................................29 
5.4 
Discontinuation of Treatment or Assessments .........................................................31 
5.5 
Dietary and Lifestyle Restrictions ............................................................................33 
6.
STUDY TREATMENTS ...................................................................................................33
6.1 
Investigational Products and Controls ......................................................................33 
6.2 
Dosing Regimen .......................................................................................................33 
6.3 
Dose Modification ....................................................................................................36 
6.4 
Packaging and Labeling ...........................................................................................36 
6.5 
Storage ......................................................................................................................36 
6.6 
Assignment to Treatment .........................................................................................37 
6.6.1 
Randomization .............................................................................................37 


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6.6.2 
Blinding ........................................................................................................37 
6.7 
Prior and Concomitant Therapy ...............................................................................38 
6.8 
Treatment Compliance .............................................................................................39 
7. 
VISIT SCHEDULE AND ASSESSMENTS .....................................................................40 
7.1 
Study Procedures ......................................................................................................40 
7.2 
Study Visits and Assessments ..................................................................................40 
7.2.1 
Visit 1 Screening (Day -28 to Day -1) .........................................................40 
7.2.2 
Visit 2 – Randomization/Baseline (Day 0) ..................................................41 
7.2.3 
Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 
16), Visit 7 (Week 20), and Visit 8 (Week 24) ............................................42 
7.2.4 
Early Termination Visit ................................................................................43 
7.2.5 
Safety Follow-up Visit (Week 25 [+3 days], or 1 Week [+3 days] after 
ETV, unless final dose was taken >7 days prior to Week 24/ETV) .............44 
7.2.6 
Unscheduled Visit ........................................................................................44 
7.3 
Efficacy Assessments ...............................................................................................44 
7.3.1 
Co-Primary Efficacy Assessments: Psoriasis Area and Severity Index 
and Investigator’s Global Assessment .........................................................45 
7.3.2 
Secondary Efficacy Assessments .................................................................46 
7.3.2.1 
Affected Body Surface Area ............................................................46 
7.3.2.2 
Nail Psoriasis Severity Index ..........................................................46 
7.3.2.3 
Psoriasis Scalp Severity Index ........................................................46 
7.3.2.4 
Palmoplantar Psoriasis Physician’s Global Assessment (PP 
PGA) ................................................................................................47 
7.3.2.5 
Pruritus Numerical Rating System ..................................................47 
7.3.3 
Health-related Quality of Life Assessments .................................................47 
7.3.3.1 
Dermatology Life Quality Index......................................................47 
7.3.3.2 
12-Item Short Form Survey .............................................................47 
7.3.3.3 
Quick Inventory of Depressive Symptomatology-Self Report (16 
Items) ...............................................................................................47 
7.3.3.4 
Work Productivity and Activity Impairment Questionnaire: 
Psoriasis ..........................................................................................47 
7.3.3.5 
Health Economics and Outcomes Research ...................................47 
7.4 
Assessment of Pharmacokinetics .............................................................................48 
7.5 
Assessment of Safety ...............................................................................................48 
7.5.1 
Adverse Events .............................................................................................48 
7.5.1.1 
Adverse Events Assessments ...........................................................48 
7.5.1.2 
Timing .............................................................................................49 
7.5.1.3 
Severity of Adverse Events ..............................................................50 


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7.5.1.4 
Relationship of an Adverse Event to Study Treatment ....................51 
7.5.1.5 
Adverse Event of Special Interest (AESI) ........................................51 
7.5.2 
Serious Adverse Event .................................................................................52 
7.5.3 
Safety Laboratory Assessments ...................................................................53 
7.5.4 
Pregnancy Testing ........................................................................................54 
7.5.5 
Vital Signs ....................................................................................................55 
7.5.6 
Physical Examination ...................................................................................55 
7.5.7 
Electrocardiogram ........................................................................................55 
7.6 
Appropriateness of Measurements ...........................................................................55 
8. 
STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE 
STATISTICAL AND ANALYTICAL PLANS ...............................................................55 
8.1 
General Considerations for Data Analysis ...............................................................55 
8.2 
Sample Size and Power Considerations ...................................................................56 
8.3 
Analysis Populations ................................................................................................56 
8.4 
Background and Demographic Characteristics ........................................................57 
8.5 
Study Medication/Visit Compliance ........................................................................57 
8.6 
Prior and Concomitant Therapy ...............................................................................58 
8.7 
Analysis of Efficacy .................................................................................................58 
8.7.1 
Co-Primary Efficacy Endpoint(s) .................................................................58 
8.7.2 
Secondary Efficacy Endpoints .....................................................................58 
8.7.3 
Handling of Missing Values/Censoring/Discontinuations ...........................59 
8.7.4 
Control of Multiplicity .................................................................................61 
8.8 
Analysis of Safety ....................................................................................................61 
8.8.1 
Adverse events .............................................................................................61 
8.8.2 
Laboratory Evaluations ................................................................................61 
8.8.3 
Vital Signs ....................................................................................................61 
8.8.4 
Cardiac Assessments ....................................................................................62 
8.8.5 
Other Safety Assessments ............................................................................62 
8.9 
Futility Analysis .......................................................................................................62 
8.10 
Protocol Deviations and Violations ..........................................................................62 
9. 
CHANGES IN THE PLANNED STUDY ........................................................................62 
9.1 
Protocol Amendments ..............................................................................................62 
9.2 
Termination or Suspension of the Study ..................................................................63 
10. 
DATA HANDLING AND RECORD KEEPING ............................................................63 
10.1 
Recording of Data ....................................................................................................63 


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10.1.1 
Source Documents ........................................................................................63 
10.1.2 
Case Report Forms .......................................................................................63 
10.2 
Retention of Documents ...........................................................................................64 
11. 
QUALITY CONTROL AND QUALITY ASSURANCE ...............................................64 
11.1 
Direct Access to Source Documents ........................................................................64 
11.2 
Monitoring Procedures .............................................................................................65 
11.3 
Audit and Inspection ................................................................................................65 
12. 
ETHICS ...............................................................................................................................65 
12.1 
Ethical Conduct of the Study ...................................................................................65 
12.2 
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) ...........65 
12.3 
Subject Information and Consent .............................................................................65 
12.4 
Disclosure and Confidentiality .................................................................................65 
12.4.1 
Confidentiality of Study Documentation .....................................................65 
12.4.2 
Privacy of Individual Health Information ....................................................66 
13. 
EMERGENCY PROCEDURES .......................................................................................66 
13.1 
Emergency Unblinding ............................................................................................66 
13.2 
Reporting of Serious Adverse Events and Pregnancies ...........................................66 
13.2.1 
Contact Person(s) and Number(s) ................................................................66 
13.2.2 
Reporting Procedures ...................................................................................67 
Serious Adverse Events ........................................................................................................67 
14. 
PUBLICATION POLICY .................................................................................................67 
15. 
REFERENCE LIST ...........................................................................................................68 
16. 
APPENDICES ....................................................................................................................71 
 
LIST OF TABLES 
Table 1-1 Visit Schedule and Assessments .................................................................................18 
Table 6-1 Treatment Schedule - Titration Period (Weeks 1-5) ...................................................35 
Table 6-2 Titration Regimen .......................................................................................................35 
Table 6-3 Treatment Schedule: Treatment Period (Weeks 6-24) ...............................................35 
Table 7-1 Investigator’s Global Assessment (IGA) ....................................................................46 
Table 7-2 Routine Clinical Laboratory Assessments ..................................................................54 
 


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LIST OF FIGURES 
Figure 4-1 Study Design ...............................................................................................................26 
 
 


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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation 
Definition 
AE 
Adverse event 
ALT  
Alanine transaminase 
ANOVA 
Analysis of variance 
ANCOVA 
Analysis of covariance 
Anti-HBc 
Antibody to hepatitis B virus core antigen 
AST 
Aspartate transaminase 
ATC 
Anatomical Therapeutic Chemical Classification System 
BDM 
Biostatistics and Data Management Group 
BID 
Twice a day 
BMI 
Body mass index 
BSA 
Body surface area 
BUN 
Blood urea nitrogen 
CRO 
Contract Research Organization 
CXR 
Chest x-ray 
DLQI 
Dermatology Life Quality Index 
DSM-5 
Diagnostic and Statistical Manual of Mental Disorders (version 5) 
DMF 
Dimethyl fumarate 
ECG 
Electrocardiogram 
eCOA 
Electronic Clinical Outcome Assessments 
eCRF 
Electronic Case Report Form 
EOS 
End of study 
ER 
Extended release 
ETV 
Early termination visit 
EU 
European Union 
FAE 
Fumaric acid ester 
FAS 
Full analysis set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GGT 
Gamma glutamyl transferase 
GI 
Gastrointestinal 
GMP 
Good Manufacturing Practice 
HBc 
Hepatitis B virus core antigen 
HbsAg 
Surface antigen of the hepatitis B virus 
HCP 
Healthcare professional 
HCV 
Hepatitis C virus 
HDL 
High density lipoprotein 


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Abbreviation 
Definition 
HEOR 
Health Economics and Outcomes Research 
HIV 
Human immunodeficiency virus 
hsCRP 
High-sensitivity C reactive protein 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IP 
Investigational product 
IGA 
Investigator’s Global Assessment 
IRB 
Institutional Review Board 
IL2 
InfoLink2 
IXRS 
Interactive voice and web response system 
LDH 
Lactate dehydrogenase 
LDL 
Low density lipoprotein 
LLN 
Lower limit of normal 
LOCF 
Last observation carried forward 
MCH 
Mean corpuscular hemoglobin 
MCHC 
Mean corpuscular hemoglobin concentration 
MCMC 
Markov Chain Monte Carlo method 
MCV 
Mean corpuscular volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
MEF 
Monoethyl fumarate 
MI 
Multiple imputation 
MMF 
Monomethyl fumarate 
MMRM 
Mixed model for repeated measures 
mNRI 
Modified non-responder imputation 
MTX 
Methotrexate 
NAPSI 
Nail Psoriasis Severity Index 
NRS 
Numeric rating scale 
OC 
Observed-cases 
OTC 
Over-the-counter 
PASI 
Psoriasis Area and Severity Index   
PASI-50 
At least 50% reduction in PASI score 
PASI-75 
At least 75% reduction in PASI score 
PD 
Pharmacodynamic(s)  
PDS 
Protocol deviation specification  
PGA 
Physician’s Global Assessment 
PML 
Progressive multifocal leukoencephalopathy 


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Abbreviation 
Definition 
PP 
Per protocol 
PP PGA 
Palmoplantar Psoriasis Physician’s Global Assessment 
PSSI 
Psoriasis Scalp Score Index 
PT 
Preferred Term 
PUVA 
Psoralen and ultraviolet A 
QD 
Once daily 
QIDS-SR16 
Quick Inventory of Depressive Symptomatology-Self Report (16 Items) 
QoL 
Quality of Life 
RBC 
Red blood cell 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SF-12 
12-item Short Form Survey 
SOC 
System Organ Class 
sPGA 
Static physician’s global assessment 
SUSAR 
Suspected unexpected serious adverse reaction 
TB 
Tuberculosis 
TEAE 
Treatment-emergent adverse event 
ULN 
Upper limit of normal 
UPT 
Urine pregnancy test 
US  
United States 
UV 
Ultraviolet 
VAS 
Visual analog scale 
WBC 
White blood cell 
WNL 
Within normal limits 
WPAI:PSO 
Work Productivity and Activity Impairment Questionnaire: Psoriasis 
 


Dr. Reddy’s Laboratories, SA  
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1. 
SYNOPSIS 
Study Title: 
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 24-Week 
Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate) 
Extended Release Tablets in Subjects with Moderate-to-Severe Plaque 
Psoriasis 
Protocol Number: 
PPC-06-CD-004 
Sponsor:  
Dr. Reddy’s Laboratories, SA 
Development Phase: 
2 
Study Objectives: 
Co-primary objectives: 
1. To demonstrate the efficacy of PPC-06 with respect to Psoriasis Area and 
Severity Index (PASI) for the treatment of moderate-to-severe plaque 
psoriasis, as compared to placebo at 24 weeks 
2. To demonstrate the efficacy of PPC-06 with respect to Investigator’s 
Global Assessment (IGA) at 24 weeks 
Secondary objectives: 
1. To assess the efficacy of PPC-06 as it relates to psoriasis-related 
symptoms and health-related quality of life (QoL) measures 
2. To assess the safety and tolerability of PPC-06 in subjects with moderate-
to-severe plaque psoriasis 
3. To evaluate the pharmacodynamics (PD) of PPC-06 through 
immunological analysis of peripheral blood samples. 
Study Design: 
This is a randomized, double-blind, placebo-controlled, multicenter study 
designed to assess the safety and efficacy of PPC-06 (tepilamide fumarate) 
extended release [ER] tablets in subjects with moderate-to-severe plaque 
psoriasis. Study subjects will be enrolled at approximately 75 sites in the 
United States (US). The study will be comprised of 4 study periods: 1) 
Screening Period, 2) Double-Blind Titration Period, 3) Double-Blind 
Treatment Period, and 4) Post-treatment Follow-Up Period.  
Following completion of the pre-randomization Screening Period (up to 4 
weeks), approximately 400 eligible subjects will be randomly assigned in a 
1:1:1:1 ratio to one of the 4 arms (PPC-06 400 mg QD, PPC-06 400 mg BID, 
PPC-06 600 mg BID, or placebo BID) and the subjects will enter the 5-week 
Double-Blind Titration Period. At Visit 3 (Week 4), the subjects will continue 
1 more week of titration dose (Week 5 of blister wallets) and will also be given 
a kit of bottles which will allow dosing until Visit 4 (Week 8). 
Subjects will receive double-blind treatment from Week 6 through Week 24. 
Subjects will return to the clinic every 4 weeks (±3 days) thereafter, until 
Week 24, for drug accountability and to undergo safety and efficacy 
evaluations.  Subjects will return at Week 25 for an End of Study (EOS) Safety 
Follow-Up Visit. There are 9 expected visits total per subject. 
Blood samples for pharmacodynamics (PD) assessments will be collected at 
Baseline and at Weeks 4, 8, 12, 16, 20, and 24. PD assessments will be 
conducted for all subjects, with the intent of evaluating psoriasis-associated 
inflammatory markers. Details of PD assessment will be provided in a separate 
protocol. 
The Early Termination Visit (ETV) will be scheduled if the study drug is 
permanently discontinued for any reason (for example: due to meeting the 
protocol-mandated safety monitoring criteria or unresolved gastrointestinal 
[GI]-related intolerability).  


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The EOS Safety Follow-up Period will consist of 1 visit 1-week (± 3 days) 
following the Week 24 Visit or the ETV. In the event that the Week 24 Visit or 
the ETV occurs > 1 week following the last dose of the study drug, the EOS 
Safety Follow-up Visit may not be required. The ETV and/or EOS Safety 
Follow-Up Visit are not expected to be completed for subjects who withdraw 
full consent or are lost to follow up. 
If necessary, the Investigator may decide to extend the follow-up visits beyond 
1 week to monitor recovery of safety parameters (e.g., lymphopenia). 
Planned Sample Size: 
Approximately 400 subjects (~100 subjects per treatment arm)  
Study Population: 
Inclusion criteria: Subjects must meet all of the following criteria to be 
eligible for participation in the study: 
1. Generally healthy males or non-pregnant females age ≥18 years at the 
time of screening (or who have reached the state minimum legal age of 
consent). 
2. Stable, moderate-to-severe plaque psoriasis diagnosed for at least 
6 months prior to randomization (no morphology changes or significant 
flares of disease activity in the last 6 months in the opinion of the 
investigator or as reported by the subject). 
3. Severity of disease meeting all 3 of the following criteria prior to 
randomization (at the Baseline [Day 0] visit): 
a. 
PASI score of ≥12 
b. Total body surface area (BSA) affected by plaque psoriasis of ≥10% 
c. 
IGA score of >3 
4. Must be a candidate for phototherapy and/or systemic therapy for 
psoriasis.  
5. Ability to independently travel to study center and to comply with all 
study medication and procedures or identification of a caregiver 
committed to assuring compliance with those study related activities. 
6. Able to understand and have voluntarily signed an informed consent form 
(ICF) prior to undergoing any study-specific procedures.  
7. Women of child-bearing potential must have had a negative serum 
pregnancy test at the Screening Visit and a negative urine pregnancy test 
(UPT) at Baseline prior to randomization. 
8. Heterosexual female subjects of childbearing potential must agree to use 
contraception during the study which can include abstinence with an 
adequate secondary option should the subject become sexually active. All 
women of childbearing potential must complete a urine pregnancy test at 
the baseline visit and the test must be negative to be eligible for 
enrollment. (Test must have a sensitivity of at least 25 mIU/mL for human 
chorionic gonadotropin). A female is considered of childbearing potential 
unless she is a) postmenopausal for at least 12 months prior to study 
product administration b) without a uterus and/or both ovaries; or has been 
surgically sterile (i.e., tubal ligation) for at least 6 months prior to study 
product administration. Reliable methods of contraception are: a) 
hormonal methods or intrauterine device in use ≥ 90 days prior to study 
product administration or barrier method plus spermicide in use at least 14 
days prior to study product administration or partner has had a vasectomy 
at least 3 months prior to study product administration or Essure®. 
Exception: Sexually inactive female subjects of childbearing potential are 
not required to practice a reliable method of contraception and may be 


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enrolled at the investigator’s discretion provided that they are counseled to 
remain sexually inactive for the duration of the study and understand the 
possible risks involved in getting pregnant during the study. An abstinent 
heterosexual female must agree that if she becomes sexually active during 
the study she will use an acceptable form of contraception 
9. Willing to avoid excessive sun exposure/tanning during the study. 
Note: If a subject does not meet the inclusion criteria in terms of PASI, 
total BSA, and/or IGA at Screening, but in the opinion of the Investigator, 
the subject could meet the inclusion criteria related to PASI, total BSA, 
and IGA at the Baseline Visit, the subject can be scheduled for the 
Baseline Visit where these eligibility criteria as well as all other 
inclusion/exclusion criteria must be met before the subject can be 
randomized into the study. 
 
Exclusion Criteria: Any of the following will be regarded as a reason for 
exclusion from the trial: 
1. Subjects with non-plaque psoriasis (ie, predominantly inverse, 
erythrodermic, predominantly guttate, or pustular psoriasis). 
2. Subjects with drug-induced psoriasis or subjects with drug-exacerbated 
psoriasis that has not resolved within 4 weeks prior to screening. 
3. Subjects who have received systemic non-biologic psoriasis therapy or 
phototherapy (including either oral and topical psoralen and ultraviolet A 
(PUVA) light therapy, ultraviolet B, or self-treatment with tanning beds or 
therapeutic sunbathing) within 4 weeks prior to the Baseline Visit. 
 
Subjects who had topical psoriasis treatment within the previous 2 weeks 
prior to the Baseline Visit. 
 
Exceptions: Mild/least potent topical steroids will be permitted for use 
limited to the face, axilla, and/or genitalia. Medicated shampoos 
containing the active ingredients zinc pyrithione, salicylic acid, selenium 
sulfide, or ketoconazole will be permitted for use in the shower on the 
scalp only. 
4. Subjects with history of concurrent or recent use of any biologic agent 
within the following washout periods prior to baseline visit: 
• 
Etanercept – 35 days 
• 
Infliximab, adalimumab - 12 weeks 
• 
Ustekinumab – 24 weeks 
• 
Any other biologic agent <5 half-lives prior to the Baseline Visit  
 Note 1: Screening visit can be extended on case-by-case basis (but no 
more than additional 4 weeks) to complete the wash out. 
 Note 2: A maximum of 30% of subjects with prior biologic use (ie, 
subjects who received systemic biologic drugs in the past) will be 
enrolled, but they must be washed out prior to randomization. 
5. Subjects with prior exposure to natalizumab, rituximab, or belilumab in 
the past 1 year prior to screening visit. 
6. Subjects with history of use of any investigational drug within 28 days 
prior to randomization, or 5 pharmacokinetic/ pharmacodynamic half-lives 
(whichever is longer). 
7. Subjects who have failed on 3 or more systemic therapies. 


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8. Subjects who cannot avoid excessive sun exposure or use of tanning 
booths for at least 4 weeks prior to the Baseline Visit and during the day 
for the entire duration of the study. 
9. Subjects with unstable or significant illness, including the presence of 
laboratory abnormalities or electrocardiogram (ECG) abnormalities, at 
screening that, in the opinion of the Investigator, would place the subject 
at unacceptable risk if he/she were to participate in the study (eg, 
clinically significant abnormality on ECG, any other auto-immune 
conditions where subject is on immunosuppressive agents).  
10. Subjects with sarcoidosis, active tuberculosis, or incompletely treated 
tuberculosis (TB), or any other serious systemic infection. 
11. Any skin condition (eg, eczema) that would confound the ability to 
interpret data from the study. 
12. Subjects whose BMI is >39. 
13. Subjects with a present or past history of any major neurological 
conditions such as stroke, transient ischemic attack, seizures, cranial nerve 
palsies, major head trauma, brain tumor, demyelinating disorders. 
14. Subjects with a current history of any medical condition associated with 
significant gastrointestinal (GI) events such as nausea, vomiting, 
constipation, abdominal pain, or diarrhea, which in the opinion of the 
investigator would affect the tolerability of the drug. 
15. Subjects with severe gastritis, duodenal ulcer, severe symptomatic lactose 
intolerance, irritable bowel syndrome, present or a past history of 
inflammatory bowel disease or severe dysphagia. 
16. Subjects with a persistent history (more than 3 consecutive months) of 
lymphopenia (below the lower limit of normal [LLN]) in the last 2 years. 
17. Subjects who had prior treatment with dimethyl fumarate (Fumaderm® or 
Tecfidera®) or any other fumaric acid ester (FAE) containing products. 
18. Subjects who at Screening and/or randomization have uncontrolled high 
blood pressure values, which, in the opinion of the Investigator, may 
increase the risk of cardiovascular events. 
19. Subjects who at Screening have creatinine clearance <60 mL/min. 
20. Subjects who, according to the Reference Laboratory Manual, at 
Screening have: 
a. 
White blood cells (WBC) < 3000/mm³ 
b. Neutrophils/granulocytes less than the LLN 
c. 
Platelets <110,000/ mm³ 
d. Lymphocytes <1000/mm³ 
e. 
Serum creatinine >1.5× the upper limit of normal (ULN) 
f. 
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 
>2×ULN 
g. Significant proteinuria measured as 3+ or above in urine dipstick in 
two samples taken on two different days 
h. Non-fasted blood glucose > 200mg/dL 
Note: Laboratory tests that cross these thresholds can be repeated once if 
the Investigator has a clinical reason to believe that a result may be 
erroneous in which case the laboratory result should be discussed and 
agreed with the Medical Monitor before repeating it. The repeat value can 
be accepted if it meets protocol criterion. 


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Subjects who have chronically abnormal laboratory values beyond any of 
the above exclusionary thresholds are excluded even if they are deemed 
clinically normal. 
21. Subjects who had positive results at Screening for hepatitis B (HBsAg and 
anti-HBc), hepatitis C, or human immunodeficiency virus (HIV). 
22. Subjects who have a known immunodeficiency, receive immune 
modulatory/immune suppressant therapy, or are immunocompromised.  
23. Subjects with malignancy (except for adequately treated basal cell 
carcinoma, squamous cell carcinoma and carcinoma in situ of the cervix) 
or subjects with history of malignancy, with evidence of recurrence within 
the previous 5 years. 
24. Subjects with a history of drug or alcohol use disorder based on the 
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria 
(within the 6 months prior to screening) as reported by the subject or 
known to the Investigator. 
25. Subjects with cognitive deficit or psychiatric syndrome of any etiology 
that may influence compliance with study procedures or study outcome.  
26. Subjects with a history of allergy to any component of the study drug. 
27. Women who are lactating or breastfeeding. 
28. Investigator site personnel directly affiliated with this study and/or their 
immediate families. 
29. Sponsor employees or its designee or employees of third-party 
organizations involved in the study. 
30. Prisoners or subjects who are involuntarily incarcerated. 
Investigational Product(s): 
PPC-06 (tepilamide fumarate) Extended Release Tablets for oral 
administration: 400 mg QD regimen, 400 mg BID regimen, 600 mg BID 
regimen, or Placebo BID regimen. A 5-week Double-Blind Titration Period 
will be followed by a 19-week Double-Blind Treatment Period. 
Reference Product(s): 
Not applicable 
Control Product(s): 
Placebo tablets for oral administration to match PPC-06 Extended Release 
Tablets 
Efficacy Evaluation 
Criteria: 
Efficacy assessments include the PASI, the affected BSA, and the IGA.  
Health-related QoL assessments include the Quick Inventory of Depressive 
Symptomatology-Self Report (16 Items) (QIDS-SR16), the Dermatological 
Life Quality Index (DLQI), the 12-item Short Form Survey (SF-12), the Work 
Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO), 
and evaluation of Health Economics and Outcomes Research (HEOR).  
Other assessments (for subjects with psoriasis in the relevant areas) include the 
Nail Psoriasis Severity Index (NAPSI), the Psoriasis Scalp Score Index (PSSI), 
the Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) score, 
and the Pruritus Numerical Rating scale (NRS). PD assessments would include 
immunological analysis of peripheral blood samples. Details of PD assessment 
will be provided in a separate protocol. 
Pharmacokinetics 
Evaluation Criteria: 
Not applicable 
Safety Evaluation Criteria: 
Adverse event (AE) incidence and severity, laboratory test results 
(hematology, clinical chemistry, urinalysis), vital signs (systolic and diastolic 
blood pressure, heart rate, respiratory rate), physical examination, ECGs, and 
pregnancy testing. 


Dr. Reddy’s Laboratories, SA  
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Efficacy Endpoints 
The co-primary efficacy endpoints will be the proportion of subjects who 
achieve a reduction of 75% or greater from Baseline PASI (PASI-75) at the 
end of Week 24 and the proportion of subjects who achieved an IGA score of 
clear or almost clear (IGA 0, 1) at the end of Week 24. 
Secondary efficacy endpoints include the following: 
• 
Change from Baseline and percent change from Baseline in total PASI 
score at each visit in the Double-Blind Treatment Period 
• 
The proportion of subjects who achieve PASI-50 and PASI-75 at each 
visit in the Double-Blind Treatment Period 
• 
The proportion of subjects who achieved an IGA score of clear or almost 
clear at each visit in the Double-Blind Treatment Period 
• 
The change from Baseline and percent change from Baseline in percent of 
affected BSA at each visit in the Double-Blind Treatment Period 
• 
Mean change in the NAPSI of the target fingernail (score range 0-8) from 
Baseline at Weeks 12, 16 and 24 in the target fingernail with the most 
severe abnormalities for those who present with lesions in nails at baseline 
• 
Mean change in the PSSI score from Baseline at each visit in the  Double-
Blind Treatment Period for those that present with lesions on scalp at 
baseline 
• 
Mean change in the Palmoplantar Psoriasis Physician’s Global Assessment 
(PP PGA) score from Baseline at each visit in the  Double-Blind 
Treatment Period for those that present with lesions on the palms/soles at 
baseline 
• 
The change from Baseline and percent change from Baseline in pruritus 
NRS score at each visit in the Double-Blind Treatment Period 
• 
Time to achieving a PASI-75 response, defined as time in days from 
baseline to first achieving a reduction of 75% or greater from Baseline in 
PASI 
• 
Time to achieving an IGA score of clear or almost clear, defined as time 
in days from baseline to first achieving an IGA score of 0 or 1 
 
Health-related QoL assessments include: 
• 
QIDS-SR16 total score 
• 
DLQI total score 
• 
SF-12 total score 
• 
WPAI:PSO score 
• 
HEOR evaluation 
Safety Endpoints: 
Safety will be assessed through the monitoring of AEs, laboratory test results, 
vital signs, physical examinations, pregnancy testing and ECGs.  
Study Sites: 
Approximately 75 study sites in the US 
Planned Dates of Study: 
November 2017 to January 2019 


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Table 1-1 
Visit Schedule and Assessments 
Evaluation 
Screening 
Period1 
Double-Blind 
Titration Period  
(5 weeks) 
Double-Blind Treatment Period 
ETV and EOS Safety  
Follow-up Period2 
Un- 
scheduled  
Visit3 
Weeks 
-4 to 0 
Baseline 
visit 
Week 
4 
Week 
8 
Week 
12 
Week 
16 
Week 
20 
Week 
24 
Early 
Termin-
ation 
Visit 
Week 25 
(1 Week 
AfterWeek 
24/ETV) 
 
Study Day 
Day -28 to 
Day -1 
Day 0 
Day 
28  
(± 3 
days) 
Day 56  
(± 3 
days) 
Day 
84  
(± 3 
days) 
Day 
112  
(± 3 
days) 
Day 
140  
(± 3 
days) 
Day 
168  
(± 3 
days) 
- 
175 (+3 
days) 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
ETV 
9 
UNS 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X4 
X5 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
Psoriasis Medical 
History/Prior Psoriasis 
Therapies 
X 
X 
 
 
 
 
 
 
 
 
 
Other Medical History/Prior 
Meds 
X 
X 
 
 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Washout of Prohibited Meds 
X 
 
 
 
 
 
 
 
 
 
 
Confirm washout of 
prohibited meds 
 
X 
 
 
 
 
 
 
 
 
 
Study Process / Study Drug Dispensation 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
Study Drug Dispensing 
 
X6 
X 
X 
X 
X 
X 
 
 
 
 
Drug Accountability/ 
Compliance 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Collect Baseline stool 
consistency using Bristol 
Stool Chart 
 
X 
 
 
 
 
 
 
 
 
 
Dispense Educational 
Materials for AE 
Management 
 
X 
 
 
 
 
 
 
 
 
 
Safety Assessments 


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Evaluation 
Screening 
Period1 
Double-Blind 
Titration Period  
(5 weeks) 
Double-Blind Treatment Period 
ETV and EOS Safety  
Follow-up Period2 
Un- 
scheduled  
Visit3 
Weeks 
-4 to 0 
Baseline 
visit 
Week 
4 
Week 
8 
Week 
12 
Week 
16 
Week 
20 
Week 
24 
Early 
Termin-
ation 
Visit 
Week 25 
(1 Week 
AfterWeek 
24/ETV) 
 
Study Day 
Day -28 to 
Day -1 
Day 0 
Day 
28  
(± 3 
days) 
Day 56  
(± 3 
days) 
Day 
84  
(± 3 
days) 
Day 
112  
(± 3 
days) 
Day 
140  
(± 3 
days) 
Day 
168  
(± 3 
days) 
- 
175 (+3 
days) 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
ETV 
9 
UNS 
Complete Physical 
Examination 
X 
 
 
 
 
 
 
 
 
 
 
Partial Physical Examination 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height 
X 
 
 
 
 
 
 
 
 
 
 
Weight 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
Waist Circumference 
X 
 
 
 
 
 
 
X 
X 
 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECGs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Serum Pregnancy Test 
X 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy Test 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Laboratory Assessments7 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
Blood collection – PD study  
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Blood collection for 
lymphocyte  subset & Ab 
titer study8 
 
X 
 
 
 
 
 
X 
X 
 
 
Serology (HIV, HBsAg, Anti-
HBc, HCV) 
X 
 
 
 
 
 
 
 
 
 
 
Adverse Event Assessment 
X9 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Efficacy Assessments10 
PASI, BSA, IGA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
PSSI, PP PGA, Pruritus NRS 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
NAPSI  
 
X 
 
 
X 
X 
 
X 
X 
X 
 
Health-related Quality of Life Assessments10 
QIDS-SR16, DLQI, SF-12, 
WPAI:PSO, HEOR 
 
X 
 
 
X 
X 
 
X 
X 
X 
 
Photography 


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Evaluation 
Screening 
Period1 
Double-Blind 
Titration Period  
(5 weeks) 
Double-Blind Treatment Period 
ETV and EOS Safety  
Follow-up Period2 
Un- 
scheduled  
Visit3 
Weeks 
-4 to 0 
Baseline 
visit 
Week 
4 
Week 
8 
Week 
12 
Week 
16 
Week 
20 
Week 
24 
Early 
Termin-
ation 
Visit 
Week 25 
(1 Week 
AfterWeek 
24/ETV) 
 
Study Day 
Day -28 to 
Day -1 
Day 0 
Day 
28  
(± 3 
days) 
Day 56  
(± 3 
days) 
Day 
84  
(± 3 
days) 
Day 
112  
(± 3 
days) 
Day 
140  
(± 3 
days) 
Day 
168  
(± 3 
days) 
- 
175 (+3 
days) 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
ETV 
9 
UNS 
Photography (4 sites, 
5 subjects/site) 
 
X 
 
 
X 
X 
 
X 
 
 
 
1. The Screening Period can only be extended on a case-by-case basis if a longer than 4 weeks’ washout is required; however, the Investigator will need to obtain approval 
from the Medical Monitor in advance of the extension. 
2. Subjects who permanently discontinue the study drug for any reason or who withdraw from the study prematurely prior to the end of the Double-Blind Treatment Period 
should undergo the ETV followed by the EOS Safety Follow-up Period Visit. In the event that the ETV or Week 24 Visit occurs > 1 week following the last dose of the 
study drug, the EOS Safety Follow-up Visit may not be required. If necessary, the Investigator may decide to extend the EOS Safety Follow-up Visits beyond 1 week to 
monitor recovery of safety parameters (eg, lymphopenia). 
3. Table includes recommended. Unscheduled procedures, whichever are applicable, should be performed at the Investigator’s discretion. 
4. Initial eligibility assessment. 
5. Mandatory confirmatory eligibility assessment. 
6. Study drug will be dispensed as per the titration schedule described in Double-Blind Titration section. 
7. Laboratory assessments include routine laboratory evaluations (i.e., chemistry, hematology, and urinalysis), and assessment of lipid panel and hsCRP  
8. Blood collection for lymphocyte subset & Ab titer study can be collected at any study visit if the subject shows signs of progressive multifocal leukoencephalopathy 
(PML). 
9. SAEs will be collected following the signing of the Informed Consent Form; AEs will be collected following the first dose of study drug. 
10. Electronic device (for example: Electronic Clinical Outcome Assessments [eCOA]) will be used to record the efficacy and the health-related QoL assessments. The PSSI, 
PP PGA, and NAPSI will be assessed for all subjects at Baseline; if score is 0 at Baseline for any of these assessments, then the respective assessment(s) would not be 
required to be completed at future study visits, At baseline, the NAPSI will be evaluated for the 10 fingernails and the worst affected nail (maximum score) will be chosen 
as the target nail. Only the target nail will be evaluated in the subsequent visits. 
Abbreviations: Ab = antibody; Anti-HBc = Hepatitis B virus core antigen; BSA = Body surface area; DLQI = Dermatological Life Quality Index; ECG = Electrocardiogram; 
EOS = End of Study; ETV = Early Termination Visit; HBsAg = Hepatitis B virus surface antigen; HCV = Hepatitis C virus; HEOR = Health Economics and Outcomes 
Research; HIV = Human immunodeficiency virus; hsCRP = High-sensitivity C reactive protein; NAPSI = Nail Psoriasis Severity Index; PASI = Psoriasis Area and Severity 
Index;  PD = pharmacodynamics; PP PGA = Palmoplantar psoriasis physician’s global assessment; PSSI = Psoriasis Scalp Score Index; QIDS-SR16 = Quick Inventory of 
Depressive Symptomatology-Self Report (16 Items); SF-12 = 12-item Short Form Survey; IGA = Investigator’s Global Assessment; NRS = Numerical rating scale; 
WPAI:PSO = Work Productivity and Activity Impairment Questionnaire: Psoriasis 


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2. 
INTRODUCTION 
The investigational product (IP) in this study is PPC-06 (tepilamide fumarate) extended release 
(ER) tablets, previously known as XP23829, which is a patented, oral product candidate that 
utilizes prodrug technology for efficient absorption into the body. Once absorbed, PPC-06 is 
rapidly converted to monomethyl fumarate (MMF), a fumaric acid ester (FAE) compound that 
has shown immunomodulatory and neuroprotective effects in cell-based systems and various 
preclinical models of disease. The current trial will examine the safety and efficacy of PPC-06 in 
the treatment of moderate-to-severe plaque-type psoriasis. 
2.1 
Plaque Psoriasis 
Psoriasis is a chronic T-cell–mediated autoimmune disease (Ghoreschi, 2007) that affects 2% to 
3% of the US population (Stern, 2004; Kurd, 2009) and 0.6% to 6.5% of the European 
population (Chandran, 2010). As many as an estimated 7.5 million Americans are thought to 
have psoriasis, making it the most common autoimmune disease in the United States (National 
Psoriasis Foundation). The most common phenotypic form of psoriasis, plaque psoriasis, 
manifests as raised, well-demarcated, red plaques with silver scales that may remit spontaneously 
or recur in response to environmental triggers (Nestle, 2009).  
In addition to the appearance of skin plaques, there is a high degree of physical morbidity 
associated with psoriasis. Up to 30% of patients develop psoriatic arthritis (Zanni, 2012). 
Individuals with psoriasis appear to be at higher risk for a number of co-morbid conditions 
including obesity, myocardial infarction, cancer, diabetes mellitus, Crohn’s disease and 
depression (Krueger, 2001; Davidovici, 2010; Mehta, 2010). Patients with severe psoriasis, on 
average, die five years younger than patients without psoriasis, an observation that is largely 
attributable to an increased risk of cardiovascular disease (Prodanovich, 2009). In addition, 
psoriasis can represent both a significant social and financial burden for patients. Individuals 
suffer from both disfigurement and social stigmatization, with an impact on mental disability 
comparable with that of other major medical illnesses such as heart disease and rheumatoid 
arthritis (Sterry, 2009). Patients with psoriasis, like those with other major medical disorders, 
have a reduced quality of life (QoL) and reduced levels of employment and income (Horn, 
2007).  
The currently available psoriasis treatments do not offer a cure. Treatment is aimed at reducing 
the burden of disease and achieving an improvement in its signs and symptoms (Laws, 2012). 
Topical agents are generally prescribed for mild and some moderate cases, while systemic agents 
(including biologics), and phototherapy are reserved for moderate and severe cases. Treatment 
decisions are based not only on the severity of the disease, but also on existing comorbidities, 
tolerability, side effects, and patient preferences. Several systemic agents, including methotrexate 
(MTX), cyclosporine, and retinoids are most commonly used (Laws, 2012). Various factors limit 
favorable long-term outcomes; in particular, a lack of consistent efficacy over time and the risk 


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of serious cumulative toxicity. Injectable biologic agents are effective for a substantial number of 
patients, but there is concern regarding long-term safety due to the risk of immunosuppression 
and the potential for development of infections, opportunistic diseases, or malignancy (Laws, 
2012; Palfreeman, 2013).  
2.2 
Fumaric Acid Esters 
Fumaric acid, an unsaturated dicarboxylic acid, is an intermediate in the citric acid cycle (Krebs 
cycle) and is present naturally in all cells capable of aerobic respiration. Orally administered 
fumaric acid is poorly absorbed and is believed to pass through the body without causing 
significant systemic effects. To overcome the absorption limitations of fumaric acid, simple alkyl 
esters of fumaric acid (FAEs), including dimethyl fumarate (DMF) and monoethyl fumarate 
(MEF) were synthesized and evaluated for the treatment of psoriasis in the late 1950s 
(Schweckendiek, 1959).  
Fumaderm®, an enteric-coated oral formulation of DMF together with the calcium, magnesium 
and zinc salts of MEF (Fumaderm Summary of Product Characteristics [SPC] 2009) and 
Tecfidera®, an oral formulation of DMF without the additional MEF salts, were the first and 
second commercial products in the FAE class. Fumaderm was first approved in Germany for the 
treatment of severe psoriasis and for moderate-to-severe psoriasis vulgaris. Tecfidera is approved 
in the US for the treatment of relapsing forms of multiple sclerosis. In clinical trials, both 
Fumaderm (Ormerod, 2004; Nast, 2006; Altmeyer, 1994, 1996; Mrowietz, 1997, 1999) and 
Tecfidera (Langner 2005, Mrowietz 2005) demonstrated clinical efficacy in subjects with 
psoriasis. Both products are associated with flushing and gastrointestinal (GI) side effects such as 
nausea and diarrhea, and abdominal pain is also a common effect of Tecfidera. Reversible 
leucopenia, lymphopenia, and transient eosinophilia are frequently observed with Fumaderm; 
however, Tecfidera has been shown to reduce blood lymphocyte counts in multiple sclerosis 
patients during the first year of treatment (Tecfidera Prescribing Information, 2017).  
2.3 
Investigational Product 
PPC-06 (tepilamide fumarate), previously known as XP23829, is a novel ester prodrug of MMF 
and a member of the FAE class of drugs. In a similar manner to DMF, tepilamide fumarate 
generates MMF during absorption and intact PPC-06 prodrug does not reach systemic 
circulation. MMF is the presumed active metabolite of both Tecfidera and Fumaderm. Following 
oral administration, PPC-06 is rapidly absorbed and hydrolyzed to release MMF and promoiety 
by non-specific esterases in intestinal tissues. Systemic exposure to intact PPC-06 after oral 
dosing in humans is negligible and the pharmacologic activity of PPC-06 is attributed to the 
release of the active moiety, MMF. PPC-06 is absorbed throughout the GI tract, and therefore 
has been successfully incorporated into an extended-release (ER) formulation, in contrast to 
existing immediate-release formulations of currently available FAEs (Fumaderm SPC, 2009; 
Tecfidera Prescribing Information, 2017). 


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Administration of PPC-06 reduced lymphocytes and increased eosinophils in healthy subjects. 
After 7 days of dosing PPC-06 (Day 8), the mean absolute reduction in blood lymphocytes from 
baseline ranged from -0.84 to -1.16 × 109 /L (compared to reductions of -0.32 for DMF and -0.23 
for placebo). Lymphocytes remained within normal limits (WNL) in the majority of subjects and 
did not drop below 0.5 × 109 /L (or below grade 2) in any subject evaluated. These lymphocyte 
reductions were reversible, restoring to near baseline levels at the follow-up visit. Blood 
eosinophils were increased within normal limits by a mean of 0.12 to 0.20 × 109/L from baseline 
for PPC-06, 0.01 for DMF, and 0.02 for placebo (see Investigator’s Brochure for PPC-06 
[tepilamide fumarate] Extended Release Tablets).  
In 3 Phase 1 studies in healthy volunteers conducted to date, PPC-06 was generally well-
tolerated and safe. The most common adverse events (AEs) of flushing and GI symptoms 
(nausea, diarrhea and abdominal pain) were consistent with AEs known to be associated with 
FAEs (see Investigator’s Brochure for PPC-06 [tepilamide fumarate] Extended Release Tablets). 
A Phase 2 study (XP-H-093) examined the safety and efficacy of PPC-06 400 mg QD, 800 mg 
QD, 400 mg twice daily (BID), and placebo in approximately 200 patients with moderate-to-
severe plaque-type psoriasis. Efficacy assessments included the Psoriasis Area and Severity 
Index (PASI), the affected body surface area (BSA), the static Physician’s Global Assessment 
(sPGA), the Dermatology Life Quality Index (DLQI), and the Pruritus Visual Analog Scale 
(VAS). The PPC-06 800 mg QD and PPC-06 400 mg BID formulations demonstrated 
statistically significant efficacy as defined by the primary efficacy endpoint (percent change from 
Baseline in total PASI score at Week 12), but did not achieve statistical significance for key 
secondary endpoints such as PASI-75 (at least 75% reduction in PASI score) and sPGA responder 
analyses, for which the study was not powered (see Investigator’s Brochure for PPC- 06 
[tepilamide fumarate] Extended Release Tablets). The safety profile of XP2829 was consistent 
with the known safety profile of the FAE medication class, particularly GI-related AEs, but some 
tolerability results, although limited by the short duration of the study, were potentially favorable 
in terms of lymphopenia and flushing (see Investigator’s Brochure for PPC- 06 [tepilamide 
fumarate] Extended Release Tablets). 
2.4 
Rationale of the Study 
There remains a strong unmet need for safe and convenient oral therapies that can be used long-
term for the treatment of moderate-to-severe chronic plaque-type psoriasis. Despite the 
availability of other therapeutic options, the long-term management of psoriasis is complicated 
by a number of serious treatment-related limitations. Various factors limit favorable long-term 
outcomes, in particular, their lack of consistent efficacy over time and the risk of serious 
cumulative toxicity. 
Based on Phase 1 studies in healthy volunteers (studies XP-H-058, XP-H-059, XP-H-076, and 
XP-H-116) and a Phase 2 study in moderate-to-severe plaque psoriasis patients (XP-H-093), 


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PPC-06 (tepilamide fumarate) ER tablets can provide not only a more sustained MMF exposure, 
but also may have the potential to provide an improved tolerability profile compared to other 
FAE prodrugs (ie, lower incidence and intensity of flushing and GI symptoms). In addition to a 
potential improvement in tolerability, the sustained exposure of MMF provided by PPC-06 ER 
tablets may also offer the convenience of a once-daily oral treatment in psoriasis. The current 
trial is aimed at investigating the safety and efficacy of PPC-06 in the treatment of moderate-to-
severe plaque-type psoriasis. 
3.
TRIAL OBJECTIVES AND PURPOSE
The co-primary objectives of this study are as follows: 
1. To demonstrate the efficacy of PPC-06 with respect to PASI for the treatment of
moderate-to-severe plaque psoriasis, as compared with placebo at 24 weeks
2. To demonstrate the efficacy of PPC-06 with respect to IGA at 24 weeks
Secondary objectives are as follows: 
1. To assess the efficacy of PPC-06 as it relates to psoriasis-related symptoms and health-
related QoL measures
2. To assess the safety and tolerability of PPC-06 in subjects with moderate-to-severe
plaque psoriasis
3.
To evaluate the pharmacodynamics (PD) of PPC-06 through immunological analysis of
peripheral blood samples.
4.
STUDY DESIGN
4.1 
Overall Study Design 
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to 
assess the safety and efficacy of PPC-06 in subjects with moderate-to-severe plaque psoriasis. 
Study subjects will be enrolled at approximately 75 sites in the United States (US).  
Approximately 400 subjects who meet the study entry criteria will be randomly assigned in a 
1:1:1:1 ratio to 1 of the 4 treatment arms: 
1. PPC-06 400 mg once daily (QD)
2. PPC-06 400 mg BID
3. PPC-06 600 mg BID
4. Placebo BID
The maximum study duration for each subject will be approximately 29 weeks. The study will 
include an up-to-4-week screening phase (which can be extended if necessary on a case-by-case 


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basis for washout of prohibited prior medication), a 24-week treatment phase (that includes a 
5-week titration phase and a 19-week treatment period at the maintenance dose), and a 1-visit, 
1-week End-of-Study (EOS) Safety Follow-up Period. If necessary, the Investigator may decide 
to extend the EOS beyond 1 week to monitor recovery of safety parameters (eg, lymphopenia).  
Blood samples for PD assessments will be collected at baseline and at Weeks 4, 8, 12, 16, 20, 
and 24. PD assessments will be conducted in all subjects, with the intent of evaluating psoriasis-
associated inflammatory markers. Details of PD assessment will be provided in a separate 
protocol. 
 
Subjects who discontinue study drug for more than 2 consecutive weeks due to tolerability issues 
or for any other reason at any point during the study will not be allowed to resume treatment with 
study drug and will be scheduled for the early termination visit (ETV). For those subjects where 
the ETV occurs 1 week or more post the last study drug dose, the safety follow up visit is not 
required. Subjects who discontinue from the study for any other reason at any time point will 
directly continue to the ETV and then enter the EOS Safety Follow-up period (if required).  
After having provided written informed consent, the subject will undergo screening procedures. 
At the end of the screening period, eligible subjects will be randomly assigned to one of the 
study treatment groups on Day 0 (Baseline). During the Titration/Treatment Periods, subjects 
will return to the study site according to the study schedule for efficacy assessments, review of 
study drug compliance, and assessment of concomitant medications, vital signs, AEs, and other 
safety parameters. At specified visits, subjects will be asked to complete questionnaires for QoL 
assessments. The study design is illustrated in Figure 4-1. 


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Figure 4-1 
Study Design 
 
4.2 
Study Endpoints 
4.2.1 
Efficacy Endpoints 
The co-primary efficacy endpoints are as follows: 
• The proportion of subjects who achieve a reduction of 75% or greater from Baseline in 
the Psoriasis Area and Severity Index (PASI-75) at the end of Week 24 
• The proportion of subjects who achieve an IGA score of clear or almost clear (IGA score 
0 or 1) at the end of Week 24 
Secondary efficacy endpoints include the following: 
• Change from Baseline and percent change from Baseline in total PASI score at each visit 
in the Double-Blind Treatment Period 
• The proportion of subjects who achieve PASI-50 and PASI-75 at each visit in the 
Double-Blind Treatment Period 
• The proportion of subjects who achieve an IGA score of clear or almost clear at each visit 
in the Double-Blind Treatment Period 
• The change from Baseline and percent change from Baseline in percent of affected BSA 
at each visit in the Double-Blind Treatment Period 


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• Mean change in the NAPSI (score range 0-8) from Baseline at Weeks 12, 16 and 24 in 
the target fingernail with the most severe abnormalities for those who present with 
lesions in fingernails at baseline 
• Mean change in the PSSI score from Baseline at each visit in the  Double-Blind 
Treatment Period for those that present with lesions on scalp at baseline 
• Mean change in the Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) 
score from Baseline at each visit in the  Double-Blind Treatment Period for those that 
present with lesions on the palms/soles at baseline 
• The change from Baseline and percent change from Baseline in pruritus NRS score at 
each visit in the Double-Blind Treatment Period 
• Time to achieving a PASI-75 response, defined as time in days from baseline to first 
achieving a reduction of 75% or greater from Baseline in PASI  
• Time to achieving an IGA score of clear or almost clear, defined as time in days from 
baseline to first achieving an IGA score of 0 or 1 
 
4.2.2 
Health Outcome/Quality of Life Endpoints 
Change from Baseline in the following health outcome/QoL assessments at Weeks 12, 16, and 
24: 
• Quick Inventory of Depressive Symptomatology-Self Report (16 Items) (QIDS-SR16) 
total score 
• DLQI total score 
• SF-12 total score 
• Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) score 
• Health Economics and Outcome Research (HEOR) evaluation (see Section 7.3.3.5) 
4.2.3 
Safety Endpoints 
Safety will be assessed through the monitoring of AEs, laboratory test results, vital signs, 
physical examinations, pregnancy testing, and 12-lead ECGs.  
5. 
SELECTION OF STUDY POPULATION 
5.1 
Subject Population 
Approximately 400 subjects (~100 subjects per treatment arm) will be enrolled in the study. A 
rationale for the choice of sample size is provided in Section 8.2 of this protocol. 
Each potential subject will sign and date the most recently IRB approved informed consent 
document before any study-specified procedures are performed.  


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5.2 
Inclusion Criteria 
Subjects must meet all the following criteria to be eligible for participation in the study: 
1. Generally healthy males or non-pregnant females age ≥18 years at the time of screening 
(or who have reached the state minimum legal age of consent). 
2. Stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to 
randomization (no morphology changes or significant flares of disease activity in the last 
6 months in the opinion of the investigator or as reported by the subject). 
3. Severity of disease meeting all 3 of the following criteria prior to randomization (at the 
Baseline [Day 0] visit): 
a. PASI score of ≥12 
b. Total body surface area (BSA) affected by plaque psoriasis of ≥10% 
c. IGA score of >3 
4. Must be a candidate for phototherapy and/or systemic therapy for psoriasis.  
5. Ability to independently travel to study center and to comply with all study medication 
and procedures or identification of a caregiver committed to assuring compliance with 
those study related activities. 
6. Able to understand and have voluntarily signed an informed consent form (ICF) prior to 
undergoing any study-specific procedures.  
7. Women of child-bearing potential must have had a negative serum pregnancy test at the 
Screening Visit and a negative urine pregnancy test (UPT) at Baseline prior to 
randomization. 
8. Heterosexual female subjects of childbearing potential must agree to use contraception 
during the study which can include abstinence with an adequate secondary option should 
the subject become sexually active. All women of childbearing potential must complete a 
urine pregnancy test at the baseline visit and the test must be negative to be eligible for 
enrollment. (Test must have a sensitivity of at least 25 mIU/mL for human chorionic 
gonadotropin). A female is considered of childbearing potential unless she is a) 
postmenopausal for at least 12 months prior to study product administration; b) without a 
uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 
6 months prior to study product administration. Reliable methods of contraception are: a) 
hormonal methods or intrauterine device in use ≥ 90 days prior to study product 
administration or barrier method plus spermicide in use at least 14 days prior to study 
product administration or partner has had a vasectomy at least 3 months prior to study 
product administration or Essure®. Exception: Sexually inactive female subjects of 
childbearing potential are not required to practice a reliable method of contraception and 
may be enrolled at the investigator’s discretion provided that they are counseled to remain 
sexually inactive for the duration of the study and understand the possible risks involved 
in getting pregnant during the study. An abstinent heterosexual female must agree that if 
she becomes sexually active during the study she will use an acceptable form of 
contraception. 
9. Willing to avoid excessive sun exposure/tanning during the study. 
 


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Note: If a subject does not meet the inclusion criteria in terms of PASI, total BSA, and/or IGA at 
Screening, but in the opinion of the Investigator, the subject could meet the inclusion criteria 
related to PASI, total BSA, and IGA at the Baseline Visit, the subject can be scheduled for the 
Baseline Visit where these eligibility criteria as well as all other inclusion/exclusion criteria must 
be met before the subject can be randomized into the study. 
 
5.3 
Exclusion Criteria 
Any of the following will be regarded as a reason for exclusion from the trial: 
1. Subjects with non-plaque psoriasis (ie, predominantly inverse, erythrodermic, 
predominantly guttate, or pustular psoriasis). 
2. Subjects with drug-induced psoriasis or subjects with drug-exacerbated psoriasis that has 
not resolved within 4 weeks prior to screening. 
3. Subjects who have received systemic non-biologic psoriasis therapy or phototherapy 
(including either oral and topical psoralen and ultraviolet A (PUVA) light therapy, 
ultraviolet B, or self-treatment with tanning beds or therapeutic sunbathing) within 
4 weeks prior to the Baseline Visit. 
Subjects who had topical psoriasis treatment within the previous 2 weeks prior to the 
Baseline Visit. 
Exceptions: Mild/least potent topical steroids will be permitted for use limited to the face, 
axilla, and/or genitalia. Medicated shampoos containing the active ingredients zinc 
pyrithione, salicylic acid, selenium sulfide, or ketoconazole will be permitted for use in 
the shower on the scalp only 
4. Subjects with history of concurrent or recent use of any biologic agent within the 
following washout periods prior to baseline visit: 
• Etanercept – 35 days 
• Infliximab, adalimumab - 12 weeks 
• Ustekinumab – 24 weeks 
• Any other biologic agent <5 half-lives prior to the Baseline Visit  
Note 1: Screening visit can be extended on case-by-case basis (but no more than 
additional 4 weeks) to complete the wash out. 
Note 2: A maximum of 30% of subjects with prior biologic use (ie, subjects who received 
systemic biologic drugs in the past) will be enrolled, but they must be washed out prior to 
randomization. 
5. Subjects with prior exposure to natalizumab, rituximab, or belilumab in the past 1 year    
prior to screening visit. 
6. Subjects with history of use of any investigational drug within 28 days prior to 
randomization, or 5 pharmacokinetic/ pharmacodynamic half-lives (whichever is longer). 
7. Subjects who have failed to improve on 3 or more systemic therapies. 
8. Subjects who cannot avoid excessive sun exposure or use of tanning booths for at least 
4 weeks prior to the Baseline Visit and during the day for the entire duration of the study. 


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9. Subjects with unstable or significant illness, including the presence of laboratory 
abnormalities or electrocardiogram (ECG) abnormalities, at Screening that, in the opinion 
of the Investigator, would place the subject at unacceptable risk if he/she were to 
participate in the study (eg, clinically significant abnormality on ECG, any other auto-
immune conditions where subject is on immunosuppressive agents).  
10. Subjects with sarcoidosis, active tuberculosis, or incompletely treated tuberculosis (TB), 
or any other serious systemic infection. 
11. Any skin condition (eg, eczema) that would confound the ability to interpret data from the 
study. 
12. Subjects whose BMI is >39. 
13. Subjects with a present or past history of any neurological conditions such as stroke, 
transient ischemic attack, seizures, cranial nerve palsies, major head trauma, brain tumor, 
demyelinating disorders. 
14. Subjects with a current history of any medical condition associated with significant 
gastrointestinal (GI) events such as nausea, vomiting, constipation, abdominal pain, or 
diarrhea, which in the opinion of the investigator would affect the tolerability of the drug. 
15. Subjects with severe gastritis, duodenal ulcer, severe symptomatic lactose intolerance, 
irritable bowel syndrome, present or a past history of inflammatory bowel disease or 
severe dysphagia. 
16. Subjects with a persistent history (more than 3 consecutive months) of lymphopenia 
(below the lower limit of normal [LLN]) in the last 2 years. 
17. Subjects who had prior treatment with dimethyl fumarate (Fumaderm® or Tecfidera®) or 
any other fumaric acid ester (FAE) containing products. 
18. Subjects who at Screening and/or randomization have uncontrolled high blood pressure 
values, which, in the opinion of the Investigator, may increase the risk of cardiovascular 
events. 
19. Subjects who at Screening have creatinine clearance <60 mL/min. 
20. Subjects who, according to the Reference Laboratory Manual, at Screening have: 
a. 
White blood cells (WBC) < 3000/mm³ 
b. 
Neutrophils/granulocytes less than the LLN 
c. 
Platelets <110,000/ mm³ 
d. 
Lymphocytes <1000/mm³ 
e. 
Serum creatinine >1.5× the upper limit of normal (ULN) 
f. 
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2×ULN 
g. 
Significant proteinuria measured as 3+ or above in urine dipstick in two samples 
taken on two different days 
h. 
Non-fasted blood glucose > 200 mg/dL 
Note: Laboratory tests that cross these thresholds can be repeated once if the Investigator 
has a clinical reason to believe that a result may be erroneous in which case the 
laboratory result should be discussed and agreed with the Medical Monitor before 
repeating it. The repeat value can be accepted if it meets protocol criterion. 


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Subjects who have chronically abnormal laboratory values beyond any of the above 
exclusionary thresholds are excluded even if they are deemed clinically normal. 
21. Subjects who have positive results at Screening for hepatitis B (HBsAg and anti-HBc), 
hepatitis C, or human immunodeficiency virus (HIV). 
22. Subjects who have a known immunodeficiency, receive immune modulatory/immune 
suppressant therapy, or are immunocompromised.  
23. Subjects with malignancy (except for adequately treated basal cell carcinoma, squamous 
cell carcinoma, and carcinoma in situ of the cervix) or subjects with history of 
malignancy, with evidence of recurrence within the previous 5 years. 
24. Subjects with a history of drug or alcohol use disorder based on the Diagnostic and 
Statistical Manual of Mental Disorders (DSM-5) criteria (within the 6 months prior to 
screening) as reported by the subject or known to the Investigator. 
25. Subjects with cognitive deficit or psychiatric syndrome of any etiology that may influence 
compliance with study procedures or study outcome. 
26. Subjects with a history of allergy to any component of the study drug. 
27. Women who are lactating or breastfeeding. 
28. Investigator site personnel directly affiliated with this study and/or their immediate 
families. 
29. Sponsor employees or its designee or employees of third-party organizations involved in 
the study. 
30. Prisoners or subjects who are involuntarily incarcerated. 
 
5.4 
Discontinuation of Treatment or Assessments 
Subjects can be removed from the study for any of the following reasons:  
• AE(s) 
• Protocol violation 
• Withdrawal by subject (subject voluntarily discontinued study participation) 
• Lost to follow-up 
• Pregnancy 
• Study terminated by sponsor 
• Investigator decision 
• Non-compliance with study drug (<80% or >120%) 
• Loss of ability to freely provide consent through imprisonment or involuntary 
incarceration for treatment of either a psychiatric or physical (eg, infectious disease) 
illness 
• Unblinding of a subject for any reason 
All subjects meeting the above withdrawal criteria are to be evaluated at the safety follow-up 
EOS visits unless they have withdrawn full consent. The reason for a subject’s permanent 
withdrawal is to be recorded on the appropriate electronic case report form (eCRF). Subjects 


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who prematurely withdraw from the study for AEs are to be monitored for up to 30 days after the 
subject stopped study treatment or until the abnormal parameter resolves or stabilizes. 
Pregnancies are to be reported to the sponsor or designee within 24 hours of learning of its 
occurrence, and the pregnancy is to be monitored to determine outcome. Investigators are to 
document their attempts to contact subjects who are lost to follow-up.  
As a class, FAEs are known to have an effect on lymphocyte and eosinophil counts and can have 
hepatotoxic and nephrotoxic effects at excessive exposures. The following study drug 
discontinuation criteria are to be implemented to reduce the risk of toxicity for individual 
subjects and to investigate the time course of recovery of affected safety parameters. 
If any of the following criteria are met, study treatment will be permanently discontinued and the 
subject will be scheduled for an ETV followed by the Safety Follow-up Visit.  
• Lymphocytes <500/mm3 at any visit 
• Lymphocytes <800/mm3 on 3 consecutive visits 
• ALT or AST >8×ULN on repeat examination (if assumed increase is related to study 
drug) 
• ALT or AST >5×ULN for more than 2 weeks on repeat examination (if assumed increase 
is related to study drug) 
• ALT or AST >3×ULN and either total bilirubin >2 × the ULN or International 
Normalized Ratio (INR) >1.5 on repeat examination (if assumed increase is related to 
study drug) in presence of normal alk phosphate. 
• ALT or AST >3×ULN with concurrent appearance or worsening of fatigue, nausea, 
vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia (>5% 
eosinophils on differential leukocyte count 
• Serum creatinine >1.5×ULN on repeat exam (if assumed increase is related to study 
drug) 
• Proteinuria measured as 3+ or above in urine dipstick on 2 consecutive samples, 4 weeks 
apart 
• If advised by the Medical Monitor or PML experts. 
Laboratory tests can be repeated earlier than the next scheduled consecutive visit at the 
investigator’s discretion and any associated safety issue should be followed up as per the 
Investigator’s clinical judgment until resolution/stabilization.  
Replacement Policy 
Subjects who prematurely discontinue from the study after randomization will not be replaced. 


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5.5 
Dietary and Lifestyle Restrictions 
Subjects must avoid phototherapy, excessive or prolonged sun exposure, or use of ultraviolet 
(UV) light sources within 28 days of randomization and throughout the study. Subjects will not 
otherwise alter their lifestyle and will not alter their diet during the study except to remain 
compliant with the inclusion and exclusion criteria.  
6. 
STUDY TREATMENTS 
6.1 
Investigational Products and Controls 
The study product under investigation in this study, PPC-06 (tepilamide fumarate) is a prodrug 
of MMF and a member of the FAE class of compounds. It will be administered as an extended 
release (ER) tablet formulation for oral administration via blister wallets during the Double-
Blind Titration Period and via bottles during the Double-Blind Treatment Period. Three dosages 
of PPC-06 ER tablets (400 mg QD, 400 mg BID, and 600 mg BID) and a placebo BID regimen 
(using placebo tablets identical in appearance to the active-treatment tablets) will be studied.  
PPC-06 ER tablets are white round tablets of 100 mg and 200 mg dose strength, and are 
manufactured and packaged under Good Manufacturing Practice (GMP) regulations. Tablets are 
formulated with PPC-06 and the following excipients: lactose, hypromellose, colloidal silicon 
dioxide, hydroxypropyl cellulose, and magnesium stearate.  
The placebo tablets will contain the same ingredients as the active formulation(s) without the 
active ingredient, and will be identical in appearance to the active PPC-06 ER tablets. Depending 
on the dose group, subjects are expected to ingest 2.98g to 2.31g of lactose daily from study 
medication, which is approximately the amount of lactose in ¼ cup of whole milk.  
6.2 
Dosing Regimen 
Dosages and pill allocations for the Titration Period (Weeks 1-5) and for the Treatment Period 
(Weeks 6-24) are shown in Table 6-1 and Table 6-3, respectively. The dosing regimen for the 
Titration Period is presented in Table 6-2. Note: Doses specified in red followed by a ‘P’ indicate 
Placebo.  
Double-Blind Titration Period (Baseline through Week 5) 
Following completion of the pre-randomization Screening Period, eligible subjects will be 
randomized in a 1:1:1:1 ratio to 1 of the 4 treatment arms and will enter the 5-week 
Double-Blind Titration Period. The first dose of study drug will be taken the day after the 
Baseline Visit (on Day 1). If a subject misses a dose (or several doses) during the Titration 
Period, they should skip that dose and continue with the next scheduled dose. At least 4 hours 
should elapse between doses, but ideally 8-12 hour intervals should be maintained. If a subject 
misses 7 or more consecutive days of dosing during the Titration Period, the site should contact 
the Sponsor or designee for guidance on how to proceed. At Visit 3 (Week 4), the subjects will 


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be instructed to continue 1 more week of Titration dose (Week 5 of blister wallets) and will also 
be given a kit of bottles which will allow dosing until Visit 4. Please refer to Table 6-1 for 
titration schedule. 
Double-Blind Treatment Period (Week 6 through Week 24) 
Subjects will receive PPC-06 400 mg QD, PPC-06 400 mg BID, PPC-06 600 mg BID, or 
Placebo BID from Week 6 through Week 24, based on the treatment arm to which they were 
randomized. Subjects will return to the clinic every 4 weeks (±3 days) thereafter for drug 
accountability and to undergo safety and efficacy evaluations per the schedule of assessments 
(Table 1-1). 
• Visit 4: End of Week 8 
• Visit 5: End of Week 12 
• Visit 6: End of Week 16 
• Visit 7: End of Week 20 
• Visit 8: End of Week 24 
• Visit 9: End of Week 25 


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Table 6-1 
Treatment Schedule - Titration Period (Weeks 1-5) 
 
400 mg QD 
400 mg BID 
600 mg BID 
Placebo BID 
Week 1 
(Days 1-7) 
100 P (am) + 100 P (am)  
100 P (pm) + 100 (pm) 
100 P (am) + 100 P (am)  
100 P (pm) + 100 (pm) 
100 (am) + 100 P (am)  
100 P (pm) + 100 (pm) 
100 P (am) + 100 P (am)  
100 P (pm) + 100 P (pm) 
Week 2 
(Days 8-14) 
200 P (am) + 200 P (am)  
200 P (pm) + 200 (pm) 
200 P (am) + 200 P (am)  
200 P (pm) + 200 (pm) 
200 (am) + 200 P (am)  
200 P (pm) + 200 (pm) 
200 P (am) + 200 P (am) 
200 P (pm) + 200 P (pm) 
Week 3 
(Days 15-21) 
100 P (am) + 100 P (am)   
200 (pm) + 200 (pm) 
100 P (am) + 100 (am)   
200 P (pm) + 200 (pm) 
100 (am) + 100 (am)   
200 (pm) + 200 (pm) 
100 P (am) + 100 P (am)   
200 P (pm) + 200 P (pm) 
Week 4 
(Days 22-28) 
200 P (am) + 200 P (am)   
200 (pm) + 200 (pm) 
200 P (am) + 200 (am)   
200 P (pm) + 200 (pm) 
200 (am) + 200 (am)  
200 (pm) + 200 (pm) 
200 P (am) + 200 P (am)  
200 P (pm) + 200 P (pm) 
Week 5 
(Days 29-35) 
200 P (am) + 200 P (am)   
200 (pm) + 200 (pm) + 200 P (pm) 
200 P (am) + 200 (am)   
200 (pm) + 200 (pm) + 200 P (pm) 
200 (am) + 200 (am)  
200 (pm) + 200 (pm) + 200 (pm) 
200 P (am) + 200 P (am)  
200 P (pm) + 200 P (pm) + 200 P (pm) 
Table 6-2 
Titration Regimen 
Visit  
Weeks (Days) 
Tablet regimen for all groups 
Baseline* 
Week 1 (Days 1-7) 
Take 2 tabs in the morning and 2 tabs in the evening from the blister 
Week 2 (Days 8-14) 
Take 2 tabs in the morning and 2 tabs in the evening from the blister 
Week 3 (Days 15-21) 
Take 2 tabs in the morning and 2 tabs in the evening from the blister 
Week 4 (Days 22-28) 
Take 2 tabs in the morning and 2 tabs in the evening from the blister 
Week 5 (Days 29-35) 
Take 2 tabs in the morning and 3 tabs in the evening from the blister 
Week 4# (Day 28) 
Week 6 (Days 36-42) to 
Week 8 (Days 50-56)  
Take 1 tab from AM Bottle 1 and 2 tabs from AM Bottle 2; repeat the process in the night with PM bottles. 
* = Subjects will be given 5 blister wallets (for Weeks 1-5) 
# = Subjects will be given 2 sets of 2 Bottles as mentioned. 
Table 6-3 
Treatment Schedule: Treatment Period (Weeks 6-24) 
Visit 
PPC-06 400 mg QD Regimen 
PPC-06 400 mg BID Regimen 
PPC-06 600 BID Regimen 
PPC-06 Placebo BID Regimen 
 
Week 6 – Week 24 
Week 6 – Week 24 
Week 6 – Week 24 
Week 6 – Week 24 
Weeks 8-20 
(Dispense 2 sets 
of 2 Bottles)1 
 
200 P (am) + 200 P (am) + 200 P (am)  
200 (pm) + 200 (pm) + 200 P (pm) 
 
200 P (am) + 200 (am) + 200 (am) 
200 (pm) + 200 (pm) + 200 P (pm) 
 
200 (am) + 200 (am) + 200 (am) 
200 (pm) + 200 (pm) + 200 (pm) 
 
200 P (am) + 200 P (am) + 200 P (am)   
200 P (pm) + 200 P (pm) + 200 P (pm) 
1 Subjects will be given 2 sets of 2 bottles (2 morning (AM) bottles + 2 evening (PM) bottles) 
AM Bottles: AM Bottle 1 (30 count) and AM Bottle 2 (60 count) 
PM Bottles: PM Bottle 1 (30 count) and PM Bottle 2 (60 count) 
Take 1 tablet from (AM) Bottle 1 and 2 tablets from (AM) Bottle 2; repeat the process in the evening with (PM) bottles 
 


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6.3 
Dose Modification 
At any point during the Double-Blind Titration or Treatment Periods, a temporary dose reduction 
or interruption may be considered in circumstances where a subject has a tolerability issue such 
as flushing or GI intolerance. The Investigator may use other medications such as loperamide for 
diarrhea (or local standard of care) for tolerability management as long as the medication is not 
one of the prohibited/restricted medications.  
During the Double-Blind Treatment Period (Weeks 6-24), in the event of a temporary dose 
reduction (no more than 2 weeks), 1 tablet from each Bottle 2 (AM and PM) will be reduced. 
When the tolerability issues resolve, study drug should be titrated back up to the respective 
treatment dose. If the tolerability issues return at the higher dose, subjects may be discontinued 
from the study. 
Note: Subjects who discontinue study treatment for more than 2 weeks during the Double-Blind 
Titration or Treatment Periods due to tolerability issues or for any other reason at any point 
during the study will not be allowed to resume their study treatment and will be scheduled for an 
ETV. Subjects who discontinue from the study for any reason at any time point will directly 
continue to the ETV.  
6.4 
Packaging and Labeling 
The IP will be labeled according to all applicable federal regulations and be printed in the local 
language.  
The study medication will be supplied to the clinical site(s) in kits containing 5 weeks of blister 
wallets which will be used for the Titration Period, as well as kits containing 2 sets of 2 Bottles 
which will be used for the Treatment Period. The blister wallet kits will contain a total of 147 
tablets, and the Bottle kits will contain 2 AM and 2 PM bottles: 
• AM Bottle 1 – 30 tablets 
• AM Bottle 2 – 60 tablets 
• PM Bottle 1 – 30 tablets 
• PM Bottle 2 – 60 tablets  
6.5 
Storage 
Investigational product must be stored at controlled room temperature (20-25°C, 68-77°F) with 
excursions permitted to 15°-30°C (59°-86°F). Subjects will be advised to keep study medication 
out of reach of children and persons who may not be able to read or understand the label. All 
study medication should be kept in a secure area inaccessible to unauthorized individuals. 


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All remaining IP will be returned to the sponsor or its designee after final drug accountability has 
been completed. 
6.6 
Assignment to Treatment 
6.6.1 
Randomization 
All subjects who enter into the screening period for the study (defined as the point at which the 
subject signs the ICF) will receive a subject identification number through the Interactive Web 
Response System (IWRS). This number (which will consist of the site number followed by the 
subject number) will be used to identify the subject throughout the study and must be used on all 
study documentation related to that subject. The subject identification number must remain 
constant throughout the entire study; it must not be changed at the time of screening or 
randomization. This number will not be the same as the assigned randomization number. The 
IWRS will be used for randomization. A subject can be rescreened on a case by case basis with 
input from the Medical Monitor. In the event a subject is rescreened, the subject will be 
(re)presented with the ICF and a new subject identification number will be given by IWRS. 
Once assigned to a subject, a subject identification number will not be reused. If the subject fails 
to be randomized for any reason, the reason for not being randomized will be entered in the 
subject’s eCRF.  
The randomization scheme will be reviewed and approved by a member of the sponsor’s 
Biostatistics and Data Management (BDM) group or designee. The sites will randomize eligible 
subjects by contacting IWRS at Visit 2 after all of the relevant Baseline procedures are 
completed and assessed as appropriate. A subject who fulfills the study eligibility requirements 
will be randomly assigned to treatment. The randomization will be stratified by prior biologic 
use. 
The IWRS will assign a randomization number to the subject, which will be used to link the 
subject to the treatment group and will specify a unique Blister Wallet IP kit number for the IP to 
be dispensed to the subject at Visit 2 for the Titration Period. The sites will log in to IWRS 
during each subsequent subject visit to obtain the kit numbers of the Bottle Kits to be dispensed 
at study Visits 3-7. 
6.6.2 
Blinding 
This is a double-blind study. The investigator, study coordinator(s), subjects and the Sponsor 
study team and its representatives, will be blinded to the identity of the randomized treatment 
assignment from the time of randomization until database lock. Randomization data will be kept 
in strict confidence by the statistician who generated the randomization schedule, the IWRS 
provider, and the vendor involved in the IP labeling. All active and placebo IP will be of 
identical appearance, regardless of the dose. Study materials will be packaged and issued in a 
manner designed to maintain the blind. 


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Unblinding by study site personnel for AEs should only be performed in an emergency, when 
knowledge of the subject’s treatment assignment is essential for the clinical management or 
welfare of the subject (Section 13.1, Emergency Unblinding).  
Prior to unblinding, the investigator should make every effort to first contact the Medical 
Monitor (or designee) and should assess the relationship of an AE to the administration of the IP. 
The investigator must then log in to the IWRS to unblind the individual subject’s treatment 
assignment. If the blind is broken for any reason, the investigator must record the date and reason 
for breaking the blind on the appropriate eCRF and source documents. 
For details of the procedure for unblinding of individual subjects in cases of emergency see 
Section 13.1. 
6.7 
Prior and Concomitant Therapy 
All medications, including over-the-counter (OTC) drugs, taken within 30 days prior to the start 
of the study (Screening Visit) will be recorded at Screening. Thereafter, a record of all 
medications and supportive therapy taken during the course of the study will be made. 
Information regarding the total daily dose, route of administration, start and discontinuation 
dates, and indication are to be recorded on the subject’s eCRF. 
Changes to medications, including prescription, OTC, herbal preparations, or mineral 
supplements taken for treatment of psoriasis will not be allowed without prior approval of the 
Medical Monitor or designee. Use of hormonal contraceptives is to be stabilized for at least 
3 months prior to randomization.  
The use of non-medicated emollients is permitted during the study; every effort is to be made to 
maintain the same regimen following Screening and throughout the study. The use of color-
cosmetics and sunscreens/sunblocking agents is allowed; however, excessive and/or prolonged 
exposure to direct sun must be avoided during the trial. 
The use of non-steroidal anti-inflammatory drugs (NSAIDs) or analgesic treatments will be 
permitted to treat symptoms of psoriatic arthritis on a PRN basis. 
Restrictions regarding prior and concomitant therapies, as listed in the Exclusion Criteria, must 
be observed during the study, including the treatment and follow-up periods. Dose adjustments 
of any permitted concomitant medications should be avoided during the study, if possible. 
The following therapies are prohibited from use at any time during the study:  
• Any drug known to influence the course of psoriasis such as lithium, beta-blockers, and 
antimalarial therapies 
- 
Stable doses of beta-blockers are permitted if there is no history of exacerbation of 
psoriasis due to beta-blockers and the dose will be kept unchanged throughout the 
trial. 


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• Any live vaccines, except flu vaccines. 
• Any systemic non-biologic immunosuppressive medication (eg, MTX, cyclosporine, 
mycophenylate mofetil, 6-thioguanine) 
• Biologic agents (eg, etanercept, alefecept) and any antibody (eg, infliximab, adalimumab, 
golimumab, ustekinumab) 
• Any systemic steroid (steroid inhalers, nasal sprays and eye drops or intra-articular 
injections are permitted) 
• Phototherapy 
• Laser therapy for psoriasis or other skin conditions 
• Topical corticosteroids (other than the limited use of mild topical steroids specified below 
under “Rescue Medication”), vitamin D analogs, tar preparations, salicylic acid, or urea 
preparations 
• Topical or systemic calcineurin inhibitors (eg, tacrolimus, pimecrolimus) 
• Topical or systemic retinoids (eg, tazarotene, tretinoin, adapalene) 
• Topical (ointment and/or baths) or oral fumaric acid derivatives 
• Cytostatic drugs (eg, cyclophosphamide, ifosfamide, vinblastine, vincristine, procarbazine, 
dacarbazine, 6-mercaptopurine, 5-fluorouracil, adriamycin) 
• Any investigational drug or therapy, or approved drug or therapy for investigational use 
 
Rescue and Concomitant Medication 
The use of rescue medications for the treatment of psoriasis may be permitted during the Double-
Blind Titration and/or Treatment Period at the investigator’s discretion. Subjects will be 
considered a treatment failure if rescue therapy is required; however, they can continue for safety 
monitoring, if required. Concomitant medications permitted for use for psoriasis are restricted to 
bland emollients and other non-medicated interventions. This excludes any topical agents that 
contain pharmacologically active ingredients (eg, salicylic acid, alpha-hydroxy acids, urea, etc.). 
Dose adjustments of any permitted concomitant medications should be avoided during the study, 
if possible.   
Note: Limited use of mild topical steroids (Class VI or VII in North America) for the treatment 
of psoriasis on limited areas (face, axilla, and/or genitalia) is permitted. Subjects will be 
permitted to use medicated shampoos (on the scalp only in the shower). This will not be 
considered as rescue medication. 
6.8 
Treatment Compliance 
Subject compliance with study drug will be assessed by the investigator and/or study personnel 
at each visit using direct questioning, and pill counts. Deviations from the prescribed treatment 
regimen will be recorded on the source document and the subjects’ eCRFs. All returned blister 
wallets or bottles must be reviewed at every visit while the subject is still at the clinic to 


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determine if the subject is dosing as instructed. Deviations from the prescribed treatment regimen 
will be recorded on the source document and the subjects’ eCRFs. 
During the Titration Period, if a subject misses a dose (or several doses), they should skip that 
dose and continue with the next scheduled dose. If a subject misses 7 or more consecutive days 
of dosing during the Titration Period, the site should contact the Sponsor or designee for 
guidance on how to proceed.  
During the Double-Blind Treatment Period, a subject is said to be compliant if they have taken 
80% to 120% of the expected tablets of study medication. If a subject has taken less than 80% or 
more than 120% of the expected tablets since the last visit, the subject should be counseled. In 
cases where noncompliance is continual, the site should contact the study Medical Monitor or 
designee to discuss other options, such as withdrawing the subject. 
Compliance calculation has been defined in Section 8.5. 
7. 
VISIT SCHEDULE AND ASSESSMENTS 
7.1 
Study Procedures 
The visit schedule and assessments are summarized in Table 1-1.  
7.2 
Study Visits and Assessments 
7.2.1 
Visit 1 Screening (Day -28 to Day -1)  
Screening of subjects will start at Visit 1 and continue up to 4 weeks prior to Baseline/ 
Randomization (Visit 2) unless an extension is granted by the Medical Monitor in advance of the 
Visit 2. Screening procedures will include: 
• 
Review study information with subject and obtain written informed consent 
• 
Register subject in IWRS to receive Screening Number 
• 
Review inclusion and exclusion criteria with the subject to determine the subject’s 
eligibility 
• 
Perform psoriasis assessments to ensure that subject will meet PASI, IGA, and BSA 
requirements at Baseline visit 
• 
Collect medical history and demographic information 
• 
Collect psoriasis medical history and use of all prior medications and non-drug therapies to 
treat psoriasis 
• 
Review and record prior medications (used within the previous 30 days) and concomitant 
medications (medications currently used) 
• 
Perform a complete physical examination, including height, weight, and waist 
circumference 


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• 
Measure vital signs (systolic and diastolic blood pressure, heart rate, and respiratory rate) 
with subject in a seated position 
• 
Obtain a 12-lead ECG 
• 
Obtain blood and urine samples for routine laboratory profile evaluations including 
hematology, serum chemistry, and urinalysis 
• 
Obtain samples for serology: human immunodeficiency virus (HIV), hepatitis B virus 
surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), and hepatitis C 
virus (HCV) 
• 
Obtain a sample for a serum pregnancy test for all female subjects. Instruct all female 
subjects to use approved form(s) of contraception  
• 
Record any SAEs (from time of signing ICF) 
• 
If subject meets the inclusion/exclusion criteria, instruct the subject to begin washout of 
prohibited medications and schedule Visit 2 pending receipt of lab and ECG results 
7.2.2 
Visit 2 – Randomization/Baseline (Day 0) 
• 
Perform psoriasis assessments: 
• 
PASI, BSA, IGA 
• 
NAPSI for fingernails, PSSI, PP PGA for all subjects; if score is 0 at Baseline for any 
of these assessments, then the respective assessment(s) would not be required to be 
completed at future study visits  
• 
Confirm psoriasis medical history and previous psoriasis therapies 
• 
Confirm medical history and record any new findings 
• 
Review and record medication changes since the Screening visit, including changes in 
prescription and OTC medications, herbal preparations, and vitamin and/or mineral 
supplements and non-drug therapies 
• 
Confirm washout of prohibited medications 
• 
Perform a partial physical examination with focus on previously noted abnormalities in 
organ systems, including skin 
• 
Measure vital signs (systolic and diastolic blood pressure, heart rate, and respiratory rate) 
with subject in a seated position 
• 
Obtain a 12-lead ECG (Baseline Visit central ECG reading will not be available prior to 
Randomization; Investigator must review Baseline ECG tracing to confirm eligibility prior 
to Randomization. Subject with clinically significant ECG findings in the Investigator’s 
opinion will be screen failed. Investigator also must review the central ECG reading when 
results are available. Subjects with unacceptable ECG findings will be discontinued from 
the study) 
• 
Review inclusion and exclusion criteria to confirm that the subject is qualified for study 
participation 


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• 
Perform a urine pregnancy test for female subjects of childbearing potential. Instruct all 
female subjects to use approved form(s) of contraception  
• 
Obtain blood and urine samples for routine laboratory profile evaluations including 
hematology, serum chemistry, and urinalysis 
• 
Blood collection for PD study as well as lymphocyte & Ab titer study 
• 
Record any SAEs 
• 
Have the subject complete the following assessments:  
• 
Pruritus NRS, DLQI, SF-12, QIDS-SR16, WPAI: PSO, HEOR 
• 
Perform photography (at selected 3 sites only); see photography reference materials for 
details 
• 
Randomize the subject in IWRS after confirmation of eligibility criteria 
• 
Instruct subjects on dosing and dispense study drug 
• 
Dispense educational materials for AE management (provided by Sponsor) 
• 
Provide subject with Bristol Stool Chart; have the subject confirm the average frequency of 
their bowel movements for the past 15 days and the general consistency of the stool using 
the Bristol Stool Chart 
 
7.2.3 
Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 
(Week 20), and Visit 8 (Week 24) 
• 
Review any concomitant medication changes since the previous study visit 
• 
Perform a partial physical examination with focus on previously noted abnormalities in 
organ systems, including skin 
• 
Measure weight 
• 
Measure waist circumference (Week 24 only) 
• 
Measure vital signs (systolic and diastolic blood pressure, heart rate, and respiratory rate) 
with subject in a seated position 
• 
Record a 12-lead ECG 
• 
Obtain blood and urine samples for routine laboratory profile evaluations including 
hematology, clinical chemistry, and urinalysis 
• 
Blood collection for PD study 
• 
Blood collection for lymphocyte subset & Ab titer study (Week 24, or at any time during 
the study if subject shows signs of PML) 
• 
Perform a UPT for females of childbearing potential. Ensure that female subjects of 
childbearing potential are using approved method(s) of contraception. 
• 
Record any AEs 


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• 
Perform psoriasis assessments if applicable:  
• 
PASI, BSA, IGA 
• 
NAPSI for target fingernail, if applicable (weeks 12, 16 and 24 only) 
• 
 PSSI, PP PGA (if applicable)  
• 
Have the subject perform the following assessments: 
• 
Pruritus NRS  
• 
DLQI, SF-12, QIDS-SR16, WPAI: PSO, HEOR (Weeks 12, 16, and 24 only) 
• 
Perform photography (at selected 3 sites only) (Weeks 12, 16, and 24 only); see 
photography reference materials for details 
• 
Assess IP compliance/accountability  
• 
Dispense IP as applicable (Weeks 4, 8, 12, 16, and 20) 
7.2.4 
Early Termination Visit 
• 
Review any concomitant medication changes since the previous study visit 
• 
Assess IP compliance/accountability  
• 
Perform a partial physical examination with focus on previously noted abnormalities in 
organ systems, including skin 
• 
Measure weight 
• 
Measure waist circumference 
• 
Measure vital signs (systolic and diastolic blood pressure, heart rate, and respiratory rate) 
with subject in a seated position 
• 
Record a 12-lead ECG 
• 
Perform a UPT for females of childbearing potential. Ensure that female subjects of 
childbearing potential are using approved method(s) of contraception. 
• 
Obtain blood and urine samples for routine laboratory profile evaluations including 
hematology, clinical chemistry, and urinalysis 
• 
Blood collection for lymphocyte subset & Ab titer study 
• 
Record any AEs 
• 
Perform psoriasis assessments:  
• 
PASI, BSA, IGA 
• 
NAPSI for target fingernail, PSSI, PP PGA (if applicable) 
• 
Have the subject perform the following assessments: 
• 
Pruritus NRS 


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• 
DLQI, SF-12, QIDS-SR16, WPAI: PSO, HEOR 
7.2.5 
Safety Follow-up Visit (Week 25 [+3 days], or 1 Week [+3 days] after ETV, 
unless final dose was taken >7 days prior to Week 24/ETV) 
• 
Review any concomitant medications used since the previous study visit 
• 
Perform a partial physical examination with focus on previously noted abnormalities in 
organ systems, including skin 
• 
Measure vital signs (systolic and diastolic blood pressure, heart rate, and respiratory rate) 
with subject in a seated position 
• 
Record a 12-lead ECG 
• 
Perform a UPT for females of childbearing potential. Ensure that female subjects of 
childbearing potential are using approved method(s) of contraception. 
• 
Record any AEs 
• 
Perform psoriasis assessments:  
• 
PASI, BSA, IGA 
• 
NAPSI for the target fingernail , PSSI, PP PGA (if applicable) 
• 
Have the subject perform the following assessments: 
• 
Pruritus NRS 
• 
DLQI, SF-12, QIDS-SR16, WPAI: PSO, HEOR 
7.2.6 
Unscheduled Visit 
If a subject returns to the site for an unscheduled visit, the following assessments may be 
performed at the discretion of the Investigator: 
• Review any concomitant medications used since the previous study visit 
• Perform a partial physical examination with focus on previously noted abnormalities in 
organ systems, including skin 
• Measure weight 
• Measure vital signs (systolic and diastolic blood pressure, heart rate, and respiratory rate) 
with subject in a seated position 
• Obtain blood and urine samples for routine laboratory profile evaluations including 
hematology, clinical chemistry, and urinalysis 
• Record any AEs 
7.3 
Efficacy Assessments 
Efficacy will be evaluated via psoriasis assessments and measures of QoL.  


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Psoriasis assessments include the PASI, the affected BSA, and the IGA. Subject-reported 
assessments of health-related QoL include the DLQI, 12-Item Short Form Survey (SF-12), the 
Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), the WPAI:PSO, the 
HEOR, and the Pruritus NRS.  
Other psoriasis assessments to be performed as applicable include the NAPSI for the target 
fingernail, the PSSI score, and the PP PGA score. 
Brief descriptions of these assessments are presented as follows. 
7.3.1 
Co-Primary Efficacy Assessments: Psoriasis Area and Severity Index and 
Investigator’s Global Assessment 
The investigator or designee will assess the extent and severity of the subjects’ psoriasis using 
the PASI scoring system and will perform a global assessment of disease severity using the IGA. 
The PASI scale is provided in Appendix 1; the IGA is a 5-point scale which measures the 
investigator’s or designee’s impression of the disease at a single point. Assessments will be 
performed at the visits specified in Table 1-1. Sites should make every effort to ensure 
consistency in evaluators across visits, especially between Baseline and Week 24. 
Psoriasis Area and Severity Index 
The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each 
graded on a 0–4 scale) and weighted by the area of involvement (Fredriksson, 1978). There are a 
few validation studies performed describing, with some limitations, the construct validity, face 
validity, and sensitivity to change (Ashcroft, 1999). National Psoriasis Foundation Medical 
Advisory Board standardized the definitions of events of psoriasis recurrence based on PASI, 
including the definition of relapse, which is a loss of at least 50% of PASI improvement after 
discontinuation of treatment in patients who had achieved a clinically meaningful response; and 
rebound, which is PASI ≥125% of Baseline or new generalized pustular, erythrodermic, or more 
inflammatory psoriasis (Carey, 2006; Gordon, 2005). In the current trial, PASI improvement will 
be evaluated from Baseline to all visits during the Titration and Treatment Periods, and clinically 
meaningful response is defined as PASI-50 (Carlin, 2004). 
Investigator’s Global Assessment 
The IGA should be performed by the same evaluator (rater) who performs the PASI assessments 
and all efficacy assessments should be performed by the same evaluator throughout the study 
when possible. The scale in Table 7-1 will be used for the IGA assessment:  


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Table 7-1 
Investigator’s Global Assessment (IGA) 
Score  Grade  
Definition  
0 
Clear 
No signs of psoriasis 
Post-inflammatory hyperpigmentation may be present 
1 
Almost 
clear 
No thickening to minimal plaque elevation 
Normal to slight pink coloration/faint erythema 
Focal to minimal scaling 
2 
Mild 
Slight elevation/thickening 
Pink to light red coloration 
Predominantly fine scaling partially or mostly covering lesions 
3 
Moderate 
Clearly distinguishable/distinct thickening 
Definite red coloration 
Coarse scaling covering most plaques 
4 
Severe 
Marked thickening with hard/sharp edges 
Bright to deep dark red coloration 
Thick/coarse scaling covering almost all or all lesions 
Adapted from: Langley RGB, Feldman SR, Nyirady J, van de Kerkhof P, et al. The 5-point Investigator’s 
Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J 
Dermatolog Treat. 2015;26(1): 23-31. 
 
7.3.2 
Secondary Efficacy Assessments 
Secondary efficacy assessments will be performed at the visits specified in Table 1-1. 
7.3.2.1 
Affected Body Surface Area 
BSA will be calculated using handprint methodology, comparing the size of the affected area to 
the size of the subject’s entire handprint, which equates to approximately 1% BSA. Evaluators 
should use the method consistently throughout the trial.  
7.3.2.2 
Nail Psoriasis Severity Index 
The NAPSI is a numeric, reproducible, objective, simple tool for evaluation of nail psoriasis. 
This scale is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area 
of involvement in the nail unit. The NAPSI is provided in Appendix 2. 
7.3.2.3 
Psoriasis Scalp Severity Index  
The PSSI is a grading system for scalp psoriasis, which is similar to the PASI for generalized 
psoriasis. The scale for PSSI ranges from 0 (absent) to 4 (very severe) for each of the three 
categories of erythema, desquamation and thickness, which are rated separately. The individual 
scores are then added and multiplied by a number based on the area of the scalp that is covered 
by psoriasis. The final PSSI score can range from 0 to 72.  
The PSSI is provided in Appendix 3. 


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7.3.2.4 
Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) 
The investigator or designee will assess the subject’s palmar and plantar surfaces using the PP 
PGA score. The PP PGA is provided in Appendix 4.  
7.3.2.5 
Pruritus Numerical Rating System 
The subject will be asked to rate the intensity of their pruritus using the Pruritus NRS. The 
Pruritus NRS will be used to assess pruritus intensity over the previous 24 hours. It is a 
commonly used instrument with demonstrated high reliability and concurrent validity (Phan, 
2012; Reich, 2009). The NRS records the subject’s perceptions of their pruritus and can be used 
to monitor changes over time. 
7.3.3 
Health-related Quality of Life Assessments 
Health-related QoL assessments will be performed at the visits specified in Table 1-1. 
7.3.3.1 
Dermatology Life Quality Index 
The subject will be asked to complete the DLQI, which is a validated questionnaire consisting of 
10 questions relating to the degree to which the subject’s skin condition affects their daily 
activities (Finlay 1994). The DLQI is provided in Appendix 5. 
7.3.3.2 
12-Item Short Form Survey 
The SF-12 questionnaire contains a set of generic, coherent, and easily administered patient-
reported quality-of-life measures that are useful for the monitoring and assessment of care 
outcomes in adult subjects. The SF-12 is provided in Appendix 6. 
7.3.3.3 
Quick Inventory of Depressive Symptomatology-Self Report (16 Items) 
The Quick Inventory of Depressive Symptomatology – Self Report is a questionnaire designed to 
be filled out by the subject to assess the severity of depressive symptoms. The Quick Inventory 
of Depressive Symptomology – Self Report is provided in Appendix 7. 
7.3.3.4 
Work Productivity and Activity Impairment Questionnaire: Psoriasis 
The Work Productivity and Activity Impairment (WPAI) questionnaire is an instrument designed 
to measure impairments in work and in activities. 
The Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) is 
provided in Appendix 8. 
7.3.3.5 
Health Economics and Outcomes Research 
The HEOR evaluation will be performed by asking three questions at Baseline, Week 12, Week 
16, Week 24/ETV, and Week 25 Visit. The questions are the following: 


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• Baseline visit  
o How many times, in the past 3 months, have you been to any physician's office or 
urgent care clinic? 
 Please state reason for each visit 
 
o How many times, in the past 3 months, have you seen a nurse practitioner, a 
physician assistant, a psychologist, a naturopath, an acupuncturist, a chiropractor, 
or other healthcare professional (HCP)?  
 Please state reason for each visit 
 
o How many times, in the past 3 months, have you received care from a health 
professional in your home? 
  Please state reason for each visit 
 
• 12 weeks, 16 weeks, 24 weeks and 25 weeks 
o How many times, since you started the study medication, have you been to any 
physician's office or urgent care clinic, other than the regular assessment 
appointments as part of the clinical trial?  
 Please state reason for each visit 
 
o How many times, since you started the study medication, have you seen a nurse 
practitioner, a physician assistant, a psychologist, a naturopath, an acupuncturist, a 
chiropractor, or other healthcare professional (HCP)?  
 Please state reason for each visit 
 
o How many times, since you started the study medication, have you received care 
from a health professional in your home?  
 Please state reason for each visit 
 
7.4 
Assessment of Pharmacokinetics  
No pharmacokinetics determinations will be assessed during this study. 
7.5 
Assessment of Safety 
7.5.1 
Adverse Events 
7.5.1.1 
Adverse Events Assessments 
An AE is an untoward medical occurrence in any subject during the study which does not 
necessarily have a causal relationship with the study drug treatment. Adverse events can be 
categorized as treatment-emergent or treatment-related. All AEs will be recorded and will be 
documented in the eCRF and will be captured from the time of intake of study drug. All serious 
adverse events (SAEs) will be captured from the time of signing the ICF and must be reported to 
the sponsor within 24 hours of awareness. The condition of the subject will be monitored 
throughout the study for any signs or symptoms. The occurrence of AEs should be sought by 


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nondirective questioning of the subject at each visit during the study. All AEs will be collected 
as: 
• 
The subject’s response to questions about their health 
• 
Symptoms spontaneously reported by the subject 
• 
Clinically relevant changes and abnormalities observed by the investigator (eg, local and 
systemic tolerability, laboratory measurements, results of physical examinations) 
If a Medical History condition worsens or increases in frequency after the first dose of IP, it 
should be recorded as an AE in the eCRF. If an AE worsens in intensity, it should be recorded as 
a new AE. Otherwise, it continues as the first report (counted as the same AE) until the subject is 
recovered. 
The investigator or designee will record the following on the AE eCRF: 
• 
AE and relevant clinical findings 
• 
Time/date of onset 
• 
Time/date of recovery 
• 
Intensity 
• 
Action taken on study drug/treatment 
• 
Other action taken to treat the event 
• 
Relation to study drug/treatment 
• 
Seriousness of the AE 
AEs requiring therapy must be treated with recognized standards of medical care to protect the 
health and well-being of the subject. Treatment due to an AE will be recorded. 
Subjects who prematurely withdraw from the study for AEs are to be monitored for up to 30 
days after the subject stopped study treatment or until the abnormal parameter resolves or 
stabilizes.  
The outcome of an AE will be classified as recovered, recovered with sequelae, not yet 
recovered, or death.  
7.5.1.2 
Timing 
Adverse events will be assessed at all study visits. Adverse events should be monitored by the 
investigator for up to 30 days after the subject has stopped study treatment or until the AE has 
resolved or stabilized. 


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Treatment-emergent AEs (TEAEs) include any untoward medical occurrence in a patient/subject 
or clinical investigation subject after administration of an investigational study treatment, which 
does not necessarily have to have a causal relationship with this treatment. A TEAE can 
therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of the product, whether or not related to 
the medicinal (investigational) product. It could also include accidents and reasons for changes in 
medication (drug and/or dose), any medical, nursing or pharmacy consultation, or admission to 
hospital or surgical operations. Record TEAEs that occur after the first dose through 5 days after 
the last dose. 
Treatment-related AEs are all TEAEs that are considered by the investigator as causally related 
to administration of the study drug. 
7.5.1.3 
Severity of Adverse Events 
The investigator is to classify the severity (intensity) of an AE according to the following 
definitions: 
• Mild – The subject was aware of the signs and symptoms but the signs and symptoms 
were easily tolerated. 
• Moderate – The signs and symptoms were sufficient to restrict, but did not prevent, usual 
daily activity for the subject. 
• Severe – The subject was unable to perform usual daily activity. 
The maximum intensity of an AE (mild, moderate, or severe) will be assessed taking into 
account the possible range of intensity of the symptom(s). 
The severity of diarrhea and lymphocytopenia will be graded using a modified common 
terminology criteria for adverse events (CTCAE), Version 4.03 (see Appendix 9). If the subject 
reports that they are experiencing diarrhea, they will be presented with the Bristol Stool Chart 
and asked to identify the consistency (see Bristol Stool Chart Appendix 10). Only Type 7 on the 
Bristol Stool Chart is considered diarrhea. The frequency of Type 7 diarrhea is then used to 
determine the CTCAE grade. All subjects will be provided with educational materials at Baseline 
to help prepare them for the potential GI-related adverse events. All subjects will be asked at 
Baseline to assess the average frequency of their bowel movements for the past 15 days and the 
general consistency of the stool using the Bristol Stool Chart. 


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7.5.1.4 
Relationship of an Adverse Event to Study Treatment 
The investigator is to classify the relationship of an AE to the IP using good clinical judgment 
and the following definitions: 
Not Related 
The AE is clearly explained by another cause not related to the study 
product 
Probably Not Related 
A potential relationship between study product and the AE could exist 
(ie, the possibility cannot be excluded), but the AE is most likely 
explained by causes other than the study agent 
Possibly Related 
The AE and administration of study product are temporally related, but 
the AE can be explained equally well by causes other than the study 
product 
Probably Related 
The AE and use of study product are temporally related, and the AE is 
more likely explained by study product than by other causes 
Definitely Related 
The AE and use of study product are related in time, and a direct 
association can be demonstrated 
Adverse events commonly observed in previous clinical studies with PPC-06 include GI 
disorders, including diarrhea, nausea, and abdominal pain, and flushing. As a class, FAEs are 
known to have an effect on lymphocyte and eosinophil counts. Reversible lymphopenia and 
transient eosinophilia are frequently observed with both Fumaderm and Tecfidera treatment. 
7.5.1.5 
Adverse Event of Special Interest (AESI) 
If the subject complains of any kind of neurological symptoms (such as aphasia, clumsiness, 
weakening of arms and legs or any new neurological signs or symptoms) during the scheduled 
study visits or at any time point during the study, the subject will be evaluated at the site for any 
neurological dysfunction. If the site evaluation for neurological dysfunction is positive or 
equivocal, the subject will be referred to a neurologist for consultation. If the subject is negative 
for PML after examination by the neurologist, the subject will continue in the study. If required, 
the PML experts will be consulted to assess and monitor, as the case may be. The study drug will 
be stopped in the subject only if recommended by the PML expert.  
Stopping Rules: 
The potential event of PML will be carefully managed by utilizing the below stopping criteria. If 
one or more of the below criteria are met, study drug will be permanently discontinued and the 
subject will be scheduled for an ETV followed by Safety Follow-up visits 1 week (± 3 days) 
after the last dose of study drug. 


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• Lymphocytes <500/mm3 in one reading; 
• Lymphocytes <800/mm3 in 3 consecutive visits 4 weeks apart; Lymphocyte count can be 
repeated in the interim period. If the interim lymphocyte counts are higher than 
800/cu.mm, then the PI with concurrence from Medical monitor, will decide if the 
subjects should stay in the study or discontinued from the study. 
• When recommended by the PML expert.  
Blood collection for lymphocyte subset & Ab titer can be collected at any study visit if the 
subject shows signs of PML. 
7.5.2 
Serious Adverse Event 
An SAE is any untoward medical occurrence that at any dose: 
• results in death 
• is life-threatening 
• requires in-patient hospitalization or prolongation of existing hospitalization 
• results in persistent or significant disability/incapacity 
• is a congenital anomaly/birth defect, or is an important medical event 
The death of a subject enrolled in a study is per se not an event, but an outcome. Any event 
resulting in a fatal outcome must be fully documented and reported, regardless of the causality 
relationship to the IP. 
The term life-threatening refers to an AE in which the subject was at immediate risk of death at 
the time of the event. It does not refer to an event, which may have caused death, if it was more 
severe. 
Medical and scientific judgment should be exercised in deciding whether expedited reporting is 
appropriate in other situations, such as important medical events that may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject or may require 
intervention to prevent one of the other outcomes listed in the definition above. These should 
also usually be considered serious. Examples of important medical events include AEs, which 
suggest a significant hazard, contraindication or precaution, occurrence of malignancy, or 
development of drug dependency or drug abuse. 
Any SAE, whether or not deemed drug-related or expected, must be reported immediately to the 
sponsor’s designee as soon as it becomes known to the investigator and not later than within 24 
hours of his/her knowledge of the occurrence of an SAE. The investigator will document such 
events in the best possible detail on the SAE Report Form to be transmitted to the sponsor’s 
designee.  


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An IND Safety Report (INDSR) is an SAE that is both unexpected (not consistent with the 
current Investigator’s Brochure/product information) and for which there is evidence to suggest a 
causal relationship between the drug and the AE. The Institutional Review Board (IRB) will be 
informed of INDSRs according to local requirements. All investigators participating in the trial 
will also be notified of unexpected SAEs. The sponsor will report SAEs and other events 
requiring expedited reporting to regulatory authorities as required.  
Investigator instructions for reporting SAEs are provided in Section 13.2. 
7.5.3 
Safety Laboratory Assessments 
Blood and urine samples for laboratory tests (hematology, serum biochemistry, and urinalysis) 
will be collected as specified in Table 1-1. Clinical laboratory specimens will be analyzed by a 
central licensed and accredited laboratory facility according to the laboratory’s standard 
operating procedures.  
If any of the laboratory parameters of interest show a significant shift from baseline, subjects will 
then be scheduled for an interim visit within 2 weeks to repeat the laboratory measurements. 
Non-fasting blood samples will be obtained at each visit for laboratory analysis of serum 
glucose, lipid panel, hsCRP, and PD study. 
No blood is to be collected for the PD study at Screening. 
Blood samples for serology assessment (HIV, HBsAg, Anti-HBc, and HCV) will be obtained at 
Visit 1 (Screening). 
Lymphocyte subsets and antibody titer will be collected for safety assessments per Table 1-1. 
The routine clinical laboratory tests to be performed are provided in Table 7-2. 
The investigator may collect additional blood or urine samples to repeat any laboratory test that 
was abnormal post-dosing, or was within normal limits at Baseline, and is considered clinically 
significant. Abnormal laboratory results at the last scheduled visit may require additional 
collection of samples on an “as needed” basis until: a) the values return to the baseline value, b) 
the values are within normal limits, c) the values are clinically stable, or d) the investigator 
determines that further follow-up is unnecessary. The investigator will record the date and time 
of all additional samples collected. If the investigator establishes a clear explanation for the 
laboratory abnormality, he/she will record this explanation in the eCRFs. 
Blood will also be collected and evaluated for PD study per Table 1-1. 


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Table 7-2 
Routine Clinical Laboratory Assessments 
Hematology  
• 
Platelet Count  
RBC Indices: 
Automated WBC Differential: 
• 
RBC Count 
• 
MCV 
• 
Neutrophils 
• 
WBC Count (absolute)  
• 
Lymphocytes (absolute) 
• 
Neutrophils (absolute) 
• 
Monocytes (absolute) 
• 
MCHC  
• 
MCH 
• 
Lymphocytes  
• 
Monocytes  
• 
Eosinophils  
• 
Basophils 
• 
Hemoglobin 
 
 
• 
Hematocrit 
• 
Lymphocyte subset (collected and will be assessed ) 
• 
Antibody titer (collected and stored with assessment done as required) 
 
Chemistry  
• 
Sodium 
• 
Creatine Kinase 
• 
Cholesterol  
• 
Potassium 
• 
Alkaline Phosphatase 
• 
Triglycerides 
• 
Chloride 
• 
GGT 
• 
HDL Cholesterol 
• 
Bicarbonate 
• 
LDH 
• 
LDL Cholesterol 
• 
BUN  
• 
Total Bilirubin  
• 
Calcium 
• 
Creatinine 
• 
Direct Bilirubin 
• 
Phosphorus 
• 
AST (SGOT) 
• 
Total Protein 
• 
Uric Acid 
• 
ALT (SGPT) 
• 
Glucose (non-fasting) 
• 
Magnesium 
 
• 
Albumin 
• 
Creatinine Clearance 
 
 
 
Routine Urinalysis  
• 
Appearance, color 
• 
pH, specific gravity 
• 
Glucose, blood, bilirubin, leukocyte esterase, ketones, nitrates 
• 
Urine protein, urine creatinine, protein:creatinine ratio 
• 
Microscopic examination (if indicated per clinical laboratory standards) 
 
Serology (Visit 1/Screening only) 
• 
HIV 
• 
HBsAg and Anti-HBc 
• 
HCV 
 
7.5.4 
Pregnancy Testing 
All female subjects will undergo a serum pregnancy test at the screening visit. Female subjects of 
child-bearing potential will undergo a urine pregnancy test at the baseline visit before the subject 
is randomized. If either pregnancy test is positive, the subject will not be permitted to enroll in 
the study. 
Urine pregnancy tests will be performed as per the study schedule. At the investigator’s 
discretion, additional testing for pregnancy may be performed for verification purposes. The 


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pregnancy tests must have a sensitivity of at least 25 mIU/mL. If there is a suspicion of 
pregnancy at any time during the study, a urine sample will be obtained and tested. Should a 
subject become pregnant during the study, treatment must be immediately discontinued. Subjects 
should continue with non-treatment and/or follow-up visits.  
All pregnancies should be immediately reported to the sponsor/Contract Research Organization 
(CRO)/Medical Monitor and followed through to resolution (ie, delivery, miscarriage, or 
abortion). The report should be submitted within the same timelines as an SAE (within 24 hours 
of knowledge), although a pregnancy per se is not considered an SAE. 
7.5.5 
Vital Signs 
Measurements of vital signs, including blood pressure, pulse rate, and respiratory rate, will be 
taken at every visit with the subject seated. 
7.5.6 
Physical Examination 
A complete physical examination including assessments of the head, eyes, ears, nose, throat, 
skin, neck (including thyroid), lungs, cardiovascular, abdomen, lymph nodes and extremities will 
be obtained at Screening. Weight (in kg), height (in cm) and waist circumference (in cm) will 
also be measured. 
An abbreviated physical exam including changes since the Screening Visit with focus on 
previously noted abnormalities in organ systems, including skin, will be completed at 
Baseline/Visit 2 and at all post-Baseline visits. Weight will also be measured.  
Abnormalities noted during the Screening or Baseline physical exams should be recorded on the 
Medical History eCRFs. Any abnormalities noted on the physical exam following the first dose 
of study drug should be recorded as an AE, as appropriate. 
7.5.7 
Electrocardiogram 
A 12-lead electrocardiogram (ECG) will be recorded at the visits specified in Table 1-1. 
7.6 
Appropriateness of Measurements 
The methodology used in this study to determine efficacy and safety are the standardized and 
most widely accepted methods for evaluating safety and efficacy in studies of plaque psoriasis. 
8. 
STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE 
STATISTICAL AND ANALYTICAL PLANS 
8.1 
General Considerations for Data Analysis 
The methodology presented in this section represents a brief overview of the statistical methods 
that will be fully detailed in the statistical analysis plan (SAP). The SAP will be finalized before 
the database is locked and unblinded. Any changes to the methods described in the final SAP 
will be described and justified in the clinical study report. 


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Study sites will be pooled into analysis centers for the efficacy analyses. The composition of 
pooled analysis centers will be finalized before the database is locked and unblinded. 
All statistical analyses will be performed using SAS statistical software (Version 9.2 or above). 
Statistical significance will be tested at the 2-sided 5% level. Subgroup analyses (eg, prior 
biologic use) may be performed. 
Data collected in this study will be presented using summary tables, figures, and subject data 
listings. Summary tables will present data by treatment group and, if applicable, by time of 
collection. Continuous variables will be summarized using descriptive statistics, specifically the 
mean, median, standard deviation, minimum and maximum. Categorical variables will be 
summarized by frequencies and percentages. Figures will be used to support the presentation of 
certain data. 
8.2 
Sample Size and Power Considerations 
It was determined that a sample size of 100 subjects per treatment group would detect a 
significant difference in proportion of PASI-75 and IGA responders from Baseline to Week 24 
between each dose group of PPC-06 and placebo group, assuming a 15% response rate for the 
placebo group and 45% for PPC-06 at Week 24. To provide sufficient evidence of treatment 
effect, both PASI and IGA based response rate have to be rejected at the same significance level. 
The hypothesis testing for the 3 dose groups will be conducted sequentially from high to low 
dose; therefore, the 2-sided Type I error rate from a chi-squared test remains at the 0.05 level. 
Assuming 50% dropout rate, about 100 subjects per treatment arm will be randomized to get 
approximately 50 completers in each treatment arm. The total sample size of 400 subjects will 
yield at least 84% power for hypothesis testing of the co-primary endpoints of a difference in 
PASI-75 and IGA responders from Baseline to Week 24 between PPC-06 doses and placebo. 
8.3 
Analysis Populations 
The analysis populations include the following:  
• The safety population will include all subjects who receive at least one dose of IP. The 
safety population is the population used for all safety analyses. 
•  Full Analysis Set (FAS) - All randomized subjects who receive at least one dose of 
investigational product and have at least one post dose efficacy assessment. The FAS 
population will be the primary population for the efficacy analyses. 
 
• The Per Protocol (PP) population will include subjects in the FAS population who 
complete the study without any major protocol violations. The composition of the PP 
population will be determined and documented in blind reviews of the database 
conducted prior to unblinding the study database.  


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8.4 
Background and Demographic Characteristics 
Demographic data that will be summarized include age, gender, race, weight, waist 
circumference, and BMI. Baseline characteristics assessments include the pre-dosing 
assessments for the following variables: PASI, BSA, and IGA. Demographic and Baseline 
characteristics will be summarized by treatment group.  
Any variables found to be imbalanced across treatment groups at Baseline may be included as 
covariates or be used as subgroup levels in exploratory efficacy analyses. Full details of the 
Baseline analyses will be described in the SAP. 
8.5 
Study Medication/Visit Compliance 
The number of doses received by each subject and the number of days exposed to study 
medication will be summarized by treatment group and study period (titration, treatment, overall) 
using summary statistics (mean, standard deviation [SD], median, minimum, and maximum), and 
categorically.  
The percent of subjects compliant with study medication at each visit will be presented by study 
period and overall. 
Following are the compliance parameters: 
• Total number of tablets taken during the titration period (Week 1-5), defined as number 
of dispensed tablets from blister wallets minus number of returned tablets from blister 
wallets. 
• Total number of tablets taken during the treatment period (Week 6 – 24), defined as total 
number of dispensed tablets from bottles minus total number of returned tablets from 
bottles. 
• Number of tablets taken per bottle during the treatment period (Weeks 6 - 24), defined as 
number of dispensed tablets per bottle (total of 4 bottles per visit) minus number of 
returned tablets per bottle (total of 4 bottles per visit). 
• Total number of tablets taken, defined as the summation of number of tablets taken 
during the titration and the treatment period.  
• Percent compliance will be calculated as the number of tablets taken divided by the 
expected number of tablets, as defined for the titration period, treatment period and 
overall. 
• Subject compliance, defined as 80% - 120% (inclusive) in percent. If the percentage of 
study medication compliance is unknown, the subject is assumed to be non-compliant 
with study medication. 
• The average daily dose of IP received can be calculated as the number of tablets divided 
by the number of days exposed to study medication. 


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• The average daily dose of IP received by each subject will be summarized by visit, 
treatment group using summary statistics (mean, SD, median, minimum, and maximum), 
for the overall period. 
8.6 
Prior and Concomitant Therapy 
Prior and concomitant medication information for all randomized subjects will be presented in a 
by-subject listing. Summary tables will be presented by Anatomical Therapeutic Chemical 
Classification System (ATC) therapeutic category and product based on WHO-DD coding. 
8.7 
Analysis of Efficacy 
8.7.1 
Co-Primary Efficacy Endpoint(s) 
The co-primary efficacy endpoints are as follows: 
• The proportion of subjects who achieve a reduction of 75% or greater from Baseline in 
the Psoriasis Area and Severity Index (PASI-75) at the end of Week 24 
• The proportion of subjects who achieve an IGA score of clear or almost clear (IGA score 
0 or 1) at the end of Week 24 
The null hypothesis to be tested for the primary efficacy endpoint is that the proportion of 
subjects who achieve PASI-75 and IGA success is not different between the subjects treated with 
PPC-06 and placebo. The alternative hypothesis is that the proportion of subjects who achieve 
PASI-75 and IGA success at Week 24 for placebo is different from PPC-06. Each of the PPC-06 
doses will be compared with placebo separately.  
Each of the dichotomized endpoints, PASI-75 response (Yes/No) and the IGA response, at Week 
24 will be analyzed using a logistic regression model with treatment, baseline BMI, and pooled 
analysis center as factors. Additional factors may be included in the models. Each of the PPC-06 
doses will be compared to placebo separately.  
To provide sufficient evidence of treatment effect, both PASI and IGA based response rate have 
to be rejected at the same significance level. The hypothesis testing for the 3 dose groups will be 
conducted sequentially from high to low dose; therefore, the 2-sided Type I error rate from a chi-
squared test remains at the 0.05 level. 
8.7.2 
Secondary Efficacy Endpoints 
The secondary endpoints are the following 
• Percent change from Baseline in Total PASI Score by Visit; 
• Proportion of subjects who achieve PASI-50 and PASI-75 by Visit; 
• Proportion of subjects who achieve an IGA score of clear or almost clear by Visit; 
• Absolute and percent change from Baseline in percent of affected BSA by Visit; 


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• For applicable subjects, change from baseline by visit in NAPSI of the target fingernail, 
PSSI, and PP PGA; 
• Absolute and percent change from baseline in pruritus NRS by visit 
• Time to achieving a PASI 75 response; 
• Time to achieving an IGA score of 0 or 1; 
The quality of life endpoints are the following: 
• Change from Baseline by Visit in DLQI Total Score, SF-12, QIDS-SR16, and WPAI: 
PSO; 
• Summary of HEOR questions by visit; 
Secondary efficacy variables will be analyzed as follows:  
Categorical secondary efficacy endpoints will be summarized at each visit using the number 
and percentage of subjects within each category for each treatment group. A same logistic 
regression model as used for the primary endpoint will be performed including treatment, 
baseline BMI, and pooled analysis center as factors. Additional factors may be included in 
the models. Each treatment will be compared to placebo separately as described in the 
primary analysis. 
Continuous secondary efficacy endpoints will be summarized descriptively and analyzed 
using an Analysis of Variance (ANOVA) including factors for treatment, baseline BMI, and 
pooled analysis center. Each treatment will be compared to placebo separately as described in 
the primary analysis. Additional factors along with interaction terms may be included in the 
models. 
All secondary efficacy analyses will be performed on the FAS and PP populations. Subgroup 
analyses may also be performed.  
All QoL endpoints will be summarized by visit and treatment group using descriptive 
statistics. 
8.7.3 
Handling of Missing Values/Censoring/Discontinuations 
The primary population for all efficacy analyses will be the FAS population.  
For the analyses of the primary endpoints (PASI-75 and IGA) based on the FAS population, 
several methods will be used to impute missing data, including, multiple imputation (MI),  
modified non-responder imputation (mNRI), and last-observation-carried forward (LOCF).  MI 
will be the primary imputation method. Sensitivity analyses using LOCF and m-NRI will be 
performed to assess the robustness of alternate imputation assumptions. In particular, subjects 


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who used rescue medications or who discontinue due to unsatisfactory therapeutic effect will be 
included in PP population. These subjects will be considered as treatment failures (i.e., non-
responder for both PASI-75 and IGA) for all time points after the initiation of rescue medications 
or subject discontinuation.  
MI:  Missing data will be imputed using multiple imputations. MI will be implemented for all 
subjects with missing data, including those who used rescue medications and those who 
discontinued due to unsatisfactory therapeutic effect. 
MI for missing PASI scores :  Intermittent missing values of PASI scores will be imputed 
separately for each  treatment group using the Markov Chain Monte Carlo (MCMC) method, 
generating 50 copies of the imputed dataset with monotonic missing pattern. For each of the 50 
datasets, missing values at scheduled visits (Weeks 4, 8, 12, 16, 20 and 24) will be imputed using 
a linear regression model. The imputations will include the following variables: baseline BMI, 
baseline PASI score, and PASI scores at the previous scheduled visits. SAS Proc MI will be 
used. Imputed PASI-75 response (Yes/No) will be derived for each imputed dataset.  
MI for missing IGA scores :  The imputation of post-baseline IGA scores will be performed 
following a similar approach as described for PASI scores. Intermittent missing IGA scores will 
be imputed separately for each treatment group using the Markov Chain Monte Carlo (MCMC) 
method where 50 copies of the dataset with monotonic missing pattern will be generated. For 
each of the 50 datasets, missing values at scheduled visits (Weeks 4, 8, 12, 16, 20 and 24) will be 
imputed using a logistic regression model including baseline BMI, baseline IGA score, and IGA 
scores at the previous scheduled visits. SAS Proc MI using the logistic regression method for 
monotone data will be used for the imputation. IGA Treatment Success status (Yes/No) will then 
be derived for each imputed dataset. 
The imputation of missing post-baseline BSA, NAPSI, and NRS scores will be performed using 
a similar method as described for PASI. The imputation of missing post-baseline PSSI and PP 
PGA scores will be performed using a similar method as described for IGA. No imputation will 
be done to the health-related quality of life endpoints or safety endpoints and only observed 
values will be analyzed. 
mNRI: Subjects who used rescue medications or discontinued due to unsatisfactory therapeutic 
effect are considered as treatment failures (i.e., non-responder) for all time points after the 
intitaition of rescue medications or subject discontinuation.  Other missing data are not to be 
imputed and are to be kept as missing. 
LOCF: The last observed value will be carried forward for any subsequent missing values. 
Baseline values will not be carried forward. 
All QoL endpoints will be analyzed using the OC approach. No other imputations will be made 
unless otherwise specified. 


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Note that Early Termination visit data will be analyzed at the closest visit where data are not 
obtained. Full details will be provided in the SAP. 
8.7.4 
Control of Multiplicity 
For the primary efficacy analysis (PASI-75 and IGA), each of the PPC-06 doses will be 
compared with placebo separately, sequentially from high to low dose to maintain the Type-I 
error rate. Therefore, no adjustments for multiplicity will be performed.  
8.8 
Analysis of Safety 
The assessment of safety will be based mainly on the frequency of AEs and on the number of 
laboratory values that fall outside of predetermined ranges. Adverse events will be presented in 
data listings and summarized by frequency and severity for each treatment group. Laboratory and 
vital sign data will be presented in data listings. Abnormal laboratory findings will be presented. 
The analysis of safety will be described in the SAP. 
8.8.1 
Adverse events  
All AEs recorded during the study will be coded using the MedDRA coding dictionary. Adverse 
events that occurred after the first dose of study treatment are called TEAEs. The number and 
incidence of TEAEs will be summarized by MedDRA System Organ Class (SOC)/Preferred 
Term (PT), intensity/severity, and relationship to study drug/treatment. Deaths and non-fatal 
SAEs will be listed by subject and tabulated by PT. 
8.8.2 
Laboratory Evaluations 
Clinical laboratory values will be reported as complete listings of individual subject data. All 
laboratory values will be classified as normal, low, or high based on normal ranges supplied by 
the laboratory. Subjects with values outside the normal range will be flagged and summarized 
using shift tables. A separate listing and table will identify and summarize subjects with 
markedly abnormal values. For quantitative measures, observed and changes in clinical 
laboratory values will be analyzed descriptively by time of collection and treatment group. 
Lymphocyte counts will also be summarized by clinical response at PASI-50 and PASI-75 at 
Week 24. Lymphocyte counts and hs-CRP will also be plotted against PASI scores by visit and 
treatment. 
8.8.3 
Vital Signs 
Change in vital sign data will be classified as normal, low, high, based on a reference range. 
Observed and changes in vital sign parameters will be analyzed descriptively by time of 
collection and treatment group. Subjects with markedly abnormal changes will be listed and 
tabulated separately. 


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8.8.4 
Cardiac Assessments 
Data will be listed, notable values will be flagged, and any other information collected will be 
listed as appropriate. Subjects with markedly abnormal ECG changes will be listed and tabulated 
separately. Observed changes will be analyzed descriptively by time of collection and treatment 
group. 
8.8.5 
Other Safety Assessments 
Concomitant medications/non-drug therapies taken during the study will be mapped to generic 
drug name and drug class. The number and percentage of subjects taking concomitant 
medications will be presented by treatment. 
8.9 
Futility Analysis  
Futility analysis will be done when 50, 100 and 200 subjects complete the Double-Blind 
Treatment period. The analysis will be performed on blinded data.  
8.10 
Protocol Deviations and Violations 
Protocol deviations will be identified on an ongoing basis and will be fully specified in 
InfoLink2, Novella Clinical’s web-based Clinical Management System. Subjects with major 
protocol deviations will be excluded from the per protocol population. The assessment of all 
protocol deviations will be finalized prior to database lock. A subject with more than one major 
deviation per category will be counted  only once for that category. 
If there is discrepancy between protocol and Statistical Analysis Plan (SAP), SAP will 
supersede. 
9. 
CHANGES IN THE PLANNED STUDY 
9.1 
Protocol Amendments 
With the exception of administrative changes, any changes or additions to this clinical study 
protocol require a written protocol amendment that must be approved by the sponsor, the CRO, 
and the investigator(s) before implementation. Amendments significantly affecting the safety of 
subjects, the scope of the investigation, or the scientific quality of the study, require additional 
approval by the IRB or IEC for each study center.  
These requirements for approval should in no way prevent any immediate action from being 
taken by the investigator or the sponsor in the interests of preserving the safety of all subjects 
included in the trial. If an immediate change to the protocol is felt to be necessary by the 
investigator and is implemented for safety reasons, the sponsor should be notified and the 
IRB/IEC should be informed according to their reporting requirements. 


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9.2 
Termination or Suspension of the Study 
The sponsor reserves the right to terminate or suspend the study at any time. In case of premature 
termination or suspension of the study, the CRO project manager will promptly inform the 
investigators, regulatory authorities, and IRBs/IECs about the premature termination or 
suspension, including the reason for termination. In terminating the study, the sponsor and the 
investigator will ensure that adequate consideration is given to the protection of the subjects’ 
interests. 
10. 
DATA HANDLING AND RECORD KEEPING 
10.1 
Recording of Data 
10.1.1 
Source Documents 
Source data are all the information in original records and copies of original records of clinical 
findings, observations, or other activities in the study, which are necessary for the reconstruction 
and evaluation of the study. The identification of any data to be recorded directly on the CRFs is 
to be considered source data.  
Study data collection procedures must ensure that each data element can be traced with a high 
level of confidence from its originator or recorder to its representation in the study database and 
then to its place in the analysis and report of study results. Once recorded, the study data must be 
protected from unauthorized modification or deletion, and all authorized modifications and 
deletions must be securely linked in the permanent record with their author, time of change, and 
reason for change (ie, the audit trail must be maintained). 
The investigator will permit study-related monitoring, audit(s), IRB/IEC review(s) and 
regulatory inspection(s), with direct access to all the required source records. 
The principal investigator will certify the data to be accurate and complete and will release the 
data for transmittal to the sponsor or CRO. 
Source records need to be preserved for the maximum period of time permitted by local 
requirements (see Section 10.2). For each subject enrolled, the investigator will indicate in the 
source record(s) that the subject participated in the study. 
10.1.2 
Case Report Forms 
The primary data collection tool for the study is an eCRF designed specifically for the study. For 
each subject enrolled in the study, an eCRF will be completed by the study coordinator and 
signed by the investigator or his/her designee. Some QoL assessments as well as some 
investigator efficacy assessments will be recorded directly into an electronic device which will 
serve as the source document; the data will then be transferred to the eCRF. 


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The investigator will be responsible for ensuring the accuracy of all data entered in the eCRFs. 
All eCRFs are to be completed in a timely manner. 
Errors occurring in the eCRFs will be queried. Queries raised by data reviewers must be 
addressed by site personnel. 
On request, the investigator will provide the sponsor with additional data relating to the study, or 
copies of relevant source records, duly anonymized (ie, subject’s name is redacted). 
10.2 
Retention of Documents 
The United States Food and Drug Administration (FDA)/International Conference on 
Harmonisation (ICH) regulations require all investigators participating in clinical drug trials to 
maintain detailed clinical data for one of the following periods: 
• 
at least 2 years following the date on which a Marketing Application is approved by the 
FDA/applicable regulatory or health authority, or 
• 
2 years after the sponsor notifies the investigator that no further application is to be filed 
with the health authorities 
Similarly, ICH guidelines require that essential documents be retained until at least two years 
after the last approval of a marketing application in an ICH region and until there are no pending 
or contemplated marketing applications in an ICH region, or at least 2 years have elapsed since 
the formal discontinuation of clinical development of the IP. European Union (EU) Directive 
2001/63/EC requires that essential documents be retained for at least 15 years after completion or 
discontinuation of the trial. 
To comply with these requirements, the investigator will not dispose of any records relevant to 
this study without either (1) written permission from the sponsor, or (2) providing an opportunity 
for the sponsor to collect such records. The investigator shall take responsibility for maintaining 
adequate and accurate hard copy source documents of all observations and data generated during 
this study, including any data clarification forms received from the sponsor. Such documentation 
is subject to inspection by the sponsor or its agents, the FDA and/or other regulatory agencies. 
11. 
QUALITY CONTROL AND QUALITY ASSURANCE 
11.1 
Direct Access to Source Documents 
As specified in the investigator’s agreement, the investigator agrees to allow study-related 
monitoring, audit(s), IRB/IEC review(s) and regulatory inspection(s), with direct access to all the 
required source records, and to allocate his/her time and the time of his/her staff to the 
auditor/inspector to discuss findings and any issues.  


Dr. Reddy’s Laboratories, SA  
Amendment 2  
Clinical Study Protocol 
PPC-06-CD-004 
26 October 2018 
 
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11.2 
Monitoring Procedures 
The Clinical Study Monitor will contact and/or visit the investigator site periodically to verify 
the adherence to the protocol, the maintenance of study-related source records, and the 
completeness and accuracy of all CRF entries compared to source data. The investigator will 
cooperate with the study monitor to ensure that any discrepancies that may be identified are 
resolved. 
11.3 
Audit and Inspection 
The investigator will make all the study-related source data and records available to a quality 
assurance auditor mandated by the sponsor, or to domestic or foreign regulatory inspectors, after 
reasonable notice. The main purposes of an audit or inspection are to confirm that the rights and 
well-being of the subjects have been adequately protected, and that all data relevant for the 
evaluation of the IP have been processed and reported in compliance with Good Clinical Practice 
(GCP)/ICH and applicable regulatory requirements. 
The investigator is to notify the sponsor/CRO immediately of any inspection by regulatory 
authorities or IRBs. 
12. 
ETHICS 
12.1 
Ethical Conduct of the Study 
This study must be carried out in compliance with the protocol and the applicable laws and 
regulatory requirements of the FDA. The study must be conducted in accordance with the ethical 
principles originating from the Declaration of Helsinki and amendments and the ICH-GCP 
guidelines. 
12.2 
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) 
This protocol, the proposed ICF, and other information for subjects must be reviewed and 
approved by an IRB or IEC, before the start of the trial, in compliance with local regulations. 
This committee must also approve any amendments to the protocol, other than administrative 
ones, before initiation of the amendment procedures. 
12.3 
Subject Information and Consent 
Before participation in the study, each subject is required to provide written consent to 
participate in the study. No study-specific procedures will be performed before a subject’s 
informed consent is obtained.  
12.4 
Disclosure and Confidentiality 
12.4.1 
Confidentiality of Study Documentation 
By signing the protocol, the investigator agrees to keep all information provided by the sponsor 
in strict confidence and to request similar confidentiality from his/her staff and the IRB or IEC. 


Dr. Reddy’s Laboratories, SA  
Amendment 2  
Clinical Study Protocol 
PPC-06-CD-004 
26 October 2018 
 
- 66 - 
Study documents provided by the study sponsor (ie, protocols, Investigators' Brochures, CRFs 
and other material) will be stored appropriately to ensure their confidentiality. The information 
provided by the sponsor to the investigator may not be disclosed to others without direct written 
authorization from the sponsor, except to the extent necessary to obtain informed consent from 
subjects who wish to participate in the trial. 
12.4.2 
Privacy of Individual Health Information  
The investigator will undertake to protect the privacy of all individually identifiable health 
information except as specifically authorized by each individual subject through the written 
informed consent. The Informed Consent document will include a request of the subject’s 
consent to release the collected data for research purposes in such a way that the individual’s 
identity remains masked. While all data records will be identified by the corresponding subject 
number, the identity of the subject will be held in confidential source documents at the study site. 
All study personnel with access to this information are legally bound not to disclose such 
information. 
13. 
EMERGENCY PROCEDURES 
13.1 
Emergency Unblinding 
Unblinding by study personnel should only be performed in emergencies where knowledge of 
the subject’s treatment assignment is essential for further management of the subject’s medical 
care. Unblinding a subject’s treatment assignment under any other circumstances will be 
considered a protocol violation.  
The investigator should assess the relationship of any AEs to administration of the IP prior to 
unblinding. 
The investigator is strongly encouraged to contact the study Medical Monitor before unblinding 
any subject’s treatment assignment, but must do so within 1 working day after the unblinding. 
The subject’s treatment code should not be communicated to the Medical Monitor or designee. 
The unblinding will be documented by the investigator.  
13.2 
Reporting of Serious Adverse Events and Pregnancies 
13.2.1 
Contact Person(s) and Number(s) 
Serious adverse events and pregnancies must be reported immediately (ie, not later than 24 hours 
after first knowledge) to the sponsor’s designee, who then forwards the information to the 
Medical Monitor and the sponsor. 
The telephone and fax numbers of the study personnel to be contacted in the event of an SAE are 
provided to each site and are updated as required.  
Dr. Reddy’s Laboratories Ltd, Clinical Pharmacovigilance: 


Dr. Reddy’s Laboratories, SA 
Amendment 2  
Clinical Study Protocol 
PPC-06-CD-004 
26 October 2018 
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Shahida Hasan, MD 
Associate Director 
Fax: 908-450-1510 / 1-877-445-3741 
Email: sae@drreddys.com 
13.2.2 
Reporting Procedures 
Serious Adverse Events 
For each SAE, the investigator will complete a Serious Adverse Event Report Form and assess 
the relationship of each SAE to study treatment. The completed form(s) should be sent 
electronically to the sponsor’s designee within 24 hours of first knowledge of the SAE.  
Follow-up reports regarding the status of the SAE and the subject’s subsequent course should be 
submitted until the SAE has subsided, the condition stabilized (in the case of persistent 
impairment), the subject receives alternative therapy, or the subject dies. The form and fax 
confirmation will be retained. Contacts for reporting SAEs and other safety concerns are 
provided to each site.  
14.
PUBLICATION POLICY
Written permission must be obtained from the Sponsor prior to submission to a publication or 
presentation. 
If the data merit, the Investigator and the Sponsor will discuss the preparation of a manuscript for 
publication in a peer-reviewed professional journal or an abstract for presentation, oral or 
written, to a learned society or symposium. Authorship should reflect work done by the 
Investigators and personnel of the Sponsor, in accordance with generally recognized principles 
of scientific collaboration. 


Dr. Reddy’s Laboratories, SA  
Amendment 2  
Clinical Study Protocol 
PPC-06-CD-004 
26 October 2018 
 
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15. 
REFERENCE LIST 
Altmeyer P, Hartwig R, Matthes U. Efficacy and safety profile of fumaric acid esters in oral 
long-term therapy with severe treatment refractory psoriasis vulgaris. A study of 83 patients. 
Hautarzt 1996;47:190-6.  
Altmeyer PJ, Matthes U, Pawlak F, Hoffmann K, Frosch PJ, Ruppert P, et al. Antipsoriatic effect 
of fumaric acid derivates: Results of a multicenter double-blind study in 100 patients. J Am Acad 
Dermatol 1994;30:977-81.  
Ashcroft DM, Wan Po AL, Williams HC, Griffiths CE. Clinical measures of disease severity and 
outcome in psoriasis: a critical appraisal of their quality. Br J Dermatol 1999;141:185–91. 
Carey W, Glazer S, Gottlieb AB, Lebwohl M, Leonardi C, Menter A, Papp K, Rundle AC, 
Toth D. Relapse, rebound, and psoriasis adverse events: An advisory group report. J Am Acad 
Dermatol 2006 Apr;54(4 Suppl 1):S171-81. 
Carlin CS, Feldman SR, Krueger JG, Menter A, Krueger GG. A 50% reduction in the Psoriasis 
Area and Severity Score (PASI 50) is a clinically significant endpoint in the assessment of 
psoriasis. J Am Acad Dermatol 2004;50:859–66. 
Chandran V, Raychaudhuri SP. Geoepidemiology and environmental factors of psoriasis and 
psoriatic arthritis. J Autoimmun 2010;34:J314-J321. 
Davidovici B. Psoriasis and systemic inflammatory diseases: potential mechanistic links between 
skin disease and co-morbid conditions. J Invest Dermatol 2010;130:1785-96. 
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)—a simple practical measure for 
routine clinical use. Clin Exp Dermatol 1994;19:210–16. 
Fumaderm® Summary of Product Characteristics, 2009. 
Fredriksson T, Pettersson U. Severe psoriasis—oral therapy with a new retinoid. Dermatologica 
1978;157:238–44. 
Ghoreschi K, Weigert C, Rocken M. Immunopathogenesis and role of T cells in psoriasis. Clin 
Dermatol 2007;25:574-80. 
Gordon KB, Feldman SR, Koo JY, Menter A, Rolstad T, Krueger G. Definitions of measures of 
effect duration for psoriasis treatments. Arch Dermatol 2005;141:82-4. 
Harries MJ, Chalmers RJ, Griffiths CE. Fumaric acid esters for severe psoriasis: a retrospective 
review of 58 cases. Br J Dermatol 2005 Sep;153(3):549-51. 
Horn E. Association of patient-reported psoriasis severity with income and employment. J Am 
Acad Dermatol 2007;57;963-71. 


Dr. Reddy’s Laboratories, SA  
Amendment 2  
Clinical Study Protocol 
PPC-06-CD-004 
26 October 2018 
 
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Höxtermann S, Nüchel C, Altmeyer P. Fumaric acid esters suppress peripheral CD4- and CD8-
positive lymphocytes in psoriasis. Dermatology 1998;196(2):223-30. 
Investigator’s Brochure for PPC-06 (tepilamide fumarate), Version 5, 2017. 
Krueger G. The impact of psoriasis on quality of life. Arch Dermatol 2001;137:280-84. 
Kurd SK, Gelfand JM. The prevalence of previously diagnosed and undiagnosed psoriasis in US 
adults: results from NHANES 2003-2004. J Am Acad Dermatol 2009;60:218-24. [Erratum, J 
Am Acad Dermatol 2009;61:507.] 
Langner A, et al. Results of a phase 2 dose-ranging and safety extension study of a novel oral 
fumarate, BG00012, in patients with severe psoriasis. Am Acad Derm P2787 Feb 18-22, 2005. 
Laws P. Current and emerging systemic treatment strategies for psoriasis. Drugs 2012; 
72(14):1867-1880. 
Mehta NN, Azfar RS, Shin DB, Neimann AL, Troxel AB, Gelfand JM. Patients with severe 
psoriasis are at increased risk of cardiovascular mortality: cohort study using the General 
Practice Research Database. Eur Heart J 2010 Apr; 31 (8): 1000-1006. Epub 2009 Dec 27. 
Mrowietz U, Christophers E, Altmeyer P. Treatment of psoriasis with fumaric acid esters: 
Results of a prospective multicentre study. German Multicentre Study. Br J Dermatol 
1997;138:456-60.  
Mrowietz U, Christophers E, Altmeyer P. Treatment of severe psoriasis with fumaric acid esters: 
Scientific background and guidelines for therapeutic use. The German Fumaric Acid Ester 
Consensus Conference. Br J Dermatol 1999;141:424-9.  
Mrowietz U, Spellman MC. Efficacy and safety of a novel formulation of an oral fumarate, BG-
12, in patients with moderate to severe plaque psoriasis: results of a phase III study. J AM 
ACAD Dermatol  Mar 2005;182. 
Nast A, Boehncke WH, Mrowietz U, et al. S3 — guidelines on the treatment of psoriasis vulgaris 
(English version): update. J Dtsch Dermatol Ges 2012;10:Suppl 2:S1-S95. 
Nast A, Kopp IB, Augustin M, Banditt KB, Boehncke WH, Follmann M, et al. S3-Leitlinie zur 
Therapie der Psoriasis vulgaris. J German Soc Dermatol 2006;4:51-5. 
National Psoriasis Foundation. (n.d.). About Psoriasis. Retrieved 2013, from National Psoriasis 
Foundation: http://www.psoriasis.org/about/psoriasis 
Nestle F, Kaplan D, Barker J. Psoriasis. New Engl J Med 2009;361:469-509. 
Ormerod AD, Mrowietz U. Fumaric acid esters, their place in the treatment of psoriasis. Br J 
Dermatol 2004;150:630-2.  


Dr. Reddy’s Laboratories, SA  
Amendment 2  
Clinical Study Protocol 
PPC-06-CD-004 
26 October 2018 
 
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Palfreeman A. New developments in the management of psoriasis and psoriatic arthritis: a focus 
on apremilast. Drug Design, Development and Therapy 2013;3(7):201-10. 
Phan NQ, Blome C, Fritz F, Gerss J, Reich A, Ebata T, Augustin M, Szepietowski JC, Ständer S. 
Assessment of pruritus intensity: prospective study on validity and reliability of the visual 
analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic 
pruritus. Acta Derm Venereol 2012 Sep;92(5):502-7. doi: 10.2340/00015555-1246. 
Prodanovich S. Association of psoriasis with coronary artery, cerebrovascular, and peripheral 
vascular disease and mortality. Arch Dermatol 2009;145:700-3. 
Reich A, Heisig M, Szepietowski JC. Visual Analogue Scale as a validated assessment of 
pruritus intensity. Acta Derm Venereol 2009; 89: 688.  
Roll A, Reich K, Boer A. Use of fumaric acid esters in psoriasis. Indian J Dermatol Venereol 
Leprol 2007;73:133-7 
Schweckendiek W. Heilung von Psoriasis vulgaris. Med Monatsschr 1959;13:103-4. 
Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T. Psoriasis is common, carries a 
substantial burden even when not extensive, and is associated with widespread treatment 
dissatisfaction. J Invest Dermatol Symp Proc 2004;9:136-9. 
Sterry W. Biological therapies in the systemic management of psoriasis: International Consensus 
Conference. Br J Dermatol 2009;151(Suppl 69):3-17. 
TECFIDERA [package insert]. Cambridge, MA:  Biogen Inc.; 2017 
Wain EM, Darling MI, Pleass RD, Barker JN, Smith CH. Treatment of severe, recalcitrant, 
chronic plaque psoriasis with fumaric acid esters: a prospective study. Br J Dermatol 2010 Feb 
1;162(2):427-34. doi: 10.1111/j.1365-2133.2009.09267.x. Epub 2009 Jun 12. 
Zanni G. Psoriasis: Issues far more serious than cosmetic. The Consultant Pharmacist 
2012;27(2):86-96. 
 
 


Dr. Reddy’s Laboratories, SA  
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PPC-06-CD-004 
26 October 2018 
 
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16. 
APPENDICES 
Appendix 1 
Psoriasis Area and Severity Index (PASI) 
Appendix 2 
Nail Psoriasis Severity Index (NAPSI) 
Appendix 3 
Psoriasis Scalp Severity Index (PSSI) 
Appendix 4 
Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) 
 
Appendix 5 
Quality of Life Assessment: Dermatology Life Quality Index (DLQI) 
Appendix 6 
Quality of Life Assessment: SF-12 
Appendix 7 
Quick Inventory of Depressive Symptomatology (Self-Report) 
Appendix 8 
Work Productivity and Activity Impairment Questionnaire: Psoriasis 
(WPAI:PSO) 
Appendix 9 
Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. 
Published: 28 May 2009 (v4.03: 14 June 2010) 
Appendix 10 Bristol Stool Chart 
 
 
 


Dr. Reddy’s Laboratories, SA  
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26 October 2018 
 
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Appendix 1 
Psoriasis Area and Severity Index (PASI) 
PASI consists of two major steps:  
1) calculating the BSA covered with lesions and  
2) assessment of the severity of lesions, including assessing the erythema (redness), induration 
(thickness) and scaling.  
 
All calculations are combined into a single PASI score in the range of 0 (no psoriasis on the 
body) and up to 72 (the most severe case of psoriasis).  
 
Intensity  
A representative area of psoriasis is selected for each body region. The intensity of redness, 
thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or 
very severe (4).  
 
Calculation for intensity  
The three intensity scores are added up for each of the four body regions to give subtotals A1, 
A2, A3, A4.  
Each subtotal is multiplied by the body surface area represented by that region.  
A1 x 0.1 gives B1  
A2 x 0.2 gives B2  
A3 x 0.3 gives B3  
A4 x 0.4 gives B4  
 
Area  
The percentage area affected by psoriasis is evaluated in the four regions of the body (see 
below). In each region, the area is expressed as nil (0), 1-9% (1), 10-29% (2), 30-49% (3), 50-
69% (4), 70-89% (5) or 90-100% (6): 
 
Head and neck  
Upper limbs  
Trunk  
Lower limbs  
 
Calculations for area  
Each of the body area scores is multiplied by the area affected.  
B1 x (0 to 6)= C1  
B2 x (0 to 6)= C2  
B3 x (0 to 6)= C3  
B4 x (0 to 6)= C4  
 
Total score  
The PASI score is C1 + C2 + C3 + C4 
 


Dr. Reddy’s Laboratories, SA  
Amendment 2  
Clinical Study Protocol 
PPC-06-CD-004 
26 October 2018 
 
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Appendix 2 
Nail Psoriasis Severity Index (NAPSI) 
The Nail Psoriasis Severity Index (NAPSI) is a numeric, reproducible, objective, simple tool 
for evaluation of nail psoriasis. This scale is used to evaluate the severity of nail bed psoriasis 
and nail matrix psoriasis by area of involvement in the nail unit 
• 
NAPSI is used to assign a score to each nail for nail bed and nail matrix psoriasis (Rich 
2003): 
• 
nail plate is divided into quadrants by imaginary longitudinal and horizontal lines  
o nail plate is assessed for nail matrix psoriasis by the presence of any feature of 
nail matrix psoriasis, including nail pitting, leukonychia, red spots in the lunula, 
and crumbling in each quadrant of the nail 
o nail bed psoriasis is assessed by the presence of any features of nail bed psoriasis, 
including onycholysis, oil drop (salmon patch) dyschromia, splinter hemorrhages, 
and nail bed hyperkeratosis in each quadrant of the nail 
o score is 0 if the findings are not present, 1 if they are present in 1 quadrant of the 
nail, 2 if present in 2 quadrants of a nail, 3 if present in 3 quadrants of a nail, and 
4 if present in 4 quadrants of a nail  
 
thus each nail has a matrix score (0-4) and a nail bed score (0-4), and the 
total nail score is the sum of those 2 individual scores (0-8) 
• 
All fingernails will be scored at Baseline and a target nail will be selected, which will be 
the nail with the highest score. Only the target nail will be evaluated at subsequent visits. 
Reference: 
Rich P, Scher RK. Nail Psoriasis Severity Index: a useful tool for evaluation of nail psoriasis. 
J Am Acad Dermatol. 2003 Aug;49(2):206-12. 
Cassell SE et al. The modified Nail Psoriasis Severity Index: validation of an instrument to 
assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol 2007; 34: 
123-9. 
 
 
 
 


Dr. Reddy’s Laboratories, SA  
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26 October 2018 
 
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Appendix 3 
Psoriasis Scalp Severity Index (PSSI)  
 
Psoriasis Scalp Severity Index (PSSI) 
 
Descriptor 
Score Range 
Score 
Erythema (E) 
0 - 4 
 
Induration (I) 
0 - 4 
 
Scaling (S) 
0 - 4 
 
Area scoring 
0 - 6 
 
 
 
Descriptors for severity: 
0= None 
1= Slight 
2= Moderate 
3= Marked 
4= Severe 
 
Area scoring criteria: 
1= >0 to <10%, 2= 10 to <30%, 3= 30 to <50%, 4= 50 to <70%, 5= 70 to <90%, 6= 90 to 100% 
 
Final score = (E+I+S) multiplied by area score 
 
 
 
 


Dr. Reddy’s Laboratories, SA  
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26 October 2018 
 
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Appendix 4 
Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) 
 
Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) of Disease Severity 
 
Score  Grade  
Definition  
0 
Clear 
No signs of plaque psoriasis on hands and/or feet 
1 
Almost 
clear 
Just perceptible erythema and just perceptible scaling on the hands 
and/or feet. 
2 
Mild 
Light pink erythema with minimal scaling with or without pustules 
on hands and/or feet 
3 
Moderate 
Dull red, clearly distinguishable erythema with diffuse scaling and 
thickening of the skin, with or without fissures and with or without 
pustule formation on the hands and/or feet. 
4 
Severe 
Deep, dark red erythema with clearly obvious diffuse scaling and 
thickening and numerous fissures with or without pustule formation 
on hands and/or feet. 
 
 
 
 


Dr. Reddy’s Laboratories, SA  
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Clinical Study Protocol 
PPC-06-CD-004 
26 October 2018 
 
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Appendix 5 
Quality of Life Assessment: Dermatology Life Quality Index (DLQI) 
 


Dr. Reddy’s Laboratories, SA  
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26 October 2018 
 
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Appendix 6 
Quality of Life Assessment: SF-12 
 
 
 
 
 


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26 October 2018 
 
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26 October 2018 
 
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26 October 2018 
 
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Appendix 7 
Quick Inventory of Depressive Symptomatology (Self-Report) 
 
 


Dr. Reddy’s Laboratories, SA  
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26 October 2018 
 
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Dr. Reddy’s Laboratories, SA  
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26 October 2018 
 
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Appendix 8 
Work Productivity and Activity Impairment Questionnaire: Psoriasis V2.0 
(WPAI:PSO) 
 
 


Dr. Reddy’s Laboratories, SA  
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26 October 2018 
 
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PPC-06-CD-004 
26 October 2018 
 
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Appendix 9 
Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 
 
Published: 28 May 2009 (v4.03: 14 June 2010) 
 
 
Investigations (page 42): 
 
 
 
Diarrhea (page 13): 
 
 
 


Dr. Reddy’s Laboratories, SA  
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26 October 2018 
 
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Appendix 10 Bristol Stool Chart 
 
 

SAP_001.pdf: 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004 
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 2 of 153 
Document History – Changes compared to previous final version of SAP 
 
Date 
Reason for update 
Section Updated (Current) 
2018-11-15 
Creation of initial 
version 
NA 
2019-04-15 
Creation of 
amendment 1 
• Section 8 Analysis Population: PP exclusion 
criteria updated 
• Section 9 Handling of Missing Data: PSSI final 
score imputation method updated 
• Section 11.4 Analysis Visit Windows updated 
• Section 12.7.2 Secondary Efficacy Endpoints: 
PSSI final score range updated 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004 
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 3 of 153 
Table of Contents 
Table of Contents ...........................................................................................................................3 
List of Abbreviations and Definitions of Terms ..........................................................................5 
1. 
INTRODUCTION ..................................................................................................................7 
2. 
STUDY OBJECTIVES ..........................................................................................................7 
3. 
STUDY DESIGN ....................................................................................................................7 
4. 
HARDWARE AND SOFTWARE ........................................................................................8 
5. 
DATABASE CLOSURE .......................................................................................................8 
6. 
RANDOMIZATION ..............................................................................................................8 
7. 
SAMPLE SIZE DETERMINATION ...................................................................................9 
8. 
ANALYSIS POPULATIONS ...............................................................................................9 
9. 
HANDLING OF MISSING DATA ....................................................................................10 
10. INTERIM ANALYSIS ........................................................................................................13 
11. DATA CONVENTIONS FOR ANALYSIS .......................................................................13 
11.1 General Statistical Principles ..............................................................................................13 
11.2 Study Day ..............................................................................................................................13 
11.3 Baseline and Change from Baseline ...................................................................................13 
11.4 Analysis Visit Window .........................................................................................................13 
11.5 Pooled Analysis Centers ......................................................................................................14 
12. STATISTICAL EVALUATION .........................................................................................15 
12.1 Subject Disposition ...............................................................................................................15 
12.2 Protocol Deviation ................................................................................................................15 
12.3 Demographic and Baseline Characteristics .......................................................................15 
12.4 Study Medication Exposure and Compliance ...................................................................16 
12.5 Prior and Concomitant Medications ..................................................................................16 
12.6 Medical History and Concurrent Procedures ...................................................................17 
12.7 Efficacy Endpoints ...............................................................................................................17 
12.7.1 
Primary Efficacy Endpoint .......................................................................................17 
12.7.2 
Secondary Efficacy Endpoints ..................................................................................17 
12.7.3 
Health-related Quality of Life Endpoints ................................................................19 
12.8 Efficacy Analyses .................................................................................................................20 
12.8.1 
Primary Efficacy Analyses ........................................................................................20 


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Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 4 of 153 
12.8.2 
Secondary Efficacy Analyses ....................................................................................21 
12.8.3 
Health-related Quality of Life Analyses ..................................................................22 
12.8.4 
Subgroup Analyses.....................................................................................................22 
12.9 Safety Analysis .....................................................................................................................22 
12.9.1 
Adverse Events ...........................................................................................................23 
12.9.2 
Clinical Laboratory Testing ......................................................................................24 
12.9.3 
Vital Signs ...................................................................................................................25 
12.9.4 
Physical Examination ................................................................................................25 
12.9.5 
Electrocardiogram (ECG) .........................................................................................25 
12.10 
Pharmacodynamic Analyses .....................................................................................25 
13. CHANGES FROM THE PROTOCOL AND PLANNED ANALYSES .........................25 
14. FORMATTING ....................................................................................................................25 
15. ARCHIVING AND RETENTION OF DOCUMENTS ....................................................26 
16. OUTLINE OF PROPOSED TABLES, FIGURES AND LISTINGS ..............................27 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004 
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 5 of 153 
List of Abbreviations and Definitions of Terms 
Abbreviation 
Definition 
ADaM 
Analysis dataset model 
AE 
Adverse event 
ANOVA 
Analysis of variance 
ANCOVA 
Analysis of covariance 
ATC 
Anatomical Therapeutic Chemical Classification System 
BDM 
Biostatistics and Data Management Group 
BID 
Twice a day 
BMI 
Body mass index 
BSA 
Body surface area 
DLQI 
Dermatology Life Quality Index 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
EOS 
End of study 
ETV 
Early termination visit 
FAS 
Full analysis set 
HEOR 
Health Economics and Outcomes Research 
IP 
Investigational product 
IGA 
Investigator’s Global Assessment 
LOCF 
Last observation carried forward 
MCMC 
Markov Chain Monte Carlo method 
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
Multiple imputation 
NAPSI 
Nail Psoriasis Severity Index 
m-NRI 
Modified non-responder imputation 
NRS 
Numeric rating scale 
OC 
Observed-cases 
PASI 
Psoriasis Area and Severity Index 
PASI-50 
At least 50% reduction in PASI score 
PASI-75 
At least 75% reduction in PASI score 
PD 
Pharmacodynamic/pharmacodynamics 
PGA 
Physician’s Global Assessment 
PP 
Per protocol 
PP PGA 
Palmoplantar Psoriasis Physician’s Global Assessment 
PSSI 
Psoriasis Scalp Score Index 
PT 
Preferred Term 
QD 
Once daily 


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Abbreviation 
Definition 
QIDS-SR16 
Quick Inventory of Depressive Symptomatology-Self Report (16 
Items) 
QoL 
Quality of Life 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SDTM 
Study data tabulation model 
SF-12 
12-item Short Form Survey 
SOC 
System Organ Class 
TEAE 
Treatment-emergent adverse event 
WPAI:PSO 
Work Productivity and Activity Impairment Questionnaire: Psoriasis 


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1. INTRODUCTION 
This Statistical Analysis Plan (SAP) is based on the study Protocol Amendment 2 Final v3.0 dated 
October 26th, 2018.   
This document provides additional details concerning the statistical analyses outlined in the 
protocol and reflects any changes to the protocol from any amendments. This plan will not repeat 
all the definitions given in the protocol but will provide further details of the summaries and 
analyses planned therein.     
2. STUDY OBJECTIVES 
The co-primary objectives are:  
• To demonstrate the efficacy of PPC-06 with respect to Psoriasis Area and Severity Index 
(PASI) for the treatment of moderate-to-severe plaque psoriasis, as compared to placebo 
at 24 weeks. 
• To demonstrate the efficacy of PPC-06 with respect to Investigator’s Global Assessment 
(IGA) at 24 weeks. 
The secondary objectives are: 
• To assess the efficacy of PPC-06 as it relates to psoriasis-related symptoms and health-
related quality of life (QoL) measures. 
• To assess the safety and tolerability of PPC-06 in subjects with moderate-to-severe plaque 
psoriasis. 
• To evaluate the pharmacodynamics (PD) of PPC-06 through immunological analysis of 
peripheral blood samples. The PD analysis will be covered in a separate report. 
3. STUDY DESIGN 
This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the 
safety and efficacy of PPC-06 (tepilamide fumarate) extended release [ER] tablets in subjects with 
moderate-to-severe plaque psoriasis. Study subjects will be enrolled at approximately 75 sites in 
the United States (US). The study will be comprised of 4 study periods: 1) Screening Period, 2) 
Double-Blind Titration Period 3) Double-Blind Treatment Period and 4) Post-treatment Follow-
Up Period. 
Following completion of the pre-randomization Screening Period (up to 4 weeks), approximately 
400 eligible subjects will be randomly assigned in a 1:1:1:1 ratio to one of the 4 arms (PPC-06 400 
mg QD, PPC-06 400 mg BID, PPC-06 600 mg BID, or placebo BID) and the subjects will enter 
the 5-week Double-Blind Titration Period. At Visit 3 (Week 4), the subjects will continue one 


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more week of titration dose (Week 5 of blister wallets) and will also be given a kit of bottles which 
will allow dosing until Visit 4 (Week 8). 
Subjects will receive double-blind treatment from Week 6 through Week 24. Subjects will return 
to the clinic every 4 weeks (±3 days) thereafter, until Week 24, for drug accountability and to 
undergo safety and efficacy evaluations. Subjects will return at Week 25 for an End of Study (EOS) 
Safety Follow-Up Visit. There are nine expected visits total per subject. 
Blood samples for pharmacodynamics (PD) assessments will be collected at Baseline and at Weeks 
4, 8, 12, 16, 20, and 24. PD assessments will be conducted for all subjects, with the intent of 
evaluating psoriasis-associated inflammatory markers. 
The Early Termination Visit (ETV) will be scheduled if the study drug is permanently discontinued 
for any reason (for example: due to meeting the protocol-mandated safety monitoring criteria or 
unresolved gastrointestinal [GI]-related intolerability). 
The EOS Safety Follow-up Period will consist of 1 visit 1-week (± 3 days) following the Week 24 
Visit or the ETV. In the event that the Week 24 Visit or the ETV occurs > 1 week following the 
last dose of the study drug, the EOS Safety Follow-up Visit may not be required. The ETV and/or 
EOS Safety Follow-Up Visit are not expected to be completed for subjects who withdraw full 
consent or are lost to follow up. 
If necessary, the Investigator may decide to extend the follow-up visits beyond one week to 
monitor recovery of safety parameters (e.g., lymphopenia). 
4. HARDWARE AND SOFTWARE 
Statistical analysis will be performed following Novella standard operating procedures and on the 
Novella computer network. All statistical analysis will be performed using SAS Version 9.3 or 
higher with program code prepared specifically for the project by qualified Novella statisticians 
and SAS programmers. 
5. DATABASE CLOSURE 
After completion of all data review and cleaning procedures and approval by the sponsor, the 
clinical database will be closed, and the study will be unblinded. Any change to the clinical 
database after this time will require written authorization, with explanation, by the Sponsor and 
the Biostatistician.  After final approval of analysis methodologies, population assignments, and 
database closure, the study will be unblinded.  
6. RANDOMIZATION 
IWRS will be used for randomization. The randomization scheme will be reviewed and approved 
by a member of the sponsor’s Biostatistics and Data Management (BDM) group or designee. The 
sites will randomize eligible subjects by contacting IWRS at Visit 2 after all the relevant Baseline 


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procedures are completed and assessed as appropriate. A subject who fulfills the study eligibility 
requirements will be randomly assigned to treatment. The randomization will be stratified by prior 
biologic use. 
The IWRS will assign a randomization number to the subject, which will be used to link the subject 
to the treatment group and will specify a unique Blister Wallet IP kit number for the IP to be 
dispensed to the subject at Visit 2 for the Titration Period. The sites will log in to IWRS during 
each subsequent subject visit to obtain the kit numbers of the Bottle Kits to be dispensed at study 
Visits 3-7. 
7. SAMPLE SIZE DETERMINATION 
It was determined that a sample size of 100 subjects per treatment group would detect a significant 
difference in proportion of PASI-75 and IGA responders from Baseline to Week 24 between each 
dose group of PPC-06 and placebo group, assuming a 15% response rate for the placebo group and 
45% for PPC-06 at Week 24. To provide sufficient evidence of treatment effect, both PASI and 
IGA based response rate must reject at the same significance level. The hypothesis testing for the 
three dose groups will be conducted sequentially from high to low dose (600 mg BID, 400 mg BID 
and 400 mg QD); therefore, the 2-sided Type I error rate from a chi-squared test remains at the 
0.05 level. Assuming 50% dropout rate, about 100 subjects per treatment arm will be randomized 
to get approximately 50 completers in each treatment arm. The total sample size of 400 subjects 
will yield at least 84% power for hypothesis testing of the co-primary endpoints of a difference in 
PASI-75 and IGA responders from Baseline to Week 24 between PPC-06 doses and placebo. 
8. ANALYSIS POPULATIONS 
The following analysis sets/populations will be used in this trial: 
• Safety population: include all subjects who receive at least one dose of IP. The safety 
population is the population used for all safety analyses. 
• Full analysis set (FAS) – All randomized subjects who receive at least one dose of 
investigational product and have at least one post dose efficacy assessment. The FAS 
population will be the primary population for the efficacy analyses 
• Per Protocol (PP) population: include subjects in the FAS population who complete the 
study without any major protocol violations that are considered likely to affect the efficacy 
analysis outcomes of the study. Major protocol violations will include but not be restricted 
to the following: 
 Failure to meet the inclusion/exclusion criteria that are considered likely to affect the 
efficacy analysis outcomes of the study 
 Randomization error 


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 Usage of any prohibited concomitant medications or procedures 
 Failure to have Week 24 assessment within the allowable window for either of the co-
primary endpoints 
 Failure to be compliant with treatment regimen 
Additional criteria may be added to determine PP population. The composition of the PP 
population will be determined and documented in blind reviews of the database conducted 
prior to unblinding the study database. Subjects who used rescue medications or who 
discontinued due to unsatisfactory therapeutic effect will be included in the PP population. 
These subjects will be considered as treatment failures (i.e., non-responder for both PASI-
75 and IGA) for all time points after the initiation of rescue medications or subject 
discontinuation. 
9. HANDLING OF MISSING DATA  
All imputations specified in this section will be performed for the Double-Blind Treatment and 
titration Period only; the Post-treatment Follow-Up Period data will be analyzed as observed. 
For the analyses of the co-primary endpoints (PASI-75 and IGA), multiple imputation (MI) will 
be the primary imputation method. The modified non-responder imputation (m-NRI) and last 
observation carried (LOCF) method will be used as sensitivity analyses. 
Details of the imputation methods are as following: 
• MI: Missing data will be imputed using multiple imputations, a simulation-based approach 
where missing values are replaced by multiple Bayesian draws from the conditional 
distribution of missing data given the observed data and covariates, creating multiple 
completed data sets. These completed datasets can then be analyzed using standard analysis 
methods. MI will be implemented for all subjects with missing data, included those who 
used rescue medications or discontinued due to unsatisfactory therapeutic effect. 
Multiple Imputation procedures for missing PASI scores: 
Intermittent missing values of PASI scores will be imputed separately for each treatment 
group using the Markov Chain Monte Carlo (MCMC) method, generating 50 copies of the 
imputed dataset with monotonic missing pattern. For each of the 50 datasets, missing 
values at scheduled visits (Weeks 4, 8, 12, 16, 20 and 24) will be imputed using a linear 
regression model. The imputations will include the following variables: baseline BMI, 
baseline PASI score, and PASI scores at the previous scheduled visits. SAS Proc MI will 
be used. Imputed PASI-75 response (Yes/No) will be derived for each imputed dataset.  
Example SAS code is as follows: 
PROC MI DATA = PASI1 OUT = PASI2 SEED = 132138 NIMPUTE = 50 NOPRINT; 
 
BY TRT01PN; 


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MCMC IMPUTE = MONOTONE; 
 
VAR BASEBMI BASEPASI _3 _4 _5 _6 _7 _8; 
RUN; 
 
PROC MI DATA = PASI2 OUT= PASI3 SEED = 132138 NIMPUTE = 1 NOPRINT; 
 
BY TRT01PN _IMPUTATION_; 
 
MONOTONE REGRESSION; 
 
VAR BASEBMI BASEPASI _3 _4 _5 _6 _7 _8; 
RUN; 
Multiple Imputation procedures for missing IGA scores: 
The imputation of post-baseline IGA scores will be performed following a similar approach 
as described for PASI scores. Intermittent missing IGA scores will be imputed separately 
for each treatment group using the Markov Chain Monte Carlo (MCMC) method where 50 
copies of the dataset with monotonic missing pattern will be generated. For each of the 50 
datasets, missing values at scheduled visits (Weeks 4, 8, 12, 16, 20 and 24) will be imputed 
using a logistic regression model including baseline BMI, baseline IGA score, and IGA 
scores at the previous scheduled visits. SAS Proc MI using the logistic regression method 
for monotone data will be used for the imputation. IGA Treatment Success status (Yes/No) 
will then be derived for each imputed dataset. 
Example SAS code is as follows: 
PROC MI DATA = IGA1 OUT = IGA2 SEED = 132138 NIMPUTE = 50 NOPRINT; 
 
BY TRT01PN; 
 
MCMC IMPUTE = MONOTONE; 
 
VAR BASEBMI _3 _4 _5 _6 _7 _8; 
RUN; 
 
PROC MI DATA = IGA2 OUT= IGA3 SEED = 132138 NIMPUTE = 1 NOPRINT; 
 
BY TRT01PN _IMPUTATION_; 
 
MONOTONE LOGISTIC; 
 
VAR BASEBMI _3 _4 _5 _6 _7 _8; 
RUN; 
The imputation of missing post-baseline BSA, PSSI final score, NAPSI, and NRS scores 
will be performed using a similar method as described for PASI. The imputation of missing 
post-baseline PP PGA scores will be performed using a similar method as described for 
IGA. A pre-specified seed number of 132138 will be used in all imputation procedures. No 
imputation will be done to the health-related quality of life endpoints or safety endpoints.   
• Observed cases (OC): No imputation will be performed, only observed values will be 
analyzed. 
• m-NRI (response endpoint only): Subjects who used rescue medications or discontinued 
due to unsatisfactory therapeutic effect are considered as treatment failures (i.e., non-
responder) for all time points after the initiation of rescue medications or subject 
discontinuation. For example, if a subject discontinued due to lack of efficacy, all visits 


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after the last planned visits will be imputed to non-responders. If a subject used rescue 
medication during the study, all visits after the start of the rescue medication will be 
imputed to non-responders regardless if the subject had an assessment or not. Other 
subjects with missing data will be kept as missing (i.e., no imputation). Discontinuation 
due to unsatisfactory therapeutic effect will be identified by discontinuation reason = 
“Other” with a comment “lack of efficacy” on the eCRF. 
• LOCF: The last observed value will be carried forward for any subsequent missing values. 
Baseline values will not be carried forward. 
A summary of the imputation methods for all efficacy endpoints is shown below: 
Endpoint 
Analysis 
Population Imputation Methods 
PASI-75 at Week 24 
FAS  
MI, m-NRI, LOCF, OC 
PP 
m-NRI 
IGA score of clear or almost clear at Week 24 
FAS 
MI, m-NRI, LOCF, OC 
PP 
m-NRI 
Change from Baseline and percent change from 
Baseline in PASI Total Score by Visit 
FAS 
MI, LOCF, OC 
PP 
OC 
PASI-50 and PASI-75 by Visit 
FAS 
MI, m-NRI, LOCF, OC  
PP 
m-NRI 
IGA score of clear or almost clear by Visit 
FAS 
MI, m-NRI, LOCF, OC 
PP 
m-NRI 
Change from Baseline and percent change from 
Baseline in BSA by Visit 
FAS 
MI, LOCF, OC 
PP 
OC 
Change from Baseline in NAPSI by Visit 
FAS 
MI, LOCF, OC 
PP 
OC 
Change from Baseline in PSSI by Visit  
FAS 
MI, LOCF, OC 
PP 
OC 
Change from Baseline in PP PGA by Visit  
FAS 
MI, LOCF, OC 
PP 
OC 
Change from Baseline in NRS by Visit  
FAS 
MI, LOCF, OC 
PP 
OC 
Time to PASI-75 
FAS 
OC 
Time to achieving an IGA score of clear or 
almost clear 
FAS 
OC 
QIDS-SR 16 
FAS 
OC 
DLQI 
FAS 
OC 
SF-12 
FAS 
OC 
WPAI:PSO 
FAS 
OC 


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HEOR 
FAS 
OC 
 
10. INTERIM ANALYSIS 
The overall response rate for PASI-75 and IGA success at Week 16 and 24, will be reported when 
50, 100 and 200 subjects complete the treatment period. The interim will be performed on blinded 
data using the m-NRI, OC and LOCF imputation method. All subjects in full analysis set (FAS) 
that have completed Week 24 assessments or early terminated by the interim data cut date will be 
included in the analysis. No formal shell is required. 
11. DATA CONVENTIONS FOR ANALYSIS 
11.1 
General Statistical Principles 
All statistical tests will be performed at the unadjusted 0.05 (two-sided) level of significance.  
All observed and derived variables (e.g., change from baseline, percentage change from baseline, 
response status) used in the summaries of analyses will be presented in by-subject listings. 
Descriptive statistics will be used to provide an overview of the efficacy and safety results. For 
categorical parameters, the number and percentage of subjects in each category will be presented. 
The denominator for percentage will be based on the number of subjects appropriate for the 
purpose of analysis. For continuous parameters, descriptive statistics will include number of 
subjects, mean, standard deviation (SD), median, minimum, and maximum. 
11.2 
Study Day 
Day 1 is defined as the date of first study drug administration. For subjects who used any study 
drug but did not have a recorded date of first study drug administration (e.g., due to missing Week 
4 visit), Day 1 is defined as randomization date + 1. Study day is calculated relative to the date of 
Day 1. 
11.3 
Baseline and Change from Baseline 
Baseline value is defined as the last non-missing value prior to the first dose of study drug. Change 
from baseline is defined as the post-baseline value minus the baseline value unless otherwise 
specified. Percent change from baseline is calculated as follows: Percent change = (Change from 
baseline / Baseline) * 100. 
11.4 
Analysis Visit Window 


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Efficacy and safety endpoints will be analyzed according to their windowed visits defined by 
actual study day. If more than one visit occurs within a single visit window, then the analysis will 
take the one closest to the target day. If the 2 visits are equidistant from the target day, the later 
visit will be used.  A later visit within the window will be used for LOCF. 
The following analysis visit windows will apply: 
Visit 
Week 
Target 
Day 
Efficacy Assessment 
Window 
Safety Assessment 
Window 
2 
Baseline 0 
On or prior to date of first 
dose 
On or prior to date of first 
dose 
3 
4 
28 
Post-dose – Day 42 
Post-dose – Day 42 
4 
8 
56 
Day 43 – Day 70 
Day 43 – Day 70 
5 
12 
84 
Day 71 – Day 98 
Day 71 – Day 98 
6 
16 
112 
Day 99 – Day 126 
Day 99 – Day 126 
7 
20 
140 
Day 127 – Day 154 
Day 127 – Day 154 
8 
24 
168 
≥Day 155  
≥Day 155 
9 (Follow-Up) 25 
LD+7 
> LD+15 
> LD+15 
LD = Last dose date 
Visits 3 through 8 are on-treatment visits. Therefore, only on-drug assessments or assessments 
performed within 15 days post last dose are to be analyzed within those windows, according to 
their actual study day. Visit 9 is an off-treatment visit, which will be analyzed according to their 
number of days after last dose, regardless of the actual study day. For example, a subject who has 
Visit 4 on Day 56, then discontinues with last dose on Day 84 and returns for Early Termination 
on Day 100 will have no data within the Visit 6 window. The Early Termination visit must be 
analyzed as Visit 9. For this subject, data for Visits 5, 6, 7, and 8 would be carried forward from 
Visit 4 in an LOCF analysis. If the last dose date is unknown, then all visits will be analyzed as 
on-treatment based on actual study day (i.e., no Visit 9 will be identified for the subject). 
Subjects who permanently discontinue the study drug for any reason or who withdraw from the 
study prematurely prior to the end of the Double-Blind Treatment Period should undergo the ETV 
followed by the EOS Safety Follow-up Period Visit. In the event that the ETV or Week 24 Visit 
occurs > 1 week following the last dose of the study drug, the EOS Safety Follow-up Visit may 
not be required. If necessary, the Investigator may decide to extend the EOS Safety Follow-up 
Visits beyond 1 week to monitor recovery of safety parameters (eg, lymphopenia). 
11.5 
Pooled Analysis Centers 
There will be approximately 75 trial sites in the United States. Pooling of trial sites, based on 
insufficient number of subjects, will be performed when any site does not have a minimum number 
(e.g., 5 subjects per site per arm) of subjects in the FAS population. Sites with insufficient number 


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of subjects will be combined in order of geographical proximity. The exact composition of these 
“analysis sites” will be determined and documented prior to breaking the trial blind.  
Descriptive summaries of the co-primary efficacy endpoints will be provided for each analysis 
site. Any notable site heterogeneity will be further investigated. Exploratory analyses of the co-
primary endpoints may be performed excluding analysis sites whose results differ appreciably 
from other analysis sites. 
12. STATISTICAL EVALUATION  
12.1 
Subject Disposition 
The number and percentage of subjects screened, randomized, included in each analysis 
population, completing the study, withdrawing from the study (together with the reasons for 
withdrawal), and subjects excluded from PP population (together with the reasons for exclusion) 
will be summarized using frequencies and percentages by treatment group. A by-subject listing 
will be presented for all subject enrollment and disposition. Screen failures and subjects not 
randomized will also be presented in by-subject listings.  
The number of days in the study (date of study completion / discontinuation minus date of Day 1 
plus 1) will be summarized using descriptive statistics for each treatment group. 
12.2 
Protocol Deviation 
Protocol deviations will be provided in a by-subject listing. 
12.3 
Demographic and Baseline Characteristics 
Demographics and baseline characteristics will be summarized overall and by treatment for the 
FAS, PP and Safety populations. The following demographic and baseline variables will be 
included:  
• Age 
• Gender 
• Race 
• Ethnicity 
• Weight 
• Height 
• Waist circumference 
• BMI 
• Baseline PASI score 
• Baseline BSA 
• Baseline IGA 


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12.4 
Study Medication Exposure and Compliance 
The following exposure and compliance parameters will be summarized by treatment group and 
study period (overall, titration, and treatment as applicable) using descriptive statistics: 
• Total number of days exposed to study medication, defined as date of last dose of study 
drug during the study minus date of first dose of study drug plus 1. 
• Total number of tablets taken during the titration period (Week 1 – 5), defined as number 
of dispensed tablets from blister wallets minus number of returned tablets from blister 
wallets.  
• Total number of tablets taken during the treatment period (Week 6 – 24), defined as total 
number of dispensed tablets from bottles minus total number of returned tablets from 
bottles. 
• Number of tablets per bottle taken during the treatment period (Week 6 – 24), defined as 
number of dispensed tablets per bottle (total of 4 bottles per visit) minus number of returned 
tablets per bottle. 
• Total number of tablets taken, defined as the summation of number of tablets taken during 
the titration and treatment period. 
• Percent compliance will be calculated as the number of tablets taken divided by the 
expected number of tablets, defined for the titration period, treatment period, and overall. 
The expected number of tablets are as following: 
Period 
Number of Tablets Dispensed 
Per Dosing Regimen 
Expected Total 
Number of Tablets 
Titration (Week 1 – 5) 
Week 1 – 4: 28 per week 
Week 5: 35 per week 
28*4 + 35 = 147 
Treatment (Week 6 – 24) 42 per week 
42*19 = 798 
Overall (Week 1 – 24) 
 
945 
• Subject compliance, defined as 80% - 120% (inclusive) in percent compliance. If the 
percentage of study medication compliance is unknown, the subject is assumed to be non-
compliant with study medication. Subject compliance is summarized by periods and 
overall. Overall compliance will be the main determinant of compliance. 
• Average daily dose of IP received can be calculated as the number of tablets divided by the 
number of days exposed to study medication. The average daily dose of IP received by 
each subject will be summarized by treatment group using summary statistics for the 
overall period. 
12.5 
Prior and Concomitant Medications 


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Prior (within the previous 30 days and with stop dates prior to first dose of study drug) and 
concomitant (ongoing or with stop dates on or after first dose of study drug) medications will be 
presented for the safety population in a by-subject listing for each treatment group. If the 
medication is ongoing or the stop year is missing, the medication will be considered as received 
for the entire duration of the study. Medications will be coded using WHO-DD terminology.  
For the determination of prior vs concomitant medications, the following rules regarding the stop 
date will be applied:  
• If only year was recorded, and it is before Baseline, it is a prior medication; if year is 
same or after Baseline, it is assumed to be a concomitant medication.  
• If day is missing, but month and year are before Baseline, it is a prior medication; if 
month and year are the same as Baseline, it is assumed to be a concomitant medication; if 
month and year are after Baseline, it is a concomitant medication.  
• If start date is after Baseline, it is a concomitant medication regardless.  
In addition, prior and concomitant medications will be summarized by treatment, WHO-DD 
Anatomical-Therapeutic-Chemical (ATC) classification and preferred term (PT). 
12.6 
Medical History and Concurrent Procedures 
Medical history (including previous and ongoing medical conditions) will be coded using 
MedDRA and presented in a by-subject listing.  
Psoriasis Medical History, Prior Psoriasis Treatment History and Other Medical/Surgical History 
will be presented in separate by-subject listings.  
Concurrent procedures will be coded using MedDRA and presented in a by-subject listing. 
12.7 
Efficacy Endpoints 
12.7.1 
Primary Efficacy Endpoint 
The co-primary efficacy endpoints are as follows: 
• The proportion of subjects who achieve a reduction of 75% or greater from Baseline in the 
Psoriasis Area and Severity Index (PASI-75) at the end of Week 24 
• The proportion of subjects who achieve an IGA score of clear or almost clear (IGA score 
0 or 1) at the end of Week 24 
12.7.2 
Secondary Efficacy Endpoints 
The secondary endpoints are the following: 


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• Change from Baseline and percent change from Baseline in total PASI Score by Visit in 
the Double-Blind Treatment Period 
• Proportion of subjects who achieve PASI-50 and PASI-75 at each visit in the Double-Blind 
Treatment Period 
• Proportion of subjects who achieve an IGA score of clear or almost clear at each visit in 
the Double-Blind Treatment Period 
• Change from Baseline and percent change from Baseline in percent of affected BSA at 
each visit in the Double-Blind Treatment Period 
• For applicable subjects present with non-zero baseline NAPSI score (score range 0-8) in 
target nail, change from baseline in Nail Psoriasis Severity Index (NAPSI) of the target 
fingernail at Weeks 12, 16 and 24 
 All fingernails will be scored at Baseline and the target nail will be selected as the one 
with the worst (highest) score by investigator; Only the target nail will be evaluated in 
the subsequent visits. 
 If a target nail was not identified on the CRF, for purpose of analysis, it will be selected 
programmatically as the fingernail with the worst score at Baseline. If more than 1 nail 
has the same worst score, then the target nail will be the first nail according to the order 
of digit collected on the CRF (i.e., digit 1/thumb, digit 2…digit 5). If the same digit 
from both hands have the same worst score, the target nail will be selected from the left 
hand.  
 If score is 0 at Baseline, then the respective assessments at future visits would not be 
required. 
• For applicable subjects present with non-zero baseline score, change from baseline by visit 
in Psoriasis Scalp Score Index (PSSI, score range 0-72) and Palmoplantar Psoriasis 
Physician’s Global Assessment (PP PGA, score range 0-4) in the Double-Blind Treatment 
Period; 
 If score is 0 for PSSI and PP PGA at Baseline, then the respective assessments at future 
visits would not be required; 
• Change from Baseline and percent change from Baseline in pruritus Numeric rating scale 
(NRS) score (score range 0-10) at each visit in the Double-Blind Treatment Period 
• Time to achieving a PASI-75 response, defined as time in days from baseline to first 
achieving a reduction of 75% or greater from Baseline in PASI. Subjects who did not 
achieve PASI-75 by the last assessment or withdrew prior to the last study visit will be 
censored at their last PASI assessment 


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• Time to achieving an IGA score of clear or almost clear, defined as time in days from 
baseline to first achieving an IGA score of 0 or 1. Subjects who did not achieve an IGA of 
0 or 1 at the last assessment or withdrew prior to the last study visit will be censored at 
their last IGA assessment 
12.7.3 
Health-related Quality of Life Endpoints 
The Health Outcome/Quality of Life endpoints are the change from baseline in the following 
health outcome/QoL assessments at Weeks 12, 16, and 24: 
• Quick Inventory of Depressive Symptomatology-Self Report (16 Items) (QIDS-SR16) 
total score.  The total score (range 0-27) is calculated as the sum of the following 9 
items:  Highest score on any sleep items (Q1-Q4), Q5, highest score on any 
appetite/weight items (Q6-Q9), Q10, Q11, Q12, Q13, Q14, highest score on either 
psychomotor items (Q15 & Q16). The total score will be considered as missing if any 
of the component score is missing. 
• The Dermatology Life Quality Index (DLQI) total score (0-30) will be calculated as 
the sum of 10 questions with each ranging from 0 to 3.  The scoring of each answer is 
as follows: 
Very much 
Scored 3 
A lot 
Scored 2 
A little 
Scored 1 
Not at all 
Scored 0 
Not relevant 
Scored 0 
Question unanswered  
Scored 0 
Question 7: “prevented work or studying” Scored 3 
If one question is left unanswered this is scored 0 and the scores are summed and expressed 
as usual out of a maximum of 30. If two or more questions are left unanswered the total 
DLQI score is missing. If question 7a is answered ‘no’ or ‘not relevant’, then the answer 
of 7b will be ignored. Additionally, the score of each of 6 domains (daily activities, 
personal relationships, symptoms and feelings, leisure, work/school, and treatment) will be 
summarized separately.   
• The SF-12 summary scales will be calculated using the SF-12 Health Survey Standard 
Scoring software.  Summary scores will be computed for Physical Summary (PCS) and 
Mental Summary (MCS).  Subscores will also be computed for the following 8 domains:  
 Physical Functioning (PF) 
 Role-Physical (RP) 
 Bodily Pain (BP) 


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Dr. Reddy’s Laboratories, SA 
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 Social Functioning (SF) 
 Mental Health (MH) 
 Role-Emotional (RE) 
 Vitality (VT) 
 General Health (GH) 
• Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) score. 
WPAI-PSO outcomes are expressed as impairment percentages, with higher numbers 
indicating greater impairment and less productivity, i.e., worse outcomes as follows   
 The percent work time missed due to psoriasis will be summarized for all subjects who 
answer “Yes” to Question 1, “Are you currently employed?”.  This will be calculated 
using the following formula:  100 * ((Question 2) / (Question 2 + Question 4)) 
 The percent impairment while working due to psoriasis will be summarized for all 
subjects who have worked at least 1 hour in the past 7 days (ie, response to Question 4 
is greater than zero).  This will be calculated as 100 * (Question 5 / 10) 
 The percent overall work impairment due to psoriasis will be summarized for subjects 
who answer “Yes” to Question 1 and response >0 to Question 4.  This will be calculated 
as 100 * {Question 2 / (Question 2 + Question 4) + (1- Question 2 / (Question 2 + 
Question 4)) * Question 5 / 10)} 
 The percent activity impairment due to psoriasis will be summarized for all subjects 
with a non-missing response to Question 6.   This will be calculated as 100 * (Question 
6 / 10).  
Any of the impairment percentage will be considered as missing if the contributing 
question is missing.  
• Health Economics and Outcome Research (HEOR) evaluation.  Responses to each of the 
following 3 questions will be summarized separately by visit: 
 Number of times to any physician’s office or urgent care clinic 
 Number of times to a nurse practitioner, a physician assistant, a psychologist, a 
naturopath, an acupuncturist, a chiropractor, or other healthcare professional (HCP) 
 Number of times received care from a health professional in your home 
12.8 
Efficacy Analyses 
12.8.1 
Primary Efficacy Analyses 
For each of the co-primary efficacy endpoints, proportion of subjects who achieved PASI-75 and 
IGA success at Week 24, will be tested to compare the difference between the subjects treated with 
PPC-06 and placebo, separately. To provide sufficient evidence of treatment effect, both PASI and 


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IGA based response rate must be rejected at the same significance level. The hypothesis testing 
for the three dose groups will be conducted sequentially from high to low dose; therefore, the 2-
sided Type I error rate remains at the 0.05 level. 
The primary efficacy analyses will be based on the FAS population using MI. Each multiple 
imputed dataset will be analyzed using a logistic regression model with treatment group, baseline 
BMI, and pooled analysis center as factors. The primary treatment comparisons will be the 
contrasts between the PPC-06 doses and placebo. The estimates and standard errors (SEs) of the 
log (odds ratio) based on the 50 imputed datasets will be combined by applying Rubin’s rules for 
multiple imputed datasets. The combined log (odds ratio), odds ratio and associated 95% CI, and 
the resulting p-value will be provided. SAS Proc MI, Proc LOGISTIC, and Proc MIANALYZE 
will be utilized for these analyses. The averaged proportion of PASI-75 responders and IGA 
Success Rates over the 50 imputed datasets will also be presented. 
Sensitivity analyses will be conducted using m-NRI and LOCF, following a same method as 
described above for each multiple imputed dataset. For each of the co-primary efficacy endpoints, 
proportion of subjects who achieved PASI-75 and IGA success at Week 24, will be tested to 
compare the difference between the subjects treated with PPC-06 and placebo, separately. PASI-
75 and IGA Success Rates will be analyzed using a logistic regression model with treatment group, 
baseline BMI, and pooled analysis center as factors. The odds ratio between each PPC-06 group 
and placebo, along with the 95% CI and p-value will be reported.  
Supporting analysis of the primary endpoints will also be performed using m-NRI based on the PP 
population.  
12.8.2 
Secondary Efficacy Analyses 
All secondary efficacy analyses will be performed on the FAS and PP populations. 
The following categorical secondary efficacy endpoints will be summarized using the number and 
percentage of subjects within each category for each treatment group. A same logistic regression 
model as used for the primary endpoint will be performed. Each PPC-06 group will be compared 
to placebo separately as described in the primary analysis. 
• Proportion of subjects who achieve PASI-50 and PASI-75 by visit in the Double-Blind 
Treatment Period 
• Proportion of subjects who achieve an IGA score of clear or almost clear by visit in the 
Double-Blind Treatment Period 
The observed values and change from baseline in PP PGA will be summarized as categorical 
endpoint using frequency counts and percentages. The change from baseline in severity categories 
will be compared between treatment groups using a Wilcoxon rank sum test. 
The following continuous secondary efficacy endpoints will be summarized descriptively and 
analyzed using an Analysis of Covariance (ANCOVA) including factors for treatment, baseline 


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Dr. Reddy’s Laboratories, SA 
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BMI, and pooled analysis center. Each PPC-06 group will be compared to placebo separately. The 
least square mean (LSM) difference, along with the 95% CI and p-value will be reported.  
• Change from Baseline and percent change from Baseline in total PASI Score by visit in 
the Double-Blind Treatment Period 
• Change from Baseline and percent change from Baseline in percent of affected BSA by 
Visit in the Double-Blind Treatment Period 
• For applicable subjects, change from baseline in NAPSI of the target fingernail at Weeks 
12, 16 and 24 
• For applicable subjects, change from baseline by visit in PSSI in the Double-Blind 
Treatment Period 
• Change from Baseline and percent change from Baseline in pruritus NRS score by Visit in 
the Double-Blind Treatment Period 
The following time to event variables will be analyzed using the Kaplan-Meier (KM) method. 
Subjects who have not achieved treatment response by the last visit or discontinue the study will 
be censored at their last visit. The mean, 25th, 50th, and 75th percentile time to achieving a treatment 
success will be reported; log-rank test will be performed for the comparison between each PPC-
06 arm and placebo. 
• Time to achieving PASI-75 response 
• Time to achieving IGA 0 or 1 
12.8.3 
Health-related Quality of Life Analyses 
All QoL endpoints will be summarized by visit and treatment group using descriptive statistics 
on the FAS population. 
12.8.4 
Subgroup Analyses 
The co-primary efficacy endpoints will be analyzed for the following subgroups: 
• Baseline hsCRP (< 5 mg/L, >=5 mg/L) 
• Baseline BMI (<30, >=30) 
• Occurrence of diarrhea (Subjects reported diarrhea as adverse event by Week 24, subject 
did not report diarrhea by Week 24) 
The same method as described in Section 12.8.1 will be used for the subgroup analyses, except 
that no formal hypothesis testing will be performed.  
12.9 
Safety Analysis 


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Dr. Reddy’s Laboratories, SA 
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12.9.1 
Adverse Events 
AE terms will be coded using MedDRA dictionary. A treatment-emergent AE (TEAE) is defined 
as an AE that starts after the first dose of study medication through 5 days after the last dose. If 
relationship to treatment is missing, the event will be conservatively considered as being related 
to study drug. If severity is missing, a separate category of missing severity will be included in the 
summary table, and no imputation of severity will be performed. Through the data cleaning 
process, all attempts will be made to avoid missing values for relationship and severity.  
All AEs will be presented in a by-treatment and by-subject listing, detailing the verbatim term 
given by the investigator, the preferred term (PT), system organ class (SOC), onset date and time, 
end date and time, intensity, outcome, relationship to study drug/treatment, action taken with study 
drug/treatment, other action taken to treat the event, seriousness and criteria for seriousness. 
Serious AEs (SAEs) and TEAEs leading to study discontinuation will also be presented in a 
separate listing. Deaths and non-fatal SAEs will be listed by subject and tabulated by PT. 
Each TEAE will be identified as titration period AE or treatment period AE according to the 
following rules: 
• PPC-06 400 mg QD: 
o Any TEAE starting before Day 15 is considered as a titration period AE 
o Any TEAE starting on or after Day 15 is considered as a treatment period AE 
• PPC-06 400 mg BID, PPC-06 600 mg BID: 
o Any TEAE starting before Day 36 is considered as a titration period AE 
o Any TEAE starting on or after Day 36 is consider as a treatment period AE 
• Placebo BID:  
o No study period will be further designated for this group. They should match 
equivalent phases to calculate therapeutic effect for eg: for 400 mg it should be 
Day 15 and >15 days, for other doses it should be Day 36 and >36 days. 
An overall summary of AEs will be presented by treatment and overall, for the titration period, 
treatment period, and overall. The summary will include the total number of events, frequency 
counts and percentages, and exposure-adjusted incidence rate for: 
• Any AE  
• Any TEAE  
• Any serious TEAE  
• Any treatment-related TEAE, including definitely, probably, and possibly related  
• Any TEAE leading to study drug discontinuation  
• Any SAEs (non-Fatal) 
• 
Any Deaths 


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Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
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For the 3 arms receiving active treatment, exposure-adjusted incidence rate will be defined for 
both titration and treatment periods as number of subjects with AEs divided by total number of 
subject-days with exposure to study medication. Total number of subject-days with exposure in 
each period = sum of durations in days across all subjects in each period. Duration in each period 
is defined as following: 
• PPC-06 400 mg QD: 
o Titration period = Number of days between date of first study application and the 
earlier of date of last study medication and Day 14 inclusive 
o Treatment period = Number of days between Day 15 and date of last study 
application inclusive  
• PPC-06 400 mg BID, PPC-06 600 mg BID: 
o Titration period = Number of days between date of first study application and the 
earlier of date of last study medication and Day 35 inclusive 
o Treatment period = Number of days between Day 36 and date of last study 
application inclusive  
Summaries of the incidence of TEAEs will be displayed by treatment according to the following:  
• All TEAEs by SOC in alphabetical order and PT in descending order of frequency (the 
combined frequency in the three active treatments)  
• All TEAEs by SOC, PT, and maximum severity (mild, moderate, or severe)  
• All TEAEs by SOC, PT, and maximum causality (not related, related) to the study drug  
At each level of summarization, a subject will be counted once if he/she reported one or more 
events. In the counts of subjects with TEAEs, each subject will contribute only once (maximum 
severity) regardless of the number of occurrences (events). 
The severity of TEAEs and relationship to study drug will be summarized in a similar manner. For 
summaries of relationship to study drug, a subject will be classified according to the closest 
relationship. For summaries of TEAE severity, a subject will be classified according to the highest 
severity. 
12.9.2 
Clinical Laboratory Testing 
Clinical laboratory values will be reported as complete listings of individual subject data. All 
laboratory values will be classified as normal, low, or high based on normal ranges supplied by 
the laboratory. Subjects with values outside the normal range will be flagged and summarized 
using shift tables. A separate listing and table will identify and summarize subjects with markedly 
abnormal values. For quantitative measures, observed and changes in clinical laboratory values 
will be analyzed descriptively by time of collection and treatment group.  


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Dr. Reddy’s Laboratories, SA 
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Additionally, lymphocyte counts will be summarized by clinical response of PASI-50 and PASI-
75 (Yes/No) at Week 24. Lymphocyte counts and hs-CRP will also be plotted against PASI scores 
by visit and treatment. The correlation coefficient will be reported.                                                                          
12.9.3 
Vital Signs 
Change in vital sign data will be classified as normal, low, high, based on a reference range. 
Observed and changes in vital sign parameters will be analyzed descriptively by visit and treatment 
group. Subjects with markedly abnormal changes will be listed and tabulated separately. 
 
Low 
Normal 
High 
Abnormal (Absolute) 
Change from Baseline 
Markedly Abnormal 
(Absolute) Change  
from Baseline 
SBP 
<90 mmHg 
90-140 mmHg 
>140 mmHg 
≥ 20 mmHg 
≥ 40 mmHg 
DBP 
<50 mmHg 
50-90 mmHg 
>90 mmHg 
≥ 10 mmHg 
≥ 20 mmHg 
Pulse 
<50 bpm 
50-100 bpm 
>100 bpm 
≥ 10 bpm 
≥ 30 bpm 
12.9.4 
Physical Examination  
Abnormal findings of physical examination will be presented in a by-subject listing.  
12.9.5 
Electrocardiogram (ECG) 
Data will be listed, notable values will be flagged, and any other information collected will be 
listed as appropriate. Subjects with markedly abnormal ECG changes will be listed and tabulated 
separately. Observed changes will be analyzed descriptively by time of collection and treatment 
group. 
12.10 
Pharmacodynamic Analyses 
Blood samples for pharmacodynamics (PD) assessments will be collected at Baseline and at Weeks 
4, 8, 12, 16, 20, and 24. PD assessments will be conducted for all subjects, with the intent of 
evaluating psoriasis-associated inflammatory markers. PD analysis will be covered in a separate 
report 
13. CHANGES FROM THE PROTOCOL AND PLANNED ANALYSES 
Protocol states PP PGA will be analyzed using a similar method as NAPSI, PSSI. The SAP 
summarizes PP PGA using frequency counts and percentages. Wilcoxon rank sum test will be used 
to compare the change from baseline in PP PGA between treatment groups. 
14. FORMATTING 


Statistical Analysis Plan 
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Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 26 of 153 
Each page of the analysis will show the sponsor’s name, the investigational product, and the 
protocol number. Report tables will be embedded in the MS Word report document from SAS 
program output without change. The footer of each table will show the name of the SAS program 
module which generated it, the names of all data sets providing input data in the program and the 
date and time the table was generated. 
The SAS programs will generate rich-text-formatted (RTF) output with the “RTF” extension using 
the SAS Output Delivery System (ODS). The summary tables and listings will be formatted using 
the Times New Roman 9-point font. The RTF output is included in report documents prepared 
with Microsoft Word and converted to PDF format without typographical change. 
Datasets will be created and taken as input to validated SAS programs to generate the report-ready 
tables, listings, and figures. Each output display will show the names of the data sets and SAS 
program used to produce it.  
15. ARCHIVING AND RETENTION OF DOCUMENTS 
After finalization of the analysis, the following will be archived at Novella Clinical and/or with 
the study sponsor: 
• SAP and any amendments 
• All SAS code used in the project for statistical analysis, report tables generation, and 
analysis data set creation 
• Tables, listings and figures as included in the clinical study report 
• SAS study data tabulation model (SDTM) and analysis dataset model (ADaM) datasets 
 
 
 
 
 
 
 
 
 
 
 


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Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
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16. OUTLINE OF PROPOSED TABLES, FIGURES AND LISTINGS 
Tables 
14.1 
Summary of Disposition, Demographic, and Exposure Tables 
14.1.1 
Summary of Subject Disposition 
14.1.2.1 
Summary of Subject Demographics and Baseline Characteristics; Full Analysis Set 
14.1.2.2 
Summary of Subject Demographics and Baseline Characteristics; Safety Population 
14.1.2.3 
Summary of Subject Demographics and Baseline Characteristics; PP Population 
14.1.3.1 
Summary of Exposure and Compliance, Overall, Safety Population 
14.1.3.2 
Summary of Exposure and Compliance; Titration Period (Week 1—5), Safety Population  
14.1.3.3 
Summary of Exposure and Compliance; Treatment Period (Week 6 – 24), Safety Population  
14.1.4.1 
Summary of Prior Medications by Anatomical Therapeutic Chemical Class (ATC) and Preferred 
Term; Safety Population 
14.1.4.2 
Summary of Concomitant Medications by Anatomical Therapeutic Chemical Class (ATC) and 
Preferred Term; Safety Population 
 
 
14.2.1 
Summary of Primary Efficacy and Sensitivity Analysis Tables 
14.2.1.1.1 
Analysis of Co-Primary Efficacy Outcome PASI-75 Response Rate at Week 24, Full Analysis Set, 
Multiple Imputation 
14.2.1.1.2 
Analysis of Co-Primary Efficacy Outcome PASI-75 Response Rate at Week 24, PP Population, m-
NRI 
14.2.1.1.3 
Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis, PASI-75 Response Rate at Week 
24, Full Analysis Set, m-NRI 
14.2.1.1.4 
Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis, PASI-75 Response Rate at Week 
24, Full Analysis Set, LOCF 
14.2.1.1.5 
Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis, PASI-75 Response Rate at Week 
24, Full Analysis Set, OC 
14.2.1.2.1 
Analysis of Co-Primary Efficacy Outcome, IGA Treatment Success Rate at Week 24, Full 
Analysis Set, Multiple Imputation 
14.2.1.2.2 
Analysis of Co-Primary Efficacy Outcome, IGA Treatment Success Rate at Week 24, PP 
Population, m-NRI 
14.2.1.2.3 
Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis, IGA Treatment Success Rate at 
Week 24, Full Analysis Set, m-NRI 
14.2.1.2.4 
Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis, IGA Treatment Success Rate at 
Week 24, Full Analysis Set, LOCF 
14.2.1.2.5 
Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis, IGA Treatment Success Rate at 
Week 24, Full Analysis Set, OC 
14.2.1.3.1 
Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis, PASI-75 Response Rate at Week 
24 by Baseline hsCRP (mg/L), Full Analysis Set, Multiple Imputation 
14.2.1.3.2 
Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis, PASI-75 Response Rate at Week 
24 by Baseline BMI, Full Analysis Set, Multiple Imputation 
14.2.1.3.3 
Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis, PASI-75 Response Rate at Week 
24 by Occurrence of Diarrhea, Full Analysis Set, Multiple Imputation 
14.2.1.4.1 
Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis, IGA Treatment Success Rate at 
Week 24 by Baseline hsCRP (mg/L), Full Analysis Set, Multiple Imputation 
14.2.1.4.2 
Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis, IGA Treatment Success Rate at 
Week 24 by Baseline BMI, Full Analysis Set, Multiple Imputation 
14.2.1.4.3 
Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis, IGA Treatment Success at Week 
24 by Occurrence of Diarrhea, Full Analysis Set, Multiple Imputation 
14.2.1.5.1 
Analysis of Co-Primary Efficacy Outcome, PASI-75 Response Rate at Week 24 by Visit and 
Analysis Sites, Full Analysis Set, Multiple Imputation 
14.2.1.5.2 
Analysis of Co-Primary Efficacy Outcome, IGA Treatment Success at Week 24 by Visit and 
Analysis Sites, Full Analysis Set, Multiple Imputation 
 
 
14.2.2 
Summary of Secondary Efficacy Tables 
14.2.2.1.1.1 
Analysis of Secondary Efficacy Outcome - Change from Baseline in Total PASI Score by Visit, 
Double-Blind Treatment Period, Full Analysis Set, Multiple Imputation 
14.2.2.1.1.2 
Analysis of Secondary Efficacy Outcome - Percent Change from Baseline in Total PASI Score by 
Visit, Double-Blind Treatment Period, Full Analysis Set, Multiple Imputation 


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                            Protocol No. PPC-06-CD-004 
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 28 of 153 
14.2.2.1.2.1 
Analysis of Secondary Efficacy Outcome - Change from Baseline in Total PASI Score by Visit, 
Double-Blind Treatment Period, Full Analysis Set, LOCF 
14.2.2.1.2.2 
Analysis of Secondary Efficacy Outcome - Percent Change from Baseline in Total PASI Score by 
Visit, Double-Blind Treatment Period, Full Analysis Set, LOCF 
14.2.2.1.3.1 
Analysis of Secondary Efficacy Outcome - Change from Baseline in Total PASI Score by Visit, 
Double-Blind Treatment Period, Full Analysis Set, OC 
14.2.2.1.3.2 
Analysis of Secondary Efficacy Outcome - Percent Change from Baseline in Total PASI Score by 
Visit, Double-Blind Treatment Period, Full Analysis Set, OC 
14.2.2.1.4.1 
Analysis of Secondary Efficacy Outcome - Change from Baseline in Total PASI Score by Visit, 
Double-Blind Treatment Period, PP Population, OC 
14.2.2.1.4.2 
Analysis of Secondary Efficacy Outcome - Percent Change from Baseline in Total PASI Score by 
Visit, Double-Blind Treatment Period, PP Population, OC 
14.2.2.2.1 
Analysis of Secondary Efficacy Outcome: PASI-50 Response Rate by Visit, Double-Blind 
Treatment Period, Full Analysis Set, Multiple Imputation 
14.2.2.2.2 
Analysis of Secondary Efficacy Outcome: PASI-50 Response Rate by Visit, Double-Blind 
Treatment Period, Full Analysis Set, LOCF 
14.2.2.2.3 
Analysis of Secondary Efficacy Outcome: PASI-50 Response Rate by Visit, Double-Blind 
Treatment Period, Full Analysis Set, m-NRI 
14.2.2.2.4 
Analysis of Secondary Efficacy Outcome: PASI-50 Response Rate by Visit, Double-Blind 
Treatment Period, Full Analysis Set, OC 
14.2.2.2.5 
Analysis of Secondary Efficacy Outcome: PASI-50 Response Rate by Visit, Double-Blind 
Treatment Period, PP Population, m-NRI 
14.2.2.3.1 
Analysis of Secondary Efficacy Outcome: PASI-75 Response Rate by Visit, Double-Blind 
Treatment Period, Full Analysis Set, Multiple Imputation 
14.2.2.3.2 
Analysis of Secondary Efficacy Outcome: PASI-75 Response Rate by Visit, Double-Blind 
Treatment Period, Full Analysis Set, LOCF 
14.2.2.3.3 
Analysis of Secondary Efficacy Outcome: PASI-75 Response Rate by Visit, Double-Blind 
Treatment Period, Full Analysis Set, m-NRI 
14.2.2.3.4 
 Analysis of Secondary Efficacy Outcome: PASI-75 Response Rate by Visit, Double-Blind 
Treatment Period, Full Analysis Set, OC 
14.2.2.3.5 
Analysis of Secondary Efficacy Outcome: PASI-75 Response Rate by Analysis Site and Visit, 
Double-Blind Treatment Period, PP Population, m-NRI 
14.2.2.4.1 
Analysis of Secondary Efficacy Outcome: IGA Success Rate by Visit, Double-Blind Treatment 
Period, Full Analysis Set, Multiple Imputation 
14.2.2.4.2 
Analysis of Secondary Efficacy Outcome: IGA Success Rate by Visit, Double-Blind Treatment 
Period, Full Analysis Set, LOCF 
14.2.2.4.3 
Analysis of Secondary Efficacy Outcome: IGA Success Rate by Visit, Double-Blind Treatment 
Period, Full Analysis Set, m-NRI 
14.2.2.4.4 
Analysis of Secondary Efficacy Outcome: IGA Success Rate by Visit, Double-Blind Treatment 
Period, Full Analysis Set, OC 
14.2.2.4.5 
Analysis of Secondary Efficacy Outcome: IGA Success Rate by Visit, Double-Blind Treatment 
Period, PP Population, m-NRI 
14.2.2.5.1.1 
Analysis of Secondary Efficacy Outcome: Change From Baseline in Percent of Affected Body 
Surface Area (BSA) by Visit, Double-Blind Treatment Period, Full Analysis Set, Multiple 
Imputation 
14.2.2.5.1.2 
Analysis of Secondary Efficacy Outcome: Percent Change from Baseline in Percent of Affected 
Body Surface Area (BSA) by Visit, Double-Blind Treatment Period, Full Analysis Set, Multiple 
Imputation 
14.2.2.5.2.1 
Analysis of Secondary Efficacy Outcome: Change From Baseline in Percent of Affected Body 
Surface Area (BSA) by Visit, Double-Blind Treatment Period, Full Analysis Set, LOCF 
14.2.2.5.2.2 
Analysis of Secondary Efficacy Outcome: Percent Change from Baseline in Percent of Affected 
Body Surface Area (BSA) by Visit, Double-Blind Treatment Period, Full Analysis Set, LOCF 
14.2.2.5.3.1 
Analysis of Secondary Efficacy Outcome: Change From Baseline in Percent of Affected Body 
Surface Area (BSA) by Visit, Double-Blind Treatment Period, Full Analysis Set, OC 
14.2.2.5.3.2 
Analysis of Secondary Efficacy Outcome: Percent Change from Baseline in Percent of Affected 
Body Surface Area (BSA) by Visit, Double-Blind Treatment Period, Full Analysis Set, OC 
14.2.2.5.4.1 
Analysis of Secondary Efficacy Outcome: Change From Baseline in Percent of Affected Body 
Surface Area (BSA) by Visit, Double-Blind Treatment Period, PP Population, OC 
14.2.2.5.4.2 
Analysis of Secondary Efficacy Outcome: Percent Change from Baseline in Percent of Affected 
Body Surface Area (BSA) by Visit, Double-Blind Treatment Period, PP Population, OC 


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14.2.2.6.1 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Nail Psoriasis Severity Index 
(NAPSI) of the target fingernail visit, Double-Blind Treatment Period, Full Analysis Set, Multiple 
Imputation 
14.2.2.6.2 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Nail Psoriasis Severity Index 
(NAPSI) of the target fingernail visit, Double-Blind Treatment Period, Full Analysis Set, LOCF 
14.2.2.6.3 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Nail Psoriasis Severity Index 
(NAPSI) of the target fingernail visit, Double-Blind Treatment Period, Full Analysis Set, OC 
14.2.2.6.4 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Nail Psoriasis Severity Index 
(NAPSI) of the target fingernail visit, Double-Blind Treatment Period, PP Population, OC 
14.2.2.7.1 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Psoriasis Scalp Severity Index 
(PSSI) by visit, Double-Blind Treatment Period, Full Analysis Set, Multiple Imputation 
14.2.2.7.2 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Psoriasis Scalp Severity Index 
(PSSI) by visit, Double-Blind Treatment Period, Full Analysis Set, LOCF 
14.2.2.7.3 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Psoriasis Scalp Severity Index 
(PSSI) by visit, Double-Blind Treatment Period, Full Analysis Set, OC 
14.2.2.7.4 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Psoriasis Scalp Severity Index 
(PSSI) by visit, Double-Blind Treatment Period, PP Population, OC 
14.2.2.8.1 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Palmoplantar Psoriasis 
Physician’s Global Assessment (PP PGA) by Visit, Double-Blind Treatment Period, Full Analysis 
Set, Multiple Imputation 
14.2.2.8.2 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Palmoplantar Psoriasis 
Physician’s Global Assessment (PP PGA) by Visit, Double-Blind Treatment Period, Full Analysis 
Set, LOCF 
14.2.2.8.3 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Palmoplantar Psoriasis 
Physician’s Global Assessment (PP PGA) by Visit, Double-Blind Treatment Period, Full Analysis 
Set, OC 
14.2.2.8.4 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Palmoplantar Psoriasis 
Physician’s Global Assessment (PP PGA) by Visit, Double-Blind Treatment Period, PP 
Population, OC 
14.2.2.9.1.1 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Pruritus Numeric Rating Scale 
(NRS) Score by Visit, Double-Blind Treatment Period, Full Analysis Set, Multiple Imputation 
14.2.2.9.1.2 
Analysis of Secondary Efficacy Outcome: Percent Change from Baseline in Pruritus Numeric 
Rating Scale (NRS) Score by Visit, Double-Blind Treatment Period, Full Analysis Set, Multiple 
Imputation 
14.2.2.9.2.1 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Pruritus Numeric Rating Scale 
(NRS) Score by Visit, Double-Blind Treatment Period, Full Analysis Set, LOCF 
14.2.2.9.2.2 
Analysis of Secondary Efficacy Outcome: Percent Change from Baseline in Pruritus Numeric 
Rating Scale (NRS) Score by Visit, Double-Blind Treatment Period, Full Analysis Set, LOCF 
14.2.2.9.3.1 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Pruritus Numeric Rating Scale 
(NRS) Score by Visit, Double-Blind Treatment Period, Full Analysis Set, OC 
14.2.2.9.3.2 
Analysis of Secondary Efficacy Outcome: Percent Change from Baseline in Pruritus Numeric 
Rating Scale (NRS) Score by Visit, Double-Blind Treatment Period, Full Analysis Set, OC 
14.2.2.9.4.1 
Analysis of Secondary Efficacy Outcome: Change from Baseline in Pruritus Numeric Rating Scale 
(NRS) Score by Visit, Double-Blind Treatment Period, PP Population, OC 
14.2.2.9.4.2 
Analysis of Secondary Efficacy Outcome: Percent Change from Baseline in Pruritus Numeric 
Rating Scale (NRS) Score by Visit, Double-Blind Treatment Period, PP Population, OC 
14.2.2.10 
Analysis of Secondary Efficacy Outcome, Time to Achieving PASI-75 Response, Full Analysis 
Set, OC 
14.2.2.11 
Analysis of Secondary Efficacy Outcome, Time to Achieving IGA Score of Clear or Almost Clear, 
Full Analysis Set, OC 
 
 
14.2.3 
Summary of Quality of Life (QoL) Tables 
14.2.3.1 
Analysis of Quality of Life Outcome: Change from Baseline in QIDS-SR16 Total Score by Visit, 
Full Analysis Set, OC 
14.2.3.2.1 
Analysis of Quality of Life Outcome: Change from Baseline in DLQI Total Score by Visit, Full 
Analysis Set, OC 
14.2.3.2.2 
Analysis of Quality of Life Outcome: Change from Baseline in DLQI Individual Domains by 
Visit, Full Analysis Set, OC 
14.2.3.3.1 
Analysis of Quality of Life Outcome: Change from Baseline in SF-12 Subdomains by Visit, Full 
Analysis Set, OC 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004 
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 30 of 153 
14.2.3.3.2 
Analysis of Quality of Life Outcome: Change from Baseline in SF-12 Summary Scores by Visit, 
Full Analysis Set, OC 
14.2.3.4 
Analysis of Quality of Life Outcome: Change from Baseline in WPAI: PSO Score by Visit, Full 
Analysis Set, OC 
14.2.3.5 
Analysis of Quality of Life Outcome: Summary of HEOR Score by Visit, Full Analysis Set, OC 
 
 
14.3 
Summary of Safety Tables 
14.3.1.1.1 
Overall Summary of Adverse Events by Treatment, Titration Period, Safety Population 
14.3.1.1.2 
Overall Summary of Adverse Events by Treatment, Treatment Period, Safety Population 
14.3.1.1.3 
Overall Summary of Adverse Events by Treatment, Overall, Safety Population 
14.3.1.2 
Summary of Treatment-emergent Adverse Events by System Organ Class and Preferred Term in 
Descending Frequency, Safety Population 
14.3.1.3 
Summary of Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and 
Maximum Severity, Safety Population 
14.3.1.4 
Summary of Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and 
Maximum Causality, Safety Population 
14.3.2.1 
Summary of Clinical Laboratory Results by Treatment and Visit, Chemistry, Safety Population 
14.3.2.2 
Summary of Clinical Laboratory Results by Treatment and Visit, Hematology, Safety Population  
14.3.2.3.1 
Summary of Lymphocyte Counts by Clinical Response of PASI-50 at Week 24, Safety Population  
14.3.2.3.2 
Summary of Lymphocyte Counts by Clinical Response of PASI-75 at Week 24, Safety Population  
14.3.2.4.1 
Clinical Laboratory Results, Shifts from Baseline by Visit, Chemistry, Safety Population 
14.3.2.4.2 
Clinical Laboratory Results, Shifts from Baseline by Visit, Hematology, Safety Population 
14.3.3.1 
Summary of Vital Signs by Treatment and Visit, Safety Population 
14.3.3.2 
Summary of Vital Signs, Shifts from Baseline by Visit, Safety Population 
14.3.4 
Summary of ECG Results by Treatment and Visit, Safety Population 
 
 
Figures 
14.3.1.1 
Plot of Mean Change from Baseline by Visit, Lymphocyte Counts vs PASI scores, Safety 
Population, PPC-06 400 mg QD 
14.3.1.2 
Plot of Mean Change from Baseline by Visit, Lymphocyte Counts vs PASI scores, Safety 
Population, PPC-06 400 mg BID 
14.3.1.3 
Plot of Mean Change from Baseline by Visit, Lymphocyte Counts vs PASI scores, Safety 
Population, PPC-06 600 mg BID 
14.3.1.4 
Plot of Mean Change from Baseline by Visit, Lymphocyte Counts vs PASI scores, Safety 
Population, Placebo 
14.3.2.1 
Plot of Mean Change from Baseline by Visit, hsCRP vs PASI scores, Safety Population, PPC-06 
400 mg QD 
14.3.2.2 
Plot of Mean Change from Baseline by Visit, hsCRP vs PASI scores, Safety Population, PPC-06 
400 mg BID 
14.3.2.3 
Plot of Mean Change from Baseline by Visit, hsCRP vs PASI scores, Safety Population, PPC-06 
600 mg BID 
14.3.2.4 
Plot of Mean Change from Baseline by Visit, hsCRP vs PASI scores, Safety Population, Placebo 
 
 
Listings 
16.1.7 
Subject Enrollment and Randomization, All Randomized Subjects 
16.2.1.1 
Screen Failure, All Screen Failure Subjects 
16.2.1.2 
Subject Disposition, All Randomized Subjects 
16.2.2 
Protocol Deviations, All Randomized Subjects 
16.2.3 
Population Datasets, All Randomized Subjects 
16.2.4.1 
Demographics and Baseline Characteristics, All Randomized Subjects 
16.2.4.2 
Prior and Concomitant Medication, All Randomized Subjects 
16.2.4.3 
Psoriasis Treatment History, All Randomized Subjects 
16.2.4.4 
Concurrent Procedures, All Randomized Subjects 
16.2.4.5 
Medical History, All Randomized Subjects 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004 
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 31 of 153 
16.2.4.6 
Psoriasis Medical History, All Randomized Subjects 
16.2.5.1 
Study Drug Accountability – Blister Packs, All Randomized Subjects 
16.2.5.2 
Study Drug Accountability – Bottles, All Randomized Subjects 
16.2.5.3 
Study Drug Exposure and Compliance, All Randomized Subjects 
16.2.6.1.1 
Psoriasis Area and Severity Index (PASI) score, All Randomized Subjects 
16.2.6.1.2 
PASI Change from Baseline and Responders, All Randomized Subjects 
16.2.6.2 
Investigator’s Global Assessment (IGA) of Disease Severity, All Randomized Subjects 
16.2.6.3 
Investigator’s Assessment of the Body Surface Area (BSA) Involvement of Psoriasis, All 
Randomized Subjects 
16.2.6.4.1 
Nail Psoriasis Severity Index (NAPSI) at Baseline, All Randomized Subjects 
16.2.6.4.2 
Target Nail Psoriasis Severity Index (NAPSI) , All Randomized Subjects 
16.2.6.5 
Psoriasis Scalp Severity Index (PSSI), All Randomized Subjects 
16.2.6.6 
Palmoplantar Physician’s Global Assessment of Disease Severity (PP PGA), All Randomized 
Subjects 
16.2.6.7 
Itch by NRS, All Randomized Subjects 
16.2.6.8 
Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16) , All Randomized 
Subjects 
16.2.6.9.1 
Dermatology Life Quality Index (DLQI) Individual Questions, All Randomized Subjects 
16.2.6.9.2 
Dermatology Life Quality Index (DLQI) Domains and Total Score, All Randomized Subjects 
16.2.6.10.1 
SF-12 Subdomains, All Randomized Subjects 
16.2.6.10.2 
SF-12 Individual Questions, All Randomized Subjects 
16.2.6.11 
Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO), All 
Randomized Subjects 
16.2.6.12 
Health Economics and Outcome Research (HEOR), All Randomized Subjects 
16.2.7.1 
Adverse Events, All Randomized Subjects 
16.2.7.2 
Serious Adverse Events, All Randomized Subjects 
16.2.7.3 
Adverse Events Leading to Study Drug Discontinuation, All Randomized Subjects 
16.2.8.1 
Urine Pregnancy Test, All Randomized Female Subjects with Childbearing Potential 
16.2.8.2.1 
Clinical Laboratory Test Results; Chemistry, All Randomized Subjects 
16.2.8.2.2 
Clinical Laboratory Test Results; Hematology, All Randomized Subjects 
16.2.8.2.3 
Clinical Laboratory Test Results; Urinalysis, All Randomized Subjects 
16.2.8.2.4 
Clinical Laboratory Test Results; Lymphocyte, All Randomized Subjects 
16.2.8.3 
Laboratory Values Outside of Normal Range, All Randomized Subjects 
16.2.8.4 
Vital Signs, All Randomized Subjects 
16.2.8.5 
Abnormal Physical Examination Results 
16.2.8.6.1 
12-Lead ECG Results, All Randomized Subjects 
16.2.8.6.2 
12-Lead ECG Findings, All Randomized Subjects 
16.2.8.7 
Stool Consistency, All Randomized Subjects 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 32 of 153 
 
 
 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  1 of  2 
Protocol Number: PPC-06-CD-004 
Table 14.1.1: Summary of Subject Disposition 
 
 
PPC-06 400 mg QD 
PPC-06 400 mg BID PPC-06 600 mg BID 
Placebo  
Overall 
 
 
 
 
 
 
Number of Subjects Screened  
 
 
 
XX 
 
 
 
 
 
Number of Subjects Randomized 
XX 
XX 
XX 
XX 
XX 
Number of Subjects in Full Analysis (FAS) Population, n (%) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Number of Subjects in Safety (SAF) Population, n (%) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Number of Subjects in Per Protocol (PP) Population, n (%) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Number of Subjects Excluded from PP Population 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Reason for Exclusion from PP 
 
 
 
 
        Failure to meet key Inclusion/Exclusion criteria 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
        Randomization error 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
        Usage of any prohibited concomitant medications or procedures 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
        Failure to have Week 24 assessment within the allowable window  
           for either of the co-primary endpoints 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
        Noncompliance with the trial treatment regimen 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
Note: Denominator for percentages is the number of subjects randomized. 
 
Generated on  XX/XX/XX:XXXX  by SMYDS / Uses: XXXX / Reference: Listing XXXX  


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 33 of 153 
 
 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  2 of  2 
Protocol Number: PPC-06-CD-004 
Table 14.1.1: Summary of Subject Disposition 
 
 
PPC-06 400 mg QD 
PPC-06 400 mg BID PPC-06 600 mg BID 
Placebo  
Overall 
 
 
 
 
 
 
Number of Subjects Completing the Study, n (%) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
Number of Subjects Discontinued, Overall, n (%) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Reason for discontinuation, n (%) 
 
 
 
 
 
 
Adverse event(s) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Protocol violation 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Voluntary withdrawal by subject  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
        Lost to follow-up 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Pregnancy 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Study terminated by sponsor 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Investigator decision 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Non-compliance with study drug 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Loss of ability to freely provide consent 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Unblinding of a subject for any reason 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Lack of efficacy 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
       Other [1]  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
Number of Days in the Study [2] 
 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Mean (SD) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
  Median 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
  Minimum, Maximum         
XX, XX 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
Note: Denominator for percentages is the number of subjects randomized. 
[1] This does not include those whose discontinuation reason is “Other” with a comment “lack of efficacy” on the eCRF. 
[2] The number of days in the study (date of study completion / discontinuation minus date of Day 1 plus 1) 
 
Generated on XX/XX/XX:XXXX  by SMYDS / Uses: XXXX / Reference: Listing XXXX  


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 34 of 153 
 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.1.2.X: Summary of Subject Demographics and Baseline Characteristics 
[Full Analysis Set] [Safety Population] [PP Population] 
 
 
PPC-06 400 mg QD  
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo  
(N=XX) 
Overall 
(N=XX) 
Age (years) 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Mean (SD) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
  Median 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
  Minimum, Maximum         
XX, XX 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Gender, n(%) 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Female 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Male 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
Race, n(%) 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  White 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Black or African American 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Asian 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  American Indian or Alaska Native 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Native Hawaiian or Other Pacific Islander 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Other [1] 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
Ethnicity, n(%) 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Hispanic or Latino 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Not Hispanic or Latino 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
[1] See listing 16.2.4.1 for other races. 
Generated on XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 35 of 153 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.1.2.X: Summary of Subject Demographics and Baseline Characteristics 
 [Full Analysis Set] [Safety Population] [PP Population] 
 
 
PPC-06 400 mg QD  
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo  
(N=XX) 
Overall 
(N=XX) 
Height (cm) 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Mean (SD) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
  Median 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
  Minimum, Maximum         
XX, XX 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Weight (kg) 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Mean (SD) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
  Median 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
  Minimum, Maximum         
XX, XX 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Waist Circumference (cm) 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Mean (SD) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
  Median 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
  Minimum, Maximum         
XX, XX 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
BMI (kg/m2) 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Mean (SD) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
  Median 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
  Minimum, Maximum         
XX, XX 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 36 of 153 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.1.2.X: Summary of Subject Demographics and Baseline Characteristics 
[Full Analysis Set] [Safety Population] [PP Population] 
 
 
PPC-06 400 mg QD  
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo  
(N=XX) 
Overall 
(N=XX) 
 
 
 
 
 
Baseline PASI score 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Mean (SD) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
  Median 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
  Minimum, Maximum         
XX, XX 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
Baseline BSA (%) 
 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  Mean (SD) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
XX.X (XX.XX) 
  Median 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
  Minimum, Maximum         
XX, XX 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Baseline IGA 
 
 
 
 
  N 
XX 
XX 
XX 
XX 
XX 
  3 – Moderate 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  4 – Severe 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
Note: PASI = Psoriasis Area Severity Index. BSA = Body Surface Area. IGA = Investigator’s Global Assessment. 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 37 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.1.3.1: Summary of Exposure and Compliance 
Overall  
Safety Population 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
Total Number of Days Exposed [1] 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median  
XX.X 
XX.X 
XX.X 
XX.X 
Minimum, Maximum  
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
Total Number of Tablets Taken [2] 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median  
XX.X 
XX.X 
XX.X 
XX.X 
Minimum, Maximum  
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Average Daily Dose of IP [3] 
 
 
 
 
            N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median  
XX.X 
XX.X 
XX.X 
XX.X 
Minimum, Maximum  
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Percent Compliance (%) [4] 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median  
XX.X 
XX.X 
XX.X 
XX.X 
Minimum, Maximum  
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
80-120% Compliant (Inclusive), n (%) 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Yes 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
No 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
[1] Date of last dose of study drug during the study minus date of first dose of study drug plus 1 
[2] Summation of number of tablets taken during the titration and treatment period  
[3] Number of tablets taken divided by the number of days exposed to study medication.  
[4] Number of tablets taken / number of expected tablets *100. The expected total number of tablets is 945 for the whole study. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listing XXXX  


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 38 of 153 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.1.3.2: Summary of Exposure and Compliance 
Titration Period (Week 1—5) 
Safety Population 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
Total Number of Tablets Taken [1] 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median  
XX.X 
XX.X 
XX.X 
XX.X 
Minimum, Maximum  
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Percent Compliance (%) [2] 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median  
XX.X 
XX.X 
XX.X 
XX.X 
Minimum, Maximum  
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
80-120% Compliant (Inclusive), n (%) 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Yes 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
No 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
[1] Number of dispensed tablets from blister wallets minus number of returned tablets from blister wallets. 
[3] Number of used tablets / number of expected tablets for the titration period *100. The expected total number of tablets is 147 for the titration period. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listing XXXX  
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 39 of 153 
Dr Reddy’s Laboratories, SA  
                                                                        Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.1.3.3: Summary of Exposure and Compliance 
Treatment Period (Week 6 – 24) 
Safety Population 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
Total Number of Tablets Taken [1] 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median  
XX.X 
XX.X 
XX.X 
XX.X 
Minimum, Maximum  
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Percent Compliance (%) [2] 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median  
XX.X 
XX.X 
XX.X 
XX.X 
Minimum, Maximum  
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
80-120% Compliant (Inclusive), n (%) 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Yes 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
No 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
[1] Number of dispensed tablets from bottles minus number of returned tablets from bottles. 
[2] Number of used tablets / number of expected tablets for the treatment period *100. The expected total number of tablets is 798 for the treatment period  
  
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listing XXXX  
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 40 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.1.4.1: Summary of Prior Medications 
by Anatomical Therapeutic Chemical Class (ATC) and Preferred Term 
Safety Population 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
  
Subjects with any Prior Medication, n (%) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  
 
 
 
 
  
<< Anatomical Therapeutic Chemical Class >> 
 
 
 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
 
 
 
 
  
<< Anatomical Therapeutic Chemical Class >> 
 
 
 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
 
 
 
 
  
 
 
 
 
  
 
Note: Any medication with stop date prior to first dose of study drug is a prior medication. Counts reflect number of subjects in each treatment group reporting one or more prior 
medication that map to the WHO Drug anatomical therapeutic chemical or preferred term. A subject may be counted once only in each row of the table. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 41 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.1.4.2: Summary of Concomitant Medications 
by Anatomical Therapeutic Chemical Class (ATC) and Preferred Term 
Safety Population 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
  
Subjects with any Concomitant Medication, n (%) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  
 
 
 
 
  
<< Anatomical Therapeutic Chemical Class >> 
 
 
 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
 
 
 
 
  
<< Anatomical Therapeutic Chemical Class >> 
 
 
 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
          << Medication Preferred Term >> 
XXXXX 
XXXXX 
XXXXX 
XXXXX 
  
 
 
 
 
  
 
 
 
 
  
 
Note: Any medication ongoing or with stop date on or after first dose of study drug is a concomitant medication. Counts reflect number of subjects in each treatment group 
reporting one or more prior medication that map to the WHO Drug anatomical therapeutic chemical or preferred term. A subject may be counted once only in each row of the 
table. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 42 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.1.1.1: Analysis of Co-Primary Efficacy Outcome 
PASI-75 Response Rate at Week 24 
Full Analysis Set, Multiple Imputation 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
PASI-75 Response Rate (%) [1] 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
Logistic Regression [2] 
 
 
 
Log (Odds Ratio) (SE), PPC-06 vs. Placebo 
X.XX (X.XX) 
X.XX (X.XX) 
X.XX (X.XX) 
 
Odds Ratio 
X.XX 
X.XX 
X.XX 
 
Odds Ratio 95% CI 
X.XX, X.XX 
X.XX, X.XX 
X.XX, X.XX 
 
      p-value [3] 
0.XXXX 
0.XXXX 
0.XXXX 
 
 
 
 
 
 
Pairwise Comparisons Between PPC-06 Treatments 
 
 
 
 
Log (Odds Ratio) (SE), PPC-06 vs. PPC-06 600 mg BID 
X.XX (X.XX) 
X.XX (X.XX) 
 
 
Odds Ratio 
X.XX 
X.XX 
 
 
Odds Ratio 95% CI 
X.XX, X.XX 
X.XX, X.XX 
 
 
      p-value [3] 
0.XXXX 
0.XXXX 
 
 
 
 
 
 
 
Log (Odds Ratio) (SE), PPC-06 vs. PPC-06 400 mg BID 
X.XX (X.XX) 
 
 
 
Odds Ratio 
X.XX 
 
 
 
Odds Ratio 95% CI 
X.XX, X.XX 
 
 
 
      p-value [3] 
0.XXXX 
 
 
 
 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index; SE=Standard Error; CI=Confidence Interval. PASI-75 Response is defined as achieving a reduction of 75% or greater from 
Baseline in PASI at the end of Week 24. 
[1] Average PASI75 response rate over 50 imputed datasets.  
[2] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
[3] p-value is for null hypothesis that the combined log (Odds Ratio) equals 0. 
 
Generated on XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 43 of 153 
 
 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.1.1.2: Analysis of Co-Primary Efficacy Outcome 
PASI-75 Response Rate at Week 24 
PP Population, m-NRI 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
PASI-75 Response Rate, n / N (%) [1] 
XX / XX (XX.X) 
XX / XX (XX.X) 
XX / XX (XX.X) 
XX / XX (XX.X) 
  
 
 
 
 
 Logistic Regression [2] 
 
 
 
Odds Ratio, PPC-06 vs. Placebo 
X.XX 
X.XX 
X.XX 
 
Odds Ratio 95% CI 
X.XX, X.XX 
X.XX, X.XX 
X.XX, X.XX 
 
      p-value 
0.XXXX 
0.XXXX 
0.XXXX 
 
 
 
 
 
 
Pairewise Comparisons Between PPC-06 Treatments 
 
 
 
 
Odds Ratio, PPC-06 vs. PPC-06 600 mg BID 
X.XX 
X.XX 
 
 
Odds Ratio 95% CI 
X.XX, X.XX 
X.XX, X.XX 
 
 
      p-value 
0.XXXX 
0.XXXX 
 
 
 
 
 
 
 
Odds Ratio, PPC-06 vs. PPC-06 400 mg BID 
X.XX 
 
 
 
Odds Ratio 95% CI 
X.XX, X.XX 
 
 
 
      p-value 
0.XXXX 
 
 
 
 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index; m-NRI=modified non-responder imputation; CI=Confidence Interval. PASI-75 response is defined as achieving a reduction of 
75% or greater from Baseline in PASI at the end of Week 24. 
m-NRI: subjects who used rescue medications or discontinued due to unsatisfactory therapeutic effect are considered as treatment failures for all time points after the initiation of 
rescue medications or subject discontinuation. 
[1] n = Number of responders at Week 24. N = Number of subjects with a Week 24 assessment. 
[1] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
 
 
Generated on XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 44 of 153 
< Repeat Table 14.2.1.1.2 for> 
Table 14.2.1.1.3: Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis 
PASI-75 Response Rate at Week 24 
Full Analysis Set, m-NRI 
 
Table 14.2.1.1.4: Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis 
PASI-75 Response Rate at Week 24 
Full Analysis Set, LOCF 
 
Programming note: modify the Note accordingly for the definition of LOCF 
 
 
Table 14.2.1.1.5: Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis 
PASI-75 Response Rate at Week 24 
Full Analysis Set, OC 
 
Programming note: modify the Note accordingly for the definition of OC 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 45 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.1.2.1: Analysis of Co-Primary Efficacy Outcome 
IGA Treatment Success Rate at Week 24 
Full Analysis Set, Multiple Imputation 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
 
 
IGA Treatment Success Rate (%) [1] 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
 
 
  Logistic Regression [2] 
 
 
 
 
 
    Log (Odds Ratio) (SE), PPC-06 vs. Placebo 
X.XX (X.XX) 
X.XX (X.XX) 
X.XX (X.XX) 
 
 
    Odds Ratio 
X.XX 
X.XX 
X.XX 
 
 
    Odds Ratio 95% CI 
X.XX, X.XX 
X.XX, X.XX 
X.XX, X.XX 
 
 
    p-value [3] 
0.XXXX 
0.XXXX 
0.XXXX 
 
 
 
 
 
 
 
 
Pairewise Comparisons Between PPC-06 Treatments 
 
 
 
 
 
    Log (Odds Ratio) (SE), PPC-06 vs. PPC-06 600 mg BID 
X.XX (X.XX) 
X.XX (X.XX) 
 
 
 
    Odds Ratio 
X.XX 
X.XX 
 
 
 
    Odds Ratio 95% CI 
X.XX, X.XX 
X.XX, X.XX 
 
 
 
    p-value [3] 
0.XXXX 
0.XXXX 
 
 
 
 
 
 
 
 
 
    Log (Odds Ratio) (SE), PPC-06 vs. PPC-06 400 mg BID 
X.XX (X.XX) 
 
 
 
 
    Odds Ratio 
X.XX 
 
 
 
 
    Odds Ratio 95% CI 
X.XX, X.XX 
 
 
 
 
    p-value [3] 
0.XXXX 
 
 
 
 
 
 
 
 
 
Note: IGA= Investigator’s Global Assessment; SE=Standard Error; CI=Confidence Interval. IGA Treatment Success is defined as achieving an IGA score of clear or almost clear 
(IGA score 0 or 1) at the end of Week 24. 
[1] Average IGA treatment success rate over 50 imputed datasets.  
[2] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
[3] p-value is for null hypothesis that the combined log (Odds Ratio) equals 0. 
 
Generated on XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 46 of 153 
 
 
 
Dr Reddy’s Laboratories, SA  
                                                                                          Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.1.2.2: Analysis of Co-Primary Efficacy Outcome 
IGA Treatment Success Rate at Week 24 
PP Population, m-NRI 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
IGA Treatment Success Rate, n / N (%) [1] 
XX / XX (XX.X) 
XX / XX (XX.X) 
XX / XX (XX.X) 
XX / XX (XX.X) 
  
 
 
 
 
 Logistic Regression [2] 
 
 
 
Odds Ratio, PPC-06 vs. Placebo 
X.XX 
X.XX 
X.XX 
 
Odds Ratio 95% CI 
X.XX, X.XX 
X.XX, X.XX 
X.XX, X.XX 
 
      p-value  
0.XXXX 
0.XXXX 
0.XXXX 
 
 
 
 
 
 
Pairewise Comparisons Between PPC-06 Treatments 
 
 
 
Odds Ratio, PPC-06 vs. PPC-06 600 mg BID 
X.XX 
X.XX 
 
 
Odds Ratio 95% CI 
X.XX, X.XX 
X.XX, X.XX 
 
 
      p-value  
0.XXXX 
0.XXXX 
 
 
 
 
 
 
Odds Ratio, PPC-06 vs. PPC-06 400 mg BID 
X.XX 
 
 
 
Odds Ratio 95% CI 
X.XX, X.XX 
 
 
 
      p-value  
0.XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: IGA= Investigator’s Global Assessment; m-NRI=modified non-responder imputation; CI=Confidence Interval. IGA Treatment Success is defined as achieving an IGA score 
of clear or almost clear (IGA score 0 or 1) at the end of Week 24. 
[1]  n = Number of responders at Week 24. N = Number of subjects with a Week 24 assessment. 
[2] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 47 of 153 
< Repeat Table 14.2.1.2.2 for> 
Table 14.2.1.2.3: Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis 
IGA Treatment Success Rate at Week 24 
Full Analysis Set, m-NRI 
 
Table 14.2.1.2.4: Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis 
IGA Treatment Success Rate at Week 24 
Full Analysis Set, LOCF 
 
Programming note: modify the Note accordingly for the definition of LOCF 
 
 
Table 14.2.1.2.5: Analysis of Co-Primary Efficacy Outcome, Sensitivity Analysis 
IGA Treatment Success Rate at Week 24 
Full Analysis Set, OC 
 
Programming note: modify the Note accordingly for the definition of OC 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 48 of 153 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.1.3.1: Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis  
PASI-75 Response Rate at Week 24 by Baseline hsCRP 
Full Analysis Set, Multiple Imputation 
[Baseline hsCRP < 5mg/L][Baseline hsCRP >= 5mg/L] 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
PASI-75 Response Rate 
 
 
 
 
   N 
XX 
XX 
XX 
XX 
 
   Response Rate [1] 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
 
Logistic Regression [2] 
 
 
 
 
Log (Odds Ratio) (SE), PPC-06 vs. Placebo 
X.XX (X.XX) 
X.XX (X.XX) 
X.XX (X.XX) 
 
 
Odds Ratio  
X.XX 
X.XX 
X.XX 
 
 
Odds Ratio 95% CI 
X.XX, X.XX 
X.XX, X.XX 
X.XX, X.XX 
 
 
      p-value [3] 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index; SE=Standard Error; CI=Confidence Interval. PASI-75 Response is defined as achieving a reduction of 75% or greater from 
Baseline in the Psoriasis Area and Severity Index (PASI-75) at the end of Week 24. 
[1] Average PASI-75 response rate over 50 imputed datasets.  
[2] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
[3] p-value is for null hypothesis that the combined log (Odds Ratio) equals 0. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 49 of 153 
<Repeat for> 
Table 14.2.1.3.2: Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis  
PASI-75 Response Rate at Week 24 by Baseline BMI 
Full Analysis Set, Multiple Imputation 
[Baseline BMI < 30kg/m2] [Baseline BMI >= 30kg/m2] 
 
Table 14.2.1.3.3: Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis  
PASI-75 Response Rate at Week 24 by Occurrence of Diarrhea 
Full Analysis Set, Multiple Imputation 
[Subjects Reporting any Diarrhea by Week 24] [Subjects Not Reporting any Diarrhea by Week 24] 
 
Table 14.2.1.4.1: Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis  
IGA Treatment Success Rate at Week 24 by Baseline hsCRP (mg/L) 
Full Analysis Set, Multiple Imputation 
[Baseline hsCRP < 5mg/L] [Baseline hsCRP >= 5mg/L] 
 
Programming note: modify the Note accordingly for the definition of IGA treatment success 
 
Table 14.2.1.4.2: Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis  
IGA Treatment Success Rate at Week 24 by Baseline BMI 
Full Analysis Set, Multiple Imputation 
[Baseline BMI < 30kg/m2] [Baseline BMI >= 30kg/m2] 
 
Programming note: modify the Note accordingly for the definition of IGA treatment success 
 
Table 14.2.1.4.3: Analysis of Co-Primary Efficacy Outcome, Subgroup Analysis  
IGA Treatment Success at Week 24 by Occurrence of Diarrhea 
Full Analysis Set, Multiple Imputation 
[Subjects Reporting any Diarrhea by Week 24] [Subjects Not Reporting any Diarrhea by Week 24] 
 
Programming note: modify the Note accordingly for the definition of IGA treatment success 
 
 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 50 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  1 of  1 
Protocol Number: PPC-06-CD-004 
Table 14.2.1.5.1: Analysis of Co-Primary Efficacy Outcome 
PASI-75 Response Rate at Week 24 by Visit and Analysis Sites 
Full Analysis Set, Multiple Imputation 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
Pooled Analysis Site (Clinical Sites) 
 
 
 
A01 (112 113 114) 
 
 
 
   N 
XX 
XX 
XX 
XX 
 
   Response Rate [1] 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
 
A02 (101 102 105) 
 
 
 
   N 
XX 
XX 
XX 
XX 
 
   Response Rate [1] 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
 
XXX 
 
 
 
   N 
XX 
XX 
XX 
XX 
 
   Response Rate [1] 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
<include all pooled Analysis Site> 
 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index. PASI-75 Response is defined as achieving a reduction of 75% or greater from Baseline. 
[1] Average PASI-75 response rate over 50 imputed datasets.  
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listing XXXX  
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 51 of 153 
<Repeat for> 
Table 14.2.1.5.2: Analysis of Co-Primary Efficacy Outcome 
IGA Treatment Success Rate at Week 24 by Visit and Analysis Sites 
Full Analysis Set, Multiple Imputation 
 
Programming note: modify the Note accordingly for the definition of IGA treatment success 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 52 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.1.1.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Total PASI Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, Multiple Imputation 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Week 8 
 
 
 
 
 
  Change from baseline [1] 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [2] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
<Repeat for other visits: Week 12, Week 16, Week 20, and Week 24> 
 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index, SE=Standard Error. 
[1] Average based on 50 imputed datasets. 
[2] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 53 of 153 
<Repeat for> 
Table 14.2.2.1.1.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Total PASI Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, Multiple Imputation 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 54 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.1.2.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Total PASI Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
Baseline  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 8  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
  Change from baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [1] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
<Repeat for other visits Week 12, Week 16, Week 20, and Week 24> 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index; LOCF=Last Observation Carried Forward; SD=Standard Deviation; SE=Standard Error. 
[1] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 55 of 153 
 
<Repeat table for > 
Table 14.2.2.1.2.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Total PASI Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
 
 
Table 14.2.2.1.3.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in total PASI Score by Visit 
Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: modify the Note accordingly for the definition of OC 
 
Table 14.2.2.1.3.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in total PASI Score by Visit 
Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: modify the Note accordingly for the definition of OC 
 
Table 14.2.2.1.4.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Total PASI Score by Visit 
Double-Blind Treatment Period  
PP Population, OC 
Programming note: modify the Note accordingly for the definition of OC 
 
Table 14.2.2.1.4.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Total PASI Score by Visit 
Double-Blind Treatment Period  
PP Population, OC 
Programming note: modify the Note accordingly for the definition of OC 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 56 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  1 of  1 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.2.1: Analysis of Secondary Efficacy Outcome 
PASI-50 Response Rate by Visit  
Double-Blind Treatment Period 
Full Analysis Set, Multiple Imputation 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
Week 8 
 
 
 
N 
XX 
XX 
XX 
XX 
% [1] 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
     Logistic Regression [2] 
 
 
 
 
            Log (Odds Ratio) (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
            Odds Ratio  
XX.X 
XX.X 
XX.X 
 
            Odds Ratio 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
            p-value [3] 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
<Repeat for other visits: Week 12, Week 16, Week 20, and Week 24> 
 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index; SE=Standard Error; CI=Confidence Interval. PASI-50 Treatment Success is defined as achieving a reduction of 50% or greater 
from Baseline. 
[1] Average PASI-50 response rate over 50 imputed datasets.  
[2] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
[3] p-value is for null hypothesis that the combined log (Odds Ratio) equals 0. 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX  / Uses: XXXX / Reference: Listing XXXX  
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 57 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  1 of  1 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.2.2: Analysis of Secondary Efficacy Outcome 
PASI-50 Response Rate by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
Baseline 
 
 
 
n / N (%)  
XX/XX (XX.X) 
XX/XX (XX.X) 
XX/XX (XX.X) 
XX/XX (XX.X) 
 
 
 
 
Week 8 
 
 
 
n / N (%)  
XX/XX (XX.X) 
XX/XX (XX.X) 
XX/XX (XX.X) 
XX/XX (XX.X) 
 
 
 
 
 
       Logistic Regression [1] 
 
 
 
 
            Odds Ratio, PPC-06 vs. Placebo 
XX.X 
XX.X 
XX.X 
 
            Odds Ratio 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
            p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
<Repeat for other visits: Week 12, Week 16, Week 20, and Week 24> 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index; LOCF=Last Observation Carried Forward; CI=Confidence Interval. PASI-50 Treatment Success is defined as achieving a 
reduction of 50% or greater from Baseline. n = Number of responders at each visit. N = Number of subjects available for analysis at each visit. 
[1] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listing XXXX  
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 58 of 153 
 
<Repeat for tables:> 
Table 14.2.2.2.3: Analysis of Secondary Efficacy Outcome 
PASI-50 Response Rate by Visit in the Double-Blind Treatment Period  
Full Analysis Set, m-NRI 
Programming note: modify the Note accordingly for the definition of m-NRI 
 
Table 14.2.2.2.4: Analysis of Secondary Efficacy Outcome 
PASI-50 Response Rate by Visit in the Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: modify the Note accordingly for the definition of OC 
 
Table 14.2.2.2.5: Analysis of Secondary Efficacy Outcome 
PASI-50 Response Rate by Visit in the Double-Blind Treatment Period  
PP Population, m-NRI 
Programming note: modify the Note accordingly for the definition of m-NRI 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 59 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  1 of  1 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.3.1: Analysis of Secondary Efficacy Outcome 
PASI-75 Response Rate by Visit  
Double-Blind Treatment Period 
Full Analysis Set, Multiple Imputation 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
Week 8 
 
 
 
N 
XX 
XX 
XX 
XX 
% [1] 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
     Logistic Regression [2] 
 
 
 
 
            Log (Odds Ratio) (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
            Odds Ratio  
XX.X 
XX.X 
XX.X 
 
            Odds Ratio 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
            p-value [3] 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
<Repeat for other visits: Week 12, Week 16, Week 20> 
 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index; SE=Standard Error; CI=Confidence Interval. PASI-75 Response is defined as achieving a reduction of 75% or greater from 
Baseline. 
[1] Average PASI-75 response rate over 50 imputed datasets.  
[2] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
[3] p-value is for null hypothesis that the combined log (Odds Ratio) equals 0. 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listing XXXX  
 
 
[programming note: no need to present Week 24 in this table] 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 60 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  1 of  1 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.3.2: Analysis of Secondary Efficacy Outcome 
PASI-75 Response Rate by Visit  
Double-Blind Treatment Period 
Full Analysis Set, LOCF 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
Baseline 
 
 
 
         n / N (%) 
XX/XX (XX.X) 
XX/XX (XX.X) 
XX/XX (XX.X) 
XX/XX (XX.X) 
 
 
 
 
 
Week 8 
 
 
 
         n / N (%) 
XX/XX (XX.X) 
XX/XX (XX.X) 
XX/XX (XX.X) 
XX/XX (XX.X) 
 
 
 
 
 
         Logistic Regression [1] 
 
 
 
 
            Odds Ratio, PPC-06 vs. Placebo 
XX.X 
XX.X 
XX.X 
 
            Odds Ratio 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
            p-value  
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
<Repeat for other visits: Week 12, Week 16, Week 20> 
 
 
 
 
Note:  PASI=Psoriasis Area and Severity Index; CI=Confidence Interval; LOCF=Last Observation Carried Forward. PASI-75 Response is defined as achieving a reduction of 
75% or greater from Baseline. n = Number of responders at each visit. N = Number of subjects available for analysis at each visit. 
[1] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listing XXXX  
 
 
[programming note: no need to present Week 24 in the table] 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 61 of 153 
Repeat for tables: 
 
Table 14.2.2.3.3: Analysis of Secondary Efficacy Outcome 
PASI-75 Response Rate by Visit  
Double-Blind Treatment Period  
Full Analysis Set, m-NRI 
Programming note: modify the Note accordingly for the definition of m-NRI 
 
Table 14.2.2.3.4: Analysis of Secondary Efficacy Outcome 
PASI-75 Response Rate by Visit  
Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: modify the Note accordingly for the definition of OC 
 
Table 14.2.2.3.5: Analysis of Secondary Efficacy Outcome 
PASI-75 Response Rate by Visit  
Double-Blind Treatment Period  
PP Population, m-NRI 
Programming note: modify the Note accordingly for the definition of m-NRI 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 62 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  1 of  1 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.4.1: Analysis of Secondary Efficacy Outcome 
IGA Success Rate by Visit  
Double-Blind Treatment Period 
Full Analysis Set, Multiple Imputation 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
Week 8 
 
 
 
N 
XX 
XX 
XX 
XX 
% [1] 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
     Logistic Regression [2] 
 
 
 
 
Log (Odds Ratio) (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Odds Ratio  
XX.X 
XX.X 
XX.X 
 
Odds Ratio 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
p-value [3] 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
<Repeat for other visits: Week 12, Week 16, Week 20> 
 
 
 
 
Note: IGA= Investigator’s Global Assessment; SE=Standard Error; CI=Confidence Interval. IGA Success Rate is defined as achieving an IGA score of clear or almost clear (IGA 
score 0 or 1). 
[1] Average IGA Success Rate over 50 imputed datasets.  
[2] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
[3] p-value is for null hypothesis that the combined log (Odds Ratio) equals 0. 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listing XXXX  
 
 
[programming note: no need to present Week 24 in the table] 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 63 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  1 of  1 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.4.2: Analysis of Secondary Efficacy Outcome 
IGA Success Rate by Visit  
Double-Blind Treatment Period 
Full Analysis Set, LOCF 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
Baseline 
 
 
 
 
        N 
XX 
XX 
XX 
XX 
        4 – Severe 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
        3 - Moderate 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
    
 
 
 
 
Week 8 
 
 
 
 
       N 
XX 
XX 
XX 
XX 
       4 – Severe 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
       3 – Moderate  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
       2 – Mild  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
       1 – Almost clear  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
       0 – Clear 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
     IGA Success Rate, n (%) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
         Logistic Regression [1] 
 
 
 
 
            Odds Ratio, PPC-06 vs. Placebo 
XX.X 
XX.X 
XX.X 
 
            Odds Ratio 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
            p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
<Repeat for other visits> 
 
 
 
 
Note: IGA= Investigator’s Global Assessment; CI=Confidence Interval. IGA Success Rate is defined as achieving an IGA score of clear or almost clear (IGA score 0 or 1). 
[1] Logistic model includes treatment group, baseline BMI, and pooled analysis center as factors.  
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listing XXXX  
 
[programming note: no need to present Week 24 in the table] 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 64 of 153 
Repeat for tables: 
Table 14.2.2.4.3: Analysis of Secondary Efficacy Outcome 
IGA Success Rate by Visit  
Double-Blind Treatment Period  
Full Analysis Set, m-NRI 
Programming note: modify the Note accordingly for the definition of m-NRI 
 
Table 14.2.2.4.4: Analysis of Secondary Efficacy Outcome 
IGA Success Rate by Visit  
 Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: modify the Note accordingly for the definition of OC 
 
Table 14.2.2.4.5: Analysis of Secondary Efficacy Outcome 
IGA Success Rate by Visit  
Double-Blind Treatment Period  
PP Population, m-NRI 
Programming note: modify the Note accordingly for the definition of m-NRI 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 65 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.5.1.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Affected Body Surface Area (BSA) by Visit 
Double-Blind Treatment Period  
Full Analysis Set, Multiple Imputation 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Week 8  
 
 
 
 
 
  Change from baseline [1] 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [2] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
<Repeat for Week 12, Week 16, Week 20, Week 24> 
 
 
 
 
 
[1] Average based on 50 imputed datasets. 
[2] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 66 of 153 
Repeat for 
Table 14.2.2.5.1.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Affected Body Surface Area (BSA) by Visit 
Double-Blind Treatment Period  
Full Analysis Set, Multiple Imputation 
Programming note: same structure as the change from baseline table, replace change from baseline with percent change from baseline 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 67 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.5.2.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Affected Body Surface Area (BSA) by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
Baseline  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 8  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
  Change from baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [1] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Repeat for other visits: Week 12, Week 16, Week 20, Week 24> 
 
 
 
Note: LOCF = Last Observation Carried Forward.  
[1] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
  
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 68 of 153 
Repeat for tables: 
Table 14.2.2.5.2.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Affected Body Surface Area (BSA) by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
Programming note: same structure as the change from baseline table, replace change from baseline with percent change from baseline. Update footnote for the defection of OC 
 
Table 14.2.2.5.3.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Affected Body Surface Area (BSA) by Visit  
Double-Blind Treatment Period  
Full Analysis Set, OC  
Programming note: Update footnote for the defection of OC 
 
Table 14.2.2.5.3.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Affected Body Surface Area (BSA) by Visit  
Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: same structure as the change from baseline table, replace change from baseline with percent change from baseline. Update footnote for the defection of OC 
 
Table 14.2.2.5.4.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Affected Body Surface Area (BSA) by Visit  
Double-Blind Treatment Period  
PP Population, OC 
Programming note: Update footnote for the defection of OC 
 
Table 14.2.2.5.4.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Affected Body Surface Area (BSA) by Visit  
Double-Blind Treatment Period  
PP Population, OC 
Programming note: same structure as the change from baseline table, replace change from baseline with percent change from baseline. Update footnote for the defection of OC 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 69 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.6.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) of Target Fingernail by Visit  
Double-Blind Treatment Period  
Full Analysis Set, Multiple Imputation 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Week 12  
 
 
 
 
 
  Change from baseline [1] 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [2] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Repeat for Week 16 and Week 24> 
 
 
 
 
Note: This analysis excludes subjects with baseline NAPSI score of 0.  
[1] Average based on 50 imputed datasets. 
[2] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 70 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.6.2: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) of Target Fingernail by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
Baseline  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 12  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
  Change from baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [1] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Repeat for Week 16 and Week 24> 
 
 
 
 
Note: This analysis excludes subjects with baseline NAPSI score of 0. LOCF = Last Observation Carried Forward. 
[1] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 71 of 153 
Repeat for tables: 
Table 14.2.2.6.3: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) of Target Fingernail by Visit  
Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: Update footnote for the defection of OC 
 
Table 14.2.2.6.4: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) of Target Fingernail by Visit  
Double-Blind Treatment Period  
PP Population, OC 
Programming note: Update footnote for the defection of OC 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 72 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.7.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, Multiple Imputation 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Week 8  
 
 
 
 
 
  Change from baseline [1] 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [2] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Repeat for Week12, Week16, Week20, Week24> 
 
 
 
 
Note: This analysis excludes subjects with baseline PSSI score of 0.  
[1] Average based on 50 imputed datasets. 
[2] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 73 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.7.2: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
Baseline  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 8  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
  Change from baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [1] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Repeat for Week12, Week16, Week20, Week24> 
 
 
 
 
Note: This analysis excludes subjects with baseline PSSI score of 0. LOCF = Last Observation Carried Forward. 
 [1] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 74 of 153 
Repeat for tables: 
Table 14.2.2.7.3: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: Update footnote for the defection of OC 
 
Table 14.2.2.7.4: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score by Visit  
Double-Blind Treatment Period  
PP Population, OC 
Programming note: Update footnote for the defection of OC 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 75 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.8.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) by Visit  
Double-Blind Treatment Period  
Full Analysis Set, Multiple Imputation 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
 
 
 
 
 
 
Wilcoxon Rank Sum Test p-value, PPC-06 vs. Placebo [1] 
 
 
 
 
 
       Week 8 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
       Week 12 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
       Week 16 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
       Week 20 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
       Week 24 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
Note: This analysis excludes subjects with baseline PP PGA score of 0.  
 [1] Average based on 50 imputed datasets. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 76 of 153 
 
[Programming note: Use the following syntax to perform Wilcoxon Rank Sum test for MI 
Proc NPAR1WAY data=indata Wilcoxon hl; 
By _imputation_; 
Var Chg; 
ODS OUTPUT WilcoxonTest=wilcox HodgesLehmann=hl; 
Run; 
 
Proc Mianalyze data=hl; 
 
Modeleffects shift; 
 
Stderr stderr; 
ODS OUTPUT ParameterEstimates=stats; 
Run; 
] 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 77 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.2.2.8.2: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
Baseline, n (%) 
 
 
 
 
 
1 - Almost clear 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
2 - Mild 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
3 - Moderate 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
4 - Severe 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
Week 8, n (%)  
 
 
 
 
 
0 - Clear 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
1 - Almost clear 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
2 - Mild 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
3 - Moderate 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
4 - Severe 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
   Change from baseline 
 
 
 
 
 
4 – Worsen by 4 grades 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
3 – Worsen by 3 grades 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
2 – Worsen by 2 grades 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
1 – Worsen by 1 grade 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
0 – No change 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
-1 – Improved by 1 grade 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
-2 – Improved by 2 grades 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
-3 – Improved by 3 grades 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
-4 – Improved by 4 grades 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
Wilcoxon Rank Sum Test, PPC-06 vs. Placebo 
 
 
 
 
 
   p-value  
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Repeat for Week12, Week16, Week20, Week24> 
 
 
 
 
Note: This analysis excludes subjects with baseline PP PGA score of 0. LOCF = Last Observation Carried Forward. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 78 of 153 
Repeat for tables: 
Table 14.2.2.8.3: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) by Visit  
Double-Blind Treatment Period  
Full Analysis Set OC 
Programming note: Update footnote for the defection of OC 
 
Table 14.2.2.8.4: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Palmoplantar Psoriasis Physician’s Global Assessment (PP PGA) by Visit  
Double-Blind Treatment Period  
PP Population, OC 
Programming note: Update footnote for the defection of OC 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 79 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.9.1.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Pruritus Numeric Rating Scale (NRS) Score by Visit  
Double-Blind Treatment Period 
Full Analysis Set, Multiple Imputation 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Week 8  
 
 
 
 
 
  Change from baseline [1] 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [2] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
 
<Repeat for Week12, Week16, Week20, Week24> 
 
 
 
 
[1] Average based on 50 imputed datasets. 
[2] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 80 of 153 
Repeat for 
Table 14.2.2.9.1.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Pruritus Numeric Rating Scale (NRS) Score by Visit  
Double-Blind Treatment Period 
Full Analysis Set, Multiple Imputation 
Programming note: same structure as change from baseline table, but replace change from baseline with percent change from baseline.  
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 81 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.9.2.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Pruritus Numeric Rating Scale (NRS) Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
Baseline  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 8  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
  Change from baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Analysis of Covariance (ANCOVA) [1] 
 
 
 
 
 
   LSM (SE) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
   LSM, 95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
 
 
 
 
 
   LSM Difference (SE), PPC-06 vs. Placebo 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
 
   95% CI 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
   p-value 
X.XXXX 
X.XXXX 
X.XXXX 
 
 
 
 
 
 
 
<Repeat for Week12, Week16, Week20, Week24> 
 
 
 
 
Note: LOCF = Last Observation Carried Forward. 
[1] ANCOVA model includes treatment as factor, baseline BMI and pooled analysis centers as covariates. 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 82 of 153 
Repeat for tables: 
Table 14.2.2.9.2.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Pruritus Numeric Rating Scale (NRS) Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, LOCF 
Programming note: same structure as change from baseline table, but replace change from baseline with percent change from baseline.  
 
Table 14.2.2.9.3.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Pruritus Numeric Rating Scale (NRS) Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: update footnote for definition of OC 
 
 
Table 14.2.2.9.3.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Pruritus Numeric Rating Scale (NRS) Score by Visit  
Double-Blind Treatment Period  
Full Analysis Set, OC 
Programming note: same structure as change from baseline table, but replace change from baseline with percent change from baseline. update footnote for definition of OC  
 
Table 14.2.2.9.4.1: Analysis of Secondary Efficacy Outcome 
Change from Baseline in Pruritus Numeric Rating Scale (NRS) Score by Visit  
Double-Blind Treatment Period  
PP Population, OC  
Programming note: update footnote for definition of OC 
 
Table 14.2.2.9.4.2: Analysis of Secondary Efficacy Outcome 
Percent Change from Baseline in Pruritus Numeric Rating Scale (NRS) Score by Visit  
Double-Blind Treatment Period  
PP Population, OC 
Programming note: same structure as change from baseline table, but replace change from baseline with percent change from baseline. update footnote for definition of OC  
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 83 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.10: Analysis of Secondary Efficacy Outcome 
Time to Achieving PASI-75 Response  
Full Analysis Set, OC 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
    
 
 
 
 
 
Time to Achieving PASI-75 Response [1] 
 
 
 
 
 
Kaplan-Meier Estimates 
 
 
 
 
 
       N 
XX 
XX 
XX 
XX 
 
25th percentile                          
XX 
XX 
XX 
XX 
 
Median 
XX 
XX 
XX 
XX 
 
75th percentile                          
XX 
XX 
XX 
XX 
 
 
 
 
 
 
 
Log Rank Test p-Values 
 
 
 
 
 
      PPC-06 vs. Placebo 
0.XXX 
0.XXX 
0.XXX 
 
 
      PPC-06 vs. PPC-06 600 mg BID 
0.XXX 
0.XXX 
 
 
 
PPC-06 vs. PPC-06 400 mg BID 
0.XXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: PASI= Psoriasis Area and Severity Index 
[1] Days from baseline to first achieving a reduction of 75% or greater from Baseline in PASI. Subjects who did not achieve PASI-75 by the last assessment or withdrew prior to 
the last study visit will be censored at their last PASI assessment. 
                                                
  
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 84 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.2.11: Analysis of Secondary Efficacy Outcome 
Time to Achieving an IGA Score of Clear or Almost Clear 
Full Analysis Set, OC 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
 
 
 
Time to Achieving an IGA Score of Clear or Almost Clear [1] 
 
 
 
 
 
Kaplan-Meier Estimates 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
25th percentile                          
XX 
XX 
XX 
XX 
 
Median 
XX 
XX 
XX 
XX 
 
75th percentile                          
XX 
XX 
XX 
XX 
 
 
 
 
 
 
 
Log Rank Test p-Values 
 
 
 
 
 
      PPC-06 vs. Placebo 
0.XXX 
0.XXX 
0.XXX 
 
 
      PPC-06 vs. PPC-06 600 mg BID 
0.XXX 
0.XXX 
 
 
 
PPC-06 vs. PPC-06 400 mg BID 
0.XXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: IGA= Investigator’s Global Assessment 
[1] Days from baseline to first achieving an IGA score of 0 or 1. Subjects who did not achieve an IGA of 0 or 1 at the last assessment or withdrew prior to the last study visit 
will be censored at their last IGA assessment. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 85 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.3.1: Analysis of Quality of Life Outcome 
Change from Baseline in QIDS-SR16 Total Score by Visit 
Full Analysis Set, OC 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 12  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
   Change from baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
 
 
 
 
 
<Repeat for Week 16, Week 24> 
 
 
 
 
Note: QIDS-SR16=Quick Inventory of Depressive Symptomatology-Self Report (16 Items). OC = Observed Cases. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 86 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
Table 14.2.3.2.1: Analysis of Quality of Life Outcome 
Change from Baseline in DLQI Total Score by Visit 
Full Analysis Set, OC 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 12  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
   Change from baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
 
 
 
 
 
<Repeat for Week 16, Week 24> 
 
 
 
 
Note: DLQI= Dermatology Life Quality Index. OC= Observed Cases. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 87 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.3.2.2: Analysis of Quality of Life Outcome 
Change from Baseline in DLQI Individual Domains by Visit 
Full Analysis Set, OC 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
 
 
 
 
Symptoms and Feelings 
 
 
 
 
 
Baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 12  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
   Change from baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
    <Repeat for Week 16, Week 24> 
 
 
 
 
 
 
 
 
 
    <Repeat for other domains: Daily Activities, Leisure, Personal Relationships > 
 
 
Note: DLQI= Dermatology Life Quality Index. OC = Observed Cases. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 88 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.3.2.2: Analysis of Quality of Life Outcome 
Change from Baseline in DLQI Individual Domains by Visit 
Full Analysis Set, OC 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Work and School 
 
 
 
 
 
Baseline, n (%) 
 
 
 
 
 
Yes 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
No 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Not relevant 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
Week 12, n (%) 
 
 
 
 
 
Yes 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
No 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Not relevant 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
    <Repeat for Week 16, Week 24> 
 
 
 
 
 
 
 
Note: DLQI= Dermatology Life Quality Index. OC = Observed Cases. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 89 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.3.2.2: Analysis of Quality of Life Outcome 
Change from Baseline in DLQI Individual Domains by Visit 
Full Analysis Set, OC 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Treatment 
 
 
 
 
 
Baseline, n (%) 
 
 
 
 
 
Very much 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
A lot 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
A little 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Not at all 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Not relevant 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
Week 12, n (%)  
 
 
 
 
 
Very much 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
A lot 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
A little 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Not at all 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Not relevant 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
 
 
 
 
 
 
    <Repeat for Week 16, Week 24> 
 
 
 
 
 
 
 
Note: DLQI= Dermatology Life Quality Index. OC = Observed Cases. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 90 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.3.3.1: Analysis of Quality of Life Outcome 
Change from Baseline in SF-12 Subdomains by Visit 
Full Analysis Set, OC 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Physical Functioning (PF) 
 
 
 
 
 
Baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 12  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
   Change from baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
    <Repeat for Week 16, Week 24> 
 
 
 
 
 
 
 
 
 
    <Repeat for the other scores in order:, Role-Physical (RP), Bodily Pain (BP), Social Functioning (SF), Mental Health (MH), Role-Emotional (RE), 
Vitality (VT), General Health (GH) > 
                                                 
 
 
Note: OC = Observed Cases. 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 91 of 153 
<Repeat for> 
Table 14.2.3.3.2: Analysis of Quality of Life Outcome 
Change from Baseline in SF-12 Summary Scores by Visit 
Full Analysis Set, OC 
 
[Programming Note: include the two summary scores: Physical Summary (PCS) and Mental Summary (MCS)] 
 
Table 14.2.3.4: Analysis of Quality of Life Outcome 
Change from Baseline in WPAI: PSO Score by Visit 
Full Analysis Set, OC  
[Programming Note: include summaries for questions “The percent work time missed due to psoriasis”, “The percent impairment while working 
due to psoriasis”, “The percent overall work impairment due to psoriasis” and “The percent activity impairment due to psoriasis”] 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 92 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.2.3.5: Analysis of Quality of Life Outcome 
Summary of HEOR Score by Visit  
Full Analysis Set, OC 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
# of times visited physician’s office or urgent care clinic 
 
 
 
 
 
Baseline 
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
Week 12  
 
 
 
 
 
N 
XX 
XX 
XX 
XX 
 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
 
Median 
XX 
XX 
XX 
XX 
 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
    <Repeat for Week 16, Week 24> 
 
 
 
 
   < Repeat for: “# of times visited other health care professionals”, and “# of times received care from a health professional in your home”> 
 
 
Note: HEOR = Health Economics and Outcomes Research. OC = Observed Cases. 
 
 Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 93 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.1.1.1: Overall Summary of Adverse Events by Treatment 
Titration Period 
Safety Population 
 
 
PPC-06 400 mg QD 
(N=XX)[1] 
Placebo– Definition 1 
 (N=XX) [1] 
PPC-06 400 mg BID 
(N=XX)[2] 
PPC-06 600 mg BID 
(N=XX)[2] 
Placebo– Definition 2 
 (N=XX) [2] 
 
 
 
 
 
Adverse Events 
 
 
 
 
Number of Events 
XX 
XX 
XX 
XX 
XX 
Number of Subjects, n (%) 
XX (XX.X) 
XX (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
Exposure-adjusted incidence rate [3] 
XX 
XX 
XX 
XX 
XX 
 
 
 
 
 
Treatment-Emergent Adverse Events (TEAEs)  
 
 
 
Number of Events 
XX 
XX 
XX 
XX 
XX 
Number of Subjects, n (%) 
XX (XX.X) 
XX (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
Exposure-adjusted incidence rate [3] 
XX 
XX 
XX 
XX 
XX 
 
 
 
 
 
Treatment-Related TEAEs 
 
 
 
 
Number of Events 
XX 
XX 
XX 
XX 
XX 
Number of Subjects, n (%) 
XX (XX.X) 
XX (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
Exposure-adjusted incidence rate [3] 
XX 
XX 
XX 
XX 
XX 
 
 
 
 
 
Serious TEAEs 
 
 
 
 
<etc.> 
 
 
 
 
Serious AEs (non-Fatal) 
 
 
 
 
 
<etc.> 
 
 
 
 
Death  
 
 
 
 
<etc.> 
 
 
 
 
AEs Leading to Study Drug Discontinuation 
 
 
 
 
<etc.> 
 
 
 
 
Note:  For each treatment, a subject will be counted once only within each AE category.  
[1] Titration period TEAEs include all AEs starting or worsening after the first dose of study drug and before Day 15. Titration period duration is number of days between date of 
first study medication and the earlier of date of last study medication and Day 14 inclusive. 
[2] Titration period TEAEs include all AEs starting or worsening after the first dose of study drug and before Day 36. Titration period duration is number of days between date of 
first study medication and the earlier of date of last study medication and Day 35 inclusive. 
[3] Number of subjects with AEs divided by total number of subject-days with exposure to study medication, defined as sum of duration in days across all subjects in titration 
period. 
 
Generated on  XX/XX/XX:XXXX  by SMYAE / Uses: XXXX / Reference: Listing XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 94 of 153 
 
Repeat for 
Table 14.3.1.1.2: Overall Summary of Adverse Events by Treatment 
Treatment Period 
Safety Population 
 
Programming note: modify footnotes as following: 
[1] Treatment period TEAEs include all AEs starting or worsening on or after Day 15. Treatment period duration is number of days between Day 15 and date of last study 
medication inclusive. 
[2] Treatment period TEAEs include all AEs starting or worsening on or after Day 36. Treatment period duration is number of days between Day 36 and date of last study 
medication inclusive. 
[3] Number of subjects with AEs divided by total number of subject-days with exposure to study medication, defined as sum of duration in days across all subjects in treatment 
period. 
 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 95 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.1.1.3: Overall Summary of Adverse Events by Treatment 
Overall 
Safety Population 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo  
(N=XX) 
 
 
 
 
 
 
Adverse Events 
 
 
 
 
Number of Events 
XX 
XX 
XX 
XX 
 
Number of Subjects, n (%) 
XX (XX.X) 
XX (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
 
Exposure-adjusted incidence rate [1] 
XX 
XX 
XX 
XX 
 
 
 
 
 
 
Treatment-Emergent Adverse Events (TEAEs)  
 
 
 
Number of Events 
XX 
XX 
XX 
XX 
 
Number of Subjects, n (%) 
XX (XX.X) 
XX (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
 
Exposure-adjusted incidence rate [1] 
XX 
XX 
XX 
XX 
 
 
 
 
 
 
Treatment-Related TEAEs 
 
 
 
 
Number of Events 
XX 
XX 
XX 
XX 
 
Number of Subjects, n (%) 
XX (XX.X) 
XX (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
 
Exposure-adjusted incidence rate [1] 
XX 
XX 
XX 
XX 
 
 
 
 
 
 
Serious TEAEs 
 
 
 
 
Number of Events 
XX 
XX 
XX 
XX 
 
Number of Subjects, n (%) 
XX (XX.X) 
XX (XX.X) 
XX  (XX.X) 
XX  (XX.X) 
 
Exposure-adjusted incidence rate [1] 
XX 
XX 
XX 
XX 
 
 
 
 
 
 
 
Serious AEs (non-Fatal) 
 
 
 
 
 
<etc.> 
 
 
 
 
Death  
 
 
 
 
<etc.> 
 
 
 
 
AEs Leading to Study Drug Discontinuation 
 
 
 
 
<etc.> 
 
 
 
 
Note:  For each treatment, a subject will be counted once only within each AE category. TEAEs include all AEs starting or worsening after the first dose of study drug. 
[1] Number of subjects with AEs divided by total number of subject-days with exposure to study medication, defined as sum of duration in days across all subjects during the 
study period. 
 
Generated on  XX/XX/XX:XXXX  by SMYAE / Uses: XXXX / Reference: Listing XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 96 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.1.2: Summary of Treatment-emergent Adverse Events  
by System Organ Class and Preferred Term in Descending Frequency 
Safety Population 
 
System Organ Class 
          Preferred Term 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
Subjects with any TEAE, n (%) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
<< Adverse Event System Organ Class >> 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
<< Adverse Event Preferred Term >> 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
<< Adverse Event Preferred Term >> 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
<< Adverse Event Preferred Term >> 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
<< Adverse Event System Organ Class >> 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
<< Adverse Event Preferred Term >> 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
<< Adverse Event Preferred Term >> 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
<< Adverse Event Preferred Term >> 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA system organ class or preferred term. A subject may be counted once only in 
each row of the table. 
 
Generated on XX/XX/XX:XXXX  by SMYTEAEPT / Uses: XXXX / Reference: Listings XXXX  
 
 
<Programming Note: sort by SOC in alphabetical order and PT in descending order of the combined frequency in the three active treatments> 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 97 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.1.3: Summary of Treatment-emergent Adverse Events 
by System Organ Class, Preferred Term, and Maximum Severity 
Safety Population 
 
System Organ Class 
          Preferred Term 
Severity 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
 
Subjects with any TEAE, n (%) 
Total 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Mild  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Moderate 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Severe 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
<< Adverse Event System Organ Class >> 
Total 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Mild  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Moderate 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Severe 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
          << Adverse Event Preferred Term >> 
Total 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Mild  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Moderate 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Severe 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA system organ class or preferred term. A subject may be counted only once at 
the highest severity. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 98 of 153 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.1.4: Summary of Treatment-emergent Adverse Events 
by System Organ Class, Preferred Term, and Maximum Causality 
Safety Population 
 
System Organ Class 
          Preferred Term 
Causality  
Assessment[1] 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
 
Subjects with any TEAE, n (%) 
Total 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Related  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Not Related 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
<< Adverse Event System Organ Class >> 
Total 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Related  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Not Related 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
          << Adverse Event Preferred Term >> 
Total 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Related  
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Not Related 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA system organ class or preferred term. A subject may be counted only once at 
the highest causality. 
[1] Related includes definitely related, probably related, and possibly related events. If relationship to treatment is missing, the event will be conservatively summarized as being 
related to study drug 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 99 of 153 
Dr Reddy’s Laboratories, SA  
                                                                                  Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.2.1: Summary of Clinical Laboratory Results by Treatment and Visit 
Chemistry 
Safety Population 
[Lab Tests Name (Units)] 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Baseline  
 
 
 
 
    Observed Values 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Week 4 
 
 
 
 
    Observed Values 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
    Change from Baseline 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
<Repeat for other visits: Week 8, Week 12, Week 16, Week 20, Week 24> 
 
 
 
Note: Baseline is the last available measurement prior to the first dose of study drug on Day 1. 
 
Generated on  XX/XX/XX:XXXX  by XXX / Uses: XXXX / Reference: Listing XXXX 
 
<Programming Note: Page break after each lab parameter.> 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 100 of 153 
 
<Repeat for> 
Table 14.3.2.2: Summary of Clinical Laboratory Results by Treatment and Visit 
Hematology 
Safety Population 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 101 of 153 
 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.2.3.1: Lymphocyte Counts by Clinical Response of PASI-50 at Week 24 
Safety Population 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
PASI-50 Responders: Yes  
N=XX 
N=XX 
N=XX 
N=XX 
Baseline 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 Week 24 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
    Change from Baseline 
 
 
 
 
           N  
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
 
 
 
Note: PASI-50 responder is defined as achieving a reduction of 50% or greater from baseline. Baseline is the last available measurement prior to the first dose of study drug on 
Day 1. 
Generated on  XX/XX/XX:XXXX  by XXX / Uses: XXXX / Reference: Listing XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 102 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.2.3.1: Lymphocyte Counts by Clinical Response of PASI-50 at Week 24 
Safety Population 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
PASI-50 Responders: No  
N=XX 
N=XX 
N=XX 
N=XX 
Baseline 
 
 
 
 
           N  
XX 
XX 
XX 
XX 
           Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
           Median 
XX 
XX 
XX 
XX 
           Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Week 24 
 
 
 
 
           N  
XX 
XX 
XX 
XX 
           Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
           Median 
XX 
XX 
XX 
XX 
           Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
       Change from baseline 
 
 
 
 
N  
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: PASI-50 responder is defined as achieving a reduction of 50% or greater from baseline. Baseline is the last available measurement prior to the first dose of study drug on 
Day 1. 
 
Generated on  XX/XX/XX:XXXX  by XXX / Uses: XXXX / Reference: Listing XXXX 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 103 of 153 
 
<Repeat for> 
Table 14.3.2.3.2: Lymphocyte Counts by Clinical Response of PASI-75 at Week 24 
Safety Population  
 
Note: PASI-75 responder is defined as achieving a reduction of 75% or greater from baseline. Baseline is the last available measurement prior to the first dose of study drug on 
Day 1. 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 104 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.2.4.1: Clinical Laboratory Results, Shifts from Baseline by Visit 
Chemistry 
Safety Population 
[Lab Tests Name (Units)] 
 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
Baseline - > Week 4, n (%) 
 
 
 
 
 
  N [1] 
 
XX 
XX 
XX 
XX 
  Low ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Normal -> Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  High ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
<Include all possible shifts as rows> 
 
 
 
 
 
 
 
 
 
 
 
Baseline - > Week 8, n (%) 
 
 
 
 
 
  N [1] 
 
XX 
XX 
XX 
XX 
  Low ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Normal -> Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  High ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
<Include all possible shifts as rows> 
 
 
 
 
 
 
 
 
 
 
 
Baseline - > Week 12, n (%) 
 
 
 
 
 
  N [1] 
 
XX 
XX 
XX 
XX 
  Low ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Normal -> Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  High ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
<Include all possible shifts as rows> 
 
 
 
 
 
 
 
 
 
 
 
<continue with:: Week 16, Week 20, Week 24> 
 
 
 
 
 
[1] # of subjects with both baseline and post-baseline visits, this is the denominator for calculating the percentage. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Data Listings XXXX 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 105 of 153 
<Repeat table for> 
Table 14.3.2.4.2: Clinical Laboratory Results, Shifts from Baseline by Visit 
Hematology 
Safety Population 
[Lab Tests Name (Units)] 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 106 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.3.1: Summary of Vital Signs by Treatment and Visit 
Safety Population 
[Pulse Rate (bpm)][ Systolic Blood Pressure (mmHg)][ Diastolic Blood Pressure (mmHg)] 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Baseline 
 
 
 
 
    Observed Values 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Week 4 
 
 
 
 
    Observed Values 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
     Change from Baseline 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
<Repeat for Week 8, Week 12, Week 16, Week 20, Week 24> 
 
 
 
 
Note: Baseline is the last available measurement prior to the first dose of study drug on Day 1. 
 
Generated on  XX/XX/XX:XXXX  by XXX / Uses: XXXX / Reference: Listing XXXX 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 107 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.3.2: Summary of Vital Signs, Shifts from Baseline by Visit 
Safety Population 
[Pulse Rate (bpm)][ Systolic Blood Pressure (mmHg)][ Diastolic Blood Pressure (mmHg)] 
 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
 
Baseline - > Week 4, n (%) 
 
 
 
 
 
  N [1] 
 
XX 
XX 
XX 
XX 
  Low ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Normal -> Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  High ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
<Include all possible shifts as rows> 
 
 
 
 
 
  Abnormal Change from Baseline 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Markedly Abnormal Change from Baseline 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
Baseline - > Week 8, n (%) 
 
 
 
 
 
  N [1] 
 
XX 
XX 
XX 
XX 
  Low ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Normal -> Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  High ->  Normal 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
<Include all possible shifts as rows> 
 
 
 
 
 
  Abnormal Change from Baseline 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
  Markedly Abnormal Change from Baseline 
 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
 
 
 
 
 
 
<continue with other visits: Week 12, Week 16, Week 20, Week 24> 
 
 
 
Note: Pulse Rate: Low=<50bpm; Normal=50-100bpm; High=>100bpm; Abnormal change from baseline: >=10bpm; Markedly abnormal change from baseline: >=30bpm. 
Systolic Blood Pressure: Low= <90mmHg; Normal= 90-140mmHg; High= >140mmHg; Abnormal change from baseline: >=20mmHg; Markedly abnormal change from baseline: 
>=40mmHg. Diastolic Blood Pressure: Low= <50mmHg; Normal= 50-90mmHg; High= >90mmHg; Abnormal change from baseline: >=10mmHg; Markedly abnormal change 
from baseline: >=20mmHg.  
[1] # of subjects with both baseline and post-baseline visits, this is the denominator for calculating the percentage. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX / Reference: Data Listings XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 108 of 153 
Dr Reddy’s Laboratories, SA  
                                                                                          Page  X of  Y 
Protocol Number: PPC-06-CD-004 
 
Table 14.3.4: Summary of ECG Results by Treatment and Visit 
Safety Population 
[Lab Tests Name (Units)] 
 
 
PPC-06 400 mg QD 
(N=XX) 
PPC-06 400 mg BID 
(N=XX) 
PPC-06 600 mg BID 
(N=XX) 
Placebo 
(N=XX) 
 
 
 
 
 
Baseline  
 
 
 
 
    Observed Values 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
Week 4  
 
 
 
 
    Observed Values 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
     Change from Baseline 
 
 
 
 
N 
XX 
XX 
XX 
XX 
Mean (SD) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
XX.X (XX.X) 
Median 
XX 
XX 
XX 
XX 
Minimum, Maximum 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
 
 
 
 
 
<Repeat for other visits: Week 8, Week 12, Week 16, Week 20, Week 24> 
 
 
 
Note: Baseline is the last available measurement prior to the first dose of study drug on Day 1. 
 
Generated on  XX/XX/XX:XXXX  by XXX / Uses: XXXX / Reference: Listing XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 109 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of Y 
Protocol Number: PPC-06-CD-004 
  
Figure 14.3.1.1: Plot of Mean Change from Baseline by Visit, Lymphocyte Counts vs PASI scores  
Safety Population 
PPC-06 400 mg QD 
 
                                     
 
                                                                      
 
 
 
 
Generated on XX/XX/XX XX:XX by XXXX / Uses: XXXX, XXXX, XXXX / Reference: XXXX 
 
[Programming note: y-axis is the mean change from baseline in lymphocyte counts by visit. X-axis is the mean change from baseline in PASI 
scores by visit. Use different symbols for different visits, limit color just to black and white.] 
 
0
1
2
3
4
5
6
7
8
9
-25
-24.5
-24
-23.5
-23
-22.5
-22
-21.5
-21
-20.5
-20
Lymphocyte Counts
PASI
Week 4
Week 8
Week 12
Week 16
Week 20
Week 24


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 110 of 153 
Repeat the figure for 
Figure 14.3.1.2: Plot of Mean Change from Baseline by Visit, Lymphocyte Counts vs PASI scores 
Safety Population 
PPC-06 400 mg BID 
Figure 14.3.1.3: Plot of Mean Change from Baseline by Visit, Lymphocyte Counts vs PASI scores 
Safety Population 
PPC-06 600 mg BID 
Figure 14.3.1.4: Plot of Mean Change from Baseline by Visit, Lymphocyte Counts vs PASI scores 
Safety Population 
Placebo 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 111 of 153 
Dr Reddy’s Laboratories, SA  
                                                                         Page  X of Y 
Protocol Number: PPC-06-CD-004 
  
Figure 14.3.2.1: Plot of Mean Change from Baseline by Visit, hsCRP (unit) vs PASI scores  
Safety Population 
PPC-06 400 mg QD 
 
                                     
 
                                                                      
 
 
 
 
Generated on XX/XX/XX XX:XX by XXXX / Uses: XXXX, XXXX, XXXX / Reference: XXXX 
 
 
 
[Programming note: y-axis is the mean change from baseline in hsCRP by visit. X-axis is the mean change from baseline in PASI scores by visit. 
Use different symbols for different visits, limit color just to black and white.] 
 
 
 
0
1
2
3
4
5
6
7
8
9
-25
-24.5
-24
-23.5
-23
-22.5
-22
-21.5
-21
-20.5
-20
hsCRP (unit)
PASI
Week 4
Week 8
Week 12
Week 16
Week 20
Week 24


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 112 of 153 
 
 
Figure 14.3.2.2: Plot of Mean Change from Baseline by Visit, hs-CRP (unit) vs PASI scores  
Safety Population 
PPC-06 400 mg BID 
Figure 14.3.2.3: Plot of Mean Change from Baseline by Visit, hs-CRP (unit) vs PASI scores  
Safety Population 
PPC-06 600 mg BID 
 
Figure 14.3.2.4: Plot of Mean Change from Baseline by Visit, hs-CRP (unit) vs PASI scores  
Safety Population 
Placebo 
 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 113 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                     Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.1.7:  Subject Enrollment and Randomization 
All Randomized Subjects 
 
Subject 
Number 
Date of Informed 
Consent 
Require 
Washout 
Period? 
Washout Period 
Completed? If No, Reason 
 
Randomization 
Date 
Randomization 
Number 
Randomized 
Treatment 
Actual Treatment 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
DDMMMYYYY 
Yes 
Yes  
 
DDMMMYYYY 
XXXXXXX 
PPC-06 400 mg QD PPC-06 400 mg QD 
 
XX-XXX 
DDMMMYYYY 
No 
-- 
 
DDMMMYYYY 
XXXXXXX 
PPC-06 400 mg BID PPC-06 400 mg BID  
XX-XXX 
DDMMMYYYY 
Yes 
No: XXXX 
 
DDMMMYYYY 
XXXXXXX 
PPC-06 600 mg BID Not Treated 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Generated on  XX/XX/XX:XXXX   by XXXX / Uses: XXXX 
  
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 114 of 153 
 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                    Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.1.1: Screen Failures 
All Screen Failure Subjects 
 
Subject 
Number 
Date of Informed  
Consent 
Date of  
Screening 
Date of Birth 
Age  
(Years) 
Sex 
Primary Reason for  
Screen Failure 
 
 
 
 
 
 
XX-XXX 
DDMMMYYYY 
DDMMMYYYY 
DDMMMYYYY 
XX 
X 
I/E criteria not met: Inclusion 2 
XX-XXX 
DDMMMYYYY 
DDMMMYYYY 
DDMMMYYYY 
XX 
X 
Other: XXXXXXX 
XX-XXX 
DDMMMYYYY 
DDMMMYYYY 
DDMMMYYYY 
XX 
X 
XXXXXXXXXXX 
XX-XXX 
DDMMMYYYY 
DDMMMYYYY 
DDMMMYYYY 
XX 
X 
XXXXXXXXXXX 
XX-XXX 
DDMMMYYYY 
DDMMMYYYY 
DDMMMYYYY 
XX 
X 
XXXXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX  / Uses: XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 115 of 153 
 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                         Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.1.2: Subject Disposition 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
 
Date (Day) of [1] 
Subject 
Number 
Screening 
Randomization 
First Dose 
Last Dose 
Last Visit 
Last Contact 
Completion 
Status / 
Discontinuation 
Reason 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
DDMMMYYYY(XX) DDMMMYYYY(XX) DDMMMYYYY(XX) DDMMMYYYY(XX) DDMMMYYYY(XX) DDMMMYYYY(XX) XXXXX 
 
XX-XXX 
DDMMMYYYY(XX) DDMMMYYYY(XX) DDMMMYYYY(XX) DDMMMYYYY(XX) DDMMMYYYY(XX) DDMMMYYYY(XX) XXXXX 
 
001-001 
19JUN2017(-10) 
29JUN2017(1) 
29JUN2017(1) 
-- 
06JUL2017(8) 
-- 
Completed 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXX/ Uses: XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 116 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                    Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.2: Protocol Deviation 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
 
 
<Programming Note: The format of protocol deviation listing depends on the actual protocol deviation report form layout.  Additional columns may be added, such as 
“Reference” “Type”. If site deviation or deviation for SF subjects are also available, include those at the very end of this listing.> 
 
 
 
Subject Number 
Category 
Protocol Deviation 
 
 
 
XX-XXX 
XXXX 
XXXX 
 
XXXXX 
XXXX 
 
 
 
 
 
 
 
 
 
 
 
Generated on  XX/XX/XX:XXXX  by XXXX/ Uses: XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 117 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                    Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.3: Population Datasets 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
 
 
Subject 
Number 
In Full Analysis Set? 
In Safety Population? 
In PP Population? 
 
Reason for Exclusion from 
PP Population 
 
 
 
 
 
 
 
 
XX-XXX 
Yes 
Yes 
Yes 
 
XXX 
 
XX-XXX 
Yes 
No 
No 
 
XXX 
 
XX-XXX 
No 
No 
No 
 
NA 
 
 
 
 
 
  
 
Generated on  XX/XX/XX:XXXX  by XXXX/ Uses: XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 118 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                    Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.4.1: Demographics and Baseline Characteristics  
All Randomized Subjects  
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
 
Subject 
Number 
Date of Birth 
Age 
(years) Sex 
Race Ethnicity 
Weight 
(kg) 
Height 
(cm) 
BMI 
(kg/m2) [1] 
Waist Circum-
ference (cm) 
PASI 
BSA 
IGA [2] 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX DDMMMYYYY 
XX 
M 
Asian 
NH 
XXX 
XXX 
XX.X 
XXX 
X 
XX.X 
X 
 
DDMMMYYYY 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX DDMMMYYYY 
XX 
F 
White 
H 
XXX 
XXX 
XX.X 
XXX 
X 
XX.X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: BMI = Body Mass Index; PASI = Psoriasis Area and Severity Index; BSA = Body Surface Area; IGA = Investigator’s Global Assessment  
NH=Not Hispanic or Latino; H=Hispanic or Latino 
[1] Baseline BMI is calculated as baseline weight / baseline height^2. 
[2] 0 = Clear; 1=Almost clear; 2=Mild; 3=Moderate; 4=Severe 
 
Generated on  XX/XX/XX:XXXX  by XXXX/ Uses: XXXX 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 119 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                          Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.4.2: Prior and Concomitant Medication 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject 
Number 
Category 
WHO Preferred Term 
(Verbatim Term) /  
ATC Classification 
Indication/ 
Total Daily Dose/ 
Unit/Frequency/Route 
Start Date (Day)-Stop Date (Day)  
Rescue Medication?/ 
Taken to treat an 
AE? AE # 
 
 
 
 
 
 
XX-XXX 
Prior 
XXXXXX (xxxxx)/ 
XXXXXX 
XXX/ 
XX/XX/XXX/XXXX 
 
DDMMMYYYY (XX) – DDMMMYYYY (XX) 
Yes/Yes: 2 
 
 
 
 
 
 
XX-XXX 
Concomitant 
XXXXXX (xxxxx)/ 
XXXXXX 
XXX/ 
XX/XX/XXX/XXXX 
 
DDMMMYYYY (XX) –  
ONGOING  
No/Yes: 3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXX/ Uses: XXXX 
 
 
<Programming Note: List medication in ascending start date for each subject.> 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 120 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                           Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.4.3: Psoriasis Treatment History  
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject Number 
Medication Name 
 
Start Date (Day) - Stop Date (Day)  
 
 
 
 
XX-XXX 
XXXXXXXX 
 
DDMMMYYYY (XX) – DDMMMYYYY (XX) 
 
XXXXXXXXXXX 
 
DDMMMYYYY (XX) – DDMMMYYYY (XX) 
XXXXXXXXXX 
 
DDMMMYYYY (XX) – ONGOING 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXX/ Uses: XXXX 
 
<Programming Note: List medication in ascending start date for each subject.> 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 121 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                           Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.4.4: Concurrent Procedures 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject Number 
Preferred Term/ 
System Organ Class/ 
Procedure 
Diagnosis 
 
Procedure Start Date (Day) - Stop Date (Day)  
 
 
 
 
 
XX-XXX 
XXXXXXXX/ 
XXXXX/ 
XXXXXX 
XXXXXXX 
 
DDMMMYYYY (XX) – DDMMMYYYY (XX) 
 
 
 
 
 
XX-XXX 
XXXXXXXX/ 
XXXXX/ 
XXXXXX 
XXXXXXXXXXX 
 
DDMMMYYYY (XX) – ONGOING 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXX/ Uses: XXXX 
 
<Programming Note: List medication in ascending start date for each subject.> 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 122 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                     Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.4.5: Medical/Surgical History 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
 
 
 
Subject Number 
Condition/Surgery/Procedure 
System Organ Class/ 
Preferred Term 
Procedure Start Date (Day) - Stop Date (Day)   
 
 
 
 
 
XX-XXX 
XXXX 
XXXXX/ 
XXXXXX 
DDMMMYYYY (XX) – DDMMMYYYY (XX)  
 
 
 
 
 
XX-XXX 
XXXX 
XXXXX/ 
XXXXXX 
DDMMMYYYY (XX) – ONGOING 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
Generated on  XX/XX/XX:XXXX  by  XXXXX / Uses: XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 123 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                    Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.4.6: Psoriasis Medical History 
All Randomized Subjects  
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
 
 
 
Subject Number 
Date of Initial Diagnosis of Plaque Psoriasis 
Other Anatomical Areas  
Affected by Psoriasis 
 
 
 
 
 
  
XX-XXX 
YYYY 
Scalp 
  
 
 
 
  
XX-XXX 
YYYY 
Other: XXXXX 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX/ Uses: XXXX 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 124 of 153 
 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                      Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.5.1: Study Drug Accountability – Blister Packs 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject 
Number 
Kit Number 
Blister Number 
Date (Day) Returned [1] 
 
Number of Tablets Returned 
 
 
 
 
 
XX-XXX 
XXXXXXX 
Week 1 
DDMMMYYYY(XX) 
XX 
 
 
Week 2 
DDMMMYYYY(XX) 
XX 
 
 
Week 3 
DDMMMYYYY(XX) 
XX 
 
 
Week 4 
DDMMMYYYY(XX) 
XX 
 
 
Week 5 
DDMMMYYYY(XX) 
XX 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
XXXXXXX 
Week 1 
DDMMMYYYY(XX) 
XX 
 
 
Week 2 
DDMMMYYYY(XX) 
XX 
 
 
Week 3 
DDMMMYYYY(XX) 
XX 
 
 
Week 4 
DDMMMYYYY(XX) 
XX 
 
 
 
 
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 125 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                      Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.5.2 Study Drug Accountability – Bottles 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject 
Number 
Kit Number 
Bottle Number 
Date (Day) Returned [1] 
Number of Tablets 
Dispensed 
Returned 
Used 
 
 
 
 
 
 
 
XX-XXX 
XXXXXXX 
AM1 
DDMMMYYYY(XX) 
30 
XX 
XX 
 
 
AM2 
DDMMMYYYY(XX) 
60 
XX 
XX 
 
 
PM1 
DDMMMYYYY(XX) 
30 
-- 
-- 
 
 
PM2 
DDMMMYYYY(XX) 
60 
XX 
XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
XXXXXXX 
DDMMMYYYY(XX) 
DDMMMYYYY(XX) 
XX 
XX 
XX 
 
 
DDMMMYYYY(XX) 
DDMMMYYYY(XX) 
XX 
XX 
XX 
 
 
DDMMMYYYY(XX) 
DDMMMYYYY(XX) 
XX 
XX 
XX 
 
 
DDMMMYYYY(XX) 
DDMMMYYYY(XX) 
XX 
XX 
XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 126 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.5.3: Study Drug Exposure and Compliance 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject 
Number 
Study Period 
Total # of Days  
Exposed [1] 
Total # of  
Expected Tablets 
Total # of Tablets  
Taken [2] 
Average Daily  
Dose of IP [3] 
Compliance 
 
%Compliance [4] 
Compliant? 
 
 
 
 
 
 
 
 
 
 
XX-XXX Overall 
XX 
945 
XX 
XX 
XX.X 
Yes 
 
 
Titration  
- 
147 
XX 
- 
XX.X 
 
             No 
 
 
Treatment 
- 
798 
XX 
- 
XX.X 
Yes 
 
 
 
 
 
 
 
 
 
 
XX-XXX Overall 
XX 
945 
XX 
XX 
XX.X 
No 
 
 
Titration  
- 
147 
XX 
- 
XX.X 
Yes 
 
 
Treatment 
- 
798 
XX 
- 
XX.X 
Yes 
 
 
 
 
 
 
 
 
 
 
Note: Titration Period: Week 1 – 5. Treatment Period: Week 6 – 24. Overall: Week 1 – 24. 
[1] Defined as date of last dose of study drug during the study minus date of first dose of study drug plus 1.  
[2] Defined as the summation of number of tablets taken during the titration, treatment, or overall period.  
[3] Calculated as the number of tablets divided by the number of days exposed to study medication for the overall period.  
[4] Calculated as the number of tablets taken divided by the expected number of tablets, defined for the titration period, treatment period, and overall. 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 127 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                        Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.6.1.1: Psoriasis Area and Severity Index (PASI) Score  
All Randomized Subjects 
 [PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject Number 
Analysis Visit 
Date (Study Day) [1] 
Type  
Head and 
Neck 
Upper 
Limbs 
Trunk 
Lower 
Limbs 
Scores 
 
 
 
 
 
 
 
 
 
XXX-XXX 
Baseline 
DDMMMYYYY(XX) 
Erythema 
X 
X 
X 
X 
XX 
 
 
 
Induration 
X 
X 
X 
X 
XX 
 
 
 
Scaling 
X 
X 
X 
X 
XX 
 
 
 
Sum (E+I+S) 
X 
X 
X 
X 
XX 
 
 
 
Area Involved  
X 
X 
X 
X 
 
 
 
 
Sum X Area 
XX 
XX 
XX 
XX 
XX.X 
 
 
 
 
 
 
 
 
 
 
Week 4 
DDMMMYYYY(XX) 
Erythema 
X 
X 
X 
X 
XX 
 
 
 
Induration 
X 
X 
X 
X 
XX 
 
 
 
Scaling 
X 
X 
X 
X 
XX 
 
 
 
Sum (E+I+S) 
X 
X 
X 
X 
XX 
 
 
 
Area Involved  
X 
X 
X 
X 
 
 
 
 
Sum X Area 
XX 
XX 
XX 
XX 
XX.X 
 
 < continue for other visits> 
  
  
  
  
  
  
  
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on XX/XX/XX:XXXX by XXXX / Uses: XX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 128 of 153 
 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                        Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.6.1.2: PASI Total Score and Change from Baseline and Responders 
All Randomized Subjects 
 [PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
  
  
  
  
  
 
  
 
 
Subject Number 
Analysis 
Visit 
Date (Study Day) [1] 
Type 
PASI Total Score 
PASI-50? [2]  
PASI-75? [2] 
Value 
CFBL 
%CFBL 
 
 
 
 
 
 
 
 
 
XXX-XXX 
Baseline 
DDMMMYYYY (XX) 
Observed 
60 
- 
- 
- 
- 
 
Week 4 
DDMMMYYYY (XX) 
Observed 
52 
-8 
13.3 
N 
N 
 
Week 8 
DDMMMYYYY (XX) 
Observed 
40 
-20 
33.4 
N 
N 
 
Week 12 
- 
LOCF 
40 
-20 
33.4 
N 
N 
 
 
- 
m-NRI 
- 
- 
- 
N 
N 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
<continue for other visits> 
 
 
 
 
 
 
  
  
  
  
  
 
  
 
 
Note: PASI=Psoriasis Area and Severity Index; LOCF=Last Observation Carried Forward; m-NRI= Modified Non-Responder Imputation. CFBL=Change from baseline calculated 
as post-baseline minus baseline. 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
[2] PASI-50/PASI-75 responder is defined as achieving a reduction of 50%/75% or greater from baseline. 
 
Generated on XX/XX/XX:XXXX by XXXX / Uses: XX  
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 129 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                   Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.2: Investigator’s Global Assessment (IGA) of Disease Severity 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
  
  
  
  
  
  
  
Subject Number 
Analysis Visit 
Visit Date (Day) [1] 
Type 
IGA Score 
IGA Responder?[2]  
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY(XX) 
Observed 
3 – Moderate 
-- 
 
Week 4 
DDMMMYYYY(XX) 
Observed 
2 – Mild 
N 
 
Week 8 
- 
LOCF 
2 – Mild 
N 
 
 
- 
m-NRI 
- 
N 
 
Week 12 
DDMMMYYYY(XX) 
Observed 
1 – Almost clear 
Y 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
<continue for other visits> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: LOCF=Last observation-carried forward; m-NRI= Modified Non-Responder Imputation.  
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
[2] IGA responder is defined as achieving an IGA score of clear or almost clear (IGA score 0 or 1).  
    
 
 
 
 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 130 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                          Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.3: Investigator’s Assessment of the Body Surface Area (BSA) Involvement of Psoriasis 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject 
Number  
Analysis 
Visit 
Visit Date (Day) [1] 
Type 
Skin Area Involved (Number of Palms) 
 
Head and Neck 
Upper Limbs 
Trunk 
Lower Limbs 
Total 
 
Value CFBL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline DDMMMYYYY(XX) Observed 
0 
 
2 
 
1 
 
1 
 
3 
-- 
 
 
 
Week 4 
DDMMMYYYY(XX) Observed 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
 
Week 8 
DDMMMYYYY(XX) Observed 
-- 
 
-- 
 
-- 
 
-- 
 
-- 
-- 
 
 
 
 
 
LOCF 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
<continue for other visits> 
 
 
 
 
 
 
 
 
 
 
 
Note: LOCF=Last observation-carried forward. CFBL=Change from baseline: calculated as post-baseline minus baseline. 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 131 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                              Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.4.1: Nail Psoriasis Severity Index (NAPSI) at Baseline 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject Number 
Visit Date   
Hand/ 
Digit 
Nail Bed 
Nail Matrix 
Total 
1 
2 
3 
4 
5 
1 
2 
3 
4 
5 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
DDMMMYYYY 
Left/1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
X 
X 
 
 
Right/1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
  
[Programming Note: put a star next to the total score of the selected target nail] 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 132 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                              Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.4.2: Target Nail Psoriasis Severity Index (NAPSI) 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject 
Number 
Analysis Visit 
Visit Date (Day) [1] 
 
 
Nail Bed Score 
Nail Matrix Score 
Total score 
CFBL 
Observed 
LOCF 
Observed 
LOCF 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY(XX) 
 
 
X 
X 
X 
- 
- 
- 
 
Week 12 
DDMMMYYYY(XX) 
 
 
X 
X 
X 
- 
X 
- 
 
Week 16 
- 
 
 
- 
- 
- 
X 
- 
X 
 
Week 24 
DDMMMYYYY(XX) 
 
 
X 
X 
X 
- 
X 
- 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 CFBL=Change from baseline calculated as post-baseline minus baseline. 
 [1] Study day is calculated relative to the date of first study drug administration (Day 1).  
  
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 133 of 153 
 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                          Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.5: Psoriasis Scalp Severity Index (PSSI) 
All Randomized Subjects 
[PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
Subject 
Number  
Analysis 
Visit 
Visit Date (Day) [1] 
Type 
 
 
 
 
 
 
 
Erythema 
Induration 
Scaling 
Area scoring 
Total 
 
Value 
CFBL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline DDMMMYYYY(XX) 
Observed 
0 
2 
1 
1 
3 
-- 
 
 
 
Week 4 
DDMMMYYYY(XX) 
Observed 
X 
X 
X 
X 
X 
X 
 
 
 
Week 8 
- 
LOCF 
X 
X 
X 
X 
X 
X 
 
 
 
Week 12 DDMMMYYYY(XX) 
Observed 
X 
X 
X 
X 
X 
X 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note LOCF=Last observation-carried forward; CFBL=Change from baseline: calculated as post-baseline minus baseline. 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 134 of 153 
 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                   Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.6: Palmoplantar Physician’s Global Assessment of Disease Severity (PP PGA)  
All Randomized Subjects 
 [PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
  
  
  
  
  
  
  
Subject 
Number 
Analysis Visit 
Visit Date (Day) [1] 
Type 
 
 
Value 
CFBL 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY(XX) 
Observed 
3 – Moderate 
-- 
 
 
Week 4 
DDMMMYYYY(XX) 
Observed 
2 – Mild 
-1 
 
 
Week 8 
DDMMMYYYY(XX) 
Observed 
2 – Mild 
-1 
 
 
Week 12 
DDMMMYYYY(XX) 
Observed 
1 – Almost clear 
-2 
 
 
Week 16 
DDMMMYYYY(XX) 
Observed 
1 – Almost clear 
-2 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY(XX) 
Observed 
3 – Moderate 
-- 
 
 
Week 4 
DDMMMYYYY(XX) 
Observed  
3 – Moderate 
X 
 
 
Week 8 
DDMMMYYYY(XX) 
Observed 
2 – Mild 
-1 
 
 
Week 12 
-- 
LOCF 
2 – Mild 
-1 
 
 
Week 16 
DDMMMYYYY(XX) 
Observed 
XXX 
X 
 
 
Week 20 
DDMMMYYYY(XX) 
Observed 
XXX 
X 
 
 
Week 24 
DDMMMYYYY(XX) 
Observed 
XXX 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
Note: LOCF=Last observation-carried forward. CFBL=Change from baseline calculated as post-baseline minus baseline. 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
  
 
 
 
 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 135 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                          Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.6.7: Itch by NRS 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
 
 
 
 
 
 
Subject  Number 
Analysis Visit 
Visit Date (Day) [1] 
Type 
Value  
CFBL 
 
 
 
 
 
 
XXX-XXX 
Baseline 
DDMMYYYY (XX) 
Observed 
X 
- 
 
Week 4 
DDMMYYYY (XX) 
Observed 
X 
X 
 
Week 8 
- 
LOCF 
X 
X 
 
Week 12 
DDMMYYYY (XX) 
Observed 
X 
X 
 
Week 16 
DDMMYYYY (XX) 
Observed 
X 
X 
 
Week 20 
DDMMYYYY (XX) 
Observed 
X 
X 
 
Week 24 
DDMMYYYY (XX) 
Observed 
X 
X 
 
<Etc.> 
 
 
 
 
 
 
 
 
 
 
Note: NRS = Numerical Rating Scale.   LOCF=Last observation-carried forward. CFBL=Change from baseline calculated as post-baseline minus baseline. 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
Generated on  XX/XX/XX:XXXX  by XXXX/ Uses: XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 136 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                        Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.8: Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16) 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
Subject 
Number 
Analysis 
Visit 
Visit Date (Day) [1] 
Q1 
Q2 
Q3 
Q4 
Q5 
Q6 
Q7 
Q8 
Q9 
Q10 
Q11 Q12 Q13 Q14 Q15 Q16 
Total 
Value 
CFBL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX Baseline 
DDMMMYYYY(XX) 
0 
0 
0 
2 
1 
1 
1 
3 
0 
1 
1 
1 
1 
1 
1 
1 
X 
X 
 
Week 12 
DDMMMYYYY(XX) 
1 
1 
1 
3 
2 
1 
1 
3 
1 
1 
1 
1 
1 
1 
1 
1 
X 
X 
 
Week 16 
DDMMMYYYY(XX) 
1 
0 
0 
1 
0 
0 
0 
1 
1 
0 
0 
0 
0 
0 
0 
0 
X 
X 
 
Week 24 
DDMMMYYYY(XX) 
1 
0 
0 
1 
0 
0 
0 
1 
1 
0 
0 
0 
0 
0 
0 
0 
X 
X 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
  
Note: CFBL=Change from baseline calculated as post-baseline minus baseline. 
1. Falling asleep; 2. Sleep during the night, 3. Waking up too early; 4. Sleeping too much 5. Feeling sad, 6. Decreased appetite, 7. Decreased appetite 8. Decreased weight (within the 
last two weeks), 9. Increased weight (within the Last two weeks), 10. Concentration/decision making, 11. View of myself, 12. Thoughts of death or suicide,13. General interest, 14. 
Energy level, 15. Feeling slowed down, 16. Feeling restless 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 137 of 153 
 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                            Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.9.1: Dermatology Life Quality Index (DLQI) Individual Questions 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject Number Analysis Visit 
Visit Date (Day) [1] 
Q1 
Q2 
Q3 
Q4 
Q5 
Q6 
Q7 
Q8 
Q9 
Q10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Week 12 
DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Week 16 
DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Week 24 
DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
  
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 138 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                          Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.9.2: Dermatology Life Quality Index (DLQI) Domains and Total Score 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject 
Number  
Analysis 
Visit 
Visit Date (Day) [1] 
Symptoms and 
Feelings 
Daily Activities 
Leisure 
Work and 
School 
Personal 
Relationships 
Treatment 
Total 
Value CFBL 
Value CFBL Value CFBL 
Value 
Value CFBL 
Value 
Value 
CFBL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline DDMMMYYYY(XX) 
X 
-- 
X 
-- 
X 
-- 
X 
 
X 
-- 
X 
 
X 
-- 
 
Week 12 DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
 
Week 16 DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
 
Week 24 DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline DDMMMYYYY(XX) 
X 
-- 
X 
-- 
X 
-- 
X 
 
X 
-- 
X 
 
X 
-- 
 
Week 12 DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
 
Week 16 DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
 
Etc 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: CFBL=Change from baseline calculated as post-baseline minus baseline. 
Symptoms and Feelings includes Q1 and Q2; Daily Activities includes Q3 and Q4; Leisure includes Q5 and Q6; Work and School includes Q7 and Q7a; Personal Relationships 
includes Q 8 and Q9; Treatment includes Q10 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 139 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                            Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.10.1: SF-12 Subdomains 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject  
Number 
Analysis Visit 
Visit Date (Day) [1] 
Type 
PF 
RP 
BP 
SF 
MH 
RE 
VT 
GH 
PCS 
MCS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY(XX) 
Value 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
 
 
 
CFBL 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
 
Week 12 
DDMMMYYYY(XX) 
Value 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
 
 
 
CFBL 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
 
Week 16 
DDMMMYYYY(XX) 
Value 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
 
 
 
CFBL 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
 
Week 24 
DDMMMYYYY(XX) 
Value 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
 
 
 
CFBL 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
  
Note: PF =Physical Functioning, RP=Role-Physical, BP=Bodily Pain, SF=Social Functioning, MH=Mental Health, RE=Role-Emotional, VT=Vitality, GH=General Health, 
PCS =Physical Summary, MCS=Mental Summary. CFBL=Change from baseline calculated as post-baseline minus baseline.  
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 140 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                            Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.10.2: SF-12 Individual Questions 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject Number Analysis Visit 
Visit Date (Day) [1] 
Q1 
Q2 
Q3 
Q4 
Q5 
Q6 
Q7 
Q8 
Q9 
Q10 
Q11 
Q12 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Week 12 
DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Week 16 
DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Week 24 
DDMMMYYYY(XX) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 141 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                          Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.11: Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) 
All Randomized Subjects 
 [PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
Subject 
Number 
Analysis 
Visit 
Visit Date (Day) [1] 
 
 
 
% work time missed 
% impairment while 
working 
% overall work 
impairment 
% activity 
impairment 
 
Value 
CFBL 
Value 
CFBL 
Value 
CFBL 
Value 
CFBL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY(XX) 
 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
 
 
 
Week 12 
DDMMMYYYY(XX) 
 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
Week 16 
DDMMMYYYY(XX) 
 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
Week 24 
DDMMMYYYY(XX) 
 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY(XX) 
 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
 
 
 
 
Week 12 
DDMMMYYYY(XX) 
 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
Week 16 
DDMMMYYYY(XX) 
 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: WPAI-PSO outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. 
CFBL=Change from baseline calculated as post-baseline minus baseline. 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 142 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                    Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.6.12: Health Economics and Outcome Research (HEOR) 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject 
Number Analysis Visit 
Visit Date (Day) [1]  # Visits to Physician’s Office or  
Urgent Care Clinic/ Reason 
# Visits to Other Health Care 
Professionals / Reason 
# Times Received Care from a  
Health Professional at Home /Reason 
 
 
 
 
  
 
 
 
XX-XXX Baseline 
DDMMMYYYY(XX)  XX / XXXXXXXXXXXX 
XX / XXXXXXXXXXXX 
XX / XXXXXXXXXXXX 
 
 
 
 
  
 
 
 
 
Week 12 
DDMMMYYYY(XX)  XX / XXXXXXXXXXXX 
XX / XXXXXXXXXXXX 
XX / XXXXXXXXXXXX 
 
 
 
 
  
 
 
 
 
Week 16 
DDMMMYYYY(XX)  XX / XXXXXXXXXXXX 
XX / XXXXXXXXXXXX 
XX / XXXXXXXXXXXX 
 
 
 
 
  
 
 
 
 
Week 24 
DDMMMYYYY(XX)  XX / XXXXXXXXXXXX 
XX / XXXXXXXXXXXX 
XX / XXXXXXXXXXXX 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 143 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                     Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.7.1: Adverse Events 
All Randomized Subjects 
[PPC-06 400 mg QD] [ PPC-06 400 mg BID] [ PPC-06 600 mg BID] [Placebo] 
 
Subject 
Number AE # 
MedDRA SOC Term/ 
MedDRA Preferred 
Term/ 
(Verbatim Term)  
Treatment-emergent? [1] 
Onset Date (Day) –  
End Date (Day) [2] 
SSAE: Criteria? 
Outcome/ 
Action taken with 
IP 
Severity 
CTCAE Grade [3]/ 
Relationship to IP 
Action taken to treat AE/ 
Withdraw due to AE? 
 
XX-XXX 
1 
XXXXXXXX /  
XXXXXXXX  /  
(XXXXXXXX) 
Yes / 
DDMMMYYYY(XX) –  
DDMMMYYYY(XX) 
Yes: 
Hospitalization 
XXXXXXXX/ 
XXXXXXXX 
Mild 
-/ 
XXXXXXXX  
XXXXXXXX /  
No 
 
 
2 
XXXXXXXX /  
XXXXXXXX /  
(Diarrhea) 
No / 
DDMMMYYYY(XX) –  
DDMMMYYYY(XX) 
No 
XXXXXXXX/ 
XXXXXXXX 
XXXXXXXX Grade 2/ 
XXXXXXXX  
XXXXXXXX /  
No 
 
 
 
 
 
 
 
 
 
XX-XXX 
1 
XXXXXXXX /  
XXXXXXXX /  
(XXXXXXXX) 
XXX / 
DDMMMYYYY(XX) –  
DDMMMYYYY(XX) 
No 
XXXXXXXX/ 
XXXXXXXX 
XXXXXXXX -/ 
XXXXXXXX  
XXXXXXXX /  
Yes 
 
 
 
 
[1] A treatment-emergent AE (TEAE) is defined as an AE with a start date on or after the first application to trial medication. 
[2] Study day is calculated relative to the date of first study drug administration (Day 1). 
[3] Assessed for Lymphocytopenia or Diarrhea ONLY 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 144 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                     Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.7.2: Serious Adverse Events 
All Randomized Subjects 
[PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
Subject 
Number AE # 
MedDRA SOC Term/ 
MedDRA Preferred 
Term/ 
(Verbatim Term)  
Treatment-emergent? [1] 
Onset Date (Day) –  
End Date (Day) [2] 
SSAE: Criteria? 
Outcome/ 
Action taken with 
IP 
Severity 
CTCAE Grade [3]/ 
Relationship to IP 
Action taken to treat AE/ 
Withdraw due to AE? 
 
XX-XXX 
1 
XXXXXXXX /  
XXXXXXXX  /  
(XXXXXXXX) 
Yes / 
DDMMMYYYY(XX) –  
DDMMMYYYY(XX) 
Yes: 
Hospitalization 
XXXXXXXX/ 
XXXXXXXX 
Mild 
-/ 
XXXXXXXX  
XXXXXXXX /  
No 
 
 
2 
XXXXXXXX /  
XXXXXXXX /  
(Diarrhea) 
No / 
DDMMMYYYY(XX) –  
DDMMMYYYY(XX) 
XX 
XXXXXXXX/ 
XXXXXXXX 
XXXXXXXX Grade 2/ 
XXXXXXXX  
XXXXXXXX /  
No 
 
 
 
 
 
 
 
 
 
XX-XXX 
1 
XXXXXXXX /  
XXXXXXXX /  
(XXXXXXXX) 
XXX / 
DDMMMYYYY(XX) –  
DDMMMYYYY(XX) 
XX 
XXXXXXXX/ 
XXXXXXXX 
XXXXXXXX -/ 
XXXXXXXX  
XXXXXXXX /  
Yes 
 
 
 
 
[1] A treatment-emergent AE (TEAE) is defined as an AE with a start date on or after the first application to trial medication. 
[2] Study day is calculated relative to the date of first study drug administration (Day 1). 
[3] Assessed for Lymphocytopenia or Diarrhea ONLY 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 145 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                     Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.7.3: Adverse Events Leading to Study Drug Discontinuation 
All Randomized Subjects 
[PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
Subject 
Number AE # 
MedDRA SOC Term/ 
MedDRA Preferred 
Term/ 
(Verbatim Term)  
Treatment-emergent? [1] 
Onset Date (Day) –  
End Date (Day) [2] 
SSAE: Criteria? 
Outcome/ 
Action taken with 
IP 
Severity 
CTCAE Grade [3]/ 
Relationship to IP 
Action taken to treat AE/ 
Withdraw due to AE? 
 
XX-XXX 
1 
XXXXXXXX /  
XXXXXXXX  /  
(XXXXXXXX) 
Yes / 
DDMMMYYYY(XX) –  
DDMMMYYYY(XX) 
Yes: 
Hospitalization 
XXXXXXXX/ 
XXXXXXXX 
Mild 
-/ 
XXXXXXXX  
XXXXXXXX /  
No 
 
 
2 
XXXXXXXX /  
XXXXXXXX /  
(Diarrhea) 
No / 
DDMMMYYYY(XX) –  
DDMMMYYYY(XX) 
No 
XXXXXXXX/ 
XXXXXXXX 
XXXXXXXX Grade 2/ 
XXXXXXXX  
XXXXXXXX /  
No 
 
 
 
 
 
 
 
 
 
XX-XXX 
1 
XXXXXXXX /  
XXXXXXXX /  
(XXXXXXXX) 
XXX / 
DDMMMYYYY(XX) –  
DDMMMYYYY(XX) 
No 
XXXXXXXX/ 
XXXXXXXX 
XXXXXXXX -/ 
XXXXXXXX  
XXXXXXXX /  
Yes 
 
 
 
 
[1] A treatment-emergent AE (TEAE) is defined as an AE with a start date on or after the first application to trial medication. 
[2] Study day is calculated relative to the date of first study drug administration (Day 1). 
[3] Assessed for Lymphocytopenia or Diarrhea ONLY 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XX 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 146 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                         Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.8.1: Urine Pregnancy Test 
All Randomized Female Subjects with Childbearing Potential 
[PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
  
 
 
Subject Number 
Childbearing Potential 
Visit 
Date of Test (Day)[1] 
Result 
 
 
 
 
 
 
 
XX-XXX 
Abstinence 
Baseline 
DDMMMYYYY(XX)  
Negative 
 
 
 
Week 4 
DDMMMYYYY(XX) 
Negative 
 
 
 
Week 8 
DDMMMYYYY(XX) 
Negative 
 
 
 
Etc. 
 
 
 
XX-XXX 
XXXXXXX 
Baseline 
DDMMMYYYY(XX)  
Negative 
 
 
 
Week 4 
DDMMMYYYY(XX) 
Negative 
 
 
 
Week 8 
DDMMMYYYY(XX) 
Negative 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXX / Uses: XX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 147 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                   Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.8.2.X: Clinical Laboratory Test 
[Chemistry] [Hematology] [Urinalysis] [Lymphocyte] 
All Randomized Subjects 
[PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
Subject 
Number 
Analysis 
Visit 
Date (Day) [1] 
Parameter (Unit) 
Reference Range 
Results  
CFBL 
Abnormality 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY (XX) 
XXXX 
XXXX,XXXX 
XX.XX 
XX 
 
 
 
 
XXXX 
XXXX,XXXX 
XX.XX 
XX 
High 
 
 
 
XXXX 
XXXX,XXXX 
XX.XX 
XXX 
Low 
 
Week 4 
DDMMMYYYY (XX) 
XXXX 
XXXX,XXXX 
XX.XX 
XXX 
 
Week 8 
DDMMMYYYY (XX) 
XXXX 
XXXX,XXXX 
XX.XX 
XXX 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CFBL = Change from Baseline  
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XX 
 
[Programming Note: for lymphocyte listing, drop the parameter (unit) column] 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 148 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                     Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.8.3: Laboratory Values Outside of Normal Range 
All Randomized Subjects 
[PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
 
 
Subject 
Number 
Analysis Visit 
Date (Day)  [1] 
Category 
Parameter (Unit) 
Reference Range 
Result 
Abnormality 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY (XX) 
Chemistry 
XXXX 
XXXX,XXXX 
XX.XX 
Low 
 
 
 
Hematology 
XXXX 
XXXX,XXXX 
XX.XX 
Low 
 
 
 
Urinalysis 
XXXX 
XXXX,XXXX 
XX.XX 
Low 
 
Week 4 
DDMMMYYYY (XX) 
XXX 
XXXX 
XXXX,XXXX 
XX.XX 
High 
 
Week 8 
DDMMMYYYY (XX) 
XXX 
XXXX 
XXXX,XXXX 
XX.XX 
XXX 
 
Week 24 
DDMMMYYYY (XX) 
XXX 
XXXX 
XXXX,XXXX 
XX.XX 
XXX 
 
Etc. 
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXX/ Uses: XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 149 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                         Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.8.4: Vital Signs  
All Randomized Subjects 
[PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
 
 
 
 
 
SBP (mmHg) 
DBP (mmHg) 
Pulse Rate (bpm) 
Subject 
Number 
Analysis Visit 
Visit Date (Day) [1] 
Weight 
(kg) 
Value 
CFBL 
Value 
CFBL 
Value 
CFBL 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMYYYY (XX) 
 
XX.X 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
 
Week 4 
DDMMYYYY (XX) 
 
XX.X 
XX.X [H] 
XX.X * 
XX.X 
XX.X 
XX.X 
XX.X 
 
Week 8 
DDMMYYYY (XX) 
 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMYYYY (XX) 
 
XX.X 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
 
Week 4 
DDMMYYYY (XX) 
 
XX.X 
XX.X 
XX.X 
XX.X [L] 
XX.X** 
XX.X 
XX.X 
 
Week 8 
DDMMYYYY (XX) 
 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
XX.X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
Note: SBP=Systolic blood pressure; DBP=Diastolic blood pressure; CFBL= change from baseline; *=abnormal change from baseline; **=markedly abnormal change from 
baseline. 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXX / Uses: XXXX 
 
[Programming Note: put abnormality flag (L, H) in bracket next to the observed abnormal values. Include * or ** for abnormal CFBL values ] 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 150 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                      Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.8.5: Abnormal Physical Examination Results 
Randomized Subjects with Abnormal Results 
[PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
Subject 
Number 
Analysis Visit 
Visit Date (Day) [1] 
Findings 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMMYYYY (XX) 
Abnormal Not Clinically Significant 
 
 
 
 
 
 
XX-XXX 
XXXX 
DDMMMYYYY (XX) 
Abnormal Clinically Significant  
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXXX / Uses: XXXX 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 151 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                         Page X of Y 
Protocol Number: PPC-06-CD-004 
 
Listing 16.2.8.6.1: 12-Lead ECG Results  
All Randomized Subjects 
[PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
 
 
 
HR  
(beats/min) 
PR (msec) 
QRS (msec) QTcB (msec) 
QTcF (msec) 
RR (msec) 
QT (msec) 
Subject 
Number Analysis Visit 
Date and Time (Day) [1] 
Value CFBL Value CFBL Value CFBL Value CFBL Value 
CFBL 
Value 
CFBL Value CFBL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMYYYY T HH:MM (XX)  XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
 
Week 4 
DDMMYYYY T HH:MM (XX)  XX.X XX.X XX.X XX.X XX.X XX.X XX.X XX.X XX.X 
XX.X 
XX.X 
XX.X XX.X XX.X 
 
Week 8 
DDMMYYYY T HH:MM (XX)  XX.X XX.X XX.X XX.X XX.X XX.X XX.X XX.X XX.X 
XX.X 
XX.X 
XX.X XX.X XX.X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XX-XXX 
Baseline 
DDMMYYYY T HH:MM (XX)  XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
XX.X 
-- 
 
Week 4 
DDMMYYYY T HH:MM (XX)  XX.X XX.X XX.X XX.X XX.X XX.X XX.X XX.X XX.X 
XX.X 
XX.X 
XX.X XX.X XX.X 
 
Week 8 
DDMMYYYY T HH:MM (XX)  XX.X XX.X XX.X XX.X XX.X XX.X XX.X XX.X XX.X 
XX.X 
XX.X 
XX.X XX.X XX.X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: HR = heart rate, CFBL= change from baseline 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by XXXX / Uses: XXXX 
 
 
 
 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 152 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                           Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.8.6.2: 12-Lead ECG Findings 
All Randomized Subjects 
 [PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
 
 
 
 
Subject 
Number 
 Analysis 
Visit 
Date and Time (Day) [1] 
 
Interpretations 
Findings 
Comments 
Vendor 
Investigator 
 
  
 
 
 
 
XX-XXX 
 Baseline 
DDMMYYYY T HH:MM (XX) 
Normal 
Normal 
Conduction evaluation: Right bundle branch 
block 
Rhythm evaluation: normal sinus 
rhythm 
 
  
 
 
Axis evaluation: Left axis deviation 
Physician comment: artifact 
 
  
 
 
 
 
 
 Week 4 
DDMMYYYY T HH:MM (XX) 
XXX 
XXX 
XXXX 
XXXXX 
 
 <Etc.> 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
 
Generated on  XX/XX/XX:XXXX  by  XXXXX / Uses: XXXX 


Statistical Analysis Plan 
                            Protocol No. PPC-06-CD-004  
Novella No. OYAA4621 
Dr. Reddy’s Laboratories, SA 
Page 153 of 153 
Dr Reddy’s Laboratories, SA                                                                                                                                                                                                                           Page X of Y 
Protocol Number: PPC-06-CD-004 
Listing 16.2.8.7: Stool Consistency 
All Randomized Subjects 
 [PPC-06 400 mg QD][ PPC-06 400 mg BID][ PPC-06 600 mg BID][ Placebo] 
 
 
 
Subject Number 
 
Analysis Visit 
Visit Date (Day) [1] 
Number of bowel  
movements per day [2] 
Bristol Chart Stool Type 
 
 
 
 
 
 
XX-XXX 
 
Baseline 
DDMMMYYYY (XX) 
2 
Type 3 
 
 
Week 4 
DDMMMYYYY (XX) 
3 
XXXXX 
 
 
<Etc.> 
 
 
 
 
 
 
 
 
 
 
[1] Study day is calculated relative to the date of first study drug administration (Day 1). 
[2] Average per day over the past 2 weeks. 
 
Generated on  XX/XX/XX:XXXX  by  XXXXX / Uses: XXXX