A Single Center Study to Evaluate the Effectiveness and Safety of SOTYKTU® (Deucravacitinib) in Combination With Enstilar® for Moderate to Severe Plaque Psoriasis
Phase: PHASE4
Conditions: Psoriasis
Sponsor: Psoriasis Treatment Center of Central New Jersey

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Psoriasis Treatment Center of New Jersey 
IM011-231 
 
 
 
 
Clinical Study Protocol 
A Single Center Study to Evaluate the Effectiveness and Safety of 
SOTYKTU® (deucravacitinib) in combination with Enstilar® for Moderate to 
Severe Plaque Psoriasis 
 
Testing Facility 
Psoriasis Treatment Center of New Jersey 
59 One Mile Road 
East Windsor, NJ 08520 
(609) 443-4500 
 
Study Sponsor and Principal Investigator 
Jerry Bagel, MD 

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Table of Contents 
PROTOCOL TITLE PAGE 
1 
SYNOPSIS ...........................................................................................................................…4 
2 
ETHICS AND REGULATORY OBLIGATIONS ...................................................................7 
2.1 
Institutional Review Board (IRB) ......................................................................................7 
2.2 
Ethical Conduct of the Study .............................................................................................7 
2.3 
Subject Information and Consent ......................................................................................7 
3 
INTRODUCTION ..................................................................................................................7 
3.1 
Overview of Psoriasis ........................................................................................................7 
3.2 
Rationale for Treating Plaque Psoriasis with Deucravacitinb and Enstilar .......................8 
4 
STUDY OBJECTIVE ...............................................................................................................8 
5 
INVESTIGATIONAL PLAN ...................................................................................................8 
5.1 
Overall Study Design and Plan .........................................................................................8 
5.2 
Study Population Criteria ..................................................................................................9 
5.2.1 
Inclusion Criteria ...........................................................................................................9 
5.2.2 
Exclusion Criteria ..........................................................................................................9 
5.3 
Source of Subjects and Recruitment Methods .................................................................10 
5.4 
Subject Enrollment and Treatment Assignment ..............................................................10 
5.5 
Study Treatment ..............................................................................................................11 
5.5.1 
Deucravacitinib Treatment ..........................................................................................11 
5.5.2 
Deucravactinib Description ......................................................................................11 
5.5.2.1 
Deucravacitinib Dosing Schedule ............................................................................11 
5.5.2.2 
Deucravacitinib Dispensing .....................................................................................11 
5.5.2.3 
Deucravacitinib Dosage Adjustments ......................................................................11 
5.5.3 
Enstilar .........................................................................................................................12 
5.5.3.1 
Enstilar Description ..................................................................................................12 
5.5.3.2 
Enstilar Dosing Schedule .........................................................................................12 
5.5.3.3 
Enstilar Dispensing Record ......................................................................................12 
5.5.3.4 
Enstilar Dosing Adjustments ...................................................................................12 
5.5.4 
Permitted Concomitant Therapy ..............................................................................12 
5.6 
Study Procedures and Assessments ...............................................................................12 
5.6.1 
Informed Consent ........................................................................................................13 
5.6.2 
Inclusion and Exclusion Criteria ..................................................................................13 

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5.6.3 
Demographics and Medical History ............................................................................13 
5.6.4 
Pregnancy Test .............................................................................................................13 
5.6.5 
Laboratory Testing .......................................................................................................14 
5.6.6 
Physical Examination ...................................................................................................14 
5.6.7 
Physician’s Global Assessment (PGA) ........................................................................14 
5.6.8 
Psoriasis Area Severity Index ......................................................................................14 
5.6.9 
Body Surface Area .......................................................................................................15 
5.6.10 
Patient Reported Outcomes .........................................................................................15 
5.6.11 
Early Discontinuation Procedures ................................................................................15 
6. ADVERSE EVENTS ...........................................................................................................16 
7 INVESTIGATIONAL PRODUCT HANDLING ................................................................23 
7.1 
Investigational Product receipt ....................................................................................23 
7.2 
Investigational Product Storage ...................................................................................23 
8 RECORD RETENTION ......................................................................................................23 
8.1 
Study Monitoring .........................................................................................................24 
8.2 
Statistical Considerations ............................................................................................25 
8.2.1 
Exploratory Analysis ...................................................................................................25 
8.3 
Schedule of Events .......................................................................................................19 
10 REFERENCES ...................................................................................................................26 
11 APPENDICES ...................................................................................................................27 

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PROTOCOL SYNOPSIS 
 
Study Title 
A Single Center Study to Evaluate the Effectiveness and 
Safety of Deucravacitinib in combination with Enstilar for 
Moderate to Severe Plaque Psoriasis 
Sponsors 
Jerry Bagel, MD 
Study Objectives 
Primary Objective:   
●To evaluate the efficacy of combining 
Deucravacitinib and Enstilar 
Secondary Objectives:   
●To evaluate the safety of combining Deucravacitinib 
and Enstilar. 
●To evaluate the subject quality of life when 
combining Deucravacitinib and Enstilar. 
Study Design 
30 adult patients with moderate to severe plaque psoriasis 
will be given Deucravacitinib 6mg QD  for the first 8 weeks 
of the study. 
 At week 8: 
Subjects who do not meet PASI 25 at week 8 will 
be discontinued from the study as non-responders. 
Subjects who achieve ≥PASI 75 at week 8 will remain 
enrolled and continue Deucravacitinib 6mg QD 
monotherapy through week 24. 
Subjects who achieved between PASI 25-74 response will 
receive 4 weeks of Enstilar (calcipotriene and 
betamethasone dipropionate) Foam, 0.005%/0.064% 
applied QD in addition to continuing Deucravacitinib 6mg 
QD. 
 
At week 12, (after 4 consecutive weeks of Enstilar), 
subjects in the PASI 25-74 group, will discontinue Enstilar 
QD and continue Deucravacitinib as monotherapy through 
week 24. 
 
Subjects will return at week 28 for safety follow evaluation. 
Study Centers 
Psoriasis Treatment Center of New Jersey 

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Study Population 
Adult male and female subjects with moderate to severe 
chronic plaque psoriasis 
Main Inclusion 
Criteria 
Subjects must meet the following criteria to be enrolled in this 
study: 
1. Male or female adult ≥ 18 years of age; 
2. Diagnosis of chronic plaque-type psoriasis 
3. Moderate to severe plaque type psoriasis as 
defined at baseline by: 
• BSA affected by plaque-type psoriasis of 10% or greater 
• PGA score of 3 or greater 
• PASI ≥ 12. 
4. Able and willing to give written informed consent prior 
to performance of any study-related procedures 
Must be in general good health (except for 
disease under study) as judged by the 
Investigator, based on medical history, 
physical examination, clinical laboratories, and 
urinalysis. 
Main Exclusion 
Criteria 
Subjects who meet any of the following criteria will be 
excluded from participation in this study: 
1. Other than psoriasis, any clinically significant (as 
determined by the investigator) cardiac, endocrinologic, 
pulmonary, neurologic, psychiatric, hepatic, renal, 
hematologic, immunologic disease, or other major disease 
that is uncontrolled. 
2. Forms of psoriasis other than chronic plaque-type (e.g., 
Pustular erythrodermic and/or guttate psoriasis) or drug 
induced psoriasis 
3. Use of oral systemic medications or PUVA phototherapy 
for the treatment of psoriasis within 4 weeks (includes, but 
not limited to, oral corticosteroids, methotrexate, acitretin and 
cyclosporine). 
4. Prior use of biologics within the following periods: 
• Etanercept – 4 weeks 
• Adalimumab or certolizumab pegol – 8 weeks 
• IL-17 antagonists – 16 weeks 
• Ustekinumab or IL-23 pathway inhibitors – 24 weeks 
• Other biologics - 5 half-lives 
5. Patient used topical therapies or UVB phototherapy to treat 
psoriasis within 2 weeks of the Baseline Visit (includes, but not 
limited to, topical corticosteroids, vitamin D analogs, or 
retinoids). 

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Study Drug 
Dosage and 
Administration 
All subjects will receive Deucravacitinib 6mg daily at week 0 
(baseline) through week 8. At week 8, patients who achieved 
between PASI 25-74 response will receive 4 weeks of 
Enstilar (calcipotriene and betamethasone dipropionate) 
Foam, 0.005%/0.064% once daily in addition to continuing 
Deucravacitinib 6mg daily. 
At week 12 (after 4 consecutive weeks of Enstilar therapy), 
Enstilar will be discontinued and patients will continue 
Deucravacitinib 6mg daily as monotherapy through week 24.  
Patients who achieve ≥PASI 75 at week 8 will 
remain enrolled on Deucravacitinib 6mg QD 
monotherapy through week 24. 
Study Endpoints 
Primary Endpoint: 
Proportion of subjects achieving PASI 75 at week 12 for 
patients in the Deucravacitinib + Enstilar combination arm. 
Secondary Endpoints: Proportion of subjects achieving PASI 
25-74 at week 8. 
PASI, PGA, BSA, PGAxBSA and DLQI improvement at 
weeks 8, 12, 16, 20, 24. 
PASI 75 at weeks 16 and 24 
Serious Adverse Events (SAE’s) 
Study Duration 
28 weeks 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2 
ETHICS AND REGULATORY OBLIGATIONS 
 
2.1 Institutional Review Board (IRB) 
Written IRB approval of this protocol must be obtained before the study is initiated. 
Compliance with Title 21 of the US Code of Federal Regulations (CFR), Part 56, is 
required in order to protect the rights and welfare of human subjects involved in this study. 
 
2.2 Ethical Conduct of the Study 
The study will be conducted in accordance with the ethical principles that have their 
origins in the Declaration of Helsinki and its amendments. In addition, the study will be 
performed in compliance with Good Clinical Practices (GCP), including the archiving of 
essential documents. 
 
2.3 Subject Information and Consent 
The Informed Consent Form will be reviewed and approved by the IRB. The purpose, 
duration and possible risks and benefits will be explained to each potential subject. 
Consent in writing must be obtained from the subject before enrollment into the study. 
Consents will be signed and dated as required by Title 21 of CFR, Part 50. The consent 
will also comply with the requirements of the Health Insurance Portability and 
Accountability Act (HIPAA). The original, signed Informed Consent Form will be retained 
by the Investigator. A signed copy of the Informed Consent Form will be given to the 
subject. Each subject will be assigned a subject number that will be used in lieu of the 
subject’s name on further research documentation. 
 
3 
INTRODUCTION 
 
3.1 
Overview of Psoriasis 
Psoriasis is a chronic immunological disease characterized by infiltration of the skin with 
activated T cells and by abnormal keratinocyte proliferation and differentiation, resulting 
in marked inflammation and thickening of the epidermis. Psoriasis affects 1-3% of the 
world population, making it one of the most prevalent inflammatory immunological 
diseases.1 There are several clinical subtypes of psoriasis: plaque, guttate, 
erythrodermic, inverse, and pustular. Plaque psoriasis is the most common type of 
psoriasis affecting 75-80% of psoriasis sufferers.² It presents as raised silvery scale, 
which can cover large areas, with underlying erythema, itching, and discomfort

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3.2 Rationale for Treating Plaque Psoriasis with Deucravacitinib + Enstilar 
Deucravacitinib is an investigational TYK2 inhibitor that has been tested for the 
treatment of moderate-to-severe psoriasis.  Combination regimens that utilize a 
systemic agent with light therapy and/or a topical agent are becoming the standard of 
care in the United States3 and Europe4, confirming the observation of Lebwohl et al5 in 
2004, that the use of two or more therapies to treat patients with moderate to severe 
psoriasis seems to be the rule rather than the exception. Topical steroids play an in 
important role in the long-term management of psoriasis and data from the COBRA trial 
suggests that super potent topical corticosteroids are appropriate and well tolerated for 
use when added to existing therapeutic regimens i.e. phototherapy, systemic and 
biologic therapy.6   In a similarly designed clinical trial using apremilast with Enstilar 
add- on therapy it was shown that most week-8 partial apremilast responders achieved 
PASI 75 at week 12 with combination C/BD topical therapy, and maintained PASI 75 
through week 16 with apremilast monotherapy.7  This study is being conducted to 
determine if adding topical Enstilar to deucravacitinib therapy can help patients who 
received a partial response at week 8 reach PASI 75 by week 12. 
 
4. STUDY OBJECTIVES 
The primary objective of this study is to explore the effectiveness of combining 
deucravacitinib and Enstilar.  Secondary objectives will explore the safety and impact 
on quality of life for subjects receiving deucravacitinib in combination with Enstilar.  
 
5. INVESTIGATIONAL PLAN 
 
5.1 Overall Study Design and Plan 
30 subjects affected with plaque psoriasis with body surface area greater than or equal 
to 10%, and physician’s global assessment greater than or equal to 3 and PASI greater 
than or equal to 12 will receive deucravacitinib 6 mg once daily for 8 weeks. 
Subjects who do not achieve at least a PASI 25 at week 8 will be discontinued from 
treatment and study procedures. 
 
At week 8, subjects who have achieved between a PASI 25-74 will receive Enstilar 
(calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% once daily for 4 
weeks in addition to continuing deucravacitinib 6mg daily.  These subjects will then 
discontinue Enstilar at week 12 and remain on deucravacitinib monotherapy through 
week 24. 
 
Subjects who achieve ≥PASI 75 at week 8 will remain enrolled in the study and continue   
deucravacitinib QD through week 24. These subjects will not receive Enstilar add-on 
therapy. 
 
All subjects will be asked to return for a safety follow up visit 4 weeks after the last dose 
of deucravacitinib.  

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5.2 Study Population Criteria 
Males and females ≥ 18 years of age with moderate-to-severe chronic plaque psoriasis 
 
5.2.1 Inclusion Criteria 
Patients who meet all of the following criteria will be enrolled in the study: 
1.Male or female adult ≥ 18 years of age 
2. Diagnosis of chronic plaque-type psoriasis 
 
3. Moderate to severe plaque type psoriasis as defined at baseline by: 
• Physician’s Global Assessment (PGA) score of 3 or greater 
• Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater 
• Psoriasis Area Severity Index of 12 or greater 
 
4. Able and willing to give written informed consent prior to performance of any 
study-related procedures 
5. Must be in general good health (except for disease under study) as judged by 
the Investigator, based on medical history, physical examination, clinical 
laboratories, and urinalysis. (NOTE: The definition of good health means a 
subject does not have uncontrolled significant co-morbid conditions). 
 
6.Females of childbearing potential (FCBP) must have a negative serum 
pregnancy test at Screening and negative urine pregnancy test at Baseline. 
FCBP who engage in activity in which conception is possible must use one of the 
approved contraceptive options: hormonal contraception; intrauterine device 
(IUD); tubal ligation; or partner’s vasectomy; Male or female condom diaphragm 
with spermicide, cervical cap with spermicide, or contraceptive sponge with 
spermicide. 
 
5.2.2 Exclusion Criteria 
Patients will NOT be enrolled in this study if they meet any of the following criteria: 
1. Other than psoriasis, any clinically significant (as determined by the 
Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, 
hepatic, renal, hematologic, immunologic disease, or other major disease that 
is currently uncontrolled. 
2. Pregnant or breast feeding, or considering becoming pregnant during the 
study. 
3. Subjects with a current malignancy or prior malignancy within the last 5 years 
(excluding successfully treated basal cell carcinoma, squamous cell carcinoma 
of the skin or carcinoma in situ of the cervix that has been adequately treated). 
4. Subjects with diagnosis of active tuberculosis or untreated latent tuberculosis.  
Subjects will be eligible if they have previously received adequate treatment 
for latent TB or initiate 4 weeks of prophylactic LTBI treatment prior to 

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Baseline visit and agree to complete treatment course as prescribed. 
5. History of or positive screening serology for Hepatitis B surface antigen 
(HBsAg); Hepatitis C virus antibody and/or HIV. 
6. Use of any investigational drug within 4 weeks prior to randomization, or within 
5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). 
7. Prior treatment with deucravacitinib. 
8. Active forms of psoriasis other than chronic plaque-type (e.g., pustular 
erythrodermic and/or guttate psoriasis) or drug induced psoriasis 
 
9. Prior use of biologics within the following periods: 
• Etanercept – 4 weeks 
• Adalimumab or certolizumab pegol – 8 weeks 
• IL-17 antagonists – 16 weeks 
• Ustekinumab or IL-23 pathway inhibitors – 24 weeks 
• Other biologics - 5 half-lives 
 
10. Use of oral systemic medications or PUVA for the treatment of psoriasis within 
4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, 
acitretin and cyclosporine). 
 
11. Patient used topical therapies within 2 weeks of the Baseline Visit (includes, 
but not limited to, topical corticosteroids, vitamin D analogs, or retinoids). 
 
12. Patient received UVB phototherapy within 2 weeks of Baseline. 
 
13. Patient has a known hypersensitivity to the excipients of deucravacitinib or 
Enstilar. 
14. Any condition which would place the subject at unacceptable risk if he/she 
were to participate in the study. 
 
5.3 
Source of Subjects and Recruitment Methods 
The Investigator will manage the recruitment of subjects upon approval of the study by 
the Institutional Review Board. Subjects may be recruited from internal patient lists and 
outside IRB approved advertisements. 
 
5.4 
Subject Enrollment and Treatment Assignment 
30 subjects of either gender with moderate-to severe plaque psoriasis will receive 
deucravacitinib 6mg QD for 8 weeks. Participation beyond week 8 will be determinate of 
subject response according to the study design. 
 
 
 
 
 

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5.5  STUDY TREATMENT 
 
5.5.1 Deucravacitinib Treatment 
 
5.5.2 Deucravacitinib Description 
 
Deucravacitinib is manufactured by Bristol Myers Squibb.  Tyrosine kinase 2 (TYK2) is 
associated with specific cytokine receptors and catalyzes the phosphorylation of signal 
transducer and activator of transcription (STAT) proteins downstream of these receptors 
including the receptors for p40-containing cytokines, interleukin (IL)-12, and IL-23, as 
well as the interferon-α and interferon-β. Type I interferon [IFN]) receptor. TYK2 
activity  results  in  the  activation  of  STAT-dependent  transcription  and  functional 
responses specific for these receptors. Deucravacitinib is a stable deuterium-
labeled compound (where deuterium is a stable, nonradioactive isotope of 
hydrogen) and a potent, highly selective small molecule inhibitor of TYK2. 
Deucravacitinib has a unique mode of binding that provides the high selectivity over 
the other members of the JAK family of non-receptor tyrosine kinases.8   Selective 
inhibition of TYK2 with the oral agent deucravacitinib at doses of 3 mg daily and higher 
resulted in greater clearing of psoriasis than did placebo.9 
 
5.5.2.1 
Deucravacitinib Dosing Schedule 
Deucravacitinib 6mg tablets will be supplied by Bristol Myers Squibb and administered 
once daily (recommended in the mornings). It is recommended the first dose of IP will 
be taken in the clinic at the baseline visit. 
 
5.5.2.2 
Deucravacitinib Dispensing 
Subjects will return all unused deucravacitinib tablets to the study site. Site personnel 
will keep a record of deucravacitinib dispensed to and returned by each subject and 
note any missed doses. 
 
5.5.2.3 
Deucravacitinib Dosage Adjustments 
If an SAE or an adverse event that is thought to be related to deucravacitinib and is not 
alleviated by symptomatic intervention, deucravacitinib will be discontinued. 
Subjects who permanently discontinue deucravacitinib therapy under this protocol should 
receive standard care of psoriasis treatment as prescribed by their physician. 
 
 
 

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5.5.3 ENSTILAR 
(calcipotriene 
and 
betamethasone 
dipropionate) 
Foam, 
0.005%/0.064% 
5.5.3.1 
Enstilar Description 
Enstilar foam is a combination of calcipotriene, a vitamin D analog, and betamethasone 
dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis in 
patients 18 years of age and older. Each gram of Enstilar Foam contains 52.2 mcg 
calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of 
betamethasone dipropionate (equivalent to 0.5 mg of betamethasone). 
 
5.5.3.2 
Enstilar Dosing Schedule 
 
Enstilar will be supplied by LEO Pharma A/S. and applied once daily for 4 weeks for 
those patients that qualify based on PASI response at week 8. 
 
5.5.3.3 Enstilar Dispensing and Dosing Record 
 
Enstilar will be dispensed to the study subjects by the authorized site personnel following 
instructions in Enstilar Label. Subjects will return all unused Enstilar to the study site. Site 
 personnel will keep a record of Enstilar dispensed to and returned by each subject and   
missed doses will be recorded on a subject diary. See Appendix A 
 
5.5.3.4 Enstilar Dosage Adjustments 
 
If an SAE or an adverse event that is thought to be related to Enstilar and is not 
alleviated by symptomatic intervention, Enstilar will be discontinued. 
 
5.5.4 Permitted Concomitant Therapy 
The use of steroid-free topical emollients is allowed during the study. Appropriate 
interventions (e.g., prescribed medications) may be performed as the investigator deems 
necessary to treat concomitant illnesses and/or safeguard the subjects’ wellbeing. No 
investigational product or device may be used during the study. 
 
5.6 Study Procedures and Assessments 
This protocol will consist of a Screening Period (0-30 days), followed by an open-label 
treatment period of deucravacitinib 6mg QD for 8 weeks. At week 8, subject’s PASI scores 
will be evaluated and subjects who achieve PASI 25-74 will be given add-on Enstilar 
treatment for 4 weeks (through week 12) followed by deucravacitinib monotherapy 
through week 24. Subjects who do not achieve PASI 25 at week 8 will be discontinued 
from the study and follow standard of care from their provider.  Subjects who achieve 
PASI 75 at week 8 will remain on deucravacitinib monotherapy and will not initiate 
treatment with Enstilar. 

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5.6.1 Informed Consent 
This Study will be conducted in compliance with CFR Title 21, Part 50 (Informed Consent 
of Human Subjects). Informed consent will be obtained from each subject in writing 
before participation in the Study. A signed copy of the Informed Consent Form will be 
provided to each subject. A provision to obtain a signed authorization to provide protected 
health information to the study sponsor, internal quality assurance agencies, health 
insurance agencies, and other parties as specified in the Federal Health Insurance 
Portability and Accountability Act (HIPAA) privacy regulation will be included in the 
Informed Consent Document. HIPAA authorization is voluntary. However, since the use 
and release of health information is critical to the conduct of the study, subjects who do 
not provide authorization to use and disclose their health information will not be enrolled 
into the study.   Subjects who withdraw their authorization to use and release health 
information during study participation will be formally discontinued from the study. The 
investigator may use and release at any time all the information collected prior to a 
subject’s withdrawal of the authorization to all authorized parties to satisfy scientific, 
regulatory, and financial concerns. 
 
5.6.2 Inclusion and Exclusion Criteria 
Subjects’ eligibility to participate in the study will be determined according to the Inclusion 
and Exclusion Criteria during the screening period (0 – 30 days prior to the first dose of 
the study drug). Subjects who ultimately do not satisfy the eligibility criteria except 
changing treatments and undergoing a washout period, will not be enrolled into the study. 
Subjects who need to meet eligibility requirements will be asked to make the necessary 
changes. Subjects who agree and comply will be re-evaluated prior to Baseline. 
 
5.6.3 Demographics and Medical History 
The following information will be obtained for each subject during screening: date of birth, 
sex, race/ ethnic origin, relevant medical and surgical history, including year of diagnosis 
of plaque psoriasis, and current and previous anti-psoriasis treatments for the last 6 
months. All current therapies for other medical conditions will be documented. Medical 
history will be reviewed and updated at the Baseline Visit to ensure that the patient 
remains eligible to participate in the study. 
 
5.6.4 Pregnancy Testing 
Serum Pregnancy testing (urine β-human chorionic gonadotrophin [β-HCG]) will be 
conducted in all female subjects, except those without childbearing potential at Screening 
(-30 to -1). Urine pregnancy tests will be conducted at Baseline (prior to first dose of  

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deucravacitinib) and at each visit through week 28. An interim urine pregnancy test may 
be performed if there is reason to believe the subject may have become pregnant during 
the study. Subjects with a positive pregnancy test will not be eligible to participate or to 
continue to receive study treatment. 
 
A female of childbearing potential is a sexually mature female who 1) has not undergone 
a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical 
removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive 
months (that is, has had menses at any time during the preceding 24 consecutive 
months). The female subject’s chosen form of contraception must be effective by the time 
the female subject is randomized into the study (for example, hormonal contraception 
should be initiated at least 28 days before randomization). 
 
5.6.5 Laboratory Testing 
Serum chemistry, hematology, fasting lipids, Hepatitis B surface antigen (HBsAg); 
Hepatitis C virus antibody and HIV and Quantiferon Gold testing will be performed at 
screening to ensure subject safety prior to baseline. Serum chemistry, hematology and 
fasting lipids will be performed at weeks 16 and 28. 
 
5.6.6 Physical Examination 
A physical examination, including vital signs measurements (blood pressure, pulse and 
temperature), will be performed according to the schedule of events. The physical 
examination should include a thorough evaluation of the subject's skin. Any clinically 
significant abnormalities discovered during physical examinations after the Screening / 
Baseline visit should be documented and evaluated as potential adverse events. 
 
5.6.7 Physician’s Global Assessment (PGA) 
PGA will be determined for all subjects throughout the study. PGA is a 6 point scale that 
records the overall disease severity at each clinical evaluation based on the average 
degree of erythema, induration, and scaling of areas affected by psoriasis. PGA uses a 
scale of 0 = Clear, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very Severe. 
See Appendix B 
 
5.6.8  Psoriasis Area Severity Index (PASI) 
PASI will be determined for all subjects throughout the study. Four anatomical sites 
(head, trunk, upper and lower limbs) are assessed for erythema, thickness, and scaling 
on a scale of 0-4 and degree of skin surface area on a scale of 6. The PASI is a validated 
instrument that has become standard in clinical trials for psoriasis. The sum of the scores 

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are then totaled for the PASI score. Psoriasis Area Severity Index scores range from 0 to 
72, with higher scores reflecting greater disease severity.10 See Appendix C 
 
5.6.9  Body Surface Area (BSA) 
BSA will be determined for all subjects throughout the study. The subjects palm will be 
selected for the measuring unit of body surface area. The physician will equate the 
number of palms affected by psoriasis to derive the BSA total. 
 
5.6.10 Patient Reported Outcomes 
Subjects will complete the PRO’s based on the schedule of assessments. Questionnaires 
should be prior to medical procedures and clinical evaluations. 
Dermatology Life Quality Index (DLQI)11 to assess symptoms and impacts of 
dermatologic diseases on quality of life. See Appendix D 
 
5.6.11 Photography 
Investigator will choose target lesion representative of subject’s psoriatic disease at 
baseline which will be photographed according to the scheduled of assessments. Patients 
who do not wish to participate in clinical photography may opt out in the informed consent.
 
 
5.6.12 Early Discontinuation Procedures 
Subjects will be prematurely discontinued from the study under the following conditions: 
1. Subject does not reach PASI 25 or greater at week 8 
2. Subject requests to withdraw from the study. 
3. Subject is noncompliant with protocol schedule, restrictions, and/or 
requirements as deemed per investigator. 
4. Subject experiences an adverse event that makes it difficult or intolerable for 
the subject to continue treatment, or increases risk to the subject, or interferes 
with the investigator’s ability to clinically evaluate the progress of the subject’s 
treatment. 
5. Subject begins an unapproved concomitant therapy for psoriasis or another 
medical condition that may increase risk to the subject if continuing study 
treatment. 
6. Subject cannot be reached / lost to follow-up. 
7. The study investigator suspends or terminates the study. 
8. Other unanticipated reason. 
 
Any subject who prematurely discontinues the study should complete the week 24 (End 
of Study) assessments and subjects should be encouraged return 4 weeks later for the 
safety follow up visit. 

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6. ADVERSE EVENTS 
 
ADVERSE EVENTS, SERIOUS ADVERSE EVENTS,  PREGNANCY, & PRODUCT 
QUALITY COMPLAINTS 
An Adverse Event (AE) is defined as any new untoward medical occurrence or 
worsening of a preexisting medical condition in a clinical investigation participant 
administered study drug and that does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and unintended sign (such as 
an abnormal laboratory finding), symptom, or disease temporally associated with the 
use of investigational product, whether or not considered related to the investigational 
product. 
A NON-SERIOUS ADVERSE EVENT is an AE not classified as serious.  
The protocol must include a definition for Serious Adverse Events (SAE). 
SERIOUS ADVERSE EVENTS 
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any 
dose:  
• results in death 
• is life-threatening (defined as an event in which the participant was at risk of 
death at the time of the event; it does not refer to an event which hypothetically 
might have caused death if it were more severe) 
• requires inpatient hospitalization or causes prolongation of existing 
hospitalization (see NOTE below) 
• results in persistent or significant disability/incapacity 
• is a congenital anomaly/birth defect  
• is an important medical event (defined as a medical event(s) that may not be 
immediately life-threatening or result in death or hospitalization but, based upon 
appropriate medical and scientific judgment, may jeopardize the subject or may 
require intervention [eg, medical, surgical] to prevent one of the other serious 
outcomes listed in the definition above.) Examples of such events include, but 
are not limited to, intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in 
hospitalization.)  
• Suspected transmission of an infectious agent (eg, pathogenic or 
nonpathogenic) via the study drug is an SAE.  
Below is supplemental information that is included in BMS-Sponsored trials. It is the 
responsibility of the Sponsor-Investigator to determine if this information regarding 
hospitalization is considered SAEs or not and whether it should be included in the 
protocol. 
− a visit to the emergency room or other hospital department < 24 hours, that 
does not result in admission (unless considered an important medical or life-

30August2021 
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threatening event) 
− elective surgery, planned prior to signing consent 
− admissions as per protocol for a planned medical/surgical procedure 
− routine health assessment requiring admission for baseline/trending of health 
status (eg, routine colonoscopy) 
− Medical/surgical admission other than to remedy ill health and planned prior 
to entry into the study. Appropriate documentation is required in these cases. 
− Admission encountered for another life circumstance that carries no bearing 
on health status and requires no medical/surgical intervention (eg, lack of 
housing, economic inadequacy, caregiver respite, family circumstances, 
administrative reason). 
− Admission for administration of anticancer therapy in the absence of any 
other SAEs (applies to oncology protocols) 
 
NOTE: Although pregnancy and potential drug-induced liver injury (DILI), are not 
always serious by regulatory definition,  these events must be reported within the 
SAEs timeline. 
NOTE: Any component of a study endpoint that is considered related to study therapy 
should be reported as an SAE (eg, death is an endpoint, if death occurred due to 
anaphylaxis, anaphylaxis must be reported). 
 
The causal relationship to study drug is determined by a physician and should be 
used to assess all adverse events (AE). The casual relationship can be one of the 
following: 
Related: There is a reasonable causal relationship between study drug administration 
and the AE. 
Not related: There is not a reasonable causal relationship between study drug 
administration and the AE.  
The term "reasonable causal relationship" means there is evidence to suggest a 
causal relationship.  
An appropriate SAE form (e.g.  ex-US = CIOMS form or USA = Medwatch form) 
should be used to report SAEs to BMS.  If the Sponsor-Investigator prefers to a study 
specific/Institutional form, it must be sent to the BMS ISR Trial Manager prior to study 
initiation for internal BMS review to ensure that at a minimum all of the data elements 
on the CIOMS form are present.   
Please include the BMS Protocol number on the SAE form or on the  cover sheet with 
the SAE form transmission.   
✓ The CIOMS form is available at: https://cioms.ch/cioms-i-form/   
✓ The MedWatch form is available at: https://www.fda.gov/safety/medical-
product-safety-information/medwatch-forms-fda-safety-reporting  

30August2021 
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NOTE: If a CIOMS I or Medwatch form is selected for reporting, the investigator 
causal assessment must be provided in the narrative section, otherwise the BMS form 
must be used. 
NOTE: For studies with long-term follow-up period in which safety data are being 
reported, include the definition of end date of SAE collection.  
 
SERIOUS ADVERSE EVENT COLLECTION AND REPORTING 
All Serious Adverse Events (SAEs) that occur following the subject’s written consent 
to participate in the study through 30 days of discontinuation of dosing must be 
reported to BMS Worldwide Safety, whether related or not related to study drug. If 
applicable, SAEs must be collected that relate to any follow-up protocol-specified 
procedure (eg, a follow-up skin biopsy). 
• Following the subject’s written consent to participate in the study, all SAEs, 
whether related or not related to study drug, are collected, including those 
thought to be associated with protocol-specified procedures. The Investigator 
should report any SAE occurring after these aforementioned time periods, which 
is believed to be related to study drug or protocol-specified procedure. 
• An SAE report should be completed for any event where doubt exists regarding 
its seriousness;  
• If the Investigator believes that an SAE is not related to study drug, but is 
potentially related to the conditions of the study (such as withdrawal of previous 
therapy or a complication of a study procedure), the relationship should be 
specified in the narrative section of the SAE Report Form. 
 
SAEs, whether related or not related to study drug, and pregnancies must be reported 
to BMS within 24 hours \ 1 Business Day of becoming aware of the event. SAEs must 
be recorded on either CIOMS, MedWatch, or approved study specifi/institutional SAE 
form.   
 
SAE Email Address:  Worldwide.Safety@BMS.com 
SAE Facsimile Number:  +1-609-818-3804 
If only limited information is initially available, follow-up reports are required. (Note: 
Follow-up SAE reports should include the same investigator term(s) initially reported.)  
If an ongoing SAE changes in its intensity or relationship to study drug or if new 
information becomes available, a follow-up SAE report should be sent within 24 hours 
\ 1 Business Day to BMS using the same procedure used for transmitting the initial 
SAE report.  
All SAEs should be followed to resolution or stabilization. 
NOTE: The Sponsor-Investigator must provide a single centralized e-mail address 
(not an individual’s e-mail address) to be used by BMS to send AE/SAE report related 
queries. The single centralized e-mail address must be provided in the Study Contract 

30August2021 
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and sent to aepbusinessprocess@bms.com. 
 
Expedited and periodic safety update reporting by BMS: 
It is the Sponsor-Investigator’s responsibility to report events to their Local HA. In 
addition, suspected serious adverse reactions (whether expected or unexpected) shall 
be reported by BMS to the relevant competent health authorities in all concerned 
countries according to local regulations (either as expedited and/or in aggregate 
reports). 
In accordance with local regulations, BMS will notify Sponsor-Investigator of all 
reported SAEs that are suspected (related to the investigational product) and 
unexpected (ie, not previously described in the IB). An event meeting these criteria is 
termed a Suspected, Unexpected Serious Adverse Reaction (SUSAR). Sponsor-
Investigator notification of these events will be in the form of either a SUSAR Report or 
a Semi-Annual SUSAR Report. Sponsor-Investigator (or delegate) will receive these 
reports through the FastTrack portal. 
Other important findings which may be reported by BMS as an Expedited Safety 
Report (ESR) include: increased frequency of a clinically significant expected SAE, an 
SAE considered associated with study procedures that could modify the conduct of 
the study, lack of efficacy that poses significant hazard to study subjects, clinically 
significant safety finding from a nonclinical (eg, animal) study, important safety 
recommendations from a study data monitoring committee, or Sponsor-Investigator or 
BMS decision to end or temporarily halt a clinical study for safety reasons. 
Upon receiving an ESR from BMS, the Sponsor-Investigator must review and retain 
the ESR with the IB. Where required by local regulations or when there is a central 
IRB/IEC for the study, the Sponsor-Investigator will submit the ESR to the appropriate 
IRB/IEC. The investigator and IRB/IEC will determine if the informed consent requires 
revision. The investigator should also comply with the IRB/IEC procedures for 
reporting any other safety information.  
NON-SERIOUS ADVERSE EVENT COLLECTION AND REPORTING 
The collection of non-serious AE information should begin following the subject’s 
written consent to participate in the study. All non-serious adverse events (not only 
those deemed to be treatment-related) should be collected continuously during the 
treatment period and for a minimum of 30 days following the last dose of study 
treatment.  
Non-serious AEs should be followed to resolution or stabilization, or reported as SAEs 
if they become serious. Follow-up is also required for non-serious AEs that cause 
interruption or discontinuation of study drug and for those present at the end of study 
treatment as appropriate. 
Non-serious Adverse Events (AE) are to be provided to BMS in aggregate via interim 
or final study reports as specified in the agreement or, if a regulatory requirement [eg, 
IND US trial] as part of an annual reporting requirement.   
 
 

30August2021 
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PREGNANCY 
If, following initiation of the investigational product, it is subsequently discovered that a 
study participant is pregnant or may have been pregnant at the time of investigational 
product exposure, including during at least 5 half-lives after product administration, the 
investigational product will be permanently discontinued in an appropriate manner (eg, 
dose tapering if necessary for participant).  
The Sponsor-Investigator must immediately notify Worldwide.Safety@bms.com of 
this event and complete one of the following forms within 24 hours of awareness of 
the event via either the CIOMS, MedWatch or appropriate Pregnancy Surveillance 
Form in accordance with SAE reporting procedures.  
Protocol-required procedures for study discontinuation and follow-up must be 
performed on the participant. 
Follow-up information regarding the course of the pregnancy, including perinatal and 
neonatal outcome and, where applicable, offspring information must be reported on 
the CIOMS, MedWatch, BMS Pregnancy Surveillance Form, or approved site 
SAE form.  A BMS Pregnancy Surveillance Form may be provided upon request. 
Any pregnancy that occurs in a female partner of a male study participant should be 
reported to BMS. Information on this pregnancy will be collected on the Pregnancy 
Surveillance Form. In order for Sponsor-Investigator or designee to collect any 
pregnancy surveillance information from the female partner, the female partner must 
sign an informed consent form for disclosure of this information.  
LABORATORY TEST ABNORMALITIES 
All laboratory test results captured as part of the study should be recorded following 
institutional procedures. Test results that constitute SAEs should be documented and 
reported to BMS as such. 
The following laboratory abnormalities should be documented and reported 
appropriately: 
• any laboratory test result that is clinically significant or meets the definition of an 
SAE 
• any laboratory abnormality that required the participant to have study drug 
discontinued or interrupted 
• any laboratory abnormality that required the subject to receive specific corrective 
therapy.  
It is expected that wherever possible, the clinical rather than laboratory term would be 
used by the reporting investigator (eg, anemia versus low hemoglobin value). 
 
OTHER SAFETY CONSIDERATIONS 
Any significant worsening noted during interim or final physical examinations, 
electrocardiograms, X-rays, and any other potential safety assessments, whether or 
not these procedures are required by the protocol, should also be recorded as a non-

30August2021 
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serious or serious AE, as appropriate, and reported accordingly.  
 
ADVERSE EVENT REPORTING FOR SPECIFIC SITUATIONS (remove if not 
applicable): 
 
➢ Assets with no marketing authorization: Potential Drug Induced Liver 
Injury (DILI)  
Definition of criteria is mandatory for all pre-marketed asset protocols enrolling 
participants without known abnormalities in liver function at baseline AND for protocols 
involving participants with known liver abnormalities at baseline or with other clinical 
confounders where asset specific criteria for potential drug induced liver injury have 
been defined. Use for marketed assets is optional.  
For protocols without known abnormalities in liver function at baseline, use the 
mandatory standard DILI definition listed below. Wherever possible, timely 
confirmation of initial liver-related laboratory abnormalities should occur prior to the 
reporting of a potential DILI event. All occurrences of potential DILIs, meeting the 
defined criteria, must be reported as SAEs. 
Potential drug induced liver injury is defined as:  
1) AT (ALT or AST) elevation > 3 times upper limit of normal (ULN) 
AND 
2) Total bilirubin > 2 times ULN, without initial findings of cholestasis (elevated serum 
alkaline phosphatase) 
AND 
3) No other immediately apparent possible causes of AT elevation and 
hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic 
or acute liver disease, or the administration of other drug(s) known to be 
hepatotoxic. 
 
➢ Immune-Mediated AEs (Product Specific, Usually a regulatory 
requirement) 
Immune-Mediated AEs are required in ISR Protocols with Registrational Intent.  
Every AE must be assessed by the investigator with regard to whether it is considered 
immune-mediated. For events which are potentially immune-mediated, additional 
information must be collected. 
 
Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-
mediated mechanism or immune-mediated component for which non-inflammatory 
etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include 
events with an alternate etiology which were exacerbated by the induction of 
autoimmunity. Information supporting the assessment will be collected. 

30August2021 
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➢ AEs of Interest  
ADVERSE EVENT RECONCILIATION PROCESS 
AEIs may be serious or non-serious and may require further investigation to better 
characterize and understand them. In the deucravacitinib clinical development 
program, select infections (opportunistic, TB, herpes zoster) and malignancies have 
been identified as AEIs based on the mechanism of action of deucravacitinib. 
Therefore, in order to better characterize and understand these AEIs, information may 
be collected on supplemental CRFs.  Additionally, information on potential AEIs based 
on the disease or population under study may be collected on supplemental CRFs. 
The Sponsor-Investigator (or designee) will reconcile the clinical database AE cases 
(case level only) transmitted to BMS Global Pharmacovigilance 
(Worldwide.Safety@bms.com).  
• The Sponsor-Investigator will request the SAE reconciliation report (and include 
the BMS protocol number) from BMS GPV&E (aepbusinessprocess@bms.com) 
every 3 months and prior to data base lock or final data summary 
• GPV&E will send the Sponsor-Investigator the report to verify and confirm all AE 
and SAEs have been transmitted to BMS GPV&E. 
• The data elements listed on the GPV&E reconciliation report will be used for 
case identification purposes. If the Sponsor-Investigator determines a case was 
not transmitted to BMS GPV&E, the case should be sent immediately to BMS 
(Worldwide.Safety@bms.com). 
 
PRODUCT QUALITY COMPLAINTS (PQCs)  
Definition 
Any communication about a BMS Product that alleges deficiencies related to identity, 
quality, durability, reliability, safety, effectiveness, performance, tampering, diversion, 
and/or counterfeiting/falsification of a drug, combination product, or device after it is 
released for distribution to market or clinic by either: (1) BMS or (2) distributors or 
partners for whom BMS manufactures the material. This includes all components co-
packaged with the drug, such as drug containers, delivery system, labelling, and 
inserts. 
 
BMS product: Commercial or investigational materials (i.e., drugs, devices, biologics 
or any combination thereof) and their packaging components, whether they are 
produced or distributed by BMS or by third parties under contract with BMS, and 
products that are being manufactured for BMS by third parties. 
 
Reporting 
Product Quality Complaints must be reported to BMS within one (1) business day of 
awareness to IMPQualityComplaints@bms.com. 

30August2021 
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In the event of a suspected product quality issue, the affected product must be 
quarantined immediately at the Investigational site.   
The affected product should not be disposed unless retention presents a risk to 
personnel (e.g., cytotoxic, risk of injury from broken glass or sharps). 
When reporting, as much product information as possible should be reported. At a 
minimum, but not limited to, include: 
ISR Study number, site reference, product description, impacted batch number, container 
number(s), photographs, and any other supporting information. 
 
7 INVESTIGATIONAL PRODUCT HANDLING 
 
7.1 Investigational Product Receipt 
At study initiation and as needed thereafter, deucravacitinib and Enstilar will be shipped 
to a responsible person at the investigator's institution, who will check the amount and 
condition of the drug, and maintain a record of this information. 
 
7.2 Investigational Product Storage 
Investigational product will be stored per the storage conditions identified on drug label. 
At the study site, all IP will be stored in a locked, safe area to prevent unauthorized 
access. 
Records of the actual storage conditions during the period of the study will be maintained. 
 
8 RECORD RETENTION 
The investigator must retain these documents according to local laws or requirements. 
Essential documents include, but are not limited to, the following: 
 
• Signed informed consent documents for all subjects; 
• Subject identification code list, screening log (if applicable), and enrollment log; 
• Record of all communications between the Investigator and the IRB/EC; 
Composition of the IRB/EC; 
• Record of all communications between the Investigator and Bristol Myers Squibb. 
• List of Sub-investigators and other appropriately qualified persons to whom the 
Investigator has delegated significant study-related duties, together with their roles 
in the study, curriculum vitae, and their signatures; 
• Copies of CRFs (if paper) and of documentation of corrections for all subjects; 
• IP accountability records; 
• All other source documents (subject records, hospital records, laboratory records, 
etc); 

30August2021 
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• All other documents as listed in Section 8 of the ICH consolidated guideline on 
GCP (Essential Documents for the Conduct of a Clinical Trial). 
 
The Investigator must notify Bristol Myers Squibb if he/she wishes to assign the 
essential documents to someone else, remove them to another location or is unable to 
retain them for a specified period. The Investigator must obtain approval in writing from 
Bristol Myers Squibb prior to destruction of any records. If the Investigator is unable to 
meet this obligation, the Investigator must ask Bristol Myers Squibb for permission to 
make alternative arrangements. Details of these arrangements should be documented. 
All study documents should be made available if required by relevant health authorities. 
Investigator/Institution should take measures to prevent accidental 
or premature 
destruction of these documents. 
 
8.1 Study Monitoring 
The investigator will self-monitor all study records for accuracy, completeness, and 
compliance with the protocol and GCPs and federal regulations. All study records will be 
made available to Bristol Myers Squibb representatives upon request. Study site facilities 
and study records will be made available to regulatory authorities’ inspectors if an 
inspection takes place. The investigator will notify Bristol Myers Squibb if this occurs. 
 
8.2 Statistical Considerations 
 
It is desired to enroll 30 patients. Since this is a pilot study with no formal hypothesis testing, 
statistical power/sample size is not formally presented in this protocol. 
The study will analyze data based on the non-responder imputation (NRI) method. This 
will be performed for each arm of the study (PASI 75 responders at week 8 and PASI 25- 
74 responders at week 8. Subjects who do not complete week 12 assessments will be 
classified as non-responders 
Analysis will be performed by the Investigator on proportion of subjects achieving Psoriasis 
Area Severity Index (PASI) 75 response at week 12 
The investigator will also analyze PASI 25-74 at week 8, PASI, PGA, BSA, PGAxBSA 
and DLQI improvement at week 8, BSA, PGA and BSA x PGA and DLQI improvement at 
week 12. PASI, BSA, PGA, BSA x PGA and DLQI at weeks 16, 20 and 24. This 
analysis will be done separately for both cohorts (PASI 75 responders at week 8 
and PASI25-74 responders at week 8) using summary statistics. The Investigator will also 
analyze SAE’s by cohort. 
 

30August2021 
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8.2.1  Exploratory Analysis  
Additional  exploratory analysis  may  be  detailed  in  and  performed  according  to  a 
separate statistical plan at the discretion of sponsor-investigator. 
 
8.3 Schedule of Events 
 
Procedure 
Screening 
BASELINE 
Week4 
Week 8 
Week 
12 
Week 
16 
Week 
20  
Week 
24 
Week 28  
Safety FU 
Informed Consent 
X 
Demographics/Medical History 
X 
X 
Inclusion/Exclusion 
X 
X 
Physical Exam 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serum Pregnancy Test 
X 
Urine Pregnancy Test 
X 
X 
X 
X 
X 
X 
X 
X 
Serum Chemistry, Hematology 
& Fasting Lipids 
X 
X 
  
 x 
Quantiferon Gold, HBV, HBC, HIV 
X 
PASI 
X 
X 
X 
X 
X 
X 
X 
BSA 
X 
X 
X 
X 
X 
X 
X 
PGA 
X 
X 
X 
X 
X 
X 
X 
DLQI 
X 
X 
X 
X 
X 
X 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
Photography 
X 
X 
X 
X 
X 
X 
Deucravacitinib 
dispensing 
X 
X 
X 
X 
X 
X 
Enstilar dispensing 
X 
IP accountability  
X 
X 
X 
X 
X 
X 

30August2021 
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REFERENCES 
 
1 Greaves MW, Weinstein GD. Treatment of psoriasis.  New Engl J Med. 1995;332(9):581-8. 
 
2 
Camp RDR.   Psoriasis.   In:   Champion RH, Burton JL, Burbs DA, Breathnach SM, eds.   Textbook of 
Dermatology, 6th Edition. 1998;2:1589-1649. 
 
3. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM et al. Guidelines of care for the 
management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of 
psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010 Jan;62(1):114-35. 
 
4. Jensen P, Skov L, Zachariae C. Systemic combination treatment for psoriasis: A review.  Acta Derm 
Venereol. 2010; 90: 341-349. 
 
5. Lebwohl M, Menter A, Koo J, Feldman SR. Combination therapy to treat moderate to severe psoriasis. 
J Am Acad Dermatol. 2004; 50(3): 416-30. 
 
6. Koo JY. Relevance of the COBRA trial in current psoriasis practice. Cutis. 2007 Nov;80(5 Suppl):4-11. 
 
7. Bagel J, Nelson E, Riley C, Hetzel A. Apremilast with Add-On Calcipotriene/Betamethasone 
Dipropionate for Treating Moderate to Severe Plaque Psoriasis. J Drugs Dermatol. 2020 Dec 
1;19(12):1149-1155. doi: 10.36849/JDD.2020.5435. 
 
8. Deucravacitinib Investigator Brochure. V7.0 11Feb2021 
 
9. Papp   K,   Gordon   K,   Thaci   D,   et   al.   N   Engl   J   Med.   2018   Oct   4;379(14):1313-1321.   doi: 
10.1056/NEJMoa1806382. Epub 2018 Sep 11. 
 
10. Frederiksson T, Pettersson U. Severe psoriasis: oral therapy with a new retinoid. Dermatologica. 
1978;157:238-244. 
 
11. Finlay  AY,  Khan  GK. 
Dermatology  Life  Quality  Index  (DLQI). 
April  1992. 
Available  from: 
www.dermatology.org.uk. 

30August2021 
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7. APPENDICES 
 
Appendix A 
Subject Diaries 
 
Storage 
●Keep study medication at room temperature. 
●Keep out of reach of children 
 
Enstilar Dosing 
●Apply once daily 
●Do not apply on face, underarms or groin 
●Avoid heat, flames or smoking when applying. 
●Do not bandage, cover, or wrap the treated area 
●Apply to affected areas and gently rub in. 
●Avoid bathing, showering or swimming right after applying the study medication. 
 
Dosing Diary 
●Record all doses on the diary as soon as possible. 
●Return diary and medication to all of your appointments. 
●Record any comments or information in “remarks” section for missed dose, 
adverse event, or change in medication. 
●Please make recordings clear and legible. 

30August2021 
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30August2021 
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Appendix B 
Physician’s Global Assessment 
 
 
 
 
 
Physician’s Global Assessment (PGA) 
 
Score 
Grade 
Definition 
0 
Clear 
Plaque elevation = 0 (no elevation) 
Scaling = 0 (no scale) 
Erythema = 0 (residual post-inflammatory hyperpigmentation or 
hypopigmentation may be present) 
1 
Minimal 
Plaque elevation = ± (possible, but difficult to ascertain whether 
there is a slight elevation) 
Scaling = ± (surface dryness with some white coloration) 
Erythema = up to moderate (up to definite red color) 
2 
Mild 
Plaque elevation = slight (slight, but definite elevation, typically 
edges are indistinct or sloped) 
Scaling = fine (fine scale partially or mostly covering lesions 
Erythema = up to moderate (up to definite red coloration) 
3 
Moderate 
Plaque elevation = moderate (moderate elevation with rough or 
sloped edges) 
Scaling = coarser (course scale covering most of all of the lesions) 
Erythema = moderate (definite red coloration) 
4 
Severe 
Plaque elevation = marked (marked elevation typically with hard or 
sharp edges) 
Scaling = course (course, non-tenacious scale predominates) 
Erythema = severe (very bright red coloration) 
5 
Very Severe 
Plaque elevation = very marked (very marked elevation typically 
with hard sharp edges) 
Scaling = very coarse (course, thick tenacious scale of over most of 
all of the lesions; rough surface) 
Erythema = very severe (extreme red coloration; dusky to deep red 
coloration) 

30August2021 
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Appendix C 
Psoriasis Area Index Severity 
 
 

30August2021 
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Appendix D 
Dermatology Life Quality Index 
DERMATOLOGY LIFE QUALITY INDEX 
 
Hospital No: 
Date: 
Name: 
Score: 
Address: 
Diagnosis: 
 
The aim of this questionnaire is to measure how much your skin problem has 
affected your life OVER THE LAST WEEK. Please tick  
one box for each question. 
 
1. 
Over the last week, how itchy, sore, 
painful or stinging has your skin 
been? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
2. 
Over the last week, how embarrassed 
or self conscious have you been because 
of your skin? 
A lot 
Very much 
 
A little 
 
 
Not at all 
 
3. 
Over the last week, how much has your 
skin interfered with you going  
shopping or looking after your home or 
garden? 
relevant  
Very much 
A lot 
A little 
Not at all 
 
 
 
 
Not 
4. 
Over the last week, how much has your 
skin influenced the clothes 
you wear? 
relevant  
Very much 
A lot 
A little 
Not at all 
 
 
 
 
Not 
5. 
Over the last week, how much has your 
skin affected any social or 
leisure activities? 
relevant  
Very much 
A lot 
A little 
Not at all 
 
 
 
 
Not 
6. 
Over the last week, how much has your 
skin made it difficult for 
you to do any sport? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
Not 
relevant  
7. 
Over the last week, has your skin prevented 
you from working or studying? 
relevant  
Yes 
No 
 
 
Not 
If "No", over the last week how much has 
your skin been a problem at 
A lot 
A little 
 
 
 
DLQI 

30August2021 
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32 
 
 
 
 
8. 
work or studying? 
Over the last week, how much has your 
Not at all 
Very much 
 
 
skin created problems with your 
partner or any of your close friends 
or relatives? 
relevant  
A lot 
A little 
Not at all 
 
 
 
Not 
9. 
Over the last week, how much has your 
skin caused any sexual 
difficulties? 
relevant  
Very much 
A lot 
A little 
Not at all 
 
 
 
 
Not 
10. 
Over the last week, how much of a 
problem has the treatment for your 
Very much 
A lot 
 
 
skin been, for example by making 
your home messy, or by taking up time? 
relevant  
A little 
Not at all 
 
 
Not 
Please check you have answered EVERY question. Thank you. 
AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the permission of 
the authors.