Clinical trial NCT03924427
Conditions: Psoriasis
Sponsor: Bristol-Myers Squibb
Start date: 2019-04-10; Completion date: 2021-03-24
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate BMS-986165 given to Japanese participants with moderate-to-severe psoriasis.

Detailed description:

Arms: arm 1: Given daily
Interventions: intervention 1: BMS-986165
Intervention descriptions: intervention 1: Oral tablet administration

Protocol documents:
Prot_SAP_000.pdf: 
Official Title of Study: 
An Open-Label, Single-arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of BMS-
986165 in Japanese Subjects with Moderate-to-Severe Psoriasis 
 
NCT Number: NCT03924427 
Document Date (Date in which document was last revised): May 7, 2020 


Page: 1 
Protocol Number: IM011066 
IND Number: 131,993 
EX-US Non-IND 
EUDRACT 
Number: 
N/A 
Date, Version: 07-May-2020, Final Approved v5.0
Clinical Protocol IM011066 
An Open-Label, Single-arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy and 
Safety of BMS-986165 in Japanese Subjects with Moderate-to-Severe Psoriasis  
Short Title: Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Psoriasis 
Revised Protocol 04 
Based on the Protocol IM011066, version 4.0, dated 11-Feb-2019 Amendment 
Study Director 
Medical Monitor 
24-hr Emergency Telephone Number
North America: 
 
Asia-Pacific: 
 
Bristol-Myers Squibb Research and Development 
3401 Princeton Pike  
Lawrenceville, NJ 08648 
6-5-1 Nishi-Shinjuku, Shinjuku-ku,
Tokyo, 163-1328, Japan 
This document is the confidential and proprietary information of Bristol-Myers Squibb Company and its 
global affiliates (BMS). By reviewing this document, you agree to keep it confidential and to use and disclose 
it solely for the purpose of assessing whether your organization will participate in and/or the performance of 
the proposed BMS sponsored study. Any permitted disclosures will be made only on a confidential "need to 
know" basis within your organization or to your independent ethics committee(s). Any other use, copying, 
disclosure or dissemination of this information is strictly prohibited unless expressly authorized in writing by 
BMS. Any supplemental information (eg, amendments) that may be added to this document is also 
confidential and proprietary to BMS and must be kept in confidence in the same manner as the contents of 
this document. Any person who receives this document without due authorization from BMS is requested to 
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return it to BMS or promptly destroy it. All other rights reserved. References to BMS in this protocol may 
apply to partners to which BMS has transferred obligations, eg, a Contract Research Organization. 
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DOCUMENT HISTORY 
Document 
Date of Issue 
Approver(s) 
Summary of Change 
Original Protocol 
27-June-2018 
Not applicable 
Amendment 01 
16-Nov-2018 
x Further clarified the 
diagnoses parameters for 
subjects with PsA, GPP, 
and EP.  
x Updated contact 
information 
x Corrected minor 
procedural and 
typographic errors. 
x Updated Appendix 3 to 
be consistent with all 
BMS-986165 studies 
Amendment 02 
08-Jan-2019 
x Revised certain 
exclusion criteria (eg, 
criteria related to urine 
drug screen and thyroid-
stimulating hormone) to 
be consistent with the 
global Phase 3 study, 
BMS-986165 IM011046 
x Corrected minor 
procedural and 
typographic errors. 
Amendment 03 
11-Feb-2019 
x Aligned the HBV testing 
and the related exclusion 
criterion to the most 
recent guidelines for the 
Management of HBV 
Infection provided by the 
Japan Society of 
Hepatology  
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Revised Protocol 
04 
 
(im011066-
revprot04) 
07-May-2020 
Made the following 
updates: 
x 
Added infection, 
cardiovascular and 
suicidal ideation and 
behavior (SIB) 
adjudication 
committees to the study 
x 
Provided clarifications 
in the protocol to aid 
sites and subjects in the 
conduct of the study 
x 
Corrected typographical 
errors 
 
 
 
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SUMMARY OF CHANGES 
Rationale: 
The primary purpose of this global revised protocol is to add the infection, cardiovascular, and 
suicidal ideation and behavior adjudication committees to the study to align with other studies in 
the psoriasis program. 
Key modifications and clarifications are summarized as follows:  
o Added clarifying detail to several items in the protocol  
o 
 
 
Substantive changes made to the previous version of the global protocol and the rationale for these 
changes are noted below in the summary of key changes table. All changes applied to the protocol 
body were applied to the synopsis, as necessary; synopsis changes are not included in the summary 
of key changes table. Only major additions and deletions are provided in this summary document; 
all minor grammatical, formatting, stylistic changes, or clarifications as well as organizational 
changes are not included. 
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Protocol Section 
Revised Protocol Text 
Rationale for Change 
4.1.6.1 Infection 
Adjudication 
Committee 
 
 
 
 
 
 
 
 
 
 
4.1.6.2 
Cardiovascular 
Adjudication 
Committee 
 
 
 
 
 
 
 
 
 
 
 
4.1.6.3 Suicidal 
Ideation and 
Behavior (SIB) 
Adjudication 
Committee 
 
Addition of the following Adjudication Committees:  
An independent Infection Adjudication Committee, composed 
of individuals with relevant expertise, will blindly review and 
adjudicate infection AEs, such as opportunistic infections, 
influenza, herpes zoster, and TB, reported in the study per 
criteria specified in a separate charter. Additional information 
about these infections may be collected on the case report 
form (CRF) in order to characterize and understand them. 
The Adjudication Committee members will be blinded to the 
treatment assignment of subjects. The structure, 
responsibilities, and procedures of the Adjudication 
Committee will be outlined in a charter. The Adjudication 
Committee members will not be investigators on the study. 
 
An independent cardiovascular (CV) Adjudication 
Committee, composed of individuals with relevant expertise, 
will blindly review and adjudicate cardiovascular and 
cerebrovascular AEs such as, but not limited to, Major 
Adverse Cardiovascular Events (MACE) that include death, 
non-fatal myocardial infarction, non-fatal stroke; 
revascularization procedures; heart failure; dysrhythmias; 
heart blocks; and thrombotic events reported in the study per 
criteria specified in a separate charter. Additional information 
about cardiovascular and cerebrovascular AEs may be 
collected on the CRF in order to characterize and understand 
them. The Adjudication Committee members will be blinded 
to the treatment assignment of subjects. The structure, 
responsibilities, and procedures of the Adjudication 
Committee will be outlined in a charter. The Adjudication 
Committee members will not be investigators on the study. 
 
An independent Suicidal Ideation and Behavior Adjudication 
Committee, composed of individuals with relevant expertise, 
will blindly review and adjudicate suicidal ideation/behavior 
reported in the study per criteria specified in a separate 
charter. Additional information about suicidal 
ideation/behavior may be collected on the CRF. The 
Adjudication Committee members will be blinded to the 
treatment assignment of subjects. The structure, 
responsibilities, and procedures of the Adjudication 
Committee will be outlined in a charter. The Adjudication 
Committee members will not be investigators on the study. 
Addition of 3 
adjudication committees 
to align with other Phase 
3 studies in the psoriasis 
program which include 
these committees 
5.3 Lifestyle 
Restrictions 
Updated text: 
General skin care measures (with above restrictions for topical 
treatments) that are standard for subjects with plaque psoriasis are 
permitted. 
To clarify general skin 
care measures used in the 
trial 
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Protocol Section 
Revised Protocol Text 
Rationale for Change 
6.7.1 Prohibited 
and/or Restricted 
Treatments 
 
 
 
Updated or added text: 
6) Any use of oral psoriasis medications (eg, methotrexate, 
cyclosporine, retinoids, fumaric acid derivatives) for any 
indication 
a. 
For subjects with generalized pustular psoriasis, one of 
the following agents is permitted: cyclosporine, methotrexate, 
or retinoids. 
b. 
For subjects with erythrodermic psoriasis, concomitant 
use of cyclosporine is permitted until Week 2. 
7) Any use of oral or injectable corticosteroids (eg, prednisone, 
methylprednisolone), unless it is considered necessary for the 
subject’s welfare and/or treatment of an AE/SAE 
a. 
For subjects with erythrodermic psoriasis or generalized 
pustular psoriasis, use of prednisone or its equivalent at a 
daily dose ≤ 10 mg/day is permitted. 
b. Otic, ophthalmic, nasal, or inhaled corticosteroids 
within recommended doses and with no systemic effects 
are permitted. 
8) Any topical medications/treatments, which are used for any 
indication, that could affect psoriasis evaluation (including, but 
not limited to, ultra-high to moderate potency corticosteroids 
(WHO Classes I-V), >3% salicylic acid, urea, alpha- or beta-
hydroxyl acids, anthralin, calcipotriene, topical vitamin D 
derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, 
picrolimus, and tacrolimus). 
Exception: The following topical treatments may be initiated only 
at Week 24 per investigator’s discretion in subjects who have 
 (See Section 4.1.4): 
• 
Ultra-high to moderate potency corticosteroids (Classes 
I-V), >3% salicylic acid, urea, alpha- or beta-hydroxyl acids, 
anthralin, calcipotriene, vitamin D derivatives, retinoids, 
tazarotene 
Note: Low potency topical steroids (WHO Classes VI and VII) 
are permitted on the palms, soles, face, and intertriginous 
areas but should not be used within 24 hours prior to any 
study visit. Bland emollients (defined as emollients without 
urea or alpha- or beta hydroxy acids or other ingredients 
which are pharmacologically active) are allowed on all body 
regions but should not be used within 24 hours prior to any 
study visit. 
Added clarifying detail 
around these prohibited 
medications 
6.7.2 Permitted 
Concomitant 
Medications 
Low potency topical steroids (WHO Classes VI and VII) are 
permitted on the palms, soles, face, and intertriginous areas but 
should not be used within 24 hours prior to any study visit. 
Bland emollients (defined as emollients without urea or alpha- or 
beta-hydroxy acids or other ingredients which are 
pharmacologically active) are allowed on all body regions but 
should not be used within 24 hours prior to any study visit. 
Added clarifying detail 
around these medications 
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Protocol Section 
Revised Protocol Text 
Rationale for Change 
8.4.5 Clinical 
Safety Laboratory 
Assessments 
Added the following tests under the Other Analyses section: 
 
Serum Immunoglobulin Levels (IgM, IgG, IgA, IgE) 
Addition of tests to 
harmonize with all other 
Phase 3 studies in the 
psoriasis program 
8.4.7 Suicidal 
Ideation and 
Behavior 
Monitoring 
 
 
Subjects who answer yes to Questions 4 or 5 which indicates a 
suicidal ideation severity level of 4 or 5 or document suicidal 
behavior or suicidal attempts on the eC-SSRS will have their 
treatments discontinued and be immediately referred to a mental 
health professional for further evaluation. 
Clarified to sites to what 
levels of suicidal 
ideation Questions 4 and 
5 refer 
9.5.1 Adverse 
Events 
Treatment-emergent adverse events (TEAEs), SAEs and deaths, 
AEs leading to study treatment discontinuation, AEs by maximum 
severity, and AEs by relationship will be summarized by the 
MedDRA system organ class and preferred term. All TEAEs as 
well as each AE-adjudicated category (ie, infections, 
cardiovascular, and SIB) will also be summarized by preferred 
term sorted by decreasing frequency. 
Added the 
summarization of these 
categories because of the 
addition of the 
adjudication committees 
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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
DOCUMENT HISTORY .................................................................................................................3 
SUMMARY OF CHANGES ...........................................................................................................5 
TABLE OF CONTENTS .................................................................................................................9 
1 
PROTOCOL SUMMARY ..........................................................................................12 
1.1 
Synopsis ......................................................................................................................12 
1.2 
Schedule of Activities (SOA) .....................................................................................15 
2 
INTRODUCTION ......................................................................................................31 
2.1 
Study Rationale ...........................................................................................................31 
2.2 
Background .................................................................................................................32 
 
3 
OBJECTIVES AND ENDPOINTS ............................................................................34 
4 
STUDY DESIGN .......................................................................................................37 
4.1 
Overall Design ............................................................................................................37 
4.2 
Number of Subjects ....................................................................................................39 
4.3 
End of Study Definition ..............................................................................................39 
4.4 
Scientific Rationale for Study Design ........................................................................39 
 
5 
STUDY POPULATION .............................................................................................41 
5.1 
Inclusion Criteria ........................................................................................................41 
5.2 
Exclusion Criteria .......................................................................................................42 
5.3 
Lifestyle Restrictions ..................................................................................................48 
5.4 
Screen Failures ............................................................................................................48 
6 
TREATMENT ............................................................................................................49 
6.1 
Treatments Administered ............................................................................................49 
6.2 
Method of Treatment Assignment ..............................................................................50 
6.3 
Blinding ......................................................................................................................50 
6.4 
Dosage Modification ..................................................................................................50 
6.5 
Preparation/Handling/Storage/Accountability ............................................................50 
6.6 
Treatment Compliance ................................................................................................51 
6.7 
Concomitant Therapy .................................................................................................51 
6.8 
Treatment After the End of the Study .........................................................................53 
7 
DISCONTINUATION CRITERIA ............................................................................53 
7.1 
Discontinuation from Study Treatment ......................................................................53 
7.2 
Discontinuation from the Study ..................................................................................55 
7.3 
Lost to Follow-up .......................................................................................................55 
8 
STUDY ASSESSMENTS AND PROCEDURES ......................................................56 
8.1 
Efficacy Assessments .................................................................................................56 
8.2 
Adverse Events ...........................................................................................................61 
8.3 
Overdose .....................................................................................................................65 
8.4 
Safety ..........................................................................................................................65 
8.8 
Health Economics OR Medical Resource Utilization and Health Economics ...........73 
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9 
STATISTICAL CONSIDERATIONS .......................................................................73 
 
9.2 
Populations for Analyses ............................................................................................73 
9.3 
Endpoints ....................................................................................................................73 
9.4 
Efficacy Analyses .......................................................................................................76 
9.5 
Safety Analyses ..........................................................................................................76 
9.6 
Other Analyses ............................................................................................................77 
9.7 
Interim Analysis ..........................................................................................................77 
10 
REFERENCES ...........................................................................................................78 
11 
APPENDICES ............................................................................................................82 
APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS .............................................83 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS ......................................88 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP AND REPORTING ...............................96 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION ............................................100 
APPENDIX 5 
STATIC PHYSICIAN’S GLOBAL ASSESSMENT OF 
PSORIASIS (sPGA) ................................................................................104 
APPENDIX 6 
PSORIASIS AREA AND SEVERITY INDEX (PASI) ..........................105 
 
 
 
 
 
 
APPENDIX 13 
CLASSIFICATION CRITERIA FOR PSORIATIC ARTHRITIS 
(CASPAR) ...............................................................................................113 
APPENDIX 17 
JDA CRITERIA FOR SEVERITY ASSESSMENT OF 
PUSTULAR PSORIASIS (GENERALIZED PSORIASIS) ...................118 
APPENDIX 23 
PSORIATIC ARTHRITIS SCREENING AND EVALUATION 
(PASE) QUESTIONNAIRE ....................................................................130 
APPENDIX 24 
EIGHT-ITEM PATIENT HEALTH QUESTIONNAIRE (PHQ-8) ........131 
APPENDIX 25 
SUICIDAL IDEATION AND BEHAVIOR CATEGORIES AND 
DEFINITIONS .........................................................................................132 
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LIST OF TABLES 
Table 1: 
Screening Procedural Outline (IM011066) ................................................16 
Table 2: 
On Treatment Procedural Outline (IM011066): Week 0 through 
Week 20 .....................................................................................................20 
Table 3: 
On Treatment Procedural Outline (IM011066): Week 24 Through 
Week 52 .....................................................................................................25 
Table 4: 
Study Treatments for Study Number .........................................................49 
Table 5: 
Selection and Timing of Dose ....................................................................49 
 
 
LIST OF FIGURES 
No table of figures entries found. 
 
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1 
PROTOCOL SUMMARY 
1.1 
Synopsis 
Protocol Title: An Open-Label, Single-Arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy 
and Safety of BMS-986165 in Japanese Subjects with Moderate-to-Severe Psoriasis  
Short Title: Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Psoriasis 
Study Phase: 3 
Rationale: 
BMS-986165 is being evaluated as a therapeutic option for the treatment of subjects with 
moderate-to-severe plaque psoriasis based on results of a recently completed 12-week, randomized 
Phase 2, placebo-controlled, parallel-group study (Study IM011011). The Phase 2 study was 
conducted with the following 5 different BMS-986165 treatment arms: 3 mg every other day 
(QOD); 3 mg once daily (QD); 3 mg twice daily (BID); 6 mg BID; and 12 mg QD.  
Overall, 267 subjects were randomized (44 to 45 subjects per treatment arm) in the Phase 2 study. 
All BMS-986165 treatment groups, except 3 mg QOD, achieved the primary endpoint of 
superiority compared with placebo in the proportion of subjects experiencing at least a 75% 
improvement in the Psoriasis Area and Severity Index (PASI 75) after 12 weeks of treatment. 
Compared with the placebo treatment group (6.7%), 38.6% (P = 0.0003), 68.9% (P < 0.0001), 
66.7% (P < 0.0001) and 75% (P < 0.0001) of the subjects treated with BMS-986165 at 3 mg QD, 
3 mg BID, 6 mg BID and 12 mg QD doses, respectively, achieved a PASI 75 response. The 
PASI 75 responses plateaued at a dose of 3 mg BID. The dose selected (6 mg QD) for the current 
global Phase 3 studies is expected to demonstrate equivalent efficacy to the 3 mg BID dose. 
This open-label study (IM011066) being conducted in Japan is a supplement to the global  
Phase 3 study (IM011046) which is designed to confirm the efficacy and safety of BMS-986165 
in a larger global population of subjects with moderate-to-severe plaque psoriasis. For approval in 
Japan, safety data collected from approximately 100 subjects dosed with BMS-986165 is needed. 
To achieve this: the IM011046 study is targeting to randomize approximately 52 Japanese subjects 
of which approximately 26 subjects will be dosed with BMS-986165; the IM011066 study is 
targeting to enroll and dose approximately 80 Japanese subjects.  
In addition to subjects with plaque psoriasis, subjects with erythrodermic psoriasis and generalized 
pustular psoriasis will be allowed to enter the open-label study to explore the safety and efficacy 
in those rare variants of psoriasis for whom additional treatment options are limited. The 
open-label study design allows subjects with erythrodermic psoriasis and generalized pustular 
psoriasis to receive active treatment during the entire duration of the study as it would be unethical 
to have those subjects with these severe variants of psoriasis to receive placebo. To ensure the 
safety of these subjects, certain concomitant medications will be allowed at the time points defined 
per protocol.  
 
 
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Study Population: 
Japanese men and women ≥ 20 years of age: 
1. Diagnosed with stable (defined as no morphology changes or significant flares of disease 
activity in the opinion of the investigator) plaque psoriasis for ≥ 6 months.  
NOTE: Subjects with plaque psoriasis can also be classified to have psoriatic arthritis 
confirmed by Classification Criteria for Psoriatic Arthritis (CASPAR) (APPENDIX 13). 
2. Having moderate-to-severe disease by involvement of ≥10% of body surface area (BSA) at 
both Screening Visit and Day 1, static Physician’s Global Assessment (sPGA) ≥3 at both 
Screening Visit and Day 1, and PASI score ≥12 at both Screening Visit and Day 1.  
3. Who are candidates for phototherapy or systemic therapy.  
4. For generalized pustular psoriasis, those with prior history of or newly diagnosed generalized 
pustular psoriasis based on Japanese Dermatological Association (JDA)1 criteria and have been 
on a stable treatment regimen for at least 2 weeks prior to Day 1; have erythematous lesions 
pustules involving ≥ 10% of body surface area (ie, score of at least 2 on the evaluation of skin 
symptoms [APPENDIX 17]) at both Screening Visit and Day 1; have a total JDA severity 
index score <14 (APPENDIX 17) at Screening Visit; and who are candidates for phototherapy 
or systemic therapy. 
5. For erythrodermic psoriasis, involving ≥80% of BSA at screening and Day 1, who also have a 
history of plaque psoriasis, and who are candidates for phototherapy or systemic therapy. 
Objectives and Endpoints: 
The objective of the study is to assess safety and efficacy of BMS-986165 6 mg QD in subjects 
with stable moderate-to-severe plaque psoriasis (with or without psoriatic arthritis), erythrodermic 
psoriasis, or generalized pustular psoriasis. 
The primary endpoints are: 
x sPGA 0/1 response assessed as a proportion of subjects with a sPGA score of 0 or 1 at Week 16 
x PASI 75 response assessed as a proportion of subjects who achieve a 75% improvement from 
baseline in the PASI score at Week 16 
The additional endpoints can be found in Section 3. 
Overall Design: 
This will be a 52-week, multi-center, open-label, single-arm, Phase 3 study in approximately 
80 Japanese subjects with moderate-to-severe stable, plaque psoriasis, generalized pustular 
psoriasis, or erythrodermic psoriasis. Subjects will undergo screening evaluations to determine 
eligibility within 28 days prior to administration of study medication. Following the screening 
process, approximately 80 qualified subjects will receive BMS-986165 6 mg QD for up to 52 
weeks. 
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Enrollment should not occur until at least 8 days after the Screening Visit 
 
.  
A subject with 
 at Week 24 may be treated with restricted topical medications, such as 
topical ultra-high to moderate potency corticosteroids (World Health Organization [WHO] Classes 
I-V), only at this time point at the discretion of the investigator. 
Subjects who discontinue study treatment early are expected to remain in the study for continued 
follow-up until Week 52. Those completing 52 weeks of treatment may be eligible to roll over to 
a long-term extension study and be treated with BMS-986165 6 mg QD. 
Note: Enrollment into the study will be divided into 2 enrollment periods: Parts A and B.  
Part A will only enroll subjects diagnosed with generalized pustular psoriasis (~10 subjects) or 
erythrodermic psoriasis (~10 subjects). Part B will only enroll subjects diagnosed with plaque 
psoriasis (~60 subjects). Part A enrollment will begin at the initiation of IM011066. Part B 
enrollment will begin only after the targeted number of Japanese subjects (~52 subjects) have been 
randomized into the IM011046 study. Part A enrollment may continue once Part B enrollment has 
begun. 
Treatment Arms and Duration:  
Study treatment: Single-Arm BMS-986165 6 mg QD for 52 weeks 
Study Drug for IM011066 
Medication  
Potency  
IP/Non-IP  
BMS-986165 tablet 
6 mg 
IP 
IP = investigational product 
 
Statistical Methods: 
 
 
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General Methodology: 
As this is a single-arm study, no statistical tests for treatment comparisons will be conducted. All 
binary efficacy endpoints will be summarized using counts and percentages of subjects and all 
continuous efficacy endpoints will be summarized using descriptive statistics (n, mean, standard 
deviation, median, minimum, and maximum). Summaries will be provided for plaque psoriasis 
(including psoriatic arthritis), generalized pustular psoriasis, or erythrodermic psoriasis subjects 
separately.
 
Safety Analysis: 
Treatment-emergent AEs and SAEs will be summarized using counts and percentages of subjects 
experiencing the event as well as the number of events by system organ class, preferred term, and 
treatment group. Vital signs, clinical laboratory test results, and ECG test results will be 
summarized using descriptive statistics (n, mean, standard deviation, median, minimum, and 
maximum) for continuous variables and frequency distributions (counts and percentages) for 
categorical variables. 
1.2 
Schedule of Activities (SOA) 
The schedules of assessments and procedures are documented in Table 1 for screening, Table 2 
for baseline through Week 20, and Table 3 for Week 24 through Week 52.
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Table 1: 
Screening Procedural Outline (IM011066) 
Procedure 
Screening 
V1 
PsA Classification 
Visita 
V1A 
Notes 
Eligibility Assessments 
Informed Consent 
X 
A subject is considered enrolled only when a protocol-specific informed consent is signed 
Enroll Subject 
X 
Obtain number from IRT 
Inclusion/Exclusion Criteria 
X 
Includes duration of plaque, erythrodermic, or generalized pustular psoriasis and 
documentation of presence of the type of psoriasis by the investigator 
Medical History 
X 
See Section 5.2 for complete eligibility criteria associated with medical history. Of note, 
subjects need to be screened for any current uncontrolled neuropsychiatric illness or history 
of suicidality; any history of TB; any congenital or acquired immunodeficiency; any 
significant drug allergy such as anaphylaxis; any cancer currently or in the previous 5 years. 
Investigators are encouraged to check whether subjects have had preventive health measures 
such as cancer screening (eg Pap smear, colonoscopy, mammograms) that is up-to-date 
according to local guidelines. 
History of Tobacco Use 
X 
Include description of current tobacco use 
Psoriasis-related History 
X 
Includes scalp symptoms, psoriatic arthritis/joint pain, nail involvement, palmoplantar 
involvement, genital involvement, history of other forms of psoriasis (eg, generalized pustular 
psoriasis, erythrodermic psoriasis) 
Psoriasis-related Systemic Treatment 
X 
History of: conventional systemic (eg, methotrexate), biologic, and/or phototherapy. For each 
therapy, include length of time on treatment and reason(s) for discontinuation (eg lack of 
efficacy, intolerance, side effects, loss of access to treatment) if applicable. 
Psoriatic arthritis-related History 
Xa 
Includes history or presence of swollen joints/digits, joint pain, entheseal pain, and/or 
morning stiffness. 
Psoriatic arthritis classification based on 
CASPAR criteria  
Xa 
Subjects with a medical history of psoriatic arthritis or who report symptoms of psoriatic 
arthritis with a PASE questionnaire score of ≥47, will undergo confirmation of their 
classification of psoriatic arthritis by the CASPAR criteria. 
For the CASPAR Criteria, historical rheumatoid factor results, and historical hand or foot 
radiograph results are acceptable. 
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Table 1: 
Screening Procedural Outline (IM011066) 
Procedure 
Screening 
V1 
PsA Classification 
Visita 
V1A 
Notes 
 
Assessment of GPP severity using JDA 
criteria (ie, skin symptoms, systemic 
symptoms and laboratory findings)b 
X 
 
See APPENDIX 17 
Other Prior and Concomitant Treatments 
X 
 
Includes topical treatments and shampoos for psoriasis and all medications for other 
conditions such as cardiovascular and mood disorders. 
Safety Assessments 
 
 
 
Physical Examination (PE) 
X 
 
Complete PE 
Physical Measurements 
X 
 
Includes height and weight 
Vital Signs 
X 
 
Includes (ear or oral) body temperature, respiratory rate, seated blood pressure and heart rate. 
Blood pressure and heart rate should be measured after the subject has been resting quietly for 
at least 5 minutes. 
Electrocardiogram (ECG) 
X 
 
ECGs should be recorded after the subject has been supine for at least 5 minutes. 
Chest Imaging (eg, Chest x-ray) 
X 
 
Chest imaging is required if not performed within 6 months of Screening Visit, copy of 
radiology report must be on file and reviewed by PI. Section 8.4.4 
Neuropsychiatric Illness Assessment 
X 
 
Based on subject/family response, medical history/medical records, investigator judgment 
PHQ-8 
X 
 
For establishing baseline depression severity 
Suicidal Ideation and Behavior 
Assessment 
X 
 
Based on subject/family response, medical history/medical records, investigator judgment 
eC-SSRS 
X 
 
eC-SSRS Assessment: Response of “Actual Suicide Attempt-Lifetime” or suicidal ideation 
(Severity of 4 or 5) or suicidal behavior will be exclusionary. Rescreening will not be 
allowed. Section 8.4.7 
Monitor for Serious Adverse Events 
X 
 
All SAEs must be collected from the date of subject’s written consent until 30 days post 
discontinuation of dosing or subject’s participation in the study. 
Laboratory Tests 
 
 
 
Hematology 
X 
 
Complete Blood Count (CBC) with differential 
Chemistry Panel 
X 
 
 
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Table 1: 
Screening Procedural Outline (IM011066) 
Procedure 
Screening 
V1 
PsA Classification 
Visita 
V1A 
Notes 
 
Lipid Panel 
X 
 
 
Urinalysis 
X 
 
 
Hemoglobin A1C 
X 
 
 
TSH 
X 
 
If TSH above normal reference range, test free T4; if TSH below normal range, test free T4 & 
T3 
Serology 
X 
 
Includes HCV antibody, HBsAg, HBsAb, HBcAb, HBV DNA, and HIV antibodies 
Tuberculosis Test 
X 
 
In accordance with QuantiFERON®-TB Gold. (details are described in Section 8.4.4). 
Pregnancy Test (serum) 
X 
 
For WOCBP only 
Follicle Stimulating Hormone (FSH) 
X 
 
To confirm menopausal status (see APPENDIX 4) 
(1Ѝ3)-beta-D glucan 
X 
 
 
Clinical Efficacy/Health Outcomes 
 
 
 
sPGA 
X 
 
 
PASI 
X 
 
 
BSA 
X 
 
 
PASE Questionnaire 
X 
 
For subjects with psoriatic arthritis type complaints to screen for presence of psoriatic arthritis 
BSA = body surface area; CASPAR = Classification Criteria for Psoriatic Arthritis; CBC = complete blood count; DNA = deoxyribonucleic acid; ECG = electrocardiogram; eC-SSRS 
= electronic Columbia-Suicide Severity Rating Scale; FSH = follicle-stimulating hormone; GPP  =  generalized pustular psoriasis; HBV = hepatitis B virus; HBcAb = hepatitis B core 
antibody; HBsAb = hepatitis B surface antibody; HBsAg = hepatitis B surface antigen; HCV = hepatitis C virus; HIV = human immunodeficiency virus; 
 
 IRT = interactive response technology; PASE = psoriatic arthritis screening and evaluation; PASI = Psoriasis Area and Severity Index; PE = physical examination; 
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PHQ-8 = eight-item Patient Health Questionnaire; PI = principal investigator; PsA = psoriatic arthritis; 
 SAE = serious adverse events; 
sPGA = static Physician Global Assessment; T3 = triiodothyronine; T4 = thyroxine; TB = tuberculosis; TSH = thyroid-stimulating hormone; V = visit; WOCBP = women of 
childbearing potential 
aVisit 1A applies to subjects only with a medical history of psoriatic arthritis (PsA) or suspected to have symptoms of PsA. This visit is needed only if PsA assessments can’t be 
completed at Visit 1. If the visit is needed, it must occur prior to the baseline visit (Visit 2). See Section 4.1.1 for more details. 
bOnly in subjects with generalized pustular psoriasis  
 
 
 
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Table 2: 
On Treatment Procedural Outline (IM011066): Week 0 through Week 20 
Procedure 
Week 0 
Baseline/
D1 
V2 
Week 1 
D8 
(±3 d) 
V3 
Week 2 
D15 
(±3 d) 
V4 
Week 4 
D29 
(±3 d) 
V5 
Week 8 
D57 
(±3 d) 
V6 
Week 12 
D85 
(±3 d) 
V7 
Week 16 
D113 
(±3 d) 
V8 
Week 20 
D141 
(±3 d) 
V9 
Notes 
Clinical Efficacy/Health Outcomes 
sPGA 
X 
X 
X 
X 
X 
X 
X 
PASI  
X 
X 
X 
X 
X 
X 
X 
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Table 2: 
On Treatment Procedural Outline (IM011066): Week 0 through Week 20 
Procedure 
Week 0 
Baseline/
D1 
V2 
Week 1 
D8 
(±3 d) 
V3 
Week 2 
D15 
(±3 d) 
V4 
Week 4 
D29 
(±3 d) 
V5 
Week 8 
D57 
(±3 d) 
V6 
Week 12 
D85 
(±3 d) 
V7 
Week 16 
D113 
(±3 d) 
V8 
Week 20 
D141 
(±3 d) 
V9 
Notes 
Safety Assessments 
Complete PE 
X 
 
 
 
 
 
X 
 
 
Targeted PE 
 
X 
X 
X 
X 
X 
 
X 
See Section 
8.4.1 
Body Weight 
X 
 
 
 
X 
 
X 
 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
 
Electrocardiogram (ECG) 
X 
 
 
 
 
 
X 
 
 
PHQ-8 
X 
 
 
 
X 
 
X 
 
See Section 
8.4.6.1 
eC-SSRS Assessment 
X 
 
 
 
X 
 
X 
 
Suicidal 
Ideation and 
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Table 2: 
On Treatment Procedural Outline (IM011066): Week 0 through Week 20 
Procedure 
Week 0 
Baseline/
D1 
V2 
Week 1 
D8 
(±3 d) 
V3 
Week 2 
D15 
(±3 d) 
V4 
Week 4 
D29 
(±3 d) 
V5 
Week 8 
D57 
(±3 d) 
V6 
Week 12 
D85 
(±3 d) 
V7 
Week 16 
D113 
(±3 d) 
V8 
Week 20 
D141 
(±3 d) 
V9 
Notes 
Behavior since 
last visit 
Adverse Event Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant Medication Use 
X 
X 
X 
X 
X 
X 
X 
X 
 
Laboratory Tests 
Hematology  
X 
X 
X 
X 
X 
X 
X 
X 
 
Lymphocyte Subsets (TBNK) 
X 
 
 
 
X 
 
X 
 
 
Chemistry Panel 
X 
X 
X 
X 
X 
X 
X 
X 
If CK >2.5 x 
ULN, reflex 
testing is 
required (See 
Section 8.4.5) 
Hemoglobin A1C 
X 
 
 
 
 
 
X 
 
 
Fasting Lipid Panel 
X 
 
 
 
X 
 
X 
 
 
Fasting Plasma Glucose 
X 
 
 
 
X 
 
X 
 
 
Urinalysis 
X 
 
 
 
 
 
X 
 
 
Serum Immunoglobulin Levels 
(IgM, IgG, IgA, IgE) 
X 
 
 
 
X 
 
X 
 
 
Pregnancy Test (Urine) 
X 
 
 
X 
X 
X 
X 
X 
WOCBP only 
HBV DNA Testh 
X 
 
 
X 
X 
X 
X 
X 
 
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Table 2: 
On Treatment Procedural Outline (IM011066): Week 0 through Week 20 
Procedure 
Week 0 
Baseline/
D1 
V2 
Week 1 
D8 
(±3 d) 
V3 
Week 2 
D15 
(±3 d) 
V4 
Week 4 
D29 
(±3 d) 
V5 
Week 8 
D57 
(±3 d) 
V6 
Week 12 
D85 
(±3 d) 
V7 
Week 16 
D113 
(±3 d) 
V8 
Week 20 
D141 
(±3 d) 
V9 
Notes 
Study Treatment 
 
 
 
 
 
 
 
 
 
Enrollment 
X 
 
 
 
 
 
 
 
 
Dispense Study Treatment 
X 
 
X 
X 
X 
X 
X 
X 
 
Study Treatment Compliance 
 
X 
X 
X 
X 
X 
X 
X 
See Section 6.6 
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Table 2: 
On Treatment Procedural Outline (IM011066): Week 0 through Week 20 
Procedure 
Week 0 
Baseline/
D1 
V2 
Week 1 
D8 
(±3 d) 
V3 
Week 2 
D15 
(±3 d) 
V4 
Week 4 
D29 
(±3 d) 
V5 
Week 8 
D57 
(±3 d) 
V6 
Week 12 
D85 
(±3 d) 
V7 
Week 16 
D113 
(±3 d) 
V8 
Week 20 
D141 
(±3 d) 
V9 
Notes 
ACR = American College of Rheumatology; 
 CASPAR = Classification Criteria for Psoriatic Arthritis; CK = creatine kinase; 
 
 D = Day; d = days; 
 DNA = deoxyribonucleic acid; ECG = electrocardiogram; eC-SSRS = electronic 
Columbia-Suicide Severity Rating Scale; 
 
HBV = hepatitis B virus; 
 Ig = immunoglobulin; 
 
PASI = Psoriasis Area and Severity Index; PE = physical examination; 
 
PHQ-8 = eight-item Patient Health Questionnaire;
 
sPGA = static Physician Global Assessment; 
 
TBNK = T cells, B cells, and natural killer cells; ULN = upper limit of normal; V = visit; 
 Wk = Week; WOCBP = women of childbearing 
potential 
 
 
 
 
 
 
gIf sample is missed, it may be taken at any visit once informed consent is obtained 
hTesting for HBV DNA will occur every 4 weeks for subjects who are negative HBsAg, but positive HBsAb and/or positive HBcAb with Hepatitis B virus DNA 
<2.1 log copies/mL [20IU/mL] at screening.  
 
When multiple assessments are conducted at a single visit, the following is the order in which they should be done: 
1) Health outcomes assessments 
2) Safety assessments (eg, vitals, AEs) 
3) Clinical efficacy assessments 
4) Laboratory tests (eg, safety laboratory tests, 
) 
 
On fasting days, safety assessments can be done first followed by blood draws, and then health outcomes and finally efficacy assessments. The dose of the drug on a 
visit day is to be taken after blood draws. 
 
 
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Table 3: 
On Treatment Procedural Outline (IM011066): Week 24 Through Week 52 
Procedure 
Week 24 
D169 
(±3 d) 
V10 
Week 28 
D197 
(±3 d) 
V11 
Week 32 
D225 
(±3 d) 
V12 
Week 36 
D253 
(±3 d) 
V13 
Week 40 
D281 
(±3 d) 
V14 
Week 44 
D309 
(±3 d) 
V15 
Week 48 
D337 
(±3 d) 
V16 
Week 52a 
(or early 
DC) 
D365 
(±3 d) 
V17 
Safety 
Follow-Upb 
(Week 56) 
D393 
(±3 d) 
V18 
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Table 3: 
On Treatment Procedural Outline (IM011066): Week 24 Through Week 52 
Procedure 
Week 24 
D169 
(±3 d) 
V10 
Week 28 
D197 
(±3 d) 
V11 
Week 32 
D225 
(±3 d) 
V12 
Week 36 
D253 
(±3 d) 
V13 
Week 40 
D281 
(±3 d) 
V14 
Week 44 
D309 
(±3 d) 
V15 
Week 48 
D337 
(±3 d) 
V16 
Week 52a 
(or early 
DC) 
D365 
(±3 d) 
V17 
Safety 
Follow-Upb 
(Week 56) 
D393 
(±3 d) 
V18 
Notes 
Safety Assessments 
 
 
 
 
 
 
 
 
 
 
Full Physical Examination 
X 
 
 
 
 
 
 
X 
X 
 
Targeted Physical 
Examination 
 
X 
X 
X 
X 
X 
X 
 
 
 
Body Weight 
X 
 
 
X 
 
 
 
X 
X 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Electrocardiogram 
X 
 
 
 
 
 
 
X 
 
 
PHQ-8 
 
X 
 
 
X 
 
 
X 
 
See Section 8.4.6.1 
eC-SSRS 
 
X 
 
 
X 
 
 
X 
 
Suicidal Ideation and 
Behavior since last visit 
Adverse Event Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant Medication 
Use 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
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Table 3: 
On Treatment Procedural Outline (IM011066): Week 24 Through Week 52 
Procedure 
Week 24 
D169 
(±3 d) 
V10 
Week 28 
D197 
(±3 d) 
V11 
Week 32 
D225 
(±3 d) 
V12 
Week 36 
D253 
(±3 d) 
V13 
Week 40 
D281 
(±3 d) 
V14 
Week 44 
D309 
(±3 d) 
V15 
Week 48 
D337 
(±3 d) 
V16 
Week 52a 
(or early 
DC) 
D365 
(±3 d) 
V17 
Safety 
Follow-Upb 
(Week 56) 
D393 
(±3 d) 
V18 
Notes 
Laboratory Tests 
 
 
 
 
 
 
 
 
 
 
Hematology  
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Lymphocyte Subsets 
(TBNK) 
 
 
 
X 
 
 
 
X 
 
 
Chemistry Panel 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If CK > 2.5 x ULN, 
reflex testing is required 
(see Section 8.4.5) 
Fasting Lipid Panel 
X 
 
 
 
 
 
 
X 
 
 
Fasting Plasma Glucose 
X 
 
 
 
 
 
 
X 
 
 
Hemoglobin A1C 
 
 
 
X 
 
 
 
X 
 
 
Urinalysis 
 
 
 
X 
 
 
 
X 
X 
 
Serum Immunoglobulin 
Levels (IgM, IgG, IgA, IgE) 
 
 
 
X 
 
 
 
X 
 
 
Pregnancy Test (Urine) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
WOCBP only 
HBV DNA Testi 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
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Table 3: 
On Treatment Procedural Outline (IM011066): Week 24 Through Week 52 
Procedure 
Week 24 
D169 
(±3 d) 
V10 
Week 28 
D197 
(±3 d) 
V11 
Week 32 
D225 
(±3 d) 
V12 
Week 36 
D253 
(±3 d) 
V13 
Week 40 
D281 
(±3 d) 
V14 
Week 44 
D309 
(±3 d) 
V15 
Week 48 
D337 
(±3 d) 
V16 
Week 52a 
(or early 
DC) 
D365 
(±3 d) 
V17 
Safety 
Follow-Upb 
(Week 56) 
D393 
(±3 d) 
V18 
Notes 
Study Treatment 
 
 
 
 
 
 
 
 
 
 
Dispense Study Treatment 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Study Treatment 
Compliance 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
ACR = American College of Rheumatology; 
 CASPAR = Classification Criteria for Psoriatic Arthritis; CK = creatine kinase; 
 D 
= Day; d = days; 
; DNA = deoxyribonucleic acid; ECG = electrocardiogram; eC-SSRS = electronic Columbia-Suicide Severity Rating 
Scale;
 
HBV = hepatitis B virus; 
 Ig = 
immunoglobulin; 
 PE = physical 
examination; 
 PHQ-8 = eight-item Patient Health Questionnaire; 
 
 
 TBNK = T cells, B cells, and natural killer cells; ULN = upper limit of 
normal; V = visit; 
; Wk = Week; WOCBP = women of childbearing potential 
aFor subjects who discontinue treatment prior to Week 52, please refer to Section 7.1 for more details. 
bFor subjects who do not continue in a long-term extension study  
 
 
 
 
 
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iTesting for HBV DNA will occur every 4 weeks for subjects who are negative HBsAg, but positive HBsAb and/or positive HBcAb with Hepatitis B virus DNA <2.1 log 
copies/mL [20IU/mL] at screening.  
  
 
When multiple assessments are conducted at a single visit, the following is the recommended order in which they should be done: 
1) Health outcomes assessments 
2) Safety assessments (eg, vitals, AEs) 
3) Clinical efficacy assessments 
4) Laboratory tests (eg, safety laboratory tests, 
) 
On fasting days, safety assessments can be done first followed by blood draws, and then health outcomes and finally efficacy assessments. 
The dose of the drug on a visit day is to be taken after blood draws. 
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STUDY ACKNOWLEDGMENT/DISCLOSURE 
I understand that this protocol contains information that is confidential and proprietary to Bristol-Myers Squibb 
Company (BMS). Any supplemental information that may be added to this document is also confidential and 
proprietary to BMS and must be kept in confidence in the same manner as the contents of this protocol. 
I have read the original protocol/revised protocol and agree that it contains all necessary details for carrying out the 
study as described. I will conduct this protocol as outlined therein and will make a reasonable effort to complete the 
study within the time designated. 
I will provide copies of the protocol and access to all information furnished by BMS to study personnel under my 
supervision. I will discuss this material with them to ensure that they are fully informed about the investigational 
product and the study.  
I will provide protocol information to my Institutional Review Board(s) [IRB(s)] or Independent Ethics Committee(s) 
[IEC(s]. I understand that original protocol/revised protocols must be reviewed by the Institutional Review Board or 
Independent Ethics Committee overseeing the conduct of the study and approved or given favorable opinion by all 
necessary health authorities before implementation unless to eliminate an immediate hazard to subjects. 
I agree that the contents of the protocol may not be disclosed to any other person or entity or used for any other purpose 
without the prior written consent of BMS. The foregoing shall not apply to disclosure required by governmental 
regulations or laws; however, I will give prompt notice to BMS of any such disclosure. 
I agree that the study data derived from this protocol may only be used and disclosed in furtherance of the protocol, 
for the medical treatment of a study subject or for publication of study results in accordance with the terms of the 
clinical trial agreement or as otherwise permitted by the terms of the clinical trial agreement. 
I agree not to collect or use samples (eg, tissue, blood, serum, urine) or collect data (other than for diagnostic or 
treatment purposes) from the study subjects while enrolled in the study, except as expressly permitted by the protocol 
or the terms of the clinical trial agreement. 
I understand that I may terminate or suspend enrollment of the study at any time if it becomes necessary to protect the 
best interests of the study subjects. Unless otherwise provided in the clinical trial agreement, the study may be 
terminated at any time by BMS, with or without cause. 
Original Protocol: 
 
 
Revised Protocol: 
 
Protocol Number: IM011066 Revised Protocol 04 
 
Site Number:  
Date of Protocol or Revised Protocol: 07-May-
2020 
 
 
IND Number: 131,993 
 
EUDRACT Number: N/A 
 
 
 
Investigator:  
 
Date:  
(signature) 
 
 
(printed name) 
 
 
 
 
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2 
INTRODUCTION 
Psoriasis is a chronic inflammatory skin disorder, characterized primarily by erythematous scaly 
plaques, that affects up to 3% of the general population. Men and women are equally affected and 
it can present at any age.2, 3 Several studies have observed a bimodal distribution of psoriasis onset 
with the first peak ranging from 15 to 22 years of age, and the second peak ranging from 55 to 60 
years of age.4-6 The most common form of psoriasis (58% to 97% of cases) is plaque psoriasis 
(psoriasis vulgaris), with less common forms being guttate, pustular, inverse (flexural), and 
erythrodermic psoriasis. The disease can have a fluctuating relapsing course, with flares that may 
be induced by factors such as infections, trauma, smoking, and stress4 Psoriasis can involve skin 
in any part of the body; particularly disabling is the involvement of specific anatomic regions, such 
as hands and feet (palmoplantar), face, scalp, and nails. Disease severity can be classified by body 
surface area (BSA) involvement with mild defined as ≤ 10% BSA, and moderate-to-severe as 
> 10% BSA.7 Psoriasis has a profound impact on quality of life and can lead to psychological, 
social and economic consequences, especially in moderate-to-severe disease. This condition is also 
associated with an increased risk of depression, occurrence of sleep disturbances, social stigma 
and decreased work productivity.8 Commonly associated comorbidities found in psoriasis patients 
include diabetes mellitus and metabolic syndrome. In patients with more severe forms of the 
disease, life expectancy is decreased due to an increase of cardiovascular risk.9 
Treatments include topical preparations, eg, corticosteroids, vitamin D analogs, calcineurin 
inhibitors, and salicylic acid; phototherapy modalities, including PUVA (psoralens with ultraviolet 
A) and narrow band ultraviolet B (UVB); and systemic therapies. In moderate-to-severe disease, 
systemic treatments are usually needed and may include oral agents (retinoids, methotrexate, 
cyclosporine, and apremilast) or injectables (eg, biologics such as tumor necrosis factor (TNF) 
inhibitors etanercept, infliximab, and adalimumab) anti- interleukin (IL)-12/23p40 antibody 
(ustekinumab), IL-17 antagonists (secukinumab, ixekizumab, brodalumab), and anti-IL-23p19 
antibody (guselkumab). Many of these treatments are associated with increased risk of AEs such 
as hepatotoxicity and neutropenia (methotrexate);10 nephrotoxicity (cyclosporine);11 depression 
and weight loss (apremilast);12 serious infections (cytokine inhibitors);13-16 candidiasis and 
Crohn’s disease (IL-17 antagonists).16-18 
Although effective therapeutic options are available, under-treatment or nontreatment of psoriasis 
has been reported in up to half of surveyed patients (based on absence of treatment and/or 
dissatisfaction with treatment).19 Many patients with severe disease are still being managed with 
only topicals therapies,5 and patients consider many of the treatments to be inadequate. 
Accordingly, there remains a need for more effective oral options, when compared with currently 
available agents, that would improve efficacy responses and increase adherence to treatment. 
2.1 
Study Rationale 
BMS-986165 is being evaluated as a therapeutic option for the treatment of subjects with 
moderate-to-severe plaque psoriasis based on results of a recently completed 12-week randomized 
Phase 2, placebo-controlled, parallel-group study with 5 different BMS-986165 treatment arms: 
3 mg QOD; 3 mg QD; 3 mg BID; 6 mg BID; and 12 mg QD (Study IM011011). Overall, 
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267 subjects were randomized (44 to 45 subjects per treatment arm) in the Phase 2 study. All 
BMS-986165 treatment groups, except 3 mg QOD, achieved the primary endpoint of superiority 
compared with placebo in the proportion of subjects achieving at least a 75% improvement in the 
Psoriasis Area and Severity Index (PASI 75) after 12 weeks of treatment. Compared with placebo 
treatment group, in which 6.7% of the subjects achieved PASI 75 response, 38.6% (P = 0.0003), 
68.9% (P < 0.0001), 66.7% (P < 0.0001) and 75% (P < 0.0001) of subjects treated with 3 mg QD, 
3 mg BID, 6 mg BID and 12 mg QD achieved PASI 75, respectively. The PASI 75 responses 
plateaued at a dose of 3 mg BID, and the Phase 3 dose selected (6 mg QD) is expected to 
demonstrate equivalent efficacy to the 3 mg BID dose. 
 
 Also, there was a clinically significant proportion 
of subjects treated with BMS-986165 achieving an sPGA score of 0 or 1 compared with placebo 
at Week 12. Compared with the placebo treatment group in which 6.7% of the subjects achieved 
an sPGA score of 0 or 1, 41.5%, 75.6%, 65.9%, and 75% of the subjects treated with 3 mg QD, 
3 mg BID, 6 mg BID and 12 mg QD achieved an sPGA score of 0 or 1, respectively.20 
This open-label study (IM011066) being conducted in Japan is a supplement to the global Phase 3 
study (IM011046) which is designed to confirm the efficacy and safety of BMS-986165 in a larger 
global population of subjects with moderate-to-severe plaque psoriasis. For approval, Japan 
requires safety data collected on approximately 100 subjects who receive BMS-986165. To 
achieve this number, this open-label study is expected to enroll approximately 80 Japanese subjects 
and the global study is expected to enroll approximately 52 Japanese subjects of which 
approximately 26 subjects will be dosed with BMS-986165 from Day 1.  
In addition to subjects with plaque psoriasis, subjects with erythrodermic psoriasis and generalized 
pustular psoriasis will be allowed to enter the open-label study to explore the safety and efficacy 
in those rare variants of psoriasis, for whom additional treatment options are limited. The open-
label study design allows subjects with erythrodermic psoriasis and generalized pustular psoriasis 
to receive active treatment during the entire duration of the study as it would be unethical to have 
those subjects with severe variants of psoriasis receive placebo. To ensure the safety of these 
subjects, certain concomitant medications will be allowed at the time points defined per protocol. 
2.2 
Background 
Tyrosine kinase 2 (TYK2) is a nonreceptor tyrosine kinase associated with receptors for the 
p40-containing cytokines IL-12 and IL-23, as well as the Type I interferon (IFN) receptor, and is 
required for the activation of downstream signaling pathways. TYK2 catalyzes the 
phosphorylation of the intracellular receptor domains and signal transducer and activator of 
transcription (STAT) proteins resulting in the activation of STAT-dependent transcription and 
functional responses specific for these cytokines.21-23 Because TYK2-dependent cytokines (eg, 
Type I IFNs, IL-12, IL-23) are distinct from those dependent on closely related Janus kinase (JAK) 
family members JAK1/JAK3 (eg, IL-2, IL-15, IL-7) or JAK2 (eg, erythropoietin, thrombopoietin, 
GM-CSF), a TYK2 Inhibitor would be expected to have a highly differentiated profile from 
inhibitors of other JAK family kinases. TYK2-dependent pathways and the cytokine networks they 
modulate (eg IL-23/IL-17, IFNα) have been implicated in the pathophysiology of multiple 
immune-mediated diseases, including psoriasis, lupus, spondyloarthritides, and Crohn’s disease. 
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BMS-986165 is a potent, highly selective, oral, small molecule-inhibitor of TYK2. A 
comprehensive in vitro and in vivo characterization of BMS-986165 has been established and 
supports the development of this compound in humans. Inhibition of TYK2 is expected to provide 
therapeutic benefit for subjects with psoriasis for multiple reasons: 1) Many of the pathways in the 
TYK2 signaling cascade (IFNα, IL-12/IL-23 and the downstream mediators IL-17 and IL-22) have 
been implicated in pathogenesis of psoriasis5 2) Biologic agents targeting the IL-17, IL-23p19, and 
IL-12/23 p40 pathways have been approved and are highly efficacious in the treatment of psoriasis. 
 
 
 
 
2.2.1 
Early Clinical Development 
The clinical data available to date supporting the safety, pharmacokinetics (PK), and 
pharmacodynamics (PD) of BMS-986165 are from 5 completed Phase 1 studies in healthy subjects 
(IM011002, 
IM011015, 
IM011016, 
IM011031, 
and 
IM011039) 
and 
1 completed  
Phase 2 study in adult subjects with moderate-to-severe plaque psoriasis (IM011011).  
Overall, BMS-986165 has been generally well-tolerated across all studies, and no safety issues 
have been identified to limit the investigation of the dose of BMS-986165 up to 12 mg QD in 
further clinical studies. A detailed description of the chemistry, pharmacology, efficacy, and safety 
of BMS-986165 is provided in the Investigator Brochure (IB). 
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3 
OBJECTIVES AND ENDPOINTS 
The objective of the study is to assess safety and efficacy of BMS-986165 6 mg QD in subjects 
with stable moderate-to-severe plaque psoriasis (with or without psoriatic arthritis [PsA]), 
erythrodermic psoriasis, or generalized pustular psoriasis. 
The primary endpoints are: 
x sPGA 0/1 response assessed as a proportion of subjects with a sPGA score of 0 or 1 at Week 16 
x PASI 75 response assessed as a proportion of subjects who achieve a 75% improvement from 
baseline in the PASI score at Week 16 
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4 
STUDY DESIGN 
4.1 
Overall Design 
This will be a 52-week, multi-center, open-label, single-arm, Phase 3 study in approximately 
80 Japanese subjects with moderate-to-severe stable, plaque psoriasis, generalized pustular 
psoriasis, or erythrodermic psoriasis. 
The duration of study participation is approximately 60 weeks and will be divided into the 
following periods: screening (up to 4 weeks), treatment (52 weeks), and follow-up (4 weeks). 
Physical examinations, 12-lead ECGs, clinical laboratory evaluations, and other assessments will 
be done at select visits during the study. Subjects in this study will be monitored for AEs. 
 
 
 
Note: Enrollment into the study will be divided into 2 enrollment periods: Parts A and B. 
Part A will only enroll subjects diagnosed with generalized pustular psoriasis (~10 subjects) or 
erythrodermic psoriasis (~10 subjects). Part B will only enroll subjects diagnosed with plaque 
psoriasis (~60 subjects). Part A enrollment will begin at the initiation of IM011066. Part B 
enrollment will begin only after the targeted number of Japanese subjects (~52 subjects) have been 
randomized into the IM011046 study. Part A enrollment may continue once Part B enrollment has 
begun. 
4.1.1 
Screening Period 
Subjects will be evaluated during the screening period to ensure they meet eligibility criteria. A 
detailed medical history will be done at this time, as well as a complete physical examination. 
Psoriasis-related history, which will include length of diagnosis, body involvement, and history of 
systemic treatment, will be assessed here. Depression and suicidality assessments will also be 
performed. An evaluation for tuberculosis (TB) will be done based on medical history, recent chest 
imaging, and a QuantiFERON®-TB Gold test. 
Subjects with a medical history of psoriatic arthritis or who report symptoms of psoriatic arthritis 
with a PASE questionnaire score of ≥47, will undergo confirmation of their classification of 
psoriatic arthritis by the ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria 
(APPENDIX 13) 
 
 
 
 It is preferable that a rheumatologist classify PsA by CASPAR criteria and perform joint 
assessments in a subject who has a history of psoriatic arthritis or who is presenting with symptoms 
suggestive of PsA. If assistance from a rheumatologist is not possible at the site, then a 
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dermatologist who is trained by a rheumatologist can classify a subject by CASPAR criteria as 
having PsA and perform the joint assessments for the subject in the study. 
If these assessments can’t be completed at Visit 1, subjects may return to complete these 
assessments at Visit 1A which must occur prior to the baseline visit (Visit 2).  
4.1.2 
Treatment Period 
Qualified subjects who have completed the screening procedures and have met the 
inclusion/exclusion criteria will be enrolled on Day 1 to receive BMS-985165 6 mg QD. 
Additional details are provided in Section 6.1. 
Enrollment should not occur until at least 8 days after the Screening Visit 
 
. 
4.1.3 
Week 16 
The primary endpoints (sPGA 0/1 and PASI 75) will be assessed at Week 16. 
4.1.4 
Week 24 
During the Week 24 assessment, a subject who has an 
 may be treated with 
restricted topicals/shampoos as described in Section 6.7.1 at the investigator’s discretion. These 
treatments may be only initiated at Week 24, and not at subsequent time points. A subject who is 
initiated on these treatments at Week 24 may use them as needed per the investigator’s judgment 
through Week 52. 
4.1.5 
Week 52 and Follow-up Period 
The follow-up period is a 4-week window after the Week 52 visit, unless the subject rolls over into 
the long-term extension study. The subject will be encouraged to report any SAEs or AEs 
experienced during this time. 
Subjects who discontinue study treatment early should remain in the study for protocol-specified 
procedures (please refer to Section 7.1 for more details). 
Subjects completing 52 weeks of treatment may be eligible to roll over to a long-term extension 
study and be treated with BMS-986165 6 mg QD. 
4.1.6 
Data Monitoring Committee and Other External Committees 
4.1.6.1 
Infection Adjudication Committee 
An independent Infection Adjudication Committee, composed of individuals with relevant 
expertise, will blindly review and adjudicate infection AEs, such as opportunistic infections, 
influenza, herpes zoster, and TB, reported in the study per criteria specified in a separate charter. 
Additional information about these infections may be collected on the case report form (CRF) in 
order to characterize and understand them. The Adjudication Committee members will be blinded 
to the treatment assignment of subjects. The structure, responsibilities, and procedures of the 
Adjudication Committee will be outlined in a charter. The Adjudication Committee members will 
not be investigators on the study. 
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4.1.6.2 
CV Adjudication Committee 
An independent cardiovascular (CV) Adjudication Committee, composed of individuals with 
relevant expertise, will blindly review and adjudicate cardiovascular and cerebrovascular AEs such 
as, but not limited to, Major Adverse Cardiovascular Events (MACE) that include death, non-fatal 
myocardial infarction, non-fatal stroke; revascularization procedures; heart failure; dysrhythmias; 
heart blocks; and thrombotic events reported in the study per criteria specified in a separate charter. 
Additional information about cardiovascular and cerebrovascular AEs may be collected on the 
CRF in order to characterize and understand them. The Adjudication Committee members will be 
blinded to the treatment assignment of subjects. The structure, responsibilities, and procedures of 
the Adjudication Committee will be outlined in a charter. The Adjudication Committee members 
will not be investigators on the study. 
4.1.6.3 
Suicidal Ideation and Behavior (SIB) Adjudication Committee 
An independent Suicidal Ideation and Behavior Adjudication Committee, composed of individuals 
with relevant expertise, will blindly review and adjudicate suicidal ideation/behavior reported in 
the study per criteria specified in a separate charter. Additional information about suicidal 
ideation/behavior may be collected on the CRF. The Adjudication Committee members will be 
blinded to the treatment assignment of subjects. The structure, responsibilities, and procedures of 
the Adjudication Committee will be outlined in a charter. The Adjudication Committee members 
will not be investigators on the study. 
4.2 
Number of Subjects 
Approximately 80 qualified subjects will receive BMS-986165 6 mg QD. It is anticipated that, 
among these 80 subjects, there will be approximately 60 subjects with plaque psoriasis, 
approximately 10 subjects with generalized pustular psoriasis, and approximately 10 subjects with 
erythrodermic psoriasis. 
 
4.3 
End of Study Definition 
The duration of study participation for individual subjects is expected to be up to 60 weeks 
(420 days), which includes screening (up to 4 weeks), treatment (52 weeks) and follow-up (up to 
4 weeks) periods. 
The start of the study is defined as the first visit for the first subject screened. The end of the study 
is defined as the last visit or scheduled procedure shown in the Schedule of Activities (Section 1.2) 
for the last subject. Study completion is defined as the final date on which data were or are expected 
to be collected (Week 56 for collection of potential SAEs). 
4.4 
Scientific Rationale for Study Design 
This open-label, Phase 3 study will be conducted in Japanese subjects with moderate-to-severe 
psoriasis who are candidates for systemic psoriasis therapy This study is a supplement to the Phase 
3 study (IM011046) designed to confirm the efficacy and safety of BMS-986165 compared with 
placebo and apremilast in a larger global population of subjects with moderate-to-severe plaque 
psoriasis that will include around 52 Japanese subjects with 26 dosed from Day 1 with 
BMS-986165 in a blinded manner. This study will closely mimic the global study and will evaluate 
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the subjects achieving sPGA of 0/1 and PASI 75 at Week 16, which are standard measures of 
efficacy in clinical trials of psoriasis treatments.  
For approval in Japan, safety data collected from approximately 100 subjects dosed with 
BMS-986165 is needed. To achieve this: the IM011046 study is targeting to randomize 
approximately 52 Japanese subjects of which approximately 26 subjects will be dosed with BMS-
986165; the IM011066 study is targeting to enroll and dose approximately 80 Japanese subjects. 
In addition to subjects with plaque psoriasis, subjects with erythrodermic psoriasis and generalized 
pustular psoriasis will also be allowed to enter the open-label study to explore the safety and 
efficacy in those rare variants of psoriasis, for whom additional treatment options are limited. The 
open-label study design allows subjects with erythrodermic psoriasis and generalized pustular 
psoriasis to receive active treatment during the entire duration of the study as it would be unethical 
to have those subjects with severe variants of psoriasis receive placebo. To ensure the safety of 
these subjects, certain concomitant medications will be allowed at the time points defined per 
protocol. 
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5 
STUDY POPULATION 
Eligibility criteria for this study have been carefully considered to ensure 1) selection of 
appropriate subjects with psoriasis, 2) safety of the study subjects and 3) the results of the study 
can be used for regulatory filing and other purposes. It is imperative that subjects fully meet all 
eligibility criteria. 
All screening and enrollment evaluations must be completed and reviewed to confirm that potential 
subjects meet all eligibility criteria. The investigator will maintain a screening log to record details 
of all subjects screened and to confirm eligibility or record reasons for screening failure, as 
applicable. 
5.1 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
 Signed Written Informed Consent
D Subjects must be willing to participate in the study and sign the informed consent form
(ICF)
 Type of Subject and Target Disease Characteristics
D For subjects with plaque psoriasis:
L
Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable
plaque psoriasis is defined as no morphology changes or significant flares of disease
activity in the opinion of the investigator
LL Deemed by the investigator to be a candidate for phototherapy or systemic therapy
LLL ≥10% of BSA involvement at both Screening Visit and Day 1
LY PASI score ≥12, sPGA ≥3 at both Screening Visit and Day 1
NOTE: Subjects with plaque psoriasis can also be classified to have psoriatic arthritis
(confirmed by CASPAR criteria [APPENDIX 13])
E For subjects with generalized pustular psoriasis:
L
Men and women with a prior history of or newly diagnosed generalized pustular
psoriasis based on JDA criteria (APPENDIX 17)
LL Have generalized pustular psoriasis and have been on a stable treatment regimen for at
least 2 weeks prior to Day 1
LLL At Screening Visit and Day 1, have erythematous lesions with pustules involving ≥10%
of body surface area (ie, score of at least 2 on this skin symptom [APPENDIX 17])
LY At Screening Visit, total JDA severity index score <14 (APPENDIX 17)
Y Deemed by the investigator to be a candidate for phototherapy or systemic therapy
F For subjects with erythrodermic psoriasis: 
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i) Men and women with a prior history of or newly diagnosed erythrodermic psoriasis  
ii) A history of plaque-type psoriasis 
iii) At Screening Visit and Day 1, have ≥80% of BSA involvement  
iv) Deemed by the investigator to be a candidate for phototherapy or systemic therapy 
 
3) Age and Reproductive Status 
a) Men and women aged ≥20 years at the time of Screening Visit 
b) Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at 
Screening Visit, and a negative urine pregnancy test (minimum sensitivity 25 IU/L or 
equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start 
of study drug 
c) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the 
study period. Women must not enroll even if lactation or breastfeeding is interrupted. 
d) Women of childbearing potential must agree to use correctly a highly effective method(s) 
of contraception for the duration of treatment (52 weeks) with study drug(s) BMS-986165 
plus 5 half-lives of study drug (3 days) plus 30 days (duration of ovulatory cycle) for a total 
of 33 days post-treatment completion (total of 33 days after last dose of study drug). 
WOCBP who are continuously not heterosexually active are exempt from contraceptive 
requirements, but must still undergo pregnancy testing as described in this protocol 
e) Male subjects who are sexually active with WOCBP must agree to follow instructions for 
method(s) of contraception (APPENDIX 4) for the duration of treatment with study 
treatment(s) plus 5 half-lives of the study treatment (3 days) for a total of 3 days 
post-treatment completion. In addition, male subjects must be willing to refrain from sperm 
donation during this time 
Investigators shall counsel WOCBP, and male subjects who are sexually active with WOCBP, on 
the importance of pregnancy prevention and the implications of an unexpected pregnancy. 
Investigators shall advise on the use of highly effective methods of contraception, (APPENDIX 4) 
which have a failure rate of < 1% when used consistently and correctly. 
5.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1) Target Disease Exceptions 
a) Subjects with guttate, inverse, or drug-induced psoriasis at Screening or Day 1. 
Note: the study allows men and women diagnosed with generalized pustular psoriasis or 
erythrodermic psoriasis. 
2) Infectious/Immune-related Exclusions 
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a) History or evidence of outpatient active infection and/or febrile illness within 7 days of 
Day 1  
b) History of serious bacterial, fungal, or viral infections requiring hospitalization and/or 
intravenous (IV) antibiotic treatment within 60 days prior to Day 1 
c) Any untreated bacterial infection within 60 days prior to Day 1 
d) Any ongoing evidence of chronic, bacterial infection (eg chronic pyelonephritis, chronic 
osteomyelitis, chronic bronchiectasis) 
e) Any history of proven infection of a joint prosthesis in which the prosthesis was not 
removed or replaced, or received antibiotics for suspected infection of a joint prosthesis in 
which the prosthesis was not removed or replaced 
f) Received live vaccines within 60 days prior to Day 1, or plans to receive a live vaccine 
during the study, or within 60 days after completing study treatment 
g) Presence of herpes zoster lesions at Screening or Day 1  
h) History of serious herpes zoster or serious herpes simplex infection which includes, but is 
not limited to, any episode of disseminated herpes simplex, multidermatomal herpes zoster, 
herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (recurrent is defined as 
2 episodes within 2 years) 
i) Evidence of, or test positive for, hepatitis B virus (HBV) at Screening. Positive hepatitis B 
lab testing is defined as: 1) Positive hepatitis B surface antigen (HBsAg+) OR 2) Presence 
of HBV deoxyribonucleic acid (DNA) OR 3) Positive hepatitis B core antibody subjects 
with detectable HBV DNA by Polymerase Chain Reaction (PCR) OR 4) Positive hepatitis 
B surface antibody subjects with detectable HBV DNA by PCR. 
Subjects with negative HBsAg but positive anti-HBs Ab, and/or positive anti-HBc Ab must 
also be tested for quantitative HBV DNA. Subjects with HBV DNA ≥2.1 Log copy/mL 
(20 IU/mL) are excluded from the study. Subjects with HBV DNA < 2.1 Log copy/mL 
(20 IU/mL) can be enrolled in the study but must undergo periodic monitoring of HBV 
DNA and liver enzymes, such as AST and ALT. Monitoring should be performed every 4 
weeks throughout the duration of the study and at the Safety Follow-Up visit at Week 56.  
j) Evidence of, or test positive for, hepatitis C virus (HCV) at Screening. A positive test for 
HCV is defined as: 1) positive for hepatitis C antibody (anti-HCV Ab) AND 2) positive 
via a confirmatory test for HCV (eg, HCV PCR) 
k) Positive for human immunodeficiency virus by antibody testing (HIV-1 and -2 Ab) at 
Screening 
l) Any history of known or suspected congenital or acquired immunodeficiency state or 
condition that would compromise the subject’s immune status (eg, history of opportunistic 
infections [eg, Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidioidomycosis], 
history of splenectomy, primary immunodeficiency) 
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3) Any of the following TB criteria: 
a) History of active TB prior to Screening Visit, regardless of completion of adequate 
treatment 
b) Signs or symptoms of active TB (eg, fever, cough, night sweats, and weight loss) during 
Screening as judged by the investigator 
c) Any imaging of the chest (eg, chest x-ray, chest computed tomography [CT] scan) obtained 
during the Screening period or anytime within 6 months prior to Screening with 
documentation, showing evidence of current active or history of active pulmonary TB 
d) Latent TB infection (LTBI) defined as positive IFN gamma release assay (IGRA), by 
QuantiFERON®-TB Gold testing at Screening, in the absence of clinical manifestations 
Note: Subject is eligible if (i) there are no current signs or symptoms of active TB AND 
(ii) subject has received adequate documented treatment for LTBI within 5 years of 
screening OR has initiated prophylactic treatment for LTBI per local guidelines and is 
rescreened after 1 month of treatment. To continue in the study, subject must agree to 
complete a locally-recommended course of treatment for LTBI.  
Note: An IGRA test that is indeterminate with no signs or symptoms of active TB must be 
retested for confirmation. If the second test is again indeterminate, the subject will be 
excluded from the study. If the retest is positive, the subject should be treated as having 
LTBI. If the retest is negative, subject may be eligible provided no other exclusion criteria 
for TB are met. 
4) Medical History and Concurrent Diseases 
a) Any major surgery within 8 weeks prior to Day 1, or any planned surgery for the first 
52 weeks of the study 
b) Has donated blood >500 mL within 4 weeks prior to Day 1, or plans to donate blood during 
the course of the study 
c) Drug or alcohol abuse, as determined by the investigator, within 6 months prior to Day 1 
d) Medical marijuana or prescription marijuana taken for medicinal reasons 
e) Any major illness/condition or evidence of an unstable clinical condition (eg, renal, 
hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, 
immunologic, or local active infection/infectious illness) that, in the investigator’s 
judgment or after consultation with the Medical Monitor, will substantially increase the 
risk to the subject if he or she participates in the study 
f) Unstable cardiovascular disease, defined as a recent clinical cardiovascular event (eg, 
unstable angina, myocardial infarction, stroke, rapid atrial fibrillation) in the last 3 months 
prior to Screening, or a cardiac hospitalization (eg, revascularization procedure, pacemaker 
implantation) within 3 months prior to Screening 
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g) Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) 
>160 mm Hg or diastolic BP >100 mm Hg 
Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this 
limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If 
the repeat value is less than the criterion limits, the second value may be accepted 
h) Class III or IV congestive heart failure by New York Heart Association Criteria 
i) Has cancer or history of cancer (solid organ or hematologic including myelodysplastic 
syndrome) or lymphoproliferative disease within the previous 5 years (other than resected 
cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has 
been treated with no evidence of recurrence) 
j) Any uncontrolled neuropsychiatric illness judged as clinically significant by the 
investigator during Screening or at Day 1 
OR 
Any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by medical 
history or by electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) 
documentation, or by answering “yes” to Question 4 or 5 for suicidal ideation on the 
eC-SSRS at Screening or at Day 1, or is clinically deemed to have a suicide risk by the 
investigator 
k) Prior exposure to BMS-986165 
l) If the subject has received biologics previously, the following exclusion criteria for 
washout will apply:  
i) Antibodies to IL-12, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, 
ixekizumab, or guselkumab) within 6 months of Day 1 
ii) TNF inhibitor(s) (eg etanercept, adalimumab, infliximab, certolizumab) within 
2 months of Day 1 
iii) Agents that modulate integrin pathways to impact lymphocyte trafficking (eg 
natalizumab), or agents that modulate B cells or T cells (eg, alemtuzumab, abatacept, 
or visilizumab) within 3 months of Day 1 
iv) Rituximab within 6 months of Day 1 
m) Has received systemic nonbiologic psoriasis medications and/or any systemic 
immunosuppressants (including, but not limited to, methotrexate [MTX], azathioprine, 
cyclosporine, JAK inhibitors, 6-thioguanine, mercaptopurine, mycophenolate mofetil, 
hydroxyurea, tacrolimus, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy 
vitamin D3 and analogs, psoralens, sulfasalazine, or fumaric acid derivatives) within 
4 weeks prior to Day 1 with the following exceptions: 
i) For subjects with erythrodermic psoriasis or generalized pustular psoriasis, use of 
prednisone or its equivalent at a daily dose ≤ 10 mg/day is permitted 
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ii) For subjects with generalized pustular psoriasis, one of the following agents is 
permitted: cyclosporine, methotrexate, or retinoids 
iii) For subjects with erythrodermic psoriasis, concomitant use of cyclosporine is permitted 
until Week 2 
n) Has used leflunomide within 6 months prior to Day 1 
o) Has used opioid analgesics within 4 weeks prior to Day 1 
p) Has received lithium, antimalarials, or intramuscular (IM) gold within 4 weeks of the first 
administration of any study medication 
q) Has received phototherapy (including either oral and topical PUVA light therapy, (UVB) 
or self-treatment with tanning beds or therapeutic sunbathing) within 4 weeks prior to Day 
1 
r) Has used topical medications/treatments that could affect psoriasis evaluation (including, 
but not limited to, ultra-high to moderate potency corticosteroids (Classes I-V), >3% 
salicylic acid, urea, alpha- or beta-hydroxyl acids, anthralin, calcipotriene, topical vitamin 
D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, picrolimus, and 
tacrolimus) within 2 weeks prior to Day 1 
Note: Low potency topical steroids (WHO Classes VI and VII) are permitted on the palms, 
soles, face, and intertriginous areas but should not be used within 24 hours prior to any 
study visit. Bland emollients (defined as emollients without urea or alpha- or beta- hydroxy 
acids or other ingredients which are pharmacologically active) are allowed on all body 
regions but should not be used within 24 hours prior to any study visit. 
s) Use of shampoos that contain corticosteroids, coal tar, >3% salicylic acid, or vitamin D3 
analogues within 2 weeks prior to Day 1 
t) Has received an experimental antibody or experimental biologic therapy within the 
previous 6 months, OR received any other experimental therapy or new investigational 
agent within 30 days or 5 half-lives (whichever is longer) prior to Day 1 OR is currently 
enrolled in an investigational study 
u) The following conditions for subjects with generalized pustular psoriasis:  
i. 
Drug-induced generalized pustular psoriasis 
ii. 
Subcorneal pustular dermatosis 
iii. 
Previous psoriasis vulgaris who experienced temporary pustulation  
iv. 
Circinate annular form of generalized pustular psoriasis 
v) For subjects with psoriatic arthritis: 
i. Received any parenteral corticosteroid injections within 6 weeks of 
Screening 
w) Any other sound medical, psychiatric and/or social reason as determined by the investigator 
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5) Physical and Laboratory Test Findings 
a) At Screening 
i) Absolute WBC count <3000/mm3  
ii) Absolute lymphocyte count <500/mm3 
iii) Absolute neutrophil count <1000/mm3 
iv) Platelet count <100,000/mm3 
v) Hemoglobin <9 g/dL 
vi) ALT and/or AST >3X upper limit of normal (ULN) 
vii) Total, unconjugated, and/or conjugated bilirubin >2X ULN 
viii) Thyroid-stimulating hormone (TSH) outside the normal reference range 
AND 
Free T4 (thyroxine) or T3 (triiodothyronine) outside the normal reference range 
b) ECG abnormalities that are considered clinically significant and would pose an 
unacceptable risk to the subject if participating in the study  
c) Renal impairment based on an estimated glomerular filtration rate (eGFR) <45 mL/min  
d) Inability to be venipunctured and/or tolerate venous access 
e) Any other significant laboratory abnormalities that, in the opinion of the investigator, might 
place the subject at unacceptable risk for participation in this study 
f) (1→3)-beta-D-glucan positive 
6) Allergies and Adverse Drug Reaction 
a) History of any significant drug allergy (such as anaphylaxis) 
7) Other Exclusion Criteria 
a) Prisoners or subjects who are involuntarily incarcerated. (Note: under certain specific 
circumstances a person who has been imprisoned may be included or permitted to continue 
as a subject. Strict conditions apply and BMS approval is required). 
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical 
(eg, infectious disease) illness 
c) Inability to comply with restrictions and prohibited activities/treatments as listed in the 
study protocol 
d) Site personnel or their immediate family 
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5.3 
Lifestyle Restrictions 
General skin care measures (with above restrictions for topical treatments) that are standard for 
subjects with plaque psoriasis are permitted. Subjects should avoid excessive sun exposure and 
avoid risks that are known to provoke flare of psoriasis. 
5.3.1 
Meals and Dietary Restrictions 
Study treatment may be taken without regard to meals; however, subjects are required to fast for a 
minimum of 10 hours before visits on which fasting lipid samples 
 
will be drawn. 
 
5.3.2 
Caffeine, Alcohol and Tobacco 
No restrictions are required; however extensive use of caffeine, alcohol, and tobacco should be 
avoided. 
5.3.3 
Activity 
No restrictions are required; however, unusual physical exertion should be avoided during the 
study. 
5.4 
Screen Failures 
Screen failures are defined as subjects who consent to participate in the clinical study but are not 
subsequently enrolled in the study for any reason. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure subjects, to meet the Consolidated 
Standards of Reporting Trials (CONSORT) publishing requirements, and to respond to queries 
from regulatory authorities. Minimal set of screen failure information includes date of consent, 
demography, screen failure details (ie, eligibility criteria that the subject did not meet), and any 
SAEs during the Screening period. 
5.4.1 
Retesting During Screening or Rescreening 
For laboratory parameters that initially do not meet eligibility requirements, a single retest within 
the 28-day screening period is permitted before subject is declared a screen failure. This is an effort 
to find all possible well-qualified subjects. Consultation with the Medical Monitor may be needed 
to identify whether repeat testing of any particular parameter would be clinically relevant. 
The study permits the rescreening (after the end of the initial 28-day screening period) of a subject 
who discontinues the study as a pretreatment failure (ie, the subject fails to meet eligibility criteria 
and has not been treated). The subject must be reconsented, will be assigned a new identification 
number, and a full Screening Visit must be performed again. A subject can only be rescreened 1 
time (ie, if the subject fails 1 rescreening attempt, no additional rescreening is allowed). Depending 
on the timing of rescreening, repeat chest imaging may not be required. Duration of existing 
treatments and required discontinuation periods shall be considered relative to the new Screening 
Visit and/or enrollment. 
The most current result prior to enrollment is the value by which study inclusion will be assessed, 
as it represents the subject’s most current clinical state. 
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6 
TREATMENT 
Study treatment is defined as any investigational treatment(s), marketed product(s), placebo, or 
medical device intended to be administered to a study subject according to the study randomization 
or treatment allocation. 
Study 
treatment 
includes 
both 
Investigational 
[Medicinal] 
Product 
(IP/IMP) 
and 
Non-investigational [Medicinal] Product (Non-IP/Non-IMP) and can consist of the following: 
BMS-986165. 
An IP, also known as IMP in some regions, is defined as a pharmaceutical form of an active 
substance or placebo being tested or used as a reference in a clinical study, including products 
already with a marketing authorization but used or assembled (formulated or packaged) differently 
than the authorized form, or used for an unauthorized indication, or when used to gain further 
information about the authorized form. 
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis, may be considered as 
noninvestigational products. Table 4 shows the study treatments for Protocol IM011066. 
Table 4: 
Study Treatments for Study Number 
Product 
Description/Class 
and Dosage 
Form 
Potency 
IP/Non-
IMP 
Open-
Label 
Packaging/Appearance 
Storage 
Conditions 
(per label) 
BMS-986165 
tablet 
6 mg 
IP 
Open-
Label 
Bottle 
Store at 15 to 
25°C; Store in a 
tightly closed 
container; Protect 
from light 
 
6.1 
Treatments Administered 
Study treatment will be administered as described in Section 4.1.2. The selection and timing of 
dose for each subject is in Table 5: 
Table 5: 
Selection and Timing of Dose 
Study Treatment 
Unit dose 
strength(s)/Dosage 
level(s) 
Dosage formulation 
Frequency of 
Administration 
Route of 
Administration 
6 mg QD BMS-986165 
6 mg 
1 active tablet QD in 
the morning 
oral 
Abbreviations: QD = once daily 
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6.2 
Method of Treatment Assignment 
Before the study is initiated, each user (at investigative sites) will receive log-in information and 
directions on how to access the interactive response technology (IRT) system. At the time of the 
Screening Visit, immediately after informed consent is obtained and before any study-related 
procedures are performed, the investigative site will access the enrollment option of the IRT 
system for assignment of a subject number for all subjects including subjects not subsequently 
treated. The subject number is assigned sequentially by the system and will be unique across all 
sites. All enrolled subjects, including those not dosed, will be assigned sequential subject numbers. 
The subject number may not be used for any other subject. If a subject is rescreened, they will be 
given a new identification number. 
A kit will contain adequate study treatment for a 4-week supply. At subsequent visits, when new 
treatment kits need to be provided, the investigative site will access the IRT to obtain the kit 
number to assign to the subject. Study treatment will be dispensed at study visits as shown in the 
Schedule of Activities (Section 1.2). 
6.3 
Blinding 
This is an open-label study, blinding procedures are not applicable. 
6.4 
Dosage Modification 
There is no provision for dose modification of study treatment. If a subject interrupts treatment 
due to an AE, study treatment can be restarted in consultation with the Medical Monitor. 
6.5 
Preparation/Handling/Storage/Accountability 
The IP should be stored in a secure area according to local regulations. It is the responsibility of 
the investigator to ensure that IP is only dispensed to study subjects. The IP must be dispensed 
only from official study sites by authorized personnel according to local regulations. 
The product storage manager should ensure that the study treatment is stored in accordance with 
the environmental conditions (temperature, light, and humidity) as determined by BMS. If 
concerns regarding the quality or appearance of the study treatment arise, the study treatment 
should not be dispensed and BMS should be contacted immediately. 
Investigational product documentation (whether supplied by BMS or not) must be maintained, that 
includes all processes required to ensure drug is accurately administered. This includes 
documentation of drug storage, administration and, as applicable, storage temperatures, 
reconstitution, and use of required processes (eg, required diluents, administration sets). 
Guidance and information for final disposition of unused study treatment are provided in 
APPENDIX 2. 
6.5.1 
Retained Samples for Bioavailability/Bioequivalence 
Not applicable. 
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6.6 
Treatment Compliance 
Study treatment compliance will be periodically monitored using standard drug accountability 
procedures (comparing the number of tablets returned to number dispensed, considering the 
expected regimen and any reported missed doses). Drug accountability will be reviewed by the 
investigative site staff at each visit to confirm treatment compliance. Site staff will discuss any 
discrepancies with the subject and remind the subject of the importance of compliance with the 
assigned regimen. A real-time monitoring platform may be used. 
6.7 
Concomitant Therapy 
6.7.1 
Prohibited and/or Restricted Treatments 
Prohibited and/or restricted medications during the study are described below. Medications taken 
within 4 weeks prior to study drug administration must be recorded on the CRF. 
1) Exposure to any investigational drug or placebo outside of the current study 
2) Use of any medications/therapy that would aggravate psoriasis. These include agents such as 
lithium, antimalarials (quinacrine, chloroquine, and hydroxychloroquine), propranolol, 
indomethacin, and quinidine unless it is considered necessary for the subject’s welfare and/or 
treatment of an AE/SAE. 
3) Use of opioid analgesics unless it is considered necessary for the subject’s welfare and/or 
treatment of an AE/SAE 
4) Phototherapy, use of tanning booths or therapeutic sunbathing  
5) Any use of biologic medications (eg, adalimumab, etanercept, infliximab, ustekinumab) 
6) Any use of oral psoriasis medications (eg, methotrexate, cyclosporine, retinoids, fumaric acid 
derivatives) for any indication 
a. For subjects with generalized pustular psoriasis, one of the following agents is 
permitted: cyclosporine, methotrexate, or retinoids. 
b. For subjects with erythrodermic psoriasis, concomitant use of cyclosporine is 
permitted until Week 2. 
7) Any use of oral or injectable corticosteroids (eg, prednisone, methylprednisolone), unless it is 
considered necessary for the subject’s welfare and/or treatment of an AE/SAE 
a. For subjects with erythrodermic psoriasis or generalized pustular psoriasis, use of 
prednisone or its equivalent at a daily dose ≤ 10 mg/day is permitted. 
b. Otic, ophthalmic, nasal, or inhaled corticosteroids within recommended doses and 
with no systemic effects are permitted. 
8) Any topical medications/treatments, which are used for any indication, that could affect 
psoriasis evaluation (including, but not limited to, ultra-high to moderate potency 
corticosteroids (WHO Classes I-V), >3% salicylic acid, urea, alpha- or beta-hydroxyl acids, 
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anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, 
trimethylpsoralens, picrolimus, and tacrolimus). 
Exception: The following topical treatments may be initiated only at Week 24 per 
investigator’s discretion in subjects who have
 (See Section 4.1.4): 
x
Ultra-high to moderate potency corticosteroids (Classes I-V), >3% salicylic acid, urea,
alpha- or beta- hydroxyl acids, anthralin, calcipotriene, vitamin D derivatives,
retinoids, tazarotene
  Note: Low potency topical steroids (WHO Classes VI and VII) are permitted on the palms,
soles, face, and intertriginous areas but should not be used within 24 hours prior to any study
visit. Bland emollients (defined as emollients without urea or alpha- or beta-hydroxy acids or
other ingredients which are pharmacologically active) are allowed on all body regions but
should not be used within 24 hours prior to any study visit.
9) Any medicated shampoos that contain corticosteroids, coal tar, >3% salicylic acid, or vitamin
D3 analogues
Exception: The above shampoos may be initiated only at Week 24 per investigator’s discretion
in subjects who have 
 (See Section 4.1.5).
10) Live vaccination
No concomitant medications (prescription, over-the-counter or herbal) are to be administered 
during study unless they are prescribed for treatment of specific clinical events. Any concomitant 
therapies must be recorded on the CRF. 
The investigator should contact and confirm agreement with the Medical Monitor prior to the 
administration of any concomitant medications. 
6.7.2 
Permitted Concomitant Medications 
Stable doses of concomitant medication for chronic medical conditions are permitted as long as 
neither the medication nor the medical condition meet exclusion criteria as detailed in Section 5.2. 
Dose adjustments of these medications should be avoided during the study unless clinically 
indicated. If a dose adjustment of these medications should occur, they must be recorded on the 
Concomitant Medications electronic case report form (eCRF) or the Procedures and Significant 
nondrug therapies eCRF. The investigator should instruct the subject to notify the study site about 
any new treatments he/she takes after the start of the study treatment. All medications and 
significant nondrug therapies (including physical therapy and blood transfusions) administered 
after the subject starts study treatment must be listed on the Concomitant Medications eCRF or the 
Procedures and Significant non-drug therapies eCRF. 
Note: 
x
Low potency topical steroids (WHO Class VI and VII) are permitted on the palms, soles,
face, and intertriginous areas but should not be used within 24 hours prior to any study visit.
Bland emollients (defined as emollients without urea or alpha- or beta-hydroxy acids or
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other ingredients which are pharmacologically active) are allowed on all body regions but 
should not be used within 24 hours prior to any study visit. 
x For subjects with erythrodermic psoriasis or generalized pustular psoriasis, use of 
prednisone or its equivalent at a daily dose ≤ 10 mg/day is permitted. 
x For subjects with erythrodermic psoriasis, concomitant use of cyclosporine is permitted 
until Week 2. 
x For subjects with generalized pustular psoriasis, one of the following agents is permitted: 
cyclosporine, methotrexate, or retinoids. 
6.7.3 
Rescue Medications 
At Week 24, a subject who has an 
 may be treated with restricted 
topicals or shampoos, respectively, as described in Section 6.7.1 at the investigator’s discretion. 
These treatments may only be initiated at Week 24, and not at subsequent time points. A subject 
who is initiated on these treatments at Week 24 may use them as needed per the investigator’s 
judgment through Week 52. 
6.8 
Treatment After the End of the Study 
At the end of the study, the investigator should ensure that subjects continue to receive appropriate 
standard of care to treat the condition under study.  
In addition, for subjects who continue to demonstrate clinical benefit, BMS may continue to 
provide study treatment via a rollover extension study requiring approval by responsible health 
authority and ethics committee, or through another mechanism at the discretion of BMS.  
BMS reserves the right to terminate access to BMS supplied study treatment if any of the following 
occur: a) the study is terminated due to safety concerns; b) the development of BMS-986165 is 
terminated for other reasons, including but not limited to lack of efficacy and/or not meeting the 
study objectives; c) the subject can obtain medication from a government sponsored or private 
health program. In all cases BMS will follow local regulations. 
7 
DISCONTINUATION CRITERIA 
7.1 
Discontinuation from Study Treatment 
Subjects MUST discontinue IP (and non-IP at the discretion of the investigator) for any of the 
following reasons: 
x Subject requests to stop study treatment. Subjects who discontinue study treatment early 
should remain in the study for protocol-specified procedures. The only exception to this is 
when a subject specifically withdraws consent for any further contact with him/her or 
persons previously authorized by subject to provide this information. 
x Any clinically significant AE, laboratory abnormality, or intercurrent illness which, in the 
opinion of the investigator, indicates that continued participation in the study is not in the 
best interest of the subject. If treatment is discontinued due to an AE, the AE eCRF must 
be completed to show that the AE caused discontinuation. 
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x eGFR <45 mL/min on repeat assessment within 7 days 
x Abnormal liver tests suggestive of drug-induced liver injury (DILI), as defined in 
Section 8.2.8 or if the investigator believes that it is in the best interest of the subject 
x Subject reports suicidal ideation, suicidal behavior, or suicide attempts at any time after 
enrollment, or documents suicidal ideation by answering “Yes” to Question 4 or 5 on the 
eC-SSRS, or documents suicidal behavior on the eC-SSRS at any time during the study. 
The subject should then be immediately referred to a mental health professional for 
evaluation of suicide risk. 
x The subject develops a malignancy, with the exception of a subject who develops 
non-melanoma skin cancer who may continue in the study at the discretion of the 
investigator 
x Pregnancy, positive pregnancy test or subject expresses an interest in becoming pregnant 
(refer to Section 8.2.6) 
x Subject develops active TB during the study or prematurely discontinues treatment for 
LTBI, or subject is noncompliant with LTBI therapy (refer to Section 8.4.4) 
x Termination of the study or program by BMS 
x Inability or failure to comply with protocol requirements in the opinion of the investigator 
x Loss of ability to freely provide consent through imprisonment or involuntary incarceration 
for treatment of either a psychiatric or physical (eg, infectious disease) illness 
x Subjects with a positive HBsAb at screening or a positive HBcAb at screening and negative 
HBV DNA (< 2.1 Log copy/mL [20 IU/mL] at screening have a quantitative HBV DNA 
≥2.1 Log copy/mL (20 IU/mL) during study treatment 
 
Refer to the Schedule of Activities (Section 1.2) for data to be collected at the time of treatment 
discontinuation and follow-up and for any further evaluations that can be completed. 
All subjects who discontinue BMS-986165 should comply with protocol-specified follow-up 
procedures as outlined in Section 1.2. The only exception to this requirement is when a subject 
withdraws consent for all study procedures including post-treatment study follow-up or loses the 
ability to consent freely (ie, is imprisoned or involuntarily incarcerated for the treatment of either 
a psychiatric or physical illness). Replacement of subjects is not permitted. 
If study treatment is discontinued prior to the subject’s completion of the study, the reason for the 
discontinuation must be documented in the subject’s medical records and entered on the 
appropriate eCRF page. 
7.1.1 
Temporary Discontinuation 
Temporary study treatment discontinuation is only allowed if the subject develops an AE which, 
in the opinion of the investigator, indicates that it is in the subject’s best interest that the study 
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treatment be placed on hold. Study treatment in this situation should be stopped until the AE is 
medically treated and/or has resolved per investigator judgment. 
Any temporary study treatment discontinuation as well as restart must be documented on the 
corresponding eCRF. 
7.1.2 
Post-Study Treatment Follow-Up 
Post-study follow-up is of critical importance and is essential to preserving subject safety and the 
integrity of the study. Subjects who discontinue study treatment must continue to be followed for 
collection of outcomes and/or survival follow-up data as required and in line with Section 4 until 
death or the conclusion of the study. 
Subjects who discontinue study treatment should be encouraged to undergo all study-related visits 
for the full treatment period in order to support the final efficacy and safety analysis. 
7.2 
Discontinuation from the Study 
Subjects who request to discontinue study treatment will remain in the study and must continue to 
be followed for protocol-specified follow-up procedures as specified in Section 1.2. The only 
exception to this is when a subject specifically withdraws consent for any further contact with 
him/her or persons previously authorized by subject to provide this information.  
x Subjects should notify the investigator of the decision to withdraw consent from future 
follow-up in writing, whenever possible. 
x The withdrawal of consent should be explained in detail in the medical records by the 
investigator and entered on the appropriate CRF page. 
x In the event that vital status (whether the subject is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as 
appropriately directed in accordance with local law. 
x If the subject withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
7.3 
Lost to Follow-up 
x All reasonable efforts must be made to locate subjects to determine and report their ongoing 
status. This includes follow-up with persons authorized by the subject. 
x Lost to follow-up is defined by the inability to reach the subject after a minimum of three 
documented phone calls, faxes, or emails as well as lack of response by subject to one 
registered mail letter. All attempts should be documented in the subject’s medical records. 
x If it is determined that the subject has died, the site will use permissible local methods to 
obtain date and cause of death. 
x If investigator’s use of third-party representative to assist in the follow-up portion of the 
study has been included in the subject’s informed consent, then the investigator may use a 
Sponsor retained third-party representative to assist site staff with obtaining subject’s 
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contact information or other public vital status data necessary to complete the follow-up 
portion of the study.  
x The site staff and representative will consult publicly available sources, such as public 
health registries and databases, in order to obtain updated contact information. 
x If after all attempts, the subject remains lost to follow-up, then the last known alive date as 
determined by the investigator should be reported and documented in the subject’s medical 
records. 
8 
STUDY ASSESSMENTS AND PROCEDURES 
x Study procedures and timing are summarized in the Schedule of Activities (Section 1.2) 
and described in Section 4.1.  
x Protocol waivers or exemptions are not allowed. 
x All significant safety concerns must be discussed with the Medical Monitor immediately 
upon occurrence or awareness to determine if the subject should continue or discontinue 
treatment. 
x Adherence to the study design requirements, including those specified in the Schedule of 
Activities (Section 1.2), is essential and required for study conduct. 
x All screening evaluations must be completed and reviewed to confirm that potential 
subjects meet all eligibility criteria before enrollment. Enrollment should not occur until at 
least 8 days after the Screening Visit 
 
. The investigator will maintain a screening log to 
record details of all subjects screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
x Procedures conducted as part of the subject’s routine clinical management (eg, blood 
count) and obtained before signing of informed consent may be utilized for screening or 
baseline purposes provided the procedure meets the protocol-defined criteria and has been 
performed within the timeframe defined in the Schedule of Activities (Section 1.2). 
x For several assessments, appropriate training will be provided to investigators and 
designated personnel at sites. Only those individuals trained and certified to perform these 
assessments will be performing them during the study. 
8.1 
Efficacy Assessments 
Every effort must be made to ensure that the same evaluator(s) complete the 
investigator-administered assessments for each subject at each visit. If the evaluator(s) is unable 
to complete the evaluation, then a qualified individual with overlapping experience may perform 
the evaluation. Documentation of who performed the evaluation is to be recorded in source 
documents. Assessments are to be performed at approximately the same time of day throughout 
the duration of the study.  
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Baseline assessments must be performed per protocol. Procedures not specified in the protocol that 
are part of standard care may be performed if they do not interfere with study procedures; any data 
arising from such procedures are not to be reported in the eCRF. 
8.1.1 
Investigator-administered Assessments 
8.1.1.1 
static Physician Global Assessment (sPGA) 
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, 
scale, and induration.25 The sPGA measure determines psoriasis severity at a single point in time 
(without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), 
moderate (3), or severe (4). sPGA assessments should be performed by a trained physician (eg, 
dermatologist) or appropriately trained investigator who is experienced in the assessment of 
psoriasis patients. Every effort should be made to ensure that the physician or designee who 
performed the sPGA evaluations for a subject at enrollment performs the sPGA for that subject at 
all subsequent visits (see APPENDIX 5). 
8.1.1.2 
Psoriasis Area and Severity Index (PASI) 
The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions 
(each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, 
and legs to top of buttocks).26 The PASI produces a numeric score that can range from 0 to 72, 
with higher PASI scores denoting more severe disease activity. The PASI can also be used to 
assess response to treatment. The PASI 50 is the proportion of subjects who experience at least a 
50% improvement in PASI score as compared with the baseline value. The PASI 75
 
 are defined similarly. BMS will host a training session prior to initiation of the study to 
demonstrate proper PASI scoring. All PASI assessments should be performed by a trained 
physician (dermatologist) or appropriately trained investigator who is experienced in the 
assessment of psoriasis patients (see APPENDIX 6).  
8.1.1.3 
Body Surface Area (BSA) 
Measurement of psoriasis BSA involvement is estimated using the handprint method with the size 
of a subject’s handprint (including fingers and thumb) representing 1% of BSA involved.27-29 The 
total BSA = 100% with breakdown by body region as follows: head and neck = 10% 
(10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin = 30% 
(30 handprints), lower extremities including buttocks = 40% (40 handprints). BSA assessments 
should be performed by a dermatologist or appropriately trained investigator who is experienced 
in the assessment of psoriasis patients. 
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8.1.1.12 
Severity Criteria for Generalized Pustular Psoriasis by the Japanese 
Dermatological Association (JDA) 
The severity will be categorized as: mild (0 to 6), moderate (7 to 10) or severe (11 to 17) by total 
score. Total score (0 to 17) will be calculated by the evaluation of skin symptoms (0 to 9) and 
systemic symptoms and laboratory findings (0 to 8) (see APPENDIX 17). 
8.1.2 
Subject-Reported Assessments 
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8.1.2.6 
Psoriatic Arthritis Screening and Evaluation (PASE) Questionnaire 
The PASE questionnaire will be administered at screening in subjects with psoriatic arthritis type 
complaints. The PASE questionnaire is a self-administered tool that is used to screen for psoriatic 
arthritis among subjects who have psoriasis. The PASE questionnaire consists of 15 questions 
subdivided into 7 questions focusing on symptoms of psoriatic arthritis, and 8 questions focusing 
on the impact of psoriatic arthritis on function. Each question is scored on a 1 to 5 scale, with a 
maximum score of 75. A score of 47 or above has been shown to distinguish between psoriatic 
arthritis and non-psoriatic arthritis.44 This questionnaire is only intended to be a screening tool for 
psoriatic arthritis and does not replace a comprehensive musculoskeletal exam performed by a 
rheumatologist. The PASE questionnaire should take 6 to 10 minutes to complete and is only done 
at Screening (See APPENDIX 23). 
8.2 
Adverse Events 
The definitions of an AE or SAE can be found in APPENDIX 3. 
AEs will be reported by the subject (or, when appropriate, by a caregiver, surrogate, or the subject’s 
legally authorized representative).  
The investigator and any designees are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or SAE and remain responsible for following up AEs that 
are serious, considered related to the study treatment or the study, or that caused the subject to 
discontinue before completing the study.  
Contacts for SAE reporting are specified in APPENDIX 3. 
8.2.1 
Adverse Events of Interest 
Adverse events of interest (AEIs) are AEs for a particular product or class of products that a 
Sponsor may wish to monitor carefully. Adverse events of interest may be serious or non-serious. 
Such events may require further investigation to better characterize and understand them. In the 
BMS-986165 clinical development program, certain skin-related AEs (eg, acne), infection AEs, 
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and CK elevation have been identified as potential AEIs; however, there has been no definitive 
assessment on the causal relationship between these events and treatment with BMS-986165. 
Additionally, given a potential association between treatment for autoimmune diseases and 
increased risk for cancer, malignancy has been identified as a potential AEI. Suicidal 
ideation/behavior and an increased risk of cardiovascular disease may also be prevalent in patients 
with psoriasis. Therefore, additional information about certain skin-related AEs, infection AEs, 
CK elevation, suicidal ideation/behavior, cardiovascular events, and malignancy may be collected 
on the CRF in order to better characterize and understand them. 
8.2.2 
Time Period and Frequency for Collecting AE and SAE Information 
The collection of non-serious AE information should begin at initiation of study treatment until 
discharge from the study (ie, final study visit for a given subject) , at the timepoints specified in 
the Schedule of Activities (Section 1.2).  
The Reference Safety Information in sections 5.6.1 and 5.6.2 of the IB should be used to determine 
expectedness of SAEs for expedited reporting. Following the subject’s written consent to 
participate in the study, all SAEs, whether related or not related to study drug, must be collected, 
including those thought to be associated with protocol-specified procedures. 
All SAEs must be collected from the date of subject’s written consent until 30 days after the final 
dose of the study drug or subject’s participation in the study if the last scheduled visit occurs at a 
later time. Monitoring for SAEs will occur at every study visit.  
x The investigator must report any SAE that occurs after these time periods and that is 
believed to be related to study drug or protocol-specified procedure. Medical occurrences 
that begin before the start of study treatment but after obtaining informed consent will be 
recorded on the appropriate section of the CRF. 
x All SAEs will be recorded and reported to Sponsor or designee within 24 hours, as 
indicated in APPENDIX 3.  
x The investigator will submit any updated SAE data to the Sponsor within 24 hours of this 
being available. 
Investigators are not obligated to actively seek AEs or SAEs in former study subjects. However, 
if the investigator learns of any SAE, including a death, at any time after a subject has been 
discharged from the study, and he/she considers the event reasonably related to the study treatment 
or study participation, the investigator must promptly notify the Sponsor. 
The method of evaluating and assessing causality of AEs and SAEs and the procedures for 
completing and reporting/transmitting SAE reports are provided in APPENDIX 3. 
8.2.3 
Method of Detecting AEs and SAEs 
Adverse events can be spontaneously reported or elicited during open-ended questioning, 
examination, or evaluation of a subject. (In order to prevent reporting bias, subjects should not be 
questioned regarding the specific occurrence of one or more AEs.) 
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8.2.4 
Follow-up of AEs and SAEs 
x Non-serious AEs should be followed to resolution or stabilization, or reported as SAEs if 
they become serious (see APPENDIX 3). 
x Follow-up is also required for non-serious AEs that cause interruption or discontinuation 
of study treatment and for those present at the end of study treatment as appropriate. 
x All identified non-serious AEs must be recorded and described on the non-serious AE page 
of the CRF. Completion of supplemental CRFs may be requested for AEs and/or laboratory 
abnormalities that are reported/identified during the course of the study. 
After the initial AE/SAE report, the investigator is required to proactively follow each subject at 
subsequent visits/contacts. All SAEs will be followed until resolution, until the condition 
stabilizes, until the event is otherwise explained, or until the subject is lost to follow-up (as defined 
in Section 7.3). 
Further information on follow-up procedures is given in APPENDIX 3. 
8.2.5 
Regulatory Reporting Requirements for SAEs 
x Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities toward the safety of subjects and the safety of a 
product under clinical investigation are met. 
x An investigator who receives an investigator safety report describing SAEs or other 
specific safety information (eg, summary or listing of SAEs) from the Sponsor will file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local 
requirements. 
Sponsor or designee will be reporting AEs to regulatory authorities and ethics committees 
according to local applicable laws including European Directive 2001/20/EC and Food and Drug 
Administration (FDA) Code of Federal Regulations 21 CFR Parts 312 and 320. A SUSAR 
(Suspected, Unexpected Serious Adverse Reaction) is a subset of SAEs and will be reported to the 
appropriate regulatory authorities and investigators following local and global guidelines and 
requirements. 
8.2.6 
Pregnancy 
In the event a subject becomes pregnant during the trial, the study treatment must be discontinued 
immediately. If the subject becomes pregnant while on treatment or within 3 days of discontinuing 
study treatment, the investigator must immediately notify 
 Drug Safety of this event and 
complete and forward a Pregnancy Surveillance Form to 
 Drug Safety within 24 hours of 
awareness of the event and in accordance with SAE reporting procedures described in APPENDIX 
3. The investigator must also notify the Medical Monitor or designee of this event within 24 hours 
of awareness of pregnancy.  
The pregnant subject will need to be followed up until the conclusion of the pregnancy for 
pregnancy outcomes. The safety data of the subject will continue to be collected under the same 
rules as instructed in Section 7.1. 
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Any pregnancy that occurs in a female partner of a male study subject should be reported to 
 
Drug Safety. In order for Sponsor or designee to collect any pregnancy surveillance information 
from the female partner, the female partner must sign an ICF for disclosure of this information. 
Information on this pregnancy will be collected on the Pregnancy Surveillance Form. 
8.2.7 
Laboratory Test Result Abnormalities 
The following laboratory test result abnormalities should be captured on the AE eCRF page. 
x Any laboratory test result that is clinically significant or meets the definition of an AE or 
SAE  
x Any laboratory test result abnormality that required the subject to have study treatment 
discontinued or interrupted 
x Any laboratory test result abnormality that required the subject to receive specific 
corrective therapy 
If a laboratory test result meets the definition of an AE or SAE, the laboratory test result should be 
reported as an AE or SAE and submitted to 
 Drug Safety, as specified in APPENDIX 3.  
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). 
8.2.8 
Potential Drug-Induced Liver Injury (DILI) 
All occurrences of potential DILIs, meeting the defined criteria, must be reported as SAEs (see 
Section 8.2 and APPENDIX 3 for reporting details). Wherever possible, timely confirmation of 
initial liver-related laboratory abnormalities should occur prior to the reporting of a potential DILI 
event. 
Potential DILI is defined as:  
1) ALT or AST elevation > 3 times 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 liver function test elevation and 
hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver 
disease, or the administration of other drug(s) known to be hepatotoxic. 
8.2.9 
Other Safety Considerations 
Any significant worsening of a preexisting medical condition noted during interim or final physical 
examinations, ECG, x-ray filming, any other potential safety assessment required or not required 
by protocol should also be recorded as a non-serious or serious AE, as appropriate, and reported 
accordingly. 
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8.3 
Overdose 
For this study, taking more than 2 days’ study medication within a 24-hour time period will be 
considered an overdose. 
In the event of an overdose the investigator should: 
1) Contact the Medical Monitor immediately
2) Closely monitor the subject for AEs/SAEs and laboratory abnormalities
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the Medical Monitor based on the clinical evaluation of the subject. 
8.4 
Safety 
Planned time points for all safety assessments are listed in the Schedule of Activities (Section 1.2). 
8.4.1 
Physical Examinations 
A complete physical examination will include general appearance, vital signs, eyes, ears, nose, 
mouth, throat, neck, respiratory, cardiovascular, respiratory, GI/abdomen, lymphatic, 
musculoskeletal, skin, psychiatric and neurologic exams. A targeted physical examination will 
include any organ system associated with an AE or a laboratory abnormality. 
8.4.2 
Vital Signs 
Refer to Schedule of Activities (Section 1.2). 
8.4.3 
Electrocardiograms 
A 12-lead ECG will be performed at the visits indicated in the Schedule of Activities (Section 1.2). 
The subject will remain supine for 5 to 10 minutes prior to the ECG, and must have their lab work 
done after the tracing so that the ECG results remain as accurate as possible. The ECG results will 
be read by the primary study investigator or a designee. 
8.4.4 
Tuberculosis Screening and Chest Imaging 
Chest imaging results and PE are part of the process to assess a subject’s eligibility, as outlined in 
Section 1.2 and as defined in exclusion criterion 3.c). Chest imaging (eg, chest x-ray, chest CT 
scan) at the Screening Visit is required if not already performed and documented within 6 months 
of obtaining written informed consent. A subject must not have active signs or symptoms of TB, 
as judged by the investigator, to be eligible for the study. 
In addition to a complete PE and medical history to evaluate exposure to TB, all subjects will 
have a screening test, an IGRA (eg, QuantiFERON®-TB Gold) performed centrally. If unable to 
obtain central laboratory results, an IGRA test could be obtained locally, after consultation with 
the 
 Medical Monitor. A subject with an indeterminate IGRA test result must be 
retested for confirmation. If the second result is again indeterminate, the subject will be 
excluded from the study. If the second result is positive, the subject should be considered as 
having LTBI provided there are no signs or symptoms of active TB. If the second result is 
negative, the subject may be eligible provided no other exclusion criterion for TB is met. 
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8.4.5 
Clinical Safety Laboratory Assessments 
Investigators must document their review of each laboratory safety report. 
Hematology 
Hemoglobin (Hgb) 
Hematocrit (Hct) 
White Blood Cell Count, including differential 
Platelet Count 
Chemistry 
Aspartate Aminotransferase (AST) 
Alanine Aminotransferase (ALT) 
Total Bilirubin 
Direct Bilirubin (if total bilirubin > ULN)  
Alkaline Phosphatase 
Lactate Dehydrogenase (LDH) 
Creatinine 
Blood Urea Nitrogen (BUN) 
Uric Acid  
Glucose (fasting at some visits) 
Total Protein 
Albumin 
Sodium 
Potassium 
Chloride 
Calcium 
Phosphorus 
Creatine Phosphokinase (CK)* 
Estimated Glomerular Filtration Rate (eGFR) 
Urinalysis 
Protein 
Glucose 
Blood 
Leukocyte Esterase 
Specific Gravity 
pH 
Microscopic Examination (reflex if abnormal) 
Lipid Panel 
Cholesterol (total) 
High Density Lipoprotein (HDL) 
Low Density Lipoprotein (LDL) 
Triglycerides  
Infectious Serologies 
Hepatitis C Antibody with reflex to Hepatitis C RNA if positive 
Hepatitis B Surface Antigen (HBsAg) 
Hepatitis B Surface Antibody (HBsAb) 
Hepatitis B Core Antibody (HBcAb) 
Hepatitis B DNA Viral Load (HBV DNA) ** 
HIV-1 and -2 antibody 
Other Analyses 
Pregnancy test (WOCBP only: serum hCG test at screening, followed by urine hCG test every 4 weeks) 
Follicle-Stimulating Hormone (FSH) (to confirm menopausal status [see APPENDIX 4], at screening) 
Hemoglobin A1C  
Thyroid–Stimulating Hormone (TSH) 
If TSH above normal reference range, test free T4; if TSH below normal range, test free T4 & T3 
 
Serum Immunoglobulin Levels (IgM, IgG, IgA, IgE) 
(1Ѝ3)-beta-D glucan (at screening only)  
*If CK > 2.5X ULN, then reflex testing (ie, CK-MB, Troponin I will be required) 
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**Testing for HBV DNA will occur every 4 weeks for subjects who are negative HBsAg but positive HBsAb and/or 
positive HBcAb with Hepatitis B virus DNA <2.1 log copies/mL [20IU/mL] at screening. 
8.4.5.1 
Estimated Glomerular Filtration Rate (eGFR) 
Glomerular filtration rate will be estimated using the Modification of Diet in Renal Disease 
(MDRD) equation at screening. 
The MDRD equation is as follows:45 
 
eGFR = 175 × standardized SCr−1.154 × age−0.203 × 1.212 [if black] or 0.742 [if female] 
Note: GFR is expressed as mL/min/1.73 m2 of body surface area and SCr (serum creatinine) is expressed in mg/dL. 
Subjects with an eGFR <45 mL/min will be excluded from participation 
8.4.6 
Depression Monitoring 
Depression will be monitored by administration of the eight-item Patient Health Questionnaire 
(PHQ-8) at Screening and during visits as outlined in Section 1.2. 
8.4.6.1 
Eight-Item Patient Health Questionnaire (PHQ-8) 
The PHQ-8 is established as a valid diagnostic and severity measure for depressive disorders in 
large clinical studies.46 Each of the 8 questions is based on a 2-week recall and scored on a scale 
of 0 to 3 by a tick box as: Not at All, Several Days, More than Half the Days, and Nearly Every 
Day. A score of ≥10 is suggestive of moderate depressive symptoms (APPENDIX 24).47 If a 
subject scores ≥ 15 on the PHQ-8 during the study, the investigator will review the situation and 
refer the subject to a mental health professional if deemed necessary. 
8.4.7 
Suicidal Ideation and Behavior Monitoring 
Subjects in this clinical trial will be monitored for SIB by the eC-SSRS (Section 8.4.7.1) at the 
visits outlined in the Schedule of Activities (Section 1.2). Subjects who answer yes to questions 4 
or 5 which indicates a suicidal ideation severity level of 4 or 5 or document suicidal behavior or 
suicidal attempts on the eC-SSRS will have their treatments discontinued and be immediately 
referred to a mental health professional for further evaluation. In addition, family members or 
caregivers of the subjects will be instructed to immediately report any suicidal ideation, suicidal 
behavior, or suicide attempt to the investigator. 
8.4.7.1 
electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) 
The eC-SSRS is a computer-automated, patient reported version of the C-SSRS instrument that 
defines 11 categories of SIB events.48-50 The categories are as follows: 
x Suicidal ideation 
1. Passive 
2. Active: Nonspecific (no method, intent, or plan) 
3. Active: Method, but no intent or plan 
4. Active: Method and intent, but no plan 
5. Active: Method, intent, and plan 
x Suicidal behavior 
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1. Completed suicide 
2. Suicide attempt 
3. Interrupted attempt 
4. Aborted attempt 
5. Preparatory actions toward imminent suicidal behaviors 
x Self-injurious behavior, no suicidal intent 
Definitions of these categories can be found in APPENDIX 25.51 
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8.8 
Health Economics OR Medical Resource Utilization and Health 
Economics 
Health Economics/Medical Resource Utilization and Health Economics parameters will not be 
evaluated in this study. 
9 
STATISTICAL CONSIDERATIONS 
9.2 
Populations for Analyses 
For purposes of analysis, the following analysis sets will be used in this trial: 
Enrolled Population: All subjects who sign informed consent. 
As-treated Population: All enrolled subjects who took at least one dose of study treatment. 
Plaque Psoriasis (PP) Population: Subgroup of the As-treated population with plaque psoriasis 
per the inclusion criteria. 
Generalized Pustular Psoriasis (GPP) Population: Subgroup of the As-treated population with 
generalized pustular psoriasis per the inclusion criteria. 
Erythrodermic Psoriasis (EP) Population: Subgroup of the As-treated population with 
erythrodermic psoriasis per the inclusion criteria.  
9.3 
Endpoints  
9.3.1 
Primary Endpoints 
x sPGA 0/1 response assessed as a proportion of subjects with a sPGA score of 0 or 1 at 
Week 16 
x PASI 75 response assessed as a proportion of subjects who achieve a 75% improvement 
from baseline in the PASI score at Week 16 
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9.4 
Efficacy Analyses 
As this is a single-arm study, no statistical tests for treatment comparisons will be conducted. 
Categorical data will be summarized as frequency counts and percentages. Continuous data will 
be summarized using n, mean, standard deviation, median, minimum, and maximum unless 
otherwise specified. Efficacy variables will be summarized for all visits in which the variable is 
assessed. Complete details of the planned analyses will be documented in the statistical analysis 
plan and finalized before database lock. Summaries will be provided for plaque psoriasis 
(including psoriatic arthritis), generalized pustular psoriasis, and erythrodermic psoriasis subjects 
separately. 
 
 
9.5 
Safety Analyses 
Safety data will be analyzed for AEs, SAEs, laboratory analytes, vital signs, ECGs, and suicidality 
and depression. Safety will be summarized using the As-treated population. Categorical data will 
be summarized as frequency counts and percentages. Continuous data will be summarized using 
n, mean, standard deviation, median, minimum, and maximum unless otherwise specified.  
Additionally, safety data from the IM011-046 Japan subgroup will be integrated with safety data 
from IM011066 for descriptive summaries. Full details will be provided in the statistical analysis 
plan. 
9.5.1 
Adverse Events 
Treatment-emergent adverse events (TEAEs), SAEs and deaths, AEs leading to study treatment 
discontinuation, AEs by maximum severity, and AEs by relationship will be summarized by the 
MedDRA system organ class and preferred term. All TEAEs as well as each AE-adjudicated 
category (ie, infections, cardiovascular, and SIB) will also be summarized by preferred term sorted 
by decreasing frequency.  
9.5.2 
Vital Signs and ECGs 
Vital signs and ECGs will be summarized as raw, change from baseline, and change from 
maximum postbaseline value. Incidence of abnormal ECG findings will also be summarized. 
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9.5.3 
Clinical Laboratory Tests 
Laboratory analytes will be summarized as raw, change from baseline, and change from maximum 
postbaseline value. Incidence of abnormal, high, or low values will be summarized. 
9.5.4 
Suicidality and Depression Assessments 
Suicidality and depression will be assessed using eC-SSRS and PHQ-8. Data will be summarized, 
as applicable. 
9.6 
Other Analyses 
9.6.1 
Demographics and Baseline Data 
Demographics and baseline data will be summarized using the As-treated population. Categorical 
data will be summarized as frequency counts and percentages. Continuous data will be 
summarized using n, mean, standard deviation, median, minimum, and maximum unless otherwise 
specified. 
9.6.2 
Prior and Concomitant Medications 
Prior and concomitant medications, categorized by medication group and subgroup according to 
the WHO Drug Dictionary, will be summarized for the As-treated population. Medications with 
an end date prior to the first dose of study drug will be considered prior medications. 
9.7 
Interim Analysis  
No interim analysis is currently planned. 
 
 
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10 
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Parisi R, Symmons DP, Griffiths CE, et al. Global epidemiology of psoriasis: a systematic 
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Kupetsky EA, Keller M. Psoriasis vulgaris: an evidence-based guide for primary care. J 
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Global Report on Psoriasis. World Health Organization. Published 2016.  
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Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and 
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Mrowietz U, Kragballe K, Reich K, et al. Definition of treatment goals for moderate to 
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Mehta NN, Azfar RS, Shin DB, et al. Patients with severe psoriasis are at increased risk of 
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18. 
Siliq (brodalumab) [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North 
America LLC; 2017. 
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Armstrong AW, Robertson AD, Wu J, et al. Undertreatment, treatment trends, and 
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in Psoriasis. N Engl J Med 2018;379(14):1313-21. 
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Watford WT, Hissong BD, Bream JH, et al. Signaling by IL-12 and IL-23 and the 
immunoregulatory roles of STAT4. Immunol Rev 2004;202:139-56. 
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Tokarski JS, Zupa-Fernandez A, Tredup JA, et al. Tyrosine kinase 2-mediated signal 
transduction in T lymphocytes is blocked by pharmacological stabilization of its 
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Shaw MH, Boyartchuk V, Wong S, et al. A natural mutation in the Tyk2 pseudokinase 
domain underlies altered susceptibility of B10.Q/J mice to infection and autoimmunity. 
Proc Natl Acad Sci U S A 2003;100(20):11594-9. 
 
 
 
 
 
25. 
Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis 
2005;64 Suppl 2:ii65-8; discussion ii9-73. 
26. 
Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. 
Dermatologica 1978;157(4):238-44. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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44. 
Husni ME, Meyer KH, Cohen DS, et al. The PASE questionnaire: pilot-testing a psoriatic 
arthritis screening and evaluation tool. J Am Acad Dermatol 2007;57(4):581-7. 
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45. 
Levey AS, Coresh J, Greene T, et al. Using standardized serum creatinine values in the 
modification of diet in renal disease study equation for estimating glomerular filtration rate. 
Ann Intern Med 2006;145(4):247-54. 
46. 
Kroenke K, Strine TW, Spitzer RL, et al. The PHQ-8 as a measure of current depression 
in the general population. J Affect Disord 2009;114(1-3):163-73. 
47. 
Dhingra SS, Kroenke K, Zack MM, et al. PHQ-8 Days: a measurement option for DSM-5 
Major Depressive Disorder (MDD) severity. Popul Health Metr 2011;9:11. 
48. 
Draft Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of 
Occurrence in Clinical Trials. U.S. Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research. Draft August 2012. 
Publication UCM225130. 
49. 
Greist JH, Mundt JC, Gwaltney CJ, et al. Predictive value of baseline electronic Columbia-
Suicide Severity Rating Scale (eC-SSRS) assessments for identifying risk of prospective 
reports of suicidal behavior during research participation. Innov Clin Neurosci 2014;11(9-
10):23-31. 
50. 
Mundt JC, Greist JH, Jefferson JW, et al. Prediction of suicidal behavior in clinical research 
by lifetime suicidal ideation and behavior ascertained by the electronic Columbia-Suicide 
Severity Rating Scale. J Clin Psychiatry 2013;74(9):887-93. 
51. 
Posner K, Oquendo MA, Gould M, et al. Columbia Classification Algorithm of Suicide 
Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk 
analysis of antidepressants. Am J Psychiatry 2007;164(7):1035-43. 
 
 
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11 
APPENDICES 
APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS .............................................83 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS ......................................88 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP AND REPORTING ...............................96 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION ............................................100 
APPENDIX 5 
STATIC PHYSICIAN’S GLOBAL ASSESSMENT OF 
PSORIASIS (sPGA) ................................................................................104 
APPENDIX 6 
PSORIASIS AREA AND SEVERITY INDEX (PASI) ..........................105 
APPENDIX 13 
Classification Criteria for Psoriatic Arthritis (CASPAR) ........................113 
 
 
 
APPENDIX 17 
JDA criteria for Severity assessment of pustular psoriasis 
(generalized psoriasis) .............................................................................118 
APPENDIX 23 
PSORIATIC ARTHRITIS SCREENING AND EVALUATION 
(PASE) QUESTIONNAIRE ....................................................................130 
APPENDIX 24 
EIGHT-ITEM PATIENT HEALTH QUESTIONNAIRE (PHQ-8) ........131 
APPENDIX 25 
SUICIDAL IDEATION AND BEHAVIOR CATEGORIES AND 
DEFINITIONS .........................................................................................132 
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APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS 
Term 
Definition 
ACR 
American College of Rheumatology 
 
 
 
 
AE 
adverse event 
AEI 
Adverse event of interest 
ALT 
alanine aminotransferase 
Anti-HCV ab 
hepatitis C virus antibody 
AST 
aspartate aminotransferase 
 
 
 
 
BID 
twice daily 
BMS 
Bristol-Myers Squibb 
 
 
BID 
twice daily 
BMS 
Bristol-Myers Squibb 
BP 
blood pressure 
BSA 
body surface area 
BUN 
Blood urea nitrogen 
 
 
CASPAR 
Classification Criteria for Psoriatic Arthritis 
CBC 
complete blood count 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
 
 
 
 
CK 
creatine phosphokinase 
CRF 
case report form 
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Term 
Definition 
CSR 
clinical study report 
 
 
CT 
Computed tomography 
CTA 
clinical trial agreement 
 
 
 
  
 
 
 
 
 
 
DILI 
drug-induced liver injury 
DLQI 
Dermatology Life Quality Index 
DNA 
deoxyribonucleic acid 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
eC-SSRS 
electronic Columbia-Suicide Severity Rating 
Scale 
eGFR 
Estimated Glomerular Filtration Rate 
EHR 
electronic health records 
EMR 
electronic medical records 
EP 
Erythrodermic psoriasis 
 
 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
 
 
GPP 
Generalized pustular psoriasis 
 
 
 
 
 
HBcAb 
hepatitis B core antibody 
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Term 
Definition 
HbsAb 
hepatitis B surface antibody 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus  
hCG 
human chorionic gonadotropin 
Hct 
hematocrit 
HCV 
hepatitis C virus 
HDL 
High Density Lipoprotein 
Hgb 
hemoglobin 
HIPAA 
Health Insurance Portability and 
Accountability Act of 1996 
HIV 
human immunodeficiency virus 
HRT 
hormone replacement therapy 
 
 
IB 
Investigator Brochure 
 
 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
IFN 
interferon 
IgG 
immunoglobulin gamma 
IGRA 
interferon gamma release assay 
IL 
interleukin 
IMP 
investigational medicinal product 
IP 
investigational product  
IRB 
Institutional Review Board 
IRT 
interactive response technology 
IV 
intravenous 
JAK 
Janus kinase 
JDA 
Japanese Dermatological Association 
LAM 
lactation amenorrhea method 
LDH 
lactate dehydrogenase  
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Term 
Definition 
LDL 
low density lipoprotein  
LTBI 
latent tuberculosis infection 
 
 
 
 
 
 
 
 
 
 
PASE 
psoriatic arthritis screening and evaluation 
PASI 
Psoriasis Area and Severity Index 
PCR 
Polymerase Chain Reaction 
PD 
pharmacodynamics 
PE 
physical examination 
PCP 
phencyclidine 
PHQ-8 
Eight-Item Patient Health Questionnaire 
PK 
pharmacokinetics 
 
 
 
 
 
PRO 
patient reported outcome 
PsA 
psoriatic arthritis 
 
 
 
 
 
 
PUVA 
Psoralens with ultraviolet A  
QD  
once daily 
QOD 
every other day 
RNA 
ribonucleic acid  
SAE 
serious adverse event 
 
 
SIB 
Suicidal Ideation and Behavior 
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Term 
Definition 
SOA 
schedule of events 
sPGA 
static Physician Global Assessment 
 
 
STAT 
signal transducer and activator of 
transcription 
SUSAR 
Suspected, Unexpected Serious Adverse 
Reaction 
T3 
Triiodothyronine 
T4 
Thyroxine 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
 
 
 
TSH 
thyroid-stimulating hormone 
TNF 
tumor necrosis factor  
TYK2 
tyrosine kinase 2 
ULN 
upper limit of normal 
UVB 
ultraviolet B 
 
 
WOCBP 
women of childbearing potential 
WHO 
World Health Organization 
 
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APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS 
Regulatory and Ethical Considerations 
Good Clinical Practice 
This study will be conducted in accordance with: 
x Good Clinical Practice (GCP) 
x as defined by the International Council on Harmonisation (ICH) 
x in accordance with the ethical principles underlying European Union Directive 2001/20/EC 
x United States Code of Federal Regulations, Title 21, Part 50 (21CFR50)  
x applicable local requirements. 
The study will be conducted in compliance with the protocol. The protocol and any amendments 
and the subject informed consent will receive approval/favorable opinion by Institutional Review 
Board/Independent Ethics Committee (IRB/IEC), and regulatory authorities according to 
applicable local regulations prior to initiation of the study. 
All potential serious breaches must be reported to Sponsor or designee immediately. A serious 
breach is a breach of the conditions and principles of GCP in connection with the study or the 
protocol, which is likely to affect, to a significant degree, the safety or physical or mental integrity 
of the subjects of the study or the scientific value of the study. 
Personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks. 
This study will not use the services of study personnel where sanctions have been invoked or where 
there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment).  
Institutional Review Board/Independent Ethics Committee 
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, consent form, subject recruitment materials 
(eg, advertisements), and any other written information to be provided to subjects. The investigator 
or BMS should also provide the IRB/IEC with a copy of the Investigator Brochure or product 
labeling information to be provided to subjects and any updates.  
The investigator, Sponsor or designee should provide the IRB/IEC with reports, updates and other 
information (eg, expedited safety reports, amendments, and administrative letters) according to 
regulatory requirements or institution procedures. 
Compliance with the Protocol and Protocol Revisions 
The investigator should not implement any deviation or change to the protocol without prior 
review and documented approval/favorable opinion of an amendment from the IRB/IEC (and if 
applicable, also by local health authority) except where necessary to eliminate an immediate 
hazard(s) to study subjects.  
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If a deviation or change to a protocol is implemented to eliminate an immediate hazard(s) prior to 
obtaining relevant approval/favorable opinion(s) the deviation or change will be submitted, as soon 
as possible to: 
x IRB/IEC for  
x Regulatory Authority(ies), if applicable by local regulations (per national requirements) 
Documentation of approval/favorable opinion signed by the chairperson or designee of the 
IRB(s)/IEC(s) and if applicable, also by local health authority must be sent to BMS. 
If an amendment substantially alters the study design or increases the potential risk to the subject: 
(1) the consent form must be revised and submitted to the IRB(s)/IEC(s) for review and 
approval/favorable opinion; (2) the revised form must be used to obtain consent from subjects 
currently enrolled in the study if they are affected by the amendment; and (3) the new form must 
be used to obtain consent from new subjects prior to enrollment. 
If the revision is done via an administrative letter, investigators must inform their IRB(s)/IEC(s). 
Financial Disclosure 
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate financial 
information in accordance with local regulations to allow the Sponsor to submit complete and 
accurate financial certification or disclosure statements to the appropriate health authorities. 
Investigators are responsible for providing information on financial interests during the course of 
the study and for 1 year after completion of the study. 
Informed Consent Process 
Investigators must ensure that subjects are clearly and fully informed about the purpose, potential 
risks, and other critical issues regarding clinical studies in which they volunteer to participate.  
In situations where consent cannot be given to subjects, their legally acceptable representatives (as 
per country guidelines) are clearly and fully informed about the purpose, potential risks, and other 
critical issues regarding clinical studies in which the subject volunteers to participate.  
Sponsor or designee will provide the investigator with an appropriate (ie, Global or Local) sample 
informed consent form which will include all elements required by ICH, GCP, and applicable 
regulatory requirements. The sample informed consent form will adhere to the ethical principles 
that have their origin in the Declaration of Helsinki. 
Investigators must: 
x Provide a copy of the consent form and written information about the study in the language in 
which the subject is most proficient prior to clinical study participation. The language must be 
non-technical and easily understood.  
x Allow time necessary for subject or subject's legally acceptable representative to inquire about 
the details of the study. 
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x Obtain an informed consent signed and personally dated by the subject or the subject's legally 
acceptable representative and by the person who conducted the informed consent discussion.  
x Obtain the IRB/IEC’s written approval/favorable opinion of the written informed consent form 
and any other information to be provided to the subjects, prior to the beginning of the study, 
and after any revisions are completed for new information. 
If informed consent is initially given by a subject’s legally acceptable representative or legal 
guardian, and the subject subsequently becomes capable of making and communicating his or her 
informed consent during the study, consent must additionally be obtained from the subject. 
Revise the informed consent whenever important new information becomes available that is 
relevant to the subject's consent. The investigator, or a person designated by the investigator, 
should fully inform the subject or the subject's legally acceptable representative or legal guardian, 
of all pertinent aspects of the study and of any new information relevant to the subject's willingness 
to continue participation in the study. This communication should be documented.  
The confidentiality of records that could identify subjects must be protected, respecting the privacy 
and confidentiality rules applicable to regulatory requirements, the subjects' signed ICF and, in the 
US, the subjects’ signed HIPAA Authorization. 
The consent form must also include a statement that BMS and regulatory authorities have direct 
access to subject records. 
For minors, according to local legislation, one or both parents or a legally acceptable representative 
must be informed of the study procedures and must sign the informed consent form approved for 
the study prior to clinical study participation. The explicit wish of a minor, who is capable of 
forming an opinion and assessing this information to refuse participation in, or to be withdrawn 
from, the clinical study at any time should be considered by the investigator.  
Minors who are judged to be of an age of reason must also give their written assent. 
Subjects unable to give their written consent (eg, stroke or subjects with or severe dementia) may 
only be enrolled in the study with the consent of a legally acceptable representative. The subject 
must also be informed about the nature of the study to the extent compatible with his or her 
understanding, and should this subject become capable, he or she should personally sign and date 
the consent form as soon as possible. The explicit wish of a subject who is unable to give his or 
her written consent, but who is capable of forming an opinion and assessing information to refuse 
participation in, or to be withdrawn from, the clinical study at any time should be considered by 
the investigator. 
The rights, safety, and well-being of the study subjects are the most important considerations and 
should prevail over interests of science and society. 
Source Documents 
The investigator is responsible for ensuring that the source data are accurate, legible, 
contemporaneous, original, and attributable, whether the data are hand-written on paper or entered 
electronically. If source data are created (first entered), modified, maintained, archived, retrieved, 
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or transmitted electronically via computerized systems (and/or any other kind of electronic 
devices) as part of regulated clinical trial activities, such systems must be compliant with all 
applicable laws and regulations governing use of electronic records and/or electronic signatures. 
Such systems may include, but are not limited to, electronic medical/health records (EMRs/EHRs), 
adverse event tracking/reporting, protocol required assessments, and/or drug accountability 
records). 
When paper records from such systems are used in place of electronic format to perform regulated 
activities, such paper records should be certified copies. A certified copy consists of a copy of 
original information that has been verified, as indicated by a dated signature, as an exact copy 
having all of the same attributes and information as the original.  
Study Treatment Records 
Records for study treatments (whether supplied by BMS, its vendors, or the site) must substantiate 
study treatment integrity and traceability from receipt, preparation, administration, and through 
destruction or return. Records must be made available for review at the request of BMS/designee 
or a health authority. 
If 
Then 
Supplied by BMS (or its vendors): 
Records or logs must comply with applicable 
regulations and guidelines and should include: 
x amount received and placed in storage area 
x amount currently in storage area 
x label identification number or batch 
number 
x amount dispensed to and returned by each 
subject, 
including 
unique 
subject 
identifiers 
x amount transferred to another area/site for 
dispensing or storage 
x nonstudy disposition (eg, lost, wasted)  
x amount destroyed at study site, if 
applicable 
x amount returned to BMS 
x retain 
samples 
for 
bioavailability/bioequivalence, 
if 
applicable  
x dates and initials of person responsible for 
Investigational 
Product 
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If 
Then 
dispensing/accountability, 
as 
per 
the 
Delegation of Authority Form. 
Sourced by site, and not supplied by BMS or 
its vendors (examples include IP sourced from 
the sites stock or commercial supply, or a 
specialty pharmacy) 
The 
investigator 
or 
designee 
accepts 
responsibility for documenting traceability and 
study treatment integrity in accordance with 
requirements applicable under law and the 
SOPs/standards of the sourcing pharmacy.   
These records should include: 
x label identification number or batch 
number  
x amount dispensed to and returned by each 
subject, 
including 
unique 
subject 
identifiers 
x dates and initials of person responsible for 
Investigational 
Product 
dispensing/accountability, 
as 
per 
the 
Delegation of Authority Form. 
BMS or designee will provide forms to facilitate inventory control if the investigational site does not have an 
established system that meets these requirements. 
 
Case Report Forms 
An investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the CRF must be consistent with the source documents or the discrepancies must be 
explained. Additional clinical information may be collected and analyzed in an effort to enhance 
understanding of product safety. CRFs may be requested for AEs and/or laboratory abnormalities 
that are reported or identified during the course of the study. 
For sites using the Sponsor or designee electronic data capture tool, electronic CRFs will be 
prepared for all data collection fields except for fields specific to SAEs and pregnancy, which will 
be reported on the electronic SAE form and paper Pregnancy Surveillance Form, respectively. If 
electronic SAE form is not available, a paper SAE form can be used. 
The confidentiality of records that could identify subjects must be protected, respecting the privacy 
and confidentiality rules in accordance with the applicable regulatory requirement(s). 
The investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on CRFs.  
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The completed CRF, SAE/pregnancy CRFs, must be promptly reviewed, signed, and dated by the 
investigator or qualified physician who is a subinvestigator and who is delegated this task on the 
Delegation of Authority Form. Sub-investigators in Japan may not be delegated the CRF approval 
task. For electronic CRFs, review and approval/signature is completed electronically through the 
electronic data capture tool. The investigator must retain a copy of the CRFs including records of 
the changes and corrections. 
Each individual electronically signing electronic CRFs must meet Sponsor or designee training 
requirements and must only access the electronic data capture tool using the unique user account 
provided by Sponsor or designee. User accounts are not to be shared or reassigned to other 
individuals 
Monitoring 
Sponsor or designee representatives will review data centrally to identify potential issues to 
determine a schedule of on-site visits for targeted review of study records.  
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable. Certain CRF pages and/or electronic files may serve as the source 
documents. 
In addition, the study may be evaluated by Sponsor or designee internal auditors and government 
inspectors who must be allowed access to CRFs, source documents, other study files, and study 
facilities. BMS audit reports will be kept confidential. 
The investigator must notify BMS promptly of any inspections scheduled by regulatory authorities, 
and promptly forward copies of inspection reports to Sponsor or designee.  
Records Retention 
The investigator (or head of the study site in Japan) must retain all study records and source 
documents for the maximum period required by applicable regulations and guidelines, or 
institution procedures, or for the period specified by BMS or designee, whichever is longer. The 
investigator (or head of the study site in Japan) must contact BMS prior to destroying any records 
associated with the study. 
BMS or designee will notify the investigator (or head of the study site in Japan) when the study 
records are no longer needed. 
If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed upon designee (eg, another investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or designee.  
 
Return of Study Treatment 
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For this study, study treatments (those supplied by BMS, a vendor or sourced by the investigator) 
such as partially used study treatment containers, vials and syringes may be destroyed on site.  
If 
Then 
Study treatments supplied by BMS (including 
its vendors) 
Any unused study treatments supplied by BMS 
can only be destroyed after being inspected and 
reconciled by the responsible Study Monitor 
unless study treatments containers must be 
immediately destroyed as required for safety, 
or to meet local regulations (eg, cytotoxics or 
biologics). 
If study treatments will be returned, the return 
will be arranged by the responsible Study 
Monitor. 
Study treatments sourced by site, not supplied 
by BMS (or its vendors) (examples include 
study treatments sourced from the sites stock 
or 
commercial 
supply, 
or 
a 
specialty 
pharmacy) 
It 
is 
the 
investigator’s 
or 
designee’s 
responsibility to dispose of all containers 
according to the institutional guidelines and 
procedures. 
 
It is the investigator’s or designee’s responsibility to arrange for disposal, provided that procedures 
for proper disposal have been established according to applicable federal, state, local, and 
institutional guidelines and procedures, and provided that appropriate records of disposal are kept. 
The following minimal standards must be met: 
x On-site disposal practices must not expose humans to risks from the drug. 
x On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances. 
x Written procedures for on-site disposal are available and followed. The procedures must be 
filed with the site’s SOPs and a copy provided to BMS upon request. 
x Records are maintained that allow for traceability of each container, including the date 
disposed of, quantity disposed, and identification of the person disposing the containers. The 
method of disposal, ie, incinerator, licensed sanitary landfill, or licensed waste disposal vendor 
must be documented. 
x Accountability and disposal records are complete, up-to-date, and available for the Monitor to 
review throughout the clinical trial period. 
It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers. 
If conditions for destruction cannot be met the responsible Study Monitor will make arrangements 
for return of study treatments provided by BMS (or its vendors). Destruction of non-study 
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treatments sourced by the site, not supplied by BMS, is solely the responsibility of the investigator 
or designee. 
Clinical Study Report and Publications 
A Signatory Investigator must be selected to sign the clinical study report. 
For this protocol, the Signatory Investigator will be selected as appropriate based on the following 
criteria: 
x External Principal Investigator designated at protocol development 
x National Coordinating Investigator  
x Study Steering Committee chair or their designee 
x Subject recruitment (eg, among the top quartile of enrollers) 
x Involvement in trial design 
x Regional representation (eg, among top quartile of enrollers from a specified region or country) 
x Other criteria (as determined by the study team) 
The data collected during this study are confidential and proprietary to Sponsor or designee. Any 
publications or abstracts arising from this study must adhere to the publication requirements set 
forth in the clinical trial agreement (CTA) governing study site or investigator participation in the 
study. These requirements include, but are not limited to, submitting proposed publications to 
Sponsor or designee at the earliest practicable time prior to submission or presentation and 
otherwise within the time period set forth in the CTA. 
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APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP AND REPORTING 
Adverse Events 
Adverse Event Definition: 
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 study drug, whether or not 
considered related to the study drug. 
Events Meeting the AE Definition 
x Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
results from other safety assessments (eg, ECG, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically 
significant in the medical and scientific judgment of the investigator. Note that 
abnormal lab tests or other safety assessments should only be reported as AEs if the 
final diagnosis is not available. Once the final diagnosis is known, the reported term 
should be updated to be the diagnosis.  
x Exacerbation of a chronic or intermittent preexisting condition including either an 
increase in frequency and/or intensity of the condition. 
x New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study. 
x Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
x Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose, as a verbatim term (as reported by 
the investigator), should not be reported as an AE/SAE unless it is an intentional 
overdose taken with possible suicidal/self-harming intent. Such overdoses should be 
reported regardless of sequelae and should specify "intentional overdose" as the 
verbatim term. 
Events NOT Meeting the AE Definition 
x Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads 
to the procedure is the AE. 
x Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
DEFINITION OF SAE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met. 
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SERIOUS ADVERSE EVENTS 
Serious Adverse Event Definition: 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) 
Note: The following hospitalizations are not considered SAEs in BMS clinical studies:  
x 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-threatening event) 
x elective surgery, planned prior to signing consent 
x admissions as per protocol for a planned medical/surgical procedure 
x routine health assessment requiring admission for baseline/trending of health status 
(eg, routine colonoscopy) 
x medical/surgical admission other than to remedy ill health and planned prior to entry 
into the study. Appropriate documentation is required in these cases. 
x 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) 
x 
admission for administration of anticancer therapy in the absence of any other SAEs 
(applies to oncology protocols) 
Results in persistent or significant disability or permanent damage 
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 participant 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. Potential drug-induced liver injury (DILI) is also considered an important 
medical event (see Section 8.2.8 for the definition of potential DILI).  
 
Pregnancy and potential DILI must follow the same transmission timing and processes to BMS as 
used for SAEs (see Section 8.2.5 for reporting pregnancies). 
 
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EVALUATING AES AND SAES 
Assessment of Intensity 
The intensity of AEs is determined by a physician and will use the following levels: 
x Mild: An event that is easily tolerated by the subject, causing minimal discomfort, 
and not interfering with everyday activities. 
x Moderate: An event that causes sufficient discomfort and interferes with normal 
everyday activities. 
x 
Severe: An event that prevents normal everyday activities. An AE that is assessed 
as severe should not be confused with an SAE. Severe is a category utilized for 
rating the intensity of an event; and both AEs and SAEs can be assessed as severe. 
Assessment of Causality 
x The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE. A “reasonable possibility of a relationship” 
conveys that there are facts, evidences, and/or arguments to suggest a causal 
relationship rather than a relationship cannot be ruled out.  
x The investigator will use clinical judgment to determine the relationship. 
x Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated. 
x The investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment. 
x For each AE/SAE, the investigator must document in the medical notes that 
he/she has reviewed the AE/SAE and has provided an assessment of causality. 
x There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to Sponsor. However, it is very 
important that the investigator always make an assessment of causality for every 
event before the initial transmission of the SAE data to Sponsor. 
x The investigator may change his/her opinion of causality in light of follow-up 
information and send a SAE follow-up report with the updated causality 
assessment. 
x 
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
 
 
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Follow-up of AEs and SAEs 
If only limited information is initially available, follow-up reports are required. Note: 
Follow-up SAE reports must 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, the SAE report must be updated and submitted within 
24 hours to BMS (or designee) using the same procedure used for transmitting the initial 
SAE report. 
All SAEs must be followed to resolution or stabilization. 
 
REPORTING OF SAES TO SPONSOR OR DESIGNEE 
SAEs, whether related or not related to study drug, and pregnancies must be reported to 
 Drug Safety within 24 hours of awareness of the event. 
SAEs must be recorded on the SAE Report Form. For studies capturing SAEs through 
electronic data capture , electronic submission is the required method for reporting. In the 
event the electronic system is unavailable for transmission, paper forms must be used and 
submitted immediately. When paper forms are used, the original paper forms are to 
remain on site. 
Pregnancies must be recorded on a paper Pregnancy Surveillance Form and transmitted 
via email or confirmed facsimile (fax) transmission to: 
SAE Email Address: 
 
SAE Fax Number:  
 
Americas: 
 
 
Europe/East Asia Pacific: 
  
SAE Telephone Contact - For questions on SAE/pregnancy reporting, please call:  
 
Americas: 
 
 
Europe/East Asia Pacific: 
 
 
 
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APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION 
DEFINITIONS 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy. 
Women in the following categories are not considered WOCBP 
x Premenarchal 
x Premenopausal female with 1 of the following: 
 Documented hysterectomy 
 Documented bilateral salpingectomy 
 Documented bilateral oophorectomy 
 
Note: Documentation can come from the site personnel’s review of the subject’s medical records, 
medical examination, or medical history interview. 
x Postmenopausal female 
 A postmenopausal state is defined as 12 months of amenorrhea in a woman over age 
45 years in the absence of other biological or physiological causes. In addition, females 
under the age of 55 years must have a serum follicle-stimulating hormone, (FSH) level 
> 40 mIU/mL to confirm menopause. 
 
Note: Females treated with hormone replacement therapy (HRT) are likely to have artificially 
suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH 
level. The duration of the washout period is a function of the type of HRT used. The duration of 
the washout period below are suggested guidelines and the investigators should use their judgment 
in checking serum FSH levels.  
x 1 week minimum for vaginal hormonal products (rings, creams, gels) 
x 4 week minimum for transdermal products 
x 8 week minimum for oral products 
Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/ml at any time during the washout period, the woman can be considered 
postmenopausal. 
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CONTRACEPTION GUIDANCE FOR FEMALE SUBJECTS OF CHILD BEARING 
POTENTIAL 
One of the highly effective methods of contraception listed below is required during study duration 
and until the end of relevant systemic exposure, defined as 3 days after the end of study treatment, 
plus 30 days. 
Local laws and regulations may require use of alternative and/or additional contraception methods. 
Highly Effective Contraceptive Methods That Are User Dependent  
Failure rate of <1% per year when used consistently and correctly.a  
x Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulationb  
 oral  
 intravaginald  
 transdermald 
x Progestogen-only hormonal contraception associated with inhibition of ovulationb  
 oral  
 injectabled  
Highly Effective Methods That Are User Independent  
x Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulationbd 
x Intrauterine devicecd  
x Intrauterine hormone-releasing systemcd 
x Bilateral tubal occlusion 
x Vasectomized partner  
A vasectomized partner is a highly effective contraception method provided that the partner is 
the sole male sexual partner of the WOCBP and the absence of sperm has been confirmed. If 
not, an additional highly effective method of contraception should be used.  
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x Sexual abstinence  
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study treatment. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study 
and the preferred and usual lifestyle of the subject. 
x It is not necessary to use any other method of contraception when complete abstinence is 
elected.  
x WOCBP subjects who choose complete abstinence must continue to have pregnancy tests, 
as specified in Section 5.1.  
x Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP subjects chooses to forego complete abstinence.  
NOTES:  
a 
Typical use failure rates may differ from those when used consistently and correctly. Use 
should be consistent with local regulations regarding the use of contraceptive methods for 
subjects participating in clinical studies.  
b 
Hormonal contraception may be susceptible to interaction with the study treatment, 
which may reduce the efficacy of the contraceptive method. Hormonal contraception is 
permissible only when there is sufficient evidence that the IMP and other study medications will 
not alter hormonal exposures such that contraception would be ineffective or result in increased 
exposures that could be potentially hazardous. In this case, alternative methods of contraception 
should be utilized.  
c 
Intrauterine devices and intrauterine hormone-releasing systems are acceptable methods 
of contraception in the absence of definitive drug interaction studies when hormone exposures 
from intrauterine devices do not alter contraception effectiveness. 
d                These methods are not approved nor certified in Japan. 
 
Less Than Highly Effective Contraceptive Methods That Are User Dependent  
Failure rate of >1% per year when used consistently and correctly. 
x Male condom with spermicidea or male condom without spermicide or male condom applied 
spermicide 
x Female condom with spermicidea or without spermicidea 
x Diaphragm with spermicidea 
x Cervical cap with spermicidea 
x Vaginal Sponge with spermicidea 
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x Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action 
Unacceptable Methods of Contraception 
x Periodic abstinence (calendar, symptothermal, post-ovulation methods) 
x Withdrawal(coitus interruptus). 
x Spermicide only 
x Lactation amenorrhea method (LAM) 
 
CONTRACEPTION GUIDANCE FOR MALE SUBJECTS WITH PARTNER(S) OF 
CHILD BEARING POTENTIAL. 
Male subjects with female partners of childbearing potential are eligible to participate if they agree 
to the following during the treatment and until the end of relevant systemic exposure. 
x Inform any and all partner(s) of their participation in a clinical drug study and the need to 
comply with contraception instructions as directed by the investigator. 
x Male subjects are required to use a condom for study duration and until the end of relevant 
systemic exposure defined as 3 days after the end of treatment in the male subject. 
x Female partners of males participating in the study to consider use of effective methods of 
contraception until the end of relevant systemic exposure, defined as 3 days after the end of 
treatment in the male subject. 
x Male subjects with a pregnant or breastfeeding partner must agree to remain abstinent from 
penile vaginal intercourse or use a male condom during each episode of penile penetration 
during the treatment and until 3 days after the end of treatment.  
x Refrain from donating sperm for the duration of the study treatment and for 3 days after the 
end of treatment. 
 
COLLECTION OF PREGNANCY INFORMATION 
Guidance for collection of Pregnancy Information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 8.2.5 and APPENDIX 3.
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APPENDIX 5 
STATIC PHYSICIAN’S GLOBAL ASSESSMENT OF PSORIASIS 
(sPGA) 
The static PGA is used to determine the subject’s psoriasis lesions overall at a given time point. 
Overall lesions will be graded for erythema, induration, and scaling based on the scales below. 
The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA 
score. 
 
Characteristics 
Score 
Rating Score 
Erythema (E) 
(averaged over the whole body)  
0 = No evidence of erythema, but post inflammatory 
hyper/hypopigmentation changes may be present 
1 = Faint erythema 
2 = Light red coloration 
3 = Moderate red coloration  
4 = Bright red coloration 
Induration (I) 
(averaged over the whole body)  
0 = No evidence of plaque elevation 
1 = Minimal plaque elevation, barely palpable, = 0.25 mm 
2 = Mild plaque elevation, slight but definite 
elevation, indistinct edge, = 0.5 mm 
3 = Moderate plaque elevation, elevated with distinct edges, 
= 0.75 mm 
4 = Severe plaque elevation, hard/sharp 
borders, ≥ 1 mm 
Scaling (S) 
(averaged over the whole body)  
0 = No evidence of scaling 
1 = Minimal; occasional fine scaling 
2 = Mild; fine scale dominates 
3 = Moderate; coarse scale predominates 
4 = Severe; thick scale predominates 
 
E + I + S = / 3 = (Total Average) 
 
Physician’s Static Global Assessment based upon above Total Average  
 
0 = Clear, except for residual discoloration  
1 = Almost clear -majority of lesions have individual scores for E + I + S / 3 that averages 1  
2 = Mild -majority of lesions have individual scores for E + I + S / 3 that averages 2  
3 = Moderate -majority of lesions have individual scores for E + I + S / 3 that averages 3  
4 = Severe -majority of lesions have individual scores for E + I + S / 3 that averages 4  
 
Note: Scores should be rounded to the nearest whole number. If total ≤ 1.49, score = 1; if total 
≥ 1.50, score = 2.
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APPENDIX 6 
PSORIASIS AREA AND SEVERITY INDEX (PASI) 
Psoriasis Area and Severity Index (PASI); a quantitative rating scale for measuring the 
severity of psoriatic lesions based on area coverage and plaque appearance. Please 
complete all sections of the table and shade in the affected areas on the body diagrams 
below. 
 
 
Plaque Characteristic 
Rating score 
Body region (and weighting factor) 
Head 
Upper Extremities 
Trunk 
Lower Extremities 
Erythema (Redness) 
0 = None 
1 = Slight 
2 = Moderate 
3 = Severe 
4 = Very severe 
 
Infiltration (Thickness) 
 
Desquamation (Scaling) 
 
Add together each of the 3 scores for each of the body regions to give 4 separate sub totals. 
Sub Totals A1 = 
A2 = 
A3 = 
A4 = 
Multiply each sub total by amount of body surface area represented by that region ie A1 x 0.1 for head, A2 x 0.2 for upper 
extremities, A3 x 0.3 for trunk, A4 x 0.4 for lower extremities to give a value B1, B2, B3 and B4 for each body region respectively 
 
A1 x 0.1 = B1 
A2 x 0.2 = B2 
A3 x 0.3 = B3 
A4 x 0.4 = B4 
B1 = 
B2 = 
B3 = 
B4 = 
 
Degree of involvement 
as % for each body 
region affected; (score 
each region with score 
between 0-6) 
0 = None 
1 = 1-9 % 
2 = 10-29% 
3 = 30-49% 
4 = 50 -69% 
5 = 70-89% 
6 = 90-100% 
 
For each body region multiply sub total B1, B2, B3 and B4 by the score (0-6) of the % of body region involved to give 4 subtotals 
C1, C2, C3 and C4 
 
B1 x score = C1 
B2 x score = C2 
B3 x score = C3 
B4 x score = C4 
C1 = 
C2 = 
C3 = 
C4 = 
The patient’s PASI score is the sum of C1 + C2 + C3 + C4 
PASI= 
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APPENDIX 13 
CLASSIFICATION CRITERIA FOR PSORIATIC ARTHRITIS 
(CASPAR)  
To meet the CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria, a subject must 
have inflammatory articular disease (joint, spine, or entheseal) with 3 points from the following 5 
categories: 
 
Current psoriasis is assigned 2 points, while all other features are assigned a score of 1. 
1. Evidence of current psoriasis, a personal history of psoriasis, or a family history of psoriasis.  
Current psoriasis is defined as psoriatic skin or scalp disease present today as judged by a 
rheumatologist or dermatologist. A personal history of psoriasis is defined as a history of 
psoriasis that may be obtained from a patient, family physician, dermatologist, rheumatologist, 
or other qualified health care provider. A family history of psoriasis is defined as a history of 
psoriasis in a first-or second-degree relative according to patient report 
2. Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed 
on current physical examination.  
3. A negative test result for the presence of rheumatoid factor by any method except latex but 
preferably by enzyme-linked immunosorbent assay or nephelometry, according to the local 
laboratory reference range. 
4. Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded 
by a rheumatologist. 
5. Radiographic evidence of juxtaarticular new bone formation, appearing as ill-defined 
ossification near joint margins (but excluding osteophyte formation) on plain radiographs of 
the hand or foot. 
 
 
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APPENDIX 17 
JDA CRITERIA FOR SEVERITY ASSESSMENT OF PUSTULAR 
PSORIASIS (GENERALIZED PSORIASIS) 
 
Severity assessment of pustular psoriasis (generalized psoriasis) 
 
A. Evaluation of skin symptoms: 
Erythema, cyst, edema (0 to 9) 
B. Evaluation of systemic symptoms and laboratory findings: 
Pyrexia, WBC count, serum CRP, serum 
albumin (0 to 8) 
○Severity scale: 
Mild 
Moderate 
Severe 
(Total score) 
(0 to 6) 
(7 to 10) 
(11 to 17) 
 
A. Evaluation of skin symptoms (0 to 9) 
 
Severe 
Moderate 
Mild 
None 
Area of erythematous lesion (total)* 
3 
2 
1 
0 
Area of erythematous lesion with pustula ** 
3 
2 
1 
0 
Area of edema lesion** 
3 
2 
1 
0 
*Ratio (%) against the body surface area (Severe: ≥75%, Moderate: ≥25% and <75%, Mild: <25%) 
**Ratio (%) against the body surface area (Severe: ≥50%, Moderate: ≥10% and <50%, Mild: <10%) 
 
B. Evaluation of systemic symptoms and laboratory findings (0 to 8) 
Score 
2 
1 
0 
Pyrexia (°C) 
≥38.5 
≥37 and <38.5 
<37 
WBC count (/mL) 
≥15,000 
≥10,000 and <15,000 
<10,000 
CRP (mg/dL) 
≥7.0 
≥0.3 and <7.0 
<0.3 
Serum albumin (g/dL) 
<3.0 
≥3.0 and <3.8 
≥3.8 
 
 
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APPENDIX 23 
PSORIATIC ARTHRITIS SCREENING AND EVALUATION 
(PASE) QUESTIONNAIRE 
 
PSORIATIC ARTHRITIS SCREENING AND EVALUATION (PASE) 
QUESTIONNAIRE 
 
Please circle or mark ONLY ONE of the five choices on the following 15 questions. The 
answers to these questions will help us better understand your symptoms. This should take about 
5 to 6 minutes to complete. Thank you for your time. 
 
Symptoms sub-scale 
Strongly 
Disagree 
Disagree 
Neutral 
Agree 
Strongly 
Agree 
1. I feel tired for most of the day 
1 
2 
3 
4 
5 
2. My joints hurt 
1 
2 
3 
4 
5 
3.  My back hurts 
1 
2 
3 
4 
5 
4.  My joints become swollen 
1 
2 
3 
4 
5 
5.  My joints feel ‘hot’ 
1 
2 
3 
4 
5 
6.  Occasionally, an entire finger or toe becomes 
swollen, making it look like a ‘sausage’ 
1 
2 
3 
4 
5 
7.  I have noticed that the pain in my joints moves 
from one joint to another, eg my wrist will hurt for a few 
days then my knee will hurt and so on. 
1 
2 
3 
4 
5 
SYMPTOM SCORE (Max 35) 
Add scores for questions 1-7 and write in box A 
A. 
Function sub-scale 
Strongly 
Disagree 
Disagree 
Neutral 
Agree 
Strongly 
Agree 
8.  I feel that my joint problems have affected my 
ability to work 
1 
2 
3 
4 
5 
9.  My joint problems have affected my ability to care 
for myself, eg getting dressed or brushing my teeth 
1 
2 
3 
4 
5 
10.  I have had trouble wearing rings on my fingers or 
my watch 
1 
2 
3 
4 
5 
11.  I have had trouble getting into or out of a car 
1 
2 
3 
4 
5 
12.  I am unable to be as active as I used to be 
1 
2 
3 
4 
5 
13. I feel stiff for more than 2 hours after waking up in 
the morning 
1 
2 
3 
4 
5 
14.  The morning is the worst time of day for me 
1 
2 
3 
4 
5 
15.  It takes me a few minutes to get moving to the best 
of my ability, any time of the day 
1 
2 
3 
4 
5 
FUNCTION SCORE (Max 40) 
Add scores for questions 8-15 and write in box B 
B. 
TOTAL PASE SCORE (Max 75) 
Add scores in boxes A and B and write in box C 
C. 
Approved
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Approved
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APPENDIX 24 
EIGHT-ITEM PATIENT HEALTH QUESTIONNAIRE (PHQ-8) 
 
The eight-item Patient Health Questionnaire depression scale is established as a valid 
self-administered diagnostic and severity measure for depressive disorders. It consists of 8 
different questions, with an answer scale from 0 to 3. The overall score is determined by adding 
up each of the individual answers from each question.  
Scoring interpretation is as follows: 0 to 4 no significant depressive symptoms, 5 to 9 mild 
depressive symptoms, 10 to 14 moderate depressive symptoms, 15 to 19 moderately severe 
depressive symptoms, and 20 to 24 severe depressive symptoms 
 
Over the last 2 weeks, how often have you 
been bothered by any of the following 
problems? 
 
 
Not at all 
Several 
days 
More than 
half the 
days 
Nearly 
every day 
1. Little interest or pleasure in doing things 
0 
1 
2 
3 
2. Feeling down, depressed, or hopeless 
0 
1 
2 
3 
3. Trouble falling or staying asleep, or 
sleeping too much 
0 
1 
2 
3 
4. Feeling tired or having little energy 
0 
1 
2 
3 
5. Poor appetite or over eating 
0 
1 
2 
3 
6. Feeling bad about yourself, or that you 
are a failure, or have let yourself or your 
family down 
0 
1 
2 
3 
7. Trouble concentrating on things, such as 
reading the newspaper, or watching 
television 
0 
1 
2 
3 
8. Moving or speaking so slowly that other 
people could have noticed? Or the 
opposite, being so fidgety or restless that 
you have been moving around a lot more 
than usual 
0 
1 
2 
3 
 
Total Score: 
 
Approved
2.0
v
Approved
1.0
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APPENDIX 25 
SUICIDAL IDEATION AND BEHAVIOR CATEGORIES AND 
DEFINITIONS 
 
Suicidal Ideation 
Passive suicidal ideation: wish to be dead 
Patient has thoughts about a wish to be dead or not alive anymore, or wish to fall asleep 
and not wake up. 
Active suicidal ideation: nonspecific (no method, intent, or plan) 
General nonspecific thoughts of wanting to end one’s life or commit suicide (eg, “I’ve 
thought about killing myself”) without general thoughts of ways to kill oneself/associated 
methods, intent, or plan during the assessment period. 
Active suicidal ideation: method, but no intent or plan 
Patient has thoughts of suicide and has thought of at least one method during the assessment 
period. This situation is different than a specific plan with time, place, or method details 
worked out (eg, thought of method to kill self but not a specific plan). Includes person who 
would say, “I thought about taking an overdose but I never made a specific plan as to when, 
where, or how I would actually do it . . . and I would never go through with it.” 
Active suicidal ideation: method and intent, but no plan 
Active suicidal thoughts of killing oneself, and patient reports having some intent to act on 
such thoughts, as opposed to “I have the thoughts but I definitely will not do anything about 
them.” 
Active suicidal ideation: method, intent, and plan 
Thoughts of killing oneself with details of plan fully or partially worked out and patient 
has some intent to carry it out (ie, some degree of intent is implicit in the concept of plan). 
Suicidal Behavior 
Completed suicide 
A self-injurious behavior that resulted in fatality and was associated with at least some 
intent to die as a result of the act. Evidence that the individual intended to kill him- or 
herself, at least to some degree, can be explicit or inferred from the behavior or 
circumstance. 
Suicide attempt 
A potentially self-injurious behavior, associated with at least some intent to die as a result 
of the act. Evidence that the individual intended to kill him- or herself, at least to some 
degree, can be explicit or inferred from the behavior or circumstance. A suicide attempt 
may or may not result in actual injury. 
Approved
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Approved
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Interrupted suicide attempt 
When the person is interrupted (by an outside circumstance) from starting a potentially 
self-injurious act (if not for that, actual attempt would have occurred). 
Aborted suicide attempt 
When person begins to take steps toward making a suicide attempt, but stops before 
actually engaging in any self-destructive behavior. Examples are similar to interrupted 
attempts, except that the individual stops before being stopped by something else. 
Preparatory acts toward imminent suicidal behaviors 
This category can include anything beyond a verbalization or thought, but it stops short of 
a suicide attempt, an interrupted suicide attempt, or an aborted suicide attempt. This might 
include behaviors related to assembling a specific method (eg, buying pills, purchasing a 
gun) or preparing for one’s death by suicide (eg, giving things away, writing a suicide 
note). 
Self-Injurious Behavior Without Suicidal Intent 
Self-injurious behavior associated with no intent to die. The behavior is intended purely for other 
reasons, either to relieve distress (often referred to as self-mutilation (eg, superficial cuts or 
scratches, hitting or banging, or burns)) or to effect change in others or the environment. 
 
Approved
2.0
v
Approved
1.0
v