A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Phase: PHASE3
Conditions: Psoriasis
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study 
with Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in 
Subjects with Moderate-to-Severe Plaque Psoriasis 
 
 
NCT Number: NCT03611751 
Document Date (Date in which document was last revised): May 21, 2020  

Protocol Number:
IM011047
IND Number:
131,993
EX-US
Non-IND
EUDRACT Number:
2018-001925-24
Date, Version:
21 May 2020, Global Protocol v7.0,
Revised Protocol 09 Final Approved
Clinical Protocol IM011047
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled 
Phase 3 Study with Randomized Withdrawal and Retreatment to Evaluate the Efficacy and 
Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
Short Title: Efficacy, Safety, and Durability of Response of BMS-986165 versus Placebo and 
Active Comparator in Subjects with Psoriasis
Clinical Trial Physician
Medical Monitor
24-hr Emergency Telephone Number
USA: 
International: 
Bristol-Myers Squibb Research and Development
3401 Princeton Pike
Lawrenceville, NJ 08648
Avenue de Finlande 4
B-1420 Braine-l’Alleud, Belgium
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 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 (CRO).
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IM011047
BMS-986165
TYK2 Inhibitor
21 May 2020, Revised Protocol 09 Final Approved      BMS Confidential
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DOCUMENT HISTORY
Document
Date of Issue
Approver(s)
Summary of Change
Original 
Protocol
11-May-2018
Not applicable
Amendment 01
15-June-2018
Clarified that Psoriasis 
Symptoms and Signs Diary 
(PSSD) daily data collection 
will begin at the Screening 
Visit and, for randomized 
subjects, will continue daily 
through Week 52.
Amendment 02
20-Nov-2018
Updated the Sponsor’s 
contact information, made 
typographic corrections to 
the protocol, clarified certain 
procedures, updated wording 
in Appendix 3 to be 
consistent across studies of 
BMS-986165, described 
treatment assignment details, 
and revised certain exclusion 
criteria to be consistent with 
certain elements of the Phase 
2 study of BMS-986165 in 
psoriasis as well as other 
Phase 3 studies in psoriasis
Amendment 03
12-Dec-2018
German-Specific 
Amendment
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Amendment 04
13-Mar-2019
Italy-Specific Amendment
Amendment 05
14-May-2019
As this is designed to be a 
global study across multiple 
countries, randomization in 
each country will be targeted 
to approximately 35% or less 
of the total sample size. This 
change is being implemented 
to achieve geographical 
representation across 
countries and to minimize the 
potential for any single 
country to have a 
disproportionate impact on 
the overall efficacy and/or 
safety profile.
Other changes include:
-Updated text in the 
definition of sPGA in Section 
8.1.1.1 to be consistent with 
the description in 
Appendix 5. 
-Updated the description for 
the following endpoints: 
‘Time to relapse until Week 
52’ and ‘Time to rebound in 
subjects re-randomized to 
placebo’
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-Added the ‘Time to relapse
until Week 52’ endpoint to
Section 9.3.2.1 and to the
Testing Order of Key
Secondary Endpoints table in
Section 9.4.3 in place of the
‘Maintenance of PASI 75’
endpoint.
-Section 9.4.4 was updated to
define relapse during the
Randomized Withdrawal and
Maintenance Period.
Amendment 06
06-June-2019
Revised the testing order 
(hierarchy) of key secondary 
endpoints 
 and 
revised the text in Sections 
9.3.2.1 and 9.3.2.2 
accordingly as follows: 
x Removed endpoints 
containing ‘PSSD sign 
score.’ The reason for this 
change is that PSSD sign 
score is redundant with 
components assessed by 
PASI and sPGA which 
are already in the 
hierarchy.
x Removed ‘change from 
baseline in DLQI score.’ 
The reason for this change 
is that DLQI endpoint 
‘DLQI 0/1 among 
subjects with baseline 
DLQI score ≥2’ is 
clinically meaningful and 
is already in the hierarchy.
Amendment 07
12-Jul-2019
Germany-Specific 
Amendment – Included 
changes listed above for 
Global Amendment 02, 05
and 06.
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Global Revised 
Protocol 08
17-Dec-2019
Made the following updates:
x
provided clarifications in 
the protocol to aid sites 
and subjects in the 
conduct of the study.
x
added and updated 
relevant protocol 
deviation criteria for the 
Per Protocol Set
x
corrected typographical 
errors
x
added a new analysis for 
systemic treatment-naïve 
subjects to the set of 
subgroup analysis for the 
coprimary efficacy 
endpoints
Global Revised 
Protocol 09
(im011047-
revprot07)
21-May-2020
This global protocol 
amendment outlines changes 
for subjects who are unable 
or unwilling to attend 
protocol-specified trial visits 
and procedures during the 
COVID-19 pandemic,
including:
x method of study 
treatment assignment 
when COVID-19 related 
issues result in the Week 
24 visit and/or 
subsequent visits being 
missed or conducted
x statistical impacts due to 
COVID-19
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SUMMARY OF CHANGES
Rationale:
The primary purpose of this global revised protocol is to outline changes resulting from visits being 
missed or conducted remotely due to the COVID-19 pandemic, including:
•
method of study treatment assignment when COVID-19-related issues result in the 
Week 24 and/or subsequent visits being missed or conducted remotely 
•
statistical impacts due to COVID-19
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.
Protocol Section
Revised Protocol Text
Rationale for Change
6.2.1 Method of 
Study Treatment 
Assignment at 
Week 24 and 
Subsequent Visits 
Impacted by 
COVID-19-related 
Issues 
New Section Text:
6.2.1 Method of Study Treatment Assignment at Week 24 and 
Subsequent Visits Impacted by COVID-19-related Issues 
At Week 24, when COVID-19-related issues result in the subject 
visit being missed or conducted remotely the study treatment 
assigned by the IRT system will not be determined by the PASI 75 
response, because PASI assessments will not be done.  The study 
treatment assigned by the IRT system will be defaulted to BMS-
986165 6 mg QD for the duration of the study.
For all subsequent visits post Week 24, when COVID-19-related 
issues result in the subject visit being missed or conducted 
remotely, the study treatment assigned by the IRT system will not 
be determined by the PASI relapse response, because PASI 
assessments will not be done. Study treatment assignment will be 
done as per the following:
o
Missed visits: the study treatment assigned by the IRT system 
will be the study treatment assigned at the previous visit  
o
Visits conducted remotely: the study treatment assigned by
the IRT system will be defaulted to BMS-986165 6 mg QD for the 
duration of the study
To address study treatment assignment 
at Week 24 and post Week 24 for 
subjects who have visits missed or 
conducted remotely. 
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Protocol Section
Revised Protocol Text
Rationale for Change
9.8 Statistical 
Impacts Due to 
COVID-19
9.8.1 Impact on
Efficacy Endpoints
9.8.2  Impact on 
Safety Variables
New Section Text:
9.8  Statistical Impacts Due to COVID-19
9.8.1  Impact on Efficacy Endpoints 
There are no COVID-19-related impacts to the Week 16 efficacy 
endpoints as all subjects remaining in the trial completed the 
Week 16 visit prior to COVID-19 site restrictions. Efficacy 
endpoints involving Week 24 and later visits may be impacted by 
COVID-19 in the form of missing data and/or study treatment 
assignment defaulting to BMS-986165. 
Censoring rules will be applied to the PASI 75 time-to-relapse 
endpoint for re-randomized subjects due to the following
COVID-19-related issues post Week 24:
x
Subject’s study treatment assignment was defaulted to 
BMS-986165 because they had a remote safety 
monitoring visit due to COVID-19 and efficacy 
assessments were not performed. The subject will be 
censored at the time of the remote visit if relapse had 
not been observed already;
x
Subject has missing visit(s) (ie, efficacy assessments 
not performed) after Week 24 and assuming relapse 
was not observed prior to missed visit(s):
o
If the subject returns at a later visit and is 
found to have relapsed, midpoint imputation 
will be used to determine time-to-relapse (ie, 
midpoint of the censoring interval).
o
If the subject returns at a later visit and has not 
relapsed, then the subject will continue to be 
evaluated for relapse.
o
If the subject is discontinued from study 
treatment, then the subject will be censored at 
the time of study treatment discontinuation.
Sensitivity analyses for time-to-relapse may be performed with 
additional details provided in the statistical analysis plan prior to 
database lock.
Data handling due to COVID-19-related issues for other efficacy 
endpoints 
 will be described in the statistical 
analysis plan prior to database lock.
9.8.2  Impact on Safety Variables 
No modifications are planned for the analysis of safety data due to 
COVID-19-related issues. There will not be any additional safety 
data handling considerations for missing data or treatment 
interruptions due to COVID-19.
To specify impact on efficacy endpoints 
and safety variables due to COVID-19. 
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TABLE OF CONTENTS
TITLE PAGE...................................................................................................................................1
DOCUMENT HISTORY.................................................................................................................2 
SUMMARY OF CHANGES...........................................................................................................6 
TABLE OF CONTENTS.................................................................................................................8 
1.1 
Synopsis......................................................................................................................11 
1.2 
Schema........................................................................................................................17 
1.3 
Schedule of Activities (SOA) .....................................................................................17 
2 
INTRODUCTION ......................................................................................................30 
2.1 
Study Rationale...........................................................................................................30 
2.2 
Background.................................................................................................................31 
3 
OBJECTIVES AND ENDPOINTS............................................................................33 
4 
STUDY DESIGN .......................................................................................................35 
4.1 
Overall Design............................................................................................................35 
4.2 
Number of Subjects ....................................................................................................39 
4.3 
End of Study Definition..............................................................................................39 
4.4 
Scientific Rationale for Study Design ........................................................................40 
5 
STUDY POPULATION.............................................................................................40 
5.1 
Inclusion Criteria ........................................................................................................41 
5.2 
Exclusion Criteria.......................................................................................................42 
5.3 
Lifestyle Restrictions..................................................................................................46 
5.4 
Screen Failures............................................................................................................46 
6 
TREATMENT ............................................................................................................47 
6.1 
Treatments Administered............................................................................................49 
6.2 
Method of Treatment Assignment..............................................................................49 
6.3 
Blinding ......................................................................................................................51 
6.4 
Dosage Modification ..................................................................................................52 
6.5 
Preparation/Handling/Storage/Accountability............................................................52 
6.6 
Treatment Compliance................................................................................................53 
6.7 
Concomitant Therapy .................................................................................................53 
6.8 
Treatment After the End of the Study.........................................................................54 
7 
DISCONTINUATION CRITERIA............................................................................55 
7.1 
Discontinuation from Study Treatment ......................................................................55 
7.2 
Discontinuation from the Study..................................................................................56 
7.3 
Lost to Follow-up .......................................................................................................57 
8 
STUDY ASSESSMENTS AND PROCEDURES......................................................57 
8.1 
Efficacy Assessments .................................................................................................58 
8.2 
Adverse Events ...........................................................................................................62 
8.3 
Overdose.....................................................................................................................65 
8.4 
Safety ..........................................................................................................................65 
8.7 
Health Economics OR Medical Resource Utilization and Health Economics...........72 
9 
STATISTICAL CONSIDERATIONS .......................................................................72 
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9.2 
Populations for Analyses ............................................................................................73 
9.3 
Endpoints....................................................................................................................73 
9.4 
Efficacy Analyses .......................................................................................................78 
9.5 
Safety Analyses ..........................................................................................................82 
9.6 
Other Analyses............................................................................................................84 
9.7 
Interim Analyses.........................................................................................................85 
9.8 
Statistical Impacts Due to COVID-19 ........................................................................85 
10 
REFERENCES ...........................................................................................................87 
11 
APPENDICES ............................................................................................................91 
APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS .............................................92 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS......................................96 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP AND REPORTING .............................104 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION............................................108 
APPENDIX 5 
STATIC PHYSICIAN’S GLOBAL ASSESSMENT OF 
PSORIASIS (sPGA) ................................................................................112 
APPENDIX 6 
PSORIASIS AREA AND SEVERITY INDEX (PASI)..........................113 
APPENDIX 7 
SCALP SPECIFIC PHYSICIAN’S GLOBAL ASSESSMENT 
(ss-PGA) ..................................................................................................114 
APPENDIX 9 
PHYSICIAN’S GLOBAL ASSESSMENT-FINGERNAILS  
(PGA-F) ...................................................................................................116 
APPENDIX 11 
PALMOPLANTAR PSORIASIS PHYSICIAN’S GLOBAL 
ASSESSMENT (pp-PGA).......................................................................119 
APPENDIX 13 
PSORIASIS SYMPTOMS AND SIGNS DIARY (PSSD) .....................121 
APPENDIX 14 
DERMATOLOGY LIFE QUALITY INDEX (DLQI)............................122 
 
 
 
 
 
APPENDIX 20 
PSORIATIC ARTHRITIS SCREENING AND EVALUATION 
(PASE) QUESTIONNAIRE....................................................................134 
APPENDIX 21 
EIGHT ITEM PATIENT HEALTH QUESTIONNAIRE (PHQ-8)........135 
APPENDIX 22 
SUICIDAL IDEATION AND BEHAVIOR CATEGORIES AND 
DEFINITIONS.........................................................................................136 
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LIST OF TABLES
Table 1: 
Screening Procedural Outline (IM011047)................................................18 
Table 2: 
On Treatment Procedural Outline (IM011047): Week 0 through 
Week 20 .....................................................................................................21 
Table 3: 
On Treatment Procedural Outline (IM011047): Week 24 Through 
Week 52 .....................................................................................................25 
Table 4: 
Objectives and Endpoints ..........................................................................33 
Table 5: 
Study Treatments for IM011047................................................................48 
Table 6: 
Selection and Timing of Dose....................................................................49 
LIST OF FIGURES
Figure 1: 
Study Design Schematic ............................................................................38 
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1
PROTOCOL SUMMARY
1.1
Synopsis
Protocol Title:
A Multi-Center, Randomized, Double-Blind, Placebo-
and Active 
Comparator-Controlled Phase 3 Study with Randomized Withdrawal and Retreatment to Evaluate 
the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
Short Title: Efficacy, Safety, and Durability of Response of BMS-986165 versus Placebo and 
Active Comparator in Subjects with Psoriasis
Study Phase: 3
Rationale:
BMS-986165 could be 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) with 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 achieved a PASI 75 response, respectively. 
The PASI 75 responses plateaued at a dose of 3 mg BID. The current Phase 3 study is designed to 
confirm the efficacy and safety of BMS-986165 6 mg QD, which is expected to have equivalent 
efficacy as the 3 mg BID dose in Phase 2, in a larger global population of subjects with stable 
moderate-to-severe plaque psoriasis and will assess the durability of a PASI 75 response after 
treatment withdrawal. 
Study Population:
Men and women ≥18 years of age diagnosed with stable (defined as no morphology changes or 
significant flares of disease activity in the opinion of the investigator) moderate-to-severe plaque 
psoriasis for ≥ 6 months and with ≥10% of body surface area (BSA) involvement, who have a 
static Physician’s Global Assessment (sPGA) ≥3, a PASI score ≥12, and who are candidates for 
phototherapy or systemic therapy may be eligible to participate in the study.
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Objectives and Endpoints:
Objective
Endpoint
Primary
x
Assess whether BMS-986165 is superior 
to placebo at Week 16 in the treatment of 
subjects with moderate-to-severe plaque 
psoriasis
x
sPGA 0/1
x
PASI 75
Selected Secondary Endpoints
x
Assess whether BMS-986165 is superior 
to apremilast at Week 16
x
sPGA 0/1
x
PASI 75
x
PASI 90
x
sPGA 0
x
PASI 100
x
Assess whether BMS-986165 is superior 
to apremilast at Week 24
x
sPGA 0/1
x
PASI 75
x
PASI 90
x
Assess whether BMS-986165 is superior 
to placebo over the first 16 weeks of 
treatment
x
sPGA 0/1
x
PASI 75
x
PASI 90
x
sPGA 0
x
PASI 100
x
Evaluate 
improvement 
in 
patient-reported 
outcomes 
for 
BMS-986165 compared with placebo 
through Week 16
x
Evaluate 
improvement 
in 
patient-reported outcomes for BMS-
986165 
compared 
with 
apremilast 
through Week 24
x
Change from baseline in Psoriasis 
Symptoms and Signs Diary (PSSD) 
symptom score, sign score, and total 
score
x
Change from baseline in Dermatology 
Life Quality Index (DLQI) score
x
Evaluate maintenance and durability of 
efficacy of BMS-986165 during the 
randomized withdrawal period through 
Week 52 among Week 24 PASI 75
responders continuing on treatment 
compared with those re-randomized to 
placebo
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Objective
Endpoint
x
Time to relapse until Week 52
Overall Design:
This will be a 52-week, multi-center, randomized double-blind, double-dummy, placebo- and 
active comparator-controlled study in subjects with stable moderate-to-severe plaque psoriasis. 
Subjects will undergo screening evaluations within 28 days prior to administration of study 
medication to determine eligibility.
Active Comparator-Controlled Period
Following the screening process, qualified subjects will be randomized in a 2:1:1 ratio to one of 
the following 3 treatment groups:
x
BMS-986165 6 mg QD
x
Placebo
x
Apremilast 30 mg BID (with initial titration per label)
Randomization should not occur until at least 8 days after the screening visit to allow collection 
of PSSD data during screening in order to calculate a baseline PSSD score. Randomization will be 
stratified by geographic region (US/rest of the world), previous biologic use for psoriasis, psoriatic 
arthritis or other inflammatory disease (yes/no), and body weight (≥90 kg and <90 kg). As this is 
designed to be a global study across multiple countries, randomization in each country will be 
targeted to approximately 35% or less of the total sample size. This change is being implemented 
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to achieve geographical representation across countries and to minimize the potential for any single 
country to have a disproportionate impact on the overall efficacy and/or safety profile.
x
At Week 16, subjects receiving placebo will be switched in a blinded manner to 
BMS-986165 6 mg QD.
Subjects in the other treatment groups will continue their current regimen through Week 24.
Randomized Withdrawal and Maintenance Period
At Week 24, subjects originally randomized to BMS-986165 6 mg QD who do not achieve 
PASI 75 response will continue to receive BMS-986165 6 mg QD in a blinded manner. Subjects 
who achieve PASI 75 response will enter the randomized withdrawal and maintenance period. 
These subjects will be re-randomized in a blinded manner to one of the following 2 treatment 
groups in a 1:1 ratio:
x
BMS-986165 6 mg QD
x
Placebo
If the subjects re-randomized to placebo experience a relapse as defined below at any visit during 
this period, they will be treated with BMS-986165 6 mg QD until the end of the maintenance 
period (Week 52).
At Week 24, subjects receiving apremilast who achieve PASI 75 response will be switched in a 
blinded manner to placebo. If a subject experiences a relapse at any visit during this period, the 
subject will be treated with BMS-986165 6 mg QD until the end of the maintenance period 
(Week 52). Subjects who do not achieve PASI 75 response at Week 24 will be switched to BMS-
986165 6 mg QD.
During the randomized withdrawal period, relapse will be defined as at least a 50% loss of 
Week 24 PASI percent improvement from baseline.
Please refer to Section 6.2.1 for information regarding the method of study treatment assignment 
when COVID-19-related issues result in the at Week 24 and/or post Week 24 visits being missed 
or conducted remotely. 
Any subject with sPGA ≥ 3 at Week 24 may be treated with restricted topical medications, such 
as topical high potency corticosteroids (WHO Classes I-V), only at this time point at the discretion 
of the investigator.
Number of Subjects: 
Approximately 1000 qualified subjects will be randomized in a 2:1:1 ratio to BMS-986165 
6 mg QD, apremilast 30 mg BID, and placebo, respectively. This sample size will provide 
adequate power (≥90%) to compare BMS-986165 6 mg QD with placebo for each of the coprimary 
efficacy endpoints (sPGA 0/1 and PASI 75 at Week 16) and BMS-986165 6 mg QD compared
with apremilast for sPGA 0/1 and PASI 75 (Week 16).
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Treatment Arms and Duration:
Study treatment: Subjects in all treatment groups will take oral doses of the investigational 
product (IP) for 52 weeks during treatment as follows: BMS-986165 6 mg QD, apremilast 30 mg
BID (titrated as per label), or placebo QD.
Study Treatment for IM011047
Medication 
Potency 
IP/Non-IP
BMS-986165 tablet
6 mg
IP
apremilast tablet
10 mg*
IP
apremilast tablet
20 mg†
IP
apremilast tablet
30 mg‡
IP
placebo tablet
n/a
IP
IP = investigational produce; n/a = non-applicable
*Used for titration Day 1 through Day 3 morning dose
†Used for titration Day 3 evening dose through Day 5 morning dose.
‡From Day 5 evening dose onwards
Statistical Methods:
General Methodology
The primary efficacy analysis population will be the Full Analysis Set (FAS). The FAS will 
include all randomized subjects who are dispensed study drug. 
The analysis model for the coprimary efficacy endpoints and secondary binary endpoints will use 
stratified Cochran-Mantel-Haenszel (CMH) tests stratified by geographic region (US and rest of 
world), prior biologic treatment use for psoriasis, psoriatic arthritis or other inflammatory disease
(yes/no), and body weight (≥90 kg and <90 kg) to compare the response rates of BMS-986165
6 mg QD to placebo. If expected cell counts are not sufficient for each strata level, then strata 
levels will be combined for the analysis. Non-responder imputation will be used for binary 
endpoints for subjects who discontinue study or treatment of study prior to Week 16, start a 
protocol prohibited medication/therapy that could improve psoriasis during the first 16 weeks of 
treatment, or who have otherwise missing endpoint data at the specified timepoint.
The analysis model for continuous secondary endpoints will use analysis of covariance 
(ANCOVA) with treatment, geographic region (US and rest of world), prior biologic treatment 
use for psoriasis, psoriatic arthritis or other inflammatory disease (yes/no), and body weight 
(≥90 kg and <90 kg) as fixed effects. The baseline value will be added into the model as a 
covariate. Treatment differences based on least-squares (LS) means and the corresponding 2-sided
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95% confidence intervals will be provided for the difference between BMS-986165 6 mg QD and 
placebo or active comparator depending on the endpoint being assessed.
For continuous secondary efficacy endpoints, baseline observation carried forward (BOCF) will 
be used for subjects who discontinue study treatment due to:
x
Lack of efficacy
x
Adverse events
Additionally, BOCF will be used for subjects who start a protocol prohibited medication/therapy 
that could improve psoriasis. LOCF will be used for all other missing data.
The Kaplan-Meier product limit method will be used to estimate the distribution curves for 
time-to-relapse during the randomized withdrawal period. Treatment comparisons of subjects re-
randomized during the Maintenance Period for BMS-986165 6 mg QD and placebo will be 
performed using the log-rank test stratified by geographic region (US and rest of world), prior 
biologic treatment use for psoriasis, psoriatic arthritis or other inflammatory disease, and body 
weight (≥90 kg and <90 kg). 
Testing Strategy for Efficacy Endpoints
The primary family of coprimary endpoints will each be tested at a Type I error =0.05 first and, if 
significant for both endpoints, testing will proceed for the secondary family of key secondary 
endpoints
. The primary family of coprimary endpoints will be the serial gatekeeper for 
proceeding with testing of the secondary family of key secondary efficacy endpoints.
Primary Family – Coprimary endpoints compared with placebo; both must be significant at a Type 
I error=0.05 in order to proceed with the secondary family tests for the key secondary endpoints: 
x
Primary 1: Proportion of subjects who achieve sPGA 0/1 at Week 16
x
Primary 2: Proportion of subjects who achieve PASI 75 at Week 16
In order to control for Type I error rate inflation within the secondary family of key secondary 
endpoints, separate testing branches with a 2-sided Type I error=0.025 will be used for 
comparisons of BMS-986165 6 mg QD compared to placebo and BMS-986165 6 mg QD 
compared to apremilast. A hierarchical testing method within each testing branch will be 
implemented for the key secondary endpoints. The hierarchical test may only proceed to the next 
key secondary endpoint within each testing branch if the null hypothesis is rejected at a Type I 
error=0.025. If an endpoint fails at any step, then all subsequent comparisons will be considered 
descriptive.
Please refer to Section 9.8.1 for the impact on efficacy endpoints due to COVID-19.
Safety Analysis
Safety data 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.
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Please refer to Section 9.8.2 for the impact on safety variables due to COVID-19.
1.2
Schema
*Upon relapse (at least a 50% loss of Week 24 PASI percent improvement from baseline), subjects will be switched 
to BMS-986165 6 mg QD.
†Apremilast is titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing.
Abbreviations: BID = twice daily; PASI = Psoriasis Area and Severity Index; QD = once daily; R = randomize
The coprimary endpoints will be evaluated at Week 16. The duration of the study for each 
subject will be up to 52 weeks on treatment, and 4 additional weeks for safety follow-up.
1.3
Schedule of Activities (SOA)
The schedules of assessments and procedures are documented in Table 1 for screening, Table 2
for the active comparator-controlled period (through Week 20), and Table 3 for the Randomized 
Withdrawal and Maintenance Period (Week 24 and after).
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Table 1:
Screening Procedural Outline (IM011047)
Procedure
Screening
V1
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 psoriasis and documentation of presence of plaque 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 (e.g. 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, PsA/joint pain, nail involvement, palmoplantar involvement, 
genital involvement, history of other forms of 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.
Other Prior and Concomitant Treatments
X
This includes topical treatments for psoriasis and all medications for other conditions 
such as cardiovascular and mood disorders. 
Safety Assessments
Physical Examination 
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.
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Table 1:
Screening Procedural Outline (IM011047)
Procedure
Screening
V1
Notes
Electrocardiogram 
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 the investigator. 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
Section 8.4.5
Hematology
X
Complete Blood Count (CBC) with differential
Chemistry Panel
X
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
hs-CRP
X
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 5.2
Criterion 3)d.
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BMS-986165
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Table 1:
Screening Procedural Outline (IM011047)
Procedure
Screening
V1
Notes
Pregnancy Test (serum)
X
For WOCBP only
FSH 
X
To confirm menopausal status (see APPENDIX 4)
Clinical Efficacy/Health Outcomes
sPGA
X
PASI
X
BSA
X
PASE Questionnaire
X
For subjects with peripheral joint complaints to screen for presence of psoriatic arthritis
PSSD
X
All consented subjects will be given a diary device at the Screening Visit and will begin 
recording psoriasis signs and symptoms on a daily basis in the diary device. Subjects 
who are not randomized will stop recording and return their diary device to the site. 
Subjects who are randomized will continue recording their psoriasis signs and symptoms 
on a daily basis in the diary device through Week 52.
BSA = body surface area; DNA = deoxyribonucleic acid; ECG = electrocardiogram; eC-SSRS = electronic Columbia-Suicide Severity Rating Scale; FSH = follicle-stimulating 
hormone; 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; hs-CRP = High-sensitivity C-reactive protein; IRT = Interactive Response Technology; PASE = psoriatic arthritis screening and 
evaluation; PASI = Psoriasis Area and Severity Index; PE = physical examination; PHQ-8 = Eight-item Patient Health Questionnaire; PsA =  psoriatic arthritis; PSSD = Psoriasis 
Symptoms and Signs Diary; SAE = serious adverse event; sPGA = static Physician Global Assessment; T3 = triiodothyronine; T4 = thyroxine; TB = tuberculosis; TSH = thyroid-
stimulating hormone; V = Visit; WOCBP = women of childbearing potential
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BMS-986165
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Table 2:
On Treatment Procedural Outline (IM011047): 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
DLQI
X
X
X
X
X
X
X
X
sPGA
X
X
X
X
X
X
X
X
PASI
X
X
X
X
X
X
X
X
ss-PGA*
X
X
X
X
X
X
PGA-F†
X
X
X
X
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BMS-986165
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Table 2:
On Treatment Procedural Outline (IM011047): 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
Palmoplantar PGA‡
X
X
X
X
X
X
X
PSSD
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 
X
X
PHQ-8
X
X
X
See Section 8.4.6.1
eC-SSRS Assessment
X
X
X
Suicidal Ideation and 
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 × ULN, 
reflex testing is 
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BMS-986165
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Table 2:
On Treatment Procedural Outline (IM011047): 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
required (see Section 
8.4.5)
Hemoglobin A1C
X
X
hs-CRP
X
X
X
X
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
Study Treatment
Randomize
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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Clinical Protocol
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BMS-986165
TYK2 Inhibitor
21 May 2020, Revised Protocol 09 Final Approved
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Table 2:
On Treatment Procedural Outline (IM011047): 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
 eC-SSRS = electronic Columbia-Suicide Severity Rating Scale; CK = creatine kinase; 
 D = Day; d = days; DLQI = Dermatology Life Quality 
Index; 
 ECG – electrocardiogram; 
 hs-
CRP = High-sensitivity C-reactive protein; 
 PASI = Psoriasis Area and Severity Index; PE = physical examination; PGA-F = Physician 
Global Assessment-Fingernails; 
 PSSD = Psoriasis Symptoms and Signs Diary; 
 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
*In subjects with scalp psoriasis at baseline; †In subjects with nail psoriasis at baseline; ‡In subjects with palmoplantar psoriasis at baseline; §If sample is missed, it may 
be taken at any visit once informed consent is obtained.
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.
Approved
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BMS-986165
TYK2 Inhibitor
21 May 2020, Revised Protocol 09 Final Approved
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Table 3:
On Treatment Procedural Outline (IM011047): 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 52#
(or early 
DC)
D365
(±3 d)
V17
Safety 
Follow-Up*
(Week 56)
D393
(±3 d)
V18
Notes
Clinical Efficacy/Health 
Outcomes
DLQI
sPGA
PASI
X
X
X
X
X
X
X
X
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BMS-986165
TYK2 Inhibitor
21 May 2020, Revised Protocol 09 Final Approved
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Table 3:
On Treatment Procedural Outline (IM011047): 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 52#
(or early 
DC)
D365
(±3 d)
V17
Safety 
Follow-Up*
(Week 56)
D393
(±3 d)
V18
Notes
PSSD
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
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
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BMS-986165
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21 May 2020, Revised Protocol 09 Final Approved
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Table 3:
On Treatment Procedural Outline (IM011047): 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 52#
(or early 
DC)
D365
(±3 d)
V17
Safety 
Follow-Up*
(Week 56)
D393
(±3 d)
V18
Notes
Fasting Plasma Glucose
X
X
hs-CRP
X
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
Study Treatment
Blinded PASI Response 
Transferred Electronically 
to IRT
X
X
X
X
X
X
X
X
To determine PASI 75
response at Week 24 and 
to monitor for relapse and 
rebound afterwards
Dispense Study Treatment
X
X
X
X
X
X
X
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Table 3:
On Treatment Procedural Outline (IM011047): 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 52#
(or early 
DC)
D365
(±3 d)
V17
Safety 
Follow-Up*
(Week 56)
D393
(±3 d)
V18
Notes
Study Treatment 
Compliance
X
X
X
X
X
X
X
X
 CK = creatine kinase; 
 D = Day; d = days; DC = discontinuation; 
 eC-SSRS = electronic Columbia-
Suicide Severity Rating Scale; 
 hs-CRP = high-sensitivity C-reactive 
protein; Ig = immunoglobulin; IRT = interactive response technology; 
 PASI = Psoriasis Area and Severity Index; 
 
 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; 
 WOCBP = women of childbearing potential
*For subjects who do not continue in a long-term extension study: 
 
#For subjects who discontinue study treatment prior to Week 52, please refer to Section 7.1 for more details.
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.
Approved
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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  6
Protocol Number:  IM011047
Site Number: 
Date of Protocol or Revised Protocol:  21 May 2020
IND Number:  131,993
EUDRACT Number:  2018-001925-24
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.1,2 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.3, 4, 5 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 stress.3 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.6 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.7,8 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 analogues, calcineurin 
inhibitors, and salicylic acid; phototherapy modalities, including psoralens with ultraviolet A 
(PUVA) 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-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 adverse 
events (AEs) such as hepatotoxicity and neutropenia (methotrexate);10
nephrotoxicity 
(cyclosporine);11 depression and weight loss (apremilast);12 serious infections (cytokine 
inhibitors);13,14,15,16 and candidiasis and Crohn’s disease (IL-17 antagonists).16, 17, 18
Although effective therapeutic options are available, under-treatment or non-treatment 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,4,8 and many patients consider their psoriasis treatment 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 could be 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 every 
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other day (QOD); 3 mg once daily (QD); 3 mg twice daily (BID); 6 mg BID; and 12 mg QD 
(Study IM011011). 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 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. 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 with responses again plateauing at dose of 3 mg BID. The Phase 3 dose selected 
(6 mg QD) is expected to demonstrate equivalent efficacy to the 3 mg BID dose. Please refer to 
This Phase 3 study is designed to confirm the efficacy and safety of BMS-986165 6 mg QD and 
demonstrate its superiority to a widely used oral agent, apremilast, in a larger global population of 
subjects with moderate-to-severe plaque psoriasis. 
2.2
Background
Tyrosine kinase 2 (TYK2) is a nonreceptor tyrosine kinase associated with receptors for the 
p40-containing cytokines interleukin (IL)-12 and IL 23, as well as the Type I interferon (IFN) 
receptor, and is required for the activation of their 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.20,21,22 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, granulocyte macrophage colony-stimulating factor, 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.
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 (IL-23 and the downstream mediators IL-17, IL-22, and IFNα) have been 
implicated in pathogenesis of psoriasis.7 2) Biologic agents targeting the IL-17, IL-23p19, and 
IL-12/23 p40 pathways have been approved for and are highly efficacious in the treatment of 
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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
Table 4:
Objectives and Endpoints
Objective
Endpoint
Primary
x
Assess whether BMS-986165 is superior to placebo at 
Week 16 in the treatment of subjects with moderate-to-
severe plaque psoriasis
x
static Physician Global Assessment (sPGA) 
0/1 response
x
Psoriasis Area and Severity Index (PASI) 75 
response (defined as a 75% improvement in 
PASI score from baseline)
Key Secondary 
x
Assess whether BMS-986165 is superior to apremilast at 
Week 16
x
sPGA 0/1 response
x
PASI 75 response
x
PASI 90 response
x
sPGA 0 response
x
PASI 100 response
x
Assess whether BMS-986165 is superior to apremilast at 
Week 24
x
sPGA 0/1 response
x
PASI 75 response
x
PASI 90 response
x
Assess whether BMS-986165 is superior to placebo over 
the first 16 weeks of treatment
x
sPGA 0/1 response
x
PASI 90 response
x
sPGA 0 response
x
PASI 100 response
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Table 4:
Objectives and Endpoints
Objective
Endpoint
x
Assess whether BMS-986165 is superior to placebo in 
scalp psoriasis through Week 16 among subjects with a 
baseline scalp severity Physician’s Global Assessment 
(ss-PGA) score ≥3
x
ss-PGA 0/1 response 
x
Assess whether BMS-986165 is superior to apremilast in 
scalp psoriasis through Week 16 among subjects with a  
baseline ss-PGA score ≥3
x
ss-PGA 0/1 response
x
Assess whether BMS-986165 is superior to placebo in 
nail psoriasis through Week 16 among subjects with a 
baseline Physician’s Global Assessment of Fingernail 
psoriasis (PGA-F) score ≥3
x
PGA-F 0/1 
x
Assess whether BMS-986165 is superior to placebo in 
palmoplantar psoriasis through Week 16 among subjects 
with a baseline palmoplantar Physician’s Global 
Assessment (pp-PGA)  score ≥3
x
pp-PGA 0/1 response
x
Evaluate improvement in patient-reported outcomes for 
BMS-986165 compared with placebo through Week 16
x
Evaluate improvement in patient-reported outcomes for 
BMS-986165 compared with apremilast through 
Week 24
x
PSSD symptom score of 0 (among subjects 
with a baseline PSSD symptom score ≥ 1)
x
DLQI 0/1 (among subjects with a baseline 
DLQI score ≥ 2)
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Table 4:
Objectives and Endpoints
Objective
Endpoint
x
Evaluate maintenance and durability of efficacy of 
BMS-986165 during the randomized withdrawal period 
through Week 52 among Week 24 PASI 75 responders 
continuing on treatment compared with those 
re-randomized to placebo
x
Time to relapse until Week 52
4
STUDY DESIGN
4.1
Overall Design
This will be a 52-week, multi-center, randomized double-blind, double-dummy, placebo- and 
active comparator-controlled study to evaluate the safety and efficacy of BMS-986165 vs placebo
and apremilast. The maintenance and durability of BMS-986165 efficacy will also be evaluated. 
A total of 1000 qualified subjects with moderate-to-severe plaque psoriasis will be enrolled.
The duration of study participation is approximately 60 weeks and will be divided into the 
following periods: screening (up to 4 weeks), treatment (24 weeks), re-randomization and 
withdrawal (28 weeks), and follow up (4 weeks).
Physical examinations (PEs), 12-lead electrocardiograms (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. 
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4.1.1
Active Comparator-controlled Period (Week 0-24)
4.1.1.1
Screening Period
Subjects will be evaluated during the screening period to ensure that they meet eligibility criteria 
for this study. A detailed medical history will be done at this time, as well as a complete PE. 
Psoriasis-related history, which will include length of diagnosis (duration of disease), body surface 
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.
4.1.1.2
Treatment Period
Qualified subjects who have completed the screening procedures and have met the 
inclusion/exclusion criteria will be randomized on Day 1 in a 2:1:1 ratio, respectively, to one of 
the following 3 treatment groups:
x
BMS-986165 6 mg QD
x
Placebo
x
Apremilast titrated to 30 mg BID as follows:
o
Day 1: 10 mg tablet in the morning
o
Day 2: 10 mg tablet in the morning and evening
o
Day 3: 10 mg tablet in the morning and 20 mg tablet in the evening
o
Day 4: 20 mg tablet in the morning and the evening
o
Day 5: 20 mg tablet in the morning, and 30 mg tablet in the evening
o
Day 6 and thereafter: 30 mg tablet in the morning and the evening
Dummy tablets (placebo to the BMS-986165 6 mg tablet, placebo to apremilast 30 mg tablet BID, 
and placebo to apremilast 10 mg, 20 mg, and 30 mg during titration) will be administered to the 
subjects to maintain blinding. Additional details are provided in Section 6.1.
Randomization should not occur until at least 8 days after the screening visit to allow collection 
of PSSD data during screening in order to calculate a baseline PSSD score. Randomization will be 
stratified by geographic region (US and rest of world), previous biologic use for psoriasis, psoriatic 
arthritis or other inflammatory disease (yes/no), and body weight (≥90 kg and <90 kg). As this is 
designed to be a global study across multiple countries, randomization in each country will be 
targeted to approximately 35% or less of the total sample size. This change is being implemented 
to achieve geographical representation across countries and to minimize the potential for any single 
country to have a disproportionate impact on the overall efficacy and/or safety profile.
4.1.1.3
Week 16
The coprimary endpoints (sPGA 0/1 and PASI 75) will be assessed at Week 16. Subjects receiving 
placebo will be switched in a blinded manner to BMS-986165 6 mg QD at Week 16. Subjects who 
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are receiving BMS-986165 6 mg QD or apremilast 30 mg BID will continue the same treatment 
through Week 24.
4.1.2
Randomized Withdrawal and Maintenance Period (Week 24-52)
The Randomized Withdrawal and Maintenance Period will start at Week 24 and continue to 
Week 52. The subjects who had been in the placebo arm and switched to BMS-986165 6 mg QD 
at Week 16 will continue this treatment until Week 52.
4.1.2.1
Week 24
At Week 24, subjects originally randomized to BMS-986165 6 mg QD who do not achieve 
PASI 75 response will continue to receive BMS-986165 6 mg QD in a blinded manner. Subjects 
who achieve PASI 75 response will be re-randomized in a blinded manner to one of the following 
2 treatment groups in a 1:1 ratio:
x
BMS-986165 6 mg QD
x
Placebo
If the subjects who were re-randomized to placebo experience a relapse as defined below at any 
visit during this period, they will be switched back in a blinded manner to  BMS-986165 6 mg QD 
until the end of the maintenance period (Week 52). Relapse will be defined as at least a 50% loss 
of Week 24 PASI percent improvement from baseline.
Subjects originally randomized to apremilast who achieve PASI 75 response will be switched in a 
blinded manner to placebo. If the subject experiences a relapse at any visit during this period, the 
subject will be treated with BMS-986165 6 mg QD until the end of the maintenance period 
(Week 52). Subjects receiving apremilast who do not achieve PASI 75 response at Week 24 will 
be switched to BMS-986165 6 mg QD.
During the assessment at Week 24, a subject who has an sPGA ≥ 3 
 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.
4.1.2.2
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. All subjects (excluding those in the long-term extension) should be off 
treatment after the Week 52 visit. Subjects will be encouraged to report any serious adverse events
(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 will be offered the opportunity to roll over to a separate 
long-term extension study (≥2 years) where they will be treated with BMS-986165 6 mg QD.
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The study design schematic is presented in Figure 1.
Figure 1:
Study Design Schematic
*Upon relapse (at least a 50% loss of Week 24 PASI percent improvement from baseline), subjects will be switched 
to BMS-986165 6 mg QD. 
†Apremilast is titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing as described in Section 4.1.1.2
Abbreviations: BID = twice daily; PASI = Psoriasis Area and Severity Index; QD = once daily; R = randomize
The coprimary endpoints will be evaluated at Week 16. The duration of the study for each 
subject will be up to 52 weeks on treatment, and 4 additional weeks for safety follow-up.
4.1.3
Data Monitoring Committee and Other External Committees
4.1.3.1
Data Monitoring Committee
An external data monitoring committee (DMC) with multi-disciplinary representation will be 
established to evaluate on a periodic basis AEs, laboratory measurements, and safety assessments 
to ensure the ongoing safety of study subjects. An independent reporting statistician not involved 
in the conduct of the study will be designated by 
 to provide the DMC with essential safety 
data during the study.
The DMC responsibilities, authorities, and procedures will be documented and followed according 
to the DMC charter.
4.1.3.2
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. 
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Additional information about these infections may be collected on the case report form 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 is distinct from 
the DMC and Adjudication Committee members will not be investigators on the study.
4.1.3.3
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 
case report form 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 is distinct from the DMC and Adjudication Committee members will not be 
investigators on the study.
4.1.3.4
Suicidal Ideation and Behavior 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 case report form. 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 is distinct from the DMC and Adjudication Committee members will not be 
investigators on the study.
4.2
Number of Subjects
Approximately 1000 qualified subjects will be randomized in a 2:1:1 ratio to BMS-986165 6 mg 
QD, apremilast 30 mg BID, and placebo, respectively. Sample size considerations are described 
in Section 9.1.
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 trial is defined as first visit for first subject screened. The end of the trial is defined 
as the last visit or scheduled procedure shown in the Schedule of Activities (Section 1.3) 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).
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4.4
Scientific Rationale for Study Design
This Phase 3 study will be conducted in a population of subjects with stable moderate-to-severe 
plaque psoriasis who are candidates for systemic psoriasis therapy. This study is designed to 
confirm the efficacy and safety of BMS-986165 compared with placebo and apremilast in 
achieving sPGA of 0/1 and PASI 75 at Week 16. The sPGA and PASI 75 are standard measures 
in clinical trials of demonstrating efficacy of systemic psoriasis treatments. This study will also 
examine the efficacy durability after re-randomized withdrawal at Week 24 in subjects who had 
achieved PASI 75 in the BMS-986165 treatment arm. A placebo arm is included in this study for 
a short duration of 16 weeks to provide a control for the natural fluctuation of psoriasis activity 
that may occur and to provide a safety standard for comparison. Subjects in the placebo arm will 
be switched to BMS-986165 at Week 16 to provide them psoriasis treatment after the endpoints 
are collected. Apremilast is included as the active control in this study as it is an approved, widely 
used, oral daily medication for psoriasis. Week 16 was chosen as it would allow enough time for 
BMS-986165 as well as apremilast to treat psoriasis. In addition, prior apremilast registrational 
trials had reported psoriasis-related outcomes at Week 16 as their primary endpoints. Randomized 
withdrawal at Week 24 through Week 52 is considered enough time to assess the efficacy 
maintenance and durability of BMS-986165 in subjects who had achieved a PASI 75 at Week 24.
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.
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All screening and randomization 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:
1) Signed Written Informed Consent
a) Subjects must be willing to participate in the study and sign the informed consent form 
(ICF)
2) Type of Subject and Target Disease Characteristics
a) Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable 
psoriasis is defined as no morphology changes or significant flares of disease activity in 
the opinion of the investigator.
b) Deemed by the investigator to be a candidate for phototherapy or systemic therapy
c) ≥10% of BSA involvement at screening visit and Day 1
d) Psoriasis Area and Severity Index (PASI) score ≥12, and static Physician’s Global 
Assessment (sPGA) ≥3 at screening visit and Day 1
3) Age and Reproductive Status
a) Men and women aged ≥18 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
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.
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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) Has non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced 
psoriasis) at screening or Day 1
2) Infectious/Immune-related Exclusions
a) History or evidence of outpatient active infection and/or febrile illness within 7 days prior 
to Day 1 
b) History of serious bacterial, fungal, or viral infection requiring hospitalization and 
intravenous (IV) antimicrobial 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 Ag (HBsAg+) OR 2) Presence of 
Hepatitis B Virus DNA OR 3) Positive anti-hepatitis B core antibody without concurrent 
positive hepatitis B surface antibody (HBcAb+ and HBsAb-)
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 (for example, HCV polymerase chain reaction)
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. Use of rifampin, however, 
is not recommended as it can reduce efficacy of apremilast used as a comparator in this 
trial
Note: An IGRA test that is indeterminate 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 (GI), 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 investigational product (ie, BMS-986165 or apremilast)
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 non-biologic psoriasis medications and/or any systemic 
immunosuppressants therapy (including, but not limited to, methotrexate, azathioprine, 
cyclosporine, JAK inhibitors, 6-thioguanine, mercaptopurine, mycophenolate mofetil, 
hydroxyurea, tacrolimus, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy
vitamin D3 and analogues, psoralens, sulfasalazine, or fumaric acid derivatives) within 4 
weeks prior to Day 1
n) Has used leflunomide within 6 months prior to Day 1
o) Has used opioid analgesics within 4 weeks prior to Day 1
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p) Has received lithium, antimalarials, or intramuscular (IM) gold within 4 weeks of the first 
administration of any study medication
q) Has used any strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, 
phenytoin) within 4 weeks prior to Day 1
r)
Has received phototherapy (including either oral and topical PUVA light therapy, 
ultraviolet B [UVB] or self-treatment with tanning beds or therapeutic sunbathing) within 
4 weeks prior to Day 1
s) Has used topical medications/treatments that could affect psoriasis evaluation (including, 
but not limited to, high 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, pimecrolimus, and tacrolimus) 
within 2 weeks prior to Day 1
Note: 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 other ingredients which are pharmaceutically active) are allowed on all body 
regions but should not be used within 24 hours prior to any study visit
t)
Use of shampoos that contain corticosteroids, coal tar, >3% salicylic acid, or vitamin D3 
analogues within 2 weeks prior to Day 1
u) 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
v) Any other sound medical, psychiatric and/or social reason as determined by the investigator
5) Physical and Laboratory Evaluations
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 >3 × upper limit of normal (ULN)
vii)
Total, unconjugated, and/or conjugated bilirubin >2 × ULN
viii) Thyroid-stimulating hormone (TSH) outside the normal reference range
AND
Free T4 (thyroxine) or T3 (triiodothyronine) outside the normal reference range
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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
6) Allergies and Adverse Drug Reactions
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
e) Any contraindications listed in the country-specific label for apremilast
5.3
Lifestyle Restrictions
General skin care measures (with above restrictions for topical treatments) that are standard for 
patients 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. Details are provided in Section 8.5.
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 randomized 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 
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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 
serious AEs 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 is 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 and 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 randomization.
The most current result prior to randomization is the value by which study inclusion will be 
assessed, as it represents the subject’s most current clinical state.
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, placebo, and apremilast.
An investigational product, also known as investigational medicinal product 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
non-investigational products. Table 5 shows the study treatments for Protocol IM011047.
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Table 5:
Study Treatments for IM011047
Product Description / 
Class and Dosage Form
Potency
IP/Non-IMP
Blinded or Open 
Label
Packaging / 
Appearance
Storage Conditions
(per label)
BMS-986165 tablet
6 mg
IP
Blinded
Bottle
Store at 15 to 25°C; 
Store in a tightly closed 
container; Protect from 
light
Placebo tablet to match 
BMS-986165 6 mg
n/a
IP
Blinded
Bottle
Store at 15 to 25°C; 
Store in a tightly closed 
container; Protect from 
light
Apremilast tablet
10 mg*
IP
Blinded
Blister card
Store tablets below 
30°C (86°F). Store in 
original container
Placebo tablet to match 
apremilast 10 mg
n/a
IP
Blinded
Blister card
Store tablets below 
30°C (86°F). Store in 
original container
Apremilast tablet
20 mg†
IP
Blinded
Blister card
Store tablets below 
30°C (86°F). Store in 
original container
Placebo tablet to match 
apremilast 20 mg
n/a
IP
Blinded
Blister card
Store tablets below 
30°C (86°F). Store in 
original container
Apremilast tablet
30 mg‡
IP
Blinded
Bottle
Store tablets below 
30°C (86°F). Store in 
original container
Placebo tablet to match 
apremilast 30 mg
n/a
IP
Blinded
Bottle
Store tablets below 
30°C (86°F). Store in 
original container
IP = investigational product; IMP = investigational medicinal product; n/a = not applicable
*Used for titration Day 1 through Day 3 morning dose
†Used for titration Day 3 evening dose through Day 5 morning dose
‡From Day 5 evening dose onwards.
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6.1
Treatments Administered
Study treatment will be administered as described in Section 4.1.1.2. The selection and timing of 
dose for each subject is as follows:
Table 6:
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; 1 
placebo titration kit* then 2 apremilast 
placebo (1 tablet in the morning, 1 
tablet in the evening)
oral
30 mg BID 
apremilast
30 mg
1 active titration kit* then 1 active 
morning and evening and 1 
BMS-986165 placebo QD in the 
morning
oral
Placebo BID
n/a
1 placebo apremilast titration kit* then 
2 apremilast placebo (1 tablet in the 
morning, 1 tablet in the evening) and 1 
BMS-986165 placebo QD in the 
morning
oral
Abbreviations: BID = twice daily; n/a = not applicable; QD = once daily
*Titration kit described in Section 6.1.1.
6.1.1
Titration Kit for Active and Placebo Apremilast
Apremilast will be titrated over 5 days to a maintenance dose of 30 mg BID. To maintain the blind 
between subjects receiving apremilast and BMS-986165 during the titration period, active 
apremilast and matching apremilast placebo tablets will be provided. This will be supplied in an 
18-day titration kit as follows:
One 10 mg tablet in the morning on Day 1; two 10 mg tablets (one in the morning, one in the 
evening) on Day 2; one 10 mg tablet in the morning and one 20 mg tablet in the evening on Day 3; 
two 20 mg tablets (one tablet in the morning, one tablet in the evening) on Day 4; one 20 mg tablet 
in the morning and one 30 mg tablet in the evening on Day 5; one 30 mg tablet in the morning and 
one 30 mg tablet in the evening for each Day 6 through Day 18.
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 
randomized or treated. The subject number is assigned sequentially by the system and will be 
unique across all sites. All enrolled subjects will be assigned sequential subject numbers. The 
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subject number will not be used for any other subject. If a subject is rescreened, they will be given 
a new identification number.
At Week 0 (Day 1), subjects who meet all criteria for enrollment at Screening and Day 1 will be 
centrally randomized in a 2:1:1 ratio to BMS-986165 6 mg QD, placebo, or apremilast 30 mg BID 
as determined by a computer-generated randomization schedule using IRT. The randomization 
lists will be generated by the IRT vendor using a permuted block design within each combination 
of stratum level. The randomization in this study will be stratified by geographic region geographic 
region (US and rest of world), previous biologic use for psoriasis, psoriatic arthritis or other 
inflammatory disease (yes/no), and body weight (≥90 kg and <90 kg). As this is designed to be a 
global study across multiple countries, randomization in each country will be targeted to 
approximately 35% or less of the total sample size. This change is being implemented to achieve 
geographical representation across countries and to minimize the potential for any single country 
to have a disproportionate impact on the overall efficacy and/or safety profile.
After all inclusion/exclusion criteria have been met for a subject, the investigative site will access 
the IRT on Day 1 for the purposes of randomizing a subject. A treatment group will be assigned 
by IRT based on the above-described randomization schedule and each subject will be assigned a 
unique randomization number. In addition, a unique kit number will be assigned to the subject 
corresponding to the treatment assignment.
At the Week 0 and Week 2 visits, a kit with a 2-week supply of study treatment is provided. At all 
subsequent visits, kits will contain adequate study treatment for a 4-week supply. At subsequent 
visits, when new treatment kits are to be dispensed, 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 1.3).
At Week 16, subjects receiving placebo will be switched in a blinded manner to BMS-986165
6 mg QD.
At Week 24, subjects originally randomized to BMS-986165 6 mg QD who do not achieve 
PASI 75 will continue to receive BMS-986165 6 mg QD in a blinded manner. Subjects who 
achieve PASI 75 response will be re-randomized in a blinded manner to either BMS-986165 6 mg 
QD or placebo. Subjects re-randomized to placebo who experience a relapse at a subsequent visit 
will be switched back onto BMS-986165 6 mg QD in a blinded manner. The investigative site and 
other study personnel will not be provided with the PASI 75 scores at these visits.
At Week 24, subjects originally randomized to apremilast 30 mg BID who do not achieve PASI 75 
response will be switched in a blinded manner to BMS-986165 6 mg QD while subjects who 
achieve PASI 75 response at Week 24 will be switched in a blinded manner to placebo. If a relapse 
occurs at a subsequent visit, they will be switched in a blinded manner to BMS-986165 6 mg QD. 
The investigative site and other study personnel will not be provided with the PASI 75 scores at 
these visits.
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6.2.1
Method of Study Treatment Assignment at Week 24 and Subsequent 
Visits Impacted by COVID-19-related Issues
At Week 24, when COVID-19-related issues result in the subject visit being missed or conducted 
remotely, the study treatment assigned by the IRT system will not be determined by the PASI 75 
response, because PASI assessments will not be done.  The study treatment assigned by the IRT 
system will be defaulted to BMS-986165 6 mg QD for the duration of the study.
For all subsequent visits post Week 24, when COVID-19-related issues result in the subject visit 
being missed or conducted remotely, the study treatment assigned by the IRT system will not be 
determined by the PASI relapse response, because PASI assessments will not be done. Study 
treatment assignment will be done as per the following:
o
Missed visits: the study treatment assigned by the IRT system will be the study 
treatment assigned at the previous visit  
o
Visits conducted remotely: the study treatment assigned by the IRT system will be 
defaulted to BMS-986165 6 mg QD for the duration of the study
6.3
Blinding
6.3.1
Maintaining the Blind
Blinded treatment assignments will be managed using IRT. 
All tablets are identical in appearance and will be supplied in blister cards or bottles with each 
daily dose made up of the appropriate combination of active and/or placebo tablets to provide the 
correct treatment, as shown in Table 5. Investigative site staff, Sponsor and designee personnel, 
and subjects and their families will remain blinded to treatment assignments.
 
 
 
 
6.3.2
Circumstances for Unblinding
Blinding of treatment assignment is critical to the integrity of this clinical study. However, in the 
event of a medical emergency or pregnancy in an individual subject in which knowledge of the 
investigational product is critical to the subject's management, the blind for that subject may be 
broken by the investigator. The subject’s safety takes priority over any other considerations in 
determining if a treatment assignment should be unblinded.
Before breaking the blind of an individual subject's treatment, the investigator should determine 
that the unblinded information is necessary, ie, that it will alter the subject's immediate 
management. In many cases, particularly when the emergency is clearly not related to the 
investigational product, the problem may be properly managed by assuming that the subject is 
receiving active product. It is highly desirable that the decision to unblind treatment assignment 
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be discussed with the medical monitor, but the investigator always has ultimate authority for the 
decision to unblind. The principal investigator should only call in for emergency unblinding 
AFTER the decision to discontinue the subject has been made.
In case of an emergency, the investigator has unrestricted access to randomization information via 
IRT and is capable of breaking the blind through the IRT system without prior approval from the 
sponsor. After the unblinding, the investigator shall notify the medical monitor and/or study 
director. The method of unblinding for emergency purposes is described in the IRT manual. 
Subject and unblinded treatment information and the reason for the blind being broken must be 
recorded on the appropriate study status page of the electronic case report form (eCRF). After 
unblinding via IRT, the investigator shall notify the medical monitor.
In cases of accidental unblinding, contact the medical monitor and ensure every attempt is made 
to preserve the blind. Any request to unblind a subject for non-emergency purposes must be 
discussed with the medical monitor prior to unblinding.
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 investigational product should be stored in a secure area according to local regulations. It is 
the responsibility of the investigator to ensure that investigational product is only dispensed to 
study subjects. The investigational product 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.
Study treatment not supplied by BMS will be stored in accordance with the package insert.
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).
x
Guidance and information for final disposition of unused study treatment are provided in 
APPENDIX 2.
x
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) Any concurrent use of strong CYP450 inducers according to the US package insert for 
apremilast as it may reduce apremilast efficacy. Examples include rifampin, phenobarbital, 
carbamazepine, and phenytoin, unless it is considered necessary for the subject’s welfare 
and/or treatment of an AE/SAE.
3) 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.
4) Use of opioid analgesics unless it is considered necessary for the subject’s welfare and/or 
treatment of an AE/SAE.
5) Phototherapy; use of tanning booths or therapeutic sunbathing.
6) Any use of biologic medications (eg, adalimumab, etanercept, infliximab, ustekinumab).
7) Any use of oral psoriasis medications (eg, methotrexate, cyclosporine, retinoids, fumaric acid 
derivatives) for any indication.
8) Any use of oral or injectable corticosteroids (prednisone, methylprednisolone, etc.), unless it 
is considered necessary for the subject’s welfare and/or treatment of an AE/SAE.
Note: otic, ophthalmic, nasal, or inhaled corticosteroids within recommended doses and with 
no systemic effects are permitted.
9) Any topical medications/treatments, which are used for any indication, that could affect 
psoriasis evaluation (including, but not limited to, high potency corticosteroids (WHO Classes 
I-V), >3% salicylic acid, urea, alpha- or beta-hydroxyl acids, anthralin, calcipotriene, vitamin 
D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, pimecrolimus, and 
tacrolimus).
Exception: The following topical treatments may be initiated only at Week 24 per 
investigator’s discretion in subjects who have 
 (See Section 4.1.2.1):
x
High potency corticosteroids (WHO 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 
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visit. Bland emollients (defined as emollients without urea or alpha or beta hydroxy acids or
other ingredients which are pharmaceutically active) are allowed on all body regions but should 
not be used within 24 hours prior to any study visit.
10) 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 4.1.2.1):
11) 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, except for psoriasis, 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 eCRF or the Procedures and Significant non-drug
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 
non-drug 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: 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 pharmaceutically active) are allowed on all body regions but should not be used within 
24 hours prior to any study visit.
6.7.3
Rescue Medications
At Week 24, a subject who has an sPGA 
 may be treated with restricted topicals or 
shampoos, respectively, at the investigator’s discretion (see Section 6.7.1). 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.
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. 
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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
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 
randomization, 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
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x
Unblinding of a subject’s treatment assignment for any reason (emergency or 
nonemergency)
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
Refer to the Schedule of Activities (Section 1.3) 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 1.3. 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 of Study Medication
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 
treatment be placed on hold. Study treatment in this situation should be stopped until the AE is 
medically treated and 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-treatment 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 specified in Section 1.3. 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.
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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 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 1.3) 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, 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 randomization. Randomization should not occur until at least 
8 days after the screening visit to allow collection of PSSD data during screening in order to 
calculate a baseline PSSD score. 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 
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purposes provided the procedure meets the protocol-defined criteria and has been performed 
within the timeframe defined in the Schedule of Activities.
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 assessment for each 
subject. If the evaluator(s) is/are 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. 
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’s Global Assessment (sPGA)
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, 
scale, and induration.24 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 randomization 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 -4 scale), weighted by the area of involvement (head, arms, trunk to groin, and 
legs to top of buttocks).25 PASI produces a numeric score that can range from 0 to 72, with higher 
PASI scores denoting more severe disease activity. 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, PASI 90, and PASI 100 are 
defined similarly. BMS will host a training session prior to initiation of the study to demonstrate 
proper PASI scoring. 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 body surface area involvement is estimated using the handprint method 
with the size of a subject’s handprint (including fingers and thumb) representing 1% of body 
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surface area involved.26,27,28 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.
8.1.1.4
scalp specific Physician’s Global Assessment (ss-PGA)
For this assessment in subjects with scalp involvement,29 scalp lesions are evaluated in terms of 
clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA 
scale:
0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe 
disease.
The ss-PGA should be performed by a dermatologist or appropriately trained investigator who is 
experienced in the assessment of psoriasis patients. An example of the ss-PGA is provided in 
APPENDIX 7.
8.1.1.6
Physician’s Global Assessment-Fingernails (PGA-F)
In this assessment,31 the overall condition of the fingernails is rated on a 5-point scale:
0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
The PGA-F will be performed only in subjects with psoriatic fingernail involvement to assess 
severity and subsequent improvement. An example is provided in APPENDIX 9. The PGA-F
should be performed by a dermatologist or appropriately trained investigator who is experienced 
in the assessment of psoriasis patients.
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8.1.1.8
Palmoplantar PGA (pp-PGA)
This measure will be used for subjects with palmoplantar (including the finger and toe surfaces) 
involvement at baseline.33 The pp-PGA uses a 5-point (0-4) scale:  0 = clear; 1 = almost clear; 2 = 
mild; 3 = moderate; and 4 = severe (see APPENDIX 11). The pp-PGA should be performed by a 
dermatologist or appropriately trained investigator who is experienced in the assessment of 
psoriasis patients.
8.1.2
Subject-reported Assessments
8.1.2.1
Psoriasis Symptoms and Signs Diary (PSSD)
The PSSD is an 11-item subject-reported instrument that assesses severity of symptoms and 
subject-observed signs commonly associated in plaque psoriasis.35,36 It has been shown to be 
reliable and valid in measuring symptoms and signs of subjects with moderate-to-severe plaque 
psoriasis in the clinic and has strong psychometric properties in assessing treatment effects in 
clinical trials.37 The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin 
tightness) and 6 subject-observed signs (skin dryness, cracking, scaling, shedding or flaking, 
redness, bleeding) using 0 to10 numerical ratings. The severity of each item is rated on an 11-point 
numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Two versions of the PSSD 
were developed, one with a 24-hour recall period (PSSD-24h) and one with a 7-day recall period. 
The PSSD-24h will be administered daily in this trial to avoid recall bias with a longer recall period 
(see APPENDIX 13).
8.1.2.2
Dermatology Life Quality Index (DLQI)
The DLQI38 is a subject-reported quality of life index which consists of 10 questions concerning 
symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment 
during the last week. Each question is scored on a scale of 0 to 3 by a tick box: 0 - “not at all,” 1 –
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“a little,” 2 – “a lot,” or 3 – “very much.” The scores are summed, giving a range from 0 (no 
impairment of life quality) to 30 (maximum impairment) (see APPENDIX 14).
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8.1.2.8
Psoriatic Arthritis Screening and Evaluation (PASE) Questionnaire
The psoriatic arthritis screening and evaluation (PASE) questionnaire will be administered at 
screening in subjects with peripheral joint 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 20).
8.2
Adverse Events
The definitions of an AE and SAE can be found in APPENDIX 3.
Adverse events 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, 
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. Therefore, additional 
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information about certain skin-related AEs, infection AEs, CK elevation, and malignancy may be 
collected on the case report form in order to better characterize and understand them.
8.2.2
Time Period and Frequency for Collecting AE and SAE Information
The collection of nonserious 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 1.3).
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.)
8.2.4
Follow-up of AEs and SAEs
x
Nonserious 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 nonserious AEs that cause interruption or discontinuation of 
study treatment and for those present at the end of study treatment as appropriate.
x
All identified nonserious AEs must be recorded and described on the nonserious 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.
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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 Investigator Brochure 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 (CFR) 21 CFR Parts 312 and 320. A 
Suspected, Unexpected Serious Adverse Reaction (SUSAR) 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.
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 informed consent form 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 nonserious AE CRF 
page or SAE Report Form electronic, as appropriate. Paper forms are only intended as a back-up 
option when the electronic system is not functioning.
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x
Any laboratory test result that is clinically significant or meets the definition of an 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
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 drug-induced liver injury is defined as: 
1) Alanine aminotransferase (ALT) or aspartate aminotransferase (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, pre-existing 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 pre-existing medical condition noted during interim or final PE, 
ECG, x-ray filming, any other potential safety assessment required or not required by protocol 
should also be recorded as a nonserious or serious AE, as appropriate, and reported accordingly.
8.3
Overdose
For this study, taking more than 2 days’ worth of study treatment 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 1.3).
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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, and 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 1.3).
8.4.3
Electrocardiograms
A 12-lead electrocardiogram will be performed at the visits indicated in the Schedule of Activities. 
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 1.3 and as defined in exclusion criterion 3.c (Section 5.2). 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.
8.4.5
Clinical Safety Laboratory Assessments
x
Investigators must document their review of each laboratory safety report.
x
Hematology
Hemoglobin (Hgb)
Hematocrit (Hct)
White Blood Cell Count, including differential
Platelet Count
Chemistry
AST
ALT
Total Bilirubin
Total Protein
Albumin
Sodium
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Direct Bilirubin (if total bilirubin > ULN)
Alkaline Phosphatase
Lactate Dehydrogenase (LDH)
Creatinine
Blood Urea Nitrogen (BUN)
Uric Acid 
Glucose (fasting at some visits)
Potassium
Chloride
Calcium
Phosphorus
Creatine Kinase (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)
x
If TSH above normal reference range, test free T4; if TSH below normal range, test 
free T4 & T3
High-Sensitivity C Reactive Protein (hs-CRP)
Serum Immunoglobulins (IgM, IgG, IgA, IgE)
*If CK > 2.5 × ULN, then reflex testing (ie, CK-MB, Troponin I) will be required.
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 and during the study at select visits.
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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 <45mL/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 1.3.
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 (see APPENDIX 21).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 (SIB) Monitoring
Subjects in this clinical trial will be monitored for suicidal ideation and behavior by the eC-SSRS 
(Section 8.4.7.1) at the visits outlined in the Schedule of Activities (Section 1.3). 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 electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a computer-automated, 
patient-reported version of the C-SSRS instrument that defines 11 categories of suicidal ideation 
and behavior events.48,49,50 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
1. Completed suicide
2. Suicide attempt
3. Interrupted attempt
4. Aborted attempt
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5. Preparatory actions toward imminent suicidal behaviors
x
Self-injurious behavior, no suicidal intent
APPENDIX 22 provides definitions of these categories.51
8.4.8
Imaging Safety Assessment
Not applicable.
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8.7
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
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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.
Full Analysis Set (FAS): All subjects who were randomized to receive assigned study treatment.
Following the intent-to-treat principle, subjects will be analyzed according to the treatment group
assigned at randomization. The FAS will be the primary efficacy analysis population.
Per Protocol Set (PPS): A subset of the FAS who are compliant with study treatment and who 
do not have any relevant protocol deviations that may impact the coprimary efficacy endpoint 
assessments (Section 9.6.3). The PPS will be analyzed for the coprimary endpoint comparisons
according to the treatment assigned at randomization.
Randomized Withdrawal Population:
Defined as all Week 24 responder subjects who are 
re-randomized and received at least one dose of study treatment during the randomized withdrawal 
and maintenance period. Subjects will be analyzed according to the treatment assigned at Week 24.
As-treated Population:  All randomized subjects who take at least one dose of study treatment. 
Subjects will be analyzed according to treatment received. The As-treated population will be for 
safety analyses.
9.3
Endpoints 
9.3.1
Primary Endpoints
The coprimary efficacy endpoints for BMS-986165 compared to placebo at Week 16 are defined 
as:
x
sPGA 0/1 response assessed as a proportion of subjects with a sPGA score of 0 or 1
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x
PASI 75 response assessed as a proportion of subjects who achieve a 75% improvement 
from baseline in the PASI score
9.3.2
Secondary Endpoints
9.3.2.1
Key Secondary Endpoints for Comparisons to Placebo
The key secondary endpoints for BMS-986165 compared to placebo at Week 16 are defined as:
x
PASI 90 response assessed as a proportion of subjects who achieve a 90% improvement 
from baseline in the PASI score
x
PASI 100 response assessed as a proportion of subjects who achieve a 100% improvement 
from baseline in the PASI score
x
sPGA 0 response assessed as a proportion of subjects with a sPGA score of 0
x
Change from baseline in PSSD symptom score
x
PSSD symptom score of 0 assessed as a proportion of subjects with a PSSD symptom score 
of 0 among subjects with a baseline PSSD symptom score ≥ 1
x
ss-PGA 0/1 assessed as a proportion of subjects with a ss-PGA score 0 or 1 among subjects 
with a baseline ss-PGA score ≥ 3
x
DLQI 0/1 assessed as a proportion of subjects with a DLQI score of 0 or 1 among subjects 
with a baseline DLQI score ≥ 2
x
PGA-F 0/1 assessed as a proportion of subjects with a PGA-F score of 0 or 1 among 
subjects with a baseline PGA-F score ≥ 3
x
pp-PGA 0/1 assessed as a proportion of subjects with a pp-PGA score of 0 or 1 among 
subjects with a baseline pp-PGA score ≥ 3
An additional key secondary endpoint to assess the maintenance and durability of efficacy of 
BMS-986165 during the randomized withdrawal period through Week 52 among Week 24 
PASI 75 responders compared with re-randomized placebo is defined as:
x
Time to relapse until Week 52
9.3.2.2
Key Secondary Endpoints for Comparisons to Apremilast
The key secondary endpoints for BMS-986165 compared to apremilast at Week 16 are defined as:
x
PASI 75 response assessed as a proportion of subjects who achieve a 75% improvement 
from baseline in the PASI score
x
PASI 90 response assessed as a proportion of subjects who achieve a 90% improvement 
from baseline in the PASI score
x
PASI 100 response assessed as a proportion of subjects who achieve a 100% improvement 
from baseline in the PASI score
x
sPGA 0/1 response assessed as a proportion of subjects with a sPGA score of 0 or 1
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x
sPGA 0 response assessed as a proportion of subjects with a sPGA score of 0
x
Change from baseline in PSSD symptom score
x
PSSD symptom score of 0 assessed as a proportion of subjects with a PSSD symptom score 
of 0 among subjects with a baseline PSSD symptom score ≥ 1
x
ss-PGA 0/1 assessed as a proportion of subjects with a ss-PGA score 0 or 1 among subjects 
with a baseline ss-PGA score ≥ 3
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9.4
Efficacy Analyses
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.
During the active-controlled comparator period data will be presented for the following treatments:
x
BMS-986165 6 mg QD
x
Apremilast 30 mg BID
x
Placebo
For the randomized withdrawal and maintenance period data will be presented for the following 
treatments for assessment of maintenance and durability of re-randomized Week 24 PASI 75 
responders originally randomized to BMS-986165 6 mg QD:
x
BMS-986165 6 mg QD
x
Placebo
For other summaries of the randomized withdrawal and maintenance period data will be presented 
for the following treatments:
x
All BMS-986165 6 mg QD (all subjects exposed to BMS-986165 6 mg QD; includes 
subjects on placebo during the randomized withdrawal and maintenance period that 
switched)
x
BMS-986165 6 mg QD (responders/nonresponders)
x
BMS-986165 6 mg QD→Placebo
x
Placebo-BMS-986165 6 mg QD (starting from Week 16 rather than Week 24)
x
Apremilast 30 mg BID→Placebo
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x
Apremilast 30 mg BID→BMS-986165 6 mg QD
9.4.1
Coprimary Endpoint Analyses
The analysis model for the coprimary efficacy endpoints, sPGA 0/1 and PASI 75 (responder / non-
responder) at Week 16, will use stratified Cochran-Mantel-Haenszel (CMH) tests stratified by 
geographic region (US and rest of world), previous biologic use for psoriasis, psoriatic arthritis or 
other inflammatory disease (yes/no), and body weight (≥90 kg and <90 kg) to compare the 
response rates of BMS-986165 6 mg QD to placebo using the Week 16 data of the FAS. If expected 
cell counts are not sufficient for each strata level, then strata levels will be combined for the
analysis. The odds ratio (ratio of odds in BMS-986165 6 mg QD group to the /odds in placebo 
group) and the corresponding 2-sided 95% confidence interval (CI) will be provided. Estimates of 
proportions and their 2-sided 95% CIs will be provided.
9.4.1.1
Imputation Methods for Coprimary Endpoints
Non-responder imputation (NRI) will be used for coprimary efficacy endpoints for subjects who 
discontinue study or treatment of study prior to Week 16, start a protocol prohibited 
medication/therapy that could improve psoriasis during the first 16 weeks of treatment, or who 
have otherwise missing endpoint data at the specified timepoint. NRI will the primary method of 
imputation for the coprimary efficacy endpoints.
9.4.1.2
Sensitivity Analyses for the Coprimary Endpoints
The following imputation methods will be used in sensitivity analyses of the coprimary efficacy 
endpoints:
x
Last observation carried forward (LOCF) for subjects with missing values at Week 16
x
For subjects with missing values at Week 16, LOCF will be used for placebo subjects. NRI 
will be used for BMS-986165 6 mg QD subjects. This will include subjects who 
discontinue early, start a protocol prohibited medication/therapy prior to Week 16 that 
could improve psoriasis, or who have otherwise missing endpoint data at Week 16
9.4.1.3
Supportive Analyses for the Coprimary Endpoints
The coprimary efficacy endpoints will be analyzed using the Week 16 data of the PPS using the 
analysis described in Section 9.4.1 and the imputation methods described in Section 9.4.1.1.
Additionally, the coprimary efficacy endpoints for the FAS will be analyzed with a logistic 
regression model with treatment, geographic region, prior biologic treatment use, and body weight 
strata. Proportions and 2-sided 95% confidence intervals will be provided.
9.4.1.4
Subgroup Analyses for the Coprimary Endpoints
Subgroup analyses will be conducted for the coprimary efficacy endpoints for the FAS using the 
analysis described in Section 9.4.1 and the imputation methods described in Section 9.4.1.2.
Subgroups to be evaluated may include the following:
x
Gender
x
Age categories (< 65; ≥65)
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x
Race
x
Body weight categories (< 90 kg; ≥90 kg)
x
Prior biologic use (yes/no)
x
Prior systemic treatment of psoriasis (yes/no)
x
Geographic region (per stratification factor; US or rest of world)
9.4.2
Secondary Endpoint Analyses 
The analysis model for the binary secondary endpoints will use stratified CMH tests stratified by 
geographic region (US and rest of world), prior biologic treatment use (yes/no), and body weight 
(≥90 kg and <90 kg) to compare the response rates of BMS-986165 6 mg QD to placebo or 
apremilast for the FAS. If expected cell counts are not sufficient for each strata level, then strata 
levels will be combined for the analysis. The odds ratio (ratio of odds in BMS-986165 6 mg QD 
group to the /odds in placebo group or active comparator group) and the corresponding 2-sided 
95% CI will be provided.
The analysis model for continuous secondary endpoints will use analysis of covariance 
(ANCOVA) with treatment, geographic region (US and rest of world), prior biologic treatment 
use (yes/no), and body weight (≥90 kg and <90 kg) as fixed effects. The baseline value will be
added into the model as a covariate. Treatment differences based on least-squares (LS) means and 
the corresponding 2-sided 95% CIs will be provided for the difference between BMS-986165 6 mg 
QD and placebo or active comparator depending on the endpoint being assessed.
9.4.2.1
Imputation Methods for Secondary Endpoints
NRI will be applied to the analyses of binary secondary efficacy endpoints for subjects who 
discontinue early, start a protocol prohibited medication/therapy that could improve psoriasis, or 
who have otherwise missing endpoint data at the specified timepoint. 
For continuous secondary efficacy endpoints, baseline observation carried forward (BOCF) will 
be used for subjects who discontinue study treatment due to:
x
Lack of efficacy
x
Adverse events
Additionally, BOCF will be used for subjects who start a protocol prohibited medication/therapy 
that could improve psoriasis. LOCF will be used for all other missing data.
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9.4.4
Time-to-Relapse Endpoint
The Kaplan-Meier product limit method will be used to estimate the distribution curves for 
time-to-relapse during the Randomized Withdrawal and Maintenance Period. Relapse is defined 
as the first loss of 50% or greater of the PASI percent improvement at Week 24 any time during 
the Randomized Withdrawal and Maintenance Period. Treatment comparisons of subjects re-
randomized at Week 24 to BMS-986165 6 mg QD or placebo will be performed using the log-
rank test stratified by geographic region (US and rest of world), prior biologic treatment use 
(yes/no), and body weight (≥90 kg and <90 kg).
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 for the active 
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comparator-controlled period, randomized withdrawal period, and overall. 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.
During the active comparator-controlled period, data will be presented for the following 
treatments:
x
BMS-986165 6 mg QD
x
Apremilast 30 mg BID
x
Placebo
For the randomized withdrawal and maintenance period data will be presented for the following 
treatments for assessment of maintenance and durability of re-randomized Week 24 PASI 75 
responders originally randomized to BMS-986165 6 mg QD:
x
BMS-986165 6 mg QD
x
Placebo
For other summaries of the randomized withdrawal and maintenance period data will be presented 
for the following treatments:
x
All BMS-986165 6 mg QD (all subjects exposed to BMS-986165 6 mg QD; includes 
subjects on placebo during the randomized withdrawal and maintenance period that 
switched)
x
BMS-986165 6 mg QD (responders/nonresponders)
x
BMS-986165 6 mg QD-Placebo
x
Placebo-BMS-986165 6 mg QD (starting from Week 16 rather than Week 24)
x
Apremilast 30 mg BID-Placebo
x
Apremilast 30 mg BID-BMS-986165 6 mg QD
9.5.1
Adverse Events
Treatment-emergent adverse events (TEAEs), SAEs, 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 AEIs, and each AE 
adjudicated category (ie, infections, cardiovascular, and suicidal ideation/behavior) 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 by treatment for each applicable analysis 
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 World Health Organization (WHO) Drug Dictionary, will be summarized by treatment for the 
As-treated population. Medications with an end date prior to the first dose of study drug will be
considered prior medications.
9.6.3
Relevant Protocol Deviations
Relevant protocol deviations are deviations that can have an impact on the primary efficacy 
endpoints. The impact of relevant protocol deviations on the primary efficacy results will be 
assessed by excluding subjects from the FAS to define the PPS in supportive analyses of the 
primary efficacy endpoints. Relevant protocol deviations to be considered regarding exclusion of 
subjects from the FAS will include the following:
x
Subject randomized but did not take any study treatment
x
Subject failed to meet any study inclusion criteria but was randomized to receive study 
treatment
x
Subject met a study exclusion criterion which may have an impact on the coprimary 
efficacy endpoints but was randomized to receive study treatment
x
Subject non-compliant with study treatment within the first 16 weeks of treatment; defined 
as <80% compliant with study treatment 
x
Subject took prohibited concomitant medication prior to Week 16
x
Subject received treatment different to intended treatment at any visit prior to Week 16
All subjects with relevant protocol deviations will be identified prior to database lock. Relevant 
protocol deviations will be summarized by treatment group and deviation category for the FAS
population.
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9.7
Interim Analyses
No interim analysis is currently planned.
9.8
Statistical Impacts Due to COVID-19
9.8.1
Impact on Efficacy Endpoints 
There are no COVID-19-related impacts to the Week 16 efficacy endpoints as all subjects 
remaining in the trial completed the Week 16 visit prior to COVID-19 site restrictions. Efficacy 
endpoints involving Week 24 and later visits may be impacted by COVID-19 in the form of 
missing data and/or a treatment assignment defaulting to BMS-986165.
Censoring rules will be applied to the PASI 75 time-to-relapse endpoint for re-randomized subjects 
due to the following COVID-19-related issues post Week 24:
x
Subject study treatment assignment was defaulted to BMS-986165 because they had a 
remote safety monitoring visit due to COVID-19 and efficacy assessments were not 
performed. The subject will be censored at the time of the remote visit if relapse had not 
been observed already;
x
Subject has missing visit(s) (ie, efficacy assessments not performed) after Week 24 and 
assuming relapse was not observed prior to missed visit(s):
o
If the subject returns at a later visit and is found to have relapsed, midpoint 
imputation will be used to determine time-to-relapse (ie, midpoint of the censoring 
interval).
o
If the subject returns at a later visit and has not relapsed, then the subject will 
continue to be evaluated for relapse.
o
If the subject is discontinued from study treatment, then the subject will be 
censored at the time of study treatment discontinuation.
Sensitivity analyses for time-to-relapse may be performed with additional details provided in the 
statistical analysis plan prior to database lock.
Data handling due to COVID-19-related issues for other efficacy endpoints 
 will 
be described in the statistical analysis plan prior to database lock.
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9.8.2
Impact on Safety Variables
No modifications are planned for the analysis of safety data due to COVID-19-related issues. There 
will not be any additional safety data handling considerations for missing data or treatment 
interruptions due to COVID-19.
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10
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Kupetsky EA, Keller M. Psoriasis vulgaris: an evidence-based guide for primary care. J Am 
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Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality 
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17 Eli Lilly. Taltz® (ixekizumab). United States Prescribing Information. 2017.
18 Valeant. Siliq® (brodalumab). United States Prescribing Information. 2017.
19 Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, Treatment 
Trends, and Treatment Dissatisfaction Among Subjects with Psoriasis and Psoriatic Arthritis 
in the United States. Findings from the National Psoriasis Foundation Surveys, 2003-
2011. JAMA Dermatol 2013;149(10):1180–1185.
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20 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.
21 Tokarski JS, Zupa-Fernandez A, Tredup JA, et al.. Tyrosine Kinase 2-Mediated Signal 
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22 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;100:11594-11599.
 
 
 
24 Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis 
2005;64:ii65-ii68.
25 Fredriksson T, Pettersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 
1978;157(4):238-44.
26 Rossiter ND, Chapman P, Haywood IA. How big is a hand? Burns. 1996;22:230-1.
27 Thomas CL, Finlay AY. The 'handprint' approximates to 1% of the total body surface area 
whereas the 'palm minus the fingers' does not. Br J Dermatol. 2007;157(5):1080-1.
28 Long CC, Finlay AY, Averill RW. The rule of hand: 4 hand areas = 2 FTU = 1 g. Arch 
Dermatol. 1992;128:1129–30.
29 Kragballe K, Menter A, Lebwohl M, et al. Long-term management of scalp psoriasis: 
perspectives from the international psoriasis council. J Dermatol Treat. 2013;24:188-192.
 
 
31 Tan EST, Chong W-S, Liang Tey H. Nail psoriasis: a review. Am J Clin Dermatol. 
2012;13:375-388.
 
 
33 Bissonnette R, Pariser DM, Wasel NR, et al. Apremilast, an oral phosphodiesterase-4 inhibitor, 
in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-
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(ESTEEM) clinical trials in patients with moderate to severe psoriasis. J Am Acad Dermatol. 
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35 Feldman SR. Development of a patient-reported outcome questionnaire for use in adults with 
moderate-to-severe plaque psoriasis: The Psoriasis Symptoms and Signs Diary. Journal of 
Dermatology & Dermatologic Surgery. 2016;20:19–26.
36 Mathias SD. Measurement properties of a patient-reported outcome measure assessing
psoriasis severity: The psoriasis symptoms and signs diary. Journal of Dermatological 
Treatment. 2016;27(4):322-327.
37 Armstrong A, Puig L, Langley R, et al. Validation of psychometric properties and development 
of response criteria for the Psoriasis Symptoms and Signs Diary (PSSD): results from a phase 
III 
clinical 
trial. 
Journal 
of 
Dermatological 
Treatment. 
2017: 
1-31.
DOI: 
10.1080/09546634.2017.1364694.
38 Finlay, AY, Khan, GK: Dermatology Life Quality Index (DLQI): A simple practical measure 
for routine clinical use. Clin Exp Dermatol. 1994;19:210–216.
 
 
 
 
 
44 Husni ME, Meyer KH, Cohen DS, Mody E, Qureshi AA. J Am Acad Dermatol 
2007;57(4):581-7
45 Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, 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):163-173.
47 Dhingra SS, Kroenke K, Zack MM, Strine TW, Balluz LS. PHQ-8 Days: a measurement option 
for DSM-5 Major Depressive Disorder (MDD) severity. Population Health Metrics. 2011;9:11. 
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https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidanc
es/UCM225130.pdf. Accessed 22-Mar-2018.
49 Greist JH, Mundt JC, Gwaltney CJ, Jefferson JW, Posner K. 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, Federico M, Mann JJ, Posner K. 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):887-893.
51 Posner, K, Oquendo MA, Gould M, Stanley B, Davies M. 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;164:1035-1043.
52 Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate 
pain in millimetres? Pain. 1997;72(1-2):95-7.
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11
APPENDICES
APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS .............................................92 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS......................................96 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP AND REPORTING .............................104 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION............................................108 
APPENDIX 5 
STATIC PHYSICIAN’S GLOBAL ASSESSMENT OF 
PSORIASIS (sPGA) ................................................................................112 
APPENDIX 6 
PSORIASIS AREA AND SEVERITY INDEX (PASI)..........................113 
APPENDIX 7 
SCALP SPECIFIC PHYSICIAN’S GLOBAL ASSESSMENT 
(ss-PGA) ..................................................................................................114 
 
APPENDIX 9 
PHYSICIAN’S GLOBAL ASSESSMENT-FINGERNAILS  
(PGA-F) ...................................................................................................117 
 
APPENDIX 11 
PALMOPLANTAR PSORIASIS PHYSICIAN’S GLOBAL 
ASSESSMENT (pp-PGA).......................................................................120 
APPENDIX 13 
PSORIASIS SYMPTOMS AND SIGNS DIARY (PSSD) .....................122 
APPENDIX 14 
DERMATOLOGY LIFE QUALITY INDEX (DLQI)............................123 
APPENDIX 20 
PSORIATIC ARTHRITIS SCREENING AND EVALUATION 
(PASE) QUESTIONNAIRE....................................................................135 
APPENDIX 21 
EIGHT ITEM PATIENT HEALTH QUESTIONNAIRE (PHQ-8)........136 
APPENDIX 22 
SUICIDAL IDEATION AND BEHAVIOR CATEGORIES AND 
DEFINITIONS.........................................................................................137 
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APPENDIX 1
ABBREVIATIONS AND TRADEMARKS
Term
Definition
 
 
AE
adverse event
AEI
adverse event of interest
ALT
alanine aminotransferase
ANCOVA
analysis of covariance
Anti-HCV
hepatitis C virus antibody
AST
aspartate aminotransferase
 
BID
twice daily
BMS
Bristol-Myers Squibb
BSA
body surface area
BUN
blood urea nitrogen
CFR
Code of Federal Regulations
CI
confidence interval
Cmax
maximum plasma concentration
CMH
Cochran-Mantel-Haenszel 
CK
creatine kinase
CT
computed tomography
 
CYP450
cytochrome P450
DILI
drug-induced liver injury
DLQI
Dermatology Life Quality Index
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Term
Definition
DMC
Data Monitoring Committee
DNA
deoxyribonucleic acid
ECG
electrocardiogram
eCRF
electronic case report form
eC-SSRS
electronic Columbia-Suicide Severity Rating 
Scale
eGFR
Estimated Glomerular Filtration Rate
FAS
Full Analysis Set
FDA
Food and Drug Administration
FSH
follicle-stimulating hormone
GI
gastrointestinal
HBcAb
hepatitis B core antibody
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
HIV
human immunodeficiency virus
hs-CRP
high-sensitivity C-reactive protein
IB
Investigator Brochure
ICF
informed consent form
IEC
Independent Ethics Committee
IFN
interferon
IFNJ
interferon gamma
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Term
Definition
IGRA
interferon gamma release assay
IL
interleukin
IM
intramuscular
IMP
investigational medicinal product
IP
investigational product 
IRT
interactive response technology
ITT
intent-to-treat
IV
intravenous
JAK
Janus kinase
LDH
lactate dehydrogenase
LDL
low density lipoprotein
LTBI
latent tuberculosis infection
MACE
Major Adverse Cardiovascular Events
MedDRA
Medical Dictionary for Regulatory Activities
NRI
non-responder imputation
PASE
psoriatic arthritis screening and evaluation
PASI
Psoriasis Area and Severity Index
PD
pharmacodynamics
PE
physical examination
PHQ-8
Eight-Item Patient Health Questionnaire
PK
pharmacokinetics
 
pp-PGA
palmoplantar Physician’s Global Assessment
PsA
psoriatic arthritis
PSSD
Psoriasis Symptoms and Signs Diary
QD
once daily
QOD
every other day
PGA-F
Physician Global Assessment- Fingernails
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Term
Definition
PUVA
Psoralens with ultraviolet A
RNA
ribonucleic acid 
SAE
serious adverse event
SIB
Suicidal Ideation and Behavior
sPGA
static Physician Global Assessment
ss-PGA
scalp specific Physician’s Global Assessment
STAT
signal transducer and activator of 
transcription
TB
tuberculosis
T4
thyroxine
T3
triiodothyronine
 
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
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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 for 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
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. Subinvestigators 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
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. 
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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 
treatments sourced by the site, not supplied by BMS, is solely the responsibility of the investigator 
or designee.
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Clinical Study Report and Publications
A Signatory Investigator must be selected to sign the CSR.
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 subject 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 pre-existing 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).
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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.
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 subject was at risk of death at the time of 
the event; it does not refer to an event which hypothetically might have caused death if it were 
more severe)
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 subject or may require intervention [eg, medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above). Examples 
of such events include, but are not limited to, intensive treatment in an emergency room or at 
home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in 
hospitalization. Potential drug-induced liver injury (DILI) is also considered an important 
medical event (see Section 8.2.8 for the definition of potential DILI). 
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Pregnancy and potential DILI must follow the same transmission timing and processes to BMS as 
used for SAEs (see Section 8.2.6 for reporting pregnancies).
Evaluating AEs and SAEs
Follow-up of 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 even; 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 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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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 (EDC), 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 post-menopausal 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 

intravaginal 

transdermal 
x
Progestogen-only hormonal contraception associated with inhibition of ovulationb

oral 

injectable 
Highly Effective Methods That Are User Independent
x
Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation b
x
Intrauterine device (IUD)c
x
Intrauterine hormone-releasing system (IUS)c
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
Less Than Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of >1% per year when used consistently and correctly.
x
Male or female condom with or without spermicide. Male and female condoms cannot be 
used simultaneously
x
Diaphragm with spermicide
x
Cervical cap with spermicide
x
Vaginal Sponge with spermicide
x
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action
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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 8.2.6 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 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 subtotal 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 7
SCALP SPECIFIC PHYSICIAN’S GLOBAL ASSESSMENT 
(ss-PGA)
Please rate overall scalp psoriasis severity by selecting the overall score based on the following 
rating scale:
Score
Category
Description
0
Absence of 
Disease
No evidence of redness, no evidence of thickness, and no 
evidence of scaliness on the scalp
1
Very Mild Disease
The overall clinical picture consists of flat lesions with barely 
perceptible erythema, with or without a trace of overlying fine 
scale
2
Mild Disease
The overall clinical picture consists of lesions with mild 
erythema, slight, but definite, thickness, and a thin scale layer
3
Moderate Disease
The overall clinical picture consists of lesions with moderate 
erythema, a moderate thickness, and a moderate scaled layer
4
Severe Disease
The overall clinical picture consists of lesions with bright 
erythema, severe thickness, and a severe, coarse thick scale 
layer
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APPENDIX 9
PHYSICIAN’S GLOBAL ASSESSMENT-FINGERNAILS 
(PGA-F)
For this assessment in subjects with psoriasis fingernail involvement, the overall condition of the 
fingernails is rated by the investigator on a 0-4 (5-point) scale. The overall score assigned is based 
on the higher of the nail bed/nail matrix score:
Nail Bed Signs
Nail Matrix Signs
Clear
0
Onycholysis- consistent with a normal nail
AND
Hyperkeratosis- none
AND
Splinter Hemorrhages-consistent with non-psoriatic splinter 
hemorrhages
AND
Nail Bed Erythema- none
No nonpsoriatic nail plate 
irregularities including 
pitting, crumbling, Beau’s 
lines, senile onychorrhexis, 
and nonpsoriatic leukonychia
Minimal
1
Onycholysis- < 10% involved on all nails
OR
Hyperkeratosis- present, but barely detectable elevation of 
nail plate
OR
Nail Bed Erythema- faint
AND
Splinter Hemorrhages- consistent with non-psoriatic splinter 
hemorrhages
No more than 5 pits or 
psoriatic leukonychia on any 
nail
AND
No crumbling
Mild
2
Onycholysis- > 10% on five or more nails
OR
Hyperkeratosis- present with mild elevation of nail plate
OR
Splinter Hemorrhages- present on four or fewer nails
OR
Nail Bed Erythema- mild
Five or more nails with mild 
pitting (eg, >10 pits/nail) or 
psoriatic leukonychia
AND
No crumbling
Moderate
3
Onycholysis- >30% on at least one nail
OR
Hyperkeratosis- present with moderate elevation of nail plate
OR
Splinter Hemorrhages- scattered and present on five or more 
nails
OR
Nail Bed Erythema- moderate
Five or more nails with 
moderate pitting (eg, >25 
pits/nail)
AND
≤25% crumbling on any nails
Severe
4
Onycholysis- > 50% on at least one nail
OR
Hyperkeratosis- present with severe elevation of nail plate
OR
Splinter Hemorrhages- numerous and present on five or more 
nails
OR
Nail Bed Erythema- severe
Five or more nails with 
severe pitting (> 50 pits/nail)
OR
>25% crumbling on any nail
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APPENDIX 11
PALMOPLANTAR PSORIASIS PHYSICIAN’S GLOBAL 
ASSESSMENT (pp-PGA)
Palmoplantar (including finger and toe surfaces) psoriasis lesions are evaluated by the investigator 
based on overall severity, then scored on the following 5-point scale:
Score
Category
Description
0
Clear
No signs of plaque psoriasis
1
Almost 
Clear
Just perceptible erythema and just perceptible scaling
2
Mild
Light pink erythema, with minimal scaling with or without pustules
3
Moderate
Dull red, clearly distinguishable erythema with diffuse scaling, some 
thickening of the skin, with or without fissures, with or without pustule 
formation
4
Severe
Deep, dark red erythema with obvious and diffuse scaling and 
thickening as well as numerous fissures with or without pustule 
formation
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APPENDIX 13
PSORIASIS SYMPTOMS AND SIGNS DIARY (PSSD)
Please answer each question to the best of your ability. There are no right or wrong answers. Please 
pay close attention to the time period of interest. These questions ask you to think about the past 
24 hours. Please complete the diary at the same time every day.
Individuals with psoriasis may experience a range of symptoms. Please indicate how severe each 
of the following skin symptoms was in the past 24 hours. Please select only one number for  each 
item on the 0 to 10 scale (0=Absent and 10= Worst imaginable).
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APPENDIX 14
DERMATOLOGY LIFE QUALITY INDEX (DLQI)
Hospital No:
Date:
Score:
Name:
Diagnosis:
Address:
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER THE 
LAST WEEK. Please tick one box for each question.
Please check you have answered EVERY question. Thank you
1.
Over the last week, how itchy, sore, painful or stinging has your skin been?
Very much 
A lot
A little 
Not at all
2.
Over the last week, how embarrassed or self-conscious have you been because 
of your skin?
Very much 
A lot
A little 
Not at all
3.
Over the last week, how much has your skin interfered with you going shopping 
or looking after your home or garden?
Very much 
A lot
A little 
Not at all
Not relevant
4.
Over the last week, how much has your skin influenced the clothes you wear?
Very much 
A lot
A little 
Not at all
Not relevant
5.
Over the last week, how much has your skin affected any social or leisure activities? Very much 
A lot
A little 
Not at all
Not relevant
6.
Over the last week, how much has your skin made it difficult for you to do any sport? Very much 
A lot
A little 
Not at all
Not relevant
7.
Over the last week, has your skin prevented you from working or studying?
yes 
no
Not relevant
If “No”, over the last week how much has your skin been a problem at work or
studying?
A lot 
A little
Not at all
8.
Over the last week, how much has your skin created problems with your partner 
or any of your close friends or relatives?
Very much 
A lot
A little 
Not at all
Not relevant
9.
Over the last week, how much has your skin caused any sexual difficulties?
Very much 
A lot
A little 
Not at all
Not relevant
10. Over the last week, how much of a problem has the treatment for your skin been, 
for example by making your home messy, or by taking up time?
Very much 
A lot
A little 
Not at all
Not relevant
Approved
2.0
v
Approved
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Approved
2.0
v
Approved
2.0
v

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Approved
2.0
v
Approved
2.0
v

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Approved
2.0
v
Approved
2.0
v

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Approved
2.0
v
Approved
2.0
v

Clinical Protocol
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Approved
2.0
v
Approved
2.0
v

Clinical Protocol
IM011047
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TYK2 Inhibitor
21 May 2020, Revised Protocol 09, Final Approved BMS Confidential
128
Approved
2.0
v
Approved
2.0
v

Clinical Protocol
IM011047
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TYK2 Inhibitor
21 May 2020, Revised Protocol 09, Final Approved BMS Confidential
129
Approved
2.0
v
Approved
2.0
v

Clinical Protocol
IM011047
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TYK2 Inhibitor
21 May 2020, Revised Protocol 09, Final Approved BMS Confidential
130
Approved
2.0
v
Approved
2.0
v

Clinical Protocol
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Approved
2.0
v
Approved
2.0
v

Clinical Protocol
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Approved
2.0
v
Approved
2.0
v

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Approved
2.0
v
Approved
2.0
v

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APPENDIX 20
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 5-6 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
2.0
v
Approved
2.0
v

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APPENDIX 21
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 0-3. The overall score is determined by adding up each of 
the individual answers from each question. 
Scoring interpretation is as follows: 0-4 no significant depressive symptoms, 5-9 mild depressive 
symptoms, 10-14 moderate depressive symptoms, 15-19 moderately severe depressive symptoms, 
and 20-24 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
2.0
v

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APPENDIX 22
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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v

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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
2.0
v