Clinical trial NCT03881059
Conditions: Active Psoriatic Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2019-04-01; Completion date: 2021-01-27
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily \[QD\]) at Week 16 in the treatment of participants with active PsA.

Detailed description:
The study is intended to evaluate the safety and efficacy of BMS-986165 Dose A or B once daily (QD) compared with placebo in adults with active PsA. The primary endpoint is american college of rheumatology (ACR) 20 response at Week 16 (Part A).

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: BMS-986165 Placebo intervention 2: BMS-986165 Dose A intervention 3: BMS-986165 Dose B intervention 4: Ustekinumab intervention 5: Ustekinumab Placebo
Intervention descriptions: intervention 1: Participants will receive BMS-986165 matching placebo QD intervention 2: Participants will receive BMS-986165 Dose A QD. intervention 3: Participants will receive BMS-986165 dose B QD. intervention 4: Participants will receive ustekinumab SQ injection QD. intervention 5: Participants will receive ustekinumab SQ matching placebo QD

Protocol documents:
Prot_000.pdf: 
Clinical Protocol 
IM011084 
BMS-986165 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
1 
 
 
Page: 1 
Protocol Number:  IM011084 
IND Number: 137, 445 
 
EX-US Non-IND 
 
EUDRACT Number: 2018-004293-10 
Date, Version: 23 September 2019 
Revised Protocol 05, Global, 
v2.0, Final, Approved 
  
 
 
Clinical Protocol IM011084 
A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and 
Safety of Multiple Doses of BMS-986165 in Subjects with Active Psoriatic Arthritis (PsA) 
Short Title: Efficacy and Safety of BMS-986165 Compared with Placebo in Subjects with 
Active Psoriatic Arthritis (PsA) 
Revised Protocol Number 05 
Based on the Global Protocol IM011084, version 1.0, dated 06 December 2018 
Study Director 
 
Dr. Miroslawa Nowak 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Clinical Protocol 
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BMS-986165 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
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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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DOCUMENT HISTORY 
Document 
Date of Issue 
Approver(s) 
Summary of Change 
Original Protocol 
03-December-2018 
 
 
  
  
 
 
 
 
 
 
 
Not applicable 
Amendment 1 
(Czech Republic, 
Hungary, Italy, and 
Russia) 
02 April 2019 
 
 
 
  
 
 
 
 
 
 
This country-specific 
amendment applies to all 
subjects enrolled in the 
Czech Republic, Hungary, 
Italy, and Russia. This 
amendment is to limit the 
PROMIS questionnaire to 
the standard short 
form 13a. The additional 
5 questions that are 
included in the global 
protocol v1.0 
Appendix 13 were 
removed because they are 
not translated into the 
languages of these 
4 countries. 
Amendment 2 
(Poland) 
14 May 2019 
 
 
  
  
 
 
 
 
 
 
This country-specific 
amendment applies to all 
subjects enrolled in 
Poland. This amendment 
is to limit the PROMIS 
questionnaire to the 
standard short form 13a. 
The additional 5 questions 
that are included in the 
global protocol v1.0 
Appendix 13 were 
removed because they are 
not translated into the 
local language. 
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Revised Protocol 3 
(United Kingdom) 
11 July 2019 
 
 
 
  
 
 
 
 
  
 
This country-specific 
amendment applies to all 
subjects enrolled in the 
United Kingdom. The 
purpose and management 
of Part B of the study 
have been clarified with 
regard to 
, study 
objectives, and use of 
ustekinumab. Several 
exclusion criteria and, 
where applicable, the 
corresponding item in 
Section 6.7.1 (Prohibited 
and/or Restricted 
Treatments) have been 
revised. Language in 
APPENDIX 4 (Women of 
Childbearing Potential 
Definitions and Methods 
of Contraception) and 
Section 7 
(Discontinuation Criteria) 
has been clarified. 
Revised Protocol 4 
(Germany) 
08 August 2019 
 
 
 
  
 
 
 
 
 
 
This country-specific 
amendment applies to all 
subjects enrolled in 
Germany. Changes 
incorporated into this 
protocol include:  
1) Exclusion Criterion 7a 
has been revised to 
exclude prisoners or 
subjects who are 
involuntarily incarcerated 
from trial participation.  
2) Section 7.1.1 (Post 
Study Treatment Follow-
up) has been revised to 
state that participants who 
discontinue study 
treatment will be followed 
through the 30-day safety 
follow-up visit or longer, 
as required, and in line 
with Section 8.2.4. 
3) Section 8.2.2 and 
Appendix 3 have been 
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revised to state that SAEs 
need to be reported 
‘immediately’ to Sponsor 
or designee but no later 
than 24 hours, after 
awareness of the event 
4) Section 8.2.6 
(Pregnancy) has been 
revised to state that study 
drug treatment must be 
discontinued immediately 
in case of pregnancy and 
language regarding any 
consideration regarding 
re-instating treatment has 
been removed. 
Revised Protocol 5 
(Global) 
TBD 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
conditions for the 
exclusion of TNFi-
experienced subjects have 
been clarified. 
3) Part B, allowed rescue 
meds and conditions for 
discontinuation have been 
clarified 
4) Time frames for 
assessments of endpoints 
have been clarified. 
5) Use of the FACIT-
Fatigue and PROMIS-
Fatigue questionnaires for 
assessing fatigue has been 
clarified.  
6) Inclusion criteria have 
been modified to  allow 
the use of Class V or 
higher topical 
corticosteroids  
7) Text has been added to 
confirm that unblinded 
site monitors will be 
involved in drug 
accountability in Part B 
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8) Text has been added to 
clarify that only prior and 
prescribed meds are 
allowed during study and 
are recorded in the CRF 
9) Specification that the 
WLQ short form is being 
used in the study 
 
 
 
 
11) Systemic exposure to 
BMS-986165 defined as 3 
days after the end of study 
treatment, plus 30 days. 
12) Added reference to 
Appendix 4 for 
contraception instructions 
13) Clarified time periods 
pre- and post-study when 
subjects are allowed live 
vaccinations 
14) Redefined exclusion 
criteria re: prohibition of 
prior psoriasis meds 
This global amendment 
supersedes and replaces 
the country-specific 
Amendment 1 in the  
Czech Republic, Hungary, 
Italy, and Russia and the 
country-specific 
Amendment 2 in Poland. 
 
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SUMMARY OF CHANGES 
 
 
 
 
 
 
 
 
  
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Protocol Section 
Revised Protocol Text 
Rationale for Change 
Document 
History  
Amendment 1: (Czech Republic, Hungary, Italy, and Russia) 
Amendment 2: (Poland) 
Amendment 3: (United Kingdom) 
Amendment 4: (Germany) 
 
 
 
 
Section 1.3, 
Schedule of 
Assessments, 
Table 2 and Table 
3, Clinical 
Efficacy/Health 
Outcomes 
Clinical Efficacy/Health Outcomes: 
Fatigue (PROMIS Fatigue or FACIT-Fatigue) 
Column Note: 
See Section 8.1.15 
 
 
 
 
 
 
 
 
 
 
Section 1.3 
Schedule of 
Assessments, 
Table 3 
 
 
 
 
 
 
 
 
 
 
 
Section 3 
Objectives and 
Endpoints 
Efficacy:  
• PROMIS-Fatigue where available or FACIT-Fatigue where 
PROMIS is not available 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
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Protocol Section 
Revised Protocol Text 
Rationale for Change 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
Section 4.1 
Overall Design, 
Part B 
All Part A placebo subjects willwho receive ustekinumabplacebo 
in Part B; Part A A will receive ustekinumab in Part B 
according to approved labeling for PsA; subjects who receive 
BMS- 986165 subjects who in Part A and achieve MDA will 
continue treatment with BMS-986165 at the same dose in Part B, 
and Part Asubjects who receive BMS-986165 subjects who in 
Part A and fail to achieve MDA will receive ustekinumab in Part 
B. 
 
 
 
 
 
 
 
Section 4.1 
Overall Design, 
Part B 
Section 6.7.2 
Rescue 
Medications 
Section 7.2 
Discontinuation 
from Study 
Subjects 
who 
need 
additional 
rescue 
therapy 
with 
glucocorticosteroidsor additional therapy for PsA and/or flares 
after the Week 28 timepoint of Part B will be discontinued from the 
study. 
 
 
 
 
Sec 4.1.1 Data 
Monitoring 
Committee and 
Other External 
Committees 
4.1.1 Data Monitoring Committee and Other External Committees 
4.1.1.1 Data Monitoring Committee 
4.1.1.2 Infection Adjudication Committee 
An independent Infection Adjudication Committee, composed 
of individuals with relevant expertise, will review and 
adjudicate infection AEs, such as opportunistic infections, 
influenza, herpes zoster, and TB, reported in the study. 
Additional information about these infections may be collected 
on the case report form (CRF) in order to characterize and 
understand them. The Adjudication Committee members will 
 
 
 
 
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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. 
4.1.1.3 Cardiovascular (CV) Adjudication Committee 
An independent cardiovascular (CV) Adjudication Committee, 
composed of individuals with relevant expertise, will review 
and adjudicate CV and cerebrovascular AEs such as, but not 
limited to, Major Adverse Cardiovascular Events (MACE) 
that include death, nonfatal myocardial infarction, nonfatal 
stroke; revascularization procedures; heart failure; 
dysrhythmias; heart blocks; and thrombotic events reported in 
the study. Additional information about CV and 
cerebrovascular AEs may be collected on the CRF in order to 
characterize and understand them. The Adjudication 
Committee members will be blinded to the treatment 
assignment of subjects. The structure, responsibilities, and 
procedures of the Adjudication Committee will be outlined in 
a charter. The Adjudication Committee is distinct from the 
DMC and Adjudication Committee members will not be 
investigators on the study 
Section 5.1 
Inclusion Criteria, 
2(b) 
b) Note: If a prospective subject was previously exposed to a 
second TNFi and discontinued for reasons other than 
intolerance or lack of response (eg, used < 3 months), the 
Medical Monitor should be contacted to discuss whether the 
subject should be enrolled. 
 
 
 
 
 
 
Section 5.1 
Inclusion 
Criteria 2j 
Section 6.7.1 
Prohibited and/or 
restricted 
treatments, 9 
Note: Only low potency (Class V or VIhigher) topical 
corticosteroids are permitted and restricted to use solely on the 
palms, soles, face, and intertriginous areas 
 
 
 
 
 
 
  
Section 5.1 
Inclusion Criteria, 
2k 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
Section 5.1 
Inclusion Criteria, 
3d and 3e 
3 d) Women of childbearing potential (WOCBP) must agree to 
follow instructions for method(s) of contraception (APPENDIX 4) 
for the duration of treatment with study drugs and until the end of 
relevant systemic exposure plus 5 half-lives of study drug plus 30 
 
 
 
 
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days (duration of ovulatory cycle) post-treatment completion. 
Therefore, in Part A, WOCBP must agree to follow instructions 
for methods of contraception for 33 days post- treatmenttreatment 
completion, while and in Part B, WOCBP must agree to follow 
instructions for methods of contraception for 190 days post-
treatmentafter completion of treatment. 
i) Note: 
(1) Longer durationLocal laws and regulations may require use 
of alternative and/or additional contraception methods; 
additionally, alternative and/or additional contraceptive may 
be required eg, based on local guidelines or ifbackground 
DMARDS the subject ismay be taking background DMARDs, 
such as MTX or methotrexate, leflunomide, etc. 
3 e) Males who are sexually active with WOCBP must also agree 
to follow instructions for method(s) of contraception (APPENDIX 
4) for the duration of treatment with study treatment plus 5 half-
lives of drugs and until the study treatment plus 90 days (duration 
of sperm turnover) post-treatment completion end of relevant 
systemic exposure. Therefore, in Part A, males who are sexually 
active with WOCBPmale subjects must agree to follow 
instructions for methods of contraception for 93 days post-
treatment completion, while(5 half-lives of study treatment plus 
duration of sperm turnover) after end of treatment, and in Part  
B males must agree to follow instructions for methods of 
contraception , for 250 days post-after end of treatment 
completion. 
i) Note: 
(1) Longer durationLocal laws and regulations may be 
requiredrequire 
use 
of 
alternative 
and/or 
additional 
contraception methods; eg, based on local guidelines or 
ifbackground DMARDS the subject ismay be taking background 
DMARDs, such as MTX ormethotrexate, leflunomide, etc. 
 
 
 
 
 
 
 
 
 
 
 
 
Section 5.2 
Exclusion 
Criteria, 2d  
2 d) Received live vaccine(s) within 60 days prior to Day 1, or 
plans to receive a live vaccine during the study, or within 60 days 
after completing studyPart A, or within 15 weeks of receiving 
the last dose of Part B treatment 
 
 
 
 
 
 
Section 5.2 
Exclusion 
Criteria, 4a iii 
iii) History of use of agents that modulate lymphocyte trafficking 
(eg, natalizumab, efalizumab), or agents that modulate B cells or T 
cells (eg, alemtuzumab, abatacept, alefacept, or visilizumab)  
 
 
 
 
 
 
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Section 5.2 
Exclusion 
Criteria, 4c and 
5g  
4 c) Any major surgery within 4 weeks prior to Day 1, or any 
planned surgery for the first 52 weeks of during the study 
5 g) Total, unconjugated and/or conjugated bilirubin 
> 1.5 × upper limit of normal (ULN) at screening except for any 
subject with a diagnosis of Gilbert’s syndrome 
 
 
 
 
 
 
 
 
 
 
Section 6.1.1 
Dose Schedule, 
Part A 
Any missed dosesdose should be taken within the next 6 hours. 
If the subject is unable to take this dose within this time 
period, the subject should skip this dose. Any missed dose 
should be returned at the next study visit 
 
 
 
Section 6.3.1 
Maintaining the 
Blind 
Investigative site staff, the Sponsor, and subject will remain 
blinded to treatment assignment with the exception of an 
unblinded pharmacist (or appropriate drug preparation person), an 
unblinded study drug administrator (Part B), and an unblinded site 
monitor who will only be involved only with drug accountability 
in Part B. 
The syringe used for administration of ustekinumab or placebo must 
be identical.  However; the color and viscosity of the solutions may 
be different.  Even though the subject will not be able to distinguish 
the difference, study personnel who administers both preparations 
may be able to perceive the difference.  Even though the subject will 
not be able to distinguish the difference, study personnel who 
administer both preparations may be able to perceive the difference. 
 
 
 
 
 
  
Section 6.7.1 
Prohibited and/or 
Restricted 
Treatments, (2), 
(3), (11), and 
(12), plus text at 
end of section 
2) Use of any medications/therapy that would aggravate psoriasis. 
These include agents such as lithium, antimalarials, propranolol, 
indomethacin, and quinidine, unless allowed (see Section 5.1) or it 
is considered necessary for the subject’s welfare and/or treatment of 
an AE/SAE. 
3) Use of opioid analgesics, if the average daily dose is 
> 30 mg/day (Section 5.2), unless it is considered necessary for the 
subject’s welfare and/or treatment of an AE/SAE 
11) Live vaccination during the study or within 60 days after 
completing Part A, or within  15 weeks of receiving the last dose 
of Part B study treatment (Section 5.2) 
12) 
Immune 
suppressing 
immunomodulatory 
agents 
tacrolimus, sirolimus, mycophenolate mofetil, JAK inhibitors, 
and immunosuppressant biologic agents including TNF 
antagonists, natalizumab, vedolizumab, and abatacept 
No additional concomitant medications (prescription, over-the-
counter, or herbal medications not being taken at Day 1) are to be 
administered during the study unless prescribed for treatment of 
specific clinical events.  
 
 
 
 
 
 
 
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Section 7.1 
Discontinuation 
from Study 
Treatment 
• Clinically significant worsening of disease, while taking 
study treatment, that requires the use of medications listed as 
prohibited in the protocol 
 
 
 
 
 
 
Section 7.1.1 
Post-Treatment 
Study Follow-Up 
Subjects who discontinue study treatment will not be followed 
beyondthrough the scheduled 30-day safety follow-up visitperiod 
or longer, as required, and in line with Section 8.2.4. 
 
 
 
Section 7.2 
Discontinuation 
from the Study 
• During Part B of the study (Week 16 to Week 52), and after at 
least 812 weeks of treatment (at Week 28 only), for subjects who 
do not achieve MDA, the study design provides for rescue therapy 
for relief of joint symptoms with NSAIDs, intra-articular 
injections of steroids, systemic glucocorticoids or DMARDs. 
SubjectsAfter Week 28, subjects who need additional 
glucocorticosteroid rescue therapy or additional therapy for PsA 
and/or flares will be discontinued from the study. 
 
 
 
 
 
 
 
Section 8.1.1 
Rater 
Qualification 
Every effort must be made to ensure the same assessor will complete 
the clinical efficacy/health outcome assessments for each subject at 
all visits at approximately the same time throughout the study, 
according to the Schedule of Activities (Section 1.3). Visits should 
be scheduled with the availability of the evaluator(s) taken into 
account. If the assessor is unable to complete the evaluation, then 
another qualified individual can take the place of the initial 
evaluator, but the substitute evaluator should have examined and 
reviewed the subject with the initial evaluator in order to assure 
overlapping experience (consistency between subject evaluations). 
Documentation of who performed the evaluation is to be recorded 
in source notes. 
To be an eligible Joint Assessor, individuals must receive the 
standardized joint count training provided by BMS or be trained by 
an individual who did receive the standardized training 
(documentation filed in the Investigator File and the BMS Study 
File). Such individuals should have appropriate medical credentials 
and/or should be individuals with appropriate scientific/medical 
background who are experienced in performing joint assessments. 
If the individual does not have medical credentials, documentation 
of their experience (preferably on a curriculum vitae) must be 
provided to the BMS site manager, and their eligibility as joint 
assessor must be confirmed by the BMS medical monitor before the 
individual’s participation in the study as joint assessor. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section 8.1.4, 
PASI  
All PASI assessments should be performed by a trained physician 
(dermatologist)assessor or appropriately trained investigator who 
is experienced in the assessment of psoriasis patients.  
 
 
 
 
 
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Section 8.1.8, 
PGA-F 
The PGA-F should be performed by an dermatologist or 
appropriately trained assessor investigator who isexperienced in 
the assessment of psoriasis patients. 
 
 
 
 
 
 
 
Section 8.1.15 
Patient-Reported 
Outcome 
Measures 
Information 
System-Fatigue 
(PROMIS-
FATIGUE) and 
Functional 
Assessment of 
Chronic Illness 
Therapy Fatigue 
(FACIT-Fatigue) 
 
Section 8.1.15 Title: 
Patient Reported Outcome Measures Information System-Fatigue 
(PROMIS-FATIGUE) and Functional Assessment of Chronic 
Illness Therapy Fatigue (FACIT-Fatigue) 
Section Text: 
The Patient Reported Outcome Measures Information System 
Fatigue (PROMIS-Fatigue) and Functional Assessment of 
Chronic Illness Therapy Fatigue (FACIT-Fatigue) instruments 
evaluate a range of self-reported symptoms over the past week, 
from mild subjective feelings of tiredness to an overwhelming, 
debilitating and sustained sense of exhaustion that likely decreases 
one’s ability to execute daily activities. … Fatigue is divided into 
the experience of fatigue (frequency, duration, and intensity) and 
the impact of fatigue on physical, mental; and social activities. 
The first 13 questions of the PROMIS-Fatigue questionnaire 
comprise the FACIT-Fatigue questionnaire.  
The PROMIS-Fatigue questionnaire is not yet available in all 
languages and will be administered at sites where it is available 
in the local language. In countries where the PROMIS-Fatigue 
questionnaire is not available in the local language, sites will 
administer the FACIT-Fatigue questionnaire to start the 
protocol. Once the PROMIS-Fatigue questionnaire is available 
in the local language, and with approval from the ethics 
committee, any newly enrolled subjects will complete the 
PROMIS-Fatigue questionnaire. Subjects who were 
administered the FACIT-Fatigue at Day 1 will continue to be 
administered the FACIT-Fatigue throughout the study. The 
PROMIS-Fatigue Short Form 13a (FACIT-Fatigue), along with 
5 supplemental fatigue items from the PROMIS item bank, are 
provided in APPENDIX 13. 
 
 
 
 
 
Section 8.1.16 
Work Limitation 
Questionnaire 
(WLQ) 
The WLQ Short Form will be used in this study. 
 
 
 
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Section 8.4.5, 
Chemistry 
Fasting glucoseGlucose (fasting at some visits) 
 
 
 
 
 
   
Section 8.5 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
. 
Section 8.5.1 
Sampling 
Schedule 
 
 
 
 
 
 
 
 
 
 
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Section 8.5.2 
Sampling 
Window 
 
 
 
 
 
 
   
 
 
 
   
 
 
 
 
 
 
Section 9.1 
Sample Size 
Determination 
A total sample size of 60 subjects per arm randomized in a blinded 
fashion at a 1:1:1 ratio to BMS-986165 6 mg QD arm, BMS-986165 
12 mg QD arm, and placebo will provide 87.5% power in a mixed 
population to detect a significant dose-response trend compared to 
placebo for the primary endpoint of ACR 20 response at Week 16 
using a trend test with α=0.05 (1-sided). Alternatively, if the test is 
conducted at a 2-sided 0.05 level of significance, the planned 
sample size will provide approximately 79.5% power to detect the 
above difference. α= 0.05 (1-sided) or with α = 0.10 (2-sided). 
 
 
 
 
 
 
 
 
 
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Section 9.4.1.1 
Primary Endpoint 
Analyses 
The primary efficacy analysis model for binary endpoints 
(responder/non-responder) will use a logistic regression model to 
assess whether there is a dose-response trend between ACR 20 
response and dose level. The model will include dose level (0, 6, 
12) as a continuous variable, and the following covariates: 
geographic region, TNFi use (experienced/naïve), DMARD use 
(yes/no), glucocorticosteroid use (yes/no),) and body weight (≥ 90 
kg and < 90 kg) in the model. If the model does not converge, then 
pre-specified covariates will be removed from the model. The odds 
ratio of the dose parameter and the corresponding 2-sided 95% 
confidence interval (CI) will be provided. 
 
 
 
 
 
 
Section 9.4.1.2.2 
 
 
 
 
 
 
 
 
 
 
Section 9.4.1.3 
Secondary 
Endpoint 
Analyses 
The followingsecondary continuous endpoints will be assessed at 
Week 16 using dose-response linear regression analysis. The 
change from baseline in HAQ-DI score will be calculated at 
Week 16 and analyzed using an analysis of covariance (ANCOVA). 
Dose level (0, 6, 12) will be assessed in the model as a continuous 
variable and the following covariates as fixed effects: geographic 
region, TNFi use (experienced/naïve), DMARD use (yes/no), 
glucocorticosteroid use (yes/no),) and body weight (< 90 kg and ≥ 
90 kg). The baseline HAQ-DI 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 dose-response parameter. 
The change from baseline in SF-36 PCS score at Week 16 will use 
a similar analysis method as was used for the change from baseline 
in HAQ-DI score. 
 
 
 
 
 
Section 9.4.1.4 
Adjustment for 
Multiplicity of 
Primary and Key 
Secondary 
Endpoints 
… Testing of secondary endpoints will occur sequentially and may 
only proceed to the next secondary endpoint if the null hypothesis 
is rejected at alpha = 0.05 (0.10 (2-sided) for the prior endpoint 
showing a positive dose-response in that endpoint. If an endpoint 
fails at any step, then all subsequent p-values will be considered 
nominal. 
Secondary Family – secondarySecondary endpoints will be tested 
for a positive dose-response trend at a 1-sided alpha = 0.05. Testing 
order of secondary endpoints will be tested in the following order: 
if the primary endpoint is significant at 1-sided alpha = 0.05 for a 
dose-response relationship: 
a. Change from baseline in HAQ-DI score at Week 16 
 
 
 
 
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Rationale for Change 
b. PASI 75 response at Week 16 
c. Change from baseline in SF-36 PCS score at Week 16 
If the above dose-response analyses provide a significant 
relationship, pairwise comparisons between each BMS-986165 
dose group compared to placebo will follow. Testing for each BMS-
986165 dose group will be set-up in separate testing branches. The 
primary endpoint, ACR 20 at Week 16, will be tested for each BMS-
986165 dose compared to placebo at an alpha = 0.025 (1-sided) 
using Bonferroni adjustment to the overall Type 1 error rate of 0.05 
(1-sided). If the primary endpoint is significant for a particular 
BMS-986165 dose compared to placebo, then testing will proceed 
for the secondary endpoints for that BMS-986165 dose. A similar 
testing order as described above within each branch will be followed 
for each secondary endpoint.  
There will be no multiplicity adjustment for testing of additional 
endpoints. Nominal p-values will be provided as descriptive 
statistics. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section 9.4.3.6 
PROMIS-Fatigue 
and FACIT-
Fatigue 
PROMIS-Fatigue score will be summarized by treatment and 
time point for subjects who were administered PROMIS-
Fatigue. FACIT-Fatigue scores will be similarly presented as a 
pooled analysis, which will include FACIT-Fatigue scores 
combined with scores from the first 13 PROMIS-Fatigue 
questions. 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
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Protocol Section 
Revised Protocol Text 
Rationale for Change 
 
 
. 
APPENDIX 4, 
Contraception 
Guidance for 
Female subjects 
of Childbearing 
Potential 
Contraception 
Guidance for 
Male Subjects 
with Partner(s) of 
Childbearing 
Potential  
CONTRACEPTION GUIDANCE FOR FEMALE SUBJECTS OF 
CHILD BEARING POTENTIAL 
One of the highly effective methods of contraception listed below, 
in conjunction with the required restrictions in Inclusion Criterion 
Section 5.1 (3d) of the protocol, is required during study duration 
and until the end of relevant systemic exposure, defined as # Days/ 
Weeks Relevant Exposure days/weeks after the end of study 
treatment, plus 30 days. As such, in Part A WOCBP must agree 
to follow instructions for methods of contraception for 33 days 
post-treatment completion, and in Part B WOCBP must agree 
to follow instructions for methods of contraception for 190 days 
post-treatment completion. 
Local laws and regulations may require use of alternative and/or 
additional contraception methods. Additionally, alternative 
and/or additional contraception methods may be required 
based on background DMARDS the subject may be taking (eg, 
methotrexate, leflunomide, etc.) 
CONTRACEPTION 
GUIDANCE 
FOR 
MALE 
PARTICIPANTSSUBJECTS 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. 
• Male subjects are required to use a condom for study duration and 
until the end of relevant systemic exposure defined as # Days/ 
Weeks Relevant Exposurefor 93 days/weeks after the end of  
btreatment completion in the male participantPart A and 250 days 
post-treatment completion in Part B. 
• 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 # Days/ Weeks Relevant Exposurefor 
93 days/weeks after the end of treatment in the male subject in 
Part A and 250 days after the end of treatment in the male subject 
in Part B. 
• 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 # Days/ Weeks Relevant Exposurefor 93 
days/weeks after the end of treatment in Part A and 250 days after 
the end of treatment in Part B.  
• Refrain from donating sperm for the duration of the study 
treatment and for # Days/ Weeks Relevant Exposure days/weeks93 
 
 
 
 
 
 
 
  
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Protocol Section 
Revised Protocol Text 
Rationale for Change 
days after the end of treatment in Part A and 250 days after the 
end of treatment in Part B. 
 
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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
DOCUMENT HISTORY.................................................................................................................3 
SUMMARY OF CHANGES ...........................................................................................................7 
TABLE OF CONTENTS ...............................................................................................................21 
LIST OF TABLES .........................................................................................................................27 
LIST OF FIGURES .......................................................................................................................27 
1 
PROTOCOL SUMMARY ..........................................................................................28 
1.1 
Synopsis ......................................................................................................................28 
1.2 
Schema ........................................................................................................................39 
1.3 
Schedule of Activities (SOA) .....................................................................................39 
 
 
 
 
 
 
 
 
 
 
 
3 
OBJECTIVES AND ENDPOINTS ............................................................................58 
4 
STUDY DESIGN .......................................................................................................60 
4.1 
Overall Design ............................................................................................................60 
4.1.1 
Data Monitoring Committee and Other External Committees ...................................64 
4.1.1.1 
Data Monitoring Committee .......................................................................................64 
4.1.1.2 
Infection Adjudication Committee ..............................................................................64 
4.1.1.3 
CV Adjudication Committee .......................................................................................64 
4.2 
Number of Subjects ....................................................................................................64 
4.3 
End of Study Definition ..............................................................................................65 
 
 
 
 
5 
STUDY POPULATION .............................................................................................69 
5.1 
Inclusion Criteria ........................................................................................................69 
5.2 
Exclusion Criteria .......................................................................................................71 
5.3 
Lifestyle Restrictions ..................................................................................................75 
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5.3.1 
Meals and Dietary Restrictions ..................................................................................75 
5.3.2 
Caffeine, Alcohol, and Tobacco..................................................................................75 
5.3.3 
Activity ........................................................................................................................75 
5.4 
Screen Failures ............................................................................................................75 
5.4.1 
Retesting During Screening or Lead-in Period ..........................................................75 
6 
TREATMENT ............................................................................................................76 
6.1 
Treatments Administered ............................................................................................78 
6.1.1 
Dose Schedule for Part A ...........................................................................................78 
6.1.2 
Dose Schedule for Part B ...........................................................................................79 
6.2 
Method of Treatment Assignment ..............................................................................80 
6.3 
Blinding ......................................................................................................................81 
6.3.1 
Maintaining the Blind .................................................................................................81 
6.3.2 
Circumstances for Unblinding ....................................................................................82 
6.4 
Dosage Modification ..................................................................................................83 
6.5 
Preparation/Handling/Storage/Accountability ............................................................83 
 
 
6.6 
Treatment Compliance ................................................................................................83 
 
 
 
 
 
 
6.8 
Treatment After the End of the Study .........................................................................85 
7 
DISCONTINUATION CRITERIA ............................................................................86 
7.1 
Discontinuation from Study Treatment ......................................................................86 
7.1.1 
Post-Study Treatment Study Follow Up .....................................................................87 
7.2 
Discontinuation from the Study ..................................................................................87 
7.3 
Lost to Follow-Up.......................................................................................................87 
8 
STUDY ASSESSMENTS AND PROCEDURES ......................................................88 
8.1 
Efficacy Assessments .................................................................................................88 
8.1.1 
Rater Qualification .....................................................................................................88 
8.1.2 
American College of Rheumatology (ACR) Improvement Criteria ............................89 
8.1.3 
Health Assessment Questionnaire-Disability Index (HAQ-DI) ..................................89 
8.1.4 
Psoriasis Area and Severity Index (PASI) ..................................................................90 
8.1.5 
Disease Activity Score (DAS) 28 CRP ........................................................................90 
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8.1.6 
Dactylitis .....................................................................................................................90 
8.1.7 
Enthesitis .....................................................................................................................91 
8.1.8 
Physicians Global Assessment-Fingernails (PGA-F) ................................................91 
8.1.9 
Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) ................91 
8.1.10 
Psoriatic Arthritis Disease Activity Score (PASDAS) ................................................92 
8.1.11 
Disease Activity Index for Psoriatic Arthritis Score (DAPSA) ...................................92 
8.1.12 
PsA Response Criteria (PsARC) .................................................................................92 
8.1.13 
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) .................................92 
8.1.14 
Short Form Health Survey-36 Item (SF-36) ...............................................................92 
8.1.15 
Patient Reported Outcome Measures Information System-Fatigue (PROMIS-
FATIGUE)) .................................................................................................................93 
8.1.16 
Work Limitation Questionnaire (WLQ) ......................................................................93 
8.1.17 
Psoriatic Arthritis Impact of Disease (PsAID) ...........................................................94 
8.1.18 
Routine Assessment of Patient Index Data 3 (RAPID3) .............................................94 
8.1.19 
Imaging Assessment for the Study ..............................................................................94 
8.2 
Adverse Events ...........................................................................................................94 
8.2.1 
Adverse Events of Interest ..........................................................................................94 
8.2.2 
Time Period and Frequency for Collecting AE and SAE Information .......................95 
8.2.3 
Method of Detecting AEs and SAEs ............................................................................95 
8.2.4 
Follow-up of AEs and SAEs ........................................................................................95 
8.2.5 
Regulatory Reporting Requirements for SAEs ...........................................................96 
8.2.6 
Pregnancy ...................................................................................................................96 
8.2.7 
Laboratory Test Result Abnormalities ........................................................................96 
8.2.8 
Potential Drug-Induced Liver Injury (DILI) ..............................................................97 
8.2.9 
Other Safety Considerations .......................................................................................97 
8.3 
Overdose .....................................................................................................................97 
8.4 
Safety ..........................................................................................................................97 
8.4.1 
Physical Examinations ................................................................................................98 
8.4.2 
Vital Signs ...................................................................................................................98 
8.4.3 
Electrocardiograms ....................................................................................................98 
8.4.4 
Tuberculosis Screening and Chest Imaging ...............................................................98 
8.4.5 
Clinical Safety Laboratory Assessments .....................................................................98 
8.4.5.1 
Estimated Glomerular Filtration Rate (eGFR) ........................................................100 
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8.4.6 
Imaging Safety Assessment .......................................................................................100 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 
STATISTICAL CONSIDERATIONS .....................................................................105 
9.1 
Sample Size Determination ......................................................................................105 
9.2 
Populations for Analyses ..........................................................................................105 
9.3 
Endpoints ..................................................................................................................106 
9.3.1 
Primary Endpoint .....................................................................................................106 
9.3.2 
Secondary Endpoints ................................................................................................106 
9.3.3 
Additional Endpoints ................................................................................................106 
 
 
 
 
 
 
 
 
9.4 
Statistical Analyses ...................................................................................................108 
9.4.1 
Efficacy Analyses ......................................................................................................108 
9.4.1.1 
Primary Endpoint Analyses ......................................................................................108 
9.4.1.1.1 
Imputation Methods for Primary Endpoint ..............................................................109 
9.4.1.2 
Sensitivity Analyses for the Primary Endpoint .........................................................109 
9.4.1.2.1 
Supportive Analyses for the Primary Endpoint ........................................................109 
9.4.1.2.2 
Subgroup Analyses for the Primary Endpoint ..........................................................109 
9.4.1.3 
Secondary Endpoint Analyses ...................................................................................110 
9.4.1.3.1 
Imputation Methods for Secondary Endpoints .........................................................110 
9.4.1.4 
Adjustment for Multiplicity of Primary and Key Secondary Endpoints ...................111 
9.4.2 
Safety Analyses .........................................................................................................111 
9.4.2.1 
Adverse Events ..........................................................................................................111 
9.4.2.2 
Vital Signs, ECGs and Physical Examinations .........................................................112 
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9.4.2.3 
Clinical Laboratory Tests .........................................................................................112 
9.4.3 
Other Analyses ..........................................................................................................112 
9.4.3.1 
Demographics and Other Baseline Characteristics .................................................112 
 
 
9.4.3.3 
Relevant Protocol Deviations ...................................................................................112 
 
 
 
 
9.4.3.6 
PROMIS-Fatigue and FACIT-Fatigue .....................................................................113 
 
 
 
 
 
 
9.4.4 
Interim Analyses .......................................................................................................114 
9.5 
Analysis and Reporting .............................................................................................114 
 
 
11 
APPENDICES ..........................................................................................................122 
APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS ...........................................123 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS ....................................128 
REGULATORY AND ETHICAL CONSIDERATIONS ...........................................................128 
GOOD CLINICAL PRACTICE ..................................................................................................128 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE ...................128 
COMPLIANCE WITH THE PROTOCOL AND PROTOCOL REVISIONS............................129 
FINANCIAL DISCLOSURE ......................................................................................................129 
INFORMED CONSENT PROCESS ...........................................................................................129 
SOURCE DOCUMENTS ............................................................................................................130 
STUDY TREATMENT RECORDS............................................................................................131 
CASE REPORT FORMS ............................................................................................................133 
MONITORING ............................................................................................................................133 
RECORDS RETENTION ............................................................................................................134 
RETURN OF STUDY TREATMENT ........................................................................................134 
CLINICAL STUDY REPORT AND PUBLICATIONS .............................................................135 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW UP AND REPORTING ..............................136 
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ADVERSE EVENTS ...................................................................................................................136 
SERIOUS ADVERSE EVENTS .................................................................................................137 
EVALUATING AEs AND SAEs ................................................................................................138 
REPORTING OF SAES TO SPONSOR OR DESIGNEE ..........................................................139 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION ............................................140 
DEFINITIONS .............................................................................................................................140 
CONTRACEPTION GUIDANCE FOR FEMALE SUBJECTS OF CHILD BEARING 
POTENTIAL ............................................................................................................140 
CONTRACEPTION GUIDANCE FOR MALE SUBJECTS WITH PARTNER(S) OF 
CHILD BEARING POTENTIAL. ...........................................................................142 
COLLECTION OF PREGNANCY INFORMATION ................................................................143 
APPENDIX 5 
AMERICAN COLLEGE OF RHEUMATOLOGY CORE 
DATASET AND RESPONSE DEFINITIONS .......................................144 
APPENDIX 6 
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF PHYSICAL FUNCTION SCALE: HEALTH 
ASSESSMENT QUESTIONNAIRE (HAQ) ...........................................145 
APPENDIX 7 
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF DISEASE ACTIVITY VISUAL 
ASSESSMENT SCALE ..........................................................................148 
APPENDIX 8 
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF PAIN SCALE ..........................................................149 
APPENDIX 9 
PSORIASIS AREA AND SEVERITY INDEX (PASI) ..........................150 
APPENDIX 10 
PHYSICIAN’S GLOBAL ASSESSMENT-FINGERNAILS (PGA-
F) ..............................................................................................................151 
APPENDIX 11 
THE BATH ANKYLOSING SPONDYLITIS DISEASE 
ACTIVITY INDEX (BASDAI) ...............................................................152 
APPENDIX 12 
SHORT FORM HEALTH SURVEY-36 ITEM (SF-36) .........................153 
APPENDIX 13 
PROMIS-FATIGUE ................................................................................156 
APPENDIX 14 
WORK LIMITATIONS QUESTIONNAIRE (WLQ) .............................158 
APPENDIX 15 
THE EULAR PSORIATIC ARTHRITIS IMPACT OF DISEASE: 
PsAID 12 FOR CLINICAL PRACTICE .................................................164 
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LIST OF TABLES 
Table 2: 
Procedural Outline IM011084: Part A (Week 0 to Week 20) ...................43 
Table 4: Objectives and Endpoints ................................................................................................58 
Table 5: Study Treatments for IM011084 .....................................................................................77 
Table 6: Part A – Treatment Group and Dosing ............................................................................78 
Table 7: Part B-Treatment Group and Dosing ...............................................................................80 
 
 
 
LIST OF FIGURES 
Figure 1 
Study Design Schematic ............................................................................63 
 
 
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1 
PROTOCOL SUMMARY 
1.1 
Synopsis 
Protocol Title: A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess 
the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects with Active Psoriatic 
Arthritis (PsA)    
Short Title: Efficacy and Safety of BMS-986165 Compared with Placebo in Subjects with Active 
Psoriatic Arthritis (PsA) 
Study Phase: Phase 2 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
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Study Population: 
Men and women ≥18 years of age with PsA for ≥ 6 months, with at least 1 confirmed ≥ 2 cm lesion 
of plaque psoriasis, having active arthritis (a minimum of ≥ 3 swollen joints and ≥ 3 tender joints), 
and who are either biologic-naïve (approximately 70% of the study population) or who have failed 
or been intolerant to 1 TNF-inhibitor (TNFi-experienced, approximately 30% of the study 
population), will be eligible to participate in the study. In addition, subjects entering the study who 
have failed or have been intolerant to non-biologic DMARDs, NSAIDs and /or steroids will be 
allowed to continue their background medications during the study, the details of which are as 
specified in inclusion criteria.  
It is imperative that subjects meet all eligibility criteria. 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. 
Objectives and Endpoints: 
Objective  
Endpoint 
Efficacy 
Primary 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg once daily [QD]) 
at Week 16 in the treatment of subjects with 
active PsA 
• ACR 20 response 
Secondary  
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
daily functional activities  
• Change from baseline in HAQ-DI score  
 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
reducing PsO severity 
• PASI 75 response 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
Patient-Reported Outcomes (PROs) 
• Change from baseline in the Physical 
Component Summary (PCS) score of the SF-36 
Questionnaire  
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Additional  
• Assess the extent of the dose-response 
relationship of BMS-986165 treatment (6 or 
12 mg QD) at Week 16 in active PsA 
• ACR 50 response  
• ACR 70 response 
 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
DAS 28 CRP  
• DAS 28 CRP Low Disease Activity 
• DAS 28 CRP Remission 
• Change from baseline in DAS 28 CRP score 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
dactylitis 
• Change from baseline in dactylitis count 
• Change from baseline in LDI Basic 
• Dactylitis resolution 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
enthesitis 
• Change from baseline in enthesitis count by 
LEI and SPARCC index 
• Enthesitis resolution by LEI and SPARCC 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
Physician’s global assessment – fingernails 
(PGA-F) PsO 
• PGA-F response of 0/1 
 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
MDA 
• MDA response 
 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
psoriatic arthritis activity 
• PASDAS 
• DAPSA 
• Psoriatic Arthritis Response Criteria (PsARC) 
• Assess the dose-response relationship of 
BMS-986165 (6 or 12 mg QD) at Week 16 in 
ankylosing spondylitis activity 
• Bath Ankylosing Spondylitis Disease Activity 
Index (BASDAI) 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
PROs 
• SF-36 Score 
• 
Mental Component Summary (MCS) 
• PsAID 12 
• PROMIS-Fatigue where available or FACIT-
Fatigue where PROMIS is not available 
• Work Limitation Questionnaire (WLQ)  
• Routine Assessment of Patient Index Data 3 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
daily functional activities  
• HAQ-DI 0.35 response  
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• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
reducing PsO severity 
• PASI 90 response 
 
Safety 
• To assess the safety and tolerability of 
BMS-986165 in subjects with active PsA 
• Incidence of adverse events (AEs), SAEs, AEs 
leading to study discontinuation, and target AEs 
of interest (AEIs)  
• Change in laboratory, electrocardiogram (ECG), 
physical examination, and vital sign parameters 
over time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Overall Design: 
This is a 16-week (Part A) randomized, double-blind, placebo-controlled, multicenter study to 
evaluate the safety and efficacy of multiple doses of BMS-986165 in subjects with active PsA. A 
total of approximately 180 subjects with active PsA will be randomized in Part A. This Phase 2 
study will be conducted in a mixed population of subjects with active PsA who have either not 
received prior treatment with a biologic (biologic-naïve, approximately 70%) or who have failed 
or been intolerant to 1 TNF-inhibitor (TNFi-experienced, approximately 30%). In addition, 
investigators will need to specify if the subject’s phenotype is peripheral arthritis or peripheral plus 
psoriatic spondyloarthritis. 
The total duration of participation in Part A is approximately 24 weeks and will be divided into 
the following periods: screening (up to 4 weeks), double-blind placebo-controlled treatment for 
16 weeks (Week 1 to Week 16, Part A), and follow-up (up to 4 weeks). Subjects completing 
double-blind treatment in Part A will have an opportunity to enroll in an optional double-blind 
double-dummy Part B. Treatment in Part B will be given for up to 36 weeks (Week 16 to Week 
52). For subjects completing both Part A and B of the study, the anticipated study duration is 
approximately 60 weeks: screening (up to 4 weeks), double-blind placebo-controlled treatment for 
16 weeks (Week 1 to Week 16, Part A), double-blind double-dummy treatment for 36 weeks 
(Week 16 to Week 52, Part B), and follow-up (up to 4 weeks). 
Efficacy and safety will be assessed throughout the study. 
 
  
Part A 
Subjects will undergo screening evaluations to determine eligibility within 28 days prior to 
administration of study medication. Following the screening process, if subjects are eligible for 
randomization then subjects will be randomized in a 1:1:1 ratio (approximately 60 subjects per 
arm) to 1 of the following 3 treatment groups: 
• Placebo  
• BMS-986165 6 mg QD  
• BMS-986165 12 mg QD  
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Randomization will be stratified by TNFi use (experienced/naïve) and body weight (≥ 90 kg and 
< 90 kg). 
The primary endpoint is ACR 20 response at Week 16.  
In Part A, subjects who discontinue study treatment early for any reason other than consent 
withdrawal will be expected to complete the early termination (ET) visit followed by the safety 
follow-up period. 
Part B 
At Week 16, subjects will have the option to continue to participate in the double-blind Part B of 
the study. All subjects who receive placebo in Part A will receive ustekinumab in Part B according 
to approved labeling for PsA; subjects who receive BMS-986165 in Part A and achieve MDA will 
continue treatment with BMS-986165 at the same dose in Part B, and subjects who receive BMS-
986165 in Part A and fail to achieve MDA will receive ustekinumab in Part B. The treatment 
assignment in Part B will be double-blind, double-dummy as follows: 
• Placebo in Part A: ustekinumab subcutaneous (SQ) injection plus placebo matching  
BMS-986165 QD in Part B 
• BMS-986165 6 mg QD in Part A with MDA at Week 16: BMS-986165 6 mg QD plus 
placebo matching ustekinumab SQ injection in Part B 
• BMS-986165 6 mg QD in Part A without MDA at Week 16: ustekinumab SQ injection 
plus placebo-matching BMS-986165 QD in Part B according to respective country product 
monographs (See Table 5, table note a) 
• BMS-986165 12 mg QD in Part A with MDA at Week 16: BMS-986165 12 mg QD plus 
placebo matching ustekinumab SQ injection in Part B 
• BMS-986165 12 mg QD in Part A without MDA at Week 16: ustekinumab SQ injection 
plus placebo matching BMS-986165 QD in Part B 
In Part B at Week 28, at the discretion of the investigator, the study design provides for rescue 
therapy for relief of joint symptoms with NSAIDs, intra-articular injections of steroids, systemic 
glucocorticoids or DMARDs, as follows:  
• NSAIDs may be added or the dose may be increased according to labeling guidelines  
• A single oral tapering dose of glucocorticosteroid (no greater than 20 mg of prednisone [or 
prednisone equivalent]) per day, not to exceed 2 weeks  
• An intra-articular dose of glucocorticoids (no greater than 40 mg methylprednisolone or  
40 mg of triamcinolone [or methylprednisolone or triamcinolone equivalent]) into 1 joint 
or divided into 2 joints  
• A single intramuscular dose of glucocorticoids (no greater than 40 mg methylprednisolone 
or 40 mg of triamcinolone [or methylprednisolone or triamcinolone equivalent])   
• DMARD treatment may not be started; however: 
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36 
o If already taking MTX, an increase in dose is allowed  (maximum of 25 mg weekly)  
o If already taking sulfasalazine, an increase in dose is allowed  
Subjects who need rescue therapy or additional therapy for PsA and/or flares after the Week 28 
timepoint of Part B will be discontinued from the study. 
At Week 48, subjects will discuss with their investigator/treating physician plans for treatment 
with ustekinumab after study completion. In order to maintain the study blind and to ensure 
continuity of care for those electing to be treated with ustekinumab after the study completion (ie, 
completion of the Week 56 visit), the following Week 52 procedure should be performed: 
• Subjects that elect to be treated with ustekinumab following study completion will receive 
the following treatment at Week 52: 
• 
Subjects that were on ustekinumab treatment in Part B will receive a placebo matching 
ustekinumab SQ injection 
• 
Subjects that were on BMS-986165 6 mg or BMS-986165 12 mg treatment in Part B 
will receive ustekinumab SQ injection  
• Subjects that elect not to be treated with ustekinumab after the study will not receive any 
treatment at Week 52 (regardless of the treatment that they received in Part B).  
Following completion of the Week 56 visit (ie, at the conclusion of the follow-up period of the 
study), subjects that elected to be treated with ustekinumab following study completion, will be 
due for their ustekinumab injection, as follows: 
• Subjects that were on ustekinumab treatment in Part B will be due for their next scheduled 
(12-week) dose of ustekinumab SQ injection following completion of the Week 56 visit 
• Subjects that were on BMS-986165 6 mg or BMS-986165 12 mg treatment in Part B will 
be due for their next scheduled (4-week) dose of ustekinumab SQ injection following 
completion of the Week 56 visit  
Note: Ustekinumab treatment at Week 56 and beyond will be part of standard of care and will not 
be provided by the study Sponsor.  
In Part B, subjects who discontinue study treatment early for any reason other than consent 
withdrawal will be expected to complete the ET visit followed by the safety follow-up period. 
 
Statistical Methods:  
Sample Size and Power Determination: 
A total sample size of 180 subjects randomized in a blinded fashion at a 1:1:1 ratio to BMS-986165 
6 mg QD arm, BMS-986165 12 mg QD arm, and placebo (approximately 60 subjects per arm) will 
provide 87.5% power to detect a significant dose-response trend for the primary endpoint of  
ACR 20 response at Week 16. Power determination is based on the assumption of a placebo 
response rate of 30% and BMS-986165 response rates of 50% and 55% in the 6 mg QD and 12 mg 
QD doses respectively, using a linear trend test with α=0.05 (1-sided) or α=0.10 (2-sided). 
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Clinical Protocol 
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BMS Confidential 
37 
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. Following the intent-to-treat 
principle, subjects will be analyzed according to the treatment assigned at randomization.  
The primary efficacy analysis model for the binary endpoint of ACR 20 response (responder/non-
responder) will use a logistic regression model to assess whether there is a dose-response trend 
between ACR 20 response and dose level. The model will include dose level (0, 6, 12) as a 
continuous variable, and the following covariates: TNFi use (experienced/naïve) and body weight 
(≥ 90 kg and < 90 kg) in the model. Odds ratios and the corresponding 2-sided 95% confidence 
intervals (CIs) will be provided.  
The composite strategy as defined in ICH E9 R1 will be used to address the following intercurrent 
events: 
- 
Subjects who discontinue the treatment or study early (ie, prior to Week 16),  
- 
Start a protocol prohibited medication/therapy,  
- 
Subjects who are lost to follow-up, 
- 
Subjects who otherwise have missing endpoint data at or prior to Week 16.  
Subjects with the above intercurrent events will be imputed using the non-responder imputation 
(NRI) method. 
Additional sensitivity analyses will be conducted considering different strategies used for 
addressing intercurrent events. Supportive analyses on the primary endpoint will be conducted 
using the Per Protocol (PP) set. Tipping point analysis may be performed to assess the robustness 
of the primary imputation method. 
The analysis model for binary secondary and additional endpoints will use a similar analysis model 
as the primary efficacy endpoint. 
The analysis model for continuous secondary and additional endpoints will use analysis of 
covariance (ANCOVA) to assess the dose-response trend. The model will include dose level (0, 
6, 12) as a continuous variable and the following covariates as fixed effects: TNFi use 
(experienced/naïve) and body weight (≥ 90 kg and < 90 kg). 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 also be provided for contrast-based tests. 
For continuous efficacy endpoints, the “Composite” and “While on Treatment” strategies will be 
used to address specific intercurrent events. For subjects who discontinue study treatment and/or 
study due to: 
• Lack of efficacy 
• Adverse events 
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Clinical Protocol 
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38 
or who start a protocol prohibited medication/therapy, the baseline observation will be used as the 
subject’s Week 16 value. For all other intercurrent events, the last valid observation while on 
treatment will be used as the Week 16 value. 
 
 
 
 
 
 
 
 
 
 
 
 
Testing Strategy for Efficacy Endpoints: 
Statistical analysis of secondary endpoints will be performed in a hierarchical fashion. In order to 
preserve the overall Type I error rate, a fixed-sequence testing method will be implemented. 
Testing of secondary endpoints will occur sequentially and may only proceed to the next secondary 
endpoint if the null hypothesis is rejected at alpha = 0.10 (2-sided) for the prior endpoint showing 
a positive dose-response in that endpoint. If an endpoint fails at any step, then all subsequent 
p-values will be considered nominal.  
Safety Analysis: 
Treatment-emergent AEs (TEAEs) and SAEs will be summarized using counts and percentages of 
subjects experiencing the event as well as the number of events by system organ class, preferred 
term, and treatment group. Physical examination findings, vital signs, clinical laboratory test 
results, and ECG test results will be summarized using descriptive statistics (n, mean, standard 
deviation, median, minimum, and maximum) for continuous variables and frequency distributions 
(counts and percentages) for categorical variable. 
 
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Clinical Protocol 
 
IM011084 
BMS-986165 
 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
40 
Table 1: 
 Screening Procedural Outline IM011084 
Procedure 
Screening 
Visit 
Notes 
 
Eligibility Assessments 
 
 
Informed Consent 
X 
A subject is considered enrolled only when a 
protocol-specific informed consent is signed 
Enroll Subject in the interactive response technology (IRT) system 
X 
 
Inclusion/Exclusion Criteria 
X 
Includes PsA Classification Criteria for Psoriatic 
Arthritis (CASPAR), active arthritis 
(tender/swollen joints), plaque psoriasis 
PsA History, Treatment 
X 
PsA history to include investigator assessment of 
the subject’s phenotype as peripheral arthritis or 
peripheral plus psoriatic spondyloarthritis. 
History of: conventional synthetic DMARDs 
(e.g. MTX), biologic, and/or phototherapy.  
For each therapy, include length of time on 
treatment and reason(s) for discontinuation (eg, 
lack of efficacy, intolerance, adverse events, loss 
of access to treatment) if applicable. 
Other Medical History 
X 
See Section 5.1 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 should check 
whether subjects have had preventive health 
measures such as cancer screening (eg, Pap 
smear, colonoscopy, mammograms) that are up-
to-date according to local guidelines. Subjects 
who are not up to date should be encouraged to 
have up to date screenings conducted. 
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Clinical Protocol 
 
IM011084 
BMS-986165 
 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
41 
Table 1: 
 Screening Procedural Outline IM011084 
Procedure 
Screening 
Visit 
Notes 
 
History of Tobacco Use 
X 
Include description of current tobacco use 
 
X 
 
 
 
Safety Assessments 
 
 
Physical Examination 
X 
Complete PE 
Physical Assessments  
X 
Includes height, weight, and BMI. 
Vital Signs 
X 
Includes (ear or oral) body temperature, 
respiratory rate, and 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.  
ECG 
X 
ECGs should be recorded after the subject has 
been supine for at least 5 minutes. 
Chest Imaging (eg, Chest x-ray) 
X 
Chest imaging is required if not performed within 
6 months of Screening visit, copy of radiology 
report must be on file and reviewed by the 
investigator. Section 8.4.4 
 
 
 
 
Serious Adverse Events Assessment 
X 
All SAEs must be collected from the date of 
subject’s written consent until 28 days post 
discontinuation of dosing or subject’s 
participation in the study. 
Laboratory Tests 
 
Includes blood and urine samples. See Section 
8.4.5. 
Hematology 
X 
Complete Blood Count (CBC) with differential 
Chemistry Panel 
X 
 
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Clinical Protocol 
 
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42 
Table 1: 
 Screening Procedural Outline IM011084 
Procedure 
Screening 
Visit 
Notes 
 
Lipid Panel (Fasting) 
X 
Subjects are required to fast for at least 10 hours 
prior to collection 
Urinalysis 
X 
 
Hemoglobin A1c 
X 
 
TSH 
X 
 
hsCRP 
X 
 
Serology 
X 
Includes HCV antibody, HBsAg, HBsAb, 
HBcAb, and HIV antibodies. 
Tuberculosis Test 
X 
In accordance with QuantiFERON TB Gold. 
(details described in Section 8.4.4). 
Pregnancy Test (Serum or Urine) 
X 
WOCBP only 
FSH 
X 
For postmenopausal women only. Serum FSH 
level will be determined to confirm menopausal 
status (see APPENDIX 4) 
 
 
 
 
 
 
 
 
 
 
 
 
BMI = body mass index; DMARD = disease-modifying antirheumatic drug; ECG = electrocardiogram; FSH = follicle-stimulating hormone; HBcAb = hepatitis B 
core antibody; HBsAb = hepatitis B surface antibody; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human 
immunodeficiency virus; hsCRP = high-sensitivity C-reactive protein; PE = physical examination; PsA = psoriatic arthritis; RNA = ribonucleic acid; SAE = serious 
adverse event; TSH = Thyroid Stimulating Hormone; WOCBP = women of childbearing potential 
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Clinical Protocol 
 
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23 September 2019, v2.0, Final, Approved 
BMS Confidential 
43 
Table 1: 
Procedural Outline IM011084: Part A (Week 0 to Week 20) 
Procedure 
Week 0 
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 
(or ET) 
D113 
(± 3 d) 
V8 
Safety 
Follow-
Upe 
(Week 
20) 
D141 (±3 d) 
V9 
Notes 
Safety Assessments 
 
 
 
 
 
 
 
 
 
Physical Examination 
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 
 
ECG 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
AE and SAE Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
 
Laboratory Tests  
 
 
 
 
 
 
 
 
 
Hematology 
X 
X 
X 
X 
X 
X 
X 
X 
 
Chemistry Panel 
X 
X 
X 
X 
X 
X 
X 
X 
Some visits 
may require 
fasting 
Lipid Panel (Fasting) 
X 
 
 
X 
 
 
X 
 
 
Urinalysis 
X 
X 
X 
X 
X 
X 
X 
X 
 
Serum Immunoglobulin Levels 
(IgM, IgG, IgA, IgE) 
X 
 
 
 
X 
 
X 
 
 
Hemoglobin A1c 
X 
 
 
 
 
 
X 
 
 
Pregnancy Test (Urine or 
Serum) 
X 
 
 
X 
X 
X 
X 
X 
WOCBP 
TBNK 
X 
 
 
 
X 
 
X 
 
 
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Clinical Protocol 
 
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23 September 2019, v2.0, Final, Approved 
BMS Confidential 
44 
Table 1: 
Procedural Outline IM011084: Part A (Week 0 to Week 20) 
Procedure 
Week 0 
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 
(or ET) 
D113 
(± 3 d) 
V8 
Safety 
Follow-
Upe 
(Week 
20) 
D141 (±3 d) 
V9 
Notes 
Study Treatment 
 
 
 
 
 
 
 
 
 
Randomize 
X 
 
 
 
 
 
 
 
 
Dispense Study Treatment 
X 
 
X 
X 
X 
X 
 
 
 
Study Treatment Compliance 
X 
X 
X 
X 
X 
X 
X 
 
See Section 
6.6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
Clinical Efficacy/Health 
Outcomes 
 
 
 
 
 
 
 
 
 
ACR: Tender/Painful Joint 
Count (68) 
X 
X 
X 
X 
X 
X 
X 
 
 
ACR: Swollen Joint Count (66) 
X 
X 
X 
X 
X 
X 
X 
 
 
ACR: Subject Assessment of 
Pain  
X 
X 
X 
X 
X 
X 
X 
 
 
ACR: Physician Global 
Assessment of psoriatic arthritis  
X 
X 
X 
X 
X 
X 
X 
 
 
ACR: Subject Global 
Assessment of Disease Activity  
X 
X 
X 
X 
X 
X 
X 
 
 
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Clinical Protocol 
 
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23 September 2019, v2.0, Final, Approved 
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45 
Table 1: 
Procedural Outline IM011084: Part A (Week 0 to Week 20) 
Procedure 
Week 0 
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 
(or ET) 
D113 
(± 3 d) 
V8 
Safety 
Follow-
Upe 
(Week 
20) 
D141 (±3 d) 
V9 
Notes 
ACR: hsCRP 
X 
X 
X 
X 
X 
X 
X 
 
 
ACR: HAQ-DI 
X 
X 
X 
X 
X 
X 
X 
 
 
Dactylitis (Count, LDI) 
X 
 
 
X 
X 
X 
X 
 
 
Enthesitis (LEI, SPARCC) 
X 
 
 
X 
X 
X 
X 
 
 
Nail Changes (PGA-F)a 
X 
 
 
X 
X 
X 
X 
 
 
PASIb 
X 
X 
X 
X 
X 
X 
X 
 
 
PASDAS 
X 
X 
X 
X 
X 
X 
X 
 
 
DAS 28 CRP 
X 
X 
X 
X 
X 
X 
X 
 
 
PsAID 12 
X 
 
X 
X 
 
 
X 
 
 
MDA/VLDA 
X 
X 
X 
X 
X 
X 
X 
 
 
DAPSA 
X 
X 
X 
X 
X 
X 
X 
 
 
BASDAIc 
X 
X 
X 
X 
X 
X 
X 
 
 
SF-36 
X 
 
 
 
 
 
X 
 
 
Fatigue (PROMIS-Fatigue or 
FACIT-Fatigue) 
X 
 
 
 
 
 
X 
 
See Section 
8.1.15 
WLQ (short form) 
X 
 
 
 
 
 
X 
 
 
RAPID3 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Clinical Protocol 
 
IM011084 
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23 September 2019, v2.0, Final, Approved 
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46 
Table 1: 
Procedural Outline IM011084: Part A (Week 0 to Week 20) 
Procedure 
Week 0 
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 
(or ET) 
D113 
(± 3 d) 
V8 
Safety 
Follow-
Upe 
(Week 
20) 
D141 (±3 d) 
V9 
Notes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
ACR = American College of Rheumatology; AE = adverse event; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; CV = cardiovascular; DAPSA = Disease Activity 
Index for Psoriatic Arthritis Score; DAS = Disease Activity Score; DNA = deoxyribonucleic acid; ECG = electrocardiogram; ET = early termination; FACIT = Functional Assessment 
of Chronic Illness Therapy; HAQ-DI = Health Assessment Questionnaire-Disability Index; hs-CRP = high-sensitivity C-reactive protein; LDI = Leeds Dactylitis Index; LEI = Leeds 
Enthesitis Index; MDA = Minimal Disease Activity; PASDAS = Psoriatic Arthritis Disease Activity Score; PASI = Psoriatic Area and Severity Index ; PGA-F = Physician Global 
Assessment-Fingernails; PROMIS = Patient Reported Outcome Measures Information System; PsA = psoriatic arthritis; PsAID = Psoriatic Arthritis Impact of Disease; RAPID3 = 
routine assessment of patient index data 3; RNA = ribonucleic acid; SAE = serious adverse events; SF-36 = Short Form Health Survey-36 Item; SPARCC = Spondyloarthritis 
Research Consortium of Canada (SPARCC) Enthesitis index; TBNK = T cells, B cells, NK cells; V = visit; VLDA = very low disease activity; WLQ =Work limitation Questionnaire;  
WOCBP = women of childbearing potential 
a In subjects with nail psoriasis at baseline 
b In subjects with at least 3% body surface area (BSA) involvement at baseline 
c In subjects with baseline evidence of PsA spondylitis 
d If sample is missed, it may be taken at any visit once informed consent is obtained. 
e Subjects that complete treatment in Part A and opt to enroll in Part B, will complete the Safety Follow-Up following completion of Part B 
When multiple assessments are conducted at a single visit, the following is the order in which they should be done: 
1) 
Health outcomes assessments 
2) 
Safety assessments (eg, vitals, AEs) 
3) 
Clinical efficacy assessments 
4) 
Laboratory tests (eg, safety laboratory tests, 
) 
On fasting days, safety assessments can be done first followed by blood draws, and then health outcomes and finally efficacy assessments. The dose of the drug on a visit day is to 
be taken after blood draws 
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Clinical Protocol 
 
IM011084 
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23 September 2019, v2.0, Final, Approved 
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47 
Table 3: 
Procedural Outline IM011084: Part B – Optional (Week 16 to Week 56) 
Procedure 
Week 
16 
D113 
(± 3 d) 
V8 
Week 
20 
D141 
(± 3 d) 
V9 
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 
ET) 
D365 
(± 3 d) 
V17 
Safety 
Follow-
Up 
Week 
56 
D393 
(±3 d) 
V18 
Notes 
Part A to Part B 
Transition 
 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
Safety Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
Physical Examination 
 
X 
 
 
 
 
 
 
 
X 
X 
 
Targeted Physical 
Examination 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Body Weight 
 
X 
 
 
 
 
 
 
 
X 
X 
 
Vital Signs 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
ECG 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AE and SAE Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Laboratory Tests  
 
 
 
 
 
 
 
 
 
 
 
 
Hematology 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Chemistry Panel 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Lipid Panel (Fasting) 
 
X 
 
 
 
 
 
 
 
X 
 
 
Urinalysis 
 
 
 
 
 
X 
 
 
 
X 
X 
 
Serum Immunoglobulin 
Levels (IgM, IgG, IgA, 
IgE) 
 
 
 
 
 
X 
 
 
 
X 
 
 
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Clinical Protocol 
 
IM011084 
BMS-986165 
 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
48 
Table 3: 
Procedural Outline IM011084: Part B – Optional (Week 16 to Week 56) 
Procedure 
Week 
16 
D113 
(± 3 d) 
V8 
Week 
20 
D141 
(± 3 d) 
V9 
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 
ET) 
D365 
(± 3 d) 
V17 
Safety 
Follow-
Up 
Week 
56 
D393 
(±3 d) 
V18 
Notes 
Hemoglobin A1c 
 
 
 
 
 
X 
 
 
 
X 
 
 
hs-CRP 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Pregnancy Test (Urine or 
Serum) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
WOCBP 
TBNK 
 
 
 
X 
 
 
X 
 
 
X 
 
 
Study Treatment 
 
 
 
 
 
 
 
 
 
 
 
 
Randomize  
 
 
 
 
 
 
 
 
 
 
 
 
Dispense Study Treatment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Study Treatment 
Compliance 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
See Section 
6.6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
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Clinical Protocol 
 
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49 
Table 3: 
Procedural Outline IM011084: Part B – Optional (Week 16 to Week 56) 
Procedure 
Week 
16 
D113 
(± 3 d) 
V8 
Week 
20 
D141 
(± 3 d) 
V9 
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 
ET) 
D365 
(± 3 d) 
V17 
Safety 
Follow-
Up 
Week 
56 
D393 
(±3 d) 
V18 
Notes 
Clinical Efficacy/Health 
Outcomes 
 
 
 
 
 
 
 
 
 
 
 
 
ACR: Tender/Painful Joint 
Count (68) 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
ACR: Swollen Joint Count 
(66) 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
ACR: Patient Assessment 
of Pain  
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
ACR: Physician Global 
Assessment of psoriatic 
arthritis  
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
ACR: Subject Global 
Assessment of Disease 
Activity  
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
ACR: hs-CRP 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
ACR: HAQ-DI 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
Dactylitis (Count, LDI) 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
Enthesitis (LEI, SPARCC) 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
Nail Changes (PGA-F)a 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
PASIb 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
PASDAS 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
DAS 28 CRP 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
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50 
Table 3: 
Procedural Outline IM011084: Part B – Optional (Week 16 to Week 56) 
Procedure 
Week 
16 
D113 
(± 3 d) 
V8 
Week 
20 
D141 
(± 3 d) 
V9 
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 
ET) 
D365 
(± 3 d) 
V17 
Safety 
Follow-
Up 
Week 
56 
D393 
(±3 d) 
V18 
Notes 
PsAID 12 
 
X 
X 
 
 
 
 
 
 
X 
 
 
MDA/VLDA 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
DAPSA 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
BASDAIc 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
SF-36 
 
X 
 
 
 
 
 
 
 
X 
 
 
Fatigue (PROMIS-Fatigue 
or FACIT-Fatigue) 
 
X 
X 
 
 
 
 
 
 
X 
 
See Section 
8.1.15 
WLQ (short form) 
 
 
 
 
 
 
 
 
 
X 
 
 
RAPID3 
 
X 
X 
 
X 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
Post-study Completion 
Ustekinumab Treatment? 
 
 
 
 
 
 
 
 
 
 
 
 
Post-study Ustekinumab 
Evaluation 
 
 
 
 
 
 
 
 
X 
 
 
 
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Clinical Protocol 
 
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BMS Confidential 
51 
Table 3: 
Procedural Outline IM011084: Part B – Optional (Week 16 to Week 56) 
Procedure 
Week 
16 
D113 
(± 3 d) 
V8 
Week 
20 
D141 
(± 3 d) 
V9 
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 
ET) 
D365 
(± 3 d) 
V17 
Safety 
Follow-
Up 
Week 
56 
D393 
(±3 d) 
V18 
Notes 
Dispense/Administer 
appropriate study treatment 
for all subjects that elect to 
be treated with ustekinumab 
post-study completion 
 
 
 
 
 
 
 
 
 
X 
 
 
ACR = American College of Rheumatology; AE = adverse event; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; CV = cardiovascular; DAPSA = Disease Activity 
Index for Psoriatic Arthritis Score; DAS = Disease Activity Score; DNA = deoxyribonucleic acid; ECG = electrocardiogram; ET = early termination; FACIT = Functional Assessment 
of Chronic Illness Therapy; HAQ-DI = Health Assessment Questionnaire-Disability Index; hs-CRP = high-sensitivity C-reactive protein; LDI = Leeds Dactylitis Index; LEI = Leeds 
Enthesitis Index; MDA = Minimal Disease Activity; PASDAS = Psoriatic Arthritis Disease Activity Score; PASI = Psoriatic Arthritis Severity Index ; PGA-F = Physician Global 
Assessment-Fingernails; PROMIS = Patient Reported Outcome Measures Information System; PsA = psoriatic arthritis; PsAID = Psoriatic Arthritis Impact of Disease; 
RAPID3 =  routine assessment of patient index data 3; RNA = ribonucleic acid; SAE = serious adverse events; SF-36 = Short Form Health Survey-36 Item; SPARCC = 
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis index; TBNK = T cells, B cells, NK cells; TB = tuberculosis; V = visit; VLDA = very low disease activity; 
WLQ =Work limitation Questionnaire;  WOCBP = women of childbearing potential 
a In subjects with nail psoriasis at baseline 
b In subjects with at least 3% body surface area (BSA) involvement at baseline 
c In subjects with baseline evidence of PsA spondylitis 
When multiple assessments are conducted at a single visit, the following is the order in which they should be done: 
1) 
Health outcomes assessments 
2) 
Safety assessments (eg, vitals, AEs) 
3) 
Clinical efficacy assessments 
4) 
Laboratory tests (eg, safety laboratory tests, 
) 
On fasting days, safety assessments can be done first followed by blood draws, and then health outcomes and finally efficacy assessments. The dose of the drug on a visit day is to 
be taken after blood draws. 
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52 
STUDY ACKNOWLEDGMENT/DISCLOSURE 
I understand that this protocol contains information that is confidential and proprietary to Bristol-Myers Squibb 
Company (BMS). Any supplemental information that may be added to this document is also confidential and 
proprietary to BMS and must be kept in confidence in the same manner as the contents of this protocol. 
I have read the original protocol/revised protocol and agree that it contains all necessary details for carrying out the 
study as described. I will conduct this protocol as outlined therein and will make a reasonable effort to complete the 
study within the time designated. 
I will provide copies of the protocol and access to all information furnished by BMS to study personnel under my 
supervision. I will discuss this material with them to ensure that they are fully informed about the investigational 
product and the study. 
I will provide protocol information to my Institutional Review Board(s) [IRB(s)] or Independent Ethics Committee(s) 
[IEC(s]. I understand that original protocol/revised protocols must be reviewed by the Institutional Review Board or 
Independent Ethics Committee overseeing the conduct of the study and approved or given favorable opinion by all 
necessary Health Authorities before implementation unless to eliminate an immediate hazard to subjects. 
I agree that the contents of the protocol may not be disclosed to any other person or entity or used for any other purpose 
without the prior written consent of BMS. The foregoing shall not apply to disclosure required by governmental 
regulations or laws; however, I will give prompt notice to BMS of any such disclosure. 
I agree that the study data derived from this protocol may only be used and disclosed in furtherance of the protocol, 
for the medical treatment of a study subject or for publication of study results in accordance with the terms of the 
clinical trial agreement or as otherwise permitted by the terms of the clinical trial agreement. 
I agree not to collect or use samples (eg, tissue, blood, serum, urine) or collect data (other than for diagnostic or 
treatment purposes) from the study subjects while enrolled in the study, except as expressly permitted by the protocol 
or the terms of the clinical trial agreement. 
I understand that I may terminate or suspend enrollment of the study at any time if it becomes necessary to protect the 
best interests of the study subjects. Unless otherwise provided in the clinical trial agreement, the study may be 
terminated at any time by BMS, with or without cause. 
Original Protocol: 
 
 
Revised Protocol: 
 
Protocol Number: IM011084 
 
Site Number: 
Date of Protocol or Revised Protocol: 
 
TBD 
IND Number: 137,445 
 
EUDRACT Number: 2018-004293-10 
 
 
 
Investigator: 
 
Date: 
(signature) 
 
 
(printed name) 
 
 
 
 
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3 
OBJECTIVES AND ENDPOINTS 
Table 2: Objectives and Endpoints 
Objectives  
Endpoints 
Efficacy 
Primary 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg once daily [QD]) 
at Week 16 in the treatment of subjects with 
active PsA 
• ACR 20 response 
Secondary  
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
daily functional activities  
• Change from baseline in HAQ-DI score  
 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
reducing PsO severity 
• PASI 75 response 
 
 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
Patient-reported Outcomes 
• Change from baseline in the Physical 
Component Summary (PCS) score of the 
SF-36 Questionnaire 
Additional  
• Assess the extent of the dose-response 
relationship of BMS-986165 treatment (6 or 
12 mg QD) at Week 16 in active PsA 
• ACR 50 response  
• ACR 70 response 
 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
DAS 28 CRP 
• DAS 28 CRP Low Disease Activity 
• DAS 28 CRP Remission 
• Change from baseline in DAS 28 CRP score 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
dactylitis 
• Change from baseline in dactylitis count 
• Change from baseline in LDI Basic 
• Dactylitis resolution 
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• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
enthesitis 
• Change from baseline in enthesitis count by 
LEI and SPARCC index 
• Enthesitis resolution by LEI and SPARCC 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
Physician’s global assessment – fingernails 
(PGA-F) PsO  
• PGA-F response of 0/1 
 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
minimal disease activity (MDA) 
• MDA response 
 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
psoriatic arthritis activity 
• PASDAS 
• DAPSA 
• Psoriatic 
Arthritis 
Response 
Criteria 
(PsARC) 
• Assess the dose-response relationship of 
BMS-986165 (6 or 12 mg QD) at Week 16 in 
ankylosing spondylitis activity 
• Bath 
Ankylosing 
Spondylitis 
Disease 
Activity Index (BASDAI) 
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
Patient-Reported Outcomes 
• SF-36 Score 
• 
Mental Component Summary (MCS) 
• PsAID 12 
• PROMIS-Fatigue where available or FACIT-
Fatigue where PROMIS is not available 
• Work Limitation Questionnaire (WLQ short 
form)  
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
daily functional activities  
• HAQ-DI 0.35 response  
• Assess the dose-response relationship of  
BMS-986165 (6 or 12 mg QD) at Week 16 in 
reducing PsO severity 
• PASI 90 response 
 
Safety 
• To assess the safety and tolerability of BMS-
986165 in subjects with active PsA 
• Incidence of adverse events (AEs), serious 
AEs 
(SAEs), 
AEs 
leading 
to 
study 
discontinuation, and target AEs of interest 
(AEIs) 
• Change in laboratory, electrocardiogram 
(ECG), physical examination, and vital sign 
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60 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 
STUDY DESIGN 
4.1 
Overall Design 
This is a 16-week (Part A) randomized, double-blind, placebo-controlled, multicenter study to 
evaluate the safety and efficacy of multiple doses of BMS-986165 in subjects with active PsA. A 
total of approximately 180 subjects with active PsA will be randomized in Part A. This Phase 2 
study will be conducted in a mixed population of subjects with active PsA who have either not 
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23 September 2019, v2.0, Final, Approved 
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61 
received prior treatment with a biologic (biologic-naïve, approximately 70%) or who have failed 
or been intolerant to 1 TNF-inhibitor (TNFi-experienced, approximately 30%). In addition, 
investigators will need to specify if the subject’s phenotype is peripheral arthritis or peripheral plus 
psoriatic spondyloarthritis. 
The total duration of participation in Part A is approximately 24 weeks and will be divided into 
the following periods: screening (up to 4 weeks), double-blind placebo-controlled treatment for 
16 weeks (Week 1 to Week 16, Part A), and follow-up (up to 4 weeks). Subjects completing 
double-blind treatment in Part A will have an opportunity to enroll in an optional double-blind 
double-dummy Part B. Treatment in Part B will be given for up to 36 weeks (Week 16 to 
Week 52). For subjects completing both Part A and B of the study, the anticipated study duration 
is approximately 60 weeks: screening (up to 4 weeks), double-blind placebo-controlled treatment 
for 16 weeks (Week 1 to Week 16, Part A), double-blind double-dummy treatment for 36 weeks 
(Week 16 to Week 52, Part B), and follow-up (up to 4 weeks). 
Part A 
Subjects will undergo screening evaluations to determine eligibility within 28 days prior to 
administration of study medication. Following the screening process, if subjects are eligible for 
randomization then subjects will be randomized in a 1:1:1 ratio (approximately 60 subjects per 
arm) to 1 of the following 3 treatment groups: 
• Placebo  
• BMS-986165 6 mg QD  
• BMS-986165 12 mg QD  
Randomization will be stratified by TNFi use (experienced/naïve) and body weight (≥ 90 kg and 
< 90 kg). 
The primary endpoint is ACR 20 response at Week 16. 
In Part A, subjects who discontinue study treatment early for any reason other than consent 
withdrawal will be expected to complete the ET visit followed by the safety follow-up period. 
Part B 
At Week 16, subjects will have the option to participate in the double-blind Part B of the study. 
All subjects who receive placebo in Part A will receive ustekinumab in Part B according to 
approved labeling for PsA; subjects who receive BMS-986165 in Part A and achieve MDA will 
continue treatment with BMS-986165 at the same dose in Part B, and subjects who receive BMS-
986165 in Part A and fail to achieve MDA will receive ustekinumab in Part B. The treatment 
assignment in Part B will be double-blind, double-dummy as follows 
• Placebo in Part A: ustekinumab subcutaneous (SQ) injection plus placebo matching 
BMS-986165 QD in Part B 
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62 
• BMS-986165 6 mg QD in Part A with MDA at Week 16: BMS-986165 6 mg QD plus 
placebo matching ustekinumab SQ injection in Part B 
• BMS-986165 6 mg QD in Part A without MDA at Week 16: ustekinumab SQ injection 
plus placebo matching BMS-986165 QD in Part B 
• BMS-986165 12 mg QD in Part A with MDA at Week 16: BMS-986165 12 mg QD plus 
placebo matching ustekinumab SQ injection in Part B 
• BMS-986165 12 mg QD in Part A without MDA at Week 16: ustekinumab SQ injection 
plus placebo matching BMS-986165 QD in Part B 
In Part B at Week 28, at the discretion of the investigator, the study design provides for rescue 
therapy for relief of joint symptoms with nonsteroidal anti-inflammatory drugs (NSAIDs), intra-
articular injections of steroids, systemic glucocorticoids, or DMARDs, as follows:  
• NSAIDs may be added or the dose  may be increased according to labeling guidelines  
• A single oral tapering dose of glucocorticosteroid (no greater than 20 mg of prednisone [or 
prednisone equivalent]) per day, not to exceed 2 weeks  
• An intra-articular dose of glucocorticoids (no greater than 40 mg methylprednisolone or  
40 mg of triamcinolone [or methylprednisolone or triamcinolone equivalent]) into 1 joint 
or divided into 2 joints  
• A single intramuscular dose of glucocorticoids (no greater than 40 mg methylprednisolone 
or 40 mg of triamcinolone [or methylprednisolone or triamcinolone equivalent])   
• DMARD treatment may not be started; however: 
o If already taking MTX, an increase in dose is allowed  (maximum of 25 mg weekly)  
o If already taking sulfasalazine, an increase in dose is allowed  
Subjects who need rescue therapy or additional therapy for PsA and/or flares after the Week 28 
timepoint of Part B will be discontinued from the study. 
At Week 48, subjects will discuss with their investigator/treating physician plans for treatment 
with ustekinumab after study completion. In order to maintain the study blind and to ensure 
continuity of care for those electing to be treated with ustekinumab after the study completion (ie, 
completion of the Week 56 visit), the following Week 52 procedure should be performed: 
• Subjects that elect to be treated with ustekinumab following study completion will receive 
the following treatment at Week 52: 
• 
Subjects that were on ustekinumab treatment in Part B will receive a placebo matching 
ustekinumab SQ injection 
• 
Subjects that were on BMS-986165 6 mg or BMS-986165 12 mg treatment in Part B 
will receive an ustekinumab SQ injection  
• Subjects that elect not to be treated with ustekinumab after the study will not receive any 
treatment at Week 52 (regardless of the treatment that they received in Part B).  
Approved
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IM011084 
BMS-986165 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
64 
4.1.1 
Data Monitoring Committee and Other External Committees 
4.1.1.1 
Data Monitoring Committee 
An external independent Data Monitoring Committee (DMC) with multi-disciplinary 
representation will be established to evaluate safety data on a periodic basis. An independent 
reporting statistician not involved in the conduct of the study will be designated to provide the 
DMC with essential unblinded to treatment group safety data during the study. 
Details of DMC responsibilities, timing of safety reviews, authorities, and procedures will be 
specified in the DMC charter. 
4.1.1.2 
Infection Adjudication Committee 
An independent Infection Adjudication Committee, composed of individuals with relevant 
expertise, will review and adjudicate infection AEs, such as opportunistic infections, influenza, 
herpes zoster, and TB, reported in the study. Additional information about these infections may be 
collected on the case report form (CRF) in order to characterize and understand them. The 
Adjudication Committee members will be blinded to the treatment assignment of subjects. The 
structure, responsibilities, and procedures of the Adjudication Committee will be outlined in a 
charter. The Adjudication Committee is distinct from the DMC and Adjudication Committee 
members will not be investigators on the study. 
4.1.1.3 
Cardiovascular (CV) Adjudication Committee 
An independent cardiovascular (CV) Adjudication Committee, composed of individuals with 
relevant expertise, will review and adjudicate CV and cerebrovascular AEs such as, but not limited 
to, Major Adverse Cardiovascular Events (MACE) that include death, nonfatal myocardial 
infarction, nonfatal stroke; revascularization procedures; heart failure; dysrhythmias; heart blocks; 
and thrombotic events reported in the study. Additional information about CV and cerebrovascular 
AEs may be collected on the CRF in order to characterize and understand them. The Adjudication 
Committee members will be blinded to the treatment assignment of subjects. The structure, 
responsibilities, and procedures of the Adjudication Committee will be outlined in a charter. The 
Adjudication Committee is distinct from the DMC and Adjudication Committee members will not 
be investigators on the study. 
4.2 
Number of Subjects 
Approximately 180 qualified subjects will be randomized in a 1:1:1 ratio in Part A to  
BMS-986165 6 mg QD, BMS-986165 12 mg QD, or placebo matching BMS-986165 QD, 
respectively. Sample size considerations are described in Section 9.1. All subjects completing Part 
A will have the option to enroll in Part B. 
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BMS Confidential 
65 
4.3 
End of Study Definition 
The duration of study participation in Part A for individual subjects is expected to be 24 weeks 
(168 days), which includes screening (up to 4 weeks), treatment (16 weeks) and follow-up (up to 
4 weeks) periods.  
For subjects who continue in Part B of the study, the total duration of study participation is 
expected to be up to 60 weeks (420 days), which includes screening (up to 4 weeks), double-
blind treatment (16 weeks, Part A; 36 weeks, Part B), and follow-up (up to 4 weeks) periods.   
The start of the study is defined as first visit for first subject screened. The end of the study is 
defined as the last visit or scheduled procedure shown in the Schedule of Activities (Section 1.3) 
for the last subject.  
For subjects who do not continue in Part B of the study, study completion is defined as the final 
date on which data was or is expected to be collected (Week 20 for collection of potential SAEs). 
For subjects who continue in Part B of the study, study completion is defined as the final date on 
which data was or is expected to be collected (Week 56 for collection of potential SAEs). 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
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69 
 
 
5 
STUDY POPULATION 
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) Diagnosed with PsA for at least 6 months before screening, and who meet the Classification 
Criteria for Psoriatic Arthritis (CASPAR) at screening.  
b) Subjects either (i) cannot have prior exposure to biologics (biologic-naïve) or (ii) have 
failed or been intolerant to 1 TNF-inhibitor (TNFi-experienced). Failure is defined as lack 
of response or loss of response with at least 3 months of therapy with an approved dose of 
a TNFi, as judged by the investigator. Failure must have occurred at least 2 months prior 
to Day 1. Note: If a prospective subject was previously exposed to a second TNFi and 
discontinued for reasons other than intolerance or lack of response (eg, used < 3 months), 
the Medical Monitor should be contacted to discuss whether the subject should be enrolled. 
c) Subjects have at least 1 confirmed ≥ 2 cm lesion of plaque psoriasis at screening  
d) Subjects have active arthritis as shown by a minimum of ≥ 3 swollen joints and ≥ 3 tender 
joints (66/68 joint counts) at screening and Day 1 (APPENDIX 5) 
e) High sensitivity C-reactive protein (hsCRP) ≥ 3mg/L at screening 
f) If on a conventional non-biologic DMARD (eg, MTX, leflunomide, sulfasalazine or 
hydroxychloroquine) subjects can only take 1 DMARD. The DMARD must have been 
used for at least 3 months with a stable dose for at least 28 days prior to Day 1 
g) Have failed or been intolerant to at least 1 non-biologic DMARD (or had to stop because 
of pregnancy or lactation but still eligible for the trial), NSAID and/or corticosteroid 
h) If using an NSAID, the dose must be stable for at least 14 days before Day 1 and consistent 
with labeling recommendations 
i) If using oral corticosteroids (≤ 10 mg/day prednisone equivalent), the dose must be stable 
for at least 14 days before Day 1 
j) Concurrent topical therapy for plaque psoriasis must have been stable for at least 14 days 
before Day 1. Note: Only low potency (Class V or higher) topical corticosteroids are 
permitted and restricted to use solely on the palms, soles, face and intertriginous areas. 
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Bland emollients (without urea or alpha or beta hydroxy acids, eg, salicylic acid) can be 
used on skin lesions. These should not be used within 24 hours prior to any study visit. 
k) Treatment with targeted synthetic disease-modifying antirheumatic drugs (eg, apremilast) 
is not permitted during the study, but subjects who have previously received apremilast 
could be eligible if treatment has been discontinued at least 4 weeks prior to Day 1. 
3) Age and Reproductive Status 
a) Men and women aged ≥18 years at screening 
b) Women of childbearing potential (WOCBP) must have a negative serum or 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 treatment. 
c) Women must not be pregnant, lactating, breastfeeding or be planning pregnancy during the 
study period 
d) Women of childbearing potential (WOCBP) must agree to follow instructions for 
method(s) of contraception (APPENDIX 4) for the duration of treatment with study drugs 
and until the end of relevant systemic exposure plus 5 half-lives of study drug plus 30 days 
(duration of ovulatory cycle) post-treatment completion. Therefore, in Part A, WOCBP 
must agree to follow instructions for methods of contraception for 33 days post-treatment 
completion and, in Part B, WOCBP must agree to follow instructions for methods of 
contraception for 190 days after completion of treatment. 
i) Note: 
(1) Local laws and regulations may require use of alternative and/or additional 
contraception methods; additionally, alternative and/or additional contraceptive 
may be required eg, based on background DMARDS the subject may be taking, 
such as methotrexate, leflunomide, etc. 
(2) WOCBP who are continuously not heterosexually active are also exempt from 
contraceptive requirements, but must still undergo pregnancy testing as described 
in this section. 
e) Males who are sexually active with WOCBP must also agree to follow instructions for 
method(s) of contraception (APPENDIX 4) for the duration of treatment with study drugs 
and until the end of relevant systemic exposure. Therefore, in Part A, male subjects must 
agree to follow instructions for methods of contraception for 93 days (5 half-lives of study 
treatment plus duration of sperm turnover) after end of treatment, and in Part B, for 250 
days after end of treatment. 
i) Note: 
(1) Local laws and regulations may require use of alternative and/or additional 
contraception methods; eg, based on background DMARDS the subject may be 
taking, such as methotrexate, leflunomide, etc. 
(2) Male subjects must be willing to refrain from sperm donation during this time. 
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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, which have a 
failure rate of < 1% when used consistently and correctly. 
5.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1) Target Disease Exceptions 
a) Has non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced 
psoriasis) at screening or Day 1 
b) Has any other autoimmune condition such as rheumatoid arthritis, etc. There are exceptions 
for inflammatory bowel disease or uveitis as follows:  currently active disease is excluded 
but, a history of no longer active disease for at least 12 months (including not being on 
medication) is allowed 
c) Has active (ie currently symptomatic) fibromyalgia 
2) Infectious/Immune-related Exclusions 
a) History or evidence of active infection and/or febrile illness within 7 days prior to Day 1 
(eg, bronchopulmonary, urinary, gastrointestinal, etc.) 
b) History of recent serious bacterial, fungal, or viral infections requiring hospitalization and 
intravenous (IV) antimicrobial treatment within 90 days prior to screening, or any infection 
requiring antimicrobial treatment within 15 days prior to Day 1 
c) Any bacterial infection within the last 60 days prior to screening, unless treated and 
resolved with antibiotics, or any chronic bacterial infection such as chronic pyelonephritis, 
osteomyelitis, and bronchiectasis 
d) Received live vaccine(s) within 60 days prior to Day 1, or plans to receive a live vaccine 
during the study, or within 60 days after completing Part A, or within 15 weeks of receiving 
the last dose of Part B treatment 
e) Presence of herpes simplex lesions or herpes zoster at screening or Day 1 
f) History of severe herpes zoster or severe 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 (defined as 2 episodes 
within 2 years) 
g) Evidence of, or test positive for, hepatitis B.  Positive hepatitis B lab testing is defined as 
1) Positive Hepatitis B Surface Antigen (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-) or 4) Positive anti-hepatitis B core antibody and 
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positive hepatitis B surface antibody with elevated liver transaminases (HbcAb+, HbsAb+, 
and abnormal ALT and AST) 
h) Evidence of, or test positive for, hepatitis C virus (HCV). A positive test for HCV is defined 
as: 1) positive for hepatitis C antibody (anti-HCVAb), and 2) positive via a confirmatory 
test for HCV (for example, HCV polymerase chain reaction) 
i) Positive for human immunodeficiency virus antibody (HIVAb) at screening 
j) Any history of known or suspected congenital or acquired immunodeficiency state or 
condition that would compromise the subject’s immune status (eg, infections with 
Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidioidomycosis, history of 
splenectomy, primary immunodeficiency, etc.) 
3) Any of the following tuberculosis (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 old 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 may be 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 
rescreening now after 1 month of treatment. To continue in the study, subject must agree 
to complete a locally-recommended course of treatment for LTBI. 
Note: An IGRA test that is indeterminate with no signs or symptoms of active TB must be 
re-tested for confirmation. If the second test is again indeterminate the subject will be 
excluded from the study. If the re-test is positive, the subject should be treated as having 
LTBI. If the re-test is negative, subject may be eligible provided no other exclusion criteria 
for TB are met. 
4) Medical History and Concurrent Diseases 
a) If the subject is biologic-experienced, the following exclusion criteria will apply:  
i) History of use of antibodies to IL-12, IL-17, or IL-23 (eg, ustekinumab, secukinumab, 
bimekizumab, tildrakizumab, risankizumab, ixekizumab, or guselkumab)  
ii) TNF-inhibitor(s) (eg, etanercept, adalimumab, infliximab, certolizumab, golimumab) 
within 2 months of Day 1 
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iii)  History of use of agents that modulate lymphocyte trafficking (eg, natalizumab, 
efalizumab), or agents that modulate B cells or T cells (eg, alemtuzumab, abatacept, 
alefacept, or visilizumab) 
b) If the subject is biologic-naïve: has received any biologic immunomodulatory treatment, 
eg, anti-TNF agents, anti-IL-23 agents, anti-IL-17 agents 
c) Any major surgery within 4 weeks prior to Day 1, or any planned surgery during the study 
d) Has donated blood > 500 mL within 4 weeks prior to Day 1, or intends to donate blood 
during the course of the study 
e) Drug or alcohol abuse, as determined by the investigator within 6 months prior to Day 1 
(Note: medical marijuana is not allowed) 
f) Any major illness/condition or evidence of an unstable clinical condition (eg, renal, 
hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, 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 
g) Unstable CV disease, defined as a recent clinical deterioration (eg, unstable angina, 
myocardial infarction, stroke, rapid atrial fibrillation) in the last 3 months prior to 
screening, or a cardiac hospitalization within the 3 months prior to screening 
h) 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 
i) Class III or IV congestive heart failure by New York Heart Association Criteria 
j) History of cancer (solid organ or hematologic including myelodysplastic syndrome) or 
lymphoproliferative disease within the previous 5 years. Exception: subjects with  resected 
cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has 
been treated with no evidence of recurrence can be included 
k) Any other sound medical, and/or social reason as determined by the investigator 
l) Prior exposure to the investigational product (IP, ie, BMS-986165) 
m) Has received any JAK inhibitors, eg baricitinib, tofacitinib, upadacitinib, etc 
n) Has received systemic psoriasis medications other than biologics and/or any systemic 
immunosuppressants therapy (including, but not limited to, azathioprine, cyclosporine, 6-
thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus, injectable 
corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, or fumaric 
acid derivatives) within 4 weeks prior to Day 1 
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o) Use of any opioid analgesic at average daily doses of > 30 mg/day of morphine or its 
equivalent or use of variable doses of any opiate analgesic within 6 weeks prior to Day 1 
p) Has received phototherapy (including either oral and topical psoralen ultraviolet A [PUVA] 
light therapy, ultraviolet B [UVB] or self-treatment with tanning beds or therapeutic 
sunbathing) within 4 weeks prior to Day 1 
q) Has used topical medications/treatments that could affect psoriasis evaluation, including, 
but not limited to, high potency corticosteroids (Class I or higher), anthralin, calcipotriene, 
topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralen, 
picrolimus, and tacrolimus, within 2 weeks of Day 1 
Note: As stated above, low potency topical steroids (Class V and higher) are permitted on 
the palms, soles, face and intertriginous areas as well as bland emollients [without urea or 
alpha or beta hydroxy acids]); those should not be used within 24 hours prior to any study 
visit 
r) Use of shampoos that contain corticosteroids, coal tar, or vitamin D3 analogues within  
2 weeks prior to Day 1 
s) Has received any 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 
5) Physical and Laboratory Test Findings 
a) Absolute white blood cell (WBC) count < 3000/mm3 at screening 
b) Absolute lymphocyte count < 500/mm3 at screening 
c) Absolute neutrophil count < 1000/mm3 at screening 
d) Platelet count < 100,000/mm3 at screening 
e) Hemoglobin < 9 g/dL at screening 
f) ALT and/or AST > 2x upper limit of normal (ULN) at screening 
g) Total, unconjugated, and/or conjugated bilirubin > 1.5 × upper limit of normal (ULN) at 
screening 
h) Estimated glomerular filtration rate (eGFR) < 45 mL/min  
i) Any other significant laboratory or procedure 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 or intolerance (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 
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c) Inability to comply with restrictions and prohibited activities/treatments as listed in  
Section 5.3. 
d) Site personnel or their immediate family 
5.3 
Lifestyle Restrictions 
General skin care measures (with above restrictions for topical treatments) are recommended that 
are standard for patients with plaque psoriasis. 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, fasting glucose, and post-dose PK 
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 who are 
not subsequently randomized in the study. A minimal set of screen failure information is required 
to ensure transparent reporting of screen failure subjects, to meet the Consolidated Standards of 
Reporting Trials (CONSORT) publishing requirements, as applicable, and to respond to queries 
from regulatory authorities. Minimal information includes date of consent, demography, screen 
failure details, eligibility criteria, and any serious AEs. 
5.4.1 
Retesting During Screening or Lead-in Period 
For laboratory parameters that initially do not meet eligibility requirements, a single retest within 
the 28-day screening period is permitted before subject is declared a screen failure. This is an effort 
to find all possible well-qualified subjects. Consultation with the Medical Monitor may be needed 
to identify whether repeat testing of any particular parameter would be clinically relevant. 
The study permits the rescreening (after the end of the initial 28-day screening period) of a subject 
who discontinues the study as a pretreatment failure (ie, the subject fails to meet eligibility criteria 
and has not been treated). The subject must be reconsented, will be assigned a new identification 
number, and a full screening visit must be performed again. A subject can only be rescreened 1 
time (ie, if the subject fails 1 rescreening attempt, no additional rescreening is allowed). Duration 
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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.  
Rescreening is allowed once with consultation with the Medical Monitor. 
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 for IM011084 includes both Investigational [Medicinal] Product (IP/IMP) and 
Noninvestigational [Medicinal] Product (Non-IP/Non-IMP) as shown in Table 3. 
An IP, also known as IMP in some regions, is defined as a pharmaceutical form of an active 
substance or placebo being tested or used as a reference in a clinical study, including products 
already with a marketing authorization but used or assembled (formulated or packaged) differently 
than the authorized form, or used for an unauthorized indication, or when used to gain further 
information about the authorized form. 
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis, may be considered as non-IPs. 
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Table 3: Study Treatments for IM011084 
Product 
Description/ 
Class and 
Dosage Form 
Potency 
IP/Non-IMP 
Blinded or 
Open Label 
Packaging/ 
Appearance 
Storage 
Conditions 
(per label) 
BMS-986165  
6 mg tablet 
6 mg 
IP 
Blinded 
Blister Card  
Store at 15 to 
25°C; 
Protect from light 
Placebo matching 
BMS-986165 
6 mg tablet 
n/a 
IP 
Blinded 
Blister Card 
Store at 15 to 
25°C; 
Protect from light 
BMS-986165  
12 mg tablet 
12 mg 
IP 
Blinded 
Blister Card 
Store at 15 to 
25°C; 
Protect from light 
Placebo  
matching BMS-
986165 12 mg 
tablet 
n/a 
IP 
Blinded 
Blister Card 
Store at 15 to 
25°C; 
Protect from light 
Ustekinumab for 
subcutaneous 
injectiona 
45 mg 
IP 
Blinded 
Vials for Injection 
Store at  2ºC to 
8ºC,  Protect from 
light, Do not 
freeze, Do not 
shake 
Normal salinea,b 
n/a 
IP 
Blinded  
Per manufacturers 
specifications 
Per manufacturers 
specifications 
a These products may be obtained by the investigational sites as local commercial products in certain countries if 
allowed by local regulations. In these cases, products may be in a different pack size/potency/pharmaceutical form 
than listed in the table. These products should be prepared/stored/administered in accordance with the package inserts 
or summaries of product characteristics 
b Normal saline will be used as the placebo for ustekinumab 
 
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6.1 
Treatments Administered 
6.1.1 
Dose Schedule for Part A 
In Part A, subjects will take BMS-986165 12 mg QD, 6 mg QD, or placebo matching BMS-
986165over 16 weeks (Table 4). 
Study treatment will be dispensed and administered in a double-blind fashion as described in 
Section 4.1. As the blister cards provided to the sites will be double-blind, all dispensing must be 
performed via the interactive response technology (IRT) system. Blister cards will be dispensed at 
Weeks 0, 2, 4, 8, and 12. An adequate supply of blister cards will be dispensed to cover the subject 
until their next scheduled visits.   
The tablets will be arranged into sets and the subject will be instructed to take 2 tablets daily in the 
morning (total of 2 tablets daily). Any missed dose should be taken within the next 6 hours. If the 
subject is unable to take this dose within this time period, the subject should skip this dose. Any 
missed dose should be returned at the next study visit.  
Table 4: Part A – Treatment Group and Dosing 
Treatment Group 
Product Description  
Potency 
Blinded or Open 
Label 
Frequency 
Placebo 
Placebo matching  
BMS-986165 6 mg 
n/a 
Blinded 
Daily 
Morning 
Placebo matching  
BMS-986165 12 mg 
n/a 
Blinded 
Daily 
Morning 
BMS-986165 6 mg QD 
 
BMS-986165 6 mg tablet 
6 mg 
Blinded 
Daily 
Morning 
Placebo matching  
BMS-986165 12 mg 
n/a 
Blinded 
Daily 
Morning 
BMS-986165 12 mg QD 
 
Placebo matching  
BMS-986165 6 mg 
n/a 
Blinded 
Daily 
Morning 
BMS-986165 12 mg tablet 
12 mg 
Blinded 
Daily 
Morning 
 
 
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6.1.2 
Dose Schedule for Part B 
Subjects that complete Part A will have the option to enroll in Part B of the study to receive study 
drug in a double-blind, double-dummy fashion over 36 weeks (Table 5). The treatment group 
assignment in Part B will depend on the treatment the subject received in Part A as well as if the 
subject achieved MDA at Week 16 (Part A). Subjects will be assigned to 1 of 3 treatment groups: 
• Ustekinumab SQ injection PLUS Placebo matching BMS-986165 
• BMS-986165 6 mg PLUS Placebo matching ustekinumab injection 
• BMS-986165 12 mg PLUS Placebo matching ustekinumab injection 
Study treatment will be dispensed and administered in a double-blind, double-dummy fashion as 
described in Section 4.1.  
BMS-986165 6 mg, 12 mg, or placebo matching BMS-986165 tablets: 
As the blister cards provided to the sites will be double-blind, all dispensing must be performed 
via the IRT system. Blister cards will be dispensed at Weeks 16, 20, 24, 28, 32, 36, 40, 44, and 48. 
An adequate supply of blister cards will be dispensed to cover the subject until their next scheduled 
visits.  
The tablets will be arranged into sets and the subject will be instructed to take 2 tablets daily in the 
morning (total of 2 tablets daily). Any missed doses should be returned at the next study visit. 
Ustekinumab or placebo matching ustekinumab: 
The ustekinumab or placebo matching ustekinumab will be administered SQ at Weeks 16, 20, 32, 
and 44.  Additionally another dose of ustekinumab or placebo matching ustekinumab will be 
administered at Week 52 based on the investigator/treating physician’s and subject’s decision to 
take ustekinumab post-study completion (ie, following Week 56 visit completion). 
The ustekinumab vials provided by the Sponsor will be open-label. Normal saline will be used as 
the placebo for ustekinumab. An unblinded pharmacist (or appropriate drug preparation person) 
will need to prepare the SQ injection based on the subject’s treatment assignment (ie,  ustekinumab 
SQ injection or placebo matching ustekinumab SQ injection). The syringe used for administration 
of ustekinumab or placebo must be identical. However, the color and viscosity of the solutions 
may be different. Even though the subject will not be able to distinguish the difference, study 
personnel who administer both preparations may be able to perceive the difference. For this reason, 
the person designated as the unblinded drug administrator will not be involved in any other study 
conduct. Depending on the site, the unblinded pharmacist (or appropriate drug preparation person) 
and the unblinded study drug administrator may be the same person.  
Guidance on the preparation of the ustekinumab or placebo matching ustekinumab SQ injection is 
contained in the Pharmacy Manual. 
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Table 5: Part B -- Treatment Group and Dosing 
Treatment Group 
Product Description  
Dosage in 
mg 
Frequency of 
Administrationa 
Ustekinumab SQ injection 
PLUS 
Placebo matching BMS-
986165  
Placebo matching  
BMS-986165 6 mg 
n/a 
Daily Morning 
Placebo matching  
BMS-986165 12 mg 
n/a 
Daily Morning 
Ustekinumab 
45 mg / 
90 mgb 
Weeks 16, 20, 32, and 44 
BMS-986165 6 mg  
PLUS 
Placebo matching 
ustekinumab injection 
BMS-986165 6 mg 
6 mg 
Daily Morning 
Placebo matching  
BMS-986165 12 mg 
n/a 
Daily Morning 
Normal saline 
n/a 
Weeks 16, 20, 32, and 44 
BMS-986165 12 mg  
PLUS 
Placebo matching 
ustekinumab injection 
BMS-986165 12 mg 
12 mg 
Daily Morning 
Placebo matching  
BMS-986165 6 mg 
n/a 
Daily Morning 
Normal saline 
n/a 
Weeks 16, 20, 32, and 44 
a Based on the Week 48 Post-study Ustekinumab Evaluation, for subjects that elect to be treated with ustekinumab 
after the study completion (ie, completion of the Week 56 visit), the following treatment will be administered at 
Week 52: 1) subjects that were on ustekinumab treatment in Part B will receive a placebo matching ustekinumab 
SQ injection, or 2) subjects that were on BMS-986165 6 mg or BMS-986165 12 mg treatment in Part B will receive 
ustekinumab SQ injection 
b Ustekinumab is weight based dosing. Two vials will be used for injections to create 90 mg doses. Dosing will be 
in quick succession and different syringes will be needed 
 
6.2 
Method of Treatment Assignment 
At the time of the screening visit, 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. This number is assigned sequentially by the system and will be unique across all sites. If 
a potential subject is rescreened, a new identification number will be used. 
At Week 0 (Day 1) of Part A, subjects who meet all criteria for enrollment at Screening and  
Day 1 will be centrally randomized in a 1:1:1 ratio to BMS-986165 6 mg QD, BMS-986165  
12 mg QD, or placebo matching BMS-986165, 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. Randomization will be 
stratified by TNFi use (experienced/naïve) and body weight (< 90 kg and ≥ 90 kg). After all 
inclusion/exclusion criteria have been met for a subject, the investigative site will access the IRT 
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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 kit number will be assigned to the subject corresponding to 
the treatment assignment. 
Subjects completing Part A will have the option to enroll into Part B of the study. Treatment 
assignment in Part B will be based on the subject’s treatment assignment in Part A as well as the 
patient’s MDA score at Week 16. Similar to Part A, blister cards will be dispensed to create a 
1-month supply. 
6.3 
Blinding  
6.3.1 
Maintaining the Blind 
Treatment assignments and study drug dispensing in Part A and in Part B will be managed using 
IRT. Investigative site staff, the Sponsor, and subject will remain blinded to treatment assignment 
with the exception of an unblinded pharmacist (or appropriate drug preparation person), an 
unblinded study drug administrator (Part B), and an unblinded site monitor who will be involved 
only with drug accountability in Part B. Depending on the site, the unblinded pharmacist (or 
appropriate drug preparation person) and the unblinded study drug administrator may be the same 
person. 
BMS-986165 6 mg, 12 mg tablets, or placebo matching BMS-986165: 
Each strength of BMS-986165 (6 mg or 12 mg) will have a matching placebo. The tablets will be 
provided to the sites in blister cards and each subject will need to take 2 tablets daily.   
Ustekinumab or placebo matching ustekinumab: 
Ustekinumab vials for SQ injection will be provided by the Sponsor. Normal saline will be used 
as the placebo for ustekinumab and will be procured by the site. An unblinded pharmacist (or 
appropriate drug preparation person) will need to prepare the SQ injection based on the subject’s 
treatment assignment (i.e. ustekinumab SQ injection or placebo matching ustekinumab SQ 
injection). The syringe used for administration of ustekinumab or placebo must be identical; 
however, the color and viscosity of the solutions may be different. Even though the subject will 
not be able to distinguish the difference, study personnel who administer both preparations may 
be able to perceive the difference. For this reason, the person is designated as the unblinded drug 
administrator and will not be involved in any other study conduct. Depending on the site, the 
unblinded pharmacist (or appropriate drug preparation person) and the unblinded study drug 
administrator may be the same person. 
Guidance on the preparation of the ustekinumab or placebo matching ustekinumab SQ injection is 
contained in the Pharmacy Manual. 
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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 IP 
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 IP, 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 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). In 
addition, the information that is requested on the emergency unblinding envelope must be 
completed. 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 nonemergency purposes must be 
discussed with the Medical Monitor.   
The DMC will assess safety and risk benefit on an ongoing basis, and will have access to unblinded 
treatment codes for individual subjects An analysis team, including a reporting statistician and 
programming support, who are not involved with the conduct of the study, will provide analyses 
to the DMC. The procedures to be respected and the reasons for unblinding of the DMC are 
discussed in the DMC charter. 
In addition, an unblinded analysis of the safety and endpoint data will be performed after all 
subjects complete their Week 16 visit (Part A). The analysis will be performed by an independent 
statistical team who are not involved in the conduct of the study and reviewed by non-study team 
members who will use the data to support Phase 3 development decision making. Study team 
members will remain blinded as subjects move into Part B. 
A bioanalytical scientist in the Bioanalytical Sciences department of BMS Research & 
Development (or a designee in the external central bioanalytical laboratory) will be unblinded to 
the randomized treatment assignments in order to minimize unnecessary bioanalytical analysis of 
samples. 
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If a subject is unblinded for any reason, the subject will be discontinued from treatment. 
6.4 
Dosage Modification 
There is no provision for dose-modification of study treatment. If a subject interrupts treatment 
due to an AE, study treatment can be restarted in consultation with the Medical Monitor. 
6.5 
Preparation/Handling/Storage/Accountability 
The IP should be stored in a secure area according to local regulations. It is the responsibility of 
the investigator to ensure that IP is only dispensed to study subjects. The IP must be dispensed 
only from official study sites by authorized personnel according to local regulations. 
The product storage manager should ensure that the study treatment is stored in accordance with 
the environmental conditions (temperature, light, and humidity) as determined by BMS. If 
concerns regarding the quality or appearance of the study treatment arise, the study treatment 
should not be dispensed and contact BMS immediately. 
Study treatment not supplied by BMS will be stored in accordance with the package insert. 
IP 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). 
Further guidance and information for final disposition of unused study treatment are provided in 
APPENDIX 2. 
The unblinded pharmacist (or appropriate drug preparation person) will obtain treatment 
assignment by IRT in Part B and prepare the ustekinumab or placebo injection. 
 
 
 
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. 
 
 
 
 
 
 
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6.8 
Treatment After the End of the Study 
At the end of the study, BMS will not continue to provide BMS-supplied study treatment to 
subjects/investigators unless BMS chooses to extend the study. The investigator should ensure that 
the subject receives appropriate standard of care to treat the condition under study.  
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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:  
• Subject’s request to stop study treatment. Subjects who request to discontinue study treatment 
will remain in the study and must continue to be followed for protocol specified follow-up 
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 
• Any clinical 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 
• Termination of the study by BMS 
• Loss of ability to freely provide consent through imprisonment or involuntarily incarceration 
for treatment of either a psychiatric or physical (eg, infectious disease) illness 
• eGFR <45 mL/min confirmed on a repeat assessment within 7 days 
• 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 
• The subject develops a malignancy, with the exception of a subject who develops 
nonmelanoma skin cancer who may continue in the study at the discretion of the investigator 
• Pregnancy, positive pregnancy test, or subject expresses an interest in becoming pregnant 
(refer to Section 8.2.6) 
• 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) 
• Unblinding of a subject’s treatment assignment for any reason (emergency or nonemergency) 
• Inability or failure to comply with protocol requirements in the opinion of the investigator 
• Clinically significant worsening of disease, while taking study treatment, that requires the use 
of medications listed as prohibited in the protocol  
Refer to the Schedule of Activities for data to be collected at the time of treatment discontinuation 
and follow-up and for any further evaluations that can be completed. 
In the case of pregnancy, the investigator must immediately, within 24 hours of awareness of the 
pregnancy, notify the Medical Monitor/designee of this event. In most cases, the study treatment 
will be permanently discontinued in an appropriate manner (eg, dose tapering if necessary for 
subject safety). Refer to Section 8.2.6 Pregnancy. 
All subjects who discontinue study treatment should comply with protocol-specified follow-up 
procedures as outlined in the Schedule of Activities, Section 1.3. The only exception to this 
requirement is when a subject withdraws consent for all study procedures including post-treatment 
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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). 
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 CRF page. 
7.1.1 
Post-Study Treatment Study Follow Up  
Subjects who discontinue study treatment will be followed through the scheduled 30-day safety 
follow-up period or longer, as required, and in line with Section 8.2.4. 
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. 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.  
• Subjects should notify the investigator of the decision to withdraw consent from future follow-
up in writing, whenever possible. 
• The withdrawal of consent should be explained in detail in the medical records by the 
investigator and entered on the appropriate CRF page. 
• 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. 
• 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. 
• During part B of the study (Week 16 to Week 52), and after 12 weeks of treatment (at Week 28 
only), for subjects who do not achieve MDA, the study design provides for rescue therapy for 
relief of joint symptoms with NSAIDs, intra-articular injections of steroids, systemic 
glucocorticoids or DMARDs. After Week 28, subjects who need rescue therapy or additional 
therapy for PsA and/or flares will be discontinued from the study. 
7.3 
Lost to Follow-Up 
• 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. 
• 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. 
• If it is determined that the subject has died, the site will use permissible local methods to obtain 
date and cause of death. 
• 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 
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information or other public vital status data necessary to complete the follow-up portion of the 
study.  
• The site staff and representative will consult publicly available sources, such as public health 
registries and databases, in order to obtain updated contact information. 
• 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 
• Study procedures and timing are summarized in the Schedule of Activities (Section 1.3).  
• Protocol waivers or exemptions are not allowed. 
• All immediate safety concerns must be discussed with the Medical Monitor immediately upon 
occurrence or awareness to determine if the subject should continue or discontinue treatment. 
• Adherence to the study design requirements, including those specified in the Schedule of 
Activities, is essential and required for study conduct. 
• All screening evaluations must be completed and reviewed to confirm that potential subjects 
meet all eligibility criteria before randomization. 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. 
• Procedures conducted as part of the subject’s routine clinical management (eg, blood count) 
and obtained before signing of informed consent may be utilized for screening or baseline 
purposes provided the procedure meets the protocol-defined criteria and has been performed 
within the timeframe defined in the Schedule of Activities. 
8.1 
Efficacy Assessments 
8.1.1 
Rater Qualification 
All rheumatologic and dermatologic evaluations must be performed by a qualified assessor that 
is blinded to the subject’s safety data, previous efficacy data, and treatment. Every effort must be 
made to ensure the same assessor will complete the clinical efficacy/health outcome assessments 
for each subject at all visits at approximately the same time throughout the study, according to 
the Schedule of Activities (Section 1.3). Visits should be scheduled with the availability of the 
evaluator(s) taken into account. If the assessor is unable to complete the evaluation, then another 
qualified individual can take the place of the initial evaluator, but the substitute evaluator should 
have examined and reviewed the subject with the initial evaluator in order to assure overlapping 
experience (consistency between subject evaluations). Documentation of who performed the 
evaluation is to be recorded in source notes. 
To be an eligible Joint Assessor, individuals must receive the standardized joint count training 
provided by PRA/BMS or be trained by an individual who did receive the standardized training 
(documentation filed in the Investigator File and the Study File). Such individuals should have 
appropriate medical credentials and/or should be individuals with appropriate scientific/medical 
background who are experienced in performing joint assessments. If the individual does not have 
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medical credentials, documentation of their experience (preferably on a curriculum vitae) must 
be provided to the study site manager, and their eligibility as joint assessor must be confirmed by 
the PRA or BMS medical monitor before the individual’s participation in the study as joint 
assessor. 
The Joint Assessor may also perform the enthesitis and dactylitis, as well as assess the Target 
Lesion and conduct the PASI scoring. Training in these assessments will be provided by BMS or 
PRA and is required in order to perform this function. 
Individuals performing the Physician’s Global Assessment of psoriatic arthritis must be a 
physician or other healthcare professional who is competent to perform the assessment.   
Subjects will complete all subject reported questionnaires, which will be considered source 
documents in this study. All subject reported outcomes must be performed prior to all other 
assessments, including phlebotomy, physical exam, joint and skin assessments.  
8.1.2 
American College of Rheumatology (ACR) Improvement Criteria  
The ACR 20, ACR 50 or ACR 70 definition of improvement is a 20%, 50% or 70% 
improvement, respectively, over baseline in tender and swollen joint counts and a 20%, 50% or 
70% improvement, respectively, in 3 of the 5 remaining core data set measures (APPENDIX 5): 
 
≥ 20%, 50% or 70% improvement from baseline in the number of tender joints (68 joint count) 
≥ 20%, 50% or 70% improvement from baseline in the number of swollen joints (66 joint count) 
≥ 20%, 50% or 70% improvement from baseline in 3 of the following 5 domains: 
• Subject Global Assessment of disease activity (APPENDIX 7) 
• Physician Global Assessment of psoriatic arthritis  
• Subject global assessment of pain (APPENDIX 8) 
• Health Assessment Questionnaire-Disability Index (HAQ-DI, APPENDIX 6) 
• hsCRP 
8.1.3 
Health Assessment Questionnaire-Disability Index (HAQ-DI) 
The HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a subject 
has experienced during the past week in 8 domains of daily living activities: dressing and 
grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity 
category consists of 2 to 3 items. For reach item in the questionnaire the level of activity is cored 
from 0 to 3 with 0 representing “no difficulty”, 1 as “some difficulty”, 2 as much “difficulty”, and 
3 has “unable to do”. Any activity that requires assistance from another individual or requires the 
use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional 
status (see APPENDIX 6). 
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8.1.4 
Psoriasis Area and Severity Index (PASI) 
The PASI is a measure of the average erythema, induration thickness and scaling of psoriatic skin 
lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to 
groin, and legs to top of buttocks).26 The PASI produces a numeric score that can range from  
0 to 72, with higher PASI scores denoting more severe disease activity. The PASI can also be used 
to assess response to treatment. The PASI 50 is the proportion of subjects who experience at least 
a 50% improvement in PASI score as compared with the baseline value. The PASI 75, 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. All PASI assessments should be performed by a trained 
assessor experienced in the assessment of psoriasis patients (see APPENDIX 9). 
8.1.5 
Disease Activity Score 28 CRP  
A Disease Activity Score (DAS) can be used to assess patients’ PsA disease activity, to 
determine whether it is under control, and if any treatment adjustments are required. It can also 
assist in establishing a target score to aim for, to help inform treatment decisions, and optimize 
disease management.  
DAS 28 CRP is a composite outcome measure that assesses:  
• How many joints in the hands (including metacarpophalangeal and proximal 
interphalangeal joints , but excluding distal interphalangeal joints), wrists, elbows, 
shoulders, and knees are swollen and/or tender over a total of 28 
• CRP in the blood to measure the degree of inflammation 
• Subject Global Assessment of disease activity (APPENDIX 7) 
The results are combined to produce the DAS 28 CRP score, which correlates with the extent of 
disease activity: 
•    < 2.6: Disease remission 
•    2.6 – 3.2: Low disease activity  
•    3.2 – 5.1: Moderate disease activity 
•    >5.1: High disease activity 
8.1.6 
Dactylitis 
The number of digits in hands and feet with dactylitis will be counted by a blinded assessor. The 
Leads Dactylitis Index (LDI) Basic is a quantitative measurement of dactylitis in the 20 digits 
using a dactylometer. The circumference of the affected and contralateral digits, and tenderness of 
the affected digits are measured to generate a total score. A higher score indicates worse dactylitis 
and is based on the current evaluation. Training will be provided so dactylitis will be evaluated in 
a consistent manner throughout the study.77 
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8.1.7 
Enthesitis  
The number of sites with enthesitis will be evaluated by a blinded assessor using the 
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis index and the Leeds 
Enthesitis index (LEI). 
The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: 
the greater trochanter (R/L), quadriceps tendon insertion into the patella (R/L), patellar ligament 
insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia 
insertion (R/L), medial and lateral epicondyles (R/L), and the supraspinatus insertion (R/L). A 
higher count indicates a higher enthesitis burden based on the current evaluation. It has been 
validated in ankylosing spondylitis and correlates well with the LDI.78 
The LEI was developed specifically for PsA. An overall score of 0 to 6 is derived from the presence 
or absence of tenderness at 6 entheseal sites (right and left: lateral epicondyle, medial femoral 
condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater 
enthesitis burden.79 
8.1.8 
Physicians Global Assessment-Fingernails (PGA-F) 
In this assessment, 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 Physician’s Global Assessment – fingernails (PGA-F) will be performed only in subjects with 
psoriatic fingernail involvement to assess severity and subsequent improvement. An example is 
provided in APPENDIX 10. The PGA-F should be performed by an appropriately trained assessor  
experienced in the assessment of psoriasis patients. 
8.1.9 
Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) 
Minimal Disease Activity (MDA) response is where an MDA responder is defined as a subject 
fulfilling 5 of 7 of the following outcomes: 
• tender joint count ≤ 1 
• swollen joint count ≤ 1 
• PASI ≤ 1 or body surface area (BSA) ≤ 3% 
• Subject Global Assessment of pain ≤ 15 (APPENDIX 8)  
• Subject Global Assessment of disease activity ≤ 20 (APPENDIX 7) 
• HAQ-DI ≤ 0.5 
• Tender entheseal points ≤ 1 
Very low disease activity (VLDA) response is where a VLDA responder is defined as a subject 
fulfilling all 7 of 7 of the MDA outcomes. 
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8.1.10 
Psoriatic Arthritis Disease Activity Score 
A composite measure calculated from the Physician Global Assessment of psoriatic arthritis, the 
Subject Global Assessment of disease activity, the Short Form Health Survey-36 Item (SF-36) 
Physical Component Summary (PCS), the swollen joint count, the tender joint count, the LEI, the 
LDI (Basic), and the hsCRP. 
8.1.11 
Disease Activity Index for Psoriatic Arthritis Score 
The Disease Activity Index for Psoriatic Arthritis Score (DAPSA) is a composite measure to assess 
peripheral joint involvement that is based upon numerical summation of 5 variables of disease 
activity: tender/painful joint count, swollen joint count, Subject Global Assessment of disease 
activity (APPENDIX 7), Subject Global Assessment of pain (APPENDIX 8), and CRP.  
8.1.12 
PsA Response Criteria (PsARC) 
The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender/painful 
joint count, swollen joint count, Physician Global Assessment of psoriatic arthritis, and Subject 
Global Assessment of pain ≤ 15 (APPENDIX 8). 
In order to be classified as a PsARC responder, subjects must achieve improvement in 2 of 4 
measures, one of which must be joint pain or swelling, without worsening in any measure. 
8.1.13 
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 
In subjects with baseline evidence of PsA spondylitis, symptoms will be evaluated using the 
BASDAI 
(APPENDIX 
11), 
which 
consists 
of 
a  
0 to 100 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 
5 major symptoms of ankylosing spondylitis: 
• Fatigue (medical) 
• Spinal pain 
• Joint pain and swelling 
• Areas of localized tenderness 
• Morning stiffness duration 
• Morning stiffness severity 
A higher count indicates worse disease. The recall period is one week. 
8.1.14 
Short Form Health Survey-36 Item (SF-36) 
The SF-36 is a patient-reported outcome measure in clinical practice and research. The instrument 
includes 36 items in a Likert-type format to measure the following 8 health dimensions over the 
past week: 1) limitations in physical activities, such as bathing or dressing; 2) limitations in social 
activities because of physical or emotional problems; 3) limitations in usual role activities because 
of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and 
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well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality 
(energy and fatigue); and 8) general health perceptions. Scores for each domain range from  
0 to 100, with high scores indicating a better status. An example of the SF-36 is provided in  
APPENDIX 11. 
8.1.15 
Patient Reported Outcome Measures Information System-Fatigue 
(PROMIS-FATIGUE) and Functional Assessment of Chronic Illness 
Therapy Fatigue (FACIT-Fatigue) 
The Patient-Reported Outcome Measures Information System-Fatigue (PROMIS-Fatigue) and 
Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue) instruments evaluate 
a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness 
to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one’s 
ability to execute daily activities and function normally in family or social roles. Fatigue is divided 
into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on 
physical, mental, and social activities. The first 13 questions of the PROMIS-Fatigue questionnaire 
comprise the FACIT-Fatigue questionnaire.  
The PROMIS-Fatigue questionnaire is not yet available in all languages and will be administered 
at sites where it is available in the local language. In countries where the PROMIS-Fatigue 
questionnaire is not available in the local language, sites will administer the FACIT-Fatigue 
questionnaire to start the protocol. Once the PROMIS-Fatigue questionnaire is available in the 
local language, and with approval from the ethics committee, any newly enrolled subjects will 
complete the PROMIS-Fatigue questionnaire. Subjects who were administered the FACIT-Fatigue 
at Day 1 will continue to be administered the FACIT-Fatigue throughout the study. The PROMIS-
Fatigue Short Form 13a (FACIT-Fatigue), along with 5 supplemental fatigue items from the 
PROMIS item bank, is provided in APPENDIX 13.  
8.1.16 
Work Limitation Questionnaire (WLQ) 
The Work Limitation Questionnaire (WLQ) is a 25-item self-report that measures the on-the-job 
impact of chronic health conditions and treatment over the past 2 weeks. It focuses on assessing 
limitations while performing specific job demands from the following 4 domains: 
1) Time management: difficulty with handling time and scheduling demands (5 items) 
2) Physical demands: ability to perform job tasks that involve bodily strength, 
movement, endurance, coordination, and flexibility (6 items) 
3) Mental-interpersonal demands: cognitively demanding tasks and on-the-job 
social interactions (9 items) 
4) Output demands: concerns reduced work productivity (5 items) 
 
The score can be used to calculate a percent of lost work productivity due to a particular disease 
state. The WLQ Short Form will be used in this study. An example is provided in APPENDIX 14). 
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8.1.17 
Psoriatic Arthritis Impact of Disease (PsAID) 
The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures psoriatic 
arthritis symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale 
with a one week recall period. The PsAID has a total score, with a higher value indicating worse 
health (APPENDIX 15). 
8.1.18 
Routine Assessment of Patient Index Data 3 (RAPID3) 
RAPID3 (routine assessment of patient index data 3) is a pooled index of the 3 patient-reported 
ACR Core Data Set measures: function, Subject Global Assessment of pain, and Subject Global 
Assessment of disease activity. Each of the 3 individual measures is scored 0 to 10, for a total of 
30. Disease severity may be classified on the basis of RAPID3 scores: >12 = high; 6.1-12 = 
moderate; 3.1-6 = low; < or =3 = remission. RAPID3 scores are correlated with the disease activity 
score 28 (DAS 28) in clinical trials and clinical care, and are comparable to DAS 28 scores in the 
capacity to distinguish active from control treatments in clinical trials.80 
8.1.19 
Imaging Assessment for the Study 
Not applicable. 
8.2 
Adverse Events 
The definitions of an AE or SAE can be found in APPENDIX 3. 
AEs will be reported by the subject (or, when appropriate, by a caregiver, surrogate, or the subject’s 
legally authorized representative).  
The investigator and any designees are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or SAE and remain responsible for following up AEs that 
are serious, considered related to the study treatment or the study, or that caused the subject to 
discontinue before completing the study.  
Contacts for SAE reporting 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. AEIs may be serious or nonserious. 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 creatine 
kinase (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 immune-mediated diseases and 
increased risk for cancer, malignancy has been identified as a potential AEI. Therefore, additional 
information about certain skin-related AEs, infection AEs, CK elevation, MACE, and malignancy 
may be collected on the CRF in order to better characterize and understand them. 
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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, at the timepoints specified in the Schedule of Activities (Section 1.3). Nonserious AE 
information should also be collected from the start of a placebo lead-in period or other 
observational period intended to establish a baseline status for the subjects. The Reference Safety 
Information in Sections 5.6.1 and 5.6.2 of the Investigator’s Brochure (IB) should be used to 
determine the expectedness of SAEs for expedited reporting.  
All SAEs must be collected from the time of signing the consent, including those thought to be 
associated with protocol-specified procedures and within 30 days of discontinuation of dosing.  
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 (eg, a follow-up skin biopsy). 
• Medical occurrences that begin before the start of study treatment but after obtaining informed 
consent will be recorded on the appropriate section of the eCRF module. 
• All SAEs will be recorded and reported to Sponsor or designee within 24 hours, as indicated 
in APPENDIX 3.  
• The investigator will submit any updated SAE data to the Sponsor or designee within 24 hours 
of updated information 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 
• Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see APPENDIX 3). 
• 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. 
• 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. 
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). 
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Further information on follow-up procedures is given in APPENDIX 3. 
8.2.5 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities towards the safety of subjects and the safety of a product 
under clinical investigation are met. 
• An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the IB and will notify the IRB/IEC, if appropriate according to local requirements. 
Sponsor or designee will be reporting AEs to regulatory authorities and ethics committees 
according to local applicable laws including European Directive 2001/20/EC and FDA Code of 
Federal Regulations 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 
If, following initiation of the study treatment, it is subsequently discovered that a subject is 
pregnant or may have been pregnant at the time of study exposure, including during at least 
5 half-lives after product administration, the investigator must immediately notify PRA Drug 
Safety of this event and complete and forward a Pregnancy Surveillance Form to PRA Drug Safety 
within 24 hours of awareness of the event and in accordance with SAE reporting procedures 
described in APPENDIX 3. 
If the investigator determines a possible favorable benefit/risk ratio that warrants continuation of 
study treatment, or re-initiation of study treatment, a discussion between the investigator and the 
BMS Medical Monitor/designee must occur.  
Protocol-required procedures for study discontinuation and follow-up must be performed on the 
subject. 
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable, offspring information, must be reported on the Pregnancy 
Surveillance Form. 
Any pregnancy that occurs in a female partner of a male study subject should be reported to PRA 
Drug Safety. In order for Sponsor or designee to collect any pregnancy surveillance information 
from the female partner, the female partner must sign an ICF for disclosure of this information. 
Information on this pregnancy will be collected on the Pregnancy Surveillance Form. 
8.2.7 
Laboratory Test Result Abnormalities 
The following laboratory test result abnormalities should be captured on the AE eCRF page. 
• Any laboratory test result that is clinically significant or meets the definition of an AE or SAE  
• Any laboratory test result abnormality that required the subject to have study treatment 
discontinued or interrupted 
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• Any laboratory test result abnormality that required the subject to receive specific corrective 
therapy 
If a laboratory test result meets the definition of an AE or SAE, the laboratory test result should be 
reported as an AE or SAE and submitted to PRA Drug Safety, as specified in APPENDIX 3.  
It is expected that wherever possible, the clinical rather than laboratory term would be used by the 
reporting investigator (eg, anemia versus low hemoglobin value). 
8.2.8 
Potential Drug-Induced Liver Injury (DILI) 
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential DILI event. All occurrences of potential DILIs, meeting 
the defined criteria, must be reported as SAEs (see Section 8.2 and APPENDIX 3 for reporting 
details). 
Potential DILI is defined as:  
1) ALT or AST elevation > 3 times ULN 
AND 
2) Total bilirubin > 2 times ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase), 
AND 
3) No other immediately apparent possible causes of AT elevation and hyperbilirubinemia, 
including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the 
administration of other drug(s) known to be hepatotoxic. 
8.2.9 
Other Safety Considerations 
Any significant worsening noted during interim or final physical examinations, ECG, x-ray 
filming, any other potential safety assessment required or not required by protocol should also be 
recorded as a nonserious or SAE, 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 
Refer to Schedule of Activities (Section 1.3). A complete physical examination will include 
general appearance, vital signs, eyes, ears, nose mouth, throat, neck, respiratory, CV, respiratory, 
gastrointestinal/abdomen, lymphatic, musculoskeletal, skin, psychiatric, and neurologic exams. A 
targeted physical examination will include any organ system associated with an AE or a laboratory 
abnormality. 
8.4.2 
Vital Signs 
Refer to Schedule of Activities (Section 1.3). 
8.4.3 
Electrocardiograms 
Refer to Schedule of Activities. A 12-lead ECG will be performed at the visits indicated in the 
Schedule of Activities (Section 1.3). 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 physical examinations 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 PRA 
Medical Monitor. A subject with an indeterminate IGRA test result must be re-tested 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 
Investigators must document their review of each laboratory safety report. 
A central/local laboratory will perform the analyses and will provide reference ranges for these 
tests. 
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Hematology 
Hemoglobin 
Hematocrit 
Total leukocyte count, including differential 
Platelet count 
Chemistry 
Aspartate aminotransferase (AST) 
Alanine aminotransferase (ALT) 
Total bilirubin 
Direct bilirubin 
Alkaline phosphatase 
Lactate dehydrogenase (LDH) 
Creatinine 
Blood Urea Nitrogen (BUN) 
Uric acid  
Glucose (fasting at some visits) 
Total Protein 
Albumin 
Sodium 
Potassium 
Chloride 
Calcium 
Phosphorus 
Creatine 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 
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) 
HIV antibody 
Other Analyses 
Pregnancy test (WOCBP only: serum or HCG test at Screening, prior to first study drug 
administration, and every 4 weeks thereafter) 
Follicle-Stimulating Hormone (FSH) (Screening only for WOCBP only) 
Hemoglobin A1C 
Thyroid-Stimulating Hormone (TSH) 
High-Sensitivity C-Reactive Protein (hs-CRP) 
Serum Immunoglobulins (IgM, IgG, IgA, IgE) 
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*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. 
The MDRD equation is as follows: 
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 BSA and SCr (serum creatinine) is expressed in mg/dL.  
Subjects with an eGFR <45 mL/min will be excluded from participation. 
8.4.6 
Imaging Safety Assessment 
Not applicable. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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9 
STATISTICAL CONSIDERATIONS 
9.1 
Sample Size Determination  
Sample size considerations are based on providing exposure in a sufficient number of subjects for 
2 dose levels of BMS-986165, 6 mg QD and 12 mg QD, to be able to observe a true dose-response 
trend that is significantly greater than placebo in the primary endpoint of ACR 20 after 16 weeks 
of treatment.  
BMS-986165 is expected to provide similar PsA efficacy as observed in current biological trials. 
With this assumption, the expected overall placebo response rate is assumed to be 30% and  
BMS-986165 response rates to be 50% and 55% in the 6 mg QD and 12 mg QD doses respectively. 
A total sample size of 60 subjects per arm randomized in a blinded fashion at a 1:1:1 ratio to  
BMS-986165 6 mg QD arm, BMS-986165 12 mg QD arm, and placebo will provide 87.5% power 
in a mixed population to detect a significant dose-response trend compared to placebo for the 
primary endpoint of ACR 20 response at Week 16 using a trend test with α = 0.05 (1-sided) or 
with α = 0.10 (2-sided). 
9.2 
Populations for Analyses 
For purposes of analysis, the following analysis sets will be used in this trial: 
Population 
Description 
Enrolled Population 
All subjects who sign informed consent. 
Full Analysis Set (FAS)  
All randomized subjects who are dispensed study drug. Following 
the intent-to-treat principle, subjects will be analyzed according to 
the treatment assigned at randomization. The FAS will be the 
primary efficacy analysis population. This is the same as the 
intent-to-treat population. 
Per Protocol Set (PPS) 
A subset of the FAS who are compliant with the study treatment 
(compliance criteria will be defined in the SAP) and who do not 
have any important protocol deviations that may impact the 
primary efficacy endpoint assessments. The PPS will be a 
supportive efficacy analysis population. 
Safety Set (All Treated) 
All randomized subjects who receive at least one dose of 
double-blind study treatment. Subjects will be analyzed according 
to treatment received.  
 
 
 
 
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Population 
Description 
 
  
 
 
 
9.3 
Endpoints  
9.3.1 
Primary Endpoint 
The primary endpoint is the ACR 20 response at Week 16. A subject is considered an ACR 20 
responder if the following 3 conditions are met: 
• ≥ 20% improvement from baseline in the number of tender joints (68 joint count) 
• ≥ 20% improvement from baseline in the number of swollen joints (66 joint count) 
• ≥ 20% improvement from baseline in at least 3 of the following 5 domains: 
o Subject Global Assessment of disease activity (APPENDIX 7) 
o Physician Global Assessment of psoriatic arthritis  
o Subject Global Assessment of pain (APPENDIX 8) 
o HAQ-DI 
o hsCRP 
9.3.2 
Secondary Endpoints 
The secondary endpoints assessed at Week 16 include the following: 
• Change from baseline in HAQ-DI score 
• PASI 75 response in subjects with at least 3% BSA involvement at baseline 
• Change from baseline in SF-36 PCS score  
9.3.3 
Additional Endpoints 
Additional endpoints at Week 16 include: 
• ACR 50/70 response  
• HAQ-DI 0.35 response, where HAQ-DI 0.35 responder is defined as a subject with an 
improvement from baseline in HAQ-DI score of 0.35 
• PASI 90 response in subjects with at least 3% BSA involvement at baseline 
• Dactylitis mean change from baseline (dactylitis count) 
• Dactylitis change from baseline (LDI) 
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• Dactylitis resolution, where resolution is defined as a dactylitis count of 0 in subjects 
with dactylitis count ≥ 1 at baseline 
• Enthesitis mean change from baseline 
• Enthesitis resolution, where resolution is defined as a LEI score of 0, in subjects with  
LEI ≥ 1 at baseline 
• Change from baseline in SPARCC enthesitis index 
• Enthesitis resolution, where resolution is defined as a SPARCC enthesitis index score of 
0, in subjects with SPARCC ≥ 1 at baseline 
• MDA response, where an MDA responder is based on a subject fulfilling at least 5 of the 
below outcomes: 
o Tender joint count ≤ 1 
o Swollen joint count ≤ 1 
o PASI ≤ 1 or BSA ≤ 3% 
o Subject Global Assessment of pain ≤ 15 (APPENDIX 8)  
o Subject Global Assessment of disease activity ≤ 20 (APPENDIX 7) 
o HAQ-DI ≤ 0.5 
o Tender entheseal points ≤ 1 
• PGA-F 0/1, assessed as a proportion of subjects with a PGA-F score of 0 or 1 in subjects 
with a baseline PGA-F score ≥ 3 
• Change from baseline in PASDAS 
• Change from baseline in DAPSA 
• PsARC response 
• DAS 28 CRP response: 
o Proportion of subjects with Low Disease Activity defined as DAS 28 CRP score  
< 3.2 
o Proportion of subjects in remission and time to remission, remission is defined as a 
DAS 28 CRP score < 2.6 
• Change from baseline in DAS 28 CRP score 
• Change from baseline in PsAID score  
• Change from baseline in BASDAI, in subjects with baseline evidence of PsA spondylitis 
• Change from baseline in SF-36 MCS score 
• Change from baseline in PROMIS-Fatigue or FACIT-Fatigue score 
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• Change from baseline in WLQ score 
• Change from baseline in RAPID3 score 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
9.4 
Statistical Analyses 
A description of the subject population will be included in a statistical output report, including 
subgroups of age, gender, and race. 
9.4.1 
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 data will be primarily summarized using the FAS population unless 
otherwise stated. Variables will be summarized for all visits in which the variable is assessed. 
Complete details of the planned analyses will be documented in the SAP and finalized before 
database lock. 
During the first 16 weeks of treatment, data will be presented for the following treatments: 
• BMS-986165 6 mg QD 
• BMS-986165 12 mg QD 
• Placebo 
9.4.1.1 
Primary Endpoint Analyses 
The primary efficacy analysis model for binary endpoints (responder/non-responder) will use a 
logistic regression model to assess whether there is a dose-response trend between ACR 20 
response and dose level. The model will include dose level (0, 6, 12) as a continuous variable, and 
the following covariates: TNFi use (experienced/naïve) and body weight (≥ 90 kg and < 90 kg) in 
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the model. The odds ratio and the corresponding 2-sided 95% confidence interval (CI) will be 
provided. 
9.4.1.1.1 Imputation Methods for Primary Endpoint 
The estimand of interest is to assess the dose-response of multiple doses of BMS-986165 on 
subject response to ACR 20 criteria at Week 16 for all randomized subjects receiving at least one 
dose of study treatment. Occurrence of intercurrent events such as: 
• Subjects who discontinue the treatment or study early (ie, prior to Week 16) 
• Start a protocol prohibited medication/therapy 
• Subjects who are lost to follow-up 
• Subjects who otherwise have missing endpoint data at or prior to Week 16 will use the 
“Composite Strategy” as defined in ICH E9 R1 addendum and will be considered as a 
measure of non-response to treatment. Non-responder imputation (NRI) will be used for 
binary endpoints for the above intercurrent events 
9.4.1.2 Sensitivity Analyses for the Primary Endpoint 
The following strategies for addressing intercurrent events will be used in sensitivity analyses of 
the primary efficacy endpoint: 
1. While on Treatment Strategy – the last observation while the subject was on blinded 
treatment will be considered as their Week 16 value. This is essentially the last observation 
carried forward (LOCF) imputation methodology. 
2. For subjects with an intercurrent event at Week 16, “While on Treatment” strategy will be 
used for placebo subjects and “Composite” strategy will be used for BMS-986165 subjects. 
Therefore, placebo subjects with an intercurrent event will be imputed using the LOCF 
method and BMS-986165 subjects will be imputed using the NRI method in this analysis. 
Furthermore, tipping point analysis may be performed to assess the robustness of the primary 
imputation method. The goal of this analysis is to identify assumptions about the missing data 
under which the conclusions change. Further details of this procedure may be described in the 
SAP. 
9.4.1.2.1 Supportive Analyses for the Primary Endpoint 
The primary efficacy endpoint will also be analyzed for the PPS using the analysis described in 
Section 9.4.1.1. 
9.4.1.2.2 Subgroup Analyses for the Primary Endpoint 
Subgroup analyses will be conducted for the primary efficacy endpoint for the FAS using the 
analysis model described in Section 9.4.1.1 as well as the imputation method described in  
Section 9.4.1.1.1. Subgroups will not be further stratified based on the factors used for 
randomization. Subgroups that may be evaluated include the following: 
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• Gender 
• Age categories (< 65, ≥ 65) 
• Race 
• Body weight categories (< 90 kg; ≥ 90 kg) 
• TNFi use (experienced/naïve) 
• Glucocorticosteroid use (yes/no) 
• Geographic region 
• Country 
• DMARD use (yes/no) 
In addition, additional subgroups defined for descriptive summaries will be specified in the SAP. 
9.4.1.3 
Secondary Endpoint Analyses 
The secondary endpoint of PASI 75 response at Week 16 will be assessed in a dose-response 
analysis. The binary endpoint (responder/non-responder) will use a logistic regression analysis 
similar to the primary analysis. 
The secondary continuous endpoints will be assessed at Week 16 using dose-response linear 
regression analysis. The change from baseline score will be calculated at Week 16 and analyzed 
using an analysis of covariance (ANCOVA). Dose level (0, 6, 12) will be assessed in the model as 
a continuous variable and the following covariates as fixed effects: TNFi use (experienced/naïve) 
and body weight (< 90 kg and ≥ 90 kg). 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. 
9.4.1.3.1 Imputation Methods for Secondary Endpoints 
Similar strategies for addressing intercurrent events will be used for binary secondary efficacy 
endpoints. 
For continuous secondary efficacy endpoints, the “Composite” and “While on Treatment” 
strategies will be used to address specific intercurrent events. For subjects who discontinue study 
treatment and/or study due to: 
• Lack of efficacy 
• Adverse events 
or who start a protocol prohibited medication/therapy, the baseline observation will be used as the 
subject’s Week 16 value. For all other intercurrent events, the last valid observation while on 
treatment will be used as the Week 16 value. 
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9.4.1.4 Adjustment for Multiplicity of Primary and Key Secondary Endpoints 
Statistical analysis of secondary endpoints will be performed in a hierarchical fashion. In order to 
preserve the overall Type I error rate, a fixed-sequence testing method will be implemented. 
Testing of secondary endpoints will occur sequentially and may only proceed to the next secondary 
endpoint if the null hypothesis is rejected at alpha = 0.10 (2-sided) for the prior endpoint showing 
a positive dose-response in that endpoint. If an endpoint fails at any step, then all subsequent 
p-values will be considered nominal.  
Secondary Family – Secondary endpoints will be tested for a positive dose-response trend in the 
following order: 
a. Change from baseline in HAQ-DI score at Week 16 
b. PASI 75 response at Week 16 
c. Change from baseline in SF-36 PCS score at Week 16 
There will be no multiplicity adjustment for testing of additional endpoints. Nominal p-values will 
be provided as descriptive statistics. 
9.4.2 
Safety Analyses 
Safety data will be analyzed for AEs, SAEs, laboratory analytes, physical exam, vital signs, and 
ECGs. Safety will be summarized using the Safety 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. Safety 
data for Part A and B will be summarized separately. 
During the first 16 weeks of treatment, data will be presented for the following treatments: 
• BMS-986165 6 mg QD 
• BMS-986165 12 mg QD 
• Placebo 
After Week 16, subjects continuing in Part B of the study will have their data presented depending 
on MDA response in Part A, as follows: 
• BMS-986165 6 mg QD → BMS-986165 6 mg QD 
• BMS-986165 12 mg QD → BMS-986165 12 mg QD 
• Placebo → Ustekinumab injection 
• BMS-986165 6 mg QD → Ustekinumab injection 
• BMS-986165 12 mg QD → Ustekinumab injection 
9.4.2.1 
Adverse Events 
Treatment-emergent adverse events (TEAEs), SAEs and deaths, and AEs leading to study 
treatment discontinuation, AEs by maximum severity, and AEs by relationship will be summarized 
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by the Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred 
term. All TEAEs, AEIs, as well as MACE (cardiac death, nonfatal myocardial infarction, nonfatal 
stroke) will be summarized by preferred term sorted by decreasing frequency. 
9.4.2.2 
Vital Signs, ECGs and Physical Examinations 
Vital signs and ECGs will be summarized as raw, change from baseline, and change from 
maximum postbaseline value. Incidence of abnormal ECG and physical examination findings will 
also be summarized. 
9.4.2.3 
Clinical Laboratory Tests 
Laboratory analytes will be summarized as raw, change from baseline, and change from maximum 
post-baseline value. Incidence of abnormal, high, or low values will be summarized. Shift tables 
will also be provided. 
9.4.3 
Other Analyses  
9.4.3.1 
Demographics and Other Baseline Characteristics 
Demographics and other baseline characteristics will be summarized by treatment for each 
applicable analysis set. 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. 
Baseline demographic and disease characteristic comparability of the randomized treatment 
groups will be assessed. Categorical variables will be evaluated by a Fisher’s exact test and 
continuous variables will be evaluated by a t-test. These tests of comparability are performed for 
descriptive purposes only. 
 
 
 
 
 
 
9.4.3.3 
Relevant Protocol Deviations 
The impact of relevant protocol deviations on the efficacy results will be assessed by excluding 
subjects from the PPS in supportive analyses of the primary efficacy endpoint. Relevant protocol 
deviations to be considered regarding exclusion of subjects from the PPS may include but are not 
limited to the following: 
• Subject did not take study drug per protocol 
• Subject failed to meet study inclusion criteria but was entered into the study 
• Subject met study exclusion criteria but was entered into the study 
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• Subject took prohibited concomitant medication 
• Subject did not have a Week 16 assessment 
Relevant protocol deviations will be summarized descriptively by treatment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9.4.3.6 
PROMIS-Fatigue and FACIT-Fatigue 
PROMIS-Fatigue score will be summarized by treatment and time point for subjects who were 
administered PROMIS-Fatigue. FACIT-Fatigue scores will be similarly presented as a pooled 
analysis, which will include FACIT-Fatigue scores combined with scores from the first 
13 PROMIS-Fatigue questions. 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
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9.4.4 
Interim Analyses  
No interim analysis is currently planned. 
9.5 
Analysis and Reporting 
A database lock (16-week database lock) will occur once all randomized subjects have completed 
the Week 16 efficacy assessments or have discontinued prior to Week 16. Analyses of the collected 
efficacy and safety results during the 16-week Part A will be performed in order to aid in planning 
for subsequent clinical development. Details of these analyses will be described in the SAP. The 
study team responsible for managing the study, including medical monitors, will remain blinded 
to treatment assignment and the results of this analysis throughout the study. 
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11 APPENDICES 
APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS ...........................................123 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS ....................................128 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW UP AND REPORTING ..............................136 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION ............................................140 
APPENDIX 5 
AMERICAN COLLEGE OF RHEUMATOLOGY CORE 
DATASET AND RESPONSE DEFINITIONS .......................................144 
APPENDIX 6 
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF PHYSICAL FUNCTION SCALE: HEALTH 
ASSESSMENT QUESTIONNAIRE (HAQ) ...........................................145 
APPENDIX 7 
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF DISEASE ACTIVITY VISUAL 
ASSESSMENT SCALE ..........................................................................148 
APPENDIX 8 
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF PAIN SCALE ..........................................................149 
APPENDIX 9 
Psoriasis Area and Severity Index (PASI) ...............................................150 
APPENDIX 10 
PHYSICIAN’S GLOBAL ASSESSMENT-FINGERNAILS (PGA-
F) ..............................................................................................................151 
APPENDIX 11 
THE BATH ANKYLOSING SPONDYLITIS DISEASE 
ACTIVITY INDEX (BASDAI) ...............................................................152 
APPENDIX 12 
SHORT FORM HEALTH SURVEY-36 ITEM (SF-36) .........................153 
APPENDIX 13 
PROMIS-FATIGUE ................................................................................156 
APPENDIX 14 
WORK LIMITATIONS QUESTIONNAIRE (WLQ) .............................158 
APPENDIX 15 
THE EULAR PSORIATIC ARTHRITIS IMPACT OF DISEASE: 
PsAID 12 FOR CLINICAL PRACTICE .................................................155 
 
 
 
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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 
AST 
aspartate aminotransferase 
AT 
aminotransaminases 
AUC(TAU) 
area under the concentration-time curve in one dosing interval 
-HCG 
beta-human chorionic gonadotrophin 
BASDAI 
Bath Ankylosing Spondylitis Disease Activity Index 
BID 
bis in die, twice daily 
BMI 
body mass index 
BMS 
Bristol-Myers Squibb 
BP 
blood pressure 
BSA 
Boy surface area 
BUN 
blood urea nitrogen 
CASPAR 
Classification Criteria for Psoriatic Arthritis 
CBC 
complete blood count 
CFR 
Code of Federal Regulations  
CI 
confidence interval 
CK 
creatine kinase 
cm 
centimeter 
CMH 
Cochran-Mantel-Haenszel 
Cmax, CMAX 
maximum observed concentration 
CNS 
Central nervous system 
CRF 
Case Report Form, paper or electronic 
CS 
corticosteroid 
CT 
computed tomography 
Ctrough 
Trough observed plasma concentration 
CV 
cardiovascular 
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Term 
Definition 
DAPSA 
Disease Activity Index for Psoriatic Arthritis Score 
DAS 
Disease Activity Score 
dL 
deciliter 
DMARD 
disease-modifying antirheumatic drug 
DILI 
drug-induced liver injury 
DMC 
data monitoring committee 
DSM IV 
Diagnostic and Statistical Manual of Mental Disorders (4th Edition) 
ECG 
electrocardiogram 
eCRF 
Electronic Case Report Form 
eg 
exempli gratia (for example) 
eGFR 
Estimated glomerular filtration rate 
ESR 
erythrocyte sedimentation rate 
ET 
early termination 
E-R 
exposure-response 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
FSH 
follicle stimulating hormone 
g 
gram 
GCP 
Good Clinical Practice 
GFR 
glomerular filtration rate 
h 
hour 
HAQ-DI 
Health Assessment Questionnaire-Disability Index 
HBcAb 
hepatitis B core antibody 
HBsAb 
hepatitis B surface antibody 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
Human Immunodeficiency Virus 
HR 
heart rate 
HRT 
hormone replacement therapy 
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Term 
Definition 
hsCRP 
high-sensitivity C-reactive protein 
ICH 
International Conference on Harmonisation  
ie 
id est (that is) 
IEC 
Independent Ethics Committee 
IGRA 
IFN gamma release assay 
IMP 
investigational medicinal products 
IND 
Investigational New Drug Exemption 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
IV 
intravenous 
kg 
kilogram 
L 
liter 
LDH 
lactate dehydrogenase 
LDI 
Leeds Dactylitis Index 
LEI 
Leeds Enthesitis Index 
LOCF 
Last observation carried forward 
LS 
least-squares 
LTBI 
Latent TB Infection 
LTE 
long term extension 
MDA 
Minimal Disease Activity 
MDRD 
Modification of Diet in Renal Disease 
mg 
milligram 
min 
minute 
mL 
milliliter 
g 
microgram 
X 
methotrexate 
N 
number of subjects or observations 
n/a 
not applicable 
NRI 
non-responder imputation 
NSAID 
nonsteroidal anti-inflammatory drug 
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Term 
Definition 
PASI 
Psoriasis Area and Seventy Index 
PASDAS 
Psoriatic Arthritis Disease Activity Score 
PD 
pharmacodynamics 
PGA-F 
Physician’s Global Assessment-Fingernails 
PK 
pharmacokinetics 
PO 
per os (by mouth route of administration) 
PP 
Per Protocol 
PPS 
Per Protocol Set 
PRO 
Patient Reported Outcome 
PROMIS 
Patient Reported Outcome Measurement Information System 
PsA 
psoriatic arthritis 
PsAID 
Psoriatic Arthritis Impact of Disease 
PsARC 
Psoriatic Arthritis Response Criteria 
PsO 
psoriasis 
QD 
quaque die, once daily 
QSP 
quantitative systems pharmacology 
RAPID3 
routine assessment of patient index data 3 
RBC 
red blood cell 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SCr 
serum creatinine 
SF-36 
Short Form Health Survey-36 Item 
SPARCC 
Spondyloarthritis Research Consortium of Canada 
SQ 
subcutaneous 
STAT 
signal transducer and activator of transcription 
SUSAR 
Suspected, Unexpected Serious Adverse Reaction 
TB 
tuberculosis 
TEAE 
treatment emergent adverse event 
TH 
T-helper 
TNF 
tumor necrosis factor 
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Term 
Definition 
TNFi 
TNF-inhibitor 
TYK2 
tyrosine kinase 2 
Tmax 
time of maximum observed concentration 
TNF 
tumor necrosis factor 
ULN 
upper limit of normal 
VLDA 
Very Low Disease Activity 
WBC 
white blood cell 
WHO 
World Health Organization 
WLQ 
work limitation questionnaire 
WOCBP 
women of childbearing potential 
 
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APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS 
The term ‘Subject’ is used in the protocol to refer to a person who has consented to participate in 
the clinical research study. The term ‘Subject’ used in the eCRF is intended to refer to a person 
(Subject) who has consented to participate in the clinical research study. 
REGULATORY AND ETHICAL CONSIDERATIONS 
GOOD CLINICAL PRACTICE 
This study will be conducted in accordance with: 
• Good Clinical Practice (GCP),  
• as defined by the International Council on Harmonisation (ICH) 
• in accordance with the ethical principles underlying European Union Directive 2001/20/EC 
• United States Code of Federal Regulations, Title 21, Part 50 (21CFR50)  
• 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. 
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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.  
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: 
• IRB/IEC for  
• 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: 
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• 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.  
• Allow time necessary for subject or subject's legally acceptable representative to inquire about 
the details of the study. 
• 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.  
• 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.  
Subjects unable to give their written consent (e.g., 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, 
or transmitted electronically via computerized systems (and/or any other kind of electronic 
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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. 
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If 
Then 
Supplied by BMS (or its vendors): 
Records or logs must comply with applicable 
regulations and guidelines and should include: 
• amount received and placed in storage 
area 
• amount currently in storage area 
• label identification number or batch 
number 
• amount dispensed to and returned by each 
subject, including unique subject 
identifiers 
• amount transferred to another area/site for 
dispensing or storage 
• nonstudy disposition (e.g., lost, wasted)  
• amount destroyed at study site, if 
applicable 
• amount returned to BMS 
• retain samples for 
bioavailability/bioequivalence, if 
applicable  
• dates and initials of person responsible for 
Investigational Product 
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: 
• label identification number or batch 
number  
• amount dispensed to and returned by each 
subject, including unique subject 
identifiers 
• 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. 
 
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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.  
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. 
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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.  
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: 
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• On-site disposal practices must not expose humans to risks from the drug. 
• On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances. 
• 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. 
• 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. 
• 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. 
CLINICAL STUDY REPORT AND PUBLICATIONS 
A Signatory Investigator must be selected to sign the clinical study report.  
For this protocol, the Signatory Investigator will be selected as appropriate based on the following 
criteria: 
• External Principal Investigator designated at protocol development 
• National Coordinating Investigator  
• Study Steering Committee chair or their designee 
• Subject recruitment (eg, among the top quartile of enrollers) 
• Involvement in trial design 
• Regional representation (eg, among top quartile of enrollers from a specified region or country) 
• 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 
• 
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.  
• 
Exacerbation of a chronic or intermittent pre-existing condition including either an increase in 
frequency and/or intensity of the condition. 
• 
New conditions detected or diagnosed after study intervention administration even though it 
may have been present before the start of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• 
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 
• 
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to the 
procedure is the AE. 
• 
Situations in which an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital). 
 
DEFINITION OF SAE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met. 
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SERIOUS ADVERSE EVENTS 
Serious Adverse Event Definition: Any untoward medical occurrence that, at any dose: 
Results in death 
Is life-threatening (defined as an event in which the 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:  
• 
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) 
• 
elective surgery, planned prior to signing consent 
• 
admissions as per protocol for a planned medical/surgical procedure 
• 
routine health assessment requiring admission for baseline/trending of health status (eg, routine 
colonoscopy) 
• 
medical/surgical admission other than to remedy ill health and planned prior to entry into the 
study. Appropriate documentation is required in these cases. 
• 
admission encountered for another life circumstance that carries no bearing on health status 
and requires no medical/surgical intervention (eg, lack of housing, economic inadequacy, 
caregiver respite, family circumstances, administrative reason) 
• 
admission for administration of anticancer therapy in the absence of any other SAEs (applies to 
oncology protocols) 
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 8.2.7 for the definition of potential DILI).  
 
Pregnancy and potential DILI must follow the same transmission timing and processes to BMS as 
used for SAEs (see Section 8.2.5 for reporting pregnancies). 
Any component of a study endpoint that is considered related to study therapy should be reported 
as SAE (eg, death is an endpoint, if death occurred due to anaphylaxis, anaphylaxis must be 
reported). 
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EVALUATING AEs AND SAEs 
Assessment of Intensity 
The intensity of AEs is determined by a physician and will use the following levels: 
• 
Mild: An event that is easily tolerated by the subject, causing minimal discomfort, and 
not interfering with everyday activities. 
• 
Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities. 
• 
Severe: An event that prevents normal everyday activities. An AE that is assessed as 
severe should not be confused with an SAE. Severe is a category utilized for rating the 
intensity of an event; and both AEs and SAEs can be assessed as severe. 
Assessment of Causality 
• 
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.   
• 
The investigator will use clinical judgment to determine the relationship. 
• 
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. 
• 
The investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment. 
• 
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. 
• 
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. 
• 
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. 
• 
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
Follow-up of AEs and SAEs 
If only limited information is initially available, follow-up reports are required. Note: 
Follow-up SAE reports must include the same investigator term(s) initially reported.  
If an ongoing SAE changes in its intensity or relationship to study drug or if new 
information becomes available, the SAE report must be updated and submitted within 
24 hours to BMS (or designee) using the same procedure used for transmitting the initial 
SAE report. 
All SAEs must be followed to resolution or stabilization. 
 
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REPORTING OF SAES TO SPONSOR OR DESIGNEE 
SAEs, whether related or not related to study drug, and pregnancies must be reported to 
PRA 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: BMSSafety@prahs.com 
SAE Fax Number:  
 
Americas: 1-888-772-6919 (or 1-434- 951-3482) 
 
Europe/East Asia Pacific: +44-1792-525-720  
SAE Telephone Contact - For questions on SAE/pregnancy reporting, please call:  
 
Americas: 1-800 772 2215 (or 1-434-951-3489) 
 
Europe/East Asia Pacific: +49-621-878-2154. 
 
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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 
• Premenarchal 
• 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. 
• 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 judgement in checking serum FSH levels.  
• 1 week minimum for vaginal hormonal products (rings, creams, gels) 
• 4 week minimum for transdermal products 
• 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. 
CONTRACEPTION GUIDANCE FOR FEMALE SUBJECTS OF CHILD BEARING 
POTENTIAL 
One of the highly effective methods of contraception listed below, in conjunction with the required 
restrictions in Inclusion Criterion Sec 5.1 (3d) of the protocol, is required during study duration 
and until the end of relevant systemic exposure plus 30 days. As such, in Part A WOCBP must 
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agree to follow instructions for methods of contraception for 33 days post-treatment completion, 
and in Part B WOCBP must agree to follow instructions for methods of contraception for 190 days 
post-treatment completion. 
Local laws and regulations may require use of alternative and/or additional contraception methods. 
Additionally, alternative and/or additional contraception methods may be required based on 
background DMARDS the subject may be taking (eg, methotrexate, leflunomide, etc.) 
Highly Effective Contraceptive Methods That Are User Dependent  
Failure rate of <1% per year when used consistently and correctly.a  
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulationb  
− oral  
− intravaginal  
− transdermal  
• Progestogen-only hormonal contraception associated with inhibition of ovulationb  
− oral  
− injectable  
Highly Effective Methods That Are User Independent  
• Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation b 
• Intrauterine device (IUD)c  
• Intrauterine hormone-releasing system (IUS)c 
• Bilateral tubal occlusion 
• 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.  
• 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. 
• It is not necessary to use any other method of contraception when complete abstinence is 
elected.  
• WOCBP subjects who choose complete abstinence must continue to have pregnancy tests, 
as specified in Section 2.  
• Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP subjects chooses to forego complete abstinence  
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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. 
• Male or female condom with or without spermicide.  Male and female condoms cannot be 
used simultaneously 
• Diaphragm with spermicide 
• Cervical cap with spermicide 
• Vaginal Sponge with spermicide 
• Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action 
Unacceptable Methods of Contraception 
• Periodic abstinence (calendar, symptothermal, post-ovulation methods) 
• Withdrawal (coitus interruptus). 
• Spermicide only 
• 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. 
• 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. 
• Male subjects are required to use a condom for study duration and for 93 days post-treatment 
completion in Part A and 250 days post-treatment completion in Part B. 
• Female partners of males participating in the study to consider use of effective methods of 
contraception for 93 days after the end of treatment in the male subject in Part A and 250 days 
after the end of treatment in the male subject in Part B. 
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• 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 for 93 days after the end of treatment in Part A and 250 days after the 
end of treatment in Part B.  
• Refrain from donating sperm for the duration of the study treatment and for 93 days after the 
end of treatment in Part A and 250 days after the end of treatment in Part B. 
 
COLLECTION OF PREGNANCY INFORMATION 
Guidance for collection of Pregnancy Information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 8.2.5 and APPENDIX 3. 
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APPENDIX 5 
AMERICAN COLLEGE OF RHEUMATOLOGY CORE DATASET 
AND RESPONSE DEFINITIONS 
ACR core data set component 
Validated Measurement Tool 
Tender joint count 
Standardized 68 joint count 
Swollen joint count 
Standardized 66 joint count 
Subject global assessment of pain 
A 0-100 mm visual analog scale 
Subject global assessment of disease activity 
A 0-100 mm visual analog scale 
Physician global assessment of psoriatic 
arthritis 
A 0-100 mm visual analog scale 
Subject assessment of physical function 
Health Assessment Questionnaire (HAQ) 
Acute phase reactant value 
ESR (Westergren) and C-reactive protein 
 
The ACR 20, ACR 50, or ACR 70 definition of improvement is a 20%, 50%, or 70% 
improvement, respectively, over baseline in tender and swollen joint counts (#1 and #2) 
and a 20%, 50%, or 70% improvement, respectively, in 3 of the 5 remaining core data 
set measures (components #3 to #7). 
 
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APPENDIX 6 
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF PHYSICAL FUNCTION SCALE: HEALTH 
ASSESSMENT QUESTIONNAIRE (HAQ) 
HEALTH ASSESSMENT QUESTIONNAIRE 
In this section we are interested in learning how your illness affects your ability to function in daily life. Please 
feel free to add any comments on the back of this page. 
Please check the response which best describes your usual abilities OVER THE PAST WEEK: 
DRESSING & GROOMING 
Are you able to: 
Without 
ANY 
Difficulty 
(0) 
With 
SOME 
Difficulty 
(1) 
With 
MUCH 
Difficulty 
(2) 
UNABLE 
To Do 
(3) 
- Dress yourself, including tying shoelaces and 
doing buttons? 
    0   
    1   
    2   
    3   
- Shampoo your hair? 
    0   
    1   
    2   
    3   
ARISING 
Are you able to: 
- Stand up from a straight chair? 
    0   
    1   
    2   
    3   
- Get in and out of bed? 
    0   
    1   
    2   
    3   
EATING 
Are you able to: 
- Cut your meat? 
    0   
    1   
    2   
    3   
- Lift a full cup or glass to your mouth? 
    0   
    1   
    2   
    3   
- Open a new milk carton? 
    0   
    1   
    2   
    3   
WALKING 
Are you able to: 
- Walk outdoors on flat ground? 
    0   
    1   
    2   
    3   
- Climb up five steps? 
    0   
    1   
    2   
    3   
 
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Please check any AIDS OR DEVICES that you usually use for any of these activities: 
  
Cane 
  
Devices used for dressing (button hook, zipper 
pull, long-handled shoe horn, etc.) 
  
Walker 
  
Built up or special utensils 
  
Crutches 
  
Special or built up chair 
  
Wheelchair 
  
Other (Specify:  
) 
Please check any categories for which you usually need HELP FROM ANOTHER PERSON: 
  
Dressing and Grooming 
  
Eating 
  
Arising 
  
Walking 
Please check the response which best describes your usual abilities OVER THE PAST WEEK: 
HYGIENE 
Are you able to: 
Without 
ANY 
Difficulty 
(0) 
With 
SOME 
Difficulty 
(1) 
With 
MUCH 
Difficulty 
(2) 
UNABLE 
To Do 
(3) 
- Wash and dry your body? 
    0   
    1   
    2   
    3   
- Take a tub bath? 
    0   
    1   
    2   
    3   
- Get on and off the toilet? 
    0   
    1   
    2   
    3   
REACH 
Are you able to: 
- Reach and get down a 5 pound object 
(such as a bag of sugar) from just above your head? 
    0   
    1   
    2   
    3   
- Bend down to pick up clothing from the floor? 
    0   
    1   
    2   
    3   
GRIP 
Are you able to: 
- Open car doors? 
    0   
    1   
    2   
    3   
- Open jars which have been previously opened? 
    0   
    1   
    2   
    3   
- Turn faucets on and off? 
    0   
    1   
    2   
    3   
ACTIVITIES 
Are you able to: 
- Run errands and shop? 
    0   
  
 
    2   
    3   
- Get in and out of a car? 
    0   
    1   
    2   
    3   
- Do chores such as vacuuming or yardwork? 
    0   
    1   
    2   
    3   
 
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Please check any AIDS OR DEVICES that you usually use for any of these activities: 
  
Raised toilet seat 
  
Bathtub bar 
  
Bathtub seat 
  
Long-handled appliances for reach 
  
 Jar opener (for jars 
  
Long-handled appliances in bathroom 
previously opened) 
  
Other (Specify: 
Please check any categories for which you usually need HELP FROM ANOTHER PERSON: 
  
Hygiene 
  
Gripping and opening things 
  
Reach 
  
Errands and chores 
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APPENDIX 7 
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF DISEASE ACTIVITY VISUAL ASSESSMENT 
SCALE 
Measure with a metric ruler. Line on Case Report Form is exactly 10 cm long. Scores should be 
recorded in millimeter format.  DO NOT USE THIS APPENDIX AS SOURCE DOCUMENT 
OR CASE REPORT FORM. 
 
 
In all the ways in which your psoriatic arthritis as a whole, affects you, how would you rate the 
way you felt over the past week ? 
 
 
 
Very 
Well 
Very 
Poorly 
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APPENDIX 8 
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF PAIN SCALE 
Measure with a metric ruler. Line on Case Report Form is exactly 10 cm long. Scores should be 
recorded in millimeter format.  DO NOT USE THIS APPENDIX AS SOURCE DOCUMENT 
OR CASE REPORT FORM. 
How much pain have you had because of your psoriatic arthritis over the past week? Place 
a mark on the line below to indicate how severely your pain has been: 
 
 
 
 
No Pain 
Pain as 
Bad as it 
Could be 
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APPENDIX 9 
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. 
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 i.e. 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 10 
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 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 
No non-psoriatic nail plate 
AND 
irregularities including 
Hyperkeratosis- none 
pitting, crumbling, Beau’s 
AND 
lines, senile onychorrhexis, 
Splinter Hemorrhages-consistent with non-psoriatic splinter 
and non-psoriatic 
hemorrhages 
leukonychia 
AND 
Nail Bed Erythema- none 
Minimal 
1 
Onycholysis- < 10% involved on all nails 
No more than 5 pits or 
OR 
psoriatic leukonychia on any 
Hyperkeratosis- present, but barely detectable elevation of 
nail 
nail plate 
AND 
OR 
No crumbling 
Nail Bed Erythema- faint 
AND 
Splinter Hemorrhages- consistent with non-psoriatic splinter 
hemorrhages 
Mild 
2 
Onycholysis- >10% on five or more nails 
Five or more nails with mild 
OR 
pitting (eg, >10 pits/nail) or 
Hyperkeratosis- present with mild elevation of nail plate 
psoriatic leukonychia 
OR 
AND 
Splinter Hemorrhages- present on four or fewer nails 
No crumbling 
OR 
Nail Bed Erythema- mild 
Moderate 
3 
Onycholysis- >30% on at least one nail 
Five or more nails with 
OR 
moderate pitting (eg, >25 
Hyperkeratosis- present with moderate elevation of nail plate 
pits/nail) 
OR 
AND 
Splinter Hemorrhages-  scattered and present on five or more 
≤25% crumbling on any nails 
nails 
OR 
Nail Bed Erythema- moderate 
Severe 
4 
Onycholysis- >50% on at least one nail 
Five or more nails with 
OR 
severe pitting (>50 pits/nail) 
Hyperkeratosis- present with severe elevation of nail plate 
AND 
OR 
>25% crumbling on any nail 
Splinter Hemorrhages- numerous and present on five or more 
nails 
OR 
Nail Bed Erythema- severe 
 
 
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APPENDIX 11 
THE BATH ANKYLOSING SPONDYLITIS DISEASE ACTIVITY 
INDEX (BASDAI) 
 
 
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APPENDIX 12 
SHORT FORM HEALTH SURVEY-36 ITEM (SF-36) 
 
 
 
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APPENDIX 13 
PROMIS-FATIGUE 
 
Fatigue – Short Form 13a (FACIT-Fatigue) and 5 Supplemental Item Bank 
Items 
 
Please respond to each question or statement by marking one box per row. 
   
During the past 7 days… 
Not at all A little 
bit 
Somewhat Quite a 
bit 
Very 
much 
HI7 I feel fatigued ................................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
HI12 
I feel weak all over ......................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
AN1 
I feel listless ("washed out")............. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
AN2 
I feel tired ........................................ 
 
1 
 
2 
 
3 
 
4 
 
5 
 
AN3 
I have trouble starting things 
because I am tired.......................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
AN4 
I have trouble finishing things 
because I am tired.......................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
AN5 
I have energy ................................... 
 
5 
 
4 
 
3 
 
2 
 
1 
 
AN7 
I am able to do my usual activities ... 
 
5 
 
4 
 
3 
 
2 
 
1 
 
AN8 
I need to sleep during the day........... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
AN12 
I am too tired to eat ......................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
AN14 
I need help doing my usual 
activities .......................................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
AN15 
I am frustrated by being too tired 
to do the things I want to do .......... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
AN16 
I have to limit my social activity 
because I am tired.......................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Approved
2.0
v


Clinical Protocol 
IM011084 
BMS-986165 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
157 
  
During the past 7 days… 
Not at all A little 
bit 
Somewhat Quite a 
bit 
Very 
much 
FATEXP36 How exhausted were you on 
average?.......................................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 
FATIMP2 
To what degree did your fatigue 
make you feel slowed down in your 
thinking?........................................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 
FATIMP36 
To what degree did your fatigue 
make it difficult to make decisions? 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 
FATIMP52 
To what degree did your fatigue 
make you feel less alert?.................. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 
FATIMP44 
To what degree did your fatigue 
make you more forgetful?............... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
20 February 2017 
© 2008-2017 PROMIS Health Organization and PROMIS Cooperative Group 
Approved
2.0
v


Clinical Protocol 
IM011084 
BMS-986165 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
158 
APPENDIX 14 
WORK LIMITATIONS QUESTIONNAIRE (WLQ) 
 
Are you currently employed (working for pay)?  If you have more than one job, report on your main 
job only. 
 
_____NO  ____ YES 
 
If NO, check "NO" and skip to question 4.  
 
 
The next two questions are about the past seven days, not including today. 
 
 
During the past seven days, how many hours did you miss from work because of your health 
problems?  Include hours you missed on sick days, times you went in late, left early, etc., because of your 
health problems.  Do not include time you missed to participate in this study.  
 
_____HOURS 
 
 
During the past seven days, how many hours did you actually work?  
 
______HOURS 
Approved
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Approved
2.0
v


Clinical Protocol 
IM011084 
BMS-986165 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
164 
APPENDIX 15 
THE EULAR PSORIATIC ARTHRITIS IMPACT OF DISEASE: 
PsAID 12 FOR CLINICAL PRACTICE 
 
 
 
Approved
2.0
v


Clinical Protocol 
IM011084 
BMS-986165 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
165 
 
 
Approved
2.0
v


Clinical Protocol 
IM011084 
BMS-986165 
TYK2 Inhibitor 
23 September 2019, v2.0, Final, Approved 
BMS Confidential 
166 
PsAID12 SCORING AND CALCULATION RULES 
 
The PsAID is calculated based on 12 Numerical rating scales (NRS) questions. Each 
NRS is assessed as a number between 0 and 10. 
 
Calculation 
 
PsAID final value = 
(PsAID1 (pain) NRS value 
(range 0-10) x 3) 
+ (PsAID2 (fatigue) NRS value (range 0-10) x 2) 
+ (PsAID3 (skin) NRS value (range 0-10)  x 2) 
+ (PsAID4 (Work and/or leisure activities) NRS value (range 0-10)  x 2) 
+ (PsAID5 (function) NRS value (range 0-10)  x 2) 
+ (PsAID6 (discomfort) NRS value (range 0-10)  x 2) 
+ (PsAID7 (sleep) NRS value (range 0-10)  x 2) 
+ (PsAID8 (coping) NRS value (range 0-10)  x 1) 
+ (PsAID9 (anxiety) NRS value (range 0-10)  x 1) 
+ (PsAID10 (embarrassment) NRS value (range 0-10)  x 1) 
+ (PsAID11 (social life) NRS value (range 0-10)  x 1) 
+ (PsAID12 (depression) NRS value (range 0-
10) x 1) The total is divided by 20. 
Thus, the range of the final PsAID value is 0-10 where higher figures indicate worse status. 
 
Missing data imputation 
 
If one of the 12 NRS values composing the PsAID is missing, the imputation is as 
follows: calculate the mean value of the 11 other (non-missing) NRS (range, 0-10) 
impute this value for the missing NRS 
Then, calculate the PsAID as explained above. 
 
If 2 or more of the NRS are missing, the PsAID is considered as missing value (no imputation). 
Approved
2.0
v

SAP_001.pdf: 
Official Title of Study: 
A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety 
of Multiple Doses of BMS-986165 in Subjects with Active Psoriatic Arthritis (PsA) 
 
NCT Number: NCT03881059 
 
Document Date (Date in which document was last revised): 05 June 2020 
 


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Approvals .................................................................................................................................................................................... 2 
Table of Contents ..................................................................................................................................................................... 3 
Abbreviations ............................................................................................................................................................................ 5 
 Purpose ................................................................................................................................................................................ 8 
 Study Description ............................................................................................................................................................. 8 
2.1 Study Design .................................................................................................................................................................. 8 
2.2 Sample Size and Power ........................................................................................................................................... 10 
2.3 Treatment Assignment and Randomization .................................................................................................. 10 
2.4 Unblinding Information .......................................................................................................................................... 10 
2.5 Changes in Statistical Considerations from the Protocol .......................................................................... 11 
 Objectives .......................................................................................................................................................................... 11 
3.1 Primary Objective ..................................................................................................................................................... 11 
3.2 Secondary Objectives ............................................................................................................................................... 11 
3.3 Additional Objectives ............................................................................................................................................... 11 
3.4 Safety Objectives ........................................................................................................................................................ 12 
 
 
 
 
 Outcomes ........................................................................................................................................................................... 12 
4.1 Efficacy ........................................................................................................................................................................... 12 
4.1.1 Primary Endpoint ............................................................................................................................................. 12 
4.1.2 Secondary Endpoints....................................................................................................................................... 13 
4.1.3 Additional Endpoints ...................................................................................................................................... 13 
 
4.2 Safety .............................................................................................................................................................................. 14 
 
 
 Populations for Analyses ............................................................................................................................................ 16 
5.1 Relevant Protocol Deviations ............................................................................................................................... 16 
 Statistical Analyses ........................................................................................................................................................ 17 
6.1 Efficacy Analyses ....................................................................................................................................................... 17 
6.1.1 Primary Endpoint(s)........................................................................................................................................ 18 
6.1.2 Secondary Endpoint(s) ................................................................................................................................... 18 
6.1.3 Adjustment for Multiplicity .......................................................................................................................... 19 
6.1.4 Subgroup Analyses ........................................................................................................................................... 19 
6.1.5 Additional Endpoints ...................................................................................................................................... 20 
 
6.2 Safety .............................................................................................................................................................................. 21 
6.2.1 Adverse Events .................................................................................................................................................. 22 
6.2.2 Deaths .................................................................................................................................................................... 23 
6.2.3 Clinical Laboratory Data ................................................................................................................................ 23 
6.2.4 Vital Signs and Physical Findings ............................................................................................................... 23 
6.2.5 ECGs ........................................................................................................................................................................ 23 
6.3 General Methodology ............................................................................................................................................... 24 
6.3.1 Subject Populations and Disposition ........................................................................................................ 24 
6.3.2 Demographic and Baseline Characteristics ........................................................................................... 24 
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6.3.4 Exposure ............................................................................................................................................................... 25 
 
 
 Sequence of Planned Analyses .................................................................................................................................. 27 
7.1 Interim Analyses ........................................................................................................................................................ 27 
7.2 Week 16 Endpoint Analyses ................................................................................................................................. 27 
7.3 Final Analyses and Reporting............................................................................................................................... 28 
 Conventions ...................................................................................................................................................................... 28 
8.1 General Definitions ................................................................................................................................................... 28 
8.2 Calculation of Key Measures ................................................................................................................................. 29 
8.2.1 Investigator-Administered Assessments ................................................................................................ 29 
8.2.2 Subject-Reported Assessments ................................................................................................................... 32 
8.3 Missing, Unknown, or Partial Dates ................................................................................................................... 34 
8.4 Study Periods .............................................................................................................................................................. 35 
8.5 Day Ranges for Analysis Visits ............................................................................................................................. 35 
 
 
 Document History ....................................................................................................................................................... 38 
Appendix 1 Planned Analyses .......................................................................................................................................... 57 
Appendix 2 Summary of Efficacy Assessments ......................................................................................................... 61 
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