Clinical trial NCT03943147
Conditions: Lupus Nephritis
Sponsor: Bristol-Myers Squibb
Start date: 2019-07-15; Completion date: 2021-09-17
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).

Detailed description:

Arms: arm 1: Specified Dose on Specified Days arm 2: Specified Dose on Specified Days arm 3: Specified Dose on Specified Days arm 4: Specified Dose on Specified Days
Interventions: intervention 1: BMS-986165 intervention 2: Placebo intervention 3: Mycophenolate Mofetil
Intervention descriptions: intervention 1: Specified dose on specified days intervention 2: Specified dose on specified days intervention 3: Specified dose on specified days

Protocol documents:
Prot_SAP_000.pdf: 
Official Title of Study: 
A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and 
Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis  
 
PROTOCOL(S) IM011-073 
 
NCT Number: NCT03943147 
  
Document Date (Date in which document was last revised): August 06, 2020 


Protocol Number: IM011073 
IND Number: 134253 
EX-US Non-IND 
EUDRACT Number: 2018-004142-42 
Date, Version: 06-Aug-2020
Revised Protocol 04, Final Approved 
Protocol IM011073 
A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and 
Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis 
Study Director 
Medical Monitors 
24-hr Emergency Telephone Number
USA: 
International: 
Bristol-Myers Squibb Research and Development 
3401 Princeton Pike 
Lawrenceville, NJ 08648 
Avenue de Finlande 4 
B-1420 Braine-l’Alleud, Belgium
6-5-1 Nishi-Shinjuku, Shinjuku-ku,
Tokyo, 163-1328, Japan 
This document is the confidential and proprietary information of Bristol-Myers Squibb 
Company and its global affiliates (BMS). By reviewing this document, you agree to keep it 
confidential and to use and disclose it solely for the purpose of assessing whether your 
organization will participate in and/or the performance of the proposed BMS sponsored 
study. Any permitted disclosures will be made only on a confidential “need to know” basis 
within your organization or to your independent ethics committee(s). Any other use, copying, 
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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. 
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DOCUMENT HISTORY 
Document 
Date of Issue 
Approvers 
Summary of Changes 
Original 
Global 
Protocol v1.0 
14-Nov-2018
Not applicable 
Global 
v2.0_Revised 
Protocol 1 
Global 
03-Dec-2018
1.
In Section 2.3, preliminary
data from Study IM011071
was added.
2.
The storage temperature
for BMS-986165 was
corrected.
3.
Section 8.2.1 was updated
to be consistent with
Table 3.
Global 
v3.0_Revised 
Protocol 2 
Global 
22-Jan-2019
Clarified endpoints, changed 
urine specimen type to be used 
for UPCR at various times, 
added a second stratification 
variable, added text regarding 
calculation of UPCR,
 
 
and other 
changes listed in Amendment 
02 (Summary of Changes) 
Global 
Protocol 
v3.0_Revised 
Protocol 3 
China 
12-Mar-2019
Adapted Global Protocol v3.0 
to create Revised Protocol 3 
China:  
1.
2.
Clarified that the screening
DAT will be performed at
a local laboratory
3.
Added exclusion criterion
3m regarding herbal
supplements or traditional
Chinese medicines
4.
Clarifying language was
added to Section 8.7
5.
Section 8.7.3 was deleted
6.
In Appendix 2, roles
specific to investigators in
China were noted.
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Document 
Date of Issue 
Approvers 
Summary of Changes 
Global 
Protocol 
v3.0_Revised 
Protocol 4 
Germany 
03-Jun-2019
Adapted Global Protocol v3.0 
to create Revised Protocol 4 
Germany:  
1.
Consistent with the SmPC
for MMF, a pregnancy test
was added 8 to 10 days
before Visit A1 for
WOCBP who will be
starting MMF therapy in
Part A, and subjects must
not donate blood for at
least 6 weeks after the final
dose of MMF
2.
A subject status evaluation
at Week 24 was added
3.
The unit for MPA
concentration was
corrected from ng/mL to
μg/mL
4.
Several sections were
amended to clarify that all
study treatment will be
stopped immediately if a
subject becomes pregnant
Global 
Protocol 
v3.0_Revised 
Protocol 5 
Italy 
10-Jul-2019
Adapted Global Protocol v3.0 
to create Revised Protocol 5 
Italy:  
Added serum lipase and 
amylase to screening and 
routine laboratory assessments. 
Global 
v4.0_Revised 
Protocol 6 
Global 
20-Sep-2019
1.
Corrected the units for
MPA concentration
2.
Modified Table 1 to
include enrollment, timing
of beginning of the
screening period, and
SLICC classification
3.
Modified several inclusion
and exclusion criteria
4.
Allowed for rescreening
more than once with
medical monitor approval
5.
Clarified that
corticosteroid tapering will
be the same for all subjects
6.
Emphasized that all
treatment medications
must be stopped
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Document 
Date of Issue 
Approvers 
Summary of Changes 
immediately in the case of 
pregnancy 
7.
Updated Appendix 7
8.
Clarified that subjects may
begin treatment with non-
study-supplied MMF
during the screening period
Global 
v4.0_Revised 
Protocol 7 
China 
11-Oct-2019
Same as for Global Protocol 
v4.0_Revised Protocol 6 
Global 
Global 
v4.0_Revised 
Protocol 8 
Germany 
14-Oct-2019
1.
Modified Table 1 to
include enrollment, timing
of beginning of the
screening period, and
SLICC classification
2.
Modified several inclusion
and exclusion criteria
3.
Allowed for rescreening
more than once with
medical monitor approval
4.
Clarified that
corticosteroid tapering will
be the same for all subjects
5.
Emphasized that all
treatment medications
must be stopped
immediately in the case of
pregnancy
6.
Updated Appendix 7
7.
Clarified that subjects may
begin treatment with non-
study-supplied MMF
during the screening period
Global 
v4.0_Revised 
Protocol 9 
Italy 
14-Oct-2019
1.
Corrected the units for
MPA concentration
2.
Modified Table 1 to
include enrollment, timing
of beginning of the
screening period, and
SLICC classification
3.
Modified several inclusion
and exclusion criteria
4.
Allowed for rescreening
more than once with
medical monitor approval
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Document 
Date of Issue 
Approvers 
Summary of Changes 
5.
Clarified that
corticosteroid tapering will
be the same for all subjects
6.
Emphasized that all
treatment medications
must be stopped
immediately in the case of
pregnancy
7.
Updated Appendix 7
8.
Clarified that subjects may
begin treatment with non-
study-supplied MMF
during the screening period
Revised 
Protocol 04 
(Global 
v5.0_Revised 
Protocol 10 
Globala) 
(im011073-
revprot04) 
06-Aug-2020
1.
2.
Modified study objectives
and endpoints, including
new primary and
secondary efficacy
endpoints
3.
Updated UPCR
requirements at screening
4.
Modified assessments and
procedures, including
biopsy requirements, prior
MMF treatment allowed at
screening, and MMF
requirements during study
5.
Modified inclusion/
exclusion criteria with
details regarding the
prescreening biopsy, prior
MMF treatment, dialysis,
current administration of
immunosuppressants, and
TB screening results
6.
7.
Modified previous and
concomitant therapy
allowed and prohibited
during the study
8.
Clarified requirements for
TB screening for subjects
who test indeterminate for
TB at screening
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Document 
Date of Issue 
Approvers 
Summary of Changes 
9.
a Document naming conventions have been updated. Legacy 
 numbering is provided for consistency. 
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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
DOCUMENT HISTORY .................................................................................................................3 
TABLE OF CONTENTS .................................................................................................................8 
LIST OF TABLES .........................................................................................................................13 
LIST OF FIGURES .......................................................................................................................13 
1 
PROTOCOL SUMMARY ..........................................................................................14 
1.1 
Synopsis ......................................................................................................................14 
1.2 
Schema ........................................................................................................................20 
1.3 
Schedules of Activities ...............................................................................................22 
2 
INTRODUCTION ......................................................................................................37 
2.1 
Study Rationale ...........................................................................................................37 
3 
OBJECTIVES AND ENDPOINTS ............................................................................40 
4 
STUDY DESIGN .......................................................................................................43 
4.1 
Overall Design ............................................................................................................43 
4.1.1 Part A: Open-label Mycophenolate Mofetil Run-in Period .......................................48 
4.1.2 Part B: Randomized, Blinded Treatment Period Through Week 52 ..........................51 
4.1.4 Post-treatment Follow-up ...........................................................................................52 
4.1.5 Data Monitoring Committee .......................................................................................53 
4.1.6 Central Review Services .............................................................................................53 
4.2 
Number of Subjects ....................................................................................................53 
4.3 
End-of-Study Definition .............................................................................................53 
4.4 
Scientific Rationale for Study Design ........................................................................53 
4.4.1 Rationale for Overall Study Design ............................................................................53 
4.4.2 Rationale for 12-Week Mycophenolate Mofetil Run-in Period ..................................54 
4.4.3 Rationale for Optional Week 52, 
 and Early Discontinuation Renal 
Biopsies .......................................................................................................................55 
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5 
STUDY POPULATION .............................................................................................57 
5.1 
Inclusion Criteria ........................................................................................................57 
5.2 
Exclusion Criteria .......................................................................................................59 
5.3 
Lifestyle Restrictions ..................................................................................................64 
5.3.1 Meals and Dietary Restrictions ..................................................................................64 
5.3.2 Caffeine, Alcohol, and Tobacco ..................................................................................64 
5.3.3 Activity ........................................................................................................................64 
5.4 
Screen Failures ............................................................................................................64 
5.4.1 Retesting During the Screening Period ......................................................................65 
6 
TREATMENT ............................................................................................................65 
6.1 
Mycophenolate Mofetil Target Dose and Dose Modification ....................................66 
6.2 
Laboratory Monitoring for Mycophenolate Mofetil Toxicity ....................................67 
6.3 
Treatments Administered ............................................................................................67 
6.3.1 Open-label Mycophenolate Mofetil – All Subjects .....................................................67 
6.3.2 Blinded Study Treatment in Part B – Randomized Subjects Only ..............................67 
6.4 
Subject Number Assignment ......................................................................................68 
6.5 
Blinding – Part B 
 ...................................................68 
6.6 
Dosage Modification ..................................................................................................70 
6.6.1 Corticosteroid Tapering and Corticosteroid Rescue in Part B 
 ................................................................................................70 
6.7 
Treatment After the End of the Study .........................................................................72 
6.8 
Preparation/Handling/Storage/Accountability ............................................................72 
6.8.1 Retained Samples for Bioavailability/Bioequivalence ................................................73 
6.9 
Treatment Compliance ................................................................................................73 
6.10 
Previous and Concomitant Therapy ............................................................................73 
6.10.1 
Prohibited and/or Restricted Treatments in Part A and Part B ............................74 
6.10.2 
Permitted Concomitant Medications in Part A and Part B ...................................74 
7 
DISCONTINUATION CRITERIA ............................................................................75 
7.1 
Discontinuation from Study Treatment ......................................................................75 
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7.2 
Week 24 Subject Status Evaluation ............................................................................76 
7.3 
Discontinuation from the Study ..................................................................................76 
7.4 
Follow-Up After Early Discontinuation from Study Treatment .................................76 
7.5 
Lost to Follow-Up .......................................................................................................76 
8 
STUDY ASSESSMENTS AND PROCEDURES ......................................................77 
8.1 
Part A Assessments .....................................................................................................77 
8.2 
Part B Assessments .....................................................................................................78 
8.4 
Efficacy, Safety
 Assessments .........................................................79 
8.4.1 Efficacy Assessments ..................................................................................................79 
8.5 
Adverse Events ...........................................................................................................82 
8.5.1 Adverse Events of Interest (Part B 
) .......................82 
8.5.2 Time Period and Frequency for Collecting Information About Adverse Events 
and Serious Adverse Events ........................................................................................82 
8.5.3 Method of Detecting Adverse Events and Serious Adverse Events ............................83 
8.5.4 Follow-up of Adverse Events and Serious Adverse Events ........................................83 
8.5.5 Regulatory Reporting Requirements for Serious Adverse Events ..............................83 
8.5.6 Pregnancy ...................................................................................................................84 
8.5.7 Laboratory Test Result Abnormalities ........................................................................84 
8.5.8 Potential Drug-induced Liver Injury ..........................................................................84 
8.5.9 Other Safety Considerations .......................................................................................85 
8.6 
Overdose .....................................................................................................................85 
8.7 
Safety ..........................................................................................................................85 
8.7.1 Physical Examinations ................................................................................................86 
8.7.2 Tuberculosis Screening and Chest Imaging ...............................................................86 
8.7.3 Clinical Safety Laboratory Assessments .....................................................................88 
8.7.4 Body Weight and Vital Signs ......................................................................................90 
8.7.5 Electrocardiograms ....................................................................................................90 
8.7.6 Renal Biopsy ...............................................................................................................90 
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STATISTICAL CONSIDERATIONS .......................................................................95 
9.1 
Sample Size Determination ........................................................................................95 
9.2 
Populations for Analyses ............................................................................................96 
9.3 
Endpoints ....................................................................................................................96 
9.3.1 Primary Efficacy Endpoint .........................................................................................96 
9.3.2 Primary Safety Endpoint .............................................................................................96 
9.3.3 Secondary Efficacy Endpoints ....................................................................................97 
9.4 
Efficacy Analyses .......................................................................................................99 
9.4.1 Primary Endpoint Analysis .........................................................................................99 
9.4.2 Secondary 
 Efficacy Endpoint Analyses During Week 52 
(Part B) .....................................................................................................................100 
9.5 
Safety Analyses ........................................................................................................102 
9.5.1 Adverse Events ..........................................................................................................102 
9.5.2 Vital Signs, Electrocardiograms, and Physical Examinations .................................102 
9.5.3 Clinical Laboratory Tests .........................................................................................102 
9.6 
Other Analyses ..........................................................................................................102 
9.6.1 Demographics and Baseline Data ............................................................................102 
9.6.2 Previous and Concomitant Medications ...................................................................103 
9.6.5 Week 24 Database Lock ............................................................................................103 
10 
REFERENCES .........................................................................................................104 
APPENDIX 1 
ABBREVIATIONS .................................................................................107 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS ....................................111 
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APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING ............................119 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION ............................................123 
APPENDIX 5 
SYSTEMIC LUPUS INTERNATIONAL COLLABORATING 
CLINICS CLASSIFICATION CRITERIA FOR SYSTEMIC 
LUPUS ERYTHEMATOSUS .................................................................126 
APPENDIX 6 
COMMONLY USED CORTICOSTEROID EQUIVALENTS ..............129 
APPENDIX 7 
REQUIRED RECOVERY (WASHOUT) TIMES FOR SPECIFIC 
MEDICATIONS PRIOR TO SCREENING ...........................................130 
APPENDIX 8 
DIAGNOSTIC CRITERIA FOR SUBSTANCE DEPENDENCE 
AND ABUSE ...........................................................................................132 
APPENDIX 10 
SYSTEMIC LUPUS INTERNATIONAL COLLABORATING 
CLINICS/AMERICAN COLLEGE OF RHEUMATOLOGY 
DAMAGE INDEX ...................................................................................136 
APPENDIX 12 
INTERNATIONAL SOCIETY OF NEPHROLOGY/RENAL 
PATHOLOGY SOCIETY 2003 CLASSIFICATION OF LUPUS 
NEPHRITIS .............................................................................................144 
APPENDIX 13 
UPDATED CLASSIFICATION CRITERIA FOR 
ANTIPHOSPHOLIPID SYNDROME ....................................................145 
APPENDIX 14 
DIAGNOSIS AND CLASSIFICATION OF CATASTROPHIC 
ANTIPHOSPHOLIPID SYNDROME ....................................................147 
APPENDIX 15 
MORPHINE MILLIGRAM EQUIVALENTS FOR OPIOIDS ..............148 
APPENDIX 16 
OHIO SLE STUDY – CLASSIFICATION OF RENAL FLARE...........149 
APPENDIX 17 
REVISED SELENA FLARE INDEX .....................................................150 
APPENDIX 20 
TUBERCULOSIS RISK ASSESSMENT TOOL ...................................158 
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LIST OF TABLES 
Table 1: Screening Procedures and Assessments for Protocol IM011073 ....................................23 
Table 2: Procedures and Assessments in Part A of Protocol IM011073 (Open-label MMF 
Run-in Period) ............................................................................................25 
Table 3: Procedures and Assessments in Part B of IM011073 (52-Week Blinded 
Treatment Period) ......................................................................................28 
Table 5: Study Treatments for Protocol IM011073 .......................................................................66 
Table 6: Selection and Timing of Blinded Study Treatment Dosing .............................................68 
Table 7: Selection and Timing of Blinded Study Treatment Dosing .............................................68 
Table 8: Corticosteroid Dose Tapering Sequence by Dose at Randomization (Visit B1) .............72 
Table 9: Pharmacokinetic and Pharmacodynamic Sampling Schedule .........................................91 
LIST OF FIGURES 
Figure 1: Study Design: Part A and Part B ....................................................................................46 
Figure 3: Path to Enrollment for Subjects Not Taking Mycophenolate Mofetil or Who 
Are Taking Less Than 1.5 g/day at the Time of Screening .......................50 
Figure 4: Paths to Enrollment for Subjects with ≥ 1 Day but ≤ 24 Weeks of 
Mycophenolate Mofetil at a Dose of 1.5 to 3.0 g/day at the Time of 
Screening....................................................................................................50 
Figure 5: Path for Subjects with Two Indeterminate Interferon-Gamma Release Assay 
Results at Screening ...................................................................................87 
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1 
PROTOCOL SUMMARY 
1.1 
Synopsis 
The primary objectives of this study are to evaluate the safety and efficacy of BMS-986165 
compared with placebo with regard to measures of renal function in subjects with lupus nephritis 
(LN). 
Prospective subjects may be enrolled if they meet all eligibility criteria including biopsy results 
that confirm active LN International Society of Nephrology/Renal Pathology Society (ISN/RPS)1 
Class III or IV (alone or in combination with Class V).  
After at least 12 weeks (but ≤ 24 weeks) of treatment with mycophenolate mofetil (MMF) at a 
dose of 1.5 to 3.0 g/day, subjects with an inadequate renal response may be randomized in a 
double-blind manner to one of the BMS-986165 treatment groups or placebo as add-on treatment 
to MMF and corticosteroids. Subjects will be monitored and evaluated every 4 weeks for 52 weeks 
while they receive blinded study treatment plus continued MMF. Subjects who do not qualify for 
randomization may continue taking open-label MMF in Part B. 
 
 
 
 
 
 
 
 
 
 
Protocol Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the 
Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis 
Study Phase: 2 
Rationale: Lupus nephritis is one of the most serious manifestations of systemic lupus 
erythematosus (SLE) but the prognosis for patients with LN has not substantially improved since 
the 1980s.2 BMS-986165 is a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a 
unique mechanism of action distinct from other kinase inhibitors that has shown efficacy in 
subjects with autoimmune diseases and in murine models of SLE and LN.3, 4, 5 This study is 
designed to assess whether add-on therapy with BMS-986165 might improve renal function in 
subjects who do not adequately respond to initial treatment with MMF. 
Study Population: 
Individuals aged 18 (or local age of majority) to 75 years inclusive who meet all the inclusion 
criteria and none of the exclusion criteria may be eligible to enroll in the study. Key inclusion 
criteria include the following: 
x
Meet the SLE International Collaborating Clinics criteria for SLE
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x
ISN/RPS Class III or IV (or Class V in combination with Class III or IV) lupus nephritis
x
Urine protein:creatinine ratio (UPCR) ≥ 1.5 mg/mg assessed in a 24-hour urine sample
for subjects who have had a biopsy within 6 months of screening
x
UPCR ≥ 1 mg/mg assessed in a 24-hour urine sample for subjects who have had a biopsy
within 3 months of screening
Individuals with any of the following key exclusion criteria will not be eligible to participate: pure 
ISN/RPS Class V membranous LN; an estimated glomerular filtration rate (eGFR; calculated using 
the Modification of Diet in Renal Disease [MDRD] equation) ≤ 30 mL/minute/1.73 m2; end-stage 
renal disease, body mass index ≥ 40 kg/m2; active infection, or certain other serious illnesses.  
See the full protocol for a complete list of inclusion and exclusion criteria. 
Primary and Secondary Objectives and Endpoints: 
Objective 
Endpoint 
Primary – 52-week Blinded Treatment Period (Part B) 
x
Safety: To assess the safety and tolerability of
BMS-986165 in LN
x
AEs, vital signs, ECGs, and laboratory
abnormalities from baseline through Week 52
x
Efficacy: To evaluate the efficacy of
BMS-986165 compared with placebo with
regard to proteinuria
x
Percentage change from baseline in 24-hour UPCR
at Week 24
Secondary– 52-week Blinded Treatment Period (Part B) 
x
Efficacy – To evaluate the efficacy of
BMS-986165 with regard to measures of renal
function and SLE activity
x
PRR at Week 24, defined as ≥ 50% reduction from
baseline in 24-hour UPCR
x
CRR at Week 24, defined as both of the following:

24-hour UPCR ≤ 0.5 mg/mg

eGFR ≥ 60 mL/min or ≤ 20% decrease from
baseline
x
CRR at Week 52
x
CRR + successful CS taper to ≤ 7.5 mg/day at
Week 24
x
CRR + successful CS taper to ≤ 7.5 mg/day at
Week 52
x
PRR at Week 52
AE = adverse event; CRR = complete renal response; CS = corticosteroid; ECG = electrocardiogram; eGFR = estimated 
glomerular filtration rate; LN = lupus nephritis; PRR = partial renal response; SLE = systemic lupus erythematosus; 
UPCR = urine protein:creatinine ratio 
Note: eGFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation 
Overall Design: 
This is a 3-part, multicenter, randomized, double-blind study in which eligible subjects will be 
assessed for renal response after having received a total of at least 12 weeks (but ≤ 24 weeks) of 
treatment with MMF at a target dose of 1.5 to 3.0 g/day. Subjects will receive 12 weeks of target-
dose MMF in Part A of the study if they have not been taking target-dose MMF at screening. 
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Subjects who have been taking target-dose MMF for ≥ 1 day but < 12 weeks at screening will 
continue to receive target-dose MMF in Part A until they reach 12 weeks of total MMF treatment. 
Subjects who have been taking target-dose MMF for ≥ 12 weeks but ≤ 24 weeks at screening will 
enter the study at Visit A4 to immediately be assessed for renal response and entry into Part B.  
Subjects with an inadequate renal response to MMF may be randomized to blinded study treatment 
with one of two doses of BMS-986165 or placebo as add-on therapy to MMF in Part B. Inadequate 
response is defined as < 50% reduction in 24-hour UPCR from the pre-MMF value and a 24-hour 
UPCR ≥ 1.0 mg/mg. Randomized subjects will continue taking open-label MMF with or without 
corticosteroids. Randomization will be stratified by baseline UPCR < 3.0 mg/mg versus 
≥ 3.0 mg/mg and the total cumulative intravenous (IV) corticosteroid (methylprednisolone or 
parenteral equivalent) dose given in the 16 weeks before randomization (< 250 mg versus 
≥ 250 mg). 
Subjects who meet the criteria to continue in Part B but do not meet the randomization criteria may 
continue in Part B on open-label MMF with or without corticosteroids and will have the same 
assessments in Part B as randomized subjects. These nonrandomized subjects will exit the study 
at the end of Part B. 
Corticosteroids are permitted but not required in this study. Subjects who are taking corticosteroids 
will have their dose tapered (if possible) during Part B. 
In Part B, all (randomized and nonrandomized) subjects will be evaluated at study visits every 
4 weeks through Week 52. 
 
 
 
 
 
 
 
 
Optional renal biopsies may be performed at Week 52 
, as well as at the end of 
treatment for subjects who discontinue early if discontinuation occurs after Week 24 of Part B. 
After the last treatment visit (Week 52
 or early discontinuation), subjects will attend a 
final end-of-study visit at the end of a 28-day follow-up period. 
Number of Subjects: 
A sufficient number of individuals will be screened so that approximately 78 subjects will be 
randomized in Part B of the study (52 subjects in the combined BMS-986165 groups and 
26 subjects in the placebo group). 
16
Approved
1.0
v
Approved
1.0
v


Clinical Protocol 
IM011073 
BMS-986165 
TYK2 Inhibitor 
06-Aug-2020, Revised Protocol 04
Final Approved
BMS Confidential 
Treatment Arms and Duration: 
Subjects who are eligible to continue in Part B of the study will continue open-label MMF with or 
without corticosteroids. Subjects who also meet the randomization criteria will be randomized in 
a double-blind manner to add-on therapy with one of the following: 
x
3 mg BMS-986165 BID
x
6 mg BMS-986165 BID
x
Placebo BID
The total duration of participation in the study is up to 
 weeks, which includes the following 
periods:  
x
Screening period: approximately 28 days
x
Treatment period:
o
Part A: Open-label MMF (1.5 to 3.0 g/day) run-in period of up to 12 weeks,
depending on duration of treatment with MMF at the time of screening, with
study visits as indicated in Table 2
o
Approximately 1 week between the last visit in Part A and the first visit in Part B
o
Part B: Randomization followed by blinded study treatment for 52 weeks plus
continued open-label MMF with or without corticosteroids (or just continued
open-label MMF with or without corticosteroids for those who are not
randomized); all subjects will attend study visits every 4 weeks and undergo
assessments as indicated in Table 3
o
x
A follow-up period of 28 ± 3 days followed by an end-of-study visit
17
Approved
1.0
v
Approved
1.0
v


Clinical Protocol 
IM011073 
BMS-986165 
TYK2 Inhibitor 
06-Aug-2020, Revised Protocol 04
Final Approved
BMS Confidential 
Study Treatments: 
Study Treatments for Protocol IM011073 
Product 
Description/ Class 
and Dosage Form 
Potency 
IP/Non-IP 
Blinded or 
Open Label 
Packaging/ 
Appearance 
Storage Conditions 
(per label) 
BMS-986165 
oral tablet 
3 mg or 
6 mg 
IP 
Blinded 
Blister card 
containing 
64 tablets 
Store at 15°to 25°C. 
Store in original 
container. Protect from 
light. 
Placebo matching 
BMS-986165 oral 
tablet 
N/A 
IP 
Blinded 
Blister card 
containing 
64 placebo tablets 
Store at 15°to 25°C. 
Store in original 
container. Protect from 
light. 
Mycophenolate 
mofetil 
500 mg 
IP 
Open label 
Bottles or blister 
card of tablets 
See storage conditions 
on the container 
IP = investigational product 
Statistical Methods: 
A sample size of 52 randomized subjects in the combined BMS-986165 treatment groups 
(26 subjects in the BMS-986165 6 mg BID group and 26 in the BMS-986165 3 mg BID group) 
and 26 subjects in the placebo group will provide 88% power (at a one-sided significance level of 
0.10) 
 
 
 
 
 
 
. 
The change from baseline in log-transformed 24-hour UPCR at Week 24 will be analyzed using 
analysis of covariance (ANCOVA) with treatment groups and randomization stratification factors 
as fixed effects and the log-transformed baseline value as a covariate added in the model. Relative 
treatment differences on least-square means and corresponding 2-sided 95% CIs in primary 
endpoint, the percentage change from baseline in 24-hour UPCR at Week 24 on the original scale, 
will be provided for combined BMS-986165 treatment groups and placebo. Additionally, 
least-square means and 2-sided CIs will be provided for the relative difference between each 
BMS-986165 treatment group and placebo will be provided in similar method for the Full Analysis 
Set (FAS). There will be no adjustment of the Type 1 error rate for multiple comparisons or testing 
of multiple endpoints. 
Treatment-emergent adverse events (TEAEs), serious adverse events, deaths, adverse events (AEs) 
leading to discontinuation of the investigational product (IP), AEs by maximum severity, and AEs 
by relationship to IP will be summarized by the Medical Dictionary for Regulatory Activities 
18
Approved
1.0
v
Approved
1.0
v


Clinical Protocol 
IM011073 
BMS-986165 
TYK2 Inhibitor 
06-Aug-2020, Revised Protocol 04
Final Approved
BMS Confidential 
system organ class and preferred term. All TEAEs, AEs of interest, as well as any adjudicated AE 
category will also be summarized by preferred term sorted by decreasing frequency. 
 
 
An external Data Monitoring Committee will perform safety 
monitoring by blinded treatment group.
19
Approved
1.0
v
Approved
1.0
v


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Approved
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Clinical Protocol 
IM011073 
BMS-986165 
TYK2 Inhibitor 
06-Aug-2020, Revised Protocol 04
Final Approved
BMS Confidential 
APPENDIX 20 
TUBERCULOSIS RISK ASSESSMENT TOOL 
A subject with any of the 3 following high-risk factors will have an interferon-gamma release 
assay (IGRA): 
Yes No 
1. Recent close or prolonged contact with someone with infectious TB disease
2. High-risk profession or situations, like being patient-facing, eg, healthcare
providers
3. Recent travel to or from a high burden country for TB (please see country list
from UN partner website, Stop TB):
http://www.stoptb.org/countries/tbdata.asp
TB = tuberculosis; UN = United Nations 
158
Approved
1.0
v
Approved
1.0
v