An Investigational Study to Evaluate BMS-986165 in Partic... | NCT03252587

NCT03252587

ID	Type	Description	Link
2017-001203-79	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
BMS-986165 Dose 1 oral administration	Experimental	Drug: BMS-986165
BMS-986165 Dose 2 oral administration	Experimental	Drug: BMS-986165
BMS-986165 Dose 3 oral administration	Experimental	Drug: BMS-986165
Placebo oral administration	Placebo Comparator	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986165	Drug	Specified dose on specified days	BMS-986165 Dose 1 oral administration BMS-986165 Dose 2 oral administration BMS-986165 Dose 3 oral administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32	SRI(4) responder is defined as a patient whose disease course fulfills all of the following: A 4-point or greater reduction from baseline in SLEDAI-2K score No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity	At week 32

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48	SRI(4) responder is defined as a patient whose disease course fulfills all of the following: A 4-point or greater reduction from baseline in SLEDAI-2K score No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0178		Birmingham	Alabama	35205	United States
Little Rock Diagnostic Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40451616	Derived	Mosca M, Arnaud L, Askanase A, Hobar C, Becker B, Singhal S, Banerjee S, Pomponi S, Choi J, Strand V. Deucravacitinib, an oral, selective, allosteric, tyrosine kinase 2 inhibitor, in patients with active SLE: efficacy on patient-reported outcomes in a phase II randomised trial. Lupus Sci Med. 2025 Jun 1;12(1):e001517. doi: 10.1136/lupus-2025-001517.
36369798

Label	URL
BMS Clinical Trial Information	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo	Placebo PO BID
FG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
FG002

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 15, 2020	Jun 29, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo PO BID
BG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
BG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
BG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00040.1± 13.1 BG00140.2± 11.9 BG00240.9± 12.5 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00080 BG00185 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00031 BG00131 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0004 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32

SRI(4) responder is defined as a patient whose disease course fulfills all of the following:

A 4-point or greater reduction from baseline in SLEDAI-2K score
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity

All Randomized Participants

Posted

Count of Participants

Participants

At week 32

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts
Participants	OG00090 OG00191 OG00293 OG003

Title

Denominators

Categories

Title	Measurements
	OG00031 OG00153 OG00246 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	BMS-986165 3 mg vs Placebo	Regression, Logistic	1-sided	0.0006		Odds Ratio (OR)	2.8			2-Sided	95	1.5	5.1					Superiority
OG000 OG002	BMS-986165 6 mg vs Placebo

Secondary

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48

SRI(4) responder is defined as a patient whose disease course fulfills all of the following:

A 4-point or greater reduction from baseline in SLEDAI-2K score
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity

All Randomized Participants

Posted

Count of Participants

Participants

At week 48

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Secondary

Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response

BICLA responder is defined as a patient whose disease course fulfills all of the following:

Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline
No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B
No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score)
No increase ≥ 10% in the Physician's Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity
No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment

All Randomized Participants

Posted

Count of Participants

Participants

At week 48

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID

Secondary

Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)

LLDAS is defined as follows:

SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System
No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters
Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity
A current prednisolone (or equivalent) dose ≤ 7.5 mg daily
Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents

All Randomized Participants

Posted

Count of Participants

Participants

At Week 48

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID

Secondary

Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10

Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia

All Randomized Participants with Baseline CLASI Activity Score ≥ 10

Posted

Count of Participants

Participants

At week 48

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Secondary

Change From Baseline in the 40-Joint Count

Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of:

Tender joint count (0 to 40)
Swollen joint count (0 to 40)
Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.

All Randomized Participants

Posted

Mean

Standard Deviation

Units on a scale

Baseline and week 48

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment

All treated participants

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (Up to 52 weeks)

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Secondary

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following:

Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation > 3× Upper Limit of Normal (ULN)
Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase)
No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic

All treated participants with evaluable measurements

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (Up to 52 weeks)

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003

Secondary

Number of Participants With Abnormalities in Vital Signs

Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure

All treated participants with evaluable measurements

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (Up to 52 weeks)

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts
Participants

Secondary

Number of Participants With Abnormalities in Electrocardiograms (ECGs)

Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval

All treated participants with evaluable measurements

Posted

Count of Participants

Participants

From baseline to up to week 48

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts
Participants

Secondary

BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)

Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.

All evaluable PK participants (all treated participants with available concentration-time data)

Posted

Geometric Mean

Geometric Coefficient of Variation

NG/ML

Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12

ID	Title	Description
OG000	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG001	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG002	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts
Participants

Secondary

BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)

Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.

All evaluable PK participants (all treated participants with available concentration-time data)

Posted

Median

Full Range

Hours

Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12

ID	Title	Description
OG000	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG001	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG002	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts
Participants	OG000

Secondary

BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)

Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.

All evaluable PK participants (all treated participants with available concentration-time data)

Posted

Geometric Mean

Geometric Coefficient of Variation

NG/ML

Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48

ID	Title	Description
OG000	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG001	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG002	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts
Participants

Secondary

Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels

Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.

All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Posted

Mean

Standard Deviation

Percent Change from Baseline

From baseline to week 44

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Secondary

Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32

All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Posted

Mean

Standard Deviation

Percent Change from Baseline

From baseline to week 32

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Secondary

Percent Change From Baseline in Complement Proteins C3 and C4 Levels

Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.

All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Posted

Mean

Standard Error

Percent Change from Baseline

From baseline to week 52

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts

Secondary

Percent Change From Baseline in Complement (C3, C4) Levels at Week 32

Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.

All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Posted

Mean

Standard Error

Percent Change from Baseline

From baseline to week 32

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts

Secondary

Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels

Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.

All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Posted

Mean

Standard Error

Percent Change from Baseline

From baseline to week 52

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts

Secondary

Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32

Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.

All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Posted

Mean

Standard Error

Percent Change from Baseline

From baseline to week 32

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID
OG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD

Units	Counts

Secondary

Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status

Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following:

A 4-point or greater reduction from baseline in SLEDAI-2K score
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity

All randomized participants with SLE clinical response

Posted

Count of Participants

Participants

At week 32

ID	Title	Description
OG000	Placebo	Placebo PO BID
OG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID
OG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo PO BID	90	11	90	52	90
EG001	BMS-986165 3 mg	BMS-986165 3 mg PO BID	91	7	91	56	91
EG002	BMS-986165 6 mg	BMS-986165 6 mg PO BID	93	8	93	60	93
EG003	BMS-986165 12 mg	BMS-986165 12 mg PO QD	89	7	89	45	89

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG0031 affected89 at risk
Deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0011 affected91 at risk EG0020 affected93 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Scleritis	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0011 affected91 at risk EG0021 affected93 at risk EG003
Generalised oedema	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0011 affected91 at risk EG0020 affected93 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0021 affected93 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0021 affected93 at risk EG003
Pyelonephritis chronic	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0011 affected91 at risk EG0020 affected93 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected90 at risk EG0010 affected91 at risk EG0022 affected93 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0011 affected91 at risk EG0020 affected93 at risk EG003
Squamous cell carcinoma of the vagina	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Optic neuritis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0021 affected93 at risk EG003
Seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0011 affected91 at risk EG0020 affected93 at risk EG003
Spinal cord disorder	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Abortion spontaneous incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0021 affected93 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0011 affected91 at risk EG0020 affected93 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0021 affected93 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0010 affected91 at risk EG0020 affected93 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0010 affected91 at risk EG0021 affected93 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0011 affected91 at risk EG0020 affected93 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected90 at risk EG0014 affected91 at risk EG0028 affected93 at risk EG0033 affected89 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected90 at risk EG0016 affected91 at risk EG0025 affected93 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected90 at risk EG0013 affected91 at risk EG0024 affected93 at risk EG003
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0006 affected90 at risk EG0013 affected91 at risk EG0025 affected93 at risk EG003
Cystitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0015 affected91 at risk EG0021 affected93 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00011 affected90 at risk EG0018 affected91 at risk EG00213 affected93 at risk EG003
Oral herpes	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0014 affected91 at risk EG0024 affected93 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected90 at risk EG0017 affected91 at risk EG0025 affected93 at risk EG003
Sinusitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected90 at risk EG0014 affected91 at risk EG0025 affected93 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0008 affected90 at risk EG00113 affected91 at risk EG00218 affected93 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected90 at risk EG00110 affected91 at risk EG0026 affected93 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected90 at risk EG0015 affected91 at risk EG0021 affected93 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected90 at risk EG0011 affected91 at risk EG0028 affected93 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00015 affected90 at risk EG0017 affected91 at risk EG0028 affected93 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected90 at risk EG0011 affected91 at risk EG0020 affected93 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected90 at risk EG0013 affected91 at risk EG0028 affected93 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected90 at risk EG0012 affected91 at risk EG0023 affected93 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected90 at risk EG0014 affected91 at risk EG0023 affected93 at risk EG003

First MCP Posted Date

ID	Term
D008180	Lupus Erythematosus, Systemic

ID	Term
C000628674	deucravacitinib

Units	Counts
Participants	OG00090 OG00191 OG00293 OG00389

OG00089
OG00190
OG00292
OG00389

OG00046
OG00152
OG00264

Title	Measurements
	OG000-8.3± 6.9 OG001-8.5± 4.2 OG002-8.8± 7.2 OG003-9.9± 6.1

Title	Measurements
	OG000-8.2± 6.7 OG001-8.2± 4.3 OG002-8.5± 7.0 OG003-9.7± 5.9

Title	Measurements
	OG0002 OG0011 OG0021 OG0031

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Title	Measurements
	OG0001 OG0011 OG0020 OG0030

Title	Measurements
	OG0000 OG0010 OG0021 OG0030

Title	Measurements
	OG0005 OG0016 OG0025 OG0036

Title	Measurements
	OG0000 OG0012 OG0021 OG0030

Title	Measurements
	OG0000 OG0010 OG0020 OG0031

Title	Measurements
	OG0007 OG0017 OG0024 OG0035

Title	Measurements
	OG0007 OG0015 OG0026 OG0031

Title	Measurements
	OG0000 OG0010 OG0021 OG0032

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Title	Measurements
	OG0005 OG0016 OG0025 OG0036

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Title	Measurements
	OG0003 OG0014 OG0026 OG0038

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Title	Measurements
	OG0000 OG0010 OG0020 OG0031

Title	Measurements
	OG0005 OG0015 OG0022 OG0035

Title	Measurements
	OG0000 OG0010 OG0022 OG0030

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 67.77

OG00112.133± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 59.50

OG00211.748± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 67.17

OG0014.0000(1.017 to 9.533)

OG0023.7330(0.500 to 6.067)

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53.234

OG00122.9170± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 51.043

OG00220.1182± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 81.084

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 69.792

OG00112.9587± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 64.799

OG00226.7961± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 67.090

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 93.540

OG00128.7751± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 47.282

OG00222.1237± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 85.920

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 66.763

OG00113.9273± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 67.922

OG00221.8720± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 78.559

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 60.425

OG00115.5285± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 61.704

OG00224.5060± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75.647

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 70.206

OG00121.7890± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53.718

OG00215.9576± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 102.367

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 48.679

OG0018.4841± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 54.717

OG0028.7920± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 61.993

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 56.764

OG0017.7803± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53.563

OG0027.2703± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 70.461

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 62.816

OG0015.2290± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 71.924

OG0028.1451± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 57.216

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 96.323

OG0019.3281± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 54.823

OG0027.4071± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 82.009

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 56.381

OG0015.2229± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 71.104

OG0026.6608± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 63.748

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 55.379

OG0015.2925± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 63.200

OG0026.8734± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 77.329

Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 73.450

OG0016.8838± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 58.302

OG0025.8602± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75.536

Title	Measurements
	OG0004.7381± 8.8696 OG001-18.0641± 27.0491 OG002-36.4510± 22.4759 OG003-41.7645± 26.1519

Title	Measurements
	OG000-2.6555± 9.2649 OG001-27.4897± 20.0078 OG002-42.8107± 19.7669 OG003-42.9701± 23.8323

Title	Measurements
	OG00021 OG00146 OG00235 OG00335

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases