A Study to Evaluate Efficacy and Safety of Deucravacitini... | NCT04857034

NCT04857034

ID	Type	Description	Link
2020-000071-21	EudraCT Number
U1111-1246-1726	Registry Identifier	WHO

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
Active Treatment: Deucravacitinib Dose 1	Experimental	Drug: Deucravacitinib
Active Treatment: Deucravacitinib Dose 2	Experimental	Drug: Deucravacitinib
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Deucravacitinib	Drug	Specified dose on specified days	Active Treatment: Deucravacitinib Dose 1 Active Treatment: Deucravacitinib Dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage Change From Baseline in CLASI Activity Score at Week 16	The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70	From first dose to Week 16 (approximately 16 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).	The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

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 - 0077		Scottsdale	Arizona	85259	United States
Local Institution - 0076

References Module

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
FG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period

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

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 15, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
BG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
BG002	Placebo-Controlled Period: Placebo	Placebo
BG003	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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00047.3± 15.06 BG00142.8± 12.16 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00017 BG00119 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0009 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 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

Percentage Change From Baseline in CLASI Activity Score at Week 16

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

It separately scores:

Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
Damage (e.g., dyspigmentation, scarring)

CLASI enables classification of disease severity:

Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A

Posted

Mean

Standard Deviation

Percentage change from baseline

From first dose to Week 16 (approximately 16 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Placebo-Controlled Period: Placebo	Placebo

Units	Counts
Participants	OG00025 OG00124 OG00223

Title

Denominators

Categories

Title	Measurements
	OG000-48.56± 44.684 OG001-48.93± 33.302 OG002-27.31± 29.716

Secondary

Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

It separately scores:

Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
Damage (e.g., dyspigmentation, scarring)

CLASI enables classification of disease severity:

Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A

Posted

Number

Percentage of participants

From first dose to Week 16 (approximately 16 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Placebo-Controlled Period: Placebo	Placebo

Secondary

Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline.

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

It separately scores:

Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
Damage (e.g., dyspigmentation, scarring)

CLASI enables classification of disease severity:

Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A

Posted

Number

Percentage of participants

From first dose to Week 16 (approximately 16 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Placebo-Controlled Period: Placebo	Placebo

Secondary

Mean Change From Baseline in CLASI-A Score.

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

It separately scores:

Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
Damage (e.g., dyspigmentation, scarring)

CLASI enables classification of disease severity:

Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A

Posted

Mean

Standard Deviation

Score on a Scale

From first dose to Week 16 (approximately 16 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Placebo-Controlled Period: Placebo	Placebo

Secondary

Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of "0".

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

It separately scores:

Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
Damage (e.g., dyspigmentation, scarring)

CLASI enables classification of disease severity:

Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

Complete Response (CR) on CLASI-A defined as a score of "0".

All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A

Posted

Number

Percentage of Participants

From first dose to Week 16 (approximately 16 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Placebo-Controlled Period: Placebo	Placebo

Secondary

Number of Participants With Safety Related Events in the Placebo Controlled Period

Number of participants with safety related events in the placebo controlled period

All Treated Population in the Placebo Controlled Period

Posted

Count of Participants

Participants

From signing informed consent to end of safety follow up period (Approximately 60 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Placebo-Controlled Period: Placebo	Placebo

Units	Counts
Participants

Secondary

Number of Participants With Safety Related Events in the Active Treatment Period

Number of participants with safety related events in the active treatment period

All Treated Population in the active treatment period

Posted

Count of Participants

Participants

From signing informed consent to end of safety follow up period (Approximately 60 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Active-Treatment Period: Treatment 1	Deucravacitinib 3mg
OG003	Active-Treatment Period: Treatment 2	Deucravacitinib 6mg

Secondary

Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period

Number of participants with clinically significant laboratory abnormalities in the placebo controlled period

All Treated Population in the Placebo Controlled Period

Posted

Count of Participants

Participants

From signing informed consent to end of safety follow up period (Approximately 60 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Placebo-Controlled Period: Placebo	Placebo

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period

Number of participants with clinically significant laboratory abnormalities in the active treatment period

All Treated Population in the active treatment period

Posted

Count of Participants

Participants

From signing informed consent to end of safety follow up period (Approximately 60 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Active-Treatment Period: Treatment 1	Deucravacitinib 3mg
OG003	Active-Treatment Period: Treatment 2	Deucravacitinib 6mg

Secondary

Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period

Number of participants with clinically significant vital sign abnormalities in the placebo controlled period

All Treated Population in the Placebo Controlled Period

Posted

Count of Participants

Participants

From signing informed consent to end of safety follow up period (Approximately 60 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Placebo-Controlled Period: Placebo	Placebo

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period

Number of participants with clinically significant vital sign abnormalities in the active treatment period

All Treated Population in the active treatment period

Posted

Count of Participants

Participants

From signing informed consent to end of safety follow up period (Approximately 60 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Active-Treatment Period: Treatment 1	Deucravacitinib 3mg
OG003	Active-Treatment Period: Treatment 2	Deucravacitinib 6mg

Secondary

Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period

Number of participants with clinically significant ECG abnormalities in the placebo controlled period

All Treated Population in the Placebo Controlled Period

Posted

Count of Participants

Participants

From signing informed consent to end of active treatment period (Approximately 56 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Placebo-Controlled Period: Placebo	Placebo

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period

Number of participants with clinically significant ECG abnormalities in the active treatment period

All Treated Population in the active treatment period

Posted

Count of Participants

Participants

From signing informed consent to end of active treatment period (Approximately 56 weeks)

ID	Title	Description
OG000	Placebo-Controlled Period: Treatment 1	Deucravactinib 3mg
OG001	Placebo-Controlled Period: Treatment 2	Received Deucravacitinib 6mg in placebo controlled period and Deucravacitinib 6mg in active treatment period
OG002	Active-Treatment Period: Treatment 1	Deucravacitinib 3mg
OG003	Active-Treatment Period: Treatment 2	Deucravacitinib 6mg

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo-Controlled Period - DEUC 3 mg BID	Deucravactinib 3mg in the Placebo controlled period	25	2	25	15	25
EG001	Placebo-Controlled Period - DEUC 6 mg BID	Deucravactinib 6 mg in the Placebo controlled period	24	2	24	15	24
EG002	Placebo-Controlled Period - Placebo BID	Placebo in the Placebo controlled period	24	1	24	8	24
EG003	Active Treatment Period - DEUC 3 mg BID	Deucravactinib 3mg in the Placebo controlled period and Deucravactinib 3mg in the Active Treatment Period	16	1	16	11	16
EG004	Active Treatment Period - DEUC 6 mg BID	Deucravactinib 6mg in the Placebo controlled period and Deucravactinib 6mg in the Active Treatment Period	20	0	20	10	20
EG005	Active Treatment Period - Placebo-DEUC 3 mg BID	Placebo in the Placebo controlled period and Deucravactinib 3mg in the Active Treatment Period	9	0	9	5	9
EG006	Active Treatment Period - Placebo-DEUC 6 mg BID	Placebo in the Placebo controlled period and Deucravactinib 6mg in the Active Treatment Period	9	1	9	6	9

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG0030 affected16 at risk EG0040 affected20 at risk EG0050 affected9 at risk EG0060 affected9 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Oral herpes	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Abortion induced incomplete	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG0031 affected16 at risk EG0040 affected20 at risk EG0050 affected9 at risk EG0060 affected9 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected25 at risk EG0012 affected24 at risk EG0020 affected24 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Asthenia	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Influenza like illness	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Peripheral swelling	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Folliculitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected25 at risk EG0012 affected24 at risk EG0020 affected24 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0011 affected24 at risk EG0022 affected24 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 affected25 at risk EG0013 affected24 at risk EG0021 affected24 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0011 affected24 at risk EG0021 affected24 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0003 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0012 affected24 at risk EG0020 affected24 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0022 affected24 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0002 affected25 at risk EG0015 affected24 at risk EG0020 affected24 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0012 affected24 at risk EG0020 affected24 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Palpitations	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0021 affected6 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Vision blurred	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Mucous stools	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Oral mucosa erosion	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Mass	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0011 affected24 at risk EG0021 affected24 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Ear infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Erythrasma	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Fungal infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Groin abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Oral herpes	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Pertussis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Pustule	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Schistosomiasis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Tooth infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Viral infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Respiratory syncytial virus test positive	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Weight decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
White blood cell count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0021 affected24 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0011 affected24 at risk EG0020 affected24 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Burning sensation	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Nerve degeneration	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Sciatica	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Somnolence	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Depression	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected4 at risk EG0020 affected6 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0021 affected6 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected4 at risk EG0020 affected6 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Perioral dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected25 at risk EG0010 affected24 at risk EG0020 affected24 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected4 at risk EG0021 affected6 at risk EG003

ID	Term
D008179	Lupus Erythematosus, Discoid
D008178	Lupus Erythematosus, Cutaneous

ID	Term
C000628674	deucravacitinib

Units	Counts
Participants	OG00025 OG00124 OG00223

Units	Counts
Participants	OG00025 OG00124 OG00223

Units	Counts
Participants	OG00025 OG00124 OG00223

Units	Counts
Participants	OG00016 OG00120 OG0029 OG0039

Units	Counts
Participants	OG00016 OG00120 OG0029 OG0039

Units	Counts
Participants	OG00016 OG00120 OG0029 OG0039

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0061 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0041 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0051 affected9 at risk

EG0060 affected9 at risk

EG0041 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0041 affected20 at risk

EG0052 affected9 at risk

EG0060 affected9 at risk

EG0042 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0051 affected9 at risk

EG0061 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0041 affected20 at risk

EG0051 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0041 affected20 at risk

EG0051 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0041 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0041 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0051 affected9 at risk

EG0060 affected9 at risk

EG0041 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0050 affected9 at risk

EG0060 affected9 at risk

EG0040 affected20 at risk

EG0051 affected9 at risk

EG0060 affected9 at risk

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases