A Study to Investigate the Safety and Efficacy of Elsubru... | NCT03978520

ID	Type	Description	Link
2019-000638-20	EudraCT Number

A Study to Investigate the Safety and Efficacy of Elsubru... | NCT03978520 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elsubrutinib placebo/upadacitinib placebo	Placebo Comparator	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks	Drug: Placebo for elsubrutinib Drug: Placebo for upadacitinib
ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)	Experimental	60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks	Drug: Elsubrutinib Drug: Upadacitinib
Elsubrutinib placebo/upadacitinib 30 mg	Experimental	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks	Drug: Placebo for elsubrutinib Drug: Upadacitinib
ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)	Experimental	60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks	Drug: Elsubrutinib Drug: Upadacitinib
Elsubrutinib 60 mg/upadacitinib placebo	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elsubrutinib	Drug	Capsule; Oral	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24	SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA]) No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.	Baseline, Week 24

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24	SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA]) No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522		Mesa	Arizona	85210-6871	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33687069	Derived	Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Label	URL
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Elsubrutinib Placebo/Upadacitinib Placebo	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
FG001	ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Oct 25, 2021	Jun 27, 2023

Type	Comment	Reasons
Adverse Event		FG0002 subjects FG0015 subjects FG0023 subjects FG0035 subjects FG0046 subjects
Withdrawal by Subject		FG00010 subjects FG0014 subjects FG0025 subjects FG0036 subjects FG004
Lost to Follow-up		FG0002 subjects FG0012 subjects FG0022 subjects FG0030 subjects FG004
COVID-19 infection		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004
Other, not specified		FG0009 subjects FG0014 subjects FG0021 subjects FG0031 subjects FG004
Sponsor decision based on interim analysis data review		FG0000 subjects FG0010 subjects FG0020 subjects FG00333 subjects

Arm/Group Information

ID	Title	Description
BG000	Elsubrutinib Placebo/Upadacitinib Placebo	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
BG001	ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)	60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
BG002	Elsubrutinib Placebo/Upadacitinib 30 mg	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
BG003	ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)	60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
BG004	Elsubrutinib 60 mg/Upadacitinib Placebo	60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
BG005	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
	BG00041.7± 12.05 BG00142.7± 11.27 BG00242.5± 11.89 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00075 BG00162 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0003 BG0013 BG002

Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score

The SLEDAI-2K is a global SLE disease activity index that focuses on high-impact disease manifestations across 9 organ systems. It includes 24 clinical and laboratory variables with manifestations weighted by the affected organ system. Scores range from 0 to 105, with higher scores indicating more severe disease.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0009.1± 3.88 BG001

Physician's Global Assessment (PhGA) score

Physician's assessment of patient's overall disease activity due to Systemic Lupus Erythematosus (SLE), as compared with all possible participants with SLE. The benchmarks of the visual analog scale are 0, 1, 2, and 3 on the line corresponding to no, mild, moderate, and severe SLE disease activity, respectively.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0001.75± 0.440 BG001

Daily dose of corticosteroid

Mean

Standard Deviation

mg/day

Title

Denominators

Categories

Title	Measurements
	BG0007.937± 7.1270 BG0016.743± 6.3736 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 of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24

SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:

≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA])
No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.

Full Analysis Set: all randomized participants who received at least 1 dose of study drug; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Week 24

ID	Title	Description
OG000	Elsubrutinib Placebo/Upadacitinib Placebo	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
OG001	ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)	60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
OG002	Elsubrutinib Placebo/Upadacitinib 30 mg	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks

Units	Counts
Participants	OG00075 OG00168 OG00262

Title

Denominators

Categories

Title	Measurements
	OG00037.3(26.4 to 48.3) OG00148.5(36.7 to 60.4) OG00254.8(42.5 to 67.2)

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	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or > 10 mg), screening SLEDAI-2K (< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate [MTX], mycophenolate) (yes or no).	Cochran-Mantel-Haenszel		=0.081		Response Rate Difference	12.8			2-Sided	95	-1.6	27.1					Superiority

Secondary

Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24

SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:

≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA])
No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Week 24

ID	Title	Description
OG000	Elsubrutinib Placebo/Upadacitinib Placebo	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
OG001

Secondary

Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24

BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment [PhGA], < 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Week 24

ID	Title	Description
OG000	Elsubrutinib Placebo/Upadacitinib Placebo	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
OG001	ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)	60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks

Secondary

Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24

LLDAS is a state of low disease activity based on Systemic Lupus Erythematosus Disease Activity Index 2000 score (SLEDAI-2K score ≤4 excluding SLEDAI-2K activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA ≤1), and concomitant medication usage (steroid dose ≤7.5 mg QD and toleration of immunosuppressive drugs at standard maintenance doses).

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Week 24

ID	Title	Description
OG000	Elsubrutinib Placebo/Upadacitinib Placebo	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
OG001	ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)	60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks

Secondary

Change From Baseline in Daily Prednisone Dose at Week 24

Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.

Full Analysis Set: all randomized participants who received at least 1 dose of study drug with available data; Mixed-Effect Model Repeat Measurement was used. When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.

Posted

Least Squares Mean

95% Confidence Interval

From Baseline to Week 24

ID	Title	Description
OG000	Elsubrutinib Placebo/Upadacitinib Placebo	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
OG001	ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)	60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
OG002	Elsubrutinib Placebo/Upadacitinib 30 mg

Secondary

Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24

The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.

Full Analysis Set: all randomized participants who received at least 1 dose of study drug with available data; data as observed. When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.

Posted

Number

95% Confidence Interval

Events per patient-year

From Baseline to Week 24

ID	Title	Description
OG000	Elsubrutinib Placebo/Upadacitinib Placebo	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
OG001	ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)	60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
OG002

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Elsubrutinib Placebo/Upadacitinib Placebo	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks	0	75	13	75	39	75
EG001	ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)	60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks	2	68	7	68	38	68
EG002	Elsubrutinib Placebo/Upadacitinib 30 mg	Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks	0	62	13	62	35	62
EG003	ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)	60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks	0	69	9	69	28	69
EG004	Elsubrutinib 60 mg/Upadacitinib Placebo	60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks	2	67	7	67	36	67

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG0031 events1 affected69 at risk EG0040 events0 affected67 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
STRESS CARDIOMYOPATHY	Cardiac disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
ACCIDENTAL DEATH	General disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
ABSCESS LIMB	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0021 events1 affected62 at risk EG003
DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
DIVERTICULITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
ENDOCARDITIS BACTERIAL	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
MENINGITIS TUBERCULOUS	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
MYCOPLASMA INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
OESOPHAGEAL CANDIDIASIS	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
PELVIC ABSCESS	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0022 events2 affected62 at risk EG003
PNEUMONIA FUNGAL	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
SEPSIS	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE ACTIVITY INDEX INCREASED	Investigations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
SYSTEMIC LUPUS ERYTHEMATOSUS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0011 events1 affected68 at risk EG0021 events1 affected62 at risk EG003
CENTRAL NERVOUS SYSTEM LUPUS	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
MIGRAINE	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
RUPTURED CEREBRAL ANEURYSM	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0021 events1 affected62 at risk EG003
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
BIPOLAR DISORDER	Psychiatric disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
LUPUS NEPHRITIS	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0021 events1 affected62 at risk EG003
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
URETEROLITHIASIS	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment		EG0002 events2 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
BREAST MASS	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003
ABORTION INDUCED	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment		EG0002 events2 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
HYPERTENSIVE URGENCY	Vascular disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected75 at risk EG0010 events0 affected68 at risk EG0020 events0 affected62 at risk EG003
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA 25.0	Systematic Assessment	Clotted peripheral IV catheter in participant's arm	EG0000 events0 affected75 at risk EG0011 events1 affected68 at risk EG0020 events0 affected62 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
CONSTIPATION	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected75 at risk EG0011 events1 affected68 at risk EG0021 events1 affected62 at risk EG0034 events4 affected69 at risk EG0041 events1 affected67 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0006 events6 affected75 at risk EG0014 events3 affected68 at risk EG0025 events4 affected62 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected68 at risk EG0022 events2 affected62 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG00011 events6 affected75 at risk EG0014 events4 affected68 at risk EG0024 events4 affected62 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected75 at risk EG0013 events2 affected68 at risk EG0026 events4 affected62 at risk EG003
FATIGUE	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected75 at risk EG0014 events4 affected68 at risk EG0020 events0 affected62 at risk EG003
PYREXIA	General disorders	MedDRA 25.0	Systematic Assessment	EG0006 events6 affected75 at risk EG0013 events3 affected68 at risk EG0023 events3 affected62 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected75 at risk EG0011 events1 affected68 at risk EG0024 events4 affected62 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0008 events8 affected75 at risk EG0013 events3 affected68 at risk EG0027 events7 affected62 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected75 at risk EG0017 events7 affected68 at risk EG0023 events3 affected62 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected75 at risk EG0016 events6 affected68 at risk EG0021 events1 affected62 at risk EG003
ORAL HERPES	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected75 at risk EG00111 events5 affected68 at risk EG0024 events3 affected62 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG00010 events8 affected75 at risk EG00113 events7 affected68 at risk EG0026 events5 affected62 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG00010 events9 affected75 at risk EG00114 events8 affected68 at risk EG00215 events11 affected62 at risk EG003
WEIGHT INCREASED	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected75 at risk EG0018 events4 affected68 at risk EG0022 events1 affected62 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected75 at risk EG0013 events3 affected68 at risk EG0021 events1 affected62 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected75 at risk EG0013 events3 affected68 at risk EG0021 events1 affected62 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG00013 events9 affected75 at risk EG0014 events4 affected68 at risk EG0022 events2 affected62 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected75 at risk EG0012 events2 affected68 at risk EG0024 events4 affected62 at risk EG003
ACNE	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected75 at risk EG0014 events4 affected68 at risk EG0022 events2 affected62 at risk EG003

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or > 10 mg), screening SLEDAI-2K (< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate [MTX], mycophenolate) (yes or no).	Cochran-Mantel-Haenszel	=0.013	Response Rate Difference	18.3	2-Sided	95	3.9	32.6	Superiority
OG000 OG002	Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or > 10 mg), screening SLEDAI-2K (< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate [MTX], mycophenolate) (yes or no).	Cochran-Mantel-Haenszel	=0.018	Response Rate Difference	18.1	2-Sided	95	3.0	33.2	Superiority
OG001 OG002	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or > 10 mg), screening SLEDAI-2K (< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate [MTX], mycophenolate) (yes or no).	Cochran-Mantel-Haenszel	=0.882	Response Rate Difference	-1.2	2-Sided	95	-17.6	15.2	Superiority

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or > 10 mg), screening SLEDAI-2K (< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate [MTX], mycophenolate) (yes or no).	Cochran-Mantel-Haenszel	=0.049	Response Rate Difference	14.7	2-Sided	95	0.0	29.4	Superiority
OG000 OG002	Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or > 10 mg), screening SLEDAI-2K (< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate [MTX], mycophenolate) (yes or no).	Cochran-Mantel-Haenszel	=0.091	Response Rate Difference	13.9	2-Sided	95	-2.2	30.1	Superiority
OG001 OG002	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib 30 mg The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or > 10 mg), screening SLEDAI-2K (< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate [MTX], mycophenolate) (yes or no).	Cochran-Mantel-Haenszel	=0.447	Response Rate Difference	-6.3	2-Sided	95	-22.5	9.9	Superiority

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or > 10 mg), screening SLEDAI-2K (< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate [MTX], mycophenolate) (yes or no).	Cochran-Mantel-Haenszel	=0.007	Response Rate Difference	16.7	2-Sided	95	4.5	28.9	Superiority
OG000 OG002	Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo	Cochran-Mantel-Haenszel	<0.001	Response Rate Difference	31.0	2-Sided	95	18.1	44.0	Superiority
OG001 OG002	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or > 10 mg), screening SLEDAI-2K (< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate [MTX], mycophenolate) (yes or no).	Cochran-Mantel-Haenszel	=0.068	Response Rate Difference	-13.7	2-Sided	95	-28.4	1.0	Superiority

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose > 10 mg prednisone-equivalent (≤ 10 mg or >10 mg), screening SLEDAI-2K (<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline.	Mixed-effect model repeat measurement	=0.710	LS Mean Difference	0.20	Standard Error of the Mean	0.527	2-Sided	95	-0.84	1.23	Superiority
OG000 OG002	Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose > 10 mg prednisone-equivalent (≤ 10 mg or >10 mg), screening SLEDAI-2K (<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline.	Mixed-effect model repeat measurement	=0.963	LS Mean Difference	0.03	Standard Error of the Mean	0.545	2-Sided	95	-1.05	1.10	Superiority
OG001 OG002	ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose > 10 mg prednisone-equivalent (≤ 10 mg or >10 mg), screening SLEDAI-2K (<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline.	Mixed-effect model repeat measurement	=0.754	LS Mean Difference	0.17	Standard Error of the Mean	0.547	2-Sided	95	-0.90	1.25	Superiority

Title

Denominators

Categories

Mild/Moderate

Title	Measurements
	OG0002.45(1.92 to 2.99) OG0011.39(0.97 to 1.81) OG0021.76(1.28 to 2.25)

Severe

Title	Measurements
	OG0000.36(0.16 to 0.56) OG0010.26(0.08 to 0.44) OG0020.10(-0.01 to 0.22)

Overall

Title	Measurements
	OG0002.81(2.24 to 3.38) OG0011.65(1.20 to 2.10) OG0021.87(1.37 to 2.36)

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Mild/Moderate ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib placebo A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.	Binomial regression	=0.002	Rate difference	-1.06	2-Sided	95	-1.74	-0.39	Superiority
OG000 OG002	Mild/Moderate Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.	Binomial regression	=0.059	Rate Difference	-0.69	2-Sided	95	-1.41	0.03	Superiority
OG001 OG002	Mild/Moderate ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.	Binomial regression	=0.252	Rate Difference	-0.37	2-Sided	95	-1.01	0.27	Superiority
OG000 OG001	Severe ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.	Binomial regression	=0.467	Rate Difference	-0.10	2-Sided	95	-0.37	0.17	Superiority
OG000 OG002	Severe Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.	Binomial regression	=0.033	Rate Difference	-0.26	2-Sided	95	-0.49	-0.02	Superiority
OG001 OG002	Severe ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.	Binomial regression	=0.156	Rate Difference	0.15	2-Sided	95	-0.06	0.37	Superiority
OG000 OG001	Overall ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.	Binomial regression	=0.002	Rate Difference	-1.16	2-Sided	95	-1.89	-0.44	Superiority
OG000 OG002	Overall Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.	Binomial regression	=0.014	Rate Difference	-0.95	2-Sided	95	-1.70	-0.19	Superiority
OG001 OG002	Overall ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.	Binomial regression	=0.526	Rate Difference	-0.22	2-Sided	95	-0.89	0.46	Superiority

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