A Study to Evaluate the Efficacy and Safety of CEP-33457... | NCT01135459

NCT01135459

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

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	Description	Intervention Names
CEP-33457	Experimental	Participants will receive CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).	Drug: CEP-33457
Placebo	Placebo Comparator	Participants will receive placebo matching to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
CEP-33457	Drug	CEP-33457 will be administered per dose and schedule specified in the arm description.	CEP-33457

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Achieving a Combined Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24	An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of >3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of >0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=patient needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.	Week 24

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Achieving an SRI Response at Each Visit During the Treatment Period	An SRI response was defined as a reduction from baseline in SLEDAI-2K score of ≥4 points, no worsening in PhGA, no new BILAG A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of >3 points = improvement. PhGA was completed by physician using a VAS from 0=none to 3=severe. A change of >0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant has an established diagnosis of systemic lupus erythematosus (SLE) as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met.
The participant has a positive test for antinuclear antibody (ANA) at screening and/or a positive test for anti-double-stranded deoxyribonucleic acid antibody (anti-dsDNA Ab) at screening.
Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of contraception, and must agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug treatment.
The participant has a clinical SLEDAI-2K score of at least 6 points during screening.
The participant does not have an "A" score on the BILAG-2004 scale.
If the patient is using oral corticosteroids, the weekly cumulative dose must not exceed 80 mg of prednisone equivalent; the weekly dose must be stable over the 4 weeks preceding the first dose of study drug.
If the participant is using antimalarials, methotrexate, leflunomide, mycophenolate mofetil, or azathioprine, the start date must be at least 3 months prior to the first dose of study drug, and the daily dose must be stable over the 4 weeks preceding the first dose of study drug.
If the participant is not currently using corticosteroids, antimalarials, methotrexate, mycophenolate mofetil, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to the first dose of study drug. For leflunomide, the stop date must be at least 8 weeks before the first dose of study drug, unless an adequate cholestyramine washout has been completed.

Exclusion Criteria:

The participant has been treated with intramuscular or intravenous (iv) pulse steroids (ie, 250 to 1000 milligrams [mg] iv total daily dose of methylprednisolone) within 4 weeks of the first dose of study drug. The use of intra-articular steroids may be allowed after consultation with the medical expert.
The participant has received tacrolimus, cyclosporine A, or iv immunoglobulins (IVIG) within 3 months of the first dose of study drug.
The participant has received cyclophosphamide within 12 months prior to the first dose of study drug.
The participant has been treated for SLE with agents such as fusion proteins, therapeutic proteins, or monoclonal antibodies or antibody fragments, within 12 months of the first dose of study drug.
The participant has received B-cell depleting agents such as rituximab and has not yet normalized the B-cell count (ie, CD20+ B-cell count is less than 200 and the absolute lymphocyte count [ALC] is less than 1500/μL).
The participant has New York Heart Association (NYHA) Class III or IV congestive heart failure.
The participant has severe active lupus nephritis or cerebritis.
The participant has an estimated glomerular filtration rate (eGFR) of less than 30 milliliters (mL)/minute (min)/1.73 square meter (m^2) (via Modification of Diet in Renal Disease [MDRD] equation).
The participant has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 2 times the upper limit of normal (ULN) or a total bilirubin level greater than 1.5 times ULN.
The participant has a planned immunization with a live or live attenuated vaccine within 3 months prior to administration of the first dose of study drug and for 3 months after administration of the last dose of study drug.
The participant has any clinically significant abnormalities on electrocardiogram (ECG) that are not related to SLE, as determined by the investigator. Participant with stable ECG changes without evidence of active cardiovascular disease may participate at the discretion of the investigator and medical monitor.
The participant has an ongoing active systemic infection requiring treatment or a history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to administration of the first dose of study drug. Less severe infections in the 3 months prior to administration of the first dose of study drug are permitted at the discretion of the investigator and medical monitor.
The participant has any concomitant medical condition unrelated to SLE that may interfere with his or her safety or with evaluation of the study drug, as determined by the investigator.
The participant has a history of a medical condition other than SLE that has required treatment with steroids in excess of 80 mg of prednisone equivalent/week within 6 months of the first dose of study drug.
The participant has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C (HCV Ab).
The participant has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease.
The participant has a history of alcohol or substance dependence or abuse (with the exception of nicotine), according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM-IV-TR), within 3 months of the screening visit or has current substance abuse.
The participant has a history of severe allergic reactions to or hypersensitivity to any component of the study drug or placebo.
The participant has undergone or is undergoing treatment with another investigational drug for the treatment of lupus within 6 months prior to the 1st dose of study drug or has received any other investigational drug for any other condition within 30 days prior to the 1st dose of study drug.
The participant has previously participated in a Cephalon- or ImmuPharma-sponsored clinical study with CEP-33457.
The participant is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
The participant is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.

Contacts/Locations Module

Name	Affiliation	Role
Teva Medical Expert	Teva Branded Pharmaceutical Products R&D, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Teva Investigational Site 27		Birmingham	Alabama	35233	United States
Teva Investigational Site 20

References Module

No data available

No data is available for this block.

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	Participants received placebo matched to CEP-33457 subcutaneously (SC) every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
FG001	CEP-33457	Participants received CEP-33457 200 micrograms (mcg) SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

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

No data available

No data is available for this block.

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

All randomized participants.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
BG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
BG002	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± 11.88 BG00142.0± 11.25 BG00241.0± 11.58

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00083 BG00186 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00010 BG00111 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
White	BG00064 BG00167 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 Achieving a Combined Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24

An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of >3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of >0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=patient needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.

Full analysis set included all randomized participants who took at least 1 dose of study drug and had the baseline SLEDAI-2K total score, BILAG 2004 body system scores, and the PhGA score.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Units	Counts
Participants	OG00092 OG00190

Title

Denominators

Categories

Title	Measurements
	OG00037 OG00131

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	Analysis was performed using a logistic regression model with treatment and stratification factors as main factors.	Regression, Logistic		0.3989		Odds Ratio (OR)	0.7649			2-Sided	95	0.4	1.4					Other

Secondary

Number of Participants Achieving an SRI Response at Each Visit During the Treatment Period

An SRI response was defined as a reduction from baseline in SLEDAI-2K score of ≥4 points, no worsening in PhGA, no new BILAG A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of >3 points = improvement. PhGA was completed by physician using a VAS from 0=none to 3=severe. A change of >0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.

Full analysis set included all randomized participants who took at least 1 dose of study drug and had the baseline SLEDAI-2K total score, BILAG 2004 body system scores, and the PhGA score.

Posted

Count of Participants

Participants

Weeks 4, 8, 12, 16, and 20

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Secondary

Number of Participants Achieving a Reduction of at Least 4 Points in the SLEDAI-2K Total Score

The SLEDAI-2K is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105. A SLEDAI-2K score of 6 to 10 is indicative of moderate disease activity, and improvement is defined as a reduction of more than 3 points.

Full analysis set included all randomized participants who took at least 1 dose of study drug and had the baseline SLEDAI-2K total score, BILAG 2004 body system scores, and the PhGA score.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Units	Counts
Participants

Secondary

Number of Participants Achieving a British Isles Lupus Assessment Group (BILAG) 2004 Response

The BILAG 2004 is a validated objective and subjective global measure of the disease activity of SLE based on the physician intention to treat. It includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems; each organ system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and the organ system has never been involved. BILAG 2004 response was defined as no new A body system score and no more than 1 new BILAG B body system score from baseline.

Full analysis set included all randomized participants who took at least 1 dose of study drug and had the baseline SLEDAI-2K total score, BILAG 2004 body system scores, and the PhGA score.

Posted

Count of Participants

Participants

Weeks 4, 8, 12, 16, 20, and 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Secondary

Number of Participants Achieving a BILAG 2004 Clinical Response

The BILAG 2004 is a validated objective and subjective global measure of the disease activity of SLE based on the physician intention to treat. It includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems; each organ system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and the organ system has never been involved. BILAG 2004 clinical response was defined as having an improvement in at least 1 category from a B score at baseline to a C or D score with no worsening in any other category from baseline.

Full analysis set included all randomized participants who took at least 1 dose of study drug and had the baseline SLEDAI-2K total score, BILAG 2004 body system scores, and the PhGA score.

Posted

Count of Participants

Participants

Weeks 4, 8, 12, 16, 20, and 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Secondary

Number of Participants Achieving a Physician Global Assessment (PhGA) Response

The PhGA was completed by the physician using a 3 inch VAS labeled from 0=none to 3=severe. The PhGA response was defined as having no worsening in PhGA (with worsening defined as an increase in PhGA of more than 0.30 inch from baseline).

Full analysis set included all randomized participants who took at least 1 dose of study drug and had the baseline SLEDAI-2K total score, BILAG 2004 body system scores, and the PhGA score.

Posted

Count of Participants

Participants

Weeks 4, 8, 12, 16, 20, and 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Units	Counts
Participants	OG000

Secondary

Number of Participants Achieving a Patient's Global Assessment (PtGA) Response

The PhGA was completed by the participant using a 3 inch VAS labeled from 0=none to 3=severe. The PtGA response was defined as having no worsening in PtGA (with worsening defined as an increase in PtGA of more than 0.30 inch from baseline).

Full analysis set included all randomized participants who took at least 1 dose of study drug and had the baseline SLEDAI-2K total score, BILAG 2004 body system scores, and the PhGA score.

Posted

Count of Participants

Participants

Weeks 4, 8, 12, 16, 20, and 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Units	Counts
Participants	OG000

Secondary

Change From Baseline in the Medical Outcome Survey Short-Form 36 (SF-36) Patient-Reported Questionnaire For Physical Component Summary (PCS) Score at Weeks 12 and 24

The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, role physical, 2) bodily pain, 3) general health, 4) vitality, 5) social functioning, 6) role, 7) emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Items 1 to 4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item were summed and averaged (range: 0=worst to 100=best). Higher scores represent better health status and functional ability.

Full analysis set included all randomized participants who took at least 1 dose of study drug and had the baseline SLEDAI-2K total score, BILAG 2004 body system scores, and the PhGA score. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable at specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Secondary

Change From Baseline in the Medical Outcome Survey SF-36 Patient-Reported Questionnaire For Mental Component Summary (MCS) Score at Weeks 12 and 24

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Secondary

Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index

SLICC/ACR score or damage index is a measure of cumulative damage due to SLE. Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.

Full analysis set included all randomized participants who took at least 1 dose of study drug and had the baseline SLEDAI-2K total score, BILAG 2004 body system scores, and the PhGA score. Number analyzed = participants evaluable at specified timepoint.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Secondary

Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Safety analysis set included all randomized participants who took at least 1 dose of study drug.

Posted

Count of Participants

Participants

Baseline up to Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
OG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Units	Counts

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	Placebo	Participants received placebo matched to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).	0	92	13	92	58	92
EG001	CEP-33457	Participants received CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).	0	91	9	91	61	91

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Goitre	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Medical device complication	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected92 at risk EG0012 events1 affected91 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Cognitive disorder	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Convulsion	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected92 at risk EG0010 events0 affected91 at risk
Encephalopathy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Polyneuropathy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Syncope	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected92 at risk EG0011 events1 affected91 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected91 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk
Venous insufficiency	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected91 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00010 events8 affected92 at risk EG00110 events6 affected91 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00011 events7 affected92 at risk EG0017 events5 affected91 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected92 at risk EG0017 events6 affected91 at risk
Fatigue	General disorders	MedDRA 13.0	Systematic Assessment	EG0005 events4 affected92 at risk EG0017 events6 affected91 at risk
Injection site erythema	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG00123 events7 affected91 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG00010 events7 affected92 at risk EG0015 events4 affected91 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0007 events7 affected92 at risk EG0017 events7 affected91 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00011 events9 affected92 at risk EG0019 events7 affected91 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00010 events9 affected92 at risk EG0016 events3 affected91 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0006 events5 affected92 at risk EG0013 events3 affected91 at risk
Weight decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0005 events5 affected92 at risk EG0013 events3 affected91 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00010 events7 affected92 at risk EG00115 events12 affected91 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0009 events5 affected92 at risk EG00122 events16 affected91 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0005 events5 affected92 at risk EG0013 events3 affected91 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0015 events5 affected91 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0003 events3 affected92 at risk EG0017 events7 affected91 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00016 events9 affected92 at risk EG00114 events11 affected91 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0009 events9 affected92 at risk EG00111 events8 affected91 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0006 events6 affected92 at risk EG0014 events4 affected91 at risk
Systemic lupus erythematosus rash	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG00022 events12 affected92 at risk EG00115 events11 affected91 at risk

ID	Term
D008180	Lupus Erythematosus, Systemic

ID	Term
C535176	spliceosomal peptide P140

Units	Counts
Participants	OG00092 OG00190

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