A Phase 2a, Randomized, Placebo Controlled, Study to Eval... | NCT02334306

NCT02334306

Status Module

Sponsor/Collaborators Module

Name	Class
Amgen	INDUSTRY

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	Description	Intervention Names
MEDI5872 210 mg	Experimental	Participants will receive a fixed SC dose of 210 mg MEDI5872 every week (QW) from Days 1 to 15 and then every 2 weeks (Q2W) from Days 29 to 85 in double-blind period. In open-label period, participants will continue dosing of MEDI5872 210mg Q2W from Days 99 to 183 and will receive an additional dose of blinded placebo on Day 106.	Biological: AMG 557/MEDI5872
Placebo/MEDI5872 210 mg	Placebo Comparator	Participants will receive a SC dose of placebo matching with MEDI5872 QW on Days 1, 8, and 15 and then Q2W from Days 29 to 85 in double-blind period. In open-label period, participants will receive a fixed SC dose of 210 mg MEDI5872 QW (Days 99 to 113) and Q2W (Days 127 to 183) in open-label period.	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AMG 557/MEDI5872	Biological	Participants will receive a fixed SC dose of 210 mg MEDI5872 (AMG 557/MEDI5872) QW for 3 weeks (Days 1 to 15) and then Q2W for 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, all participants from double-blind period will receive a fixed SC dose of 210 mg MEDI5872 from Day 99 to Day 183 (QW from Days 99 to 113 for participants from Placebo arm and on Days 99 and 113 for participants from MEDI5872 210 mg arm; and Q2W from Days 127 to 183 for participants from both arms).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99	The European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of 12 organ-specific domains (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological). Each domain is assessed for activity level in 3 or 4 levels (i.e., no, low, moderate, high) according to their severity (no disease activity equals to 0 and for high disease activity the domain score equals 3 or 4). Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease. Adjusted mean change and standard error are presented.	Baseline (Day 1 predose) and Day 99

Secondary Outcomes

Measure	Description	Time Frame
Ratio to Baseline in Peripheral Blood Biomarkers at Day 99	The peripheral blood biomarkers included total plasma cell levels (including plasma blast levels) and T follicular helper (TFH) cells. Adjusted geometric mean ratio to baseline and standard error (log) are presented.	Baseline (Day 1 predose) and Day 99

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 through 75 years at the time of signing the ICF.
Fulfill American-European Consensus Group (AECG) criteria for pSS
ESSDAI score ≥ 6.
Positive anti-SS-A and/or anti-SS-B autoantibodies and at least IgG > 13 g/L or RF level > upper limit of normal (ULN) or positive test for cryoglobulins
Willingness to undergo protocol-required minor salivary gland biopsies.
Negative TB test during screening
Immunization up to date as determined by local standard of care.

Exclusion Criteria:

Previous treatment with AMG 557/MEDI5872.
Evidence of signs or symptoms of a viral, bacterial, or fungal infection within 2 weeks (14 days) prior to randomization (Day 1) according to the assessment of the investigator; any infection requiring IV antibiotic or antiviral treatment within 8 weeks of randomization (Day 1); history of herpes zoster within 3 months prior to randomization (Day 1).
Evidence of significant renal insufficiency
Positive test at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) antibody.
Prior administration of any of the following:
1. Belimumab in the past 6 months prior to randomization (Day 1);
2. Rituximab in the past 12 months or CD19+ B cells < 5/µL if rituximab treatment was more than 12 months prior to randomization (Day 1);
3. Abatacept in the past 6 months prior to randomization (Day 1);
4. Tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab) in the past 3 months prior to randomization (Day 1);
5. Tocilizumab in the past 3 months prior to randomization (Day 1);
6. Cyclophosphamide (or any other alkylating agent) in the past 6 months prior to randomization (Day 1); cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil, azathioprine, or leflunomide in the past 3 months prior to randomization (Day 1).
Receiving any of the following:
1. Corticosteroids: > 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1); Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to signing the ICF through randomization (Day 1); Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to signing the ICF through randomization (Day 1);
2. Antimalarials: any increase or initiation of new dose of antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) within 12 weeks prior to signing the ICF through randomization (Day 1).
3. Methotrexate: > 20 mg/week methotrexate; Any change or initiation of new dose of methotrexate within 4 weeks prior to signing the ICF through randomization (Day 1); Any change in route of administration.
4. Any increase or initiation of new dose of regularly scheduled nonsteroidal anti inflammatory drugs (NSAIDs) within 2 weeks prior to signing the ICF through randomization (Day 1).
5. Cevimeline or pilocarpine and cyclosporine eye drops (Restasis): any increase or initiation of new doses within 2 weeks prior to signing the ICF through randomization (Day 1).

Contacts/Locations Module

Name	Affiliation	Role
Maria Dall'Era, MD	University of California, San Francisco	Principal Investigator
Ghaith Noaiseh, MD	University of Pittsburgh	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		San Francisco	California	94143	United States
Research Site

References Module

Label	URL
Related Info	View source
Related Info	View source
Related Info

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/MEDI5872 210 mg	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, participants received MEDI5872 QW from Days 99 to 113 and Q2W from Days 127 to 183.

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
SAP	No	Yes	No	Statistical Analysis Plan	Sep 25, 2017	Jan 16, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo/MEDI5872 210 mg	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, participants received MEDI5872 QW from Days 99 to 113 and Q2W from Days 127 to 183.
BG001	MEDI5872 210 mg/MEDI5872 210 mg	Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, participants continued dosing of MEDI5872 210mg Q2W from Days 99 to 183 and received an additional dose of blinded placebo on Day 106.
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

The As-treated population included all treated participants, grouped according to actual treatment received.

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00050.2± 12 BG00151.1± 14.3 BG00250.7± 13

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG00114 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 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

Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99

The European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of 12 organ-specific domains (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological). Each domain is assessed for activity level in 3 or 4 levels (i.e., no, low, moderate, high) according to their severity (no disease activity equals to 0 and for high disease activity the domain score equals 3 or 4). Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease. Adjusted mean change and standard error are presented.

Intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.

Posted

Mean

Standard Error

Scores on a scale

Baseline (Day 1 predose) and Day 99

ID	Title	Description
OG000	Placebo	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
OG001	MEDI5872 210 mg	Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.

Units	Counts
Participants	OG00016 OG00113

Title

Denominators

Categories

Title	Measurements
	OG000-2.3± 0.8 OG001-3.8± 0.9

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		ANCOVA		0.262		Mean Difference (Net)	-1.4	Standard Error of the Mean	1.3	2-Sided	90	-3.6	0.7			Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.		Superiority

Secondary

Ratio to Baseline in Peripheral Blood Biomarkers at Day 99

The peripheral blood biomarkers included total plasma cell levels (including plasma blast levels) and T follicular helper (TFH) cells. Adjusted geometric mean ratio to baseline and standard error (log) are presented.

The ITT population included all randomized and treated participants, grouped according to assigned treatment.

Posted

Geometric Mean

Standard Error

Ratio

Baseline (Day 1 predose) and Day 99

ID	Title	Description
OG000	Placebo	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
OG001	MEDI5872 210 mg	Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.

Units	Counts
Participants

Secondary

Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99

The minor salivary gland biopsy biomarkers included total plasma cell levels, CD4/ inducible T-cell costimulator (ICOS) TFH cells, and PD-1/ICOS TFH cells. Adjusted geometric mean ratio to baseline and standard error (log) are presented.

The ITT population included all randomized and treated participants, grouped according to assigned treatment.

Posted

Geometric Mean

Standard Error

Ratio

Baseline (Day 1 predose) and Day 99

ID	Title	Description
OG000	Placebo	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
OG001	MEDI5872 210 mg	Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.

Units	Counts
Participants

Secondary

Ratio to Baseline in Focus Score at Day 99

The focus score is a semi-quantitative assessment of focal lymphocytic sialoadenitis, which is defined as the presence of >= 1 dense aggregate of 50 or more lymphocytes in a 4 mm2 area. Higher numbers are associated with more inflammation.

The ITT population included all randomized and treated participants, grouped according to assigned treatment. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.

Posted

Mean

Standard Deviation

Ratio

Baseline (Day 1 predose) and Day 99

ID	Title	Description
OG000	Placebo	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
OG001	MEDI5872 210 mg	Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.

Units	Counts
Participants

Secondary

Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) Score at Day 99

The European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported, subjective symptom index for primary Sjögren's syndrome. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Adjusted mean change and standard error are presented.

The ITT population included all randomized and treated participants, grouped according to assigned treatment.

Posted

Mean

Standard Error

Scores on a scale

Baseline (Day 1 predose) and Day 99

ID	Title	Description
OG000	Placebo	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
OG001	MEDI5872 210 mg	Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.

Secondary

Percentage of ESSDAI Responders at Day 99

The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of 12 organ-specific domains (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological). Each domain is assessed for activity level in 3 or 4 levels (no, low, moderate, high) according to their severity (0=no disease activity and ¾ = high disease activity of the domain). Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 [best] to 123 [worst activity]). Participants are considered to be an ESSDAI[x] responder as they achieved a reduction of x points or more in ESSDAI score, did not prematurely discontinue the study drug, and did not receive prohibited concomitant medications.

The ITT population included all randomized and treated participants, grouped according to assigned treatment.

Posted

Number

Percentage of participants

Baseline (Day 1 predose) and Day 99

ID	Title	Description
OG000	Placebo	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
OG001	MEDI5872 210 mg

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were collected from Day 1 (postdose) until Day 99 for 'Placebo' arm and Day 296 for 'Any MEDI5872 210 mg' arm that were absent before treatment or that worsened relative to pre-treatment state.

Placebo: As-treated population (participants grouped per actual treatment received).

Any MEDI5872 210 mg: Any MEDI5872 population (participants received at least 1 dose of MEDI5872 either in double-blind and/or open-label). 1 participant from 'Placebo' discontinued treatment before Day 99 and didn't receive MEDI5872 dose in open-label period.

Posted

Count of Participants

Participants

Placebo arm: Day 1 (postdose) through Day 99 (predose); Any MEDI5872 210 mg arm: Day 1 (postdose) through Day 296 for MEDI5872 210 mg arm, and Day 99 (postdose) through Day 296 for participants who received placebo at double-blind period

ID	Title	Description
OG000	Placebo	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.

Secondary

Number of Participants With Adverse Events of Special Interest (AESIs)

An AESI (serious or non-serious) was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, new or reactivated tuberculosis infection, malignancy, and hypersensitivity and anaphylactic reactions. Treatment-emergent AESIs were collected from Day 1 (postdose) until Day 99 for 'Placebo' arm and Day 296 for 'Any MEDI5872 210 mg' arm.

Placebo: As-treated population (participants grouped per actual treatment received).

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Placebo	Participants received a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.
OG001	Any MEDI5872 210 mg

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 a subcutaneous (SC) dose of placebo matching with MEDI5872 every week (QW) for 3 weeks (Days 1, 8, and 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.	0	16	0	16	14	16
EG001	Any MEDI5872 210 mg	Participants received at least one dose of MEDI5872 treatment either during double-blind and/or open-label period of the study. In double-bind period, participants received a fixed SC dose of 210 mg MEDI5872 QW for 3 weeks (Days 1, 8, and 15) and then every Q2W for 9 weeks (Days 29 to 85). In open-label period, participants who received MEDI5872 210mg in double-blinded period received MEDI5872 210mg on Days 99 and Day 113; and participants who received placebo in double-blinded period received MEDI5872 210mg QW from Days 99 to 113, later all participants received MEDI5872 210mg Q2W from Days 127 to 183 and were followed up till Day 296.	0	31	1	31	29	31

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Small intestine polyp	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Palpitations	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0014 events2 affected31 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Vision blurred	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0014 events3 affected31 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0015 events4 affected31 at risk
Dental caries	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events3 affected31 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0014 events4 affected31 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Lip blister	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected31 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected16 at risk EG0012 events2 affected31 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Parotid gland enlargement	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0011 events1 affected31 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Tongue blistering	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Tooth loss	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Toothache	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected31 at risk
Facial pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events1 affected31 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected31 at risk
Feeling hot	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Influenza like illness	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Injection site bruising	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected31 at risk
Injection site erythema	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0017 events2 affected31 at risk
Injection site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Injection site pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0015 events3 affected31 at risk
Injection site rash	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0015 events4 affected31 at risk
Injection site reaction	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Local swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Vaccination site reaction	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Conjunctivitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0012 events2 affected31 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected31 at risk
Genital candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected31 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected31 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Oral herpes	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0017 events3 affected31 at risk
Paronychia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected31 at risk
Parotitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Pharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Serratia infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Tongue fungal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Tooth abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected16 at risk EG0018 events8 affected31 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0016 events4 affected31 at risk
Viral pharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected16 at risk EG0012 events2 affected31 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Accidental device ingestion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected31 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected31 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events1 affected31 at risk
Tooth avulsion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Blood urine present	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Calcium deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected31 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0015 events4 affected31 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected31 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Limb mass	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected31 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected31 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events3 affected31 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0013 events2 affected31 at risk
Dysgeusia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0018 events5 affected31 at risk
Paraesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected31 at risk
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected31 at risk
Stress	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected31 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected31 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected31 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected31 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected16 at risk EG0011 events1 affected31 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0014 events3 affected31 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events1 affected31 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected31 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0017 events2 affected31 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0012 events2 affected31 at risk
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0014 events2 affected31 at risk
Hot flush	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected31 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected31 at risk

Units	Counts
Participants	OG00016 OG00116

Participants received a fixed SC dose of 210 mg MEDI5872 every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for next 9 weeks (Days 29 to 85) in double-blind period of the study.