Mode of Action Study of Omalizumab in Patients With Chron... | NCT01599637

ID	Type	Description	Link
2011-004216-31	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IGE025	Experimental	Patients will receive omalizumab administered subcutaneously every 4 weeks at the study center.	Drug: IGE025
Placebo to IGE025	Placebo Comparator	Placebo administered subcutaneously every 4 weeks at the study center.	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
IGE025	Drug	Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.	IGE025

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin	Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2	Baseline through Day 85 post-treatment
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin	Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2	Baseline through Day 85 post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status	Correlation of primary endpoint with The UAS7 which is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Dresden	Germany	01307	Germany
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29974963	Derived	Metz M, Torene R, Kaiser S, Beste MT, Staubach P, Bauer A, Brehler R, Gericke J, Letzkus M, Hartmann N, Erpenbeck VJ, Maurer M. Omalizumab normalizes the gene expression signature of lesional skin in patients with chronic spontaneous urticaria: A randomized, double-blind, placebo-controlled study. Allergy. 2019 Jan;74(1):141-151. doi: 10.1111/all.13547. Epub 2018 Oct 15.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
FG001	Placebo to IGE025	Placebo administered subcutaneously every 4 weeks at the study center.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
BG001	Placebo to IGE025	Placebo administered subcutaneously every 4 weeks at the study center.
BG002	Healthy Volunteers	Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00020 BG00110 BG00210 BG00340

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

Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin

Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis

Posted

Mean

Standard Deviation

FcεRI positive skin cells

Baseline through Day 85 post-treatment

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG00020 OG00110

Title

Denominators

Categories

FcεRI +ve skin cells: dermis lesional D1 (n=19,8)

Title	Measurements
	OG00018.14± 7.08 OG00115.17± 3.11

FcεRI +ve skin cells: dermis lesional d85 (n=10,7)

Title	Measurements
	OG000

Primary

Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin

Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

Posted

Mean

Standard Deviation

IgE positive skin cells

Baseline through Day 85 post-treatment

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants

Secondary

Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status

Correlation of primary endpoint with The UAS7 which is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.

Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.

Posted

Number

correlation coefficient

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Secondary

Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status

Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.

Posted

Number

correlation coefficient

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Secondary

Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit

The average number of cells derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Day 29 was an optional sampling time point in this paramter. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

Posted

Mean

Standard Deviation

# positive cells

Baseline to Day 85

ID	Title	Description
OG000	IGE025	Dosed every 4 weeks up to 12 weeks
OG001	Placebo IGE025	Dosed every 4 weeks up to 12 weeks

Units	Counts
Participants	OG000

Secondary

Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Posted

Mean

Standard Deviation

ug/mL

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG000

Secondary

Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes.

Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Posted

Mean

Standard Deviation

% out of leukocytes

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Secondary

Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units.

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.• FACS parameters: FceRI expression on basophils and IgE bound, FceR2 expression on B cells and IgE bound, and FceRI expression on dendritic cells

Posted

Mean

Standard Deviation

Flourescence units

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025

Secondary

Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set

The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis

Posted

Mean

Standard Deviation

# positive cells

Baseline

ID	Title	Description
OG000	Healthy Subjects	Baseline Value, healthy volunteers, no treatment applied
OG001	Urticaria Patients	All patients for study at baseline

Units	Counts
Participants	OG000

Secondary

Serum Levels of Omalizumab

Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks

PK analysis set which included all subjects who received at least one dose of study drug and had evaluable IGE025 concentrations.

Posted

Mean

Standard Deviation

ng/mL

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG00020

Secondary

Mean (SD) Serum Total IgE Concentration From Baseline by Visit

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Posted

Mean

Standard Deviation

ng/mL

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG000

Secondary

Mean (SD) Serum Total IgE % Change From Baseline by Visit

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Posted

Mean

Standard Deviation

Percent Change from Baseline

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG000

Secondary

Mean (SD) Serum Free IgE Concentration From Baseline by Visit

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Posted

Mean

Standard Deviation

ng/mL

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG000

Secondary

Mean (SD) Serum Free IgE % Change From Baseline by Visit

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Posted

Mean

Standard Deviation

% change

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG000

Secondary

Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit

All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Posted

Mean

Standard Deviation

IU/mL

Baseline through Day 140

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Urticaria Activity Score (UAS7)

Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement.

Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data. If the Week 12 value was missing, it was imputed as the last available UAS7 value (LOCF).

Posted

Mean

Standard Deviation

units on a scale

Baseline, Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025

Secondary

Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment

The investigator or the person he or she designated and the patient provided scoring of the patient's global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient's condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe

Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

Posted

Mean

Standard Deviation

score

Baseline, Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG000

Secondary

Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment

Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

Posted

Mean

Standard Deviation

Percentage of days

Day 29 to Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment

The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.

Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

Posted

Mean

Standard Deviation

Score

Baseline through Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Secondary

Skindex-29 by Treatment

The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients' quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe.

Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

Posted

Mean

Standard Deviation

Score

Baseline and Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants

Secondary

Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment

The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity.

Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

Posted

Mean

Standard Deviation

score

Baseline and Day 85

ID	Title	Description
OG000	IGE025	IGE025 administered subcutaneously every 4 weeks at the study center
OG001	Placebo IGE025	Placebo IGE025 administered subcutaneously every 4 weeks at the study center

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Tongue pruritus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected20 at risk EG0012 affected10 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected20 at risk EG0013 affected10 at risk
Periodontitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk
Tooth abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Fungal test positive	Investigations	MedDRA	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0011 affected10 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected20 at risk EG0011 affected10 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0011 affected10 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Alopecia areata	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 affected20 at risk EG0011 affected10 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected20 at risk EG0010 affected10 at risk

ID	Term
D014581	Urticaria
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IGE025 300mg	IGE025 administered subcutaneously every 4 weeks at the study center			0	20	17	20
EG001	Placebo	Placebo administered subcutaneously every 4 weeks at the study center.			2	10	6	10

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment		EG0000 affected20 at risk EG0011 affected10 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment		EG0000 affected20 at risk EG0011 affected10 at risk