A Study of the Efficacy and Safety of Omalizumab (Xolair)... | NCT01287117

ID	Type	Description	Link
GA00887

A Study of the Efficacy and Safety of Omalizumab (Xolair)... | NCT01287117 | Trialant

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.	Drug: Placebo
Omalizumab 75 mg	Experimental	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.	Drug: Omalizumab
Omalizumab 150 mg	Experimental	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.	Drug: Omalizumab
Omalizumab 300 mg	Experimental	Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.	Drug: Omalizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omalizumab	Drug	Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.	Omalizumab 150 mg Omalizumab 300 mg Omalizumab 75 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 12 in the Weekly Itch Severity Score	The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.	Baseline to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)	The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) refractory to H1 antihistamines at the time of randomization.

Exclusion Criteria:

Treatment with an investigational agent within 30 days prior to screening.
Weight < 20 kg (44 lbs).
Clearly defined underlying etiology for chronic urticarias other than CIU.
Evidence of parasitic infection.
Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or other skin disease associated with itch.
Previous treatment with omalizumab within a year prior to screening.
Routine doses of the following medications within 30 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening.
Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening.
Any H2 antihistamine use within 7 days prior to screening.
Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to screening.
Any H1 antihistamines at greater than approved doses within 3 days prior to screening.
Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
Hypersensitivity to omalizumab or any component of the formulation.
History of anaphylactic shock.
Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients.
Evidence of current drug or alcohol abuse.
Nursing women or women of childbearing potential, unless they meet the following definition of post-menopausal: 12 months of natural amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL or 6 weeks post surgical bilateral oophorectomy (with or without hysterectomy) or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods.

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Genentech, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35209	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41847564	Derived	Mosnaim G, Seetasith A, Holden M, Trzaskoma BL, Saini SS. Matching-adjusted indirect comparison analysis of omalizumab versus dupilumab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol Glob. 2026 Feb 14;5(3):100668. doi: 10.1016/j.jacig.2026.100668. eCollection 2026 May.
39193419	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
FG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0002 subjects FG0011 subjects FG0021 subjects FG0031 subjects
Lost to Follow-up		FG0001 subjects FG0011 subjects FG0020 subjects FG0030 subjects
Physician Decision		FG0000 subjects FG0011 subjects FG0021 subjects FG0031 subjects
Patient/Legal Guardian's Decision		FG0002 subjects FG0016 subjects FG0028 subjects FG0035 subjects
Disease Progression		FG00010 subjects FG0015 subjects FG0026 subjects FG0035 subjects

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
BG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
BG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
BG003	Omalizumab 300 mg	Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
BG004	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
	OG000-3.63± 5.22 OG001-6.46± 6.14 OG002-6.66± 6.28 OG003

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	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.	ANCOVA	Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0010	A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).	Least squares mean difference	-2.96			2-Sided	95	-4.71	-1.21				No	Superiority or Other

Secondary

Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)

The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.

Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.

Posted

Mean

Standard Deviation

Units on a scale

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
OG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG002	Omalizumab 150 mg

Secondary

Change From Baseline to Week 12 in the Weekly Number of Hives Score

The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.

Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.

Posted

Mean

Standard Deviation

Units on a scale

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
OG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.

Secondary

Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12

The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score.

Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.

Posted

Median

95% Confidence Interval

Weeks

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
OG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG003	Omalizumab 300 mg

Secondary

Percentage of Participants With a UAS7 Score ≤ 6 at Week 12

Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.

Posted

Number

Percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
OG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.

Secondary

Percentage of Weekly Itch Severity Score MID Responders at Week 12

The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline.

Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.

Posted

Number

Percentage of participants

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
OG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG003	Omalizumab 300 mg	Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.

Secondary

Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score

The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.

Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.

Posted

Mean

Standard Deviation

Units on a scale

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
OG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.

Secondary

Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12

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 on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.

Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.

Posted

Mean

Standard Deviation

Units on a scale

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
OG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.

Secondary

Percentage of Angioedema-free Days From Week 4 to Week 12

The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded "No" to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.

Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.

Posted

Mean

Standard Deviation

Percentage

Week 4 to Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
OG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG003	Omalizumab 300 mg

Secondary

Percentage of Complete Responders (UAS7 = 0) at Week 12

A complete responder was defined as a participant with a UAS7 score = 0 at Week 12.

Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.

Posted

Number

Percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
OG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
OG003	Omalizumab 300 mg	Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.	5	80	38	80
EG001	Omalizumab 75 mg	Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.	2	70	37	70
EG002	Omalizumab 150 mg	Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.	5	87	46	87
EG003	Omalizumab 300 mg	Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.	2	81	40	81

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0010 affected70 at risk EG0021 affected87 at risk EG0030 affected81 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0011 affected70 at risk EG0020 affected87 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0010 affected70 at risk EG0020 affected87 at risk EG003
Appendicitis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0010 affected70 at risk EG0021 affected87 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (15.1)	Systematic Assessment	EG0001 affected80 at risk EG0010 affected70 at risk EG0020 affected87 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected80 at risk EG0010 affected70 at risk EG0020 affected87 at risk EG003
Shock hypoglycaemic	Metabolism and nutrition disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0010 affected70 at risk EG0020 affected87 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0010 affected70 at risk EG0021 affected87 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected80 at risk EG0010 affected70 at risk EG0020 affected87 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected80 at risk EG0010 affected70 at risk EG0020 affected87 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0011 affected70 at risk EG0021 affected87 at risk EG003
Idiopathic urticaria	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0001 affected80 at risk EG0010 affected70 at risk EG0020 affected87 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0010 affected70 at risk EG0021 affected87 at risk EG003
Abortion induced	Surgical and medical procedures	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0010 affected70 at risk EG0021 affected87 at risk EG003
Hypertension	Vascular disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0010 affected70 at risk EG0021 affected87 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG00017 affected80 at risk EG0015 affected70 at risk EG00214 affected87 at risk EG00310 affected81 at risk
Sinusitis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0005 affected80 at risk EG0016 affected70 at risk EG0027 affected87 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0003 affected80 at risk EG0016 affected70 at risk EG0024 affected87 at risk EG003
Bronchitis	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0006 affected80 at risk EG0015 affected70 at risk EG0022 affected87 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (15.1)	Systematic Assessment	EG0003 affected80 at risk EG0013 affected70 at risk EG0027 affected87 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0000 affected80 at risk EG0013 affected70 at risk EG0025 affected87 at risk EG003
Headache	Nervous system disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected80 at risk EG0015 affected70 at risk EG00212 affected87 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected80 at risk EG0011 affected70 at risk EG0024 affected87 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected80 at risk EG0012 affected70 at risk EG0025 affected87 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment	EG0003 affected80 at risk EG0014 affected70 at risk EG0023 affected87 at risk EG003
Idiopathic urticaria	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0004 affected80 at risk EG00110 affected70 at risk EG0027 affected87 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (15.1)	Systematic Assessment	EG0008 affected80 at risk EG0018 affected70 at risk EG0027 affected87 at risk EG003

Ancestor Terms

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

Ancestor Terms

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

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.	ANCOVA	Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0035	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-5.75	2-Sided	95	-9.59	-1.92	No	Superiority or Other
OG000 OG002	The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.	ANCOVA	Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0008	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-6.54	2-Sided	95	-10.33	-2.75	No	Superiority or Other
OG000 OG003	The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.	ANCOVA	Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-12.80	2-Sided	95	-16.44	-9.16	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.	ANCOVA	Covariates included in the analysis were baseline weekly number of hives score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0149	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-2.75	2-Sided	95	-4.95	-0.54	No	Superiority or Other
OG000 OG002	The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.	ANCOVA	Covariates included in the analysis were baseline weekly number of hives score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0017	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-3.44	2-Sided	95	-5.57	-1.32	No	Superiority or Other
OG000 OG003	The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.	ANCOVA	Covariates included in the analysis were baseline weekly number of hives score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-6.93	2-Sided	95	-9.10	-4.76	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.	Cox proportional hazards model	Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0879	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Hazard Ratio (HR)	1.39	2-Sided	95	0.95	2.03	No	Superiority or Other
OG000 OG002	The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.	Cox proportional hazards model	Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0301	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Hazard Ratio (HR)	1.49	2-Sided	95	1.04	2.14	No	Superiority or Other
OG000 OG003	The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.	Cox proportional hazards model	Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Hazard Ratio (HR)	2.34	2-Sided	95	1.63	3.36	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.	Cochran-Mantel-Haenszel	Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0148	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other
OG000 OG002	The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.	Cochran-Mantel-Haenszel	Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other
OG000 OG003	The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.	Cochran-Mantel-Haenszel	Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.	Cochran-Mantel-Haenszel	Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0118	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other
OG000 OG002	The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.	Cochran-Mantel-Haenszel	Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0226	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other
OG000 OG003	The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.	Cochran-Mantel-Haenszel	Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.	ANCOVA	Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0124	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-2.34	2-Sided	95	-4.17	-0.51	No	Superiority or Other
OG000 OG002	The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.	ANCOVA	Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.0012	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-3.16	2-Sided	95	-5.05	-1.27	No	Superiority or Other
OG000 OG003	The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.	ANCOVA	Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-5.73	2-Sided	95	-7.59	-3.87	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.	ANCOVA	Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.7956	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	0.26	2-Sided	95	-1.76	2.28	No	Superiority or Other
OG000 OG002	The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.	ANCOVA	Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.2286	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-1.31	2-Sided	95	-3.46	0.84	No	Superiority or Other
OG000 OG003	The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.	ANCOVA	Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	Least squares mean difference	-4.08	2-Sided	95	-5.96	-2.20	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.	Stratified Wilcoxon	Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).	0.4867	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other
OG000 OG002	The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.	Stratified Wilcoxon	Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).	0.1747	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other
OG000 OG003	The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.	Stratified Wilcoxon	Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.	Cochran-Mantel-Haenszel	Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.4580	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other
OG000 OG002	The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.	Cochran-Mantel-Haenszel	Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	0.2087	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other
OG000 OG003	The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.	Cochran-Mantel-Haenszel	Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).	<0.0001	A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.	95	No	Superiority or Other