A Study Evaluating the Persistency of Response With or Wi... | NCT01125748

ID	Type	Description	Link
ML01347	Other Identifier	Hoffmann-La Roche

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omalizumab	Experimental	Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.	Drug: Omalizumab Drug: Asthma therapies
Placebo	Placebo Comparator	Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.	Drug: Placebo Drug: Asthma therapies

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omalizumab	Drug	Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.	Omalizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study	A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.	Baseline to the end of the study (up to 52 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Time to the First Protocol-defined Severe Exacerbation	A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed Informed Consent Form (ICF). In the case of a minor, consent must be given by the child's parent or legally authorized representative.
Participants who have completed the EXCELS study prior to this study must have met all inclusion criteria for enrollment in the EXCELS study.
History of positive skin test or in vitro reactivity to an aeroallergen.
Continuous Xolair (omalizumab) exposure from the beginning of the EXCELS study to randomization into this study (if the participant participated in the EXCELS study), or within the previous 5 years prior to randomization into this study (if the participant did not participate in the EXCELS study). For the purposes of this study, continuous Xolair exposure is defined as having missed no more than 25% of scheduled Xolair doses. In addition, a maximum of 2 doses can be missed within the last 6 months before being randomized into this study. For participants who did not participate in the EXCELS study, missed-dose rates will be based on their injection records.
Patients who participated in the EXCELS study must have completed the EXCELS study and not discontinued Xolair since the completion of the EXCELS study.
Diagnosis of moderate to severe persistent allergic asthma while on Xolair as defined per physician's assessment.
Stable dosing of current asthma therapies, in addition to Xolair, over 2 months prior to enrollment.
Serum IgE level ≥ 30 to ≤ 700 IU/mL before initiation of Xolair treatment (prior to the EXCELS study enrollment or earlier).
Body weight ≥ 30 to ≤ 150 kg.
Treatment with Xolair consistent with the US package insert (USPI) (based on the dosing table, recommended dose, administration, and dosing interval) prior to enrollment to this study.
Participants who participated in the EXCELS study must be willing to allow their EXCELS study data to be used in this study as part of baseline demographic values (such as forced expiratory volume in 1 second [FEV1] and Asthma Control Test [ACT]), as documented in the ICF.

Exclusion Criteria:

Participation in other therapy trials or planned participation during the following year from screening.
Contraindication to Xolair therapy (eg, participants who experienced a severe hypersensitivity reaction to Xolair).
Acute asthma exacerbation within the 2 months immediately prior to screening that required any of the following: Initiation of systemic corticosteroids, increased dosing of systemic corticosteroids relative to "stable" dose, doubling of inhaled corticosteroid (ICS) dosing, emergency room visit, and hospitalization.
Any significant, or unstable, systemic disease (eg, infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of systemic disease within the previous 2 months.
Diagnosis of active lung disease other than asthma.
Having more than 10 pack-years smoking history.
Diagnosis of cystic fibrosis.
Use of an experimental drug within 30 days prior to study screening.
Unable or unwilling to comply with study procedures and visits (eg, spirometry, blood draws).
Have elevated serum IgE levels for reasons other than allergy (eg, parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich syndrome, or bronchopulmonary aspergillosis).
Pregnancy, lactation, or any planned pregnancy in the following year.

Name	Affiliation	Role
Clinical Trials	Genentech, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama	35801	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Omalizumab	Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study

A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.

Intent-to-treat population: All randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to the end of the study (up to 52 weeks)

ID	Title	Description
OG000	Omalizumab	Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
OG001	Placebo	Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.

Units	Counts
Participants	OG00088 OG00188

Title

Denominators

Categories

Title	Measurements
	OG00067.0(57.2 to 76.9) OG00147.7(37.3 to 58.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Mean Difference (Final Values)	19.3			2-Sided	95	5.0	33.6				No	Superiority or Other

Secondary

Time to the First Protocol-defined Severe Exacerbation

Intent-to-treat population: All randomized participants.

Posted

Mean

95% Confidence Interval

Weeks

Baseline to the end of the study (up to 52 weeks)

ID	Title	Description
OG000	Omalizumab	Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
OG001	Placebo	Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0010 affected88 at risk
Dyskinesia oesophageal	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0010 affected88 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0010 affected88 at risk
Eosinophilic oesophagitis	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0010 affected88 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected121 at risk EG0011 affected88 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected121 at risk EG0011 affected88 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0010 affected88 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0010 affected88 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected121 at risk EG0011 affected88 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0010 affected88 at risk
Mueller's mixed tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected121 at risk EG0011 affected88 at risk
Syncope	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0010 affected88 at risk
Anxiety	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected121 at risk EG0011 affected88 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected121 at risk EG0014 affected88 at risk
Haematoma	Vascular disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0010 affected88 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0009 affected121 at risk EG0018 affected88 at risk
Acute sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG00013 affected121 at risk EG0019 affected88 at risk
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected121 at risk EG0015 affected88 at risk
Sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG00026 affected121 at risk EG00112 affected88 at risk
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG00023 affected121 at risk EG00111 affected88 at risk
Urinary tract infection	Renal and urinary disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected121 at risk EG0016 affected88 at risk
Asthma	Immune system disorders	MedDRA (16.0)	Systematic Assessment	EG00028 affected121 at risk EG00130 affected88 at risk
Rhinitis allergic	Immune system disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected121 at risk EG0017 affected88 at risk

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
BG000	Omalizumab	Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
BG001	Placebo	Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Omalizumab	Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.			10	121	100	121
EG001	Placebo	Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.			8	88	88	88