A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy

NCT ID: NCT01125748

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-08-31

Brief Summary

This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair. In addition, participants who did not participate in the EXCELS study but received long-term (~5 years) treatment with Xolair were allowed to enter the study.

Detailed Description

The treatment designation for participants who reached the primary efficacy endpoint (1 protocol-defined severe asthma exacerbation) was unblinded to allow appropriate clinical intervention. Participants who had their treatment designation unblinded remained in the study for ongoing evaluation of safety and were allowed to continue on study drug known to be Xolair (or to start study drug known to be Xolair if they were in the placebo group).

Conditions

Allergic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Omalizumab

Intervention Type: DRUG

Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.

Asthma therapies

Intervention Type: DRUG

Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.

Placebo

Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.

Asthma therapies

Intervention Type: DRUG

Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.

Interventions

Omalizumab

Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.

Intervention Type: DRUG

Placebo

Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.

Intervention Type: DRUG

Asthma therapies

Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.

Intervention Type: DRUG

Other Intervention Names

Xolair

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.
• 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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Huntsville, Alabama, United States

Little Rock, Arkansas, United States

Bakersfield, California, United States

Fresno, California, United States

Fresno, California, United States

Granada Hills, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Napa, California, United States

Redwood City, California, United States

Sacramento, California, United States

San Francisco, California, United States

San Mateo, California, United States

Studio City, California, United States

Walnut Creek, California, United States

Centennial, Colorado, United States

Thornton, Colorado, United States

Waterbury, Connecticut, United States

Bay Pines, Florida, United States

Clearwater, Florida, United States

Loxahatchee Groves, Florida, United States

Ocala, Florida, United States

Pensacola, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Albany, Georgia, United States

Columbus, Georgia, United States

Gainesville, Georgia, United States

Chicago, Illinois, United States

Glen Carbon, Illinois, United States

Park Ridge, Illinois, United States

Fort Wayne, Indiana, United States

Fort Wayne, Indiana, United States

Overland Park, Kansas, United States

Topeka, Kansas, United States

Lexington, Kentucky, United States

Mandeville, Louisiana, United States

Metairie, Louisiana, United States

Baltimore, Maryland, United States

Ellicott City, Maryland, United States

Gaithersburg, Maryland, United States

Boston, Massachusetts, United States

Gardner, Massachusetts, United States

North Dartmouth, Massachusetts, United States

Taunton, Massachusetts, United States

Liberty, Missouri, United States

Sasint Louis, Missouri, United States

Springfield, Missouri, United States

St Louis, Missouri, United States

St Louis, Missouri, United States

Bellevue, Nebraska, United States

Omaha, Nebraska, United States

Cranford, New Jersey, United States

Edison, New Jersey, United States

Hillsborough, New Jersey, United States

Verona, New Jersey, United States

Albany, New York, United States

Middletown, New York, United States

Mineola, New York, United States

Mount Vernon, New York, United States

New Paltz, New York, United States

New York, New York, United States

Newburgh, New York, United States

Olean, New York, United States

Rockville Centre, New York, United States

Staten Island, New York, United States

The Bronx, New York, United States

The Bronx, New York, United States

The Bronx, New York, United States

Asheville, North Carolina, United States

High Point, North Carolina, United States

Fargo, North Dakota, United States

Fargo, North Dakota, United States

Beavercreek, Ohio, United States

Centerville, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Altoona, Pennsylvania, United States

Beaver, Pennsylvania, United States

Carlisle, Pennsylvania, United States

Harrisburg, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Upland, Pennsylvania, United States

Lincoln, Rhode Island, United States

Greenville, South Carolina, United States

Knoxville, Tennessee, United States

Dallas, Texas, United States

Dallas, Texas, United States

El Paso, Texas, United States

Garland, Texas, United States

Heath, Texas, United States

Round Rock, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

Richmond, Virginia, United States

Spokane, Washington, United States

Tacoma, Washington, United States

Wheeling, West Virginia, United States

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

ML01347

Identifier Type: OTHER

Identifier Source: secondary_id

Q4777n

Identifier Type: -

Identifier Source: org_study_id