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

NCT01125748 | Completed Phase 4 Results

• 2 other identifiers: Q4777nML01347
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 100

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.

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Time to the First Protocol-defined Severe Exacerbation

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

Study Arms (2)

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

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.

Also known as: Xolair

Omalizumab

Placebo DRUG

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

Placebo

Asthma therapies 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.

Omalizumab; Placebo

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (100)

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Huntsville, Alabama, 35801, United States

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Little Rock, Arkansas, 72205, United States

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Bakersfield, California, 93301, United States

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Fresno, California, 93720, United States

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Fresno, California, 93726, United States

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Granada Hills, California, 91344, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90064, United States

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Napa, California, 94558, United States

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Redwood City, California, 94063, United States

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Sacramento, California, 95819, United States

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San Francisco, California, 94104, United States

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San Mateo, California, 94401, United States

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Studio City, California, 91607, United States

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Walnut Creek, California, 94598, United States

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Centennial, Colorado, 80112, United States

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Thornton, Colorado, 80233, United States

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Waterbury, Connecticut, 06708, United States

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Bay Pines, Florida, 33744, United States

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Clearwater, Florida, 33765, United States

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Loxahatchee Groves, Florida, 33470, United States

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Ocala, Florida, 34471, United States

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Pensacola, Florida, 32503, United States

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Tampa, Florida, 33613, United States

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West Palm Beach, Florida, 33401, United States

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Albany, Georgia, 31707, United States

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Columbus, Georgia, 31904, United States

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Gainesville, Georgia, 30501, United States

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Chicago, Illinois, 60612, United States

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Glen Carbon, Illinois, 62034, United States

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Park Ridge, Illinois, 60068, United States

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Fort Wayne, Indiana, 46804, United States

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Fort Wayne, Indiana, 46815, United States

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Overland Park, Kansas, 66210, United States

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Topeka, Kansas, 66606, United States

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Lexington, Kentucky, 40513, United States

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Mandeville, Louisiana, 70471, United States

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Metairie, Louisiana, 70002, United States

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Baltimore, Maryland, 21236, United States

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Ellicott City, Maryland, 21042, United States

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Gaithersburg, Maryland, 20878, United States

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Boston, Massachusetts, 02114, United States

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Gardner, Massachusetts, 01440, United States

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North Dartmouth, Massachusetts, 02747, United States

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Taunton, Massachusetts, 02780, United States

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Liberty, Missouri, 64068, United States

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Sasint Louis, Missouri, 63104, United States

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Springfield, Missouri, 65807, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63141, United States

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Bellevue, Nebraska, 68123, United States

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Omaha, Nebraska, 68130, United States

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Cranford, New Jersey, 07016, United States

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Edison, New Jersey, 08820, United States

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Hillsborough, New Jersey, 08844, United States

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Verona, New Jersey, 07044, United States

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Albany, New York, 12205, United States

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Middletown, New York, 10940, United States

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Mineola, New York, 11501, United States

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Mount Vernon, New York, 10552, United States

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New Paltz, New York, 12561, United States

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New York, New York, 10022, United States

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Newburgh, New York, 12550, United States

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Olean, New York, 14760, United States

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Rockville Centre, New York, 11570, United States

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Staten Island, New York, 10304, United States

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The Bronx, New York, 10423, United States

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The Bronx, New York, 10461, United States

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The Bronx, New York, 10465, United States

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Asheville, North Carolina, 28801, United States

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High Point, North Carolina, 27262, United States

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Fargo, North Dakota, 58103, United States

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Fargo, North Dakota, 58104, United States

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Beavercreek, Ohio, 45434, United States

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Centerville, Ohio, 45458, United States

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Oklahoma City, Oklahoma, 73112, United States

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Tulsa, Oklahoma, 74133, United States

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Altoona, Pennsylvania, 16601, United States

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Beaver, Pennsylvania, 15009, United States

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Carlisle, Pennsylvania, 17013, United States

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Harrisburg, Pennsylvania, 17110, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15221, United States

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Upland, Pennsylvania, 19013, United States

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Lincoln, Rhode Island, 02865, United States

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Greenville, South Carolina, 29607, United States

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Knoxville, Tennessee, 37909, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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El Paso, Texas, 79925, United States

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Garland, Texas, 75044, United States

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Heath, Texas, 75032, United States

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Round Rock, Texas, 78681, United States

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San Antonio, Texas, 78233, United States

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San Antonio, Texas, 78251, United States

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Richmond, Virginia, 23298, United States

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Spokane, Washington, 99204, United States

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Tacoma, Washington, 98405, United States

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Wheeling, West Virginia, 26003, United States

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Madison, Wisconsin, 53715, United States

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MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 18, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 15, 2014
• Results First Posted: October 15, 2014

Record last verified: 2014-10

Locations

US (100)