Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies

Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered With Omalizumab, an Anti-IgE Monoclonal Antibody (ITN019AD)

A series of allergy shots may reduce symptoms of seasonal ragweed allergies. This study will determine whether taking a drug called omalizumab (also known as Xolair) before getting the allergy shots is more effective than allergy shots alone or other treatments, such as prescription antihistamines.

Study Overview

Detailed Description

Allergic rhinitis affects 20 to 40 million Americans annually. Allergy symptoms, which can range from mild to seriously debilitating, may affect quality of life. Left untreated, allergic rhinitis can exacerbate or trigger more serious conditions, such as asthma and sinus inflammation.

Individuals with allergies react to harmless particles such as dust or pollen. Proteins in the blood called IgE antibodies treat the harmless particles as invaders and trigger an immune system response. The immune response results in harmful inflammation of healthy tissues. In ragweed allergy, inflammation occurs in the airways and causes familiar allergy symptoms like sneezing, coughing, and general discomfort.

Omalizumab is an investigational drug that has been shown to block the effects of IgE antibodies. The blocking effect of omalizumab is temporary, but giving the drug to people before their regular allergy shots may make the shots more effective.

Participants in this study will be randomly assigned to receive injections of omalizumab or a placebo before an accelerated course of allergy shots (given over 12 weeks). The participants will return for follow-up for up to one year, and they may have as many as 27 study visits.

Study Type

Interventional

Enrollment

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Able to comprehend and grant a witnessed, written informed consent prior to any study procedures.
  • Female participants of child bearing age must have a negative urine pregnancy test at Screening Visit and subsequent visits. In addition, female participants must be using a medically acceptable form of birth control.
  • History of seasonal allergic rhinitis for at least 2 years with symptoms during the ragweed pollen season requiring pharmacotherapy.
  • A positive skin test by prick method to ragweed pollen at the Screening Visit. A positive skin prick test will be defined as a ragweed pollen-induced wheal greater than 3 mm larger in diameter than diluent control (measurements will be made 15-20 minutes after application).
  • Must be capable of faithfully completing the diary and of attending regularly scheduled study visits.
  • Must intend to remain in the ragweed pollen area during the entire ragweed season.
  • Willing to avoid prohibited medications for the periods indicated in the protocol.
  • Participants must meet pretrial eligibility requirements for trial enrollment (acceptable medical history, physical examination results, normal electrocardiogram and acceptable laboratory test results).
  • Participants must have a baseline serum Immunoglobulin E (IgE) level greater than 10 and less than 700 IU/mL.

Exclusion Criteria

  • weigh less than 30 kg or more than 120 kg.
  • pregnant or lactating.
  • history of severe anaphylactoid (non-IgE mediated) or anaphylactic reactions).
  • history of immunotherapy within the past 10 years, if received one full year of immunotherapy, or within the past 5 years if received less than one year of immunotherapy.
  • known hypersensitivity to trial rescue medication (fexofenadine HCl).
  • taking beta-adrenergic antagonists in any form.
  • taking allergic ophthalmologic medication.
  • clinically significant perennial rhinitis that would interfere in assessment of ragweed-induced seasonal allergic rhinitis symptoms.
  • Presence of a severely deviated nasal septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction.
  • History of an upper respiratory or sinus infection requiring treatment with an antibiotic within 2 weeks prior to Screening Visit.
  • Documented evidence of acute or significant chronic sinusitis, as determined by the Investigator.
  • Asthma (either history of, abnormal spirometry, [forced expiratory volume in 1 second (FEV1) less than 80% predicted] or use of asthma medications).
  • Chronic or intermittent use of inhaled, oral, intra-muscular, or intra-venous corticosteroids; or chronic or intermittent use of topical corticosteroids within 4 weeks of Visit Screening Visit.
  • Chronic use of medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication.
  • Rhinitis medicamentosa.
  • History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal or other significant medical condition including, autoimmune or collagen vascular disorders, aside from organ-specific autoimmune disease limited to the thyroid that in the Investigator's opinion could interfere with the study or require medical treatment that would interfere with the study.
  • History of cancer other than basal cell carcinoma of the skin.
  • History within the past year of excessive alcohol intake or drug addiction.
  • Current smokers, greater than 10 pack year history, or participants who quit smoking less than one year prior to Screening.
  • Use of any prohibited concomitant medications during the washout period (i.e., before screening) and throughout the study period.
  • Participants currently undergoing immunotherapy.
  • Participants with clinically significant abnormality on 12-lead Electrocardiogram (ECG) on screening visit.
  • Treatment with an experimental, non-approved drug, or investigational drug within the past 30 days.
  • Participants with a history of noncompliance to medical regimens and participants who are considered potentially unreliable.
  • Previous treatment with a monoclonal antibody for any reason including anti-IgE in any form (e.g., omalizumab).
  • Participants with known hypersensitivity to trial drug ingredients (i.e., sucrose, histidine, polysorbate 20) or related drugs (i.e., monoclonal antibody; polyclonal gamma-globulin).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omalizumab pre-treatment, ragweed RIT, omalizumab + ragweed IT
Participants are pre-treated with omalizumab followed by ragweed rush immunotherapy (RIT) followed by dual therapy with omalizumab plus ragweed immunotherapy (IT).
A minimum equivalent dose of 0.016 mg/kg/IgE (IU/mL) every 4 weeks will be administered. Omalizumab is administered in two separate phases. In the pre-treatment period omalizumab will be administered to condition the participants to an immune tolerance state. Omalizumab will be also administered after RIT and during the maintenance immunotherapy phase.
Other Names:
  • Xolair™
  • anti-Immunoglobulin E (IgE)
RIT will consist of a series of injections containing ragweed extract. The series of injections will have progressively greater amounts of ragweed extract: starting from the 1:1000 dilution of the maintenance vial and progressing to the 0.3 mL of 1:10 dilution of the maintenance vial or the maximally tolerated amount.
Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
Experimental: Omalizumab pre-treatment, omalizumab
Participants are pre-treated with omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with Omalizumab plus placebo immunotherapy (IT).
A minimum equivalent dose of 0.016 mg/kg/IgE (IU/mL) every 4 weeks will be administered. Omalizumab is administered in two separate phases. In the pre-treatment period omalizumab will be administered to condition the participants to an immune tolerance state. Omalizumab will be also administered after RIT and during the maintenance immunotherapy phase.
Other Names:
  • Xolair™
  • anti-Immunoglobulin E (IgE)
The placebo for rush immunotherapy will contain the diluents and histamine.
The placebo for immunotherapy will contain the diluents and histamine.
Active Comparator: Ragweed RIT, ragweed IT
Participants are pre-treated with placebo omalizumab followed by ragweed rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus ragweed immunotherapy (IT).
RIT will consist of a series of injections containing ragweed extract. The series of injections will have progressively greater amounts of ragweed extract: starting from the 1:1000 dilution of the maintenance vial and progressing to the 0.3 mL of 1:10 dilution of the maintenance vial or the maximally tolerated amount.
Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
The placebo for omalizumab will contain the excipients and diluents of the omalizumab.
Placebo Comparator: Placebo
Participants are pre-treated with placebo omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus placebo immunotherapy (IT).
The placebo for rush immunotherapy will contain the diluents and histamine.
The placebo for immunotherapy will contain the diluents and histamine.
The placebo for omalizumab will contain the excipients and diluents of the omalizumab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average daily allergy severity score
Time Frame: 2003 ragweed pollen season
The average daily allergy severity score will be calculated from participants' 5 symptom scores (sneezing; rhinorrhea/runny nose; itchy nose, throat, and palate; itchy, watery eyes; and nasal congestion/stuffiness) during the ragweed pollen season. Symptom scores are recorded twice daily (AM and PM). The sum of the individual symptom scores will be averaged over AM and PM to give a daily score. Each daily score will then be averaged to obtain one measure of the average daily allergy severity score for each participant. The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
2003 ragweed pollen season

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events
Time Frame: 2003 ragweed pollen season
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
2003 ragweed pollen season
Number of days with rescue medication (fexofenadine HCl 60 mg) use
Time Frame: 2003 ragweed pollen season
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
2003 ragweed pollen season
Number of rescue medication capsules used
Time Frame: 2003 ragweed pollen season
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
2003 ragweed pollen season
Rhinoconjunctivitis quality of life (QOL) questionnaire (RQLQ) scores
Time Frame: 2003 ragweed pollen season
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
2003 ragweed pollen season
Daily morning allergy symptom scores
Time Frame: 2003 ragweed pollen season
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
2003 ragweed pollen season
Daily nighttime allergy symptom scores during the 2003 ragweed season
Time Frame: 2003 ragweed pollen season
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
2003 ragweed pollen season
Individual allergy symptom scores during the 2003 ragweed season
Time Frame: 2003 ragweed pollen season
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
2003 ragweed pollen season

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas Casale, MD, Creighton University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

February 19, 2004

First Submitted That Met QC Criteria

February 19, 2004

First Posted (Estimate)

February 20, 2004

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Participant level data and additional relevant materials are available to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research data sharing portal.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: SDY1
    Information comments: ImmPort study identifier is SDY1
  2. Study Protocol
    Information identifier: SDY1
    Information comments: ImmPort study identifier is SDY1
  3. Study design, -summary, -files, -interventions, participant schedule of events, -demographics, et al.
    Information identifier: SDY1
    Information comments: ImmPort study identifier is SDY1
  4. Individual Participant Data Set
    Information identifier: CASALE ITN019AD
    Information comments: TrialShare study identifier is CASALE ITN019AD
  5. Study protocol synopsis; -schedule of assessments; -data and reports; -specimens availability et al.
    Information identifier: CASALE ITN019AD
    Information comments: TrialShare study identifier is CASALE ITN019AD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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