Completed

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

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What is being tested

omalizumab

+ Placebo omalizumab
+ Ragweed rush immunotherapy (RIT)
Biological
Who is being recruted

Hay Fever
+1

+ Hypersensitivity
+ Allergy
From 18 to 50 Years
How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: April 2003

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 18, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleEfficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered With Omalizumab, an Anti-IgE Monoclonal Antibody (ITN019AD) 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 18, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
168 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled
: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hay Fever
Hypersensitivity
Allergy
Rhinitis
Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
4 intervention groups 

are designated in this study

25% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Participants are pre-treated with omalizumab followed by ragweed rush immunotherapy (RIT) followed by dual therapy with omalizumab plus ragweed immunotherapy (IT).
Group II
Experimental
Participants are pre-treated with omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with Omalizumab plus placebo immunotherapy (IT).
Group III
Active Comparator
Participants are pre-treated with placebo omalizumab followed by ragweed rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus ragweed immunotherapy (IT).
Group IV
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).
Study Objectives
Primary Objectives

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.
Secondary Objectives

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.

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.

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.

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.

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.

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.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
University of IowaIowa City, United StatesSee the location
Suspended
Creighton UniversityOmaha, United States
Suspended
University of WisconsinMadison, United States

Completed3 Study Centers