NCT00078195

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Hay Fever
• Hypersensitivity
• Allergy
• Rhinitis

Interventions

Type	Name	Description
BIOLOGICAL	omalizumab	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.
BIOLOGICAL	Placebo omalizumab	The placebo for omalizumab will contain the excipients and diluents of the omalizumab.
BIOLOGICAL	Ragweed rush immunotherapy (RIT)	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.
BIOLOGICAL	Placebo rush immunotherapy (RIT)	The placebo for rush immunotherapy will contain the diluents and histamine.
BIOLOGICAL	Ragweed immunotherapy (IT)	Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
BIOLOGICAL	Placebo immunotherapy (IT)	The placebo for immunotherapy will contain the diluents and histamine.

Timeline

• Start date: 2003-04-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2004-02-20
• Last updated: 2016-10-18

Locations

3 sites across 1 country: United States