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

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.

Conditions

• Hay Fever
• Hypersensitivity
• Allergy
• Rhinitis

Interventions

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.

Sponsors & Collaborators

• Immune Tolerance Network (ITN)

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Thomas Casale, MD · Creighton University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-04-30

Primary Completion

2005-05-31

Completion

2005-05-31

Countries

• United States

Study Locations