Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies
Condition: Hay Fever; Hypersensitivity; Allergy; Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): omalizumab; Placebo omalizumab; Ragweed rush immunotherapy (RIT); Placebo rush immunotherapy (RIT); Ragweed immunotherapy (IT); Placebo immunotherapy (IT)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 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.; The placebo for omalizumab will contain the excipients and diluents of the omalizumab.; 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.; The placebo for rush immunotherapy will contain the diluents and histamine.; Participants will receive weekly maintenance IT dosing for a total of 12 weeks.; The placebo for immunotherapy will contain the diluents and histamine.
Other intervention name(s): Xolair™; anti-Immunoglobulin E (IgE)
Intervention MeSH terms: Omalizumab; Immunoglobulins; Immunologic Factors; Antibodies, Monoclonal; Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ragweed; Immunotherapy; Rush Immunotherapy; RIT; Hayfever; Seasonal Allergic Rhinitis