Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis

Novartis

Status and phase: Completed; Phase 3

Conditions: Allergic Asthma

Treatments: Drug: Omalizumab; Drug: Placebo; Drug: Depigoid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396409

CIGE025ADE03

Details and patient eligibility

About

Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.

Full description

This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in seasonal asthma.

This study was a follow-up to the core IGE025ADE03 study, in which patients received omalizumab treatment. In this follow-up study, no patient received omalizumab.

Enrollment: 128 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females of any race who are 12-45 years of age with a body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml (suitable weight for dosing)
• Patients with the diagnosis of not adequately controlled seasonal grass pollen (and/or rye pollen) and allergic asthma with concomitant seasonal allergic rhinoconjunctivitis within > 2 previous seasons
• patients with a positive RAST (>CAP2) result for grass pollen (and/or rye pollen) specific IgE at screening (Visit 1 (V1) or within the previous 12 months.
• Patients with FEV1 > 80% of the predicted normal value for the patient at screening [V1](demostrable at least 6 hours after last short acting B-2 agonist use or 12 hours after last long B-2 acting agonist use).

Exclusion criteria

• Females of childbearing potential: pregnancy, birth control,breast-feeding

• Concurrent diseases/conditions and history of other diseases/conditions

  1. patients who have a positive history of significant clinical manifestations of allergy as a result of sensitization against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite).
  2. patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).

• Ingredient hypersensitivity

  1. patients with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication, any immunotherapy, or drugs related to Omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
  2. patients with hypersensitivity to the trail's asthma rescue- or escalation-medication or related drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups

Depigold+Omalizumab

Experimental group

Description:

Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50)

Treatment:

Drug: Depigoid

Drug: Omalizumab

Depigoid+Placebo

Experimental group

Description:

Depigoid® (grass/rye pollen 50/50) + Placebo

Treatment:

Drug: Placebo

Drug: Depigoid