Omalizumab to Accelerate a Symptom-driven Multi-food OIT

This is a phase 2b, multi-center randomized controlled trial comparing 2 doses of omalizumab to placebo in subjects 6 to 25 years old with multiple food allergies undergoing a symptom-driven multi-food OIT protocol.

Subjects will undergo a screening period involving a DBPCFC to a mix of three allergens which will determine their eligibility and eliciting dose.

Eligible subjects will be randomized to one of 2 omalizumab dosages or placebo at a ratio of 2:2:1 for a total period of 20 weeks.

They will undergo initial food escalation (IFE) to determine their starting food treatment mix dose for three simultaneous food allergens after a pre-treatment period of 8 weeks with the study drug.

Subjects will undergo up-dosing OIT visits at the clinic every two weeks, until a maintenance dose of 1500mg of protein (500mg per food) is reached (primary endpoint).

Inclusion criteria

• Male or female subjects 6 to 25 years old at screening visit.
• History of IgE-mediated allergy to at least three foods within the following list: peanut, milk, egg, wheat, oat, soy, barley, rye, buckwheat, hazelnut, pecan, cashew, pistachio, almond, walnut and sesame.
• Subjects currently following a strict avoidance of these three foods.
• Positive SPT with a largest wheal diameter ≥ 6 mm to all three foods.
• Food-specific IgE level greater than 15 kU/L for all three foods
• Positive DBPCFC to treatment food mix with an eliciting dose ≤ 300 mg of total food protein.
• Signed informed consent and assent.

Exclusion criteria

• Subjects reacting objectively to the placebo during the screening DBPCFC.
• Severe asthma as defined by GINA 201948.
• Active or past confirmed eosinophilic oesophagitis.
• Subject currently under allergen immunotherapy.
• Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion.
• Subject/parent unwillingness to comply with study requirements.
• Subject unwillingness to ingest a daily food dose of up to 1500 mg of allergen protein.
• Inability to discontinue anti-histamine medication prior to study procedures.
• Known allergy to omalizumab or its excipients.
• Known allergy to components of the placebo food treatment mix that cannot be substituted without interfering with the blind (e.g.: dates, banana, chocolate syrup)
• Use of immunosuppression or immunomodulatory drug (including omalizumab) or food oral immunotherapy or investigational treatment or procedure within 1 year.
• Relative contraindication or inability to use epinephrine auto-injector.
• Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors.
• Pregnancy or lactation for the duration of the study.
• Any condition that is not compatible with the study treatment or procedures as per investigator judgment.