Omalizumab 16mg/kg: Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
Omalizumab 8mg/kg: Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
Placebo: Participants will receive placebo for 8 weeks prior to the initiation of oral immunotherapy and 12 weeks after for a total of 20 weeks including a taper period.
Multi-food oral immunotherapy (OIT): Multi-food oral immunotherapy will be conducted to a mix of three foods. It will be started 8 weeks after study drug with an initial food escalation. Participants will undergo biweekly increase until they tolerate a maintenance dose of 1500 mg (500 mg per food) of food protein.
Study summary
This study will determine the dose-related efficacy of a 20-week treatment of omalizumab started 8 weeks before the onset of a symptom-driven multi-food oral immunotherapy (OIT) protocol at decreasing time to OIT maintenance dose. Two dosages of omalizumab will be compared to placebo during an oral immunotherapy protocol for three simultaneous food allergens.
Eligibility
Sex
ALL
Min age
6 Years
Max age
25 Years
Healthy volunteers
No
Inclusion criteria:
1. Male or female subjects 6 to 25 years old at screening visit.
2. 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.
3. Subjects currently following a strict avoidance of these three foods.
4. Positive SPT with a largest wheal diameter ≥ 6 mm to all three foods.
5. Food-specific IgE level greater than 15 kU/L for all three foods
6. Positive DBPCFC to treatment food mix with an eliciting dose ≤ 300 mg of total food protein.
7. Signed informed consent and assent.
Exclusion criteria
1. Subjects reacting objectively to the placebo during the screening DBPCFC.
2. Severe asthma as defined by GINA 201948.
3. Active or past confirmed eosinophilic oesophagitis.
4. Subject currently under allergen immunotherapy.
5. Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion.
6. Subject/parent unwillingness to comply with study requirements.
7. Subject unwillingness to ingest a daily food dose of up to 1500 mg of allergen protein.
8. Inability to discontinue anti-histamine medication prior to study procedures.
9. Known allergy to omalizumab or its excipients.
10. 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)
11. Use of immunosuppression or immunomodulatory drug (including omalizumab) or food oral immunotherapy or investigational treatment or procedure within 1 year.
12. Relative contraindication or inability to use epinephrine auto-injector.
13. Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors.
14. Pregnancy or lactation for the duration of the study.
15. Any condition that is not compatible with the study treatment or procedures as per investigator judgment.
Primary outcome measure(s)
To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol. — Assessed up to 52 weeks after IFE Time from IFE to target multi-food protein maintenance dose of 1500 mg of total food protein
Trial sites (3)
Facility
City
Region
Status
The Hospital for Sick Children
Toronto
Ontario
Centre Hospitalier Universitaire Sainte-Justine
Montreal
Quebec
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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