Status:
ACTIVE_NOT_RECRUITING
Omalizumab to Accelerate a Symptom-driven Multi-food OIT
Lead Sponsor:
Philippe Bégin
Collaborating Sponsors:
The Hospital for Sick Children
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Food IgE-mediated Allergy
Immunotherapy
Eligibility:
All Genders
6-25 years
Phase:
PHASE2
Brief 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...
Detailed Description
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-foo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04045301
Start Date
November 11 2019
End Date
March 1 2026
Last Update
November 27 2024
Active Locations (3)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
2
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
3
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada, J1H 5N4