Who is eligible for clinical trial NCT04045301?

Participants must meet protocol criteria for Food IgE-mediated Allergy. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04045301 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-11-26

Omalizumab to Accelerate a Symptom-driven Multi-food OIT (NCT04045301)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Philippe Bégin

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (16 items).

Location: The Hospital for Sick Children — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

The Hospital for Sick Children — Toronto, Ontario
Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS) — Sherbrooke, Quebec

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗