Omalizumab to Accelerate a Symptom-driven Multi-food OIT (NCT04045301) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Omalizumab to Accelerate a Symptom-driven Multi-food OIT
Canada90 participantsStarted 2019-11-11
Plain-language 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.
Who can participate
Age range6 Years – 25 Years
SexALL
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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.
What they're measuring
1
To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol.