Omalizumab to Accelerate a Symptom-driven Multi-food OIT

  • STATUS
    Recruiting
  • End date
    Mar 29, 2023
  • participants needed
    90
  • sponsor
    Philippe Bégin
Updated on 29 January 2021

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.

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-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).

Details
Condition Physiological Effects of Drugs, Immunotherapy, Omalizumab, Food IgE-mediated Allergy, immunotherapies, Food IgE-mediated Allergy, Food IgE-mediated Allergy, Food IgE-mediated Allergy
Treatment Placebo, Omalizumab 16mg/kg, Omalizumab 8mg/kg, Multi-food oral immunotherapy (OIT)
Clinical Study IdentifierNCT04045301
SponsorPhilippe Bégin
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 6 yrs and 25 yrs?
Gender: Male or Female
Do you have any of these conditions: Food IgE-mediated Allergy or Omalizumab or Immunotherapy or Physiological Effects of Drugs?
Do you have any of these conditions: Immunotherapy or immunotherapies or Food IgE-mediated Allergy or Physiological Effects of Drugs or Omalizumab?
Do you have any of these conditions: Physiological Effects of Drugs or Omalizumab or Food IgE-mediated Allergy or Immunotherapy or immunotherapies?
Do you have any of these conditions: Immunotherapy or Omalizumab or Food IgE-mediated Allergy or Physiological Effects of Drugs or immunotherapies?
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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