Immunotherapy Clinical Trial
— BOOMOfficial title:
A 15 Months, Double-Blind, Randomized Controlled Trial Comparing 20 Weeks of Two Dosages of Omalizumab to Placebo to Accelerate a Symptom-driven Oral Immunotherapy Schedule in Subjects Aged 6 to 25 Years With Multiple Food Allergies
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | March 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 25 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Universitaire Sainte-Justine | Montréal | Quebec |
Canada | CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS) | Sherbrooke | Quebec |
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Philippe Bégin | Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre hospitalier de l'Université de Montréal (CHUM), The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol. | Time from IFE to target multi-food protein maintenance dose of 1500 mg of total food protein | Assessed up to 52 weeks after IFE | |
Secondary | Change in reactivity threshold to food treatment mix after pre-treatment with study drug. | Measured as the amount of food allergen eliciting an objective allergic reaction on double-blinded oral food challenge or initial food escalation. | Measured 8 weeks after starting investigational product | |
Secondary | Average up-dosing speed while on study drug. | Average of (log of escalation %)/(days since last escalation) for all escalation visits while on study drug | From week 0 to week 12 post IFE | |
Secondary | Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial. | AEs will be captured using the daily dosing diary throughout the trial, including during maintenance. Any systemic reaction having occurred since the last visit will be reviewed and graded by the investigator according to the CoFAR grading system. | For one year following IFE | |
Secondary | Rate of treatment failure | Subject which stop daily ingestion of food treatment mix, prior to achieving study maintenance dose, for a period of 14 days or more | At any time during the 12-month OIT phase |
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