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

November 24, 2023 updated by: Philippe Bégin

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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-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).

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital For Sick Children
        • Contact:
        • Principal Investigator:
          • Julia Upton, MD
        • Sub-Investigator:
          • Thomas Eiwegger, MD
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • Recruiting
        • Centre Hospitalier Universitaire Sainte-Justine
        • Contact:
        • Principal Investigator:
          • Philippe Bégin, MD, PhD
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Not yet recruiting
        • CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
        • Contact:
        • Principal Investigator:
          • Alexandra Langlois, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omalizumab 16 mg/kg

Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks.

Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Biological: Omalizumab 16mg/kg
Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
Other: Multi-food oral immunotherapy (OIT)
Multi-food oral immunotherapy will be conducted to a mix of three foods. It will be started 8 weeks after study drug with an initial food escalation. Participants will undergo biweekly increase until they tolerate a maintenance dose of 1500 mg (500 mg per food) of food protein.
Experimental: Omalizumab 8 mg/kg

Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks.

Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Other: Multi-food oral immunotherapy (OIT)
Multi-food oral immunotherapy will be conducted to a mix of three foods. It will be started 8 weeks after study drug with an initial food escalation. Participants will undergo biweekly increase until they tolerate a maintenance dose of 1500 mg (500 mg per food) of food protein.
Biological: Omalizumab 8mg/kg
Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
Placebo Comparator: Placebo

Participants will receive placebo doses for 20 weeks. The doses will be injected every 2 or 4 weeks depending on the weight of the participant.

Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
Other: Multi-food oral immunotherapy (OIT)
Multi-food oral immunotherapy will be conducted to a mix of three foods. It will be started 8 weeks after study drug with an initial food escalation. Participants will undergo biweekly increase until they tolerate a maintenance dose of 1500 mg (500 mg per food) of food protein.
Biological: Placebo
Participants will receive placebo for 8 weeks prior to the initiation of oral immunotherapy and 12 weeks after for a total of 20 weeks including a taper period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol.
Time Frame: Assessed up to 52 weeks after IFE
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in reactivity threshold to food treatment mix after pre-treatment with study drug.
Time Frame: Measured 8 weeks after starting investigational product
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
Average up-dosing speed while on study drug.
Time Frame: From week 0 to week 12 post IFE
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
Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial.
Time Frame: For one year following IFE
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
Rate of treatment failure
Time Frame: At any time during the 12-month OIT phase
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philippe Bégin

Collaborators

The Hospital for Sick Children
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Philippe Bégin, MD, PhD, St. Justine's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITO-OMA-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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