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Omalizumab-Assisted Oral Immunotherapy for Food Allergies (BOOM Trial)

Phase 2

Recruiting

Led By Philippe Bégin, MD, PhD

Research Sponsored by Philippe Bégin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive DBPCFC to treatment food mix with an eliciting dose ≤ 300 mg of total food protein

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at any time during the 12-month oit phase

Awards & highlights

BOOM Trial Summary

This trial will study whether omalizumab can help people with multiple food allergies complete an oral immunotherapy protocol more quickly.

Who is the study for?

This trial is for individuals aged 6 to 25 with a history of IgE-mediated allergy to at least three specific foods and positive skin and blood tests indicating severe allergies. They must avoid these allergens strictly, not have used immunotherapy or certain drugs in the past year, and cannot be pregnant or lactating.Check my eligibility

What is being tested?

The study is testing how well omalizumab works in different doses (16mg/kg and 8mg/kg) compared to a placebo when given before starting oral immunotherapy for multiple food allergies. It aims to see if it can shorten the time needed to reach maintenance dose of OIT.See study design

What are the potential side effects?

Omalizumab may cause side effects such as injection site reactions, headaches, fatigue, joint pain, earache, hair loss, dizziness; rare but serious risks include anaphylaxis and heart-related issues.

BOOM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I reacted to a food allergy test with a small amount of the allergen.

BOOM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at any time during the 12-month oit phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at any time during the 12-month oit phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and at any time during the 12-month oit phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol.

Secondary outcome measures

Average up-dosing speed while on study drug.

Change in reactivity threshold to food treatment mix after pre-treatment with study drug.

Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial.

+1 more

BOOM Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Omalizumab 8 mg/kgExperimental Treatment2 Interventions

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.

Group II: Omalizumab 16 mg/kgExperimental Treatment2 Interventions

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.

Group III: PlaceboPlacebo Group2 Interventions

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre de recherche du Centre hospitalier universitaire de SherbrookeOTHER

58 Previous Clinical Trials

31,075 Total Patients Enrolled

Philippe BéginLead Sponsor

2 Previous Clinical Trials

512 Total Patients Enrolled

The Hospital for Sick ChildrenOTHER

689 Previous Clinical Trials

6,945,331 Total Patients Enrolled

2 Trials studying Food Allergy

139 Patients Enrolled for Food Allergy

Media Library

Multi-food oral immunotherapy (OIT) Clinical Trial Eligibility Overview. Trial Name: NCT04045301 — Phase 2

Food Allergy Research Study Groups: Omalizumab 8 mg/kg, Omalizumab 16 mg/kg, Placebo

Food Allergy Clinical Trial 2023: Multi-food oral immunotherapy (OIT) Highlights & Side Effects. Trial Name: NCT04045301 — Phase 2

Multi-food oral immunotherapy (OIT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04045301 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions can be treated with Multi-food oral immunotherapy (OIT)?

"Multi-food oral immunotherapy (OIT) is the recommended treatment for perennial aeroallergen reactivity, and can also ameliorate symptoms in those who have not responded to inhaled corticosteroids, histamine h1 antagonists, non-sedating medications, or moderate asthma."

Answered by AI

How many subjects are contributing to this research endeavor?

"Affirmative, clinicaltrials.gov confirms that the trial is currently recruiting participants. This study was first posted on 11/11/2019 and its details have been updated most recently on 1/31/2022. As of writing, 90 people are needed to be recruited from 5 locations."

Answered by AI

How many venues are currently supporting this investigation?

"Patients have 5 potential clinical trial sites to choose from, such as Sherbrooke's CHUS and Toronto's Gordon Sussman Clinical Research. Montréal's Hospital for Sick Children is also an option, in addition to five other medical centres."

Answered by AI

Is the population of participants in this trial limited to those aged twenty-five and above?

"Per the parameters of this clinical trial, those eligible to participate must be between 6 and 25 years old."

Answered by AI

Has Multi-food OIT been ratified by the FDA?

"Multi-food oral immunotherapy (OIT) receives a score of 2, as Phase 2 trials have only yielded evidence of safety rather than efficacy."

Answered by AI

Are there any other investigations that have explored the potential of Multi-food oral immunotherapy (OIT)?

"Multi-food oral immunotherapy (OIT) was initially researched in 2010 at the London Chest Hospital. Since then, 18381 medical studies have been completed with an impressive number of current clinical trials taking place out of Sherbrooke, Ontario. Thus far there are 22 active investigations being conducted."

Answered by AI

What individuals would qualify to participate in this experiment?

"Eligibility for this investigation requires patients to have previously received immunotherapy as well as being between 6 and 25 years old. The medical trial is currently in search of 90 participants."

Answered by AI

Are there any opportunities for eligible participants to join this research?

"Affirmative. According to data from clinicaltrials.gov, the trial that was originally posted on November 11th 2019 is presently recruiting participants. 90 subjects need to be enrolled at 5 distinct medical centres."

Answered by AI

Recent research and studies

Allergy, Asthma & Clinical ImmunologyJournal

Protocol for a Double-blind, Randomized Controlled Trial on the Dose-related Efficacy of Omalizumab in Multi-food Oral Immunotherapy

Langlois, Alexandra, Marie-Hélène Lavergne, Hélène Leroux, Kerstin Killer, Pauline Azzano, Louis Paradis, Kathryn Samaan, et al.. 2020. “Protocol for a Double-blind, Randomized Controlled Trial on the Dose-related Efficacy of Omalizumab in Multi-food Oral Immunotherapy”. Allergy, Asthma & Clinical Immunology. Springer Science and Business Media LLC. doi:10.1186/s13223-020-00419-z.

clinicaltrials.govStudy

Omalizumab to Accelerate a Symptom-driven Multi-food OIT

Philippe Bégin 2019. "Omalizumab to Accelerate a Symptom-driven Multi-food OIT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04045301.

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