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

Primary Purpose

Food IgE-mediated Allergy, Immunotherapy, Omalizumab

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Omalizumab 16mg/kg

Omalizumab 8mg/kg

Placebo

Multi-food oral immunotherapy (OIT)

About this trial

This is an interventional treatment trial for Food IgE-mediated Allergy focused on measuring multi-food OIT, oral immunotherapy, omalizumab, symptom-driven protocol, double-Blind, randomized controlled trial

Eligibility Criteria

6 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.
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.

Sites / Locations

The Hospital for Sick ChildrenRecruiting
Centre Hospitalier Universitaire Sainte-JustineRecruiting
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Omalizumab 16 mg/kg

Omalizumab 8 mg/kg

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

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.

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

Full Information

NCT ID

NCT04045301

First Posted

November 30, 2018

Last Updated

January 31, 2022

Sponsor

Philippe Bégin

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04045301

Brief Title

Omalizumab to Accelerate a Symptom-driven Multi-food OIT

Acronym

BOOM

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 11, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Philippe Bégin

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food IgE-mediated Allergy, Immunotherapy, Omalizumab, Physiological Effects of Drugs

Keywords

multi-food OIT, oral immunotherapy, omalizumab, symptom-driven protocol, double-Blind, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omalizumab 16 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Omalizumab 8 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Omalizumab 16mg/kg

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Omalizumab 8mg/kg

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Multi-food oral immunotherapy (OIT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time from IFE to target multi-food protein maintenance dose of 1500 mg of total food protein

Time Frame

Assessed up to 52 weeks after IFE

Secondary Outcome Measure Information:

Title

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

Description

Measured as the amount of food allergen eliciting an objective allergic reaction on double-blinded oral food challenge or initial food escalation.

Time Frame

Measured 8 weeks after starting investigational product

Title

Average up-dosing speed while on study drug.

Description

Average of (log of escalation %)/(days since last escalation) for all escalation visits while on study drug

Time Frame

From week 0 to week 12 post IFE

Title

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

Description

Time Frame

For one year following IFE

Title

Rate of treatment failure

Description

Subject which stop daily ingestion of food treatment mix, prior to achieving study maintenance dose, for a period of 14 days or more

Time Frame

At any time during the 12-month OIT phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie-Christine Auclair, B.Sc.N.

Phone

(514) 345-4931

Ext

4180

marie-christine.auclair.hsj@ssss.gouv.qc.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Sabrina Cerro

Phone

(514)-345-4931

Ext

3200

sabrina.cerro.hsj@ssss.gouv.qc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Bégin, MD, PhD

Organizational Affiliation

St. Justine's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alana Galper

alana.galper@sickkids.ca

First Name & Middle Initial & Last Name & Degree

Julia Upton, MD

First Name & Middle Initial & Last Name & Degree

Thomas Eiwegger, MD

Facility Name

Centre Hospitalier Universitaire Sainte-Justine

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-Pier Roy, RN

Phone

514-345-4931

Ext

4201

marie-pier.roy@recherche-ste-justine.qc.ca

First Name & Middle Initial & Last Name & Degree

Philippe Bégin, MD, PhD

Facility Name

CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Côté-Bigras, M.Sc.

Phone

819 346-1110

Ext

13315

sarah.cote-bigras.ciussse-chus@ssss.gouv.qc.ca

First Name & Middle Initial & Last Name & Degree

Alexandra Langlois, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32328115

Citation

Langlois A, Lavergne MH, Leroux H, Killer K, Azzano P, Paradis L, Samaan K, Lacombe-Barrios J, Masse B, Des Roches A, Begin P. Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy. Allergy Asthma Clin Immunol. 2020 Apr 17;16:25. doi: 10.1186/s13223-020-00419-z. eCollection 2020. Erratum In: Allergy Asthma Clin Immunol. 2020 May 20;16:38.

Results Reference

derived

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Omalizumab to Accelerate a Symptom-driven Multi-food OIT

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