Food IgE-mediated AllergyPhase 2BOOMNCT04045301

Omalizumab to Accelerate a Symptom-driven Multi-food OIT

A Phase 2 study testing Omalizumab 16mg/kg, Omalizumab 8mg/kg and Multi-food oral immunotherapy (OIT) in people with Food IgE-mediated Allergy and Immunotherapy, run by Philippe Bégin at 3 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 to 25 years
Conditions the study is for: Food IgE-mediated Allergy, Immunotherapy, Omalizumab
What is being tested?: Omalizumab 16mg/kg, Omalizumab 8mg/kg and Multi-food oral immunotherapy (OIT)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 3 sitesCanada
Study dates: 11 Nov 2019to Mar 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

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

Read the 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).

Conditions: Food IgE-mediated Allergy, Immunotherapy, Omalizumab, Physiological Effects of Drugs
Being tested: Omalizumab 16mg/kg, Omalizumab 8mg/kg, Placebo, Multi-food oral immunotherapy (OIT)
Keywords: multi-food OIT, oral immunotherapy, omalizumab, symptom-driven protocol, double-Blind, randomized controlled trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omalizumab 16mg/kgBiological
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.
Omalizumab 8mg/kgBiological
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.
PlaceboBiological
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.
Multi-food oral immunotherapy (OIT)Other
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.

Study groups in NCT04045301
Study group	Role	What they receive
Omalizumab 16 mg/kg	Experimental	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. Receives: Biological: Omalizumab 16mg/kg; Other: Multi-food oral immunotherapy (OIT)
Omalizumab 8 mg/kg	Experimental	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. Receives: Biological: Omalizumab 8mg/kg; Other: Multi-food oral immunotherapy (OIT)
Placebo	Placebo comparator	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. Receives: Biological: Placebo; Other: Multi-food oral immunotherapy (OIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Assessed up to 52 weeks after IFE

Secondary outcomes (4)

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: Measured 8 weeks after starting investigational product
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
Measured: From week 0 to week 12 post IFE
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.
Measured: For one year following IFE
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
Measured: At any time during the 12-month OIT phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 2019Mar 2026

First posted5 Aug 2019
Study start11 Nov 2019
Primary completionDec 2025 (estimated)
Study completionMar 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Food IgE-mediated AllergyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04045301
Sponsor's protocol ID: ITO-OMA-2018-01
Acronym: BOOM
Status last verified: Nov 2024
First submitted: 30 Nov 2018
Last updated: 27 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32328115

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Food IgE-mediated Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04045301
Acronym / sponsor ID: BOOM / ITO-OMA-2018-01
Conditions: 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
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 90 participants (actual)
Lead sponsor: Philippe BéginUniversity, hospital or other
Collaborators: The Hospital for Sick Children, Centre hospitalier de l'Université de Montréal (CHUM), Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study start: 11 Nov 2019 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Mar 2026 (estimated)
First posted: 5 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Omalizumab 16 mg/kg	Experimental	Biological: Omalizumab 16mg/kg, Other: Multi-food oral immunotherapy (OIT)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.
Omalizumab 8 mg/kg	Experimental	Biological: Omalizumab 8mg/kg, Other: Multi-food oral immunotherapy (OIT)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.
Placebo	Placebo comparator	Biological: Placebo, Other: Multi-food oral immunotherapy (OIT)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.

Who may qualify

Ages: 6 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omalizumab 16mg/kgParticipants 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.	Biological	Omalizumab 16 mg/kg
Omalizumab 8mg/kgParticipants 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.	Biological	Omalizumab 8 mg/kg
PlaceboParticipants 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.	Biological	Placebo
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.	Other	Omalizumab 16 mg/kg, Omalizumab 8 mg/kg, Placebo

Primary outcome

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

4 secondary outcomes

Change in reactivity threshold to food treatment mix after pre-treatment with study drug.
Time frame: 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
Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial.
Time frame: For one year following IFE
Rate of treatment failure
Time frame: At any time during the 12-month OIT phase

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Derived from this study: PubMed 32328115Langlois 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.
Individual participant dataSharing planned: No

Related trials for Food IgE-mediated Allergy

RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Recruiting
Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy
Food Hypersensitivity, Shellfish Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
RecruitingObservational study
Non-Immunoglobulin E-mediated Food Allergies in Children
Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philippe Bégin, MD, PhD principal investigator

St. Justine's Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04045301, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.