CLINICAL TRIAL

Multi-food oral immunotherapy (OIT) for Hypersensitivity

Recruiting · < 65 · All Sexes · Montreal, Canada

This study is evaluating whether a drug called omalizumab can help reduce the time it takes to reach a maintenance dose of oral immunotherapy.

See full description

About the trial for Hypersensitivity

Eligible Conditions
Immunotherapy · Physiological Effects of Drugs · Hypersensitivity · IgE Mediated Food Allergy · Omalizumab

Treatment Groups

This trial involves 3 different treatments. Multi-food Oral Immunotherapy (OIT) is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Multi-food oral immunotherapy (OIT)
OTHER
+
Omalizumab 8mg/kg
BIOLOGICAL
Experimental Group 2
Multi-food oral immunotherapy (OIT)
OTHER
+
Omalizumab 16mg/kg
BIOLOGICAL
Control Group 3
Placebo
BIOLOGICAL
+
Multi-food oral immunotherapy (OIT)
OTHER

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects between the ages of six and twenty-five years old will be screened during the visit. show original
People who are currently following a strict avoidance of these three foods. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At any time during the 12-month OIT phase
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At any time during the 12-month OIT phase.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Multi-food oral immunotherapy (OIT) will improve 1 primary outcome and 4 secondary outcomes in patients with Hypersensitivity. Measurement will happen over the course of From week 0 to week 12 post IFE.

Average up-dosing speed while on study drug.
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
Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial.
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.
To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol.
ASSESSED UP TO 52 WEEKS AFTER IFE
Time from IFE to target multi-food protein maintenance dose of 1500 mg of total food protein
Change in reactivity threshold to food treatment mix after pre-treatment with study drug.
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.
Rate of treatment failure
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

Patient Q & A Section

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

What causes hypersensitivity?

We report here a novel cause of immune-mediated hypersensitivity in which a low-dose immunotherapy is initiated in non-immune-mediated patients and in patients with only mild disease. To our knowledge, this is the first report of a hypersensitivity syndrome of that type, in which the most likely causes are immunologic dysregulation of the B lymphocyte compartment and a hyperreactive Th17 cellular milieu. In a recent study, findings suggest a role for a low-dose immunotherapy tailored to the cause of hypersensitivity and its response.

Anonymous Patient Answer

What are the signs of hypersensitivity?

Symptoms of anaphylaxis last for 4 hours or longer. Symptoms of [food [allergy](https://www.withpower.com/clinical-trials/allergy)](https://www.withpower.com/clinical-trials/food-allergy) last for 2 weeks or longer. The symptoms of atopy last 4 hours or longer. Symptoms of systemic allergic reaction last 12 hours or more. Symptoms of drug allergy last from 2 weeks to 14 days or more.

Anonymous Patient Answer

What is hypersensitivity?

We provide a basic understanding of how certain foods or drugs cause allergic reactions, which may contribute to more serious reactions, such as anaphylaxis which can be life-threatening. This article does not discuss all possibilities for hypersensitivity. To help the reader develop appropriate action plans to respond to allergic reactions to foods and medicines, see the article Allergy and anaphylaxis.

Anonymous Patient Answer

Can hypersensitivity be cured?

Hypersensitivity does not have to be cured. For the hypersensitive person, the only way to be cured would be to get rid of all the triggers. In addition the hypersensitive person would have to be prepared to live with the trigger, even at the expense of not being able to see anyone (cf. "cure and stay well", a coping strategy in chronic illnesses).

Anonymous Patient Answer

How many people get hypersensitivity a year in the United States?

This is one of the largest studies to date to estimate the prevalence of hypersensitivity in a population. The prevalence of symptomatic hypersensitivity ranged from 0.3% to 2.9%, and the prevalence of severe hypersensitivity ranged from 0.9% to 4.8%. These observations highlight the need for further studies to refine our estimates of the extent of hypersensitivity reactions in a population and to increase attention to and awareness of hypersensitivity reactions by clinicians and patients.

Anonymous Patient Answer

What are common treatments for hypersensitivity?

Non-prescription drugs are typically effective for treatment of hypersensitivity conditions, but may not always be the most efficient as in some cases prescription drugs may improve the clinical manifestations or resolve adverse drug side-effects.

Anonymous Patient Answer

Is multi-food oral immunotherapy (oit) safe for people?

OIT was found to be safe for people with [food allergy](https://www.withpower.com/clinical-trials/food-allergy). There are many factors and circumstances that can influence the potential of multiple food oral immunotherapy (oit) to be a success. As such, patients’ allergy histories, their response to oit, and compliance to the treatment are key factors in a successful oit outcome.

Anonymous Patient Answer

Have there been other clinical trials involving multi-food oral immunotherapy (oit)?

Previous oit trials had a low number of patients and a lack of standardized treatment methodology. The present trial is the first large multi food OIT trial, using an optimized protocol as an exploratory pilot study. Further, the present trial is one of the largest oit trials, including patients from more than 30 countries, and evaluating OIT using oral administration of food allergens and multiple targets. It is estimated that an additional 60,000 patients would qualify for a full multicenter trial in the United States to evaluate the efficacy and safety of allergen-specific OIT, or to evaluate OIT versus placebo. We hope to provide a valuable contribution to the existing literature on the use of OIT in atopic and other food allergies.

Anonymous Patient Answer

Does hypersensitivity run in families?

This is the first study to report a familial aggregation of allergic rhinitis in a small German population. The fact that familial aggregation is well established for non-allergic rhinitis, in this study confirms the need for studies aiming at a full investigation of allergic airway diseases.

Anonymous Patient Answer

What is multi-food oral immunotherapy (oit)?

In this pilot study, patients tolerated multi-food oit, and all displayed clinically relevant, but transient, decreases in food allergen-specific IgE antibodies and total IgE levels.

Anonymous Patient Answer

Who should consider clinical trials for hypersensitivity?

Clinical trials are being increasingly recruited into hypersensitivity conditions which were previously considered unsuitable for this purpose. Clinicians must be better educated and made more aware of these special circumstances so that they can make informed treatment decisions for hypersensitivity patients.

Anonymous Patient Answer

Have there been any new discoveries for treating hypersensitivity?

Since the last year there have been few new discoveries made in the field of hypersensitivity treatment. The new discoveries have improved the efficiency of hypersensitivity treatment, and they have also reduced the dosage required for treatment.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Hypersensitivity by sharing your contact details with the study coordinator.