What side effects are associated with this type of intervention?

The most common treatments for peanut allergy, particularly Multi-allergen Oral Immunotherapy (OIT), are associated with several side effects. These include an increased risk of allergic reactions such as anaphylaxis, which is more frequent during the build-up and maintenance phases of OIT. Other non-anaphylactic allergic reactions include vomiting, angioedema, and respiratory tract reactions. Additionally, there is a risk of developing eosinophilic esophagitis. Local reactions at the site of administration, such as oropharyngeal symptoms, are also common. Despite these risks, OIT has shown a higher likelihood of desensitization compared to avoidance alone.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments of peanut allergy. However, it discusses various approaches to desensitization, including oral immunotherapy (OIT) and sublingual immunotherapy (SLIT). These methods involve gradually increasing exposure to peanut allergens to build tolerance. Omalizumab, an anti-IgE antibody, is also mentioned as a potential adjunct to OIT to improve safety and efficacy. While specific FDA approvals are not detailed, these therapies represent the current strategies being explored for peanut allergy treatment.

What other types of research exist?

Promising novel alternatives to Multi-allergen Oral Immunotherapy (OIT) for peanut allergy patients include: 1) Epicutaneous Immunotherapy (EPIT), which involves applying a patch containing peanut protein to the skin, showing significant desensitization in children aged 6-11 years. 2) Anti-IgE therapy with Omalizumab, which can be used as monotherapy or in combination with OIT to improve safety and efficacy. 3) Ligelizumab, a more potent anti-IgE molecule currently in phase-III trials, which may offer enhanced efficacy. 4) Dupilumab, an anti-IL-4 receptor antibody, which inhibits key cytokines involved in allergic responses and is under investigation for its potential benefits in food allergies.

← Back to Search

Biologics for Food Allergies

Phase 2

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Age 4 through 55 years (inclusive)

Be younger than 65 years old

Must not have

History of eosinophilic esophagitis (EoE), another eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food 'getting stuck'), or recurrent gastrointestinal symptoms of undiagnosed etiology

Use of immunomodulator therapy (not including corticosteroids)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 44 weeks

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial tests omalizumab and dupilumab with oral immunotherapy in people aged 4 to 55 who have multiple food allergies, including peanut. The treatments aim to reduce allergic reactions and help the body build tolerance to allergens. Omalizumab has shown potential in speeding up the process and making it safer.

Who is the study for?

The COMBINE study is for people aged 4-55 with multiple food allergies, including peanut. Participants must have a confirmed allergy through specific tests and react to small amounts of allergens in a controlled challenge. They should not be severely asthmatic, pregnant, or on certain heart or immune-modifying medications.

What is being tested?

This trial is testing the effectiveness of Omalizumab and Dupilumab—two biologic drugs—in improving outcomes for patients undergoing oral immunotherapy (OIT) for multiple food allergies compared to a placebo group.

What are the potential side effects?

Possible side effects from Omalizumab and Dupilumab may include irritation at the injection site, headaches, fatigue, joint pain, and potential allergic reactions. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 4 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had issues like severe acid reflux, trouble swallowing, or unexplained stomach problems.

Select...

I am currently using or have used immunomodulator therapy.

Select...

I have a chronic disease that is stable and doesn't require frequent medication changes, excluding asthma, eczema, or hay fever.

Select...

I weigh less than 15 kg.

Select...

I cannot tolerate treatments that involve antibodies.

Select...

I have a history of heart disease or high blood pressure that is not well controlled.

Select...

I have severe asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 44 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~44 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 44 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The success rates of passing a DBPCFC to peanut and at least one other FA

The success rates of passing a DBPCFC to peanut and two other FAs

The success rates of passing a peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort C: DupilumabExperimental Treatment2 Interventions

Participants will be treated with placebo for 8 weeks, followed by 24 weeks of treatment with dupilumab.

Group II: Cohort B: Omalizumab/DupilumabExperimental Treatment2 Interventions

Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab.

Group III: Cohort A: OmalizumabExperimental Treatment2 Interventions

Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omalizumab

FDA approved

Dupilumab

FDA approved

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for peanut allergy include Oral Immunotherapy (OIT), Epicutaneous Immunotherapy (EPIT), and the use of adjunctive therapies like omalizumab. OIT works by gradually exposing patients to increasing amounts of peanut protein, which helps to desensitize the immune system and increase the threshold for allergic reactions. EPIT involves applying a peanut protein patch to the skin, which allows for gradual desensitization through skin absorption. Omalizumab, an anti-IgE antibody, is sometimes used in combination with OIT to reduce allergic reactions and facilitate faster desensitization. These treatments are crucial for peanut allergy patients as they can significantly reduce the risk of severe allergic reactions and improve the quality of life by potentially allowing the safe consumption of peanuts.