What side effects are associated with this type of intervention?

Common treatments for food allergies, such as oral immunotherapy (OIT), often result in adverse events. Nearly all patients report adverse events, with moderate-to-severe symptoms occurring less frequently in the treatment group compared to placebo. Serious or severe adverse events, including the need for epinephrine administration, are higher in the active treatment group. Common side effects include oropharyngeal symptoms, gastrointestinal discomfort, and, in rare cases, eosinophilic esophagitis. The rate of adverse events tends to be higher during the initial phases of treatment.

What prior FDA approvals exist?

The FDA has approved Palforzia, an oral immunotherapy (OIT) for peanut allergy, which involves the gradual introduction of peanut protein to desensitize the immune system. Additionally, there are ongoing studies and trials investigating the combination of OIT with probiotics and anti-IgE therapy, such as omalizumab, to enhance efficacy and safety. However, these combination therapies have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives to ADP101 for food allergy patients include: 1) Oral Immunotherapy (OIT) combined with anti-IgE therapy (e.g., omalizumab), which has shown to decrease life-threatening side effects and allow for rapid desensitization. 2) Subcutaneous Immunotherapy (SCIT) with hypoallergenic recombinant proteins, such as the chemically modified, aluminum hydroxide adsorbed peanut extract (HAL-MPE1), which has demonstrated safety and immunological changes in peanut-allergic patients.

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ADP101 for Food Allergy

Phase 1 & 2

Waitlist Available

Research Sponsored by Alladapt Immunotherapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Must not have

any food immunotherapy currently or within the previous 12 weeks, except ADP101

investigational agents other than ADP101

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 4-6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment called ADP101, which is taken by mouth to help people with food allergies. It is specifically for children and adults who participated in a previous study. The treatment works by slowly exposing the body to small amounts of the allergen, helping to reduce severe allergic reactions over time.

Who is the study for?

This trial is for individuals who completed the Harmony study and followed its medication guidelines. They can't join if they've used therapeutic antibodies or investigational agents recently, have a hypersensitivity to epinephrine, are on certain heart medications, undergoing other immunotherapies for food allergies, or have specific gastrointestinal diseases.

What is being tested?

The trial is testing ADP101's long-term safety in participants from a previous study. It's an open-label extension which means everyone knows they're getting ADP101 and there’s no placebo group involved.

What are the potential side effects?

While not specified here, potential side effects of ADP101 may include reactions at the injection site, allergic responses due to hypersensitivity ingredients in the drug formulation, and possibly others as observed in prior studies.

Eligibility Criteria

Exclusion Criteria

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

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I haven't had any food allergy treatments in the last 3 months, except for ADP101.

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I am not taking any experimental drugs except ADP101.

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I have or had swallowing issues, severe heartburn, or eosinophilic disorders.

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I regularly use steroid medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 4-6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 4-6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 4-6 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Long-term safety and tolerability of ADP101

Secondary study objectives

Food Allergy Desensitization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment Options 1, 2, 3, 4, 5Experimental Treatment1 Intervention

Participants will fall into 1 of 5 treatment options dependent on the treatment received (ADP101 or placebo) during the parent study and their tolerance of the treatment regimen during the parent study.

0 / 4Eligibility 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

Common treatments for food allergies, such as oral immunotherapy (OIT) and subcutaneous immunotherapy (SCIT), work by gradually exposing the patient to increasing amounts of the allergen to build tolerance. OIT involves ingesting small, controlled doses of the allergen, while SCIT involves injections. Adjunctive therapies like omalizumab, an anti-IgE antibody, can be used to reduce allergic reactions during desensitization. These treatments aim to modify the immune response, decreasing sensitivity to allergens and improving quality of life. Understanding these mechanisms helps patients and doctors make informed decisions about managing food allergies effectively.

Oral desensitisation in cow milk allergy: immunological findings.