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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

Summary

This trial is for people who already participated in a study testing a new drug. It's purpose is to see if the drug is safe.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long-term safety and tolerability of ADP101
Secondary outcome measures
Food Allergy Desensitization

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.

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.

Find a Location

Who is running the clinical trial?

Alladapt Immunotherapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
73 Total Patients Enrolled
1 Trials studying Food Allergy
73 Patients Enrolled for Food Allergy
Mei-Lun Wang, MDStudy DirectorVP of Clinical Development, Alladapt Immunotherapeutics, Inc.
1 Previous Clinical Trials
73 Total Patients Enrolled
1 Trials studying Food Allergy
73 Patients Enrolled for Food Allergy

Media Library

ADP101 Clinical Trial Eligibility Overview. Trial Name: NCT05243719 — Phase 1 & 2
Food Allergy Research Study Groups: Treatment Options 1, 2, 3, 4, 5
Food Allergy Clinical Trial 2023: ADP101 Highlights & Side Effects. Trial Name: NCT05243719 — Phase 1 & 2
ADP101 2023 Treatment Timeline for Medical Study. Trial Name: NCT05243719 — Phase 1 & 2
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