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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 4-6 years
Awards & highlights
Study 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.
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
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking or have taken beta-blockers, ACE inhibitors, ARBs, or calcium channel blockers.I haven't had any food allergy treatments in the last 3 months, except for ADP101.I am not taking any experimental drugs except ADP101.I have not had antibody treatment in the last 6 months.I am currently in the early stages of allergy shots not related to food.I have or had swallowing issues, severe heartburn, or eosinophilic disorders.You have any other condition that could make it unsafe for you to take part in the study.I regularly use steroid medication.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Options 1, 2, 3, 4, 5
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to enroll in this experimental research?
"This medical trial is enrolling up to 73 participants who are aged between 4 and 57 years old, as well as display signs of food hypersensitivity."
Answered by AI
Is recruitment still open for this research experiment?
"As indicated on clinicaltrials.gov, this trial has concluded its search for participants and is no longer recruiting. The study was initially posted on March 14th 2022 with a final edit occurring July 1st of the same year. However, there are 261 alternative trials currently seeking patients at present."
Answered by AI
Is this experiment open to elderly patients aged seventy and over?
"The trial is seeking subjects aged 4 to 57, with 85 studies dedicated to minors and 158 allocated for seniors."
Answered by AI
Are there a considerable number of healthcare facilities running this experiment within the state?
"Currently, this trial is running in 14 locations spread across the nation; with notable sites located in Normal, Denver, and Cincinnati. To reduce any burdens associated with travel, it may be beneficial to seek out a site that is close by."
Answered by AI
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