Status:
COMPLETED
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
Lead Sponsor:
Alladapt Immunotherapeutics, Inc.
Conditions:
Food Allergy
Eligibility:
All Genders
4-55 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of ADP101 for oral immunotherapy in food allergic children and adults.
Eligibility Criteria
Inclusion
- Age 4 to 55 (inclusive)
- Clinical history of allergy to at least 1 of the foods contained in ADP101
- Experience dose-limiting symptoms at or below the 100-mg dose level to 1 or multiple food sources in ADP101
Exclusion
- Experience dose limiting symptoms at or below the 100 mg challenge dose level to more than 5 food sources contained in ADP101
- History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 60 days of screening
- History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
- Severe asthma
- Mild or moderate asthma, if uncontrolled or difficult to control
- History of mast cell disorder, including mastocytosis, urticaria pigmentosa or angioedema
- History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) at risk of becoming unstable or requiring a change in chronic therapeutic regimen e.g. uncontrolled diabetes
- History of cardiovascular disease, including hypertension requiring \> 2 antihypertensive medications
- History of interstitial lung disease
- History of celiac disease
- Active autoimmune disease that has required systemic treatment within 3 months
- Known malignancy that is progressing or has required active treatment within the past 3 years
- Known history of HIV, known active hepatitis B infection or known active hepatitis C virus infection
- Prior/concurrent therapies as follows:
- beta-blockers, ACE inhibitors, ARBs or calcium channel blockers
- regular steroid medication use
- therapeutic antibody treatment currently or within the previous 6 months
- any food immunotherapy currently or within the previous 12 weeks
- In the build up phase of non-food immunotherapy
- Residing at the same address as another subject (e.g. siblings) participating in this or any other OIT study
- Develops dose-limiting symptoms to placebo during the Screening DBPCFC
- Any other condition that might preclude safe participation in the study
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04856865
Start Date
April 20 2021
End Date
December 13 2022
Last Update
May 16 2024
Active Locations (15)
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1
Study Site
Mission Viejo, California, United States, 92691
2
Study Site
Rolling Hills Estates, California, United States, 90274
3
Study Site
San Diego, California, United States, 92123
4
Study Site
Denver, Colorado, United States, 80230