ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Food Allergy

In brief

The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.

Key facts

Study ID

NCT04856865

Run by

Alladapt Immunotherapeutics, Inc.

People needed

73

Starts

2021-04-20

Expected to finish

2022-12-13

Last updated by the study team

2024-05-16

Who can join

Age: 4 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study Site — Mission Viejo, California, United States
• Study Site — Rolling Hills Estates, California, United States
• Study Site — San Diego, California, United States
• Study Site — Denver, Colorado, United States
• Study Site — Tampa, Florida, United States
• Study Site — Atlanta, Georgia, United States
• Study Site — Marietta, Georgia, United States
• Study Site — Normal, Illinois, United States
• Study Site — Ann Arbor, Michigan, United States
• Study Site — Chapel Hill, North Carolina, United States
• Study Site — Cincinnati, Ohio, United States
• Study Site — Happy Valley, Oregon, United States
• Study Site — Philadelphia, Pennsylvania, United States
• Study Site — Charleston, South Carolina, United States
• Study Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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