ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (NCT04856865) | Clinical Trial Compass
CompletedPhase 1/2
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
United States73 participantsStarted 2021-04-20
Plain-language summary
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
Who can participate
Age range4 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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-bloc…
What they're measuring
1
600mg Desensitization in at Least One Qualifying Food