The company Alladapt Immunotherapeutics, Inc is commencing a study of the ADP101 in food-allergic children and adults

 

A new clinical trial is recruiting patients in the following locations: United States. The condition is Food Allergy.

The trial officially began on the April 20, 2021 and is planned to complete on December 2022.

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

The population that can be enrolled into this study includes:

  • 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.

Patients with the following pathologies are excluded from participation:

  • 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.

 

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04856865.

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