Clinical Trials

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Study Purpose

Tree nut immunotherapy Route Assessment and DEvelopment (TRADE) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Year - 16 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.

Exclusion Criteria:

1. History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation. 2. Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years. 3. Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months. 4. Use of biologics, other food immunotherapy or experimental treatment in past 6 months. 5. Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits. 6. Pregnancy or significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease; allergy to the oat-based placebo) which would put the participant at excessive risk for food allergic reactions as judged by local investigator

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05521711
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hamilton Health Sciences Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Derek Chu, MD PhD FRCPC
Principal Investigator Affiliation	Hamilton Health Sciences & McMaster University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Tree Nut Allergy, Food Allergy

Arms & Interventions

Arms

Experimental: Active low dose oral immunotherapy and Placebo sublingual immunotherapy

Experimental: Placebo low dose oral immunotherapy and Active sublingual immunotherapy

Experimental: Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy

Interventions

Other: - Food

Commercially available powders or liquids

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Sue Beaudin, CCRA

beaudins@mcmaster.ca

905-525-9140

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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