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Clinical Trials/NCT05521711
NCT05521711RecruitingNot Applicable

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Hamilton Health Sciences Corporation1 site in 1 country60 target enrollmentStarted: September 1, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Eliciting dose thresholds to food challenge
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
1 Year to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation
  • •Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years
  • •Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months
  • •Use of biologics, other food immunotherapy or experimental treatment in past 6 months.
  • •Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits
  • •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

Outcomes

Primary Outcomes

Eliciting dose thresholds to food challenge

Time Frame: 1 year

Secondary Outcomes

  • Quality of life(1 Year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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