TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

NCT05521711 | Recruiting DMC

• 1 other identifier: HAH-21-013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tree Nut Allergy; Food Allergy

Keywords

Immunotherapy; Randomized Controlled Trial (RCT)

Outcome Measures

Primary Outcomes (1)

• Eliciting dose thresholds to food challenge

  1 year

Secondary Outcomes (1)

• Quality of life

  1 Year

Study Arms (3)

Active low dose oral immunotherapy and Placebo sublingual immunotherapy

EXPERIMENTAL

Other: Food

Placebo low dose oral immunotherapy and Active sublingual immunotherapy

EXPERIMENTAL

Other: Food

Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy

EXPERIMENTAL

Other: Food

Interventions

Food OTHER

Commercially available powders or liquids

Active low dose oral immunotherapy and Placebo sublingual immunotherapy; Placebo low dose oral immunotherapy and Active sublingual immunotherapy; Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• AAAAI Foundation: collaborator

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Nut Hypersensitivity; Food Hypersensitivity

Interventions

Food

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Derek Chu, MD PhD FRCPC

  Hamilton Health Sciences & McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Le

CONTACT

905-521-2100; lehea@hhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 30, 2022
• Study Start: September 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)