Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew Allergy

NCT07868731 | Not Yet Recruiting DMC

• 1 other identifier: 129383
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children with cashew allergy have no approved treatment and must rely on lifelong avoidance, which is stressful and often fails. Less than 10% outgrow their allergy. Cashew is a leading cause of severe reactions in young children. Oral immunotherapy (OIT) can induce remission in peanut allergy, allowing children to eat peanut safely, but this has not been tested for cashew. This study will assess whether cashew OIT can safely achieve remission and improve quality of life.

Conditions

Food Allergy in Children

Keywords

oral immunotherapy; food allergy; paediatrics

Outcome Measures

Primary Outcomes (6)

• Proportion of consented participants who are eligible for the Ultra-Rush Day

  72% is defined as successful. This outcome will determine the feasibility of recruitment.

  Day 1

• Proportion of participants who complete the Ultra-Rush Day schedule according to the protocol

  72% is defined as successful. This outcome will determine the feasibility of the protocol.

  Day 1

• Proportion of participants who complete the Build-Up schedule according to the protocol

  72% is defined as successful.

  Week 2 through to Week 16

• Proportion of participants who complete the Ultra-Rush Day (Day 1) to the post-treatment visit done 8 weeks after ceasing treatment

  72% is defined as successful

  Day1 through to Month 14

• Proportion of participants with a treatment-related unexpected serious adverse event

  This outcome will allow assessment of the safety of the intervention

  Day 1 through to Month 12

• Proportion of participants who discontinue due to adverse events

  This will allow assessment of the safety of the intervention

  Day 1 through to Month 12

Study Arms (1)

cashew oral immunotherapy

OTHER

open label pilot study

Other: cashew oral immunotherapy

Interventions

cashew oral immunotherapy OTHER

Enrolled participants will receive cashew immunotherapy daily for 12 months

cashew oral immunotherapy

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 1 year and 5 years
• \>7kg (the weight considered safe for the administration of an adrenaline device)
• Cashew allergy confirmed by failed cashew oral food challenge (OFC) AND positive cashew skin prick test (SPT) or specific Immunoglobulin E (sIgE) at screening
• Has a legal representative capable of understanding the informed consent document and providing consent on the participant's behalf

You may not qualify if:

• History of severe anaphylaxis to cashew (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
• Severe anaphylaxis during the study entry challenge (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
• Ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
• Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis
• History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE)
• Current use of beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, cardiovascular disease or ongoing chronic persistent asthma that increase the risks associated with anaphylaxis
• Have received other food immunotherapy treatment in the preceding 12 months or currently taking immunomodulatory therapy (including allergen immunotherapy)
• Currently taking immunomodulatory therapy (including allergen immunotherapy)
• Past or current major illness that in the opinion of the Principal Investigator may affect the participant's ability to participate in the study e.g. increased risk to the participant
• Participants who in the opinion of the Principal Investigator are unable to follow the protocol
• Another family member already enrolled in the trial (to maintain safety and equity of access)

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mimi Tang, Prof

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Chebar Lozinsky Rolnik

CONTACT

+61399366435; cashew.study@mcri.edu.au

Amanda Burgess

CONTACT

+61383416200

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 24 months after publication of the primary outcome.
• Access Criteria: Access: The data must be obtained from the Murdoch Children's Research Institute. Prior to release, the following are required: a signed data access/transfer agreement between the relevant parties; review and approval of the proposed analysis plan by the Study Management Group; agreement on appropriate acknowledgment; and coverage of any additional costs. The data access agreement will address intellectual property, including that no rights in the study's background intellectual property (IP) are transferred and how any results or inventions arising from use of the data are treated. Data will only be shared with a recognised research organisation that has agreed to these terms and whose analysis plan has been approved. Where the Study Management Group is unavailable, this role is delegated to the Murdoch Children's Research Institute.