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UNC Cashew Sublingual Immunotherapy

ConditionsCashew Nut AllergyTree Nut Allergies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-11
SponsorUniversity of North Carolina, Chapel Hill

About this trial

The CASCADES study will investigate the safety and efficacy of sublingual immunotherapy (SLIT) for the treatment of cashew allergy in children ages 1-11 years old. Primary efficacy will be assessed after 18 months of cashew SLIT. Lab studies and an oral food challenge after 6 months of cashew SLIT will help determine how quickly cashew SLIT begins to take effect.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 1-11 years at enrollment

History of clinical reaction to cashew AND cashew-specific IgE >/=0.35 kUA/L AND cashew SPT >/=3 mm

OR if no prior reaction, cashew-specific IgE >/=5 kUA/L AND cashew SPT >/=3 mm

Positive Double-Blind Placebo Controlled Food Challenge (DBCPFC) to 443 mg cumulative cashew at enrollment

Disqualifiers

Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol

History of severe anaphylaxis to cashew defined as neurological compromise or requiring intubation/mechanical ventilation

Known oat, wheat, or glycerin allergy

Global Initiative for Asthma (GINA) 2024 criteria for uncontrolled asthma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cashew sublingual immunotherapy

    Drug

    Glycerinated cashew extract for use in sublingual immunotherapy

  • Placebo sublingual immunotherapy

    Drug

    Glycerinated saline for placebo sublingual immunotherapy

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Cashew SLITActive comparator 1 intervention
Group B: Placebo controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Desensitization to cashew at month 18

Percentage of participants tolerating \>/= 1043 mg during cashew DBPCFC at month 18

Time frame
18 months

Secondary outcomes

1

Full desensitization to cashew at month 18

Percentage of participants passing the 4043 mg cashew DBPCFC at month 18

Time frame
18 months
2

Desensitization to cashew at month 6

Percentage of participants passing the 1043 mg cashew DBPCFC at month 6

Time frame
6 months
3

Adverse events related to study drug dosing

Percentage of participants reporting adverse events within 2 hours of study drug administration determined by the PI to be possibly or probably associated with study drug dosing.

Time frame
18 months
4

Change in cashew skin prick testing

Change in SPT wheal to cashew extract

Time frame
Baseline, Months 6 and 18

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Food Allergy Research & Education

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: