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.
Who can participate
Age range1 Year – 11 Years
SexALL
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Inclusion Criteria:
* Age 1-11 years at enrollment
* Cashew allergy, with allergy defined as:
* 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
* If female of child-bearing potential, must have a negative urine or serum pregnancy test
* If female of childbearing potential (defined as females who have reached menarche or who are 12 years or older), must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods (barrier methods or oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy) during the treatment period
Exclusion Criteria:
* 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
* Poorly controlled or severe asthma/wheezing at screening, defined by at least one of the following criteria:
* Global Initiative for Asthma (GINA) 2024 criteria for uncontrolled asthma
* History of 2 or more systemic corticosteroid courses within 6 months of screen…