Status:
NOT_YET_RECRUITING
UNC Cashew Sublingual Immunotherapy
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Food Allergy Research & Education
Conditions:
Cashew Nut Allergy
Tree Nut Allergies
Eligibility:
All Genders
1-11 years
Phase:
PHASE2
Brief Summary
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 af...
Detailed Description
The CASCADES study is an 18-month randomized, placebo-controlled trial of cashew sublingual immunotherapy (CASHEW SLIT) in children 1-11 years of age with cashew allergy . Children ages 1-11 years wit...
Eligibility Criteria
Inclusion
- 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
- 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 screening or one course of systemic corticosteroids within 3 months of screening to treat asthma/wheezing
- Prior intubation/mechanical ventilation for asthma/wheezing
- Hospitalization or overnight Emergency Department (ED) visit for asthma/wheezing within 6 months of screening
- Forced expiratory volume in one second (FEV1) \<80% of predicted or FEV1/forced vital capacity (FVC) \<75%, with or without controller medications (for participants \>/= 6 years and older, able to perform spirometry)
- Peak expiratory flow rate (PEFR) \<80% of predicted for participants \>6 and able to perform peak flow
- Inhaled corticosteroid (ICS) dosing of \>500 mcg daily fluticasone (or equivalent ICS)
- Eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease
- Inability to discontinue antihistamines at least 5 half-lives before scheduled SPT and DBPCFC
- Food immunotherapy such as Oral Immunotherapy (OIT), Sublingual Immunotherapy (SLIT), or Epicutaneous (EPIT) for cashew or pistachio within 6 months of enrollment
- Monoclonal antibodies such as omalizumab (Xolair), dupilumab (Dupixent), benralizumab (Fasenra), mepolizumab (Nucala), or other immunomodulatory therapy within 6 months of enrollment
- Currently on dose escalation of environmental allergen immunotherapy (SCIT or SLIT). Individuals on maintenance allergen immunotherapy can be enrolled
- Participation in any interventional study within the past 3 months
- Pregnant or breastfeeding
- Past or current medical condition or clinical significant laboratory abnormality that, in the opinion of the PI, would make the participant unsafe or otherwise unsuitable for participation in the clinical trial
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07170540
Start Date
January 1 2026
End Date
February 1 2028
Last Update
October 14 2025
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599