NCT07170540

UNC Cashew Sublingual Immunotherapy

Cashew Allergy Study in Children: Assessing Desensitization, Efficacy, and Safety (CASCADES Study)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 1 Year – 11 Years
• Healthy volunteers: Not accepted

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 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.

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 with double-blind placebo-controlled food challenge (DBPCFC) proven allergy to cashew randomized 2:1 to active cashew SLIT or placebo. Participants will undergo a 5-month dose buildup period followed by a DBPCFC at month 6. Participants will then complete an additional 12 months of maintenance cashew SLIT or placebo followed by a DBPCFC at month 18. Safety will be assessed throughout the study. Skin prick testing (SPT), blood sampling, and saliva collection will be performed at baseline and at months 1, 3, 6, 12, and 18 to evaluate for immune biomarker changes.

Conditions

• Cashew Nut Allergy
• Tree Nut Allergies

Interventions

Type	Name	Description
DRUG	Cashew sublingual immunotherapy	Glycerinated cashew extract for use in sublingual immunotherapy
DRUG	Placebo sublingual immunotherapy	Glycerinated saline for placebo sublingual immunotherapy

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-09-12
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study