UNC Cashew Sublingual Immunotherapy

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07170540
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cashew Nut Allergy
  • Tree Nut Allergies

Eligibility Criteria

Sex
ALL
Age
1 Year - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Cashew sublingual immunotherapy — DRUG
    Glycerinated cashew extract for use in sublingual immunotherapy
  • Placebo sublingual immunotherapy — DRUG
    Glycerinated saline for placebo sublingual immunotherapy

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cashew SLIT
    Glycerinated cashew extract for sublingual immunotherapy
  • Placebo Comparator: Placebo control
    Glycerinated for placebo sublingual immunotherapy

Primary Outcome Measure

Desensitization to cashew at month 18 [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27599
Edwin H Kim, MD
919-537-3193
Edwin H Kim, MD (PRINCIPAL_INVESTIGATOR)

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