A Phase 2 interventional study of Cashew sublingual immunotherapy and Placebo sublingual immunotherapy in Cashew Nut Allergy and Tree Nut Allergies, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in United States. Open to participants aged 1 Year to 11 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Treatment
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.
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.
33 studies on the registry are indexed under Nut Hypersensitivity; 9 are open to participants now.
This study's planned enrollment of 45 is close to the median of 47 across 20 interventional studies indexed under Nut Hypersensitivity.
Browse Nut Hypersensitivity studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glycerinated cashew extract for sublingual immunotherapy
Drug: Cashew sublingual immunotherapy
Glycerinated for placebo sublingual immunotherapy
Drug: Placebo sublingual immunotherapy
Glycerinated cashew extract for use in sublingual immunotherapy
Glycerinated saline for placebo sublingual immunotherapy
Desensitization to cashew at month 18
Percentage of participants tolerating \>/= 1043 mg during cashew DBPCFC at month 18
Time frame: 18 months
Full desensitization to cashew at month 18
Percentage of participants passing the 4043 mg cashew DBPCFC at month 18
Time frame: 18 months
Desensitization to cashew at month 6
Percentage of participants passing the 1043 mg cashew DBPCFC at month 6
Time frame: 6 months
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
Change in cashew skin prick testing
Change in SPT wheal to cashew extract
Time frame: Baseline, Months 6 and 18
Change in cashew Immunoglobulin E (IgE)
Change in cashew-specific IgE (blood samples)
Time frame: Baseline, Months 6 and 18
Change in cashew Immunoglobulin G4 (IgG4)
Change in cashew-specific IgG4 (blood samples)
Time frame: Baseline, Months 6 and 18
Change in Cashew-Specific IgG4/IgE Ratio
Change in cashew-specific IgG4/IgE ratio (blood samples)
Time frame: Baseline, Months 6 and 18
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 and continuing for 36 months following publication
Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Sep 2029, 30 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: start Jun 2026 → Mar 2027, primary completion Dec 2028 → Sep 2029 and completion Dec 2028 → Sep 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill →