Cashew Nut AllergyPhase 2CASCADESNCT07170540
UNC Cashew Sublingual Immunotherapy
A Phase 2 study testing Cashew sublingual immunotherapy in people with Cashew Nut Allergy and Tree Nut Allergies, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- Cashew Nut Allergy, Tree Nut Allergies
- What is being tested?
- Cashew sublingual immunotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
Edwin H Kim, MD, 919-537-3193, edwinkim@email.unc.edu
Edwin H Kim, MD
About this study
Official title: Cashew Allergy Study in Children: Assessing Desensitization, Efficacy, and Safety (CASCADES Study)
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.
Read the 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
- Being tested
- Cashew sublingual immunotherapy, Placebo sublingual immunotherapy
- Keywords
- cashew allergy, tree nut allergy, food allergy, sublingual immunotherapy, SLIT
- Medical subject headings
- Nut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cashew sublingual immunotherapyDrug
Glycerinated cashew extract for use in sublingual immunotherapy
Placebo sublingual immunotherapyDrug
Glycerinated saline for placebo sublingual immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cashew SLIT | Active comparator | Glycerinated cashew extract for sublingual immunotherapy Receives: Drug: Cashew sublingual immunotherapy |
| Placebo control | Placebo comparator | Glycerinated for placebo sublingual immunotherapy Receives: Drug: Placebo sublingual immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desensitization to cashew at month 18
Percentage of participants tolerating >/= 1043 mg during cashew DBPCFC at month 18
Measured: 18 months
Secondary outcomes (7)
Full desensitization to cashew at month 18
Percentage of participants passing the 4043 mg cashew DBPCFC at month 18
Measured: 18 months
Desensitization to cashew at month 6
Percentage of participants passing the 1043 mg cashew DBPCFC at month 6
Measured: 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.
Measured: 18 months
Change in cashew skin prick testing
Change in SPT wheal to cashew extract
Measured: Baseline, Months 6 and 18
Change in cashew Immunoglobulin E (IgE)
Change in cashew-specific IgE (blood samples)
Measured: Baseline, Months 6 and 18
Change in cashew Immunoglobulin G4 (IgG4)
Change in cashew-specific IgG4 (blood samples)
Measured: Baseline, Months 6 and 18
Change in Cashew-Specific IgG4/IgE Ratio
Change in cashew-specific IgG4/IgE ratio (blood samples)
Measured: Baseline, Months 6 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study startMar 2027 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cashew Nut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Food Allergy Research & Education
- Responsible party
- Sponsor
- Investigators
- Edwin H Kim, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170540
- Sponsor's protocol ID
- 24-2373
- Other IDs
- G-202401-00621
- Acronym
- CASCADES
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cashew Allergy Study in Children: Assessing Desensitization, Efficacy, and Safety (CASCADES Study)
- ClinicalTrials.gov ID
- NCT07170540
- Acronym / sponsor ID
- CASCADES / 24-2373
- Conditions
- Cashew Nut Allergy, Tree Nut Allergies
- Keywords
- cashew allergy, tree nut allergy, food allergy, sublingual immunotherapy, SLIT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Food Allergy Research & Education
- Study start
- Mar 2027 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Cashew SLIT | Active comparator | Drug: Cashew sublingual immunotherapyGlycerinated cashew extract for sublingual immunotherapy |
| Placebo control | Placebo comparator | Drug: Placebo sublingual immunotherapyGlycerinated for placebo sublingual immunotherapy |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cashew sublingual immunotherapyGlycerinated cashew extract for use in sublingual immunotherapy | Drug | Cashew SLIT |
| Placebo sublingual immunotherapyGlycerinated saline for placebo sublingual immunotherapy | Drug | Placebo control |
Primary outcome
Desensitization to cashew at month 18
Time frame: 18 months
Percentage of participants tolerating >/= 1043 mg during cashew DBPCFC at month 18
7 secondary outcomes
Full desensitization to cashew at month 18
Time frame: 18 months
Desensitization to cashew at month 6
Time frame: 6 months
Adverse events related to study drug dosing
Time frame: 18 months
Change in cashew skin prick testing
Time frame: Baseline, Months 6 and 18
Change in cashew Immunoglobulin E (IgE)
Time frame: Baseline, Months 6 and 18
Change in cashew Immunoglobulin G4 (IgG4)
Time frame: Baseline, Months 6 and 18
Change in Cashew-Specific IgG4/IgE Ratio
Time frame: Baseline, Months 6 and 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Cashew Nut Allergy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edwin H Kim, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cashew sublingual immunotherapy in people with Cashew Nut Allergy and Tree Nut Allergies, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edwin H Kim, MD (919-537-3193, edwinkim@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desensitization to cashew at month 18 (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.