Phase 2 N=14 Randomized Quadruple-blind Treatment

Walnut Oral Immunotherapy for Tree Nut Allergy

Tree Nut Allergy

Bottom Line

View on ClinicalTrials.gov: NCT01546753 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Effectiveness of Walnut OIT on Clinical Desensitization to Test Tree Nut as Measured by Change in Cumulative Tolerated Dose From Baseline to Week 38 at Oral Food Challenge — 2.6; 0.05 grams — p=0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Walnut Protein Powder (Drug); Oat Powder (placebo) (Drug); Open-label Walnut Protein Powder (Drug)
Age: Pediatric, Adult · 6+ yrs
Sex: All
Sponsor: University of Arkansas
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Effectiveness of Walnut OIT on Clinical Desensitization to Test Tree Nut as Measured by Change in Cumulative Tolerated Dose From Baseline to Week 38 at Oral Food Challenge	2.6; 0.05	0.001 sig
SECONDARY Evaluation of Desensitization to Walnut Protein as Measured by Change in Cumulative Tolerated Dose From Baseline to Week 38 Oral Food Challenge	4.4; 0.6	0.01 sig
SECONDARY Number (Percentage) of Subjects Reaching a Cumulative Tolerated Dose of 2000mg Walnut Protein at Desensitization OFC at Week 38	6; 0	<0.01 sig
SECONDARY Number (Percentage) of Subjects Reaching a Cumulative Tolerated Dose of 2000mg Test Tree Nut Protein at Desensitization OFC at Week 38	6; 0	<0.01 sig
SECONDARY Number (Percentage) of Subjects Attaining Sustained Unresponsiveness to Walnut and Test Tree Nut Proteins at Week 298 Oral Food Challenge	5	—
SECONDARY Change in Skin Prick Test Wheal Size From Baseline to Week 142 in Active and Placebo Cross-over Subjects Receiving Active Walnut OIT	3.4	<0.001 sig
SECONDARY Serious Adverse Events Related to Walnut OIT Treatment	0; 0; 0	—

Summary

The purpose of this study is to determine if walnut oral immunotherapy can be used in participants allergic to tree nuts to reduce tree nut allergy and induce changes in the participant's immune system.

Eligibility Criteria

Inclusion Criteria

Age 6 to 45 years, either sex, any race, any ethnicity with a convincing clinical history of walnut or another tree nut allergy and either a positive prick skin test (≥ 3mm) or serologic evidence of allergic sensitization (defined as specific IgE > 0.35 kU/L) to walnut and at least one other tree nut.
A positive 2000 mg oral food challenge at enrollment to walnut and to one other tree nut.
Written informed consent from participant and/or parent/guardian
Written assent from all subjects as appropriate
All females of child bearing age must be using appropriate birth control

Exclusion Criteria

History of severe anaphylaxis to walnut or other tree nuts, defined as symptoms associated with hypoxia, hypotension or neurologic compromise (cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence).
Known allergy to oat
Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy or other respiratory or medical conditions deemed by the investigator to put the subject at increased risk of anaphylaxis or poor outcomes from receiving OIT or undergoing food challenge.
Poor control or persistent activation of atopic dermatitis
Active eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease in the past 2 years.
Participation in any interventional study for food allergy in the past 6 months
Participant is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing).
Severe asthma (2007 NHLBI Criteria Steps 5 or 6, see Appendix 2) or poorly controlled mild or moderate asthma
Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
Pregnancy or lactation

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Data sourced from ClinicalTrials.gov (NCT01546753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.