History of other chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) requiring therapy (e.g., heart disease, diabetes) that is, or is at significant risk of becoming unstable or requiring a change in chronic therapeutic regimen and, in the opinion of the Principal Investigator, would represent a risk to the subject's health or safety in this study or the subject's ability to comply with the study protocol.History of uncontrolled cardiovascular disease, including uncontrolled hypertension.Inability or unwillingness of a participant to give written informed consent or comply with study protocol.Use of effective birth control by female participants of child-bearing potential.All female subjects of child-bearing potential will be required to provide a blood or urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements).Written informed consent from parent/guardian for minor participants.Written informed consent from adult participants.Experience dose-limiting symptoms at or before the 300 mg challenge dose of FA protein on Screening DBPCFC conducted in accordance with PRACTALL guidelines.Serum IgE to cashew or shrimp of ≥0.35 kUA/L and/or a SPT to cashew or shrimp ≥3 mm compared to control.Clinical history of allergy to cashew or shrimp-containing foods.Subject and/or parent guardian must be able to understand and provide informed consent.Week 58 will be end of study for those who do not opt for this continuation of withdrawal. Those participants who pass the Week 58 challenge up to a cumulative of 2043 mg will be given the option to continue the withdrawal phase up to Week 64 which will be end of study. Participants that pass their food challenge with no or mild objective reactions to up to a cumulative 2043 mg of the FA allergen in their OIT at the end of this phase (primary outcome) will be considered desensitized and have successfully met the primary endpoint.Īll participants then will continue in the study by undergoing withdrawal from OIT for 6 weeks to examine mechanisms underlying sustained responsiveness (SU) which will be defined as a participant's passing a DBPCFC with no or mild objective reaction to up to a cumulative 2043 mg of the FA allergen in their DBPCFC at week 58. OIT treatment groups will be cashew or shrimp.Īll cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks.Īt the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT).Įnrolled participants must be positive at or before the 300 mg (443 mg cumulative) dosing level of FA protein. A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively.
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