Food Allergen OIT for Shrimp and Cashew

Trial ID or NCT#

NCT03504774

Status

not recruiting iconNOT RECRUITING

Purpose

A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. 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).

Official Title

T Cell Reagent Research for Monitoring T Cells in Food Allergy (MOTIF) Phase 2 Study Using Food Allergen Oral Immunotherapy for Shrimp or Cashew Allergies

Eligibility Criteria

Ages Eligible for Study: 7 Years to 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Subject and/or parent guardian must be able to understand and provide informed consent - Age 7 through 55 years (inclusive) - Clinical history of allergy to cashew or shrimp-containing foods - Serum IgE to cashew or shrimp of ≥0.35 kUA/L [determined by UniCAPTM within the past 12 months] and/or a SPT to cashew or shrimp ≥3 mm compared to control - Experience dose-limiting symptoms at or before the 300 mg challenge dose of FA protein on Screening DBPCFC conducted in accordance with PRACTALL guidelines - Written informed consent from adult participants - Written informed consent from parent/guardian for minor participants - Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements) - 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. - Use of effective birth control by female participants of child-bearing potential.
Exclusion Criteria:
  1. - Inability or unwillingness of a participant to give written informed consent or comply with study protocol - History of uncontrolled cardiovascular disease, including uncontrolled hypertension - 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 eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD) grade 3 according to CTCAE version 5.0, symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology - Current participation in any other interventional study - Subject is currently in the build-up phase of immunotherapy to another allergen and is on maintenance immunotherapy dose for any allergen related to cashew or shrimp - Severe asthma (NAEPP EPR-3 Medication Criteria Steps 5 or 6) - Mild or moderate asthma (NAEPP EPR-3 Medication Criteria Steps 1-4), if not controlled as indicated by an ACT<19 - A hospitalization for asthma in the past 6 months - ER visit for asthma within the past 6 months - Burst or steroid course for asthma in the past 6 months - Use of omalizumab or biologic therapy (e.g., infliximab, rituximab, etc.) within the past 6 months - Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal remedies) for atopic and /or non-atopic disease within 90 days preceding Initial Dose Escalation Day (IDED) or at any time after the IDED - Use of beta-blockers (oral) - Pregnancy or lactation - Allergy to oat - History of severe anaphylaxis to cashew or shrimp with symptoms including hypotension requiring fluid resuscitation and/or the need for mechanical ventilation within the last year - Use of investigational drugs within 12 weeks of participation - Past or current medical problems or findings from physical assessment or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
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Investigator(s)

Sayantani Sindher
Allergist, Immunologist
Clinical Associate Professor, Medicine Clinical Associate Professor, Pediatrics - Allergy and Clinical Immunology

View on ClinicalTrials.gov