Food Allergen OIT for Shrimp and Cashew

NCT ID: NCT03504774

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-09
• Study Completion Date: 2023-03-03

Brief Summary

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).

Detailed Description

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). Enrolled participants must be positive at or before the 300 mg (443 mg cumulative) dosing level of FA protein. OIT treatment groups will be cashew or shrimp.

All 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. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC. 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.

All 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.

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. Week 58 will be end of study for those who do not opt for this continuation of withdrawal.

Conditions

Allergy;Food; Allergy to Shrimp; Allergy to Cashew Nut (Disorder)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cashew or Shrimp Oral Immunotherapy

Participants, ages 7 to 55 years, inclusive, with an allergy to Cashew or Shrimp.

Group Type: EXPERIMENTAL

Cashew or Shrimp Oral Immunotherapy

Intervention Type: DRUG

All 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. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC.

Interventions

Cashew or Shrimp Oral Immunotherapy

All 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. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC.

Intervention Type: DRUG

Other Intervention Names

OIT

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Sayantani B. Sindher

OTHER

Sponsor Role: lead

Responsible Party

Sayantani B. Sindher

Sponsor Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sayantani Sindher, MD

Role: STUDY_DIRECTOR

Stanford University, SNP Center for Food Allergy and Asthma Research

Locations

Sean N Parker Center For Allergy and Asthma Research

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1U01AI140498-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-48330

Identifier Type: -

Identifier Source: org_study_id