NCT03504774

Food Allergen OIT for Shrimp and Cashew

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Sayantani B. Sindher · Academic / Other
• Sex: All
• Age: 7 Years – 55 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2019-07-09
• Primary completion: 2023-01-13
• Completion: 2023-03-03
• First posted: 2018-04-20
• Last updated: 2024-03-26
• Results posted: 2024-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study