Clinical Study Using Biologics to Improve Multi OIT Outcomes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 200
Summary
- Conditions
- Food Allergy
- Hypersensitivity
- Hypersensitivity, Food
- Peanut Allergy
- Peanut Hypersensitivity
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a prospective Phase 2, single-center, multi-allergen OIT in participants with proven allergies to 2 or 3 different foods in which one must be peanut. Our intent to treat population will be 110 participants, ages 6 to 21 years with a history of multiple food allergies of 2 or 3 different foods including peanut. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive during the DBPCFCs at or before the 300 mg (444 mg cumulative) dosing level of FA proteins.Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 25 years
- Gender
- Both males and females
Description
This is a prospective Phase 2, single-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. The total population will be 110 participants, ages 6 to 25 years that present with a history of multiple food allergies of 2 or 3 diffe...
This is a prospective Phase 2, single-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. The total population will be 110 participants, ages 6 to 25 years that present with a history of multiple food allergies of 2 or 3 different foods including peanut, food-allergen (FA)-specific IgE levels, and positive skin prick test (SPT). Enrolled participants must react positively during DBPCFCs at or before the 300 mg (444 mg cumulative) dosing level of FA proteins of 2 or 3 allergens in which one must be a peanut. There will be three study cohorts, all will be double blinded: Cohort A (50 participants) will be treated with omalizumab for 8 weeks followed by 24 weeks of treatment with placebo. Cohort B (50 participants) will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab. Cohort C (10 participants) will be treated with placebo for 8 weeks followed by 24 weeks treatment with dupilumab. All cohorts will receive multifood allergen oral immunotherapy.
Tracking Information
- NCT #
- NCT03679676
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Food Allergy Research & Education
- Investigators
- Study Director: Rebecca S Chinthrajah, M.D. Sean N Parker Center for Allergy and Asthma Center at Stanford
Get Well Soon