Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Stanford University
Study ID
NCT03679676
Phase
PHASE2
Status
Completed

Conditions

  • Food Allergy
  • Hypersensitivity
  • Hypersensitivity, Food
  • Peanut Allergy
  • Peanut Hypersensitivity

Eligibility Criteria

Sex
ALL
Age
4 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Omalizumab is injected every 2 or 4 weeks
  • Dupilumab — DRUG
    Dupilumab is injected every 2 or 4 weeks combination, or placebo.
  • Placebo for Dupilumab — OTHER
    Placebo for dupilumab is injected every 2 or 4 weeks
  • Placebo for Omalizumab — OTHER
    Placebo for omalizumab is injected every 2 or 4 weeks

Study Details

Food allergy is a serious public health concern that causes potentially-life threatening reactions in affected patients. The prevalence of food allergy in the United States (U.S.) has increased substantially and now affects 15 million patients:4-8% of children (6 million children, 30% with multiple food allergies) and about 9% of adults. This is a prospective Phase 2, multi-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. The intent-to-treat population in the clinical study will be 110 participants, ages 4 to 55 years with a history of multiple food allergies of 2 to 3 different foods including peanut. Allergy will be confirmed by food allergen (FA)-specific Immunoglobulin E (IgE) levels or positive Skin Prick Test (SPT). Enrolled participants must be positive during the Double-blind Placebo-controlled Food challenge (DBPCFC) at or before the 300 mg protein (444 mg cumulative) dosing level of FA proteins.

Key Dates

Start date
Feb 5, 2020
Status verified
May 2026
Primary completion
Apr 15, 2025
Completion
May 2, 2025

Study Design

Enrollment
130 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Cohort A: Omalizumab
    Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with placebo for dupilumab.
  • Other: Cohort B: Omalizumab/Dupilumab
    Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab.
  • Other: Cohort C: Dupilumab
    Participants will be treated with placebo for omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab.

Primary Outcome Measure

The Success Rates of Passing a Peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC) [ Time Frame: 44 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California Los Angeles (UCLA)Los AngelesCalifornia90095-
Sean N. Parker Center for Allergy & Asthma Research at Stanford UniversityPalo AltoCalifornia94304-
University of California San Diego (UCSD)San DiegoCalifornia92123-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles (UCLA)· Los Angeles, CASean N. Parker Center for Allergy & Asthma Research at Stanford University· Palo Alto, CAUniversity of California San Diego (UCSD)· San Diego, CA

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