Purpose

This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.

Conditions

Eligibility

Eligible Ages
Between 1 Year and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevant foods (peanut, cashew, walnut, egg, or milk) - Positive food specific IgE (≥2.0 kUA/L) to at least two of the relevant foods - A positive history of clinical reaction to at least one of the qualifying foods other than the challenge-qualifying food (If meeting above criteria): - Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)

Exclusion Criteria

  • Weight >80 kg at time of screening - Clinically significant laboratory abnormalities at screening. - Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab. - Poorly controlled or severe asthma/wheezing at screening - History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise, PICU admission f for continuous epinephrine for hypotension or severe respiratory compromise requiring intubation. - Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of screening. - Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers. - Past or current history of eosinophilic gastrointestinal disease within three years of screening. - Past or current history of cancer, or currently being investigated for possible cancer. - Past or current history of any food immunotherapy (e.g., OIT, SLIT, EPIT) within 6 months of screening. - Treatment with monoclonal antibody therapy, or other immunomodulatory therapy within 6 months of screening. - Inability to discontinue antihistamines for minimum wash-out periods required for SPTs or OFCs. - Pregnant or breastfeeding or intending to become pregnant during the study. - Evidence of clinically significant chronic disease.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Patients Receiving 5mg/kg of omalizumab
Participants randomized to this arm will receive a does of 5mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.
  • Drug: 5mg/kg omalizumab injection
    5mg/kg of omalizumab
    Other names:
    • Xolair
Active Comparator
Patients Receiving 15mg/kg of omalizumab
Participants randomized to this arm will receive a does of 15mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.
  • Drug: 15mg/kg omalizumab injection
    15mg/kg of omalizumab
    Other names:
    • Xolair

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Jannat Gill
614-643-8683
Jgill0@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Jannat Gill
617-643-8683
Jgill@mgh.harvard.edu

Detailed Description

This research is being conducted to assess the safety and effectiveness of omalizumab for food allergies dosed differently from what is currently FDA approved. The study hypothesizes the current way of dosing omalizumab may not work well for all patients with food allergy and it unnecessarily excludes some individuals with very high allergic antibody (IgE) who may benefit. This study will include subjects regardless of IgE level. One of the goals is to learn more about how safe and effective Omalizumab is for people with these high IgE levels, since this has not been fully studied before.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.