Allergies, Food Allergy
Conditions
Keywords
omalizumab
Brief summary
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
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.
Interventions
DRUG5mg/kg omalizumab injection
5mg/kg of omalizumab
DRUG15mg/kg omalizumab injection
15mg/kg of omalizumab
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants that tolerate the 600 mg dose after treatment. | 16 Weeks | The primary analysis of outcome is on the proportion of subjects tolerating at least 600 mg at the post-treatment OFC in either group against the expected outcome without treatment based on OUTMATCH data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other measures of omalizumab treatment effect on food allergy | 16 Weeks | Secondary efficacy endpoint analysis will also be determined at OFC following 16-weeks of treatment: ● The proportion of participants that tolerate a single dose 1000 mg allergen |
Countries
United States
Contacts
CONTACTJannat Gill
PRINCIPAL_INVESTIGATORWayne Shreffler, MD, PhD
Massachusetts General Hospital
Outcome results
None listed