Clinical trial NCT06943534: Omalizumab Weight-Based Dosing Efficacy Trial
Official title: Omalizumab Weight-Based Dosing Efficacy Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Allergies
Food Allergy
Keywords: omalizumab
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants that tolerate the 600 mg dose after treatment.
timeFrame: 16 Weeks
Secondary outcomes:
measure: Other measures of omalizumab treatment effect on food allergy
timeFrame: 16 Weeks
measure: Other measures of omalizumab treatment effect on food allergy
timeFrame: 16 Weeks
measure: Other measures of omalizumab treatment effect on food allergy
timeFrame: 16 Weeks
measure: Other measures of omalizumab treatment effect on food allergy
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Wayne Shreffler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: