Recruiting
Phase 2

Omalizumab

Sponsor:

Massachusetts General Hospital

Code:

NCT06943534

Conditions

Allergies

Food Allergy

Eligibility Criteria

Sex: All

Age: 1 - 55

Healthy Volunteers: Not accepted

Interventions

5mg/kg omalizumab injection

15mg/kg omalizumab injection

Study Details

Brief summary:

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

Conditions

Allergies

Food Allergy

Study ID

NCT06943534

Start date

Jul 3, 2025

Status verified date

Feb, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 55

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

5mg/kg omalizumab injection

5mg/kg of omalizumab

15mg/kg omalizumab injection

15mg/kg of omalizumab

Primary outcome measure

  • Proportion of participants that tolerate the 600 mg dose after treatment. [ Time Frame: 16 Weeks ]

Central Contacts and Locations

Central contacts

Jannat Gill

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jannat Gill

614-643-8683Jgill0@mgh.harvard.edu

Principal Investigator:

Wayne Shreffler, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Lauren Herlihy

lherlihy@unc.edu

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Dolores Santoyo

Dolores.Santoyo@UTSouthwestern.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • omalizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-02-05.