Omalizumab Weight-Based Dosing Efficacy Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-55
SponsorMassachusetts General Hospital
About this trial
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
Eligibility criteria
Qualifiers
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
Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)
Disqualifiers
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
Trial design
Treatments tested in this trial
- 5mg/kg omalizumab injection
- 15mg/kg omalizumab injection
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
3Massachusetts General Hospital02114, BostonMassachusetts, United States
University of North Carolina at Chapel Hill27599, Chapel HillNorth Carolina, United States
University of Texas Southwestern75390, DallasTexas, United States
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Source ClinicalTrials.gov