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 groupsSponsors and collaborators
Source ClinicalTrials.gov