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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
5mg/kg omalizumab injection
Drug5mg/kg of omalizumab
15mg/kg omalizumab injection
Drug15mg/kg of omalizumab
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Patients Receiving 5mg/kg of omalizumabActive comparator 1 intervention
Group B: Patients Receiving 15mg/kg of omalizumabActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants that tolerate the 600 mg dose after treatment.
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.
Time frame
16 WeeksSecondary outcomes
1
Other measures of omalizumab treatment effect on food allergy
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
Time frame
16 Weeks2
Other measures of omalizumab treatment effect on food allergy
Secondary efficacy endpoint analysis will also be determined at OFC following 16-weeks of treatment: ● The proportion of participants that tolerate a single dose 2000 mg allergen
Time frame
16 Weeks3
Other measures of omalizumab treatment effect on food allergy
Secondary efficacy endpoint analysis will also be determined at OFC following 16-weeks of treatment: ● The proportion of participants that tolerate two doses of 2000 mg allergen
Time frame
16 Weeks4
Other measures of omalizumab treatment effect on food allergy
Secondary efficacy endpoint analysis will also be determined at OFC following 16-weeks of treatment: ● Reaction severity of positive post treatment reactions using the CoFAR grading scale ranging from 1 (mild) to 5 (death)
Time frame
16 WeeksSponsors and contacts
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Source ClinicalTrials.gov