AllergiesPhase 2OWED-TNCT06943534
Omalizumab Weight-Based Dosing Efficacy Trial
A Phase 2 study testing 5mg/kg omalizumab injection and 15mg/kg omalizumab injection in people with Allergies and Food Allergy, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies. Read more about this study
- Who is it for?
- Ages 1 year to 55 years
- Conditions the study is for
- Allergies, Food Allergy
- What is being tested?
- 5mg/kg omalizumab injection and 15mg/kg omalizumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jul 2025to 1 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jannat Gill, 614-643-8683, Jgill0@mgh.harvard.edu
Wayne Shreffler, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Lauren Herlihy, lherlihy@unc.edu
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Dolores Santoyo, Dolores.Santoyo@UTSouthwestern.edu
About this study
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
Read the 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.
- Conditions
- Allergies, Food Allergy
- Being tested
- 5mg/kg omalizumab injection, 15mg/kg omalizumab injection
- Keywords
- omalizumab
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mg/kg omalizumab injectionDrug
Also called Xolair
5mg/kg of omalizumab
15mg/kg omalizumab injectionDrug
Also called Xolair
15mg/kg of omalizumab
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving 5mg/kg of omalizumab | Active comparator | Participants randomized to this arm will receive a does of 5mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks. Receives: Drug: 5mg/kg omalizumab injection |
| Patients Receiving 15mg/kg of omalizumab | Active comparator | Participants randomized to this arm will receive a does of 15mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks. Receives: Drug: 15mg/kg omalizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 Weeks
Secondary outcomes (4)
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
Measured: 16 Weeks
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
Measured: 16 Weeks
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
Measured: 16 Weeks
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)
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start3 Jul 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergiesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital
- Investigators
- Wayne Shreffler, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943534
- Sponsor's protocol ID
- 2025P000538
- Acronym
- OWED-T
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omalizumab Weight-Based Dosing Efficacy Trial
- ClinicalTrials.gov ID
- NCT06943534
- Acronym / sponsor ID
- OWED-T / 2025P000538
- Conditions
- Allergies, Food Allergy
- Keywords
- omalizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving 5mg/kg of omalizumab | Active comparator | Drug: 5mg/kg omalizumab injectionParticipants randomized to this arm will receive a does of 5mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks. |
| Patients Receiving 15mg/kg of omalizumab | Active comparator | Drug: 15mg/kg omalizumab injectionParticipants randomized to this arm will receive a does of 15mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks. |
Who may qualify
- Ages
- 1 year to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5mg/kg omalizumab injectionAlso: Xolair5mg/kg of omalizumab | Drug | Patients Receiving 5mg/kg of omalizumab |
| 15mg/kg omalizumab injectionAlso: Xolair15mg/kg of omalizumab | Drug | Patients Receiving 15mg/kg of omalizumab |
Primary outcome
Proportion of participants that tolerate the 600 mg dose after treatment.
Time frame: 16 Weeks
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.
4 secondary outcomes
Other measures of omalizumab treatment effect on food allergy
Time frame: 16 Weeks
Other measures of omalizumab treatment effect on food allergy
Time frame: 16 Weeks
Other measures of omalizumab treatment effect on food allergy
Time frame: 16 Weeks
Other measures of omalizumab treatment effect on food allergy
Time frame: 16 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wayne Shreffler, MD, PhD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5mg/kg omalizumab injection and 15mg/kg omalizumab injection in people with Allergies and Food Allergy, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jannat Gill (617-643-8683, Jgill@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants that tolerate the 600 mg dose after treatment. (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.