Trial Outcomes & Findings for Multi OIT to Test Immune Markers After Minimum Maintenance Dose (NCT NCT03181009)
NCT ID: NCT03181009
Last Updated: 2026-04-27
Results Overview
Change in allergen-specific serum IgG4 and IgE from baseline to Week 18 (End of Study)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
18 weeks
Results posted on
2026-04-27
Participant Flow
Participant milestones
| Measure |
Group A (300 mg Maintenance Dose)
After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.
Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
|
Group B (1200 Maintenance Dose)
After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.
Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi OIT to Test Immune Markers After Minimum Maintenance Dose
Baseline characteristics by cohort
| Measure |
Group A (300 mg Maintenance Dose)
n=30 Participants
After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.
Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
|
Group B (1200 Maintenance Dose)
n=30 Participants
After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.
Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10 years
n=226 Participants
|
10 years
n=240 Participants
|
10 years
n=236 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=226 Participants
|
10 Participants
n=240 Participants
|
19 Participants
n=236 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=226 Participants
|
20 Participants
n=240 Participants
|
41 Participants
n=236 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
1 Participants
n=236 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=226 Participants
|
28 Participants
n=240 Participants
|
56 Participants
n=236 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
3 Participants
n=236 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=226 Participants
|
30 Participants
n=240 Participants
|
60 Participants
n=236 Participants
|
|
Total IgE
|
648 IU/mL
n=226 Participants
|
701 IU/mL
n=240 Participants
|
665.00 IU/mL
n=236 Participants
|
PRIMARY outcome
Timeframe: 18 weeksChange in allergen-specific serum IgG4 and IgE from baseline to Week 18 (End of Study)
Outcome measures
| Measure |
Group A (300 mg Maintenance Dose)
n=30 Participants
After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.
Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
|
Group B (1200 Maintenance Dose)
n=30 Participants
After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.
Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
|
|---|---|---|
|
Change in Allergen-specific Serum IgG4 and IgE
|
578.5 Total serum IgE (kU/L)
Interval 64.6 to 6538.0
|
738.5 Total serum IgE (kU/L)
Interval 61.0 to 4367.0
|
Adverse Events
Group A (300 mg Maintenance Dose)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Group B (1200 Maintenance Dose)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A (300 mg Maintenance Dose)
n=30 participants at risk
After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.
Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
|
Group B (1200 Maintenance Dose)
n=30 participants at risk
After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.
Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
46.7%
14/30 • 18 weeks
|
40.0%
12/30 • 18 weeks
|
|
General disorders
chills, facial edema, fatigue
|
10.0%
3/30 • 18 weeks
|
40.0%
12/30 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough, sneezing
|
3.3%
1/30 • 18 weeks
|
3.3%
1/30 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
pruritus, rash
|
3.3%
1/30 • 18 weeks
|
3.3%
1/30 • 18 weeks
|
Additional Information
Dr Andres Alvarez Pinzon, Director of Regulatory Affairs and Translational Medicine
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University
Phone: 650 - 521 - 7237
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place