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Multi OIT to Test Immune Markers After Minimum Maintenance Dose

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ClinicalTrials.gov Identifier: NCT03181009
Recruitment Status : Completed
First Posted : June 8, 2017
Results First Posted : September 20, 2019
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Kari Christine Nadeau, MD PhD, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Food Allergy
Interventions Drug: Omalizumab
Drug: Food Flour Allergens
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A (300 mg Maintenance Dose) Group B (1200 Maintenance Dose)
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 30 30
Completed 30 28
Not Completed 0 2
Arm/Group Title Group A (300 mg Maintenance Dose) Group B (1200 Maintenance Dose) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
Sixty-five participants were initially screened for eligibility with 60 ultimately randomized 1:1 to the 300 mg and 1200 mg arms at two sites. Two participants withdrew early and 11 did not reach maintenance, but continued in the study throughout duration.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
10
(4 to 20)
10
(4 to 17)
10
(4 to 20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
9
  30.0%
10
  33.3%
19
  31.7%
Male
21
  70.0%
20
  66.7%
41
  68.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Hispanic or Latino
0
   0.0%
1
   3.3%
1
   1.7%
Not Hispanic or Latino
28
  93.3%
28
  93.3%
56
  93.3%
Unknown or Not Reported
2
   6.7%
1
   3.3%
3
   5.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30
 100.0%
30
 100.0%
60
 100.0%
Total IgE  
Median (Full Range)
Unit of measure:  IU/mL
Number Analyzed 30 participants 30 participants 60 participants
648
(64 to 6538)
701
(61.00 to 4367)
665.00
(61 to 6538.00)
1.Primary Outcome
Title Change in Allergen-specific Serum IgG4 and IgE
Hide Description Change in allergen-specific serum IgG4 and IgE from baseline to Week 18 (End of Study)
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (300 mg Maintenance Dose) Group B (1200 Maintenance Dose)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: Total serum IgE (kU/L)
578.5
(64.6 to 6538)
738.5
(61.0 to 4367)
Time Frame 18 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A (300 mg Maintenance Dose) Group B (1200 Maintenance Dose)
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Group A (300 mg Maintenance Dose) Group B (1200 Maintenance Dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Hide Serious Adverse Events
Group A (300 mg Maintenance Dose) Group B (1200 Maintenance Dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A (300 mg Maintenance Dose) Group B (1200 Maintenance Dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   19/30 (63.33%)   16/30 (53.33%) 
Gastrointestinal disorders     
Abdominal pain  [1]  14/30 (46.67%)  12/30 (40.00%) 
General disorders     
chills, facial edema, fatigue   3/30 (10.00%)  12/30 (40.00%) 
Respiratory, thoracic and mediastinal disorders     
cough, sneezing   1/30 (3.33%)  1/30 (3.33%) 
Skin and subcutaneous tissue disorders     
pruritus, rash   1/30 (3.33%)  1/30 (3.33%) 
Indicates events were collected by systematic assessment
[1]
nausea or vomiting
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Andres Alvarez Pinzon, Director of Regulatory Affairs and Translational Medicine
Organization: The Sean N. Parker Center for Allergy and Asthma Research at Stanford University
Phone: 650 - 521 - 7237
EMail: andresap@stanford.edu
Layout table for additonal information
Responsible Party: Kari Christine Nadeau, MD PhD, Stanford University
ClinicalTrials.gov Identifier: NCT03181009    
Other Study ID Numbers: eProtocol 39519
First Submitted: April 7, 2017
First Posted: June 8, 2017
Results First Submitted: April 1, 2019
Results First Posted: September 20, 2019
Last Update Posted: April 20, 2020