Trial Outcomes & Findings for Omalizumab in the Treatment of Peanut Allergy (NCT NCT00949078)
NCT ID: NCT00949078
Last Updated: 2017-07-12
Results Overview
Presence or absence of this change
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
up to 6 months
Results posted on
2017-07-12
Participant Flow
51 participants underwent screening history and laboratory evaluation. Of those, 14 underwent a screening food challenge and were randomized to subsequent arms.
Participant milestones
| Measure |
Open Label Omalizumab Group A
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
|
Overall Study
COMPLETED
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omalizumab in the Treatment of Peanut Allergy
Baseline characteristics by cohort
| Measure |
Open Label Omalizumab Group A
n=5 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=9 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsPresence or absence of this change
Outcome measures
| Measure |
Open Label Omalizumab Group A
n=5 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=9 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8
|
5 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: change from baseline to up to 6 monthspercentage
Outcome measures
| Measure |
Open Label Omalizumab Group A
n=5 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=9 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Percent Change in Peanut Specific Immunoglobulin E (IgE) From Baseline to After Pn-BHR Response
|
1.9 percentage change Peanut specific IgE
Interval 0.5 to 3.3
|
32 percentage change Peanut specific IgE
Interval 3.3 to 41.0
|
PRIMARY outcome
Timeframe: up to 6 monthskU/L (range)
Outcome measures
| Measure |
Open Label Omalizumab Group A
n=5 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=9 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Peanut Specific Immunoglobulin E (IgE) After Pn-BHR Response
|
2.1 kU/L
Interval 1.1 to 13.0
|
30.5 kU/L
Interval 8.3 to 184.0
|
PRIMARY outcome
Timeframe: up to 6 monthskU/L (range)
Outcome measures
| Measure |
Open Label Omalizumab Group A
n=5 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=9 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Total Immunoglobulin E (IgE) After Pn-BHR Response
|
201 kU/L
Interval 110.0 to 523.0
|
129 kU/L
Interval 36.0 to 527.0
|
PRIMARY outcome
Timeframe: up to 8 weeksmg
Outcome measures
| Measure |
Open Label Omalizumab Group A
n=5 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=8 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Dose of Peanut Protein Inducing Allergic Symptoms at Oral Food Challenge (OFC) 1
|
80 mg
Interval 30.0 to 380.0
|
80 mg
Interval 10.0 to 700.0
|
PRIMARY outcome
Timeframe: up to 8 weeksmg
Outcome measures
| Measure |
Open Label Omalizumab Group A
n=4 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=9 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Dose of Peanut Protein Inducing Allergic Symptoms at OFC 2
|
6500 mg
Interval 3080.0 to 10000.0
|
6790 mg
Interval 180.0 to 100000.0
|
PRIMARY outcome
Timeframe: up to 8 weeksmg
Outcome measures
| Measure |
Open Label Omalizumab Group A
n=4 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=6 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Dose of Peanut Protein Inducing Allergic Symptoms at OFC 3
|
8540 mg
Interval 1830.0 to 10000.0
|
2455 mg
Interval 1830.0 to 10000.0
|
PRIMARY outcome
Timeframe: up to 6 monthsNumber of doses
Outcome measures
| Measure |
Open Label Omalizumab Group A
n=5 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=9 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Omalizumab Received Before OFC 2
|
1 number of doses
Interval 1.0 to 3.0
|
3 number of doses
Interval 2.0 to 5.0
|
PRIMARY outcome
Timeframe: up to 6 monthstotal mg
Outcome measures
| Measure |
Open Label Omalizumab Group A
n=5 Participants
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
Open Label Omalizumab Group B
n=9 Participants
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
|
|---|---|---|
|
Omalizumab Received Before OFC 2
|
300 mg
Interval 300.0 to 675.0
|
900 mg
Interval 300.0 to 1875.0
|
Adverse Events
Open Label Omalizumab Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Open Label Omalizumab Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Robert Wood, M.D.
Johns Hopkins University School of Medicine
Phone: [email protected]
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place