Trial Outcomes & Findings for A Study of Sublingual Immunotherapy in Peanut-allergic Children (NCT NCT00597727)
NCT ID: NCT00597727
Last Updated: 2018-03-27
Results Overview
Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
12 months
Results posted on
2018-03-27
Participant Flow
Participant milestones
| Measure |
Blinded Peanut SLIT
Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
|
Blinded Placebo SLIT
Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
|
Ext Maint Open Label Peanut SLIT
After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
|
Early Unblinded Peanut SLIT
Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
|
Pilot Peanut SLIT Rollover Cohort
Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
|
|---|---|---|---|---|---|
|
12 Month Blinded Phase
STARTED
|
14
|
15
|
0
|
27
|
4
|
|
12 Month Blinded Phase
COMPLETED
|
14
|
15
|
0
|
17
|
3
|
|
12 Month Blinded Phase
NOT COMPLETED
|
0
|
0
|
0
|
10
|
1
|
|
Open-label Extended Maintenance Phase
STARTED
|
0
|
0
|
29
|
17
|
3
|
|
Open-label Extended Maintenance Phase
COMPLETED
|
0
|
0
|
23
|
14
|
1
|
|
Open-label Extended Maintenance Phase
NOT COMPLETED
|
0
|
0
|
6
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Sublingual Immunotherapy in Peanut-allergic Children
Baseline characteristics by cohort
| Measure |
Blinded Peanut SLIT
n=14 Participants
Blinded subjects who received peanut sublingual drops) at the beginning of the study.
|
Blinded Placebo SLIT
n=15 Participants
Blinded subjects who receive placebo (glycerin sublingual drops) at the beginning of the study.
Placebo SLIT: Liquid glycerin without peanut which are dosed under the tongue.
|
Early Unblinded Peanut SLIT
n=27 Participants
Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
|
Pilot Peanut SLIT Rollover Cohort
n=4 Participants
Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
6.0 years
n=5 Participants
|
6.6 years
n=7 Participants
|
6.0 years
n=5 Participants
|
15.6 years
n=4 Participants
|
6.4 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
4 participants
n=4 Participants
|
60 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Interim analysis in 7/2010 showed statistically significant difference in peanut tolerated during oral food challenge (OFC) by active treatment vs placebo (1710mg vs 85mg). Further OFCs for those on placebo was considered more risk than benefit thus were discontinued resulting in subsequent patients being unblinded after 12 months without an OFC
Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.
Outcome measures
| Measure |
Blinded Peanut SLIT
n=11 Participants
Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
|
Blinded Placebo SLIT
n=7 Participants
Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
|
Early Unblinded Peanut SLIT
n=17 Participants
Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
|
Pilot Peanut SLIT Rollover Cohort
n=3 Participants
Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
|
|---|---|---|---|---|
|
Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing
|
45.5 percentage of participants
|
0 percentage of participants
|
11.8 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: 36-60 monthsPopulation: Although the 12 month OFC was discontinued beginning in 7/2010, all subjects reaching the end of study (36-60 months of treatment) underwent an OFC resulting in more patients performing the end of study OFC than the 12 month OFC.
Upon completion of 36-60 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. Peanut SLIT therapy was then discontinued for 2-4 weeks to assess for persistence of the desensitization response called sustained unresponsiveness (SU). The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5000 mg peanut protein DBPCFC without developing symptoms 2-4 weeks after discontinuing peanut SLIT therapy.
Outcome measures
| Measure |
Blinded Peanut SLIT
n=23 Participants
Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
|
Blinded Placebo SLIT
n=14 Participants
Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
|
Early Unblinded Peanut SLIT
n=1 Participants
Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
|
Pilot Peanut SLIT Rollover Cohort
Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
|
|---|---|---|---|---|
|
Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing
|
26.1 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
—
|
Adverse Events
Blinded Peanut SLIT
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Blinded Placebo SLIT
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Ext Maint Open Label Peanut SLIT
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Early Unblinded Peanut SLIT
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Pilot Peanut SLIT Rollover Cohort
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blinded Peanut SLIT
n=14 participants at risk
Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
|
Blinded Placebo SLIT
n=15 participants at risk
Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
|
Ext Maint Open Label Peanut SLIT
n=29 participants at risk
After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
|
Early Unblinded Peanut SLIT
n=27 participants at risk
Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
|
Pilot Peanut SLIT Rollover Cohort
n=4 participants at risk
Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
13.3%
2/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
10.3%
3/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
3.7%
1/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
6.7%
1/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
3.4%
1/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
7.4%
2/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Skin and subcutaneous tissue disorders
Erythematous rash
|
28.6%
4/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
26.7%
4/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
13.8%
4/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
18.5%
5/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
25.0%
1/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
7.1%
1/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
26.7%
4/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
3.4%
1/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
3.7%
1/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
1/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
10.3%
3/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Skin and subcutaneous tissue disorders
Oropharyngeal itching
|
57.1%
8/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
46.7%
7/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
58.6%
17/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
48.1%
13/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
25.0%
1/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Skin and subcutaneous tissue disorders
Sneezing
|
7.1%
1/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
20.0%
3/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
13.8%
4/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
7.4%
2/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
7.1%
1/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
24.1%
7/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
7.4%
2/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Skin and subcutaneous tissue disorders
Itchy nose
|
0.00%
0/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
20.0%
3/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
3.7%
1/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Skin and subcutaneous tissue disorders
Skin itch
|
21.4%
3/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
40.0%
6/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
27.6%
8/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
11.1%
3/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Skin and subcutaneous tissue disorders
Lip or eye swelling
|
21.4%
3/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
6.7%
1/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
24.1%
7/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
18.5%
5/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
25.0%
1/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Eye disorders
Eye itch
|
0.00%
0/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
6.7%
1/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
13.8%
4/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
3.7%
1/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Eye disorders
Eye tearing
|
7.1%
1/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
6.7%
1/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
3.4%
1/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
7.4%
2/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Skin and subcutaneous tissue disorders
Hives
|
35.7%
5/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
13.3%
2/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
17.2%
5/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
18.5%
5/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
4/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
40.0%
6/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
3.4%
1/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
70.4%
19/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/15 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
3.4%
1/29 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
7.4%
2/27 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
0.00%
0/4 • AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
|
Additional Information
Edwin Kim, Director UNC Food Allergy Initiative
University of North Carolina at Chapel Hill
Phone: 919-843-9087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place