Trial Outcomes & Findings for Mechanisms of Desensitization During Peanut Oral Immunotherapy (NCT NCT01814241)
NCT ID: NCT01814241
Last Updated: 2018-03-01
Results Overview
The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.
COMPLETED
PHASE2
20 participants
40 weeks
2018-03-01
Participant Flow
Participant milestones
| Measure |
Open Label Peanut OIT
Open label orally ingested peanut flour with maintenance dose of 1450mg
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms of Desensitization During Peanut Oral Immunotherapy
Baseline characteristics by cohort
| Measure |
Open Label Peanut OIT
n=20 Participants
Open label orally ingested peanut flour with maintenance dose of 1450mg
|
|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
8.8 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 40 weeksThe percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.
Outcome measures
| Measure |
Open Label Peanut OIT
n=16 Participants
Open label orally ingested peanut flour with maintenance dose of 1450mg
|
|---|---|
|
Percentage of Subjects Who Develop Desensitization
|
81.25 percentage of participants
|
SECONDARY outcome
Timeframe: 4 weeksThe percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals.
Outcome measures
| Measure |
Open Label Peanut OIT
n=14 Participants
Open label orally ingested peanut flour with maintenance dose of 1450mg
|
|---|---|
|
Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped
|
21.43 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 44 weeksAllergic reactivity of mast cells is assessed by skin prick testing through measurement of the wheal diameter after exposure to peanut. This outcome measure reports the change in skin prick test wheal diameter from baseline through the end of the treatment period.
Outcome measures
| Measure |
Open Label Peanut OIT
n=16 Participants
Open label orally ingested peanut flour with maintenance dose of 1450mg
|
|---|---|
|
Change From Baseline in the Wheal Diameter, as Assessed by the Skin Prick Test (SPT) to Peanut
|
-8.8 mm
Interval -24.5 to 5.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 44 weeksPopulation: Blood work was not able to be obtained from 1 of 16 evaluable subjects
The investigation of mechanistic changes that occur in the immune system over the duration of the study - Peanut specific immunoglobin E (IgE)
Outcome measures
| Measure |
Open Label Peanut OIT
n=15 Participants
Open label orally ingested peanut flour with maintenance dose of 1450mg
|
|---|---|
|
Change in Peanut Specific Immunoglobin E (IgE) From Baseline Until Desensitization Food Challenge
|
-19 kU/L of peanut-specific IgE
Interval -466.0 to 544.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 44 weeksPopulation: Blood work was not able to be obtained from 1 of 16 evaluable subjects
The investigation of mechanistic changes that occur in the immune system dover the duration of the study - Immunoglobin G4 (IgG4) to peanut
Outcome measures
| Measure |
Open Label Peanut OIT
n=15 Participants
Open label orally ingested peanut flour with maintenance dose of 1450mg
|
|---|---|
|
Change in Immunoglobin G4 (IgG4) to Peanut From Baseline Until Desensitization Food Challenge
|
3.68 mg/dL of IgG4
Interval 0.47 to 92.88
|
Adverse Events
Open Label Peanut OIT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label Peanut OIT
n=20 participants at risk
Open label orally ingested peanut flour with maintenance dose of 1450mg
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • 31 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • 31 months
|
|
Skin and subcutaneous tissue disorders
Erythematous rash
|
20.0%
4/20 • 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
25.0%
5/20 • 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
20.0%
4/20 • 31 months
|
|
Skin and subcutaneous tissue disorders
Oropharyngeal itching
|
35.0%
7/20 • 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.0%
1/20 • 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • 31 months
|
|
Skin and subcutaneous tissue disorders
Itchy nose
|
5.0%
1/20 • 31 months
|
|
Skin and subcutaneous tissue disorders
Skin itch
|
10.0%
2/20 • 31 months
|
|
Skin and subcutaneous tissue disorders
Lip or eye swelling
|
20.0%
4/20 • 31 months
|
|
Eye disorders
Eye itch
|
5.0%
1/20 • 31 months
|
|
Eye disorders
Eye tearing
|
0.00%
0/20 • 31 months
|
|
Skin and subcutaneous tissue disorders
Hives
|
20.0%
4/20 • 31 months
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
8/20 • 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • 31 months
|
|
Gastrointestinal disorders
Throat tightness
|
5.0%
1/20 • 31 months
|
Additional Information
Dr. Edwin Kim, Director of the UNC Food Allergy Initiative
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place