Trial Outcomes & Findings for Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour) (NCT NCT02203799)

NCT ID: NCT02203799

Last Updated: 2024-01-19

Results Overview

Patients underwent a build-up phase (month 0-12). The patients returned every 2 weeks during the build-up phase until the maintenance dose of 3900 mg was achieved. The 12-month double blind placebo controlled food challenge (DBPFC) was performed on achieving the maintenance dose. The primary objective was to determine the percentage of subjects tolerating a cumulative dose of 26255 mg of peanut flour with absence of clinical symptoms during the 12-month DBPCFC.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Month 12 after first dose of peanut flour

Results posted on

2024-01-19

Participant Flow

Study recruitment began on 7/31/2014 and the last subject was recruited on 12/23/2016. Participants were recruited from the Food Allergy Program at Texas Children's Hospital and by referral from community physicians.

Participants were brought in for a screening visit to assess for eligibility in the study. 28 subjects were seen for screening visit and 13 subjects were ineligible due to failure to complete food challenge (1), FEV1\<90% predicted on spirometry (4), Peanut IgE \< 7 kU/L (1), and were not interested due to time commitment (5), unable to tolerate initial dose (2).

Participant milestones

Participant milestones
Measure	Peanut Oral Immunotherapy (POIT) Peanut Oral Immunotherapy (POIT): The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Peanut Oral Immunotherapy (POIT) Peanut Oral Immunotherapy (POIT): The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peanut Oral Immunotherapy (POIT) n=15 Participants Peanut Oral Immunotherapy (POIT): The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.
Age, Continuous	8.74 years STANDARD_DEVIATION 2.42 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Number of Participants that Completed the Protocol Withdrawal	3 Participants n=5 Participants
Number of Participants that Completed the Protocol Completed	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12 after first dose of peanut flour

Population: Three (3) subjects withdrew from the trial prior to maintenance phase. Only 12 subjects were analyzed for this objective.

Outcome measures

Outcome measures
Measure	Percentage of Subjects Who Tolerated 6000mg n=12 Participants The percentage of subjects who tolerated 6000mg at the double-blind placebo control food challenge after completing the build-up phase (50 weeks). The participant was challenged to the following doses: 75, 150, 500, 1000, 2000, 3000, 4000, 4500, 5000, and 6000 mg of peanut protein. The doses were given every 15 minutes in the form of peanut flour.
Determine the Percentage of Patients Tolerating the 12-month DBPCFC Tolerated	2 Participants
Determine the Percentage of Patients Tolerating the 12-month DBPCFC Did not tolerate	10 Participants

SECONDARY outcome

Timeframe: Month 36 and 37 after first dose of peanut flour

Population: Nine (9) patients did not complete the food challenge after one month of abstaining from peanut. Six (6) patients were analyzed.

To compare the change in dose tolerated after one month of abstaining from peanut to determine sustained unresponsiveness. The subjects underwent a DBPCFC at month 36 and month 37. The mean of the highest dose tolerated by the subjects was assessed at these two timepoints.

Outcome measures

Outcome measures
Measure	Percentage of Subjects Who Tolerated 6000mg n=6 Participants The percentage of subjects who tolerated 6000mg at the double-blind placebo control food challenge after completing the build-up phase (50 weeks). The participant was challenged to the following doses: 75, 150, 500, 1000, 2000, 3000, 4000, 4500, 5000, and 6000 mg of peanut protein. The doses were given every 15 minutes in the form of peanut flour.
Sustained Unresponsiveness After 1 Month of Treatment Discontinuation 36 month challenge	2736.67 mg Standard Error 854.70
Sustained Unresponsiveness After 1 Month of Treatment Discontinuation 37 month challenge	1010.88 mg Standard Error 835.33

Adverse Events

Frequency of Symptom Occurrence During Dosing

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Frequency of Symptom Occurrence During Dosing n=15 participants at risk Frequency of Symptom Occurrence During Dosing which was as follows: 1.8, 3.6, 7.2, 14.4, 28.8, 40, 60, 80, 100, 120, 240, 300, 450, 600, 750, 900, 1050, 1200, 1350, 1500, 1800, 2100, 2400, 3000, 3600, and 3900 mg of peanut protein daily with every 2 week up-dosing. Participants maintained daily dosing of 3900 mg of peanut protein for 24 months.
Skin and subcutaneous tissue disorders Rash	86.7% 13/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.
Skin and subcutaneous tissue disorders Skin Itchiness	86.7% 13/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.
Skin and subcutaneous tissue disorders Hives	80.0% 12/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.
Respiratory, thoracic and mediastinal disorders Sneezing/Itching	53.3% 8/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.
Respiratory, thoracic and mediastinal disorders Stuffy Nose	46.7% 7/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	53.3% 8/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.
Respiratory, thoracic and mediastinal disorders Throat Symptoms	66.7% 10/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.
Respiratory, thoracic and mediastinal disorders Wheezing	26.7% 4/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.
Gastrointestinal disorders Gastrointestinal, Subjective Complaints	60.0% 9/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.
Gastrointestinal disorders Gastrointestinal, Objective Complaints	40.0% 6/15 • Adverse event data were collected throughout the build up phase (ranged from 50-71 weeks for the eligible participants) and 2 years of the maintenance phase.

Additional Information

Carla M. Davis, MD

Baylor College of Medicine

Phone: 832-824-1319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place