Trial Outcomes & Findings for Oral Immunotherapy (OIT) for Peanut Allergy (NCT NCT00815035)

Last Updated: 2018-03-01

Results Overview

Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy

Results posted on

2018-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Blinded Phase-Peanut OIT Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.	Blinded Phase-Placebo Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion	Open Label Phase-Peanut OIT Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.
Blinded Phase STARTED	10	6	0
Blinded Phase COMPLETED	9	6	0
Blinded Phase NOT COMPLETED	1	0	0
Open Label Extension Phase STARTED	0	0	15
Open Label Extension Phase COMPLETED	0	0	9
Open Label Extension Phase NOT COMPLETED	0	0	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Immunotherapy (OIT) for Peanut Allergy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blinded Phase-Peanut OIT n=10 Participants Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.	Blinded Phase-Placebo n=6 Participants Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	5.1 years n=5 Participants	4.8 years n=7 Participants	5.0 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy

Population: Subjects completing 60 months of OIT treatment, then passing the DBPCFC on the last day of treatment, then completing the DBPCFC after 1 month off of treatment were analyzed.

Outcome measures

Outcome measures
Measure	Open Label Phase-Peanut OIT n=9 Participants Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.	Blinded Phase-Placebo Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion	Open Label Phase-Peanut OIT Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.
Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy.	89 percentage of participants	—	—

SECONDARY outcome

Timeframe: 60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy

Population: Subjects completing 60 months of OIT treatment and completing the DBPCFC on the last day of treatment were analyzed.

Upon completion of 60 months of peanut OIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCPFC) to assess desensitization. The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms after completing peanut OIT therapy.

Outcome measures

Outcome measures
Measure	Open Label Phase-Peanut OIT n=9 Participants Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.	Blinded Phase-Placebo Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion	Open Label Phase-Peanut OIT Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.
The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy.	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: first day of peanut OIT dosing

Population: Open label phase includes subjects initially randomized to placebo and then subsequently crossed over to open label treatment. Subjects initially randomized to Peanut OIT maintained their dose and did not repeat this 6 mg initial-day escalation.

The first day of peanut OIT dosing involved multiple increasing doses of peanut flour in what was called an initial escalation day up to a maximum dose of 6 mg of peanut protein. The secondary outcome measure assessed the percentage of subjects were successfully able to reach this 6 mg dose.

Outcome measures

Outcome measures
Measure	Open Label Phase-Peanut OIT n=10 Participants Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.	Blinded Phase-Placebo n=6 Participants Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion	Open Label Phase-Peanut OIT n=6 Participants Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.
The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut	90 percentage of participants	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: approximately 40 weeks (10 months)

During the desensitization phase of the study, subjects under go an initial day escalation up to a maximum of 6 mg of peanut protein. They then undergo biweekly dose escalation over approximately 10 months up to a maximum dose of 4000 mg of peanut protein. This outcome reports the percentage of subjects that achieve this.

Outcome measures

Outcome measures
Measure	Open Label Phase-Peanut OIT n=10 Participants Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.	Blinded Phase-Placebo n=6 Participants Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion	Open Label Phase-Peanut OIT n=6 Participants Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.
The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study	90 percentage of patients	100 percentage of patients	66.7 percentage of patients

SECONDARY outcome

Timeframe: 61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study.

Population: The initial 10-11 months of the study were blinded. After unblinding, subjects completing the blinded phase continued on open label peanut OIT for the duration of the study.

All serious adverse events during the blinded and open-label phases of the study were recorded and reported as a safety outcome.

Outcome measures

Outcome measures
Measure	Open Label Phase-Peanut OIT n=10 Participants Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.	Blinded Phase-Placebo n=6 Participants Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion	Open Label Phase-Peanut OIT n=15 Participants Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.
Incidence of All Serious Adverse Events During the Study	0 number of discrete SAE events	0 number of discrete SAE events	0 number of discrete SAE events

Adverse Events

Blinded Phase-Peanut OIT

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Blinded Phase-Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Open Label Phase-Peanut OIT

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Measure	Blinded Phase-Peanut OIT n=10 participants at risk Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.	Blinded Phase-Placebo n=6 participants at risk Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour. Placebo: Oat flour used as a placebo that is orally ingested a graded fashion	Open Label Phase-Peanut OIT n=15 participants at risk Subjects receiving open-label peanut OIT treatment after unblinding through the end of study. Peanut OIT: Peanut flour that is orally ingested in a graded fashion.
Gastrointestinal disorders Vomiting	90.0% 9/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 2/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 5/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Gastrointestinal disorders Diarrhea	20.0% 2/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 2/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	20.0% 3/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Skin and subcutaneous tissue disorders Erythematous rash	60.0% 6/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	16.7% 1/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 5/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	30.0% 3/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	16.7% 1/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	26.7% 4/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Respiratory, thoracic and mediastinal disorders Wheezing	20.0% 2/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	0.00% 0/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	20.0% 3/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Skin and subcutaneous tissue disorders Oropharyngeal itching	90.0% 9/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 2/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	46.7% 7/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Respiratory, thoracic and mediastinal disorders Sneezing	40.0% 4/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 2/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	26.7% 4/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Respiratory, thoracic and mediastinal disorders Coughing	60.0% 6/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	50.0% 3/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	40.0% 6/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Skin and subcutaneous tissue disorders Itchy nose	30.0% 3/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	0.00% 0/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	13.3% 2/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Skin and subcutaneous tissue disorders Skin itch	50.0% 5/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 2/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	40.0% 6/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Skin and subcutaneous tissue disorders Lip or eye swelling	20.0% 2/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	16.7% 1/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 5/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Eye disorders Eye itch	10.0% 1/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	0.00% 0/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	20.0% 3/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Eye disorders Eye tearing	10.0% 1/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	0.00% 0/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	6.7% 1/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Skin and subcutaneous tissue disorders Hives	30.0% 3/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 2/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	40.0% 6/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Gastrointestinal disorders Abdominal pain	90.0% 9/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	33.3% 2/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	73.3% 11/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	16.7% 1/6 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.	13.3% 2/15 • Adverse events were collected over the initial 44+ weeks of blinded therapy and then over the 60 month duration of the open-label phase of the study.