Trial Outcomes & Findings for Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study (NCT NCT00932828)

Last Updated: 2018-05-24

Results Overview

The goal of the study is to treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes SU. We expect to demonstrate the effectiveness of peanut OIT in inducing SU by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT followed by avoidance of therapy for 4 weeks.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

After 36 months of OIT dosing followed by 1 month of avoidance

Results posted on

2018-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Peanut Oral Immunotherapy All subjects are treated with peanut oral immunotherapy for primary outcome. Patients randomized to 300mg or 3000mg for secondary dose finding outcome.
Overall Study STARTED	37
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peanut Oral Immunotherapy n=37 Participants All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed ITT.
Age, Categorical <=18 years	37 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.5 months n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	3 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants
Peanut immunoglobin E (IgE)	14.4 kUA/L n=5 Participants
Peanut skin prick test (SPT)	11.5 mm wheal size n=5 Participants

PRIMARY outcome

Timeframe: After 36 months of OIT dosing followed by 1 month of avoidance

Population: 37 subjects considered with ITT analysis including 5 withdrawals

Outcome measures

Outcome measures
Measure	Peanut Oral Immunotherapy n=37 Participants All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).	29 Participants

SECONDARY outcome

Timeframe: After 36 months of OIT dosing

Population: 37 subjects considered with ITT analysis including 5 withdrawals

We expect to demonstrate the effectiveness of peanut OIT in inducing desensitization by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT .

Outcome measures

Outcome measures
Measure	Peanut Oral Immunotherapy n=37 Participants All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).	30 Participants

SECONDARY outcome

Timeframe: After 36 months of OIT dosing followed by 1 month of avoidance

Population: 37 subjects considered with ITT analysis including 5 withdrawals

In addition to studying the effectiveness of peanut OIT, we will also determine the safety of peanut OIT by reporting the average rate of TAEs per person per dose.

Outcome measures

Outcome measures
Measure	Peanut Oral Immunotherapy n=37 Participants All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT.	0.8 AEs per person per dose Interval 0.3 to 1.4

Adverse Events

Peanut Oral Immunotherapy

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Peanut Oral Immunotherapy n=37 participants at risk All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
Gastrointestinal disorders Abdominal pain	59.5% 22/37 • TAEs reported over the course of 36 months of peanut OIT treatment for each subject
Skin and subcutaneous tissue disorders Skin/oral pruritus	51.4% 19/37 • TAEs reported over the course of 36 months of peanut OIT treatment for each subject
Gastrointestinal disorders Nausea/vomiting	62.2% 23/37 • TAEs reported over the course of 36 months of peanut OIT treatment for each subject
Respiratory, thoracic and mediastinal disorders Sneezing/congestion	35.1% 13/37 • TAEs reported over the course of 36 months of peanut OIT treatment for each subject
Skin and subcutaneous tissue disorders Hives	54.1% 20/37 • TAEs reported over the course of 36 months of peanut OIT treatment for each subject
Skin and subcutaneous tissue disorders Rash (not hives)	78.4% 29/37 • TAEs reported over the course of 36 months of peanut OIT treatment for each subject
General disorders Multiple symptoms	29.7% 11/37 • TAEs reported over the course of 36 months of peanut OIT treatment for each subject

Additional Information

Dr. Edwin Kim, Director of the 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