Trial Outcomes & Findings for Oral Immunotherapy for Peanut and Mammalian Meat Allergies (NCT NCT02350660)

Last Updated: 2020-11-03

Results Overview

consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37

Results posted on

2020-11-03

Participant Flow

Due to changes in funding structure, the study was unable to be completed with the designed number of participants and was therefore closed to enrollment

Participant milestones

Participant milestones
Measure	Cow's Milk for Alpha-gal Allergics daily consumption of cow's milk cow's milk: daily consumption of cow's milk	Peanut Powder peanut oral immunotherapy peanut powder: peanut oral immunotherapy
Overall Study STARTED	7	17
Overall Study COMPLETED	7	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Immunotherapy for Peanut and Mammalian Meat Allergies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cow's Milk for Alpha-gal Allergics n=7 Participants daily consumption of cow's milk cow's milk: daily consumption of cow's milk	Peanut Powder n=17 Participants peanut oral immunotherapy peanut powder: peanut oral immunotherapy	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 7 • n=5 Participants	8 years STANDARD_DEVIATION 3 • n=7 Participants	23 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	17 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37

consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly.

Outcome measures

Outcome measures
Measure	Cow's Milk for Alpha-gal Allergics n=7 Participants daily consumption of cow's milk cow's milk: daily consumption of cow's milk	Peanut Powder n=17 Participants peanut oral immunotherapy peanut powder: peanut oral immunotherapy
The Level of Allergen Consumed Post-oral Immunotherapy	6 milligrams Standard Deviation 1.3	300 milligrams Standard Deviation 57

Adverse Events

Cow's Milk for Alpha-gal Allergics

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Peanut Powder

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cow's Milk for Alpha-gal Allergics n=7 participants at risk daily consumption of cow's milk cow's milk: daily consumption of cow's milk	Peanut Powder n=17 participants at risk peanut oral immunotherapy peanut powder: peanut oral immunotherapy
Gastrointestinal disorders food intolerance	14.3% 1/7 • Number of events 1 • 3 years	17.6% 3/17 • Number of events 3 • 3 years

Additional Information

Department of Medicine and Pediatrics

University of Virginia

Phone: 434.924.0000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place