Trial Outcomes & Findings for The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults (NCT NCT03361072)

NCT ID: NCT03361072

Last Updated: 2025-05-09

Results Overview

Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 1 year, through study completion
• Results posted on: 2025-05-09

Participant Flow

Participant milestones

Measure	Milk Allergy Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Peanut Allergy Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Egg Allergy Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy
Overall Study STARTED	12	14	4
Overall Study COMPLETED	8	5	2
Overall Study NOT COMPLETED	4	9	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults

Baseline characteristics by cohort

Measure	Milk Allergy n=12 Participants Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Peanut Allergy n=14 Participants Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Egg Allergy n=4 Participants Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	14 Participants n=7 Participants	4 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	34.8 years STANDARD_DEVIATION 12.5 • n=5 Participants	29.6 years STANDARD_DEVIATION 11.0 • n=7 Participants	25.3 years STANDARD_DEVIATION 20.5 • n=5 Participants	31.1 years STANDARD_DEVIATION 10.3 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	14 Participants n=7 Participants	4 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Finland	12 participants n=5 Participants	14 participants n=7 Participants	4 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 year, through study completion

Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants

Outcome measures

Measure	Milk Allergy n=12 Participants Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Peanut Allergy n=14 Participants Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Egg Allergy n=4 Participants Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy
Desensitisation	7 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year, through study completion

Quality of life and reported concerns and worries associated with food allergy using a VAS scale (visual analogue scale) from 0 (no worries) to 100 mm (maximal worries) before OIT and at one year after OIT

Outcome measures

Measure	Milk Allergy n=10 Participants Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Peanut Allergy n=7 Participants Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Egg Allergy n=4 Participants Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy
Worries Associated With Food Allergy Before OIT (VAS)	77.7 score on a scale Standard Deviation 19.2	69.7 score on a scale Standard Deviation 12.4	61.0 score on a scale Standard Deviation 13.0
Worries Associated With Food Allergy After OIT, at one year (VAS)	79.00 score on a scale Standard Deviation 5.6	39.5 score on a scale Standard Deviation 19.1	25.0 score on a scale Standard Deviation 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year, through study completion

Follow-up of safety of OIT, Number of participants with treatment-related adverse events

Outcome measures

Measure	Milk Allergy n=12 Participants Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Peanut Allergy n=14 Participants Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Egg Allergy n=4 Participants Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy
Number of Participants With Treatment-related Adverse Events	12 Participants	14 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year, through study completion

Population: S-IgE milk for milk allergy, S-IgE peanut for peanut allergy, S-IgE egg white for egg allergy

Allergen specific IgE values before OIT and after OIT (kU/l)

Outcome measures

Measure	Milk Allergy n=11 Participants Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Peanut Allergy n=14 Participants Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Egg Allergy n=4 Participants Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy
Decrease in Allergen Specific IgE Values IgE pre OIT	100.7 kU/l Standard Deviation 112.4	88.4 kU/l Standard Deviation 212.8	81.3 kU/l Standard Deviation 81.1
Decrease in Allergen Specific IgE Values IgE post OIT	4.1 kU/l Standard Deviation 5.4	26.4 kU/l Standard Deviation 27.2	27.6 kU/l Standard Deviation 3.3

Adverse Events

Milk Allergy

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Peanut Allergy

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Egg Allergy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Milk Allergy n=12 participants at risk Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Peanut Allergy n=14 participants at risk Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Egg Allergy n=4 participants at risk Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy
Skin and subcutaneous tissue disorders Allergic reaction	33.3% 4/12 • Number of events 4 • OIT after two years post start OIT after two years post start	14.3% 2/14 • Number of events 2 • OIT after two years post start OIT after two years post start	0.00% 0/4 • OIT after two years post start OIT after two years post start

Other adverse events

Measure	Milk Allergy n=12 participants at risk Milk oral immunotherapy intervention for milk allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Peanut Allergy n=14 participants at risk Peanut oral immunotherapy intervention for peanut allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy	Egg Allergy n=4 participants at risk Egg oral immunotherapy intervention for egg allergy Oral immunotherapy: Milk, peanut or egg oral immunotherapy
Skin and subcutaneous tissue disorders Local itching	66.7% 8/12 • Number of events 8 • OIT after two years post start OIT after two years post start	85.7% 12/14 • Number of events 12 • OIT after two years post start OIT after two years post start	100.0% 4/4 • Number of events 4 • OIT after two years post start OIT after two years post start

Additional Information

Dr Paula Kauppi

Helsinki University Hospital

Phone: +358504286802

Email: paula.kauppi@hus.fi

Results disclosure agreements

• Principal investigator is a sponsor employee Investigators will postpone single-site publications until after publication.
• Publication restrictions are in place

Restriction type: OTHER